ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS Meeting of October 11-13 Tuesday, October 11, 1994 Attending: Ruth Faden, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. As the designated Federal official, Executive Director Dan Guttman opened the meeting at 2 p.m. Tuesday, October 11, at the Press Club, 555 Post Street, San Francisco. Dr. Faden briefed the public about the background of the Committee. Dr. Faden noted that the meeting is in San Francisco to hear from citizens who might be unable to go to Washington, D.C., where Committee meetings are usually held. Dr. Faden noted that Drs. Eli Glatstein and Jay Katz, and Professor Patricia King were unable to attend the meeting. Mr. Ken Feinberg joined the Committee on Wednesday. Subcommittee Report: Oral Histories. Susan Lederer. Dr. Lederer said two interviews have been completed and are being transcribed and submitted for approval to interviewees; these will be distributed to members for comments and suggestions. The interviews may help to provide a fuller portrait of ethical practices in 1944-74 by the November meeting. Dr. Lederer said there are opportunities to follow up with questions to interviewees. Mr. Guttman reported that interviews conducted by the staff to investigate specific experiments would also ask about the core concerns in the oral history project. Dr. Thomas asked that a full list of interviewees from both projects be provided by the staff. Dr. Lederer said that interviews conducted by government agencies would be obtained where they can assist the Committee's efforts. Subcommittee Report: Subject Interviews. Ruth Faden. Jeremy Sugarman reported on the interview project, which has benefited from consultations with three panels of medical professionals. Sites will be selected that include a major research medical university, Veterans Health Administration hospital, community hospital, a national laboratory or research facility, and/or a military hospital. Dr. Sugarman said the Committee has obtained Office of Management and Budget clearance under the Paperwork Reduction Act, and received information from funding agencies needed for selecting institutions. The Department of Energy expects its procurement paperwork to be done soon. Dr. Faden said the institutional review boards' clearance at participating institutions will be done as quickly as possible. She said there was a gratifying level of support from physicians consulted about the process. Subcommittee Report: Research Proposal Review. Ruth Macklin. Dr. Macklin reported that after lengthy discussion the subcommittee, joined by Professor King and Dr. Thomas, decided against identifying research projects for review based on an analysis of the published literature. Dr. Macklin briefed members on the review of research proposals. Members agreed to include proposals involving tissue samples drawn for research after the subjects were exposed to ionizing radiation. At the suggestion of Dr. Thomas, members agreed to a strategy of quota sampling, in which proposals initiated as early as 1990 may be included in order to obtain an adequate number of proposals in each category of interest. Specifically, the Committee agreed to anchor the study in FY93 and work outward to reach a goal of at least five studies in each cell of the sampling chart presented by the subcommittee. Members discussed composition of teams for review of proposals. Dr. Macklin said that as many Committee members as possible should begin working on the review so that the Committee as a whole can reach informed conclusions. Dr. Thomas said it is important that multiple reviewers identify the relevant issues so that fairness can be assured. Dr. Macklin suggested that a pilot of a few proposals be done as soon as possible to provide guidance about time required for the reviews and what difficulties arise in the process. Subcommittee Report: Outreach. Reed Tuckson. Dr. Tuckson noted that the Committee and staff work required in a West Coast meeting, and the extension of the meeting to involve four hours of public comment on October 12, demonstrates the importance the Committee assigns to outreach. He reported that Dr. Faden and others met with the editorial board of the San Francisco Chronicle, and that members would be asked to visit editorial boards in other cities to ensure that the public is aware of the Committee's work. He reported that small panel meetings are scheduled for Cincinnati on October 21, Spokane on November 21 and Albuquerque/Santa Fe on January 30. He said the staff continues to work daily with interested parties to maximize communication and cooperation. Committee Discussion: Agency Updates. Ruth Faden. Dr. Faden reported that the Committee continues to receive a substantial amount of cooperation from agencies in their searches for relevant information, although she noted that most public discussion tends to focus on remaining difficulties. These include working closely with the Department of Energy to complete descriptions of record collections, and with the Department of the Army to get records from key headquarters, including the Chemical Corps, as well as documentation from experiments already identified. The Department of Health and Human Services is working on a more useful list of experiments from its radiation study division from 1944-74, and reports from the Clinical Center from 1954-74. The Committee has asked NASA for its list of experiments and supporting documentation, and the agency expects to complete that task, originally scheduled for September 23, at some date in November. The Department of Veterans Affairs has had limited success in finding relevant Central Office documents, and it will be shifting its focus to key field sites. Subcommittee Report: Biomedical Research. Selection of Case Studies. Duncan Thomas and Barbara Berney. Dr. Berney reported that the staff and subcommittee have concluded that random sampling of experiments is not useful as a strategy because of the fragmentary nature of much of the data from experiments of 1944-74. The subcommittee recommended that experiments be grouped into categories for purposes of intensive study, and members debated the rationale for grouping experiments together. Mr. Guttman and Dr. Faden noted that a great deal of discovery remains to be done within proposed categories. Members discussed at length the ethical issues brought into focus by the categories proposed, and the evidence available to deal with the issues in each category. Members approved four categories: Biodistribution experiments, such as plutonium injections and other experiments related to the toxicology of transuranic elements. Experiments in this area include uranium injections in comatose patients and tests of chelating agents. Total body irradiation (TBI) experiments in Cincinnati and elsewhere. Experiments involving or affecting children and pregnant women, as at Nashville, Boston and elsewhere. Radioisotope research with both therapeutic and diagnostic intentions, and which may have involved fallout research. Members deferred approval of a fifth category, boron neutron capture therapy, until a full presentation can be made at the November meeting. Members agreed to discuss on October 13 the category of testicular and other partial-body irradiation that was performed without therapeutic intent, as in the Washington and Oregon prisoner experiments. October 12, 1994 Attending: Ruth Faden, Ken Feinberg, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. Public Comment Period Dr. Faden briefed members of the audience on the work of the Committee. The Committee heard from the following persons during its extended public comment session: Mrs. Nancy Lynch, Santa Barbara, California. She briefed members on the case of her late husband, involved in Operation Teapot in 1955. She said the first victim of radiation experiments is the truth, and explained her difficulties in getting records and satisfaction from government agencies. Dr. Thomas questioned Mrs. Lynch about reasons for denial of VA claims, and Dr. Tuckson asked her to send the Committee more information on that issue because of its potential relevance to the work of the remedies subcommittee. Mrs. Jackie Maxwell, Menlo Park, California. She testified concerning the genetic defects suffered by her children with her late husband, a prisoner of war forced to work in the immediate fallout of Hiroshima in 1945. Mr. Vernon Sousa, San Francisco. A veteran of the Defense Atomic Support Agency, Mr. Sousa said that test events at Sandia base have been covered up by the government. Dr. Tuckson questioned Mr. Sousa about the secrecy rules in effect at the time of the incidents, and Ms. Norris inquired about service and medical records. Mrs. Gwynne Burroughs, Chico, California. Mrs. Burroughs spoke to the Committee about medical problems she ascribed to exposure as a child at Sandia base in the late 1950s. Mr. Israel Torres. Nipomo, California. Mr. Torres told members of his experiences as a Marine at Camp Desert Rock atomic weapons tests. He said that he was the subject of extensive medical monitoring following the tests. Mrs. Audrey Hack, Union City, California. The widow of a Marine who served in Nagasaki in 1945, Mrs. Hack commended the Committee for its research and urged the Committee to add to its membership a victim of radiation exposure. She said that the Committee's experts should also include some members from universities with no history of involvement in radiation research. Mr. Richard Harley, Bakersfield, California. Mr. Harley is a Navy veteran of the first H-bomb test in 1952 and detailed his medical and psychological difficulties since. Mr. Donald Arbitblit, San Francisco. Attorney for the plaintiffs in the class action lawsuit about Vanderbilt tracer experiments, Mr. Arbitblit provided the Committee with statements and a videotaped deposition regarding the case. He asked the Committee to urge Vanderbilt University to release names of all patients who may have been subjects in the 1945-47 experiments at the university's clinic. Geoffrey Sea, Oakland. Mr. Sea, a radiological health physicist working on the Vanderbilt litigation for the plaintiffs, stated that he was speaking as an individual and founder of International Radiation Injury Survivors. He urged members to pursue vigorously evidence of exposures that may have been covered up by government agencies. Mr. Harold Bibeau, Portland, Oregon. Mr. Bibeau briefed members on his experience as a subject in the Oregon prison experiments. Members questioned Mr. Bibeau about issues of consent and disclosure by the investigator, the late Dr. Carl Heller. Mrs. Cherie Anderson and Mr. Tom Wilson, Placerville, California. Mrs. Anderson and Mr. Wilson briefed the members on problems with radium treatments that occurred in childhood. They urged members to find why the government approved such therapies, why they were discontinued, and how these experiences helped define what is experimental and what is a typical medical procedure. Michael Yesley, Los Alamos National Laboratory (LANL). Mr. Yesley briefed members on informed consent policies at LANL discovered by the laboratory's Human Studies Project Team. Dr. Royal asked Mr. Yesley to provide a tape of a CNN report which included interviews with children tested. In response to a question from Mr. Guttman, Mr. Yesley said he had no information about destruction of records at Los Alamos Medical Center. Lynn Stembridge, Hanford Education Action League (HEAL), Spokane. She briefed members on the Green Run and other exposures at Hanford and urged the Committee to make every effort to bring to light still-classified documents regarding the exposures. She also urged that the Committee recommend a formal apology to citizens by the government of the United States. Trisha Pritikin, Berkeley, California. A Hanford downwinder, Ms. Pritikin provided the Committee with documentation about finding further information on Hanford releases. She urged the Committee to recommend remedies for downwinders that include medical monitoring, no-cost health care and compensation for pain and suffering. Lois Camp, Hanford Downwinder Health Effects Group. Mrs. Camp briefed members on health issues related to the downwind exposures and urged close study of research involving students in Richland-area public schools. She urged the Committee to see that all health-related information is immediately declassified. She praised the work of the Committee but added that its work could be improved by the addition of persons immediately affected by experiments and exposures. Darcy Thrall, Richland, Washington. Ms. Thrall related her experiences as a schoolchild involved in an apparent research study in Richland. She reported threats and other harassment as a result of publicly raising questions about the purpose of these unexplained activities. Dr. Bernard Lo, San Francisco. Dr. Lo, professor of medicine at the University of California at San Francisco, reported on the efforts of the UCSF committee to investigate experiments performed under the university's auspices. He said the UCSF committee will make its findings public and available to the Advisory Committee. Members questioned Dr. Lo about ethical standards and the search process by the UCSF committee. Jackie Cabasso, Oakland, California. The director of the Western States Legal Foundation, which advises nuclear and environmental activists, Ms. Cabasso urged the Committee to use an expansive definition of "experiment" because of the wide range of radiation exposures. Marylia Kelly, Livermore, California. Mrs. Kelly, representing a Livermore citizens group, called for the Committee to recommend a comprehensive sampling program around nuclear facilities. She stated that many radiation exposures were for experimental purposes, whether in a clinical setting or in an environmental release. Dr. Faden thanked members of the public for their presentations and asked that they communicate with staff members to provide additional documentation for the Committee. Staff Report: Case Study, Plutonium Injections. Gregg Herken and Jonathan Moreno. Dr. Herken outlined the story of the 1946-47 series of transuranic injections. He reported on the distinction drawn in an interview with one of the researchers, Patricia Durbin, between the case of Cal-1, in wartime, and the cases Cal-2 and Cal-3. While Cal-1 could be described as science in service to the state, the two later cases were said by Dr. Durbin to be research efforts to find "the magic bullet" against cancer. Other injections through 1950 were argued as fitting into the second category. All occurred after elaboration of some consent standards by the Atomic Energy Commission. Dr. Moreno discussed the ideas of clinical research standards relative to subjects under current human subjects protection regulations (45 CFR 46). He described the staff's exercise of developing the historical story as well as determining whether today's rules would permit the same experiments. Members discussed issues of consent; the lack of prior review of experiments; the apparent lack of reliable diagnoses, and the highly public nature of the trip from Australia taken by Cal-2. Members said the process of discussing the plutonium experiments was helpful and Dr. Faden said that the November meeting would include more discussion about ethical standards and retrospective judgments. Dr. Royal asked that papers be made available to members as early as possible in the process. Staff Report: Institutional Case Study Selection. Donald Weightman and Barbara Berney. Mr. Weightman presented the staff recommendations that Oak Ridge National Laboratories and the University of California's San Francisco Bay area institutions be selected as institutional case studies. He noted that research regarding other institutions which are being studied by staff (such as Los Alamos and the School of Aviation Medicine) would generate valuable material, and that those efforts would continue, but that the study of the interplay of institutional processes and research development would be concentrated at Oak Ridge and San Francisco. Mr. Weightman said Oak Ridge's history represents a sizeable number of experiments and considerable mass of associated institutions and agencies. There is some documentation there as well about evolving levels of institutional review of human experimentation. Records review at the University of California complex in the Bay area includes institutions where the records search is well-advanced but significant questions remain to be answered. Mr. Weightman also cautioned that neither time nor staff exists for a comprehensive look at such large institutions. Work would be targeted on specific times and experiments and determining how management and operational systems worked. The goal is a "vertical slice" through chains of command, funding sources, and research management at the experiment level. Members approved the staff recommendation. October 13, 1994 Attending: Ruth Faden, Ken Feinberg, Susan Lederer, Ruth Macklin, Lois Norris, Nancy Oleinick, Henry Royal, Philip Russell, Mary Ann Stevenson, Duncan Thomas, Reed Tuckson. Subcommittee Report: Remedies. Kenneth Feinberg. Mr. Feinberg presented a staff report outlining what has been enacted by Congress to compensate persons involved in mass exposures. The responses by Congress have been generally designed to remedy harms resulting from environmental releases; there is little precedent for those designed to deal with individual cases of radiation experimentation. There are a few examples of private legislation for particular cases, as in CIA experimentation involving LSD. The government tends to create statutory presumptions for cause, but compensation tends to be limited, almost on the model of workers compensation, Mr. Feinberg said. Mr. Feinberg noted that most people who apply for claims are denied, and the claimants tend not to be happy with the programs. The remedies subcommittee hopes to bring additional reports before the full Committee at the November or December meetings. Dr. Thomas asked that staff inquire about the reasons that many claimants are denied under existing programs. He said that many common cancers are excluded from compensation because of cost, even though there is much evidence, as in the case of lung cancer, that specific cancers are associated with radiation exposure. Dr. Thomas said the radioepidemiologic tables have not been updated for ten years, and the remedies recommendations might well include a strong recommendation that the tables be updated. Mr. Feinberg noted that an expansion of the presumptions in the black lung legislation resulted in compensation to more people than are known to have worked in the mines. Subcommittee Report: Intentional Releases. Nancy Oleinick and Duncan Thomas. Dr. Oleinick said that gaps in information remain a serious problem in assessing even the 13 intentional releases listed in the Committee's charter. Secrecy remains a serious problem. Dr. Oleinick asked that staff prepare a report on classification and why events of 50 years ago remain secret. Questions to be addressed should include why medical records from biomedical experiments remain secret and whether such events could occur today. Dr. Thomas said time is pressing for decisions on what secret documents to see and how to go about getting them. Dr. Thomas recommended that a Green Run discussion at the November meeting be structured along the lines of the plutonium injections presentation on October 12. Dr. Thomas said the Committee should also begin to think about the ethical principles involved in intentional releases. Disclosure issues may loom larger than informed consent in the clinical sense. Risk/benefit analysis includes the risk to populations rather than individuals. Dr. Thomas said that he will research the draft guidelines being considered by groups like the International Society of Environmental Epidemiology. The concomitant issues include environmental impact statements. Today's regulations allow for secret EIS documents in cases of national security. The issues include whether a Green Run could occur today. Dr. Thomas noted that there are much different perceptions of threat and national necessity in the post-Cold War era. Members approved the subcommittee proposal to hear a November report in which members could assess whether the Green Run could occur today and whether the actions were appropriate by today's standards. Committee Discussion: Interim Report. Anna Mastroianni. Members were asked for their changes to the draft interim report circulated by Ms. Mastroianni. The report is to be released on Friday, October 21. The section on boron neutron capture will be deleted from the interim report pending the November meeting. Members agreed that all should review the report on selection of case studies in biomedical research. Issues targeted for revision included references to dose reconstructions; public policy on intentional releases; isotopes picked for inclusion in specific sections; total body irradiation; exploitable populations. Members discussed the categorization of research involving healthy adults in various circumstances, e.g. soldiers, prisoners. Members approved five general categories for investigation of biomedical experiments: external radiation with patients (formerly the TBI group, expanded to include partial-body irradiation); research with healthy adults (group to include research involving prisoners, military personnel, students and employees); children; radioisotopes; biodistribution. Members asked that decisions taken in the October meeting be incorporated into the intentional releases section and the discussion of research proposal reviews. Members asked that there be a strong statement that the archive to be left by the Committee is an important legacy. Records management details were included in an appendix. Committee Discussion: Strategies and Direction. Ruth Faden. Dr. Faden proposed groupings of members to both direct the staff and keep members informed between meetings. Dr. Royal asked that weekly or otherwise regular mailings would be made to members to keep them informed of the trend of discussions in other subcommittees. Continuing are subcommittees dealing with intentional releases; outreach; remedies; oral history; research subject interviews and research proposal reviews. Five categories of biomedical research were discussed as potential working groups, and there are two institutional studies regarding Oak Ridge and the UC Bay-area complex. Members discussed the idea of an ethical criteria subcommittee that would generate the criteria by which retrospective ethical judgments are made. Members agreed to divide themselves into the following new subcommittees: ethical criteria; UCSF/Bay area case study; Oak Ridge case study; external radiation with patients (formerly the TBI group, now expanded to include partial-body irradiation); reseach with healthy adults (group to include research involving prisoners, military personnel, students and employees); children; radioisotopes; biodistribution. Dr. Faden also noted that all members will review contemporary research proposals at the same time. Members organized themselves as follows: Oral History. Lederer, Macklin, Russell. Subject Interviews. Faden and Lederer. Research Proposal Review. Katz, Macklin, Faden, Glatstein, Norris, Royal, Stevenson, Thomas. Ethical Criteria. Macklin, Norris, Thomas. Bay Area Case Study. Lederer, Stevenson. Oak Ridge Case Study. Oleinick, Lederer, Russell. Biomedical Experiments/Biodistribution. Royal. Biomedical Experiments/External Radiation With Patients. Stevenson. Biomedical Experiments/Radiation Research with Healthy Adults. Macklin, Stevenson, Royal, Thomas, Norris. Biomedical Experiments/Research Involving or Affecting Children. Macklin, King, Stevenson. Biomedical Experiments/Radioisotopes. Oleinick, Royal. Intentional Releases and Exposures/Experiments of Opportunity. Oleinick, Thomas, Feinberg, Katz, Macklin. Outreach. Tuckson, Macklin, Norris, Royal. Remedies. Feinberg, King, Thomas. Dr. Faden said absent members would be consulted about their choices. She said that the Committee should consider a few extra hours of scheduled discussions at each meeting, and the Committee agreed. Mr. Guttman, acting as the designated federal official, closed the meeting at 11:30 a.m. APPROVAL The minutes above for the October meeting of the Advisory Committee on Human Radiation Experiments are correct and approved by members. Ruth R. Faden Chair