Which Principles, Doctor? The early crystallization of clinical research ethics in the Netherlands, 1947-1955 Noortje Jacobs Student: Noortje Jacobs Supervisor: Prof.dr Frank Huisman Date: 01-08-2012 RMA-Thesis Historical and Comparative Studies of the Sciences and the Humanities Descartes Centre, Utrecht University The image on the front cover is a segment of the painting Roadmap by the young Dutch artist Fransje Pansters. The painting conveys the journey of finding one's way and establishing meaningful boundaries, while taken-for-granted categorizations disappear. When she is asked whether Roadmap, with its portrayal of human legs attached to a mouse's romp, also reflects upon the ontological relationship between humans and animals, Pansters answers: “It is in the eye of the beholder which images come floating to the surface of Roadmap. It could be that the human mouse is the theme you see as central to the painting, but that is only ever your individual point of view”. For more work of Fransje Pansters, visit: www.fransjepansters.com. Which Principles, Doctor? Table of Contents Preface p. 7 Introduction p. 11 Chapter 1. From Principle to Problem: Perspective and Methodology p. 22 An essentialist approach to the history of medical ethics p. 24 Adam's fig leaf – a social history perspective p. 27 A third way of remembering: from principle to problem p. 30 The culture of public problems: concept clarification p. 33 Chapter 2. A Good Code for Barbarians: Nuremberg and the Netherlands p. 39 The rationale behind the Nazi experiments p. 40 Framing the problem: the limiting indictment of the Doctor's Trial p. 44 The boundary-work of Andrew Ivy and Leo Alexander p. 48 Disowning the problem: the legacy of the Nuremberg Code p. 53 The Nuremberg Code in the Netherlands p. 56 Chapter 3. Research in the Laboratory: a Slippery Slope p. 63 The 1947 request for a chair in vivisection-free medicine p. 65 The staged drama of a Health Council committee p. 72 The historical crystallization of vivisection as a medico-ethical problem p. 77 The post-war equation of antivivisectionism with 'anti-science' p. 84 Chapter 4. Tests upon Human Beings: Defining the Problem p. 89 The honoured representatives of the Dutch medical profession p. 91 The looming presence of the Anti-Vivisection Foundation p. 98 The gradual emergence of the 'description of the problem' p. 104 The responsibilities of both patient and practitioner in a modern society p. 108 ∙ 5 ∙ Professional identity and the growing need for medical expertise p. 111 The actual legacy of the Nuremberg Code p. 117 Conclusion p. 121 Thank you p. 131 Appendix I: The 1947 Nuremberg Code p. 133 Appendix II: Andrew Ivy's and Leo Alexander's principles p. 135 Appendix III: The 1949 Declaration of Geneva p. 136 Appendix IV: The 1954 WMA Principles p. 137 Appendix V: The 1955 Guidelines for Tests upon Human Beings p. 139 Bibliography p. 141 ∙ 6 ∙ ∙ Preface ∙ On 1 February 2012 I attended the symposium 'Wishes and Boundaries in the Practice of Medicine' of the Dutch Centre for Ethics and Health. I was already working on this thesis project and interested in the ideas and opinions regarding the ethics of permissible medical interventions of some of the leading authorities on health and medicine in the Netherlands. Representatives of the Dutch Health Council, the Dutch Council for Public Health Care, the Dutch Council of Health Insurances, the Royal Dutch Medical Association and the Dutch Patients Consumers Federation were present, as well as specialists in the field of vascular medicine, plastic surgery, psychiatry and medical ethics. The topic of discussion was how far medical practitioners should go in meeting the ever-growing desires of patients. Do doctors have any paternalistic responsibilities towards their patients or should the individual patient be treated as a royal costumer who is free to do with his or her body whatever (s)he finds desirable? Up until that symposium I had been investigating for my thesis how medico-ethical principles have historically come to crystallize. To do so, I had been mapping the historical relationship between the internationally promulgated 1947 Nuremberg Code and the locally formulated Dutch Guidelines for Tests upon Human Beings of 1955, whilst trying to understand how such principles had come to be formulated and to what extent two documents separated in time and space can be evaluated as two members of the same family tree. This was inspired by a summer and autumn's worth of wild reading into a wide range of books and articles on the history of clinical research ethics. During this exercise I had come to notice that historians of medical ethics seem to be modestly obsessed with the epistemological status of medico-ethical documents, or rather, with the principles contained in these documents and their applicability to contexts other than the ones in which they had first been formulated. ∙ 7 ∙ ∙ preface ∙ During the 'Wishes and Boundaries' symposium however, I discovered something that is probably very basic to physicians, but surprisingly novel to someone who had read only works on medical ethics written by ethicists and historians: medical doctors are not interested in principles. Each of the specialists speaking at the symposium repeated the very same message: the responsible physician has to decide on a case-by-case basis whether or not the particular wishes of the individual patient transgress some fundamental ethical boundaries. What these boundaries precisely are, is something that cannot be decided a priori – it all depends upon the specific medical problem that has to be dealt with and upon the specific patient who is asking. In theory, that did not really help me. If no absolute principles can be determined, then why has a myriad of medico-ethical Declarations and Codes been promulgated in the past 60 years to do precisely that: establishing principles? And in addition, on what grounds does the medical practitioner separate right from wrong in these individual cases if there is no yardstick to measure them by? But in this context, there was one talk I found particularly illuminating. One of the plastic surgeons present had filled his entire presentation with photos of men and women that he had operated on for cosmetic reasons: penis and breast enlargements, fat and skin reductions, etc. When asked by a member of the audience whether he sometimes felt he should stop one of his patients from having another breast enlargement, he responded: “No, I let the patient decide. My duty is to inform them carefully about their options and about the risks and benefits of the operation. I require them to demonstrate that their decision has been well thought- through, but I am not their father. If they want a DD cup, that's their decision.” After a moment of pause, he added however: “Of course there are always exceptions. There are some cases in which I obviously would not operate. If patients for example request a metal plating to be implanted under the skins of their forehead to look more like a dinosaur, I advice them to go and see a tattoo artist. Or better yet, a psychologist.” There was one person in the audience who responded and said: “Wait, but how do you decide that the second example is ethically problematic and the first one is not?”, but no real discussion took off after that. For the majority of the audience, that the wishes of the second patient did not qualify as a proper medical request seemed to be self-evident. It was after that symposium that I started thinking that the focus of historians of medical ethics on the veracity of medico-ethical principles is rather misleading. After all, the promulgation of medico-ethical principles is only ever ∙ 8 ∙ ∙ preface ∙ an answer to some fundamental set of problems imagined in certain societies at certain times. To better understand the historical embedding of ethics in society therefore, it is much more interesting to investigate how certain issues come to crystallize as either morally problematic or acceptable in public debates and performances. Why is it that a plastic surgeon anno 2012 finds it self-evident that he does not operate to give someone a 'dinosaur-head', while it is simultaneously unproblematic for him to submit a healthy woman to intensive surgery to size her up with that desired DD cup? To that end, by historically seeking to understand which set of problems medico-ethical documents like the Nuremberg Code and the 1955 Dutch Guidelines fundamentally aimed to solve, I hope to offer some modest insights into the nitty-gritty of how meaningful ethical frameworks come to 'be made'. And who knows, in that process this thesis might even inspire present-day medical ethicists, as well as physicians, to similarly reflect upon the intricacies of their own patterns of thought when it comes to deciding which medical cases presented to them they consider to be ethically problematic and which they ultimately qualify as morally just. ∙ 9 ∙ ∙ Introduction ∙ In 1958, the 70-year-old internist Cornelis Douwe de Langen (1887-1967) wrote an article for the Dutch Journal for Medicine1 wherein he expressed a deep concern over the 'shifting standards for tests upon human beings' within the Dutch medical profession.2 Interestingly, to illustrate that the ethical standards for human experimentation were strongly subject to 'the changing of time', De Langen made use of a historical case-study. In the year 1903, medical students of the University of Groningen had rebelled against internist Karel Frederik Wenckebach, for they felt he had conducted unacceptable experiments upon his patients. The students' complaints were picked up by a local newspaper and caused a minor medical scandal.