Tab E-1 Excerpt from: A Report on the Use of Radioactive Materials in Human Subject Research that Involved residents of State-Operated Facilities within the Commonwealth of Massachusetts from 1943 through 1973 A Report on the Use of Radioactive Materials in Human Subject Research that Involved Residents of State-Operated Facilities within the Commonwealth of Massachusetts from 1943 through 1973 Submitted by the Task Force on Human Subject Research to Philip Campbell, Commissioner Commonwealth of Massachusetts Executive Office of Health & Human Services Department of Mental Retardation April 1994 1775 "All people are born free and equal and have certain natural, essential and unalienable rights, among which may be reckoned the right of enjoying and defending their lives and liberties; that of acquiring, possessing and protecting property ; in fine, that of seeking and obtaining their safety and happiness." Article 1: Massachusetts Declaration of Rights 1891 It was noted by the Humane Society of Washington, D.C., that a public declaration had been made by a Swedish physician (not named) that he preferred experimenting on institutionalized children because they are "cheaper than calves." The Humane Society, Washington, D.C. 1914 Institutions were found to be the perfect place to conduct research, because the supervised and standardized conditions came close as possible "to conditions which are insisted on in considering the course of experimental infection among laboratory animals, but which can rarely be controlled in a study of infection of man." Alfred F. Hess, Medical Director, Hebrew Infant Asylum 1964 "Considering the nature of the population from another perspective also presents its pros and cons for research. Traditionally, institutions have been assigned the deviant, the troublesome, and the discarded individuals of society. Their services have been directed toward relieving the community of its problem population and toward modifying the patients or residents' capacity to function acceptably within the community." Joseph J. Parnicky, Superintendent, Bordentown, N.J. 1972 "What must be recognized is the enormous ambivalence toward the sick reflected in conflicting wishes to exculpate and to blame, to sanction and not to sanction, to teat and to mistreat, to protect and to destroy." Jay Katz, Experimentation with Human Beings 1976 "Mentally retarded individuals are always among the first to have their human rights denied, the first to be experimented upon, to be placed in institutions, to be sterilized, to be allowed to wither and even to be destroyed." Eunice Kennedy Shriver, Joseph P. Kennedy Jr. Foundation ACKNOWLEDGMENTS A project of this size and intensity can be accomplished with the support and cooperation of many individuals, staff and volunteers. On behalf of the Task Force membership and the Advisory Group, we wish to thank the following people: Tom Philbin, John Abbotts and David Moulton of Congressman Markey's Office Vann Dunne and Jessica Riviere of Senator Kennedy's office Mary Barnes, Editor Kimberly Fahrenstock, Chris Lang and Ken Pickering for legal research Jim McInnis, Northeastern Co-Op Student Helen Samuel, Librarian/Archivist Louisa Orr, Executive Assistant Anne Parker, Shriver Clinical Susan Kilgore & Mark Leicester Helen Hickey Penny Ford Carlton and Susan Ford, MGH Donna Lutz Carol Cerf Bruce Gale Fernald Staff: Paul Duhamel, Bonnie Stecher, Paul Procaccini, Debbie Merrullo, Rick Fraser, Dorothy Neri, Joe Foley, Karen Liazos, Joan Rickets, Paula Potvin, Linda Gershman, Lisa Bradley, Peter Brand, Janine Dedon, Richard Dutton, Salwa Esa, James Heithmar, Maria Lazzaro, Patricia Mascelluti, David Maxfield, Judith Rheaume, Stephen Rogers, Kay Schodak, Gail Wangler, Moe O'Connel, Joe Almeida. Wrentham Staff: Nick D'Alusio (Facility Director), Linda McCarthy and the Consumer Resources Department Staff, Paula Potvin and Linda Gershman of Social Services Staff at each of the other DMR facilities including: Monson Developmental Center, Hogan Regional Center, Dever State School, Glavin Regional Center, Templeton Developmental Center DMR Central Office Joanne Carney (Administrative Assistant to Deputy Commissioner Misilo) and Berni Davis (Administrative Assistant to Commissioner Campbell) And other individuals too numerous to mention -Frederick Misilo, Task Force Chairperson -Peter O'Meara, task Force Manager -Doe West, Project Coordinator TABLE OF CONTENTS _ LETTERS FROM: Philip Campbell, Commissioner Senator Edward M. Kennedy Congressman Edward J. Markey Frederick M. Misilo, Jr., Chairperson _ CHARGE TO THE TASK FORCE _ INTRODUCTION 1 _ THE TASK FORCE 5 _ WHAT HAPPENED? 13 _ ARCHIVAL RECORD CHRONOLOGY 21 _ HOW COULD IT HAVE HAPPENED? 29 _ COULD IT HAPPEN TODAY? 39 _ FINDINGS & RECOMMENDATIONS 43 _ APPENDIX 47 A. Listing of Task Force & Advisory Group Members B. Archival Record Chronology C. Information Request Subcommittee D. Methodology Subcommittee E. Contact with Subjects Subcommittee F. Introduction to Radioactivity & Radiation Primer G. Expert Opinions: Radioactivity & Radiation Primer H. Nuremberg Code & Declaration of Helsinki I. Governor Weld's Proposed Legislation J. Consumer Organization List K. Department of Mental Retardation Research Regulations L. White-Lief & Tisei Research on Informed Consent The Commonwealth of Massachusetts Executive Office of Health & Human Service Department of Mental Retardation 160 North Washington Street Boston, MA 02114 Philip Campbell Area Code (617) Commissioner 727-5608 TDD Line 7274-9866 April 15, 1994 To Whom It May Concern: On December 26, 1993 the Boston Globe reported the discovery of information regarding the use of former residents of the Fernald State School as human subjects for research involving radioactive substances during the 1940's and 50's. The shock and horror of that discovery made news, literally around the world. I shared the public's disbelief that some of the most vulnerable individuals in our society were deliberately exposed to harmful substances without their consent or ability to understand the risks involved. The Department of Mental Retardation (DMR) is the agency of state government charged with the responsibility to support and protect individuals with retardation. As Commissioner of DMR, I felt it was critically important to investigate those reports and fully disclose any research activity at any DMR facility that involved the use of radioactive substances. To accomplish such an immense task in a responsive manner, I appointed a task force of interested individuals who would maintain the best interest of the people involved and work diligently to discover the truth. I issued a charge which challenged the task force with an urgent time frame, knowing that it would be very difficult to accomplish. However, for the sake of those individuals who believed they may have been involved, the importance of a prompt disclosure could not be underestimated. The individuals who agreed to accept the challenge and serve on the task force deserve wide recognition for their dedicated service. They are parents, former residents, advocates, doctors, lawyers, clergy, legislators and educators. Their common goal was to seek the truth no matter what. Since January, the task force and its sub-committees have met at least weekly. They have become experts in the history of the type of research that was occurring in that day. I particularly wish to acknowledge and thank the parents for their unwavering focus on the well being of individuals with mental retardation, and those courageous former residents who shared their insights into institutional life of that day. Letter from Commissioner Campbell April 15, 1994 Page 2 I also wish to acknowledge and thank those scientists, medical personnel, and nationally known experts in matters of radiation and epidemiology who have assisted the task force members to better understand technical and scientific information. In addition, recognition goes to Deputy Commissioner Fred Misilo who agreed to chair the task force, to Peter O'Meara, Facility Director at Fernald who provided the management expertise, and to the Rev. Doe West, who was hired by the Task Force to serve as the official coordinator of the task force activities. Without their expertise and dedication this report would not have been completed. Finally, this disclosure will not be complete if it simply remains a study of history. Instead, the lessons to be learned from life experiences of those individuals 3, 4, or 5 decades ago must be brought forth for the protection of the rights and dignity of children and adults with mental retardation today and for 3 or 4 or 5 decades yet to come. In response to someone who asked, "Could the same thing happen today?" I offered the comment, "If you think it can't, then it probably can." The need for diligence and safeguarding vulnerable populations is a task all must accept each and every day. I am grateful to the Task Force for their recommendations and will ensure that all necessary protections are acted upon in a timely manner. Thank you all for a job well done. Sincerely, Philip Campbell Commissioner United States Senate COMMITTEE ON LABOR AND HUMAN RESOURCES WASHINGTON, D.C.20510-6300 April 12, 1994 Frederick M. Misilo, Jr., Esq. Chairperson Task Force to Review Human Subjects Research Massachusetts Department of Mental Retardation Post Office Box 9108 Belmont, Massachusetts 02178 Dear Chairperson Misilo: I am pleased to offer comments on the preliminary report of Task Force to Review Human Subjects Research. It is heartening to see the vigor with which the task Force has pursued its investigation of radiation experiments on children challenged Massachusetts citizens. As you know in 1973 I chaired a series of hearings in the Subcommittee on Health entitled the "Quality of Health care - Human Experimentation." These landmark hearings brought to light serious violations of subjects rights as exemplified in the Tuskegee Syphilis Study, prison research, and the involuntary sterilization of the Reif sisters. I sponsored the National Research Act in 1974 which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was charged with reviewing the policies protecting biomedical and behavioral research subjects and making recommendations to improve those policies. The Commission also issued recommendations for the protection of vulnerable populations, which were adopted with the exception of those protecting the mentally infirmed. The Subcommittee on Health which I chaired, focused on the use of hallucinogenic drugs during hearings in 1975. We learned that LSD was administered by the CIA to individuals without their knowledge or consent, and resulted in a subject's suicide in one instance. I sponsored legislation in 1978 which established the President's Commission for the Study of Ethical Problems in Medicine and Biomedical Research. My committee recognized the need for a President's Commission when we discovered the broad range of federal agencies funding biomedical and behavioral research which violated subject's rights. In 1983 the President's Commission recommended that Congressional Committee with oversight responsibility for biomedical and behavioral research monitor the response of administrative agencies to the Commission's recommendations on the protection of human subjects. The Commission also asked for appropriate continued oversight of local institutional review boards. During hearings at the Fernald School on January 13, 1994, we learned that: (1) The Fernald radiation studies were not ethically justified because they involved the use of a vulnerable population as a means to a researcher's end; and (2) Current federal regulations are insufficient to protect the rights and welfare of childrem and the institutionalized mentally challenged. At the hearing we heard a call for creating an Ethics Advisory Board within the Department of Health and Human Services to provide oversight of human subject protection for research sponsored by all Federal agencies. Lastly, our attention was once again directed to implementing the 1978 recommendations for regulations on the institutionalized mentally disabled. Currently I am drafting legislation with Mr. Markey to establish the National Commission on Biomedical ethics for the purpose of determining the scope and effectiveness of current laws to protect human subjects in biomedical and behavioral research. The Commission will direct its attention to human subjects identified as members of a vulnerable population. I appreciate working with you on this important issue. Together we will uncover the full extent of the problem and assure this will not occur again. Sincerely, Edward M. Kennedy Congress of the United States House of Representatives Washington, D.C. 20515-2107 March 4, 1994 Frederick M. Misilo, Jr. Esq. Chairperson The Task Force to Review Human Subject Research Massachusetts Department of Mental Retardation Post Office Box 9108 Belmont, Massachusetts 02178 Dear Chairperson Misilo: It has been my privilege to be involved with the Task Force, and I am honored by your request for my comments on the occasion of the Task Force Report. I am pleased to inform you that the response of officials and institutions in Massachusetts to the experiments at the Fernald School stands in stark contrast to the past response at the federal level in rgard to experiments with ionising radiation and human subjects. While it has taken years to prompt an adequate response at the federal level, the response in Massachusetts was vigorous from the outset, with the goals of full disclosure and rectification of past events. I wish to commend the members of the Task Force, and to especially acknowledge your leadership as Chairperson. I take special note of the untiring efforts of those whose work supported the Task Force, particularly Projcet Manager Peter O'Meara amd Project Coordinator Doe West. I also appreciate the indulgence of yourself and the other members of the Task Force in allowing members of my staff to attend meetings in my absence. As you know, in Octobe 1986, I released a staff report of the House Subcommittee on Energy Conservation and Power, which described experiments with human subjects and ionizing radiation that provided little or no medical benefit to those exposed. This report was based on documents requested from the Department of Energy, related to experiments funded by its predecessor agencies. The staff report recommended medical follow-up of the subjects of these experiments, and recommended that experiments of the type described, which apparently ended in the early 1970's, never be conducted again. An Appendix to the 1986 reprot described current federal regulations on human experimentation, including four general principles: Frederick M. Misilo, Jr., Esq. Page 2 March 4, 1994 . Risks to subjects should be minimized; . Risks to subjects should be reasonable in relation to anticipated benefits, and the importance of the knowledge that may reasonably be expected to result; . Subjects should be selected in an equitable manner; and . Informed consent shall be sought from each prospective subject or authorized representative. Informed consent includes a clear description of the risks and benefits of the experimental procedure. Additional restrictions are in effect for experiments with children, and such experiments generally require a benefit for the subject or a benefit for the health of children generally. The Subcommittee staff report was essentially ignored by the Reagan administration, and it was left to gather dust on a shelf until Secretary of Energy Hazel O'Leary accepted its findings late in 1993. Secretary O'Leary and the Clinton administration, through its Human Radiation Interagency Working Group. are committed to full disclosure of experiments with ionizing radiation and human subjects, while protecting the privacy of subjects and their families, and to medical follow-up where it is feasible and indicated. Although it has taken a long time for action at the federal level, I have been gratified by the leadership of the Clinton administration on this issue. Late in 1993, information was released on the Fernald School experiments, where schoolboys were fed radioactive iron or calcium in their breakfast meals in the 1940s and 1950s. These experiments violated at least two of the present standards for using human subjects: The children at the school represented a segment of society that deserved protection, not exploitation; and their parents were deceived about the nature of the experiments when they gave their consent for participation (details of these and other experiments are contained in the Task Force report). In contrast to the experience at the federal level, officials of the Massachusetts Department of Mental Retardation from the outset registered profound shock and dismay over the experiments. The DMR has shown no interest in defending mistakes committed in the past. The formation of the Task Force and the investigation by its staff have been designed to provide full disclosure of the extent of human experimentation with ionizing radiation at all DMR facilities. I have also been impressed with the response of Massachusetts academic institutions, whose affiliated scientists conducted the experiments of the 1940s, 50s, and 60s. Dr. Charles Vest, present president of MIT, acknowledged that while doses at the Fernald School may have been relatively low, he was "sorry" for the experiments, because of the children Frederick M. Misilo, Jr., Esq. Page 3 March 4, 1994 selected and the lack of informed consent. MIT explained that President Vest issued his statement because "it seemed the decent thing to do," and I applaud his decency. Likewise, the efforts of present officials and scientists at Harvard University brought to the attention of the Task Force experiments in the 1960s at the Wrentham School, where tiny children were fed non-radioactive iodide and radioactive iodine-131, to test a possible "countermeasure" to fallout from atomic bombs. Present leaders of academic institutions have been interested in full disclosure, not in defending mistake of the past. The revelation of these experiments at Massachusetts institutions has raised my concern over whether the full extent of testing nationally has been identified. The experiments at the Fernald School were funded in part by the National Institutes of Health and the Atomic Energy Commission, and should have been reported to my Subcommittee in response to its requests in the 1980s. The scientific paper reporting the Wrentham School experiments noted that the test subjects were chosen "because it was desirable to secure children living under constant conditions of environment, diet, and iodide uptake, "and similar considerations contributed to selection of students at the Fernald School as experimental subjects. These revelations cause concern about whether institutionalized populations presented too great a temptation for experimental investigators across the country. Accordingly, I have written to Secretary of Health and Human Services Donna Shalala, whose department is reviewing its files as part of the federal Interagency Working Group. I have requested that in its review, her Department give heightened attention to experiments on the developmentally challenged. The experiments at the Wrentham School were funded by the U.S. Public Health Service, Division of Radiological Health, and I have also requested special attention to the files of that office, to determine if other questionable experiments were conducted in the name of understanding exposures from atomic fallout. I recognize that because of the limits of time, the Task Force report is focused on experiments with ionizing radiation. I also recognize and commend your determination in the future to examine exposures to other agents at DMR facilities. The Task Force efforts thus represents a prototype that can be replicated across the country in at least two regards: Firstly, this is to my knowledge the first systematic governmental investigation of experiments with ionizing radiation and institutionalized subjects. Secondly, the DMR has recognized that it is appropriate to investigate experimental exposures to dangerous chemical and biological agents in addition to radiation. I have already recommended expanding the efforts at the federal level to identify experiments with such additional hazardous agents. Frederick M. Misilo, Jr., Esq. Page 4 March 4, 1994 Once again, I commend your leadership, and I appreciate the opportunity to be associated with this admirable effort. I offer whatever assistance would be appropriate in implementing the recommendations of the Task Force, and I would welcome the chance to continue assisting your investigations at the DMR. Sincerely, Edward J. Markey Member of Congress