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Beyond Therapy? Investigating Biomedical Enhancement in The Beyond Therapy? Investigating biomedical enhancement in the case of human growth hormone Michael Morrison, BSc, MA Thesis submitted to the University of Nottingham For the degree of Doctor of Philosophy May 2008 ABSTRACT This project is an investigation of the issue of human biomedical enhancement, taking human growth hormone as a case study. Growth hormone is mainly used to increase the adult height of short children, and is also employed illicitly as an anti-ageing treatment. Both these applications are viewed by bioethicists as going beyond the scope of therapeutic medicine by enhancing normal human traits rather than treating diseases and as such are considered ethically suspect. This project adopts a comparative and retrospective stance, examining the socio-historical development of human growth hormone in the US, where much of the impetus for enhancement uses has originated, and also in the UK where the potential for enhancement uses of pharmaceuticals and other medical technologies is a growing concern. This project combines a social constructivist approach to bodies and disease categories with science and technology studies theory on the emergence and shaping of new (medical) technologies. Research focuses on the development of growth hormone as a medical technology and the construction of the diagnostic categories that define the illness it is employed to treat. A combination of archive material and contemporary interview data is used to investigate and identify factors that shape the way some applications of hGH have 2 come to be viewed as legitimate, accepted practices while others remain unstable and controversial. Enhancement suggests an inappropriate use of biomedicine, but in the case of growth hormone at least, the determination of medical need and entitlement is shown to be more than a matter of instrumental measurements. It is a contingent and socially shaped procedure that is applied in heterogeneous ways at different sites in the networks of healthcare provision. This technique provides a different model for thinking about those biomedical practices labelled as enhancement, which does not share the limitations of that framing. 3 ACKNOWLEDGEMENTS This research was funded by the Economic and Social Research Council (award number PTA-030-2004-00601) My most sincere thanks must go to my supervisors, Paul Martin and Richard Tutton, for their unflagging support, insight, and enthusiasm throughout this project. I would also like to extend my gratitude to my colleagues at the Institute for Science and Society, whose ready and helpful advice and encouragement have benefitted both my work and my experience during the past four years. Particular thanks must go to Alison Kraft, Brigitte Nerlich and Sujatha Raman for their academic support and to Gill Farmer, Pat Hulme and Alice Phillips for their skill and patience in smoothing out the many administrative wrinkles that would otherwise threaten to derail any academic enterprise. I would like to thank all of the informants in the UK and North America who generously volunteered their time and the benefit of their expertise to this project. Finally, thanks to Neil and Betty Morrison for their unflagging support and encouragement throughout this project, and to the rest of my proofreading ”assistants‘, Clare Corlett , Carly Higginbottom, Pru Hobson-West , Anna Hughes, and Allison Pearson. 4 CONTENTS ABSTRACT 2 ACKNOWLEDGEMENTS 4 CONTENTS 5 CHAPTER 1: Introduction 11 What is enhancement? 13 Human growth hormone and ”enhancement‘ 17 Bioethics and the origins of the enhancement / therapy 21 dichotomy The limitations of the enhancement model 25 Human growth hormone as a case study 29 Framework for the thesis 31 CHAPTER 2: Conceptual Background 36 Theorising medicine and the body 41 The birth of modern medicine: A scientific medicine, a 47 social medicine The birth of modern medicine: Biopolitics and public health 54 The era of medicalisation and enhancement 59 Limitations in this framing and the relevance of STS theory 66 Medical technologies in an STS perspective 71 The social shaping of medical technologies 74 5 Networks of health 78 Conclusion 85 CHAPTER 3: Methodology 92 Project design 95 i) Relevant parties: mapping the domain of growth hormone 95 ii) matching cases and methods 97 Data Collection 104 i) Document collection 104 ii) The interview schedule 106 iii) The interview process; practical, ethical and reflexive 110 considerations Data analysis 114 Conclusion 126 Guide to interview respondents 130 CHAPTER 4: The Historical Beginnings of 133 Endocrinology SECTION 1: The New Physiology ”Internal secretions‘: The emergence of endocrinology 137 Brown-Séquard‘s organotherapy 140 Schäfer, Starling, and the rise of scientific endocrinology 143 SECTION 2: The New Master Molecules Hormones in the twentieth century 1: From gynaecology to 149 monkey glands 6 Hormones in the twentieth century 2: Industry and insulin 154 The commercial model 160 Renegades or pioneers? The scientific basis of rejuvenation 164 therapies SECTION 3: Growth and the Pituitary The pituitary in the laboratory 170 Child health, paediatrics and auxology 173 The endocrinology of growth 176 Conclusion 181 CHAPTER 5: The History of Human Growth Hormone 188 SECTION 1: The Pituitary Era New networks in the creation of a new therapeutic 192 Making growth hormone deficient short stature: New 202 technologies of measurement and old ones rediscovered Rationalising and rationing growth hormone therapy 209 SECTION 2: The Recombinant Era The origins of biosynthetic growth hormone and the CJD 218 crisis The new networks of biosynthetic growth hormone 221 And growth for all? 225 Growing markets, shrinking consensus 227 The contemporary uses of human growth hormone 232 Conclusion 236 7 CHAPTER 6: Endocrinologists‘ contemporary 242 discourse on growth hormone The diagnostic repertoire: dual scales of deficit in GH- 247 deficient children The impact of biosynthetic growth hormone: Maximising 258 opportunities for therapy and research Expanded uses of growth hormone: Contingent accounts 260 and the prioritisation of height Beyond biochemical deficit: Growth hormone in non-GH 264 deficient short children Idiopathic short stature 269 Empiricist and contingent repertoires in evaluating 273 treatment Beyond the diagnostic repertoire: Quality of life and the 276 burden of short stature Physicians‘ understanding of the social and psychological 279 deficits of being short Informants evaluations of psychological testing for short 283 patients Physicians‘ strategies for patient assessment 289 Conclusions 293 8 CHAPTER 7: Historical and Contemporary Accounts of 300 Growth Hormone in Anti-Ageing SECTION 1: The Making of Growth Hormone as an Anti-Ageing drug The cultural history of anti-ageing enterprises 304 The origins of growth hormone treatment in adults and the 311 aged The biosynthetic explosion 316 Growth hormone and the rise of the new anti-ageing 321 movement SECTION 2: Producing the Scientific and Unscientific in Endocrinologists‘ Discourse ”Classic endocrinology‘: Treating adults with growth 326 hormone deficiency The production of scientifically valid ideas about growth 333 hormone in the elderly ”It‘s how you go about it‘: Anti-ageing medicine as beyond 337 science Institutional and conceptual obstacles to hormonal therapy 343 for ageing Conclusion 347 CHAPTER 8: Conclusions 354 Creating the hormonal model of the body 358 9 Molecules of character 361 Deploying growth hormone as a new technology: Growth 363 hormone deficiency in the 1960s Stable and contested indications in the biosynthetic era 367 Key components in the success or failure of indications 375 Rationing and the biological basis of disease 377 Physical and psychosocial components of entitlement 379 The impact of heterogeneous national healthcare systems 382 in producing idiopathic short stature as a contested indication Reflections on medicalisation and enhancement 386 REFERENCES 395 APPENDIX ONE: CONTACT LETTERS AND INTERVIEW 421 SCHEDULES 10 CHAPTER 1: Introduction Introduction On July 25 th 2003 the United States Food and Drug Administration (FDA) announced that it had granted regulatory approval to Eli Lilly‘s Humatrope brand of synthetic human growth hormone (hGH) for treatment of children diagnosed with idiopathic short stature (FDA, 2003). The decision was a significant, if contentious one in the oft- controversial history of growth hormone. The category of idiopathic short stature (ISS) effectively extends the availability of growth- promoting hormone therapy to all children whose height is below a specified statistical cut-off point (2.25 standard deviations below the average, adjusted for age and gender). This decision represents the largest, though not the first, expansion of the patient population for the hormone drug, which was initially approved for small group of patients, numbering not more than a few thousand, whose pituitary glands produced little or no native growth hormone (Tattersall, 1996). To many bioethicists the use of growth hormone to increase the height of short, but otherwise healthy, ISS children represents the culmination of a worrying progression away from bona-fide therapy towards the ethically suspect terrain of human biomedical enhancement (Tauer, 1995). To others, the expanding use of growth hormone marks the power of the pharmaceutical industry in promoting their products to ever greater sections of the public. The 11 approval for ISS raises the uncomfortable prospect that short but otherwise normal children are being
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