S. HRG. 103-511; Human Subjects Research: Radiation Experimentation; Hearing of the Committee on Labor and Human Resources United States Senate

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HUMAN SUBJECB RESEARCH: RADIATION LABOR AND HUMAN RESOURCES UNITED STATES SENATE ONE HUNDRED THIRD CONGRESS DETERMINING THE MAGNITUDE OF THE RADIATION RESEARCH, TO DETERMINE WHERE THESE EXPERIMENTS TOOK PLACE, TO DETERMINE WHAT RECORDS EXZST, TO DETERMINE HOW GREAT THE DANGERS WERE, TO DETERMINE IF PARTICIPANTS WERE INFORMED OF THE TERMINE HOW MUCH HARM WAS DONE. RISKS AM) BENEFITS OF THE RADIATION EXPERIMENTS AND TO DEJANUARY 13, 1994 WALTHAM, MA.) Printed for the use of the Committee on Labor and Human Resources U.S. GOVERNMENT PRINTING OFFICE For sale by the U S Government Pnnting Office Supenntendent of Documents. Congrewonal Sales Office, Washington, DC 20402

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COMMITTEE ON LABOR AND HUMAN RESOURCES EDWARD M. KENNEDY, Maesachllsetts, Chairman CWBORNE PELL, Rhode Island HOWARD M. METZENBAUM, Ohio CHRISTOPHER J. DODD, Connecticut BARBARA A. MIKUISKI, Mayland JEFF BINGAMAN, New Mexlw PAUL D. WELLSIYINE, Mind HARRIS WOFFORD, Penneylvania NANCY LANDON KASSEBAUM, Karma JAMES M. JEFFORDS, Vennant DAN COATS, Indiana JUDD GREW, New Hampshire ORRIN G. HATCH, Utah DAVE DURENBERGER, Minnesota SUBANK. mmm, Mvrority Staf Dimtor

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Campbell, Hon. Philip. Commissioner, Commonwealth of Massachusetts Department of Mental Retardation ......................................................................... 2 Kennedy, Hon. Joseph P. II, a Representative in Congress from the State of Massachusetts, prepared statement ............................................................... 3 Markey, Hon. Edward J., a Representative in Congress from the State of Dyer, Charles, former mident of Fernald School; member of the science club; Austin LaRocque, former resident of Fernald School, member of the science club; Bertran Brill, M.D., research director and professor of nuclear medicine, University of Massachusetts medical Center; and Belton Burrows, M.D., chief of the department of nuclear medicine, Boston Veterans Adminment of Energy, Washington, DC; Gordon Soper, tor of Medical Research, Department of Veterans Affairs, Wa-n, DC; Wendy Baldwin, M.d., Actmg Deputy Director of Extramural search, National Institutes of Health, Department of Health and Human Services, dent and dean of reseamh, Massachusetts Institute of %chnolo ? m s Adelstein, M.D., Harvard Medical School, Cambridge, MA, an&rederic Misilo, Jr., chairman, human subject research review task force, Department of Mental Retardation ................................................................................ 23 Ryan,. Kenneth, M.D., Harvard School of Medicine; George Annas, M.D., chaw, health law department, Boston University school of Medicine and

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HUMAN SUBJECTS RESEARCH: RADIATION The Committee met pursuant to notice, at 10:30 a.m., in the Howe Hall, Fernald School, 200 Trapelo Road, Waltham, MA, Senator Edward M. Kennedy (chairman of the committee) presiding. Present: Senator Kennedy. The C m . Good morning. We might come to order if we We want to welcome all of you. And first of all we want to thank Mr. O’Meara who is the superintendent here for all of his courtesies in making available the opportunity for us to be here today, essman Markey and myself. just say before we get started, I understand we had a That always happens when Ed Markey has a hearing. I can’t help with just opening the hearing on a lighter note. One of my very favonte recollectaons was of President Kennedy when he was in Naval Intelli ence before goin out to the Pacific in South Carolina, and he was tag ng to the factory members about the dangers of espionage and sabotage and that if the workers saw a fire in the factory, they ought to determine the origin of the fire before they determine how to extinguish it. And if the fire was made from wood, put water on it. If it was oil and gas, put C02 on it. Electricity, put foam on it. But never put water on an oil and gas fire because it just spreads and you have disastrous reAnd aRer he gave this kind of briefin he asked whether there said, Wow, Mr. Kenned , how are we going to know by lookin or gas or electricity to know what t o put on it and what not to put on it so that it wouldn’t spread.” So he said, That’s a very good question. There will be someone here next week t o talk on that So I’m sure that isn’t oing to be the case with our hearings here and I apologize for the inconvenience. And before making a very in World War 11. And he told tEe sto of when ae went to a factory were any questions. A man stood from tae back of the room and Bfrom the back of the ha1rwhether that fire is made from wood, oi today, but I thank all of you for being with us and to stay with us

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brief opening comment, I'd recognize our Commissioner Campbell for what words he has to say.- STATEMENT OF PHILIP CAMPBELL, COMMISSIONER, COMCommissioner CAMPBELL. Thank you, Senator. On behalf of the Department of Mental Retardation, the Fernald State School, I just wanted to welcome both the Senator and the Congressman and to emphasize the importance of the subject before this Committee The recently appointed Task Force and this Committee will continue to look into a rather bleak period of time, over 40 years ago, in the care and services to peo le with mental retardation. I think happened those decades ago. Because although safeguards, greater safeguards are in place today, it is only through remaining vigilance will we continue to minimize the chances that people with mental retardation will be exploited. And I thank both the Con essman and the Senator for their leadership in this area and 10% forward to full acknowledgment of what may have happened decades ago and in turn see what steps could be taken in the fiture to minimize any exploitation of the vulnerable population of people with mental retardation. So on behalf of the Department, I a ain want to thank you for The CHAIRMAN.Well, thank you very much, Commissioner. We have, as you mentioned, I know Ed Markey and I have had a number of opportunities to be out here at Fernald School over a long period of time. We have had special interest in the issues of the mental retardation and the workings of the Fernald School. And so we welcome very much the chance to be here and I think speaking just personal1 , once again underlines the importance of the issues most vulnerable in our society. Last month, the Nation was shocked to learn that at the years after World War I1 the Federal government sponsored radiation experiments on human subjects wthout their consent. A governmentwide and nation-wide effort is now under way to uncover the nature and extent of such experiments, the harm that was done, the remedies that should be made available to those who were the victims of those experiments, and the steps needed to assure that this kind of irresponsible and degrading research never takes place It is already clear that a number of these experiments took place in Massachusetts, including some here at the Fernald School where our Senate Committee is meeting today. I am pleased that Ed Markey is joining us, because he has played a leading role in recent years in the efforts to bring the experimentation to li ht. Often he has been a lonely eloquent voice In 1986, as Chairman of the House Subcommittee on Ener Conservation and Power, Congressman Markey released alany it is important that we take tR e time to review what might have our leadership and welcome you baca to Massachusetts at the which are bePore us here today, that particularly affect some of the in uncovering this saameful chapter in our medical history.

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mark report entitled “American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on US. Citizens.” That report revealed the frequent, systematic use of human subjects in radiation research, including 31 experiments in which 695 persons were exposed to radiation that provided little or no medical benefit to the Congressman Markey’s report was stonewalled by the Administration then in power. But today there is a different leadership and a different attitude, and I commend Secretary of Energy Hazel OZeary and the Clinton Administration for their commitment to do t thing, to tell the Nation what happened, and to make to those whose lives and health were endangered. And in rectifying this situation, Congress intends to work closely with the Administration. Our hearing this morning is the b - nin of a lengthy oversi h t and legislative process to deal e$”ecWe intend to get answers. We want to know what was done in Massachusetts and in every other State where these experiments were conducted. We want to know what records-exist, how great the dangers were, how much consent, if any, was obtained for the research, and how much harm was done. Once we have this information, we can enact legislation to help the victims and prevent an repetition of these abominable practices. &e will now receive a statement for the record by Representative tivefy and responsibly wit% this issue. I would like to thank Senator Kennedy for convening t h i s important hearing of the Senate Labor and Human Resources Committee. I would also l i e to recognize Rep. Edward Markey for being at the forefront of investigating human radiation tests at a time when the former Rea an and Bush administrations turned a deaf ear. Each of today’s witnesses will kay a critical role in a thorough examination of human radiation experiments, ant1 thank each of you for participating in today’s Today’s hearing at the Fernald School causes us to revisit a chilling chapter in our Nation’s hi& -an era where human radiation experiments were conducted on often unwitting ajecta in the name of the Cold War. This setting challenges us not only to remember but to respond. Some say that even the most egregious cases, those involving human guinea pigs, were conducted for the “greater good.” But it is pestionable whose best interests were at stake in every case, particularly when subjects may not have been properly informed and when many were among society’s most vulnerable. Many already determined to have been participants in government-sponsored radiation tests were among those who frequently turn to our government for care. By pre g upon an essentially captive audience of subjects rang- @gfrom the intirm and g e l d e r l to those on active duty military and others seek- ?t is time for our government to acknowledge this dark legacy and make amends. We can accept no less than a compmhensive investigation and a full, impartial disclosure demanded of a free aociety. Now, our government will be put to the test. Every phase of its investigation d be subject to the close scrutiny and the watchful eye of a skeptical American public who has learned the hard lessons of desades of Cold War secn?cy. President Clinton and Energy secretay O‘Leary, in particular, are to be commended for their Tick actions to respond to these troubling accounts. Already, Secthe lost puzzle @xes of history will not be eas ,it is now im rative that we move cam at veterans hospitals, megcal ethics standards are put to the test.

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The Cold War itself may now be a part of our Nation's past, but ita legacy of radiation experimentation cannot be put behind us and must never be forgotten. Our government agencies and Congress cannot and will not rest until we have the answera to the many questiona that have gone unanswered for so long. The CHAIRMAN.Our witnesses today will include two subjects of the experiments conducted here at Fernald School in Massachusetts. We will also here from representatives of the Federal Agencies, private institutions involved in these and many other experiments that were carried out. Finally, we will hear from medical and ethical experts about precautions and safeguards needed in order to prevent any further abuses. And I want to welcome all of our witness and we look forward to their testimony. And I recognize Congressman Markey. STATEMENT OF HON. EDWARD J. MARHEY, A REPRESENTATIVE IN CONGRESS FROM TEE STATE OF MASSACEUSETTS Mr. MARKEY. Thank you Senator Kennedy, very much, and thank you for holding this hearing and for investi ating the disturbing revelations that have come out concerning!Iuman experimentation and the Fernald School. These experiments shock and sadden me and lead me to question just how much we know about the extent and the kind of human experimentation that took place in this count from 1944 up through the 1970s. In fact, a primary biomedical research in the early 1970s. As a result of those l?ear-On the leadership of Senator Kennedy, who held landmark hearin ings, Senator Kennedy sponsored legislation to protect human subects of biomedical research. And I commend his early pioneering eadership on this im ortant issue. ment conducted human radiation experiments has grabbed the attention of all Americans. And the reason is that most people assumed that our country would not engage in that kind of activity. I think the fact that the Federal government, our government, funded or engaged in this kind of activity is the most disturbing aspect of this entire story. Most Americans thought that our country would not do that kind of thing. I was articularly shocked by the Fernald School experiments bements back in 1986 and at the time was not told about these experiments. Yet clearly these experiments fit within the scope of the documents that I requested from the Reagan Department of Energy. Therefore, one question I have here today is whether the experiments described in the 1986 report constitutes the iceberg, and the more recent Fernald revelations are just the tip, or whether the report is the tip, and we have yet to find the iceberg. The Subcommittee report that I released in 1986, American Nuclear Guinea pigs: Three Decades of Radiation experiments on US. Citizens, was a staff report of the House Subcommittee on Energy. This report revealed the frequent systematic use of human sub'ects tails on 31 cases in which a total of nearly 700 persons were exposed to ionizin radiation in experiments which provided little or reason why i! ose experiments stopped in the 1970s is because of The recent acknowPedgment by Federal officials that the governcause I Rad conducted an investigation of human radiation experias guinea pigs for radiation expenments. The report provided deno medical beneBt to the subjects.

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The report described current Federal regulations on the use of human subjects for experiments and noted four general principles for such experiments. One, the risk to subject should be minimized. Two, risk to subject should be reasonable in relation to anticipated benefit and the importance of the knowledge that may reasonably be expected to result. Three, subjects should be selected in an equitable manner. And four, informed consent shall be sou h t from each prospective clear description of the risk and the benefits of the experimental The experiments where children at the Fernald School were fed or injected with radioactive material violated at least two of these rinciples. The children at the school were members of society that Beserved protection, not exploitation as experimental subjects. And their parents were deceived about the nature of the …