Archives for the month of: February, 2014

Screen Shot 2014-02-23 at 17.58.19Andrew C. Ivy being sworn in at the Nuremberg Doctors’ Trial, June 1947.  Photo courtesy of the National Archives RG 238 OMT-1-W-60.

Reality and revisionism: new evidence for Andrew C. Ivy’s claim to authorship of the Nuremberg Code

(In press in the Journal of the Royal Society of Medicine, 2014)

 Introduction

Maurice H. Pappworth (1910-1994) was an English physician who had developed a deep concern for the ethics of human research.  In 1966, while researching his book – Human Guinea Pigs, which would be published the following year (3) – he wrote to Ivy regarding experimentation on prisoners.  Andrew C. Ivy  (1893-1978) was an eminent physician and physiologist and according to Moreno “by the end of the war he was probably…the most famous doctor in the country [US]…the prototype of today’s media medical expert” (4).  Perhaps because of this status, and the fact that he had been actively involved in research involving prison inmates, he had been invited to serve as the American Medical Association’s (AMA) adviser to the Nuremberg prosecutors (fig. 1).  Ivy responded to Pappworth’s enquiry on April 6, 1966 (5) and began by stating:

I was considering the subject of your letter before I testified at Nuremberg and gave the Judges my Version of the Code

thus indicating from the outset his involvement.  In his letter, he told Pappworth that he had been interested in research ethics since 1917 and that he had always tried to apply the “Golden Rule” as a guiding principle in all his own research, i.e. that you should only do to others that which you would allow them to do to you.  He indicated finally his belief that the natural extension of this principle was that you should always take your “own ‘Medicine’ first” (5).  This allusion to self-experimentation as a preliminary and necessary step in research becomes relevant when we consider Ivy’s appendix to the letter.

To the Pappworth letter, Ivy attached a copy of another letter he had sent in March 1964 to three academic colleagues (Ladimer, Newman and Curran).  That letter set out Ivy’s version of “the origin and development” of the Nuremberg Code and the copy in Ivy’s own archive at the University of Wyoming has already been discussed in the literature (6,7).  However, what has not previously been realized is that the copy he sent to Pappworth in 1966 carries an additional penciled note in Ivy’s own hand claiming unequivocally that he was the author of the Code with the exception of a single word in Article 5.

This annotation to the Pappworth version states:

Note:  I did not include the word “perhaps” in the 5th article of the Nurenberg [sic] Code when I turned …over to the Judges my version of the Code.  Nothing else in my version was materially changed.  I see NO rational or defensible reason for the word “perhaps”

This provides the scientist to believe that he is intrinsically worth more than his experimental subject, and is contrary to the best historical heritage.

I do not know who introduced the word “perhaps”.  The remainder of the code I turned in was not essentially changed (5).

This newly discovered annotation raises two lines of enquiry.  First, we may examine Ivy’s claim for essentially full authorship of the Code; and second, we may question Ivy’s concern over the addition of a single word to Article 5.

Claims to Authorship

The Code, although largely ignored shortly after it was pronounced, had, some two decades later, acquired a much greater significance (1,8).  With its authorship unclear from the outset, the potential for rival claims for its genesis was great.  Who was present in Nuremberg at the time?  Who had the ear of the Judges? And, who could see the need for such a code of conduct?  Ivy was certainly there – indeed he had attended portions of the early trial and he was the key rebuttal witness for the prosecution, taking the stand for four days late in the trial in mid-June, 1947.  As the most senior physician present he would certainly have had access to the judges and indeed he claimed to have been invited to lunch by the judges in January 1947 – just over a month into the trial – where they explained to him their concerns for the case before them (5).  That Ivy would also have been acutely aware of the need for a code of conduct may be safely assured from his long experience as a clinical researcher.

The other main contender who may reasonably claim authorship of the Code, apart from the judges themselves, is Leo Alexander.  He was an Austrian-born American physician who served first as a medical war crimes investigator and then as medical expert to the Nuremberg Doctors’ Trial (9).  Like Ivy, he prepared and submitted several sets of ethical principles to the court, but because of the lack of documentary evidence detailing the judges thinking while drafting their ruling we must speculate as to the relative importance of each man’s contribution.

In this speculation timing seems to be all-important.  As we shall see when we examine the development of Article 5 of the Code, Ivy’s drafts do appear to have precedence over Alexander’s, but neither present the exact wording used by the Judges and it is necessary to invoke the bench’s involvement either collectively or singly, perhaps most credibly in the person of Judge Sebring. Brigadier General Telford Taylor, the Chief Counsel for the Prosecution, believed Sebring to be the author of the Code and later described him as “the moving spirit on legal and evidentiary problems on the court”(10).

Ivy clearly claims credit for the Code in his letter to Pappworth (5), but equally Alexander some three decades after the trial, would also claim its sole authorship (11).  Does it matter who wrote the Code? In one sense — no.  Irrespective of its authorship it remains a key contribution to the development of clinical research ethics.  However, in another sense, an historical one, it matters greatly.  How was the Code conceived, in what context and to what ends?  These questions may only be meaningfully answered if the author of the Code is identified.

If Ivy was the author, as he claims unequivocally in his letter to Pappworth, then we may view the Code, not as a minor aside within the judgment at Nuremberg that has since, perhaps by accident, achieved a wider significance, but rather as the culmination and completion of a strategy conceived by Ivy before the trial began. Indeed, in his 1964 letter he states:

I might add that I accepted the invitation to serve at the Nurenberg [sic] Trials only because I had in mind the objective of placing in an international judicial decision the conditions under which human beings may serve as subjects in a medical experiment, so that these conditions would become the international common law on the subject.  Otherwise I would have had nothing to do with the nasty and obnoxious business.  I believe in prevention, not a “punitive cure”….The Judges and I were determined that something of a preventative nature had to come out of the “Nurenberg Trial of the Medical Atrocities” (5).

The concept of an “international common law” is attractive, but far from concrete even today.  Guzman and Meyer note that “decisions of international tribunals interpret binding legal obligations but are not themselves legally binding beyond the particular states and the particular facts before the tribunal” (12).  In the case of Nuremberg, the trial although held on German soil was essentially a US one, with American judges and an American prosecution team.  How internationally applicable and legally binding could the judgments of such a court be?  However, these authors also conclude that “the decisions of international tribunals create a form of non-binding yet nevertheless influential international common law” (12).  Perhaps, then, Ivy’s objective was feasible.

However, setting aside the legal arguments, this story of objective setting may be one argument against Ivy’s version of events and for this being a piece of revisionist history.  Rarely, in practice, does a complex plan like this come to pass – much easier to revise the sequence of events, even some of the key facts, to make the story a better and more coherent one.

If this was the case then this would not be the first time Ivy had adjusted the facts to suit the narrative. Indeed one historian has described him as a “master of the white lie” (13). In his testimony at Nuremberg, Ivy referred to the report of a committee that had been established to evaluate prison research.  During his cross-examination he all but perjured himself (4) for, in reality, the committee had never met and the “report” referred to was written by Ivy alone.  After the trial, the committee did meet to ratify the so-called Green Report and it was subsequently published, but the sequence of events had clearly been manipulated by Ivy for his own ends (13).

Article 5

Almost irrespective of our conclusions on the veracity of Ivy’s claim to be the sole author of the code we must examine separately his obvious concern over the exact wording of Article 5 of the Code, which states:

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects (1).

A reconstruction of the genesis of Article 5 is informative here.

The first formulation of what would become Article 5 appears in a document prepared by Ivy for a meeting of the International Scientific Commission on Medical War Crimes (ISC) in Paris on July 31, 1946.  This meeting had been convened to investigate and document medical war crimes.  Section IIIc of Ivy’s “Outline of Principles and Rules of Experimentation on Human Subjects” runs:

The experiment should not be conducted if there is a priori reason to believe that death or disabling injury will occur (6, 14).

Importantly, this early version contains no mention of self-experimentation as a justification for such experiments.

Ivy’s Code was submitted to the AMA on his return to the US and was eventually ratified on Dec 10, 1947 in a shortened and considerably weaker form entitled “Principles of Ethics Concerning Experimentation on Human Beings” and was published on Dec 28, 1946 in their Journal (15). Any reference to the specifics that would comprise Article 5 had been lost.

Ivy expanded his Paris Code in an undated memo written, according to Schmidt, sometime between Aug 9-Oct 16, 1946 (16) and submitted this to the Prosecution Team in Nuremberg at approximately the same time as his AMA report (17).  This report again contained three principles and IIIc states:

The experiment must be conducted…so, that, on the basis of the results of previous adequate animal experimentation, there is no a priori reason to believe that death or disabling injury will occur, except in such experiments as those on Yellow Fever where the experimenters serve as subjects along with non-scientific personnel  (17).

The principle has now been developed to include for the first time the exception of self-experimentation, and, interestingly, Ivy has referred specifically to the Yellow Fever experiments of 1900 conducted in Cuba by Walter Reed and his colleagues (18).  Ivy reiterated these principles during his testimony as a rebuttal witness for the prosecution in June 1947 (17).

At the same time, Alexander was also actively seeking the ear of the Prosecution Team and 48 hours before the start of the trial in December 1946 he submitted a memo to Telford Taylor, entitled “Ethical and Non-Ethical Experimentation on Human Beings” in which he also defined three principles.  His principle 2 states:

…the medical Hippocratic attitude prohibits an experiment if the foregone conclusion, probability or a priori reason to believe exists that death or disabling injury of the experimental subject will occur (11).

This form is similar to Ivy’s Paris Code of four months earlier in that it uses very similar language but later in the memo Alexander does introduce self-experimentation as an exception.  Just as Ivy revised his version so did Alexander.  In January 1947, Alexander expanded his three principles to six and submitted these in the form of a second memo on April 15, 1947.  His new principle 5 now stated:

It is ethically permissible for an experimenter to perform experiments involving significant risks only if the solution, after thorough exploration along all other lines of scientific investigation is not accessible by any other means, and if he considers the solution of the problem important enough to risk his own life along with those of his non-scientific colleagues, such as was done in the case of Walter Reed’s yellow fever experiments (11).

When the closing arguments for the prosecution were delivered on July 14, 1947, the chief Prosecutor for the Medical Case, James McHaney, revisited and emphasized the need for self-experimentation to justify dangerous experiments:

If there is a priori reason to believe that death or disabling injury might occur, the experimenters must serve as subjects themselves, along with the nonscientific personnel…we have yet to find one defendant who subjected himself to the experiments which killed and tortured their victims in concentration camps (19).

The final drafting of Article 5, with the addition of Ivy’s contested word, was most probably undertaken by Judge Harold L. Sebring, and indeed, when the section of the judgment that would later be termed the Nuremberg Code was unveiled to the world on August 19, 1947 it was Judge Sebring who read it to the court (16).

Ivy, in his note to Pappworth, takes great exception to the inclusion of the word “perhaps” in this Article.  Why?   It has been argued that this Article of the Code was specifically included to counter one of the lines of defence put forward by the counsel for the Nazi physicians and administrators in Nuremberg, i.e. that previous US military research had knowingly put the lives of research subjects at risk (20).  In particular, the example of Walter Reed and the Cuban yellow fever experiments from 1900 was cited.  Perhaps to counter this specific charge, Ivy’s revised version of what would become Article 5 refers to “such experiments as those on Yellow Fever” and this pre-emptive reference to the Walter Reed experiments was also echoed by Alexander’s memos to Telford Taylor.

Interestingly, Ivy was not concerned with the omission of any reference to the yellow fever experiments in the final version of the Article, but rather to a softening of the self-experimentation exception.  Perhaps he was aware that Walter Reed himself was never a subject of the mosquito experiments designed to prove the etiology of yellow fever, only his junior medical staff participated, and one physician – Jesse Lazear – paid for it with his life (18).  But, even if an investigator is willing to be the first subject in a potentially life-threatening experiment does this really make it ethical to put others at risk?  Self-experimentation, it has been argued by Annas, is not research at all, but simply “self indulgence” or even “self abuse” (20).  Clearly those involved in drafting the Nuremberg Code did not share this distinction and believed that the personal participation of the investigator in the experiment lent a special justification to putting the lives of others at similar risk.

However, the insertion of the word “perhaps” would seem to indicate that even this caveat is not absolute.  The jurists may have wished to indicate that not every life-threatening experiment could be justified in this way.  Alternatively, they may have wished, as Ivy seems to have interpreted it, to indicate some lack of parity between the investigator and the subject.  If someone, as important as a physician, is willing to risk his or her life in an experiment then maybe that should be sufficient to justify the recruitment of ordinary subjects.  Indeed in his letter to Pappworth, Ivy emphasized his concern here by stating, “the idea that the experimenter is worth more than the subject is ruinous.  This ideology has crept into American Clinical Investigation to some extent.  In 1947 I predicted it would do so” (5).

Overall, this seems a relatively small point for Ivy to labor and to highlight to Pappworth almost twenty years later. Ivy’s disproportionate concern over the insertion of a single word into Article 5 of the Code is interesting, as this addition does not fundamentally change the meaning of the Article as Ivy seems to contend.  What exactly is going on here? Perhaps his concern, real or manufactured, reveals more about his state of mind in the mid 1960s than about the detailed drafting of the Code.  By focusing on such a small discrepancy is Ivy in effect emphasizing his ownership of the whole, which particularly at this stage in his life he may have been eager to do?

In 1964, two years before writing to Pappworth, Ivy along with three others had been indicted for fraud over the alleged anti-cancer drug Krebiozen (21).  The court case was lengthy and although Ivy and his co-defendants were finally found not guilty the following year, his reputation would have been tarnished.  Perhaps, the letters Ivy wrote in 1964 to Ladimer, Newman and Curran, and in 1966 to Pappworth were part of his personal rehabilitation strategy.  With an eye on his legacy, the 73 year-old Ivy may have wanted to emphasize the part he had played in the development of the preeminent code of research ethics to compensate for any perceived misconduct.  By conspicuously drawing attention to a single word that was not his, he was firmly staking his claim to the other 499.

Ivy’s last letter to Pappworth was in June of the following year requesting a copy of Human Guinea Pigs, which had just been published.  “I am sure I shall profit by reading your book”, he noted (22).  Whether he did or not we are unlikely ever to know.

Conclusion

Ivy’s professed intention of participating in the Nuremberg Doctors’ Trial in order to place a code of ethical conduct in the context of international common law may have been not only a revision but a reversal of the true course of events.  However, the reality of what took place after 1947 must have gone beyond even Ivy’s ambitions, real or re-imagined.  The Nuremberg Code not only entered the legal landscape, but also became the prototype for all future codes of ethical practice across the globe.  Shuster has described the Nuremberg Code as “the most important document in the history of the ethics of medical research” (1).  To be recognized as the author of such a document would be a prize worth fighting for, especially if, as in Ivy’s case, any doubt had been cast on your professional reputation.  Ivy’s claims for virtually exclusive authorship made almost twenty years after the fact do, however, seem to be at odds with some of the key facts and given his history of manipulation of other narratives, we may express reasonable doubt about the truth of his claims.  That said, he undoubtedly played an important role in the genesis of the Code, but so did others including Leo Alexander and the Judges. The Code began life as a relatively minor component of a Tribunal Judgment; what it then became was a touchstone for the development of modern research ethics, acquiring a significance that transcended any issue of individual authorship.  Shuster has argued eloquently that the Code was the product of the trial proceedings (1) and perhaps in this light the true author of the Code should be identified as Justice itself.

Acknowledgements

All quotations from the unpublished Ivy/Pappworth correspondence are reproduced by kind permission of the Wellcome Library, London. This work would not have been possible without the generous assistance of the staff of the Rare Materials Viewing Room, Wellcome Library, London, and Shaun A. Hayes from the American Heritage Center, University of Wyoming.

References

1. Shuster E.  Fifty years later: the significance of the Nuremberg Code.  N Engl J Med. 1997; 13: 1436-40.

2. Gaw A, Burns MHJ. “More subtle degrees of contempt” – Leo Alexander and codes of practice.  In: On Moral Grounds: Lessons from the History of Research Ethics. SA Press Glasgow, 2011.

3.       Gaw A.  Exposing Unethical Human Research: The Transatlantic Correspondence of Beecher and Pappworth.  Ann Int Med. 2012; 156: 150-5.

4.       Moreno JD. Undue Risk: Secret State Experiments on Humans.  Routledge, New York, 2001.

5. Ivy to Pappworth. Letter April 6, 1966, PP/MHP/C5 Wellcome Library, London.

6.        Weindling P. The origins of informed consent: the International Scientific Commission on Medical War Crimes, and the Nuremburg code. Bull Hist Med 2001; 75: 37-71.

7. Weindling PJ.  Nazi medicine and the Nuremberg trials. New York, USA: Palgrave Macmillan 2004.

8. Faden RR, Lederer SE, Moreno JD.  US medical researchers, the Nuremberg Doctors’ Trial, and the Nuremberg Code.  A review of findings of the Advisory Committee on Human Radiation Experiments.  JAMA. 1996; 276: 1667-71.

9.     Temme LA. Ethics in human experimentation: the two military physicians who helped develop the Nuremberg Code. Aviat Space Environ Med. 2003; 74: 1297–1300.

10. Grodin MA.  Historical origins of the Nuremberg Code.  In: The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation.  Annas GJ and Grodin MA (Eds). Oxford University Press, Oxford, 1992.

11 Alexander L.  Ethics of human experimentation.  Psychiatr J Uni Ott.  1976; 1: 40-6.

12.       Guzman AT,  Meyer T. International Common Law: The Soft Law of International Tribunals. UC Berkeley Public Law Research Paper No. 1267446. Available at SSRN: http://ssrn.com/abstract=1267446 (Accessed May 14, 2012).

13.        Harkness JM. Nuremberg and the issue of wartime experiments on US prisoners. The Green Committee. JAMA. 1996; 276:1672-5.

14.       The National Archives: Public Record Office WO 309/471 Minutes of a Meeting to Discuss War Crimes of Medical Nature executed in Germany under the Nazi Regime, 31 July 1946, Appendix B.

15.       Supplementary report of the Judicial Council.  JAMA. 1946; 132: 1090.

16. Schmidt U. The Nuremberg Code. In: Schmidt U. Justice at Nuremberg. Leo Alexander and the Nazi Doctors’ Trial. New York, USA: Palgrave Macmillan 2006: 199-263.

17.       A. C. Ivy, “Report on War Crimes of a Medical Nature Committed in Germany and Elsewhere on German Nationals and the Nationals of Occupied Countries by the Nazi Regime during World War II,” 1946. National Library of Medicine. Quoted in ACHRE Report Chapter 2. Final Report of the Advisory Committee on Human Radiation Experiments.  Washington DC: US Government Printing Office; October 1995.

18.        Pierce JR, Writer J. Yellow Jack: How Yellow Fever Ravaged America and Walter Reed Discovered Its Deadly Secrets. John Wiley & Sons, Inc., New Jersey, 2005.

19. Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law 10 (Washington, D.C.: Superintendent of Documents, U.S. Government Printing Office, 1950) Closing Argument for the United States of America by James M. McHaney, July 14, 1947, transcript pp.10718-96.

20. Annas GJ. Self experimentation and the Nuremberg Code. Brit Med J. 2010; 341: c7103.

21. Ward PS. “Who will bell the cat?” Andrew C. Ivy and krebiozen. Bull. Hist. Med. 58: 28-52, 1984.

22. Ivy to Pappworth. Letter June 5, 1967, PP/MHP/C5 Wellcome Library, London.

© Allan Gaw 2014

This paper is currently in press in the Journal of the Royal Society of Medicine

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A laboratory, bubbling chemicals, glassware and, most probably, gaslight—the scene is set for the physician-scientist to drink his transforming potion. This is our stock image of self-experimentation in clinical research, and, apart from the bubbling and the gaslight it is probably not too far from the truth.  Researchers have always self-experimented, both in fact and fiction.  In the latter, these experiments have usually resulted in mayhem, while in the former they have, on occasion, earned their scientists the Nobel Prize, while leading others to their death.

Dr Jekyll sipped his concoction to discover the beast of Mr Hyde within, while Dr Brundle’s dabbling with teleportation in “The Fly” led to a self-experiment with distinctly unfortunate consequences when he inadvertently shared his pod with a housefly.  Comic-books abound with villains—such as The Lizard, Spider-Man’s arch enemy—who are often the product of self-experimentation by mad-geniuses or initially well-meaning, but ultimately evil, scientists.  But, what of the reality of self-experimentation?  Does it happen and if so why?  Two examples from the 20th century may be used to answer these questions.

In 1984, Marshall and Warren postulated that Helicobacter pylori was the causative agent of peptic ulcer disease. The implications of this for medicine and surgery would be enormous, as Marshall thought the disease might be treated using antibiotics rather than surgery, which had been the only treatment for decades. However, his proposals were laughable to many, and he needed to gather some convincing proof quickly.

Increasingly frustrated by the negative criticism of his work and his failed attempts to produce an animal model for Helicobacter infection, Marshall decided to self-experiment.   He successfully infected himself without discussing his plans with an ethics committee or, “more significantly” he noted later, with his wife.  “This was one of those occasions,” he added, “when it would be easier to get forgiveness than permission.”

One of his colleagues mentioned the self-experiment to a journalist and the story was instantly sensationalized under the headline: “Guinea-pig doctor discovers new cure for ulcers … and the cause.”  It would, however, take ten years before his evidence was finally accepted, and another ten before he and Warren would be awarded the Nobel Prize.

Unravelling another infection was the task given in 1900 to Maj. Walter Reed, a US Army doctor who led a team to investigate the transmission of yellow fever on Cuba.  They tested a number of theories, the most crackpot of which had been proposed 20 years earlier: that the disease was spread by mosquitoes.

Concerned about the ethics of such investigations Reed and his team decided that before they sought volunteers they should experiment on themselves.  First, they “loaded” mosquitoes by allowing them to feed on yellow fever patients. The mosquitoes were then allowed to feed on a pair of junior doctors, Carroll and Lazear, all while Reed was safely in Washington D.C.  Both doctors developed the disease and while Carroll recovered, Lazear died aged 34.

This self-experimentation in Cuba became famous and, for many, one of the hallmarks of ethical research.  Indeed, when the ten principles of bioethical research were pronounced at the conclusion of the Nuremberg Doctors’ Trial in 1947, article 5 stated:

No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

This caveat may have been included to counter one line of defence put forward by the counsel for the Nazi defendants, i.e. that previous US military research had knowingly put the lives of research subjects at risk.  In particular, the lawyers cited the example of Reed and the yellow fever experiments. The fact that Reed himself was never a subject of the experiments was conveniently overlooked.

Thus, self-experimentation is used partly as an expedient, as in the case of Marshall, and partly as a justification, as in the case of Reed.  Expediency, however, may lead to a loss of objectivity that is so vital to good research, and justification may be challenged. Even if an investigator is willing to be the first subject in a potentially life-threatening experiment does this really make it ethical to put others at risk?

Self-experimentation, it has been argued, is not research at all, but simply “self indulgence” or even “self abuse”. However, one eminent researcher, Thomas Chalmers, summed up his view as, “…you shouldn’t be involved in a trial unless you would be willing to be randomized yourself.”

Today, self-experimentation continues, but is increasingly controversial, raising uncomfortable ethical and scientific questions.  The quality of the work, the safety and the motivations are all debatable, but, for the self-experimenter, perhaps no more debatable than the same work done on volunteers.  We certainly need rules of clinical research but whether we need different rules for researchers who wish to take that first step themselves is far from clear.

© Allan Gaw 2014

This article was published on Jan 31, 2014 in ‘FYi’ from the MDDUS and the online pdf can be accessed free at:

http://www.mddus.com/mddus/resource-library/2014/fyi—issue-12/diy-research.aspx

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