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Part I

Chapter 2

Introduction

The American Expert, the American Medical Association, and the Nuremburg Medical Trial

The "Real World" of Human Experimentation

Nuremburg and Research with Patients

American Medical Researchers' Reactions to News of the Nuremburg Medical Trial

New Times, New Codes

Conclusion

Chapter 2: The American Expert, the American Medical Association, and the Nuremburg Medical Trial

In the fall of 1943, the United States, Great Britain, and the Soviet Union agreed that, once victorious, they would prosecute individuals among the enemy who might have violated international law during the war. On August 8, 1945--exactly three months after V.E. Day and two days after the bombing of

Hiroshima--representatives of the American, British, French, and Soviet governments officially established the International Military Tribunal in Nuremberg, Germany. An assemblage of Allied prosecutors presented cases against twenty-four high-ranking German government and military officials, including Hermann Goering and Rudolph Hess, before this international panel of judges. Quite early in the course of these initial Nuremberg trials, which ran from October 1945 to October 1946, "it became apparent," according to the recent recollections of American prosecutor Telford Taylor, "that the evidence had disclosed numerous important Nazis, military leaders, and others" who should also be tried.[1] In January 1946, President Harry Truman approved a supplementary series of war crimes trials. These trials were to take place in the same Nuremberg courtroom, and international law would continue to be the standard by which guilt or innocence would be determined. America's wartime allies would not, however, participate; responsibility for prosecuting and judging defendants in the second set of Nuremberg trials was left exclusively to the United States.

The first of twelve cases that would eventually make up this second series of trials in Nuremberg is technically called United States v. Karl Brandt et al. More popularly, this trial is known by a variety of other names such as "The Doctors' Trial" and "The Medical Case." For the sake of convenience and consistency we will refer to the trial by another common name: the Nuremberg Medical Trial. This case began on December 9, 1946, when U.S. Chief of Counsel for War Crimes Telford Taylor delivered the prosecution's opening statement against the twenty-three defendants (twenty of whom were physicians). To one degree or another, Taylor charged the defendants with "murders, tortures, and other atrocities committed in the name of medical science." The trial ended in late August 1947 when the judges handed down a ruling that included the so-called Nuremberg Code and seven death sentences.[2]

In the spring of 1946, the American prosecution team preparing for the Medical Trial, which was made up of lawyers commissioned in the Army, cabled Secretary of War Robert P. Patterson with a request for a medical expert. Patterson consulted with Army Surgeon General Norman T. Kirk, who suggested turning to the American Medical Association. Kirk contacted the AMA, and, after some internal consultation, the association's Board of Trustees voted in May 1946 to appoint Dr. Andrew C. Ivy as the AMA's official consultant to the Nuremberg prosecutors.[3] Dr. Ivy was one of America's leading medical researchers at the time. Early in the war, Ivy was the civilian scientific director of the Naval Medical Research Institute in Bethesda, Maryland.[4] During the summer of 1946, he was in the process of moving from a position as head of the Division of Physiology and Pharmacology at Northwestern University Medical School to the University of Illinois, where he would serve as a vice president with responsibility for the university's professional schools in Chicago.

The precise rationale behind Ivy's selection as the AMA's adviser to the Nuremberg prosecutors remains unclear, but it is likely that the AMA turned to Ivy for at least two reasons. First, his wartime research interests corresponded in topic, though not in style, to some of the most shocking experiments that had taken place in the Nazi concentration camps. Ivy supervised and carried out experiments in seawater desalination, sometimes using human subjects, with the intent of developing techniques to aid Allied pilots and sailors lost at sea. He also conducted some pioneering human experiments in aviation medicine dealing with the physiological challenges posed by high altitudes. These are two of the areas in which Nazi researchers had conducted especially gruesome human experiments. Second, Ivy was well known for his energetic defense of animal experimentation against American antivivisectionists. For example, he served for eight years as the founding secretary-treasurer of the National Society for Medical Research, an organization formed by scientists in 1946 to ward off challenges to medical research posed by antivivisectionists. It seems likely that the AMA Board of Trustees would have recognized Ivy as someone who possessed an unusual combination of familiarity with the scientific aspects of experiments carried out in the concentration camps and broad understanding of the moral issues at stake in medical research, whether the experimental subjects were animals or humans. Also, Ivy was almost certainly perceived as someone who could be trusted to look out for the interests of the American medical research community during the Nuremberg Medical Trial. The AMA Board of Trustees probably realized that the entire enterprise of medical research would, to some degree, be on trial in Germany.

In July or early August of 1946, Ivy went to Germany to meet with the Nuremberg prosecution team. Ivy offered technical assistance to the lawyers struggling with the scientific details of the experiments, but he also recognized, as he put it, that the prosecutors "appeared somewhat confused regarding the ethical and legal aspects" of human experimentation.[5]

After returning from his initial trip to Europe in aid of the Nuremberg prosecutors, Ivy offered a preliminary oral report to the Board of Trustees of the American Medical Association at the board's August 1946 meeting. After his presentation, the trustees asked Ivy to provide a written summary of his findings, so that the AMA's Judicial Council (a committee of five whose duties included deliberating on matters of medical ethics) could "make a report as to the manner in which these [Nazi] experiments [were] infringements of medical ethics."[6]

In mid-September, Ivy submitted a written report to the AMA as he had been directed.[7] At roughly the same time, he also turned over a copy of the twenty-two-page typescript to the Nuremberg prosecution team. In this piece, Ivy laid out "the rules" of human experimentation. He stated without equivocation that these standards had been "well established by custom, social usage and the ethics of medical conduct." Ivy's rules read as follows:

1. Consent of the human subject must be obtained. All subjects must have been volunteers in the absence of coercion in any form. Before volunteering the subjects have been informed of the hazards, if any. (In the U.S.A. during War, accident insurance against the remote chance of injury, disability and death was provided. [This was not true in all cases.])

2. The experiment to be performed must be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease under study that the anticipated results will justify the performance of the experiment. That is, the experiment must be such as to yield results for the good of society unprocurable by other methods of study and must not be random and unnecessary in nature.

3. The experiment must be conducted

(a) only by scientifically qualified persons, and

(b) so as to avoid all unnecessary physical and mental suffering and injury, and

(c) 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.[8]

A comparison of these rules with the Nuremberg Code, which the Nuremberg Tribunal issued as part of its judgment on August 19, 1947, reveals that the three judges extracted important elements of clause 1 from Ivy's first rule and clauses 2, 3, 4, 5, and 8 almost verbatim from the rest of Ivy's formulation. Significantly, the judges also reiterated Ivy's assertion that these rules were already widely understood and followed by medical researchers.[9]

It is possible that the Nuremberg judges never read Ivy's report directly. During his testimony at the trial, Ivy essentially read his set of rules into the court record.[10] Also, the judges could have gained exposure to Ivy's thinking through two additional indirect sources. First, another medical expert who aided the prosecution, an American Army psychiatrist named Leo Alexander, submitted on April 15, 1947, a memorandum to the prosecutors entitled "Ethical and Non-Ethical Experimentation on Human Beings." In this memorandum, which would have been passed to the judges, Alexander repeated in very similar language significant portions of Ivy's rules as outlined in the September 1946 report.[11] Second, American prosecutor James McHaney closely followed the text of Ivy's rules when setting before the judges the "prerequisites to a permissible medical experiment on human beings" during the prosecution's closing statement on July 14, 1947.[12]

But Ivy's standards for human experimentation served as even more than the primary textual foundation for the Nuremberg Code; his set of rules also undergirded the AMA's first formal statement on human experimentation. As the Board of Trustees had directed when asking Ivy to prepare his written report, the finished document was immediately forwarded to the AMA Judicial Council. The board gave the Judicial Council three months to prepare a presentation for the House of Delegates, the large policy-making body of the AMA that was scheduled to hold an annual meeting in early December 1946.[13] Unfortunately, records of the Judicial Council's consideration of Ivy's report have not survived, but published proceedings of the House of Delegates meeting reveal the results of the council's deliberations.[14] Dr. E. R. Cunniffe, chair of the Judicial Council, summarized his panel's response to Ivy's report at an executive session of the House of Delegates on December 10, 1946 (the day immediately following the prosecution's opening statement in the Nuremberg Medical Trial). Cunniffe condemned the Nazi experiments described in Ivy's report as gross violations of standards that were already inherent in the existing "Principles of Medical Ethics of the American Medical Association," which had undergone only minor revision since the AMA adopted them in 1847, the first year of the association's existence. But in recognition of the fact that guidelines for human experimentation were not explicitly laid out in these "Principles," the Judicial Council offered the following distillation of Ivy's rules:

In order to conform to the ethics of the American Medical Association, three requirements must be satisfied: (1) the voluntary consent of the person on whom the experiment is to be performed [must be obtained]; (2) the danger of each experiment must be previously investigated by animal experimentation, and (3) the experiment must be performed under proper medical protection and management.[15]

These three rules became the official policy of the AMA when the House of Delegates voted its approval "section by section and as a whole" on the morning of December 11, 1946. The AMA's official governing body also added a general admonition: "This House of Delegates condemns any other manner of experimentation on human beings than that mentioned herein."[16] It is worth noting that in 1946 roughly 70 percent of American physicians belonged to the AMA. In absolute terms, 126,835 physicians belonged to the association, but it must be acknowledged that membership in the national association came automatically with membership in county and state medical societies, which was often necessary for professional privileges at local hospitals.[17] Each member of the AMA would have received a regular subscription to the Journal of the American Medical Association, and all of these subscribers would have had an opportunity to read the three rules for human experimentation approved by the House of Delegates. At the same time, however, these rules were not published prominently; they were set in small type along with a variety of other miscellaneous business items in the lengthy published minutes of the meeting. Only an exceptionally diligent member, or one with a special interest in medical ethics, is likely to have located this item.

In mid-June 1947, Ivy took the stand late in the Nuremberg Medical Trial as a rebuttal witness for the prosecution to counter the claims of the defense that standards for proper conduct in human experimentation had not been clearly established before the initiation of the trial. The contents of Ivy's September 1946 report, and the AMA standards that arose from it, played a major role during his three days of testimony. At one point, prosecution associate counsel Alexander G. Hardy carefully walked Ivy through a verbatim oral recitation of the rules for human experimentation contained in Ivy's report and the condensed version of his rules as approved by the AMA. After a reading of the AMA principles, Hardy and Ivy had the following exchange:

Q. . . . Now, [do these rules] purport to be the principles upon which all physicians and scientists guide themselves before they resort to medical experimentation on human beings in the United States?

A. Yes, they represent the basic principles approved by the American Medical Association for the use of human beings as subjects in medical experiments.[18]

Hearing this specific, and obviously important, claim about research with human subjects in the United States, Judge Harold E. Sebring interjected with a broad question about the international significance of Ivy's assertion: "How do the principles which you have just enunciated comport with the principles of the medical profession over the civilized world generally?" Ivy responded: "They are identical, according to my information."[19]

Later in his testimony, Ivy faced cross-examination by Fritz Sauter, counsel for two of the German medical defendants. Sauter pushed Ivy to acknowledge that the AMA guidelines had come into formal existence only as the Nuremberg Medical Trial was getting under way. In response to this attempt to diminish the legal force of the AMA standards with the obvious suggestion that the rules had been made up too recently to be of relevance, Ivy made an explicit claim in court that the ideas inherent in the AMA standards significantly predated their official formulation:

Q. You told us that . . . an association had made a compilation regarding the ethics of medical experiments on human beings. . . . Can you recall what I am referring to?

A. Yes.

Q. That was in December 1946, I believe.

A. Yes, I remember. . . .

Q. Did that take place in consideration of this trial?

A. Well, that took place as a result of my relations to the trial, yes.

Q. Before December of 1946 were such instructions in printed form in existence in America?

A. No. They were understood only as a matter of common practice.[20]

Thus, if Ivy is to be taken literally, the standards he forcefully articulated during the Nuremberg Medical Trial, which were affirmed by the AMA House of Delegates as the trial was just beginning and codified by three American judges as the trial came to an end, were the standards of practice at the time.

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