Advisory Committee on Human Radiation Experiments: Public Comment Outreach Panel Meeting (PP. 310-325, 327, Statements by Geoffrey Ea Regarding Uccm Research and Saenger Regarding Ethics, Nurem ..

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ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS OUTREACH PANEL MEETING Cincinnati, Ohio USA Registered Professional Reporters Worldwide Post Office Box 1602 Glenrock, Wyoming 82637 USA In USA 1-800-435-2468 Worldwide 001-307-436-2468

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So, anyway, I look forward to that. I don't know if our committee has any other questions. MS. SALBURY: Thank you. DR. TUCKSON: Thank you. MS. SALSBURY: That is the most encouraging thing we have heard on that site in 4 0 years. Thank you. happy to be hearing from Geoffrey Sea, and after three times I've got it. Geoffrey, thank you. And you get all the attention now, because you're it. MR. SEA: Well, I guess it's my job to wake everyone up. DR. TUCKSON: No, no. No, no. We're MR. SEA: Well, this ought to do it MR. SEA: There are two possible attitudes toward the Holocaust which can be produced by nuclear warfare. One is total despair and confusion. The alternative is the adoption of an

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attitude of making the best of an admittedly bad Those are not my words. They are the words of Eugene Saenger and one of his military medical colleagues at the University of Cincinnati. Dr. Saenger and his team believed that they were working f o r some larger good, the preservation of combat effectiveness and a solidification of some selective elite in the event of a nuclear war. They knew that their actions would cause pain and death and suffering of individuals, some of which you've seen evidenced here today, but they believed that it was worth it for the attainment of some larger good. They believed it. They really believed it. And so did the physicians we hanged at Nuremberg. My name is Geoffrey Sea. I'm a health physicist. I'm here representing IRIS, International Radiation Injury Survivors, and involved in research with the law firm of Leiff, Cabraser & Heimann, a law firm in San Francisco that represents the classes of victims of the Vanderbilt University experiments on pregnant women, and with our co-counsel, the Alexander law firm, the one surviving subjects and

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six surviving families of the University of Now, the physicians we hanged at Nuremberg were executed because we found them to have violated certain universal principles involving human experimentation. They didn’t have to be written down, these principles, though they were written down. They didn’t have to be codified or approved or We said that they were universal standards of human conduct. Summarized, those principles are: One, that, the subjects must give voluntary consents after being informed of the true potential hazards and true purposes of the research. Two, that appropriate animal experimentation must precede human use, and those animal experiments must prove the experimental treatment to be both safe and effective; That, three, that no injury must be done to the subject that is not outweighed by some potential benefit to that same individual, and this is the essential point. That benefit must not be to society at large or to some abstract notion in some hypothetical event. It must be to the individual to, who, who has that risk.

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What we've said.at Nuremberg is that to violate these principles in war or in preparation for war constitutes a war crime; a crime against peace; a crime against humanity. What we said in Nuremberg was that such crimes are punishable. What will we say here in Cincinnati? What will you say in Washington, D.C.? We contend that the Saenger team violat'ed each one of the principles of the Nuremberg Code. A 1 9 7 1 review by the University of Cincinnati junior faculty essentially reached the same They said, quote, Many patients in this project paid severely for their participation, and often without even knowing that they were part of an Now, there were two other so-called reviews in 1 9 7 1 and 1 9 7 2 . I say " ~ o - c a l l e d , ~ ~because both were conducted by individuals closely connected with the experimenters. In neither one of these reviews was any experimental subject or family member contacted or interviewed. That is an extraordinary fact, and i t In neither of these reviews was any

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experimental subject or family member contacted or interviewed. In addition, none of these reviewers vigorously pursued the salient questions asked by the One, was cancer study the main object Two, what were the real risks to the Three, did patients give informed consents to being used as experimental subjects? One of these so-called reviews was conducted by an ad hoc committee appointed by the Dean of the UCN Medical College and included two UC faculty members. We need not belabor the conflict of interests inherent in such a project, but we do need to point out some obvious and we think intentional errors of their report. First, the ad hock committee gave the history of written standards for human experimentation to 1 9 6 4 in the Declaration of Helsinki. There's no mention of any ethical code before that date. The ad hoc committee failed to consider that initial errors in patient diagnosis may have been responsible for the long survival times of some

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of the patients, and you‘ve heard in testimony today that may indeed have been the case. There was no mention of the suspiciously low autopsy rate, eight out of 7 4 patients as of 1 9 7 1 , contrary to what one would expect if the experiments were for, for therapeutic purposes or part of a therapeutic study. And in their discussion of informed consent the ad hoc committee completely passed over, as they did many things, the requirement that patients must be told the true purposes and known side effects of the research, not only the risks. The other so-called review was conducted by a three-member panel of the American College of Radiology, which I’ll refer to as ACR, who visited the University of Cincinnati a total of two times for interviews of the, their friends. I say “friends” because one of the reviews has been, one of the reviewers has been described as, quote, a long-time fishing partner, unquote, of Dr. Saenger. At the time of the so-called outside review, Dr. Saenger was a member of no less than five different committees of the ACR, including a Commission on Radiological Units, Standards, and Protection; the Committee on Research and Development

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in Nuclear Medicine; the Commission on Public Health; the Subcommittee on Nuclear Medicine Technology; and a Committee to Ethicacy. Dr. Saenger was by 1 9 7 2 a Luminary in the ACR, and was one of the organization's leading organizers and activists. What is the ACR? Well, American College of Radiology is an advocacy organization and society promoting the use of radiology against alternative modes of treatment and diagnosis, and defending its practitioners against threat of medical legal suits by patients. From the 1930s on the ACR was the leading pressure group against the extension of radiation protection standards from workers to medical patients. Acting from within and without such organizations as the Advisory Committee on X-ray and Radium Protection, the Gestault (phonetic) Commission on Radiological Protection, and the National Committee on Radiation Commission. When the NCRP finally did take up the issue of extending its recommendations to the medical industry, the ACR, in desperation, attempted to subsidize the financially struggling NCRP and move the two organizations into the same office s p a c e SO as to further extend the control of the radiologists

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over the radiation protection community. In 1962, when Carl Morgan and, and Dr. Mueller finally succeeded in getting the radiation protection community to adopt the ten-day rule which provided protection to, f o r the first time to pregnant women and their children, and said you couldn't do radiological examinations within ten days after the beginning, or the end of menstruation, - - You would know, Dr. Stevenson. What guess. Okay, when that was finally adopted by almost every professional organization in the world, the A C R was the lone organizational holdout, and to this day has not adopted the ten-day rule or an equivalent protection for pregnant women. In 1 9 8 7 the ACR was found guilty of conspiracy with three other medical organizations in suppressing the chiropractic profession. Today the ACR still warns against reduction in the five rem limit lest radiologists and other physicians be restricted in the course of their choice in the course of therapy.

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Now, the leading spokespeople in this, this campaign against more stringent radiation protection guidelines, and by two of its major culprits, who were Dr. Robert Stone and Eugene Saenger, who are also major culprits in the whole human radiation experimentation, is a gentleman, the ACR, and, and these two physicians who were its spokespeople, consistently argued that physicians should be free' from external regulation because physicians must be free to determine their patients' course of care as they see fit withzut constraint either by other professionals or by their patients. This attitude is reflected in the ACR report on the Saenger experiment which states, quote, the treatment of an individual represents a series of choices f o r his physicians which are based upon diagnostic findings and their best judgment, unquote. Contrary to the ACR, we believe that treatment should involve a series of choices for the patient as well, and that it should b e based on the best judgment of the community of health professionals, not only that of the individual Not surprisingly, the ACR report condoned the Saenger experiments. In fact, t h e

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review committee could not even find its own words in which to state its conclusion, and so it chose to cite the words of Dr. Saenger as its own concluding Now, I have spent some time on the three reviews for one particular reason. At your July meeting Dr. Royal, one of your members, summarized the findings of these reviews by saying essentially that there were two in favor of the experiments and one against. Dr. Royal suggested that the junior faculty report, because it was the odd study out, must be wrong, and he speculated as to the reason for its, quote, bias, unquote. Dr. Royal, who it must be said is a member of the ACR, and a co-author of two Journal articles with Dr. Saenger, said that in the early ' 7 0 s the Viet Nam war was going on and many campus activists were attacking anything connected with the Department of Defense. He proposed with that this anti-war sentiment was responsible for the harsh tone of the junior faculty review, and that this might constitute a conflict of interest and a reason to dismiss their report. Well, I hope you now have been

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convinced that it is the ACR, and the ad hoc committee reports that truly suffer from conflict of interests, and should be dismissed. The junior faculty report should be lauded. For whatever its motivations, it tells the truth. real pain and suffering? The experiments were unethical and should be universally condemned as They would have been unethical at any time in any place, in any context. I went to Harvard. I know it's more erudite or profound, more respectable to try to understand a thing in context, to put it into historical perspective than it is to say that the thing is wrong. We have heard the words, I1contextr1lthe history, perspective, from the Advisory Committee as if they were mantras. You're an erudite bunch of people, but there will come a time, and it is fast approaching, when you, when we expect you to say simply and clearly, like the Nuremberg Tribunal, that the thing is wrong. And I would just like to add one other note. You've heard a lot about the Pitken and

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I did, used to live here in Cincinnati, and, and southwestern Ohio. I worked for unions both at the Fernald and Pitken plants, and there's already been some previous reference in fact. If I can answer any questions I ' d enjoy the opportunity to answer the questions, and certain experiments that did occur at both of those facilities involving workers. DR. TUCKSON: Thank you. Let me, I asked a lot of detailed questions earlier, somebody had thought naively, about the notion of the, of, of, of how often patients and their families saw a What is your reaction to this quote from the ACR review which you are familiar with and It says that the current consent-seeking procedure was reviewed. The team internist interviews patients two times, at least 2 4 hours apart, and discusses in extensive detail the procedures that will be undertaken. This is done not only for the patient, but for members of his family when available. The specific and detailed consents for it a r e not

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presented to the patient until completion of the second interviews, modified with specificity from the basic ones prepared by the NIH. Except in the case of the three children who were treated curatively, the patients knew before being referred to the study team that they had malignant disease which no curative treatment is possible. They knew that the efforts of the study team were not offered as curative. And it goes on to say, finally, many patients expressed a desire to participate in this study and possibly help the plight of other cancer patients in the future. What is your observation of that statement based on what you know and understand has to be said is that their review of the informed consent issue was done without contacting, without speaking to any patient or family member of a patient; only by talking to the physicians involved in the study at a time when the study was under very critical review. It was receiving a lot of publicity in the local media and the national media, and which one might expect that there might be all kinds of reasons why physicians might not be entirely

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forthcoming, or at least should be checked in terms of what they say about what they’re telling patients or have not told patients. That has to be borne in The other thing that’s striking about the ACR review, though, is that they seem never to have read the Nuremberg Code or any of its supporting documents, because the Nuremberg principles state clearly that the informed consent involves not only what the procedures are and the risks involved, but also the purposes of the research and the side, and the known side effects of the research. Now, while there are conflicting claims about what patients were told about the actual procedures and about the risks involved in the research, I don’t believe that anybody has said that the patients were routinely informed of the purposes of the research. There have been some statements made that if they asked about i t , then they would be told, but I ask you: If …