Minutes of the Meeting of February 15-17, 1995 Wednesday, February 15, 1995 Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Patricia King, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Duncan Thomas, Reed Tuckson. Philip Caplan, Special Assistant to the President for Cabinet Affairs, opened the meeting on February 15, 1995, at 1 p.m. in the Blue Room at the Omni Shoreham Hotel, 2500 Calvert Street, Washington, D.C. Dr. Faden briefed members on the agenda and noted that March and April meetings of the Advisory Committee would be over three days rather than two. Public Comment Alex Reinhart, of Braintree, Massachusetts. Mr. Reinhart represented Dr. David Egilman, who was unable to attend the meeting. Mr. Reinhart presented a statement from the Scientific and Medical Advisory Committee of the Task Force on Radiation and Human Rights. The statement criticized the Committee for lacking sufficient representation of lay and victim representatives, and said members included too many persons with professional biases. The statement questioned the Committee s willingness to judge culpable those involved with the Cincinnati total-body irradiation experiments. Ambassador Wilfred I. Kendall and Holly Barker of the Embassy of the Republic of the Marshall Islands, Senator Henchi Balos of the Republic, and Jonathan Weisgall of Washington. The Marshalls representatives briefed members on the republic s research since Senator Tony deBrum spoke to members in July 1994. Ambassador Kendall expressed concern that U.S. government efforts to research the issues important to the Marshalls would expire with the mandate of the Advisory Committee. He asked that the Committee recommend establishment of an independent panel to review documents regarding the Marshalls issues and fulfill its moral obligation to Marshallese exposed in the course of atomic weapons tests by recommending subsequent medical monitoring. Senator Balos spoke about the lack of information given to Bikini residents about the threats to health caused by exposure to fallout products. He said that residents were actively misled by such demonstrations as U.S. government technicians making a show of drinking a coconut s milk during brief visits to the atoll. Mr. Weisgall noted that extensive U.S. government data- gathering extended into the 1970s and cited specific documentation for the statements by the Marshallese delegation. He said U.S. payments for cleanup of Bikini Island are clearly inadequate and do not address other islands in the atoll or elsewhere in the Marshalls. Members questioned the panel about the activities of medical teams in the islands over the years and inducements offered to islanders for invasive procedures such as bone-marrow samples. Cooper Brown, Takoma Park, Maryland. Mr. Brown said the Task Force on Radiation and Human Rights will present a detailed report on remedies at the March meeting. He said the Advisory Committee should not be forced to rush its judgments because of the late spring deadline for its report, and urged that the Committee seek more time to prepare its report. Cliff Honicker, Knoxville, Tennessee. Mr. Honicker spoke about experiments at the Medical College of Virginia, saying that the college and the Committee have failed to follow up. He said the case should have been pursued intensively because of the oversight role of experiments at MCV by the Joint Panel on the Medical Aspects of Atomic Warfare in the Department of Defense. Executive Director Dan Guttman briefed Mr. Honicker and members about new documents regarding classification of MCV research in the 1950s to avoid press scrutiny. Mr. Honicker provided to the Committee some 500 pages of documents on MCV experimentation. Pat Broudy, Monarch Beach, California. Mrs. Broudy said that veterans of the atomic weapons tests were also survivors of experiments. She said the remedies should include 100 percent disability benefits to atomic veterans exposed to ionizing radiation, and illnesses attributable to exposure should be compensable under statutes governing veterans exposure. She said elimination of the necessity of dose reconstructions and the Nuclear Test Personnel Review program may save more money than that spent in fully compensating veterans. Members questioned Mrs. Broudy about the congressional reaction to atomic veterans efforts to obtain compensation. Update: Santa Fe Small Panel Meeting. Reed Tuckson. Dr. Tuckson briefed members on the Santa Fe meeting and the large number of witnesses that appeared there on January 30. He cited in particular the contributions of the uranium miners and millers, Utah prison experiment families, plutonium injection experiment families, Alaskans and atomic veterans. Dr. Thomas briefed members on the Los Alamos National Laboratory personnel who spoke at the meeting, and the January 31 Los Alamos site visit. Dr. Thomas said Los Alamos officials noted their disagreement with the scope of material requested by the Committee, but that Los Alamos officials said they would provide all materials sought by the Committee whether or not they agreed with the Committee s definitions. Committee Discussion: Experiments on Prisoners. Stephen Klaidman and Jon Harknesss. Mr. Klaidman said the purpose of a prisoner chapter is to assess the ethics of using captive populations as experimental subjects and to assess whether experiments were ethically conducted by the standards of the time. Members raised concerns about draft material on the issue. Dr. Royal noted that radiation is incidental to the ethical issues raised by the cases examined in the drafts. Dr. Thomas said that generally members need to focus on whether experiments represented meaningful scientific advances; he noted that what was learned from the prisoner experiments while only footnoted, is important. Dr. Macklin suggested ways to better focus the chapter, including the idea that testicular irradiation studies could have been done only in prisons; and that institutions can be demonstrated to be in violation of the Nuremberg Code and other policies governing human experimentation. Coercion and inducements are separate ethical issues, Dr. Macklin said, and suggested that inducements raise ethical concerns in other research situations besides prisons. Professor King said that the chapter may demonstrate the principle that there are some scientific questions that it is unethical to seek experimental results to resolve. Dr. Faden said that chapters may well deal with multiple issues, but that clearly that members felt that major issues ought to be highlighted. Professor King said the chapters must be organized around its purposes, such as remedies recommendations or delivering ethical principles. Dr. Macklin and Dr. Harkness discussed the treatment of the 1962 conference transcripts on ethical practices in prisoner experiments. Dr. Faden said it is important that the report make clear that there may be other experiments of concern not treated in the report, and that the experiments extensively treated were chosen as illustrations of principles drawn from the Committee s deliberations. Update: Agency Oversight Project. Wilhelmine Miller. Ms. Miller briefed members on responses from agencies about their oversight of human subjects research, including classified research since 1974. Dr. Faden said there would be a substantial discussion of the subject at the March meeting, and she urged agency representatives in the audience to make information available as soon as possible. Thursday, January 16, 1995 Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Jay Katz, Patricia King, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Duncan Thomas, Reed Tuckson. Approval of Minutes Members approved minutes of the January 19-20, 1995, meeting without change. Committee Discussion: Intentional Releases. Patrick Fitzgerald, Mark Goodman. Members discussed questions of harm arising from intentional releases. Dr. Thomas said that harm from Hanford emissions generally is likely to be established by dose reconstructions, but it is probably impossible to establish what part of that harm is attributable to the Green Run. He pointed out that becoming involved with all nuclear production emissions, as well as all nuclear testing, posed problems related to the Committee's scope. Dr. Royal said the chapter on intentional releases raises issues of risk communication, and the Committee s report should try to reassure those whose illnesses are unlikely to have been caused by exposures from Hanford or other sites. Dr. Tuckson said that the widespread belief in harms remains, whether the fear is well-founded or not. He added that there are also issues to be raised about the connection between secrecy and public health threats. Dr. Macklin said that harm and benefit are only one category of concern for the Committee, noting that persons being studied without information or consent were wronged. She said that the Green Run should be dealt with, even if it was not a human subject experiment per se. Dr. Goodman noted that citizens were put in harm s way in the course of research. Dr. Oleinick said the Committee must give great weight to psychological harm to people exposed in the Green Run, which she noted is popularly considered a human experiment. She said that the Committee needs to discuss the issues in order to recommend improvements in a basically unintelligible patchwork of policies and regulations governing releases of radioactivity. Dr. Glatstein suggested a moral distinction between the benefits and at least a modicum of consent in typical biomedical experimentation, and intentional releases and experiments of opportunity in which no consent was obtained and no good for those exposed could come of it. Dr. Thomas noted the difficulty in parsing causal relationships in exposures, but he said it is a problem the Committee must address. Dr. Royal said there is a good argument that more epidemiological studies would not be a wise expenditure of money, and that the public needs to be able to choose between studies and public health programs. A 1953-54 internal Atomic Energy Commission memo about obligations to downwinders from the Nevada Test Site was cited by Dr. Thomas as the model for policies that ought to be adopted as recommendations regarding intentional releases. Dr. Russell said that it s important to be precise in assessing issues of causality and psychological harms, but that issues of environmental releases done in secret, as well as failures of public health responsibilities, represent real harms that can be addressed in the Committee's report. Dr. Tuckson noted the powerful public testimony received by the Committee around the country, and Dr. Thomas said that the fears engendered in downwinders are real harms. Yet, he said, the Committee must not raise more concerns than warranted by evidence. Members discussed how to address the fears without setting off false alarms in a draft chapter, and Dr. Tuckson said the report must also address more directly the public health responsibilities with respect to intentional releases. Ms. Norris and Dr. Tuckson noted the necessity of giving appropriate weight to mitigating factors such as national security decisions in a dangerous era. Dr. Goodman said it s very difficult to determine if in fact the Green Run did any good in terms of goals of the experiment and the national security imperatives that led to it. Dr.Russell said the harms that arose from citizen concerns and secrecy were caused by mismanagement of the follow-up activities by the military and government. Dr. Royal noted that the harms were widely distributed in atmospheric testing and the Green Run, but Dr. Macklin noted that Native Americans and Hispanic Americans were significantly more affected in the RaLa releases from Bayo Canyon at Los Alamos National Laboratory. Professor Fitzgerald noted that some nuclear devices were not exploded to test new designs, but to evaluate effects of well-known weapons designs. Professor King said the chapter should contrast the public debate over recombinant DNA research to the secrecy and evasions in intentional releases. The American people would not have agreed to have been experimented upon in this way, had they known all the facts and had the opportunity to say no, even in the name of national security, Professor King said. The Committee should assert the need for civilian control or oversight, and means to ensure that public discussion occurs before future releases. Mr. Feinberg said accountability issues are where the Committee can make most clear-cut recommendations. Committee Discussion: Experiments of Opportunity. Barbara Berney, Gil Whittemore and Faith Weiss. Dr. Macklin said the chapter needs restructuring to stress the justification for calling the exposures experiments. Dr. Thomas said the chapter should focus on cases, e.g. uranium miners, in which exposures continued for sufficient time to allow for actual study of the effects of the exposures. He said it is less clear in the case of the Marshall Islands. Dr. Thomas noted that the Atomic Energy Commission failed to reconcile its duties with adequate protection of workers, and that constitutes a broad theme, official responsibility and accountability. A second broad theme is misinformed consent, where citizens were misled. Members discussed the virtues of the term experiments of opportunity, with members agreeing that it is a rhetorical construction that could more properly be described as research involving human subjects. Members decided to agree on a chapter title later. Ms. Berney said the jurisdictional issue -- the federal authorities' citing mining safety as a state responsibility in the 1940s -- was important in the case of the uranium miners and millers, but that employers generally did not wish to acknowledge hazards, with attendant difficulties arising with workers. She contrasted the enforcement of beryllium standards with the neglect of hazards in the uranium mines, apparently because news reports had raised concerns of workers in the beryllium plants. Members discussed how the chapter should be organized, focusing on questions of individual or professional culpability and the institutional issues raised. Dr. Thomas said both issues must be covered in the experiments of opportunity chapter. Dr. Faden noted that early chapter drafts need input from the Committee to synthesize facts and recommendations. Dr. Thomas said the chapter needs to be edited to include essential facts in light of the Committee s direction on conclusions. Members proceeded to discuss the questions raised in the chapter draft. Drs. Thomas and Katz discussed the culpability of Public Health Service investigators in the case of the uranium miners. Dr. Russell analogized the decision to that of cigarette smoking, in which many years of studies were needed to demonstrate the conclusions persuasively. Dr. Macklin said the key issue is the responsibility of researcher to subject. Dr. Thomas outlined the ethical problems of epidemiologists in assessing when data are conclusive and should be reported to subject or population. Dr. Macklin said the case studies provide the facts for conclusions, as that government and the miners should have known about the problems from uranium mining experience in Eastern Europe. Members discussed the high risks from radon in the uranium mines, but Dr. Macklin said the obligation to disclose the risks was fundamental, whether or not miners agreed to continue in the mines. Dr. Russell said national security was not a legitimate reason for deluding American Indian populations, given options for manning mines differently or making mines safer. Dr. Oleinick suggested that members should answer the questions in writing and circulate the answers to members. Professor King said that the staff, and members who wish to do so, should draft interpretations and analysis as part of redrafting the chapter. Dr. Thomas strongly urged members to take their own cut at answering the questions raised by the chapter draft. Committee Discussion: Strategy and Direction. Ruth Faden. Dr. Royal expressed concern about the scope of the project undertaken by the Committee. He asked for guidance on consulting with colleagues. Dr. Faden said the only difficulty would be in circulating prematurely any chapter drafts. She asked that members consult with Mr. Guttman before doing so. Mr. Guttman noted that fact reviews would be allowed by interested agencies. Members discussed the issue of retrospective moral judgment. Dr. Royal said that he is troubled that the Committee s work tends to hold radiation scientists to a very high ethical standard, perhaps higher than that of medicine generally at the time, and Dr. Macklin added that it is important that context be provided about the nature of practices at the time. Members agreed to defer the discussion to the February 17 discussion of practice standards. Dr. Thomas noted the suggestion that a chapter provide, basically without comment, a platform for extensive excerpts from public comments to the Committee. He said members may wish to consider adding context and analysis about the Committee's take on public testimony. Dr. Thomas also suggested that little attention had so far been paid to the benefits to the American people of radiotherapy and nuclear medicine. Mr. Guttman said that some of those issues would be addressed early in the report. Committee Discussion: Human Experimentation in Connection with Atomic Bomb Tests. Dan Guttman and Patrick Fitzgerald. Dr. Thomas raised the issue of scope, noting the relatively few service personnel exposed to explicitly biomedical experimentation. While much experimentation, e.g. HumRRO phsychological studies, were also done in connection with weapons tests, they cannot be construed as radiation effects test. He noted that swallowing of film badges by fliers going through mushroom clouds was more clearly a radiation study. Dr. Thomas said the chapter turns on the issue of the meaning of informed consent in a military situation; as a practical matter, he said, there was no opportunity to refuse to participate. Dr. Thomas also cited the practice of misinforming soldiers, via false answers to a questionnaire distributed as part of HumRRO indoctrinations in 1950s weapons tests. Dr. Faden noted that there remain unresolved questions about the differences between occupational/training experiences and biomedical research, but Dr. Macklin said it differs mainly because people want to call it different things, and what rules apply change with the definition. Dr. Oleinick said the HumRRO studies were clearly experiments, but there was no consent involved. Mr. Guttman noted that officer/volunteers placed nearer to Ground Zero were involved in some kind of consent process. Dr. Macklin noted that the word used to describe HumRRO activities was indoctrination, suggesting that the information presented to troops was not meant to be unbiased. Indoctrination is antithetical to truly informed consent, she said. Professor Fitzgerald noted that the behavior of test personnel changed in light of the data generated by the activities. He noted that the risk assessment for future operations was greatly reduced after the initial cloud fly- throughs. Mr. Guttman cited the possibilities of long-term harms from exposure, and noted that the 1950s military focused entirely on short-term effects of exposures. Dr. Thomas suggested that redrafting add context about the impact of long-term risks from exposure; he said that might be important information for policymakers focusing on compensation. Dr. Thomas added that the military can clearly be faulted for sloppy recordkeeping, because there was sufficient knowledge of some long-term effects to know that follow-up was necessary. Dr. Faden said the harms include secrecy inspired distrust and anger, similar to that in the intentional releases and experiments of opportunity discussions. Dr. Macklin said the lack of good information on risks raises serious ethical issues about any exposure. Mr. Guttman said that doctors advising the Defense Department were simultaneously expressing private uncertainty and public confidence in the safety of exposures for troops at the Test Site. Mr. Guttman also cited the NEPA debates in the late 1940s and early 1950s. Dr. Macklin said those concerns expressed in secret should be highlighted in the report. Mrs. Norris noted that a continuing theme is the small number of professionals wearing too many hats, serving on too many committees with different objectives and imperatives. Professor Fitzgerald noted that military exposure standards were raised, to avoid higher costs of decontamination, because of the data generated by cloud fly-throughs. Mr. Guttman noted that Los Alamos test managers objected to the higher standards, and Dr. Glatstein suggested that additional experimentation was often producing little incremental data. Mr. Feinberg said the bottom line for the Committee is whether there was an ethically acceptable process for informing subjects and ensuring accountability for exposures. Committee Discussion: Experiments on Children. Jeff Botkin, Greg Moskun. Members discussed the scientific basis for remedies recommendations in the draft chapter, particularly relative to Iodine-131 exposures. Dr. Royal questioned the rationale for a recommendation of medical followup for specific risk levels. Dr.Botkin said the thyroid studies indicated the highest likelihood of longterm effects. Dr. Tuckson said the recommendation ought to be appropriate for the risks. Professor King called attention to a lack of culpability standards; she said the chapter tends to assume strict liability of the government to provide medical followup to surviving subjects. Dr. Royal and Dr. Faden noted the administrative difficulties of finding records for a large population of persons who believe that they were exposed as children. Dr. Macklin noted that the draft chapter is organized differently from others and requires editing attention to make it more consistent. Dr. Macklin also noted the need to address the Nuremberg Code s requirement of informed consent, suggesting that parents or guardians could not provide consent consistent with the code. She listed ways to improve the ethical argumentation concerning use of children in research generally. Dr. Thomas asked that the chapter address investigators using their children in studies. Dr. Lederer asked that issues of social class be addressed. Committee Discussion: Plutonium Experiments. Duncan Thomas, Eli Glatstein. Dr. Thomas briefed members on the current understanding of the scientific purpose and utility of the plutonium injection experiments. Excretion rates were the primary dosimeter for the human body, set from animal studies. However, a precise ratio of excretion rate to exposure was the goal of the plutonium injection experiments. The members questioned the utility of the data given that radiation exposure in the studies was by injection and the primary occupational exposure was from inhalation. Dr. Thomas said the impact of the body burden on the liver and other organs would be usefully derived from the Langham data from the plutonium injections, but not the lung. Dr. Thomas said more research was necessary to solve the puzzle: the plutonium injections appear to be a case of tackling a problem one could solve but that was of limited value, and leaving alone a more important problem, i.e. the impact of plutonium inhaled into workers' lungs. Friday, February 17, 1995 Attending: Ruth Faden, Kenneth Feinberg, Eli Glatstein, Patricia King, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Duncan Thomas, Reed Tuckson. Staff Report: Research Proposal Review Project. Sara Chandros. Sara Chandros briefed members on progress in reviewing research proposals. She explained the rating system and some preliminary results from reviews already completed. Her observations were seconded by Dr. Katz, but both deferred conclusions until more reviews are completed. Ms. Chandros said five studies raised serious ethical concerns among initial reviewers, and these were scheduled for further evaluation by the proposal review subcommittee and members of the staff before any final determination about how to classify those studies. Staff Report: Subject Interview Study. Jeremy Sugarman, Nancy Kass. Dr. Sugarman briefed members on the status of IRB approval for the subject interviews. He said 10 of 19 institutions had approved the study and interviews would be complete in those institutions on schedule. Dr. Sugarman outlined the staff's process to check anonymously the progress of the interviews, and to call back a sample of interviewees to see how they viewed the interviews conducted by the interviewing organization. Dr. Faden said the institutions cooperating in the study should be commended for their participation. Committee Discussion: Professional Standards and Practices. Jon Harkness. Members questioned Dr. Harkness about draft pages of the chapter on professional standards and practices. Dr. Harkness noted that Rebecca Lowan would be reviewing microfilm records of newspapers and magazines to flesh out the perception of the Nuremberg process among the American professional communities. Members discussed the importance in the 1940s of the American Medical Association presentation of Nuremberg issues in the AMA journal, and whether doctors of the time perceived the Nuremberg Code as applicable to research involving patients. Committee Discussion: Cold War Research Ethics Standards in Retrospect. Jonathan Moreno. Dr. Moreno briefed members on development of a chapter to outline the criteria by which the Committee's report will evaluate the actions of government agents and individual investigators. Members made several suggestions for improvements in parts of the text, and discussed the evidence available to make ethical judgments. Committee Discussion: Remedies. Gary Stern. Members discussed retrospective remedies, with Dr. Faden saying time will be scheduled for discussion of prospective remedies during the March meeting. Dr. Thomas distributed a grid matching proposed remedies with sections of the draft chapter. Members discussed the matching of remedies to categories of behavior, and how to categorize classes of experiments for purposes of remedies. A staff memorandum was distributed which outlined the case for a no-fault scheme for remedies for identified harms to research subjects. Members discussed the no-fault principle and its application to cases in which no physical harms are found. Members discussed whether an increased risk could constitute a harm even in cases where no physical harm manifested itself over a period of years after an experimental exposure of a subject. Mr. Feinberg outlined difficulties with the attempt to tailor remedies to specific categories of experiments. He said the historical evidence may not allow members to make those decisions, and that structuring remedies will be problematical given the scientific disputes over causality of, for example, specific medical problems. Mr. Feinberg added that the purpose of recommendations is to put the country past the harms of the Cold War era, and that remedies shoehorned into various categories would not comprehensively meet the needs of citizens who have appealed to the Committee. He said the Committee should fit remedies to classes of experiments were the facts to allow members to draw those conclusions, but otherwise present a menu of policy options for the Congress or the Executive Branch to apply as they will. Dr. Thomas and Dr. Macklin argued that the Committee should make specific remedies recommendations to fit specific experiments. Professor King said the discussion will remain abstract until members debate specific remedies recommendations. Dr. Katz suggested that overly specific recommendations would bog down the Committee in what Mr. Feinberg characterized as invidious distinctions among groups of experiment subjects. Mr. Guttman, acting as the designated federal official, closed the meeting at 4:20 p.m.