Presidential Advisory Committee on Human Radiation Experiments Meeting, 21-22 April 1994, Washington, DC; Summary, Advisory Committee Meeting, 21 April 1994

Page 1

MEMORANDUM FOR RECORD 1. Presidential Advisory Committee on Human Radiation Experiments Meeting,- 21-22 The Presidential Advisory Committee on Human Radiation Experiments conducted its first meeting on 21-22 April 1994 in the Federal Hall Room of the Ramada Hotel, Thomas Circle, Washington, DC. The Committee Chairperson is Dr. Ruth Faden. A list of Committee members is at Tab A. At Tab B is the agenda for each day of the meeting. 2. Summary, Advisory Committee Meeting, 21 April 1994. a. The meeting was called to order by Ms. Christine Varney, Secretary to the b. In her opening statement Ms. Varney welcomed the Committee and those others present, and described the Committee members as expert medical doctors, lawyers, clinicians, and ethicists. She then related the Committee's purpose, mission, responsibilities. Ms Varney said: (1) One mission was to provide expert advice to the Interagency Working (2) The Committee's work was critical for the President and the Administration. The Committee was an example of the Administration's commitment to the public to be open and forthright on the issues. (3) The Committee's task was not easy, but it was a worthwhile endeavor. Later, Ms. Varney said that the Committee had "a difficult but do-able (4) The Interagency Working Group (IWG) had conducted several meetings ( 5 ) The Committee is to develop the criteria to analyze and judge the experiments, and, in accordance with that criteria, to consider if (a) The experiments had a clear purpose. (b) The experiments were appropriate. (d) There were any wrongs committed.

Page 2

( 6 ) The Committee was to examine experiments from 1944 to 1974. After 1974 they were to review and sample research to evaluate the Government’s application of the Federal guidelines. (7) The Committee’s work will be closely observed. The issues that it encounters, and the Committee’s resolution of these issues will have farreaching policy implications. (8) They have lllicense to hold the Government’s feet to the fire.” c. After Ms. Varney concluded her remarks, the Committee was sworn in. d. Following this formality the Committee Chairperson, Dr. Ruth Faden, stated, “we are now official,” and then made her opening remarks. (1) She extended a formal welcome and stated that she was honored by the responsibility and takes the public’s trust seriously. (2) Dr. Faden then provided an orientation on the structure and flow of the meeting. She outlined five objectives for the Committee’s initial sessions: To get the Committee and its staff to know each other. To develop an understanding of the Committee’s relationship to the Administration and to Government agencies. To acquaint the Committee with congressional interest in this issue. Senator Glenn and Representative Markey were scheduled to appear during the afternoon session. (Note: There was a name tag made up for Senator Kennedy, but for some unannounced reason he did not To define and refine the Committee’s mission, which is critical. To define how the Committee will function (frequency of meetings, internal organization [subcommittees], priorities, and procedures). This was to be discussed in depth on Friday, 22 April 1994. Dr. Faden also said that, throughout its deliberations, public comment would be a critical component of the Committee’s proceedings. (3) Dr. Faden then asked the Committee members and primary staff to introduce themselves. Committee and staff members then introduced themselves, provided a synopsis of their background, stated what expertise they brought to Committee, and in some cases related specific issues that were of particular interest to them. Some areas of specific interest identified by Committee members were informed consent, use of human subjects in research, the effects on radiation on humans, and human

Page 3

experimentation ethics. One member (Mr. Feinberg) was the courtappointed master for the Agent Orange settlement. After the introductions, Dr. Faden noted the excellent credentials of the Committee and staff. f. Following a short break, the meeting reconvened at 10:17 a.m. to hear the statements of the Interagency Working Group (IWG). Presenting statements were Secretary of Energy O’Leary, Secretary of Health and Human Services Shalala, Attorney General Reno, Secretary of Veterans Affairs Brown, Deputy Secretary of Defense Deutch, Deputy Director of the CIA Admiral Studeman, and NASA Director Golden. A note-based summary of their remarks follows. Secretary of Enerm O’Learv Secretary O’Leary thanked the Advisory Committee for agreeing to serve and said that they were being asked to give more time and effort than they could imagine. Secretary O’Leary then provided background information on her decision to make the experimentation information public. The Secretary said that in late November she first heard that the Albuquerque Tribune was going to publish stories on the Government’s role in human radiation experimentation over the last 50 years and that DOE was going to be asked to release information about human radiation experiments. While considering her response, she thought of the people who lived by DOE facilities, who did not trust the Department or its science, and the thousands that she had talked to who had no faith in their Government. After considering the issue, and what she thought the Government should be, Secretary O’Leary made the decision to release the She said that she did not expect the firestorm that followed or the questions that subsequently arose about science and technology. As this reaction developed the need for someone or something to stand between the Government and the public became evident. During this period Dr. Faden was one of those from whom she sought advice. Secretary O’Leary then described the issues/questions that she thought the Committee needed to address. (a) What is the whole story regarding the Government’s role in human radiation experimentation? (A point echoed by Senator Glenn.) (c) Were the experiment subjects adequately informed? (d) Was anyone harmed as a result of the experiments?

Page 4

Were vulnerable populations selected? Is compensation to experiment participants appropriate? What considerations will be given to the scientists and researchers who conducted the experiments? Will the Committee’s findings possibly harm the nation’s research To reassure the public on the diagnostic and practical benefits of What can be learned from the review that can be applied as a guide for the future? This is another recurring theme of the Committee ( 5 ) Secretary O’Leary explained that the Committee members were selected because they were eminent in their field. She also said because of the Committee’s efforts the Government teeters on the edge of an opportunity to restore public confidence. ( 6 ) The Secretary closed by stating that she did not regret her decision. Secretary of Health and Human Services Shalala (1) Secretary Shalala was next and started her remarks by expressing her admiration for Secretary O’Leary’s leadership on this issue. She said that it was important to get to the bottom of the experiments. Also at stake was the integrity of the Government and science. Secretary Shalala then related that as one of those who are trying to sell the President’s health plan across the country she observed that the people were skeptical of what goes on in Washington. She further stated that she takes this very seriously, as does the President. (2) The Secretary then described her Department’s actions on the matter. On 27 January 1994, Secretary Shalala signed a memorandum that directed the Department of Health and Human Services (HHS) to search its records. Also, as the largest supporter of the biomedical research in the nation, HHS wrote to 27,000 research institutions and universities asking them to preserve their files from the period under investigation. The most difficult cases were those from the early portion of the period. The records search was difficult, and complicated by the fact that many titles and abstracts do not tell if the research was conducted on humans.

Page 5

(3) As an indication of HHS’s serious view of these matters, Secretary Shalala stated that senior HHS officials who report directly to her are directing the Department’s efforts. She then tried to convey a sense of the magnitude of the Committee’s task by stating some of the issues. These included (a) The need to focus the HHS effort. What discriminators should be employed to better focus the search--vulnerable populations? high (b) The need to be careful not to give the idea that all radiation uses are (c) The need to educate the public on the benefits of radiation. She estimated that three quarters of the research at the National Institutes of Health (NIH) employed radiation or radioactive material. (d) She also noted elsewhere in her discussion that there are an enormous number of files to examine at the NIH. (4) The Secretary noted that the first regulations on human use in research were promulgated by the NIH in 1953 and were followed in 1974 by the Department of Health, Education and Welfare (HEW) guidelines. ( 5 ) Secretary Shalala ended her remarks by reaffirming HHS’s commitment to support the Advisory Committee efforts and pledged her Department’s openness and enthusiasm to the project. Attornev General Reno The Attorney General stated she was pleased to be at the meeting and echoed the praise of Secretary O’Leary. She said that the Committee’s determination of the ethical criteria will shape the Administration’s response and reiterated the theme of openness in Government. The Attorney General described the Justice Department’s role in the IWG’s efforts as one that offered assistance and counsel to IWG members. Attorney General Reno also reaffirmed the IWG commitment to a thorough investigation. She then described the Justice Department’s actions to discover its role, if any, in radiation research. Similar to other agencies, the Department of Justice conducted a records search. Of particular interest was the possible participation of Federal prisoners in research. Because of revelations concerning use of state prisoners, she specifically directed the Bureau of Prisons to search its records for Federal prisoner involvement. Attorney General Reno reported that no records were found. Secretarv of Veterans Affairs Brown Secretary Brown publicly thanked Secretary O’Leary and stated that he could not condone some of what occurred in the past. He reported on Department of Veteran’s Affairs (DVA) efforts and stated that the DVA had learned much and still had much to learn. Secretary Brown stated that many of the earliest uses of nuclear medicine were developed in

Page 6

VA hospitals and it was on VA hospitals that the DVA focused its search. He then related some statistics to impart a sense of the scope of the search, reported that some studies had been uncovered, and that he did not know if all the studies met medical and ethical standards. Secretary Brown also related that in the late 1940’s the VA established an Atomic Medicine Division and that initially its existence was classified. Secretary Brown stated that he did not know why the Division’s existence was initially classified or that if, because of its classification, it violated the veteran’s trust. He ended by pledging his and his Department’s support for the Advisory Committee’s efforts. Deputy Secretary of Defense Deutch Deputy Secretary Deutch acknowledged Secretary O’Leary’s efforts and also the role of Christine Varney. He made the point to the Advisory Committee that it was hearing from an interagency group whose efforts were coordinated and not from individual departments with individual efforts (a point reinforced later by Ms. Varney). The Committee’s task was important and the issues they will confront include the credibility of science, how scientist’s operate, and the evaluation of past scientific practices. Deputy Secretary Deutch described the Department of Defense’s efforts. He highlighted the establishment of the Steering Committee in January 1994 and revealed that the Department had identified 1,749 experiments--the great majority of which were clinical procedures. He also noted the establishment of the Radiation Experiments Command Center (RECC) to collect and analyze data. Deputy Secretary Deutch ended his remarks by stating that in the mid-1970’s the Department established practices for the protection of human subjects that compared favorably with the practices used at other Deputv Director of the CIA Admiral Studeman Admiral Studeman stated that there was no evidence that the Central Intelligence Agency (C1A)conducted experiments. He then described how the CIA arrived at this conclusion. It has appointed a central working group that meets weekly to oversee the Agency’s efforts. They reviewed documents from the 1970’s Rockefeller and Church Commissions inquiries into Agency activities. It also conducted a records search and interviewed 30 specific individuals. NASA Director Golden Director Golden thanked everybody on the Committee and stated that the National Aeronautics and Space Administration (NASA) supported the open approach taken by the Administration and Committee. Director Golden then said that the Committee’s efforts will help restore hope in the future. He then went on to describe NASA’s search efforts--retiree interviews, data base searches, and literature reviews. He also added that NASA is using a more comprehensive experiment definition then the one contained in the 19 January 1994 White House Memorandum. This definition includes the injection of radioisotopes into healthy individuals to study bodily functions.

Page 7

f. Director Golden’s remarks were the last prepared statement from the IWG. Dr. Faden thanked them and then opened the meeting for a short period of questions. Several important issues were raised during the question and answer period: The importance of defining the types of radiation experiments the Committee wants to examine as a means to focus the departments’ efforts. Defining what type research or experiments should be included within the definition of an experiment occupied the committee for the rest of the day. A member asked if the search, thus far, revealed that more experiments were done without informed consent than with informed consent. Informed consent will be an important issue for the Committee. The inquiry motivated agencies to conduct internal reviews of current g. Several general points were revealed by the prepared statements and the questions (1) The agencies tried to provide the Committee a sense of the scope and size of their efforts. At this juncture the Committee members seemed to be satisfied with what they heard. (2) The IWG members also wanted to impress upon the Committee that they were responsive and that their efforts to date reflected that fact (3) A significant point raised by IWG members was the need for guidance on the scope, focus, and depth of their inquiries. The IWG appears to be waiting for instructions from the Committee on what direction to follow. (4) The point was repeatedly made that Committee efforts were important to help restore faith in the Government, in science, and in research activities. h. After the IWG had completed its presentation, the Committee then turned its attention to organizational matters. Two sessions (one morning session and one afternoon session) were scheduled for this day and what follows is a summary of discussions during both sessions. (1) At the start of the morning session Dr. Faden stated that, in this phase, the Committee would begin to refine its mission. A more refined mission will enable the Committee to provide needed guidance to the IWG. She then outlined her perception of the Committee’s tasks, duties, and some of the issues confronting the group.

Page 8

(2) Dr. Faden identified three …