 Section 1 of Final Report of the Advisory Committee on Human Radiation Experiments. This is a LibriVox recording, while LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Final Report of the Advisory Committee on Human Radiation Experiments. Let her after table of contents, acknowledgements, documentary note. Advisory Committee on Human Radiation Experiments. 1726 M Street, NW, Suite 600, Washington, D.C., 20036, October 1995, to the members of the Human Radiation Interagency Working Group, Secretary Hazel O'Leary, Department of Energy, Secretary William Perry, Department of Defense, Attorney General Janet Reno, Department of Justice, Secretary Donna Shalala, Department of Health and Human Services, Secretary Jesse Brown, Department of Veterans Affairs, Director Alice Rivlin, Office of Management and Budget, Director John Deutch, Central Intelligence Agency, Administrator Daniel Golden, National Aeronautics and Space Administration. On behalf of the Advisory Committee on Human Radiation Experiments, it is my privilege to transmit to you our final report. Since the committee's first meeting, in April 1994, we have been able to conduct an intensive inquiry into the history of government-sponsored Human Radiation Experiments, and international environmental releases of radiation that occurred between 1944 and 1974. We have studied the ethical standards of that time, and of today, and have developed a moral framework for evaluating these experiments. Finally, we have examined the extent to which current policies and practices appear to protect the rights and interests of today's human subjects. This report documents our findings, and makes recommendations for your consideration. The committee listened to the testimony of more than 200 public witnesses who appeared before us. We are deeply grateful to all those witnesses who overcame the obstacles of geography and emotions to assist us. Our work and this report would not have been possible without the extraordinary effort the President and you put forth to open the government's records to our inquiry, and thus to the nation. We are especially pleased that, through our joint efforts, the American people now have access to tens of thousands of documents that bear on this important history. None of our conclusions came easily. We endeavored, both as individuals and as committee, to live up to the responsibility with which we were entrusted. This report represents the consensus of fair-minded people who gave the best they had to offer to their fellow citizens. We thank President Clinton for this opportunity, and for his courage and leadership in appointing the advisory committee. Ruth R. Fadden, Chair, Advisory Committee on Human Radiation Experiments. Acknowledgments The committee's work over the past year and a half would have been impossible without the assistance of an extraordinary number of individuals and groups from all corners of the United States and beyond. We wish to express the depth of gratitude to the many people who assisted, informed, and advised us. Some of these people are identified by name elsewhere in this report and its supplemental volumes. An appendix in this volume lists the more than two hundred witnesses who appeared before the committee at our public meetings in Washington, D.C., Cincinnati, Knoxville, San Francisco, Santa Fe, and Spokane. The supplemental volumes identify the dozens of individuals who agreed to formal, taped interviews in connection with the committee's oral history projects. We thank all these people and many more. The hundreds of people who contacted the committee with information about their own experience or the experiences of their family members. Many of these people shared not only their personal stories but also the information they had collected in the course of conducting their own research into government archives. The representatives of many groups whose interests coincided with the work of the committee. These include organizations of former subjects of biomedical radiation experiments and their families, downwinders, atomic veterans, uranium miners, and workers in and around atomic energy communities. These groups as well shared the accumulated information and perspective of years of experience and research. The numerous professionals and fields related to our research who gave of their time and expertise to provide information or comment on the myriad factual, technical, and policy questions before the committee. These experts provided help in understanding areas ranging from military and human rights law to the laws of the atom, from the history of the government's use of secrecy to the history of radiation science. Two dozens of universities and independent hospitals located in regions of the country that willingly provided us with the documents we needed to conduct our research proposal review project. The nearly 1,900 individuals who graciously participated in our subject interview study and the university hospitals, veterans' hospitals, and community hospitals that permitted us to conduct the study. The numerous chairs of institutional review boards and radiation safety committees who were kind enough to share with us their views about the current status of human subject protections. Archivists at public and private libraries, universities, and research institutions who assisted the committee in our search for information. The many journalists and scholars who have previously researched and written about the subjects covered in this report for sharing the knowledge and wisdom embodied in their own many years of inquiry and reflection. A variety of state and local agencies for sharing with the committee the results of their own reviews of activities that we explored. Members of Congress and congressional staff, including the staffs of the General Accounting Office and the Office of Technology Assessment for sharing the product of their own inquiries into many of the areas discussed in this report. The members of the Human Radiation Interagency Working Group who provided invaluable assistance. We are particularly grateful to the many employees at the Department of Energy, the Department of Defense, the Department of Health and Human Services, the Department of Veterans Affairs, the National Aeronautics and Space Administration, and the Central Intelligence Agency who aided us in the search and retrieval of the many thousands of documents that provided the backbone for the committee's review of human radiation experiments that took place between 1944 and 1974 and the history of government requirements for the conduct of that research. We are also grateful to the staffs of the Nuclear Regulatory Commission and the National Archives and Records Administration for their invaluable assistance. Many of the same people, as well as others, also provided advice and information as we undertook our evaluation of the conduct of research involving human subjects today. We wish to thank both the professional and administrative members of our staff who worked so hard and showed such dedication to our task. Their talent and energy and commitment provided the foundation for our work. It is impossible to overstate our gratitude and appreciation for their extraordinary efforts. Finally, we wish to acknowledge our indebtedness to President Clinton for the honor he bestowed upon us when he selected us to serve on the Advisory Committee. Documentary note. In fulfilling its mandate, the Advisory Committee on Human Radiation Experiments, ACHRE, relied on several thousand separate sources, primary and secondary published monographs, journal articles, historical records and manuscripts, original correspondence and surveys, interviews, specially constructed databases, searches of public and commercial databases, and documentary films. Only a fraction of these, however, is represented in the final report. More extensive information may be found in the supplemental volume Sources and Documentation, which contains a full account of the ACHRE research program, a finding aid to the complete research document collection, a bibliography of published sources used, an index to significant documents and identified experiments and other auxiliary materials. Further information, both about the sources used by the Advisory Committee, generally, and about the particular sources cited in this volume, should be sought there. The unpublished documents referenced in this report are identified by their places in the ACHRE research document collection. These identifiers, or ACHRE document numbers, have four parts. For example, DOE-051094-A-123 is the 123rd document described in the first A Department of Energy, DOE-SHITMENT, or Accession, received on May 10, 1994, O51094. One of the appendices, A Citizen's Guide to the Nation's Archives, provides instructions for using references to the ACHRE collection to find documents there and in the collections of the National Archives and at the agencies. Section 2, a final report of the Advisory Committee on Human Radiation Experiments. This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Final report of the Advisory Committee on Human Radiation Experiments. List of committee members and staff. Ruth R. Faden, PhD, MPH, Chair, Philip Franklin-Wagley Professor of Biomedical Ethics and Director, the Bioethics Institute, John Hopkins University, Baltimore, Maryland, Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University, Washington, D.C. Kenneth R. Feinberg, J.D. Kenneth R. Feinberg and Associates, Washington, D.C. Eli Gladstein, M.D., Professor and Chair, Department of Radiation Oncology, the University of Texas, Southwestern Medical Center at Dallas, Dallas, Texas. Jay Katz, M.D., Elizabeth K. Dollard, Professor Emeritus of Law, Medicine and Psychiatry, Harvey L. Karp Professorial Lecturer in Law and Psychological Analysis, Yale Law School, New Haven, Connecticut. Patricia A. King, J.D., Professor of Law, Georgetown University Law Center, Washington, D.C. Susan E. Litterer, PhD, Associate Professor, Department of Humanities, the Pennsylvania State University College of Medicine, Hershey, Pennsylvania. Ruth Macklin, PhD, Professor of Bioethics, Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, New York. Lois L. Norris, Second Vice President of Omaha National Bank and Omaha National Corporation. Retired, Omaha, Nebraska. Nancy L. Olenek, PhD, Professor of Radiation, Biochemistry, Division of Radiation Biology, Case Western Reserve University School of Medicine, Cleveland, Ohio. Henry D. Royal, M.D., Professor of Radiology, Associate Director, Division of Nuclear Medicine, Malanchrock University of Radiology, Washington University Medical Center, St. Louis, Missouri. Philip K. Russell, M.D., Professor, Department of International Health, John Hopkins University, School of Hygiene and Public Health, Baltimore, Maryland. Marianne Stevenson, M.D., PhD, Assistant Professor of Radiation Oncology, Joint Professor for Radiation Therapy, Harvard Medical School, Boston, Massachusetts. Deputy Chief, New England Deaconess Hospital, Department of Radiation Oncology, Boston, Massachusetts. Duncan C. Thomas, PhD, Director of Biostatistics Division, Department of Preventative Medicine, University of Southern California School of Medicine, Los Angeles, California. Reed V. Tuxin, M.D., President, Charles Drew University of Medicine and Science, Los Angeles, California. Dan Gutman, Executive Director. Jeffrey Kahn, Associate Director. Anna Mastriani, Associate Director. Stephen Kledemann, Director of Communications, Counselor to the Committee. Sarah Flynn, Editor. Staff, Senior Policy and Research Analysts. Barbara Burney, James David, John Harbert, Greg Hurkin, Jonathan Marino, Ronald Newman, Gary Stern, Jeremy Sugarman, Donald Waitman, Gilbert Whitmore, Research Analysts, Jonathan Engel, Patrick Fitzgerald, Mark Goodman, Debra Holland, Denise Holmes, Michael Jasney, Gail Javit, Wilhelmine Miller, Patricia Parentesis, Kathy Taylor, Sandra Thomas, Faith Weiss, Research Associates, Miriam Boling, Praveen Fernandez, Sarah Chandros-Hull, Valerie Hurt, John Kruger, Ellen Lee, Shobita Partisarte, Noel Fiviocio, Information Services, David Soundweber, Director, Robin Cochran, Librarian, Tom Weisner, Senior Technology Consultant, Communications and Outreach, Lanny Keller, Kristen Crote, Committee and Staff Affairs, Jerry Garcia, Gene Keper, Consultants, Jeffrey Bodkin, Ellen Buchanan, Gwen Davis, Gail Geller, Steve Goodman, John Hartness, Rebecca Lowen, Suzanne White-Junode, Nancy Kass, Charles McCarthy, Monica Shachspana, Patricia Stewart-Henney, John Till, E. W. Webster. Section 3 of Final Report of the Advisory Committee on Human Radiation Experiments. On January 15, 1994, President Clinton created the Advisory Committee on Human Radiation Experiments. In response to his concern about the growing number of reports describing possibly unethical conduct of the U.S. government, and institutions funded by the government, in the use of or exposure to ionizing radiation in human beings at the height of the Cold War, he directed us to uncover the history of human radiation experiments and intentional environmental releases of radiation, to identify the ethical and scientific standards for evaluating these events, and to make recommendations to ensure that whatever wrongdoing may have occurred in the past cannot be repeated. The Advisory Committee is composed of 14 members, a citizen representative and 13 experts in bioethics, radiation oncology and biology, epidemiology and statistics, public health, history of science and medicine, nuclear medicine, and law. We report to a cabinet-level group convened by the President, the Human Radiation Interagency Working Group, whose members are the Secretaries of Defense, Energy, Health and Human Services, and Veterans Affairs, the Attorney General, the Administrator of the National Aeronautics and Space Administration, the Director of the Central Intelligence Agency, and the Director of the Office of Management and Budget. On April 21, 1994, at the end of the first day of our opening meeting, President Clinton invited us to the White House to personally communicate his commitment to the process we were about to undertake. He urged us to be fair, thorough, and unafraid to shine the light of truth on this hidden and poorly understood aspect of our nation's past. Our most important task, he said, was to tell the full story to the American public. At the same time, we were also to examine the present, to determine how the conduct of human radiation research today compares with that of the past, and to assess whether, in the light of this inquiry, changes need to be made in the policies of the federal government to better protect the American people. This report and the accompanying supplemental volumes constitute the committee's attempt to tell the story of the past and to report on our inquiry into the present. Why the committee was created. Past research with human subjects, including human radiation research, has been a source of life-saving knowledge. Research involving human subjects continues to be essential to the progress of medical science, since most advances in medicine must at some point in their development be tested on human subjects. Every one of us who has been either a patient or a loved one of a patient has benefited from knowledge gained through research with human subjects, but medical science, like all science, does not proceed or progress without the taking of risks. In medical research, these risks often fall on the human subject, who sometimes does not stand to benefit personally from the knowledge gained. This is the source of the moral tension at the core of the enterprise of research involving human subjects. In order to secure important collective goods, scientific knowledge and advances in medicine, individuals are put in harm's way. The moral challenge is how to protect the rights and interests of these individuals, while enabling and encouraging the advancement of science. The committee had its origins when public controversy developed surrounding human radiation experiments that were conducted half a century ago. In November 1993 the Albuquerque Tribune published a series of articles that, for the first time, publicly revealed the names of Americans who had been injected with plutonium, the man made material that was a key ingredient of the atomic bomb. However Eileen Wilson put a human face to what had previously been anonymous data, published in official reports and technical journals. As World War II was ending, she wrote, �Doctors in the United States injected a number of hospitalized patients with plutonium, very likely without their knowledge or consent.� The injections were part of a group of experiments to determine how plutonium courses through the human body. The experiments and the very existence of plutonium were shrouded in secrecy. They were conducted at the direction of the U.S. government, with the assistance of university researchers in Berkeley, Chicago and Rochester, New York, with the expectation that the information gained could be used to limit the hazards to thousands of workers laboring to build the bomb.� When reading the articles, Secretary of Energy Hazel O'Leary expressed shock, first to her staff and then in response to a question posed at a press conference. She was particularly concerned because the Department of Energy had its earliest origins in the agencies responsible for building the atomic bomb and sponsoring the plutonium experiments. During the Cold War these agencies had continued to do much of their work in the Twilight Zone, between openness and secrecy. Now the Cold War was over, the time had come, Secretary O'Leary determined to make public anything that remained to be told about the plutonium experiments. Subsequent press reports soon noted that the plutonium injections were not the only human radiation experiments that had been conducted during the war and the decades that followed. In Massachusetts the press reported that members of the Science Club, at the Furnold School for the Retarded, had been fed oatmeal containing minute amounts of radioactive material. In Ohio news articles revived an old controversy about University of Cincinnati researchers who had been funded by the Defense Department to gather data on the effects of total body irradiation on cancer patients. In the Northwest the papers retold the story of Atomic Energy Commission funding of researchers to irradiate the testicles of inmates in Oregon and Washington prisons in order to gain knowledge for use in government programs. The virtually forgotten 1986 report prepared by a subcommittee headed by U.S. Representative Edward Markey, American nuclear guinea pigs, three decades of radiation experiments on U.S. citizens, was also called to public attention. Coincidentally the fact that the environment had also been used as a secret laboratory became a subject of controversy. In November 1993 congressional report uncovered 13 cases in which government agencies had intentionally released radiation into the environment without notifying the affected populations. At various times tests were conducted in Tennessee, Utah, New Mexico, and Washington State. This report had been prepared at the request of Senator John Glenn. In his capacity as chair of a committee that had undertaken a comprehensive oversight investigation of the nuclear weapons complex. As a young Marine in 1945 the senator was in a squadron being trained for possible deployment to Japan when the atomic bomb ended the war. As an astronaut he had been the subject of constant testing and medical monitoring by space administration flight surgeons. As a senator he was at the center of the country's efforts to understand and control nuclear weapons. Senator Glenn understood the importance of national security but he found it inconceivable that even at the height of the communist threat some of our scientists and doctors and military and perhaps political leaders approved some of these experiments to be conducted on an unknowing and unwitting public. In the immediate aftermath of Secretary O'Leary's press conference and the further press reports thousands of callers flooded the Department of Energy's phone lines to recount their own experiences and those of friends and family members. Underlying the outrage and concern expressed by government officials and members of the public were many unanswered questions. How many human radiation experiments were conducted? No one knew if the number was closer to one hundred or one thousand. Were all the human radiation experiments done in secret? And were any of them still secret? Are any secret or controversial studies still ongoing? Scientists and science journalists pointed out that some of the highly publicized experiments had long ago been the subject of technical journal articles, even press accounts, and were old news. Other commentators countered that for most of the public, articles in technical journals might as well be secret. How, why, and from what population groups were subjects selected for experiments? Some suspected that subjects were disproportionately chosen from the most vulnerable populations. Children, hospitalized patients, the retarded, the poor. Those too powerless to resist the government and its researchers. Did the experiments benefit the American people through the advancement of science and the enhancement of the ability to treat disease? How many intentional releases took place? And how many people were unknowingly put at risk? The answer here was sketchy. The releases identified in the November 1993 Glenn Report had all been performed in secret, and much information about them was still secret. How great were the risks to which people were exposed? Many pointed out that radiation is not only present in our natural environment, but that as a result of biomedical research most people routinely rely on radiation as a means of diagnosing and treating disease. Others noted that while this is so, radiation can be abused, and the potential dangers of low level exposure are still not well understood. What did our government and the medical researchers it sponsored do to ensure that the subjects were informed of what would be done to them and that they were giving meaningful opportunities to consent? Today federal government rules require the prior review of proposed experiments to ensure that the risks and potential benefits have been considered, and that subjects will be adequately informed and given the opportunity to consent. But the standards of today, many historians and scholars of medical ethics noted, are not those of yesterday. Others however declared that it was self-evident that no one should be experimented upon without his or her voluntary consent. Indeed it was pointed out that this very principle was proclaimed aloud to the world in 1947, as the plutonium experiments were coming to a close. It was the American judges at the International War Crimes Trials in Nuremberg, Germany, who invoked the principle in finding doctors guilty of war crimes for their vile experiments on inmates of Nazi concentration camps. How could yesterday's standard have been less strict than that of today? How moreover could the standard not have been known by the government that sponsored the experiments, and the researchers who conducted them? Finally, there were questions about how human experiments are conducted today. Insofar as wrong things happened in the past, how confident should we be that they could not happen again? Have practices changed? Do we have the right rules? And are they implemented and enforced? The President's Charge The advisory committee was created under the Federal Advisory Committee Act of 1972, which provides that committee meetings and basic decision-making be conducted in the open. The committee's charter defined human radiation experiments to include, one, experiments on individuals involving intentional exposure to ionizing radiation. This category does not include common and routine clinical practices. Two, experiments involving intentional environmental releases of radiation that, A, were designed to test human health effects of ionizing radiation, or B, were designed to test the extent of human exposure to ionizing radiation. The committee was mandated to review experiments conducted between 1944 and 1974, the latter being the year that the U.S. Department of Health, Education and Welfare issued rules for the protection of human subjects of federally sponsored research. The committee was asked to determine the ethical and scientific standards by which to evaluate the pre-1974 experiments, and the extent to which these experiments were consistent with such standards. We were also to consider whether, A, there was a clear medical or scientific purpose for the experiments, B, appropriate medical follow-up was conducted, and C, the experiments design and administration adequately met the ethical and scientific criteria, including standards of informed consent, that prevailed at that time of the experiments and that exists today. The charter also directed that upon completing our review, the committee may recommend that subjects or families be notified of potential health risks and the need for medical follow-up, and also that we may recommend further policies as needed to ensure compliance with recommended ethical and scientific standards for human radiation experiments. In order to inform the public about the conduct of research involving human subjects taking place today, we were authorized to sample and consider examples of research with human subjects currently underway. In essence, we were to answer several fundamental questions. One, what was the federal government's role in human radiation experiments conducted from 1944 to 1974? Two, by what standards should the ethics of these experiments be evaluated? And three, what lessons learned from studying past and present research standards and practices should be applied to the future? In addition, while the committee was not expressly charged with considering issues relating to remedies, including financial compensation, we have felt obliged to address the type of remedies that we believe the government, as an ethical matter, should provide to subjects of experiments where the circumstances warranted such a response. The committee's approach. When those of us selected by President Clinton to serve on the committee read about human radiation experiments in our hometown newspapers during the 1993 holiday season, none of us imagined that within months we would be embarking on such an intense and challenging investigation of an important aspect of our nation's past and present, requiring new insights and difficult judgments about enduring ethical questions. On April 21 and 22, 1994, the committee held its first meeting, and most of us met each other for the first time, and we listened to opening statements by cabinet members and members of Congress as well as the first witness from the general public. It became clear how daunting a task we were undertaking. We realized that our ability to reconstruct the story of past radiation experiments required both the capacity to join with the agencies in the search through thousands of boxes for documents, and the intuition to recognize which documents were important. We knew that the ability to tell that story depended on our ability to understand the full range of technically complex, often emotionally charged issues related to human radiation experiments. We could not understand much less tell the story until we sought out all who could enhance our understanding, a difficult job, because the voices to which we had to listen spoke in the varied languages of medicine, a multiplicity of scientific disciplines, the military, policy makers, philosophers, patients, healthy subjects, family members of former subjects, and individuals in a variety of other roles. Finally we were also convinced that an important determinant of our success in keeping faith with the American people would be to understand not only how human subject research was conducted in the past, but also how it is being conducted in the present, reaching in and reaching out. As we began our work, committee members first sought to educate one another. Early meetings included basic presentations on such topics as research ethics, radiation, the history of human experimentation, the law of remedies, and the debate over the effects of low levels of radiation. Then we determined to search broadly for those who could contribute to our understanding. We hired a staff with the expertise and experience needed for the committee's myriad tasks. Finally we sought to make ourselves available to those who wanted to speak to us directly, especially people who felt they or their loved ones were harmed, or might have been harmed by human radiation related research or exposure. Each of the committee's meetings reserved a period for public comment. Since April 1994 the full committee held 16 public meetings, each of two to three days duration. Fifteen of those meetings were held in Washington, D.C., and one was in San Francisco. In addition, subsets of committee members presided over public forums in Cincinnati, Santa Fe and Spokane. We traveled to these different cities in order to hear from people who could not come to Washington, D.C., and lived in communities where, or near where, experiments or international releases of interest to the committee have taken place. We further sought to reach out to those who could not attend our meetings. By phone, mail, and personal visit we in our staff communicated with members of the public, researchers, attorneys, investigative reporters, authors, and representatives of dozens of groups of interested people who shared some aspect of the committee's concern. The Records of the Past. The Search for Documents. One of the most difficult tasks before the committee was determining how many federally sponsored human radiation experiments occurred between 1944 and 1974, and who conducted them. When President Clinton established the committee he also directed the Human Radiation Interagency Working Group to provide us with all relevant documentary information in each of the agency's files. Teams were formed to identify the hundreds of government sites where relevant documents might be located. We discovered there was no easy way to identify how many experiments had been conducted, where they took place, and which government agencies had sponsored them. The location and retrieval of documents thus required an extraordinary effort and we appreciate the assistance of all our collaborators. We began with documents that were assembled during the 1980s, and that provided the basis for the Markey Report. But review of those materials confirmed that even for this relatively well-known group of experiments, basic information was lacking. We found that the Department of Health and Human Services, DHHS, which is the primary government sponsor of research involving human subjects, reported that as permitted by Federal Records laws, it had long since discarded files on experiments performed decades ago. Furthermore, the capsule descriptions of research that remained sometimes did not make clear whether the subjects of research had been humans or annals. To complicate matters further, the DHHS also pointed out that much research documentation had originated and been retained only in the files of non-federal grantee institutions and investigators. Other agencies did provide some lists of experiments. In many cases, however, there was no information on basic questions of concern, for example, who the subjects were, and what, if anything, they were told. What rules or policies, if any, existed to govern federally sponsored experiments in the pre-1974 period? The prevailing assumption was that with a few notable exceptions, it was not until the mid-1960s that federal agencies began to develop such policies in any significant way. Most scholarship focused on the divisions of the then Department of Health, Education and Welfare. Little was known about approaches to human experimentation at the Atomic Energy Commission and the Department of Defense. Yet it was clear from the outset of our inquiry that these agencies, as well as the DHEW, were central to the story of human radiation experiments and that many of the experiments of interest predated by decades, the mid-1960s interests in human subject protections. As we begin our search into the past, we found that it was necessary to reconstruct a vanished world. The committee and the agencies had to collect information scattered in warehouses throughout the country. At the same time we had to create and test the framework needed to ensure that there would be a big picture into which all the pieces of the puzzle would fit. After a few months, the outlines of a world that had been almost lost began to re-emerge. Working with the Defense Department, we discovered that long-forgotten government entities had played central roles in the planning of mid-century atomic warfare-related medical research and experimentation. These groups, the piecing together of long lost or forgotten records, would show, debated the ethics of human experimentation and discussed possible human radiation experimentation. Similarly, working with the Department of Energy, we pieced together the minutes and even many transcripts of the key medical advisory committee to the Atomic Energy Commission. We sought to mine agency histories when they existed, for example at the committee's request, the Defense Nuclear Agency. The air to the part of the Manhattan Project that was transferred to the Defense Department made public portions of the more than five hundred internal histories that chronicle its story, most of which had previously been available only to those with security clearances. Despite these successes it became evident that the records of much of our nation's recent history had been irretrievably lost or simply could not be located. The Department of Energy told the committee that all the records of the Intelligence Division of its predecessor, the Atomic Energy Commission, had been destroyed, mainly during the 1970s, but in some cases as late as 1989. The CIA explained, as had been previously reported, that records of the program known as MKUltra, in which unwitting subjects were experimented upon with a variety of substances, had been destroyed during the 1970s, when the program became a widely publicized scandal. Though documents related to the program referred to radiation, the CIA concluded that human experiments using ionizing radiation never took place under that program, based on currently available evidence. We also turned to non-governmental archives throughout the country. Cryptic notes and fragments of correspondence located in private and university archives were fitted into our growing outline. For example, a copy of an important 1954 Army Surgeon General Research Policy Statement, referenced in Defense Department documents, was found at Yale University, among the papers of a Nobel Laureate. By the end of the term the committee had received, organized, and reviewed hundreds of thousands of pages of documents from public and private archives. This collection will be available to individuals and scholars who wish to pursue the great many stories that remain to be told, and we view this as one of our most significant contributions. The committee listened to the testimony of more than 200 public witnesses who appeared before us. We heard from people or their family members, who had been subjects in controversial radiation experiments, including the plutonium injections, total body radiation experiments, and experiments involving the use of radioactive tracers with institutionalized children. We heard from atomic veterans, soldiers who had been marched to ground zero at atomic bomb tests, sailors who had walked the decks of ships contaminated by radioactive mist, and pilots who had flown through radioactive mushroom clouds. We also heard from their widows. We heard from people who lived downwind from nuclear weapons tests in Nevada, and intentional releases of radioactive material in Washington State. We heard from the Navajo miners, who had served the country in uranium mines filled with radioactive dust, from native Alaskans who had been experimented upon by a military cold weather research lab, and from Marshall Islanders, whose Pacific homeland had been contaminated by fallout after a 1954 hydrogen bomb test. We heard from officials and researchers responsible for human research today, and from those who were present at or near the dawn of the Cold War. We heard from individuals who, on their own time, had been long seeking to piece together the story of human radiation experiments and offer to share their findings. We heard from scholars, from members of Congress, and from people who wanted to bear witness for those who could no longer speak. We heard from a woman, who, as a high school student's intern decades ago, attended at the bedside while a terminally ill patient was injected with uranium, and from a powerfully spoken veteran of the nuclear weapons workforce, who told of the body-snatching of dead friends in the name of science. More important, we heard from many people who believed that something involving the government and radiation happened to them or their loved ones decades ago. Most had been unable to find out exactly what had happened or why, and now they wanted to know the truth. The witnesses spoke eloquently of their pain, their frustration, and the reasons they do not trust the government. Their very appearance before the committee testified to a commitment to the country and to the value of the nation's effort to understand its past. We are deeply grateful to all of these witnesses who overcame the obstacles of geography and emotions to participate in this work. We combined our public meetings with additional efforts to interview and record for the nation's archives, those who could shed light on Cold War human radiation experiments and on the ethics of biomedical experimentation. Dozens of interviews were conducted with former government officials responsible for programs that included radiation research, as well as with radiation researchers. In Mississippi we talked with a retired general who served as a military assistant to Secretaries of Defense in the 1940s and 1950s. In Berkeley we talked with the chemist who was one of the discoverers of plutonium. In Rhode Island we talked with the physicist who served as the link between the civilian health and safety agencies and the Cold War military research efforts. In Florida we talked with a pioneer in health physics, a discipline created to provide for the safety of nuclear weapons workers. In San Francisco and Washington D.C. we talked to the lawyers who advised the Atomic Energy Commission at its post-war creation. In New York we talked with a Navy radiation researcher who was rousted from his Maryland laboratory to respond to the emergency created by the exposure of the Marshall Islanders. In San Diego we talked with a researcher whose own career and massive history of radiation research had covered much of the committee's territory. We also launched a special effort called the Ethics Oral History Project to learn from eminent physicians who were beginning their careers in academic medicine in the 1940s and 1950s about how research with human subjects was then conducted. The Ethics Oral History Project also included interviews with two people who had been administrators of the National Institutes of Health during the 1950s, since they were intimately involved with ethical and legal aspects of research involving human subjects at the time. We listened to all these people and more, and through their testimony this report is informed. Bounds of Our Inquiry In the course of listening to public testimony, it became clear to us that confusion exists about what an experiment is and whether it can be distinguished from other activities in which people are put at risk, and information is gathered about them. The biomedical community, for example, struggles with the distinction between scientific research and related activities. In a medical setting, it is sometimes hard to distinguish a formal experiment designed to test the effectiveness of a treatment from ordinary medical care in which the same treatment is being administered outside of the research project. The patient receiving the treatment may discern no difference between the two, but the distinction is relevant to questions of ethics. The physician investigator may face conflicts between the obligation to do what is best for each individual patient and the requirements of scientific research, whereas the physician involved only in clinical care has a responsibility solely to the patient. Similarly, in an occupational setting, in which employees are put at risk, it is often difficult to distinguish formal scientific efforts to study effects on the health of employees, from routine monitoring of employees' exposure to hazards in the workplace for purposes of ensuring worker safety. In the first case, the rules of research ethics apply. In the second, they do not. And yet, here too, the worker may discern no difference between the two activities. A further complication for the committee to consider was the fact that research in occupational settings rarely takes the form of a classic experiment in which the investigator controls the variable under study and then randomly assigns subjects to be in the treatment or control group. Instead, most occupational research employs observational and statistical methods, drawing most heavily from the field of epidemiology. These distinctions were unimportant, however, to the representatives of atomic veterans, Iranian miners, and residents of the Marshall Islands, who told us of their belief that they or those they spoke for were subjects of research. The committee struggled with how strictly to define human radiation experiments for purposes of our inquiry. There is no single clear definition of an experiment that is widely subscribed to by every member of the biomedical community. Even our description above of a classic experiment is open to contest. Today, as well as in the past, the scientific community has rarely employed the term experiment in discussions of biomedical research. Other terms, not necessarily synonymous, such as clinical study, clinical investigation, quasi-experiment, and case-control study, are all used. We concluded that it was not possible to interpret our charge by stipulating an artificial definition of human radiation experiment. Instead, in keeping with the realities of biomedical research, we decided to interpret our charge broadly, as including both research involving human subjects in which the research design called for exposing subjects to ionizing radiation and research designed to study the effects of radiation exposure, resulting from non-experimental activities. The latter category includes the research involving uranium miners and Marshall Islanders. In these cases, we quickly determined that it was in some respects impossible to isolate the ethical questions raised by the research from the ethics of the context in which the research was conducted. A central issue was the exposure of people to risk, regardless of whether they were clearly understood to be subjects of research. This characterization is true, as well of the experience of atomic veterans. As a consequence, we considered events that might be said to be on the boundary between research and some other activity. Our inquiry underscored the importance for social policy of the need to keep focused on questions of risk and well-being, regardless of what side of that boundary the activity producing the risk falls. Human Experimentation Today In tandem with the reconstruction of the past, we undertook three projects to examine the current state of human radiation experiments. First, we studied how each agency of the federal government that currently conducts or funds research involving human subjects regulates this activity and oversees it. We surveyed what the operative rules are, how they are implemented, and how they are enforced. Second, from among the very large number of research projects involving human subjects currently supported by the federal government, we randomly selected 125 research projects for scrutiny by the committee. For each of these projects, we reviewed all available relevant documentation to assess how well it appeared the rights and interests of the subjects participating in these projects were being protected. The success of this review required the cooperation of private research institutions all over the country, on whom we were dependent for access to important documents. We had expected that perhaps no more than half of those asked to cooperate would agree to do so, but with little hesitation all the research centers that we approached agreed to cooperate. Third, to learn from the subjects themselves, the committee interviewed almost 1,900 patients receiving medical care in outpatient facilities of private and federal hospitals throughout the country. We asked patients about their attitudes towards medical research with human subjects and about the meaning they attached to the different terms used to explain medical research to potential subjects. We ascertained and attempted to verify how many of these patients were currently or ever had been subjects to research. Patient subjects were asked about their reasons for agreeing to join research projects. Patients who reported having refused offers to enter research projects were asked why they had decided against participating. In all three of these projects, we focused not only on human radiation experiments, but on human research generally. In critical, but not all respects, the government regulations that apply to human radiation research do not differ from those that govern other kinds of research involving human subjects. Moreover, the underlying ethical principles that should guide the conduct of research are identical, whether one is considering human radiation research or all research with human subjects. Finally, the committee hoped to learn whether in practice there are any differences between the conduct of radiation and non-radiation experiments, lessons from history, looking to the future. What we have found is a story about the government's attempt to serve two critical purposes, safeguarding national security and advancing medical knowledge. One half century ago, the U.S. government and its experts in the fields of radiation and medicine were seeking to learn more about radiation in order to protect workers, service personnel, and the general public against potential atomic war, and individuals against the menace of disease. Toward these laudable ends, the government used patients, workers, soldiers, and others as experimental subjects. It acted through the experts to whom we regularly entrust the well-being of our country and ourselves, elected officials, civil servants, generals, physicians, and medical researchers. Moreover, the government acted with full knowledge that the use of individuals to serve the ends of government raises basic ethical questions. If, as we look back, there could be doubt about the importance of the matter to the leaders of the time, we need only to look at the appearance before the U.S. Senate of David Lilienthal, who had been nominated to serve as the first chairman of the Atomic Energy Commission, the civilian successor to the Manhattan Project, and the predecessor to today's Department of Energy. In his testimony, Lilienthal forcefully stated, All government and private institutions must be designed to promote and protect and defend the integrity and the dignity of the individual. Any forms of government, which make men means rather than ends in themselves, are contrary to this conception, and therefore I am deeply opposed to them. The fundamental tenet of communism is that the state is an end in itself, and that therefore the powers which the state exercises over the individual are without any ethical standards to limit them. This I deeply disbelieve. What did happen when individuals were sometimes used as means to achieve national goals? How well were the national goals of preserving the peace and advancing medical science reconciled with the equally important end of respect for individual dignity and health? What rules were followed to protect people, and how well did they work? Was the public let in on the balancing of collective and individual interest? In what sense did the public, in general, and individuals in particular, know what was happening and have the opportunity to provide their meaningful consent? In this report, we try to convey our understanding of how, when only good was sought, when its pursuit was entrusted to the experts on whom we most relied, and when missions were substantially accomplished, distrust, as well as accomplishment, remains. We focus on the ways in which the government and its experts recognized the interest of individual dignity and sought to strike a balance with the national interests being pursued. We focus equally on the extent to which the public was privy to this balancing. In particular, we try to show how individuals' understanding and participation were limited by the conjunction of government secrecy and expert knowledge. All Americans should experience immense satisfaction in the strides that have been made toward accomplishing both our national security and our medical research goals. However, as attested to by the many thousands of letters and calls that led to the committee's creation and the eloquent statements of the witnesses who appeared before us, this pride is diluted by a bitter aftertaste, distrust by many Americans of the federal government and those who served it. The government has the power to create and keep secrets of immense importance to us all. Secret keeping is a part of life. Secret keeping, by the government, may be in the national interest. However, if government is to be trusted, it is important to know, at the very least, the basic rules of secrecy and to know that they are reasonable and that they are being followed. Similarly, experts by training and experience have knowledge that individual people must, as a practical matter, rely on. However, legitimate to questions arise when experts wear multiple hats or when they are relied on in areas beyond their expertise, where official secrecy is coupled with expert authority, and both are focused on a public that is not privy to secrets and does not speak the languages of experts, the potential for distrust is substantial. In telling the story and asking the questions, we have kept our eyes open for ways in which lost trust can be restored. It might be presumed that the past we report on here is so different from the present that it will be of little use in understanding research involving human subjects today. In fact, as we shall see, basic questions posed by the story of human radiation experiments conducted during the 1944-1974 period are no less relevant today. Then as now, there were standards. The question is how they worked to protect individuals and the public. Then, as now, the ethical impulse was complexly alloyed with concerns for legal liability and public image. Then, as now, the most difficult questions often concern the scope and practical meaning of ethical rules, rather than their necessity. The country has come to recognize, from its experience of the past half century, that tinkering with the regulations that govern publicly supported institutions, imposing ethical codes on experts, and altering the balance between secrecy and openness, are important but not only sufficient means of reform. The most important element is a citizenry that understands the limits of these activities. That is why the purpose of this story is not simply to learn which changes to make in rules or policies that apply to government or professionals, but to begin to learn something more about how the Cold War worked, as the most important means to making the world of tomorrow work better. How this report is organized. Though this report is addressed largely to those who can affect future policy in light of the information the advisory committee has gathered, specifically the Human Radiation Indoor Agency Working Group, it has been written in such a way that it should be accessible to a wide range of interested readers. We begin with an introduction titled The Atomic Century, which describes the intersection of several developments, the birth and remarkable growth of radiation science, the parallel changes in medicine and medical research, and the intersection of these changes with government programs that called on medical researchers to play important new roles beyond that involved in the traditional doctor-patient relationship. The introduction concludes with a section titled The Basics of Radiation Science for the lay reader. The remainder of the text is divided into four parts. Each part is preceded by an overview. Part one, Ethics of Human Subjects Research, A Historical Perspective, which contains four chapters, explores how both federal government agencies and the medical profession approached human experimentation in the period 1944 through 1974. We begin with the story of the principles stated at mid-century at the highest levels of the Cold War medical research bureaucracies, and what we have ascertained about whether these principles were translated into federal rules or requirements. We then turn to the norms and practices engaged at the time by medical researchers themselves. It is in this chapter that we report the results of our Ethics Oral History Project. In Chapter 3 we review the development of formal and public regulations concerning research involving human subjects in the 1960s and 1970s. In the last chapter in part one we present our framework for evaluating the ethics of human radiation experiments, grounded in both history and philosophical analysis. Part two, Case Studies. Approaches particular experiments from several angles, each of which raises overlapping ethical questions. The chapters on the plutonium injections and total body irradiation consider the use of sick patients to provide data needed to protect the health of workers engaged in the production of nuclear weapons. The chapter on prisoners considers the use of healthy subjects for this purpose. The chapter on children considers experimentation with particularly vulnerable people. And the chapter on the AEC program of Radioisotope Distribution considers the institutional safeguards that underlay the conduct of thousands of human radiation experiments. The chapters on intentional releases, atomic veterans, and observational studies consider, in common, situations in which entire groups of people were exposed to risk, as a consequence of government-sponsored Cold War programs. The section concludes with a review of the degree to which secrecy impaired, and may still impair, our ability to understand human radiation experiments and intentional releases conducted in the 1944-1974 period. Part III Contemporary Projects Reports the finding of our three inquiries into the present. We begin by describing what we have learned about how the different federal agencies that sponsor human research regulate and oversee this activity. Next, we report the results of our research proposal review project, followed by the results of our subject interview study. Part III concludes with the committee's synthesis of the implications of the results of all three of these projects for the current state of human subject research. Part IV, coming to terms with the past, looking ahead to the future, reports the committee's findings and recommendations. A final note. The committee's findings and recommendations represent our best efforts to distill almost 18 months of inquiry into, debate about, and analysis of human radiation experiments. But what they cannot fully express is the appreciation we developed for how much damage was done to individuals and to the American people during the period we investigated and how this damage endures today. The damage we speak of here is not physical injury, although this too did occur in some cases. Rather, the damages measured in the pain felt by the people who believe that they had, or their loved ones were, treated with disrespect for their dignity and disregard for their interests by a government and a profession in which they had placed their trust. It is measured in a too often cynical citizenry, some of whom have lost faith in their government to be honest brokers of information about risks to the public and the purposes of the government actions. And it is measured in the confusion among patients that remains today about the differences between medical research and medical care. Differences that can impede the ability of patients to determine what is in their own best interest. In the period that we examined, extraordinary advances in biomedicine were achieved, and a foundation was laid for fifty years without a world war. At the same time, however, it was a time of arrogance and paternalism on the part of government officials and the biomedical community that we would not under any circumstances wish to see repeated. As we listened to the heart-rending testimony of many public witnesses, we came to feel great sorrow about the suffering they described. Our most difficult task was determining what to recommend as the appropriate national response to these emotions and the events that stimulated them. What can best precipitate the healing of wounds and the restoration of trust? Appropriate remedies for those who were wronged or harmed were of critical importance, but remedies alone speak only to the past, not the future. It is equally important that the historical record, having been spelled out and appropriate remedies identified, we as a nation move forward and take action to prevent similar occurrences from happening in the future. In the end, if trust and government is to be restored, those in power must also act in good faith in their dealings with the citizenry. At the same time, however, we must recognize that unless we have expectations of honesty and fairness from our government, and unless we are vigilant in holding the government to those expectations, trust will never be restored. Finally, we hope that this report conveys the sense of gratitude and honor that we experienced as citizens serving on the advisory committee. We were provided by the President with extraordinary access to the records of our past and given complete liberty to deliberate on what we found, although some of what we report is a matter for national regret. Our freedom of inquiry and the cooperation we received from officials and fellow citizens of all perspectives confirms that our nation's highest traditions are not things of the past, but live very much in the present. End of Section 4. Section 5 of final report of the advisory committee on human radiation experiments. This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Recording by Jennifer Painter. Final report of the advisory committee on human radiation experiments. Introduction Part 1. The Atomic Century. 100 years ago, a half century before the atomic bombing of Hiroshima and Nagasaki, the discovery of X-rays spotlighted the extraordinary promise and peril of the atom. 100 years ago, from that time until 1942, atomic research was in private hands. The Second World War and the Manhattan Project, which planned and built the first atomic bombs, transformed a cottage industry of researchers into the largest and one of the most secretive research projects ever undertaken. Scientists who had once raced to publish their results learned to speak in codes accessible only to those with a need to know. Indeed, during the war the very existence of the man-made element plutonium was a national secret. After the war's end, the network of radiation researchers, government and military officials, and physicians mobilized for the Manhattan Project did not disband. Rather, they began working on government programs to promote both peaceful uses of atomic energy and nuclear weapons development. Having harnessed the atom in secret for war, the federal government turned enthusiastically to providing governmental and non-governmental researchers, corporations, and farmers with new tools for peace. Radioisotopes mass-produced with the same machinery that produced essential materials for the nation's nuclear weapons. Radioisotopes, the newly established Atomic Energy Commission, AEC promised, would create new businesses, improve agricultural production, and through human uses in medical research save lives. From its 1947 creation to the 1974 reorganization of atomic energy activities, the AEC produced radioisotopes that were used in thousands of human radiation experiments conducted at universities, hospitals, and government facilities. This research brought major advances in the understanding of the workings of the human body and the ability of doctors to diagnose, prevent, and treat disease. The growth of radiation research with humans after World War II was part of the enormous expansion of the entire biomedical research enterprise following the war. Although human experiments have long been part of medicine, there had been relatively few subjects. The research had not been a systematic, and there were far fewer promising interventions than there were in the late 1940s. With so many more human beings as research subjects, and with potentially dangerous new substances involved, certain moral questions in the relationship between the physician researcher and the human subject, questions that were raised in the 19th century assumed more provenance than ever. What was there to protect people if a researcher's zeal for data gathering conflicted with his or her commitment to the subject's well-being? Was the age-old ethical tradition of the doctor-patient relationship in which the patient was to defer to the doctor's expertise and wisdom adequate when the doctor was also a researcher and the procedures were experimental? While these questions about the role of medical researchers were fresh in the air, the Manhattan Project and then the Cold War presented new ethical questions of a different order. In March 1946, former British Prime Minister Winston Churchill told an audience in Fulton, Missouri that an iron curtain had descended between Eastern and Western Europe, giving a name to the hostile division of the continent that had existed since the end of World War II. By the following year, Cold War was the term used to describe this state of affairs between the United States and its allies on the one hand and the Soviet bloc on the other. A quick succession of events underscored the scope of this conflict, as well as the stakes involved. In 1948, a Soviet blockade precipitated a crisis over Berlin. In 1949, the American nuclear monopoly ended when the Soviet Union exploded its first atomic bomb. In 1950, the Korean War began. The seeming likelihood that atomic bombs would be used again in war, and that American civilians, as well as soldiers, would be targets, meant that the country had to know as much as it could, as quickly as it could, about the effects of radiation and the treatment of radiation injury. This need for knowledge put radiation researchers, including physicians, in the middle of new questions of risk and benefit, disclosure and consent. The focus of these questions was, directly and indirectly, an unprecedented public health hazard, nuclear war. In addressing these questions, medical researchers had to define the new roles that they would play. As advisors to the government, radiation researchers were asked to assist military commanders who called for human experimentation to determine the effects of atomic weapons on their troops. But these researchers also knew that human experimentation might not readily provide the answers the military needed. As physicians, they had a commitment to prevent disease and heal. At the same time, as government advisors, they were called upon to participate in making decisions to proceed with weapons development and testing programs that they knew could put citizens, soldiers and workers at risk. As experts, they were asked to ensure that the risks would not be excessive. And as researchers, they saw these programs as an opportunity for gathering data. As researchers, they were often among the first to volunteer to take the risks that were unavoidable in such research. But the risks could not always be disclosed to members of the public who were also exposed. In keeping with the tradition of scientific inquiry, these researchers understood that their work should be the subject of vigorous discussion, at least among other scientists in their field. But as government officials and advisors, they understood that their public statements had to be constrained by Cold War national security requirements. And they shared an official concern that public misunderstanding could compromise government programs and their own research. Medical researchers, especially those expert in radiation, were not oblivious to the importance of the special roles they were being asked to play. Never before in history began the 1949 medical text Atomic Medicine. Have the interests of the weaponaires and those who practice the healing arts been so closely related? This volume, edited by Captain C. F. Behrens, the head of the Navy's new Atomic Medicine Division, was evidently the first treatise on the topic. It concluded with a chapter by Dr. Shields Warren, the first chief of the AEC's Division of Biology and Medicine, who would become a major figure in setting policy for post-war biomedical radiation research. While the atomic bomb was not of medicines contriving, the book began, it was to physicians more than to any other profession that atomic energy had brought a bewildering array of new problems, brilliant prospects and inescapable responsibilities. The text, a prefatory chapter explained, treats not of high policy, of ethics, of strategy or of international control of nuclear materials, as physicians these matters are not for us. Yet what many readers of Atomic Medicine could not know in 1949 was that Behrens, along with Warren and other biomedical experts, was already engaged in vigorous but secret discussions of the ethics underlying human radiation experiments. At the heart of these discussions lay difficult choices at the intersection of geopolitics, science and medicine that would have a fundamental impact on the federal government's relationship with the American people. This chapter provides a brief survey of the development of radiation research and the changing roles of the biomedical researcher from the discovery of x-rays by a single individual to the complex world of government sponsored human radiation experimentation. Finally, at the end of this chapter, an aid to the reader titled The Basics of Radiation Science provides information needed to understand technical concepts in this report. Before the atomic age, shadow pictures, radio isotopes and the beginnings of human radiation experimentation. Radiation has existed in nature from the origins of the universe but was unknown to man until a century ago. Its discovery came by accident. On a Friday evening, November the 8th, 1895, the German physicist Wilhelm Röntgen was studying the nature of electrical currents by using a cathode ray tube, a common piece of scientific equipment. When he turned the tube on, he noticed to his surprise that a glowing spot appeared on a black paper screen coated with fluorescent material that was across the room. Intrigued, he soon determined that invisible but highly penetrating rays were being produced at one end of the cathode ray tube. The rays could expose photographic plates, leaving shadows of dense objects such as bone. After about six weeks of experimenting with his discovery, which he called x-rays, Röntgen sent a summary and several shadow pictures to a local scientific society. The society published the report in its regular journal and wisely printed extra copies. News spread rapidly. Röntgen sent copies to physicists throughout Europe. One Berlin physicist could not help thinking that I was reading a fairy tale. Only the actual photograph proved to everyone that this was a fact. Physicians immediately recognized these rays as a new tool for diagnosis, a window into the interior of the body. The useless left arm of German Emperor Wilhelm II was x-rayed to reveal the cause of his disability. While Queen Amelia of Portugal used x-rays of several of her court ladies to vividly display the dangers of pipe lacing, physicians began to use x-rays routinely for examining fractures and locating foreign objects such as needles swallowed by children or bullets shot into adults. During World War I more than 1.1 million wounded soldiers were treated with the help of diagnostic x-rays. In 1896 Röntgen's insight led to the discovery of natural radioactivity. Henri Becquerel, who had been studying phosphorescence, discovered that shadow pictures were also created when wrapped photographic plates were exposed to crystals partly composed of uranium. Could this radioactive property be concentrated further by extracting and purifying some, as yet unknown, component of the uranium crystals? Marie and Pierre Curie began laborious chemical analyses that led to the isolation of the element polonium named after Marie's native Poland. Continuing their work they isolated the element radium. To describe these elements' emission of energy they coined the word radio activity. As with x-rays popular hopes and fears for natural radioactivity far exceeded the actual applications. One 1905 headline captures it all. Radium has a substitute for gas, electricity and as a positive cure for every disease. Following initial enthusiasm that radiation could by destroying tumors provide a miracle cure for cancer. The reappearance of irradiated tumors led to discouragement. Despite distressing setbacks research into the medical uses of radiation persisted. In the 1920s French researchers performing experiments on animals discovered that radiation treatments administered in a series of fractionated doses instead of a single massive dose could eliminate tumors without causing permanent damage. With the new method of treatment doctors began to report impressive survival rates for patients with a variety of cancers. Fractionation became and remains an accepted approach to cancer treatment along with better understanding of radiation's benefits came a better practical appreciation of its dangers. Radiation burns were quickly apparent but the greater danger took longer to manifest itself. Doctors and researchers were frequently among the victims. Radiation researchers were also slow to take steps to protect themselves from the hidden danger. One journal opened its April 1914 issue by noting that we have to deplore once more the sacrifice of a radiologist the victim of his art. Clear and early evidence of tragic results sharpened both expert and public concern. By 1924 a New Jersey dentist noticed an unusual rate of deterioration of the jaw bone among local women. On further investigation he learned that all at one time had jobs painting a radium solution on to watch dials. Further studies revealed that as they painted they licked their brushes to maintain a sharp point. Doing so they absorbed radium into their bodies. The radium gradually revealed its presence in jaw deterioration, blood disease and eventually a painful disfiguring deterioration of the jaw. There was no question that radium was the culprit. The immediate outcome was a highly publicized crusade, investigation, lawsuits and payments to the victims. Despite the publicity surrounding the dial painters response to the danger remained agonizingly slow, patent medicines containing radium and radium therapies continued. The tragedy of the radium dial painters and similar cases of patients who took radium nostrums have provided basic data for protection standards for radioactive substances taken into the body. One prominent researcher in the new area of radiation safety was Robly Evans. Evans was drawn into the field by the highly publicized death in 1932 of Evan Byers following routine consumption of the nostrum radiothor. Byers death spurred Evans then a California Institute of Technology Physics graduate student to undertake research that led to a study of the effects on the body of ingesting radium. This study would continue for more than half a century. Evan's study and subsequent studies of the effects of radium treatments provided the anchor in human data for our understanding of the effects of radiation within the human body. As the dangers of the imprudent use of x-rays and internal radiation became clear, private scientific advisory committees sprang up to develop voluntary guidelines to promote safety among those working with radiation. When the government did enter the atomic age it often referred to the guidelines of these private committees as it developed as it developed radiation protection standards. The miracle of tracers. In 1913 the Hungarian chemist Georges von Hevesi began to experiment with the use of radioactive forms of elements, radioisotopes, to trace the behavior of the normal non-radioactive forms of a variety of elements. Ten years later Hevesi extended his chemical experiments to biology using a radioisotope of lead to trace the movement of lead from soil into bean plants. In 1943 Hevesi won the Nobel Prize for his work on the use of radioisotopes as tracers. Previously those seeking to understand life processes of an organism had to extract molecules and structures from dead cells or organisms and then study those molecules by arduous chemical procedures or use traceable chemicals that were foreign to the organism being studied but that mimicked normal body chemicals in some important way. Foreign chemicals could alter the very processes being measured and in any case were often as difficult to measure precisely as were normal body constituents. The radioactive tracer as our friend the atom a book written by Dr. Heinz Haber for Walt Disney Productions explained in 1956 to readers of all ages was an elegant alternative. Making a sample of material mildly radioactive is like putting a bell on a sheep. The shepherd traces the whole flock around by the sound of the bell. In the same way it is possible to keep tabs on tracer atoms with a geiger counter or any other radiation detector. By the late 1920s the tracer technique was being applied to humans in Boston by researchers using an injection of dissolved radon to measure the rate of blood circulation. An early example of using radio activity to observe life processes. However research opportunities were limited by the fact that some of the elements that are most important in living creatures do not possess naturally occurring radioactive isotopes. The answer to this problem came simultaneously at faculty clubs and seminars in Berkeley and Boston in the early 1930s. Medical researchers realized that the famed atom smasher the cyclotron invented by University of California physicist Ernest Lawrence could be used as a factory to create radio isotopes for medical research and treatment. Take an ordinary needle, our friend the atom explained, put it into an atomic reactor for a short while. Some of the ions contained in the steel will capture a neutron and be transformed into a radio isotope of iron. Now that needle could be found in the proverbial haystack without any trouble. In 1936 two of Lawrence's Berkeley colleagues, doctors Joseph Hamilton and Robert Stone, administered radio sodium to treat several leukemia patients. In 1937 Ernest Lawrence's brother, physician John Lawrence, became the first to use radio phosphorus for the treatment of leukemia. This application was extended the following year to the treatment of polycythemia vira, a blood disease. This method soon became a standard treatment for that disease. In 1938 Hamilton and Stone also began pioneering work in the use of cyclotron-produced neutrons for the treatment of cancer. The following year, not long before the war in Europe began, Ernest Lawrence unveiled a larger atom smasher to be used to create additional radio isotopes and hence dubbed the medical cyclotron. The discovery that some radio isotopes deposited selectively in different parts of the body, the thyroid for example, inspired a spirited search for a radioactive magic bullet that might treat or even cure cancer and other diseases. In Cambridge the age of nuclear medicine is said to have begun in November 1936 with a lunchtime seminar at Harvard at which MIT President Carl Compton talked on what physics can do for biology and medicine. Robby Evans, by that time at MIT, is reported to have helped prepare the portion of the talk from which medical researchers at the Massachusetts General Hospitals Thyroid Clinic came to realize that MIT's atom smasher could produce a great research tool for their work, radio isotopes. Soon doctors at the thyroid clinic began a series of experiments including some involving humans that would lead to the development of radio iodine as a standard tool for diagnosing and treating thyroid disease. In late 1938 the discovery of atomic fission in Germany prompted concern among physicists in England and the United States that Nazi Germany might be the first to harness the power of the atom as a propulsion method for submarines, as radioactive poison or most worrisome of all, as a bomb capable of unimagined destruction. In the United States a world famous physicist Albert Einstein and a recent emigrate from Hungary, Leo Zillard, alerted President Franklin D. Roosevelt to the military implications of the German discovery in an August 1939 letter. Assigning his own science advisor, Vannevar Bush, to the task of determining the feasibility of an atomic bomb, Roosevelt's simple okay, scrawled on a piece of paper, set in motion the chain of events that would lead to the largest and most expensive engineering project in history. Soon Ernest Lawrence's radiation laboratory and its medical cyclotron were mobilized to aid in the nationwide effort to build the world's first atomic bomb. In a related effort Dr. Stone and Hamilton and others would turn their talents to the medical research needed to ensure the safety of those working on the bomb. End of introduction part one.