DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB K þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: November 4, 1994 RE: Ethics Document Collection Follow-Up The Advisory Committee has recently received several particularly interesting documents. Two of these relate to the origins and drafting of the document signed by Secretary of Defense Charles E. Wilson on February 26, 1953. The "Wilson memorandum" created a Nuremberg Code-based policy to govern the Department of Defense's human experiments in atomic, biological, and chemical warfare for defensive purposes. (Attachment 1). Several other documents relate to psychomotor studies of patients who have undergone radiation for therapeutic purposes, conducted by the School of Aviation Medicine in cooperation with the University of Texas, M.D.Anderson Hospital for Cancer Research, in Houston, Texas, from 1951 to 1956. These documents appear to confirm that, at least in regard to the nuclear powered airplane, military officials did not view data gathering from patients undergoing therapy as human experimentation. Other material indicates that some officials during the early 1950's had the sense that, if human experiments for military purposes are to be approved, they should be done by public agencies. I. ORIGINS AND DRAFTING OF WILSON MEMO AND SUBSEQUENT DOD POLICY An important outstanding question has been the exact origins of the Wilson memo and subsequent Department of Defense (DoD) policy. Although it is known that technically the proposal was advanced by the Armed Forces Medical Policy Council (AFMPC), it is not clear what parties represented in the AFMPC originally proposed the Nuremberg Code as a basis for policy. Nor has it been clear how other officials in the top echelon of the Department of Defense were involved in commenting upon the draft policy. Newly acquired documents suggest that the AFMPC counsel, and perhaps the DoD General Counsel, had key roles in this story, as did the Assistant Secretary of Defense for Manpower and Personnel, Anna M. Rosenberg. 1 A. Physicians and Prisoners of War as Subjects On October 13, 1952, the same day that the AFMPC was to approve its Nuremberg Code-like policy recommendation, AFMPC counsel Stephen S. Jackson, Assistant General Counsel in the Office of the Secretary of Defense, wrote Casberg the following memorandum (Attachment 2): It is recommended that the attached principles and conditions for human experimentation, which were laid down by the Tribunal in the Nuremberg Trials, be adopted instead of those previously submitted by me, with the following change: In No. 5-delete everything after the word "occur" and insert the period after that word. Add (1) (g) of previously submitted conditions to wit: "11. Whereas prisoners incarcerated in penal institutions may and have been used if the required conditions are met, prisoners of war will not be used in human experimentation." Jackson's first change in the original text of the Nuremberg Code ["No. 5," above] eliminated an exception for physicians who used themselves as subjects. His second change ["(1))(g)," above] was an addition to the Code, though probably one that was implicit in its meaning. A December 4, 1952 memo from Jackson to Casberg noted "some question of interpretation" had arisen about the first clause of the prisoner of war rule (Attachment 3), so Jackson suggested it be altered to read : Prisoners of war will not be used in human experimentation. However, the version that ultimately prevailed and appeared in the final draft of the policy was: The established policy, which prohibits the use of prisoners of war in human experimentation, is continued and they will not be used under any circumstances. Unfortunately, we do not know what Jackson's original submission to the AFMPC was, nor if he himself originated the idea of using the Nuremberg Code and passed it on to the Council as the recommendation of their lawyer. Yet it is clear that Jackson was an important actor in the formulation of the draft policy that finally went to the Secretary of Defense. 2 B. Consent in Writing Another important participant in the drafting of the ultimate proposal was the Assistant Secretary for Manpower and Personnel, Anna M. Rosenberg. Rosenberg was a nationally recognized authority on labor relations and had been an influential New Dealer. On October 22, 1952, nine days after the AFMPC passed their Nuremberg Code recommendation, Jackson wrote Casberg the following memorandum (Attachment 4; unfortunately, the text is barely legible and is reproduced in its entirety below.): I discussed the attached with Mrs. Rosenberg on Saturday. She concurred in the conditions except that she recommended that a provision be added to 1. requiring that the consent be expressed in writing before at least one witness. I have added such language in the appropriate place under number 1. The new matter is underlined. Mrs. Rosenberg has approved this language. Mr. Kent the General Counsel, has approved this addition from the legal standpoint. I recommend that the conditions be so amended. The Wilson memo requires that "[written consent] shall be signed in the presence of at least one witness who shall attest to the signature in writing." II. SCHOOL OF AVIATION MEDICINE AND M.D. ANDERSON HOSPITAL PSYCHOMOTOR EXPERIMENTS, 1951-56 Research conducted from 1951-1956 by the School of Aviation Medicine (SAM), on a contract with the M.D. Anderson Hospital for Cancer Research in Houston, Texas, was motivated by a need for information about the psychomotor effects of radiation exposure coupled with the prior determination that "human experiments" had been forbidden by top military authority. Following debate over the need for human experimentation in connection with the Nuclear Energy Propulsion for Airplanes (NEPA) project, (Briefing Book vol. 5, Tab G), the military evidently determined against human experimentation. However, no sooner was this determination made, then, as the M.D. Anderson documents indicate, the data gathering was approved in the context of the therapeutic application of radiation. Apparently, as previously hypothesized, it was assumed that the NEPA prohibition against human experimentation applied to healthy volunteers and not patients undergoing treatment. A document called Project Specifications, dated October 19, 1950, stated: 3 It is desired to measure certain mental and psychomotor abilities of patients who are undergoing radiation therapy in order to evaluate any differences in performance that may result from radiation effects. This information is urgently required by the U.S. Air Force in connection with the NEPA [Nuclear Energy Powered Aircraft] Project. It is clear that before attempting to operate its proposed nuclear powered aircraft, the U.S. Air Force must evaluate its radiation hazards. There are no scientific data with which to assess these dangers of the NEPA aircraft in terms of their probable effects upon crew performance and well-being. The most direct approach to this information would be human experiments in specifically designed radiation studies; however, for several important reasons, this has been forbidden by top military authority. Since the need is pressing, it would appear mandatory to take advantage of the investigation opportunities that exist in certain radiology centers by conduct in special examinations and measures of patients who are undergoing radiation treatment for disease. (Attachment 5, p. 1) (emphasis added) Thus the subjects were patients at M.D. Anderson who were undergoing radiation therapy, but the testing was done by physicians from SAM. Project minutes indicate that these were mostly outpatients who were not terminally ill.1 [The Project Specifications (Attachment 5, p. 1) indicate that the study populations is drawn from "patients who are scheduled for radiation therapy for various diseases." It does not specify what diseases these patients had. The Research Council Meeting Minutes of January 14, 1954, (Attachment 6, p.7) indicate "Captain McGraw stated that he thought that the cases studied were terminal cases. He was answered in the negative." Additionally, it is noted that the patients are out-patients who are being kept in the hospital for testing purposes. More specific description of the patients' condition is not given.] Three psychomotor tests were given to subjects, called "the complex coordinator, the hand coordination test, and the rotary pursuit test." All had "a proven relationship to the skills required in basic pilotry." (Attachment 7) At first the data were not promising because the tested patients had received very low doses of radiation, but then high dose radiation treatment up to 200 r came into favor among oncologists at M.D. Anderson. Then the investigators began to feel that they got some worthwhile results. A total of 263 patients were reported to have participated in these studies. Available evidence leaves many uncertainties about the actual execution of the experiments, including how the subjects were selected and how the hospital staff "motivated" them for the testing. Outpatients were used in order to ensure that they could perform the psychological tests, but the nature of the testing required that they be boarded in the hospital. This obviously required a significant level of commitment on the part of the participants. There is no basis for concluding what the patients were actually told about the purpose of the tests, though they were ostensibly volunteers. 4 III. HUMAN EXPERIMENTS FOR MILITARY PURPOSES AND PUBLIC AGENCIES The Atomic Energy Commissions's Division of Biology and Medicine held a meeting on September 8 and 9, 1950. According to the minutes of that meeting [Attachment 8]: A full discussion was held once again on the problem of human experimentation. The Committee felt that human experimentation at the present time is not indicated, that it would have serious repercussions from a public relations standpoint if undertaken by an agency that has to do a portion of its work in secret; and that adequate data can be obtained from animal experiments, from the Los Alamos accidents, from certain observations which have been made by clinical radiologists, and from the studies at Hiroshima and Nagasaki. The Committee endorsed the action of the Director of the Division of Biology and Medicine in not concurring in a program for human experimentation. A letter dated September 25, 1952 from James G. Terrill, Jr., Acting Chief of the Radiological Health Branch of the Division of Engineering Resources of the National Institutes of Health (NIH), to Charles V. Kidd, Chief of the NIH's Research Planning Branch, demonstrates that Shields Warren's concern about the implications of doing human radiation experiments in secret was well-known in the DoD (Attachment 9): At the September 8-12 meeting of the Panel [the Joint Panel on the Medical Aspects of Atomic Warfare] at Los Alamos, several subjects were discussed that are of general interest to the Public Health Service as a whole and particularly to the National Institutes of Health. After the Panel has [sic] reviewed the animal work which has been done in the laboratory and at atomic field tests, there was a general feeling that the question of human exposure under controlled conditions should be reconsidered. The need for such studies was emphasized by military as well as scientific considerations. After a brief discussion, it was reported that Dr. Shields Warren, former Chief of the Division of Biology and Medicine, had indicated that he believed studies of this type should be conducted by the Public Health Service or some other Agency where security restrictions would not lead to public misunderstanding. 5 This letter also raises other interesting questions, such as the relationship between the NIH and the DoD in radiation experiments. The Terrill letter continues: The Panel agreed that the Executive Secretary [of the Joint Panel on the Medical Aspects of Atomic Warfare] should undertake sufficient staff work to form a basis for specific planning at the National Institutes of Health. Therefore, they wish to obtain a listing of intra-service and research grant projects in the atomic energy field. I think if we can obtain a list of the research projects currently administered by the several Bureaus [of the NIH], together with a list of any proposals for human exposure studies that may have been disapproved, we will be rendering a real service to the Defense Department. The Advisory Committee staff will continue to investigate the relationship between the DoD and the NIH in this period. Further documentation on the relationship at mid-century among DoD, the NIH, and the Atomic Energy Commission appears in Tab J. 6