Constructing the Intrauterine Device, 1908-1988
University of Wollongong Thesis Collections University of Wollongong Thesis Collection
University of Wollongong Year
Devices and desires: constructing the intrauterine device, 1908-1988
Ann Dugdale University of Wollongong
Dugdale, Ann, Devices and desires: constructing the intrauterine device, 1908-1988, Doctor of Philosophy thesis, Department of Science and Technology Studies, University of Wollongong, 1995. http://ro.uow.edu.au/theses/1710
This paper is posted at Research Online.
Devices and Desires: Constructing tlie Intrauterine Device, 1908-1988
A thesis submitted In fulfilment of the requirements for the award of the degree
PhD
from
University of Wollongong
by
Ann Dugdale BSc, DipEd, l\/IA
Department of Science and Technology Studies
1995 Except where otherwise acknowledged, the work presented in this dissertation is original.
Ann Dugdale 15 November 1995 ACKNOWLEDGEMENTS
In 1988 when I began this research, Australian feminist agendas were increasingly being expressed through a discourse of women's health, and consumer organisations were vigorously expanding their traditional interests into the health consumer arena. Australians enjoy both a publicly funded Medicare scheme and a publicly funded Pharmaceutical Benefits Scheme, and the Federal Labor Government at that time was actively fostering health consumer voices in public debates in the health arena. I soon found myself appointed as a consumer representative to an expert panel, formed by what is now the Therapeutic Goods Administration (a part of the Health Department of the Australian Federal Government), to advise the government on what action should be taken over intrauterine devices. The committee had been hurriedly formed, following the ovenwhelming response to the Chief Medical Officer's invitation to consumers to inform the Health Department of any problems they had experienced with intrauterine devices, an invitation issued on national television as part of a report on the withdrawal of the Copper-7 intrauterine device, still available at that time in Australia, from the United States market. This thesis had its genesis in my attempts to represent consumers in that environment, and the many stimulating conversations that I had with workers from women's health centres, with activists from the Consumer Health Forum and related organisations, and with lawyers who at some time had been involved with the Public Interest Advocacy Centre. There are some people whose practical support and intellectual generosity have been integral to the writing of this thesis. Dr Evelleen Richards and Dr Brian Martin from STS, University of Wollongong have been exemplary supervisors, both in their own unique ways. During the year I spent in the School of Hygiene and Public Health at Johns Hopkins University, Dr Elizabeth Fee provided invaluable guidance and assistance. Rosemary Robins and Helen Verran have contributed much by being great colleagues at the University of Melbourne's History and Philosophy of Science Department where I have been a lecturer for the past 4 years. There are many others whose ideas and encouragement have contributed to this work: Thank you Rebecca Albury, Dorothy Broome, Adele Clarke, Vivienne Colles, Jeanne Daly, Joan Fujimura, Marilys Guilleman, Jenny Harding, John Law, Harry Marks, Ed Mormon, Margie Ripper, Stewart Russell, Jennifer Tucker, Judy Wajcman, and Kevin White. I am also much indebted to the postgraduate students with whom I have worked and talked over the years, to the many undergraduate students who have influenced me in surprising ways, and to the workshop and conference participants who listened and engaged seriously with various chapters presented over the long time that I have taken to complete this work. In particular the participants in the Sex/Gender in Techno-Science Worlds Coherence held in Melbourne in 1993 inspired me to continue with the assurance that there was an audience for my work. Practical assistance from many people has also been invaluable. Sue Martin and Marilys Guilleman read drafts and considerably improved my syntax. Libby Robin gave me a great deal of help with locating references. Tom Rosenbaum from the Rockefeller Archive Centre provided invaluable guidance, and I could not have asked for better support than I received from the archivists of The Alan Mason Chesney Archives at the The Johns Hopkins Medical Institutions, and at the Countway Library of Medicine at the Harvard Medical School. The librarians at the Ballieu Library, University of Melbourne have also provided considerable and always timely assistance. Sandra Waldman, the information officer with the Population Council helped me arrange several interviews including with Irv Sivin, Howard Nash and Parker Mauldin. In America I also spoke with Hans Lehfeldt, Judy Norsigian, Jerry Keuster, and in Australia Roger Edwards, Edith Weisberg, Stefania Siedlecky, Angela Nanson, Peter Cashman, and Yong Sook Kwok - all gave generously of their time. Thanks also to the workers at the Boston Women's Health Book Collective, Public Citizen's Health Research Group, and the National Women's Health Network. Whilst this thesis is based primarily on documentary rather than interview material, the background information gained during these discussions was invaluable. This research would not have been possible without the financial support I received from the University of Wollongong and from the American Association of University Women. As an international scholar with the latter for 9 months I not only had the opportunity to attend Johns Hopkins University and to consult valuable collections in the United States, but I also met many inspiring women scholars from around the world and felt honoured to be associated with the organisation. Finally, thanks to my family, my house mates, my friends, and Suzanne, for your faith in me, your encouragement of my work, and for keeping my life interesting. SUMMARY
By 1908 a new, doctor inserted, scientific contraceptive had gained some acceptance in areas of Germany. This technology t>ecame known as the intrauterine contraceptive device. By 1930 it enjoyed limited international success through its alliance with the International Sex Reform movement. The devices became linked with campaigns to take the suffrage struggle into the private sphere, a technological means for achieving modernity for women. In the 1960s the Population Council remade this contraceptive system as a mass produced global network of population control. Then in the 1970s the Dalkon Shield became synonymous with corporate misconduct. The women's health movement accused intrauterine device protagonists of exploiting women's inequality to produce a dangerous technology that was destroying women's health. Whilst copper intrauterine devices escaped the tarnish of the Dalkon Shield, the litigation over the Copper-7 that resulted in a punitive damages finding against Searle in 1988, resulted in a serious decline in further research into intrauterine devices. This thesis explores the production processes through which the discovery, success, development and failure of intrauterine devices were constructed. My work is a case study located at the intersection of feminist critiques of science and technology, and constructivist sociology of science. I investigate gendered outcomes of the heterogeneous negotiations that stabilise intrauterine device technologies, paying attention to the effects generated by the active participation of social movements in such negotiations. This study is informed by a modified actor network framework (Latour and Gallon), presenting the social, identity, the technical, the natural and the boundary between them as network effects. I focus on the translations of human and non-human actants constitutive of intrauterine device contraceptives as socio-technical networks, whether they occur in courts or in laboratories. I examine how authority is distributed to particular research sites, and how we learn to trust in numbers as calculations of risks and benefits. I suggest that such a form of story-telling about technologies opens novel possibilities for solidarity formation and collective engagement with socio- technical networks, including issues of regulation and policy formation. Contents HIstoricizing technology: notes towards a feminist history of 1 the intrauterine contraceptive device Writing histories of contraceptive technologies 11 The struggle to historicize knowledge, practices and technologies 17 in the biomedical sciences Early interventions: medical technologies as social 19 processes Recovering context: science and ideology 24 The social construction of scientific knowledge 30 Breaking down the text/context boundary: actor-network 35 theory Combining social constructivism and actor-network theory 41 The argument and structure of the thesis 49
From local tinkering to global network: silk coils, family 52 limitation and sex reform The contraceptive context 56 The immediate stimulus for experimentation - Local tinkering in 64 Germany, 1900-1930 Germany and the politicisation of health 64 Local tinkering - a proliferation of contraceptives and the 69 emergence of the fully internal intrauterine device Grafenberg establishes the intrauterine device as a contraceptive 72 paradigm Translating the intrauterine device into the sex reform movement: 77 the woman question Inventing a Technology 84 Tietze, the Population Council, and the United Nations: The 91 1960s reconstruction of a stronger lUD socio-technical network A foothold: The Grafenberg ring in the United states, 1930 -1948 96 From enemies to allies: Pro-contraception doctors and the 98 United States birth controllers The first United States intrauterine device trials 102 Constructing population control as a research problem 109 The Population Council 117 flaking the intrauterine device the ideal solution to over- 123 population in the developing world Tietze's Second Intrauterine Device Trials 128 Beyond the clinical trials: Expanding the intrauterine device 139 socio-technical network The medical profession and the problem of abortion 140 Funding the globalisation of the intrauterine device socio- 142 technical network: Mobilising funds from the United States and United Nations for the delivery of contraceptives Constructing a socio-technical network 151 The Intrauterine device contraceptive network comes under 159 attack: the Dalkon Shield, septic abortion, and pelvic inflammatory disease Negotiating the Dalkon Shield success 165 Septic abortion reports and struggles over their interpretation 171 Constructing intrauterine device mortality and morbidity 171 statistics Robins responds on behalf of the Dalkon Shield 172 Decision making in the Food and Drug Administration 175 The Dalkon Shield and the Courts 184 Robins successfully defends the Dalkon Shield 184 The litigation context reframes Robins's response to septic 187 abortion adverse reaction reports Reconstructing the Dalkon Shield as a defective device 188 The Dalkon-Shield-as-a-defective-device construction 195 gathers strength How scientific studies reconstructed the Dalkon Shield 200 socio-technical network Reconstituting the intrauterine device network in response to the 202 Dalkon Shield controversy Constructing Failure 204
On medicated lUDs, technical Imperatives, and the 206 mobilisation of stronger social forces A contingent affair: Making the copper intrauterine device 208 'trajectory' A potential enemy is converted into an unexpected ally : The 217 Food and Drug Administration and making the copper intrauterine devices government approved drugs The Food and Drug Administration/copper intrauterine device 227 socio-technical collectivity in court The clinical trials of the Cu-7 on trial 230 Searle's response to the increasing strength of the Food 234 and Drug Administration/pelvic inflammatory disease/intrauterine device alliance A defective product? 236 The aftermath of the Copper-7 trial 241 Constructing and dismantling a technological trajectory 247
Taking stock: How helpful is actor-network constructivism 251 for opening up possibilities for feminist Interventions in/with technologies? Sex, gender and technology 253 Making actor-network constructivism feminist friendly 261 Reconnecting women, health and technology: What can we learn 269 from a constructivist history of the intrauterine contraceptive device? Invention 273 Success 276 Failure 280 Development 283 Implications for drug and device regulatory policies 285 Conclusion 293 CHAPTER 1
Historicizing technology: notes towards a feminist history of the intrauterine contraceptive device
This is a study of how intrauterine devices came to be used globally as a contraceptive technology. When I began my research hundreds of thousands of women were on the verge of receiving compensation for injuries caused by use of the Dalkon Shield intrauterine device. Many had been involved in litigation for two decades."" Just as the Dalkon Shield users were being compensated for Robins' negligence in manufacturing and distributing a hazardous device, a new group of women were also beginning to succeed in litigation against the manufacturer of the copper-7, another widely used intrauterine device. I was interested in how this technological system - the insertion of devices for contraception into the wombs of women by health professionals - came to be, and how it came to be accepted as effective and safe.
The revival of the women's liberation movement in the late 1960s has been closely associated with the problematisation of the relationship between women and medical technologies. Women's movement activists came into conflict with the claims of scientific medicine particularly in the areas of psychiatry, childbirth, contraception, abortion, and more recently the new reproductive technologies.^ For many feminists medical technologies came to be seen as tools for the enforcement of women's subjection to male
"• For accounts of these struggles see Mintz, At Any Cost. 1985; Perry and Dawson, Nightmare. 1985: Bacigal. The Limits of Litigation.1990: Sobol. Bending the Law.1991 Grant, The Selling of Contraception. 1992; and Hicks, Sun/lving the Dalkon Shield lUD. 1994 2 See Chesler, Women and Madness.1972: Smith-Rosenberg, The Hysterical Woman', 1972; Ehrenreich and English, Witches. Midwives and Nurses 1971, and Complaints and Disorders. 1974; Scully and Bart, "A funny thing happened on my way to the orifice", 1972; Scully, Men Who Control Women's Health. 1980; Arditti, Klein and Minden, Test-Tube Women. 1984; Spallone and Steinberg. Made to Order. 1987. domination. Medical technologies enhanced the power of the predominantly male medical profession, and also disempowered women.3 Contraceptive technologies have been depicted as exemplary of this analysis. Dangerous technologies, including the oral contraceptives and the intrauterine devices, made women constantly available for the satisfaction of male sexual pleasures, whilst women were subjected to health risks that have cost many their lives. The predominantly male medical profession benefited from these technologies because they were convenient to prescribe, required no explanation and avoided embarrassing discussions about sexual practice. Women became further alienated from their own bodies, missing the opportunity to know and feel comfortable with their sexuality so that they could regulate their fertility through a combination of awareness of ovulation, the use of the safer barrier methods, and engaging in sexual practices that did not involve vaginal penetration and ejaculation. Since the late 1980s there has been a shift in feminist studies of technology. Accounts depicting women as the victims of a male controlled technological expansionism have been criticised for their consistent undervaluation of women's agency. Instead of focusing on the effects of new technologies on women's lives, feminist analysts have become increasingly interested in the processes shaping the technologies. Rather than taking patriarchal power relations as a given social structure that was reflected in new technologies, more recent feminist scholarship has focused on how both gendered social relations and new technologies have been co-produced in particular situations.'*
^ For a useful recent review of feminist research on technology with a chapter on reproductive technology see Wajcman, Feminism Confronts Technology. 1991. ^ This analysis concurs with Wajcman, Feminism Confronts Technology. 1991, For examples see Cockburn and Ormrod, Gender and Technology in the Making. 1993; Probert and Wilson, Pink Collar Blues. 1993; and McNeil, Varcoe and Yearley, The New Reproductive Technologies. 1990. My thesis is part of this shift in the feminist engagement with technology. The damaging effects of intrauterine devices on women's lives have been well documented, and this process has contributed to that first project of ending women's silence on the effects of technologies on their lives.5 Considerably less attention has been paid to the development of the intrauterine device contraceptive technology, and to the contradictory experience of women using this contraceptive system.^ I was interested in exploring how gender intersected with the processes of design, development and use of a new technology. My choice of medical device, the simple, no-moving-parts, easy-to- insert intrauterine device, used in the marginal medical arena of contraception for the now non-controversial aim of fertility regulation, may appear odd. But this choice presented me with the opportunity to study a medically developed and controlled technology that intersected with highly organised social and political arenas in which women's role as agents was appreciable. Women have been at the forefront of social movements demanding reproductive rights: birth control, an end to forced sterilisation, access to safe legal abortion, fully informed consent to the use of potentially hazardous drugs, treatments and devices, and an end to dangerous experimental testing of new technologies on women's bodies. Women of most societies have also tried to control their fertility, frequently risking their lives to do so; preventing the birth of unwanted children has been in women's hands. Moreover, studying a reproductive technology in a society that defines women's essential being as reproductive, provides access to a range of sites at which the gendering of biomedical technology is produced. I also decided to focus on the intrauterine device because this technology had been in use since the early years of the twentieth century, whilst also being embroiled in recent controversy. The
^ In particular see Perry and Jim, Nightmare.1985: and Hicks, Surviving the Dalkon Shield lUD. 1994. ^ An exception to this is Grant, The Selling of Contraception. 1992. historical dimension of my research enabled the comparative study of a device. I was able to compare the differences in developmental trajectories between devices situated in different social contexts. By focusing on a controversial technology I hoped that the processes of design, development and use would be rendered more visible. Intrauterine devices have been at the centre of controversies between gynaecologists and sex reformers in the 1920s, eugenists and race purity movements in the 1930s, governments of de-colonised states and United States corporate philanthropies in the 1960s and 70s, doctors and the church from the 1960s to the present, women's health activists and pharmaceutical companies in the 1970s and 80s, and between consumer rights organisations and government therapeutic device regulatory authorities in the 1970s and 80s. Moreover, the intrauterine device has often been imagined as a political tool. At various times it has been a route to women's emancipation, a means of reducing the numbers of the poor dependent on the public purse for support, a technique for stabilising political unrest in so-called developing countries, a method for freeing women for the spontaneous expression of sexual desires, or a mechanism that women exposed to the 'uncivilised' and 'brute' demands of an oppressive existence can deploy to save their bodies. It is precisely because of its controversial history that I believe a history of the intrauterine device can tell us much about the intersection between what are usually imagined as two worlds : on the one hand, the social world of politics, power relations, economic forces and cultural subjectivity; on the other, the supposed objective world of scientific research, of scientific testing unmarked by cultural differences, a world where biases, interests and power plays do not, it is said, penetrate. The public dissent characteristic of controversies can be utilised to recover the sense of the mutability of design, knowledge claims and testing in science.-^ I hope that by studying a controversy it will be possible to grasp the socio-political and cultural factors that are systematically erased from science. Once a controversy is settled it seems that the winning 'facts' are rapidly redescribed as originating not in this very human activity but in nature itself.^ The study of technological and scientific controversies can be valuable in unpacking the historical contingency of technologies. By studying what has been such a controversial technology over a long period of time I hope to provide a glimpse of the complexities of the mobile networks of shifting power relations within which the sexes, sexuality, medicine, neo-colonialism, corporate capitalism, the state, and science intersect. It is within such shifting networks of power that claims about intrauterine devices are mutually and interactively constituted. The methodology for this thesis combines elements from both history and sociology. I have drawn widely on a variety of sources of documentation including scientific papers, training information, proceedings of congresses and conferences, archival sources such as letters, activity statements and grant applications, parliamentary inquiries, annual reports, newspaper reports, court transcripts, biographies of individuals and organisations, and semi- structured interviews with scientists, doctors, lawyers, and activists (some of which I conducted, others of which were conducted by others). I have also had available to me many previously written historical and sociological accounts such as Weindling's detailed work on German eugenics, Gordon and Reed's on the American birth control movement, Piotrow's on the United States congressional, presidential and administrative responses to the perceived population explosion, Symonds and Carder's history of population
^ See Richards, Vitamin C and Cancer, 1991; Martin, Scientific Knowledge in Controversy. 1991; Collins, "Knowledge and Controversy", 1981; also "An Empirical Relativist Programme in the Sociology of Scientific Knowledge", 1983; and Pinch, Confronting Nature. 1986. S 1 atour. Science in Action .1987. policy in the United Nations, and Mintz's account of the Dalkon Shield story.^ Without such work it would have been impossible to undertake the study of a technological device over such a prolonged period (1908 -1988) that seeks to recover the social and historical situatedness and labour processes in which the design, development, testing and use of a technology occur. I have also relied on a variety of theoretical perspectives. From the historians I have learned to read against the grain of documents that presuppose a fixed, material and universal body existing external to culture and history. This is an ahistorical body on which artifacts simply operate, successfully or unsuccessfully; their discovery stands outside of history, determined by the state of scientific knowledge or the arrival of an inventor with the right kind of genius.""^ From the sociologists 1 have learned to see technologies not as mere devices, but as systems or networks in which human/non-human hybrids are constructed. In studying the intrauterine device I have found it useful to see it as a contraceptive network involving innovations in design, plastics that spring back into shape, testing technologies, regulatory frameworks, means for counting bodies in far-flung testing stations and centrally pooling results, legal precedents, organisations manufacturing devices and the demand for them, delivery and supply systems, women wanting to prevent pregnancies, their male partners, doctors with the skills to insert the devices, aseptic insertion techniques, hospitals with the skills to manage complications when things go wrong, and so forth.''•'
^ Weindling, Health. Race and German Politics Between National Unification and Nazism. 1989; Reed, The Birth Control Movement and American Societv. 1978; Gordon, Woman's Body. Woman's Right. 1976; Piotrow, World Population Crisis: The United States Response. 1973; Symonds and Carder, The United Nations and the Population Question 1945-1970. 1973; Mintz At Any Cost. 1985. 10 Duden, The Woman Beneath the Skin. 1991; Laqueur, Making Sex. 1990; and Schiebinger, 'Skeletons in the Closet', 1987. ^ ^ I will return to this theme of technologies as networks or systems but the history of technology study foundational to this shift in perspective is Thomas Hughes, Networks of Power. 1983. From the interactions of sociology and history I have learned to be wary of technological determinism and historical determinism. Technological determinism is a way of seeing technology as an exterior and independent entity colliding head on with society, where it initiates effects, altering the social worlds we humans inhabit. This way of seeing technology is still common in the popular imagination. People talk of the steam engine causing the industrial revolution, the micro-chip being the origin of mass unemployment, or the computer as the origin of the surveillance society. The oral contraceptive pill is often thought of as the cause of women's liberation and the increasing participation of women in the paid workforce. This is a disempowering view of technology for it puts the design, development and use of technology beyond the influence of ordinary people.''^ Historical determinism is the treatment of history as somehow moving along a track under its own steam. Social processes such as enlightenment, capital accumulation, industrialisation, class conflict, imperialism or patriarchal social relations are theorised as the motor of history, driving it ineluctably towards the present. Technologies, if not thought of as standing outside of history, are often thought of in taken-for-granted commonsense ways as things whose time has come. Technologies appear as part of an inevitable capitalist development, or are inevitable developments of a patriarchal state. This kind of historical determinism is, like technological determinism, a conservative force. The possibility of social change depends on awaiting the 'right historical moment'. Moreover, progress is staked on the natural formation and struggle of a particular human grouping. Since the nineteenth century, freedom and prosperity have been thought of as naturally increasing with the growth of scientific and technological enterprises. The linkage between scientific and technological development and the advancement of the
^2 On the refutation of technological determinism see MacKenzie and Wajcman, The Social Shaping of Technology. 1985, 'Introduction'. 8
common good has come under challenge from environmentalists, trade unions, feminist anti-surrogacy groups, anti-nuclear campaigners, indigenous peoples, and the many groups who have had to fight their stigmatisation at the hands of science, including homosexuals, African-Americans, women, and Australian Aborigines. Standing at the end of the twentieth century, faith in science and technology as necessarily progressive forces in our society appears to many to be very naive. This view was partially opposed by Marxism since the enslavement of science and technology to capitalism was seen as a distorting influence. However, in the 1990s, following the collapse of the Soviet Union, it hardly seems tenable to continue to posit a working class as the privileged force in history. Feminists too have long repudiated this kind of historical determinist thinking which rests on the assumption of a unified woman's identity struggling against its oppression under patriarchy. Accusing women, or workers, who do not recognise where their 'true interests' lie, of 'false consciousness' has lost credibility in an era marked by the proliferation of social movements, and the vocalness with which different groups have challenged any single voice to speak for them. Women workers, black women, gay and lesbian rights organisations, third world women's groups, religious fundamentalists, pro-pornography women's groups, migrant workers have all mobilised around their differences. They have made new demands on trade unions or feminists and failed to identify with the privileging of any one historical pathway as the route to freedom and emancipation. 13 On the other hand, I do not want to retreat from historical determinism only to fall into the trap of an atomistic individualism that posits a human actor as pre-existing history, and as being at the causal centre of the narrative of history through exercising his agency, (and it is usually assumed to be a him).
^^ On class see Abercrombie, Hill and Turner, The Dominant Ideology Thesis. 1980; on gender see Judith Butler, Gender Trouble. 1990. Writing the history of technologies in ways that encompass the contingent choices made by the various interest groups concerned with their development makes it possible to imagine that things might have been different. The importance of questioning the ways of seeing technology embedded in traditional historical accounts of technological change is not simply to denounce the complicity of historians with what many would now view more pessimistically as the social changes wrought by new technologies.
Rather, it is to reveal what follows in practice from such histories, and to ask
what might follow from a different way of working as an historian.''"^ I do not
share the goal of traditional histories of science and technology to defend
science and reason as something to hang onto at a time when the rapid pace
of technological innovation and the apparent breakdown of the social
consensus confronts us with uncertain futures. I do not think women are, or
have been, well served by looking to science as the singular voice of truth in a
world where there seems no longer to be one authoritative voice.
I live in a world in which a myriad of voices - working-class, women's,
indigenous peoples', post-colonial - increasingly struggle to articulate and
defend competing versions of history and 'reality'. I want to pursue a vision of the future in which 'ordinary' people, particularly women, no longer feel powerless in the face of science and technology. I believe that this requires a
re-visioning of the merged worlds of techno-science. Rather than being complicit with modes of thinking about scientific and technological innovation as standing outside of history, unmediated by society, I want to re-constitute the bio-medical field as a field of collective human action which is negotiated
(sometimes violently) across social fields, so as to produce the beliefs we privilege as 'facts' and the success of the technologies we consider workable.
For me this promises greater hope for a future in which a multitude of voices
^^ For this particular formulation of the shift from an epistemological to an ethical perspective I am indebted to Morris, Ecstacy and Economics. 1992. 10 will not again be silenced by the claims of expert elites, in the past mainly white. Western and male, that they alone have access to socially unmediated
universal truths.
My goal in this thesis is to unravel the threads which have constituted the intrauterine device as a specific kind of object for us. This us is plural, not
singular. The intrauterine device has had different meanings for different
people at different times and places. It is also an us that is, in part,
manufactured in the process of intrauterine device construction. Intrauterine
devices, like many technologies, operate by deforming our bodies, by putting
into place an imagining of a new body - a body into which a device can be
inserted to turn off reproduction. This body is slightly different from the bodies
imaginable in the social fabric prior to its invention and circulation. I want to
ask, not is it true that intrauterine devices are safe or unsafe, but how have
these safety claims about intrauterine devices been produced, how have they
been constituted into particular forms, how have the bodies into which such
devices can be routinely inserted become imaginable?
This chapter is about making the intellectual space to approach the
intrauterine device as fully historical, and as fully social. The remainder of this
chapter is divided into three sections. The first is a review of some of the more
common forms of writing historical accounts of contraceptives, and of
intrauterine devices in particular. In this section I want to frame what is at
stake in re-historicizing medical technologies, and to indicate some of the
persistent problems that operate in the history of the biomedical sciences. I do this by reading between historical accounts of the intrauterine device focused on technological innovation and scientific discovery, and accounts of the social history of contraception. By reading each against the grain from the perspective of the other I have been able to counter the tendency in the former to take the bio-medical sciences as, at least ideally, an objective engine cut-off from the social environment and therefor able to generate 11 factual beliefs and efficacious technologies. I have also been able to extend the sociological attention paid in the later to the political worlds in which contraceptives were produced and utilised into the internal technical realm of design, manufacture, and testing. The next section follows with an exploration of some of the approaches of scholars whose work has been influential in historicising scientific knowledge and technology, reinserting it into its social conditions of production. There are a variety of different directions from which this problem could be approached. I chart only one, drawing on the work of historians and sociologists of science, to develop an approach to the social history of intrauterine devices that enquires into both how the intrauterine contraceptive device came to be constructed through a certain kind of representational apparatus, and how that construction came to speak to so many individuals, being absorbed into their everyday realities in a myriad of local contexts. The final section outlines the structure and argument of the thesis.
Writing histories of contraceptive technologies The oral contraceptive pill has often been eulogised by historians as a remarkable scientific achievement.""s It has been seen as the origin of sweeping social changes such as the huge increase in the late twentieth century in the numbers of women in the paid work force, and the rise of the women's liberation movement at the end of the 1960s. The history of the pill is usually presented as a history of the triumph of science. We are told how the development of oral contraceptives applied knowledge gained from pure science to provide a solution for a pre-existing biological problem, thereby originating a social revolution. This is a political history, an attempt to reinstate
^5 See National Science Foundation, Science. Technology and Innovation. 1973. pp. 6-11. Also Carl Djerassi, The Politics of Contraception. 1979; Clive Wood and Beryl Suitters, The Fight for Acceptance. 1970. For alternative views of the history of the Oral Contraceptive Pill see Adele Clarke, Emergence of the Reproductive Research Enterprise. 1985; and Ramirez de Arellano etal.. Colonialism. Catholicism, and Contraception. 1983.
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science in the enlightenment narrative of progress. It promotes our faith in the alignment of emancipation and freedom with science and technology. The history of the intrauterine device has been told in the same genre.'is But it is a story that is more muted, more likely to be confined to the pages of medical journals. Typically such histories tell a story of progress achieved through technical puzzle solving. They claim a past for the intrauterine device stretching back to the writings of Hippocrates or the practices of Afghan camel drivers, representing this contraceptive as a workable technique awaiting discovery by western medicine. The origin of the era of the modern intrauterine device is placed in the hands of German clinician Ernst Grafenberg who reported on his success with an intrauterine device that became known as the Grafenberg ring in the 1920s; this was a scientifically tested technology. Traditional histories then go on to account for the hostility of gynaecologists to the intrauterine device during the 1930s and 1940s, explaining it as physician bias arising from confusions between intrauterine devices and stem pessaries, "i^ These accounts then end with the triumph of science over personal prejudice thirty years later when Grafenberg's studies were replicated in Japan, Israel and New York, and the data collected supported his claim that infection did not occur. Residual problems with infection were said to have been ameliorated by the discovery of antibiotics. New materials such as plastics and copper were seen as the cause of the increasing popularity of the devices which could now be reduced in size making them more easily inserted and removed.
Like the histories of the oral contraceptive pill, these intrauterine device histories present the success of this technological innovation as standing firmly on a bedrock of empirical, scientific testing, a sphere assumed to be
"•6 Norman Himes, Medical History of Contraception. 1936; Christopher Tietze, 'Intrauterine Contraceptive Rings', 1962. "• ^ Various kinds of stem pessaries were used for contraception and in the treatment of prolapse and infertility from the nineteenth century. They differed from the intrauterine device in that they had a hard, sometimes metallic stem that protruted through the cervix whereas the Grafenberg ring had no protrusion from the uterus into the vagina. 13 insulated from socio-historical influences. Eventually objective test results win out. This genre of historical writing about contraception makes scientific knowledge and technological innovations appear as though 'facts' are self- evldent-on-arrival, and as if nature is firmly directing our knowledge of what counts as reality and success. There is no room for discussions of the cultural influences on technologies and scientific beliefs. Women, relegated to the role of recipients, have their voices consistently erased. This kind of story of the development of the intrauterine device is profoundly ahistorical. It systematically represses the controversy surrounding claims, failing to explain why one group was successful in getting their knowledge claims and technical decisions accepted, whilst others, whose claims were just as plausible if judged within the environment of the time, failed. It is as if the present operates to draw the past towards it. Such characterisations of contraceptive development function as constitutive of the break between science and technology on the one hand and society on the other. Such histories are deployed in order to send a message: leave the development of technologies in the hands of experts for it is only they who are above influence by the social worlds of prejudice and politics. But the cost of such a claim is technological determinism. In actuality, most readers would have few difficulties in recognising that political considerations, including religious conflicts, have influenced the availability of funding for contraceptive research, or the spread of particular contraceptives in any given country. But can the socio-political context and the interests of groups involved in shaping new technologies play a part in determining the actual content of scientific knowledge, or the design of new technologies? The controversies generated by the Dalkon Shield litigation generated very different histories of intrauterine devices to the science-technology- progress narratives discussed above. Analysts of the Dalkon Shield 14 controversy have explained it as an intrusion of social forces into scientific medicine, corporate greed and the push for profits being blamed for breaching the normally objective standards of scientific testing and reporting, ""s Social forces are recognised in these histories as impinging on science in the testing of the Dalkon Shield, However, the recognition of the influence of society on science and the core activities of intrauterine device testing and development is limited. Social forces can only be viewed as a source of interference. Power has operated to influence our beliefs but the truth or falsity of these beliefs exists independently of the operation of power. Histories of the Dalkon Shield as the product of corporate misconduct are also similar to histories of intrauterine devices as scientific and therefore necessarily progressive, because they too omit the agency of women, this time by construing women as passive victims of professional and pharmaceutical company misconduct.
Histories of intrauterine devices that have been tried in court and identified as injuring thousands of women have opened up the question of the influence exerted by social forces on intrauterine device design and development. But they have also limited our understanding of that influence. I believe that the extent to which all intrauterine devices, and the knowledge claims made about them, have been socially and historically produced has been overshadowed. In order to construct the intrauterine device on trial as defective, the focus has been on the illegitimate influence of corporate power over laboratory trials. This is a power which operates from above to suppress the truth. Frequently overlooked in attempts to understand how such particularly hazardous devices as the Dalkon Shield were developed, is what
Foucault has called the productive operation of power.''9 This is a form of power that I think needs to be attended to in any historical account of intrauterine device controversies. The problem for the historian is not simply to
"•Q Morton Mintz At Any Cost. 1985; Susan Perry and Jim Dawson, Nightmare, 1985. ^^ See particularly Michel Foucault, "Power and Norm: Notes", 1979. Also The History of Sexuality. VQl. 1,1984. 15 account for the failure of a particular device but also to account for how the intrauterine device became a stable category of objects about which comparable knowledge claims could be made in the first place. As an historian I believe that it is important not to reserve social explanations for failures, providing no explanations of successes. Like the historians of corporate failure I set out to investigate the linkages between the production of intrauterine devices and the social conditions of that production, but I extended my interests to include the means by which laboratory practices and field trials have become standardised, and methods of testing devices have become routinised, ready-to-hand techniques. I am interested in opening up the question of the extent to which power operates productively inside the laboratory, as well as in the wider society, to constitute the intrauterine device and knowledge claims made on its behalf. These are not new questions. James Reed's From Private Vice to Public Virtue looks at the development of the intrauterine device in the context of the interaction between the scientific development of new contraceptives and the politics of the wider society.20 Reed presents the broader social and political debates over population as motivating individuals to take up intrauterine device research. But Reed stops short of investigating whether and how these social considerations might also have influenced the content of intrauterine device knowledge claims. In Woman's Body. Woman's Right. Linda Gordon also presents the development of contraceptive technologies as the outcome of a long history of struggle by and in birth control movements.21 Gordon describes the intrauterine device as an embodiment of the goals of a United States capitalist class seeking expanded consumer markets. Lower birth rates in Latin America and Asia would decrease pressure on limited resources and lower the
20 James Reed, The Birth Control Movement and American Society. 1978. 21 Linda Gordon. Woman's Body. Woman's Right.1976. 16
incidence of rioting and crime, hence creating safe havens for United States capitalist expansion, Gordon contrasts these corporate goals with feminist goals emphasising women's knowledge of their bodies and feelings of ease with their sexuality. She rightly argues that methods of contraception reflecting such feminist goals have received little attention and have only sporadically been developed. Gordon's approach is suggestive but it does not analyse how corporate goals were actually transmitted into the laboratory work and trials which developed the intrauterine device. More recently Nicole Grant has investigated intrauterine contraceptive devices, not from the perspective of their development, but from the point of view of their consumption.22 Grant uses interviews with United States women, many of whom continued to use the Dalkon Shield and other intrauterine devices after their dangers became known, to elucidate the networks of power to which women were subject and which moulded their choices of contraception. Grant's work is focused on the Dalkon Shield but it comes closest to an analysis of the intrauterine device as a thoroughly social and historical system that both integrates and is constitutive of women's desires and dilemmas, and the practices of health providers. Nevertheless, whilst Grant refuses to reduce the question of intrauterine device development to one of empirical testing, she maintains a division between the technical and the social, elaborating the social field as the context for women's decision making about their use of intrauterine devices. The extent to which the social field is also constitutive of the design, testing and development of devices is less clearly elaborated.
I want to extend the work of Reed, Gordon and Grant by presenting a history of intrauterine devices in their social context which explores the question of precisely how and with what effect the social 'gets into' this particular medical technology, the intrauterine device. But first a word of
22 Nicole Grant, The Selling of Contraception. 1992. 17 warning. Some readers may interpret any claim that the social has impinged on science as a claim of contamination. Evidence of the effects of social pressures or beliefs on the testing of intrauterine devices may be interpreted as meaning that all intrauterine devices are unsafe, or at least that their development and testing has been unscientific. This might lead to demands for intrauterine devices to be re-tested using 'truly objective' tests. But a corollary of my argument is that such a peeling away of the social layers to a pure core of science is impossible. The point of discussing precisely how and what social elements are carried into particular technologies is not to demand that science be purified, but to deconstruct the social significances that are articulated together in a specific technological device. New possibilities for action in the politics of reproductive rights, as well as information for individual decision making, are opened up if we can understand how social values, structures and relations are translated into specific technological artifacts.
The struggle to historicize knowledge, practices and technologies in the biomedical sciences It is commonplace for the reality of the body, and therefore of the efficacy of a technological intervention into the health of the body, to be taken as a natural given. The history of the biomedical sciences then becomes the history of the 'discovery' of reality. What follows is a brief account of some of the work of sociologists and historians of the biomedical sciences who have begun the difficult task of taking the practices, instruments and knowledge claims of biomedical researchers as thoroughly historical entities.23 This section is an exploration of some of the approaches of scholars whose work has been influential on my own work on the history of the intrauterine device, and is exemplary of several important schools Involved in historicising scientific knowledge and technology. My aim is to convey some sense of the
23 Peter Wright and Andrew Treacher (eds.) The Problem of Medical Knowledge , 1982. 18 difficulties confronted by scholars who took seriously the task of historicising science and technology. I will proceed by examining several key texts. In the first subsection I draw out what we can learn from two crucial precedents to the recent revival of interest in rehistoricising medical technologies: Stern's Social Factors in Medical Progress, written in 1927, and Ludwig Fleck's 1935 study of syphilis. The following subsections turn to a consideration of more recent work which in combination has provided me with necessary tools to reconstruct a history of the intrauterine device that situates its development within a continuum of social interaction. The second subsection, in recognition of the fact that the return to the theme of the radical historical contingency of biomedical knowledge and practice in the 1970s was undoubtedly political, looks at Kari Figlio's 1977 study of the metaphor of 'organisation' in physiology. This work, amongst that of others, has been crucial to the task of rethinking the science/ideology dichotomy. It made possible the intellectual space necessary to encounter an object such as the intrauterine device as an historical artifact in which are embedded the specific socio-political contexts of its production. Subsection three examines the work of Evelleen Richards on the testing of the efficacy of vitamin C as a cancer cure. Social constructivist historians of science and technology like Richards have made a convincing and scholarly case arguing that science is not a separate sphere from which social phenomena have been excluded. Social constructivism demanded that scientific knowledge claims and technological testing be embedded in the social, cultural, economic, and historical landscapes in which they were constructed. The fourth subection discusses actor network theory focusing on Bruno Latour's 1987 study of the invention of the microbe and drawing on the work of Michel Gallon. I have chosen to read the work of actor network theorists as extending the work of social constructivism, rather than in opposition to it, but I think it adds something crucial. This work redirects 19 attention away from the social context that stands behind the content of science and is constitutive of it, to what in semiotics would be called the reader' and her strategies for actively reading to produce meaning. In other words, according to Latour, it is what becomes of the knowledge claims and practices of science in the hands of those who take them up that determines their success or failure. The final subsection assembles the tool-kit I have taken into my analysis of the history of the intrauterine device, explaining why I have drawn eclectically on elements from all 3 of these contemporary traditions of science and technology analysis.
Earlv interventions: medical technologies as social processes In 1927 Stern wrote a history of medical innovations that presented them in their historical and social contexts. In a short monograph titled Social Factors in Medical Progress24 Stern opposed the conventional view taken by historians of medical technologies that medical discoveries sprang from the individual brains and exertions of creative individuals, and that the only role played by society was as a passive receptor of the progressive changes initiated by the new technologies.25 stern demonstrated the influence of established tradition and vested interests on the 'diffusion' of new techniques and technologies in medicine for a number of medical innovations including dissection, the theory of the circulation of the blood, vaccination, Pasteur's discoveries, and asepsis. Stern points out that in each case the value of the innovation was not self evident.26 Rather, its acceptance was the product of the social forces brought into play by 'the immediate setting' of the in novation. 27
24 Stern, Social Factors in Medical Progress. 1927. I am grateful to Dr Kevin White for drawing my attention to this work. 25 Stern, Social Factors in Medical Progress. 1927. p. 97. 26 Stern, Social Factors in Medical Progress. 1927. p. 67. 27 Stern, Social Factors in Medical Progress. 1927. p. 93. 20
Take for example Lister's antiseptic techniques. Stern points out that Lister's methods were opposed by surgeons whose training was not in the germ theory but in the spontaneous generation of purulent infection. That spontaneous generation occurred was a self evident fact to these surgeons who could point in its support to everyday observations long familiar to everyone - mould springing up on old bread, or maggots teeming in carcasses left to rot. Traditional surgeons resisted Lister's recommendations to spray carbolic acid into the air surrounding a wound during an operation, claiming that it hampered their surgical technique. They also questioned the value of a theory that provided no place for their expertise on issues long considered important such as when to use wet and dry dressings and how to differentiate 'laudable pus'. Authoritative surgeons in a position to compete with Lister promoted rival novel methods of their own and belittled Lister's innovation as merely the application of an old practice of using carbolic. Advocates from social hygiene and anti-poverty movements, whose demands included the improvement of hospital hygiene, ventilation, nursing, and overcrowding, also opposed Lister. They claimed that the improved surgical recovery rates, claimed by Lister as evidence of the success of his techniques, were evidence of the success of the hygiene movement's all encompassing changes in hospital regimen. Hospital administrators also lined up against Lister, opposing the use of the more expensive carbolic acid dressings.28
Stern was not simply charting the resistance of non-rational elements to a scientific breakthrough. He demanded that prominence be given by medical historians, not to the rational weighing of objective evidence, but to the emotional investments in habits imparted during training, enslavement to conventions, social pressures to conform, the use of authority by powerful vested interests within the profession, and the influence exerted by outside interests - economic, and popular
28 stern. Social Factors in Medinal Proare.«s.<; 1927. pp. 80 -89. 21 movements. I think Stern's work was most successful in its mapping of the influence of diverse social forces on the consumption of a new technology. He insisted on the historical precariousness of 'breakthroughs' in scientific medicine, emphasising that human elements, many of them irrational, not nature, determined what, with the benefit of hindsight, was recognised as success. Through this and his efforts to present the act of discovery itself as a social phenomenon occurring over time, shared across much human labour and depending on the accumulation of a multitude of 'prior unremarked elements'. Stern began the task of dismantling and reconfiguring normative conceptions of discovery dominant in the history of science.29 Stern's effort to bring the social and cultural contexts back into the history of medical technologies were echoed in the work of Fleck, a Polish physician, who studied the 'discovery' of the Wasserman diagnosis for syphilis. Stern left his readers wondering how, given the level of resistance to the new technologies he discusses, they could ever have possibly succeeded. Having disallowed the 'obviousness' that these innovations worked as explanatory of their success, Stern fails to provide an historical account of how they succeeded. This was the question addressed by Fleck.^o He focused on the productive and constraining power of "thought collectives', arguing in 1935 that the development of the knowledge content of medicine was a political and social process. Fleck refuted the more common view that scientific knowledge claims succeeded because they correctly represented the reality of the natural world and that it was this accuracy that brought to medicine a surety of rational and logical progress, ^i
29 Stern, Social Factors in Medical Progress. 1927. p. 105-106. 30 Fleck, Genesis and Development of a Scientific Fact. 1979. 31 Fleck's work seems to have been forgotten until it was revived by Thomas Kuhn in the 1960s. Kuhn cited Fleck in support of his claim that changes in scientific belief had a sociological dimension. It is likely that Kuhn's concept of science as paradigm-ruled owed much to Fleck's "thought collectives", particularly his rendering of paradigm as exemplars which train the student's thought processes and produce the normal science activities of a 22
Fleck represents the development of the Wasserman reaction and the claim that syphilis was a disease caused by the micro-organism Spirochaeta pallida as the outcome of the peculiar social conditions constitutive of a particular thought collective.32 The success of the Wasserman reaction to diagnose syphilis is a retrospective construction, he argues.^^ But this success was by no means ever guaranteed by the intrinsic, efficacious character of the technology. Rather, Fleck tells us, its success depended on a fundamental change in the understanding of syphilis wrought by the Wasserman technology. The conflicting and idiosyncratic methods and viewpoints of scattered research workers and physicians had to be welded together into a consistent, standardised collectivity which could readily accept the designation of Spirochaeta pallida as the causative agent of this newly constituted disease.^^ The new syphilis excluded many cases previously diagnosed as sufferers of the disease, and included many symptoms previously ignored as early stages of the disease. Fleck's thesis is that the Wasserman reaction technology became successful because it both took up and brought about a change in the ideas embedded in the nineteenth century conception of syphilis. The Wasserman reaction translated each element of the nineteenth century notion of syphilis: i) syphilis as a moral entity linked to illicit sex; ii) the treatment of syphilis with heavy metals like mercury and antimony; ill) syphilis as a disease connected with the idea of 'bad blood'.
research community. See Thomas S. Kuhn, . The Structure of Scientific Revolutions . 1962; and Kuhn's introduction in Fleck,. Genesis and Development of a Scientific Fact. 1979. 32 Fleck defines a thought collective as "a community of persons mutually exchanging ideas or maintaining intellectual interaction", arguing that it is a necessary third actor in what is usually misconstrued as the dual relationship between the knowing subject and the object to be known: It "provides the special "carrier" for the historical development of any field". Fleck,. Genesis and Development of a Scientific Fact. 1979, p. 39. ^ Fleck, Genesis and Development of a Scientific Fact. 1979. pp. 39-40. ^ Fleck, Genesis and Development of a Scientific Fact. 1979. See pp. 75-76, and 84-98 for a discussion of the collectively achieved and performative nature of this organism rather than Its simple observation, or discovery by experiment. 23
It was, for instance, the blood that was tested by the Wasserman reaction. The Wasserman diagnosis for syphilis changed the idea of the disease, re- contextualising each of the nineteenth century disease concepts.^s Kimsma has recently argued that Fleck was at pains to point to the continuities between old and new regimes to explain the acceptance of the Wasserman reaction, and the new conception and domain of the disease. For me, Fleck's most important insight was not into the influence of old ideas on new ideas, but in his insistence that an account for the rise in acceptance of the new ideas be given. Fleck argues that the fundamental change in the concept of syphilis was institutionalised through the establishment of a network of serological laboratories. This network of 'civil servants' instituted a new thought collective that eventually brought about a change in research practices, and the creation of Spirochaeta pallida as the single origin of syphilis. The test did not succeed because it had stumbled on the truth of the disease. Rather, Fleck emphasises, the institutional embedding of the new idea of syphilis as the organiser of the routine practice in a network of laboratories across the country ensured that the new understanding of syphilis won the day. Both Fleck and Stern lived at a time when the scientification of medicine was relatively new and under-challenged. Their efforts to question the epistemological privileging of science in medicine, over the art of medical practice, and their understanding of the relevance of culture in illness and health were overshadowed in the West by the rise to prominence of the scientific paradigm as a base for the increasing authority wielded by the medical profession. It was not until the 1960s, when faith in science as guarantor of progress came into question for a new generation, that historians
35 Fleck, Genesis and Development of a Scientific Fact. 1979. pp. 8-15. See also Gerrit K. Kimsma "Frames of Reference and the Growth of Medical Knowledge: L. Fleck and M. Foucault" for an analysis of Fleck's emphasis on the continuity of knowledge. Published in Henk,Ten Have, Kimsma, and Stuart Spicker, The Growth of Medical Knowledge. 1990. 24 of science, at least in the Anglo-American tradition, again took up the themes explored by Stern and Fleck.
Recovering context: science and ideology The sustained popular belief, dominant during the interwar years, that progress and improved living standards could be delivered by science and technology came into question in the 1960s.36 The development of the atomic bomb, the linkage of science and the military-industrial complex, increasing awareness of pollution, resistance to the dehumanisation of work due to automation, and concerns over the iatrogenic effects of modern medicine all contributed towards a re-examination of the science/society interface by historians of science.^^ A group of British historians of science associated with the Radical Science Journal began to grapple with the non-neutrality of science. For the Radical Science Journal Group scientific knowledge claims could be analysed as reflecting and reproducing social and political values, interests, and ideologies. Influenced by, and attempting to influence, the work of British Marxism, this school of science historians called for attention to be paid to the socio-political contexts of scientific discoveries. They traced the effects of social and political contexts into the heart of scientific knowledge claims. Conversely, they presented science as integral to any analysis of social
36 See Hilary Rose and Steven Rose, "The Radicalisation of Science", 1976. Thomas Kuhn's work of the 1960s, with its acknowledged debt to Fleck, was important to the re-emergence of approaches to the history of science that recognised its social character. Since it has been discussed elsewhere and does not deal substantively with the biomedical sciences I will not discuss it further here. For interpretations of the implications of Kuhn's work for the sociology of scientific knowledge, not all of which Kuhn would agree with, see Barnes, T.S. Kuhn and Social Science 1982, and Rouse, Knowledge and Power. 1987. 37 For discussions of the relationship between science and the military and the rising opposition to it see Dickson, The New Politics of Science , 1984, particularly chapter 7. An example of resistance to pollution is Rachel Carson, Silent Spring. 1962; David Noble, America By Design. 1977, gives a critique of the dehumanisation of labour under the corporate control of technological development. A negative view of the rise in technological medicine is presented in Ivan llllch, Limits to Medicine 1977. 25 relations, and any attempt to understand the operation and circulation of power in the modern age. The contextualist historians of the Radical Science Journal were contesting the privileging of trade union organising in the British Communist Party and attempting to make scientific knowledge construction a legitimate field on which to struggle for social change. Scientific knowledge claims were not mere representations with their content determined by the economic base, they argued. Marxist historians had long recognised that scientific 'facts', laws, theories and models could be 'distorted' by capitalism, reflecting its political and economic structural elements, then being used as rationalisations for given social relations. Radical Science Journal historians challenged the primacy of the economic as causal of particular scientific beliefs. Also under challenge was the distinction at the heart of Marxist historiography between science and ideology. For historians of science such as Figlio, science was necessarily both material and ideological. Scientific beliefs were not ideological because they were false, that is because traces of the interests of dominant social classes could be detected in them. Rather, scientific beliefs were necessarily constituted from understandings of everyday and socio-political life, and therefore necessarily contained ideological elements. It was not the operation of these elements perse that supported the interests of some social groups over those of others. It was the suppression of the memory of their social origin that then enabled the science to naturalise the interests of dominant groups that was the problem. One fruitful method of investigation developed by the group was to trace the passage of metaphors between the recognisably socio-political worlds of class struggle, imperialism, sexual politics, nationalism, and religious conflicts to the scientific and medical 'descriptions' of the natural worid. Kari Figlio was one of the Radical Science Journal Group to argue that 26
scientific knowledge claims necessarily incorporated social and political elements. Figlio opposed the science/ideology distinction. For Figlio science is ideology not in the sense that it is a distortion of reality, but because it necessarily carries the stamp of the class character of its conditions of production. In one paper Figlio examined the development of, and the role played by, the metaphor of 'organisation' in the work of early nineteenth century physiology, anatomy and natural history.ss This idea of organisation provided a common ground for the articulation of conflicting scientific models through which the idea of life came to be articulated. Figlio pointed out its 'dual character', its operation across social worids as an organiser of scientific research, and as an organiser of class conflicts. He argued that a statement such as that life was an expression of the level of anatomical organisation of the nervous system, implicitly carried value-laden meanings from the social context.39 For Figlio 'these physiological concepts, and perhaps most others as well, never were the simple value-free elements of an emerging positivistic science'.40 Moreover, these 'evaluative investments' accreted to the biological concepts were expressions of specific social interests.^i Figlio's argument concerning the life sciences is that controversies that raged around such issues as materialism versus vitalism were expressions of religious, political and social interests, with parallels in controversies raging over social organisation. In both scientific and political spheres the concept of organisation, with its focus on internal structure, mediated debates between conservatives, gradualists and radicals. Figlio tells us that it was precisely because the concept of organisation was the bearer of such covert meanings that it became the centre of scientific controversies.'^2
33 Figlio, "The Metaphor of Organisation", 1976. 39 Figlio, "The Metaphor of Organisation", 1976. pp. 18-21. 40 Figlio, "The Metaphor of Organisation", 1976. p. 26. 41 Figlio, "The Metaphor of Organisation", 1976. p.26. 42 Figlio, "The Metaphor of Organisation", 1976. pp33-34. 27
Thus, for example, Abernathy, voicing the interests of the English clergy and the pro-patronage old guard of the Royal College of Surgeons, denounced the assertions that there was a strict correspondence between the moral-intellectual faculties and the physical organisation of the physio- anatomical structures. Abernathy rejected the idea that life was the effect of organisation and insisted that life was a super-added principle, a vitalism that animated the physical. Experimental evidence was brought forward by vitalists; the effects of electricity on the body were discovered and investigated. There were plenty of critics of vitalism who saw it as a re- emergence of something comparable to occult qualities in scientific explanation. But ardent anti-materialists, fearing a godless worid, denied such charges and compared the principle of vitalism in the life-sciences to the principle of gravity in Newtonian physics.43 On the other side of the conflict, in association with the more radical Royal Medical Society of Edinburgh, stood thinkers such as John Barclay. He was an exponent of gradual social change standing between the defenders of the old order on the one side and the exponents of revolutionary change on the other. Barclay developed a school that espoused organisation and a strict 'physico/moral' correspondence, but rejected materialism. For Barclay, Figlio tells us, organisation 'reveals design, not the accidental play of matter according to mechanics.' The inextricable weaving of the moral faculties into the physiognomy of the organism as a whole showed even more clearly the hand of God in the design of the universe.44 This appropriation of the concept of organisation was, says Figlio, like those of others involved in the debates over the notion of life, ideological. It carried implications for the relationship of the individual organism to the whole, and this meant for the forms of political and economic organisation that would best promote social cohesion. Figlio
43 Figlio, "The Metaphor of Organisation", 1976. pp. 32-34. 44 Figlio, "The Metaphor of Organisation", 1976. pp. 40-42. 28 goes on to discuss how, for gradualists like Barclay associated with the reformist political agendas of the new entrepreneurial classes, just as the study of the instincts revealed Gods plan in the organism, so too was God's design evident in the structures of the social organism. The application of human intelligence and will ought to be directed to understanding and hence better perfecting God's plan by grasping the organisation embedded in the human organism by the divine intelligence. Radical change threatened God's internally balanced organisation.^5
The work of Figlio showed that our understandings of our bodies and of life itself can appear as simply descriptive of natural phenomena, while at the same time bearing the logics of their socio-political contexts of production. As Figlio puts it, the formal concepts of science are 'bricolage': Whilst having a meaning and a purpose for the generation of workable knowledges, they are constructed from elements each of which has its own history and intentions.46 Thus concepts which advance the interests of particular social groups are naturalised in science and their significance for debates over political economy is rendered invisible. A weakness of the work of Figlio and other members of the Radical Science Journal Group was their privileging of social forms, particularly class relations, as the origin of new scientific concepts. This seems to me to be rather arbitrary in its delegation of the social to causal context and science as text or effect. Just as social and economic models have been deployed in generating the imagined realities of the biomedical sciences, so too have models of the body or of life been a source of inspiration for political economy. To realise this one only has to think of the eariy twentieth century firm with its management as control and integration, and its workers as muscle paid to labour manually and not to think. I consider it more appropriate to approach
45 Figlio, "The Metaphor of Organisation", 1976. p.43. 46 Figlio, "The Metaphor of Organisation", 1976. p. 31. 29 the objects of the bio-medical sciences and socio-economic relations as being co-productions, subject to similar stresses and strains and force fields. Also, I want to emphasise that metaphors do not come ready made from one sphere into another. This is I think another weakness in work such as Figlio's. The concept of organisation may have provided a matrix for the playing out of class interests in the emerging field of the life sciences. But within each contested arena, of political economy and of the life sciences, the metaphor that became the dominant means of representing reality had to be extended and worked over with and through the materials and practices already inhabiting the field. It had to be re-constructed and re-contextualised. There is another problem with this approach to science. It is clear from the example above that for Figlio, writing at that time, the class position of the protagonists determines the knowledge claims they develop. This is not the reflectivist view of consciousness or ideas as determined by the relationship of their protagonists to the economic base. For Figlio, science is part of a class's articulation of an ideology that expresses its interests. Figlio insists on human political agency as operative in science. Struggles within science are just part of the struggles on many fronts constitutive of individuals as class members and manoeuvrings for hegemonic positions. However, Figlio is caught in a double bind. Without 'knowing' the class position of protagonists, and without the certainty of class struggle as an accurate description of the social how could the determination of scientific knowledge claims be ascertained? To privilege class, as Figlio does, in causal histories of the origin of certain scientific ideas, begs the question of the relationship between class and other social structures - gender, race, colonization. Furthermore, many, if not most, scientific knowledge claims seemed to evade such ready association with social interests as the examples investigated by Figlio and other members of the Radical Science Journal Group. It thus appeared that the influence of society on science was exceptional. Moreover, it is impossible to derive in any 30
simple manner the determination of scientific knowledge claims from either class, gender, or other categories. So why position such sociological categories as preceding, and causal of, the development of science? I think it is more useful to position class, gender, race, and other social interests as part of the production of contested positionalities that become articulated in and through science and technology. This points to a process of aggregation through which interest groups and subjectivities are always in the making, not to a process of the reflection or mere expression of interests. Despite these problems I am reluctant to discard the work of Figlio and his colleagues altogether. I find it interesting because it is a positioned history. Figlio considered himself as speaking from the position of, and on the side of, the proletariat, deconstructing the authority by which scientific knowledge claims operated to enhance the interests of particular social groups by revealing how elements bearing class perspectives became incorporated into science at a fundamental level. Any history of the intrauterine device has to insert itself into an already charged field occupied with competing versions of the same history. Like many feminist historians, and I would argue any historians, the history I produce will necessarily be a situated history, written from a particular point of view as a specific intervention in the socio-political field. I want to explore the question of the connection between writing history of science and what, when I was involved in social movements, I would have called political interventions. I want to write a history that is on the side of critique, a history that is subversive. This means adopting strategies of authorisation as a sociologist and historian of the intrauterine device that enable a transformative politics.
The social construction of scientific knowledge Evelleen Richards is an Australian historian of science whose work has analysed a medical controversy, integrating both macro and micro social 31 factors in an explanation of how the outcome was determined by the interaction of the diverse interest groups involved.47 The work that had been done by the Radical Science Journal Group was extended by social constructivist historians such as Richards who followed interests into the laboratory, and expanded the notion of interests from the concept of class to include professional advancement, interests in displaying one's training, religious viewpoints, institutional links, membership of scientific associations, and other scientific agendas and goals. In other words the concept of interests was deployed descriptively to pinpoint the glues holding together coagulations of actors formed during disputes. Structural interests are not causa! precedents of action, rather interests emerge in enactments productive of subjects as members of a particular group with common goals.48
Richards theorises social interests as performative rather than as a static set of structural givens into which individuals are passively inscribed. Nevertheless, Richards attends to the positionality of actors within existing social fields, not because it determines their scientific beliefs, but because it influences what actions they are enabled to perform.
47 Richards, Vitamin C and Cancer. 1991. 48 Richards can usefully be read against Bijker and Pinch, 'The Social Construction of Facts and Artefacts', 1987. Using the bicycle as a case study, Bijker and Pinch treat a technological controversy in much the same manner as Richards approaches a scientific controversy. They argue that technological innovation can be divided into phases. First, a pre-paradigm phase is characterised by the proliferation of designs. In their case study local tinkering initially produces an assortment of bicycle designs differing in relative wheel size, arrangements for driving the wheels into motion, seating positions, and frame shapes. Different models appealed to a diversity of interest groups - high wheeler penny-farthings to young men and racing enthusiasts, low wheelers to independent women and week-end picnickers. During a second phase, that Pinch and Bijker call a paradigm establishing phase, there is closure of the interpretive flexibility of the prior phase. Pinch and Bijker describe how the safety bicycle with its two low equally proportioned wheels, inflatable tyres, and chain drive became the paradigmatic model of a bicycle. It is Pinch and Bilker's argument that this closure around a particular paradigm is not the result of objective efficiency. Indeed they show that the inflatable tyres were initially resisted by racers who viewed them as safety devices hardly befitting the dare-devil thrills of high-riders. Pinch and Bijker's argument is that the inflatable tyres were first adopted by one interest group, recreational riders interested in snnooth, sedate travel. This bicycle then had to be 'rhetorically translated' into relevant advantages for other groups; racers adopted the ugly inflatable only when it was translated into a speed device. Pinch and Bijker's article uses the concept of interests to define pre-existing social groups to which bicycle manufacturers appeal. Their bicycle story fails to consider the extent to which bicycle riders were a newly constructed entity, with the various groups of bicycle riders from larriken thrill-seekers to cullote-clad suffragettes themselves under construction in processes intersecting with the stabilisation of the modern bicycle. 32
Social constructivism in science studies cannot be neatly equated with social constructivism in sociology. For example, in sociology to talk of gender as a social construct is to differentiate it from sex, the biological or 'given in nature' raw material, onto which the cultural construct gender is projected. In history and sociology of science however, it is the natural worid object, in this example sex, that would be construed as a social artefact. Social constructivism for the sociologist is a revaluing of the culture side of a nature/culture dichotomy endemic to western thought. In science studies this dichotomy is itself under question since it is what is usually assigned to the natural that is being considered as a social construct. Richards's work elucidates the historical specificity of the outcomes of two scientific trials for testing the efficacy of vitamin C for cancer patients, conducted under the auspices of the United States National Cancer Institute at the Mayo Clinic from 1977 to 1984. Richards's research begins by discussing the political ploys required for Ewan Cameron and his powerful 'co-believer' Linus Pauling to bring about such trials and to intervene in their interpretation and outcome. Cameron was a respected Scottish medical practitioner who believed he had successfully prescribed vitamin C to prolong the lives of his terminally ill cancer patients. Faced with a cancer establishment committed to the use of highly toxic chemotherapy, vitamin C would not even have been trialed, and certainly not trialed twice, without the existing authority and resources Pauling was able to commandeer because of the interest groups within which he was already established, nor without the funds he was able to mobilise from the growing vitamin and health food lobby. This is a weak claim for the influence of social factors on science.49 Richards's primary objective is to support the much stronger claim that the interests of the Mayo clinic trial group in the use of cytotoxics, a lucrative industry for both the pharmaceutical companies and the cancer treatment
49 Richards, Vitamin C and Cancer. 1991. pp.33-51. 33
specialists, shaped the conduct of the trials. Richards argues that their outcome was coloured by the interests of the 'Cancer Establishment', and therefore of instrumental value to them in dismissing the rival claims of Cameron and Pauling. Briefly, Richards argues that the Mayo Clinic researchers, funded to trial vitamin C by the National Cancer Institute, used the standardised practices carried over from trials of cytotoxics, for example, stopping and starting the treatment regime and looking for tumour reduction or disappearance. This was a very different practice from that used by Cameron who claimed it was inappropriate for the testing of vitamin C. His regime involved taking vitamin C continually for the rest of one's life; indeed stopping, he suspected, might produce a rebound effect. Moreover, his criterion for success had been prolongation of life, perhaps through the cessation of tumour growth. He had not claimed that the vitamin C treatment destroyed existing tumours.^^ Richards shows how Pauling was able to re open the controversy after the conduct of the first trial, and how he tried to do so after the second by challenging the auxiliary hypotheses necessarily made by Moertel who conducted the trials. For instance Pauling challenged the notion that the trials were a replication of Cameron's experience because the patients, unlike Cameron's Sottish patients who were predominantly treated with surgery and radiography, were selected for the trial after already undergoing cytotoxic therapy. This he argued would have destroyed their immune systems, making it most unlikely that vitamin C could have any effect. Moertel had not seen this aspect of patient selection as important and argued that it would be unethical to offer patients vitamin C therapy, which had unknown effects, when treatment with cytotoxics was standard practice in the United States.^i It is always possible for interest groups to Interpret an experiment differently through this process of challenging the auxiliary
50 Richards, Vitamin C and Cancer. 1991. pp. 141 -167. 51 Richards. Vitamin C and Cancer. 1991. pp.120-124. 34 hypotheses that are necessarily part of experimental design. Richards argues that groups do so when they perceive their interests as best supported by such a challenge. But the scientific authority and clout required to do so is, as this study shows, very considerable.52 Richards theorises scientific knowledge claims as an arena contested by groups with conflicting desires and interests. The Nixon administration's war on cancer, the laetrile controversy, the pharmaceutical lobby, the metaphor of 'search and destroy' that infiltrated cancer treatment discussions, the financial and bureaucratic interests of cancer specialists in the United States, and Pauling's commitment to the peace movement are all macro- sociological factors that play a role in shaping the achievement, conduct and outcome of the Mayo Clinic trials. But Richards's account is not trying to re animate causal interests in the sense used by Figlio, as objective structural determinants that explain the beliefs of participants. For Richards, interests arise in the context of the controversy, providing points around which individuals organise practices. Moreover these macro-sociological factors are given the same ontological status as the actions of letter writing, rhetorical flourishes, skirmishes with journal editors, and the pre-existing practice routines of laboratory workers. Richards's work is instructive for its attention to this complex interplay between the actions of the groups who came to see the testing of a therapeutic regime as associated with their goals, and the social, political, cultural and institutional fields within which their actions were located, had to make sense, and produced effects. However, one problem to emerge from the work of Richards concerns the limit imposed by its self-positioning as redrawing the disappeared linkages between the content of science, its knowledge claims, and the wider socio political and cultural contexts, or macro-sociological forces shaping their production. With its implied boundary between text (science) and context (the
52 Richards, Vitamin C and Cancer. 1991. pp. 171-181. 35 social), the very distinction that social constructivists are breaking down is nevertheless preserved. The distinction between the macro-social and the micro-worlds of science and technology hides the contingency of the
boundary between the social and the scientific/technical that is under construction in the laboratory. In other words the very boundary that the work
of the social constructivist program has undermined is a conceptual
distinction on which their analysis is predicated. I would argue that the
assumption of a dichotomy between science and society, between the macro-
world of wider social interests and the micro-world of laboratory action has
become redundant. This is Latour's argument and it is to his work that I now
turn.
Breaking down the text/context boundary: Actor-Network Theory
Bruno Latour's The Pasteurization of France uses actor-network theory
to explain how we came to live in a world co-inhabited by microbes.^^ Like
Stern, Fleck, Figlio, and Richards, Latour begins from the assumption that it is
always possible for a scientific knowledge claim to be contested, that it is
never incontrovertible, and that it is not determined solely by the data. Latour theorises the scientist Pasteur as both a social and a biomedical engineer.
But Latour does not follow Figlio in positioning the social as an influence on
which scientific knowledge claims come to be made; nor does Latour concur
with Richards positioning of the social as explanatory of which scieintific
claims come to be accepted as representations of reality. Latour emphasises that the social is under construction in the practice of science, in the
laboratory. He rejects the interests of actors as explanatory resources in accounts of change in scientific beliefs.
This is not to say that the social context is not relevant to the analysis of the production of scientific knowledge claims, but to begin by rigorously
53 Latour, The Pasteurization of Frann^ 1988. 36 suspending the assumed correspondence between social structures, interests and human agency in stories of how meanings come to be attached to nature.54 Latour refuses to privilege social structures as causal in explanations. Rather, he argues, attention should be focused on scientific practice. Latour reads the work of the scientist for the means by which it translates the diverse interests of actors, channelling them through the laboratory.55 According to Latour it is through such processes of enrolment, which position actors in 'actor-networks', that scientific work comes to produce new natural and social worids, and the boundary between them.56 A closer consideration of Latour's account of the discovery of microbes is helpful in elucidating precisely how actor-network theory can influence the historian of science and technology. Latour documents Pasteur's genius as consisting not in any feat of the mind, but in his ingenuity as a strategist capable of building durable alliances. Pasteur's expertise is in enrolling diverse entities, both human and non-human, into relays of practice, including various sectors of French society who must be lured into routing their goals through his laboratory, accepting a Pasteurian narrative of microbial action for the events with which they were concerned.57 This narrative could only be made credible with great difficulty. It involves the construction of an actor- network in which the narrative is shared by the participants. Eventually knowledge claims or scientific practices become 'black-boxed', built into routines and instruments such that to challenge their credibility becomes unimaginable. Gallon, a colleague of Latour, suggests that this process of actor- network assemblage be analysed in four overlapping but analytically distinct
54 Latour, Science in Action. 1987, pp. 99-100 and 143-144. 55 Latour, The Pasteurization of France. 1988.. pp. 5-12. 56 Latour, The Pasteurization of Frannf? 1988. pp. 170-175. 57 Latour, The Pasteurization of France 1988. pp. 147-148. See John Law, 'Laboratories and Texts', 1986, p.39, for an interesting discussion of the unique diversity of elements brought together and linked-up in the laboratory. 37 phases.58 The first phase involves the definition of actor-groups that the protagonists of a new technology identify as necessary for the building of the envisaged technological system. This is largely done through the process of problematisation. The identification and formulation of a problem in a particular way entails the linking of particular entities to achieve a solution. These entities can be human or non-human. The protagonists of a technology offer a simplification, or set of characterisations, that they take to be descriptive of each of these entities. Applying this analysis to Latour's account of the development of Pasteur's new microbial technology it is possible to identify this problematisation phase in Latour's description of how the hygiene movement identified doctors, public health social reforms, Pasteur's language of contagion, his laboratory soups for growing microbes and promised vaccines, the French Government, its engineers, and the practices of the food and beverage industry as the entities which must be linked together if the alarming degeneration of the health of the population was to be averted.59 Already Pasteur had built a resilient actor-network that linked together his laboratory practices involving the farming of microbes, an anthrax vaccine, the fate of French farmers, the country vetinarians, the Department of Agriculture, and the the life and death of sheep. On a farm at Pouilly-le-fort Pasteur stages what Latour conceptualises as a theatre of proof in which sheep, farmers, and the anthrax vaccine are made to play the roles assigned to them by Pasteur and to respond as he decrees they will, all before a well chosen audience to whom will fall the future task of policing the detailed changes in practice required for this assemblage to become extended throughout France.^o This demonstration at Pouilly-le-fort is an interesement device, Gallon's second phase of the construction of a successful actor
5S I follow Michel Gallon, 'The Sociology of an Actor-Network", 1986, particularly. See also Gallon, 'Some Elements of a Sociology of Translation', 1986. 59 Latour, The Pasteurization of France. 1988, pp. 13-58. 50 Latour, The Pasteurization of France. 1988, pp. 85-100. 38 network. It is designed to lure French officials and country vetinarians to take on the tasks of ensuring that outbreaks of anthrax are responded to by the sending to Pasteur's laboratory of samples (stoppered in a particular way to prevent contamination), the application of vaccines, and the separation of infected animals from unvaccinated stock on surrounding farms. This second phase in Gallon's network building model describes the strategies through which the technology developers attempt to strengthen the identities they have assigned to the entities they want to link together. In part this entails weakening the links between those entities and others that may result in them identifying themselves or their goals with other networks, refusing to re-route them through an alliance in the network under construction.5i In Latour's study it is the medical doctors who prove most resistant to any attempts to associate them with the growing Pasteurian network. Unlike the hygiene movement, the doctors are not impressed by the promise of vaccines for the prevention of this and that disease. The doctors identification with their patients and the secrecy of the doctor patient relationship must be weakened before this can occur. Can people be treated like cattle? Can the well be coerced into treatments? Can the doctors tolerate the officials disinfecting their rooms every time an outbreak of typhus is notified? Finally the interests of the doctors in curing the sick are translated into the Pasteurian laboratory by a transformation of its product from vaccine to serum. A diphtheria serum that can be used to diagnose and cure the sick is the interesement device designed to lure the doctors into the network. The entities identified in the problematisation phase of actor-network formation can refuse their allocated characterisations, or can refuse their alliance with other actor-groups. Latour's network builders have to negotiate with the entities they are attempting to link together and as Latour shows some actor-groups have
51 Cation, 'Some Elements of a Sociology of Translation', 1986, pp.206-211 39 their own conditions which they insist must be met before they accept the enticements offered. Pouilly-le-fort is also a demonstration of the successful enrolment of the entities already agglomerated into a working actor-network by Pasteur. In the laboratory Pasteur had successfully struggled with material entities: the soups and their ingredients with which he fermented the microbes and induced them to multiply, the provision of spaces in which a particular microbe could grow alone, and the inoculation of animals with a ferment that was sufficiently virile to induce a response but not so virulent that it killed. Inside the laboratory there are no mysterious goings on that suddenly gave Pasteur access to the truth when all before him had failed. Latour argues that Pasteur's laboratory produced a network which wove together the microbial narrative with signs produced on ferments and the practices of laboratory workers acting on the conditions of fermentation. The microbes were induced to join the actor network with the use of soups that lured them into literally showing themselves. Having become bigger, such entities were manipulable and could be seduced into playing certain roles in Pasteur's network, although precisely what inducement was needed required considerable trial and error. This was not discovering the truth about a pre-existent group of organisms. Pasteur was constructing actor worlds inhabited by new entities.52 All of these non- human entities had been tied together in Pasteur's laboratory where he could speak for them and discipline them to behave as he said they would. Pasteur locked them into a network with the practices of his laboratory staff and the microbial script with which he made his laboratory a new spokesperson in diverse actor-worlds.53
If the strategies pursued in phase two of Gallon's model are successful then this enrolment of diverse entities both human and non-human has
62 Latour, 'Clothing the Naked Truth', 1989. 63 Latour, The Pasteurization of France 1988. pp. 72-87. 40 occurred, with each of the entities identified in the first phase firmly locked into a mutually reinforcing network. Latour tells us that Pasteur defined the problem of the anthrax epidemic as one of microbial contagion. In this process of problematisation particular entities were identified and had interests attributed to them in such a way that they were construed as best served by the formation of an alliance between themselves, the laboratory and the other identified entities. The scientist's laboratory was positioned as a 'compulsory passage point' first for for agricultural inspectors, farmers, livestock, and country vetinarians; and later for public health officials, engineers, food industry inspectors, and only very late in the day for doctors who resisted this shift from the individual health of their patient to the health of the population. The fourth phase of the building of an actor-network Gallon and Latour refer to as the test for the representativeness of spokespersons. Negotiations actually occur only between a few representatives of each actor-group enrolled into the network. It is a practical question whether such a grab to be spokesperson will hold. If it does, and no new spokespersons emerge and mutinies are damped down, then new realities have been constructed.54 Latour and Gallon call the work of actor-network building translation': entities must be displaced , induced to form alliances that route their goals through new technologies and research programs, and the characteristics and desires of others become expressed in the the new language of representation manufactured by the laboratory, transforming science and its practitioners into spokespersons and compulsory passage points. Eventually, Pasteur was speaking on behalf of farmers, wine-makers, food distributors, doctors, and public health officials.
Moreover, the acceptance of all these people of Pasteurian narratives, their acceptance of this scientist as speaking on their behalf and as representing their worlds, involved changing the habits and routines of
54 Gallon, 'Some Elements of a Sociology of Translation', 1986, pp. 214-220. 41 thousands of people. A vaccine would only do what Pasteur said it would if samples arrived at his lab uncontaminated; special techniques of sealing tubes had to be learned. An outbreak of anthrax responded to Pasteur's vaccine only if the vaccinated animals were kept separate from the unvaccinated and the neighbouring farms were forced to comply with agricultural inspections. Pasteur had to change the world of the country vet, the farmer, and the Department of Agriculture. They had to become competent spokespersons and actors in a microbial network accepting new representations of observations that they would previously have put down to the weather, the soil, or some other local variant.55 Pasteur was as much a social engineer as he was an engineer of material entities. The construction of a re-alliance between the human and non-human worlds of France required the movement of the locally achieved success of Pasteur's laboratory network, in which microbes and men accepted their disciplined roles, to a network of new sites. Gradually, the country-side, sanitation, the manufacture and distribution of food and wine, hospitals, the military, and medical practice were re-organised along Pasteurian lines. Pasteurian science and its acceptance was not simply influenced by society. According to Latour, French society was as much under construction in the work of the Pasteurians as were the objects of the natural worid.
Combining social constructivism and actor-network theory
I do not endorse Latour's focus on the single figure of the scientist as a military general steering his troops to victory.-Too often, reading Latour one gets the impression that actors are unified subjects, fully conscious of their actions and that they act rationally in the pursuit of power and control. I am deeply suspicious of the concept of the atomistic self, the human individual as an actor shaping his or her own destiny and expressing his or her authentic
65 Latour, The Pasteurization of Frannp 1988. pp. 87-100 42 interests, existing as a coherent self without reference to the web of relations which make possible the actions engaged in and make them culturally meaningful. Latour is cognisant of this problem.56 He tries to remind us that actors are socially and technologically constituted through his deployment of the term 'actant' interchangeably with the term 'actor'. This tactic, which designates the actors as the bundle of characteristics assigned to them, I think only partially succeeds. Latour's actors should not be read as heroes structured around a dichotomy of individuality versus social determinism, although they often are. They are not unified subjects with an interior psychology formed in their youth which now motivates their action. The term actant is Latour's ploy to construct actors as unstable and identities as historical effects. For Latour, interests define actors because they are so ascribed by others, not because interests precede and determine the action of the actors. I want to emphasise that the action of network builders cannot be purified of their cultural contaminants, and that these are not necessarily empirically visible in the action or talk of network builders. What 1 would like to see is the focus on action advocated by Latour used to diagnose the macro- worid of which it is a symptom, not to produce causal historical accounts in which 'men' act as the centre and creators of their worlds. Any account of science which reduces it to the rational, calculative action of individuals I think is impoverished.
Nevertheless, I have been attracted to the language and structure of actor-network approaches and have used an historicised version of actor- network theory in my case-study of the intrauterine device. My interests have been guided by questions such as how the groups and individuals tinkering with and advocating intrauterine methods of contraception managed to become the spokespersons for various entities, human and non-human, attaching characteristics to them, distributing roles, and tying them together
55 These concerns are shared by Singleton, 'Actor-Network Theory', 1993. 43 into more or less stable relationships. It was never a taken-for-granted matter that women would agree that they needed such a contraceptive, that doctors would agree that they would insert them, or that the devices themselves would be perceived as accomplishing the task set for them. The issue of whether or not these devices caused harm has continuously undermined the durable sets of relations that successive generations of intrauterine device advocates have sought to hold together. How then were these entities assembled and the intrauterine device contraceptive system constructed by linking them together, first in a few local contexts in Germany, then in an extended, if fragmented, network spanning several continents, and finally as a universally acceptable and globally distributed modern method of contraception? How were doctors, silver coils, and women assigned particular sets of characteristics, and then brought together in one network with stable relations between them, in such a manner that the a narrative of contraception by means of such devices became a possible choice for many women? Latour's schema can provide insights into how such a technology succeeded. There are some controversial aspects of Latour's work. His granting of equivalent status to human and non-human actors has caused considerable debate.57 | do not share these concerns which revolve around Latour's attribution of will to non-human entities. I interpret Latour as studying the way that people attribute characteristics, behaviour and will to things, just as they do to human groups,not as arguing that microbes make decisions or exercise will. Microbes do, however, make signs in Pasteur's laboratory; they are made to write themselves.58 it is necessary to emphasise that to characterise microbes as agents in human life-worlds is not to anthropomorphise physical entities, attributing them with consciousness, motivation, and will. To recognise the autonomy of things, that they are animate entities acting outside of human control, and independently of human attributions of meaning or
57 Collins and Yearly, 'Epistemological Chicken', 1992. 55 Latour, 'Clothing the Naked Truth', 1989. pp. 121-126. 44 appropriations, is not an exercise in anthropomorphism. What is needed is a reconceptualisation of agency itself. The second area of controversy surrounding Latour's model for the investigation of technological change concerns the focus in his work on the micro-level action of the entities involved in network construction. Critics have emphasised the role of macro-sociological factors in shaping the options and outcomes of the negotiations and strategies so well described by Latour.59 Latour specifically rules out any reference to social norms or pre-existing institutional factors to account for the stabilised locking-in of both human and non-human actors to the network. On this point I disagree with Latour. It is not inconsistent with actor-network's insistence on the interpretive flexibility of both human and non-human actants as they are drawn into actor-networks - the co-construction of both social and natural worids - to also admit the multiple identities that such actors always already occupy.7o In order to account for the success of the intrauterine device I believe it is necessary to examine the background against which the action of intrauterine device protagonists and their allies took place and made sense. I have found it useful to attend to the pre-existing positioning of entities within social norms and power relations, and to specific local contexts involving routine practices and habits, because these operate as the conditions of production for this particular contraceptive technology. This has involved developing my own approach that integrates elements from both actor-network theory and social constructivism.
This means that I reject Latour's charge that it is indefensible for the science and technology analyst to speak for social elements, just as the scientist claims to speak for nature. Latour presents his narrative on the process of technological system building as the construction of an actor- network within a conventionalist epistemology. Its truth is not grounded on the
69 Schaffer, 'The Eighteenth Brumaire of Bruno Latour', 1991. 70 Star, 'Power, Technology and the Phenomenology of Conventions', 1992. 45 action of actor-groups as referent, that is as guarantor of the accuracy of his representation. Its truth will be an outcome of the texts negotiations with its readers. If readers agree that this is a useful account of technological development they will jump onto the actor-network band-wagon7i, accepting Latour's account as descriptive of reality, and embedding it in diverse realities as they use the text in ways that advance their own goals. The validity of Latour's account is consolidated as more and more people rely on it being taken to be true, in order that the moves they themselves are making work. As others have pointed out, this means that the science analyst's account is itself a mechanism for building solidarities and collectivities.72
Some might argue that such a sociology of translation theoretically clashes with social constructivist accounts, such as Richards's story of the testing of vitamin G as a cancer therapy, that deploy social interests and pre existing patterns of social relations in their explanations. It seems to me, however, that there is no reason why pre-existing social relations and macro- social phenomena, gender or professional power for example, no matter how historically shifting, contingent, and constantly in formation we might consider them to be, cannot be dealt with from the same epistemological perspective as Latour applies to his account of action. The strategies pursued at the micro-level, of which Latour provides a convincing and rich account, contribute to our understanding of the process of technological innovation. But focusing on the action and actor-groups, which are the focus of this sociology of translation, ought not reproduce the opposition between agency and structure, simply reversing the usual sociological privileging of structure over agency. I have used Latour and Gallon's actor-network theory as a grid, a particulariy sensitive device for following the action of intrauterine device protagonists. But the sociology of translation describes events occurring in a field that
71 I have adopted this term from the work of Joan Fujimura, see Fujimura, 'The Molecular Biological Bandwagon'. 1988. 72 Scott, Richards, Martin. 'Captives of Controversy,' 1990; Martin, 'The Critique of Science Becomes Academic', 1993. 46 shapes possible choices, the likelihood of identities sticking, and the contingent subjectivities of participants. I have theorised this field as consisting of a multiplicity of overlapping, sometimes contradictory, localised social orders but it cannot, I believe be ignored altogether. Thus I will consider the wider environments in which protagonists worked, that impact on their choice of action and its effectiveness, as much a part of the formation of the intrauterine device as the battles and strategies of individual actor-groups. For example, in the following chapter, I commence the story of the intrauterine device with the broader social field and shifts in demography and contraceptive practice occurring in Europe and the United States in the early twentieth century, not because I want to privilege the broader social and economic context as the cause of the development of the intrauterine device, but because it is one possible place to begin to read the complex patterns of change with which the construction of the intrauterine device actor-network is bound-up.
In summary, this chapter has been a review of some of the work that I have found influential in profoundly historicising biomedical science and technology. All of the work I have examined here constitutes science and technology as social. No core of technical or biological determinacy remains once the layers of social activity have been peeled away. This does not mean that material entities disappear. They are identified, characterised, struggled with, and constituted as particular kinds of entities for us, but they are neither determining nor limiting of the interpretations and knowledge claims within which they circulate. How are we to theorise technologies, the body, and society given this radical challenge to entrenched ways of thinking science and technology as separate from society? I have argued for an eclectic mix of social constructivism and actor-network theory, I also want to retain some aspects of ideology critique. There are many elements of Latour's network- 47 theory that I have found valuable. His insistence that the boundary between the social and the technical is a fabrication, an outcome of the socio-technical negotiations engaged in by scientists like Pasteur, is useful. The language of network building, alliance formation, and enrolment I have also found convenient. But I find unhelpful Latour's refusal to pay attention to the multitude of social processes simultaneously and contradictorily constitutive of actors/actants. Part of my interest in intrauterine devices is as assemblages or networks productive of gendered and hierarchical social relations. I would agree with what follows from actor-network theory, that it is not simply that gender, race or class are produced elsewhere and have effects on bio medical research. Intrauterine devices are part of the apparatus of production for the establishment of what counts as natural sex, constituted as determining of gender, and the boundary between what is interpreted as biologically given sex and socially produced gender. Intrauterine devices manufacture boundaries between human subjects capable of rational action and those marked by exclusionary categories such as race, youth, poverty. However the positioning and formation of actors within other networks, sometimes productive of contradictory and unstable positionings needs, I think, to be taken into account. Rather than giving up the notion of social interests altogether as Gallon and Latour insist, I want to argue for their theorising not as a static set of structural givens into which individuals are passively inscribed, but as performative and shifting, a series of localised enactments.
This thesis discusses the action of intrauterine device protagonists, and of the entities they attempt to enrol, but I take the view that this alone is insufficient to explain the success of the process of network formation for the intrauterine device. In order to account for the success of the intrauterine device I believe it is necessary to examine the background against which the action of intrauterine device protagonists and their allies took place and made 48 sense. Following Richards' social constructivism I have found it useful to attend to the pre-existing social norms and power relations within which actors are situated because these operate as the conditions of production for the strategies of network building pursued by the actors concerned. I also want to argue that in rejecting the concept of ideology we need to be careful not to throw the baby out with the bath water. The notion of ideology as distinct from science is not useful. Nor is the determinism with which it was inextricably bound up. However, ideology critique cleariy linked the historian to the position of the oppressed, and that I think is valuable. The work of historians like Figlio has taught me the value of taking up the position of the marginalised in order to account for the development of dominant ideas and techniques in science. I think that through an understanding of repressed exclusions we can better map the contours of the landscape of scientific ideas and practices in which we live for those who have been disempowered by them and want to change them.73 if we as historians of science and technology confront our own positionality, this is I think a position which, despite all its difficulties, is worth hanging onto. I want to argue for a politicised approach to technologies and to scientific knowledge in which the account of the historian is linked to the goals of those groups who lose out in the construction of new socio-technical networks. Network builders mobilise localised knowledge production strategies circulated amongst historically contingent individuals, groups and audiences, in the pursuit of particular power effects. As an historian of intrauterine device technology I need to decide, even if I dont seek to control everything, what effects my own texts are aiming for. This thesis is an historical and sociological study of the intrauterine device which is located as an articulator between the carriages occupied by interest groups who have suffered at the hands of the histories of the device that I am trying to displace.
73 This position is beautifully elaborated in Star, 'Power, technology, and the phenomenology of conventions: on being allergic to onions', 1991. 49
The argument and structure of the thesis The aim of this thesis is to provide an historical account of the development of the intrauterine device as a contingent construction of the particular politics of the research communities responsible for the design and testing of intrauterine devices, the medical professionals responsible for their insertion, the women into whose bodies they have been inserted, and the wider society, within which all these groups are embedded. I want to explore the question of how the intrauterine device came to be significant for a variety of social groups with different goals and interests, and how for those groups the intrauterine device took on certain meanings which aligned it with those goals, transforming them, but simultaneously itself being transformed. The thesis offers a sociological history of the intrauterine device: a history of the invention and development of the devices, of the changing requirements for producing an effective contraceptive, of shifts in the material conditions determining how knowledge claims could be expressed, of the alterations in interest groups (and their alignments) as they sought to bring their goals to bear on the intrauterine device, and on the historical conceptualisations of the body into which the intrauterine device was to be inserted. I tell the story of the social construction of a series of collectivities or socio-technical networks, each with their own attempts at engineering alternative futures. Chapter 2 describes the invention of the intrauterine device. It asks how this technology came into existence and how it was taken up. Was It the result of applied science? Can it be seen as an invention with a single inventor? Was it a response to social demands? Whose needs determined its use? Why was its success limited to the margins of medical practice? Chapter 3 traces the resurrection and development of the intrauterine device from the end of the 1950s through the 1960s. It delves into the techno-scientific 50 machinery for the re-production of this technology as a safe, reversible contraceptive. Chapter 4 focuses on the failure of one intrauterine device - the Dalkon Shield - and on the efforts to construe this device as defective, and to minimise the damage wrought by this failure to the continuing development of intrauterine devices. We see how boundaries are created and how new actors, such as the state, are called on to legitimate techno-scientific processes. In chapter 5,1 examine the evolution of the copper intrauterine devices in the post-Dalkon Shield field. I question whether this innovation was simply the result of a natural developmental trajectory aimed at improvement. This chapter ends with a discussion of the legal challenge to the Gopper-7 intrauterine device, and the effects this has had on intrauterine device development and distribution. Chapter 6 explicitly poses the question of just how far we can go in seeing intrauterine devices as socially constituted. It is a dialogue with other sociologists and historians of technology who are confronting the problems posed when we recognise that truth is not simply a matter of correspondence with a real world. If we accept that knowledge claims that are presented as representing the natural world, or as describing the effects of a technological change, are actually constructions, are we simply repeating traditional dichotomies that align women and nature with passivity. In other words does constructivism lead us back to a denial of women's bodies and women's experience as active agents? This chapter also analyses gender in the intrauterine device controversies. How does male supremacy get built into the practices constitutive of intrauterine device technologies? Is it deformed, or translated, during such a transformation? How have women resisted, and themselves been active in shaping contraceptive technologies to articulate with different power alignments between the sexes? Who speaks for women's bodily experience of intrauterine devices, and does it matter? This chapter historicises gender, contrasting the intrauterine device of the 1920s 51 with its fabrication of gendered power-relations, to the 1960s and 1980s intrauterine devices with their specific gender productions and alignments. In conclusion I draw out the implications of this history of the intrauterine device for current regulatory frameworks governing the assessment of therapeutic device risks and benefits. 52
CHAPTER 2
From local tinkering to global network: silk coils, family limitation and sex reform
The eariy history of the intrauterine contraceptive device, spanning the period from the beginning of the twentieth century to the end of World War II, took place at the intersection of three social movements. It is a story about the building of national and international organisations in which women sought equality through the reform of marriage, reconstructing it as a partnership of equals cemented together by the free expression of sexual passions. Scientific contraception was to provide the means for women to control their reproductive lives whilst pursuing their sexual desires. It is also the story of the growth and development of a response to the upheavals of industrialisation, in which urban squalor was feared as race degeneration, and governments were called on to provide institutions centrally concerned with biology and health, as the means of ensuring a fit and healthy population. Simultaneously, it is the story of the gradual acceptance by medical professionals that the provision and development of contraceptives was a legitimate field of medical practice. In this chapter I analyse the processes deployed by medical practitioners and birth control agitators that interactively led to the development of the Intrauterine contraceptive device. For much of the period before Worid War II the coil, as it became known, remained an object of condemnation and suspicion. But the global distribution and information exchange networks built by family limitation movements in the inter-war years ensured that the intrauterine contraceptive device became available in a few hard won local contexts as a stable, if frequently condemned, object. After 53
World War II it could be picked up by groups concerned with such varied struggles as the improvement of the public health of women and children, averting a feared population explosion in the developing world, and the protection of women from the side-effects of the Oral Contraceptive Pill. This chapter tells the story of the intrauterine device from the first decade of the twentieth century up to World War II. It is about the invention of the intrauterine device. Conventionally, inventions are portrayed as the products of creative minds. Technological innovations are said to occur when such inventions are tested and judged by a community to be superior to existing technologies. The dispersion of a technology, according to such accounts, is simply a matter of communication, supply and the overcoming of convention and prejudice. Work in the sociology of science and technology over the past decade and a half has shown this model of innovation to be inadequate, as outlined in the previous chapter. In particular, the assumption that the scientific method, or some special form of technical rationality, guarantees the exclusion of socio- historical influences has come into question. Methodologically, I have chosen to avoid making any a priori assumptions concerning the role of the scientific method, or any special form of technical reasoning. In contrast to this approach, I set out in this chapter to account for the appearance and stabilisation of the intrauterine device as a recognisable contraceptive. Existing social and historical influences on research directions and device distribution for contraceptive technologies have long been recognised.i Moral resistance by physicians and governments to the use of contraceptives in the first half of this century certainly influenced their development and availability. However, society is not usually thought of as influencing the design of new technologies or the content of scientific knowledge claims concerning their efficacy and safety. It is my argument
1 For example see Walsh, 'Contraception: The Growth of a Technology', 1980. 54
throughout this thesis that processes of discovery, design, and testing are social through and through, and, like distribution and research direction, these phases of scientific and technological development are social activities, and as such are subject to the influence of the wider society. There is no separate realm of the purely technical. Any account attempting to understand the development of the intrauterine device would be incomplete if it exempted these processes from sociological scrutiny. This chapter is concerned with the construction of the intrauterine device. When speaking of the intrauterine device I am not only referring to the device. Technologies are not simply artefacts but are better thought of as technological systems.2 The intrauterine device is a contraceptive system integrating manufacturing know-how, materials, techniques of sterilisation, packaging and transportation, clinical skills for insertion and means for teaching such skills, health delivery mechanisms, particular norms of sexual behaviour and self-surveillance, specific models of the body and its physiological processes, and specific legal and regulatory contexts. In this chapter I am interested in how groups and individuals advocating the intrauterine device constituted it as a particular technological system with its own internal architecture forged from the linkages between people and skills, texts and materials, distribution settings and research questions. 1 am also interested in how the actor-groups advocating the intrauterine device managed the translation of this technology, from its somewhat obscure local origins in Germany, to a medically sanctioned birth control method available in different continents. 1 examine the action of intrauterine device protagonists; the environments in which they worked that impacted on their choice of action and its effectiveness; and the specific local contexts involving routine
2 The systems metaphor was used in the collection The Social Construction of Technological Systems by Bijker, Hughes and Pinch. 1987. It was developed by Hughes in Networi
The contraceptive context The use of contraceptive methods was widespread well before the introduction of the oral contraceptive pill during the 1960s. It is possible to talk about a contraceptive culture being in existence in the West by the last two to three decades of the nineteenth century. I will use the term contraceptive
3 Fujimura, 'Crafting Science', 1992. Fujimura uses the term 'standardized packages' to refer to the set of theories and methodological techniques adopted by many members of a research community that stabilise a network of actors in which the meaning of a term, in her case cancer, is shared. It is, like Hughes' metaphor of the technological system, a useful reminder that concepts such as genes and cancer combine with standardised methods such as recombinant DNA techniques in ways that interact. Processes of co-restriction facilitate fact stabilization within communities but they also facilitate interaction and communication where different social worids meet. 57 culture to signify an overlapping of communities where people sought out means for 'family limitation', where various means and techniques were invented or adapted and made available for doing so, and where organisations existed for the promotion of contraceptive knowledge, techniques and desires. This contraceptive culture was fragmented and varied. I do not mean to characterise it as uniform even amongst the classes of one country, much less to extend such generalisations across countries. Nevertheless, it was the background against which the intrauterine device was developed. It provided the resources both practical and representational for the work that went into the construction of the intrauterine device as a viable contraceptive method. By the first decade of the twentieth century, population was already an entity to be improved; women could readily be identified, at least amongst some groups, as wanting and using contraceptives; some doctors, even if under attack from their colleagues, were involved in networks providing contraceptives and contraceptive information; and certain social movements had amassed considerable experience in skirmishes with the state over questions of legality. It is not my purpose in this section to provide a complete history of the emergence of all of these entities. Rather, I set myself two much more limited tasks. First, I provide some evidence that contraceptive networks were already well established and involved large numbers of people in industrialising nations at the turn of the century. Second, I explore some of the characteristics of such networks.
Demographic data provide indirect evidence for the existence of a contraceptive culture. In Europe the falling birth rate was cause for considerable alarm in the early years of the twentieth century, as national strength became equated with population. In Britain declining birth rates were regarded as a sign of decay by both politicians and the popular media. A Fertility of Marriage Census conducted in 1911 in response to such concerns 58 reported the decline of the large family. In the 1870s, 13.5% of families had 9- 10 offspring. This had fallen to only 4% by the first decade of the twentieth century. At the other end of the scale the number of families with only one or two children had risen three-fold, from 12.5% of Victorians to neariy a third of those couples marrying from 1900 to 1910.4 France was well known in Europe for its low birth rates in the period before the Great War, despite the attitudes of its pro-natalist government which frequently pointed to the higher birth rates of its German neighbours as a military threat.5 But Germany's birthrate had also begun to decline by 1895, falling by more than two thirds by 1935.5 This trend was similar in the United States. Demographers worried over the declining birth rate amongst white American women. They reported a fall in the number of children per family from an average of just over 7 children in 1800 to 5.21 in 1860, and 3.56 in 1900.7 In Australia, the Royal Commission on the Decline of the Birth Rate in New South Wales, reporting in March 1904, plotted declining age specific birth rates for all age groups from 20 to 45 between 1891 and 1901. It concluded that there had been a 'sudden and remarkable shrinkage of the birth rate among women of all conceptive ages'.5 In the later years of the nineteenth century the causes of such demographic declines were frequently the subject of speculation . Herbert Spencer, the social Darwinist, saw the population decline as natural, a progressive characteristic of evolution. Using his theory of 'individuation and genesis', Spencer argued that as organisms became more complex they consumed greater energy and nutriment from the environment so that they became less fertile and produced fewer individuals. Resources adequate for large numbers of a less developed population would support fewer of the
4 Soloway, Birth Control. 1982, p. 8. 5 Angus McLaren, Sexuality and Social Order. 1983. 6 Woyke, Birth Control in Germany. 1988, p. 1; Weindling, Health. Race and German Politics. 1989, p. 189. 7 Reed, The Birth Control Movement. 1978, p.4. 3 Hicks, This Sin and Scandal. 1978, pp. 18-21 & 40. Royal Commission on the Decline of the Birth-Rate. Volume 1.1904. 59 more complicated, energetic, intellectually superior individuals.9 Others blamed the falling birth rate on the extensive migration from rural areas to overcrowded cities, with fertility degeneration seen as an inevitable consequence of urban squalor and overcrowding. 10 Natural cycles of storage and expenditure of 'racial energy', reflecting fluctuations in germinal activity, was a popular explanation amongst demographers for the downward trends they were finding.""i The rise in militant women's campaigns raised the charge that higher education was sterilising the nation's better class women.''2 But the spectre that population decline was resulting from the widespread practice of contraception was given a high profile. At least in Britain, the small and widely denounced Neo-Malthusian League, used every opportunity to claim success for its activities promoting contraception. This may have been an attempt to inflate its influence, and legitimate its advocacy of the practice of family limitation, but it was a view that governments did not neglect. 13 In Australia contraception also became a culprit. By the early years of the twentieth century the fledgling Australian government was experiencing a wave of political concern over its falling birth rate. Australia was seen as an empty, uninhabited land, a country waiting to be populated with the superior European race as its own aboriginal people continued to die out under the force of Danrt/inian competition. Whilst we now know that this emptiness was both a fiction and achievement of the white settlers, at the beginning of the twentieth century Australia was seen by many as offering ideal conditions for raising prosperous families. The declining birth rate was lamented by many commentators. 14 There was no doubt in the minds of the Australian
9 Soloway, Birth Control. 1982, pp. 14-15. 10 Soloway, Birth Control, p. 6; Weindling, Health. Race and German Politics. 1989. pp. 189- 90. 11 Soloway, Birth Contrpl, p. 12. 12 Soloway, Birth Control, pp. 142-143. 13 Soloway, Birth Control, particularly chapters 3, & 9. 14 Quoted in Hicks, This Sin and Scandal. 1978, p.40. Royal Commission on the Decline of the Birth-Rate. Volume 1.1904. See also Volume 2, for detailed hearings on the availability of contraceptives in the colony. 60 commissioners reporting on the declining birth rate in New South Wales in 1904 that the country's ambition to become a great nation was being thwarted by the widespread and growing practice of 'deliberate interference with the function of procreation'i5. Contraceptive techniques and the resort to abortion, preached by the vicious doctrine of family limitation, were, the commission concluded, leading the people astray so that they were 'neglecting their true duty to themselves, to their fellow countrymen, and to posterity'. 15 The publicity created by state concerns that falling birth rates were a sign of national decay certainly contributed to the popularisation of techniques of family limitation. In Britain and Australia widespread newspaper reporting accompanied such events as the British trial of Annie Besant and Charles Bradlaugh in 1877 for distributing Charles Knowlton's Fruits of Philosophy, an explicit tract on family limitation first published in 1832.17 in the United States the press brought knowledge of the existence of methods of family limitation into every home with ongoing coverage of campaigns by Margaret Sanger to overturn the Gomstock law, passed in 1873 to prohibit the use of the United States mail for the distribution of obscene materials - including preventatives. 15 That such knowledge was acted on by many, despite the ovenwhelming condemnatory stance taken towards family limitation by both governments and medical professionals is supported by the demographic evidence already cited. Additional evidence is provided by reports that by the first two decades of the twentieth century there was sufficient demand for contraceptive information and appliances to support a thriving commercial manufacturing and retail industry. By the 1920s abortifacient pills, contraceptive supplies, and literature were readily available in most of the industrialised western nations through 'rubber shops' or through mail order
15 Cited by Hicks, This Sin and Scandal. 1978^ p. 21. See also Siedlecky and Wyndham, Populate and Perish. 1990, ch 1. 16 Hicks, This Sin and Scandal. 1978, p. 29. 17 Knowlton. Fruits of Philosophy. 1832. 13 Kennedy, Birth Control in America 1970. 61 services.i9 Techniques and devices discussed in such advertisements and tracts included douching, the use of the sponge, caps and diaphragms, chemical suppositories, condoms, and mechanical pessaries. In Australia for instance, the New South Wales Commission found that stem pessaries, sheaths and Rendell's quinine suppositories were being imported in growing numbers.2o Some indication of the extent to which such artificial methods of birth control were in use is provided by retrospective surveys which included questions on past usage of contraception.21 Neuman reports the German research of Max Marcuse who interviewed a hundred women attending his Berlin skin clinic for treatment from 1911 to 1913. These women were the wives of mechanics, saddlers, bricklayers, and semi-skilled factory workers. Of Marcuse's respondents, two-thirds had used some method of birth control; one in four had aborted a pregnancy; and by far the most common means of preventing conception reported was coitus interruptus, sometimes in combination with douching.22 nimes reports information from a number of English speaking countries to show the 'democratisation' of birth control. United States studies reported a range of 60 to 95% of women having knowledge of and practicing birth control. For example, Kopp interviewed 10,000 patients at the New York Birth Control Clinic Research Bureau in 1934. He found that 93.3% of the women claimed to have used some method besides abstinence to prevent conception. Withdrawal, the condom, and the douche were the most frequent methods. Suppositories, cervical pessaries.
19 Himes, Medical History. 1970, pp. 326-330. 20 2nd volume of the Royal Commission on the Decline of the Birth-Rate. 1904. 21 There are many problems involved in interpreting these studies as providing an overall picture of contraceptive practice. Surveyors were often reluctant to ask people atx)ut the techniques and devices they used and the larger studies were not conducted until the late 1920s. Much of the data was collected by the early birth control clinics through sun/eys of the past practices of their patients. Such studies cannot be taken as representative of the population, and these eariy researchers were breaking new ground in extracting confessions in an area of practice still considered by many as not appropriate for public discussion. But such studies do give some idea that contraceptive techniques were in widespread use and that information on contraception had permeated all classes. ^^ Neuman, 'Wori
23 Himes, Medical History. 1970 24 Neuman, 'Working Class Birth Control in Wilhelmine Germany' 1978, pp. 418-419 & 424- 427. 63 most people found out about contraceptive techniques from other workers or friends. Military service, domestic work, co-workers, older women, door to door pedlars, newspaper advertisements, and cheap pamphlets were the main means by which people obtained contraceptive and abortion information and services.25 Some doctors were actively participating in the contraceptive culture, not simply as users, but busily engaged in diaphragm fitting, the insertion of stem pessaries (a forerunner of the intrauterine device) and the provision of information. This role Increased with the growth of contraceptive clinics in the 1920s and 1930s. Here doctors played a significant role in providing contraceptive advice and appliances. By the beginning of the twentieth century, this contraceptive culture was increasingly recognised by authorities and agitators alike. Whether for purposes of condemnation or proselytising, the decline in the birth rate was increasingly linked to contraception. The specificities prevailing in each country and amongst different sectors of the population within a country varied, and such variations no doubt influenced contraceptive practice. It has been my purpose here not to investigate these particularities, but to provide some general evidence of a contraceptive culture extending across nations, and across class boundaries. The existence of such a contraceptive culture is crucial to note as it provides the background conditions against which, and in relation to which, the action that led to the invention of the intrauterine device occurred. My argument is not that such a contraceptive culture was a new phenomenon in the eariy decades of the twentieth century. Rather, my focus has been on the changing contours of the contraceptive field - the increasing involvement of doctors, the involvement of demographers in the generation of a political crisis linking lack of population and contraception; and the institutionalisation of the birth control movement through the building of clinics and growth of commercial supply
25 Neuman, 'Worthing Class Birth Control in Wilhelmine Germany',1978, p.417. 64 shops and clubs, and, as I will later show, through the strengthening of international co-operatoion and organisation. A closer consideration is now required of the immediate context for the development of one such innovation, the intrauterine device. In the next section I turn to the particular conditions pertaining in early twentieth century Germany and the activities in contraceptive innovation they stimulated. Why was it in Germany that the intrauterine device was invented? I do not want to argue a causal relation between conditions and events in Germany and the invention of the intrauterine device. However, I do think that an understanding of the social conditions pertaining in Germany, particulariy the state of organisation of medicine and public health, provides a partial explanation for the proliferation of tinkering with contraceptive technologies that occurred amongst health professionals. It is my contention that he specific conditions pertaining to Germany in the years following World War I make it unsurprising that it was there that such a technology as the intrauterine device emerged.
The immediate stimulus for experimentation - Local tinkering in Germany, 1900-1930.
Germany and the politicisation of health The early years of the twentieth century saw the emergence in Germany of a dynamic social movement founded on the synthesis of Dan/vinian biology, sex reform, hygiene and public health. Advocates put their faith for improving the quality of the population, and often their own lives. In the hands of medicine. Biology was appealed to for its capacity to humanise industrial society, restore natural values, and maintain the health, fitness and vigour of individuals. State involvement in the biomedical sciences and the 65 biological supervision of its citizens would ensure progress, prosperity and civilisation.26
Germany, by comparison with Britain and neighbouring France, industrialised late and rapidly. In a single decade during the 1890s the demography of Germany changed, with large families characteristic of rural economies giving way to smaller families.27 Generally speaking, following Germany's defeat in World War I, activists from the right and left agitated for state involvement to improve the quality of the population. People's health came to be seen as a major problem for national strength, and in need of urgent attention if Germany was to realise its goals of national unity, stability, progress and imperial expansion. Conservatives called for the regeneration of the elite Aryan race as the way to preserve German cultural achievements in music, the arts and in science.28 Socialists equated class struggle with the struggle for sun/ival and espoused socialism as a higher evolutionary stage in which the redistribution of wealth would overcome the contradictions of capitalism.29 Communists organised mass movements around the rights of workers to sexual pleasures, campaigning alongside socialist and non partisan groups for the repeal of anti-abortion laws and laws forbidding the advertising of contraceptives.30 Popular campaigns demanded abolition of marriage and divorce laws, support for collective child-rearing and 'free treatment of sexual dysfunction caused by capitalism and the bourgeois family'.3i Both right and left advocated the revival of Germany's Volk through the strengthening of German families, and recognised the new women voters through appeals to a rhetoric of women's special contribution to the formation
26 Weindling, Health. Race and German Politics. 1989. pp. 1-10; Bridenthal, Grossman, and Kaplan, When Biology Became Destiny. 1984, pp. 1-29. 27 Usborne, The Politics of the Body in Weimar Gemianv. 1992. pp 1-4; Weindling, Health. Race and Remnan Politics.1989. pp. 189. 23 Weindling. Health. Race and German Politics.1989. pp. 109-112. ^^ Weindling. Health. Race and German Politics.1989. p. 95. 30 Grossman, 'Abortion and Economic Crisis', 1984. 31 Grossmann, 'Satisfaction Is Domestic Happiness', 1983; Hackett, 'Helene Stocker', 1984. 66 of the new Germany. They differed over how this was to be achieved - the left supported better social welfare schemes, maternity and health-care benefits, childcare centres, an end to the stigma of illegitimacy, and the repeal of abortion laws; the right supported schemes for colonial replenishment and a return to the healthy rural lifestyle, the revitalisation of domestic tasks through the establishment of home economics centres, the strengthening of school education, and the expansion of the number of women social workers.32 German Darwinism was appealed to in support of welfare, free medical care, and sometimes in support of family limitation for workers seeking to improve their standard of living. The anti-evolutionary pressures of such welfare measures were to be countered by eugenics and the special role of women in building community.33 The adoption of socially conscious approaches to reproduction and child rearing thus became central to all political parties.
The non-interventionist politics of laissez-faire economic policies were swept aside from as early as the 1890s when they were blamed for such horrors as the cholera epidemic that raged through Hamburg from 1891-2.34 Certainties that individualism and competition, free from government interference, would lead to progress and maximise individual fitness gave way, in the German context, to organicist understandings of the nation as a cohesive organism with systems of integration requiring careful tending by governments. Under the Weimer Republic this Darwinist organicism was translated into a language of support for a strong state with the responsibility to balance the problems associated with industrialisation - poverty, unemployment, and overcrowding - with the required welfare and integrative institutions which would function much like the central nervous system of living
32 Bridenthal and Koonz, 'Beyond Kinder, Kuche, Kurche', 1984; Weindling, Health. Race and German Politics.1989. p. 79 33 Koonz, 'The Competition for Women's Lebensraum, 1928-1934', 1984. Eugenics was not necessarily a racist movement and many of its forms, including those motivated by rightist consen/ative values, particulariy in the eariier years, were inclusive of Poles, Jews, and all classes. 34 Weindling, Health. Race and Gfirm^n P"!iti^?,iQ»Q p. 15. 67 organisms, controlling the parts so that they functioned as a cohesive whole • the body politic.35 Women's groups, biological theorists and medical practitioners found themselves thrust to the centre of debates over social organisation. The involvement of the state in the health status of the population was achieved practically through the extension of health insurance models. In 1883 Bismark had introduced compulsory sickness insurance, later extended to cover disability and pensions. This was a popular measure that replaced coercive poor laws which resulted in the splitting up of families and the stigmatisation of those interned in work-houses. Sickness insurance covered twenty percent of the population by 1913. At first it was only the more skilled and prosperous sector of the male work-force that came under the ambit of health insurance. But gradually schemes extended their cover to workers' wives and families.36 Some insurance funds became involved in preventative measures, subsidising tuberculosis sanatoria, health education and the provision of health clinics, some of which distributed information and devices for birth control. Many municipal authorities also became involved in health provision. Tuberculosis, venereal disease and high rates of infant mortality were targeted as health problems requiring medical policing. Measures for disinfection, surveillance of school-children's health, and compulsory treatment of venereal disease were sometimes difficult to implement; they gave rise to campaigns to limit the authority wielded by governments in the interests of public health. The provision of clinics and campaigns for lifestyle reform, melding health with voluntarism, were more acceptable, and spread rapidly. Some of these clinics provided contraceptives as prophylactics against venereal disease.37
35 Bridenthal, Grossman, and Kaplan, When Biology Became Destiny. 1984, pp. 1-29. 36 Weindling, Health. Race and German Politics.1989. p.16. 37 Weindling, Health. Race and German Politics 1989 pp. 350-358. 68
By the 1920s working class sex reform movements began to grow in membership. These movements were an important means through which linkages between key groups of people were formed: lay people learned to turn to medical experts for advice on contraception; doctors concerned with contraception were brought together with each other; and medical practitioners were put in contact with people whose desperate poverty, particularly in the period of hyperinflation that followed World War I in Germany, was leading them, in increasing numbers, to demand the means to limit the size of their families.38 The growth of the sex reform movement was fuelled by laws which prevented advertising of contraceptives, laws which could not be used against the distribution of information and devices to members of organisations. Controlled by lay people, organisations that sometimes began as fronts for business interests grew into genuine mass movements with newsletters crammed with advice on contraception and sexual technique, clinics for the distribution of contraceptives, and public question and answer sessions on contraception, sexology and eugenics. Many socially committed doctors were active in sex reform associations. The associations were often well organised, drawing on the resources of the major left political parties whose efforts in organising the sex reform movement rivallled their efforts in the trade union movement. There were more than 150,000 members in populist, Neo-Malthusian socialist organisations by 1933 when the National Socialists came to power and forced birth control underground. The largest sex reform organisation was banned by the Nazis. Works on contraception and the works of sexologists were burned on the streets. Contraceptive clinics were appropriated for racial hygiene, and turned into sterilisation clinics and centres for eugenic counselling.39
^5 Grossman, 'The New Woman', 1984. 39 Grossmann, 'Satisfaction Is Domestic Happiness', 1983; Bridenthal, Grossman, and Kaplan, When BiplogV Bgpamg DgStiny. 1984; Proctor. Racial Hygiene. 1988. 69
I began this section by asking: what conditions pertaining to Germany in the eariy twentieth century were conducive to medical experimentation with contraceptives by medical men? In summary: sex reform movements, municipal clinics and sickness insurance schemes provided accessible medical services that put many doctors in day to day contact with the living conditions of workers and their families. But it was the dispersion of authorities responsible for health, and the vigorous pursuit of health as an integral and populist political agenda, that meant that with local politics varying greatly, some clinics and funds were willing to experiment with the development and distribution of contraceptives, despite mainstream political opposition to birth control.
Local tinkering - a proliferation of contraceptives and the emergence of the fully internal intrauterine device By 1910 in Germany there had been a great many technical innovations in birth control devices. The burgeoning pharmaceutical industry was experimenting with creams and chemical pessaries which could be produced cheaply and sold at a cost workers could afford.4o Messinga invented the occlusive pessary as a contraceptive for women. The Messinga diaphragm was widely distributed as a female-controlled technique for fertility control. The diaphragm particularly appealed to birth control organisations in which doctors had influence; it was seen as a scientific contraceptive and its fitting was seen as a skilled medical procedure. Lay controlled organisations promoted suppositories and spermicidal creams; these could be distributed without the aid of a doctor and were perceived to be methods easily used by recipients.4i
40 Grossmann, 'Satisfaction Is Domestic Happiness', 1983. 41 Grossmann, 'Satisfaction Is Domestic Happiness', 1983. p. 269. 70
Other doctors experimented with stem pessaries. These devices, sometimes called elevators, had been used from as eariy as 1868 to enhance fertility. They consisted of a curved hollow metal stem that was inserted and left in the neck of the womb to straighten it out and open the way for the sperm. On the end inserted into the uterus there were sometimes opening wings that would hold the elevator in position. On the outside end was a ring that fitted over the cervix. This was later closed off in some designs and the device marketed as a contraceptive with sperm deterred from entering the cervix by the button or cap which fitted over the os.42 The Sterilett or Obdurator was one such contraceptive stem pessary developed in Germany. In 1902 a Dr Hollweg of Magdeburg faced criminal charges for five counts of negligence causing actual bodily harm for inserting stem pessaries for purposes of contraception. He defended himself by claiming to have inserted 700 other such devices without mishap.43 The Pust Pessary was a less lethal looking German innovation. The hard stem was replaced by a silk gut cord which opened out into a ring inside the uterus, holding a button-like occlusive over the os at the outside opening of the cervix.44 Braun added uterine projections in an attempt to catch any sperm that evaded the action of the external occluder. Dr Richter of Waldenburg is often attributed with the invention of the true intrauterine device in 1909.45 This device dispensed altogether with the button on the outside of the cervix. From 1909 Dr Ernst Grafenberg also experimented with various- shaped devices for insertion inside the womb as contraceptives. He tried a star-shape wound from silk worm gut, a circle of gut wound with silver thread,
42 Surtters, The History of Contraceptives.1967. 43 Woyke, Birth Control in Germany. 1988. pp. 42-3. 44 Tietze,' Intra-Uterine Contraceptive Rings: History', 1962. 45 There is some evidence that devices such as collar studs were inserted into the uterus for purposes of contraception in the late nineteenth century. Perhaps these should be considered the early intrauterine devices. See Letter from W St. C. Symmers, 'An I.U.C.D. Dating from 1890, British Medical Journal. 5 May 1973, p.302. 71 and later a pliable silver wire ring.45 Such innovations resulted in a greater variety of birth control methods . In Germany these various combinations of items were procurable not only from specific clinics for birth control and maternal health, but also from pedlars, drug stores, sympathetic socialist doctors, some mid-wives and naturopaths, and from the flying lay distribution centres of the sex reformers. This phase of the development of the intrauterine contraceptive device was one of local tinkering. Various adaptations of devices were tried. Criteria for judging whether they worked or not were idiosyncratic. All kinds of contraceptives were subject to a variety of chemical and mechanical tinkering and advertising and distribution ingenuity, in an attempt to get them working and to improve their efficiency. This involved constructing an alliance between a series of non-human actors, characterised in a variety of ways by the stem pessary modifiers. The fertilised egg had to be locked-in to the alliance, in such a way that its only option was to give-up the struggle to implant and grow into a foetus. Different materials were tried, and different shapes. The egg had its own allies which had to be guessed at, characterised, and from which it had to be prised loose. The expulsionary action of the womb trying to rid itself of foreign bodies was one such potential ally that those tinkering with intrauterine devices had to negotiate. Various shaped devices were tried in successive attempts to minimise expulsions. Circles were found to be better than stars, and the more rigid forms made from silver or gold wire better than the devices made from silk thread. Moreover, the different types of contraceptives competed to capture the many possible human interest groups involved with contraception.
The intrauterine device was certainly successful at constituting itself in such a way that crucial non-human entities were linked together and behaved in more or less predictable ways, and in such a way that crucial human allies
46 Gr&fenberg, 'The Intra-Uterine Method of Conception', 1930. 72 were enticed to play particular roles necessary to that success, at least in certain local areas. A 1913 survey into intrauterine device use reported the devices to be in widespread use throughout northern and central Germany and in urban areas.47 The more radical sickness funds, such as those in Berlin, sponsored public lectures on contraception in which information was presented on the diaphragm and the intrauterine device, with both rated highly as contraceptives. Perhaps the explanation for this success is that the advocacy of these intrauterine devices fitted well with the rising faith mass movements were beginning to place in science to solve social problems. Conversely, the effective deployment of German traditions of lay activism on sex issues to build support for new contraceptives, including the intrauterine devices, may account for this success.
Grafenberg establishes the intrauterine device as a contraceptive paradigm The name most frequently remembered in association with intrauterine device history is that of Dr Ernst Grafenberg. Grafenberg's most important innovation was not the particular shape of his devices but the packaging of his device with an accompanying paper technology. He took his appeals to a global network sympathetic to birth control where he could target practising gynaecologists and medical practitioners as crucial to the successful operation of the intrauterine device. He rhetorically translated the intrauterine device - with no protuberances into the cervix or vagina - into an original and new birth control technique bearing no relation to the so-often-condemned stem pessaries. Furthermore he developed new statistical criteria for determining the success of intrauterine devices, replacing the anecdotal case experience on which advocates of the harmfulness of the devices relied. Having succeeded at enrolling bits of twisted silver wire and silk gut into his
47 Woyke, Birth Control in Gennany IQRR 73 network, negotiating with the expulsionary action of the uterus, Grafenberg now sought to stabilise the enrolment of medical practitioners into a network sufficiently strong that it could move from the local to the global level. Ernst Grafenberg was born in 1881 into a Jewish family at Adelebsen, Germany. Having studied medicine at the Universities of Gottingen and Munich he passed the state medical examination in 1905. After working for a time in eye research he overcame prejudice against his Jewish origins and studied obstetrics and gynaecology at the University of Kiel, moving to Berlin in 1910 to begin his own practice. His practice thrived. He attracted wealthy patients from the arts, business and the diplomatic corp and was appointed head of gynaecology in a municipal hospital were he saw the wives and daughters of tradesmen and factory workers.48 Hans Lehfeldt, writing Grafenberg's biography, notes that he extended the same rights and freedoms to his working class patients as to the wealthy, offering them abortions and contraceptives.49 Grafenberg used his position as a gynaecologist to actively campaign for medical acceptance of contraception, and was active in the sexology movement. He lectured effectively on the intrauterine device, working hard to entice doctors into an alliance he perceived as crucial for the method to be used safely and effectively. His first series of lectures on the device was given at a postgraduate course organised by Margaret Sanger in Berlin in 1928. The following year he presented a lengthy and carefully written paper at the Sexual Reform Congress in London, and again at the 1930 International Birth Control Congress in Zurich. But in his own country the tide was turning against him. His final attempt to enrol his medical colleagues was in Frankfurt in 1931.50 He kept his presentation brief. But in his friend Lehfeldt's words.
43 Lehfeldt, 'Ernst Grafenberg and his ring,' 1975. 49 Lehfeldt, 'Ernst Grafenberg and his ring,' 1975. p.346. 50 Lehfeldt, 'Ernst Grafenberg and his ring,' 1975. p.348. The Grafenberg addresses appeared as the following publications (from Lehfeldt): Silk als Antikonzipiens', in Gerfaurtenregelung: Vortrage und Verhaundlungen des Arztekurses vom 28-30 Dezember 74 this did not prevent it 'unleash(ing) a tempest of controversy'.5i The Grafenberg Ring was denounced by the country's leading gynaecologists as extremely dangerous.52 Lehfeldt tells us that Grafenberg remained in Germany for another nine years, but that his birth control activities were severely curtailed under the pro- natalist policies of the National Socialists. Despite having the wives of high ranking Nazi officials as his patients he was arrested in 1937. The transfer of a considerable sum of money to the Nazis by Margaret Sanger led to his release from imprisonment and his arrival in the United States in 1940.53 There he was advised not to continue his work with intrauterine devices by leading gynaecologists.54
Earlier, Richter had written a paper about his own device, with accompanying illustrations.55 Published in Deutsche Medizinische Worchenschrift it discussed when the use of a contraceptive device was indicated, gave instructions on how to insert the device and how to manage cases, particularly those in which complications arose. Grafenberg's paper, presented to the Seventh International Birth Control Conference in 1930, is a statistical analysis of the results of the use of his devices by one and a half thousand of his patients. He reported a failure rate of 3.1% for the silkworm gut rings and 1.6% for the silver rings.56 Grafenberg consolidated his patient records and reduced his experience with the devices to a handful of figures.
1928. Edited and published by K Bendix, Beriin, 1929; 'Die Intrauterine Methode der Konzeptionsverhutung', in Haire, Proceedings of the Third Congress of the World League for Sexual Reform. 1930; 'The Intrauterine Silver Ring', 1930; and 'Einfluss der Intrauterine Konzeptionsverhutung aud die Schleimhaut', Arch f Gynacol. V. 144,1931. p.345. 51 Hans Lehfeldt, 'Ernst Grafenberg and his ring,' 1975. p.348. 52 Lehfeldt cites the following as key denunciations: L. Fraenkel, 'Discussion', Archiv f Gynak 144, p.380,1931; and S. Aschheim, 'Discussion', Archiv f Gynak 144, p.374,1931. 53 Hans Lehfeldt, 'Ernst Grafenberg and his ring,' 1975. p.346. 54 Personal communication, Hans Lehfeldt, March 1991. In fact he did continue his work on intrauterine devices, as Lehfeldt notes, working with Hall in the early 1960s to produce a stainless steel version of his ring, but he kept this work very quiet and never again played the network building role he had begun in the 1920s. See Hans Lehfeldt, 'Ernst Grafenberg and his ring,' 1975. p.352. 55 Richter, 'Ein Mittel zur Verhutung der Konzeption', 1909. 56 Grafenberg, 'The Intrauterine Silver Ring', 1931. 75
This introduced a new measure of the success of the ring in a bid to overcome the reluctance of his medical colleagues to insert the devices. His wealth of experience was condensed into a few easily transportable percentages that found their way into the offices of a variety of medical practitioners interested in birth control. What had previously been a local judgement made by an individual physician against the background of their personal experience, usually with a handful of intrauterine device insertions, was transformed. Advocates of intrauterine devices now had a weapon against the steady trickle of anecdotal injury reports in the medical literature. The pro-natalist medical lobby's attempts to associate birth control in general, and intrauterine devices in particular, with harm by using these reports was rendered less effective. 57
Grafenberg's intrauterine device tied together several crucial elements. He insisted that this was a contraceptive technology that required expert medical insertion conducted under sterile conditions. This was to remain a feature of intrauterine devices. Grafenberg broke with eariier traditions of peddler supply, with women seeking any of a number of health practitioners as inserters. Second, Grafenberg named his device a new method of contraception. He declared that it was not a kind of stem pessary and insisted that there be no attachment descending from the uterus into the vagina. This, he claimed, was what caused infection and had rightfully led to medical condemnation of stem pessaries, along with abortion, as quackery and dangerous to individual health.58 This aspect of intrauterine device design
57 For examples from the English language medical literature see Green-Armytage, 'A 'Contraceptive'', 1932; Andrews and Norfolk, 'Migrating Grafenberg Contraception Ring', 1936; Murphy, 'Migration of a Grafenberg Ring,' 1933. Weilerstein,' The hazards of Intrauterine Pessaries', 1957 attempts to add together injuries attributed to the intrauterine device from a variety of sources. CO °° Use of the stem pessary even for treating uterine prolapse and other uterine malformations was going out of fashion by 1930 as gynaecological surgery was being performed with more success. Some evidence that medical opinion was set firmly against the use of stem pessaries for contraceptive use is provided by the following articles: Potter, 'Complications Following the Use of the Gold Stem Pessary', 1930; Sussex, 'Penetration of the Uterus by a Gold Stem Pessary', 1933; Warner,' Dangers of Gold Stem Pessary', 1935. Dr Mary Halton in New York's Sanger Clinic was using the gold stem pessary on a regime of 76 would later change, but by then the separate identity of the intrauterine device was a fait accompli. Finally, Grafenberg's introduction of the statistical analysis of records provided a means of casting doubt on interpretations of anecdotal reports of device failures. It was these anecdotal reports of complications and injuries that dominated the medical journals, rather than stories of success. Grafenberg's statistics meant that the almost universal condemnation of the devices could now be blamed for distorting the reports of intrauterine device use in the literature. Grafenberg's tables and rhetoric proved to be useful strategies not so much in convincing his mainstream colleagues that the devices were safe, but in enrolling a dedicated core of doctors already active in birth control to this particular technique. Here were the arguments they needed to flout mainstream medical opinion. This was a new device and experience with stem pessaries was irrelevant. The success rate was high, written in black and white. The botch-ups seen by some doctors were due to incompetent insertions probably performed by quacks without training in aseptic techniques for breaching the cervical barrier. Some of the doctors at the international conferences addressed by Grafenberg took the device home with them and tried using it. They were cautious, inserting small numbers, having patients report frequently for check-ups, and changing devices every few months. Dr. Mary Halton took the Grafenberg ring to Sanger's New York clinic; Ota produced a modified version in Japan in 1934; Leuenbach took it to Copenhagen, Norman Haire took it to Britain; and it found its way to Melbourne.59 it was the availability of the devices in New York that prompted a second attempt to overcome the ongoing mainstream medical condemnation of the intrauterine device. That story I will leave for the next removal after two months with a stern warning to her patients not to practise intercourse whilst the uterus healed. It is probable that this regime meant that the devices were primarily used to induce abortion. See Dickinson, 'Contraception: A Medical View of the Situation', 1924. pp. 594-6. 59 Tietze, 'History of Contraceptive Methods', 1965; Tietze, 'History and Statistical Evaluation', 1965; inten/iew with Dr Stephania Siedlecky, March 1989. 77 chapter. Grafenberg's statistical technology was not entirely successful in its designated task of overcoming medical opposition to the use of intrauterine devices. It was however successful in establishing this particular intrauterine device as the intrauterine device paradigm, with its tailless structure and statistical reporting. It achieved the international enrolment of at least some medical practitioners into the intrauterine contraceptive system, equipping them with the Grafenberg tools for casting doubt on the ovenrt/helming impression created by the medical literature that the intrauterine was a hazardous device.This is not to say that Grafenberg's use of statistical analysis gave a more accurate picture of intrauterine device safety and efficacy than accounts of individual clinical experience. It is to emphasis the effectiveness of the entry into the field of a new spokesperson claiming to be able to speak on behalf of the intrauterine device, and the change in the field surrounding knowledge claims about intrauterine devices brought about by Grafenberg's new mechanisms for converting the experience of the clinic into a set of inscriptions.5o So far, I have said little about the third entity crucial to Grafenberg's success. Women were of course also needed as allies for the intrauterine device to work. It is to their enrolment that I will now turn. This is not simply the tale of the enticement of recipients, for just as the locking-in of doctors to the intrauterine device network required strategies that became integral to the intrauterine device paradigm, so too did the negotiations with women.
Translating the intrauterine device into the sex reform movement: the woman question At the 1929 sex reform congress at which Grafenberg won-over his group of medical supporters, there was a large group of highly articulate
®0 For a discussion of the laboratory as a series of inscription devices see Latour and Woolgar, Laboratory Lif?, 1979; Latour, 'Give me a Laboratory and I will Raise the Worid', 1983; Latour, 'The Force and Reason of Experiment', 1990. 78 women delegates. Prominent amongst those addressing the Congress were women who also occupied key positions in the organisational structure of the World League for Sexual Reform. The London Congress was organised equally by Dr Norman Haire and Dora Russell, both prominent community leaders. It was addressed by many well known women, pioneers of birth control and sex reform movements. Speakers included Vera Brittain, Dr Helene Stocker, Marie Slopes, Dr Hannah Stone, Elsie Ottesen-Jensen, Stella Browne, and Naomi Mitchison. In her opening address Dora Russell pointed out that the progress achieved in attaining the goals of the League owed much to the 'united action of organised bodies of women'5i. It was, she told her audience, newly emancipated women, following the courageous tradition set by the suffragettes, whose voices had been raised for the reform of marriage, child-care and sex.52 it was these women, spokespersons and representatives of women's emancipatory hopes, whom Grafenberg needed to enrol for his contraceptive system to be successful. Dr. Ernst Grafenberg, Dr. Norman Haire, and Dr. Hans Lehfeldt addressed the meeting on the efficacy of the intrauterine device for birth control. In order to make the claim that the intrauterine device was a safe, effective, and perhaps even superior method of birth control, the medical practitioners advocating their success with the devices had to speak on behalf of their women patients; they spoke as representatives of women's experience and as presenters of the truth of women's bodies. In other words they were constructing the subjects who would seek an alliance with the intrauterine contraceptive network, and into whose wombs the intrauterine device would be inserted. Lehfeldt stressed women's desire for a device which did not interfere with intercourse 'either before or after'.53 Grafenberg spoke of the 'subjective reaction' of 'repugnance' by many women to
61 Russell 'Welcome Speech Sex Reform Congress', 1930. p. xx. 62 Russell, 'Welcome Speech Sex Reform Congress', 1930. 63 Lehfeldt, 'Contraceptive Methods Requiring Medical Assistance', 1930. p.130. 79 contraceptive methods that involved 'deliberate preparation on each occasion'.54 This way of characterising the women who would become the future allies of the Grafenberg ring fitted well with the new sense of identity the women delegates at the conference were constructing for themselves and their sex. The congress was, then, a discursive space in which women and men struggled for a new sexual ethics and morality, founded on the recognition of their mutual equality. Women, excluded from the position of sexual subject in the sex economy of male domination under the 'old order', were agents in the creation of a platform from which women could speak of sexual freedom. But this required nothing less than the construction of something new to count as the natural woman's body. It was not simply a matter of presenting a new representation of an already existing natural woman's body, a body freed from the distorted Victorian sexual mores that had insisted on the passive and non sexual but compliant nature of women's sexual bodies.55 The women active in the Sexual Reform League were fabricating and naturalising new selves for all women. The new woman failed to identify with the Victorian model of the body. Following World War I, at a mass level, both women's and men's bodies were being remodelled to reflect the discourses of consumption.56 Women were representing themselves as sexually desiring subjects, both equal to, and similar to, their brothers. Sex outside monogomous stable relationships remained contentious, but women's desire for sexually fulfilling lives within loving partnerships had become central to most women's self-identity. Dr Hannah Stone positioned herself as speaking 'from the standpoint of the marital happiness and sex life of the woman'57. Mrs Dora Russell called
^ Grafenberg, 'The Intra-Uterine Method of Contraception', 1930. English Translation in Appendix p. 611. 65 Smith-Rosenberg. Disorderly Conduct 1985; Jordanova. Sexual Visions..1989. 66 Birkin, Consuming Desire. 1988. 67 Stone, 'Birth Control as a Factor in the Sex Life of a Woman', 1930. p. 155. 80
for a 'morality directed to human happiness', clearly including woman in the category human, and denouncing the excuse for censorship and anti birth control legislation that defended these old customs as 'demanded by women for their protection'.ss The woman director of a recently opened birth control clinic emphasised the need for education to overturn the popular expectation that 'the marriage relationship' should not be enjoyed by the wife; the lack of experience of orgasm, the Congress was told, was the cause of 'much concealed misery'.59 Elsewhere women claimed: the freedom of men in their refusal to observe monogamous mores '.7o They called for a revolt... against the deplorable convention which imposes a premature sexual death on human beings .... especially if they are women'. 7i They demanded the freedom to enjoy 'marital relations', for women whose husbands were unemployed, without the worry of raising another child in poverty.72 Women seized the opportunities within the conglomeration of interests mobilising around sex reform to construct a discourse in which they were active sexual subjects. What was marked at the 1929 Sexual Reform Congress was the passage away from a mode of thinking about sexuality through the model of production, in which contraception was debated as the means of intervening in a process of population production. In the Victorian model of the sexes men and women were seen as having different and complementary roles in the production of the population. Men were active, women passive.73 This discourse of bodily differences which dominated the
63 Russell, 'Welcome Speech Sex Reform Congress', 1930. p. XX. 69 Chance 'A Marriage Education Centre in London', 1930. pp. 37-39. 70 Calverton "Are Women Monogamous?'. 1930. pp. 48-57. 71 Stocker, 'Marriage as a Psychological Problem', 1930. p. 607. 72 Ottesen-Jensen, 'Birth Control Work Among the Poor in Sweden', 1930. pp. 173-177. 73 For a discussion of the eighteenth century emergence of the two-sex model of sexual difference see Laqueur, Making Sex. 1990; and Schiebinger, The Mind Has No Sex?.1989. Both these historians provide convincing accounts of the historical specificity of the biomedical 'knowledge' that men and women were fundamentally anatomically different. Linked contingently to the historical emergence of the sexual division of labour in industrial society this two sex model, that we take so much for granted, replaced an anatomy that represented male and female skeletal and reproductive organs as essentially the same, although women's were less perfectly fonned. 81
Victorian period was being displaced; the Victorian middle class ideal of companionate marriage between complementary but essentially different beings was under challenge. The ideology of separate spheres was losing its power - the woman reproducing the family in a domestic space, the repository of virtue, while men produced the nation's wealth in a hostile worid of competition and corruption.74 The new discourse of equality, sexual desire, and sexual freedom and happiness for women dominated the sex reform congress. As Lawrence Birkin convincingly argues, thinking the body and its sexuality through the model of consumption provided a model through which men and women could be produced as equal and as sharing in the same human ity.75
This is not to say that the plurality of interest groups participating in the conference had all abandoned a discourse in which women were construed as objects in a discourse of production. For example eugenists addressing the Congress positioned women as objects presenting a problematic fecundity that had to be curbed in the interests of improving the race. However, alongside the 'many roads lead(ing) to birth contror76 - those of the national economic planners, the eugenists, and the physicians concerned with individual health - there was, as one delegate noted, a new discourse of 'women's sexual happiness'. Women at the Congress had embraced the attribution of sexual desires to women, and articulated the rights of women to pursue individual happiness through the fulfilment of those desires, as the extension of the boundaries of democracy to include women as subjects.
74 For an interesting discussion of mid-Victorian conceptions of sexual difference see Poovey, Uneven Developments. 1988. 75 For alerting me to the possibility of reading the Congress Documents in terms of a shift from a productive to a consumptive model of sexuality, I am much indebted to Lawrence Birkin, Consuming Desire. 1988. Birkin traces the history of the emergence and spread of a new understanding of sexuality, which he calls the consumption model of desire, through the work of Freud and the sexologists, reflecting the new retail culture emerging at the time. Birkin provides an interesting account of the re-normalising of heterosexuality in the context of this newly dominant discourse which theoretically enabled the free play of desire. 76 Stone, 'Birth Control as a Factor in the Sex Life of a Woman', p. 155. 82
The goal of women's emancipation was to be pursued through the freedom of choice to satisfy individual sexual desires. But this was to be undertaken as a rational activity, guided by science and founded on sex education, including knowledge of contraception.77 Thus women's sexual urges, freed from the bounds of male domination, were to escape that long- forecast fate of destroying civilisation. Social order, under the new regime of equality between the sexes, was to be guaranteed because men and women following their sexual desires would form the bonds of social cohesion. The intrauterine device, or some similar contraceptive device such as the often preferred diaphragm, was ideal for this new worid. Just as the free-market would supposedly ensure the equitable distribution of goods and services, thereby creating a modern world without class divisions, so too would freeing sexual desires from constraint create a world without the bitter sexual divisions that had characterised the suffrage struggles. The new woman was to pursue equity in all spheres of life, and this included the pursuit of happy and harmonious marriages based on mutual respect and desire between equals. Vera Brittain, for example, called for a number of reforms including instruction in birth control methods for all couples prior to marriage in order to 'make marriage infinitely more attractive and more intelligible than it is today."78 Stella Browne argued from the principle of the 'full right of free motherhood' for the liberalisation of abortion laws and the endorsement of alternative forms of union to marriage.79 Naomi Mitchison articulated the new task to be performed by contraceptive methods in this new world:
Doctors say, and I believe them, that this kind of copulation is good and necessary, that if a couple living together (as most do under present economic and social conditions) is deprived of it they suffer in mind and
'' For an interesting discussion of rationality and spontaneity in the 1990s struggle within the birth control movement to contain the spread of AIDS, see Albury, 'Sexual Politics in the 1990s', 1990. 73 Brittain, 'The Failure of Monogamy, 1930. p. 44. 79 Browne , 'The Right to Abortion', 1930. p. 180. 83
body just as the most passionate lovers would, and of course, their suffering reacts on their household. The alternatives seem to be either complete chastity, which is unworkable for most normal people, or chastity for the wife alone, which does not make for very satisfactory social conditions. Yet often it would be disastrous for them to have more children. So: Birth Control.8o Within this context the intrauterine device was construed by Grafenberg as a particular kind of contraceptive that crystallised equality in sexual desire. In order to win the support of the new women whose leaders so articulately represented them at the sex reform congress, the attribution of a particular set of characteristics to the women who were to be the recipients of his silk coils and wound silver spirals was needed. This meant that the intrauterine device was characterised in a particular manner. The impact of the women with whom Grafenberg had to negotiate left its mark on both the content and the silences of his intrauterine device discourse. There was no talk of this being the ideal contraceptive for women incapable of exerting rational control over their sexual passions. It was presented as one possible contraceptive choice among many. It was a matter of personal preference, of aesthetic taste, whether a woman preferred to use the Grafenberg ring or the Messinga diaphragm.This positioning of the intrauterine device, whether conscious or accidental, proved to be an effective lure to at least some women, perhaps those who were having trouble transforming themselves into sexually confident new women, to volunteer for intrauterine device insertions. More critically, it was sufficient to link the clinics established and often run by and with the women activists of the sex reform movement into the network of the intrauterine device. This, I suggest, also explains the absence of a strongly eugenic rationale for Grafenberg's intrauterine device paradigm. It was not until the 1960s that the subjects for the intrauterine device were construed as less rational women - women of the developing world, poor women, black women - in a project of population control that identified the intrauterine
30 Mitchison, 'Some Comment on the Use of Contraceptives by Intelligent Persons', 1930. p. 185. 84 device, not as an equivalent contraceptive choice to voluntaristic methods, but, at least for certain categories of women, as a superior contraceptive. But that is a story for the next chapter.
Inventing a Technology In this chapter I have offered a narrative that presents the invention of the intrauterine contraceptive device as a process occurring over time, involving many diverse individuals and groups, engaged in heterogeneous activities. Richter modifying stem pessaries, Grafenberg's address to the Sex Reform Congress, or his counting and reporting on patients' success and failure with his rings, Helen Stocker's organisational work in the German sex reform mass movement. Vera Brittain's voicing the demands of many women for equality between the sexes to be achieved through women being able to satisfy their sexual desire (as men had long done) - all contributed to the invention of the intrauterine device. It is impossible to determine which of these activities were crucial to the admittedly limited success of the intrauterine device, and which were merely contextual. It is also evident that inventing a new contraceptive technology involved inventing a new social order, and that Grafenberg as much as German political agitators was intimately involved in modifying the behaviour of people, recruiting allies, and redefining the problems of the social world and their solution. It is conventionally argued that new technologies arise from the application of science to 'applied' problems. The accuracy of the scientific knowledge claim in representing the world is then taken as explanatory of the success or failure of the technology. The development of the intrauterine device had very little to do with the application of new scientific information about reproduction. At best, the application of statistical methods to data on the conception rates and reported health problems of patients fitted with the Grafenberg Ring could be construed as the application of advances in science 85
(statistics) to the problems of birth control. However, the success of the intrauterine device owes as much to the rhetorical work done by Grafenberg, in claiming that his was a new technology absolutely distinguishable from the stem pessaries, as it does to his tables of percentages. These strategies worked, not because they were scientific, but because they were effective mechanisms for linking a group of medical practitioners, already committed to the provision of contraception, to the Grafenberg ring. Similarly, the trials with various shapes and materials for the construction of intrauterine devices were effective, not because they followed a scientific method, but because they successfully negotiated with the expulsionary currents of the uterus and the properties of the uterine lining that allowed the fertilised egg to implant. The first of these was discussed by Grafenberg but the second was not. It was much later that the active property of the copper in the German silver that Grafenberg used to make his rings was attributed with contraceptive properties. 81 It was the success of these negotiations that enabled the work of Grafenberg and other intrauterine device tinkerers to be called scientific. The work done by a medical entrepreneur like Grafenberg was not insignificant because it was complementary to the work of others, or because its efficacy was not, as I am alleging, guaranteed by its pursuit of the scientific method. It is not that Grafenberg was not sufficiently careful in his science, although we would no doubt apply different standards today to judging the adequacy of clinical trials than those pertaining in the 1920s. The point I want to emphasise is that Grafenberg was involved in perfectly ordinary activities that would occur in many other places besides in science. He was tinkering around with materials and techniques in an attempt to get something to work. He was trying out ways of saying things and testing audience reactions in an effort to win over friends and allies. His achievement, whether we now want to value it positively or negatively, was to tie together some elements of the
31 Lehfeldt, 'Ernst Grafenberg and His Ring', 1975. 86 medical profession, the contraceptive choices of some women, and a silk (or silver) coil. Retrospectively, the strategies deployed by Grafenberg to achieve and stabilise these linkages, because they have been successful, have been labelled scientific. Furthermore, I have argued that the contraceptive workability achieved by Grafenberg for his construction, the intrauterine device network, was not sufficient reason for its success in becoming the intrauterine device paradigm, or even a relatively successful contraceptive paradigm. The autonomous internationally dispersed human entities with whom Grafenberg had to battle, women and general practitioners, had their own agendas; it was only by successfully characterising the intrauterine device in ways that negotiated these agendas that Grafenberg was able to extend the intrauterine device network beyond his immediate locality. I began this chapter without making a priori assumptions that it was because the procedures used by Grafenberg and his colleagues were scientific that they succeeded. I set out to account for their success. How did the intrauterine device become a contraceptive paradigm? How did the alliance between doctors, women and the Grafenberg ring become sufficiently strong to survive, at least for a period in time in particular spaces? To answer that the intrauterine device worked, and that in comparison with other contraceptives it worked more effectively, begs the question. The relative success of the intrauterine device, its workability, was simultaneously constructed as the system was pieced together. Whether or not the retrospective counting and tabulation of the record cards of intrauterine device wearers would convince doctors that this was an effective enough, and safe enough, device was a practical matter. It was neither more nor less important than the rhetorical claim that this was a new class of device. It only succeeded amongst a small number of doctors, already committed to birth control, often self-identified as radicals and accustomed to diverging from the views of their more conservative colleagues. 87
The efficiency of this method of contraception compared with the diaphragm, or even creams and jellies used alone, was highly contentious. Grafenberg and his colleagues presented the intrauterine device as a particulariy effective method because it did not involve any distasteful interruptions during sexual intimacy. But the cost of routing the goals of the women of the sex reform movement into the intrauterine device network and the cementing of the clinics some of them controlled into the intrauterine device contraceptive system was that whilst women could be seen as having the desire to pursue sexual pleasure, they were also to be attributed with the will to play out their sexual desires within a rational frame of choice and competency. This both aided Grafenberg in strengthening the tie between his ring and women, and shaped the way he characterised this method of contraception. The need for Grafenberg to negotiate with the women of the sex reform movement, as the spokespersons for all the women who were potential allies of the intrauterine device network, was an historical contingency, brought about by the strength of pronatalist movements which fuelled the hostility of most medical professionals to most contraceptives. Grafenberg had nowhere else to turn except the sex reform movement which was becoming well organised at an international level and in which women were actively renegotiating the place of the new, post-suffrage woman in society. The intrauterine device could become one possible choice open to women, but it could not have superior efficacy attributed to it when compared with the diaphragm. It was this more benign device, rather than the intrauterine device, which, because it so rarely caused any harmful effects, was gradually taken up by the medical profession in most western countries as doctors increasingly abandoned their anti-contraception moral stance. This chapter has not solely focused on the actions of Grafenberg, his predecessors, his rivals, and his potential allies. These activities intersected with arrays of linkages being forged by other network builders operating in 88 different arenas, I have tried to locate the processes and strategies essential to the success of the intrauterine device in its earliest phase within such a multiplicity of connections. I have identified some of the conditions of production for the intrauterine device. There are no doubt other historical patterns that could be mapped out as critical to the development of the intrauterine device. But I hope to have presented at least some convincing reasons explaining - how the intrauterine device was invented in Germany; why it was invented when it was, rather than sooner or later; and how it partially succeeded as a contraceptive paradigm. I have investigated the role played by various interest groups in the processes leading to these stabilisations, mobilising the shifting gender politics articulated in the sex reform movement as an explanatory factor accounting for both the particular form of the intrauterine device network and its success. I have not argued that the intrauterine device network's limited success is due to its inventors skill and acumen as negotiators with their colleagues. Rather, I have used the strategy of pursuing their actions and rhetoric to render the development of a technology transparent as a social process. By the early 1930s the intrauterine device had been inserted into a chain of connections that stabilised it as one possible contraceptive choice in some internationally dispersed, local contexts. The question to which I have always returned is: How did this happen? This is not a question of individual motivation. When Grafenberg first identified the intrauterine device as a contraceptive worthy of the attention of scientific medicine in the first decade of the twentieth century it was not a particulariy promising contraceptive for mass choice. It is unclear what motivated Grafenberg's initial interest and enthusiasm. The safety of the class of device with which, in his words, the 'wholly intrauterine devices' were classed and identified was being decried by his colleagues. But Grafenberg was able to get at least some of his professional colleagues to believe that his tailless devices could be used more 89 safely. Similarly he was able to convince his own women patients, and later the women of the sex reform movement, that this was a viable contraceptive device, warranting at least cautious interest. Grafenberg used a variety of mechanisms to enrol the various components necessary for the construction of his network. He tinkered with materials and shapes in an attempt to entice the womb's acceptance of a permanently placed foreign object, and its rejection of any fertilised eggs. He wrote articles for medical journals to lure his colleagues from the birth control movements to become supporters of intrauterine devices, fending off hostile critics with statistical analyses that created the space for the devices to be tried. He, or his medical allies, conversed with women suggesting that this new means of contraception could assist them in limiting their pregnancies without requiring them to deny their equal right to sexual expression. The doctors and women also had conditions of their own that had to be met before they allowed their goals to be translated through Grafenberg's network. Even the more radical doctors by 1930 would not have endorsed the now notorious stem pessaries. This dictated the shape of Grafenberg's devices, precluding the introduction of a tail. The characterisations Grafenberg attributed to the women contraceptive subjects in his network were also shaped by the need to find allies in the sex reform movement. As a contraceptive system, the intrauterine device had to be presented as a voluntary choice that might suit the lifestyle of the modern woman. Thus the final form and characteristics of the intrauterine device as a technological paradigm were shaped by both the mechanisms developed by Grafenberg to link together the key components he envisaged as necessary to his contraceptive solution, and by the characteristics of those entities and the conditions they imposed for their articulation into Grafenberg's set of cross- linkages. 90
Neither Grafenberg nor any other intrauterine device protagonist had the luxury of becoming the sole spokesperson for intrauterine device safety and efficacy. There were always other experts ready to condemn the devices, refusing Grafenberg's carefully crafted distinctions, or the superiority of medical statistics to clinical experience. It was these voices that dominated in the professional gynaecology organisations. They contributed to stalling the development of the intrauterine device network at a point which left it established at an international level, but as a marginalised contraceptive technology. It was not until the late 1950s that another group of innovators, working in the United States, again picked up the intrauterine device and began to remodel and extend this technology as a contraceptive network. 91
CHAPTER 3
Tietze, the Population Council, and the United Nations: The 1960s reconstruction of a stronger lUD socio-technical network
Prior to the 1960s the intrauterine device contraceptive system remained fragmented: it consisted of a few isolated and local, medically marginalised socio-technical networks such as that centred on the New York Sanger clinic. By the end of the 1960s the intrauterine device had been expanded into a massive, global, medically sanctioned research and distribution collectivity. The efforts needed to reconstruct the intrauterine device as a much expanded socio-technical network occurred in the United States. The focus of this chapter is this shift in perspective, from medical condemnation to the perception that the development of the intrauterine device and its universal availability was necessary for world peace. This process was by no means inevitable. There was not a developmental trajectory, laid out like a railway track, steering the intrauterine device ineluctably towards improvement or greater success. From the 1930s until the end of the 1950s the reception of the intrauterine device in the United States, as elsewhere, remained primarily negative. The intrauterine device did not spread beyond a few radical clinics where doctors largely presented it as an alternative to the diaphragm, requiring women to report back frequently in the hope that this could help them avoid the harmful effects for which the devices were vociferously condemned. The success of the intrauterine devices developed in the 1960s resulted from their translation into the centre of a population control network, a translation that transformed the socio- technical network constitutive of this contraceptive technology. Much more than a simple change in publicity, calls for the development and distribution of 92 the device appealed to the sensibilities of a world still recovering from World War II, and focused on eliminating population pressures perceived as a threat to future security. Throughout the 1930s and 1940s the conditions in the United States were not conducive to serious medical research into contraceptives.i But by 1958 the raw materials were in place for engineering a multiple translation of the intrauterine device - involving a new research paradigm, the use of new materials and designs, and a massive increase in both individual and institutional allies both within and outside of the medical profession. The resources that would be mobilised for this task were biomedical, political, organisational and sociological. But they would not have coalesced under their own steam. It was the concerted efforts of the Population Council, largely funded by the Rockefeller Foundation and the Ford Foundation, and greatly indebted to the work of Dr Christopher Tietze, that were primarily responsible for the renaissance of the intrauterine device. It was their efforts that ensured that, by the end of the 1960s, the intrauterine device was a stronger network, incorporating more allies, and well on its way to becoming global and uncontroversial. The Population Council, in its efforts to reconstruct the intrauterine device network, was aided by developments in other fields. Plastics provided new materials that could be compressed for easy insertion, and relied on to spring back into shape once they were inside the uterus. Similar plastics were increasingly being inserted inside the body during general surgery. Medical statisticians were developing sophisticated tools for conducting prospective trials. The oral contraceptive pill was achieving phenomenal acceptance levels amongst women and changing consumer expectations of contraceptives. Penicillin was revolutionising the treatment of pelvic infections. I could analyse
1 Clarke, 'Research Materials and Reproductive Science in the United States, 1910-1940', 1987; Gordon, Woman's Body. WQman'.«t Rjght 1977, ch. 8-10. 93 each of these 'breakthroughs' as the stabilisation of a network. Theoretically they could be historicised and the points at which they could have become othenfl/ise analysed. But the Population Council's interest was in treating them as already stabilised entities that could be strung together into new arrays to construct a more resilient intrauterine device network. The new resources available to the Population Council for this task of manufacturing a stronger intrauterine device were not only biomedical. Political changes also made available an array of entities that could be incorporated into an expanded socio-technical network - political analysts had concluded that World War II was the result of German and Japanese expansionism stimulated by over-population; Kennedy was elected to the White House and chose the issue of birth control to demonstrate his autonomy from the Catholic Church; and the rains failed in India for two years running with the resulting famine beamed into living rooms across the United States with voice-overs interpreting the tragic loss of life as the outcome of overpopulation. It is frequently thought that the essential characteristics of the environmental context in which intrauterine devices were being developed ensured their success. According to this logic it was because population control had become more urgent that the funds needed to develop and test the devices were more readily found. Or similarly, because penicillin had been invented the newer devices could be used more safely and therefore were used more frequently. Rather, I would contend, the success of the intrauterine devices of the 1960s was ensured by the strength and flexibility of the new articulations forged between such entities as distant famines, population control, intrauterine devices, and penicillin. The characteristics assigned to them stabilised a new intrauterine device network. Thus, in seeking to understand the greater success of the 1960s intrauterine devices, we need to pay attention to the social processes through which the newly 94 available resources were re-shaped for the task at hand, or especially created, and the processes involved in fitting them together into a unified working system. It is precisely the mobilisation of claims concerning penicillin or population control in intrauterine device discourses that needs to be attended to. And just as the knowledge claims that were mobilised by the builders of the intrauterine device socio-technical networks are important, so too, and in a similar mode, are the other entities mobilised, constructed and linked together in the building of a technological system. Organisations had to be built, for instance, and new policies formulated and successfully manoeuvred through national governments, or through the United Nations. New natural world entities also had to be produced. One example of this was the characterising of the ongoing pain and excessive bleeding reported by large numbers of women using intrauterine devices as temporary and of minor consequence. The labour involved in these processes of mobilisation, characterisation and unification is one of the themes developed in this chapter. However, to explain the success of the efforts of the Population Council to re-forge a stronger intrauterine contraceptive system without reference to the efficacy of those efforts being fuelled by external fears of a population explosion, would be to tell only half of the story of this chapter. The events shaping public perceptions of a third world 'population bomb', notably the overthrow of colonial rule and the emergence of independent, nationalist governments in the countries of Africa and Asia, appear unrelated to the techno-scientific enterprise engaging the attentions of intrauterine device researchers and clinicians. But, in part, the escalating concerns of the citizens of the United States with the fertility of Indian and Chinese women were themselves the result of intrauterine device protagonists' own efforts. Well before the push to redevelop the intrauterine device as a quick solution to the population problems of the so called developing countries, the Population 95
Council was actively moulding perceptions of the needs of women in developing countries, and of the developmental pathways necessary for the survival of post-colonial governments. The intrauterine device did not get developed as a routine part of medically provided contraceptive services because of a pre-existing change in social need. The social worid in which population growth was perceived to be a problem was just as much a construction as was the intrauterine device that came to be seen as its solution. This then is the second theme of this chapter. The third thematic focus is that human and social needs, technological solutions, and the technical means for deciding their success are co- produced.2 Needs, devices, facts concerning safety and efficacy, and suitable users were constructed simultaneously, from below. For example, at the same time as the United States Government was recognising that it had a stake in the 'mounting rates of population increase ... hampering or nullifying the efforts of the developing nations to achieve social and economic modernisation',3 the intrauterine device was gaining a reputation as the ideal contraceptive for mass population control.4 The remainder of this chapter is divided into five sections. I begin by outlining the fate of the first intrauterine devices to enter the United States, tracing the strictly limited transfer of the Grafenberg ring across the Atlantic. The second section draws out the shifts in United States Government policies and international strategies, and their influence on the activities of the intrauterine device constructors as population control in developing countries became a major target of United States foreign policy. The third section examines the Population Council and the important role it played through its co-ordination of clinical trials in the work of reconstructing the intrauterine device as a credible contraceptive at the centre of a stronger socio-technical
2 Clarke and Fujimura, 'What Tools? Which Jobs? Why Right?', 1992. 3 Population Council, Population Council Report. 1952-1964 ,1965. See 1960, p. 5. 4 Tietze, 'Intrauterine Contraceptive Rings: History', 1962, pp. 30-31. 96 network aimed at population control. Section four looks at other mechanisms important in the expanding intrauterine device contraceptive system - the translation of the intrauterine device into a solution for the abortion problem and therefore a prophylactic against high maternal mortality and morbidity; the linking of contraception with world hunger and women's rights; and the international boost given to intrauterine device programs by the United States State Department and the United Nations. The chapter ends at this high point, with the intrauterine device appearing to have embarked on a journey leading to a bright future.
A foothold: The Grafenberg ring in the United states, 1930 - 1948 The 1920s had seen the forging of a crucial alliance that would influence the fate of the intrauterine device in the United States. The birth control radicals joined forces with that minority of the medical profession in favour of contraception.5 This occurred despite a history of suspicion from both sides, and ongoing denouncements of birth control from more mainstream medical practitioners. Margaret Sanger, Emma Goldman and other birth control advocates were strongly associated with radical Utopian, anarchist and socialist movements in the United States. Such radicals placed contraception in the context of free love, women's rights, and an end to the burdens of the working class under the wretched conditions of capitalism. The operation of the Gomstock Law, outlawing the use of the mails for distribution of pornography and contraceptives, ensured that it was only such radicals, prepared to break the laws prohibiting the distribution of birth control information and devices, who were actively engaged in both distributing
5 Gordon, Woman's Body. Woman's Righ^, 1977 ch.8 & 10; Reed, The Birth Control Movement and American Society. 1978, ch.17; Clarke, Emergence of the Reproductive Researoh Ent9rpri$g. 1985, pp.325-356; McCann, Race. Class and Gender in U.S. Birth Control Politics. 1920-1945.1987, ch.4; and Kennedy, Birth Control in America. 1970. 97 contraceptive information and opposing its prohibition. The civil disobedience tactics employed by the birth control radicals antagonised the majority of the medical profession and confirmed them in their view that contraceptive practices were a sure cause of social degeneration, moral disease, and the corruption of the nation's youth.5 The confrontationist tactics of the birth controllers antagonised not only medical practitioners opposed to birth control, but those doctors who were potential allies. Margaret Sanger and Dr Robert Latou Dickinson, for instance, treated each other with hostility and suspicion for many years. Dickinson was a member of the medical profession who was agitating amongst his colleagues for the acceptance of birth control with the same dedication as Sanger agitated outside it. Dickinson wanted contraception under medical control; Sanger, probably rightly, feared this would prevent access for many women to contraception, due to the tendency of doctors to narrowly interpret criteria constituting medical indications for contraception. The Sanger clinic in Brooklyn, New York, started in 1916, was staffed by sympathetic women and nurses who gave advice on which drug store appliances were effective, and fitted caps and diaphragms, bypassing the medical profession.7 it was
6 See for example Kosmac, 'The Attitude and Responsibilities of the Physician in the So- Called Birth Control Movement',1917, and Kosmac 'Contraceptive Practices', 1940. In the former Kosmac denounces 'the general uselessness and filthy character of most of the methods advocated for preventing conception' (p.185). He rails against anarchists for freely distributing contraceptive information, which he argues 'incites the co-habiting males' of poor communities, 'cultivating license' (p.187). By 1940 Kosmac is urging that contraception can be reconstituted 'as a medical activity free from the purely propaganda aspects of the movement"(p.653). He recognises a wider role for the physician, expanding his narrow 1917 criteria for the medical diagnosis of contraception from women suffering from tuberculosis or other life-threatening illnesses, to include over-fertility associated with definite social implications and the desire for spaced parenthood (p.653). 7 Dickinson's campaign to make birth control a respectable part of medical practice is discussed in Reed, The Birth Control Movement. 1978. pp. 143-193. In Gordon, Woman's Body. Woman's Right. 1977, the involvement of the medical profession is presented as conservatising the birth control movement, moving it away from the politics of women's rights and towards the ideology of eugenics. Against this view MacCann argues that the coalition between the medical profession and the birth control movement was essential for the survival of birth control given the legal-medical hegemony. She argues that Sanger began courting doctors from as early as 1915, taking the struggle for women's rights from the confines of a free speech fight fought for pamphleteering against the Comstock laws, into a struggle for women's right to be personally instructed in physiological and anatomical knowledge about their own bodies and the use of contraceptives. McCann, Race. Class and Gender in U.S. Birth Control Politics. 1920-1945.1987, p.128, and ch. 4. 98 encounters with the law that eventually led Sanger into an alliance with doctors, and indirectly that led organised medicine and gynaecology into an alliance with her.
From enemies to allies: Pro-contraception doctors and the United States birth controllers When Sanger's first clinic was closed down and she was prosecuted and convicted, an appeal judge pointed out that the same ordinance that he was using to prevent the operation of the clinic had been amended to exempt doctors from its operation, ostensibly to allow doctors to distribute condoms to prevent the spread of venereal disease.8 This set a precedent for the future practices of birth control clinics. Sanger went to jail,9 but in 1923 she opened another clinic, this time under the medical supervision of Dr Dorothy Booker, ""o Without an alliance between at least some physicians and birth control activists, the intrauterine device was not a practicable contraceptive method. It was this alliance that prepared the ground for the successful transfer of the Grafenberg ring from Germany to the United States.
By 1930, when Grafenberg was publicising his intrauterine device and seeking international allies, these tentative early links between the birth controllers and the medical profession had been further strengthened. Reed tells the following story of Dickinson and Sanger's truce. In 1923, Dickinson had embarked on a program that would lead him to abandon his attempts to work entirely within the auspices of the leading gynaecological professional organisation, and seek closer ties with the Sanger clinic. Dickinson had
3 Cited by Reed, The Birth Control Movement. 1978, p. 107. 9 Sanger and the other staff of the clinic had been arrested after the first clinic had operated for only ten days. It was by interpreting pregnancy as a disease that Sanger was able to use the loop-hole offered to her by the Court of Appeals, since in upholding the right of medical doctors to disseminate birth-control informatbn for the 'cure and prevention of disease' the court offered no definition of disease. Bullough and Bullough, 'Pregnancy, Contraceptives, and Abortion', 1977, pp. 176-177. 10 For a discussion of Booker's eariy attempts to scientifically compare various contraceptive regimens see Reed, The Birth Control Movement. 1978, pp. 114-116. 99 gained hard won obstetrical support from the most hostile segment of the medical fraternity to establish a contraceptive research program based in hospitals. Establishing the Committee on Maternal Health for the scientific investigation of contraception he had manoeuvred his most outspoken opponent, George Kosmac, to agree to such a study, if only because Kosmac believed that such a study would discredit the propaganda of the birth control movement once and for all.n But Dickinson's mandate was for a study o^ birth control, not the encouragement of its greater use. Under the auspices of the Committee on Maternal Health, the program operated by paying small amounts of money to hospital outpatient clinics for providing records on patients for whom they prescribed birth control. After three years the study had only come up with the records for twenty-three patients. Dickinson realised that if the research was to be completed he would have to get his records from the Sanger clinic.12 This was the only place that had been able to guarantee a source of supply of diaphragms, which at the time could not be legally imported into the United States. It was also the only place where women knew they would not be rebuffed for seeking contraception for social and economic reasons.i3
In 1930 Dickinson joined the board of the clinic. Sanger agreed to this closer and higher profile association with organised medicine because the clinic had been having difficulties securing a licence, despite the use of medical practitioners to prescribe contraceptives. The New York authorities were reluctant to grant the licence because of opposition from the New York Catholic hierarchy. Dickinson, for his part, gave up his attempts to wrest control of the clinic from the non-professional 'propagandists' as it became
11 Reed. The Birth Control Movement. 1978, pp. 168-169. See also Bailey, 'Summary of the Answers to the Questionaire Submitted to the Members of the New York Obstetrical Society on the 'Regulation of Contraception'', 1924. This survey was conducted in response to Kosmac's obstructionism, finding that 69% of the fourty-two members of the New York Obstetrical Society who responded favoured the sponsorship of a scientific study into contraception by the Society. 12 Reed, The Birth Control Movement. 1978, pp.173-175. 13 Reed. The Birth Control Movement. 1978. pH4. 100 clearer to him that such control would likely mean the closing of the clinic. It would be impossible to operate entirely within the law. Dickinson joined the clinic committee and became a crucial collaborator, securing an important linkage for the birth control clinic with the Rockefeller Foundation, which, at Dickinson's request, provided a grant of $10,000 for the Sanger Glinic.i4 These associations between the medical profession, the birth control movement and corporate philanthropy were further consolidated when the era of illegality for American birth control ended in 1936. The Comstock law was effectively over-ruled in a case involving customs seizure of diaphragms, the judge declaring that a physician importing birth control devices was not engaging in an obscenity. 15 The erosion of religious opposition to birth control also helped consolidate the alliance between birth control activists and general practitioners. The cautious policy of acceptance passed at the 1930 Anglican Bishops' Lambeth Conference in Britain removed a forceful enemy of the pro-contraceptive movement. The Anglicans did not endorse the use of contraceptives, but they did allow for the practice of contraception in special cases. Gradually the categories of persons for whom the practice of contraception was welcomed widened. A new permissiveness and liberal tolerance replaced the well organised and vociferous opposition that had characterised the politically influential Anglicans eariier in the century, although it was not until 1958 that the Anglicans actually approved the use of contraceptives. 15 Although the Catholic Church, in the Casti Gonnubii issued by Pope Pius XI in response to the Lambeth Conference, condemned
14 See Gordon, Woman's Body. Woman's Right. 1977, pp. 257-260; Reed, The Birth Control Movement. 1978, pp.171-180. 15 Reed, The Birth Control Movement. 1978, p. 121. Gordon, Woman's Body. Woman's Right. 1977. p. 17. McCann, Race. Class and Gender in U.S. Birth Control Politics. 1920- 1945.1987, pp. 36-148. However it was not until 1971 that contraceptives were removed from the Con^tock Act, allowing ordinary citizens to import them. This occurred after a zealous customs officer forced a diaphragm to be thrown into the hartx)ur, declaring its owner in breach of the Comstock Act. It was not until 1965 that a U.S. Supreme Court ruling allowed the free exchange of birth control information, enabling, for example, planned parenthood clinics to advertise their existence in all states. Bullough and Bullough, 'Pregnancy, Contraceptives, and Abortion', 1977, p. 177. 16 Kaiser, The politics of Sex and Religion 1985. p.4. 101 contraception as 'an offence against God and nature', Pope Pius XII opened the door for the rhythm method by endorsing sexual relations even where 'new life cannot result'.''7 it would be another two decades before the political force of Catholic opposition to contraception in the United States began to wane, but following the Lambeth Conference, the Catholic Church became increasingly isolated. Despite the medical profession's increasing acceptance of and involvement in birth control, hostility and active opposition to intrauterine devices from United States physicians and gynaecologists remained entrenched. By 1937 a majority of general practitioners were in favour of medical involvement in birth control. A new consensus condoning members prescribing contraceptives had been asserted by the passing that year of a pro-birth-control resolution by the American Medical Association. 18 But this new consensus had not included an endorsement of the intrauterine device. The dominant view of the medical profession towards the intrauterine device did not shift from the policy developed in the 1924 review of contraception conducted by the Committee on Maternal Health. Whilst the committee came down on the side of contraception, it also endorsed the comments of those respondents asserting that intrauterine devices were most dangerous. As Michelle Orr rightly points out in her thesis on this shift in physician attitudes to contraception, the study inaugurated a new era for debates over contraception in which dangers were re-framed in strictly physiological terms.i9 This meant that diaphragms and condoms became acceptable as physician sanctioned methods of contraception because they were viewed as doing no harm.20 Intrauterine devices, however, continued to appear in the medical literature as
17 Cited in Piotrow, Worid Population Crisis. 1973. p. 11, pp. 9-11 discuss religious opposition to birth control. See also Kaiser, The Politics of Sex and Religion. 1985. 13 Reed, The Birth Control Movement and American Society. 1978, p. 211. 19 Orr, Conflicting Medical Evaluations of Contraceptive Safety 1916 to 1937 B.A. thesis. Harvard University, Cambridge MA, 1988. 20 Dickinson, 'Contraception: A Medical review of the Situation', 1924. 102 symbolic of the hazards that awaited the unwary medical practitioner entering this dangerous new area of practice.
The first United States intrauterine device trials The association between Robert Latou Dickinson, Dr Mary Halton at the Sanger Clinic, and the Rockefeller Foundation proved to be an important one for the intrauterine device in America. Both doctors were interested in the Grafenberg ring and the device was used in the Sanger clinic throughout the thirties and forties. Halton, Dickinson, and the Rockefeller Foundation were involved in an attempt to widen the intrauterine device network in the United States through a scientific study of its safety and efficacy, but this attempt did not occur until both doctors were near the end of their lives. It was another player, Dr Christopher Tietze, who was to take up the baton and become the driving force behind the rehabilitation of the intrauterine device that eventually led to its greater acceptance. Tietze's interest in birth control, unlike that of Sanger and Dickinson, was not that of a pioneer with an agenda for social change. It arose out of his professional interest in statistics and his employment by Clarence Gamble, an active eugenicist and influential campaigner for contraception.21 Gamble hired Christopher Tietze, a doctor and medical statistician, who had fled from Nazi Austria. Finding work as an immigrant in the United States was not easy and whilst Tietze had been employed at Johns Hopkins School of Public Health assisting with temporary contracts, when he was introduced to Gamble his work on the Johns Hopkins Mental Hygiene Study of the Eastern Health District of Baltimore was about to come to an end. In March of 1944 Tietze accepted a Gamble funded position with the National Committee for Maternal
21 For a discussions of Gamble's life see Williams and Williams, Every Child a Wanted Child. 1978. 103
Health.22 His job was to analyse the comparative contraceptive studies initiated by Gamble. Gamble's need for a medical statistician had arisen from his work in North Carolina aimed at finding the most suitable, and cheapest, contraceptive for indigent families. He was searching for 'simple methods' of contraception; methods he deemed suitable for use by people whom he viewed as feeble-minded, and whose behaviour in giving birth to children despite abject poverty appeared as a sure indication of inferiority, through his eugenic spectacles.23 Gamble was looking for a weapon to overcome the domination of the diaphragm as the preferred method in clinic practice. He believed that use of the diaphragm required a higher intelligence than was evident in the communities in which he was interested. The comparative research studies he instigated were designed to win medical support for the 'simple methods' - condoms, sponges, and spermicidal powders and jellies. Gamble possessed considerable independent wealth through his association with the soap manufacturer Proctor and Gamble.24 He was
^^ The National Committee on Maternal Health had been founded in 1923 by Dickinson as a birth control advocacy organisation for physicians and researchers interested in contraception. Its main source of funding from 1923-1936 was the Rockefeller Bureau of Social Hygiene. Its initial activities had focused on establishing and improving the standard of reproductive research, particulariy testing spermicides. But this had changed to one of publishing and publicising results after 1928. Gamble opposed this shift and urged investment in simple contraceptive methods and the means for their delivery. It was through the vehicle of the NCMH that Dickinson conducted the study into contraception for the New York Obstetrical Society, involving outspoken critic George Kosmac on the steering committee. Also through the NCMH, Dickinson pressured the American Medical Association in 1937 to sponsor a study into birth control and the status and needs for physician education, if only to bring some order into the contraceptive industry that was mushrooming all around them. By 1940 the NCMH had become a basic research organisation, its emphasis not on simple contraceptives,as Gamble urged, but on research into reproductive physiology. However when funds dried up during the war Gamble had been able to use the NCMH as the sponsor for his research comparing simple contraceptive methods and delivery techniques. It remained a Gamble front until 1957, with Gamble employing Tietze to work on these projects. In 1957 Gamble set up the Pathfinder Fund turning the f^CMH over to Tietze and the Population Council. In 1967 it was absorbed into the Population Council's Biomedical Division. Clarke, Emergence of the Reproductive Research Enterprise. 1985, pp. 231-237 & 342. 23 This emphasis on simple methods was widespread, see Clari The 'need' for comparative contraceptive studies was strengthened following the defeat of the Gomstock law by the increasing government involvement in contraceptive provision. Gamble worked hard at enrolling state governments as providers of free contraceptive assistance. State governments already had effective centres linking women in need of free or cheap services with doctors, nurses and other trained health workers whose expertise could readily be expanded to include contraceptive provision. Networks of child and maternity welfare clinics run by the public health departments crisscrossed the countryside. In North Carolina, for example, Gamble's negotiations with the public health service resulted in an expansion of contraceptive services, from two diaphragm clinics in March 1937 to 56 clinics offering contraceptives operating by October 1938.26 This pattern was impediment than a help. He failed to apply himself with the requisite dedication to the tedium and long hours demanded by the way scientific work was organised, and eventually fulfilled his ambition of becoming a physician-scientist by becoming a birth control activist and researcher. Reed, The Birth Control Movement. 1978, pp. 227-231; Williams and Williams, Even/ Child a Wanted Child. 1978. 25 On Gamble's motivation see Williams and Williams, Every Child a Wanted Child. 1978, pp. 97-109. Also Reed, The Birth Control Movement. 1978, pp.225-238. 26 Gamble provided start-up funds so that the contraceptives themselves could be supplied without generating complaints about the use of public funds for contraception amongst Catholic constituencies. The depression and the racial tensions of the South proved to be a 105 extended nationally when, in 1942, the Federal Government ruled that funds allocated to states for health care could be used to provide contraception, prompting an expansion of contraceptive clinics within the regular public health services across the United States.27 This both generated interest in Gamble style comparative research studies of which contraceptives, and which delivery methods, were most efficient at reducing birth rates, and also generated many more records for measuring the effect of contraceptives on population growth. It was one such study, a comparison of condoms and foam-powder in the Watauga area of North Carolina, that first put Gamble in touch with Tietze. The Watauga study was not entirely successful.28 But these comparative studies of simple contraceptives laid the groundwork for the intrauterine device studies that would eventually lead to its revival. Tietze gained valuable experience designing forms for the recording of data, modifying statistical methods to deal with the non-random nature of contraceptive trial participants, defining criteria for the measurement of overall fertility decline, and determining acceptable protocols of follow-up and trial design. Moreover, the acceptance of these methods in comparative studies of contraceptive techniques and their incorporation of criteria of success political context conducive to this entry into contraceptive services by the state. The depression had hit hard at the residents of North Carolina; one out of five were on the dole and many more lived in poverty. One million of the state's three and a half million citizens were black. It was the southern states, where racial tensions were highest, where governments proved most susceptible to eugenic fears that the higher fertility rates amongst the state's black population would eventually threaten whites. The six states to follow North Carolina in integrating contraceptive clinics into their public health service provisions were Alabama, Georgia, Missisippi, South Carolina, and Virginia. However, the race politics around birth control were complex. Existing clinics often did not sen/ice blacks, but whilst blacks were suspicious of white-controlled plans to reduce their numbers, the ideals of racial betterment and improved maternal health provided rallying cries for the mobilisation of black physicians. Black controlled and staffed birth control services were well received. Reed, The Birth Control Movement. 1978; Williams and Williams, Even/ Child a Wanted Child. 1978, pp.128-148; McCann, Race. Class and Gender in U.S. Birth Control Politics. 1920-1945.1987, ch.5. 27 Bullough and Bullough, 'Pregnancy, Contraceptives, and Abortion', 1977. 23 It yielded data on 658 couples who were offered condoms. These were analysed to produce figures of an 81 % reduction in pregnancies, 59% of the women willing to try the method, 27% stopping use, and 73% continuance after 3 years. But Gamble's desire to test the foam powder was thwarted by people's refusal of the method. Williams and Williams, Even/ Child a Wanted Child. 1978, pp.149-156. 106 involving effects on population, rather than on individual health, built a solid tradition of research which could be drawn upon both to justify, and provide the tools for, a study of the more contentious intrauterine devices. It was whilst working for the National Committee for Maternal Health that Tietze began planning a study of the intrauterine device, proceeding along similar lines to those he had employed in the Watauga study. Data was to be generated not by embarking on a distribution project, but by using the two decades of accumulated records collected by Halton. The intrauterine device was one of a number of contraceptive methods being investigated by the National Committee on Maternal Health, and this attention required little justification alongside the extensive program of testing which included such other devices as lorophyn suppositories used in Alabama clinics, jellies and creams used in Baltimore and Philadelphia, and x-ray sterilisation in Washington D.G.29 The involvement of the United States in Worid War II saw Tietze's work on the intrauterine device interrupted. He enlisted as a doctor and was sent to the Pacific as part of Army Medical Corps. He found himself in the Philipines and, like many others, his experiences there were to increase his enthusiasm for going global in trialing contraceptives. He wrote to Gamble from a pleasant agricultural community where the 'people are very poor, but intelligent and ambitious', suggesting it would be an ideal location for studying the introduction of contraceptives.3o Gamble's reply was that to be worthwhile a 'sufficiently inexpensive' method would have to be found. He suggested the pulp of a native fruit injected through a section of bamboo with a home-made plunger'.3i Tietze rejected this logic, citing local doctors and teachers he had met to support his view that the people were quite capable of moving from 29 Letter to Dr. Howard Taylor, Aug 12,1946. Folder 2673, Box 165, Clarence J. Gamble Archive, Countway Library. 30 Letter from Christopher Tietze to Clarence Gamble, 21 January, 1945. Box 165, Folder 2671: Clarance J. Gamble Archive, Countway Library. 31 Letter from Clarence Gamble to Christopher Tietze, May 1st 1945. Box 165, Folder 2671: Clarence J. Gamble Archive, Countway Library. 107 using 'folk remedies' to using scientific methods, and that they were more likely to continue with a method that promised a high degree of effectiveness. Tietze was already thinking that to avoid 'serious demographic disequilibrium' between East and West, the 'oriental peoples' must go through the same development of a modern civilisation as the West, including the development of the 'birth control habit'.32 But unlike Gamble, Tietze saw the Government as the provider of contraceptives through its public health program. During the war years, whilst Tietze dreamed of testing scientific contraceptives to find the best one for such a public health program, Gamble concentrated his efforts on the sterilisation of 'mental defectives' at home. Recommencing work with the National Committee for Maternal Health after the war, Tietze recognised that the intrauterine device study was highly controversial, not because of the statistical techniques he had employed, but due to the persistence of medical opposition. To add greater weight to the paper, Tietze sought out Dickinson, now in failing health, as co-signatory.33 The beliefs that Tietze, Halton and Dickinson wanted to address are summarised in a letter to Mary Halton from a patient: ...the objections raised by certain doctors and Gynecologists is that the mucous membrane of the womb through irritation by the suture prevents conception occurring and that while a surgeon's suture in time dissolves when sewn into the body it would prove irritating if permanently located, as this suture is. Also that the womb is more susceptible to irritations that result in cancer...34 In reply, Dickinson put such beliefs down to 'a curious balk against fair test or trial among some members of our profession', comparing them with the prejudice of his profession against tampons, the opposition to the use of 32 Letter from Christopher Tietze to Clarence Gamble,. 15 May, 1945. Box 165, Folder 2671: Clarence J. Gamble Archive, Countway Library. 33 Letter Tietze to Gamble, Jan 1,1947. Folder 2673, Box 165, Clarence J. Gamble Archive, Countway Library. 34 Letter from Cornelia Baekland Ditisheim to Mary Halton. Robert Latou Dickinson Papers. Folder labelled 'Intrauterine silkworm coil - Halton, Dickinson & Tietze lUD article'. Countway Library. 108 chloroform in obstetrics, and to the use of vasectomies for the sterilisation of the feeble-minded.35 Manufacturing a 'fair test or trial' of the intrauterine device from the records of Mary Halton had been no easy matter. The task of preparing the form and the instructions for its use was 'one of the most difficult tasks I have ever undertaken', Tietze wrote to Dickinson.36 Tietze's data forms could be filled out from only 266 cases out of over 1000 of Halton's case records.The work had to be done by Halton's assistant, Gelia Mesa, whose memory was combined with the records to piece the wanted observations together from the fragmentary and esoteric case history records. Between Tietze's war service. Mesa having to fit the record transformation task in around her ongoing full time job and Halton falling seriously ill, the work, begun in early 1944, was not completed until 1947. Then came the task of having the article published. The American Journal of Obstetrics and Gynecology was the most prestigious place for the research report to be published. There, it would gain maximum exposure amongst the leading specialists in gynaecology. Its publication would lend the journal's authority to the paper's findings that the coil caused no permanent sterility or damage, and that this was a highly successful contraceptive: '98% of expected conceptions were prevented'.37 But the American Journal of Obstetrics and Gynecoloav was edited by Dr. George Kosmac, Dickinson's long time opponent in the struggle for medical involvement in birth control. Kosmac rejected Tietze's paper. He never published anything positive about the intrauterine devices.38 Dickinson approached several of the other wider circulation more prestigious journals, but they were often influenced by the 35 Dickinson to Mrs. Ditsheim, Nov 14,1946. Robert Latou Dickinson Papers. Folder labelled Intrauterine silkworm coil - Halton, Dickinson & Tietze lUD article. Countway Library. 36 Tietzt to Dickinson, April 24,1944. Folder 2670, Box 165, Clarence J. Gamble Archive, Countway Library. 37 Halton, Dickinson and Tietze, 'Contraception with an Intrauterine Silk Coil Human Fertility', 194813,1, pp. 10-13. 33 Letter from Christopher Tietze to Clarence Gamble, 24 May, 1947. Box 165, NCMH 1944- 1947 : Clarence J. Gamble Archive, Countway Library. 109 American Journal of Obstetrics and Gvnecologv. All turned the 'silk skein pessary' study down.39 In March 1948 the paper 'Contraception with an Intrauterine Silk Coil' co-authored by Halton, Dickinson and Tietze appeared in the in-house journal of the birth control movement, the journal of the Margaret Sanger Research Bureau, Human Fertility. There it apparently received little attention, and certainly had little impact on the doctor prejudices it was designed to tackle. Even the National Committee on Maternal Health refused any association with the paper, and Human Fertility included the rider that this was not a method that could be used without careful discrimination, if at air.4o It is interesting to note that at this time, despite the reported success of the intrauterine contraceptive device - indeed doctors were being informed of the best rate of fertility decline of any contraceptive yet tested - the paper went almost unnoticed both inside and outside birth control circles. The Tietze-Halton- Dickinson Study was not successful at luring the physicians into using the devices, nor at stimulating interest in further research into their safety and efficacy. That same year, disillusioned by his persistent marginalisation as a contraceptive researcher, Tietze resigned from the National Committee for Maternal Health. Constructing population control as a research problem Tietze would not attempt to construct interest in the intrauterine device again until the eariy 1960s. By then a crucial change had occurred, not in intrauterine devices themselves (although they had changed in design and construction materials), but in the social goals of a wide cross-section of American society - political, business, and medical. Population increase came 39 Letter from Surgery, Gynecology and Obstetrics to Dickinson, June 11,1947. Box 165, Folder 2670, Clarence J. Gamble Archive, Countway Library. In addition to the archival sources detailing Tietze's experience with the lUD study see Reed, The Birth Control Movement. 1978, pp. 274-276. 40 Reed, Thg Birth Qpntroi Moyement, 1978, pp. 274-276. 110 to be seen as a problem. That is to say the rates of population increases in the poorer nations of the worid became perceived as a problem for many citizens of the United States. Population control, rather than family limitation, child spacing, or sexual equality became a new aim associated with contraception. This emphasis on population control was not an entirely new phenomenon. It had been named as the problem facing United States administrators in Puerto Rico in the 1930s, and used as the criterion of success for the contraceptive trials conducted by Gamble in North Carolina and other studies in the South in the 1940s.4i It was the generalisation of this attitude to population change that was crucial to the success of Tietze's second intrauterine device trial. Linda Gordon points out that it was United States foreign policy developed in Puerto Rico that provided the groundwork for this problematisation of population size.42 By the 1930s, more than thirty years of United States administration of the island protectorate of Puerto Rico had resulted in a massive transfer of the island's land and productive resources from the Puerto Rican people into the hands of American capitalists. Fearing immigration pressures and social unrest, the United States government pronounced overpopulation the primary cause of the 'Puerto Rican problem'. An inquiry into the health of the island's children, conducted by the Senate Child Health Committee, reported that the island had 174,650 'too many' 41 See Reed, The Birth Control Movement. 1978, Ch. 19. 42 Gordon, Woman's Body. Woman's Right, 1977, pp. 332-334. Linda Gordon argues that the emphasis on population as the aim of contraception was the outcome of the negotiation of a unified struggle for contraception under the banner of population research in the United States during the 1930s. The alliance between the eugenics movement, the birth control movement emphasising women's rights and better marriages, and the movement amongst physicians to make the provision of contraceptive devices and infonnation a medical sen/ice subordinated feminist and individual health arguments for birth control to arguments about race betterment and population. 1 do not disagree with this, but want to distinguish between two different conceptions of population: the population problem for eugenists was a problem of population quality - their slogan was race betterment; the population problem generalised in the 1950s was a problem of quantity, the new slogan called for population control. Gordon, Woman's Body, pp. 337-43; See also Clarke, Emergence of the Reproductive Research Enterprise. 1985, pp.352-56 & 365-76. Ill children.43 Birth control became an important political issue. Countering United States propaganda that overpopulation was the cause of poverty in Puerto Rico, independence movements blamed their country's problems on United States imperialism. The Catholic Church, a major influence on Puerto Rico's social life, also fought against the legalisation of birth control. Despite this heavy opposition, the intervention of the United States government ensured that the birth control battle was won in 1937.44 An effective public health system of free maternal clinics, offering free contraceptive advice and supplies throughout the island, was in place by 1939.45 This opened the way, not simply for people to obtain birth control if they so desired, but for the criteria for contraceptive efficacy to be locked in with population control. Reed points out that Gamble's North Carolina experiments and the free clinics provided by the southern states were also clearly aimed at reducing the population.46 Birth control was offered to poor families on a mass basis, on the assumption that they would choose to improve their standard of living by decreasing their family size and would be willing to make some effort to do so. Governments and business interests believed that this promised, at the lowest possible cost, to remove a potential source of unrest, as pooriy paid and unemployed workers adjusted the size of their families to the poor yield rural farms, and the low wages and cycles of high unemployment to which they were being subjected. Contraception was aimed at a reduction in the numbers 43 Gordon, Woman's Body. Woman's Right. 1977, p. 333, n. 131. 44 Gordon, Woman'? Body. Woman's Right. 1977, p. 332, n. 129. 45 In 1939 Gamble and Beebe, who were also involved together in the Southern States, in conjunction with Dr Hose Belavel, the medical director of birth control program in Puerto Rico, had began a two year study of two thousand couples in four urban and nine rural areas of the island. The aim was to compare the effectiveness of foam powder, jelly alone, or diaphragms in reducing the birth rate. The study reported its results as reductions in pregnancies annong women. All methods were found to be aproximately equivalent, and to reduce the birth rate by half. Neither the findings, method of analysis, nor the type of study were unusual. It was in the discussion that this study incorporated the shift in the criteria for success in a birth control program. The authors note that whilst it was possible to achieve a 50% reduction in the birth rate if use of the contraceptives was maintained, the 50% drop out rate in the first year meant that these methods did not offer an effective means of controlling population. Williams and Williams, Even/ Child a Wanted Child . 1978, pp.172 46 Reed, The Birth Control Movement. 1978, ch. 19. 112 of children born by providing mass access, not to the same contraceptive techniques that were being used by the middle and upper classes, but to workable contraceptives that could be delivered at the lowest cost, that is without the necessity to see a doctor. This marked a new phase of experimentation with birth control. In America, and in Europe, birth control movements prior to Worid War I had not questioned the importance of population growth to national prosperity. However, it was not until the 1950s that research oriented towards population control was elevated to a mainstream problem warranting large scale funding and professional efforts.47 The population debates, which prior to World War II had on the whole remained oriented around national questions, quickly became refocused on the perceived human population explosion in the developing worid. The idea that the population of the developing worid was a ticking time-bomb was popularised in the United States by Hugh Moore Fund's mass circulation of T.O. Greissimer's Population Bomb .48 This shift was in part fuelled by the internationalist outlook prioritised by the United States government after Worid War II. The cold war made economic progress amongst 'friendly' nations a United States government priority, and population control came to be seen as a government concern to ensure that economic aid raised per capita income. This was the view taken by an inquiry established by the Rockefeller Foundation in 1948 into population in the Far East under Marshall Balfour, Roger Evans, Frank Notestein and Irene Taeuber. Their report links overpopulation, economic development and public health. The legitimate aims of local peoples in developing countries for improvements in health and for 47 See Piotrow, World Population Crisis. 1973, ch. 2; Symonds and Carder, The United Nations and the Population Question 1945-1970.1973; Mass. Population Target. 1976, pp.35-70 , and Hartmann, Reproductive Rights and Wrongs. 1987, pp. 100-110 for discussions of the increasing involvement of scientists, the corporate sector, the U.S. government and the United Nations in 'the problem' of population control. 43 Greissimer, Population Bomb , 1954. 113 reductions in the death rate, and the increasing success of emerging nationalist governments in meeting such goals, are presented as fuelling a population growth spiral. Improvements in living standards, for Balfour and his team, were therefore contingent on unrealistic economic growth rates at levels that could absorb into the productive work-force the increasing numbers of people surviving to adulthood and living to retirement age. Reflecting on occupied Japan, for example, which prior to the war had encouraged population growth as part of its build-up towards militarism, the report urges deliberate policies aimed at reducing fertility: The social goal of American Policy is to increase the welfare of the Japanese people without jeopardizing the levels of living or the political independence of other peoples. Although this goal does not include the reduction of the birth rate of the Japanese, demographic developments in post-war Japan imperil the achievement of this avowed goal of the Occupation unless the fertility of the Japanese is reduced drastically throughout wide areas, if not the entire nation. Thus the diffusion of the small family pattern should logically rank with political democratization, social reorientation and the creation of a viable economy as one of the goals of the occupation.49 The report recognised that Malthusian predictions were an inadequate model of population trends. Japan had a history of industrialisation and urban growth in the twentieth century that had enabled it to accommodate an increasing population density. Industrialisation, migration of Japanese nationals to surrounding countries and the use of those countries to supply agricultural products to the urban Japanese market, were perceived by Balfour and his colleagues as shaping Japan's demography along the lines of demographic trends similar to those that had emerged in Europe in the nineteenth century. There, according to accepted demographic thinking of the post-war era, industrialisation had at first fuelled population grovAh as living standards improved and death rates declined, but this had been followed by a decline in birth rates as family ties weakened in urban culture. Individualism, women 49 Balfour, Public Health and Demography in the Far East. 1950, p.43. 114 becoming better educated and entering the work-force, and the increasing cost of raising children as longer periods of education were required for work force participation, were all thought to have contributed to this process. Balfour argued that this pattern had been evident in pre-war Japan, and that itt was in the face of population decline that imperialist forces in Japan had introduced pro-natalist policies. Despite this, the Rockefeller appointed investigation condemned Japanese population trends as disastrous for economic growth. The implicit argument is that the adjustment of the European population, during the time when death rates had lowered but fertility rates had not yet followed suit, had been achieved by mass emigration to the colonies, and the appropriation of agricultural, energy and mineral raw materials from them to Europe to expand the productive capacities of highly populated European urban centres. Japanese imperialism was however condemned by the United States occupation forces, and emigration of 'excess' population was not deemed an option. The people of Japan, China, Taiwan, Korea and the Phillipines were repeatedly described in the report as having appropriated Western technologies to reduce mortality statistics. The problem associated with this appropriation, according to Balfour and his colleagues, a view that was to become widespread in the West, was that Western value systems emphasising individualism, the weakening of family ties and the rights of women to participate in paid work had not been imported alongside these technologies. The report, having locked-in lower population growth rates with economic grov^rth then strongly urged that the 'assiduously imported' Western technologies that resulted in 'saved lives', improved health and mortality be linked with direct assistance to families 'to limit the number of their children'. 50 The idea, taken-for-granted by many people today, that reducing birth rates would encourage economic growth, was counter-intuitive to the received 50 Balfour, Public Health and Demography in the Far East. 1950, p.45. 115 view in economics and demography prior to the 1950s. Surely a growing population would mean more contributors to wealth production and an expansion of markets as increased consumption inflated demand. Encouraged by Notestein (who was to take over as director of the Population Council in 1959), Ansley Coale and Edgar Hoover used data from India to make the claim that a reduced rate of population grov\rth, far from causing economic stagnation, would stimulate economic growth because it would increase the capital available for investment. Families and governments could save money that would othen/vise have to be spent on consumption and welfare (eg. schooling) to meet the social needs of dependents.5i This thesis treated children as dependents until the age of fifteen, ignoring the increasing demand for low-quality labour in the developing countries and the value of children's labour even to those families struggling to survive in the so-called developing sectors as wage-labourers. Indeed children's labour often became more critical to survival as peasant economies collapsed, land was appropriated for cash-crops, and food had to be bought. The Coale-Hoover thesis, based on patterns of growth in the West, was predicated on the assumption that capital accumulated in a country would be available for investment in new technologies and industries, lowering the demand for cheap labour and hence increasing the value of smaller families that could invest greater resources in the education of their children. Yet very often profits were repatriated to investors and parent companies in the United States and other developed economies, allowing the relatively high costs of labour at home to be reduced by the development and purchase of labour- saving technologies, but using the developing world as a source of cheap labour. Thus the economic conditions that operated to encourage families to have relatively large numbers of children continued in the developing 51 Piotrow, World Population Crisis. 1973, p. 15. See Coale and Hoover, Population Growth and Economic Develooment in Low Income Coiintrifi.s 1958. 116 countries.52 Nevertheless, such contributions as the Coale-Hoover study from the human sciences played an important role in linking population control policies to the development agendas of national elites in post-colonial countries emerging within the United States sphere of influence. The United Nations established a Population Division within its secretariat in 1946, under Frank Notestein. At first its concerns remained focused on the defeated populations of Germany, Japan and their allies. Initially, implementation of population control programs were seen by the United Nations as preventive measures against another build up of hostilities. However, by 1954 when the Population Division of the United Nations organised the World Population Conference in Rome, this initial brief had expanded to include all the developing countries. At the Rome conference, American demographers argued that population control is necessary for developing countries on three counts - (1) Rapid population growth would aggravate existing problems of land distribution. (2) With high growth rates in population, greater inputs of capital investment were needed to create per capita gains in living standards. (3) A high birth rate would increase the number of children, encouraging high consumption and low savings, thereby aggravating capital availability for development.53 This view was, however, strongly opposed by both Catholic and Communist countries, a coalition which blocked the adoption of the Rome Conference recommendations by the United Nations, Population debates became highly polarised during the Cold War with any suggestion that economic development could be improved by limiting population growth being 52 Michaelson, 'lntroduction:Population Theory and the Political Economy of Population Processes', 1981, pp. 20-23. 53 Piotrow, World Population Crisis. 1973, p. 12. United Nations, Proceedings of the World Population Conference. 1954. See p. 133 of the Summary Report. 117 vigorously opposed by Communist countries. Marxists argued that Neo- Malthusian ideology masked the economic and social devastation caused by imperialism, and that it was the social and economic structures of imperial domination that were the real causes of under-development. By 1955 the Population Division had been downgraded and its activities remained constrained for the next decade and a half.54 The Population Council was partly responsible for filling this breach, and worked hard throughout the 1950s to link population control to development planning at an international level. Their success at projecting the struggle to win the battle against population to the forefront of public discourse in the post World War II period provides the crucial historical context for the development of intrauterine devices. The Population Council The Population Council was the primary organisation responsible for the global scale 1960s revival and development of the intrauterine device. It was established in 1952 and had a far reaching international program. On his return from occupied Japan in 1948, and in the face of opposition from established Rockefeller organisations to public outspokenness on contraception, John D. Rockefeller III established the Population Council with $100,000 to pursue his interest in the problems of fertility regulation and population control in developing countries.55 The Population Council contributed to the construction of the fertility rates of developing countries as a social problem, and of the intrauterine device as its solution. At the beginning of the 1950s, public advocacy of contraception and population control was still controversial. The use of contraception in private might have had majority support, but Rockefeller Foundation members argued 54 Piotrow, World Population Crisis. 1973, p. 13; Symonds and Carder, The United Nations and the Population Question 1945-1970.1973, pp. 69-88. 55 Harr and Johnson, The Rockefeller Century,1988. 118 that public outspokenness promoting the use of contraception for population control risked embroiling the Rockefeller Foundations in controversy by sparking public opposition from the Catholic Church. John D. Rockefeller Ill's brother. Nelson, had been very successful in establishing Rockefeller business and philanthropic programs in Latin America. Nelson feared that such interests could be detrimentally affected by the reaction of the Catholic Church in North America to any public displays of support for contraception.56 Hence a separate organisation, the Population Council, was founded for the specific purpose of pursuing solutions to the population problem.57 In the North American struggle to characterise contraception the Catholic Church had been a strong alternative voice to birth control interests. During the 1950s, whilst medical opposition to contraception waned. Catholic agencies consistently denounced contraceptives. The Catholic Church characterised any government interest in the promotion of contraceptives as a direct attack on Catholic immigrant communities, a poor substitute for a more just society, and a paranoid reaction to the increasing political power being mobilised in those communities.58 in order to win the ethnic vote, politicians at both municipal and national levels had kept silent on the issue of birth control. To publicly support contraception was perceived as political suicide.59 Thus, throughout the 1950s contraceptive development was left to private organisations. From 1952 to 1958, after which outspoken government and political support for contraception became more common5o, the Population Council, as 56 Harr and Johnson, The Rockefeller Century.1988. 57 This fear of Catholic antagonism was realistic. Within months of the Population Council's establishment smouldering tensions over birth control between New York City and the Catholic Church errupted. Planned Parenthood was elected to membership of the New York City Welfare and Health Council; all of the Catholic welfare agencies resigned in protest. Piotrow, World Population Crisis. 1973, p. 16. 53 Piotrow, World Population Crisis. 1973, p. 10. 59 Piotrow, Worid Population Crisis. 1973, Chapter 3. 60 Piotrow describes how, in 1958, a new balance of power emerged in New York City between Catholic interests and birth control interests. This occurred following a confrontation by Dr Louis Hellman with New York City policy banning the legal supply of contraceptives in 119 one of a few corporately funded private organisations in the United States focused on birth control, played a crucial role in advocating contraceptive research and in constituting population control as necessary for economic development. Established as an independent philanthropic foundation and untarnished by the anti-establishment history of the birth control movement, the Population Council was in an ideal position to act as a strong advocate and spokesperson for contraception.5i The Council succeeded at building a series of alliances between contraception and reproductive biology researchers, funding bodies, governments and health professionals. It was very successful at channelling funds from both private foundations and governments into contraceptive research without arousing controversy.52 From an annual operating budget in its early years of $500,000, its budget had jumped to $2.3 million dollars by 1961.53 One strategy which greatly assisted the Population Council in consolidating linkages between large-scale funding bodies and contraceptive research was its effective building of an alliance with mainstream biological research. The field of contraception was characterised by the Council as 'applied' science, the direct offspring of the 'basic' science of reproductive biology.54 Corporate philanthropies such as the Ford Foundation felt they were on safe ground donating money for biological research. Furthermore, the Population Council's commitment to research in reproductive biology ensured that respectable scientists and medical researchers could work alongside municipal hospitals . He precipitated the crisis by publicising his action prescribing and fitting a diaphragm for a diabetic woman in a city hospital clinic. For six months the press raged about interference in medical judgements by a religious minority. Poiticians, accustomed to avoiding controversy by maintaining silence on the issue of contraception, could not return the issue to back-room power-broking, and were forced to publicly take sides. By the end of the year not only had the policy been overturned but government officials had a new sense that supporting birth control was no longer a matter for solicitous silence. Moreover, the Catholic Church's defeat prompted the bishops to redefine their political role. They concluded that to 'strive for legislation and directives which clash with the beliefs of a large proportion of society' was counterproductive for Catholicism. Piotrow, World Population Crisis. 1973, p. 17. 61 Harr. Rockefeller Century, pp.452-467. 62 Reed, The Birth Control Movement, pp. 287-288. 63 Population Council, Population Council Annual Reports 1952-1964.1965. 64 Population Council, Population Council Annual Reports 1952-1964. 1965. 120 contraceptive researchers, forging a much stronger and enlarged scientific bloc with interests linked to contraceptive research. The Population Council argued that leads to new innovations in contraceptive technologies would emerge from basic research.55 This involved eschewing traditional methods of contraception including condoms, jellies and diaphragms as unsuccessful. Such methods were fundamentally uninteresting to researchers in reproductive biology, nor did they meet the new criterion measuring success in terms of population control. The Population Council used the argument that basic research would lead to new, more effective contraceptives to bring biologists into a joint enterprise aimed at contraceptive outcomes, by asserting that effective contraceptives would come out of animal and experimental research into the reproductive cycle.56 This Population Council strategy of consolidating the support of prestigious, mainstream research scientists for a field which had previously been seen as the domain of a few marginalised contraceptive advocates was reflected in the architecture of its laboratories. In 1956 the Biomedical Division of the Population Council developed its own laboratory facilities at Rockefeller University in New York.57 This enabled the council to establish contraceptive and reproductive biology research as two elements (pure and applied science) of one professional field, and to bring together on one site laboratory scientists from many disciplines. This facility was continually expanded throughout the 1960s so that by 1971 it boasted twenty-nine labs, fourteen animal rooms, radio-immunoassay and radio-chemistry facilities, an electronmicroscopy lab, and a large primate colony.58 ^ vvas one of the largest research facilities in the field of reproductive biology in the world, and successfully channelled funds. 65 Population Council, Population Council Annual Reports 1952-1964. 1965. 66 Clarke, Emergence of the Reproductive Research Enterprise. 1985, pp. 369-385. Clarke argues that the work of the contraceptive community was redirected by the reproductive biologists, who essentially did not change their research agendas but captured the support of the rapidly expanding contraception audience. 67 Population Council, Population Council Annual Reports 1952-1964. 1965. 53 Population Council, Population Council, Annual Reports 1971. 121 raised for the neutral sounding advancement of reproductive biology, into contraceptive research. In its laboratories embryologists, immunologists, organic chemists, physiologists, endocrinologists, and gynaecologists routinely sacrificed South African frogs, African weaver finches, six species of laboratory rodents, monkeys and baboons.59 There was nothing inevitable about the Council's emphasis on 'basic' research. In contrast, the Battelle centre on the west coast of the United States believed that advances in contraception would come from an alliance between bio-engineers and clinicians working on contraception.7o The Population Council pursued a goal of linking contraceptive research to the reproductive biology community. This strategy proved to be successful, I would contend, not so much because it led to contraceptive breakthroughs, but because it legitimated contraceptive research as a normal part of the biomedical research community. The success of the Population Council's model for the consolidation of linkages with the governments of foreign countries was its second major strength. According to Piotrow, this strategy had been articulated and put in place by 1957. She analyses the three aspects to this model which proved such a successful combination. First, responsibility for leadership and implementation of population control programs were put into the hands of local people. The Population Council believed that education of local professional elites would ensure that there would be local advocates for contraceptive services, people 'able to foster the public understanding necessary for the political support of their programs'.7i The second plank in the Population Council's model involved the promotion of studies of demographic and economic data. Claiming to be purely technical, and neutral 69 Population Council, Population Council. Annual Reports 1970. pp. 45-46. 70 See Wheeler, Duncan and Speidel, Intrauterine Devices. 1974. 71 Population Council, Population Council Reports 1952-1964.1959, p.5. This position is elaborated by a director of the Population Council, Frederick Osborne, in Population: An Intemational Dilemna. 1958. 122 with respect to social and political goals, such studies were pursued, as Piotrow points out, as a lure to encourage interest in population control amongst the governments and professional elites of developing countries. The third aspect of the model made contraceptive provision a part of the development of public health programs. This packaged population control as a program to improve maternal and child health, presenting it as similar to programs of inoculation or malaria control, thereby maximising support from local people.72 This model for consolidating links with post-colonial nationalist governments, convincing them that their development aims could best be met by routing their economic development goals through the research and birth control delivery program assistance of the Population Council, owed much to United States experience during the post-war occupation of Japan. The occupation did more than help to focus government attention on the development plans of Asia. It provided a laboratory for honing policy initiatives effective for involving foreign governments in population control. It was in Japan that United States officials worked out the way to avoid anti- contraception criticism from those American organisations that still exerted considerable political influence at home. If pro-birth-control decisions were engineered as foreign government decisions then the United States government had no right to interfere. United States assistance could then be characterised as scientific assistance in response to the requests of independent, friendly governments.73 The Population Council adopted this ^^ Piotrow, World Population Crisis. 1973. pp. 14-15. 73 In Japan, the demilitarisation and occupation forces under General MacArthur invited the demographers Warren Nelson and P.K. Whelpton to advise on population measures. The theory that the Second World War was caused by over-population and over-crowding, resulting in Japanese and German expasionism, enjoyed considerable popularity immediately after the war. In a report on economic development they included a recommendation that population and resources must remain in balance, and that this could best be achieved by keeping demand in check through a reduction in the birth rate. A visit from Margaret Sanger was also planned for 1949. However both these initiatives were scuttled by protests from the American Catholic Women's Club, a group made up primarily of the wives of the occupying United States troops. Piotrow, Worid Population Crisis. 1973, p. 32. 123 model and always claimed that it was sharing its scientific expertise in response to autonomous decisions by foreign governments. This is not to say that such requests were not forthcoming, nor that they were unwillingly entered into by post-colonial governments, but to point out that the Population Council adhered closely to this model. Making the intrauterine device the ideal solution to over-population in the developing world The intrauterine device was only one of many contraceptive technologies available in the 1950s, but it was a device attributed with particular significance by professionals concerned with curbing population growth. The intrauterine device was construed as a suitable contraceptive for 'unmotivated' women and women whose cultural background was deemed to inhibit the 'rational control' of conception.74 How could voluntaristic methods be successful when they required ongoing decisiveness on the part of women, away from the support and encouragement of specially trained clinic workers, if there were no creative and positive alternatives to motherhood available? Why would rural families who wanted four children make an effort to practise birth control when they were not, as one American involved in pioneering contraceptive programs in the developing worid put it, in the habit of planning rationally?75 it was women associated with the population crisis in developing countries who were portrayed as better served by a contraceptive such as the intrauterine device where 'the need for recurrent motivation is removed'.76 74 Population Council, The Population Council. Annual Reports. 1952-1964. 1965. 75 These sentiments are expressed in a 1965 letter of resignation from John Cobb, who had been for four years the director of the model family planning program in Pakistan started by Paul Harper under the auspices of Johns Hopkins School of Public Health and Hygiene with a grant of $800,000 from the Ford Foundation. Dr Harper had been a member of the 1959 Population Council advisory visit to Pakistan, accompanying Marshall Balfour. Letter from Cobb to Harper, May 12,1965. Folder: Division of Population Dynamics - MESOREP; Box Rl B68, Alan Mason Chesney Medical Archives. 76 FDA Obstetrics and Gynecology Advisory Committee, 1968 Report on Intrauterine Contraceptive Deyices.1968. pp.1-2. Similar arguments have been noted as rationalisations for other technological innovations - see Martin, Scientific Knowledge in Controversy: The Social Dynamics of the Fluoridation Debate. 1991. 124 The production of the 1960s intrauterine devices as a new contraceptive system involved the creation of new subjects. Women were constituted as recipients in the population control intrauterine device networks differently from the ways that they had been imagined as part of the intrauterine device networks of the 1930s. Rather than the singular category of women envisaged as the choosers of the intrauterine devices of the 1930s, women were divided into sub-groups. We were not all born equal. Experts decided which women were ideal subjects for intrauterine devices. The 1960s intrauterine device was not merely one alternative available to women contraceptors, for some women it was considered the most efficient contraceptive. This image of the intrauterine device as ideal for women who might 'forget' to use more conventional methods mobilised a powerful Western iconography about the East which helped the Population Council by linking its vision of population control in developing countries with deeply entrenched mythic beliefs in Western culture.Such myths had long equated woman, the East and nature; excluded reproduction from the realm of culture, and constructed class and race hierarchies along an imagined line of evolutionary progress from the animal realm of biology to the high culture of Western civilisation. These elements did not have to be spoken. Any Western- educated reader of the mundane statements of the intrauterine device protagonists and population control advocates understood that it was this linkage between woman, nature and tradition that could undermine the potential of the East to imitate the Western manly virtues of progress, virility and economic growth. These undercurrents were at work in discourses concerning the development of the intrauterine device. This is not to speculate on the motives for the Population Council's choice of the intrauterine device as the contraceptive that could best reduce fertility rates, but to decode the 125 meanings drawn upon by any competent audience.77 Race and sex are intricately bound together in the imagery of Western cultures that presents some peoples as 'other'. Onto women, children, Pacific islanders and all people of colour there is projected not a reflection of real lived differences, but an image of traditional subjectivity which white middle-class identities in industrial society formulate themselves as having transcended. This is not to say that women in post-colonial countries were merely passive victims of a Western imaginary unleashed through the contraceptive programs established in their countries. In Pakistan, for example, where John Cobb of the Johns Hopkins School of Public Health and Hygiene was in charge of developing a demonstration contraceptive program at Lulliani on the outskirts of Lahore, women who had tried other methods willingly agreed to try the new intrauterine devices.78 A group of women recruited into the contraceptive distribution programs run by the Centre were interviewed by staff from the Medical Social Research Project (MESOREP) and reported varying problems that they anticipated solving by using the coil intrauterine devices (Lippes Loops). One woman had broken the spermicide applicator, a husband refused to use condoms, another woman's children had spilled the foam, another had difficulty finding the peace to insert the jelly before her husband came home (necessary so that she could avoid detection), another could not predict when her husband would 'meet her', the difficulties of a mother-in-law who was against family planning discovering the box with the kit in it were alluded to by one woman, a diaphragm user felt shamed at having to ^^ Just as when listening to a radio-play 1 interpret the grand sweep of violin music as anticipating a romantic liason, so too, without having to consciously think about it, I, and many others, would respond to statements about the need for a contraceptive that does not require ongoing voluntary effort, by drawing on widespread common-sense understandings that position indiginous peoples and particulariy women from Asia or Africa as other, as in/of nature, as living spontaneously outside the constant demands made by the modern world for planning and rational control of one's passions and emotions. Non-industrial societies have been represented as closer to nature and their people as less cultured in the iconography of Western countries. 73 The following reports are from Medical Social Research Project Lahore, 'Summary of 40 Foam Recipients', August 16,1964. Folder Department of Population Dynamics - MESOREP, Box R1B68, Alan Mason Chesney Medical Archives, Johns Hopkins University. 126 discuss it with her husband even though he approved of family planning, a woman with tuberculosis wanted a very sure method, and another woman complained of the 'botheration' involved in finding everything in the dark. The enrolment of these individual women into the intrauterine device socio- technical network was a process in which they actively re-routed their goals for practising contraception through the coil. Were those who did so representative? Many women soon abandoned the coil, some removing it themselves, many because they did not like the bleeding, and a few because it pricked their husbands. How many women would prefer a contraceptive that involved no daily effort? How many could tolerate the device? In how many cases could the uterus be induced to hold such a device? This was the question that the Population Council's multi-centre trials answered, at least for the women in the trial. Uncovering the motives for the Population Council's choice of the intrauterine device as the ideal contraceptive for the developing world is a difficult task. Memories change as history forges its path and the way we remember the past is shaped by the victors. Retrospectively, the intrauterine device seemed to be the obvious choice. But in the early 1960s there were many objections that could be made to even the possibility of its success. It had a long history of being virulently opposed by the medical establishment. It was likely that its action was partially that of an abortifacient, preventing the already fertilised egg from implanting, and therefore likely to spark opposition from the Catholic Church. The oral contraceptive pill had just become widely available and was proving to be amazingly acceptable to women consumers. Why invest the enormous amounts of time and money that would be required to develop and test another contraceptive?79 The early trials of the oral 79 This has now become an enormous problem with the pharmaceutical industry putting very little effort into new contraceptive developments since the oral contraceptive pill is seen as having achieved market saturation. This viewpoint was repeatedly expressed by speakers participating in a conference I attended in October 1990, in Baltimore, titled 'Planned Parenthood of Maryland: The Crisis in Contraception'. The sentiment was shared by very diverse speakers, including Sheldon Segal (Director of Population Science, Rockefeller 127 contraceptives in illiterate, rural communities in the developing world, that used such mechanisms as aligning pill cycles with the lunar cycle, were successful. But the Population Council rejected the oral contraceptive pill as unsuited to its aims of population control. The Council argued that the cost of supplying repeat cycles, particularly given the tight hold exercised over their distribution by commercially oriented drug companies would be too high to make this contraceptive a suitable contraceptive for reducing the birth rate.8o Perhaps initially the Council's interest in intrauterine devices had been prompted by their desire to justify their basic science research programs by coming up with their own breakthrough. The Population Council negotiated with Jack Lippes to provide tax-free development costs for clinical trials of his Lippes Loop device in exchange for the rights to distribute the loop to public sector distributors in developing countries.8i By 1962 the early efforts of the Council's reproductive biologists to stimulate an immune response to sperm looked like being a long and protracted research program that would not yield quick results.82 Perhaps in the wake of the oral contraceptive pill's development, something was needed, in a hurry, to sustain the Population Council's claim to be a leader in the contraceptive field. Certainly the leaders of the Population Council, frustrated with efforts to produce fertility rate declines using conventional contraceptives, had decided by 1962 that the revival of the intrauterine device was the best hope for instituting the contraceptive habit in the worid's poorest people. Over the next few years the Foundation), Judy Norsigian (Boston Women's Health Book Collective) Faye Wattleton (President, Planned Parenthood Federation of America), and Gabriel Baily (Center for Population Research, National Institutes of Health). 30 Reed, The Birth Control Movement and American Societv. 1978. See Footnote 41 on p. 427. 31 Mauldin and Ross, 'Historical Perspectives on the Introduction of Contraceptive Technology', 1989. 32 Population Council, The Population Council. 1952-1964. 1965, pp.13-14,1960; p.11, 1962-63. 128 Council was to invest $2.5 million in the clinical testing of the intrauterine device.83 The characteristics attributed to intrauterine devices by the Population Council seemed to make it the logical solution to what was increasingly being interpreted as the threat of high birth-rates in the developing world. Here was a contraceptive device that need be inserted only once and can be left in place for some time, during which no pregnancy occurs in the vast majority of cases. Motivation is required only once, rather than before each sexual act or on a daily schedule of medication.84 Whatever the motives for the Population Council's emphasis on the intrauterine device, the strength of this articulation between the perceived need for population control in developing countries, the unsuitability of alternative contraceptives, and the intrauterine device as the ideal solution was such that it withstood the challenge to intrauterine device development posed by the success of the oral contraceptive pill. Tietze's Second Intrauterine Device Trials The dream of the intrauterine device as the perfect contraceptive faced a formidable obstacle - the entrenched hostility of the United States medical profession. In 1957 in the United States, the Food and Drug Administration sun/eyed members of the American Board of Obstetrics and Gynecology on their experience and opinion of the safety of intrauterine pessaries, a term that included a variety of devices both partly and wholly intrauterine.85 The Food and Drug Administration was responsible for the regulation of interstate commerce in dangerous or mis-branded devices. Intrauterine devices were not condoned by obstetricians and gynaecologists. Reporting the results of the Food and Drug Administration survey in the Western Journal of 33 Reed, The Birth Control Movement and American Society. 1983. 34 Population Council, The Population Council. Annual Reports 1952-1964.1965, pp. 11-12, 1962-3. 35 Weilerstein, 'The Hazards of Intrauterine Pessaries', 1957. 129 Gvnecology in June 1957, Ralph Weilerstein concluded that the distribution of intracervical and intrauterine pessaries was to be condemned. This view had been overwhelmingly supported by participants in the survey who had responded with reports of injuries including infection, perforation, the embedding of the device in the uterine wall, pregnancy complications, and cervical carcinoma. However, there were some indications by 1959 that the time was ripe for an assault on the physician values that had led to these negative judgements of the intrauterine device. Firstly, the editorship of the American Journal of Obstetrics and Gvnaecology had passed from Kosmac into the hands of Charles Taylor, who was far more sympathetic to contraception and population control. In 1959 one of the practitioners who had quietly been promoting the use of intrauterine devices in his local area, Dr. Oppenheimer from Israel, submitted a review of his use of the Grafenberg ring devices in an Israeli Hospital; it was published.86 This report, and a second favourable report appearing the same year in the English language Yokohama Medical Bulletin by Dr. Ishihama,87 represented the intrauterine ring devices very favourably. These reports provided a valuable resource in the struggle to re open the controversy over intrauterine pessaries and infection in the United States. The question that was to allow a new spate of testing of the intrauterine devices was a simple one: on the balance of risks and benefits did the intrauterine device compare favourably with other alternatives?88 36 Oppenheimer, 'Prevention of Pregnancy by the Grafenberg Ring Method', 1959. 37 Ishihama, 'Clinical Studies on Intrauterine Rings', 1959. 33 In weighing the benefits and risks of the devices both authors began by referring to the overpopulated state of the worid, presenting reduction of birth rates as a major benefit. Oppenheimer carefully aligned his own interests as a physician who was promoting the use of intrauterine devices with those newly emerging national governments who had adopted population control policies, and he argued that the intrauterine device could solve common concerns amongst medical practitioners with the health risks of illegal abortion. He pointed to the benefits offered by the intrauterine device when compared with the medically established diaphragm: the intrauterine device was likely to be more acceptable to couples than the diaphragm, which 'hinders many women from experiencing orgasm and may lead to nervous disturbances'. Tackling the other end of the risk-benefit equation, Oppenheimer dismissed fears that intrauterine devices were harmful as groundless. The paper claimed zero incidents of infection and argued that those infections found by other physicians were the result of the 130 Interestingly, the grounds for judging the value of the devices had shifted from those of a generation earlier. Then the question asked had been did the devices sometimes cause harm to othenA/ise healthy women? A second change that favoured a new push for the development of the intrauterine device occurred when Dr Alan Guttmacher, a leading United States birth control advocate and leader of Planned Parenthood International, threw his weight behind a re-examination of the intrauterine device. Guttmacher had, until the late 1950s, shared the dominant gynaecological condemnation of intrauterine devices. But, influenced by fears of a population crisis, Guttmacher had approved a clinical trial at New York's Mt. Sinai Hospital of a new intrauterine device made from polyethylene injected with barium sulphate to make it locatable by x-ray.89 These devices, with the advantage of being inserted through a narrow plastic tube that could be inserted through the cervix without dilation, had been developed by Dr Lazar Margulies. Margulies, who was working in the Department of Obstetrics and Gynecology at Mt Sinai, had trained in Berlin and had used intrauterine devices in Germany in the late 1920s. He had been encouraged by the publication of Oppenheimer and Ishihama's results. He sought and gained Guttmacher's support for the development of a new kind of device that could be made from moulded plastic and stretched into a linear shape for ease of insertion, springing back into a bulkier shape once inside the womb. His first patient was his wife. Margulies had some difficulties inducing the uterus to play its role in the socio-technical network he envisaged. How could the uterus inserting doctor's inattention to asepsis, or their failure to diagnose existing infections before inserting the devices. He also enlisted gonorrhea as the probable cause of many infections, arguing that infected partners and illegal abortionists were responsible for this disease, not the intrauterine device. Significantly, both Oppenheimer and Ishihama enlisted penicillin as a new player which they argued changed the state of play between those physicians advocating intrauterine devices and those opposing them. Fears of inserting a 'foreign body' into the uterus were relegated to the days before antibiotics could be used to treat pelvic infection. According to Oppenheimer, infection itself was no longer a risk that was sufficiently serious to negate the benefits offered by intrauterine devices for fertility control. Oppenheimer, 'Prevention of Pregnancy by the Grafenberg Ring Method', 1959; Ishihama, 'Clinical Studies on Intrauterine Rings', 1959. 39Reed, The Birth Control Movement and American Society. 1978, pp. 305-306. 131 be enticed to accept the intrauterine device? At first, he later reflected, there were quite a few pregnancies, and it wasn't until the insertion period had been restricted to the twelfth day or later in the menstrual cycle that unnoticed expulsions declined. He also added a beaded-plastic tail that protruded from the uterus through the cervix, and enrolled women themselves to check that the devices were still in place by checking that the length of tail protruding had not increased.9o Guttmacher argued that if information attesting to the safe use of intrauterine devices could be gathered, this was an ideal technology for population control. He took his argument to the Population Council but was at first treated warily. To sponsor trials of the intrauterine device when common medical practice condemned their use risked exposing the Population Council to controversy. However Guttmacher won Tietze's support, and within twelve months, Tietze and Guttmacher had worn down the Population Council's resistance to intrauterine device research. As Reed reports, Tietze later recalled this period as one where: there was such a feeling of urgency among many professional people, not among the masses, but something had to be done. And this was something that you could do to people, rather than something people could do for themselves. So it was very attractive to the doers.9i Direct involvement with intrauterine devices was vetoed by the Population Council. It was considered too dangerous by the council's more 'squeamish' members.92 But intrauterine device testing could proceed if the Population Council was protected from controversy and possible litigation. Tietze was appointed as the director of the National Committee on Maternal Health. This was no longer operating as Gamble's front organisation, and since Gamble had established the Pathfinder Fund, the National Committee on Maternal Health had been fairly inactive. This made it ideal for what Tietze 90 Margulies, 'History of Intrauterine Devices', 1975. 91 Christopher Tietze, Interview, 1973. Unpaginated. 92 Sarah Lewit Tietze and Christopher Tietze M.D., 'Inten/iew', 1975-76, p. 4. 132 referred to as the Population Council's 'wholly owned subsidiary'. Sarah Lewit Tietze, a demographic statistician and Tietze's wife, soon joined him as an employee of the National Committee on Maternal Health.93 In the early 1960s a new approach to the testing of intrauterine devices was engineered by the Tietzes. This proved crucial to the winning over of intrauterine device allies from the medical profession. This approach was launched at the 1962 international conference to promote the use of intrauterine devices in clinical trials organised by the Population Council. Chaired by Dr Alan Guttmacher, then president of the Planned Parenthood World Population Emergency Campaign, the conference brought together medical practitioners who had been inserting intrauterine devices during the long silence about their use. It was attended by Ishihama, Oppenheimer, and Hall who had been working with Grafenberg to develop a stainless steel version of his ring. Inventors of new devices included Jack Lippes, Lazar Margulies and Jaime Zipper from Santiago, Chile. Tietze's primary message to the strategically selected guests was that the reputation of the intrauterine device amongst the United States medical profession was such that any indications of trouble could quickly escalate and once again doom the device to obscurity.94 This created a pressure cooker environment with the nervous Population Council pushing for the production of fast results from any intrauterine device trials. The problem, as Christopher Tietze remembered it, was that a number of investigators collected data, and it became evident that as everyone collected his own data, that it would take years until information was accumulated on which to make policy decisions.95 93 Sarah Lewit Tietze and Christopher Tietze M.D., 'Inten/iew', 1975-76, pp.1-9. 94 See 'Discussion' in Tietze and Lewit, Intra-Uterine Contraceptive Devices: Proceedings of the Conference. 1962. 95 Sarah Lewit Tietze and Christopher Tietze M.D., 'lnten/iew',1975-76, p.44. 133 Until the policy of gynaecologists and general practitioners towards intrauterine devices changed, testing programs would remain precarious, vulnerable to charges of promoting a dangerous birth control technique. Tietze's coup was to convince his colleagues, including those currently experimenting with new shapes and materials, that intrauterine device testing should be taken out of the hands of individual inventors and out of the hands of individual clinicians. Both groups, Tietze argued, were suspect in the eyes of the majority of doctors who viewed their behaviour in developing or using a condemned contraceptive as irresponsible. To avoid suspicion of bias, Tietze convinced his colleagues that in the United States intrauterine device use should be restricted to clinical trials as far as possible, and that such trials should be reorganised under the control of the Population Council.96 Tietze hoped that this reorganisation of intrauterine device testing would bring the medical practitioners who feared the hazards of intrauterine devices into the intrauterine device network, if not as active participants, as silent condoners of the clinical trials. In 1963 the National Committee for Maternal Health began the Co operative Statistical Program to investigate intrauterine devices, centralising intrauterine device testing into a series of prospective, comparative and standardised trials. Within four years case records on 27,600 women who had an intrauterine device inserted were available - 90% of them public patients. United States intrauterine device researchers were successfully disciplined to accept standard trial protocols and standard, pre-coded data entry forms. All researchers, for example, were to adhere to the same set procedures for follow-up of women not returning after the devices had been inserted. Similarly all researchers would collect the same data. For example, women who were unable to continue in the trial because the devices were expelled by the involuntary contractions of the uterus were distinguished from those who 96 For a history of the rise of the randomised clinical trial in medicine see Marks, 'Notes from the Underground', 1988. 134 chose to have the devices removed. Tietze was able to restrict supply of intrauterine devices to those researchers who complied. Gamble, for example, had his supply of United States made Lippes Loops cut off, prompting him to fund a Hong Kong entrepreneur to begin production.97 This enabled the Tietzes to channel all the intrauterine device users they could muster in the United States through a series of standardised procedures. Methods of filing and information book-keeping, familiar to them from their work comparing condoms, foams and jellies, enabled them to keep track of information from many different centres, to compare the use of different intrauterine devices, and to ensure that data was recorded with sufficient legibility and arrived at a central location.98 The Tietzes' work enabled data on intrauterine device usage to be combined easily. It promised to generate sufficient data to alter the profession's judgements about intrauterine devices in a short time. Tietze planned to analyse the data using the Life-Table method, adapting it from its well accepted use in calculating mortality statistics in demography. Life-tables enabled insurance companies to estimate from population mortality data the comparative risks that a person would die from a variety of different causes. Tietze, following carefully the adaptation of life- table calculations in the early work examining the correlations between smoking and mortality, reasoned that, unlike with some of the other methods being used at the time in prospective contraceptive trials, Life-Table analyses allowed for the risk of one event being taken into account when calculating the risk of a second event. Insurance firms, for example, adjusted their calculation of the risk of a man dying from tuberculosis to account for the risk that he might already have died from a car accident. Intrauterine device researchers agreed that this problem was similar to the one they faced when dealing with raw data. In calculating the risk that a woman in an intrauterine device trial ^"7 Williams. Every Child a Wanted Child. 1978. 98 Williams, Every Child a Wanted Child. 1978, pp. 39-47. 135 might become pregnant, the statistician needed to adjust the raw figures to take into account that such a woman might leave the trial because the device was expelled or because she decided that she wanted to become pregnant. Tietze worked with Bob Potter to modify Life-Table techniques in a way that enabled him to satisfy the Population Council's demand for fast results. This modification concerned the problem of how to combine the data from women who had been using the devices for varying lengths of time. Tietze and Potter's aim was to eliminate the need to wait until all participants had worn their intrauterine device for at least one year prior to analysing any data. One year after the commencement of a trial the data would contain a mix of cases. Some women would have been enrolled into the trial in the first week and would have been using a device for twelve months. Others would have only commenced three months after the trial began and so would contribute nine months of experience. Perhaps the trial only recruited most of their participants after the trial had already been running for six months, so that most of their data was for women who had been using the devices for only four or five months. This was a recognised problem in contraceptive trials and the convention was to run a trial for about two years before analysing the data retrospectively. Tietze and Potter were able to shorten the time span for which a trial had to be run before yielding data not open to the accusation of skewing due to differences in start-times of participants. The Potter-Tietze method became widely accepted in intrauterine device trials as a means of analysing data almost as they became available.99 Tietze was a skilled craftsman and a good judge of what assumptions and auxiliary hypotheses he could make without sparking the opposition of the anti-intrauterine device traditionalists. This is not to say that this method of data analysis was neutral, providing an unmediated snapshot of reality. The centralisation and standardisation of protocols and data entry-forms 99 See Tietze, 'Intra-uterine contraceptive rings',1962;Tietz e and Potter, 'Applications.of life- table techniques to measurement of contraceptive effectiveness', 1966. 136 determined which elements of experiential reality were available for inscription and assembly in the picture of intrauterine device use presented in the medical literature. The testing tradition from which it drew its methodology had been developed for comparing condoms, spermicidal jellies and creams, and diaphragms. It was designed to assess the risk of pregnancy in the short term, not to investigate long term. Tietze's standardised forms did not record the individual stories circulating amongst women: Stories of the relief of not having to worry about another pregnancy when husbands demanded intercourse, of greater pain during intercourse, of symptomless birth control and the benefits of no longer suffering the bloating and mood swings brought on by the Pill, of excruciating cramps during periods, of irregular bleeding causing constant worry that a pregnancy had occurred, of not having to worry that a contraceptive will be discovered by a jealous and violent husband, of anaemia and weakness following periods where frightening amounts of blood were lost, of relaxing and learning to enjoy sex with the reassurance that the family resources would not be further stretched to support another child, or more rarely of life-threatening emergencies in response to massive infections. This is of course normal science. The messy world in all its diversity and discordance is reduced to neat clean statements. Tietze could not have done otherwise. However, the method of data analysis shaped what came to count as the reality of intrauterine device use. Whether or not the intrauterine device was a safe and efficacious contraceptive device was not an incontrovertible judgement determined by the trial's ability to capture the reality of intrauterine device experience. Rather, the trial was a mechanism which Tietze hoped would compel universal consent for intrauterine device use, and the method of analysis manufactured a particular view of intrauterine device use. Moulded by techniques employed for comparing contraceptives such as jellies, condoms and creams, the primary focus of Tietze's trials was on 137 pregnancy and dropping-out. The life-table method with its column headings influenced by its origin as a tool for analysing mortality statistics, focused on the exit of participants from the trial, deemed to have occurred when their intrauterine device was removed. Routine analysis did not provide information, for example, on the number of women who became pregnant after they had the contraceptive devices removed, nor on the number who remained infertile two or three years after they had used the intrauterine device. Moreover, the numbers involved in the trial, despite being relatively large, still influenced which events were detectable. An event that occurs with a frequency of two to five percent, such as pregnancy, was detectable with some reliability in such a large sample. Indeed the sample size had to be sufficiently large to detect differences between devices of one percent. But events such as perforation, or an extremely dangerous event, such as ectopic pregnancy, which we now know occurs more frequently amongst intrauterine device users who do become pregnant, occurred in such small numbers as to be undetectable in Tietze's sample. In part, the design of the trial protocol was determined by the method of data analysis, with both contributing to construing some events as important whilst marginalising others. Women who had the devices removed because of infection were not followed up and the severity of infections, response of infections to routine penicillin treatment, and long-term effects were not recorded. The life-table method involved deciding that such frequencies of hazardous outcomes for individual intrauterine device use were unimportant when balanced against the benefits the devices bring to the population. My point here is not that Tietze did a bad job of designing the trials. On the contrary, he worked extremely hard to produce the best trials of any contraceptive yet tested. But, as in any clinical trial or any scientific experiment, judgements about a myriad of such issues were built into the trial protocol and the calculations used to analyse the data. Tietze's skill was at making judgements that would be endorsed by his colleagues trained in the 138 same research traditions. He had also made the cost of challenging the decisions built into his analysis prohibitive. Few individual doctors could hope to enrol the same, or a greater, number of participants as Tietze had done through his multi-centre combined trials. The centralisation of data collection and analysis under the auspices of the Committee for Maternal Health was an important strategy in stabilising pro-intrauterine device sentiments in a field which had been bitterly divided, and in which testing by individual inventors was frequently met with disbelief and accusations of bias. In addition, Tietze's work established a stable intrauterine device testing tradition that provided a general system for translating field experience into tables against which the comparative success of new designs in intrauterine device technology could be measured. The tables of data that accompanied the reports of the Cooperative Statistical Program can be understood as providing a template, a paint-by-number schema which could convert what had previously been diverse records, the varying local skills of health workers, and the experiences of contraceptors as they were presented to public view, all of which had once varied enormously between trials, into standardised records that could be plugged into one central point. The Program standardised a testing protocol, and in so doing it set the criteria for what counted as success, not at the local level but in the laboratories of New York. By January 1968, the total number of intrauterine devices distributed by major United States manufacturers was estimated at three million. Later that same year, the Food and Drug Administration produced a report completely contradicting its 1959 review of intrauterine devices. 10° It listed twelve different devices which it declared had been investigated satisfactorily. The stainless steel Grafenberg ring had been joined by the Lippes loop, the Margulies spiral, Birenberg bow. Zipper's looped nylon ring, the Ota ring, and 1^^^ U. S. Food and Drug Administration, Advisory Committee on Obstetrics and Gynecology, Report on Intrauterine Contraceptive Deviceg. 1968 139 the double spiral. The medical literature was now full of reports of clinical trials describing their success. Occasionally, particular models fell into disrepute. The ring devices, for example, went out of fashion when several physicians found that in cases of perforation they could end up looped around the large intestine where they caused an obstruction which could be life threatening. However, generally speaking, it was a time of great optimism amongst intrauterine device protagonists. New shapes, new materials, new sizes, new inserters, devices with and without tail strings were all being tried. The spirit of the time is well typified by Margulies's confident announcement that whilst the ideal intrauterine device suitable for use by all women had not been found, the active programs of testing and modification currently being undertaken would soon provide a device free from adverse effects. Beyond the clinical trials: Expanding the intrauterine device socio-technical network The Co-operative Statistical Program was an important mechanism for overcoming the traditional hostilities of the medical profession to intrauterine devices, but it was not sufficient to propel the device into the routine practice of medical practitioners and health workers. The effectiveness of Tietze's carefully staged trials at winning over many of the previously antagonistic doctors was aided by the translation of the intrauterine device into a technology for doing what doctors do routinely. The intrauterine device could not become a cure for a diagnosed disease, but it did become a prophylactic protecting maternal health from the dangers of an abortion epidemic. This was one strategy pursued at the local level to extend the socio-technical network of the intrauterine device. Many more linkages, wrought at the macro-political level rather than soley in the micro-technical world of the clinical trial, were required before the intrauterine device as an artefact became a global contraceptive technology. It was not the mere transmission of the results of 140 Tietze's and others' clinical trials that established their findings as universal facts. Intrauterine device efficacy and safety became universalised only to the extent that international socio-technical networks, mimicking those of the clinical trials, could be funded and established globally. The medical profession and the problem of abortion Discussions at intrauterine device conferences sponsored by the National Committee for Maternal Health in 1962 and 1963 reveal a tension between those who viewed intrauterine devices in the context of population control and those who attempted to view them in the context of gynaecological care of their patients. Sometimes one and the same person would switch hats from one perspective to another. As medical practitioners charged with the care of individual patients they aligned themselves with the fears of their colleagues that individuals might be put at risk of infection by having an intrauterine device inserted. But as members of the population control movement they could also urge a new approach which did not involve thinking about the one patient with pelvic inflammatory disease; or the one patient, who might develop this, or that, or the other complication. 101 This tension was resolved by drawing on lessons learned during the post World War II United States occupation of Japan. In Japan, the occupying forces had not been able to make any recommendations about population control due to "American political sensitivities, but the birth rate fell dramatically from 34.3 per thousand in 1947 to 17.2 per thousand in 1957. This unprecedented drop followed the Japanese government's own initiatives in amending its eugenic laws in a manner that legalised abortion and sterilisation. By 1952, government funds for contraception in Japan, from Japanese and United States' sources, could be publicly and vigorously 101 Comment made by Dr Wilson in "Discussion" in Tietze and Lewit, Intrauterine Contraceptive Devices. 1962. 141 supported by United States interests with claims that such assistance was medically necessary to lessen the harm being caused by abortions.''02 The 1967 International Planned Parenthood Conference devoted a new section to the discussion of abortion, particulariy illegal abortion and its threat to maternal health. This focus altered the field which had produced the tension between a public health and private medicine approach to intrauterine devices. The benefits of intrauterine devices when viewed from the population perspective could now be translated into the language of individual patient care. Contraceptive provision was not only a means of population control, it was a prophylactic for the problem of illegal abortion and consequent maternal death. The relationship between the medical profession and the intrauterine device could now be conceived as similar to the relationship between doctors and their administration of an immunisation program. ''03 Chile provides an example of one country which developed its contraceptive services under this rationale. In Chile, a predominantly Catholic country with a National Health Service, public health officials had available to them statistics indicating that by the beginning of the 1960s 54,000 abortions were occurring each year in its hospitals. They estimated that many more abortions were occurring outside the hospital system and that these criminal abortions were a significant cause of maternal death. In response to the publicising of these figures, the Chilean National Committee for the Protection of the Family was formed by some of the highest ranking medical professionals in Chile. They did not lobby for the legalisation of safe abortions. Rather they recast perceptions of the problem concerning mass abortion and a high maternal death rate into the failure of the birth control movement to properly enlist Chile's women into the habit of contraception. This linkage between abortion and contraception profoundly influenced the committee's 102 Piotrow, World Population Crisis. 1973, pp. 32-33. 103 Hankinson, Proceedings of the Eighth International Conference of the Planned Parenthood Federation. 1967. p.139 142 perceptions of what would count as a successful contraceptive. Chile was amongst the first countries to develop fertility control programs which almost entirely relied on the intrauterine device. The intrauterine device was seen by the committee members as the ideal contraceptive, a method suitable for people who were not the 'high cultural and economic level patient', and were seen as 'unmotivated' to use either the pill or other methods.i04 Funding the globalisation of the intrauterine device socio-technical network: Mobilising funds from the United States and United Nations for the delivery of contraceptives By 1967, India, Pakistan, Taiwan, and Korea, along with Chile, had family planning programs that emphasised the intrauterine device. Introducing the new plastic intrauterine devices into so many different and highly diverse communities was not an easy task simply involving 'selling' the efficacy and safety of the device to physicians in various countries. Organisations had to be built that could mobilise funds from the United States and other wealthy countries and direct them to family planning programs in the developing countries; personnel with expertise in population program delivery had to be employed; device insertion skills amongst health workers had to be established; women had to be recruited, and routines for patient management had to be established under highly localised conditions. It is not my intention here to detail all of the activities that went into building these local networks, with mechanisms for channelling funds from the United States government and other wealthy countries to the rural and urban communities around the globe where intrauterine devices became available. However, some of the efforts required to expand the intrauterine device socio-technical network are 104 Hankinson, Proceedings of the Eighth International Conference of the Planned Parenthood Federation. 1967. p. 656. As early as 1959 Chile began experimenting with the mass insertion of a ring device constructed by the inserting physician by looping a length of polyethylene. The cheapness of the method was a prime consideration. These trials were conducted by Dr Jaime Zipper at R. Barros Luco Hospital in Santiago. Zipper would later become the inventor of the Copper-7. 143 worth reiterating, in particular the work done to enrol the United States government as an effective supplier of intrauterine devices, and the translation of intrauterine devices into the already extensive organisational and personnel networks of the United Nations. Private organisations including the Population Council and the International Planned Parenthood Federation played crucial roles in developing model programs and in lobbying political leaders in the United States. But it was the huge influx of funds to the United States Agency for International Development, funds earmarked for population control activities, that stimulated the growth of the intrauterine device socio-technical network in the later years of the 1960s. Interleaved with the expansion of the Population Council's clinical testing of the intrauterine device was a massive increase in funding for contraceptive testing and delivery programs, first from the United States Government, and then from the United Nations. In the United States, during the Johnson presidency, verbal support from the president was used to link the delivery of contraceptive services in developing countries to the war against hunger, a popular food aid program.io5 Outright support for contraceptive delivery programs by the United States government, including the supply of contraceptives, occurred following a massive political exercise mounted by Senator Ernest Gruening to woo political allegiance from senators and congressmen for the investment of public monies in limiting births through its foreign aid budgets.io5 The public Population Crisis Hearings from July 1965 into 1968 heard invited testimony from 120 expert witnesses, providing a valuable resource that could be mobilised to strengthen those elements in the Agency for International Development pushing for increased priority for population control programs. The Food for Peace program, later renamed Food for Freedom, authorised the sale or donation of surplus United States agricultural products to 105 Piotrow, World Pooulation Crisis. 1973. See Chapter 10. 106 Gruening was a former governor of Puerto Rico. Mass, Population Target. 1976, p.45. 144 developing nations. By the mid-1960s local currencies received in payment for such cut-price products were being used to support population control programs in Taiwan and Korea. What moved such population control programs from a quiet activity, relying on the lobbying skills of pro-population bureaucrats working in the agriculture and health dominated aid agencies, to a publicly and politically high profile activity endorsed at the highest levels of government? The perceived worid food shortages of the mid-1960s were drawn into the debate about aid. Caused by shifts in developing countries from food crops to cash crops and exacerbated by bad weather - the Indian monsoon failed in 1965 and then again in 1966 - famine was translated by the pro-population control lobby into a Malthusian crisis. Other aid workers linked worid food shortages to their projects - irrigation, improved seeds, fertiliser provision. But President Johnson publicly endorsed population control, alongside such agricultural projects, as 'self-help', and shifted the emphasis in aid from emergency food aid to self-help projects. 107 jn the field this was sometimes translated into requirements from donor agencies that the governments of developing countries be required to accept population control aid in order to obtain subsidised or free agricultural products. This linking of contraceptive distribution programs to food aid operated to neutralise Catholic opposition. International Catholic Relief Services were tightly linked to food distribution programs and were aware of the suffering caused by unrestrained family growth in areas of food shortage. Under Pope Paul VI the Catholic Church's attitude to birth control services was under review so that church resources were directed inwards rather than into fighting the political push for population control in the United States Congress. The Vatican privately gave assurances that it would not publicly oppose the War 107 Piotrow, World Population Crisis. 1973, pp.112-116. 145 on Hunger so long as it was as much concerned with preventing deaths as it was with preventing births, i^® The earmarking of aid money for population control did not actually occur until 1968 when the special 'Title X' amendment to the Foreign Aid Bill was passed and $35 million was specifically earmarked by Congress for population control programs, against the advice of the director of the Agency for International Development. In 1969 this increased to $50 million, jumping to $75 million in 1970 and $100 million in 1971.109 This increase was barely imaginable in 1966 when the Agency for International Development's expenditure on population programs was just $5 million, but General William H. Draper, an investment banker and railroad tycoon and chairman of a privately sponsored lobby group called the Population Crisis Committee, devoted his full energies to steering this increase through the White House, and the United States Congress, bringing to the task his impressive strategic skills developed as under-secretary to the army and United States Ambassador to the North Atlantic Treaty Organisation.no This increase occurred at a time when Agency for International Development funds for health expenditure were being drastically reduced as budget stringencies were introduced to fund the Vietnam war, Piotrow points out that the success of the Agency for International Development population push, whilst indebted to Draper's skill and energy, was also influenced by bureaucratic politics. The falling Agency for International Development budget in the second half of the 1960s was partly a response to the increasing emphasis on self-help projects. The increasingly high profile of food shortages in 1965 and 1966 had led the Agency for International Development towards the professionalisation of its programs in 108 Piotrow, World Population Crisis. 1973, p. 128. 109 Mass, Population Target. 1976, pp. 48-49. 110 Piotrow, World Population Crisis, 1973, pp.132-138; Mass. Population Target. 1976. p. 41. 146 an attempt to strengthen its image as an agency that could tackle and solve the problem of worid famine. But by 1966 this approach was threatening to disembowel the Agency for International Development. With the Department of Agriculture threatening to take over food relief, its most publicly popular program, the Agency for International Development would be left with the large scale government-to-government development projects that frequently seemed to get bogged down and to generate rumblings that aid was not getting to the people in most need. Thus, whilst the head of Agency for International Development from 1966, William Gaud, consistently opposed the earmarking of funds for population work, he did support the inclusion of population control activities in his agency, and saw this as a way of preventing the agency being stripped of its popular activities constructed around the War on Hunger.111 Ravenholdt, an epidemiologist and head of the Population Branch in the the Agency for International Development from 1966 to 1979, supported the oral contraceptive pill, and he negotiated a deal with the pharmaceutical companies that meant the Agency for International Development could supply a month's cycle for just 20 cents, a lot less than the Population Council had anticipated when it heavily backed the intrauterine device. Nevertheless, the range of the intrauterine device was being greatly increased by the expansion of what the Agency for International Development liked to call family planning programs. United States support of contraceptives was based on the belief that such programs would provide women with a free choice about contraception and about which methods they would use. This free choice did not always materialise, particulariy when donor funds were not available for the cost of the contraceptives. But where such a choice was offered it was often heavily weighted towards the intrauterine device and the oral contraceptive pill. Thus the Agency for International Development's entry into 111 Piotrow, World Population Crisis. 1973, pp. 126-127. 147 contraceptive delivery meant that the intrauterine device was soon being heavily promoted in contraceptive delivery programs across the globe. The success of the introduction of the device into South Korea in 1964, using local funds accumulated by the Agency for International Development in exchange for United States food surpluses, provided great optimism. By 1969, one third of all Korean women of child-bearing age had tried this new contraceptive. 112 In India, within two years of its introduction 1.7 million devices had been inserted.113 When Kenya became the first Sub-Saharan African country to adopt an official family planning program in 1966, it endorsed the intrauterine device, winning back international investment confidence shaken by the early years of turbulence following its achievement of independence.ii4 By the end of the 1960s, the United Nations and its agencies were also becoming enrolled as providers of contraceptive services. This was important for four reasons. (1) It expanded the funds available to provide grants capable of supporting and supplying delivery programs. (2) It made available existing organisational structures and on the ground programs for contraceptive supply. (3) It linked acceptance of family planning programs to the supply of development aid. (4) Family planning programs directed through the United Nations were less likely to become the focus of struggles by workers, peasants and nationalist governments against United States domination. Hostility was easily aroused at both government and popular levels by perceptions that family planning programs were aimed at reducing the population. Families frequently did not share donor countries' aspirations for 112 Mauldin and Ross, 'Historical Perspectives on the Introduction of Contraceptive Technology', 1989. 113 Soni, 'The development and cun-ent organisation of the family planning programme', 1984. 114 Warwick, Bitter Pills. 1982, pp.12-15. 148 their family size. Many governments in developing countries rejected the view that their countries were over-populated. Symonds and Carder detail the long struggle within the United Nations and its organisations which eventually led to direct funding for contraceptive delivery to the developing worid. Julian Huxley brought with his appointment as director-general of UNESCO in 1947 a long standing enthusiasm for birth control. But his attempt to link action programs supplying technical advice for delivery services to the economic development goals of UNESCO were largely unsuccessful. The Rome Population Conference was one of his initiatives but by the time it was held the governments of Catholic and Communist countries had combined to restrict the activities of the United Nations in the population field to demographic studies. Over the next decade studies supported by the United States favouring population growth rates as causal explanations for the failure of economic growth and development would be used relentlessly to win support for population control from governments, particulariy in Asia. Huxley's successors in UNESCO labelled his emphasis on population control pessimistic and reasserted their faith that the recent marriage of science and technology to the food shortage problems of the world would prove fruitful.''15 When the Worid Health Organisation made tentative steps towards providing technical support for population control programs in response to requests from governments, sending Dr Abraham Stone to India in 1951 to advise on establishing clinics to provide advice on the use of the safe period, it faced heavy criticism and a motion supporting such activities at the 1952 World Health Assembly had to be withdrawn. Catholic delegates urged that an organisation concerned with health had no place in promoting practices that could be harmful to a woman's health and were contrary to the laws of nature. Communist delegates alleged that overpopulation, far from causing poverty in 115 Symonds and Carder, The United Nations and the Population Question. 1973, pp.52-58. 149 the developing world, was a smokescreen for the true cause of poverty, the activities of imperialists who valued such countries only as sources of cheap raw materials. •'16 It was not until 1965 that the United Nations again began debating its role in population control, particularly in the provision of direct services. This time advocates of United Nations involvement in population control were more successful. There had been nothing in the United Nations' charter or its policies to prohibit contraceptive supply action programs. However, pro- population-control elements in various United Nations organisations frequently met bureaucratic resistance to the proposals for the development of such programs. Each proposal was a local issue fought out at the local level. This situation began to change following the Belgrade World Population Conference in 1965. At this conference there had been little controversy over a resolution passed at a session devoted to family planning methods calling for the rights of all couples to the information needed to enable them to have the number of children that they desired.ii7 The General Assembly passed a resolution in 1966 that endorsed greater vigour in United Nations' responses to countries requests for technical support for family planning, provided that the sovereignty of nations in determining their own population policies and the free choice of families in determining the number of children they desired were recognised. The adoption of this resolution united a variety of elements within the United Nations prepared to fund family planning and stimulated changes in the bureaucracy of the United Nations organisations that soon led to a vastly expanded United Nations program of work in the field of contraceptive supply. By the end of the decade the intrauterine device socio-technical network looked forward to increasing United Nations funding for the supply of contraceptive devices, skilled personnel able to establish programs, and 116 Symonds and Carder, The United Nations and the Population Question. 1973. pp.58-66. 117 Symonds and Carder, The United Nations and the Population Question. 1973, p.145. 150 infrastructure such as vehicles that developing countries could not afford if they had to pay in hard-earned foreign currencies. The change in the population policy of the United States government and the effectiveness of research programs aimed at highlighting the problem of population played a decisive role in the shifts that occurred in the activities of the United Nations and its organisations in the latter half of the 1960s. But the shifts at the macro-political level had to be translated into the reorganisation of policies and activities at the micro-organisational level. Thus, for example, by 1967 the World Health Organisation, despite some misgivings from countries that feared that funds for basic health infrastructure might be diverted into family planning programs, had resolved that all families had the right to family planning advice and information. UNICEF provided 3.3 million dollars for vehicles and clinic equipment between 1967 and 1970 for the provision of family planning clinics in maternal and child health services run by the Worid Health Organisation.ii8 By 1967 a special fund had been established for such activities, the United Nations Trust Fund for Population Activities, which doubled its expenditure on action programs from $5 million in 1969 to $10 million in 1970, with $24 million anticipated in 1971.ii9 In 1968 the World Bank issued instructions to its various missions indicating that increasing attention should be given to recipients' population policies as indicators of their commitment to economic growth.120 But the consensus position that was emerging throughout the United Nations emphasised the exclusive rights of parents to decide the number and spacing of their children and the rights of parents to both the information and the means to effect their decisions. This provided a mandate for the expenditure of United Nations funds on contraceptive device supply. The strategy that 113 Symonds and Carder, The United Nations and the Population Question. 1973, pp. 159- 162. 119 Symonds and Carder, The United Nations and the Population Question. 1973., p.194. 120 Symonds and Carder, The United Nations and the Population Question. 1973. 151 emerged to shift the financial resources of the United Nations into population control programs thus involved the translation of debates over contraceptive action programs from the Cold War arena, where it had become bogged down in debates between the United States and Catholic and communist countries over the causal direction of linkages between population growth and economic development, into an issue tightly linked with individual, family and women's rights. Constructing a socio-technical network The 1960s was the decade during which intrauterine devices went from being almost universally condemned by the medical profession to being seen by them as a viable, sometimes superior contraceptive with a special role to play in population control and abortion prevention. Indeed, by the end of the 1960s, intrauterine device protagonists anticipated a bright future. The transition of the intrauterine device from a local to a global technology involved much more than an innovation in the manufacturing material - from the silk-gut of the Grafenberg ring to the polyethylene of the Lippes Loop. Intrauterine device advocates in the 1960s built a new socio-technical network, of which the object we call an intrauterine device is but one component. The expanded success of this intrauterine device contraceptive system was made possible by the association of plastic loops and inserting devices, sterile techniques and doctors, women's bodies and United States foreign policy, biostatistical researchers and rapidly trained teams travelling in remote areas. The reconstruction of the intrauterine device wrought in the United States in the 1960s put a new object into society. This time there was no new name. Continuity with the devices of the 1930s, on balance, aided the new network constructors in their claims that this was a safe and effective contraceptive with a proven track record. This chapter has told the story of this transmutation of the intrauterine device. It has emphasised the human labour 152 processes that produced a re-articulation of natural, technological and social worlds, and the boundaries between them. The history of the reconstruction of the intrauterine device in the 1960s is well conceptualised as a story involving the juggling of a multitude of diverse elements. A variety of kinds of entities had to be associated together - money, people, organisations, technical skills, natural phenomena, and political acumen. Moreover, these elements cannot be separated readily into social elements pertaining to the direction of research, its funding, and use on the one hand, and technical elements pertaining to device design and the conduct of clinical trials on the other. The Population Council's embarkation on the Go-operative Statistical Program involved not merely the juggling of socio-political factors at the periphery of the trial, leaving the actual trial to deal with technical phenomena. As the Tietzes' world of statistical puzzle- solving makes clear, socio-political imperatives shaped decisions about trial protocol and the statistical methods used to analyse the data. There was no pure sphere of technical decision making, impervious to an exterior socio political world. Scientific and technical innovators involved with the development of the intrauterine device were in the business of constructing new social worlds. The intrauterine device was presented as a development to solve the population problem, but simultaneously society was produced as adjustable to prevailing economic conditions through the medical management of fertility. The Population Council refashioned the intrauterine device but it also refashioned the global society as having a population problem solvable by technical intervention. Reconstructing the intrauterine device as a new socio- technical network involved the simultaneous refashioning of a technical artefact and a worid order. To conceive of this process as a first phase of mobilising political concern around a problem, and a second phase of getting something to work 153 as its solution, would be to miss the incorporation of the perspective from which the problem was constituted into the criteria by which the success of the solution was judged. I have, in this chapter, described the socio-political strategies pursued both inside and outside the Population Council to construe population increase as a problem for developing countries, and the intrauterine device as the ideal contraceptive to solve it. But I have also traced the socio-political goal of population control into the decisions made about the design of the intrauterine device clinical trials. In addition I have shown how other social phenomena influenced the design of the trials, such as Tietze's eariier experience with 'simple contraceptive methods'. And I have demonstrated that the success of the trials at convincing doctors that intrauterine devices could be used safely depended as much on external factors, such as the shift in perspective away from individual contraceptive choice towards preventing maternal deaths from illegal abortions. I have tried to open the Pandora's box that from the outside appears as a simple contraceptive device, circulated so widely because it works. From the inside, this box appears as an expanding formation of alliances, hard-won and involving both human and non-human entities. I have traced some of the important linkages that I believe were imperative to the construction of this second generation of intrauterine devices, and to their success. My account is not comprehensive: for instance, 1 give scant attention to the important role played by the International Planned Parenthood Federation. However, by focusing on the Population Council as a key builder of the intrauterine device network, I have been able to locate it within a network of wider socio-political forces, and to trace the intricacies constitutive of the success of a clinical trial as a social performance. My aim was to emphasise that the power of the Population Council to propel to dominance its particular problematisation of development - as threatened by population growth - and the intrauterine device as its solution, was the outcome of the linkages built and made 154 manifest in the intrauterine device contraceptive network. It is not that the Population Council, the Rockefeller Foundation, the Ford Foundation, the International Planned Parenthood Federation had power derived structurally from their corporate linkages with American capital, and used this to force compliance from the medical profession and the governments of developing countries. Rather, their power in the socio-technical networks of the intrauterine device derives from their positioning of themselves as a compulsory passage point and spokesperson for a diverse range of interlinked groups, organisations, entities, and things. The success of the Population Council's problematisation, solution, and narratives enunciating the roles of both human and non-human actors in the intrauterine device network was the outcome of their effectiveness at luring into the network a whole range of entities and enticing them to play the requisite interactive roles. Governments provided policy directives and clinic infrastructure, corporations provided finance, women voluntarily sought to reduce the number of their offspring, fertilised eggs did not implant, doctors inserted devices without causing perforations, hospitals managed infections with penicillin and removals. The power of the Population Council is a consequence of its successful construction of the intrauterine device population control system, rather than its cause. As part of this chapter I have emphasised the constructed nature of Tietze's intrauterine device data and analysis. However, I am not arguing that any claim would have been possible, or that what was produced in the Population Council's statistical laboratory and field trial sites was a fabrication bearing no relationship to actual experience. It is certainly the case that the women's bodies into which the intrauterine devices were inserted became a part of the experimental laboratory, where some of the things that had previously remained invisible to researchers were made visible under a regime of intensified surveillance. The National Committee for Maternal 155 Health, and then following its absorption the Population Council, became the spokesperson for a range of actants inside women's bodies to which they ascribed characteristics and assigned roles in the intrauterine device network as it permeated the body. It was their voices that spoke for microbes, cramps, perforations, the properties of plastics inside the body, the effects of devices on sperm and on the behaviour of fertilised eggs. The babble of the uterus was reduced to a handful of often repeated statements. Similarly the babble of women's voices describing their experience of the intrauterine device was reduced to numbers on a table. I am not arguing that it is reduction perse that is the problem here. Rather, it is through such reductions that the researcher can enrol actors into a socio-technical network and become their spokesperson. Tietze's team built a new set of linkages between actors through one set of reductions, replacing the reductions made by anti-intrauterine device forces in the medical profession who had previously spoken for the conglomeration of non-human actors brought together in an intrauterine device contraceptive system. Thus, Tietze, working together with an international network of collaborators, re organised the actors in the intrauterine device collectivity and presented the world with new claims about their behaviour and characteristics. Expulsions and partial expulsions were transformed from events creating the risk of unknowingly engaging in unprotected sex into events that could be watched for and observed by feeling the knotted string protruding into the uterus. Women's reports of cramps and excessive bleeding were transformed from signs of possible infection into non-serious worries that should be responded to by reassurance from the doctor that nothing was wrong and that such symptoms would soon disappear. Germs threatening infections were transformed from ever-present actors awaiting the chance to invade the normally sterile uterus into occasional invaders, readily responding to Penicillin, and only present when the presumably infrequent practice of 156 unprotected sex with multiple partners brought a woman into contact with a population of gonorrhoea, or some similar sexually transmitted disease. Whether these stories would hold was a practical matter. Putting aside the limitations of the Tietze run clinical trials, it has to be said that his narrative of cautious success did hold together in the Go-operative Statistical Program, a not insignificant achievement involving tinkering with new designs and materials for the devices, and teaching insertion and sterile handling techniques to doctors, and self-surveillance techniques to the women using the devices. But would the representativeness of the entities that Tietze and his colleagues negotiated with hold, once the population of intrauterine device users expanded? Gould the carefully selected doctors especially interested in contraception, the primarily married women taking part in the trials, and their bodies with their particular floras and faunas, be accepted as representative? I will come back to these questions in the next chapter. Here, my point is that the performance of the clinical trials and the detailed mechanisms developed in the 'laboratory' to hold things together in a specific way made the new intrauterine device narrative credible by performing a successful enactment of it. What happened in the laboratory was not incidental. The trials acted as a lure to many general practitioners who were convinced by them that intrauterine devices could be used safely. But the papers produced from the Co-operative Statistical Program were more than propaganda. The Co-operative Statistical Program staged the operation of a successfully integrated network of both competent human entities, their symbolic claims that stood for what was happening, and the non-human entities that had to play certain roles for the system to work. Within the limits set by the trial protocol, the systems of data entry and collection, the size of the trial, and the statistical analysis, intrauterine devices were largely dissociated from infections on the risk side of the equation, and they were associated with pregnancy prevention on the benefit side of the equation. This 157 does not mean that the particular knowledges produced are not constructed. Nor does it mean that political shifts and manoeuvrings were unimportant to the settling of the controversy between the Population Council's view of intrauterine device safety, and that of the mainstream medical profession. On the one hand, I have tried to show that there is no simple objective truth about the safety and efficacy of intrauterine devices accessible through a properly conducted clinical trial, and unmediated by social phenomena both in the wider society and within the research community itself. On the other hand, I have tried to show that what goes on in a clinical trial is not meaningless. It is in the clinical trial that the non-human and human entities and the relations between them are juggled and put to work. The claims about the intrauterine device and the performances required of all the enrolled entities to make it successful only hold if that set of linkages achieved in the trial can be reconstructed in diverse circumstances. Rather than focusing on the way the macro-structures of the wider world such as gender, class, and imperialism have impacted on the directions and findings of medical research in the contraceptive field, I have sketched how successful micro-actors have been able to create alliances and grow them to macro-size, co-producing society in the process.121 However, whilst acknowledging the importance of the laboratory as a sight of assemblage, I have extended my study of the construction of a global socio-technical intrauterine device network to include those sites 'down the track' from the 'initiatory moment' of a new technology. 122 The Agency for International Development in the United States and the organisations of the United Nations served as intrauterine device consumers. It was they, rather than individual 121 In this I have followed the work of Gallon and Latour. See Chapter 1. 122 Here I concur with Cynthia Cockburn and Susan Ormrod, Gender and Technology in the Making. Sage, 1993; and Cowan, 'The Consumption Junction', 1987. Martin makes the interesting point that the initiatory moment of a new technology or scientific knowledge claim may best be located in popular culture rather than in the laboratory, see Martin, Flexible Bodies, 1994. The quote is from Cockburn, p.9. 158 women, who operated as large-scale purchasers of intrauterine devices and established programs for their distribution to individual women. It is not only those entities visible in the laboratory that play a role in the construction of a socio-technical network. To focus on the invention phase of a new technology misses this movement from the local to the global. Moreover, by paying attention to distribution and consumption, as shall be seen in the next chapter, the role can be investigated not only of powerful actors such as the Population Council, but of marginalised groups. 159 CHAPTER 4 The intrauterine device contraceptive networic comes under attack: the Dalkon Shield, septic abortion, and pelvic inflammatory disease The 1970s began with great optimism amongst medical professionals involved in family planning. The intrauterine device had joined the oral contraceptive pill in attaining high levels of acceptability amongst doctors and their patients. The intrauterine device was widely recognised and promoted as a low cost, easily insertable, highly effective, reversible, method of birth control. Because of its perception as the contraceptive method most likely to lower a population's fertility it enjoyed considerable popularity in family planning programs in developing countries and in clinics for poor, working class, black and immigrant women in the United States. 1 It very quickly came to be seen as the ideal contraceptive method for women who did not want to be sterilised but 'could not be relied on' to practise repetitive methods of birth control. In some programs it was the only method offered.2 Many who had been involved in steering the intrauterine device back into acceptability in the 1960s looked towards the coming decade thinking that the battle had been won, and expecting that intrauterine devices would enjoy a steady expansion of usage as technical improvements eliminated expulsions, bleeding and painful cramps. Furthermore, intrauterine device designers joined anti-pill activists, and promoted the intrauterine device as the solution to the fears of women of all classes concerning the safety of oral contraceptives. It was not only those women identified as lacking 'recurrent motivation', as they were called by the 1 Gordon, 'The Intrauterine Device in Retrospect', 1974. 2 Wheeler, Gordon, and Speidel, Intrauterine Devices. 1974. 160 1968 Food and Drug Administration report on intrauterine devices, who were targeted and enticed to join the intrauterine device network as consumers,3 Women's health activists were beginning to mobilise against the oral contraceptive pill, demanding informed consent and that women be warned that there were serious health risks that could affect them. As Barbara Seaman pointed out, the pill contained powerful hormonal drugs that affected every system in the body, but little was known about which patients were merely taking a risk, and which were putting themselves into danger.4 Dr. Hugh Davis, inventor of the Dalkon Shield intrauterine device, wrote the introduction to Seaman's book warning users of the hazards of the pill. 'Never in history have so many individuals consumed such a powerful medication with so little information as to potential hazards and alternatives', he wrote.5 Davis promoted the intrauterine device as operating close to the site of conception thereby avoiding the systemic effects of the oral hormonal contraceptives. In January 1970 the famous 'Nelson Pill Hearings' stimulated widespread media coverage of pill 'side-effects' including deaths from blood- clots.6 Pill side-effects, inadequate trials, and cover-ups of information about health risks by the pharmaceutical industry were well publicised during the Nelson hearings. Many women, who had been using the pill, switched to intrauterine devices. Many people felt that a 'mechanical' method would be safer than a drug, having fewer side-effects and less long-term consequences. These perceptions were vigorously encouraged by Davis.7 The Agency for International Development has estimated that up to one 3 U. S. Food and Drug Administration, Advisory Committee on Obstetrics and Gynecology, Report on Intrauterine Contraceptive Devices. 1968. 4 Bari^ara Seaman, The Doctors' Case Against the Pill. 1969. 5 Bari^ara Seaman, The Doctors' Case Against the Pill. 1969. p.1. 6 U.S. Congress, Senate, Select Committee on Small Business, Subcommittee on Monopoly, Present Status of Competition in the Pharmaceutical Industry. 1970. 7 Hugh Davis, the inventor of the Dalkon Shield, promoted the shield along these lines. See Hugh Davis, Intrauterine Devices for Contraception: The lUD. 1971. Davis appeared before the Nelson hearings, providing anti-pill testimony. 161 million women in the United States stopped using the pill because of publicity surrounding the hearings. Intrauterine devices sales rose by 500,000, possibly an increase of 25 percent.8 The wave of optimism amongst intrauterine device promoters was, however, soon overtaken by the dramatic failure of one intrauterine device - the Hugh Davis designed Dalkon Shield. The events surrounding the attempt of Robins, a small Virginian pharmaceutical company, to market the Dalkon Shield have been discussed many times.9 Newspapers, magazine and popular books have told of the company's initial success, followed by litigation brought by thousands of women from around the worid against Robins in pursuit of compensation for injuries caused by the Dalkon Shield. Following reports of septic abortion, the Food and Drug administration requested that Robins withdraw the Dalkon Shield from sale in the United States, and Robins complied voluntarily on May 28th, 1974. In the courts Robins was found guilty of suppressing information about health risks that could have saved lives and prevented injuries. The company resisted efforts to have the devices recalled in an effort to avoid admitting liability. Despite the withdrawal of the Shield from United States markets, devices continued to be distributed around the world until April, 1975. A product recall, advising women still using the Shields to have them removed, was not issued until October 1984.io I am interested in the management of, and responses to, this eruption of an intrauterine device controversy from within the bounds of the 8 Agency for International Development, 'Memorandum - An In Depth Report : Agency for Intemational Development and the Dalkon Shield Intrauterine Contraceptive Device', Feb 8, 1985, p.5. This is based on an estimate of market size for 1970-1971 as two to three million. See p.6 quoting from Robins, the Dalkon Shield's manufacturer, 'National Marketing Review", a sheet prepared for its sales force for March-April 1972. Also see Tatum, 'Intrauterine Contraception', 1972. 9 The best known accounts are Mintz, At Anv Cost: Corporate Greed. Women, and the Dalkon Shield. 1985; and Perry and Dawson, Nightmare: Women and the Dalkon Shield. 1985. More recent and up to date issues are covered in Ronald Bacigal, The Limits of Litigation. 1990: Sobol, Bending the Law. 1991; Grant, The Selling of Contraception. 1992; and Hicks, Sun/iving the Dalkon Shield lUD: Women v. The Pharmaceutical Industn/. 1994. 10 Mintz. At Anv Cost. 1985. pp.3-20. 162 professional medical, scientific and health communities into the wider political sphere of the United States Congress and Senate, the courts, the media, and the streets. By the end of the 1970s, the medical literature, consumer advocates, women's health activists, the courts, the media, the Food and Drug Administration, general practitioners, and family planning associations all agreed with a representation of the Dalkon Shield as a defective device. But this consensus was new and the result of negotiation. Detailed accounts of the Dalkon Shield litigation, the medical literature, and the activism of Dalkon Shield survivors are available elsewhere.n The question I want to address in this chapter is this: How did the Dalkon Shield come to be uniformly viewed as defective by such diverse organisations and groups? In other words, how was this particular outcome of the intrauterine devices controversy negotiated? What was the role played by data, clinical evidence, and scientific experiment? And what effects were produced by this particular consensus? When I began this thesis, the family planning and planned parenthood advocates in America on the one hand, and the consumer movement on the other, offered different interpretations of the impact of the Dalkon Shield controversy. The former believed that it had led to the dominance of an unrealistic public demand for a government guarantee of safety which was contributing to a dramatic slowdown in contraceptive research.12 The latter interpreted the Robins controversy as a warning of the need for external checks and balances, through government regulation and the courts, on pharmaceutical companies and the medical profession. It is my contention that the outcome of the Dalkon Shield controversy was the result of strategies pursued by both these interest groups, and that to understand them we must put them into the context of the particular location which each group occupied. We must also consider the claims made by each interest group evenhandedly, 11 Morton Mintz At Any Cost. 1985; Susan Perry and Jim Dawson, Nightmare.1985: Ronald Bacigal, The Limits of Litigation. 1990: Nicole Grant, The Selling of Contraception. 1992. 12 Hilts, 'Birth Control Backlash', 1990; Bacon, 'U.S. Birth Control Lags', 1990. 163 treating symmetrically the pro-population control/ pro-intrauterine device group on the one side, and the consumer rights/anti-intrauterinedevic e group on the other. This means neither dismissing nor privileging the one because it was circulated in the courts and the popular media, nor the other because it was circulated in the scientific literature and entered the courts via expert witnesses. A reading of the intrauterine devices scientific literature of the 1970s does not tell the whole story of this controversy. The social context of clinical trials or laboratory based testing leave few traces in the written texts of scientific articles. The legal battles over a device, struggles over funding, political problems encountered in establishing a trial, personal clashes, the bureaucratic decision making that sets a study undenvay, and controls exerted by journal editors tend to be erased from scientific papers. Scientific authors write with a style that systematically eliminates expressions of doubts, descriptions of failures, discussions of difficulties. It is characteristic of scientific writing for the social context, within which a piece of research is designed and seeks to have effects, to be rendered invisible in a published scientific paper. 13 Nevertheless, traces of the social context frequently remain in the published scientific literature. I believe that it is appropriate and rewarding to begin my analysis of the Dalkon Shield controversy with the scientific literature, to take seriously the scientific claims through which the Dalkon Shield was produced as a particular socio-technical object. Scientific articles can be considered as constructions designed to intervene in the social and political struggles in which the Dalkon Shield became caught up. Scientific texts are weapons, testimonials, and central artefacts in waging and resolving disputes between competing interest groups. Therefore, paying attention to 13 For an excellent discussion of scientific texts and how they have been approached by sociologists and historians of science see Greg Myers, Writing Biology : Texts in the Social Construction of Scientific Knowledge. 1990. pp. 3-40. 164 scientific texts provides one means of exploring the social negotiations which determined the outcome of the Dalkon Shield controversy. In the previous chapter I emphasised the need to go behind the texts to observe the social conditions and labour processes of their production. In this chapter, without reverting to a primacy of scientific texts which cuts off scientific ideas from their social and historical context, I discuss some of the scientific literature in an attempt to foreground the technical work through which intrauterine device researchers create their particular worlds. I will take a few selected items from the scientific literature as a starting point for exploring the relationship between conflicts in science and conflicts in the broader society, and the relations between the two. The scientific literature provides part of the picture against which the interpretation of events such as the reporting of septic abortion deaths, or the establishing of public hearings into Food and Drug Administration regulation of therapeutic devices, emerged and had to make sense. To recognise this is not to assert that scientific research was the primary cause of the public controversy over the Dalkon Shield. Nor does it mean that the actions of those groups and individuals who do not have access to the kind of authority required to produce scientific articles and have them published in reputable journals are unimportant. Scientific texts were crucial documents in the Dalkon Shield controversy because all the participants attempting to influence the outcome of the litigation, or its effects on the field of fertility control, viewed scientific studies and scientific experts as the arbiters of disputes. They all looked to the scientific literature to validate their perceptions about reality and mobilised it to have their views constituted as what would publicly count as reality. Moreover, the actions of the participants in the legal controversy shaped the research that was done and provided the context within and against which researchers knew that their work would be interpreted. 165 Negotiating the Dalkon Shield success The Dalkon Shield was one of the many intrauterine devices to emerge from the rush for new designs in the later 1960s. Invented and trialed by Hugh Davis at the Johns Hopkins University, it was purchased and aggressively marketed from January 1971 until June 1974 by Robins, best known for its cough syrup and as the manufacturer of Chapstick. Its promotion relied heavily on a report of a 12-month clinical trial involving 640 women, on average wearing the shield for under six months, conducted by Davis and published by the American Journal of Obstetrics and Gvnecology in February 1970.14 The report, in a masterful deployment of rhetoric, announced that this intrauterine device heralded a new era of 'modern devices of superior performance'. The claimed pregnancy rate of just over one pregnancy for every one hundred woman-years of use made it competitive with the oral contraceptive pill. Davis also claimed that this device with its protruding fins was designed to resist expulsion and that there was a measurably lower incidence of expulsions during the clinical trials. This made the Dalkon Shield, claimed Davis, an attractive birth control choice, 'a first choice method'. Davis confidently linked his device to the battle against injuries resulting from the oral contraceptive pill claiming that here was an intrauterine device 'without the actual or potential hazard of systemic medication for birth control.'i5 In June 1970 Davis and his partners sold the Dalkon Shield to Robins for $750,000 plus ten percent of the royalties. By then the Johns Hopkins trials were looking less favourable. Two months after the publication of trial results by the Journal of Obstetrics and Gynecology the number of reported pregnancies amongst the trial group had increased, giving a pregnancy rate of five per hundred-woman years. But Robins went ahead with an advertising 14 Davis, 'The Shield Intrauterine Device: A Superior Modern Contraceptive,' 1970. 15 Davis, 'The Shield Intrauterine Device: A Superior Modern Contraceptive,' 1970. 166 campaign, circulating the Journal of Obstetrics and Gvnecology report to physicians. And whilst the company established a ten-investigator multi-centre clinical trial they began promotion immediately, having the devices on the market by the end of 1970. The device marketed differed considerably from the model tested by Davis. Copper had been added following reports that it enhanced the contraceptive effect of intrauterine devices. Barium sulphate had been added to make the devices x-ray opaque. And a smaller device was made available for nulliparous women. But with the Food and Drug Administration still exempting therapeutic devices from the same kind of scrutiny to which drugs were subject, Robins was on safe ground'moving an untested product into the market. Doctors seeking information before trying a new contraceptive were enticed to try this new intrauterine device by circulation of 199,000 copies of the Davis clinical trial report from the Journal of Obstetrics and Gvnecology. They were not told that Davis had financial interests in the sales of the device, nor that he was its inventor.16 Within three years Robins had sold 2.2 million Dalkon Shields domestically, and a further two million for overseas use. About 30 percent of devices sold were the smaller model. 17 In its first year of promotion, sales of the Dalkon Shield displaced the Lippes Loop as the number one brand of intrauterine devices.i8 The Dalkon Shield was a phenomenal success. Part of the success of the Dalkon Shield can be explained by the elaborate deployment of the language of bio-engineering by both Davis and Robins. In 1971 the Pathfinder Fund sponsored a conference at the University of Exeter in England titled, 'Family Planning Research Conference: A 16 Morton Mintz At Any Cost. 1985, pp.29-32, 64-70; Grant, The Selling of Contraception. 1992, pp. 42-43. 17 Van Dyke, The Dalkon Shield a "Primer" in lUD Liability', 1978. pp.1-2. 18 Agency for International Development, 'Memorandum - An In Depth Report : Agency for Intemational Development and the Dalkon Shield Intrauterine Contraceptive Device', Feb 8, 1985. p. 6. 167 Multidisciplinary Approach'.i9 It was not the use of the term 'multidisciplinary' that signalled a change in research practice but the close association between intrauterine device researchers and bioengineers. In 1971, following its success in cardiology and renal biology, bioengineering was in the process of expanding its interests and was seeking to establish itself as a discipline relevant to human physiology.20 For intrauterine device advocates, bioengineering provided a new scientific basis for enlisting the support of medical and physiological research communities involved in contraceptive research. The Dalkon Shield was actually patented by Hugh Lerner, a bioengineer, since Davis had already patented a shield design whilst an employee of Johns Hopkins so that any patents in his name would have belonged to Johns Hopkins. Robins framed the shield in the new rhetoric of bioengineering. The Dalkon Shield was heralded as part of a new wave of intrauterine devices which had benefited from the application of design principles, material know-how, and a precise knowledge of physical properties for the achievement of specific criteria. Davis promoted the Dalkon Shield in his book Intrauterine Devices for Contraception: The IUD.21 Under the guise of drawing together the facts from a scattered scientific and medical literature, the book is little more than a thinly veiled promotion for the Dalkon Shield. Nevertheless Davis's deployment of the bioengineering rhetoric reflects changes in the beliefs and make-up of the community of intrauterine devices researchers and inserters. Davis's claim for the efficacy of the shield is supported on two fronts. The collection of data from clinical trials using Tietze's standardised protocols and their analysis using Tietze's statistical techniques were too well recognised to be avoided. However, it would later be shown that there were problems with the conduct 19 Goldsmith and Snowden. Proceedings of the Family Planning Research Conference. 1971. 20 Lardner, 'Biomechanics of Reproductive Biology', 1971. 21 Davis, Intrauterine Devices for Contraception , 1971. 168 and reporting of the Davis-run clinical trials. The number of participants in the trial had been only 640 women, insufficient to conclude that the 1.1 percent pregnancy rate reported by Davis had not occurred by chance, in other words to rule out the probability that an exact replication of the same trial would produce a pregnancy rate comparable with the three to five percent rates being reported for other devices. Moreover, the efficacy of the Dalkon Shield as constituted through trials carried out over the accepted twelve month minimum period recommended by Tietze produced a higher pregnancy rate figure, similar to that for other intrauterine devices. At the time Davis wrote his report for the Journal of Obstetrics and Gvnecologv only eight of the women participating had actually worn the device for twelve months with the average participation time being under six months. Moreover, the protocol adopted in the trial meant that for the first three months of their Dalkon Shield use most participants were also using a contraceptive jell or cream.22 Davis justified the publication of results at such an eariy stage in the clinical trial with the claim that his device, unlike eariier devices, was designed on the basis of sound scientific principles. The shield was promoted as a 'second generation' intrauterine device.23 its anticipated success was bolstered by frequent references to the 'engineered' character of the device. Davis made much of a series of measurements of silicone rubber casts prepared from hysterectomy specimens. The size and shape of his intrauterine devices was linked to 'scientific' data which enabled the maximisation of the surface area of the device in contact with the uterus.24 The claim that the wings, or spikes, added to the basic shield shape were designed to resist expulsion also echoed the engineering rhetoric. Lower expulsion rates were achieved, Davis wrote, "not by crude bulk or stiffness, but by utilising the forces of uterine contraction to make the device fundus- 22 Mintz At Anv Cost. 1985. p. 30. 23 Davis, Intrauterine Devices for Contraception ,1971. p.93. 24 Davis, Intrauterine Devices for Contraception , 1971. p. 85. 169 seeking'.25 The construction of the Dalkon Shield as a feat of modern engineering linked the Dalkon Shield intrauterine device with a future of trouble-free contraceptive certainty, and dissociated it from the intrauterine device problems that were beginning to be gathered together by the end of the 1960s. The 1968 report of the Food and Drug Administration's Advisory Committee on Obstetrics and Gynecology on intrauterine devices, whilst endorsing their use and commending the success of clinical trials, nevertheless found some disturbing results from surveying the Fellows of the American College of Obstetricians and Gynecologists. Members reported ten deaths amongst intrauterine device users aged 20 to 42, all resulting from pelvic infection.26 The verbal rhetoric enfolding the Dalkon Shield in the linguistic register of bioengineering separated the Dalkon Shield from these surfacing reports of intrauterine device related infection.27 Davis's rhetorical claims linking the shield, bioengineering, and the objectivity of science should not be taken at face value. Bioengineers brought with them the emphasis of their post World War II training in the techniques of performance maximisation. Contraception was perceived as a management problem: how could the lowest investment in a system of manufacturing and distributing contraceptives achieve the maximum possible success? This success was to be measured according to specific performance criteria. What were Davis's performance criteria? In his book Intrauterine Devices for Contraception: The I UP. Davis spelled out the problem that his device was designed to solve. The Dalkon Shield was a weapon in the war against global population pressures, his aim that 'the quality of life may be preserved by the prevention of excessive human life.' Davis, like many pro-intrauterine device protagonists before him, contrasted the success of his device with the oral 25Davis, Intrauterine Devices for Contraception , 1971. p. 96. 26 The full report of the survey is Scott, 'Critical Illnesses and Deaths Associated with Intrauterine Devices', 1968. Also Grant, The Selling of Contraception. 1992. 27 Mintz At Anv Cost. 1985. p. 84. 170 contraceptive pill claiming that the intrauterine device was a superior contraceptive for 'unmotivated' women.28 By 1971 the Agency for International Development was a major purchaser of intrauterine devices. The goal of population control, rather than other goals such as improving women's health by providing a combined method of contraception and protection against sexually transmitted diseases, was more influential in determining performance criteria and hence perceptions of problems in intrauterine devices research. The design criteria which Davis claimed had been met by the Dalkon Shield clearly bear the imprint of population control goals. Expulsions were significantly decreased by the addition of the fins. The efficacy of the device in pregnancy prevention was maximised by increasing the surface area and adding copper. Manufacturing price and the cost of storage and distribution were cheap. Removals for pain, bleeding and other medical removals were only two percent compared with an accepted rate of 15 percent for intrauterine devices already in use. Insertion could occur at any time - following an abortion or at any time during the menstrual cycle. The devices came in two sizes so that one or other was suitable for almost all women irrespective of parity.29 That the copper had any effect except strengthening the plastic was later denied by Robins, when the Food and Drug Administration decided that devices containing active substances, and this included copper, would be subject to pre-market approval. And as Grant has recently emphasised, the lower event rates for medical removals were an artefact of the comparative newness and lack of testing of the Dalkon Shield.3o Nevertheless, the appeal to population control goals provided the means for linking the Dalkon Shield to international intrauterine device 28 Davis, Intrauterine Devices for Contraception , 1971. pp. iv-v, 60-61. 29 Prager, and Wheeler 'Optimization of lUD Design and Performance : An Interdisciplinary Approach', 1971. 30 Grant, The Selling of Contraception. 1992. p.47. 171 networks. The United States Agency for International Development became a major international supplier of Dalkon Shields. By 1975 two million shields had been shipped to 79 countries. These Dalkon Shields were shipped at half price, unsterilized, with one inserter for every ten intrauterine devices and one set of instructions per thousand.3i Davis's claim, presented in the disciplinary framework of bioengineering, to have maximised performance across a range of criteria - expulsions, pregnancy protection, medical removals - was likely to have been influential in promoting the Dalkon Shield intrauterine device through such a rapid growth so that it soon dominated the United States market. Robins supplied a geographically dispersed network of pharmaceutical detailers who took the Dalkon Shield into doctors' surgeries and lobbied donor agencies. The rhetoric of bioengineering provided these detailers with a lever to engineer the participation of general practitioners in an intrauterine device network revolving around the Dalkon Shield, despite the minimal availability of data from clinical trials. Septic abortion reports and struggles over their interpretation Constructing intrauterine device mortality and morbiditv statistics By 1973 maternal deaths following septic spontaneous abortion were being reported as adverse reactions to intrauterine device use. This particular etiology of septic abortions and maternal deaths had been very rare and the increased incidence was readily noticed by several hospital gynecologists. One such practitioner, Dr Donald Christian, was sufficiently alarmed to submit an article to the American Journal of Obstetrics and Gynecology following a woman's death due to the sudden onset of the disease symptoms and the 31 Agency for Intemational Development, 'Memorandum - An In Depth Report : Agency for Intemational Development and the Dalkon Shield Intrauterine Contraceptive Device', Feb 8, 1985. Also Ehrenreich, Dowie and Minkin, The Charge: Gynocide; The Accused: The U.S. Government', 1979; Grant, The Selling of Contraception. 1992. p. 51. 172 failure of physicians to recognise its seriousness. Christian reported five deaths, four of which involved the Dalkon Shield. His patients had died from 31 to 72 hours after the onset of innocuous symptoms that could easily have been confused with the flu. Christian also reported seven women who had experienced septic spontaneous abortions in the second trimester of their pregnancies, achieved despite the presence of intrauterine devices. All women had become seriously ill and all but one were Dalkon Shield users.32 Similar reports were appearing elsewhere in the medical literature. In May 1974 Shine and Thompson reported that of 44 women who conceived and continued the pregnancy whilst using an intrauterine device, half being Dalkon Shield users, 21 had resulted in a spontaneous abortion.33 Forewarned of the publication of these reports, the Centers for Disease Control had begun a survey in 1973 of 35,544 United States physicians in order to obtain information about intrauterine device related deaths and hospitalisation. The survey uncovered 17 deaths, and reported that 60 percent of pregnancy-related intrauterine device complications involved the Dalkon Shield.34 Robins responds on behalf of the Dalkon Shield The reporting of adverse reactions to new drugs and therapeutic devices by doctors is alarmingly low, but Christian was one of several clinicians to have reported his concerns to Robins, the manufacturer of the intrauterine devices involved. By August 1974 Robins was admitting to having 32 Dr. Donald Christian of the Arizona Medical Centre, Tuscon, submitted a letter to the American Journal of Obstetrics and Gynecology on December 24,1973, drawing attention to the sudden onset of symptoms and the rapidity with which death could follow if the episodes were not immediately diagnosed and treatment commenced. Christian, 'Maternal Deaths Associated with Intrauterine Device,' 1974. 33 Shine and Thompson, 'In Situ lUD and Pregnancy Outcome', 1974. 34 Jennings, Report of Safety and Efficacy of the Dalkon Shield and Other lUDs Prepared bv the ad hoc Obstetrics and Gynecology Advisory Committee to the US Food and Drug Administration. 1974. p. 16. 173 been alerted to 11 deaths and over 200 cases of septic abortion.35 The company did not take immediate investigatory action on the receipt of such adverse reaction reports, blaming the increased incidence of septic abortions associated with intrauterine device use on the increasing popularity of the contraceptive devices. However, under pressure from the Centers for Disease Control Robins moved to warn doctors of the possibility that pregnancy might result in rapid and life-threatening septicaemia and abortion. According to the Dalkon Shield manufacturing company, improved patient management was needed, but recommending abortion in cases of pregnancy following device failure was all that was needed to avoid placing women's lives at risk.36 Robins took swift action to construct the problem as one requiring better physician management of a rare event that had only been detected with the increased frequencies occurring with mass intrauterine device use. Precisely how rare pregnancy complications were with the intrauterine device in situ was a question that had not been asked and could not be answered based on the data collected from the clinical trial protocols used to compare any new intrauterine devices. In Tietze's protocols, as I have noted, pregnancy was an event at which the failure of the device was recorded but which necessitated the participant being dropped from the trial. Robins called a conference on the problem in February, 1974, publicising the syndrome within the medical community. The company used the conference to vigorously pursue its interpretation of the septic abortion reports as a rare and manageable side-effect of all intrauterine devices. Whilst several studies reported pregnancy rates for the Dalkon Shield higher than the early optimistic figures given by Davis, Robins pointed to clinical trial findings that conception with a Dalkon Shield in situ was comparable with failure rates for other intrauterine devices. The number of pregnancies amongst 35 Grant, The Selling of Contraception. 1992. p.57-61; Mintz At Anv Cost. 1985. pp.149-158. 36 Templeton, 'Septic Abortion and the Dalkon Shield', 1974. 174 intrauterine device users, physicians were reminded, was low, with reports ranging from 1.1 per 100 to 5.6 per 100.37 Robins presented themselves as responsible manufacturers and recommended the relabelling of physician inserts for all intrauterine devices, warning physicians of the serious risk involved if a woman who conceived despite the shield attempted to carry the pregnancy to term.38 in May 1974 the Robins company sent out a 'Dear Doctor' letter to 120,000 physicians in the United States advising them of the serious risk of pregnancy complications associated with the shield. According to Mintz's analysis, the letter under-reported A.H. Robins' knowledge of pregnancy complications, but it did acknowledge adverse reaction reports involving five deaths, four amongst shield users, and another thirty-six non fatal episodes of septic mid-trimester spontaneous abortion, thirty-two involving Dalkon Shields.39 it cautioned doctors to remove the shield if pregnancy occurred and that mild flu-like symptoms could rapidly and suddenly give way to the severe symptoms of pelvic infection.4o The company construed the reports as indicating a physician management problem concerning all intrauterine devices. This was necessary if they were to avoid action by the Food and Drug Administration. Robins had already avoided Food and Drug Administration scrutiny by denying that the copper salts added to the plastic from which the shield was manufactured had any contraceptive effect. As I will show in the next chapter, intrauterine devices containing active 37 Ostergard, 'Intrauterine contraception in nulliparas with the Dalkon Shield', 1973, gives a pregnancy rate of 1.2. As Mintz points out, Ostergard was a member of A.H. Robins' 10- investigator study, dropped for unreliability, Mintz, At Any Cost. 1985, p.88. A British study by Jones, Parker and Elstein, 'Clinical Experience with the Dalkon Shield Intrauterine Device', 1973, found a pregnancy rate of 4.7. Elstein had close associations with Robins and testified on their behalf. See Mintz At Anv Cost. 1985, p.189. Marshall, Helper, Scott and Zirtsel, 'The Dalkon Shield in nulliparous women', 1974, report a pregnancy rate of 5.6. This figure was still below the rate of 7.2 given in the Robins lO-investigator study, as reported by Mintz, at the end of two years and with data from two of the ten investigators omitted for unreliability by their own chief investigator. Mintz At Any Cost. 1985, p.88. 38 Mintz, At Any Cost. 1985. pp. 161-16 &; 217-218. Mintz presents evidence that Robins failed to disclose all known reports of septic abortions at this conference. 39 Mintz, At Any Cost. 1985. pp. 149-158. 40 Mintz, At Any Cost. 1985. p. 162 175 ingredients were subject to premarket approval processes equivalent to the scrutiny brought to bear on new drugs. Robins was not a large company with a staff experienced in preparing premarket approvals. The Dalkon Shield had avoided premarket scrutiny by the Food and Drug Administration, but it would have fallen under the agency's jurisdiction if It was declared a faulty product. The Food and Drug Administration had responsibility for ensuring that therapeutic devices traded in interstate commerce were not hazardous and they could seize faulty products. Robins's interpretation of the septic abortion reports as pointing to a general intrauterine device problem denied that the Dalkon Shield was a defective product. If all intrauterine devices were implicated then this was a necessary hazard of the class of devices. It had long been established that where pharmaceutical goods were concerned, unavoidable dangers were acceptable. Manufacturers were expected to make goods as safe as possible, and to warn physicians of possible dangers, but if toxic side-effects occurred in some people the greater good of the population as a whole from using the drug was considered to outweigh the injuries to those few individuals adversely affected.4i Not surprisingly Robins moved rapidly to notify inserting doctors of the danger of septic abortion, and to construe the problem as a reasonable danger - a rare event - characteristic of the intrauterine device method of contraception. Decision making in the Food and Drug Administration There was, however, another group of agencies involved in construing the septic abortion deaths to meet a very different group of interests. The deaths were also coming to the attention of the general public via the open hearings of the Intergovernmental Relations Subcommittee of the United 41 This was an area well established in law in areas such as vaccine use where it was admitted that a proportion of the population vaccinated would contract the disease. See Van Dyke, 'The Dalkon Shield: A 'Primer" in lUD Liability', 1978. pp.10-16. 176 States Congress held in May and June, 1973.42 Chaired by Congressman Fountain, the hearings were aimed at supporting legislation to extend the power of the Food and Drug Administration to the regulation of therapeutic devices. The hearings were set up to bring to the attention of the United States Congress the need for such legislation. The Congressional Committee's hearings and their reporting by the media widely publicised claims that A.H. Robins' advertising for the Dalkon Shield significantly underestimated pregnancy rates, and failed to warn doctors of the risk of miscarriage and septicemia when pregnancy occurred. Under scrutiny from Congress, the Food and Drug Administration was paying close attention to intrauterine devices, and particularly to the reports of septic spontaneous abortions amongst intrauterine device users. The Food and Drug Administration was called before the Fountain hearings to testify about what it was doing to regulate intrauterine devices. The Food and Drug Administration had been taking a close interest in intrauterine devices since forming an Office of Medical Devices in September, 1971. Even though it did not have the power to require extensive trials prior to marketing, it did have the power and responsibility to take retrospective action in response to injury reports, and to ensure proper labelling. The Office of Medical Devices carried out a survey to determine what intrauterine devices were being manufactured and distributed in the United States. At the end of May 1973, it had moved against the manufacturer of the Majzlin Spring, seizing 9000 devices following 40 reports of perforation and embedding.43 Four other devices were also withdrawn from the market after the Office of Medical Devices surveyed manufacturers and identified inadequacies in record keeping and clinical trial 42 U.S. Congress, Hearing Before the Subcommittee of the Committee of Government Operations. 1973. 43 'The Intrauterine Device: A Status Report'. Report by the FDA prepared to accompany the press release on lUDs issued on December 20th, 1974. In U.S. Congress, Hearing Before the Subcommittee of the Committee of Government Operations. 1973. pp. 239-253. 177 data: The Inhiband, the Ancor and Birnbirg Bow intrauterine devices, and the LEM device distributed by G.D. Searie.44 In June 1974 the Food and Drug Administration requested that A.H Robins suspend marketing of the Dalkon Shield device. The Food and Drug Administration interpreted the survey reports of the Centers for Disease Control study as warranting the suspicion that Robins was distributing a faulty product. The Centers for Disease Control study, carried out by Dr Henry Kahn and Dr Gari Tyler, concluded that among those women hospitalized for a complicated pregnancy there was a statistically significant excess of Dalkon Shields compared to other types of intrauterine device. A substantial proportion of this excess appeared to involve infected or retained products of conception.45 This finding was based on a statistical analysis of 3,502 incidents of intrauterine device related hospitalisations during the first six months of 1973 reported to the Centers for Disease Control in response to a survey mailed to 35,544 physicians. Almost fifty percent of the physicians surveyed responded, and one percent of the non-respondents were randomly sampled and interviewed, with their reports fitting the same distribution pattern as provided by an analysis of the responders. This pattern was that among all women hospitalised with intrauterine device related diseases, the ratio of complicated pregnancies to other diagnoses was twice as high for Dalkon Shield wearers as it was for wearers of all other types of intrauterine devices.46 This figure was suggestive and it did its job of alerting the officials of the Food and Drug Administration of a possible problem with a defective intrauterine device. However, the figure could be interpreted in a number of different ways. It came under attack because the accuracy of reports was not checked. Its 44 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975. pp. 219- 222. 45 Kahn and Tyler, 'Dalkon Shield and Complicated Pregnancies', 1974. See also Kahn and Tyler, 'Mortality associated.with the use of lUDs,' 1975; Kahn and Tyler, 'An association between the Dalkon Shield and complicated pregnancies ...', 1976; Kahn and Tyler, 'lUD- related hospitalisations in United States and Puerto Rico, 1973', 1975. 46 Kahn and Tyler, 'Dalkon Shield and Complicated Pregnancies', 1974. 178 accuracy was queried because the fifty percent of doctors surveyed who responded might have been a self-selecting group with special concerns about intrauterine device safety. Some argued that the measurement itself could be a reflection of the higher frequency of Dalkon Shield users compared to other intrauterine device users. The interpretation that the Dalkon Shield device was faulty, resulting in a higher pregnancy rates amongst shield users than amongst users of other intrauterine devices, or a higher rate of pregnancy complications, was only one possible interpretation of the study.47 This was a time when the Food and Drug Administration was constantly under scrutiny as the United States Congress was embroiled in a series of attempts to bring therapeutic device regulation in line with drug regulation. The Thalidomide tragedy was also still fresh in the minds of many. When both its Obstetrics and Gynecology advisory committee and the Advisory Committee of the Bureau of Medical Devices and Diagnostic Products independently advised that further distribution of the Dalkon Shield cease whilst its safety was investigated, the Food and Drug Administration acted promptly to request that Robins suspend marketing of the Dalkon Shield, backing up its request with a readiness to institute multiple seizures as they had done with the Majzlin Spring.48 in June, 1974, Robins voluntarily suspended its Dalkon Shield marketing pending investigation by the Food and Drug Administration. Further publicity was attracted by these events when the Food and Drug Administration failed to accept the recommendations of its Ad Hoc Committee established for the purpose of reviewing its request for a moratorium on Dalkon Shield sales. This was a combined panel with membership drawn from the Panel on Obstetrical and Gynecological Devices, 47 See letter from Sheldon Segal of the Population Council to John Jennings of the Food and Drug Administration protesting the report of the subcommittee formed to review the Dalkon Shield moratorium. In U.S. Congress, Food and Drug Administration Practice and Procedure. 1975, pp. 194-196. 48 See internal memo Dalkon Shield Intrauterine Device in U.S. Congress, Food and Drug Administration Practice and Procedure. 1975, pp. 51-56. 179 and the Obstetrics and Gynecology Drug Panel. After hearing testimony on August 21st and 22nd, 1974, some differences emerged between the members of the different panels that had combined to form the Ad Hoc committee. Device Panel members were ready to decide that the moratorium on Dalkon Shield sales should remain in force pending further investigations, whilst some members drawn from the Obstetrics and Gynecology Drug panel wanted more data before deciding between the Robins interpretation designating septic abortions an intrauterine device problem and the competing view that labelled the Dalkon Shield a hazardous device. This deadlock was resolved by referring the matter to a subcommittee of the Ad Hoc Committee which was given the responsibility for drawing up a report and bringing a recommendation back to the main committee. The subcommittee met over the labor day weekend in the absence of two of its members who had previously voted to continue the moratorium. The report contained this statement: 'It is not apparent from the available information that the safety and efficacy of the Dalkon Shield is significantly different from other IUD's'.49 it went on to say that the management of pregnancy in the presence of intrauterine devices required re-evaluation and that 'product labelling should provide adequate information concerning the potential dangers of sepsis occurring'.so The finished report was circulated to all the members of the Ad Hoc Committee and then accepted using a telephone vote, with two thirds of members endorsing the report. But the subcommittee's report came under heated debate at the Ad Hoc Committee meeting to finalise its report on October 29th and 30th, 1974. By then, following the leaking of the subcommittee report, the Ad Hoc 49 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975, pp. 17-18 - Deposition by Dr Dickey a member of the Ad Hoc Committee who opposed lifting the moratorium 50 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975, pp. 65-66 and 124-139 - Statement by Dr Alexander Schmidt, Commissioner of the Food and Drug Administration. See also pp. 247 - extract from the subcommittee report. 180 Committee had received letters expressing concerns about the Dalkon Shield from the dissenting members of the committee, outlining their reasons for rejecting the subcommittee report.5i At issue was the subcommittee's rejection of the Centers for Disease Control report. The possibility of preventing death by increased vigilance was also queried given the rapid progression from mild symptoms to death in many of the reported cases. The Ad Hoc Committee received new evidence from Dr Howard Tatum at the Population Council. Tatum had presented the results of a series of laboratory experiments comparing the upward movement of bacteria in intrauterine device tailstrings dangled in a bacterial solution. The Dalkon Shield tailstring wicked bacteria by capillary action, but there was no bacterial movement along the strings of other intrauterine devices similarly placed. Tatum also analysed Dalkon Shield tails removed from users using a scanning electron microscope. Tatum provided additional evidence to the final Ad Hoc Committee meeting in support of his claim to have demonstrated that the tailstring of the Dalkon Shield was faulty and that its multifilament structure, unlike the monofilament structure of other intrauterine devices, both wicked bacteria from the vagina into the uterus, and acted as a reservoir for bacteria. When the uterus expanded in the second trimester of pregnancy, the tailstring was retracted inside the uterus, acting as a bacteriological carrier.52 When the vote was taken on whether the moratorium should continue or be lifted, some of the members who had previously accepted the report reversed their vote. The final recommendation was that 'the moratorium on commercial distribution of the Dalkon Shield remain in place pending accumulation of definitive data.'53 in addition, the committee accepted a recommendation 51 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975. pp. 186- 213. 52 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975. p. 31. See Tatum et al., 'The Dalkon Shield Controversy: Structural and Bacteriological Studies of lUD Tails', 1975. 53 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975. pp. 256-273. 181 endorsing a research proposal to collect more definitive data about the safety of the Dalkon Shield.54 Dickey, a member of the committee, later reported that it had been assumed that this research would be carried out without any further insertions of Dalkon Shields.55 Then on December 20th a commissioner of the Food and Drug Administration, Dr Alexander Schmidt, issued a press statement allowing the remarketing of the Dalkon Shield. It used the Ad Hoc Committee's recommendation for research to justify its lifting of the moratorium, restricting sales by requiring that inserting doctors keep a register designed and maintained by the Robins company. Schmidt later justified his decision by comparing the registry system with the conditions imposed for the marketing of new drugs, although the registry system operated for new drugs that had already been approved on the basis of efficacy and safety data supplied to the Food and Drug Administration. It was precisely the lack of safety data for the Dalkon Shield, data that would have been required if premarket approval provisions applied equally to drugs and devices, that had caused controversy on the Ad Hoc Committee. Schmidt's other defence for reversing the position of the Ad Hoc Committee was that the old Dalkon Shield device which had been associated with sepsis and death was not going to be remarketed, and the new Dalkon Shield devices would have a monofilament tail. Thus any attempt to investigate the safety of the new devices could not rely on following women already inserted with the old model Dalkon Shields.56 This failure of the Food and Drug Administration to take its own expert advice seriously, and the failure of the United States Congress to pass the new therapeutic device legislation, led to a new round of Congressional hearings in January 1975, this time before the Joint Subcommittees of Labor and Public Welfare, and 54 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975. pp. 256- 273. 55 U.S. Congress, Food and Dmg Administration Practice and Procedure. 1975. p. 19. 56 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975.: see 'press release', pp. 231-233, and 'Schmidt statement to the Congressional hearing', pp. 124-139. 182 Administrative Procedure.57 it is the documentary record of this committee that has provided most of the evidence I have used to reconstruct the decision making processes of the Food and Drug Administration. The controversy within the Food and Drug Administration was put down to the lack of available data for objectively assessing the Dalkon Shield risks in comparison to other device risks. The Centers for Disease Control Report and the Tatum studies were not sufficiently robust to compel consensus amongst the Ad Hoc Committee members. Nor did the report of the Ad Hoc Committee carry other officials of the Food and Drug Administration with it. The quality of the data was only one contributing factor to this outcome. The cultural context of participants also played a role. Some physicians had personal experience of Dalkon Shield complications and their judgements were influenced by their orientation as physicians to patient well-being. For them the safety questions that had been raised by the Centers for Disease Control survey and the post marketing adverse reaction reporting could not be resolved. It was a value judgement as to whether the Centers for Disease Control study was interpreted in favour of retaining the moratorium on further Dalkon Shield sales until research had been completed into the safety of the device. Or, as their colleagues whose cultural context lay more with industry assessment insisted, the inability of the study to compel consensus necessitated lifting the moratorium until there was incontrovertible evidence supporting the case that the Dalkon Shield was a hazardous device. Interestingly, it was the perception amongst some of the committee members with a long association with population control politics that the problem of septic abortion was sufficiently grave to threaten the community's acceptance of this method of contraception. Crucial to the construction of the Dalkon Shield as a defective intrauterine device was the work of Howard Tatum on the bacterial wicking action of the Dalkon Shield tailstring. By 57 U.S. Congress, Food and Drug Administration Practice and Procedure. 1975. 183 isolating the physical structure of the Dalkon Shield from all other intrauterine devices, Tatum, who was employed by the Population Council, protected the council's investment in intrauterine device fertility control programs. The acceptance of Robins's interpretation of the septic abortion reports would have placed all intrauterine devices at risk of being once again condemned, particularly given the context of the public and emotional controversy generated in the media, partly produced by the ongoing and repeated attempts that proved necessary before Congress finally implemented legislative reform in the drug and device regulation area. In the courts Tatum's evidence would come to exercise much more leverage. In 1975 the claims of this study were still regarded as the opinion of one birth control expert. Whilst they won some support in the Food and Drug Administration, and provided Robins with the basis for redesigning the Dalkon Shield and re-entering the market despite fears of device danger, there were many dissenting voices. In the face of consistent clinical trials conducted using the well accepted Tietze methodology, that achieved similar safety and efficacy rates for the Dalkon Shield and other intrauterine devices, these dissenters reserved their judgement on the matter. It was on the basis of these studies that consensus judgements concerning efficacy and safety had been institutionalised. But these studies dropped participants from the trial when they became pregnant and there were no standardised, routine procedures for judgements about in-use safety that included mechanisms for making visible such events as the mid-trimester septic abortions and maternal deaths that sparked the removal of the Dalkon Shield from the market. The planned release of a new monofilament Dalkon Shield was overtaken by events. In 1976, Congress finally passed new laws that would mean that devices like the Dalkon Shield could not be marketed without premarket trials and scrutiny of safety and efficacy data by the Food and Drug Administration. And in that same year Robins was facing negligence charges 184 filed by 600 women in the United States courts.58 The Dalkon Shield was never remarketed. The Dalkon Shield and the Courts Robins successfully defends the Dalkon Shield In February 1975 Connie Deemer was awarded $10,000 in compensation for injuries received as a result of using the Dalkon Shield. Deemer had become pregnant with a Dalkon Shield in place but had been forced to carry the baby to term with the device having perforated her uterus. The Wichita jury awarded $75,000 in punitive damages against Robins for negligence and misconduct. Bradley Post, Deemer's lawyer, in a document search at Robins, had turned up a memo written by Frederick Clark, a medical adviser employed by the manufacturer, about a meeting with Davis just prior to the Dalkon Shield being purchased by his company. The memo revealed that the company had evidence that the 1.1 percent pregnancy rate cited by Davis in his report published in the 1970 Journal of Obstetrics and Gynecology was misleading. By the time the article was published Davis had learned of additional pregnancies which would have indicated a pregnancy rate of five percent. The Clark memo noted this higher pregnancy rate. Deemer's physician gave evidence that he would not have considered the Dalkon Shield for her if the information known to Robins had been known to him. The jury compensated Deemer and punished Robins for its negligent behaviour in publicising the 1.1 per cent figure in its advertising and marketing campaigns.59 Following the verdict, increasing numbers of women filed lawsuits. The reports of the experience of these women who were suing Robins personalised the stakes involved in the competing claims: for some the 58 Wall Street Journal. 'Dalkon Shield Suits against Robins Rise, SEC Report Shows',1976 59 Mintz, At Any Cost. 198,. p.212; Perry, and Dawson. Nightmare. 1985, pp.160-170; Sobol, Bending the Law. 1991, p. 12. 185 Dalkon Shield was a defective product, for others the Dalkon Shield was an intrauterine device with the normal risks and benefits of such devices. Stories of horrendous consequences including the need for repeated bouts of hospitalisation, hysterectomy, sterility, and family breakdown were beamed into living rooms across America.5o What these stories highlighted were additional serious injuries related to the Dalkon Shield intrauterine device. From an initial concern with damage to the foetus during pregnancy resulting in disability, and mid-trimester septic abortion, public discussion of the dangers of the Dalkon Shield rapidly expanded to include life-threatening ectopic pregnancies (where pregnancy occurs in the fallopian tubes), chronic and severe pelvic inflammatory disease and infertility.5i By mid-1976, 533 Dalkon Shield suits had been filed in United States courts across the country seeking $480 million in punitive and compensatory damages.52 Under United States law, Robins could be declared negligent but also held strictly liable, and therefore be required to pay punitive damages in addition to compensating women for the injuries caused by its product. If it had known or had reason to know that the product was dangerous for the use for which it was supplied, and had failed to warn the women's physicians of such hazards or the circumstances under which injuries were most likely to occur. As the manufacturer, Robins had a duty to keep up on scientific knowledge concerning its product and to warn physicians of subsequently discovered dangerous side-effects. United States laws varied from state to state but generally the manufacturer was held to be liable for negligence where the product was inadequately tested, or where the company failed to exercise due care in product development, or in the investigation of adverse reactions.53 This meant that prosecuting lawyers had to secure documents to 50 Frizzell and Sutton, 'A young Woman's Passing: Resolving the Needless Pain', 1977; Katz, 'The lUD: Out of Sight, Out of Mind,' 1975; Epstein, 'lUD - The Bloody Truth: The Fastest- Growing Method of Birth Control May also be the Most Dangerous', 1975. 51 Perry, and Dawson, Nightmare. 1985, pp. 37-42, 89-95, & 155-159. 52 Mintz, At Any Cost. 1985. p. 241. 53 Van Dyke, 'The Dalkon Shield a "Primer" in lUD Liability', 1978. 186 show that Robins had not tested the device under reasonable standards applying at the time, or that it was in possession of information that would reasonably have alerted it to the possibility that it was marketing a dangerous device. Until the Deemer case Robins had been successful in defending itself against such charges. The cases against it were scattered around the country and most often prosecuted by small law firms with limited resources to engage in document searching. Tuttle, the company's in-house lawyer, utilised procedural manoeuvres and delaying tactics to successfully fight a war based on wearing its enemies down so that their limited resources would eventually force them to withdraw or settle for small compensatory payments.54 The other line of defence deployed by Robins when cases did proceed to trial is illustrated by the Deemer case. There, Tuttle had argued that Deemer's distress and injury were caused by the inserting physician and not the Dalkon Shield. However this strategy seemed to have backfired when the doctor, despite having been charged with negligence along with Robins, gave evidence sympathetic to Deemer's case. Following the trial the Robins insurer, Aetna Casualty & Surety Company, insisted that defence be transferred to McGuire, Woods and Battle, a large law firm experienced in defending this type of case. Tuttle was castigated for allowing such a damning document as the Clark memorandum to fall into the hands of prosecuting lawyers and, as he much later revealed, was ordered to destroy incriminating documents.65 McGuire, Woods and Battle immediately restructured the Dalkon Shield defence, steering away from attacking inserting physicians whom it saw as potential allies, and contesting causation.55 Defence lawyers aggressively interrogated plaintiffs in an attempt to argue that their infections were caused by their sexual conduct 54 Bacigal, The Limits of Litigation. 199,. pp.16-17. 65 Tuttle, 'The Dalkon Shield Disaster Ten Years Later-A Historical Perspective', 1983. 56 Sobol, Bending the Law. 1991, p.13. 187 or the sexual conduct of their partners and not by the Dalkon Shield. Many women were intimidated by the tactics pursued by McGuire, Woods and Battle and in an attempt to avoid questions requiring them to name sexual partners, discuss their promiscuity and sexual practices in court, and give details of their sexual hygiene, many women settled for small payments, or decided not to proceed. The shield was defended as being no different from other intrauterine devices. By 1979 Aetna had paid out an average of $11,000 for about three thousand cases settled out of court. Of the cases that did proceed to trial, most were successfully defended with any pay-outs kept low and attempts by lawyers to search documents vigorously opposed.67 The litigation context reframes Robins's response to septic abortion adverse rgaptipn rgpQrt? Robins had resisted any further efforts to extract information and internal business documents that would bear on the case of whether it knew the device was defective. But the women seeking compensatory payments from Robins and their lawyers were assisted in challenging this by the consolidation of pending cases across the country for the process of pre-trial discovery. United States law allowed for this consolidation under one judge in an attempt to save time and money both for the plaintiffs' attorneys and for companies defending product liability. Attorneys were saved the costs of duplicating the work of their colleagues and Robins was spared the cost of dealing with repeated requests for searching. In December 1975, this Multi- District Litigation was brought before the Kansas court. Bradley Post led the process for the plaintiffs. Robins produced over 100,000 documents, and depositions were taken from leading company officials. Further documents were produced when the court accepted on two occasions that Robins was still concealing documents, but in mid-1977 the process was closed. The 57sobol. Bending the Law. 1991, p.14. 188 lawyers concentrated on extracting those documents that could be used to demonstrate negligence in the development and manufacturing process. When the attorneys returned home to pursue the cases individually most courts restricted the process of document searching to those already disclosed in the Multi-District Litigation.68 Some important victories were won using the documents recovered during the Multi-District Litigation. In 1979 a Colorado jury awarded Carrie Palmer $600,000 in damages and ordered Robins to pay $6.2 million in punitive damages. Palmer had become pregnant whilst using a Dalkon Shield and had suffered a life-threatening septic abortion. Douglas Bragg, the Denver attorney working for Palmer, relied on a letter, recovered in the Multi-District Litigation, received by Robins in June 1972. The letter was from Thad Earl warning that five of six pregnancies amongst his Dalkon Shield patients had ended with septic miscarriages. Eari had bought into the Dalkon Corporation and had been retained by Robins as a consultant, but the company did not act on his advice to warn physicians of the need to recommend shield removal where a pregnancy occurred.69 Following the Palmer trial the average out-of- court settlement rose to $40,000 with most cases still being resolved without proceeding to trial. In those cases that did, Robins was successful in about half the cases with their defences, that the cause of plaintiffs' injuries was the sexual behaviour of the woman or her partner or the incompetence of the physician in detecting infections pre-existing insertion. Reconstructing the Dalkon Shield as a defective device It was not until 1983 that the courts accepted that the Dalkon Shield was defectively designed. The trial before a Minneapolis-St Paul Federal Court involved Brenda Stempke who was seeking compensation for a 58 Bacigal, The Limits of Litigation. 1990. pp. 22-24; Sobol, Bending the Law. 1991, p. 14. 59 Mintz, At Any Cost. 1985, pp. 149-154; Sobol, Bending the Law. 1991, pp.14. 189 rampant pelvic infection that had occurred whilst she was wearing a Dalkon Shield. Hospitalisation and antibiotics had failed to clear up the massive infection. Eventually Brenda Stempke had undergone major surgery during which her infected Fallopian tube was removed resulting in her infertility. Michael Giresi and Dale Larson were lawyers with one of Minneapolis's biggest law firms - Robins, Zelle, Larson and Kaplan (now Robins, Kaplan, Miller and Giresi). They called expert witnesses and argued their way through Robins' repeated objections to the admission of company documents from the Multi-District Litigation. The jury found that the Dalkon Shield design was hazardous.7o Robins was ordered to pay $1.5 million in punitive damages. It was not the sum involved that was the problem, for Robins had earned an after tax net profit for the period 1980-1982 of $118 million. However this case marked a turning point. The multifilament structure of the Dalkon Shield tailstring had been raised in court before. But Howard Tatum's experiments had not been sufficiently robust to consistently win debates over whether the shield design was more dangerous than it needed to be.As previously discussed, Tatum's paper, published in 1975, presented scanning electron micrographs showing the cross-sections of several intrauterine devices tails. In court, the electron microscope pictures of the multifilament Dalkon Shield tail were labelled a dogs dinner and paraded as evidence of Robins' slap-dash approach. 7i Tatum's representation of the Dalkon Shield tailstring as a hazardous design flaw provided a means for constructing the Dalkon Shield intrauterine device as defective, an important strategy if plaintiffs claiming to have been injured were to break the effectiveness of the company's contestation of causation. Concerns about contraception, septic abortions, maternal deaths and pelvic infections could be translated onto the more narrowly focused 70 Sobol. Bending the Law. 1991. p.17. 71 Tatum, Schmidt, Phillips, McCarty, and O'Leary, 'The Dalkon Shield Controversy: Structural and Bacteriological Studies of lUD Tails', 1975. 190 terrain of the tailstring that wicked. But on its own the Tatum study had not been enough to consistently convince jurors. Robins repeatedly labelled the study flawed. Gould the distinction in the tailstring design be linked to a difference in its effect in the body? Robins could point to the lack of evidence that Dalkon Shield wearers were at any higher risk of contracting pelvic inflammatory disease. It had to be argued that the ascent of bacteria on the outside of the string, something that could occur with either the Dalkon Shield or other monofilament devices, was less of a problem than ascent inside the string. Expert witnesses were called to argue that this was indeed the case because during external ascent the bacteria would be more susceptible to attack by the body's defence system particularly as the bacteria came into contact with the mucous plug in the cervix. Tatum's studies had not actually shown this. Robins' defence maintained that the in vivo situation remained far from clear with no studies detecting higher rates of pelvic infection amongst Dalkon Shield users than amongst users of other intrauterine devices. Studies had been done that linked higher rates of pelvic inflammatory disease to intrauterine device use. The two most influential studies, without which others may well have been largely ignored, were done by Westrom in Sweden and by Vessey in Britain.72 These studies provided a different basis for theorising, modelling, and presenting a picture of the risk of infection amongst intrauterine device users than was provided by conventional clinical trials which used Tietze's guidelines to construct intrauterine device risks. Both Westrom and Vessey compared the incidence of pelvic inflammatory disease In a population of intrauterine device users with its occurrence in matched cohorts of non-users. They employed conventional techniques used by epidemiologists to define cohorts likely to have the same characteristics as the population being studied. Vessey concluded that for women using an 72 Westrom, Bengstrom, and Mardh, 'The Risk of Pelvic Inflammatory Disease in Women Using Intrauterine Contraceptive Devices as Compared to Non-Users', 1976; Vessey, Doll, Peto, Johnson, and Wiggins, 'A Long Term Follow-up Study of Women Using Different Methods of Contraception: An Interim Report', 1976. 191 intrauterine device hospital admission rates for first attacks of pelvic infection were 202 per year per 100,000 women whereas for women using other contraceptive methods they were 57. Westrom put the increased risk of pelvic inflammatory disease for intrauterine device users at three times the risk for users of other contraceptives. But these studies did not differentiate between the various intrauterine devices. These two studies were not the first to use epidemiological techniques to study intrauterine device users, nor to find pelvic inflammatory disease rates were higher amongst them. Other matched cohort studies had produced an increased risk of pelvic inflammatory disease amongst intrauterine device users by a factor of 2.5 to 11.73 However, these smaller studies had been criticised for the accuracy of their diagnosis of pelvic inflammatory disease, or because their population was drawn from public hospitals in the United States and the higher rates of pelvic inflammatory disease construed as possibly artefacts of the low socio-economic status of the primarily black clientele of the inner-urban public hospitals where the research was conducted. The Vessey Oxford study involved 17,000 women and controlled for socio economic status. The higher incidence of pelvic inflammatory disease amongst intrauterine device users persisted in such a sample group mixed by race, age, marital status and income. The scale of this study meant that its auxiliary hypotheses - that calculations for the population under study could be extended to other populations, or that the selection of matched cohorts had indeed produced a comparable population - were less vulnerable to attack.74 The Westrom study had grown out of an interest in laparoscopy. The study reported only laparoscopically verified cases of pelvic inflammatory disease. This removed the worries of some that the earlier studies relied on patient 73 Wright and Laemmie, 'Acute Pelvic Inflammatory Disease in an Indigent Population', 1968; Targum and Wright, 'Association of the Intrauterine Device and Pelvic Inflammatory Disease', 1974; Faulkner and Ory, 'Intrauterine Devices and Acute Pelvic Inflammatory Disease', 1976. 74 For a discussion of eariier studies see British Medical Journal. 'Editorial', 1976. 192 observations of symptoms such as pain and discharge in order to diagnose pelvic inflammatory disease. Intrauterine device advocates had accused doctors and patients relying on verbal reporting of symptoms of overestimating rates of infection amongst intrauterine device users because of the highly-charged publicity surrounding the Dalkon Shield litigation. The Westrom study excluded data which relied only on the clinical diagnosis of pelvic inflammatory disease.75 However, Vessey and Westrom's studies did not specify any particular intrauterine device as more risky than others. Nor were their findings interpreted as a reason to abandon intrauterine devices as a contraceptive method. The British Medical Journal was typical in comparing the increased pelvic inflammatory disease risk with the estimated total mortality rate for intrauterine devices, 1-10 deaths per million woman years, and for the oral contraceptive pill, 22-45 deaths per million woman years.75 By the mid-1970s the intrauterine device had become an accepted contraceptive in medical practice, and considerable investment stood behind the devices. The epidemiological studies tying higher risks of pelvic inflammatory disease to intrauterine device use were interpreted as an unavoidable cost of the devices, outweighed by the benefits, not as a reason for changing sexual behaviour and contraceptive practice. Interpretations do not simply flow from the data. Observations must be made to have meanings, and the production of meanings takes place in a specific context. The epidemiological data on 75 Laparoscopy had become possible because of the huge increase in the use of sterilisation for contraception. This provided physicians with the opportunity to direct their gaze inside women's txxlies, to develop descriptions of the normal conditions of fallopian tubes and other reproductive organs. At sterilisation, infections became visible to medical practitioners. One outcome of this was a redefinition oif pelvic inflammatory disease as a serious disease which could occur without outward signs. Targum, and Wright, 'Association of the Intrauterine Device and Pelvic Inflammatory Disease : A Retrospective Pilot Study', 1974. Ironically the use of laparoscopy had escalated with the growth of research into infertility. Many of the women undergoing laparoscopies for infertility, now often concentrated in special infertility clinics, had been intrauterine devices users. Some researchers began publishing the results of studies conducted in such a setting. Smith, and Soderstrom, 'Salpingitis : A Frequent Response to Intrauterine Contraception', 1976. 76 British Medical Journal. 'Editorial', 1976. 193 risk were incorporated into the discourse of medical management. Women were reassured that they need not be alarmed by these studies. The risks would be 'managed' by physicians. Following the Dalkon Shield septic abortion deaths, the Food and Drug Administration had issued guidelines recommending the removal of all intrauterine devices when pregnancy occurred. Doctors, alert to the possibility of septicaemia, would supervise intrauterine device users more closely, preventing device-related spontaneous abortions, and women's deaths.77 A similar approach was taken to pelvic inflammatory disease. Researchers recommended new practices for physicians involved with intrauterine device insertions. Young women who have multiple sexual partners and frequent sex should be warned of the increased risk of pelvic infection and infertility; clinic patients should be screened for gonorrhoea to isolate women presenting the highest risk for pelvic inflammatory disease and advise them against the use of this method of birth control; and sterile insertion techniques needed to be adopted in all countries.78 These new guidelines conceded some ground. Concerns about young, sexually active women with multiple sexual partners had motivated intrauterine devices advocates to recraft the intrauterine device as a suitable method of birth control for this group. The Dalkon Shield had been manufactured in two sizes, with the smaller size recommended for nulliparous women. The new recommendations did not make nulliparity a contraindication for use but they sought a consensus amongst medical practitioners that discouraged their use amongst young women and women without children. Then in 1983 the Centers for Disease Control issued a major study reporting a five-fold increased risk of pelvic inflammatory disease amongst Dalkon Shield users compared with women using other types of intrauterine 77 Gates, Grimes, Orry and Tyler, 'Publicity and Public Health : The Elimination of lUD Related Abortion Deaths', 1977. 78 Population Information Program, Population Reports, series B - Intrauterine Devices. Number 3, May, 1979, p. 69 194 devices. Using the data from the Women's Health Study this was the first study large enough to distinguish the relative risks of different intrauterine devlces.79 This finding has continued to be contested in the medical literature but in court it proved extremely damaging, particulariy when combined with deposition and documentary evidence showing that Robins officials had known about the defective tailstring and had failed to take action.so At the Stempke trial, Robins was, for the first time, unable to hide behind the lack of evidence for increased risk of pelvic inflammatory disease amongst Dalkon Shield users, and was therefore brought face to face with their failure to take action to remedy the wicking action they had long known about. As early as June 29, 1970, Robins had received a letter from the co- inventor of the Dalkon Shield, Irwin Lerner, waming that the tailstring may present concerns because of its wicking effect. Davis and Lerner had begun using the multifilament tailstring because the monofilament string they had used initially had often broken when devices were being removed. The fins which reduced the Dalkon Shield's expulsion rate acted as barbs and created greater resistance than would have occurred with other devices. Lerner recommended that Robins subject the string or lail' situation' to 'careful review' because of the problem with a 'wicking tendency'. 81 No action was taken then, nor when Robins' quality control supervisor tested the string and reported wicking. Wayne Chowder was an inexperienced employee at the Lynchburg, Virginia Chapstick plant that was to manufacture the Dalkon Shields. He conducted the wicking experiments when questioning the value of his production crew tying a knot in the tailstrings, purportedly to stop the ascent of vaginal fluids. Chowder found that the knots did not prevent fluid 79 MMWR, 'Current Trends: Pelvic Inflammatory Disease among Women Using the Dalkon Shield', 1983. See also Lee, Rubin, Ory and Burkman, 'Type of Intrauterine Device and the Risk of Pelvic Inflammatory Disease', 1983; and Kaufman, Watson and Rosenberg et al, 'The Effect of Different Types of Intrauterine Devices on the Risk of Pelvic Inflammatory Disease', 1983. 50 The debate as to whether Dalkon Shield users had significantly nrwre problems than other lUD users has recently been re-opened. See Sivin, 'Another took at the Dalkon Shield', 1993. 51 Sobol, Bgnding the Law, 1991, p. 7. 195 from ascending through the string and recommended that the ends of the tailstring be heat-sealed so that the plastic sheath surrounding the multifilaments fully enclosed them. Chowder was reprimanded for his trouble but his suggestion did reach the medical department, and changing the tailstring was considered, but again no action was taken.82 in April 1972 Robins also learned that the nylon sheath deteriorated in situ developing holes and tears. This problem was raised with a suggestion that Robins should issue a definite time limit for leaving the Dalkon Shield in place. No changes were made to the string, but in response to extensions in recommended efficacy times by competitors, Robins ignored reports of string deterioration and reworded its instruction to imply that the shield could remain in place for up to five years. The company seriously considered changing the tailstring only once, when the German company supplying the multifilament strings proved unreliable and delivered quality product somewhat inconsistently. It tested a monofilament string called Gore-tex but rejected it because it would have increased the cost of the tail from 0.63 cents to 6.1 cents.83 The Dalkon-Shield-as-a-defective-device construction Gathers strength The other event to make the Stempke trial something of a watershed was the presiding judge's decision, following its protracted length, to expedite Dalkon Shield trials in his jurisdiction, all of which had initially been allocated to him, by sharing the remaining cases with all of the Minneapolis Federal Court judges. One of these judges was well known for his confrontations with large corporations. Miles Lord was an activist judge. Several years eariier he had been removed from a pollution case by an appeal court for a controversial 82 Sobol, Bending the Law. 1991, p. 7; Mintz, At Anv Cost. 1985, p. 138; Bacigal, The Limits of Litigation. 1990. p. 11. 53 Bacigal, The Limits of Litigation. 1990. p. 12, Sobol, Bending the Law. 1991, p. 8; Mintz, Al ADiLQeSt, 1985,p. 137. 196 decision to close down the company responsible for polluting Lake Superior, declaring that 'this court cannot honour profit over human life'. 3,100 people were laid off work following his decision.84 The first decision taken by Judge Lord in the Dalkon Shield case was to order Robins to deliver thousands of previously undisclosed documents to his Minnesota Court, and to send court employees to get them. The two court- appointed masters responsible for reading the documents and sorting those that should be made available to prosecuting attorneys concluded that there was 'a strong prima facie case that Robins Co. Inc. has, with the knowledge and participation of in-house counsel, engaged in an ongoing fraud by knowingly misrepresenting the nature, quality, safety, and efficacy of the Dalkon Shield.'85 Lord summonsed three top officials to his courtroom where he personally chastised them: Today as you sit here attempting once more to extricate yourselves from the legal consequences of your acts, none of you has faced up to the fact that more than nine thousand women have made claims that they gave up part of their womanhood so that your company might prosper. And there stand behind them legions more who have been injured but who have not sought relief in the courts of this land. I dread to think what would have been the consequences if your victims had been men rather than women, women who seem through some strange quirk of our society's mores to expect to suffer pain, shame, and humiliation. If one poor young man were, by some act of his - without authority or consent - to inflict such damage upon one woman, he would be jailed for a good portion of the rest of his life. And yet your company, without warning to women invaded their bodies by the millions and caused them injuries by the thousands. And when the time came for these women to make their claims against your company, you attacked their characters. You inquired into their sexual practices and into the identity of their sex partners. You exposed these women - and ruined families and reputations and careers - in order to intimidate those who would raise their voices against you. You introduced issues that had no relationship 84 Bacigal, The Limits of Litigation. 1990. p. 23; Grant, The Selling of Contraception. 1992, p. 67. 85 Perry and Dawson, Nightmare. 1985.pp.205. 197 whatsoever to the fact that you planted in the bodies of these women instruments of death, of mutilation, of disease.85 The jury in Lord's court, in addition to gaining access to over 100,000 previously undisclosed documents, heard the first group of consolidated claims where it was much less plausible that each woman's cause of infection could be dismissed as due to individual factors such as diabetes for one, sexual promiscuity for another, the husband's sexual conduct in another, an abortion in another, and not to the one thing they shared - use of the Dalkon Shield.57 Robins settled all cases before Judge Lord out of court rather than have them proceed to trial. Larson and Giresi held out as long as possible to allow the document search to continue but eventually settled on behalf of five clients for the huge sum of $4.6 million. In 1984 the company settled 198 cases with Larson and Giresi for a record $38 million.88 Lord's widely reported public castigation of company officials was eventually struck from the record on appeal, but not before it inspired Roger Tuttle to make a full confession of his role in document destruction over a decade before. Tuttle had become a born-again Christian and Lord's appeal to the Robins officials must have spoken directly to his new sensibilities. Lord urged 'Confession is good for the soul, gentlemen. Face up to your misdeeds. Acknowledge the personal responsibility that you have for those that work under you. Rectify this evil situation.'89 During his deposition on July 30, 1984 Tuttle produced some of the documents he had been ordered to destroy, pulling them in court from an envelope he had kept at home. One particulariy damning document he produced, which had not previously been seen, was a memo from the company's product planning division noting that copper 86 Lord's full speech is given in Mintz, At Any Cost. 1985, pp.264-269. See also Englemayer and Wagman, Lord's Justice. 1985. 87 Perry and Dawson, Nightmare. 1985, p. 201. 58 Bacigal, The Limits of Litigation. 1990. pp. 25-27; Mintz, At Any Cost. 1985, p.241; Sobol, Bending the Law. 1991, p 19. 89 For the full text see Lord, 'The Dalkon Shield Litigation: Revised Annotated Reprimand by Chief Justice Judge Miles W. Lord', 1986. 198 sulphate had been added to the shield plastic by Davis and Lerner to enhance device efficacy. Tuttle testified that this had been concealed to avoid having the Dalkon Shield classified as a drug by the Food and Drug Administration, and that following the Deemer trial this and and many thousands of other documents had been systematically destroyed to coverup any knowledge of Dalkon Shield development amongst top company personnel.9o When Tuttle's deposition was presented to a Kansas jury a few days later they awarded the plaintiffs $9.2 million, including $7.5 million in punitive damages. Robins was under increasing pressure to issue a full recall of Dalkon Shields, including recovery of those shields still implanted. Planned Parenthood of America had issued a recall to its own patients in May 1974. On the basis of investigations into septic abortions, all Planned Parenthood Centers in the United States both stopped prescribing the Dalkon Shield and had community service announcements broadcast recommending that all Shield users return to clinics to have the devices removed because of a 'serious risk to their health in the event that they should become pregnant and choose to continue the pregnancy'.9i On September 5, 1980, the Robins Company had sent a letter to physicians and hospitals in the United States and Canada suggesting that the Dalkon Shield be removed from all patients. But critics attacked the letter as inadequate. The letter had not mentioned the tailstring, nor pelvic inflammatory disease, but had suggested that the shields be removed because it was time to do so given that sales had ceased more than five years earlier. In 1981 the National Women's Health Network, an activist group based in Washington DC, established specifically to lobby congress and health administrators, filed a suit against Robins calling for world-wide recall of the Dalkon Shield and international relief for women injured by the device. The National Women's Health Network was an umbrella 90 Sobol, Bending the Law, I99i, p 22. 91 Culliton and Knopman, 'Dalkon Shield Affair: A Bad Lesson in Science and Decision Making', 1974. 199 organisation claiming to represent local women's health centres and women health consumers. It had taken action on the oral contraceptive pill, rape, domestic violence, occupational health and safety and over-supply of hysterectomy. In April, 1983, it followed up its 1981 action by filing a Citizens' Petition seeking a recall action from the Food and Drug Administration. The Food and Drug Administration, confronted also with the Centers for Disease Control study, made a recommendation that Dalkon Shields should be removed, but failed to issue a recall, or to demand that Robins pay the cost of removal, as requested by the Citizens' Petition. Judge Lord in February 1984 had also urged Robins to issue a strongly worded recall but Robins had responded by appealing Lord's extraordinary behaviour in personally summoning company executives to his court for a reprimand. In September 1984 the National Women's Health Network filed additional information in support of its appeal for a Food and Drug Administration recall of the Dalkon Shield.92 In October 1984, with 7,700 cases settled for a total cost of $260 million dollars, an additional 3,500 cases filed, and an extra ten cases per day being notified, Robins finally issued and widely publicised a recall notice publicly recommending for the first time that all Dalkon Shields be removed and offering to pay for their removal. Robins still did not admit that its devices had been defective but referred to 'new' evidence that the risk of infection for all lUDs 'may' increase with the length of time the device was in place. In the following months Robins paid out $3.8 million in advertising and paid for the removal of five thousand Dalkon Shields.93 The following year Robins filed for bankruptcy under chapter 11 of the United States Bankruptcy Code. This was highly unusual as Robins was financially buoyant and trading well at the time, but it argued before the court 92 NWHN, 'Dalkon Shield Chronology', undated; NWHN, 'Statement of the National Women's Health Network on the Dalkon Shield', 1975. 93 Robins, Clairix)rne Jr., 'A.H. Robins Company Dalkon Shield Removal Program', October 9. 1984. Also Sobol, Bending the Law 1991, p 23; 200 that its increasing liabilities for damages in Dalkon Shield cases would damage its solvency.94 The Bankruptcy Court set a deadline for all women wanting to pursue damages claims for Dalkon Shield related injuries to file their claims by April, 1986, ordering Robins to mount a publicity campaign notifying women of their right to do so. By the deadline 327,000 women had lodged claims, a number that would eventually be reduced to 197,000 claims deemed legitimate.95 Presided over by Judge Merhige, these cases and the bankruptcy proceedings eventually resulted in the establishment of the Dalkon Shield Claimants Trust with $2.45 billion paid up by December 1989. By then the Robins company had been sold to American Home Products, a large pharmaceutical conglomerate. Injured parties still pursuing claims against Robins had voted to accept the company restructure and take-over, becoming economic claimants against the company and foregoing their legal right to sue for negligence. Hicks reports that 115,000 of the outstanding cases had been settled for $1000 or less by July 1992.96 How scientific studies reconstructed the Dalkon Shield socio-technical network Grafenberg had made his devices tailless in response to fears that to leave a string dangling into the vagina would provide a route for the ascent of bacteria. The metaphor of the string that wicked bacteria from the vagina into the 'normally sterile' uterus proved to have powerful popular resonances in the extensive media coverage that accompanied the dramatic events unfolding in the courts. It was reproduced in banner headlines in the popular press throughout the Dalkon Shield trials. The meaning of this image was in part 94 This was a strategy first used by asbestos product manufacturers in 1982. See Smith, 'Beyond the Equity Power of Bankruptcy Courts: Toxic Tort Liabilities in Chapter 11 Cases', 1986. 95 Hicks, Surviving the Dalkon Shisld lun 1994. 96 Hicks, Sun/iving the Dalkon Shifild IIJD 1994, p.7. See Sobol, Bending the Law. 1991, and Bacigal, The Limits of Litigation 1990, for extensive accounts of the proceedings from the Bankruptcy Declaration. 201 produced through its references to conflicting representations of women's sexuality, locking the image into a powerful rhetoric. The vagina had long been represented in both medical and popular discourse as a repository of disease, the source of sexually transmitted diseases, and a constant threat to male health. This is an image that is over-determined in Western culture, drawing on multiple references to women's sexuality: the vagina as a sign of woman as whore; woman as temptation to a rational disembodied masculinity; woman as the embodiment of the threat of The Fall. No-one asked how women got the diseases in the first place, and there was considerable silence about men as disease vectors. The uterus on the other hand did not belong to discourses on sexuality. It was a character in the drama of reproduction, a space for the protection and nurturing of the unborn infant, disease free, a refuge from the hostile outer world. The uterus took its value from the drama of the woman as the virgin mother; it was a sign of woman as nature, as icon of a pure and harmonious worid - the Garden of Eden before the fall, nature uncontaminated by man's technologies, woman as refuge from the harsh realities of industrialisation and competition. The metaphor of the wicking tailstring provides a bridge between these usually separated worids. It is perhaps fitting that Tatum's metaphor became the central organiser in a series of expanding alliances that eventually overpowered Robins. The manufacturer's increasingly fragile network producing the Dalkon Shield as similar to other intrauterine devices, and pelvic infection as an unavoidable risk associated with all intrauterine devices, was eventually outflanked. In the Food and Drug Administration's deliberations the Tatum study had been weak. But by the time it had become allied with a powerful law firm, thousands of company documents, punitive damage awards, the Women's Health Network, Judge Lord, the Centers for Disease Control study, Planned Parenthood, the media, Roger Tuttle, and hundreds of thousands of women claiming to have been injured by the Dalkon 202 Shield, Tatum's wicking tailstring had become strong enough to reconstruct the Dalkon Shield as a defectively designed, poorly tested device, and Robins as an almost fraudulent and certainly dishonest company. The intrauterine device controversy was closed by isolating septic abortion deaths and hospitalisations, and pelvic inflammatory disease, as specifically linked to the Dalkon Shield. Other intrauterine devices remained available as physician-recommended methods of birth control. Continued publicity throughout almost two decades of the Dalkon Shield trials ensured that there would be no returning to the days when, under Tietze's guidance, the association between intrauterine devices and infection could be confidently presented as merely an old-fashioned physician prejudice. But for the time being intrauterine devices had escaped being tarred by the brush that had seen the Dalkon Shield become the largest product liability medical malpractice case in American history. Reconstituting the intrauterine device network in response to the Dalkon Shield controversy The strategy of attributing problems with intrauterine devices to peculiarities of the Dalkon Shield's tailstring produced contradictory effects for the subject positions offered to women joining the intrauterine device contraceptive network. On the one hand the medical surveillance of women was extended. The medical gaze was no longer confined to the troublesome uterus with its constant threat of pregnancy. The attraction of intrauterine devices for population controllers was the expectation that simply by inserting a plastic device into the womb, pregnancy would be prevented, with little knowledge of cultural differences and no discussion of sexual practice. But the Dalkon Shield controversy had raised fears about pelvic infection and mid- trimester septic abortion that could not entirely be contained as a Dalkon Shield problem. Talk of three-minute insertions began to give way to 203 discussion of the need for training intrauterine device delivery program workers to take detailed sexual histories, to interrogate women about previous infections, to take swabs and culture them for signs of gonorrhoea, to counsel women on the risks associated with intrauterine device use. The definition of the group for whom intrauterine device contraception was recommended gradually shifted, away from the least educated, or young, or promiscuous woman judged incompetent to voluntarily use barrier methods or remember to take the oral contraceptive pill. The new women invited to join the intrauterine contraceptive network had to be old enough to have already completed her family, in a stable mutually monogamous relationship that did not expose her to the risk of infection from sexually transmitted organisms, willing and able to adopt the medical gaze and enter into a self-surveillence regime of medical management of her own body, and to have ready access to hospital care.97 This constitution of women in the intrauterine device contraceptive network as partners in fertility management, and not simply as recipients, also generated a discourse and practice emphasising choice. The re-evaluation of intrauterine devices following the widely publicised injury reports generated by the Dalkon Shield fiasco was in part resolved by constituting the Dalkon Shield as a defective device that increased the risk of pelvic infection and sepsis during pregnancy, but also by re-casting the decision to use an intrauterine device as a woman's personal choice. This choice was construed as a reproductive right, the right of individual women to make their own decisions about which reproductive, contraceptive, and abortion risks they were willing to accept. Accepting the risks of the intrauterine device in preference to the risks of other methods of fertility control became a matter of informed consent. International programs recommended a 'supermarket' approach to contraception which stressed the improved motivation achieved by allowing women to choose between a selection of contraceptive 97 Population Information Program, Population Reports. Series B - Intrauterine Devices. Number 5,1988; Food and Drug Administration, 'Intrauterine Contraceptive Devices', 1983. 204 technologies. I have no information on how well these recommendations are being implemented. But this strategy had the effect of enrolling consumer activist organisations, legal groups and government regulatory authorities in both the United States and in aid recipient nations, diverting their struggles about intrauterine device injuries by conceding to some of the agendas developed during the Dalkon Shield litigation - the rights of women to know about device risks, and their right to control their own bodies through processes of informed consent. Constructing Failure In this chapter I have discussed the fall of the intrauterine device socio- technical network. This was not complete because the injuries which emerged as intrauterine devices became widely used in the late 1960s and eariy 1970s were isolated as the effects of a failed intrauterine device - the Dalkon Shield. I have emphasised the negotiated character of the Dalkon Shield failure. I have shown how concerns over septic abortions and maternal deaths amongst intrauterine device wearers were gradually consolidated and gathered enough supporters to involve the Food and Drug Administration in intrauterine device surveillance. I have argued that the congressional controversy already involving the Food and Drug Administration contributed to its willingness to become involved in therapeutic device regulation. And I have shown how scientific papers, such as Tatum's Dalkon Shield wicking study, need to be interpreted as strategic interventions into particular contexts. The consensus that the Dalkon Shield was a defective device that could be held responsible for the septic abortion and pelvic inflammatory disease injuries being reported amongst intrauterine device users emerged only slowly. It was a product of the widening alliances consolidated around this position. This occurred in part in response to new studies such as the Centers for Disease Control study of pelvic inflammatory disease risk that tied 205 a large part of the increased risk amongst intrauterine device users to the Dalkon Shield. But such findings remained controversial in the scientific literature. It was their usefulness in specific institutional contexts to a wide range of groups with disparate interests that made them powerful constructors of consensus. To argue that the Centers for Disease Control Study settled the Dalkon Shield controversy would mean arguing with the benefit of hindsight, but it can be said that this was a crucial resource in the achievement of a consensus damning the Dalkon Shield, and that this consensus was achieved by the use to which diverse parties to the controversy put the study, in their particular contexts and in pursuit of their own interests. Plaintiffs suing Robins for damages were able to plug a hole with the study which had enabled Robins to avoid the charge that they had known of the wicking action of the tailstring and had decided not to take any action. Population control groups used the study to prevent the controversy over pelvic inflammatory disease from expanding to include all intrauterine devices. The construction of the Dalkon Shield as a failed and defective intrauterine device, and the long battle in the United States courts over this, a battle closely reported by the media, provided a highly charged context within which any studies of intrauterine device injuries were interpreted. The intrauterine device socio-technical network did not emerge unscathed and unchanged by this process. A decade and a half after intrauterine devices had been redeveloped as a leading contraceptive system, the outlook for the technology was no longer as optimistic as it had been in the 1960s. But the survival of this contraceptive system had been assured, at least for the time being. 206 CHAPTER 5 On medicated lUDs, technical imperatives, and the mobilisation of stronger social forces At the same time that Hugh Davis began his construction of the notorious Dalkon Shield a new generation of medicated intrauterine devices had commenced development. Copper was being added to the previously inert intrauterine device structure as an active ingredient. These devices had a small body by comparison with the Dalkon Shield, perhaps in the shape of a T or 7, wound around with copper wire providing an exposed surface from which copper ions dissolved and found their way into the uterine lining. Unlike the Dalkon Shield they were equipped with a monofilament tail-string. With names like Copper-7, Gravigard, Copper-T-200, and Multiload, these are the type of devices that grew to dominate the intrauterine device socio-technical system during the 1980s. Both in developed countries and in donor-supplied programs in developing countries, despite their increased cost of production, the copper intrauterine devices steadily replaced the inert plastic devices such as the Lippes Loop and the infamous Dalkon Shield from the mid-1970s. The development of the medicated intrauterine devices is usually understood as a natural process of product improvement, a purely technical solution to a self-evident problem encountered in device use. If the increased menstrual bleeding and cramping experienced by some women using the devices, which prompted them to request device removals, could be decreased or eliminated, then the acceptability of the devices would be improved and more women would continue with their use. The addition of copper to the intrauterine device is thought of as the outcome of an internal 207 logic of technical progress. It was simply natural for those working on intrauterine devices to look for and find means of improving their efficacy.i This understanding of Intrauterine device change is seldom made explicit but it can be inferred from the fact that the addition of copper to the plastic intrauterine device simply does not rate as a phenomenon in need of an explanation. Such a model of innovation has been dubbed by scholars of technological change the technological trajectory explanation of technological development.2 Applying this common-sense model to intrauterine devices would mean that once the intrauterine device was established as a viable contraceptive, the direction of its technical development would be interpreted as simply following a natural trajectory of device improvement. Thus, for instance, analysts might accept that United State's concerns about a 'population bomb' might have influenced the decision to develop the intrauterine device, rather than, for example, developing educational programs to dramatically increase condom use. But once the particular technological choice had been made to promote the medical Insertion of devices into the uterus to prevent pregnancy, and the networks to do so had been established, there was no longer a role for social interests to impinge on the process of device design. Social factors would no longer play an important role since product improvement would become a routine activity following an already implicit trajectory. Such a view offers a very partial explanation of the development of the copper intrauterine devices. The idea that changes in technologies are powered by self-sustaining scientific or technical principles, internal to the development process, masks the extent to which the direction and shape of technological change is influenced by the social circumstances in which it takes place. It makes invisible the socially negotiated character of the iSee Fouad Hefanwi and Sheldon Segal, Analysis of Intrauterine Contraception. 1975. 2 For a critical discussion of technological trajectories see Donald MacKenzie, Inventing Missile Accuracy. 1990, pp. 166-169. 208 'success' of changes to a technology. Furthermore, the assumption that the development of the copper releasing intrauterine devices was the outcome of a natural process of technological improvement fails to come to grips with the extent to which the specific developmental pathway, of lowering population growth by the use of intrauterine devices distributed through public health initiatives, mobilised and created groups as interested parties in sustaining the particular trajectory resulting in the copper intrauterine devices. This chapter traces the copper trajectory from the first experiments on the failure of rodent fertilised eggs to implant in its vicinity, to the virtual replacement of the inert plastic intrauterine devices with copper devices at both the domestic and international levels, and then to the court trial of the Copper-7 device that resulted in the removal of all copper intrauterine devices from the United States market and threatened their availability in many other countries. My interest is in how each twist of this developmental pathway, and indeed its constitution as a developmental trajectory, was constructed by and through the disparate interests of a variety of stake-holder communities. In other words I am interested in the copper trajectory as the highly contingent outcome of a myriad of overlapping processes of negotiation. A contingent affair: Making the copper intrauterine device 'trajectory' Jaime Zipper was a bio-medical researcher in Santiago, Chile. The Chilean Government, as I pointed out in chapter 3, was amongst the first to adopt national population control programs based on the intrauterine device.3 In addition to his involvement in developing an Intrauterine device that could be quickly and cheaply made by inserting physicians working in public clinics, Jaime Zipper had conducted a number of animal experiments testing a variety 3 The oral contraceptive pill was readily available for purchase in Chile without medical prescription, so it was the programs supplying contraceptives to the poor, who lacked the purchasing power to access the orals, that relied on the intrauterine device. B. Viel, 'Family Planning in Chile', 1967. 209 of agents for their anti-fertility effects.4 In the late 1960s cytotoxic agents including an iodide and alcohol, and the metals cadmium, copper, zinc, magnesium, silver and tin, as well as freezing were all tried in the uteri of rats for their toxic effects on fertilised eggs. Rats have more than one uterus so that by comparing implantations of fertilised eggs in the affected uteri with the insertions and implantations in untreated uteri. Zipper and his team were able to work out which substances and treatments were best at preventing the implantation of blastocysts (fertilised eggs). Zipper's experiments, funded by the Population Council, were some of the many explorations of the Council into possible interventions in the female reproductive cycle. There were, however, many problems to be overcome before a linkage between a metal such as copper and the prevention of pregnancy could be made into an effective contraceptive method. Copper might be good at inducing blastocyts to self-destruct, or at least to fail to implant, but to become an effective part of a fertility control network it had to be connected to the other parts of a complex network. Would women's bodies tolerate the copper without toxic effects, either immediate or as a result of long-term accumulation of copper somewhere in the body? What was the optimal amount of copper to use? Would government agencies involved in drug surveillance allow such a device onto the market? Would aid donors pay for the extra cost of supplying the copper-wound intrauterine devices? Would the smaller devices that could prevent pregnancy with the aid of the blastocyte-unfriendly copper reduce cramping and bleeding? It was the hope of the copper advocates that the answer to this last question would be positive. That prompted them to urge its further development within the Population Council. Many other substances tried for their effects on rat 4 J. Zipper, M. Medel, and R. Prager, 'Alterations in fertility induced by unilateral intrauterine installation of cytotoxic compounds in rats', 1968; J. Zipper, M. Medel, and R. Prager, 'Suppression of fertility by intrauterine copper and zinc in rabbits', 1969; and J. Zipper, M. Medel, L. Pastene, and M. Rivera, 'Intrauterine Instillatbn of Chemical Cytotoxic Agents for Tubal Sterilization and Treatment of Functbnal Metrorrhagias', 1969. 210 blastocytes lay dormant between the pages of journal reports. But researchers looking for a solution to the acceptability problem seized on the relatively harm-free copper as a possible solution to their dilemma. Copper required a great deal more testing, all of which cost money, but it had found someone to speak on its behalf. G. D. Searle, the large American pharmaceutical company, became the developer of a commercially viable copper intrauterine device in a three-way deal involving the Population Council and Jaime Zipper. In April 1970 Searie bought the patent for an intrauterine device wound with copper wire around a plastic stem in the shape of a 7 from Zipper and his partner Rudel for $290,000.5 The Population Council would also develop a copper device for distribution at low cost to the third world. It proved to be a profitable investment for Searle with good sales from 1974 despite a reluctant market suffering the effects of the Dalkon Shield failure. By 1979 one manufacturer estimated that the copper intrauterine devices made up over 80% of the market in the United States and Western Europe. And whilst the share of the market in the developing worid outside of China was then only 10%, this figure rose rapidly in the 1980s as United States Agency for International Development and other donor agencies began supplying increasing proportions of the copper devices.6 It was probably the failure of the Population Council's efforts to successfully introduce the plastic intrauterine devices into the fertility control programs of India, that enabled the building of a sufficiently strong alliance within the Population Council to advocate a smaller intrauterine device, one that combined the anti-pregnancy effects of a substance like copper with the physical pregnancy prevention properties of an established intrauterine devices. The intrauterine device programs in India had been implemented 5 United States District Court, Minnesota, 4th division. Esther R. Kociemba and William J. Kociemba vs. G.D. Searle and Company. 1988. pp. 5550-55501. 5 Population Information Program, Population Reports: Intrauterine Devices. 1982. pp. B-111. The estimates are from Organon. 211 without first winning the full support of the local medical profession. In other places, such as Taiwan, where the devices had been successfully introduced, the authority of the medical profession had been mobilised to counter women's fears induced by excessive pain and bleeding.7 The failure of the plastic intrauterine devices in India was always interpreted by the Population Council as a failure of the program of introduction, not of the actual technology. However, by 1969 the Population Council was forced to admit that its efforts in India had become contingent on the development of a new device. Local family planning clinics had turned away from intrauterine devices to other methods in the belief that intrauterine devices currently available were not suitable for local conditions. They made it clear that they were awaiting the design of a specifically Indian intrauterine device that would have an enhanced acceptability by reducing the troublesome side-effect of increased bleeding. The failure of the so called inert intrauterine devices in India in the context of a strong nationalist movement added pressure to any moves to develop new intrauterine devices. Whether or not the Population Council agreed with local Indian interpretations of intrauterine device 1960s programs, the promise of a new intrauterine device provided hope for a new opportunity to introduce intrauterine devices into the Indian context. Despite having scaled down its intrauterine device research program, from a peak expenditure of half a million dollars in 1965 to $130,000 in 1969, the Biomedical Division began evaluating new intrauterine devices.8 One of the devices tested was the smaller T-shaped intrauterine device, developed by Howard Tatum, then employed at the Population Council. Tatum had developed a smaller intrauterine device in the hope that it would reduce the cramping and bleeding symptoms so often given by new intrauterine device 7 See R. Somanth (ed) Intra-uterine contraceptive device. 1970. Also Laumas, K.R. 'Review of research work in India on intra-uterine contraceptive devices', 1969. A useful profile of the fate of the intrauterine device in India to 1970 is provkled by Ashok Kumar, An Overview of lUCD Studies in India. 1971. 5 Population Council, Population Council Annual Report. 1969. p. 34. 212 recipients as reasons for requesting that the devices be removed. But the T- shaped intrauterine device had failed to achieve satisfactorily low pregnancy results. In 1969 the Population Council decided to clinically trial a device that combined Tatum's device and the copper wire that Zipper's animal tests had shown to be effective at preventing pregnancy. The search for a device that would enhance continuation rates was redirected, away from the endless trials testing variations in shape towards the development of chemically enhanced intrauterine devices.9 Within twelve months, trials under-way in the United States, Canada, and Chile had produced data which confirmed that the devices performed as well as currently marketed devices according to the now well standardised Tietze criteria. Zipper and Tatum claimed a drop in pregnancy rate for the T device from 18% without the added copper to 1 % for the new copper enhanced intrauterine device. They also proved to have a better than usual acceptability, as measured by the continuation rate, not always when all women using copper devices and plastic devices were compared, but more consistently when women with no children or only one child were compared.io The Indian experience with the first generation of intrauterine devices might have prompted the research direction which led to the development of the copper intrauterine device. However, the ongoing decisions required to constitute the copper 'trajectory' were also partly aimed at the pursuit of important Population Council institutional objectives. The development of the copper intrauterine device provided opportunities for both 'basic' animal and human reproductive research, and 'applied' biometric product assessment in 9 Tatum, H.J. and Zipper, J.A. Proceedings of the IV Northeast Obstetrical and Gynecological Congress of Brazil. 1968. Also Population Council, Population Council Annual Report. 1969. p. 36. 10 Population Council, Population Council Annual Report. 1971 . p48. Zipper, J., Medel, M, Segura, and L. Torres, 'Biotogical Action of Copper. Development of a New Type of Intrauterine Contraceptive, Cu-7'; Zipper, J., H.J. Tatum, L. Pastene, M. Medel, M. Rivera, 'Metallic copper as an intrauterine contraceptive adjunct to the "T" device,' 1969. For a summary of data and further references to 1980 see Population Information Program, Population Reports: Intrauterine Devices 19RP 213 clinical trials. In 1966 the Population Council greatly expanded its laboratory facilities so that by 1971 it housed in a new building twenty-nine labs, fourteen animal rooms, radio-immunoassay and radio-chemistry facilities, an electron microscopy lab, and a large primate colony.n It had become one of the largest research facilities in the field of reproductive biology. This facility was expanded and its linkage of reproductive biology to contraceptive end- products was given added emphasis by the establishment of the Intemational Committee for Contraceptive Research In December 1970. This committee put the Rockefeller University facility at the hub of a laboratory network which stretched from Santiago, Chile, to Helsinki, Finland. 12 The introduction of a substance that was released from the intrauterine device into the body provided many opportunities for basic physiological and animal research. The internal commitment of the Population Council to the development of a copper releasing intrauterine device can partly be accounted for by the capacity for such a decision to mobilise support from both 'pure' and 'applied' researchers. The development of a copper-releasing intrauterine device was a project through which the practical know-how of the Population Council's new laboratory facilities could be combined with the skills of the clinical trial statisticians to develop a new intrauterine device. The development of the copper intrauterine device was given further impetus in the early 1970s when shifts in United States domestic birth control politics refocused attention away from lowering the number of births in poor families and towards the problem of teenage pregnancy. In 1972 the Population Council received a major grant from the National Institute of Child Health and Human Development of the United States Department of Health, Education and Welfare. The Population Council immediately increased its commitment to the biometric evaluation of the copper intrauterine device. The 11 Population Council, Population Council. Annual Reports. 1971. 12 Populatbn Council, Population Council. Annual Reports. 1970. pp. 45-54. 214 multinational intrauterine device trials of the copper devices, commenced in 1971, were greatly expanded. Two models of the Copper-T, the Copper-7, the Dalkon Shield and two models of Lippes Loop were included in the trials. The new copper intrauterine devices began to circulate in Argentina, Brazil, Canada, Chile, Egypt, Finland, India, Israel, Kuwait, Mexico, the Philippines, Sweden, Tunisia, the United States and West Germany.i3 Why did the U. S. Government back the copper intrauterine device? To make sense of this government interest, it is necessary to take account of the shifting perceptions amongst politicians of the nature of the domestic population crisis. Constance Nathanson has recently argued, in an important account of the constitution of adolescent sexuality as a problem in the United States, that from the late 1960s American administrators began focusing their attention on a newly perceived object of crisis, teenage pregnancy. 14 This was a shift from the concerns of eariier contraceptive advocates whose major object of concern was the fertility of the poor, and particularly of Afro- Americans. Domestically, the advocates of intrauterine devices had contributed to campaigns which highlighted the problem of the high fertility amongst the poor, positioning intrauterine device technology as the best solution for lowering the number of births to poor families, thereby reducing the supposed over-burdening of such families with large numbers of children. It was for this group, American multiparous women, that is women who had already given birth to children, that Tietze's Cooperative Statistical Program for the evaluation of Intra-Uterine Contraceptive Devices, run from 1963 to 1969, had produced statistics rendering the intrauterine device an effective contraceptive. 97% of the women participating in the cooperative statistical 13 Population Council, 'Report of the Biomedical Division', Population Council. Annual Reports. 1972. 14 C. Nathanson, Dangerous Passage: The Social Construction of Sexuality in Women's Adolescence. 1991. 215 program had given birth to at least one child.i5 Such good data had not been stabilised for never pregnant women (nulliparous) women. Indeed Tietze cautioned against using intrauterine devices for women who had not been pregnant, pointing to low rates of acceptability due to poor tolerance of bleeding and pain. This may not have been a problem, except that by 1972 it was, as Nathanson points out, no longer poor women but teenage pregnancy that had come to be defined as a priority for United States contraceptive programs. In brief, Nathanson, I think most perceptively, argues that within the particular political context of Nixon's anti-welfare, economic rationalist policies, teenage pregnancy, which had long been a local problem for family planning clinics, became linked to a whole series of local problems until it took on the dimensions of a national crisis. Nixon's second term presidency beginning in 1972 marked a shift in political coalitions away from the use of government funds to solve social problems. Announcing a reassertion of conservative values Nixon campaigned against 'wasteful and intrusive social programs which rewarded the indolent while taxing the energetic'. 15 Family planning services were directly affected by Nixon's dismantling of social welfare programs. In this political climate concerns about teenage pregnancy, which had long existed within family planning organisations, took on a new force at the core of campaigns for funds for the regulation of fertility. Nathanson argues that such campaigns captured widespread public concern about the changing roles of women. Fears of social disintegration, fuelled by vigorous street-campaigns for black rights, withdrawal of United States troops from Vietnam, and women's liberation were frequently expressed as a deeply felt crisis over the sexuality of young white college girls. Teenage pregnancy, says Nathanson, expressed the fears of dominant social groups that society 15 C. Tietze and S.L. Tietze, 'Evaluation of the Intrauterine Device: Ninth Progress Report', 1970. pp. 3-4. 15 C. Nathanson. Dangerous Passage: The Social Construction of Sexuality in Women's Adolescence. 1991. See chapter 3. 216 as they knew it was disintegrating in their own white, middle-class backyards. 17 Planned Parenthood attempted to mobilise such public sentiments to win continued support for birth control programs. It was, I believe, no accident that when the Population Council launched its United States trial of the copper intrauterine device its protocol declared that this intrauterine device was thought to be suitable for women who had not born children.18 These nulliparous women were included in the clinical trials. By 1972, the developers of the Copper-7 were reporting that its ease of insertion and high retention rates amongst nulliparous women made it 'particularly suitable' for this group of women, for whom many physicians had decided intrauterine devices were unsuitable.i9 It was not an accident that in 1972 the Population Council received a major grant from the National Institute of Child Health and Human Development towards the development of its copper Intrauterine devices. The Population Council actually remained ambivalent about the copper intrauterine device. It was promoted as an alternative to the Lippes Loop and the 1960s intrauterine devices, but its extra cost was seen as an obstacle for fertility control efforts with minimal total expenditures on the health of women and children, and studies on the comparative reductions in requests for removals had not always been as promising as expected.20 Nevertheless, by the time the Dalkon Shield began to be publicly called to account by the Food and Drug Administration, the copper intrauterine device was well along the path of development. The development of the copper intrauterine device took place against a field of overlapping but unconnected events and relationships: the Indian demand for a contraceptive developed for them; the bureaucratic 17 C. Nathanson. Dangerous Passage: The Social Constmction of Sexuality in Women's Adolescence. 1991. Summarised from chapter 2. 15 H. Tatum, The Copper T: Investigators Manual, undated. 19 W. C. Stewart, Y, Gibor, L. Deysach and C. Nissen, Clinical Studies with the Cu-7', 1972. 20 For example, see I. Sivin, 'A comparison of the Copper T-200 and the Lippes Loop in four countries', 1976. 217 politics within the Population Council which sought to link pure and applied researchers, and researchers at its New York laboratories with researchers in its target countries; shifts in United States domestic policy that catapulted a new object of interest into the public arena, the teenage pregnancy; and the public Interest in the deaths and injuries resulting from the use of the Dalkon Shield intrauterine device. These could all be interpreted and deployed by participants to enhance the strength of the copper trajectory. The networks created by the Population Council and other intrauterine device advocates in the 1960s were constitutive of social groups who looked to improvements in intrauterine device acceptability rates, particulariy through reductions in the likelihood that women users would experience pain or bleeding during the eariy months following insertion, as the means of solving perceived social problems such as overpopulation and teenage pregnancy. However, the copper trajectory could have soon met with a sudden end when it became the first intrauterine device to be subject to the strict criteria for drug testing by the United States Food and Drug Administration. In 1971 the first plans for marketing a copper releasing intrauterine device in the United States were seriously set back when the Food and Drug Administration classified the device not as a therapeutic device, as had been the case with previously marketed intrauterine devices, but as a drug requiring premarket approval. A potential enemy is converted into an unexpected ally : The Food and Drug Administration and making the copper intrauterine devices government approved drugs At the end of the 1960s the prestige of the Food and Drug Administration was high. It was widely perceived as having protected the American public from the thalidomide tragedy that had shocked the worid.21 The Food and Drug Administration was first instituted in response to public 21 The Sunday Times Insight Team, Suffer the Children: The Story of Thalidomide. 1979. 218 protest over unsanitary conditions in the food industry in 1906. In 1938, under the Food, Drug and Cosmetic Act, the Food and Drug Administration was given responsibility for the enforcement of mandatory premarket testing for safety for all drugs. This act was passed in response to a public outcry over the Elixir of Sulfanimide calamity in which a drug manufacturer used a toxic component found in antifreeze as a solvent. 93 people died. Legislators, concerned to omit certain 'quack contraceptives' and routine aids to hospital procedures from the provisions of the act, provided for the exemption of therapeutic devices from requirements for premarket testing.22 This neglect of the therapeutics area remained unchanged when the law was again altered in 1962 following the thalidomide tragedy, this time to require drug manufacturers to provide evidence of efficacy.23 The Food and Drug Administration could only take action on therapeutic devices when mislabelled or dangerous devices were involved in interstate commerce. Under these powers the Maijzlin spring intrauterine device was seized. But such actions were difficult to uphold in court.24 More often the Food and Drug Administration resorted to pressuring industry to withdraw hazardous devices by threatening adverse publicity, as they did in the case of the Dalkon Shield. The postwar years had seen an explosion of the use of therapeutic devices in medicine. Public concem about the lack of effective regulation of such devices was aroused over an incident involving the supply of faulty heart valves. Political pressure for law reform to improve the power of the Food and Drug Administration to control medical devices was mounting by the end of the 1960s. The Cooper report of 1969 was one outcome of such pressure.25 The Fountain hearings, which heard evidence against the Dalkon Shield in 22 L.D. Rish, 'Federal Control of Bio-medical Instrumentation', 1972. 23 s. H. Patton, 'Consumer Protection and the Medical Device Amendments: Assessing the Gains', 1979. pp. 525-530. 24 Cooper Committee US Department of Health Education and Welfare, Medical Devices: A Legislative Plan. Study Group on Medical Devices. 1970 25 D.M. Link, 'Cooper Committee Report and Its Effect on Current FDA Medical Device Activities', 1972. 219 1973 and resulted in new therapeutic device regulation legislation being drawn-up, was another.26 it was not until 1976 that new laws were actually enacted.27 But throughout this period the issue of medical device regulation and the possible consequences of lack of regulation were subject to considerable public attention.28 The Dalkon Shield scandal ensured that intrauterine devices played a prominent role in the debate. An effect of the publicity over the Dalkon Shield litigation as it dragged on from the 1970s and through the 1980s was the production of new activist groups, outside the ranks of health professionals, antagonistic to, or at least suspicious of, intrauterine device safety claims. Women's health groups and health consumer watchdog organisations were changing the nature of the relationship between doctors and their patients. The technocratic rhetoric of balancing risks and benefits which dominated both the medical profession and the Food and Drug Administration was questioned by groups who pointed to the seriousness of the injuries suffered by intrauterine device users and the devastating effects such injuries had on their lives. The Boston Women's Health Book Collective, women's health campaigns that had campaigned against the inadequate testing of the oral contraceptives, Nader-style consumer groups such as the Health Research Group of Public Citizen, and later the National Women's Health Network were some of the health activist groups that organised interventions into the intrauterine device socio-technical network at both national and international levels.29 26 L.D. Rish, 'Federal Control of Bio-medical Instrumentation', 1972. pp. 423-424. 27 A detailed discussion of the operation of the 1976 Act over the next decade is provided by J.S. Kahan, Esq., 'Medical Device Reclassification: The Evolution of FDA Polrcy', 1987. 28 For an excellent discussion of how the congressional amendments intended to increase public accountability became administered in a manner that betrayed this goal, reinstating a decision making model that relied on expert authority exercised behind closed doors, see R. Leflar, 'Public Accountability and Medical Device Regulation', 1989; and R. Adier, Esq., 'The 1976 Medical Device Ameridments: A Step in the Right Directksn Needs Another Step in the Right Direction', 1988. 29 For a brief history of the Boston Women's Health Book Collective from 1969-1979 see W.C. Sanford, 'Woridng Together Growing Together*, 1979; and B. Beckwith, 'Women's Health Book Collective: Women Empowering Women', 1981. On the pill see B. Seamen, The Doctors case against the pill. 1969. 220 Activist groups were concerned with the specific problems with the Dalkon Shield but they were also interested in more general questions concerning intrauterine device safety and regulation. They demanded that devices be treated like drugs and subject to the same standards of safety and efficacy testing. Many groups participated in public hearings leading to the 1976 amendments of the Food, Drug, and Cosmetics Act.3o Activist organisations lobbied for more stringent safety testing of intrauterine devices.3i The Food and Drug Administration was taking action to improve its monitoring of the device area by reclassifying some of the more invasive or potentially dangerous devices as drugs. In 1968 and 1969 these rulings were upheld In court. The Supreme Court ruled that whenever the protection of the public health was warranted then the Food, Drug and Cosmetic Act of 1938 should be liberally interpreted. The court interpreted the word drug, used In the act, as a term of art, that therefore could be construed broadly because the act had an overriding purpose to protect the public health.32 Not surprisingly, given these recent legal decisions and the extent of political scrutiny of its operations in the device arena, the Food and Drug Administration, confronted with a proposal to market a copper intrauterine device in the United States in 1971, notified the manufacturer that this intrauterine device would be classified as a drug. It was not the Population Council but the pharmaceutical company Searle, which had been working to develop the Copper-7, that first submitted its proposal to the Food and Drug 30 See for example: Testimony of Sidney M. Wolfe and Anita Johnson, Health Research Group (Public Citizen) Before House of Representatives Health Subcommittee, October 23, 1973 on Medical Device Legislation; Letter from Anita Johnson to FDA Commissioner, January 28,1975: Request for all lUDs to be declared drugs; both from the archives of the Sidney Wolfe Public Citizen Health Research Group, Washington D.C. 31 See for example, Citizen Petition to FDA Hearing Clerk, March 1,1983, Attachment on Contraceptive Intrauterine Devices: Calls for implementation of mandatory premarket approval applicatbns for all intrauterine devices currently mari Administration.33 Designating the copper intrauterine devices as drugs, rather than devices, meant that, unlike the distributors of the plastic multishaped intrauterine devices, Searle would be put to considerable expense, both in dollars and time, to gather together and submit all the evidence required by the Food and Drug Administration to routinely scrutinise new drugs for safety and efficacy. But Searie was a large pharmaceutical company with both the financial resources and the in-house expertise required to put together a new drug marketing application to the Food and Drug Administration, and so it was able to proceed with its plans to develop and market the Gopper-7 in the United States. And, once approved, the requirement that other copper device manufacturers would have to jump the hurdle of Food and Drug Administration premarket evaluation, which required them to conduct proper clinical trials as standardised by Tietze, would work in Searle's favour. Searle went ahead with its multicentre clinical trials involving 16,000 women. In addition, the Food and Drug Administration required Searie to present evidence that copper was not toxic when it was absorbed by the uterine tissues, and that it was neither carcinogenic nor harmful to the foetus. The Food and Drug Administration used Tietze's procedures for the conduct of clinical trials as a yardstick for assessing the validity of clinical trial data. Animal studies on toxicity, carcinogenicity and effects on foetal development were routinely required of new drug applications. Searle obtained much of this information from the Population Council. In 1974 Searle was granted market approval by the Food and Drug Administration.34 A vigorous marketing campaign, coinciding with the withdrawal of the Dalkon Shield from the American market, led to the Copper-7 rapidly becoming commercially successful. By 1976 a commercial version of the Copper-T had also been approved by the Food and Drug Administration. 33 Food and Drug Administration, 'Summary of the Basis of Approval for NDA 17-408 from R.D. Searie Laboratories for Cu-7', 1974. 34 Food and Drug Administration, 'Summary of the Basis of Approval for NDA 17-408 from R.D. Searie Laboratories for Cu-7', 1974. 222 Responding to fears about intrauterine devices generated by the Dalkon Shield withdrawal, intrauterine device usage began to decline after 1973, but it was the copper intrauterine devices which quickly came to dominate the remaining market.35 The approval of the Food and Drug Administration had become an asset. As the Dalkon Shield court cases continued to generate publicity about an unscrupulous company's failure to properly test the safety of a potentially lethal device, manufacturers of copper intrauterine devices were able to point to Food and Drug Administration approval as evidence of thorough testing for safety and efficacy. The Food and Drug Administration's involvement was perceived as that of an impartial judge whose sole interest was the protection of public safety. It is remarkable that at a time when physician intrauterine device prescribing practices were becoming more cautious, Searle managed to open up a new market previously considered as attenuated by too many risks. Young women who had not yet had children became one of the main targets for marketing this new smaller intrauterine device. Here was a device which could prevent pregnancy, but which avoided the scary symptoms of cramping and bleeding of which so few young women had been tolerant. This was seen to be an ideal device for enticing the young woman, who had not yet given birth, into the intrauterine device contraceptive network. Increasingly it was these women who were the subjects of contraceptive delivery programs. 40% of Searle's market were young, nulliparous women, and by the late 1970s the copper intrauterine devices had captured almost all of the United States domestic market. This occurred despite the need for the devices to be replaced more often as the copper wore out.36 From the mid-1970s, however, manufacturers and the Food and Drug Administration had to grapple with the increasingly vigorously pressed 35 L. G. Kieth and G.S. Berger, 'lUDs and Family Planning in the United States', 1980. 35 Population Informatbn Program, Population Reports: Intrauterine Devices. 1982. 223 epidemiological findings that linked intrauterine devices with pelvic inflammatory disease. It was pelvic inflammatory disease and its serious consequences both to health and fertility that was increasingly claiming media attention, focused on the Dalkon Shield litigation, as more and more women's stories of pelvic Inflammatory disease and infertility caused by the Shield emerged. Groups such as the National Women's Health Association transferred discourses on population risk into a discourse of personal risk, publicising individual women's stories of pain, suffering and infertility. What healthy woman, they asked, with other options available for contraception, and other lifestyle choices available for delaying family formation or spacing children, would choose to have inserted into their uterus a time bomb which could arbitrarily 'explode' causing health deterioration that could ruin their lives? Any risk at all of this occurring was too high.37 The epidemiological studies, which attempted to determine the risk of pelvic inflammatory disease associated with intrauterine device use, varied considerably across studies. As I pointed out in chapter 4, the United States Women's Health Study found that amongst 4,900 women, intrauterine device users had a 1.6 times greater chance of having pelvic Inflammatory disease than women who did not use contraceptives, although the risk for intrauterine device-using women under 25 was higher.38 Vessey's large cohort British study found that intrauterine device users had a 2.5 times greater risk of pelvic inflammatory disease than non-users.39 A Swedish study involving only laparoscopically verified pelvic inflammatory disease had found a 3-5 times 37 Interview with Sybil Shainwald, former worker with Women's Health Network, July,1991. 38 Burkman, R.T. and Women's Health Study, 'Association between intrauterine device and pelvic inflammatory disease', 1981. A 4.5 times increase was found when compared with pill users. This proved difficult to grapple with and was interpreted by some to mean the the pill conferred a protective effect against pelvic inflammatory disease on its users. 39 M.P. Vessey, D. Yeats et al., 'Pelvic Inflammatory disease and the intrauterine device", 1981. 224 greater risk of pelvic inflammatory disease amongst intrauterine device users, with a 7-fold greater risk for those women who had never been pregnant.4o Such epidemiological studies did not provide groups with a window onto how to best ensure the health of women. Rather activist groups and family planning networks construed the meaning of the epidemiological studies in contradictory ways that mirrored their pre-existing commitments and goals, bringing to their reading of the studies the interested social positions in which they were located. Activist groups did not demand the total withdrawal of intrauterine devices. The National Women's Health Network concentrated their efforts on having the Dalkon Shield recalled worldwide, differentiating what was widely accepted to be a criminally faulty device from Food and Drug Administration approved intrauterine devices.4i The Boston Women's Health Book Collective was publicising the safety problems of all intrauterine devices, declaring that women using the devices were between three and five times more likely to develop pelvic inflammatory disease and that infections could spread more rapidly and further, probably being more likely to cause damage to the tubes and infertility.42 However, along with the Public Citizen Health Group the only action taken in response to the epidemiological studies was to demand that all intrauterine devices be subject to premarket approval and that manufacturers be required by law to provide consumers with full information on safety and efficacy.43 40 L.Westrom, L.P. Bengstson, and P. Mardh, 'The Risk of Pelvic Inflammatory Disease in women using intrauterine contraceptive devices as compared to non-users,' 1976. Pelvic inflammatory disease was difficult to diagnose so that laparoscopic verifkiatbn strengthened the ability of the study to silence intrauterine device protagonists who accused medical practitioners of over-diagnosing pelvic inflammatory disease in intrauterine device users; according to intrauterine device protagonists, practitbners were inclined to overdiagnose pelvic inflammatory disease in intrauterine devbe users, their judgement having been shaped by the glare of Dalkon Shield publbity. 41 National Women's Health Network Advocacy for Dalkon Shield Victims, undated document from NWHN. Despite the withdrawal of the Dalkon Shiekl from the US market in 1974, this recall did not occur until 1984 and efforts to have it implemented revealed weaknesses in FDA powers concerning recall. 42 Boston Women's Health Book Collective, The New Our Bodies Ourselves. 1984. 43 Citizen Petition to FDA Hearing Cleric, March 1,1983, Attachment on Contraceptive Intrauterine Devices: Calls for implementation of n^ndatory prerrwrket approval applications for all intrauterine devices currently mari Population statistics indicating that pelvic inflammatory disease occurred about fifty percent more often in intrauterine device users than in women using no contraception also came to be accepted by family planning experts.44 International population programs responded to these epidemiological studies by calling for better selection of candidates for intrauterine devices, in an attempt to eliminate women with high exposure to sexually transmitted diseases which they interpreted as accountable for much of the pelvic inflammatory disease. Young women in particular were to be carefully counselled of the risks of pelvic inflammatory disease, the possible consequence of infertility, and their increased risk from sexually transmitted diseases. And increased public health support was recommended so that women experiencing serious difficulties with intrauterine devices, such as pelvic inflammatory disease and ectopic pregnancy, could access medical services.45 Manufacturers distributing copper intrauterine devices in the United States also responded to the concerns being raised about the higher risks of pelvic inflammatory disease for intrauterine device users. From 1970 the Food and Drug Administration required, and scrutinised, package inserts that would be supplied with the devices and provide direct information to consumers. The courts also contributed to this shifting emphasis on patient information. Litigation over intrauterine devices was challenging the protection provided for pharmaceutical companies by the learned intermediary doctrine. Many drugs were recognised by the courts as being unavoidably unsafe. A rabies vaccine for example, in rare instances, can lead to very damaging consequences. But this high risk of damage to certain Individuals occurs in only a few patients, Committees on Obstetrics and Gynecology, Second Report on Intrauterine Contraceptive Devices. 1978. 44 Population Information Program, 'Intrauterine Devices', 1982 45 Populatbn Information Program. Population Reports: Intrauterine Devices 1979.Population Information Program, Population Reports: Intrauterine Devices'. 1982. See also J.H. Sullivan, 'Internatbnal population control: Alternative U.S. responses in the coming decade, 1978; and J.T. Speidel and R.T. Ravenholt, 'Worid experience with use of lUDs', 1980. 226 with most patients avoiding both the dire consequences of rabies and the vaccine-induced reaction. The manufacturer would be required to warn the physician, the learned intermediary, but not to directly warn the patient of these occasional bad reactions, and since the product Is not defective, merely unavoidably dangerous, would not be held liable for instances where its use proved dangerous. As consumer groups repeatedly pointed out, and courts began to rule, an intrauterine device was not like a rabies vaccine because patients having them inserted were healthy women who would not suffer any health deterioration without one.46 By 1977 Searle had moved to up-grade its information for both doctors and women consumers. Doctors were notified that there was an increased risk of salpingitis (infection of the tubes) amongst intrauterine device users and that the greatest risk was for young nulliparous women or women with multiple sex partners, although doctors were not warned against using the devices with this group of women. It recommended that patients be taught to look for symptoms and that the decision to use a Gopper-7 should be made by the physician and patient together.47 Patient brochures repeated this information, although it would be some time before such brochures became consistently available.48 What I have tried to stress in this section is that the uptake of a new technology in society is not a simple matter of diffusion. It is not only the design or research and development phase of technological change that is shaped by social interest groups and constituted through the somewhat arbitrary practices brought together in laboratories and test sites. The in-use- phase of contraceptive development can bring about some unexpected translations. The copper intrauterine devices were transformed during the clinical trial phase and consequently in-use into the ideal contraceptive device 46 For an introduction to these issues see V. Castleberry, 'Hill v Searie Laboratories: The Decline of the Learned Intermediary Doctrine in Favour of Direct Patient Warnings of Drug Product Risks', 1990. 47 Searle Laboratories, Detailed Product Information for the Cu-7 intrauterine copper contraceptive. 1977. 48 Searie Laboratories, For the Patient. Cu-7 intrauterine copper contraceptive. 1977 227 for the new targets of contraceptive providers, young women. Moreover, women of all ages in the United States were confronted with a range of choices about contraceptives, both in public programs and through private consultations with medical practitioners. To both women consumers of contraception and their advising physicians, the Food and Drug Administration's endorsement of the new copper intrauterine devices was an influential factor in shaping choices about what intrauterine device to use, particularly given the climate of distrust of intrauterine device development generated by the Dalkon Shield litigation. But the involvement of the Food and Drug Administration in the intrauterine device socio-technical network brought with it its own agendas and through it, a govemment agency, the agendas of well organised lobby groups. A decade after the copper intrauterine devices became available on the market the initial enthusiasm for the use of the device in populations of young women had been modified, with the recipients of intrauterine device contraception increasingly defined as active participants in the choice of a suitable contraceptive, and doctors charged with ensuring that devices were not supplied to candidates with lifestyles that exposed them to high risk of infection from sexually transmitted diseases. The Food and Drug Administration/copper intrauterine device socio-technical collectivity in court Consumer litigation lawyers had at first focused all their attention on the Dalkon Shield. But consumers with complaints of injuries caused by intrauterine devices frequently did not know which intrauterine device had been inserted. By 1980 copper intrauterine devices were found to be causing the reported injuries in about half of the women seeking legal assistance.49 By the 1980s, lawyers found themselves with the complaints, the expertise, and the resources to focus attention on other intrauterine devices, in addition to 49 JT. Zackey, 'The Copper-7 - A New lUD Risk',1980. 228 the Dalkon Shield, that consumers claimed to be causing injuries. The Copper-7 was put on trial. Up until 1986 Searle managed to defend its claims about the Copper-7 in court. Of 1300 lawsuits filed by consumers claiming injuries, most had been dismissed or settled out of court, leaving 470 cases pending. Of the 18 cases that had gone to court Searle had won 15. But in October 1985 Searie was taken over by Monsanto. The flood of litigation and the refusal of the insurers to renew their liability cover prompted a reassessment of its involvement in the United States intrauterine device market.5o in January 1986 Searle withdrew the Copper-7 from sale in the United States. The company blamed the escalating cost of defending Increasing numbers of product-liability law suits and declining sales.5i The Copper-7 remained on the market overseas and the Food and Drug Administration continued to give it their support. In 1988 the Minnesota law firm of Robins, Kaplan, Miller and Giresi took a Copper-7 injury claim to court for Esther Kociemba that would re-open the Food and Drug Administration/Searie alliance that had stabilised safety claims for the Gopper-7 for over a decade. Kociemba claimed her infertility was the result of damage to her tubes caused by Searie's copper intrauterine device. She sought compensation for the manufacturer's negligence in failing to adequately test the safety of the device; her husband claimed compensation for lack of consorting. This case was the first copper intrauterine device trial to be backed up with a thorough search of the manufacturer's internal documentation of its clinical trials and marketing experience with the Copper-7. Robins, Kaplan, Miller and Giresi had won an early Dalkon Shield product liability suit which Included a considerable sum awarded as a share of punitive damages. They also had the experience of winning access to and uncovering critical documents in company files 50 Ellis, 'Monsanto and the Copper-7', 1988. 51 M. Brody, 'When Products turn into Liabilities', 1986. Grant, The Selling of Contraception. 1992, pp.146-147. 229 following such involvements in the difficult and drawn out litigation over document recovery in the Dalkon Shield case. With both the experience and sufficient resources to invest in the costly exercise of document searching, the Minnesota law firm had turned Its attention to Searie's files. Rather than hoping for quick settlement of Copper-7 cases through the charge of negligence, and relying on Searie's poor representation in court, Robins, Kaplan, Miller and Gerisi set out to demonstrate the manufacturer's strict liability, systematically demonstrating that this was not a reasonably safe and well trialed device, and that Searle knew this to be the case. Robins, Kaplan and Giresi won Esther Kociemba's claim, that Searie's negligence had directly caused her infertility, by linking these internal documents and interviews with Searie employees about company conduct to claims that characterised the company as showing disregard and wilful indifference towards the safety of its consumers. The Minnesota court awarded $7 million in punitive damages against Searle for corporate misconduct. As a result, all United States manufacturers withdrew their intrauterine devices from the United States market.52 Courts and science are perhaps on a par when it comes to institutions to which western society allocates the task of determining the truth. In a trial such as those involving the Dalkon Shield and the Copper-7, the authority we invest in each of these institutions interacts in complex ways. It would be a mistake to take the findings of the court as providing a privileged insight into the truth, except in the sense that the repercussions of court findings in society do indeed privilege court outcomes. Rather, I propose to view the court simply as another site for the construction of what comes to count as objective knowledge about the performance of intrauterine devices, in this case the Gopper-7. In other words, alliances which had previously proved sufficiently robust to harden Searle's claims, about the safety and efficacy of 52 Hamilton and Carson, 'Searie's Troubles Give Alza Its Big Break', 1986. 230 the Copper-7, into facts were subject to processes of deconstruction and reconstruction in the court hearings. During the Kociemba trial the jury was presented with evidence to support three crucial claims aimed at re-characterising the Gopper-7 as defectively designed and defectively manufactured, and at constituting Searle as having failed in its duty to test and having conducted itself unreasonably in its failure to warn. First, the Kociembas' lawyers claimed the eight-year study of 16,000 women begun by Searle in December 1970 had been inadequately designed. Second, they argued that the company had suppressed information about the risks of pelvic inflammatory disease amongst nulliparous women, a large segment of Searle's market. Third, they attempted to reconstruct the Copper-7 as a defective device, a device which was not designed to be as safe as available testing would have permitted, and which could have been designed differently, achieving the same effect with lesser risk. 53 The clinical trials of the Copper-7 on trial The Kociembas' first claim, that Searle's clinical trials of the Copper-7 had been minimalist and poorly designed, relied on accepting the Population Council protocols for intrauterine device testing as the standard against which test adequacy could be measured. Data was collected during intrauterine device clinical trials by having participating physicians send in follow-up forms when the women enrolled into the trials returned to the clinic for scheduled follow-up visit. These forms allow the clinical trial investigator to construct life- table event rates which calculate the risk of women leaving the study for a range of events. The Kociembas' lavyyers charged that Searle did not design its follow-up form to solicit information on removals for pelvic inflammatory disease.54 Removals for pain, bleeding, and involuntary pregnancy simply 53 Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, Civil File No. 3-85-1599, United States Distrbt Court, Distrbt of Minnesota, Fourth Division Ciresi's final statement to the jury, Vol. XXXVI, August 25,1988, pp.5477-5600. 54 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiff v. G.D. Searie & Co. Defendant,1988. pp.5555, 5563. 231 required the participating health worker to tick a box on the form. Some doctors wrote comments on the forms indicating that removals had occurred because of symptoms of pelvic inflammatory disease. But these handwritten comments were often difficult to interpret.55 As one of the internal analysts had complained in an internal Searle memo written in April 1975, 'little side- effect information is asked for'.56 Government regulators assessing the data from the Copper-7 trials were not unaware of the mounting concerns about pelvic inflammatory disease. When asked for information about pelvic inflammatory disease, Searle supplied a figure analysed from its study begun in 1971 of a pelvic inflammatory disease incidence of less than 1%.57 Almost fifteen years later the Minnesota court was to hear that Searle's design protocol was inadequate to supply valid data on pelvic inflammatory disease rates amongst trial participants. Whilst participating physicians were carefully instructed through the Investigator's Manual in the diagnosis of pregnancy, they received no information defining pelvic inflammatory disease or on its diagnosis.58 Indeed the first time that Searle conducted a trial in which pelvic inflammatory disease was coded for on the follow-up form, was in the eariy 1980s when it tested a new product, a slightly smaller version of the Copper- 7. The calculated pelvic inflammatory disease risk based on trials in Brazil was a very high 6.9%. The Minnesota jury also heard evidence that the clinical trials of the Gopper-7 included many months of assumed trouble-free intrauterine device use that had been contributed by participants who had actually been lost to follow-up. Searie had no clear way of dropping women from the trial who had not returned for their follow-up visits. A woman inserted with an intrauterine 55 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5563. 56 United States District Court, District of Minnesota, Fourth Division , Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988,.pp. 5556. 57 Rodney P. Gwinn of G.D. Searie, Memorandum on Pelvic Inflammatory Disease to All U.S. Searie Representatives', June 4,1979. 58 United States District Court, District of Minnesota, Fourth Division , Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5554-5555. 232 device could have moved to a different state where she may or may not have been facing all kinds of problems caused by her intrauterine device; the clinic conducting the trial would never know, but Searle continued to include this woman's experience as trouble-free. This was a problem belatedly recognised by Searie's researchers. An internal company memo, dated October 1975, submitted to the court stated that the life table program counts cycles of experience to the date of the drop or to the date of the report...this counts many unknown cycles of experience as successful cycles. I'm trying to have the program altered, such that patients who are overdue will only be credited with three cycles in addition to that accumulated off the last visit.59 Michael Giresi, a lawyer for the plaintiffs, used the memo to show the sloppy design of Searie's trials when compared with knowledge at the time of how such tests should be conducted. Searie's trial drop-out rate was further evidence that the Copper-7 testing did not measure up to the standards of practice institutionalised by Tietze in the 1960s. Searle's trial drop-out rate in the Copper-7 study was over 15%.6o Tietze had recommended that cases lost to follow-up should not exceed 10%. If too many women participating in the trial inexplicably disappear then opponents can question the validity of the data by questioning the unknown status of these women. Tietze recognised that it was inadvisable to assume that the experience of such intrauterine device users was the same as that of women who continued their contact with the clinic. Perhaps they had failed to return for follow-up because they were dissatisfied with the heavy bleeding or pain brought on by wearing an intrauterine device, and so had gone to another doctor likely to be more sympathetic to their request for removal. Moreover, argued the lawyers for the Kociembas, if participants counted out of the trials due to requests for removals either for 59 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5561. 50 United States Distrbt Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5560-5563. 233 medical or non-medical reasons are also considered, the proportion of women no longer being followed at the end of three years jumps to 44%. Thus, nearly half of the women who used a Copper-7 in the study were not followed for three years, and there was no knowledge of outcomes for this group, of infection rates or fertility.6i The line of argument that pharmaceutical companies were more interested in profits than in the proper conduct of clinical trials was a familiar theme from the Dalkon Shield trials. It was this that the Food and Drug Administration surveillance and regulation of therapeutic devices was believed to be guarding against. Searie denied the charges of improper conduct. In the hands of the prosecuting lawyers internal documents revealing the messiness of scientific testing were mobilised to support claims of sloppiness and an uncaring attitude. 52 The Food and Drug Administration had examined only those documents submitted to it by Searle and, according to Giresi, made its decision to approve the Gopper-7, its first approved intrauterine device, as much on the basis of Population Council trials of their T-devices as on Searle's analysed data.63 The Food and Drug Administration issued assurances following the case that it had not withdrawn its approval of the Copper-7. On the grounds that large numbers of other researchers had included the Copper-7 in comparative trials and produced similar figures to Searle's on measures of device risks and efficacy, the Food and Drug Administration continued to approve the Copper-7. Sales continued overseas. 51 United States District Court, Distrbt of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5553 52 United States District Court, District of Minnesota, Third Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 'Defendant's application for a new trial, Order', 1989. pp. 6-7. 63 United States Distrbt Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp. 5556-5558. 234 Searle's response to the increasing strength of the Food and Drug Administration/pelvic inflammatory disease/intrauterine device alliance The jury finding of negligence in the Kociemba trial also focused on Searle's handling of the data indicating a higher incidence of pelvic inflammatory disease amongst young, nulliparous women using intrauterine devices. In the court it was not the device itself that was reconstituted as hazardous, but Searie's behaviour was found to be negligent in so far as the company had failed to warn doctors and women of the higher risks of pelvic inflammatory disease faced by young women, indeed had continued to misrepresent the Copper-7 as particularly suitable for this group of women.64 The Copper-7 came to doctors accompanied by a package insert. The insert stated that 'uncommonly pelvic infection has been reported' but did not present this information as a warning.65 As discussed in the previous chapter the Food and Drug Administration had become concerned about the association between intrauterine devices and pelvic inflammatory disease by1977, following the increasing number of epidemiological cohort comparison studies finding an increased risk of pelvic inflammatory disease amongst intrauterine device users. A Searle representative was present at the Food and Drug Administration special hearing at which studies were presented reporting on the higher incidence of pelvic inflammatory disease in cohorts using the intrauterine device for contraception. The Food and Drug Administration was concerned by a study reporting that the increased risk of pelvic inflammatory disease amongst nulliparous women under twenty-five years of age using intrauterine device was 3 to 5 times greater than amongst a similar cohort who did not use intrauterine devices.56 This, argued Gerisi, 54 United States District Court, District of Minnesota, Third Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 'Defendant's application for a new trial', 1989.pp. 6-7. 65 United States District Court, District of Minnesota, Fourth Division , Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5586. 55 Ory, H.W.,'A review of the association between intrauterine devices and acute pelvic inflammatory disease, 1978. See also The Medical Device and Drug Advisory Committees on Obstetrics and Gynecology, Second Report on Intrauterine Contraceptive Devbes. 1978. 235 should have sounded alarm-bells at Searle and prompted an immediate response. 72% of Searle's market were women under twenty-five and 40% of their market were women without children. By law it was the manufacturer's responsibility to warn doctors of such information as it came to light. 67 Robins, Kaplan, Miller and Giresi presented documents to the Minnesota court purporting to show that Searle was indeed worried by the meeting. If the Food and Drug Administration publicised its concerns, one memo warned, the identification of young nulliparous women as 'a particularly at risk group' might be 'mishandled by the laypress' in such a way as to damage Searle's established market.58 Nevertheless, Searle's clinicians recommended that further information about pelvic inflammatory disease, warning that this was a serious health problem, should be included in the package insert. The words added were that 'salpingitis can result In tubal damage and occlusion, thereby threatening future fertility.' The technical term salpingitis, meaning infection of the tubes, was thought to be less alarming than the terms pelvic infection, or pelvic inflammatory disease. Other additional warnings had been canvassed at Searie. For example, a statement recommending that an alternative means of contraception should be first choice for women under 25, the nulliparous, and those with multiple sexual partners, never found its way into print even onto the physician insert.69 This was precisely the group for whom the Gopper-7 had been designed, with the inserting tube kept to a width sufficiently narrow for the device to be easily introduced into nulliparous women.7o The Kociemba's lawyers charged Searle with failing to warn their consumers of a known risk in order to protect a 57 United States Distrbt Court, District of Minnesota, Fourth Division , Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5576, 5584. 68 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp.5584. 59 United States Distrbt Court, Distrbt of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp.5583-5585. 70 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5577. 236 marketing strategy aimed at profiting from the sale of intrauterine devices to women who should not be using it. Searle's lawyers offered alternative accounts of the evidence proffered by the Kociembas' lawyers. Searle argued that It had acted entirely responsibly in upgrading its warnings about pelvic inflammatory disease risk when data linking young, nulliparous women to increased risks of pelvic inflammatory disease had become firmly established, adopting wordings that were in excess of the requirements eventually settled on by the Food and Drug Administration. The jury rejected Searle's defence. The Kociemba case involved a punitive damages award of seven million dollars. The court accepted the allegation that Searle had not acted in a manner that showed due care towards the young women who were constituting its market. The jury agreed that the company had acted to suppress, or minimise, the relevance of known information concerning young women using its product and pelvic inflammatory disease risks. The court placed the responsibility for monitoring device safety, and warning doctors and consumers of possible safety risks, on the manufacturer, not on the Food and Drug Administration, and not on individual doctors relying only on monitoring the relevant literature. A defective product? Under United States laws it strengthens the case for a product manufacturer to be held strictly liable for injuries if the product is shown to be not only mis-labelled but also defective, that is, unnecessarily dangerous. This was the third plank in the Kociembas' case against Searle. The charge made against the Copper-7 was that the manufacturer had rushed the device onto the market without regard to tests, available at the time, that could have resulted in the elimination of design hazards. Without the expertise of a bio-engineer on hand, Searle did not consider the impact of its 237 choice of precise length of the copper supporting stem, or of the material chosen for the string, on the bio-compatability of the devices. According to the Kociembas' lawyers these choices, made without any tests, resulted in the Copper-7 being unnecessarily dangerous. Moreover, they alleged, Searie knew about these defects but did nothing to improve the design of the devices. The first charge that the size of the Copper-7 stem was dangerously long involved the re-contextualisation of internal documents from Searle produced during their project to develop a mini-device. Searle had opted in the later 1970s to develop a second copper device, designed with a smaller stem so as to be particularly suitable for young white women who had not been pregnant. 71 Copper intrauterine devices were being inserted in women as young as fifteen. In the early 1970s some of the clinicians at Searie working on the Copper-7 intrauterine device began canvassing an idea for the production of a smaller model of the device. They argued that the average size of the uterus in white nulliparous women was smaller than ideal for the Copper-7. A new mini-model was developed and tested in the early 1980S.72 It was never sold in the United States because Searle withdrew their application for premarket approval when Food and Drug Administration officials indicated that they would require its product labelling to state that nulliparous women were contraindicated for use, a decision based on the high rates of pelvic inflammatory disease reported in South American trials.73 Searle was accused by the lawyers in the Kociem(3a trial of knowing that the original Copper-7 should only be inserted after a uterine sound (a 71 United States Distrbt Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp. 5580. 72 United States Distrbt Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp. 5576, 5579- 5582. 73 United States Distrbt Court, Distrbt of Minnesota, Fourth Divisbn, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp. 5566. Searle reported to the FDA that its Chilean investigators had declared an infection rate of 6.7, but that it had reclassified the data to provide a PID rate of 3.3 per hundred woman years. 238 technique for measuring the length of the uterine cavity) had determined a measurement of 6.5 cm. This information had been circulated internally amongst Searie employees as early as 1974. But, according to the prosecuting lawyers, Searle had behaved negligently by warning doctors only that women measuring under 5.5cm were contraindicated for the Gopper-7, rather than warning that the devices were not recommended for the average nulliparous white woman.74 For the Searle advocates of the development of the mini Gopper-7 device, data comparing the length of the uterus with the length of the Copper-7 stem had been a valuable resource in promoting the development of a new device. In court, more than a decade later, this same debate over length was displaced and transformed by its new context. Expert witnesses for the Kociembas linked statements that nulliparous women were poor candidates for the quite large Gopper-7 with evidence of ulceration of the uterus and cervix, and a narrative of facilitated invasion of micro-organisms causing elevated risks of pelvic inflammatory disease.75 Argument in favour of the development of the smaller device were translated into admissions of knowledge of a product defect. The constitution of the string of the Copper-7 as hazardous relied on the debates over the multifilament structure of the Dalkon Shield string, debates that had played a significant role in gaining general medical agreement that the Dalkon Shield had been a defective device which unlike other similar devices wicked bacteria into the uterus. The Kociembas' lawyers produced scientists, with expertise in the rapidly expanding research into immunology, to argue that the Gopper-7 tail string fraying, increasing the surface area available for colonisation by bacteria, was a serious defect.76 74 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5557, 5580. 75 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5576-5578. 76 Paula Fives-Taylor whose own work is on the invasion processes involved in oral diseases acted as an expert witness on factors affecting the processes whereby micro-organisms first colonised the non-living surface of the intrauterine device and then broke away in clumps, thereby facilitating their invasion of the tissues, (personal communication) In the mouth the 239 The tail-string of the Copper-7 was described in court as deteriorating during manufacturing and in situ, so that it came to resemble the appearance of a dog's breakfast, a far cry from the smooth monofilament tails that had been contrasted with the Dalkon Shield. 77 The multi-strands of the frayed tail- string, dramatically rendered visible under the electron microscope, were presented to the court as protected and extensive tunnels available for colonisation by bacteria, but cut off from the body's usual immunological defences. Once established, pieces of such a colony could break off and attach themselves to the tissues where they would have a greater chance of success against the body's defences than single invading organisms.78 The cracking and fraying of the string was, claimed the lawyers, a product defect. Searle's intrauterine device strings were a monofilament type, but they were subject to fraying. Other intrauterine device companies used polyethylene which appeared to fray less. Indeed, this fraying characteristic of the Gopper-7 tailstrings was increased by positioning the strings on the outside of the inserter, unlike with similar devices. It had also been increased in 1975 when Searle replaced the tailstring on its devices with a stronger string following complaints of string breakages during removals. Searle employees had commented on the ragged appearance of these new untested strings, but despite proceedings in the Dalkon Shield litigation, no action was taken to investigate the problem.79 teeth provide a surface with similar characteristics to the Intrauterine device, ie a surface that is not readily accessible to the body's immune system. It was on the basis of this argued similarity that the plaintiffs called on Fives-Taylor's expertise, although this was contested by the defendant who couki readily argue that the microbbbgical processes involved in pelvic inflammatory disease were poorly understood. 77 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp. 5569. 78 United States District Court, District of Minnesota, Fourth Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 1988. pp. 5570-5574. The electron microscope pbtures were taken by Searie in 1974 but Searie had not investigated whether this fraying would increase the risk of infection. 79 United States District Court, District of Minnesota, Fourth Divisbn, Esther R. Kociemtia and William J. Kociemba, Plaintiffs v. G.D. Searle & Co. Defendant, 1988. pp. 5572. 240 Searle vigorously denied the allegations. They pointed out that there was no clinical evidence that the length of the stem caused greater problems amongst Gopper-7 users than the users of other intrauterine devices. They attacked the alliance between immunological and bacteriological specialists, colonising bacteria, frayed tail-strings, and over-run immune systems. Where, they asked, was the evidence that even frayed tail strings wicked bacteria from the vagina into the uterus? Searle presented the infections caused by its devices as a known danger of all intrauterine devices. The insertion procedure inevitably carried bacteria from the vagina into the uterus, increasing the chance of pelvic infection. The Kociembas' expert witnesses, argued Searie, had failed to establish any link between the microscopic deterioration of the tail-string and an increased rate of infection. As the manufacturer of the Copper-7 intrauterine device it had conducted itself reasonably, supplying the market with a useful and desirable product with known risks of injury that had previously been deemed reasonable.8o A risk of pelvic infection was not grounds for negligence. This time it was Searie's version of events and relationships that the court accepted. The Copper-7 was not declared a defective device, as had been the Dalkon Shield.8i The main impact of the Kociemba trial was on the effectiveness of the manufacturer-Food and Drug Administration-medical profession alliance. After the trial the intrauterine device manufacturers could no longer rely on Food and Drug Administration approval and physician responsibility to protect them from product-liability charges. Waiting for Food and Drug Administration requirements for product labelling, and complying with the letter of the regulations, had not protected Searle from a finding of misconduct in its handling of the increasingly strong claims being made about higher rates of 80 United States District Court, District of Minnesota, Third Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 'Judge Renner's denial of defendant's motion for direct verdict on design defect issue', 1988. pp432-436. 81 United States District Court, District of Minnesota, Third Division, Esther R. Kociemba and William J. Kociemba, Plaintiffs v. G.D. Searie & Co. Defendant, 'Defendant's application for a new trial', 1989. pp. 6. 241 pelvic inflammatory disease in nulliparous women. The court ruling underlined the duty of a manufacturer to conduct premarket tests of a reasonable standard, and to continue to test, where sound evidence indicated that a device may be unreasonably risky became available even after the initial trial period. The Copper-7 had already been taken off the United States market. Other device manufacturers moved rapidly to follow suit. Insurance premiums for all intrauterine device manufacturers, and inserting physicians, increased dramatically. Third world governments began expressing concems that devices considered unsafe in the United States, devices unavailable to its citizens, were being dumped in their countries. Intrauterine devices in general, and copper devices in particular, needed new allies if they were to remain a viable contraceptive system. The aftermath of the Copper-7 trial The Food and Drug Administration did not introduce any additional requirement for the testing of intrauterine devices. The Kociemba Copper-7 trial did however alter the balance of forces which had to be negotiated for the successful distribution of intrauterine devices in the United States market. This is exemplified by the actions of the Population Council in their efforts to ensure that at least one copper intrauterine device was available in the United States. For the Population Council, with its emphasis on the distribution of contraceptives in developing countries, international suspicions that copper intrauterine devices were defective were a problem. Suspicions had already been aroused towards United States policies which had enabled several scandals involving United States companies dumping faulty products on economies which could not afford the high levels of public interest scrutiny of the west.82 The trial of the Copper-7 and the withdrawal of all United States manufacturers from the United States market were interpreted by some as 52Dowie, 'The Corporate Crime of the Century', 1979. 242 evidence that the devices were sufficiently hazardous to be taken off their markets as they had been from the United States market. The Population Council moved to allay these fears by marketing the Paragard, sometimes called the Gopper-T-380, in the United States. Despite the high cost, in excess of $100, that would have to be charged to consumers in order to meet the hefty premiums set by the medical insurance industry in the United States, the Population Council applied for Food and Drug Administration approval, and found a small company with limited liability that was prepared to market the devices.83 The Paragard was distributed with one of the most informative intrauterine device consumer information leaflets ever released. The Population Council was seeking an alliance with consumer organisations and women's health activists.84 Without the tacit support of such activist groups not to campaign to keep all copper intrauterine devices off the market, the attempt to launch the Paragard may well have been unsuccessful. More critically, they were seeking to avoid the same kind of charges of misinformation that had been Searie's downfall in court. The Population Council wanted the maximum protection of United States product liability law, which enabled hazardous products to be marketed and not deemed defective, notwithstanding unavoidable hazards, given that the products were properly labelled and carried warnings of risks. The Population Council set the Paragard intrauterine device in the United States within a new context of the rights of the individual consumer to balance the risks and benefits of intrauterine device use for themselves. The attempt by Searle to position the Copper-7 as the intrauterine device which had finally achieved the dream of the 1960s intrauterine device advocates to develop a population control device suitable for use by almost 53 Grant, Nicole. The Selling of Contraception. 1992. pp. 147. 54 The NWHN was invited to endorse the marketing of the Paragard. For a critique of their action see Hicks, Sun/iving the Dalkon Shield lUD 1994. 243 any woman stood in stark contrast to the marketing strategy adopted for the Paragard. The aim of the Population Council in 1988 was to get an intrauterine device onto the United States market. The new marketing strategy actively worked to deter many women from using the device, declaring it most suitable for women with at least one child (written into the name - para) in a stable, mutually monogamous relationship. The consumer information leaflet provided detailed warnings about pelvic Inflammatory disease and its possible effects on women's fertility and lives. Written consent was sought from intrauterine device consumers indicating that they understood their increased risk of pelvic inflammatory disease, particularly if they or their partner had other sexual partners, and that this disease could result in infertility. The leaflet went on to point out that Treatment of PID may require surgical removal of your uterus (hysterectomy), tubes and ovaries. Such surgery may have to be done on an emergency basis, and may result in death. Removing the ovaries may result in lifelong need for hormonal treatment.85 The United States courts reconstructed pelvic inflammatory disease as a serious problem associated with intrauterine device use. Women's subjective and personal perspectives and the influence of these on judgements weighing the risks of intrauterine devices have, as a result, come to play a more important role in decisions about intrauterine device use, at least in the West. However, the risk of pelvic inflammatory disease for intrauterine device users has been restricted to only one consumer group to whom the devices had in the past been promoted, young nulliparous women. Those concerned with teenage pregnancy tumed their attention to newer products, including injectibles such as Depo Provera and Norplant - a hormone releasing rod that can be placed under the skin. The dream of a standardised intrauterine device, suitable for the mass of women, had been deteriorating partly as a result of the production of the copper intrauterine 85 GynoPharma, 'Paragard consent form', 1989. 244 devices. By the end of the 1980s, under the glare of the United States product-liability legislation, women's bodies had become individuated, carrying with them the specificities of their age, conduct, fears, and community context. Contraception has shifted from being a matter of mass production and distribution of an ideal device to the complex decision-making required to modify a particular body through the use of any one of an all too limited range of contraceptive devices. My aim in this section has been to show that a technological trajectory is the outcome of the complex interactions of a socio-technical network. Just as the disparate forces operating in the network can work to consolidate a particular trajectory, so too can they work to dismantle it. Moreover, the failure of the copper intrauterine devices, and of the Copper-7 in particular, was constructed using material, rhetorical and paper technologies, just as the success of the copper trajectory had itself been a heterogeneous construction. I want to emphasise that the Kociemba trial was not a privileged institution which finally forced into the open the truth regarding the defects of the Copper-7, previously concealed by Searie. In the Minnesota court, the lawyers acting for the Kociembas worked to construct their own assemblages, retelling the history of the Copper-7 as a history of known problems on which Searle failed to take action. The legal context in which the trial proceeded meant that to win the case the plaintiffs had to demonstrate not that the Copper-7 was dangerous, but that the manufacturer's conduct had been unreasonable. This involved rewriting the history of the alliances between objects and humans. What gets in the way of understanding how litigation works to derail a technological trajectory is our common-sense understandings that separate, at their roots, the world of subjects/humans from the world of objects/things. A company such as Searle is then thought of as either behaving reasonably in setting out to discover the truth, and in fairly representing that truth to the 245 users of its products, or as behaving unreasonably by acting to conceal the truth. This view is simplistic in that it does not recognise the extent to which pelvic inflammatory disease risks are themselves heterogeneous assemblages.86 Pelvic inflammatory disease was not an objective disease entity with an essential causal link to the Copper-7 intrauterine device awaiting discovery. Pelvic inflammatory disease risk amongst intrauterine device users exists as an object only within a particular collectivity of human and non- human entities and relationships. It is both a network effect and itself a sociotechnical network. When Searle began to develop the Copper-7 the strength of the pelvic inflammatory disease network was weak. The stabilisation of pelvic inflammatory disease as a diagnosable entity was poor. Its identity was easily collapsed onto Gonorrhoeal Salpingitis, a disease that Searle could readily associate with a sexually transmitted organism and the behaviour of the sufferer, and dissociate from the intrauterine device. However by the mid- 1980s, the time at which the reasonableness of Searle's behaviour in failing to warn physicians about the pelvic inflammatory disease risks associated with intrauterine devices was on trial, pelvic inflammatory disease had become a much stronger socio-technical network. It was now part of a laparoscopically visible system, linked to the discipline of epidemiology. The association between pelvic inflammatory disease and intrauterine device use amongst young women was particulariy strong following the National Institute of Health investigations in the United States and the large British epidemiological study. These studies became critical tools for 56 Watson-Verran and Turnbull adopt the term assemblages in preference to actor-network to capture the heterogeneity of bodies, skills devbes, theories, surveillance techniques, and habitual practices characteristic of technological systems. They adopt the term from Deleuze and Guttari, A Thousand Plateaus , 1987, because it does away with the emphasis in actor- network theory on the network builder and allows for robustness without fixity. I would agree with their preference for the term, but here I am using it to do the same conceptual work as does actor-networi<, or socio-technical network, ie to draw attention to the constructed and heterogeneous character of a disease entity (pelvic inflammatory disease) which it is easy to forget, given our allocation of diseases to the natural side of the nature/culture divide. See Watson-Verran and Turnbull, 'Science and Other Indigenous Knowledge Systems', 1995. 246 translating the interests of new member groups such as the Food and Drug Administration within the intrauterine device socio-technical network, epidemiology became a spokesperson for pelvic inflammatory disease risk. New package inserts and consent forms came to embody the possibility of future infertility for intrauterine device users. Searie, in acting to protect its interests in the continuation of the use of intrauterine devices amongst young women, could be found to have failed to behave reasonably because it misjudged the strength of this pelvic inflammatory disease assemblage, a strength boosted by all the interest in the Dalkon Shield, and also probably by the increasing work being done on infertility. The power of the newly constructed pelvic inflammatory disease risk assemblage did not simply derive from the strength of the human individuals and institutions, such as the United States Courts, to enforce certain beliefs by taking action to police particular behaviours, behaviours with which Searie ultimately complied. Nor did its power derive simply from the application of new tools to make visible a previously hidden natural phenomenon. Rather, the power of the new risk assemblage derived from the ability of its human actors to speak for and manipulate its non-human elements, and to translate the interests of diverse human elements through new compulsory passage points. During the trial Searle attempted to contest the representivity of those voices that claimed increased riskso f pelvic inflammatory disease amongst young women. Searle presented the insertion process itself as the cause of pelvic inflammatory disease in intrauterine device users, rather than any intrinsic characteristics of either young or nulliparous women. However, the alternative networks mobilised so effectively by Giresi in the court room were constitutive of a risk assemblage which proved too strong for Searle's attempted translation, this assemblage linked pelvic inflammatory disease, intrauterine devices, young women and infertility. To re-integrate the mutineers and reinstate the clinical trials of intrauterine devices run according 247 toTietze's model as the singular spokesperson for this intrauterine device/pelvic inflammatory disease risk assemblage was not easy. It would take the translation of this risk assemblage into an adjusted intrauterine device socio-technical network. Intrauterine device users were reconstituted as competent decision-makers and managers of the diverse risks encountered during their lives, and young women were largely excluded, simply on the basis of their assumed lack of competence to make a decision which put their future fertility at risk. Constructing and dismantling a technological trajectory In this chapter I have looked at the development of the copper intrauterine devices. As in previous chapters, I have stressed that the innovations in design that resulted in the copper intrauterine devices, and their diffusion and acceptance, can usefully be understood sociologically. I have pointed to the way in which the copper intrauterine devices were co- constructed together with the goal of increasing intrauterine device acceptance amongst young women. That is, there are no goal related criteria standing behind the action, according to which objective judgements about what constitutes an improvement can be made. My second point was that the production of an intrauterine device suited to women who were rejecting the plastic intrauterine devices was stabilised by a complex intersection of somewhat arbitrary events and relations. The development of the copper trajectory was taken up and supported by several different interest groups with a diversity of aims, each of which came to see the copper intrauterine device as enhancing their own positions. Third, the very development of the copper intrauterine devices created new participants in shaping intrauterine device technologies. Intrauterine protagonists in India, innovators in the Population Council, United States family planning groups and government agencies with an interest in regulation of young women's fertility, the Food 248 and Drug Administration, activist organisations, and United States lawyers joined the intrauterine devices socio-technical network. In this chapter I have emphasised that entities that are routinely attribute to the world of things are always constituted through the specific practices in which they become stabilised as objects. To avoid confusion I have used the term assemblages instead of socio-technical network in relation to pelvic inflammatory disease risk. This concept has been useful in handling the different concepts and parameters of the pelvic inflammatory disease risk constituted through the epidemiological studies of intrauterine device phenomena, and the pelvic inflammatory disease risk constituted through the clinical trials of intrauterine devices. I have not positioned myself as the arbiter of which of these pelvic inflammatory disease risk constructions was better. This is the job of the Food and Drug Administration, the manufacturers, the courts, the individual physicians and consumers. In this chapter, I have restricted myself to showing how such outcomes, produced by and constitutive of two separate worlds, both productive of pelvic inflammatory disease as a risk of intrauterine devices, were handled by the actors involved in the making of the copper intrauterine device trajectory. The release of the results of the first copper intrauterine device trials coincided with the release of epidemiological studies that reconstituted pelvic inflammatory disease risks. There apparently were at least some local pockets of disquiet amongst Searle clinicians, and very probably at other sites where the copper devices were being trialed. But any questions remained local. The test of whether the follow-up data being collected about side-effects in copper intrauterine device clinical trials would be adequate for the new task that it would have to meet, of answering the fears of pelvic inflammatory disease risks raised by their constitution in an epidemiological worid, would be at the practical level of how the two different pelvlc-inflammatory-disease- intrauterine-device-risk assemblages were treated by recipients. The Food 249 and Drug Administration had initially looked to the intrauterine device industry for standards of clinical testing. After ten years of testing of plastic devices, Tietze's methods of data analysis and formats for reporting results had become standardised and habitual and were adopted by the Food and Drug Administration. The Food and Drug Administration concentrated its attention on putting in place a new battery of tests which focused on the difference between the new copper intrauterine devices and the older models. They wanted testing of carcinogenicity, toxicology, and teratology (the effect on the foetus). These tests were routine procedures for the Food and Drug Administration drug surveillance work. For over ten years the alliance between the Intrauterine device industry and the Food and Drug Administration worked to support and promote the success of the copper intrauterine devices. However, in 1988 Searie was on trial for its failure to pay attention to the local problem of how well its socio-technical networks could compete in constituting its alternative pelvic inflammatory disease risk assemblage. In 1988, in a Minnesota courtroom, the law firm of Robins, Kaplan, Miller and Giresi, flush with the financial, personnel and technical resources won from the Dalkon Shield litigation, took on G.D. Searle. This was not an isolated company like A. H. Robins, and the outcome of the trial had implications for all copper intrauterine devices. What the lawyers did in that courtroom was to make visible once more the labour processes, the tinkering and layers of decision making, that had produced the risks and benefits of one copper intrauterine device. The frailty of Searle's pelvic inflammatory disease assemblage in the face of the stronger set of alliances now intertwined with the epidemiological pelvic inflammatory disease risk assemblage, for which numerous and credible epidemiological spokespersons could now be found, caused the copper intrauterine trajectory to come unstuck. This has not been permanent, and new alliances have since reconstituted the copper intrauterine device trajectory. The Food and Drug 250 Administration endorsement of the Paragard has not led to a lucrative market in the United States, where insurance for intrauterine device manufacturers and inserters remains high. But it has prevented the unravelling of the international Intrauterine device socio-technical network, reassuring third- world governments and health workers that they are not being supplied with a contraceptive that would be unacceptable to the donor country. 251 CHAPTER 6 Taking stock: How helpful is actor-network constructivism for opening up possibilities for feminist interventions in/with technologies? In this concluding chapter I want to address three issues. First I want to spend some time addressing the strengths and weaknesses of actor-network constructivism, drawing out its advantages for feminist interventions in and with technology, and suggesting some modifications. I will begin by outlining some of the problems that have persisted in feminist accounts of women's history, particularly accounts of women and technology. I ask how constructivist history and sociology of science can help overcome these problems. Actor-network constructivism, given the commitments of its protagonists to avoid such categories as gender, is not an obvious conceptual choice for feminist scholars of technology. Nevertheless, I argue, with modification, actor-network constructivism can provide an understanding of the power attributed to science and technology without reifying objectivity and abstract rationality, which feminist scholars of science have blamed for much of the woman damaging technology to emerge from science. Moreover, because of its focus on the researcher as an heterogeneous engineer building simultaneously the social and the natural, and the division between them, actor-network constructivism can provide useful insights into how techno- science worlds constitute women users of technologies as particular kinds of subjects linked with specific categorisations, collectivities and constrained choices of action. 252 In the second section of this chapter I will briefly re-examine the story of the intrauterine device presented in this thesis. My aim is to emphasise the value of the modified actor-network constructivism I have developed for feminist, political engagements with technologies. This is not, I believe, an arena we can 'leave to the boys'. Women have been active participants in many areas of intrauterine device worids: invention, development, as users, as producers of devices as safe or hazardous, and as effective and desirable, or as a failed contraceptive technology - sometimes for particular groups of women and sometimes for whole classes of device. I argue that women's health advocates need to grasp women's contraceptive history as one of successful inten/ention in the worlds of techno-science. For contraception, women have participated in the arenas in which occurred the co-construction of problems, technological solutions, criteria for judging successes and failure, and techniques for the insertion of contraceptive technologies into the everyday lives of women throughout the world. Women's agency becomes visible once these aspects of technological development are understood as socially produced and locally crafted in the context of shifting arenas of social action, and not as natural progressions driven by nature on the one hand and some pure realm of technical decision-making on the other. Finally, I end the thesis by opening up a space for critical reflection on clinical trials. The status quo position that has emerged in Australia in response to the successes and failures of intrauterine devices relies on government scrutiny of expensive pre-marketing clinical trials in order to protect women from becoming the victims of corporate developers of therapeutic technologies. If clinical trials cannot provide 'objective data' on efficacy and safety, what is their value for health activists? To those with more faith than I have in the clinical trial as a source of empowerment for women to be able to make informed choices about health technologies, I offer a caution about the representivity of trials and a reminder that no trial 'captures' the 253 reality of the in-use situation in a socially unmediated manner. To those who denounce clinical trials as distortions of a patriarchal scientification of medicine, I offer a reminder that trials do provide an arena in which the success of a device enmeshed within a limited socio-technical network, and judged by particular criteria, does have to be demonstrated. Sex, gender and technology The intrauterine device is a medical technology targeted at women. Women are the users of intrauterine devices. It is women whose pregnancies have been prevented and it Is women who have suffered injuries as a result of using intrauterine devices. Programs to develop and distribute intrauterine devices claimed benefits for women - in the 1920s, sexual enjoyment free from the worry of conception and the risk of 'psychological disturbance' that might result from interruptions to the 'love-union'; in the 1960s, improvements in maternal and child health due to increased spacing between pregnancies, and in the 1970s, fewer long term health risks due to the avoidance of systemic effects experienced with the oral contraceptives. The organisations that represented women claiming injuries from the use of intrauterine devices also made claims about the effects of intrauterine devices on women's lives. The media and the courts relayed claims that intrauterine devices were a potentially harmful device developed with little or no regard for women's health; stories of family breakdown and the pain of childlessness became commonplace associations with intrauterine device use in the pages of women's magazines. The intrauterine device is a technology which has influenced many women's lives. It is also a technology constitutive of a new form of life in which women are embedded in specific ways. The intrauterine device is a technology that positions and constitutes women's bodies, women's sexuality, and women's behaviours in particular ways as part of itself, in order for it to 254 operate as a working contraceptive system. Rather than focusing on how gender shapes intrauterine device contraceptive systems, it is, I believe, more pertinent to ask how gender and intrauterine devices are co-produced in intrauterine device socio-technical networks.i Since the 1970s there has been considerable interest in the history of those technologies that have particularly impacted on women's lives, corresponding with an upsurge in interest in history told from below. Women's histories, histories of the dispossession of colonised peoples, and workers' histories now stand alongside histories told from the perspective of dominant groups In all fields, including the history of science and medicine.2 In the context of women's history, the history of birth control took on a new significance. It contributed towards our understanding of the separate sphere of women's lives, previously omitted from histories dominated by the activities and arenas of men. The history of birth control struggles is part of a socio- history emerging from the 1970s, in which history of medicine was revitalised as part of an expanded conception of power that stretched beyond the institutions of government and corporations to locations that included the family, sex, medicine, and the body. For the most part these narratives of women's history brought a new visibility to women as historical subjects. But, as Joan Scott rightly points out, two problems continued to characterise women's history until well into the 1980S.3 First, women in the new history have often been represented as victims. The story is told from the perspective of the underdog but men remain the actors, the shapers of history. Women enter the picture but they are portrayed as passive, their lives shaped by strategies of domination pursued by men. Thus, for example, stories of the discovery of new technologies for 1 Here I am aligning myself with Wajcman, Feminism Confronts Technology. 1991, p. 22; CocWjurn and Ormrod, Gender and Technology in the Making. 1993, pp. 2-3; and Oudshoom, Beyond the Natural Body. 1994. 2 Scott, Gender and the Politics of History. 1988. pp. 19-21. 3 Scott, Gender and the Politics of History, pp. 1 -50. 255 the prevention or encouragement of childbirth are transformed from stories of progress to narratives of the control and domination of women.4 Men are still the actors in a narrative of the technologisation of life. The optimism and utopianism of the progress narrative flips to pessimism and dystopianism but remains within the same narrative structure. Men pursue strategies such as professionalisation in an attempt to increase their power; women become subject to control and domination. The second problem identified by Scott has been more recently recognised in women's history. This is that the category 'women' has been presented as self evident and unchanging. Scott has pointed to the lack of attention within women's history to the production of the category 'women'.5 Women's history has been concerned to show that the specificity of women's experience does not derive from women's biological differences. But it is only In the last decade that historians have begun to analyse how the category woman, defined through the specific attribution of characteristics, interests, and roles, has itself been produced. Gender, in many feminist accounts of social action, functions as a set of essential attributes of women's psychological identities, the result of socialisation, but assumed as the cause of women's capacity to act as a group, or to identify as sharing common interests. Gender is something produced in the family and the school and then carried into the public worlds of politics and science as a source of individual motivation. This essentialised conception of gender has recently been questioned by feminist theorists interested in the social dynamics productive of gender categories. Attention 4 For a recent example of the heroic genre see Siedlecky and Wyndham, Populate and Perish. 1990. Leavitt (ed). Women and Health in America. 1983, was a groundbreaking work that brought together the best scholarship to then that broke with the heroic tradition. Apple (ed) Women. Health, and Medbine in America. 1990, announces the shift amongst feminist historians away from victim history. ^ Scott, Gender and the Politics of History.See the chapter 'Women's History', particulariy pp.22-27. 256 needs to be directed to how categories of gender are both socially produced and enacted as productive in specific historical contexts. A gender analysis in a discipline such as science and technology studies needs to operate on many levels. It Is important to make visible women as actors who have contributed to the construction of technologies. Women were and are active in the social groups that constituted themselves as having interests affected by the development, distribution, or banning of intrauterine devices. Women's actions played a role in determining the outcome of controversies over intrauterine device design, claims about safety and risks, and methods of distribution including the configuring of suitable users. It would be a mistake to focus an actor-network analysis only on those usually male figures who work as scientists and engineers. It would be easy enough for Grafenberg, Tietze, The Population Council, Robins and Searie to become the heroes and villains of the intrauterine device story. But this would be to repeat the problem of assigning women the status of victims. I hope to have shown that many more actors, women among them, were competing and negotiating with the actor-network building strategies of such organisations and individuals, as they attempted to construct networks of their own. Indeed, it was the capacity of actor-network constructivism to be expanded to include the heterogeneous acts of diverse individuals and organisations that was partially responsible for drawing me towards this methodology. However, to simply focus on women's agency in the intrauterine device story would fail to come to grips with how the spaces, within which women could participate as actors, were themselves structured. One of the contingencies in intrauterine device controversies were struggles over the legitimacy of agency, over what characteristics were ascribed to participants thereby either enhancing or limiting their capacity to act, and over how agents were constituted as such. Thus, the means by which women could constitute 257 themselves as a group with a collective identity, and insert themselves into struggles constitutive of the intrauterine device as a contraceptive system, were themselves at stake in the production processes which have given us the intrauterine device in its present form. Moreover, to stop at making visible women's agency as shapers of intrauterine device technological systems would be to neglect the very production of sex/gender as integral to the intrauterine device technological system. To emphasise the local and most immediate power relations under production in the intrauterine device socio-technical network is to make possible an analysis of sex/gender as it Is produced in one site. Technologies and medical and scientific knowledge claims and practices have previously been largely overlooked in studies which took power to reside with governments, with the owners of capital, or with texts. Governments, capitalist firms, and the philosophical commitments embedded in language are, of course, highly influential in shaping contraceptive technologies, nowhere more-so than the intrauterine device. But their power lies precisely in their construction and incorporation into such technological systems which work on the body, and put into place at the level of the body unequal distributions of power.5 Gender is translated from an explanatory category located as the origin of repression, into a precariously stabilised and historically shifting phenomenon co-produced with and through the particular sexed bodies stabilised by specific regimes of practice. Medical technologies do not simply act on pre-given natural bodies; they construct the body as we know it. Bodies can only be known, experienced, and acted on as the objects of crafted articulations between practice, meaning, subjects and other things from which ® Here I follow Foucault, Discipline and Punish:. 1979. Foucault emphasises that power is productive - 'Our society is one not of spectacle, but of surveillance; under the surface of images, one invests txxJies in depth; behind the great abstractbn of exchange, there continues the meticubus, concrete training of useful forces; the circurts of communication are the supports of an accumulation and a centralization of knowledge; the play of signs defines the anchorages of power; it is not that the beautiful totality of the individual is amputated, repressed, altered by the social order, it is rather that the individual is carefully fabricated in it, according to a whole technique of forces and bodies.' (p. 217) 258 they are differentiated. It is not that the primarily male doctors and scientists /lad power as men, that they then used either advertently or inadvertently to produce a contraceptive technology. Rather, power relations are the outcome of the ways in which the intrauterine device contraceptive network materialised: medical specialists were articulated with contraception, specific practices of calculating risksan d benefits were routinised, and a particular female body was specified - women were envisaged as having sexual desires (measured in terms of frequency) that were equal to men's, the womb was thought of as an 'empty' space, the pain and discomfort threshold of women was imagined as high, certain women's behaviour was presented as uncontrollable In moments of passion. Thus, emphasising the heterogeneous, non-zero sum productive capacity of the socio-technical network building process both breaks with critical traditions restricting women to the role of passive recipients and victims, and emphasises processes of solidarity and subjectivity formation. It does not mean that participants negotiating the interpretative flexibility of technological systems engage on a level playing field. As John Law points out, the Foucauldian conception of power as productive - 'power to' - can be analysed as a stored capacity that some groups have access to by virtue of their pre-existing positioning within socio-technical networks, without forgetting that this power is precarious (not the privilege one has as a member of a dominant class), an effect of strategies that enact social relations.7 There is the added advantage that with this re-conceptualisation of the categories of gender and women as effects or outcomes, a self-critical space can be opened up, and the exclusions created by the strategies pursued by the marginalised, in their attempts to effect the construction of socio-technical networks, can be exposed. Thus for example, the rhetoric of the 'right to choose' which had been so critical to United States women's health 7 Law, 'Power, Discretion and Strategy', 1991, pp. 169-172. 259 movements in the early 1970s, has operated to exclude working class women, third world women and African-American women. For these groups a solidarity formation organised around a rhetoric of contraceptive choice failed to translate their struggles against enforced abortion, coerced contraception and sterilisation. Women using intrauterine devices cannot be construed as sharing a collective gendered identity - women as medical consumers duped into subjecting the control of their bodies to the male dominated bastions of scientific medicine. An actor-network approach that emphasises the translation of various recipients into the intrauterine device contraceptive system can enable the consideration of how particular subgroups of women are configured and produced as consumers with differentiated gendered identities, within particular socio-technical networks. For instance, intrauterine device users have been configured with different subject-positions from which to negotiate access to removals depending on whether they were reliant on free clinics supplying government paid for devices, or whether they were private patients. There has been a tendency in actor-network constructivism to emphasise object production: Latour analysed microbe production; Gallon accounted for the failure of scallop fishing8, Foucault's work can be interpreted as part of this tradition, although his Interest is different, being not so much the fabrication of objects, but the manufacture of subjects. This production of specific subjects, particular bodies, historically precise sexualities, is something that I have considered as part of the component architecture of the intrauterine device: How do intrauterine devices, as technological systems, stabilise and make possible particular kinds of subject positions - woman, mother, lover, user, consumer, patient, injured, careless, and so forth? Dissolving the boundary between the social and the technical and refusing to posit social characteristics such as gender, class and race as ^ For an interesting oven/iew see Latour 'Drawing Things Together", 1990. 260 explanatory of technological change and decision making does not necessarily disavow an understanding of the interaction between technologies and gender. Actor-network constructivism can be useful for feminists interested in gender and technology if gender is rethought. First, gender is not something that merely exists in the social world outside of the laboratory, the field trial, the technological test, and then Is brought to bear on the work of science, illegitimately according to some. Second, gender is not simply a preformed set of motivations and interests arising from an absolute and objectively determined position of sexual domination or subordination, produced by the universal givens of the social order - kinship and economics. Gender interests do not inhere in actors, or their structural position in institutions such as the family or the work force, accounting for how various actors behave in their attempts to influence the outcomes of technological controversies. Third, it becomes necessary to examine the politics through which gender interests and identities are produced within specific socio- technical networks through which sexed bodies and the regimes of human intervention on them are co-produced. In short, actor-network constructivism can help make technological networks and the ways that they contribute to the contingent construction of gendered power relations more transparent and open to intervention and reinvention. It has been my argument that we need to understand how contingent collective identities, such as woman, that bind individuals together in common categories, are manufactured, without making women out to be passive victims, and without attributing to them an essentialised identity. I believe that one way to do this is through socio-histories that recover the heterogeneity of the processes productive of temporarily stabilised technological systems. Such an approach allows the exploration of the things that get mixed up with and are constitutive of the social. My aim has been to deconstruct narratives constitutive of a dichotomy between a purely technical 261 realm of design, testing, and developmental trajectories and a social realm of where power and subjectivity are produced and exert effects. I want to reconstruct the work of scientists, medical researchers, doctors, and bio engineers as mixed-up with the work of administrators, lawyers, women's health groups, the courts, politicians, consumer activists, and infertile women. If technologies are rethought as sites of clotted outcomes of negotiation between diverse human and non-human entities, then women can be seen both as active negotiators, and as occupying subject positions partly brought into play through the processes of crafting a new socio-technical world. As effectors and as effects women have much at stake in struggles over what is to count as a successful contraceptive. Making actor-network constructivism feminist friendly Allow me to briefly reiterate the elements that make up an actor- network approach to constructivist history or sociology of science and technology. The approach recapitulates two principles of the strong social constructivist programme: (1) the analyst must suspend judgement about the truth or falsity of claims; (2) the analyst must explain symmetrically the success or failure of changes proposed to scientific beliefs ortechnologies.9 This principle of symmetry is extended by actor-network theorists who argue that analysts should also treat explanatory factors symmetrically, privileging neither nature nor culture in causal accounts of scientific and technological development. Actor-network theorists suspend a priori assumptions and judgements concerning the categorisation of what is natural and what is social and what is the boundary between them, seeing these questions as part of what is being settled in scientific and technological practice, and therefore as part of what requires explanation. 9 Bloor, Knowledge and Social Imagery. University of Chbago Press, Chicago, 1976. p. 7, 262 Actor-network analysts reconstruct the action of actors as these players build networks of association between a variety of human and non-human entities. Entities are enrolled into a system of characterisations, roles and scenarios in which the parts they play confirm the identities spoken for them by the network builders. Both human and non-human actors are coaxed into participating in the network centred in the laboratory or technology under construction. This process of network construction is thought of as a series of translations. Entities, both people and things, are displaced from existing networks, and their identities are reconstituted as they are inserted into new networks of associations, shared meanings and practices. 10 The building of such a network is always under threat from the emergence of alternative spokespersons providing different accounts of the action and relationships, or from the mutiny of the players, both human and non-human, who might act in ways that are not commensurate with the characterisations attributed to them by the network builders. Moreover, the fate of a technology or of a scientific claim is not determined entirely by the skill of the network builder in strongly tying together entities into durable associations, nor on their ability to enrol possible alternative spokespersons and mutineers as allies. Rather, its fate depends on what happens to the network of associations. Scientific knowledge claims and technological artefacts that survive do so because these linkages, although manufactured and consequently precarious, for all practical purposes cannot be undone because they have become indispensable in multiple social worids.n The 10 Gallon and Law, 'On Interests and their Transformatbn', 1982. pp. 615-25; Gallon, 'Society in the Making', 1987; Latour, 'The Powers of Association', 1987. 11 Latour, 'Visualisation and Cognition', 1986, pp. 1-40; Calbn, 'The Sociology of an Actor Network*, 1986. A good oven/iew of 'actor network theory', and where I first came across the phrase, is given in Singleton and Michael, 'Actor-Networks and Ambivalence', 1993, pp. 227- 64. The term social worlds has been adopted from the wori< of Symbolic Interactionist analysts of science. I am using the term as a synonym here for socio-technical network. There has been considerable overiap between social worid analysts of science and actor- network analysts. A discussion of the differences and tensbns is beyond the scope of this thesis but see Star, Regions of the Mind. 1989, Ch.1; Star, 'The Sociology of the Invisible', 1991; Star and Griesemer, 'Institutional Ecobgy, 'Translations',' and Coherence', 1989; Clarice, 'Social Worlds/Arenas Theory as Organisational Theory', 1991; Clarke, 'A Social 263 work done to construct and sustain such linkages becomes invisible as new retrospective histories represent such heterogeneous networks as reality, or in the case of technologies as the logical and efficient solutions to pre-existent problems. As indicated in chapter 1,1 have both used and modified the actor- network constructivist approach in order to write this sociological history of the intrauterine device. I have found that theorising intrauterine device technology as a series of actor-networks provided a useful methodological guide and conceptual language. I adopted many of the terms introduced into science studies by actor-network analysts. A language of human and non-human actors, enrolment, alliances, actor-networks, socio-technical collectivitiesi2, translation, and durability has been useful for analysing the co-construction of bodies, technologies, and therapeutics. The value of such a model has been that it provided an approach to the history of intrauterine device technologies sensitive to the diverse forms of power exercised through science and technology; it brought into focus the human labour and the negotiations between diverse social groups over what is to count as reality, or efficacy, or safe-enough, or hazardous. Moreover, it enabled me to follow these negotiations wherever they occurred, recovering the action of participants as it occurred across the dichotomies of modernity - science/society, nature/culture, subject/object, reason/power, machine/human. All of these dichotomies were at play in the construction of the various intrauterine device socio-technical networks scrutinised - in court-rooms, laboratories, conferences, and clinics. What is important to a strategy of confronting the interconnections between knowledge and power, technology and ethics, is that such dichotomies be positioned not as essential characteristics of the Worids Research Adventure'; Clarke and Gerson, 'Symbolic Interactionism in Science Studies', 1990; Fujimura, 'Crafting Science' 1992; Fujimura, 'On Methods, Ontologies, and Representation in the Sociology of Science', 1991; Fujimura, 'The Molecular Biological Bandwagon in Cancer Research' 1988. 12 On socio-technical networks as collectivifies or solidarities see Haraway, The Promises of Monsters', 1992. 264 world in which we live, but as outcomes of situated social practices, where the social is not other to the material, but inscribed within particular hybrid collectivities that materialise objects-subjects-meanings-practices.13 However, I have not simply taken actor-network theory off the shelf, finding it ready to use in accounting for the successes and failures of particular alignments of knowledge claims, practice, and hardware in intrauterine device contraception. From the outset I have followed at least two actor-groups - the researchers and intrauterine device protagonists, and the women users. Moreover, I began with a concem to map the conditions of production and the socio-political context shaping the knowledge claims and technological imperatives of those bringing science to the field of contraception. Both the multiple perspective afforded by the former, and the wider-angled viewpoint provided by the latter have complicated the actor- network approach of Gallon and Latour.14 I agree with their move to dismantle the text/context and science/society hierarchies, that in one order or another have dominated both traditional and sociological accounts of science and technology. But what, I ask, is to be done with those elements of the socio political landscape that escape reduction to the 'acts' of actor-network builders? One way of bringing into an actor-network account that which is usually designated the socio-political context is to re-theorise actors as always multiple. We need to pay attention to the resistances to translation contingent on existing networks within which entities circulate. The resources accessible to actors, their stored credibility, and their ability to mobilise intersecting networks and bring them to bear on various arenas vary considerably; these elements must be attended to if actors are not to slip back into a modernist rhetoric which represents them as atomistic individuals, the centred authors of 13 For an interesting discussion of 'hybrids' in modernity see Latour, We Have Never Been Msdem, 1993. pp. 1-3 & 39-43. 14 Singleton and Mbhael use the metaphor of the camera, and options for use of wide- angled and zoom lenses, to critique and build actor-network theory. See 'Actor-Networks and Ambivalence', 1993, pp. 232-233. 265 their own history.15 Moreover, just as networi< builders flexibly occupy many subject positions - statesman, politician, experimentalist, manager, parent, social visionary - we must remember that the entities enrolled into a network are never entirely pinned-down by the identity forged for and by them within that particular socio-technical actor-network. Let's look at a specific example. In Germany in the 1920s the Grafenberg ring became institutionalised in the alliance between sex-radicals and liberals, and in some state and municipal health services. The establishing of a technological-system, including the intrauterine device contraceptive system, involves a certain speaking on behalf of users, in this case women or couples. Grafenberg's authority to speak on behalf of the women he envisaged as potential users of his coils was justified not only by the actions he pursued in order to stabilise a particular contraceptive technology, but also by his and the surrounding culture's naturalisation of the problem of severing condomless-penis-in-vagina-ejaculatory sexual expression from reproduction in order, it was assumed, to produce self- fulfilment in heterosexual relationships for women. This involves a reification of a particular conception of women's sexuality imagined as universal. This is something that is never spoken by intrauterine device protagonists, but for the science analyst to gloss over it would be to fail to acknowledge that the 'need' for a contraceptive technology that does not provoke 'distaste' amongst women users is itself under construction by the protagonists of the technology. This means locating the actor-network building strategies of scientists, doctors, bio-technologists, lawyers, consumer organisations and feminists within the complex interplay of the multiple identities which both human and non-humans flexibly occupy as a result of previous and concurrent network constructions. 15 I am in agreement here with John Law who endorses a Foucauldian conception of power, but introduces back into actor network theory the concept of stored power. See Law, 'Power, discretion and strategy', 1991. 266 The actor-network analyst is also the multiple occupier of a number of subject positions. It is because I have not been fully captured by the assumptions built into heterosexism in the mid-twentieth century that the making of this woman's identity becomes visible as a construction worthy of investigation. In other words, actor-network theory in itself does not provide a critical analytical practice. It is only by opening actor-network approaches to critical perspectives developed in feminist theory, for instance, and in social movements struggling to alter conglomerates of people-things-meanings, that the promise it offers to demystify the power of technology becomes linked with a pragmatics of change. To simply describe technologies as networks that co- produce society and reality brings no imperative to alter current technological and scientific practices. Nevertheless, the crafting of actor-network sociological histories of our present socio-technical worlds does mean that we approach the future with the tools to re-make ourselves, and our relations to cultural and natural horizons, our visions a little less trapped within present socio-technical alignments. I am not arguing for a privileging of the positionality of the marginalised in order to generate a more accurate science, or more equitable technologies. Just as we must interrogate the speaking position, the network of self-other relations, that enables Grafenberg to enunciate and appropriate such a vision of women's identity, so too must we acknowledge that the sex-reformers' femaleness does not give them a privileged and singular perspective from which the needs of women can be known. The unity of the sex reform movement is a fabrication holding together disparate and multiple identities located according to divergent histories of the struggle for contraception in various countries, a variety of professional commitments, and according to differential political and professional allegiances to which the cause of contraception has become linked. And what is true of human actors is also true of non-human actors. Thus similariy, the unified identity of the various 267 coils and devices promoted by Grafenberg involves the repression of their differences, and of their similarities with certain other devices. This is not a plea for the recognition of plurality. Nor am I against the reductions involved in any categorisation per se. Rather, I want to draw attention to the achieved or constructed character of identities and collectivities thereby making available their'could-have-been-otherwiseness'. This position has emerged gradually as I have struggled with integrating elements of actor-network theory with elements drawn from the British Influenced social studies of science traditions. Motivated by a refusal to reduce the women users of intrauterine devices to mere individual recipients, and the desire to keep gender in the picture, I was sympathetic to claims urging the consideration of macro-sociological factors, or interests, as structuring influences that need to be taken into account by constructivist historians of science and technology. It was the effort to avoid determinism of any kind, whilst still encompassing those aspects of the wider socio-political context that are so embedded in the situation that they are not immediately evident from a perspective of following actors around, that I found myself confronting the question of multiple subjectivities. When I began the thesis I was content to include a general discussion of the background conditions that shaped the interests and situations of actors, and their audiences' responses. In retrospect, the problem that I faced in adopting this approach to social constructivism was that whatever elements of background context I selected tended to be read as causal determinants of action. This problem could perhaps have been overcome by focusing on the contested elements of identity to which, in Gallon's terms, interressement devices were targeted. To use an Althusserian terminology, processes of hailing are integral to processes of interpolation into socio-technical networks. What 1 labelled contextual elements of the story could perhaps better be conceptualised as accretions of identity. Pre-existent stabilised identities by 268 which I can be hailed, recognising myself as the one addressed, will influence but not determine or limit the actions of others towards me and the actions available to me. 1 would now want to emphasise that history enters the synchronic actor-network negotiations, not as mere context, but as a resource, and as a conglomerate of existing alliances constraining self-other- thing identities that must be negotiated with and through. I endorse actor-network constructivism with these modifications - (1) that actors and actants involved in constructing socio-technical networks be conceptualised as having flexible, multiple, and differentially located subjectivities; and (2) that actor-network constructivist accounts incorporate the perspectives of multiple actors. In this modified form it offers a position from which the processes of technological innovation and development can be apprehended as contingent processes in which both subjectivities and objectivities are co-constituted, assigned particular characteristics, located in specific chains of relationships, hailed as particular bundles of properties, and enrolled into relays of associations constituting self-other-thing relations, that is, remaking both social and natural worids. The 'test' of this approach to the history of the intrauterine device lies not in its ability to represent the past more accurately or more comprehensively (although if my version of the past is accepted that is what it will become given the persistence of modern understandings of knowledge), but in the political outcomes such a history makes possible. I have found the analytical concepts of actor-network constructivism useful because together they make a space free from the many assumptions that have become entangled with popular understandings of the way science and technology proceed. Within this space it has been possible to deconstruct and reconstruct the empirical and multifaceted world of scientific and technological practice 269 constitutive of the successes and failures of the intrauterine device contraceptive system, and of the women users, their sexed bodies, and the authority of the expert. Actor-network constructivism provides angles of triangulation along which to reconstruct the labour of diverse groups that went into stabilising and destabilising technological practices and scientific claims about intrauterine device efficacy and safety. This enables the constructors of the future to confront past stabilisations of socio-technical networks as potentially precarious and contingent materialisations sustained by situated and specific regimes of practice. Reconnecting women, health and technology: What can we learn from a constructivist history of the intrauterine contraceptive device? Other strategies for organising the empirical reconstructions of scientific facts and technological innovations, such as histories centred around realist epistemologies, privilege the knowing subject confronted by a world of objects. Such narratives create the impression that technologies and matters of scientific fact are set in concrete, the outcome of natural trajectories of progress and improvement. For those who want to justify and endorse the increasing technological interventions into the sphere of female reproduction - in contraception, childbirth, through the new reproductive technologies, and via embryo experimentation and human genetics - the rhetoric of progress and modernisation provides a positive resource. But opponents of reproductive technologies frequently explain their development in the same mode. The emergence of expert-controlled technologies, offering a high degree of domination over nature, but at the cost of disempowering women, are thought of as the natural outcome of an objective scientific and technological practice that cuts itself off from the sphere of human and cultural relations. The inevitability of the increasing 270 technologisation of life is frequently accepted even by critics as the natural outcome of science and engineering perse. This induces a sense of poweriessness before the onslaught of technologies that are thought to have traversed an inevitable trajectory of development under the guiding hand of science, putting it beyond ordinary human influence. Interventions into the technological realm are reduced to rejecting technologies perceived as outcomes of a patriarchal juggernaut bent on domination and control of women and nature. Whilst this approach points to the structures of science and technological development supporting technological change in a particular direction, thereby contradicting the view presented in many realist narratives of technological development that such technological trajectories are natural, and ultimately progressive, they also construe those structures as monolithic. I find this approach profoundly disempowering. Certainly, I would agree with feminist critiques of science that reject the doctrine of objectivity with its promise of a knowledge that transcends culture. As Donna Haraway points out, this is 'a story that loses track of its mediations just where someone might be held responsible for something'.15 But to throw science and technology out with the patriarchy is to take the stories told about these realms as descriptive of the action in them. Feminists would, I believe, be better served by replacing these stories of subjects confronting objects, and the transcendent unveiling of nature, with feminist notions of knowledge as situated and locally achieved. 17 1® Haraway, 'Situated Knowledges', 1991. p. 107. 17 Haraway attempts to reclaim and redefine the notion of objectivity through equating feminist objectivity with situated knowledges. It is yet to be seen whether such an attempt to take-over the privileged terms from the master's house is as successful as the attempts by marginalised groups to create new identities out of terms of abuse (eg. 'we're queer, we're here, get used to it'; 'black power"). Haraway hangs on to the pole of materiality to differentiate herself from the 'anything goes' rhetoric of certain interpretations of postmodernism that reduce everything to language use. Haraway wants a place for the n^teriality and surprising resistances that non-human, as well as human actors, exhibit towards knowledge claims made on their behalf. I am with Haraway on this, although more sceptical of rehabilitating the notion of objectivity. 271 Actor-networi< constructivism is helpful to such a project because it deconstructs the scientific certainties of historical narratives structured by epistemological realism and places scientists, engineers and doctors on the same playing field with lawyers, consumers, and politicians. This is not to say that these groups have equal power. It is to position them as possible players in a range of situations that are constitutive of new technologies. And it is to reappraise power, as Foucault has done, not as something that individuals have as a result of their social class, gender, or will, but as a function of the strategies various actors have access to and pursue, as they circulate within existing networks of conventions, mobilising resources and enacting displacements.i8 The primary message of my thesis is that medical technologies and the knowledge claims made concerning their safety and efficacy are thoroughly contingent on situated processes of negotiation and solidarity formation. There may be differences between how the situation of the court and the situation of the Population Council's clinical trials enable the negotiation of consensus, but strategies appropriate to each setting are pursued by participants. Neither the strategies nor the settings are inherently privileged as more rational, nor as neutral with respect to the production of what comes to count as truth. What I have detected is that it is in the interests of technological innovators to shroud the intensely difficult labour that enables them to link together and stabilise particular linkages - of knowledge claims, subjectivities, objects, day-to-day practice - in a history of discovery and determinism by nature. Such histories enable some social groups to embed within scientific knowledge claims and technologies their values, interests, and visions of future social worids - including what counts as natural and how this 1^ Here I am in agreement with John Law: We can tioth go along with Foucault's injunction to study the micro-physics of power, revealing the techniques which create power effects rather than treating the unequal distribution of power as a structural given, and insist that relations that are stabilised, however precariously, so as to create power effects can confer differential distributions of power on various actors. See Law, 'Power, discretion and strategy', 1991; and Law, Organising Modernity. 1994. 272 is incorporated into such social worlds - whilst repressing all trace of such mixing-up of social and techno-science worlds.i9 In contrast, I have organised my telling of the story of the development of intrauterine device technology around the contention that the value of scientific and technological work is not provided by its access to socially unmediated representations of reality, but by its clotting together the networks within which we are differentiated from our environment and empowered to act in certain ways and not others. By presenting a thorough-going constructivist narrative I have not set out to detract from the rigour with which scientists pursue the contingent construction of Interfaces between the human and material worlds, reconstituting both in the process. The protagonists of the intrauterine device were both skilled political operators and highly skilled craft-workers. Given the decisions made concerning criteria of success, they were, during clinical trials, able to stage the success of their heterogeneous network of bodies, practices, things, chains of alliances from labs to governments, linguistic representations, and knowledge claims. My point is simply that any clinical trials, no matter how carefully they are designed, always produce findings that are thoroughly saturated with the decisions and situation from which they are produced. Structuring narratives of technological invention, success, development, and failure in such a way that we no longer systematically repress the conditions of production for the certainties of science and technology that we now take for granted enables ongoing interventions into the technological networks that we inhabit. Focusing on different stages in the history of the intrauterine device enabled me to highlight the negotiated and contingent character of technologies in various ways, thereby demonstrating a range of examples of the possibilities for action that actor-network constructivism opens up.20 19 Latour, "One nfX)re turn after the social turn", 1992. 2^ This discussion is much indebted to Mackenzie, Inventing Accuracy. 1990. pp. 382 - 423. 273 Invention Examining the invention phase, particularly the work of Grafenberg from the first decade of the twentieth century to the 1930s, I have emphasised the following points: (1) The invention of the Grafenberg ring was not a single autonomous act. (2) The invention of the Grafenberg ring was highly dependant on the local conditions of production that dispersed authority for health clinics, emphasised preventive health, and had politicised health, making its management a contested terrain on which political opponents struggled to mobilise supporters. (3) The invention of the Grafenberg ring was as much the outcome of rhetorical strategies as of the mobilisation of clinical evidence. Grafenberg deployed a rhetoric labelling his devices a new method of contraception, thereby strongly disassociating them from the many designs of stem pessaries available in Germany at the beginning of the twentieth century. (4) The Grafenberg ring achieved partial success because Grafenberg paid attention to a heterogeneity of elements. Thus, the question of which shaped device would best resist the efforts of the uterus to expel it was neither more nor less important than Grafenberg's attention to professional politics. Shifting an 'A causes B' statement, to the statement 'A causes B because of C was critical to winning over other clinical practitioners. Grafenberg translated the statement 'devices inserted into the uterus cause harm', into the statement 'devices inserted into the uterus cause harm because they link the vagina to the uterus'. (5) The Grafenberg ring was partially successful in moving beyond the local German context as much due to social matters as to the persuasiveness of scientific data - the acceptance of the Grafenberg ring by some of the clinics associated with the sex reform movement was in part due to their strategy of 274 seeking doctor controlled contraceptive methods as a sign of modernity and scientificity in an attempt to legally expand contraceptive distribution. (6) The Grafenberg ring was consolidated as a particular kind of contraceptive device because it had to be constituted for an audience that included women organising for happier marriages via sex reform, and an ethics of equity in the pursuit of sexual pleasure. My aim in discussing the invention phase of the intrauterine device in chapter 2 was to demonstrate the interpretative flexibility of invention in order to emphasise how women, even without scientific expertise, exerted an impact on the invention of this contraceptive device. In order to do this I had to deconstruct the rigid boundary that had ossified between the invention of the intrauterine device, an event which according to populist assumptions occurred inside the clinics of people such as Grafenberg and Richter, and its precursors, context of production, and distribution. I wanted to highlight the work that Grafenberg had to do to categorise his device as a new invention. Was the Grafenberg ring a new device, or simply a different version of the well known and characterised class of stem pessaries? This was a matter for practical negotiation. Grafenberg's skill was not in discovering a more reliable and entirely new kind of contraceptive. It was more prosaic. He was a skilled statesman flattering his professional colleagues - they and they alone could insert such a device without mishap; distinguishing his devices from the stem pessaries by emphasising their lack of external protuberances; appealing to women who wanted to become modern women controlling reproductive outcomes whilst enjoying the pleasures of the flesh, but who felt uncomfortable admitting to their sexual desires - touching themselves. Evidence of his success with the devices played a role in his attempts to recruit new supporters into his network of shared meanings and practices, but it was not the sole determining factor. Moreover, if we take this view, then the division between invention, innovation and development begins to dissolve. 275 With it dissolves the traditional focus of history of technology on the figure of the inventor, creating an opening for the exploration of the role of other groups, downstream of the clinic, workshop or laboratory, in the formation of the new socio-technical network that is the emergent technology. My interest was particulariy in the role of women, who, frequently absent from the past ranks of scientists, engineers and researchers, are so frequently diminished by being allocated the role of mere recipients. This brings me to the second theme emphasised in chapter 2: how did women's active and organised participation in the sex reform movement make a difference to the emerging intrauterine device paradigm? At that time, given the generally hostile response of the medical profession, this was a movement with which Grafenberg was forced to seek an alliance in order to achieve international distribution for his coils. Through embracing the intrauterine device as a bearer of scientific rationality, and endorsing the extension of science into what had culturally been construed as women's realms, including that of reproduction, sex reform women hoped to annex scientific contraception to their own goals of extending the emancipation won by the suffragettes into all spheres of live, particularly that of marriage and home-life. To accuse these women of false consciousness, of being duped into accepting male medical control over women's bodies, is to miss the flexibilities of the new technologies. The marginalisation of contraception by the medical profession in many countries, even In the 1920s and 1930s, meant that women were able to Influence the shape of the intrauterine device, imagined as a collectivity of knowledge claims, devices, people, and settings. The intrauterine devices of the 1930s and 1940s were seen as an alternative to the diaphragm - a woman controlled contraceptive method enabling women to pursue happiness in their partnerships with men. This is not to say that the sex reformers were unconcerned with eugenics. But there already existed a perfectly adequate means of limiting the fertility of the poor - sterilisation. A 276 contraceptive method requiring frequent visits to the doctor, as was promoted by protagonists of the Grafenberg ring, was prohibitively expensive to compete in the networks of negative eugenics. It would be another 20 years before this device was refashioned as a superior contraceptive, ideal for insertion into women who lacked the ability or will to practice rational control over their reproductive bodies. SuPQg?? The intrauterine device network established by Grafenberg was picked up by Christopher Tietze in the 1960s and transformed to become the compulsory passage point for certain women in a new and much expanded actor-network. In chapter 3,1 emphasised that in this 'innovation phase' the work of re-making society was as important, and went hand in glove with, the work of remaking the worlds of nature and things. Social engineering was integral to the reconstruction by Tietze, working with the Population Council, of an intrauterine device contraceptive network that could control population growth on a global scale. The success of Tietze's and the Population Council's efforts relied on extensive reconstructions of social groups and their relations such as the transformation of fertility in the developing worid into a problem for the west; the building of organisational and governmental commitments to intrauterine device contraception; and the total remaking or recharacterisation of the material entities involved in the intrauterine device socio-technical network. Moreover, this episode in the history of intrauterine devices showed very clearly that protagonists of intrauterine device contraception had to have just as much an eye on the political contingencies that might impinge on their efforts as they did on the behaviour of plastics and physiology. The second task of chapter 3 was to take a more detailed look at precisely what role clinical trials played, and to examine how such a trial operated in the achievement of a new consensus amongst medical 277 professionals concerning intrauterine device efficacy and safety. It is my contention that politics are as much part of clinical trials as they are any other part of life. The interfusion of the techno-scientific and the political can be elaborated in a variety of ways that go beyond the organisational and institutional politics more commonly associated with histories of technology: (1) The National Committee on Maternal Health research into the intrauterine device was aimed at building something sufficiently robust to intervene in the prevailing professional politics within the United States in order to enrol its medical critics. (2) Tietze's success was significantly indebted to his vigorous pursuit of a supporting network that outflanked his rivals. The conferences on intrauterine devices organised by the Population Council in 1962 and 1964 played a crucial role in building an independent network of support outside the influence of the gynaecological associations. Through these conferences Tietze consolidated an international network of Intrauterine device supporters. (3) Tietze and his colleagues displayed a keen eye for strategy, and sound judgement about the persuasive powers of various interventions. By setting up the Go-operative Statistical Program, under the auspices of the National Committee for Maternal Health, a neutral face could be given to intrauterine device testing. Individual inventors such as Jack Lippes always faced a credibility problem. The struggle over who could speak for intrauterine devices remained a battle between individuals. On the one side a doctor whose patients had experienced problems following the insertion of an intrauterine device, on the other a clinician-inventor reporting a few hundred cases of success. Tietze tipped the scales by recruiting many of the latter into a single testing system. Within a year Tietze was able to enrol or at least silence many of the critics of the intrauterine device. (4) The Go-operative Statistical Program was shaped by many factors. The long-standing hostility of the medical profession in the United States 278 influenced the choice of methodology. By linking together the reports of intrauterine device use from hundreds of women from differing places who had used the device for one month, three months, perhaps six months, and later for longer periods of time, Tietze was able to produce, in a very short time reassurances that the trials were producing promising results. (5) The trials embodied many social decisions made about how to construct and analyse the data, and the 'success' of the trials cannot be separated from a host of material technologies and sometimes random decisions brought to bear on their production. Would the judgements concerning the successful staging of intrauterine device use have been different if they had been tested on groups of women where casual sex was the norm, or where the trial protocol called for the continuous observation of pregnancy rates amongst women for a year after their intrauterine device had been removed? What would the results have looked like if the trial methodology had not drawn so heavily on a comparative testing tradition developed not for devices of known dangers inserted inside the body, but for the physical barrier methods of contraception which were much less able to exert harm. We will never know. But my point is that the knowledge claims made about risks and benefits, and their articulation in these terms, cannot be separated from the conglomerate of practices, tools and decisions that produces them. (6) This is not to say that the trials are unimportant, or that one knowledge claim is as good as another, but it does reconstitute scientific knowledge production as a craft more akin to carving a bowl from a lump of wood, than a mountain-top encounter with God's truth. The 'bowl' of risks and benefits can/ed out by Tietze was strategically designed in an attempt to be compelling. However, the success of the trials is not solely due to their internal characteristics. The intrauterine device became a compulsory passage point neither because of anything designed in the laboratory, nor any attribute of the clinical trials. There remained problems with the intrauterine device, as is the 279 case with any new technology, that could have fuelled an opposition movement against them. The Co-operative Statistical Program may not have won the day unless opposition to intrauterine devices, along with opposition to all kinds of contraceptives, was collapsing anyway. Moreover, the new intrauterine device actor-network had to enrol other actors beyond the walls of the laboratory. Here, it was its ability to enrol major aid organisations in the United States and the United Nations, and its position as technical adviser to studies and clinics established throughout the developing worid - conducting studies into knowledge, attitudes and practice with respect to family planning - that enabled the Population Council to translate its intrauterine devices into a global network of contraceptive programs aimed at enrolling local doctors and women. Science studies analysts have paid a great deal of attention to what goes on inside laboratories. What I would have liked to have shown in more empirical detail is that equally important to an explanation of the success of a new technology is the downstream arena where the technology is established as a myriad of in-use situations. Given more time and resources I would very much have liked to have included in this study a deconstruction of some of the processes of technology transfer that occurred with the intrauterine device, investigating the contingency of such processes and the ways in which diverse local conditions were differentially translated and stabilised into intrauterine device socio-technical networks. What I hope to have demonstrated is that clinical trials are important in harnessing the power of non-human actors and adding them into the semiotic and practical action alliances between humans. Tietze builds a powerful alliance between the medical profession and population controllers because he is able to substitute a single paper reporting the Co-operative Statistical Program for the many papers reporting successes and failings from disparate practitioners. The trials are a crucial staging of the disciplined interaction 280 between doctors, women, plastic devices, wombs, blood, and microbes that the Population Council promises is possible. Given the background of a panic over population explosion, judgements are made that most of the women do remain healthy; most devices are inserted without perforations; enough microbes seem to be staying in their place and not breaching the normal barrier that keeps them outside the womb; and whilst some devices are expelled or removed many more women continue to use them, some without problems with anaemia. We don't need to accept the claim that clinical trials are neutral mechanisms for generating transcendent knowledge claims to appreciate that feminist groups interested in better health for women are going to need to engage in generating such stagings for alternative networks of practice strategically targeted at women, doctors, governments and other relevant groups. Failure My aim in chapter 4 was to show how failure was constructed using exactly the same mix of rhetorical, social and technical strategies apparent in the construction of success. I examined the rise and fall of the Dalkon Shield as an example of the failure of a technology. If success has to be explained rather than taken as given in the reality of experience, then so too does failure. For the Dalkon Shield the stabilisation of a particular design with a set of knowledge claims about safety and efficacy was not achieved once and for all. Clinical trials, laboratory studies, and approvals by govemment committees contribute to processes of closure, strengthening and supporting the linkages constitutive of actor-networks. But new spokespersons can always emerge and throw into question the representativeness of the entities on whose behalf the spokesperson claims to speak with authority. Tietze could speak with such authority on behalf of the various devices and thousands of women who had participated in clinical trials of intrauterine devices, but were such devices and women representative of new intrauterine 281 contraceptives, or of the women who had intrauterine devices inserted after they were released for general use? The Dalkon Shield fiasco commencing in the mid-1970s brought new players into the intrauterine device network including Congress and the Food and Drug Administration. The Population Council was able to characterise the shield as a hazardous device with a key difference from other intrauterine devices. The Dalkon Shield came to be characterised as an isolated Intrauterine device design failure, at fault because of its multi-filament tail. The United States courts found Robins, the manufacturer, negligent in its testing and reporting. The court's authority is legitimated by its self-representation as able to sort the different claims being made by a variety of experts, to put them into a rational framework or hierarchy in which fact is separated from values and opinion, so that the objectivity of science can be enhanced.21 What I hope to have demonstrated is that the failure of the Dalkon Shield involved not so much the triumph of abstract processes of reason and truth, as a multifaceted production process in which the outcome was to fabricate what counted as truth and what as reasonable. It is fruitful to think of the construction of the Dalkon Shield as a defective and dangerous intrauterine device as a lengthy process of actor- network building. A long string of alliances had to be built up before this interpretation of events became dominant. The evidence from scientific studies such as the epidemiological studies of in-use intrauterine device risks proved to be of strategic value in these negotiations, just as Grafenberg's tables and charts had been Important in achieving a space for the testing of his devices despite the extremely hostile position of most medical professionals. However, it was not the results of any particular study that dictated the Dalkon Shield be condemned outright. Rather, it was the best ^1 Wynne, "Establishing the rules of laws: constructing expert authority", in Smith and Wynne (eds.) Expert Evidence: interpreting science in the law. 1989. Also in the same volume: Smith and Wynne, "Introduction". 282 outcome for a whole range of interest groups that had formed and become part of the intrauterine device network in the United States. The very context of litigation on an unprecedented scale fed into the interpretation of studies, with the call for the banning of a defective device eventually becoming sufficiently robust that many disparate groups came to identify this categorisation with their interests. Many feminists have been uncomfortable with this unpacking of the truth claims about the Dalkon Shield. They have reminded me of the reality of the experience of pain suffered by many of the women now receiving scant compensation, and argue that this surely must be listened to and respected. A critique that suggests that the authority of the court and of the scientific and historical evidence presented there were derived from localised and situational chains of convention would seem to undermine the voices of the women who were the victims of Robins' negligence. But this is only the case because we are accustomed to thinking of the truth of knowledge claims being undenwritten by the authority vested in the subject of the judge, the scientist, the eye-witness. My argument with this is that it puts too much faith in the power of the knowing subject. This is not enough. We need to understand how such power comes about, that is how the technologies productive of the representations taken to be descriptive of reality work. It is not merely the desire for internal consistency that prompts me to deconstruct the production of the Dalkon Shield as a failed technology. What motivates me is the desire for more effective feminist engagements with the politics of knowledge production, particularly with those technologies linked to women's health. It is not enough to believe that the truth of women's experience will win out once the patriarchal silencing of women ceases. Activists require the tools for producing particular aggregations of bodies-artefacts-knowledges in the court, the clinic, the clinical trial, and the epidemiological survey, and a keen grasp of the strategies through which robust life-worlds that enhance women's 283 health can be held together. This is not to say that we should take up the master's tools uncritically. But approaching the tools required to intervene in the formation of socio-technical networks, with an actor-network perspective, a perspective that analyses how collectivities and solidarities are produced and reproduced, brings a self-critical dimension that undercuts objectivist delusions that are usually linked to their use. Even feminist knowledges and socio-technological networks prohibit and make real only some of the plurality of women's experience. Can we afford not to participate in the complex and messy interplay of materiality, knowledge claims, and alliance building that will constitute women's reports of pain as malingering, an unfortunate accident, the burden of Eve, or the result of corporate negligence, tying the pain into one network of linkages or another? As Donna Haraway has said We need the power of modern critical theories of how meanings and bodies get made, not in order to deny meanings and bodies, but in order to build meanings and bodies that have a chance for life.22 Development The future development of a technology is always a precarious matter, there is no trajectory along which it moves as though there were a railway track laid out before it.23 in chapter 5,1 considered what some would call the development phase of the intrauterine device technology. My first aim was to re-present what retrospectively appears to be a pathway of progressive improvement arising internally under the momentum of emerging problems. I wanted to examine how such an impression was created from the combination of arbitrary events and the actions of various interest groups that were, at various times and places, inserting themselves as interested parties to the development of the medicated intrauterine devices. 22 Haraway, "Situated Knowledges", 1991. p. 107. 23 In deconstructing the notion of a technobgical trajectory I follow Mackenzie, Inventing Accuracy. 1990, pp. 385-388. 284 The second issue dealt with in chapter 5 concerned the downfall of the Copper-7. Thrown into stark relief by the story of the Gopper-7 was the always provisional character of device success. The Dalkon Shield court case had dragged on for well over a decade with the result that many new players were involved in the intrauterine device socio-technical system, and many lacked the primary investment in keeping the technology as a whole viable that had characterised eariier human actors enrolled Into intrauterine device contraceptive networks. New allegiances and ways of seeing intrauterine device use were forged between these new actor groups: law firms that had built up expertise and resources for conducting contraceptive product litigation, women with injuries they thought were linked to intrauterine device use who had met each other and formed lobby groups and networks linked by newsletters and activist events, politicians and journalists who had developed audiences and constituencies concerned with therapeutic device testing and government regulation of a profit driven pharmaceutical industry, and agencies that had been formed and charged with subjecting therapeutic devices to the same kind of scrutiny established for drugs. In 1988 the Copper-7 intrauterine device was declared hazardous, or at least inadequately tested, for its prime market - young women. The 1988 finding of the United States Court that Searie suppressed data that could have led researchers to investigate the representativeness of clinical trial participants had repercussions across the globe for all intrauterine device actor-networks. This is not because the judiciary has the power to sort out the confusions in cases where scientific evidence is complex and contradictory. Rather, the court's power derives from the effects set to flow from its decrees due to its location within interlocking actor-networks of power, including the policing and administrative functions of the state. In this case, the court acted to take the question of risk out of the uncertain arena of the medical research literature and reinsert it into a new context of linkages between binding 285 conventions involving manufacturers and injured parties. The Kociemba vs. Searle findings set new standards for manufacturers, not in the testing and clinical trial arena, but in company responsibility for monitoring and responding to the in-use situation. Clinical trials institutionalised by Tietze as the measure of intrauterine device efficacy have been reinserted into a new alignment of institutionalised relations and behaviours, with the comparative trial providing predictions about expected outcomes rather than the actual safety and risks of a technology. Under pressure from insurers, Searle responded by withdrawing the Copper-7 from the market. It will be interesting to see whether in the future manufacturers of therapeutic devices will pay more attention to the in-use situation. Implications for drug and device regulatory policies The story of the Gopper-7 urges a reconsideration of the politics of knowledge production currently dominating the pharmaceutical arena. At present in both the United States and Australia, the clinical trial of a new drug or therapeutic device bears the brunt of stabilising controversy between diverse groups - manufacturers, governments, clinicians, consumers, insurance agencies, and the courts. By setting up the clinical trial as a transcendent space that cuts knowledge claims adrift from the situated network specificities operating within them, this fantasy of a neutral arbiter turns the devices into commodities with independent properties from the in- use situations within which they circulate. When usage leads to an increase in human suffering this historical tale of a fully tested technology prevents analysis of the technology, instead diverting attention to various social factors that are portrayed as undermining the good that ought to follow the proved technology.24 The belief that risks and benefits are properties of things, that 24 This point is brought home very starkly in Shiva, The Violence of the Green Revolution. 1991. 286 can be revealed by science, has lead, with each failure, to intensified attempts to standardise and expand the scope of clinical trials. The high cost of the trials misleads the public into believing that the safety and efficacy of new drugs and devices is assured. What is consistently misrecognised in attempts by government regulators to respond to the failures of its regulatory system, is that no matter how well such trials are carried out, they cannot separate facts from values. Over time, the cost of the clinical trial as a consensus generating machine has dramatically increased. Almost all parties now express concern over the prohibitive cost of bringing new drugs and devices to the market. Perhaps it is time for regulators to recognise that the packages presented by companies for market approval of new devices are necessarily partial in their presentation of the effects of a new technology, involve interpretations of rules of scientific method that are specific to and shaped by the situation, and construct a highly contingent set of data on safety and efficacy that is inseparable from both covert and overt value judgements that become built into trial protocols.25 One way of solving this problem might be to allow local rather than national decisions to be made. With state enforced requirements for surveillance open to all interest groups, this could allow incremental learning, and would enable problems that arise from the construction of technological networks at the local level to be scrutinised and attended to. In addition to demanding of our device manufacturers that they stage a successful performance of the socio-technical network under construction (the clinical trial), a more decentralised approval process might pay more attention to what Ruth Schwartz Cowan has called the consumption junction.26 in this context the local component of multicentre, multination trials could provide valuable 25 Here I am indebted to Wynne"s influential study, Risk Management and Hazardous Wastes. 1987. See p. 403. Although Wynne discusses scientific assessment of hazards with regard to wastes, I found his carefully reasoned dismantling of the certainty we attribute to scientific assessment of risk has many parallels with drug and therapeutic device evaluation. 26 Cowan, "The Consunptbn Junction", 1987. 287 information. Local trials could be conducted as new technologies were introduced, partly as a means of determining what adjustments were needed in local systems of uptake of new technologies. The failure of adverse reaction reporting schemes could also be addressed. The ways technologies in-use circulate are frequently neither predicted nor foreseen by their originators. Another possibility might involve multiplying the tools being brought to bear on the process of national consensus formation. If we recognise the partial and situated character of knowledge claims then no wonder the cost of running a trial that takes its claims beyond the reach of possible challenges has escalated. I am not demeaning the importance of clinical trials. But, I believe the fiction that such trials can stand-in for the reality of the in-use situation is losing its convenience. Instead of pouring money into a process we imagine can deliver transcendent truth, perhaps we can better direct resources towards ensuring responsible action. Such an approach would recognise that drug and device evaluation performed at the national level involved regulators in an inseparable mix of science and policy. I believe that it is often overiooked that the aim of expert panels or standing committees, frequently drawn upon in drug and device assessment following the eruption of controversy, is the generation of a consensus that will hold as credible with all stake holders, and that this has as much to do with questions of justice, as it has with information.27 At the very least, this might involve insisting that pharmaceutical manufacturers take greater responsibility for fine tuning local implementation systems. Feedback loops that enable the voices of consumers to participate in the ongoing strategies of network formation constitutive of the in-use technology could also play a role. Imagine a visit to your local family planning centre where, as well as accessing the expertise of a doctor or health worker, you could check on-line for the results of a consumer conducted report 27 Here I am in agreement with Jasanoff, The Fifth Branch. 1990. 288 investigating, from a consumer perspective, the advantages and problems encountered with long acting contraceptives that are implanted into the body. Such studies could include experiential reporting of the type that is systematically excluded from mass clinical trials. Perhaps you would also be able to access a readily understandable account of the basis for decisions regarding marketing approval. Registers of users, in the case of new technologies, could be used to monitor long term effects and events that were undetected by trials. And such registers could be deployed to enable the better tracking of adverse reactions which could also be accessed via the clinic computer. Such mechanisms would add to the existing technologies in the intrauterine device contraceptive system aimed at configuring the user, such as advice for health workers on who makes suitable candidates or information pamphlets for consumers, and actively involve users in such processes.28 if we translate the intrauterine device out of a network aimed at cheap population control, instead building a network aimed at safe-sex for women, the place of the intrauterine device as artefact, and the mechanisms of practice to which it is attached, might indeed be very different. Whilst I am not positing such mechanisms as more objective, perhaps by developing multiple means of bridging the gap between bio-engineers and manufacturers on the one hand, and doctors in general practice and consumers on the other, knowledge generating mechanisms can be implemented that will alter the relationship between participants in a technological system and take the pressure off the clinical trial as the sole edge on which increasingly diverse interest groups must be balanced and stabilised. Rather than rejecting the intrauterine device, or other long acting insertable contraceptives that have been condemned by some activist feminist groups as devices for extending (male) medical control and domination over women, I want to advocate that consumer organisations and feminist health 28 Perhaps the pharmaceutical area could learn something here from the computer area. See Woolgar, 'Configuring the user", 1991; and Suchman, Plans and Situated Action. 1987. 289 activist organisations become more involved in the co-construction of the in- use networks within which particular contraceptive artefacts take on meaning and efficacy. Such participation could begin at the level of the clinical trial. In the contraceptive field, other options, such as safe sex that does not risk pregnancy, or changing plans about family formation, are compared by individual women with use of devices and drugs. Women are increasingly expecting access to whatever information is available before opting for fertility control methods. The staging of a multi-national, multi-centre successful trial of a socio-technical system should be openly scrutinised, not only by experts operating at the national level charged with protecting the public health, but also at the local level by community based health workers and consumer oriented experts who can bring local knowledge to their scrutiny of the representivity of the trial in relation to their communities. Furthermore, such scrutiny needs to be a publicly open process if the interests and perspectives of communities underrepresented in early development phases are to be incorporated. Manufacturers have hidden behind commerclal-in-confidence legislation to keep any such negotiations closed and limited. But keeping in mind the interpretative flexibility that is always part of an experimental system, the enforcement of closure on potential controversies over trial adequacy, by a cosy alliance of pharmaceutical companies and government regulatory agencies acting behind closed doors, may backfire, with opponents forced to negotiate through litigation. Too many women have been injured by intrauterine devices because the clinical trial has been viewed as a definitive test of a device's safety and efficacy. This results in the devices being cut off from the heterogeneous technological networks required for them to be anything else but meaningless decorative items. Consequently, when things go wrong, attention is rarely directed at the technology, despite the contingency of all aspects of design, 290 testing and distribution. It needs to be remembered that a workable contraceptive technology is a situated and local achievement that is not necessarily transferable. In the contraceptive area, the use of clinical trials to promise certainty in the assessment of risks and benefits seems to have rebounded against manufacturers. Litigation against intrauterine device manufacturers seems, at least in part, to be driven by women's anger sparked by their sense of betrayal that the guarantee of safety delivered by clinical trials has failed. The problem of uncertainty, of the gap between the socio- technical network as it is staged in a clinical trial and the actual in-use network as it emerges in multiple local sites, is one that has to be managed by health workers at the clinical level and by health experts making recommendations about drugs and therapeutic devices at national and international levels. The problem has been that users have tended to be excluded from the role of managers; they have been invited to trust the experts whose own uncertainties have then to be glossed over in attempts to maintain authority. Increasingly health consumers are demanding a role as equal participants in the management of such uncertainties, a demand that goes beyond the question of informed consent. Changes at the individual level could also occur. Health workers in the contraceptive field need to develop expertise that goes well beyond providing supposedly neutral information, participating in the falsely reassuring fiction that posits safety (or efficacy) as solely the property of an object, ignoring the complex environment in which it operates. This does not erase a role for health workers in constructing the conditions under which truly informed consent can be given. What it means is that the complex life-situations of women seeking to enrol a contraceptive system into their life-worlds, in order to meet a range of goals, deserve careful eliciting and discussion. Rather than the health worker acting as an authority transmitting objective risks and benefits, the negotiations with women could involve clarification of values and 291 goals, consideration of local factors that might mean that the network assembled and operated during the clinical trial would not translate easily in a particular situation, and discussion of the subject positions that the user will or might have to occupy within the contraceptive system. Moreover, with the introduction of any new contraceptive, users have, I believe, the right to know that they are participating in an experiment involving a new device that may, or may not, 'succeed' as predicted by clinical trials. This means an increased responsibility for self surveillance, and for access to medical personnel to discuss problems, quickly obtain removals, and treat emergencies. Systems that insert slow release chemicals and devices inside the body have been developed in the contraceptive field as a relatively cheap means of ensuring efficacy of fertility control by transferring social functions from people to devices. Ensuring compliance is no longer a matter of a user's behaviour, the behaviour of their partner, or a health worker's skill at teaching women to feel comfortable with their bodies and in control of their sexuality. Yet, this quest for increased contraceptive efficiency masks the social system that takes shape and must co-exist for these devices to work safely. Women's desire to practice safe sex has been exploited by promoters of scientific contraceptives who promise certainty with the removal of the need for active, everyday negotiations and decisions to make sex safer. What is frequently left unsaid is that the very use of these same devices, in order to minimise health risks, relies on users constantly monitoring their health, being ever surveillant for symptoms that may or may not be present as indicators of infection, and feeling comfortable to negotiate with their partners about additional protective measures whenever there is an increased risk of transmitting sexually transmitted diseases. In many post-colonial countries, the desire of national governments to plan their economies and to be able to deliver higher standards of health care and education to their populations has been exploited by promoters of long acting contraceptives that can be cheaply 292 inserted and then relied upon to ensure fertility control. The lesson of intrauterine devices is that for its safe use a complex medical back-up system was required. Such devices are unlikely to offer a cheap route to safe sex and women's health. Finally, governments and the medical profession cannot rely on pharmaceutical companies to do all the trials and tests for new therapeutic goods. The present attitude seems to be that once market approval has been granted, in the case of intrauterine devices after scrutiny of clinical trials and laboratory data on carcinogenicity, the government health agencies have no role until a device has been 'proved' dangerous, in a sufficiently robust manner so as to resist the investments of the manufacturer in clinical trials that 'proved' the contrary. Both the Australian and United States governments have heavily invested in health. But very little interest seems to be taken by governments for monitoring the in-use situation of new technologies. Audits of new technologies could involve adjustments in systems design, reconfiguring the network so as to lower risks or the potential for harm. After all, in any country where substantial investments are made by governments in health care, it is governments and not manufacturers that pay when failed technological translations result in increases in hospitalisations and visits to the doctors. And that is to say nothing of the individual suffering endured by hundreds of thousands of women that could have been avoided. Improvements in the capacity of government agencies to behave at this middle level, an organisational positioning not available to individual clinics and health workers, might prove more beneficial than the current pursuit of managerialism in which doctors must seek bureaucratic approval before commencing certain treatments with their patients. It has taken almost two decades of litigation for the suffering inflicted on women users of intrauterine devices to reshape the medical networks in which they circulate. The copper intrauterine device, the Paragard, circulates, at 293 least in the United States in a reconstituted intrauterine device network. New medical practice guidelines have been issued, setting best practice standards involving counselling aimed at informed consent and weeding out potential users who might be at risk of Pelvic Inflammatory Disease, due to their or their partner's exposure to the flora and fauna of multiple sexual partners. New consent forms have given consumers detailed information about risks known through clinical trials and the courts, and made them individually responsible for weighing risks and benefits, exercising their subjective judgements about which risksthe y are willing to take, and choosing contraceptives appropriate for their individual beliefs and life-style. Health practitioners are more aware that lives of intrauterine device users can be put at increased risk if they are isolated from appropriate medical services. Hopefully what has been learned from the intrauterine device experience will be implemented with alternative contraceptives, particularly Depo-Provera and Norplant, that have emerged for 'unmotivated' women. Already stories of women unable to have Norplant removed because of inadequate training of local medical staff have begun circulating.29 Hopefully, It will not have to wait for litigation to oppose the unsafe extension of these socio-technical networks. Conclusion The stories we tell about technologies, science and medicine matter. This thesis has presented a story of the invention, testing, success, failure and development of intrauterine device contraceptive systems, a story that works against the grain of those histories favoured by the already powerful. With Leigh Star I want science studies accounts that can open up possibilities for action for those who have their lives made painful by the standardised subjectivities produced in processes of building techno-scientific worlds. I 29 Farida Akhter, presentation at the Feminist Book Fair, Melbourne, 1994. See Akhter, Depopulating Bangladesh. 1992, for a confronting analysis of population control in Bangladesh. 294 have found useful the actor-network approach favoured by Latour and Gallon - their invitation to follow the actors around through all the heterogeneous messiness as they translate human and non-human worids together. However I have tempered this with the engaged positionality once so fervently followed by the Radical Science Journal Group. Unlike them I do not espouse an emancipatory politics in which the historian works to provide an account of the past, freed from ideology, that can guarantee that present action will ensure liberation. Mine is a history designed to enhance the possibility for those who cannot comfortably step into existing socio-technical forms to surpass the possibilities encoded in socio-technical histories, and in so doing to begin the process of inventing new socio-technical worids and self-other-thing identities. My relationship to the Sociology of Scientific Knowledge tradition is more complex. The best practitioners of this sociological tradition rightlyinsis t on a social constructivism that keeps a firm hold on race, class, gender and imperialism, paying attention to how these large scale forms of social organisation play a role in determining which possible pathways are taken, given the interpretative flexibility of and in technological systems. I do not want to place these categories back on the historiographical agenda as structural givens to be revealed by the careful scholarship of the historian. However, I have taken these concepts as strategic. This does not mean that I have valorised certain forms of struggle, taking these as somehow given in the unified identities produced by such macro-social structures. Rather, I have examined the operation of such identities and the roles they have played in constructing the socio-technical worlds through which intrauterine devices can circulate. It is my hope that this socio-history of the intrauterine device will make possible the amplification and replication of a more democratically engaged practice of rebuilding socio-technical networks. Women have struggled throughout the twentieth century for a multiplicity of cultural forms that connect 295 sex with safe and chosen pregnancy and good health in diverse pleasurable situations. At the heart of the formation of these many ways of life have been contraceptive socio-technical networks. Sometimes these have been stabilised in ways that create hazardous passages for women with such goals, and that disempower users. Yet, it is not a matter of cutting ourselves, as women, off from scientific medicine and the technologies it embodies. Yes, we must insist that problems, technological solutions, and the means by which we judge them to be safe and effective are co-constructions. This means that subjectivities - identities, desires, needs - and the contingent objectivities through which and in relation to which these multiple self-identities are constructed - bodies, pain, disease, risks, the findings of clinical trials, - are simultaneously both densely bound together in a seamless web productive of the present, and sparkling with fluid possibilities from which new futures, new webs of socio-technical networks with their own arrays of subjectivities and objectivities can be invented. Women's negotiations of these futures will be diverse, but they will be impoverished if they do not include dealing with the messiness of constructing new techno-cultural worlds. 296 Bibliography Where full details of unpublished archival sources have been given in the notes, references do not reappear in the bibliography. In the course of preparing this thesis I consulted the following archival collections: The Alan Mason Chesney Medical Archives, Johns Hopkins Medical Library, Johns Hopkins University, Baltimore, MD; The Clarence J. Gamble Papers, Francis A. Countway Library of Medicine, Harvard Medical School, Boston, MA; Papers of the National Committee for Maternal Health, Rockefeller Foundation Archives, Tarrytown, N Y. I also conducted a number of interviews, most of which have assisted me with general background, rather than providing specific details: Dr Hans Lehfeldt, New York, March 1991. Parker Mauldin, Population Council, March 1991. 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