ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + PUBLIC MEETING + + + + THURSDAY, APRIL 21, 1994 + + + + The committee met in Federal Hall, Ramada Plaza Hotel, Ten Thomas Circle, N.W., Washington, D.C. at 9:30 a.m., RUTH FADEN, Chair, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H., Chair KENNETH R. FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA A. KING, J.D. SUSAN E. LEDERER, Ph.D. RUTH MACKLIN, Ph.D. LOIS L. NORRIS NANCY L. OLEINICK, Ph.D. FRANK PRESS, Ph.D. HENRY D. ROYAL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. REED V. TUCKSON, M.D. STAFF: FAITH BULGER, J.D. DAN GUTTMAN, L.L.B. JOHN HARKNESS JEFFREY KAHN, Ph.D., M.P.H. STEPHEN KLAIDMAN ANNA MASTROIANNI, J.D. RON NEUMANN, M.D. JEREMY SUGARMAN, M.D., M.P.H., M.A. I-N-D-E-X AGENDA ITEM PAGE NUMBER Call to Order 3 Christine Varney, Deputy Assistant to the President and Secretary to the Cabinet Swearing in of the Committee 6 Welcome and Orientation to First 7 Meeting Ruth Faden, Chair Introductions: Committee Members and 12 Staff Briefing by Members of the Interagency 26 Working Group Committee Question and Answer Period 56 Moderator: Ruth Faden Initial Discussion of Committee Mission 66 Moderator: Ruth Faden Comments by Members of Congress 112 Continued Committee Discussion of 141 Mission Moderator: Ruth Faden Public Comment Period 185 Moderator: Ruth Faden P-R-O-C-E-E-D-I-N-G-S (9:29 a.m.) CALL TO ORDER MS. VARNEY: If everyone will take their seats, we'll start in about a minute, please. My name is Christine Varney. I'm the Deputy Assistant to the President and Secretary to the Cabinet. I'm the designated federal official for this first meeting of the independent Advisory Committee on Human Radiation Experiments. I hereby call the meeting to order. This Advisory Committee was established by the President by executive order on January 18th of this year. This expert panel of ethicists, medical doctors, research scientists, lawyers, and clinicians is appointed and charged by the President with a very important mission: to provide expert advice and information to the members of the President's Working Group on Radiation. Members of that working group, who will join us later, include Secretary Hazel O'Leary, Secretary Donna Shalala, Attorney General Janet Reno, Secretary Jesse Brown, NASA Administrator Dan Goldin, CIA Director James Woolsey, and OMB Director Leon Panetta. Shortly we will hear presentations from the members of the interagency group. The work of the committee is critically important to the President and to this administration. It is about being open and forthright and getting to the bottom of some troubling issues that the American people are rightly concerned about. On behalf of the administration, I would like to thank the members of the committee for agreeing to serve and commit so much time to this effort. It will not be easy, but it will certainly be worthwhile. The President has asked me as Secretary to the Cabinet to help coordinate the efforts of the Interagency Working Group. We have strived to be open and accommodating in this entire endeavor. The Interagency Group has conducted several congressional briefings and made every effort to accommodate the public interest in any experiments that were conducted. The Advisory Committee will operate under the Federal Advisory Committee Act, and its meetings will be open to the public, as they are today. According to the President's executive order, the committee should consider, among other things, whether there was a clear or medical, scientific purpose for the experiments, whether appropriate medical follow-up was conducted, and whether the experiments' design and administration adequately met scientific and ethical standards, including standards of informed consent. Other questions you should answer include "By what criteria should you judge these experiments?"; "Were wrongs committed?"; "Was harm done?"; and "How might the administration intervene to avoid further harm?" You are to review experiments from 1944 to 1974. You may also review experiments conducted after 1974 to determine if federal rules adopted that year adequately protect human subjects. We hope you will do this. The Advisory Committee is a free-standing, independent body. The Interagency Working Group will rely heavily on you, the committee, for expert advice on a wide range of issues. Speaking for the interagency group, I want to emphasize the importance we place on the independence and frankness of your work and advice. I am not a scientist, but I am familiar with the work of scientific advisory committees. This committee you should realize may be different from previous committees on which you have served. As you can see by some of the media here today, you will be observed closely. Congress will be very, very interested in your work. You will not just address scientific research issues, but a range of potentially far-reaching policy implications involving ethics and the history of science. You are an impressive and incredible group of experts. Dr. Ruth Faden has assembled a very professional staff. You have a difficult, but doable, important job ahead of you. And you have license to hold the government's feet to the fire. Thank you and good luck. The first order of business for this Advisory Committee is to be sworn in. Tim Sanders is the Deputy Executive Clerk at the White House, and Tim will do the honors. If you will all stand and face this way, Tim will administer your oath. MR. SANDERS: Good morning. I'm Tim Sanders. I'm the Deputy Clerk and a Notary Public for the District of Columbia. If you would all raise your right hands? I'm going to say "I." Please fill in your name. SWEARING IN OF THE COMMITTEE (Whereupon, the members of the Advisory Committee were duly sworn.) CHAIRPERSON FADEN: We are official. We've been waiting to be official for some time. We are now official. That comes with some relief. I want to take a minute to thank Christine and Phill Caplan both for their assistance in getting us started and launching us off. We hope we will do what they hope we will do. WELCOME AND ORIENTATION TO FIRST MEETING CHAIRPERSON FADEN: My name is Ruth Faden, and I want to extend a formal welcome to my fellow committee members and to our committee staff. I want to say personally that I'm honored to be given this responsibility and take quite seriously the public trust which we have been given to protect. I'm also personally very privileged to be chairing such a distinguished committee, and I am indebted to my colleagues for agreeing to go on this venture with me. What I'd like to do at this point is take a few minutes to orient you to the structure and flow of the meeting and how these relate to what I see as the objectives for our first meeting. It might be helpful for the committee members to consult your agendas as I run through this. This is my way of orienting us to what we're going to be doing to the next two days. I have at least five specific objectives for what we should accomplish in these next two days, and they're pretty straightforward and, by and large, procedural. An obvious objective for the first meeting is for the committee members and the staff to get to know each other to learn something about our respective interests and perspectives. To that end, our first stop on the agenda is the shop-worn but effective tradition of going around the table with brief introductions and histories. We'll get to that in just a minute. A second objective of the first meeting is for us to develop an understanding of the relationship of the committee to the administration and the agencies to whom we are advisory. Now, we have allotted two sessions on the agenda to that end, a meeting to which Christine has already alluded with the secretaries and directors of the agencies that comprise the Interagency Working Group this morning and a briefing tomorrow morning by other members of the working group as to the status of agency efforts with respect to document retrieval and data collection. That will happen tomorrow morning. A third objective of this meeting is to acquaint committee members with the interests of Congress in the issues we will be addressing. We will meet after lunch today with two members, Senator Glenn and Congressman Markey, on this topic. That will happen immediately after lunch. A fourth objective of this meeting is for the committee to begin the critical task of defining and refining our mission. This is the task of making the mission that we have been given our own mission. We have to own it. We have to come to articulate it in its specifics. We're going to begin that key discussion this morning, continue it this afternoon, and no doubt continue it for many meetings to come. We will at least begin that process later this morning. A fifth objective of the committee meeting for today and tomorrow is to begin the equally important task of figuring out how we're to operate, how are we going to function in light of both committee restraints and committee resources. To that end, we'll tomorrow have an orientation by Dan Guttman, who is the Executive Director-designate of our staff, as to the structure and organization of the staff, which is, I believe, our greatest resources, as well as a presentation by Kathleen Whalen. And that will also happen tomorrow. She is Assistant Counsel to the President. She will brief us concerning conflict of interest constraints on our deliberations and functioning so we can understand how issues of conflict of interest potentially can affect our deliberations. We will also devote all of tomorrow afternoon to an initial discussion of at least three specific operational questions. We have to get going on these three practical points. We first have to decide about the frequency of our meetings, how often do we want to meet. We have to begin a discussion in the event about the use of subcommittees. Do we want to use them? How would we like to form them? Who would like to be on which ones? And also we need some way of prioritizing our efforts. We have a tremendous task to do in a very defined period of time. We cannot possibly do everything that conceivably could fall under our charge and do it well. So we need some way of developing a principal basis for determining where we're going to direct our attention. We can begin that discussion, I hope, tomorrow afternoon and then continue it in our second meeting. Now, that's it for the orientation to what's going to happen over the next two days and what I hope we can accomplish during that space of time except to point out that this meeting, as at all of our meetings, there is time reserved for the public to comment. This is an essential element of our progress and a key to our success. The time we have established for public comment in this meeting is this afternoon. Now, with that by way of backdrop, we need to go around the room and do the perennial sort of "I am" and "who I am" and "why I'm here" stuff. If you could keep it brief, it would be helpful. We are awaiting the Secretaries, who are going to amass outside that door. At some point I'm going to get a signal that all of the Secretaries are here. When they are all here, no matter where we are in the table in terms of going around, we'll stop. So my apologies in advance if we've just gotten to you and you want to tell us your life story and we have to stop. We have to stop because the Secretaries are here and they have only a small amount of time. And then we will pick up with our going around the table when the Secretaries leave us. If it turns out that we go around the table and the Secretaries are still not here, we'll figure out what to do. INTRODUCTIONS: COMMITTEE MEMBERS AND STAFF CHAIRPERSON FADEN: Let me start. My name is Ruth Faden. I am a Professor of Health Policy at the School of Public Health at Johns Hopkins and also what's called a senior research scholar, although we don't exactly know what that means, at the Kennedy Institute of Ethics at Georgetown University. I direct a program in law, ethics and health which is at the School of Public Health at Johns Hopkins, but it is also collaborative with Georgetown University Public Law Center and with the Kennedy Institute at Georgetown. My original training was not in biomedical ethics, but that belies my age. There was no place to get trained in biomedical ethics when I was a graduate student. My organization training is actually in social psychology. I do do research involving human subjects and continue to do research involving human subjects in my work in bioethics. Most of that work is observational in design and involves interviews, but, nevertheless, I have some familiarity with human subjects issues. I have been on an IRB almost my whole adult life and have chaired one of Hopkins' IRBs for five years, until recently. I think that gives enough of a background to explain why I'm interested in the work of the committee. Which way shall we go? Is there a protocol? Ruth, do you want to pick up? DR. MACKLIN: I'm another Ruth, Ruth Macklin. I'm a Professor of Bioethics at the Albert Einstein College of Medicine in the Bronx, New York. My original background or education was in philosophy, and I entered the field of biomedical ethics virtually at its inception in the late 1960s and early 1970s. I've served on my own institution's IRB since I came there full-time in 1980. And although I do not conduct research myself involving human subjects, I'm acquainted with the field, sit on an international body at the World Health Organization that reviews the ethical and scientific aspects of WHO-sponsored research throughout the world. And I've published and written and studied on human experimentation and research for all of my professional life. DR. FEINBERG: My name is Ken Feinberg. I'm an attorney here in Washington, D.C. I'm a former member of the Presidential Commission on Catastrophic Nuclear Accidents and have been the court-appointed special master who fashioned the criteria for eligibility in the Agent Orange products liability litigation. And I was also the court-appointed special master who fashioned the settlement of the Shoreham Nuclear Plant litigation in Long Island, New York. I am currently a practicing attorney and an adjunct Professor of Law at Georgetown Law School. DR. TUCKSON: My name is Reed Tuckson. I am an internist who is now President of the Charles Drew University of Medicine and Science in Los Angeles, California. Prior to that I was Senior Vice President of the March of Dimes, where I was, among other things, responsible for overseeing the research agenda for the March of Dimes Birth Defects Foundation, which gives me some interest in some of these matters. Before that I was the Commissioner of Public Health for the nation's capital, for this great city, for four years. I also have been interested in issues of consent and some of these matters when I ran the Mental Retardation, Developmental Disabilities Administration in this city for a number of years as well. And I've had an interest for the last five years in issues of nuclear testing and environmental issues concerned with radiation. Thank you. DR. LEDERER: I'm Susan Lederer. I'm Associate Professor of Humanities at the Pennsylvania State University College of Medicine. My training is in history of science and medicine, and my research has focused on the history of the use of humans and animals in medical experimentation in the United States. I have a special interest in the use of children as research subjects and the use of military personnel as research subjects. DR. THOMAS: My name is Duncan Thomas. I'm a Professor at the University of Southern California in the Department of Preventive Medicine. My background is in epidemiology and biostatistics. I first became interested in radiation epidemiology in the late 1970s, when I undertook a report for the Atomic Energy Control Board of Canada, when I was then at McGill University. Subsequent to that I've been involved in the studies of cancer and thyroid disease in the people downwind of the Nevada nuclear test site, was a member of the National Academy's BIER V Committee, which periodically reviews radiation risk assessment, and I've been co-investigator or consultant on a variety of other studies involving ionizing radiation. My main interests professionally are in the area of statistical methods development and their application in epidemiology. Thank you. MS. NORRIS: My name is Lois Norris. I am the public representative on this Advisory Committee, having served for the past nine-plus years on the University of Nebraska Institutional Review Board for the Protection of Human Research Subjects. DR. GLATSTEIN: My name is Eli Glatstein. I'm a Professor and Chairman of Radiation Oncology at the University of Texas, Southwestern Medical School in Dallas. And for 15 years before that, I was the Chief of the Radiation Oncology Branch of the National Cancer Institute. MR. GUTTMAN: My name is Dan Guttman. I'm not a committee member, Executive Director-designate. When I was in law school, I looked around and said "What do you do if you want to do real things?" and thought I'd study non-lawyers. I came to Washington to write a Ralph Nader-sponsored book on the government's use of expertise. And since then I have been interested in this whole question of expertise in the service of not only the profession but the government, worked subsequently for the Senate looking at the way in which the government uses expertise. In my private life as someone who tries to make a living, I have been privileged to represent public agencies, workers, and consumers most recently in the nuclear weapons complex context, the workers at the nuclear weapons complex. CHAIRPERSON FADEN: You need to pass the mike along. DR. NEUMANN: My name is Ron Neumann. I'm a physician, currently Chief of Nuclear Medicine at the National Institutes of Health. I'm also Professor of Clinical Nuclear Medicine at the George Washington University School of Medicine. I have had considerable experience as a member of both IRBs at the NIH as well as my university appointment at Yale University School of Medicine in the past and have been a member and chairperson of radiation safety committees in those capacities as well. I'm acting as a consultant to the committee at present. MS. BULGER: My name is Faith Bulger. And I am an environmental lawyer. I'm licensed in D.C. and in Texas. I have practiced, private practice, for three years in Houston, Texas. And I am a consultant to the committee staff right now. MR. HARKNESS: My name is John Harkness, and I am Managing Editor of a journal called "ISIS," which is the journal of the History of Science Society, and at Cornell University. I am currently completing a dissertation for a doctoral degree from the University of Wisconsin. And that dissertation deals with the history of use of prisoners as subjects in medical experimentation. So that's what brings me here. I am a staff-designate. DR. SUGARMAN: I am Jeremy Sugarman. I'm a practicing internist and Assistant Professor of Medicine at Duke University Medical Center and co-director of the program in medical ethics there. I have formal training in public health as well as in medical ethics and am a staff committee-designate. MR. KLAIDMAN: I am Steve Klaidman, another designate. I've spent 23 years in daily journalism, most of it print, as an editorial writer, a columnist, a reporter, and an editor, the New York Times, the Washington Post, and the International Herald Tribune. The last 12 years I've been a fellow at the Kennedy Institute of Ethics and also at the Institute for Health Policy Analysis at Georgetown. And I've written a book called Health in the Headlines, which deals with how the press covers complex scientific issues. And two of the chapters are radiation-related. DR. KAHN: My name is Jeffrey Kahn. I'm Acting Staff Director-designate to the committee. In addition, I'm Assistant Professor of Bioethics and Associate Director for Graduate Studies at the Bioethics Center at the Medical College of Wisconsin in Milwaukee. I'm trained as a bioethicist and also have a public health background. MS. KING: My name is Patricia King. I'm a Professor of Law at Georgetown University Law Center. I have worked with human subjects in research issues for many years. I was as member of the National Commission for the Protection of Human Subjects, the President's Commission on Biomedical Research. I am currently also involved in the formulation of policy for research on embryos, which is currently taking place at NIH. And, in addition, I have managed to do my stint on IRBs, like other members of the committee. DR. ROYAL: My name is Henry Royal. I'm an internist and nuclear medicine physician. I'm a Professor of Radiology at Washington University School of Medicine in St. Louis. I've had a long interest in the health effects of radiation, had the opportunity to serve as the co-leader of the health effects team for the international Chernobyl project, which was sponsored by the IAEA. I also serve on a number of scientific committees of both the National Academy of Sciences and the National Council for Radiation Protection and Measurement. MS. MASTROIANNI: My name is Anna Mastroianni. I am a Director of Committee Affairs-designate for the committee. I am a health care lawyer by training. I just recently completed a -- I was a Study Director at the Institute of Medicine directing a study on the legal and ethical issues related to the inclusion of women in clinical studies. DR. PRESS: My name is Frank Press. I'm currently at the Carnegie Institution of Washington as a senior fellow. Before that I served as President of the National Academy of Sciences for 12 years. Before that I was Science Adviser to President Carter. And before that I taught at Columbia University, Cal Tech, and M.I.T. With so many Yale people here, I can't help but add that I have the best of all possible training, a Yale degree and a City College education. (Laughter.) DR. STEVENSON: My name is Mary Ann Stevenson. I'm an Assistant Professor of Radiation Oncology at the Joint Center for Radiation Therapy, Harvard Medical School. I've been involved with basic science research with ionizing radiation since 1976, beginning in the Division of Radiation Biology at Stanford University. I subsequently went on and got my M.D. and Ph.D. in cancer biology at Stanford and upon completing specialty training at Harvard in radiation oncology joined the faculty there. I spend a significant amount of my time doing basic science research on the effects of ionizing radiation at a cellular, biochemical, and molecular level and particularly the effects of ionizing radiation on signal transduction cascades and de-inactivation. DR. KATZ: I'm Jay Katz. I'm the Elizabeth Dollard Professor Emeritus of Law, Medicine, and Psychiatry at Yale Law School, another Yalee, but I did have the good fortune of having undergraduate medical education at Harvard. And I've been interested in human experimentation for almost 30 years. I began teaching probably the first semester-long course on the regulation of human experimentation in 1965 and then published the first case book on human experimentation in 1972. I was on the Tuskegee syphilis study advisory committee that ultimately or very quickly recommended the termination of the Tuskegee syphilis study. And I think it's a great privilege 20 years later in a different climate to return to Washington once again and take another look at human experimentation. DR. OLEINICK: I am Nancy Oleinick. I am a Professor of Radiology, Biochemistry, Oncology, and Environmental Health Sciences at Case Western Reserve University in Cleveland. My training is in biochemistry, but I have been working in radiation biology since 1969. Most of my work in the laboratory has to do with cellular and molecular effects of ionizing radiation, but I have certainly broadened my experience on a variety of different committees and at present am serving on one of the Boards of Scientific Councilors at the National Cancer Institute as well as other committees. I have served on my department's IRB. And I have a very great interest in the effects of radiation on humans. And I am delighted to join the committee. CHAIRPERSON FADEN: I thank everybody. You can see why I said in my initial remarks why I said how privileged I am to be chairing such a distinguished committee. It's like an embarrassment of riches. It is wonderful that we have this collection of expertise and experience and wisdom on the committee, and we are assembling a terrific staff-designate situation as well. The term is because our staff is in process. And so we cannot refer to them as the staffed staff until the papers are through. This is truly an overwhelming experience for me to have an opportunity to work with so many wonderful and talented people. There is one person in the category of wonderful and talented people who isn't here with us this morning who needs to be acknowledged, and that is Dr. Tara O'Toole, who will be with us. She is here? Is Tara here? Tara, did you step out? Step back in. Tara, I was just introducing a wonderful and talented person who was very instrumental in getting this committee in place and having all of us here today, and that's you. So we want to express our appreciation to you and to your wonderful leadership within the administration together with Christine in getting this committee to the place that it is today. We have one committee member who is not with us, who is another person who needs to be acknowledged, who is Phil Russell, who is a colleague of mine, actually, at this point in his career at the School of Public Health at Johns Hopkins, but in his previous incarnation has a very distinguished career in military medicine and will be able to add to our committee the perspective of the experience in physicians in that important component of our work. We are facing dead time now. The Secretaries are not here yet. We could start business, but we expect them any minute. So I am going to suggest not really a break, but a little stretch for five minutes will fill the time. And we need to clear the chairs right here anyway so that we can have a view of the Secretaries as we speak with them. So maybe we can just take a few minutes to rearrange the room. But don't go anyplace because we expect them shortly. (Whereupon, the foregoing matter went off the record at 9:57 a.m. and went back on the record at 10:14 a.m.) CHAIRPERSON FADEN: We're waiting for just one more person to come. So it's not an intentional moment of silence. We're not up to that point yet. We may be invoking all assistance later as our work gets more complicated, but right now we're just waiting for one more Secretary. And then we will begin. (Whereupon, the foregoing matter went off the record at 10:16 a.m. and went back on the record at 10:17 a.m.) MS. VARNEY: This morning we have asked the principals of the President's Working Group on Radiation to join us to brief the committee on their work thus far. We will hear this morning from: Secretary Hazel O'Leary, Department of Energy; Secretary Donna Shalala, Department of Health and Human Services; Attorney General Janet Reno, Department of Justice; Secretary Jesse Brown, Department of Veterans Affairs; Under Secretary of Defense John Deutch; -- Secretary of Defense Perry is in Korea this morning -- Deputy Director of the CIA, Admiral William Studeman; and NASA Administrator Dan Goldin. Secretary O'Leary, would you like to start this morning? Good morning. BRIEFING BY MEMBERS OF THE INTERAGENCY WORKING GROUP MS. O'LEARY: I certainly would. First of all, to the people behind me, thank you so much for being here. Now to the President's Advisory Committee Task Group on Human Radiation Experimentation, thank you so very much for agreeing to serve. I fought and talked with Tara a great deal about this day and this morning because in so many ways, I believe I owe each of you so much personally. Tara and Dr. Faden I think have a clear idea about what we're asking you to do, and that's to give more of your time and more of your energy than you can imagine. I think if you will bear with me and allow me to get very personal, I can tell you why I believe this is the case. As I sat down next to my colleague Donna Shalala, she said "It's all your fault." (Laughter.) MS. O'LEARY: I'm guilty. I plead guilty. But I need to put that in context and hopefully take you where we must all go. In my job, it's turned out for the past year I expect once a week someone to open the door to my office and say "Secretary O'Leary, you're not going to believe this." And in late November, that happened to me. That was the first I heard of the series of stories being written in the Albuquerque Tribune regarding the 18 American citizens who were subject to human experimentation with plutonium. The question was "They're going to ask you if the Department of Energy will release information regarding these experiments. And you must decide what to do." I was scheduled to take an exercise class. So I said, "Well, let me think about this for an hour, and we'll come back. Let's discuss it. Get everyone in the room who needs to talk about this." So for an hour I pounded on a step if you know the step Reebok piece, trying to get that heart rate up. And I did what I often do when the call is tough. I went back to a set of principles, some that I've grown up with and some that I've managed to gather around me in my lifetime. I also thought about the numbers of people I had already met living nearby the Department of Energy's facilities who had no trust in us, no trust in our science, no trust in our word, but for whom much would be asked. I also thought about the fact that as a department, we were committed to declassify information to share details, specifically having to do with the health and the projection of the health of the people who had lived nearby our sites now for 50 years. Against that context and that background did I determine what I believed it was necessary to do. And that was to clearly agree to provide the information that was being sought. Now, to my colleague Janet Reno, I had some good idea about what I was going to do to her life because I was also very well-aware of the Federal Torts Claim Act and how difficult it was to lift human beings over the hurdles that, quite frankly, protect the American citizen in most instances quite correctly, from lawsuits against its treasury. But in this regard, I was thinking about real people with needs and anguish and some sense not in the case of the 18 people who were the subject of the plutonium experiments, but the thousands of people I had already met who had no faith in their government because we never heard them. We never accorded their concerns any credence. And their government seemed to be callous and uncaring and, worse than that, not worthy of trust. That's the background. I now must compliment the one colleague that I know, and that's Dr. Ruth Faden, for early on she was the person who provided the advice that guided us in the Department of Energy through this piece that has led our administration to the place I believe we need to be. She reaffirmed and pointed me to the ethical grounding that made the decision to open the records and consider all the tough questions regarding the lawsuits, which have to come. We know they've already come. My name is now being mentioned by Melvin Belli. I read about him when I was in law school. Some people say that I reacted in my gut. I did not react in my gut. I reacted in a sense of who and what I thought the government ought to be to citizens and with a clear sense of the challenge that lies ahead of us as a nation requires that the public understand that public servants do that. They serve, and they honor our people. Having done that, I also have created a furor and a storm that I did not expect, which causes people now to challenge the very institutions that we honor, especially science and technology and scientists. You're called upon to help us put that right. The President widely sought to expand this examination to include every governmental agency involved. And now the hard part falls to you. From the very beginning, we were clear that someone had to stand between the government, untrusted on these issues, and the American public. It's that role that you are asked to serve. These are tough issues. And I know you know it because you had to have contemplated your service very carefully. Here are the questions you have to answer for us, and I thank you in advance. What's the whole story about the government's involvement in the human radiation experiments? Were some or all of those experiments ethical? Were participants appropriately informed? Were people harmed? Did they know that they were experimental subjects? Were vulnerable populations selectively chosen as subjects? Might we now somehow help the subjects who are still alive or prevent harm to their descendants? How do we deal fairly with the scientists who were involved in these experiments which now are the subject of intense and sometimes, almost often, sensational media scrutiny? How can we possibly examine the failings of these experiments without damaging the best scientific research establishments in the world and establishments which have brought so many people real benefit? I often tell a story in my own life that touches me very deeply. And I'll speak to it just briefly. My husband was a victim of cancer, and he and I were convinced before his death that experimentation with radiation gave him high quality four years of his life. So I know well the value of nuclear medicine for both treatment and diagnostic work. The press does not focus on that. We need you to help us do that. What might we learn from the review of these issues that will guide us in the future and, most importantly, help us ensure that the right systems are in place. And we're speaking to the American public so they can be certain that this thing can never happen again, the fact nor the sensationalism around the fact. We need you. We need your intellect, your integrity, and all of the interpersonal skills you each muster. I know for the pressure has been on me and on our President and on Christine to pressure you to do things faster than reason would require and to present product that not only makes good sense as I know it will do for you will be involved in drafting it, but which is understandable to a broad population of the American public, who now is aware of these issues and must have the answers that you derive. We selected you because you are imminent in your fields, each and every one of you. And I know that each of you is pulled in a million directions. And to serve now and to serve well with the care that you have determined that you can serve requires very much of you. I know one of you has traveled here with your infant daughter. Who is that? CHAIRPERSON FADEN: Infant son. MS. O'LEARY: Yes. Thank you. I know that while you come trying so hard to balance your life, that we are going to ask more of you and your child than you could even imagine. And in so doing, we put great faith in you. I would remind you of this one piece. We're teetering on the edge of an opportunity to build trust with a nation who has lost trust, not really on this issue, but on so many issues. So I am personally grateful to you, but not for one minute do I apologize for having stirred this up because I believe it's very important to answer the questions which have been lingering in the dark corners of the psyches of so many of our citizens. I especially today think about those public pleas from the citizens of Hanford and Washington, citizens living nearby Oak Ridge, our own workers in plants who have come to us and said "You must answer these questions for us." This is tough work. And I honor you for doing it and also to Dr. Faden and each of you pledge whatever we can do to support this effort. We have worked very hard to pull together an excellent staff for you. And if offering Dr. Tara O'Toole, the Assistant Secretary for Environment, Health, and Safety, who is truly the person whom I follow, I believe we have given you the very best that we have to support this effort. And I'm very personally grateful to you. Thank you so much. CHAIRPERSON FADEN: Thank you so much, Secretary O'Leary. We I'm sure have members of the committee who would like to say something to you and ask some questions, but we're going to ask that we hold the questions until we hear from all of our distinguished guests. Secretary Shalala? DR. SHALALA: Thank you very much. I first should start by indicating my admiration and my respect to my colleague Secretary O'Leary for her leadership on this issue and for laying out, I think very eloquently, what the stakes are because the stakes are not simply whether we're going to get to the bottom of hundreds of research projects done during a long period of time, but the stakes are very much the integrity of government and the integrity of American science, whether the people of this country continue to have faith in those leaders that must be accountable in these areas. And as many of us have traveled the country trying to sell health care, for example, the one thing that we have noted is that Americans are not as high on what goes on in Washington, often for good reason, over a long period of time in restoring Americans' faith in what goes on in Washington. And the leadership of professionals, both in science and government, is extremely important, but, more importantly, a sense of openness and a sense of willingness. I came today to make certain that the committee knows we take this very seriously. The President of the United States certainly does or he would not have trotted out the leaders of his cabinet or, more importantly, appointed the most talented of his own assistants, Christine Varney, to represent the White House in this effort. On January 27th, I told all the agencies and offices of the Department of Health and Human Services to search for all the records of human experiments which involved ionizing radiation between 1944 and 1974. As most of you know, HHS is the largest supporter of biomedical research in the world. In fact, this year the NIH budget will be about $11 billion. In addition, the other public health agencies, including the CDC, the Food and Drug Administration, and the Indian Health Service, also support important research activities. For example, just to give you a feel for how extensive our efforts are, at the NIH Clinical Center alone, there are over $1 billion pages of medical records. This represents only a fraction of the research which is supported by the National Institutes of Health. Over 80 percent of the research at NIH is conducted at research institutions across the country. So I have also written to 27,000 research institutions across the country, colleges and universities which expand the challenge faced with my department as we looked at the entire biomedical research enterprise. And, as all of you know, research is conducted at many sites in this country. The most difficult cases are most likely to be from the earlier years that you're considering. Unfortunately, this predates in the information highway, and we're working with paper records. As I indicated to Dr. Faden, we've had to do hand searches. And there is, of course, inadequate detail in the records. For example, the National Institutes of Health has supported thousands of research projects involving radiation, but the titles and the abstracts may not tell us whether it's research on human subjects or research on insects because titles and abstracts don't necessarily mention whether it's been research on human subjects. We have in the department appointed Dr. D. A. Henderson, one of the great leaders on public health in this country, to lead our effort, which is an indication of our seriousness. And he is to be assisted by Dr. Wendy Baldwin from the National Institutes of Health. So we have put our heavy hitters into leading the effort. They report directly to me on this effort, and I have already met with both of them on a number of occasions. They're going to coordinate the search effort, and they'll provide you with the details of HHS activities tomorrow. As we examine the records of human experiments involving radiation, we will need you to tell us what to focus on. I'm trying to give you a sense of the volume of what we need to look at. For example, Secretary O'Leary has indicated that we do need to focus on certain types of experiments, perhaps experiments involving vulnerable populations, such as children or the mentally retarded or prisoners or experiments in which doses of radiation seem unusually high. In doing so, we may want to focus on the worst cases, but we have to be careful of that because we don't want to give the impression that radiation is in general bad. As Secretary O'Leary indicated, we are obviously firmly committed to uncovering inappropriate behavior, but we also want to temper this by our appreciation for the very real contributions scientifically and ethically that sound research has made in this country. In doing all of that, we may, in fact, educate the American public on the importance of some of the good things that happened, but without giving up or in any way signaling a lack of firmness or commitment uncovering what is clearly inappropriate behavior and inappropriate research during any decade. There is a range of diseases in this country that have been helped by radiation research. In fact, I would guess that three-fourths of all the research at the National Institutes of Health is performed using radiation and radioactive materials. And that research, of course, has consistently produced results which have improved the health of the American people. You're also going to be considering important ethical questions. And there are a number of the nation's leading experts on ethics on this panel, which is enormously helpful to all of us. And, as all of you know, the system of ethical guidelines has to protect the subjects of research has been evolved over time and continues to evolve. The first federal policy for the protection of human subjects was implemented, actually, in 1953 at the NIH Clinical Center. In 1974 the department issued regulations for the protection of human subjects. These regulations, which incorporated a set of principles on respect, benefice, and justice, as set forth by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, they established an institutional review board. And they have been upgraded and changed over the years. My assumption is that out of these deliberations may come recommendations that will strengthen the guidelines not only for the National Institutes of Health, but for biomedical research in general. We will be available. You will have access to us, Dr. Faden, during the course of your deliberations. CHAIRPERSON FADEN: Thank you. DR. SHALALA: I offer you a department that in the best tradition of science will be as open and as firm in our commitment to your deliberations as we can be on any subject. I also offer to you our enthusiasm on doing anything we can to strengthen existing procedures and rules and, frankly, to educate the American public in science it self about the future. Thank you. CHAIRPERSON FADEN: Thank you very much. Attorney General Reno? Thank you. I was asked to remind people to pass the mike. You're ahead of me. MS. RENO: I'm pleased to join my colleagues from the Human Radiation Interagency Working Group at this first meeting of the Advisory Committee. I, too, want to echo Secretary Shalala's commendation of Secretary O'Leary. I remember the phone call I got from her. As I told her then and as I say now, we want to do everything we can to work with the other agencies to address the legal issues that are involved and to do it the right way. You bring such a wealth of expertise in medicine, science, and ethics to this critical issue and to the administration's investigation of the nature and scope of this problem. Your determination of the ethical and scientific standards and criteria by which to judge the experiments and their advice and counsel concerning the propriety of the experiments will shape this administration's response to the subjects. And I am deeply grateful for your willingness to undertake this effort. The history of the government's conduct and sponsorship of human radiation experiments is one that has too long been shrouded in secrecy and inattention. Consistent with the principles of openness in government that have been spelled out by the department and by the administration, the Human Radiation Interagency Working Group is dedicated to conducting a thorough investigation and making records of the experiments available to the public. All records of the experiments are being reviewed for national security classification and declassified as soon as practicable and to the maximum extent possible. Working together, the federal departments and agencies engaged in this effort have already taken steps to locate and inventory experiment records for submission to your committee. With the guidance of the committee, the working group will take steps to notify and make records available to persons who were subjected to experiments and to members of their families. Copies of the record with redactions required for the protection of personal privacy interests of the individuals subjected to experimentation will be made available to the public. In support of the administration's search for all records of human radiation experiments, the Department of Justice directed its components to search for any records of possible department conduct or sponsorship of such experiments. In particular, because of public reports reflecting that prisoners at several state correctional institutions had been subjects of human radiation experiments, we specifically expressly directed the Bureau of Prisons to conduct research concerning whether federal inmates had ever been involved in radiation experiments. Following both formal record searches and contacts with former Bureau of Prison officials, including its former medical directors, no records had been found of Bureau of Prison inmates ever having been involved in human radiation experiments. The department shares the administration's commitment to conduct an open and thorough inquiry to develop an appropriate response to those citizens subjected to the experiments, to their families, and to the American people. We have participated in the work of the Human Radiation Interagency Working Group to assist and offer counsel to our colleagues in the spirit of the administration's commitment to make the public the greatest amount of information available at the earliest possible time while mindful of the personal privacy of those involved in the experiments and their families. We look forward to working with the Advisory Committed and our colleagues to ensure that a thorough record is developed concerning the purposes for the experiments and the manner in which they were conducted and in making recommendations to the President and the Congress regarding an appropriate framework for the administration's response to the subjects of human radiation experiments in the future of any such experiments involving human subjects. We look forward to working with you in every way possible and supporting your effort in every way possible. CHAIRPERSON FADEN: Thank you very much. Thank you. Secretary Brown? MR. BROWN: Thank you very much, Madam Chair. I, too, would like to take advantage of this forum to publicly thank Secretary O'Leary for standing up for what is morally correct. I personally believe that we as a nation can be the best that we can be by taking advantage of our greatest resource, and that is our people. We cannot as a nation condone unacceptable conduct involving experimentation with mustard gas, LSD, syphilis. I just finished reading a book called Black Blood [sic]. I was outraged. I think that what we're doing here, at least this administration, in my view, is moving in the right direction by coming public. That's the only way that the public can protect itself, by knowing exactly what types of behavior and what is going on in its institutions. When I heard that questions had been raised about VA's use of radiation in medical research, I promised a full and complete investigation. I have kept my promise. We are investigating. We have learned a great deal so far, but there is much more that we need to know. It is not surprising nor is it wrong that VA is involved in the field of nuclear medicine. Many of the earliest uses of atomic materials for medical diagnosis and treatment were developed in VA hospitals. Modern medicine has clearly benefitted from what VA researchers have done, but we must now have a full accounting of any radiation research done at VA hospitals. I have asked for a full review of our records. So far we have found 137 VA medical centers have nuclear medicine services. Forty-nine medical centers have found some research protocols which were used between 1947 and 1980. Twenty-four have the names of patients who participated in some of VA's research. And 54 have copies of articles that were published as a result of VA research. We do not know if all of the studies that we have uncovered met the highest ethical and scientific standard, but I do want you to know that we will find out. We know that some standards have been in place since 1947 to review research activities in this area, but we also know that in the 1940s VA established an Atomic Medicine Division, which was kept confidential. No one has yet told me what this division did or why it was necessary to keep it a secret. However, I want you to know that we are working very, very hard to find an answer to this question. We do not know if we have ever violated the trust of any of our veterans or asked any veteran to take part in research that he or she did not fully understand, but we will find out. Madam Chair, I pledge to work with you and your committee in evaluating the information that we uncover, and I pledge to assist your committee in any independent investigation you may undertake. Some may say that applying today's standards of ethics and morality to a bygone era is an inappropriate second-guessing of decades-old actions. I disagree. We owe the bright light of truth to the individuals and families who may have been adversely affected. We owe them proper redress for any harm that may have been caused. And we owe to those who hold the public's trust the lessons of history. This can only be achieved by full public disclosure. And full public disclosure we will have. This concludes my statement. Thank you. CHAIRPERSON FADEN: Thank you. Thank you very much. Deputy Secretary Deutch? MR. DEUTCH: Thank you, Madam Chairman, members of the committee. I would like to join my colleagues in paying tribute to Hazel O'Leary for having raised this important question. I also would like to join in acknowledging the role that Christine Varney has played in this. You have in front of you today something which is moderately unusual in the government. You don't have a series of individual departments reporting to you on separate activities. What you have is the result of an interagency group which has thought carefully about a way of examining this issue, collecting data, and presenting it to you. So you are today, in fact, hearing from an interagency group, not individual agencies. And in large measure, that success of that effort is due to Christine Varney. I also want to note that I join with others about the importance of the task you're embarked upon. This is an issue of openness. I'm a scientist myself. I think it is extremely important what you embarked upon. We have here an issue about the credibility of science. Certainly it's an issue about the credibility of science in the past, but it affects the public's perception of how science and scientists operate in our community for the benefit of our citizens. You are being asked to assess what were past excesses, evaluate the present circumstances, and I hope will show a way for the people of this country through the openness of this administration, show a way for how science can be used for the benefit of our people. Our agency established in January of 1994 under Secretary Les Aspin a steering committee appointing two of our senior individuals, Harold Smith and Gordon Soper, to carry out a full investigation of activities that have been underway in the department in this area. Let me briefly summarize. Their task was to identify, locate, and abstract all available records and information regarding ionizing radiation research with human subjects in the past carried out by the Department of Defense. In our own orderly way, we established a radiation experiment center to collect and collate and analyze that data. And all of that data will be available to this committee for its study and evaluation. Let me briefly say that we have identified up until now about 1,749 different experiments which involved radiation in human subjects. Of these, no more than 10 are not evidently clinical treatment and I think will deserve the scrutiny of this group. And, of course, you will want to examine all extent of that information, and it will be made available to you without any barriers whatsoever, classification or otherwise. The final point I would like to make is that we are very certain in the Department of Defense that since the mid '70s we have had research practices in place in all of our facilities, research facilities and hospitals, which compare favorably to the research practices that are in place in any institution in the country and that we think it is also important that you evaluate the present research practices so as to confirm for us, for us as officials of the department, for the administration, that we are indeed today set on a correct course for having science work for the people of this country. Thank you very much, Madam Chairman. CHAIRPERSON FADEN: Thank you very much. Admiral Studeman? MR. STUDEMAN: Madam Chairman, it's a pleasure for me to be here today. I apologize in the name of Jim Woolsey that he can't be here. He started his day and will end his day up on the Hill talking about budget and counterintelligence and security matters. I am his humble representative. I would like to also again pay tribute to the openness with which this subject is being addressed. I think it's also fair to say that the intelligence community is also trying to contribute to openness and demystification of our business as well. So it's a challenge for all of us. After three months of intensive searching, we have found no evidence, no evidence, that the CIA has conducted or sponsored human experiments involving ionizing radiation. Let me put that in context. To understand how the CIA structured its record search is first to understand how CIA is organized. There are four principal directorates. Each directorate is divided into groups, offices, and divisions. Some of these elements are located in the United States, and others are located around the world. The Director of Central Intelligence appointed a working group to coordinate the search of relevant records. Officials responsible for records management in the four directorates are members of the working group together with representatives from offices that deal with congressional, legal, public, or historical issues. The working group has met weekly in person or via conference calls since January of this year. Initial attention was focused on files of the Rockefeller Commission and the Church Committee, which in 1975 and 1976, respectively, investigated the M. K. Ultra program. Let me just read to you based on an IG document we have that goes back to 1963 the authorizing area of exploration for the project M. K. Ultra. The project was to explore additional avenues to the control of human behavior, including radiation, electroshock, various fields of psychology, psychiatry, sociology and anthropology, graphology, harassment substances, and paramilitary devices and materials. This M. K. Ultra program has been, of course, thoroughly documented and investigated by all of these groups: CIA, IG, as well as the Rockefeller Commission and the Church Committee. The term "radiation" clearly appears in the commissioning document. An exhaustive record search as well as conversations with more than 30 retired officers formerly associated with the M. K. Ultra program failed to locate evidence of any radiation experiments. So subsequent attention has turned to records, then, in all the directorates concerning experimentation of every possible description. To date nothing relevant has been found, but the search continues. CHAIRPERSON FADEN: Thank you very much. Administrator Goldin? MR. GOLDIN: Thank you, Madam Chair. I, too, would like to express the same views as my colleagues in thanking Secretary O'Leary, thanking the President for empowering us to do the right thing, and thanking Christine Varney for setting up a wonderful process because it's the process that's going to get us there, thanking the members of the commission for being part of this. NASA is really in support of the openness. And as I was thinking about what I might say, openness is important because that's what our society should be about. And if you think about the death of this young man Kurt Cobain and the negativism he expressed in his future, I think this is going to help our young people have hope that our generation is willing to deal openly with issues that are very, very painful. With that in mind, NASA is continuing its review of human radiation experiments involving agency investigators and funding. We are committed to a thorough painstaking search of NASA records and openness about our findings. We plan to leave no stone unturned. Our investigative team is going through the federal record center's databases and contacting current and retired investigators, research managers and program managers at NASA headquarters and field centers who would have had knowledge about previous radiation research and funding. In addition, a search of published literature has turned up 2,407 literature citations for initial screening. One thousand and sixteen were chosen for further review. And 213 publications were selected for detailed analysis. Just last Friday, April 15th, Dr. Harry Holloway, whom I have asked to spearhead this important effort, and others members of the investigative team met at Johnson Space Center to review the records collection process. And we are continuing to explore every avenue. We are committed to digging out every scrap of information on NASA involvement in human radiation experiments. In fact, NASA is using a definition of human radiation that is even more comprehensive than what is being used by the Human Radiation Interagency Working Group and established by the President's January 18th executive order. Because of the nature of what we do, we wanted to be more inclusive. And let me define that a little better. According to a January 19th memo to department and agency heads from Christine Varney, Secretary of the Cabinet, human radiation experiments specifically exclude common and routine clinical practices, such as established diagnosis and treatment methods involving incidental exposures of ionizing radiation. In other words, clinical practices like X-rays and injecting people with radioisotopes wouldn't be included in this effort. NASA is including some of this, specifically injection of radioisotopes in cases where this was done not because people needed it for therapeutic reasons but to study a certain function of a person's body. It was done as part of an experiment not because the person was ill or in need of some kind of treatment. So we felt that this was very important to include. So we look forward to working with the committee, getting your guidance. And we are going to be completely open because it's important for future generations in this country to have confidence in us once again. Thank you. CHAIRPERSON FADEN: Thank you. Thank you very much. I think this has been very important for the committee to hear from all of you in terms of both the level of effort, the level of commitment, and the level of sophistication with which you're approaching this issue. I'm sure we will take all of you up on your offers for assistance as we progress. We have time for a few questions, I think. We're a little off schedule, but if anyone has a question on the committee? I'm going to ask Dr. O'Toole if -- Secretary O'Leary had to leave. Tara, would it be all right if there are questions for the Secretary if you fielded them? Are there any questions? Do you want to come on up? Professor Katz? COMMITTEE QUESTION AND ANSWER PERIOD DR. KATZ: I just want to make one brief comment so others can talk, too. I think how you redefined what constitutes a radiation experiment is very, very important. I've thought about it for a long time, particularly in relation to our work. The issue is not whether the study done is also used in therapeutic settings but for what purposes were the isotopes or whatever used with human subjects of research. If it was for therapeutic purposes, individual therapeutic purposes, it's one thing, but if it was primarily done for investigative purposes, even though it can be used and has been used in therapeutic settings with patients, then those studies I think fall under the purview, in my view at least, of this committee. And I am very glad that you have broadened -- or not so much broadened, but better defined what we mean by research, particularly clinical research. CHAIRPERSON FADEN: Are there questions? Yes, Dr. Tuckson? DR. TUCKSON: Dr. Shalala, I can't help but be impressed and amazed at the amount of work that your department, in particular, is going to have to do, particularly the letters that you've written to the universities that are receiving support or have received support. First of all, have you been getting much response or feedback back from those universities? Do you know yet? DR. SHALALA: Well, with the exception of the institution where I have my own tenure, there was enormous amount of enthusiasm, I think, and seriousness. (Laughter.) DR. SHALALA: All of the heads of the research institutions that I wrote to took our efforts very seriously. And we asked them to begin to look at their records, but also to set anything aside during this period. They're waiting now for us to give them more careful direction about what we want them specifically to do. And we're waiting for direction from all of you. But I think I can speak, as John Deutch can, for the research community out there. And that is that they're as open and are taking this with as much seriousness as the Clinton administration is. So people are ready to go to work. And it's simply a matter of giving them more careful direction at this point in time. DR. TUCKSON: I think the question of focus is going to be an important one. CHAIRPERSON FADEN: For this committee, yes. DR. KATZ: Have you given them a date, a cutoff date, for record retrieval? DR. SHALALA: Let me check. We have not told them to do the search yet. We've asked them to find the records so that they know where they are. Because of the range of obvious research that was done, we need to tell them where we want them to focus in their search. So it was more of a heads up letter, "Go check with your archivists and see where the records are." CHAIRPERSON FADEN: Thank you. Are there any questions? Yes, Dr. Thomas? DR. THOMAS: I'd like to ask Attorney General Reno to clarify a point for me. The studies that have been reported in the media about the prisoners, would those have been done in non-federal prisons? And if so, are they still under our mandate, but presumably only if they were funded by other government agencies? Do you know anything about the funding source of those? MS. RENO: I don't know anything about the funding source, but we will be happy to check on that. The articles that we've seen referred to referred to state correctional institutions. DR. SHALALA: I think it's highly likely that almost all of this research was funded by some federal source. CHAIRPERSON FADEN: Dr. Royal? DR. ROYAL: I guess I'll address to Secretary Shalala, although I'd be interested in hearing anyone's comments about the question. The focus of this Advisory Committee is on human radiation experiments. Is there any evidence that the human radiation experiments -- that a greater percentage of them were performed without informed consent than human experiments not involving radiation or is there evidence that the risks from these experiments were somehow different from experiments not using radiation? So my real question is the focus on the radiation experiments. What's qualitatively different about them that other medical experiments that also might subject patients subject to risk and which also might be done without informed consent? DR. SHALALA: The answer to your question is no, that I have no evidence, but not because we've gone and looked to answer that question, but because we have not gone to look. But I have no evidence that would inform that question in any way on either side. MR. BROWN: I'd like to make an observation. Actually, you had two questions there. One had to do with informed consent. We know, at least based upon a prima facie review of our records, that the VA became involved in radioisotope research in 1947. Between 1947 and approximately 1958, there were no formalities of record that we know of that addressed the consent question. It was based upon a kind of a loose practice or loose definition or communication between the researcher, I guess, and the patient. From 1958 -- and I think that it is also important to note that the VA was the first one through a decision issued by a general counsel defining what informed consent really meant. And from that point on, I think that we were pretty safe in terms of making sure people understood that there was something of record, as opposed to maybe a note of record. With respect to your question regarding increased risks, we at this point have not really evaluated enough of the information to be able to determine if that were the case. We have looked at one hospital. We looked at about 20 percent of them, but that in and of itself could not give us a good enough picture of exactly what appeared to be the curve that this whole effort would take. But as soon as we are able to determine a pattern, we will certainly make that information available to the committee. CHAIRPERSON FADEN: Thank you. I'm mindful of the time. I know that we are asking a lot of the Secretaries and the Directors to stay for just another minute. Dr. O'Toole, did you want to comment on Dr. Royal's question about why radiation is basically the force of it? I saw a kind of eye contact with you there. DR. O'TOOLE: I think that we could talk about this for the next hour, but let me just remind you that the genesis of the exercise in which you're now engaged was the revelation in the press of plutonium injections into subjects. And those experiments were secret and were done by the government in connection with the development of atomic energy and nuclear warfare capabilities. So I think although Secretary Shalala is quite right in saying that we do not have any reason to believe that radiation experiments were somehow different or more harmful or done more secretly than other experiments, we can consider this investigation into the ethics and scientific propriety of radiation experiments a kind of case study in the whole conduct of clinical human subjects experiments in the past. And, hopefully, some of what you derive from your deliberations will be applicable to clinical research in general in ways that will benefit all manner of scientific investigation. But no, we have at this point no particular evidence to believe that radiation was somehow used more wantonly or more secretly than other forms of energy. DR. SHALALA: Dr. O'Toole makes a very important point. And that is that in answering the question that we don't have any evidence one way or another, we are not saying that we don't think that the research, whether it's radiation or not, shouldn't have the same very high and very rigorous standards for its conduct. CHAIRPERSON FADEN: Thank you. Administrator Goldin, did you want to comment on this? MR. GOLDIN: Yes. It brings me to my point. This is a very focused retrospective look. At NASA we do exploration, and we push the boundaries. And this whole issue has raised my consciousness. At NASA based upon what's happen here, we're taking a prospective look as to how what we've learned here will impact how we deal in not just radioisotope or radiation experiments but all experiments involving human subjects. And if you think about the places we go and the things we do, I think it's very important. So we're going to look for an interaction with this panel to help us not just understand what went wrong or what happened, but how we at NASA could set up the right set of standards for future work so we won't have a hearing 20 years from now on this same subject. CHAIRPERSON FADEN: I think we're all agreed on that point. We need to close this portion of the committee deliberations. Christine wants to make a comment. But let me just say on behalf of the committee, thank you all very much for your time. This is very helpful for our process. MS. VARNEY: We have said to you on the committee this morning how extraordinarily grateful we in the government are for your work. I want to take this opportunity to point out to you without the personal commitment and leadership, you would not have an extraordinary setting here. Seven different government agencies with different mandates, different constituencies, different interests have come together to provide the people and you with the information that we need to do this task. And it is really due to the personal commitment of each of the people and their staffs that you have here today. On behalf of all of us, I want to thank you for your patience and your tolerance of my pushing your staffs very hard on this. So thank you very much. CHAIRPERSON FADEN: Thank you all. We're going to take a short stretch break. Let me remind you we reconvene. This would be not a good time to make phone calls. We'll have an hour and 15 minutes at the lunch break. I would ask if you have phone calls to make, that you hold it until then so we can reconvene quickly. (Whereupon, the foregoing matter went off the record at 11:08 a.m. and went back on the record at 11:22 a.m.) INITIAL DISCUSSION OF COMMITTEE MISSION CHAIRPERSON FADEN: Well, now we start to work. The fun part is over, as it were. It was wonderful for us to hear from the Secretaries and Administrators and certainly starts our activities off with a kind of sobering acknowledgement of the importance accorded our committee, which is, I think, very significant for us all to appreciate, certainly is affecting my thinking as we proceed. We're now going to start with the beginnings of that process of refining our mission. And I think we hear very clearly from the agency heads that they need guidance from us because the work that they -- we'll hear more about this tomorrow, but it's as if at least some of the agencies have reached the point where they can't go much further without our telling them what exactly we want, what our priorities are. Now, I'd like to put off some of that priority discussion, if possible, until tomorrow, but if it comes up now, maybe that would be fine to do. What I would like to do if my colleagues will indulge me is I didn't -- the term is a "heads up" I learned since I've come to do this. I've had a heads up on this for several months now. It was actually in December that I was first contacted by the Department of Energy to start thinking about these issues. And as our process has evolved, obviously my thinking has evolved. And I thought maybe to get us started, it might be helpful for me to take just a few minutes, a very few minutes, to share with you where I am with respect to our committee's work, by no means meaning to suggest that how I'm thinking about it now is how we should be doing it or how we should all be thinking about it, but merely so that you can know where I'm coming from. And that may be the foil against which I can hear where all the rest of you are coming from and we can start to refine this together. As I've been thinking about this over the past three months, I've come to think of this in sort of three parts. I don't know what's going on here, but the number three keeps cropping up as I do this. So, for what it's worth, three pieces or three parts of what we're doing have emerged to me as significant. First, what is our task or what are our tasks? And, secondly, what are our duties? And, finally, what are the themes or the issues that frame and inform our work? What's weird about this is I have three tasks, three duties, and three themes or issues. So I'm not sure whether anything mystical is operating here or my mind is limited and I can't go beyond three, but there are three complex things. First, with respect to the tasks, it seems to me -- and these are pretty much found in our charter and in our executive order -- that we have three specific tasks. First, we are required to establish what the relevant ethical and scientific standards should be for judging experiments from 1944 to the present. And this will involve setting the cultural and scientific context for understanding what was done in the past and what is being done currently. It will also raise very difficult and challenging questions of what some of us on the panel might call historical relativism, how you understand norms and values across time and also questions of retrospective moral judgment, how you can look backward at actions of others or of institutions in the past and render some sort of judgment about them. So that's our first task. I don't mean this in chronological order. One task is that we establish for ourselves what the ethical and scientific standards should be across the decades. We need to agree, if we possibly can, about how we will understand these standards and then defend the position that we end up adopting because this will be an area, I believe, where others will take exception to whatever position we finally adopt. Secondly, we have the specific task of reviewing particular experiments against these standards. Now, the issue is which experiments, how we decide what experiments we're going to focus on. And that's this guidance that the agencies are asking from us and the triaging question that we confront. But whatever experiments we decide we want to focus our energies on, we need to evaluate them against the standards which we as a committee have adopted. And we have to look at least at three issues. We have to look at the question of whether any follow-up, medical follow-up, is appropriate for survivors or subsequent generations of people who participated or were subjects in these experiments, both for humanitarian reasons but also for scientific reasons. Is there any reason to want to follow these people up? We need to make a comment and a judgment about whether anyone is due an apology for how they have been treated by investigators or, more importantly, by the American government. Finally, we are, I believe, positioned to set the stage for the question of compensation. Our work will lay the groundwork, I believe, for then a task that I anticipate will be taken over largely by Congress. But we are in a very pivotal role with respect to the question of compensation. So that's what I see as our second task, reviewing particular experiments. And our third task -- and I think we've heard this eloquently expressed by several of our distinguished speakers from the cabinet -- is that we have an obligation to the current situation as well as to the past. As important as it is, I think, to do this retrospective review and to make it plain to the American public what has happened and why it happened, we will not have served the public nearly as well as we should if we can't also say in that same report "And things are better now" or "Things are only part- way better now, but here are some recommendations for making them better still." We have to comment. People are not only interested in hearing what happened in the past, but what they want to hear is: Do we have to worry about it happening now and happening in the future? That will entail our looking at research practices and policies currently underway. That's our third task. Now, with respect to duties, these kind of fall out. We clearly have duties of the American public. We have an obligation to be forthright. We have, I think, a very central duty, again expressed by members of our cabinet panel, to do what we can to contribute towards improving the public's confidence in science at the same time that we assure them that the story with respect to the past is being told honestly. Specifically I think with respect to radiation, we have a duty to help the public understand the proper and important and beneficial purposes to which ionizing radiation can be put in science and especially in the clinical care. And undergirding all of this is to assist the American public in coming justifiably to the view that, at least in some arenas, it is okay to trust what your government tells you. If we can help in part if, in fact, it's accurate to contribute to that, that would be very important. We also have a set of duties to subjects and their families to set their records straight, which is no mean feat to, as I've said, provide the groundwork for compensation and also for issues of medical follow-up. And, finally, we have a duty to the scientific community and the medical community to be absolutely fair in our proceedings, to in no way conduct ourselves as if we are at some sort of a witch hunt looking for the bad guy in the closet. This is not the intent of this committee. As I understand it, we are there to tell the story as best as we can understand it and to assist in understanding how the ethics of research can inform our understanding of proper conduct. And we need to be absolutely fair in our dealings with the individual investigators and the laboratories and the institutions whose work we will be evaluating. And, finally, a few comments about the theme that as I thought about our work have emerged to me as kind of central defining themes about what we will be about. The most obvious and straightforward theme and I think the reason why I got asked to do this in the first place is that there are clearly themes of research ethics, traditional ethics of research questions, like consent and like how fairly to select the subjects of research, questions of justice. These are the obvious questions that bring this committee together. We have some less common topics or issues in research ethics that we will have to confront, including the ethics of research conducted by mission agencies, the ethics of scientists in service of the state, and how we are to understand ethically research on human subjects conducted for nonmedical purposes. By that I don't mean non-therapeutic purposes, but research involving human subjects where the purpose of the research is not to advance our understanding of human health, but to advance some other human consideration. We will be dealing with these questions as well. A second theme for our work which does differentiate ourselves, this committee, from other committees that have confronted questions of ethics in science is that we will, I believe, at points be dealing with the proper role of secrecy in a liberal democracy. As has already been pointed out, some of the studies that have caused great public concern were secret studies. They were not known to the public. They were not known until quite recently in some cases. And so we will be confronting what is the role of secrecy in a liberal democracy. Finally, I believe we will be asking ourselves whether or under what conditions in the context of science the interests or rights of citizens may justifiably be set aside in the interest of the nation as a whole. So we will have these issues to address as well. This is just by way of sharing with you all my current thinking. And I would love to hear from my colleagues now as we start to work together. Yes, Henry? DR. ROYAL: In your statement, you made it sound like the committee was going to come up with a recommendation. One of my concerns is that because these are complicated topics, there may be disagreement among members of the committee. What sort of process is going to be used to develop consensus? And I guess my own feeling is that we should not try to force consensus, that if there isn't consensus, we should just say there isn't consensus. CHAIRPERSON FADEN: Jay, did you want to speak to that? DR. KATZ: Yes, just I've thought about that question, too. We do need to decide where there will be opportunities for dissenting opinions, if necessary. We should strive for consensus, I should think, but we probably won't reach it in all issues. And in the final report, there ought to be opportunities for dissenting statements. I wanted to make one other point and merely to underscore what Ruth Faden has said and what others have said, what the Secretaries have said as well, that I, too, attach particularly attention to one aspect of our charge, namely to undertake a sampling of the radiation experiments conducted since 1974, when the federal regulation for the protection of subjects of research went into effect. I hope that we will take a very thorough look at the last 20 years so that we can confer another assigned obligation under the charter, namely "to recommend further policies to ensure compliance with recommended ethical and scientific standards for human radiation experiments." For to do our job responsibly, we must examine both past and present so that we can look forward to a better future in the conduct of human experimentation. President Clinton -- all of us just got his latest press release -- said that only by dealing honestly with the past can we hope to build a better future. I would amend it just a little bit in the light of what I have just said, namely that only by dealing honestly with the past and present can we hope to build a better future. CHAIRPERSON FADEN: Frank? DR. PRESS: Coming back to Henry's comments -- CHAIRPERSON FADEN: I'm sorry. That's important. We have to keep remembering to pass the mike, as it were. This is for posterity. DR. PRESS: Under ideal circumstances, a committee which is not so highly polarized at the very beginning is a good situation. I would like to think that we all come with open minds and by discussion and analyzing the data and everything else, we strive for a consensus. A report is vitiated. It's weakened. Its impact is lessened if there are dissenting opinions. So, if possible, we should try to reach common understanding and a consensus. On the other hand, you know, in this country if somebody has a dissenting view, that has to be made known. CHAIRPERSON FADEN: If you asked the question, Henry, about process to reach consensus, I think what we have is the force of persuasion. We'll argue with each other. And if we can reach consensus on key points, that would be ideal. DR. ROYAL: There are some more formal methods that can be used to reach consensus. And, really, the thrust of my question was whether or not we were going to use informal methods to reach consensus or more formal methods. The disadvantage of more formal methods are that they're poorly described, and you never know if what is being described as consensus really means that it's the opinion of the person who happens to be writing that part of the report or whether or not it truly represents the consensus or whether or not it's the opinion of the person who sat around the table and who talked the most and yelled the loudest. CHAIRPERSON FADEN: Yes. You're quite right. DR. ROYAL: So that's really what the thrust of my question was about consensus, whether or not we were going to use informal methods or try to use some more formal methods. CHAIRPERSON FADEN: Are you thinking about something like a Delphi technique or techniques of that sort for bringing -- DR. ROYAL: I would like to see each member of the committee have to explicitly indicate whether or not they agree or disagree with certain critical points. CHAIRPERSON FADEN: Are there other reactions to that suggestion? Some nodding heads. Ruth? Pat? DR. MACKLIN: One reason it's hard to react in advance is that it's a little out of the context of what the nature or type of disagreement might be. So while, on the one hand, I could in principle endorse this kind of suggestion, it might be appropriate for us to take up this subject in the context when an agreement or a consensus is called for, not to shove it aside, but to see whether there might be different needs at different times or for different levels or types of disagreement since we're talking about a complex and, as Ruth Faden went through the list of tasks, duties, obligations, and so on, the nature of the disagreement may be different, the reasons for disagreeing. So I'm in support of our looking at this methodological piece, but I think it might be best taken up in the context in which it occurs. CHAIRPERSON FADEN: Okay. Pat, were you on this? MS. KING: I won't repeat what Ruth has said because she's said it far more eloquently than I could. I would only add one additional statement, and that is I hope tomorrow because that looks like it's the appropriate time that we can actually talk not so much about process in the way it has been raised, but the things that we can do as a committee that at least put us all on the same footing, which, in my experience at least, is helpful in helping us to come together as a group, whether we still disagree or whether we have a consensus. I am, for example, very much interested in talking about how I might learn more about radiation, about which I know nothing, and I don't know how I can reasonably talk about it at this point. And I am sure that we are colleagues on this committee who know nothing about ethics and the principles that some of us throw around and the concepts and the terms that some of us throw around. And it may be, I think, more useful to focus on the things that we need to do as a group that will be building measures or building steps and then deal with the questions of consensus or lack of it when and if it arises. CHAIRPERSON FADEN: That is a specific agenda for tomorrow afternoon. We had already been giving some thought to stretching the second meeting as basically a group educational experience. I think that's critical. Reed, I saw a hand. DR. TUCKSON: Not to be redundant on this, but, first of all, I think the question was appropriate to raise. It was important that we talked about it. But I think the real issue for us, I think, to focus on at this early stage is the hard work of how do you form groups and how we do try to at least find those interpersonal opportunities really to think together and to try to realize that consensus is what we are looking for. I would again just second the comments that are made but to not underscore the importance early in our relationship of finding those or really working hard together as a group to be a group. I think that's very important work to be done. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: May I raise a different -- CHAIRPERSON FADEN: Absolutely. This is open phones. DR. MACKLIN: All right. This is a comment about Dr. Faden's list of items. Something that struck me that I didn't hear you mention explicitly and it's an area about which I have very little background or have given relatively little thought in the ethics of research on human subjects appears in Number 2 of the charter, "objectives and scope of activity." So it's actually Number 3, "objectives and scope," Item Number 2, "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." Most of the experience in the area of human subject research has to do with patients who are normal, healthy volunteers and not with the kinds of activities that involved environmental release, and not that anything you said should have mentioned that, but it suggests to me perhaps the need to fashion something that hasn't been done before, maybe only in the context of the work here, but possibly not since this is a different kind of research from what we think of as clinical or the use of normal, healthy volunteers for study. So I only wanted to flag that and suggest that it's something we probably need to think about and possibly even get some background materials to see if there are any analogies or any historical precedence. CHAIRPERSON FADEN: Yes, I think that is important. MR. HARKNESS: If I may interject? CHAIRPERSON FADEN: Absolutely. MR. HARKNESS: There is a book called The Clouds of Secrecy. It's not the greatest book I've ever read, but it's about the use of release of biological chemical agents over cities that were research projects conducted. DR. MACKLIN: One aspect is this aspect of secrecy. And, quite clearly, it goes to that, but it's also linked with what Dr. Faden mentioned in research done in the service of another objective, a governmental mission or a political or international concern and the fact that these kinds of things were conducted not by recruiting subjects, but in a very general way. Release into the environment does suggest a look at that kind of thing. And I'd be interested in seeing this book and seeing what's in there. CHAIRPERSON FADEN: Duncan? DR. THOMAS: I'm glad you raised this issue. I've been having trouble with Item 2 as well, but my concern is a slightly different one. It's unclear to me how broadly to interpret that mandate. In particular, I'm unclear as to whether or not activities related to the atomic weapons testing program would be included. Now, as worded, it doesn't seem to be. The weapons tests were not designed for the purpose of testing human health effects nor for the purpose of testing environmental exposure distributions. In the process, of course, some people did get exposed, both veterans as well as the surrounding population. It seems to me that has already been addressed in the Radiation Compensation Act, which was debated several years ago. So it's my understanding that that activity, at least, is not part of our mandate. What's less clear to me would be instances where perhaps a veteran serviceman was deliberately exposed for research purposes. And there it seems to me that we do have a potential interest. I'd be interested to hear what the committee thinks of that issue. CHAIRPERSON FADEN: Yes. This is exactly the sort of discussion, all of this is, that I hope we would continue to undertake. We need to articulate for ourselves what we consider to be in and what we consider to be out, what we choose to have in and what we choose to have out of our purview, and with what justification. Yes, Reed? Sure. DR. TUCKSON: I just want to understand better. I think Duncan's question is important, but I want to make sure I understand the thought. Duncan, are you essentially saying that while it is very clear that scientifically sophisticated, although maybe inappropriate, issues concern us obviously, that the exposure of service personnel in an unscientific, unstructured, more casual way that would not be normally classified as science, those issues, even though they weren't "science," should they come under our purview? Am I understanding it? DR. THOMAS: I think that's the nub of it. I have a hard time drawing the line between a situation where for purely military purposes a serviceman may have been instructed without informed consent required or perhaps asked for "volunteers" with some question as to whether or not one can indeed volunteer according to the standards that we consider ethical for conduct of medical research. I mean, that's one issue. The other is where there was perhaps an attempt, whether scientifically valid or not, to collect some data -- for example, for argument's sake, suppose a hypothetical or perhaps there are real examples of military personnel being asked to, for argument's sake, fly through a fallout cloud carrying radiation dosimeters to get data. Now, does that constitute an experiment? I'm not clear at all on that. CHAIRPERSON FADEN: Duncan's raising the critical issue of how we define what we mean by an experiment or what we mean by research. The charter's account is unspecific, to say the least. DR. KATZ: Ruth? CHAIRPERSON FADEN: Yes, Jay? DR. KATZ: There's another issue that concerns me. CHAIRPERSON FADEN: It's important, very important. DR. KATZ: And I do not know whether you or staff has given some thought to already. After all, at least from where I'm coming from, the most important aspect of looking to investigating the past and present is to establish, if necessary, better policies for the future. But in reviewing the past and present, even though, at least from my perspective, I'm not that much interested in heaping blame on the conduct of investigators, it would be almost impossible implicitly to at least make some moral judgments. To the extent to which we can minimize it so much the better. But in order to understand the past and present, we may have to talk with some of these investigators. And if we do talk with these investigators, what assurances can we give them that we will not expose them to civil and even criminal liability? And if we meet with them, do we have to tell them that it may be in their best interest not to tell us anything and plead the Fifth Amendment, et cetera, et cetera, et cetera? I think these are important issues to address. And I do not know whether you have started thinking about them already. CHAIRPERSON FADEN: Well, we started thinking about them. Dan, do you want to -- MR. GUTTMAN: This is anecdotal, but for me it was a striking anecdote, anecdote, not antidote, which may provide some reassurance to the scientists amongst you. One of the first conversations I was privileged to have was an individual who ran the Kerner Commission many years ago. And I asked the question that Dr. Katz asked, which is: We have people who may be, rightly or wrongly, exposed to criminal liability and even if they're perfectly innocent, who would want to talk to the government because any kind of association with the government is kind of a scary thing today, even being President. A wonderful, wonderful man, he said, "I don't understand. You seem to be intimidated by the process of fact-finding." I said, "Well, I am. What about these questions that I didn't know but that Dr. Katz has raised?" He said, "But you have to understand this is a presidential advisory committee. Your duty is to find the facts." And I said, "Well, I guess." I thought maybe it was generational, but I guess, Dr. Katz, if I can, it isn't generational. But I thought, well, after Vietnam and all the gates, we look at the very task we're undertaking today in a very different way than an investigatory committee might have looked at that task or research committee, to use the term, might have looked at that task 30 years ago. So part of it, all of us in our own disciplines, wherever we come from, as a citizen or scientist, is to see if we can put ourselves in the shoes of these people. And the answer is we don't know how to do it. We're trying to puzzle our way through. And I think what Ruth is saying is the way hopefully you can do it is to tell a story, that we're not here as a witch hunt. We're here to find what the story of the country was, which had a lot of wonderful aspects. There's a lot of troubling aspects. The answers we don't know. CHAIRPERSON FADEN: We don't have the answers, but what we need is -- MR. GUTTMAN: But we're keenly aware of the question. CHAIRPERSON FADEN: We need the answers. And they go to larger questions about the context in which we can have conversations with investigators and the context in which we can as a committee discuss together particular incidents without unfairly exposing people to inappropriate public scrutiny. So there are lots of tough issues of that sort. I don't know the answers. And the problem is you were saying at breakfast that if your law students want to know what the law is on this, surely there must be a law. That was my first response when we started talking to the White House. It's got to be written somewhere. And apparently it's not clear. It's one of those where we may be evolving standards. Well, this part is always hard in the beginning. So quiet moments are understandable. But surely we can use up 15 minutes profitably. I actually wanted to go back to the issue Duncan raised because I think that is a key one. It is my understanding that we are positioned to interpret our charge in a way that's coherent and defensible. And as long as it is consistent with the parameters, obviously, of the executive order, we can always go for guidance back to the Interagency Working Group on points. Largely the question would be we would like to go in this direction. We are interpreting it as compatible with the charge, and we're letting you know this is the direction we're going. But I think we have tremendous latitude as a committee to articulate what we see as falling within the category of an experiment involving human subjects. Reed? DR. TUCKSON: One of the questions I'm also curious about is our opportunity to not only get at information and data from the agencies. I wonder how the committee feels about whether it is appropriate or whether they think it will be necessary for us to have any contact with any individual people who would be identified as being affected. Is there a human dimension to this that we will have the opportunity to expose ourselves to? DR. LEDERER: I think it's absolutely essential that we hear from some of the individuals who believe that they have been harmed and that their part of the story would be very important for us, particularly if our task is to restore public confidence in science and in government. CHAIRPERSON FADEN: Part of our task, yes. There's no bar to this. My understanding is if we want to talk to people who believe they've been involved inappropriately as subjects in research involving ionizing radiation, we do it. I mean, that is my understanding of how we operate. We have so many decisions to make as a committee collectively about how we want to proceed. But if the committee senses that it is important to meet with people who see themselves as having been so exploited, we will do it. The problem will be exactly the logistics, how we select these people, whether we do field hearings. Do we travel around the country? How exactly we get a proper flavor for that experience we will obviously have to debate, but yes. Pat? MS. KING: We have a public comment section this afternoon, and I gather we will have one at each one of our meetings. CHAIRPERSON FADEN: Yes, we will. MS. KING: Could you inform us or tell us the initial decisions of guidelines that have been set up for outreach and for structuring of public comment so we'll have some idea about what to anticipate this afternoon? CHAIRPERSON FADEN: I can tell you what's happening this afternoon or what has happened in advance of this meeting, which is not necessarily the procedure that we will want to adopt in the future. The minimum amount of public outreach was done for this meeting. There was a notice in the Federal Register, which is what, 15 days? Fifteen days in advance of the meeting there was a notice in the Federal Register for the masses of the American people who read the Federal Register. (Laughter.) CHAIRPERSON FADEN: So, not surprisingly, the Federal Register's notice indicated that members of the public wanting to address the committee needed to notify the committee. Within five days, was it? Five days? By Tuesday of their interest. And no one? No one has indicated to the committee such a preference. This is hardly surprising. That's the extent of the outreach. What I intended to do this afternoon was when we reached that point of our session ask if there are any members of the public who would like to make a five-minute comment to the committee. We will entertain eventually people who have walked in and haven't given us advance notice. But this is not an adequate process for getting public input. We were doing the minimum because we had such a short time frame to pull this meeting together and also because the committee I think needs to decide how it wants to do this. How do we want to? MS. KING: Are there guidelines for the committee and for the public members who choose to testify this afternoon in terms of time limits and in terms of our own role or should we play this by ear? CHAIRPERSON FADEN: Are you asking if there are guidelines for -- MS. KING: That we should decide now for this afternoon in anticipation that there will be people who would like to come up. I don't mean anything onerous, but it just helps us to know. Is it an unlimited amount of time? Are people going to be limited? Is there time for us to ask questions? What kind of monitoring? I mean, I hate to be so -- CHAIRPERSON FADEN: No. It's important. MS. KING: -- picky, but if you don't know what we're going to anticipate, we should at least, it seems to me, have some idea how we're going to react or what we intend to do just for today. CHAIRPERSON FADEN: Do people have preferences? I mean, I can tell you what I had planned to do, which is not very detailed, which was to ask people to keep their comments to 5 to 10 minutes and for the committee to have an opportunity to ask questions of the person's comment was of an interest to any member of the committee. And that was it. I hadn't thought much beyond that. But I'm open. Would you see another way to do it, Pat, or -- MS. KING: I think I would feel more comfortable with an announced ground rule before, rather than to get involved in the situation where somebody might want to speak longer than 10 or 15 minutes. CHAIRPERSON FADEN: Oh, no. I meant to announce that that was -- MS. KING: But whatever the rules are, that they be announced so that they can be fairly applied to those who come in this afternoon because if there's a great deal of interest, it's very difficult to make the rules as you go along. That's really the thrust of my question. CHAIRPERSON FADEN: Should we set it at five minutes? I don't know if we'll have any business, but we can set it at five minutes for public comment and see if that works and see if anybody walks in. The other issue that you raise about how, in fact, to do outreach, the level of the committee's interest in outreach, which relates to this issue of wanting to hear from people who perceive that they have been inappropriately used in research, is really separable in many respects because you could have that as a specific interest and seek such people out and not rely on that public commentary time to do that. I see Dan and also Henry. MR. GUTTMAN: You all shouldn't be baffled. The kinds of questions you're asking are the kinds of questions that the designated consultant staff and Dr. Faden have been discussing. And Ken Feinberg just passed me a note about "When are we getting the nitty-gritty?" And this is where this whole question of outreach -- it's not simply that we haven't had time to do outreach. I have felt a little loathe about calling up public interest group X, Y, and Z on behalf of you all without knowing how you all would think about that. Now, that doesn't mean we didn't do it, but, in any event, that whole concept, the tone you want to set, I mean, I think it's clear to us we have to have hearings where people who have been in the middle of this in every which way talk. But the tone and which kinds of groups and how, this gets into Dr. Faden's question of independence. There's a balance between wanting to hear from everybody -- and you certainly can't discriminate in any which way that anybody would say you're discriminating in. But what that means in practice, this is a very critical discussion, similar in some respects to Dr. Royal's question. These process questions may be the most difficult and the ones that you just have to get a sense of how you're going to go working them out, whether you have rules set in stone or whether you have a sense where you're going to have a process for dealing with it. From my own perspective, I encourage that this kind of thing is the kind of thing that's the nitty-gritty. You know, how do you get the information? Who do you talk to? Who do you call up? Do you say "You're a federal investigator"? Are you going to ruin their lives? What do you say? DR. ROYAL: The other issue that I was going to raise doesn't have to do with having investigators come in and talk to the committee, nor does it have to do with the public. So if anyone has any comments about those two items, maybe they should make those first. CHAIRPERSON FADEN: Thank you. That's thoughtful. Do we want to have a discussion about the public comment period now or do we want to think about it a little bit, maybe return to it, the issue here being: How do we want to approach this? All we're technically obligated to do is put this notice in the Federal Register. Do we want to be proactive and encourage people to come in and talk with us? DR. TUCKSON: I would hope that we would seek, I think, to do three things. One is that we would seek to invite people who have had firsthand experience with these issues as subjects, that human dimension. I think we want to proactively include that in our work and perhaps even if it means traveling to some place other than having all of the meetings in this place but being in the environment where there is a place of concern, giving us a better chance just to get the sense of it perhaps. I don't know, but that might be appropriate. Secondly, I would think that as we clarify the issues, issues that are unclear, as we clarify the issues that need to be more clearly focused on, I would want us to at least keep as a real possibility the thought of soliciting advocacy groups from both sides, different points of view, as we struggle to understand and listen dispassionately to different points of view from people and organizations that have been very thoughtful about it, again, after we have defined what those particular issues of interest are. And, then, third, it would seem to me that this is a democracy. And, clearly, the people that have spoken to us have made it very clear over and over again the importance of this is to be done in the sunshine. And I think that the public comment in an unstructured, unfocused way, I think that we ought to have great patience and great latitude for that because the last thing I would want to see after the enormity of the work that we have done is to have any of it challenged at the end because someone had the appearance that this experience was rigged or inappropriate. And so I think we ought to be as patient -- I mean, there have to be rules. I think there ought to be a legitimate whatever the time limit is, five minutes, but I think we ought to be as patient and be as prepared to sit as long as reasonable human beings would sit and encourage as many people who decide to come up through whatever way they come up. I mean, I think that's a responsibility that comes with this task. CHAIRPERSON FADEN: Henry, did you want to raise your other point? DR. ROYAL: Yes, please. We heard from Secretary Shalala that three-quarters of the research at the NIH involved radioactive materials. So it seems like an enormous task for the committee is to decide what radiation experiments it is that the committee is going to investigate. She mentioned a billion pages from HHS. That would take a while for me to get through. So I think the committee should discuss how we're going to decide which human radiation experiments we're going to look at. CHAIRPERSON FADEN: We have to do that. DR. ROYAL: Yes. CHAIRPERSON FADEN: And we have to reach agreement sufficient to give direction to the agencies if not by the end of this meeting, by the end of the second meeting because at this point, everything holds waiting for guidance from us on exactly that point. That's such an important topic that I'm inclined to say maybe we should wait until this afternoon and pick up with Henry's challenge, as it were, in the afternoon session that we've set aside for our mission and just start thinking about those questions now. Jay? DR. KATZ: Yes. Just one comment about the billion pages. I on a number of occasions reviewed research records. Just one research record can go to thousands and thousands of pages because in it are thousands and thousands of pages of laboratory findings, nurses' notes, diagnostic tests, et cetera. So, at least to begin with, we may not wish to examine any of these documents. But if we can get only some of these or the research protocols and other pertinent information that gives us an appreciation of what the nature of the experiment was, then we may reduce the billion pages maybe to 50,000 or 60,000, which is still an inordinate task, but much more manageable, and at least divide it up amongst ourselves, take a look at it, and then figure out after we've had a chance to sample them how we can better identify what we're interested in. That's a partial solution, but you're raising to have the important issue about what we have to read. CHAIRPERSON FADEN: That's just DHHS, too. Other departments have given it to me in sort of miles of documents or Empire State Building size, warehouses of documents. We could quickly get overwhelmed by the paper. We need a strategy. We need a principal basis for selecting our priorities. And we need a strategy for dealing with it. Ruth? DR. MACKLIN: It's I think not just the priorities, but also the categories. I mean, depending upon whether research was funded by one of these agencies and carried out by clinicians or physicians, either in a university setting or a research institution, or, alternatively, were done at the clinical center or in a veterans' hospital by people, not only funded by that agency, but also carried out by personnel from that agency, we may have different levels of specificity, depending upon what we're looking at. Quite clearly, the biggest bulk is going to be what Secretary Shalala informed us about. And that will require some principles of selection and possibly even some statistical ways of selecting. But we may not have to do the same kind of selection given different kinds of research or we may just have to look more at the protocol than at specific research records. I'm not being very clear, but I'm just suggesting that if we sort out the categories and see what it is we want to look at, we may not have to look at all of the actual records of research; that is, the billions of pages. In some cases we might choose to look at the protocols, in other cases consequences to particular human subjects, and in this environmental release category look at something entirely different. CHAIRPERSON FADEN: Yes, Nancy? DR. OLEINICK: I'd like to just comment about the categorization of radiation experiments. As someone who thinks more about the issues related to radiation, the categories are going to include issues of the dose of the radiation that the individuals were exposed to as well as the type of irradiation and the context in which those experiments were done. I think we, at least I, don't have a real sense of how many fall into any of these particular categories. I think we're going to need a lot of help from staff to identify those before we can go back to staff and say "Here's what we want more of." MR. HARKNESS: As a staff member, I have a question for the committee that I think in a sense ties together the two topics that we've just been discussing or we are discussing. The question of setting up categories of research projects that you will as a committee give attention to I think is important, but then I have another question about granting access to the deliberations of this committee to the public. Let us say we create criteria of a certain number of rems of exposure or something and we aren't going to look at anything below that. What do we do if we have someone from the public or a group from the public who demands that we give attention to an experiment that doesn't fall into a category that the committee has established as worthy of our attention? CHAIRPERSON FADEN: Duncan? That's an important question. DR. THOMAS: I've been trying to frame an answer to this question without a great deal of success, but I've been thinking about this issue that I think Ruth raised about sampling as an approach. Ultimately for our work to be credible, I think the population needs to be reassured that we have gotten to the bottom of this story, that we have found all of the relevant experiments. Now, that's a very difficult task if there are indeed tens of thousands of experiments or some of the kinds of numbers that I've heard bandied about. Nevertheless, I think sampling can be a useful first start at this problem. It will help us gauge the dimensions of the problem for us if we could begin by outlining some broad categories into which experiments could be easily classified based on the information that's easily available to us off the face page of the grant or whatever and then sub-sample within that group and look at those experiments initially in detail to try to learn something or other about the process that we need to go through ultimately to find all of the ones that really matter. Then I think there's merit in it. We certainly can't rely on sampling as the basis to give us the final answer, however. Ultimately it may help us, however, identify categories where we know that we need to dig and other categories that we know that we can pretty safely set aside. CHAIRPERSON FADEN: We've got Dan and Reed. MR. GUTTMAN: This is an informational point. Again, I shouldn't be speaking, but this raises the things that we've been thinking about for the last year -- year -- it sounds like a year. It's three days. It feels like a year. When you think about it, there are different kinds of historical evidence which can help us shortcut this sampling process. When I first got involved, I was sort of thinking maybe the way you were, "My God, 10,000 sites, 5,000 sites." Who's counting; right? But one of the things that to me with my background in at least undergraduate history that's fascinating is the opportunity to look at how this came to be, the logic of what really was the bureaucracy at the time of the dawn of the Cold War and that maybe by looking into not what went on in the field, but at both ends, you know, "What was going in Washington that may have given some logic" -- maybe not -- "to this process?" And this is where we're going to hear tomorrow from the people who have been looking for the documents in the agencies. We hope to get together a group of historians who have been focusing on what was going on in the Defense Department or its predecessors so that you're looking not simply at the sample, but maybe there are some pieces of evidence that can give you some guidance that all of those 5,000 things going on in those 3,000 places were part of one thing, which would be a shortcut. Now, maybe we can't find it, but the point is that what you're all going to have to do with your various backgrounds: What are the ways to kind of provide some informing cognitive cues, algorithms, heuristics to reduce this immense problem to some manageable problem? And that's the key. We have the final piece of information we've gotten from the Department of Energy, you know, abstracts. Dr. Neumann has seen them and says, "No problem." He can go through all 2,000 of them in a couple of days. I said, "Great." I'm sure I'd do the same for him if they were legal cases. But no. Department of Defense, as we've heard, they've got 1,700; right? So we're beginning to get the raw data at that field level. And, of course, I look at it and say, "What does this mean?" Thank God for Dr. Neumann. There are other pieces of evidence that maybe I could read or other people could read and put those two pieces together. And so this is this discussion we have to have. And we should really go at it. CHAIRPERSON FADEN: How about if we could read the last -- DR. TUCKSON: A less intellectually exciting adjunct to that work, though, is: Does this committee have a responsibility to ensure that the process of data review within the departments is a reasonable one? If the Secretary says we are reviewing and found nothing based on our guidelines as to what the highlights were, what to look for, what the criteria were, that's one thing. The question then is: Was the review procedurally process-appropriate? I don't know the answer to that, but it seems at some level, we might owe it to the department to put them through some drill and some oversight that says, in fact, that there was a legitimate review. What it seems to me is that sooner, rather than later, we really need to be really on top of the process so that they are at least having their appropriate checks and balances and guarantees that the process was reasonable. CHAIRPERSON FADEN: I think that's absolutely critical. We've been trying, the "we" meaning myself and a few of our delegate-designate staff, which is so awkward to keep saying, to think through exactly this issue. It seems to me that the integrity of the committee's work, in turn, ultimately rests on the public's confidence that the information we received isn't cooked information, I mean, the whole thing is of a piece, basically. And so the huge amount of effort being invested now by the agencies could turn out to not have the public import that it should have if there is a distrust of that process. And we've got this critical kind of middle person quality assurance role here to play, and we haven't quite yet figured out how to do that. That's part of what we need to be thinking about. But you're correct. When we get told "We looked, and nothing was there," we need to be able to say we're satisfied they really looked. DR. NEUMANN: I first need to immediately disavow my willingness to read all of this material because I am in need of bifocals already at 45. But let me just share a little practical experience from the NIH. I think that the important thing that the agencies are asking is for a set of guidelines to allow them to triage these enormous volumes of records. And if the NIH is the example, at least I can speak from some practical experience. They've established an oversight committee made up of individuals with various technical backgrounds to look into the process internally at the NIH. And I served as an ad hoc adviser to the clinical center medical records group that began looking at some of these miles and miles of data. In a practical consequence, it fundamentally comes down to a need to start with some direction from this committee in terms of what to put greatest emphasis on. You're all aware that the recordkeeping pre-'74, for example, was a different set of standards than what we have in the modern era. More importantly, if the fundamental question is whether or not the individual was properly informed, if that's the starting question, then that gives them some guidelines in asking: Can you demonstrate to the committee that there was proper information given to the individual subject prior to the experiment? A second question may be: What was the level of radiation exposure they received? A third may be: Were they members or subjects coming from these groups that we've identified as perhaps being in need of special information to be adequately informed? So if the committee can set broad general guidelines like that, I think it will be invaluable to the agencies to go back, then, and establish triage processes, which certainly can be examined prospectively and retrospectively for adequacy. Right now, again using the NIH as an example, they're waiting for some guidance because it's simply physically impossible for them to begin going through all of these without specific questions in mind to be asking. CHAIRPERSON FADEN: Okay. So that's what we're going to do this afternoon. We're going to settle on these criteria or at least we're going to begin that discussion. We do now need to break for lunch. Lunch is on the second floor for committee members. I've been asked to stay, and we'll stay for 15 to 20 minutes to talk to any members of the press who have an interest in talking to me. But everybody else go have a good and relaxing lunch. (Whereupon, a luncheon recess was taken at 12:18 p.m.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N (1:32 p.m.) CHAIRPERSON FADEN: We are very fortunate this afternoon to have the opportunity to hear from two members of Congress to alert us to the interest that Congress has in the issues that we will be addressing. This is a great opportunity I think for the committee to develop an appreciation of the interest of Congress in our work and to learn how we might work with Congress to advance our common concerns. Our first guess is Senator Glenn. Senator Glenn, thank you so much for coming. I apologize for keeping you a few minutes. We're a little disorganized, but we're getting there. Thank you. COMMENTS BY MEMBERS OF CONGRESS MR. GLENN: Thank you. I had a call from Congressman Markey on the car phone just a moment ago, just as I was arriving here. They've been on a series of 20-minute votes over there in the House. And he'll be over just as soon as he can. I hope you can accommodate his remarks when he arrives. And I have votes later this afternoon. So I have to go and get on back. So I'm sorry we have to give a rather truncated performance here, but I'm sure you understand. I thank you for the opportunity to present some of my views on the federal government's and the Congress' role in addressing human radiation experiments. I think your committee has a tremendous job ahead of it. You certainly have my thanks and everyone else who has been involved with this subject for a long time as well as the subjects of some of these experiments for taking on this assignment. I think we have an important task of helping our government to, in effect, come clean about a segment of our nation's history that was a unfortunate thing that happened. Now, all of us, I think, supported the nuclear arms buildup during the Cold War. I certainly did. And that contributed to the environment that allowed these experiments to occur, no matter how shocked or surprised or saddened we were when we found out late last year about the extent of the radiation experiments. We had a communist threat, but it's rather inconceivable to me 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. An unfortunate analogy to the radiation experiments is the cleanup problem we now face with the DOE weapons complex. You know, we did a lot of things during this time when we all thought the Russians are coming, the Russians are coming, the Russians are coming. We got a bill. You've got to get that fissile material out there. We've got to really get it out there. What are we going to do with the waste? We'll put it out in a pool or put it out someplace behind the plant here. We'll worry about that later. And, unfortunately, now is later. Now, that's in the nuclear weapons complex: Produce, produce. We are now faced with some $200 billion as a cleanup bill. We're not even sure yet. This started back some years ago when I first heard some of the things that had gone on at Fernald in Ohio, just north of Cincinnati, went out to look at it, thinking that it couldn't be as bad as the people had said and found out it was worse, started a whole series of GAO inquiries all over the country. When we went to Fernald the first time, I remember we came back and asked for estimates on how much it would cost to clean up the whole weapons complex. And the estimates were between 8 and 12 billion dollars. We're up now to estimates of plus 200 billion and 20 to 30 years if we can figure out how to do some of the cleanup. Some of you have worked in this field and are better qualified to give testimony on that than I am, but I bring that up only because the same kind of attitude prevailed with regard to some of these radiation experiments with human beings. And people thought: Well, the Russians are coming. We've got to know what is going to happen. If there is radiation spread around, how are we going to deal with this? So that created an atmosphere where things were done that we view now in retrospect, 20/20 hindsight, as being pretty much unconscionable. We're just now beginning to address the aftermath of this Cold War mentality. And it will be up to you in large part to provide guidance for the working group and for Congress as to what appropriate responses we should have now. Let me stress it's clear to me that the general principles involved in the Nuremburg trials were well-known throughout the U.S. during the '50s and '60s, even though they're not even yet codified in law completely today. And I just don't accept the defense that some advocates of these experiments have advanced that informed consent could be foregone because the radiation exposure was so low. I've had some of the people try and discuss with us, "Well, this was for a bigger purpose, and the radiation doses were very low." My answer to them was "Then why didn't they do it on their own families, their own relatives, in their own communities and tell people about it?" I just don't believe that that because they thought it was low, it may have had. That's not good enough. Let me describe just very briefly some of the background on this and interests I've had in this thing. I've chaired at least 15 Governmental Affairs Committee hearings between '79 and '91 on radiation protection and related issues. These topics have covered fragmented, overlapping federal agency regulation, effects of low-level radiation on human health, X-rays. In 1989 we did a staff report, "Early Health Problems of the U.S. Nuclear Weapons Industry and Their Implications for Today." I won't give all of the -- one of the things that was discussed under that was the Green Run at Hanford. '92 we did hearings on federal regulation of medical radiation, examined gaps in federal regulation. November '93 we had a GAO report, had a hearing on nuclear health and safety, examples of post-World War II radiation releases at U.S. nuclear sites. I won't go into details of that, but we can have those reports for you and the committee, Dr. Faden, if you wish to have those. CHAIRPERSON FADEN: We would appreciate it, Senator. MR. GLENN: Good. Thank you. We can give you more stuff than you want to read. (Laughter.) MR. GLENN: In January '94 a hearing on human radiation and other scientific experiments, the reason we had that one, we had asked GAO to go back and look at some of the stuff that happened at Hanford earlier and follow up on it to see how it had been corrected. Well, out of that, then, out of their study that I had requested came the fact that as they were going through the files out there, they found 12 more places where releases like the Green Run or something similar to that that had occurred, 12 more places that hadn't even been known before. And I would add the GAO feels there may be more than that. We don't know that we've gotten to the end of this daisy chain of radiation experiments, but every time we get into the file someplace, it seems we find somebody else did something someplace else, and that opens up two new places. So you have a mammoth job ahead of you I guess is what I'm pointing out. I would urge your Advisory Committee to keep an open mind regarding the scope of your inquiry. I don't know how you limit this thing. That's going to probably be one of your toughest problems. Your task was looking at the so-called planned releases of radiation, like the Green Run at Hanford and other experiments identified by the GAO in their November '93 study. But should other similar tests be unearthed, as happened in our GAO study we released in January, I would hope you would go ahead and consider those, too. As I said, we had 12 releases that we didn't even know about until GAO went out to Hanford and in follow-up, our request for a follow-up out there, going through the files, found these 12 others. And we don't know that we know all of them yet by any means at all. I understand that some groups of people, like the Marshall Islanders, DOE workers, the atomic veterans, are to be excluded from your scope. I don't know whether that's correct or not, but I understood that that was to be the case. I would urge you, though, to keep an open mind as you proceed with your inquiry because when you have as distinguished a group as this getting together to look at this, I would hate to think that we would not be looking at the whole overall picture and what should be done. For example, documents have been recently declassified, indicating that inhabitants of the Marshall Islands, specifically on Uterik Atoll, may have been allowed by the U.S. government to return to their island following the Bravo shot for the express purpose of determining what effects the residual radiation and fallout would have on them. Now, if true, it seems to me this event absolutely has to fall under your definition of "human radiation experiment." I don't see how it could be anything but that. If you let all of these people out there, now, granted, they may not all have Harvard degrees and have been to Stanford and all of these other things, but they're people. And they're people that we were responsible for, and they're people that we controlled as to where they were going to live out there. And if we dealt with them unfairly, then we should look into that, too, I think. Other historians and analysts familiar with the U.S. atmospheric test program in the Pacific have presented evidence before Congress indicating that the fallout patterns may have been much larger than officially acknowledged. Therefore, more islanders may have been exposed. And, as a result, the AEC and DOE medical program for the islanders could be very seriously flawed. I raise this issue not because I want to make your job more complicated than it already is. I don't envy you what you're about to get into here. But it is clear to me that for your advice and decisions to be as credible as we want them to be, you must allow your inquiry and records review to follow a logical path. And consideration of the issues I've just raised seems to me to be consistent with your charter. Now, I've asked the General Accounting Office to study the administration's plans to locate, to analyze, and to make public this information. And I would encourage you to work with the GAO and make use of their expertise in auditing data and processing information. They're a resource both for you and for the Congress. I know that your group is set up obviously out of the Executive Branch of government. And GAO is over on our side on the legislative end of things. But they've done an excellent job for us in unearthing a lot of these things. And, in fact, they probably played the key job in it. I'm sure that as important as this is, we'd be more than happy to have them cooperate with whatever your areas of inquiry are. It's likely your recommendations will lead to a legislative proposal to be submitted to the working group and then the Congress regarding compensation. So, as you begin your work, you should keep in mind the practical implications of your advice. The Congress will be very interested in your thoughts, not only on compensation, but should you have proposals for changes in current law regarding the use and protection of human subjects in research, we would certainly like to hear about them. There were a couple of things that came up on this when we had our January meeting and released the GAO report. It started a whole wave of things that, as you're aware, resulted, partly at least, in this group being formed. I think it was a major issue in it. I was concerned at that time, though, in not only just the historical records that you're going to be dealing with, but I was sitting one day thinking "Gee, if we did these things in the past, what's going on right now? What's continuing? And is it being done under informed consent or how is it? What's the basis for it?" So we had the Secretary of Energy come over. And at that time at the January 25th hearing, I think it was, she testified that she thought an initial look through their records indicated they had some 200 to 260 ongoing human experiments, radiation experiments still going on now. I asked how many of these were being done strictly under the informed consent rules. Well, when they came back later, they say -- I think the figure is now 179, I believe, actual experiments that are ongoing. They're supposedly operating under the review boards and are being done with informed consent. Now, as you're well aware, too, there are different levels of informed consent. "Will you sign this. I'm sure it's going to help you." That's one level. The other is really explaining to people what all the effects of this might or might not be. But those things are being done by informed consent. So we looked at the historical pattern. We looked at what's being done now. Then the next thing that came to my mind was: Well, if we're doing this in the radiation field, what are we doing in the medical field with FDA and NIH and all the other people that may be out there doing experiments with chemicals or new medicines or whatever? And so we talked to the White House about that. And that's what resulted, then, in two executive orders to cover that area that have already been put out. They were put out about six weeks ago now, I guess. And we worked back and forth with the White House. Those are now out. And so those hopefully protect more in the areas of non-radiation experiments on people with things where there should be informed consent also. So we've covered the three areas now, I think, and with the historical record of what happened back in those days, with the current situation now, and in other fields, where there should be informed consent also. So I think we've pretty well covered the front here on this, but there's an awful lot of work that still needs to be done. Just in conclusion, I'd say the volume of documents you have to review is substantial. The number of agencies involved makes even the most general observations difficult. And the bureaucratic obstacles I'm sure will be daunting. But on top of this, scrutiny by the media and public will be constant. And given these pressures, you are tasked with providing a voice of informed reason. And you do have a tough job. Many people expect your work -- I know your current plan is to be completed in one year. That's a big order. Dr. Faden and I talked about this in my office the other day. I don't know whether this job is going to take longer than that or not. I think you're to make a six-month report -- CHAIRPERSON FADEN: That's correct. MR. GLENN: -- and hopefully be wound up with all of your work within a year. I would just say at the outset should you require more time, you have my word that I'll support any necessary extension for your charter. I hope you don't need it. I hope you work hard enough and thoroughly enough that we have all the answers within your allotted time periods. But if you don't, I hope we have a thorough job done, whatever the time takes. And if it needs a time extension, I would certainly support that. So I wish you the best. And I don't know if there are any questions that I can provide that you don't already have answers for. But I will be glad to answer whatever questions you may have. CHAIRPERSON FADEN: First of all, thank you very much, Senator. And thank you for your support. I'm sure there are questions. I just wanted to check with Representative Markey. I know you have time constraints. MR. GLENN: One of his staff people was here. Well, there's -- come on up. Ed, I didn't know you were here. CHAIRPERSON FADEN: Would you like to come up and address the committee? And then we can hold questions and answers. MR. GLENN: You got here faster than I thought. CHAIRPERSON FADEN: The timing was flawless. This is working out wonderfully well. If we could hold committee questions until Representative's Markey's comments? And then we could ask them of both of you. And if you need to leave to vote, we certainly understand. MR. MARKEY: Thank you, Chairperson Faden and members of the committee. And I thank you for the opportunity of your need to appear here today. I'm pleased and honored to be involved with your first meeting, which reflects the leadership of the Clinton administration in addressing issues related to human radiation experiments. I will summarize my statement and ask that my full testimony be included in the record along with a staff report of the plutonium experiments. The recent acknowledgements by federal officials that the government conducted radiation experiments with human guinea pigs grabbed the attention of U.S. citizens because most people assumed that our country would not engage in this kind of activity. To close the door on this regrettable legacy, we should focus on proper remedies to respond to past wrongs, ensure these things can never happen again, and do the right thing today for those who suffered injury. Accordingly, I am introducing legislation with the goals of full disclosure, medical follow-up of subjects, and appropriate compensation for subjects or families for damages. It is my hope that the administration will accomplish these goals before legislation is enacted, but I desire the force of legislation if the Executive Branch should falter in meeting these goals. My experience with these issues stems from a report I released in October of 1986, "American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens." This report revealed the frequent and systematic use of human subjects as guinea pigs in experiments with ionizing radiation, which provided little or no medical benefit to the subjects. These experiments can be characterized as repugnant or bizarre in many cases and were marred by a lack of informed consent in some of the cases. This report was essentially ignored by the Reagan administration, and it languished on a shelf at the Department of Energy. When Secretary Hazel O'Leary learned of these experiments and my 1986 report, she decided to disclose all information on human experimentation. I commend and support her efforts to lift the shroud of secrecy at her department. It is not my desire to blame present leaders of institutions for past mistakes. My concern is that institutions work with Congress to address these past abuses. I, therefore, welcome the leadership by the Clinton administration, and I look forward to working with the administration, this committee, and the scientific community in formulating proper responses today. I also wish to submit for the record a staff analysis of documents released this March by Secretary O'Leary related to the plutonium injection experiments. These plutonium papers raise several issues which have not yet been resolved and which are relevant to the efforts of the Interagency Working Group. One issue goes to the question of what standards were in effect at the time of the experiments. The plutonium papers suggest that for a brief time in 1947, the Atomic Energy Commission required that human radiation experiments should be conducted only if the subject received medical benefits, a standard similar to those by which we judge these experiments today. I hope that the working group or the Advisory Committee as it sees fit will determine precisely what standards were in effect in 1947 and whether they deteriorated over time. In addition, I want to emphasize to this committee the need to maintain the integrity of government records during the search for documents on radiation experiments with human subjects. I recommend that immediate steps be taken to avoid review of files by individuals who may have direct conflicts of interest. I hope that the Advisory Committee will view its mission expansively. In particular, the breadth and the depth of this committee make it eminently suited to recommend standards for compensation. And I urge it to do so. A second area lies with the knowledge of the sad history of the U.S. government's use of its own citizens as guinea pigs is not limited to ionizing radiation. If the committee considers it warranted to recommend that the federal investigation be expanded to include experiments with chemical or biological agents, the areas where Senator Glenn has been the national leader, I hope it will not hesitate to do so. In summary, what has been revealed is no less than the frequent and systematic use of U.S. citizens as guinea pigs during experiments with a variety of dangerous radiation, chemical, and biological agents. These experiments shock the conscience and demand a response. I look forward to working with the administration and the Advisory Committee to gain full disclosure of the shameful past and to provide restitution to those citizens who have suffered injury. CHAIRPERSON FADEN: Thank you. MR. MARKEY: Thank you. CHAIRPERSON FADEN: Thank you, Representative Markey. That's very, very helpful. Well, do we have questions from committee members while we have Senator Glenn and Representative Markey here? It's wonderful that we have this opportunity. We ought to make use of it. MR. GLENN: I'm sorry I didn't know Representative Markey was going to arrive this soon here. I wouldn't have gone ahead and started. CHAIRPERSON FADEN: Oh, no, no, no. MR. GLENN: I was told that he was on a series of votes and wouldn't be here for a little while. CHAIRPERSON FADEN: You were almost finished. MR. GLENN: So I'm sorry we went ahead. CHAIRPERSON FADEN: No. I think, in fact, Senator, you were almost finished when Representative Markey came. So I think we're all right. Yes, Dr. Tuckson? DR. TUCKSON: Senator Glenn, your comments were very, very right on the mark for us. Earlier we had some discussion about how to ensure that the process of agency data acquisition was an appropriate one and a well-monitored one. You've spoken to that in your comments regarding the use of the GAO. Because most of us at the table are new in terms of some of the subtleties of the distinctions between the Executive and the Legislative Branches, this suggestion of the use of the GAO in that involvement seems intriguing to me, especially since you have already gotten them involved. I wonder. Are there any points of view that we should be aware of in terms of implementing or acting further on your suggestion about involvement of GAO? MR. GLENN: Well, I would think that the first thing to do is just get all of the GAO reports and all the references they have there in their bibliographies and the things that they have gone into. I'm sure they'd be glad to brief you on those. I obviously cannot as one member of Congress commit all the GAO resources to your committee, but I would suggest that you start with review of all those GAO reports we've had through quite a number of years, through Ed's and through my efforts and through others in the Congress that deal with this particular subject. And we could either get or have them prepare a bibliography of those reports for you that they think fit into your area. And it might be a good place to start right there. Then if there were further investigation needed, we could see what arrangements can be made with regard to either GAO or requests for further reports that we could work on jointly with them, with your committee or whatever. But I think a good place to start would be just review of all of the documents they've put together through the years. CHAIRPERSON FADEN: Yes, Ken? DR. FEINBERG: I have a question for Congressman Markey. Congressman, you have been obviously in the vanguard of trying to get answers to this problem, going back about a decade now. So you're sort of, for my question at least, a national resource of information on this. And the question I have is: What do your gut instincts tell you about the revelations? Do you and your committee now have a comfort level that the worst examples have been disclosed and referred to in your report and in subsequent information that your committee has provided the country or do you have a sense, anecdotal as it may be at this point, that there's still a lot out there that is hidden that we don't know about? And you've been in the vanguard, I'd like your thoughts on what you think at least is out there. MR. MARKEY: That is the question that I think at this point we still don't know the answer to. People ask me: Is my report the iceberg or is it the tip of the iceberg? It's unknowable because it's clear that in 1986, Secretary Harrington and the people at the Department of Energy were not giving me all of the information. I was able to identify 700 individuals who had been experimented on, and they told me that was the full total they could identify. Well, since then Senator Kennedy and I have had a hearing up there at the Fernald School for the Retarded up in Massachusetts, the Wrentham School for Retarded Children as well. The Boston Globe has revealed that they have identified 1,800 infants and children that may have been experimented on using radiation as well. George Miller at the Interior Committee is now looking into radiation in the islands in terms of military experimentation out there. And Senator Glenn clearly has done work which asks real questions that have yet to be answered with regard to biological, chemical, pesticides, other sources. So I think right now there's ample reason to believe that there's a lot more to know and that there is as well a lot of reason why the institutional resistance to all of this information coming out is still present in these agencies. So you've got your work cut out for you. There's no question about it. But I think there's enough, as you point out, anecdotal evidence now that has just come out since January that there's a lot more to know. DR. FEINBERG: Senator, I'd like your thoughts on that also, your gut instincts about the nature of the problem. MR. MARKEY: Could I apologize? The roll call has gone off in the House again. And I do apologize, but I -- CHAIRPERSON FADEN: We understand. Thank you for coming. MR. GLENN: The nature of our business. Do I think we've got the worst examples? I've thought it each step along the way. We had all the worst examples out. We couldn't get any worse. And each step I've been proven wrong. Now, do I think at this point? I think the stuff that's come out now and all the interest that's been generated over the past six months or so in this, I think probably if there were really bad examples, I think most of them would have probably been brought out by now. But we thought when GAO went out there to Hanford just to follow up on the Green Run, I was shocked when he found 12 other places where things like this had happened that we didn't know anything about. So I don't know. I hope that we know all the worst examples, but I couldn't, I certainly couldn't, guarantee it. And there may be others beyond those 12 that we haven't heard of yet. DR. KATZ: Senator Glenn, I really found your comments remarkable and the attitudes that you have about what's going on and what you see as our task. But, of course, only speaking for myself, I don't think we can complete our task in one year. So we will be coming to you in all likelihood and ask for your support. But my hunch is if we proceed along your lines, we will come to you during your next two terms as a senator. And the question that I have -- MR. GLENN: Let's see. I'll be roughly 95 then, something like that. (Laughter.) DR. KATZ: The question I have: Do we ultimately have to make a decision that we don't want to investigate more and find new examples of egregious research practices and that we have now enough information to write convincingly of the pattern of unethical experimentation that has been going on over the years and leave it at that and do then the work that we have to do, namely to think through, which is even a more difficult task, of now what kinds of policies do we want to recommend to the President, to Congress in order to avoid to the extent possible any recurrences? Because, in addition, for my own research, there are not just these egregious experiments. There are more low-level experiments going on throughout the United States where informed consent is compromised, where patients' consent is being engineered, et cetera, et cetera. They're not as dramatic as the experiments that you just talked about. We probably ought to pay some attention to these things also. Don't we have to stop at one point and say, "Now we have enough data, and we must reflect on where do we go from here"? MR. GLENN: Certainly I agree with you 100 percent on that. And I think that, you know, for even the youngest member of your group, you could make a lifetime work out of this thing if you tried to get down to every single case of all the millions of Americans who may have received something. In fact, I think I heard one estimate that from open-air nuclear testing, everybody on earth has now received 1.9 millirems or something like that. Well, obviously we don't want to carry it all around to everything that may have happened from back in those early days. So I think to get 100 percent, absolute 100 percent, is not likely to occur, no matter how long you worked at it. But I think the main thing is to deal with the most egregious, the most awful examples of this think, make sure that people, even at this late date, are compensated, if that is what you come up with, if that is your recommendation, how we go about that, what mechanisms would be set up to deal with that. And I'm certainly not trying to push you beyond your one year at this early date when you're just getting started. I certainly hope you can do everything within that one-year time frame or maybe even sooner if at all possible, but I agree with you that I would not presume to go beyond one year. But I'd just see the enormity of this problem, and I wouldn't want you to feel absolutely limited. If you find a very promising area you feel you should be looking at, I wouldn't want you to think that you have to give it a little broad-brush stroke and get rid of it just because you have a time schedule here. We want to see a thorough job. CHAIRPERSON FADEN: Thank you. Dr. Thomas, you have -- DR. THOMAS: Senator Glenn, I was very glad to see you raise the issue of the Marshall Islanders and the atomic veterans and the down-winders in particular because this is a question which came up this morning. And we didn't know how to deal with. The executive order appears to exclude these inasmuch as the nuclear weapons testing program was not designed for the purpose of testing human health effects or environmental exposures with the exception of the anecdote that you described, which I had not heard about before. I guess the question is: How much leeway should the committee have in interpreting this executive order? And I guess the second part of the question is: To what extent do you feel that the Radiation Compensation Act has already adequately addressed the non-experimental aspect of these exposures? MR. GLENN: I think it tried to address them. I think you might want to consider whether it was adequate or not. The Marshall Island thing, I wouldn't propose that you get into exactly how tests were conducted and things like that, but where there is something -- where the charge has been made, anyway, and there seems to be some substantial data to support it, as I understand it, that some of the people out there were deliberately moved back in when other people thought it was not safe to move them back in, deliberately to see what the effects of the radiation on them would be. We knew that there was high radiation in the area they were coming back into is my understanding of it. And where there's a deliberate radiation experiment like that, -- I don't see what else you can call it -- then my view would be that that first under your charter. But I don't have the fine print of your charter here, and maybe you interpret it a different way. I would think it should. Let's put it that way, whatever your charter says. If it turns out with a cursory look at it that it was just what way that we have records that show that they deliberately were deliberately moved back into that area just to find out what radiation effects would come from that, then I think that should fit within your categories of things to look at. CHAIRPERSON FADEN: Do we have other committee questions for Senator Glenn? (No response.) CHAIRPERSON FADEN: Thank you very much, Senator. MR. GLENN: Good luck. CHAIRPERSON FADEN: We'll need it. MR. GLENN: Thank you. CHAIRPERSON FADEN: Thank you for your support and for your time. MR. GLENN: Thank you. CHAIRPERSON FADEN: We have a request. If there are any members of the public in the audience who would like to speak during the public comment period, which will begin at 3:15, could they please sign up outside the room? Is there someone that they could sign up with? Wayne. So if you could ask for Wayne and indicate that you would like to speak? This is for members of the public, not the press, please. Wayne is right by the door. So if there are any members of the public who would like to take advantage of our public comment section on the agenda, please let Wayne know. Thank you. All right. CONTINUED COMMITTEE DISCUSSION OF MISSION CHAIRPERSON FADEN: With that, we're going back to our committee deliberations. And we're on to our charge and mission. We had left off basically with the question that Henry had raised that now many people have raised about how we are to narrow our scope, what priorities we are to adopt and so on. Did you want to start again, Henry, or -- DR. ROYAL: Yes. One of the things I wanted to point out is that we're not starting from scratch. We've heard that there are many, many documents out there that have to do with radiation experiments. And during the break, I actually went back to my hotel room to get a textbook that I think that members of the committee who aren't familiar with it should be familiar with it. CHAIRPERSON FADEN: How big is it, Henry? DR. ROYAL: Large. It looks like a Webster's Unabridged Dictionary. It's called Radioactivity and Health, A History. Remarkably, this was written by a single author. Basically, what it describes in this book is how we know what we know about radiation and radioactivity. So, for example, there's a chapter in this book about plutonium and what we know about the health effects of plutonium. In that chapter, the 18 people who were injected with plutonium are described. So I think that one way for the committee to get started would be, instead of looking at a billion pages, maybe look at 2,000 pages and get a real sense for how we know what we know about radiation and radioactivity. CHAIRPERSON FADEN: We certainly need to extend or expand our bedtime reading. That's clear. But I think that would be very helpful. Could I just ask: Is the person who wrote the book still alive and active? DR. ROYAL: Yes, he is. Do you want to know who published this book? This book was published by the DOE in -- CHAIRPERSON FADEN: By the DOE? DR. ROYAL: Yes, in October of 1988. And the author's name is Jay Newell Stannard. He is still alive. As a matter of fact, I heard indirectly that he was still writing about his experiences with radiation and radioactivity. CHAIRPERSON FADEN: I would think we would benefit from -- DR. KATZ: Are there many experiments in the data? DR. ROYAL: I think that this is the single best compendium of all of the experiments that have been done with radiation. Certainly one of the things that the public wonders about and the things that I wonder about is whether or not there were experiments that were done that have never been publicly disclosed, but anything that exists in the scientific literature about radioactivity, it is very likely that you're going to find a reference to it in this book. One of the things I was going to ask Anna to do is to Xerox the chapter on plutonium and send it around to the committee members to give people a sense for what's in this book. CHAIRPERSON FADEN: We can certainly do that. We can also order copies for members as well. Promise to read it. Yes, Duncan? DR. THOMAS: Along these lines, I was also going to suggest that the staff start assembling a library of publications in the open literature which have resulted from these experiments. CHAIRPERSON FADEN: Yes. It's my understanding -- we have to check this -- that the National Library of Medicine has been actively involved with the Interagency Working Group in collecting the published literature. We'll have to establish the extent to which that's correct and what the holdings look like and what we can make available. Dan? MR. GUTTMAN: I can comment. This is the same discussion of the shortcuts versus the comprehensives. You've got to do it both. You've got to do it efficiently. Part of the search, which you'll hear about tomorrow, is a literature search through all of the contemporaneous computer archival systems and whether that's complete or how it's complete, these are all the questions you're going to ask. But there will be, I'm sure, many hundreds and hundreds of monographs. The question is: What are the shortcut ways that you could all begin to get into that literature? I don't know whether that's the discussion now, but that's the kind of thing that we're obviously interested in discussing immediately. DR. ROYAL: One way to check on the completeness of a book like this would be to compare the experiments that are listed in this book with the experiments that were described in Representative Markey's report in 1986 and see whether or not all of those experiments are described in this book. CHAIRPERSON FADEN: I'm sorry. Were you -- DR. TUCKSON: Let me take Henry's very useful suggestion and take the opposite tack just to compare it. It seems that one of the desired utilities of this experience, both for the Interagency Task Force and this Advisory Committee, is that everything that is possible to bubble up to the surface gets bubbled up and then it all gets dealt with as ones in America puts this episode behind it. I think if you could write the script, that's what people would like to have happen and like us to be involved in. The rate-limiting step, I imagine, for that is: Is it possible to, in fact, bubble everything up or to give folks a general sense so the questions we asked Representative Markey and Senator Glenn won't have to be asked again five years from now "Do we know all we need to know?" And folks will say, but in legitimate reason, "Yes." So the question really becomes then to me: How do we make that analysis of what is possible? Is it possible to get the agencies to do their work in such a way that they can legitimately say to us "Yes, we really do feel like we know it" or is that task just so impossible that there's no point in trying to walk down a useful, futile road? What I'm trying to grapple with as I think through that is: How do we begin to answer that question so I can put it out of my mind one way or the other? DR. KATZ: Could I respond to that? Because the question we have to ask ourselves: Do we want to know everything? And why do we want to know everything? At least my answer for the moment is I don't want to know everything, only for one reason. It will become repetitive. And, as they say in Yiddish, enough is enough. And where we have enough data and enough evidence, now let's proceed with the analysis. And just to heap one more study on the other, what is the value? Let just me add one more thing because it was stimulated by what Senator Glenn said. We should not be concerned with the egregious experiments because what can already happen when we talk about the Marshall Islanders and similar kinds of experiments, we become less content in this country and say, "Look, this is really terrible. We don't have to worry about this happening here. This can't happen here." But there are the daily experiments going on that are less egregious that are almost considered now banal and commonplace but where the dignitary interests of subjects of research are being violated, to my mind at least, in egregious ways. We have to document that, too, because that's part of American life. So for the response to the challenging question -- DR. TUCKSON: What a wonderful response back. And help me, then, with what comes form that question of: How much do you have to know? And why do you have to know it? At some level if we assume that we have a legitimate number, we have exhausted the categories, whatever they may be, of episodes such that we then can draw analysis and conclusions, if we can draw relationships, interrelationships, between those categories, then we don't have to know everything. That's for sure. But where we get into difficulty in my mind will be when we come to the question of -- perhaps when may get into difficulty will be in the issue of the responsibility for medical follow-up of people that deserve attention and follow-up, for whatever reason, and then in the area of compensation. Now, the compensation may not be as tough either because maybe even there, you could have later -- I mean, individual cases you could handle maybe in individual ways. And we don't have to, therefore, be worried about or the government doesn't have to be worried about discovering the finite set of potential compensatory people, but the medical follow-up may be the one that I want in terms of: Do we have any responsibility to be thorough just because of that, the discharge of that responsibility? DR. KATZ: The only familiarity I have with that was in the Tuskegee syphilis studies, in our investigations. We could identify reasonably well the 200 remaining subjects of the research and the 200 black Americans who served as controls, but we knew that they might have infected families, their own families, and families' families with syphilis. And we didn't know how to locate them. We resorted to advertising. I mean, once we know to some extent as much as we can what experiments we are concerned about, -- and we can't be complete about it -- then we may have to advertise or let doctors, public health persons know, "Look." That's one way of going. There may be others. If you think you participated in any of these experiments -- CHAIRPERSON FADEN: Make sure we get Mary Ann into the discussion. DR. TUCKSON: Mary, can I just make sure I -- so what I hear you saying back is that at some point everything doesn't have to be completed by this group. If the mechanisms and processes are in place for longer term, which is inevitable anyway, then we can feel comfortable that perhaps we've adequately addressed some of them. I see what you're getting at. DR. STEVENSON: I think Reed's summarized most of what I wanted to say, but I think in terms of the committee's mission or ability to address the moral or ethical issues or to establish general guidelines for the future, we probably don't need to look at every single case. But I do think we have an enormous responsibility in terms of the medical follow-up and potential consequences to be as exhaustive as possible in identifying these people and trying to establish some sort of contact with them or their families or make it public through advertising, that there is now a body of evidence and people that are responsive to their concerns and that on a very pragmatic level, there is potentially going to be some compensation and response, either at the level, as we discussed this morning, of a formal apology or more probably monetary, whatever, but I think we do have a responsibility to be exhaustive in that sense. CHAIRPERSON FADEN: Frank, did you want to comment? DR. PRESS: I think it's important to have some feeling for the order of magnitude of what has happened historically for historical purposes. That doesn't mean going through a billion pages one at a time. There are statistical sampling techniques that can be used that would give us a fairly accurate indication of the total, of what did happen quantitatively. If there were any egregious cases uncovered that we didn't know about, we're not going to look very well. So I think we need to ask the agency heads to tell us everything that they know as of today, you know, that we should know, define it perhaps egregious or whatever, that we should know about. And then, finally, if we had a process, not the Federal Register, but another kind of process, where it's widely disseminated across the country that we could like to hear from individuals by mail of examples or case histories that they happen to know about, in a sense, that's sort of ground truth that would make the agencies a little bit more honest to know that we've done that. And it might reveal certain things. I agree with you we want to get a feeling for what happened, know how bad it was without imposing an enormous burden on thousands of university investigators who have been supported by NIH for all of these years, universities, a billion pages at one center here in Washington on the NIH campus. That's impossible. So I think by an intelligent approach along these lines or some other lines, we can limit the scope of the survey so as not to unduly burden the whole research community in the country and, yet, get a good feeling as to what happened, ask the agencies to tell us everything, if it's not all here, wherever else, so that we really know what they know now and then this call for any individual who has something to tell us, not that they all have to come here and testify, but we might get a good idea of what that kind of source reveals. And perhaps a few of them might be called in to testify. CHAIRPERSON FADEN: Yes, Duncan? DR. THOMAS: Regarding your last point, there is already a fairly well-advertised hotline, which has, I gather, logged several thousand calls the last I heard. It seems to me we should make this a fairly high priority, having -- I think that's DOE that runs that hotline -- make a presentation to us as to what they've learned on that and receive some sort of tabulation of what's been called in. CHAIRPERSON FADEN: Dan, did you want to make a -- MR. GUTTMAN: Just a point of information. This is focusing. Tomorrow morning we had thought it might seem tedious, but there are going to be 2 hours or an hour and 45 minutes where the agencies are going to present exactly what they're doing. So all of these questions overnight you think about and focus because that's the question. It's sort of described as bigger than a bread basket. What are we talking about here; right? And the wheels within wheels and the classification and all of these other things, this is the real nitty-gritty that you're getting into now. Tomorrow morning you're going to be able to get into it with the people who are supposedly going to have the -- CHAIRPERSON FADEN: Having been meeting now for some time with the people at the agencies in terms of what they're doing -- we're going to hear a lot of information tomorrow, but let me anticipate so that we can be thinking along the lines of this discussion, which is very helpful. Part of what I think we are likely to hear is that we now -- and we've heard this already this morning -- we need guidance from you because we have preliminary information about X number of incidents or experiments or cases. Now, do you want us to look at all of them? Do you want us to do a sample of them? Do you want us to do a stratified sample? Do you have a certain set of criteria? It seems to me that what's coming out of this discussion is a complex strategy that is starting to sound fairly good to me that we need to give some more thought to. But let me just throw out the strands of what I'm hearing, and then we can think about it and talk about it some more today and then tomorrow. These would be compatible strategies, not exclusive strategies, trying to pull on the different considerations that people have raised. In order to get a general feel for what's going on, some sort of sampling of the studies does seem appropriate. How we construct it, I'm looking at Duncan because you'll bear the full weight. Hopefully we'll get you some colleagues, but the notion of how we would construct a strategy for sampling that would give us the feel, I think, that Frank is asking for and that Jay is asking for and a way to put a denominator in part into the process. So if we have X number of really worrisome cases against a denominator of how many not so worrisome cases kind of an issue, we then do have the counsel that Frank gave us that our report will become less valuable if it subsequently appears that certain very troubling cases were not considered by this committee. So it seems to me if that's correct, that we need to give, in addition to this sampling strategy, the agency some criteria for at-risk studies, studies that we would raise red flags, "Please pull those," whether that's a stratified sampling strategy or whether it's a separate strategy that says, in addition to the sampling mode that we will work out with you, we want you to pull those studies in which X, Y, and Z seem to be in place. And we can put them in. But they're the issues we've been talking about already today, like the subjects were from certain vulnerable categories, however we define it, or there was an indication that the study was conducted for military, rather than health, purposes or that there was no indication that consent was obtained or whatever the criteria are that make us particularly worrisome, we could work on that. We do have the issue that Mary Ann is urging and together, as I understand it, with Reed, which is that we have real obligations to the people who participated in these studies to address human concerns. And so it seems that a high priority would be studies where it is reasonable to think there are still survivors. Now, how many of these studies, that may be a category that swamps everything -- I don't know -- or, in addition, studies in which the kind of intervention suggests that there may be real concerns with respect to subsequent generations. So even if the actual subjects don't exist, there's a reason to worry from a medical follow-up point of view about subsequent generations. And it seems to me if we can come up with some mix of strategies of that sort and give that back to the agencies, by the end of this meeting or the beginning of the next meeting, we will go a long way towards letting the agencies do the work that they need to do to support us because right now we'll hear it tomorrow about the huge amount of information that they're uncovering. They can't pursue every single incident or case or experiment, no matter how they've articulated it, with equal intensity. And we need to give them some focused guidance. Duncan? DR. THOMAS: I agree completely we need a variety of different mechanisms in order to try to make sure that we've covered all the basis. I just remind you that the one category which I didn't hear mentioned was the hotline or similar mechanisms to allow the public themselves to alert us. CHAIRPERSON FADEN: We absolutely need it. We need to link the hotline, too, to the issue of the experiments that we seem to know about. I didn't start listing the categories, but one category that I would take to be very important for special handling would be studies that were kept secret insofar as they were kind of a unique set of considerations. And we would, I hope, agree to flag those studies that were kept secret. One way to triangulate that is with the calls from the hotline where somebody says, "I was in the study," we find no record of the study. Well, is this something the person misunderstood or is that a lead to a study that perhaps can only be found in classified material or otherwise is unavailable? Reed? DR. TUCKSON: I don't know if it is possible, but, first of all, it is a brilliant planning to have the associate agency heads tomorrow so that we'll get a sense of the orders of magnitude in each of those agencies. If we could supplement -- I don't know if it's possible at this late time today. As to whoever is responsible for the hotline, I'm not sure which agency that's in. CHAIRPERSON FADEN: Energy. DR. TUCKSON: But it would be wonderful to get that added to that because that starts to really define the scope. So if it's possible to get the hotline person over here, it would be useful. CHAIRPERSON FADEN: Apparently we have some information about the hotline in our packets. So we can look there. But we can try and get more information tomorrow, in the presentation tomorrow. There's obviously a lot to know. There's not only the hotline. There are the letters. I mean, I have been receiving letters. The committee has been receiving letters. We don't know whether those people have called as well as written. Henry, yes? DR. ROYAL: One concern would be that this committee would promise more than it can deliver. Reed had mentioned before about the credibility of the committee relying on no further cases bubbling up after the committee does its investigation. I wouldn't want to set that as the criteria for the credibility of this committee. I think it's unrealistic to think that we're going to learn everything about everything. So when we talk about what the committee is going to do, it's important to make sure that we're not promising something that we can't deliver. CHAIRPERSON FADEN: That's good cautionary advice. I would hope that what we can do is be very clear about what we can accomplish and then leave things, leave stuff in a situation such that the scholars and the press and the general public that follow after us can continue to do the work that we can't complete. But you're right. We certainly don't want to set up unrealistic expectations and then fail by our own unrealistic standards. That's a good caution. Ruth? DR. MACKLIN: I may begin to sound like a broken record at a certain point, but I'm going to make a plea again for us to be careful even with the language that we're using. If we're talking about studies, we have one picture of what that is. If we're talking about releases into the environment or moving Marshall Islanders back, that's not a study in the same sense as a subject population. I think it's important just for our conceptual purposes to use the broadest possible language because what we heard Senator Glenn saying was to keep an open mind about the kinds of things that fall within the scope. Now, as far as identifying people, until it's discovered or known or learned that something is released into a certain environment, you don't even have any subjects. There may not be subject records. That is, there are people who may have been affected, although they weren't actually studied. CHAIRPERSON FADEN: Right. DR. MACKLIN: So it sounds like at least from the agencies that were involved in release of substances, whether or not the -- however experiments or research might have been defined; that is, whether it was a systematic look or a casual look, it would seem to me we would want to get as much as possible from those agencies to find out what they released and when and under what circumstances and what they studied. I mean, that's different from having to go into physicians' records or looking at people who are enrolled as patients. CHAIRPERSON FADEN: So you're calling for as exhaustive a strategy in that direction -- DR. MACKLIN: I think so, in part because it has a different sense of unwitting subjects. I mean, this is not a question of failing to get informed consent from identified individuals into whom something was injected. This is populations or regions of the country or islands in the Pacific that were subjected to something without their knowledge or consent. DR. KATZ: What is the difference? What is the difference that you want to bring to our attention? DR. MACKLIN: Both are ethically wrong. Both are ethically wrong. DR. KATZ: Yes. DR. MACKLIN: The difference is not a difference at the level of ethics. It's a question of whether or not one could define subject populations in the same way. In other words, in the case of patients, let's look at patients or possibly normal healthy volunteers who were people who were subjected or to whom certain procedures were done by individual researchers. That's a study in the sense that fits more the kind of picture we have of human subjects research or human subjects experiments. In that regard, as you, Jay, have been suggesting, we may not have to look at every single one or find every patient or look through all the records. On the other hand, if it's a question of looking at all releases of radiation of certain types in certain areas, we wouldn't have to look and see what happened to all the people, but we might very well -- it may be our obligation to find out all of these situations in which that was done simply to have for a record. I mean, that doesn't involve looking at the records of individuals, but, rather, at what agencies funded and what in this effort was done. CHAIRPERSON FADEN: Duncan and then Reed, if that's all right. DR. THOMAS: Yes. I think you've raised a very important question. I see a distinction in the case. Let's talk about the Marshall Islanders for a moment. I see a distinction between the situation where the islanders were moved back into a hot spot because of misguided, ill-informed understanding of what the risks were, as opposed to a situation when they were deliberately moved back for experimental purposes. The latter clearly in my view constitutes an experiment, the former probably not. Now, at least in my field, we make a distinction between an experimental and an observational study. I think this may be helpful in helping us focus on our activities. The fundamental line of distinction is whether or not the exposure of the individuals is under the investigator's control. The situation when the investigator makes the decision to expose an individual, that's an experiment. If he's simply observing something that has happened already, whether it's a natural experiment or an accident or whatever, and then simply passively following that population to find out what happens to them, that's an observational study. There are perhaps gray areas where in the process of doing an observational study, one has to enroll individuals and subject them to further investigations, which may or may not involve radiation in our case, that perhaps should come under our scrutiny. But I think we have to ask ourselves whether we really are interested in the situation of purely observational studies of radiation exposures that had no experimental content, such as, for example, routine releases from a nuclear plant, for example. That does not appear to be part of our mandate. DR. TUCKSON: Actually, Duncan has said it better than I could. So I think, Ruth, I generally see the direction you're going in. What I think you're helping me to see, though, is that there is a distinction. If there is a drum or something that fell off the truck and released things in the air, I hear your point when you suggest that that then creates some subjects in the sense that there are people now who are affected by that experience, but, as I understand it, our mandate really is to look at deliberate actions that have consequence, as opposed to, for example, accidents. Now, I wonder if that helps to draw the line at all. DR. MACKLIN: Not completely because, I mean, Jay Katz can correct me if I'm wrong here, but Tuskegee could have been described as an observational study; that is, without manipulation. But it was the failure to do something that might have been done. Now, there could also be the failure to inform or notify. Okay? That is, I take the distinction that Duncan made to be very important; that is, where there's no knowledge or no suspicion that there may be harm to individuals from another situation in which you suspect there might be harm to individuals and you stand back and do nothing. So it's an observation in nature. But an observation in nature can be culpable if people aren't warned, if people are not alerted, or if some intervention that might help them is not undertaken. So I don't think the line is going to be quite as sharp between observation and manipulation or observation and intervention. I mean, if, for example, there was an accidental release of radiation, accidental, not intentional, and it was believed that there might be some harm and people were not alerted or informed and were studied, nevertheless, under the guise, "Well, we didn't do this to them. We're just going to look at what's happened to them," then, I mean, I would argue that there's an ethical problem with that kind of observation study. DR. TUCKSON: Just to make sure I understand, -- this is helping me -- first of all, you take the example where something is released. No follow-up is done. None of the appropriate things that one human being deserves to do to another as a result of such a catastrophe are done. So it's badness and reprehensible badness. But they also didn't do any further observations. They just didn't do anything. They were crummy people. Then would you consider that within our purview, even though, I mean, it's obviously reprehensible? DR. MACKLIN: No because there wasn't any research or data gathered or anything in connection with it. DR. TUCKSON: So if there is data gathered -- DR. MACKLIN: It's just bad people failing to act. DR. TUCKSON: Okay. All right. I'm beginning to understand. DR. KATZ: A good example of the uranium experiments were the Navajo Indians. You know, they discovered that the Navajo Indians were working in radioactive mines. And, of course, the mine owners didn't want them to know anything about it. But then Public Health Service moved in and did an experimental study and didn't want to inform the Indians, American Indians, either of the study or of the dangers to which they were exposing themselves. Their reasons were good ones, namely because the Native American Indians would have then quit their jobs, and the mine owners didn't like that. And so this becomes an experiment, doesn't it? CHAIRPERSON FADEN: Susan? DR. LEDERER: Well, we also have the example, I guess, of the survivors of the deliberate releases of atomic energy, the survivors at Hiroshima and Nagasaki, who were then studied by the Atomic Bomb Casualty Commission under a no-treatment policy. So we do have that population, not in this country, but certainly in Japan, as another example that we might bring in as a point of comparison about where we're going to draw the line between an observational study and experiment. CHAIRPERSON FADEN: The floor's open. This is territory for us to chart. Henry? DR. ROYAL: I was just going to ask Susan to clarify what she said about the no-treatment policy in Japan. Are you talking about the acute radiation syndrome or are you talking about no treatment for what? I'm not sure what you're referring to. DR. LEDERER: I guess not for the acute, but I'm relying on the work of another historian, namely Susan Lindee, who has studied the Atomic Bomb Casualty Commission. Actually, it was an official no-treatment policy on the part of the American participants, although physicians actually did treat. But it goes back to the nature of whether an apology was in order. In this particular case, the no-treatment policy was adopted as a political strategy because America was not going to apologize in this case for the dropping of the bomb but was interested in the effects of radiation on the survivors in order to help the survivors. DR. ROYAL: The reason I'm confused, Susan, is I'm not aware of any treatment for radiation exposure. There's nothing that I can do to make someone have less of a chance of getting cancer once they've been exposed to radiation. So that's why I'm not sure what treatment was withheld. DR. LEDERER: Well, I guess I'll have to get clarification from her. Maybe John can -- MR. HARKNESS: I also know Susan and her work. It extended to the level of providing sort of routine first aid, bandaging of wounds and that. It was really no treatment was the policy that was supposed to be followed. Now, as I understand it, individual physicians did violate that policy in some instances, and there came to be tension among the ranks of physicians who were involved in the Atomic Bomb Casualty Commission. But, again, it's relying on Susan's work. CHAIRPERSON FADEN: If this is of interest, we can certainly ask Professor Lindee to prepare a paper. We've already been in contact with her. We are identifying the historians and scholars around the nation who can contribute to our work. She's certainly one among them. I think your point is well-taken, Henry. We have to understand these parable cases if we're going to use them in sophistication so we can draw on them in an intelligent fashion. DR. LEDERER: For me the point was to go to Ruth's comment about how an observational study can become culpable. And the Tuskegee example also came to my mind because their treatment was, again, actively withheld from subjects who might have benefitted otherwise. CHAIRPERSON FADEN: One of the agendas in my mind for the next meeting as well as staff and some other people have raised this already is that we spend a good part of our next meeting educating one another about each other's relevant disciplines. And, hopefully, tomorrow afternoon we'll spend some time identifying the areas or topics that we would like to receive many lectures on, either from one another or from outside consultants. And it would seem to me that this area of this issue that has just been discussed would be one candidate, for example, for a short presentation. DR. MACKLIN: That leads me to a question of something that I don't know, and it's probably my abysmal ignorance. But that is the extent to which -- 1974 is being mentioned as some benchmark because that's when the National Research Act gave rise to the current federal regulations. And as of now, there are uniform regulations for all of these different departments and divisions and agencies. But for a very long time, it was only -- CHAIRPERSON FADEN: Quite correct. DR. MACKLIN: -- Public Health Service. It was only NIH-supported. And there were occasionally -- and this is purely anecdotal -- hand-waving and remarks, "Oh, other biomedical research that's carried out by other federal agencies follows these rules." And that was stated. But I for one don't know the extent to which it was. I don't know the extent to which or the degree to which investigators under those auspices followed the same informed consent procedures that were put in place in 1974 or the extent to which there were two paths for quite a while going on. So, I mean, it would be useful as background to know whether 1974 is as important a date as possible and even before that because there was no magic bright line. And, therefore, if the consciousness and awareness and the practices of researchers were being -- this goes to the question of finding out what the standards were. CHAIRPERSON FADEN: That's exactly right. DR. KATZ: By the way, Ruth, as a footnote, it's sad, but delightful. The most stringent regulations were enacted by the Department of Defense in the 1950s because they only adopted the Nuremburg Code. And you know how strict that is. But then for years nobody knew about it because when they promulgated the Nuremburg Code as the document to govern research practices, they stamped it "Top Secret." (Laughter.) CHAIRPERSON FADEN: There's clearly history here that we need to uncover. There's no question about it. Your point is well-taken. I myself have been mystified by the intense focus on the 1974 bright line in our charter. I understand its role publicly, but I think that we would be mistaken as a committee if we were to act on the assumption that something magical happened in 1974. DR. MACKLIN: For two different reasons, I think: backwards looking and forward looking. One important consideration is to determine what standards were in practice, for example, by NIH-supported research, by people who read the Henry Beecher article, the landmark article in the New England Journal. So that consciousness was already raised and procedures in place in the biomedical community perhaps in NIH-supported research or in other areas before 1974 -- CHAIRPERSON FADEN: Quite correct. DR. MACKLIN: -- and not knowing, therefore, in the other agencies what might have continued to go on since the Cold War was still going on after 1974, when they were not under scrutiny from the outside or under the Public Health Service or NIH scrutiny. So I think it goes both ways to the question of standards. CHAIRPERSON FADEN: Yes, which is a large part of our task, clearly. And, hopefully, we will have the resources to be able to do right by that, but I think it's absolutely foundational targeting straight on this and that we have to remember that this is not simple with respect to this question of standards and practices in 1974 and pre and post, one another and the other. We should certainly find out if that Nuremburg Code stamped "Top Secret" is still so stamped. DR. KATZ: No, no, no. CHAIRPERSON FADEN: I'm teasing. I'm teasing. DR. KATZ: They realized there was something wrong with the "Top Secret" application. CHAIRPERSON FADEN: Hopefully, we can declassify everything else as easily. DR. TUCKSON: It sounds like we're grappling with how to come to some preliminary set of closure. I don't know. I guess some of it still depends also on what we hear tomorrow. What I guess I need to understand is: By what time do we need to have brought to closure the scope and the depth of the net? It sounds like we've gone a little beyond the book, but not so far that we over-promise that we'll discover everything and that when this work is over of our committee, everything is known and the country starts afresh and anew. It sounds like we have, though, just in the last 15 minutes of discussion through Ruth's important contributions again expanded, though, not only the scope to include a little bit broader net than we had a few moments ago, but even including some more in terms of dates that the people would have to go back and look at data, even after the '74 magic line, which, by the way, I'm okay with. I'm not faced with the realities of logistics yet and money and time. I don't know what these things mean yet. So I'm happy that it's broader. When do you want us to have this squared away? CHAIRPERSON FADEN: I think we're in something like the following situation. I imagine that our understanding of what will serve our mission best and indeed what our mission truly is is these are both evolving processes. And we may come to discover six months from now that we're in a project that has taken shape that's perhaps surprisingly different from what we're discussing now. I think we can't quite predict it. But at the same time the agencies do need guidance now. We need to get these started. And I think it's fine if we change our mind after some initial work or, say, you know, adopt the strategy, adopt this other one. We're shifting our priorities or we're seeing that this way of doing things isn't yielding what we thought it would yield. But I do think that shortly, if not by the end of this meeting, by the end of our next meeting, we need to say "Okay. Here's our first cut at how we would like you to slice this." And then we see what happens. Dan? MR. GUTTMAN: Yes. At the risk of anticipating what has already been discussed, we've got at least three different things going on in the critical path mode of discussion. One is this document. I think what's my sense and certainly others of you articulated that the committee, at least in my sense, can't be passive. It's got to make sure that, you know, it's not just sitting here and receiving what is given. Now, the other side of that, having been to many of these meetings, as has Ruth, I'm modestly daunted by the task of that. That's a daunting task. And you can't have staff or any of you going out to warehouses all over the place because you'll be flying all over the country. So the question number one is: What's the process? We have some thoughts on that which we'll discuss in the staff section. It includes having the kinds of people that Sue Lederer is talking about. Historians have been looking at this period, for example, who have been studying the AEC in 1947, giving some kind of pinpointed discussion. That's a process of how do you get into that kind of massive amount of documentation. A couple of people say it's not only going into the documentation the federal government has in the Executive Branch, but we've talked with the GAO and worked with the GAO. DR. KATZ: This just occurred to me, may be a bad suggestion. What really we're trying to figure out is how to get into the minotaur and slay the various dragons. We can lose our way, you know, and never come out. Since we will also at least to some extent, study experimentation done in the last 20 years, in their documentation may be more readily available because the records still exit by finding out what has been going on in recent decades more comprehensively and more readily and the things we should be concerned about. Let me help us with our historical task perhaps. MR. GUTTMAN: I want to just break out the three conceptually. One is this mass of information which is not only in the Executive Branch but may be out in, you know, the Harvard Library basement, the papers of some of the doctors, working with the GAO and whatever agencies have been looking at this. The second is what can begin immediately -- Dr. Neumann's got the volume -- is we have a good deal of information or the standard book may have all we need to know, maybe not all we need to know, but what we can do immediately to sort out by the categories that you people are going to decide these various kinds of things. You can in the discussion that you're going to have in the next day or two -- you know, do we have enough to begin to sort things out? And the third is this underlying continual baseline education so that you're all speaking the same common language and you know what it is that you're talking about when you're talking about these various things in your own languages. I don't know. This is why tomorrow's discussion with these agencies, you'll get into either the enormity or the triviality of the task depending upon -- you know, it's clear we have to have a process to oversee it. We're thinking about it, and you have to tell me what that mechanism is. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: Is it likely based on just what we heard so far from the Secretaries, the people from the various agencies that we're going to want different things from different agencies? I mean, the task from HEW is a much bigger one in sheer enormity and complexity than -- was it the gentleman from the CIA who said they didn't find anything? CHAIRPERSON FADEN: Right. DR. MACKLIN: So it suggests perhaps that the process has got to be different from the different -- MR. GUTTMAN: Which is the bigger task? (Laughter.) DR. MACKLIN: There are two senses of bigger. But what I'm suggesting is not that the process may have to be different, both what we request of the agency and what we draw upon. CHAIRPERSON FADEN: You raise a very important point, which is whether our strategy for giving guidance to the agencies will vary agency by agency. And we really need to think that through. It will help to hear what the agencies have to tell us, but we know that different agencies were involved in supporting different kinds of work more or less. So, for example, if we're concerned about research in which some or all of the research process was itself kept secret for some period of time, that's much less likely, for example, to involved DHEW/DHHS than some of the other agencies with which we're dealing. And so it does fall out -- DR. MACKLIN: And, for example, if some of the research was done on a population where the records are more likely to be kept or located in one place, I mean, people who were in the military, for example. That is, the different agencies may have had subject populations more closely defined or even researchers or investigators who fall into a certain category. I mean, I'm making this both because of the volume of the different agencies and also the accessibility of the information and our ability to scrutinize whatever we get. CHAIRPERSON FADEN: I think if I could just hook this up with Jay's comment, I'm not sure that it's a matter of past or present. It seems to me that this is all of a piece. Whether the study was done in 1976 or it was done in 1956 is almost irrelevant to some of the considerations that we're talking about today. We may want to over-sample in the early years or we may be expecting that certain kinds of particularly worrisome risk factors for ethically troubling research may appear disproportionately in early decades more than later decades. That's just a working hypothesis, but essentially it's that same problem. We couldn't possibly look at every study from 1974 forward any more than we could look at every study from 1974 backward. So it seems to me we're sort of stuck with that same question and strategy. I do think at the risk of repeating myself, that we are coming to some tentative not conclusions, but tentative intuitions about what we would like to see back to the agencies. And I would hope that we continue to hone that down. At the risk of putting Duncan on the spot, could you speak two minutes to the notion of a sampling strategy and how you would envision that operating or anyone else who would like to comment on that, not exclusive strategy, but a strategy? DR. THOMAS: Agreed. I said this morning it had to be just a strategy, and it was in my view a strategy for getting us started, for learning the dimensions of the problem. The concepts of stratified sampling are probably pretty familiar to most people. The idea is you have a universe of in this case studies that are of some concern to us. And we subgroup them in various ways, and then we draw a sample from each one of those subgroups so that we're sure that we've covered all of the things that are of concern to use. Now, for this strategy to work, we have to have an operational definition of these categories that has to be very simple. It's something that we can easily implement based on the information that's available. If we have to read a 1,000-page document in order to know how to classify it, we've defeated the whole purpose of stratifying sampling. Until we really get into the records, it's going to be difficult for us to know what dimensions that we might theoretically be interested in, what will be practical to define in the categories in which we're going to sample. But I think a lot of suggestions have been kicked out this morning. And perhaps part of our job tomorrow might be to raise some of these as trial balloons with the respective agencies that have more familiarity with these records than we do, say "Would it be feasible for you to use criterion X, Y, and Z as the dimensions?" Once we have identified the dimensions, once someone in each one of these agencies has then gone through their records and classified them, we then need a scheme for selecting. And as a statistician, I would be inclined to recommend some form of random sampling within each one of those groups. CHAIRPERSON FADEN: I'm surprised. DR. THOMAS: And then the next stage is to ask, "Well, what do we want to learn about these studies once we've done it?" So we need to then follow this up with some sort of a simple questionnaire, which we could develop to collect some data on each one of these things. That might lead to yet a further stage of sub-sampling, where we on the basis of what we've learned from I'll now call it the second cut, we identify those studies that are of particular interest to the committee that we think we would really learn a lot more by really reading everything we can get our hands on about those studies. On that basis, we would then iterate. We might go back and say, "Well, okay. Based on what we've learned so far, now we ought to refine our categorizations, and we ought to take a much bigger sample of the following areas, subgroups, that have proved to be particularly troubling," for example. CHAIRPERSON FADEN: We have a break time at this point. I'm almost sorry because it seems like we're kind of moving towards -- DR. THOMAS: Complexity. CHAIRPERSON FADEN: Well, even specificity. DR. MACKLIN: A broader role. CHAIRPERSON FADEN: A broader role. Thank you. I was looking for a very technical term, which Ruth just supplied to me. We were on a roll here, but we do have to take a break. We reconvene at 3:15 for public comment. (Whereupon, the foregoing matter went off the record at 3:00 p.m. and went back on the record at 3:20 p.m.) CHAIRPERSON FADEN: We are up to the public comment section of our meeting. I understand there is one person, Gwendon Plair, who has requested to address the committee. Thank you. We would appreciate it if you could keep your comments to five minutes. And then if the committee has questions, we will ask them. Thank you in advance for taking your time to come talk to us. Any of those mikes is fine. PUBLIC COMMENT PERIOD MR. PLAIR: To the Advisory Committee on Human Radiation Experiments, I would like to say I appreciate this opportunity to talk to you today. I have waited all day to do this. I prepared a 10-minute presentation, but I'll try to give you the highlights. CHAIRPERSON FADEN: That's fine. MR. PLAIR: My name is Gwendon Plair. I'm a mental health therapist living and working in Washington, D.C. But, more importantly, I am the son of Mrs. Beatrice Plair, Number 44 of the Cold War era radiation experiments that were done in Cincinnati, Ohio in the Cincinnati General Hospital in that particular state. I also come here today representing and speaking on behalf of my family and 35 other families who had loved ones who were unwitting participants in the radiation experiments conducted from 1960 to 1971 in Cincinnati. Our group, which is a support group of families formed just last Saturday, named concerned relatives of cancer study patients, wanted to let you know that we're very concerned that our voices are heard as these meetings and briefings and research that you do continue, whether it's six months or a year. You see, at least for me it's been 29 years getting some resolve to the situation. I am awed by the mental power that I see around me and have seen today and heard, but I hope you can appreciate the awe that I heard and listened to the last three weeks from families that at least from 10 to 15, my case 29, years have tried to get some resolve to an answer as to why my mother and other mothers, fathers, brothers, sisters, uncles, and aunts were exposed to ongoing radiation. And we feel that the quality of life, in many cases the shortening of the life was caused by the exposure of radiation. We ask you to please involve us as you go along in your search for the truth because we have found that just among our families, we have dug up a lot of information that in the years that have passed with the various committees, subcommittees that have tried to get the answers to this question, they have not answered it yet. And I think for that reason, that's one reason why you're here today and I'm here, is time to get the answer straight and clear, no more coverups, no more putting it under covers. We deserve an answer as families. We have a vast amount of information. I heard Dr. Tuckson say the importance of the families. I can't tell you. We have information that we have uncovered that would be of vast importance to this committee I know. We have done research in the libraries, around the country. And in a matter of three weeks, we have gotten letters. Even from my place here in D.C., I've gotten letters and calls from families as far away as Japan regarding how they can help us and give us input. That's in three weeks. That's a lot of busywork, 35 people. There's a lot more I could say, but I will conclude by saying this. Don't exclude us. Include us. And maybe I might even suggest that as you come to some conclusions, as was suggested, that you go to some of these states and talk to people, the family members, because in most cases the survivors, there aren't any. In our case there's just one. But there were family members, myself, that were with my mother every day through the radiation and saw the suffering she went through and talked to her, watched her cry and ask for help and she didn't get any, and listened to the doctors tell her that she was just receiving a treatment when we finally discovered she was part of an experiment. I heard you use different words here, but it came down to experiment, not investigation, not a study, not a research, but experimentation of my mother and other family members. I thank you for your time. I appreciate your effort. And I hope you will continue to search for and find the truth, not only for me, but the other families that I represent. Thank you very much. CHAIRPERSON FADEN: Thank you, Mr. Plair. Can I just ask you for the record if your group has a name and if there's an address or a phone number that we can contact you? MR. PLAIR: Yes. It's the Concerned Relatives of Cancer Study Patients. We call it CROCSP, C-R-O-C-S-P. And you can reach me at my number here in Washington, D.C. And I'd be more than happy to give that to you. CHAIRPERSON FADEN: You can do it right now -- it's being transcribed -- if you don't mind. MR. PLAIR: Okay. No, I don't mind. CHAIRPERSON FADEN: I mean, we can get into this privately, however you want. MR. PLAIR: It's 723-6365 or you can also reach my brother in Cincinnati, Ohio. That's Gregory Plair. And that's (513) 381-0595. CHAIRPERSON FADEN: Thank you. MR. PLAIR: Thank you very much. CHAIRPERSON FADEN: Thank you. Why don't you wait for a minute? We may have some questions. Are there questions from the committee? DR. TUCKSON: First, just how do you spell your last name? MR. PLAIR: Plair, P-L-A-I-R. DR. TUCKSON: P-L-A-I-R? MR. PLAIR: Yes. DR. TUCKSON: And first name? MR. PLAIR: Gwendon, G-W-E-N-D-O-N. DR. TUCKSON: I'm not familiar with the Cincinnati study. Can you just capsulize it real quickly for us in terms of what was involved or do you know enough to know? MR. PLAIR: Yes. Basically, what occurred, -- and I can use the example of my mother -- essentially they did an evaluation assessment to determine if she had any cancer growth. What they discovered is that after 30 days of assessment, that she had carcinoma of the trachea. She was given pinpoint radiation of five centimeters to that area. What we also discovered was that, without us knowing, she was involved in partial, then to full radiation in a period of 197 days without us knowing about that. Consequentially, what happened is that we discovered after the fact -- this was in February of this year, 18th to be exact. We discovered that the cancer had spread, and we had not known about that. We weren't told about it. The families were not involved in our case or any other families about what was going on. DR. TUCKSON: So, basically, let me make sure I understand it, that your mother became ill, -- MR. PLAIR: Yes. DR. TUCKSON: -- was diagnosed as having cancer of the trachea? MR. PLAIR: Trachea, yes. DR. TUCKSON: Once having been diagnosed with that, she was treated for it specifically with radiation at the tracheal site? MR. PLAIR: Yes. DR. TUCKSON: And then also received full-body radiation over a long period? MR. PLAIR: Partial, then to full-body radiation without us knowing about it and without her permission. DR. TUCKSON: I see. And so your emotions are around: first, that the physicians did not tell you or your mother that the cancer had spread; and, number two, that they did not tell you that she was getting a second kind of treatment and that that was occurring without your knowledge? Is that the gist of your upsetness? MR. PLAIR: That's basically the gist. The other part is that for my mother and at least eight other family members -- I heard someone mention about chemotherapy 10 days prior to her passing. She was also part of the chemo study, of a medication for cancer. And, again, she was not told about it nor we until we did some in-depth study and found it out. DR. TUCKSON: I see. The last quick question -- I don't want to monopolize it. CHAIRPERSON FADEN: Take your time. DR. TUCKSON: I'm curious how you came together in the last three weeks. What was it that causes people to form an organization? And why now? And, secondly, how is it that people have become aware of you around the country? What is it that is occurring out in the world that connects you to other people? MR. PLAIR: Well, I must say, in all honestly, one, I'm a little nervous speaking in front of this microphone in front of such an illustrious group. CHAIRPERSON FADEN: You're doing very well. MR. PLAIR: But I have a pretty big mouth, and so do my brother and several other family members who have been researching this for quite some time. There's always been a question in my mind as to the extent and reason for my mother dying. We were told prior to them discovering that my mother had cancer of the trachea that even if she had some form of cancer, she probably would live at least five or six more years. Within a matter of 190 days from start of the experiment, she passed. And this happened repeatedly over a number of families that we talked to. To answer your other question, what happened is as a result of our research and also, I must admit, with the help of the newspaper reporter researching the files that were not to be found but we found them, we discovered that, in fact, the term "experiment" came up a few times, in spite of the fact of a Dr. Saenger who was the project director and lead researcher referring to a Dr. Nortrup, who was the Director of the Defense Nuclear Agency saying he suggested that, Dr. Saenger suggested that Nortrup, not use the term "experiment," but use the term "study," "investigation," or "research" in referring to the experiment because of the reaction people might have to it. In our research that we did, we found that a few times the term "experiment." And, from that, other families we said do the same thing. They found the same thing occasionally in their research of their families' records. We had to really dig and plow. It wasn't easy to get them. DR. TUCKSON: So I guess I'm curious as to how the other families -- this case got into the newspaper? Is that what it was? MR. PLAIR: Yes, it did. Yes, it did. DR. TUCKSON: And by that mechanism, other peoples came forward to say to you that they had had -- MR. PLAIR: We asked other people "If you have a question" -- DR. TUCKSON: I see. MR. PLAIR: -- "from 1960 to 1970, if you suspect that your family's not" -- DR. TUCKSON: Now, my last question simply is again so that I understand better the nature of the experiment, again, I can understand. First of all, what is clear to me is that you are upset that you did not understand fully your mother's diagnosis, your mother was not told by the clinicians treating her what was really going on; and, secondly, that they were doing another more aggressive therapy. And so I guess your concern is they were doing it without her consent. MR. PLAIR: Let me maybe clarify something. DR. TUCKSON: And as you do that, would you help me to understand what you've come to understand about what the nature of the experimental part was. Was the experimental part the full-body radiation? They were doing that because the cancer was spreading? I'm trying to get a sense of what the experiment part was in your mind. MR. PLAIR: To answer that question, what we have discovered is that repeat least particularly in my mother's case, for example, that the involvement in the radiation experiment was not to help her, improve her condition, but to satisfy the experiment. DR. KATZ: There was a very good study published on the Cincinnati experiments. And, among other things, it revealed that the experiment was commissioned by the -- I'm not sure which department. MR. PLAIR: Department of Defense. DR. KATZ: It was Department of Defense? MR. PLAIR: Defense. DR. KATZ: Because they were interested in studying the effects on human beings of full-body radiation. This was sort of independent of that research as far as I remember, and patients were not told about the nature of the Department of Defense involvement in the research project. DR. TUCKSON: Thank you. CHAIRPERSON FADEN: Are there other questions for Mr. Plair? Dan? MR. GUTTMAN: If I can ask a couple of questions without sounding like a lawyer? First, two questions -- CHAIRPERSON FADEN: He's a friendly lawyer. MR. GUTTMAN: Right. Well, they're kind of procedural questions. These are what have been referred to as the University of Cincinnati experiments? MR. PLAIR: Well, actually, Cincinnati General Hospital at the time, but it's Cincinnati General Hospital Medical Center now. But it was Cincinnati General Hospital at the time. MR. GUTTMAN: Two kinds of questions that I think would be useful to myself and possibly for other people, one is: How did you and your family come to know about this, what you're describing? The second is all of your interactions with the other parts of the American system. Have you dealt with the Congress and the DOD and the DOE and press? So a sense of where this group fits in in terms of the basic fact-finding and what's known and what remains to be, this question about what remains to be, investigated or your sense of what's out there and where this group fits in. Is it just to look at the facts that have been developed? The first question is: How did you discover it? And the second is -- MR. PLAIR: How discover you or discover -- MR. GUTTMAN: No. Discovered that there was a problem with the treatment of your mom in the hospital. MR. PLAIR: Well, like I said, we started asking the question as to -- we just started asking one day "What happened? Why did Mom die? What was the reason?" We started researching and went down to the archives of Cincinnati General Hospital's record room. Everything was on fiche, but they wouldn't tell us what was going on. So we started digging, started asking why. And someone became very angry and told us to leave, quite frankly. And that made us more curious, and we started researching ourselves. We found the old records ourselves. MR. GUTTMAN: Was this many years ago or recently? MR. PLAIR: Recently. Actually, we found February 18th, exactly, of this year. MR. GUTTMAN: So this was after the issue of human experimentation reemerged? MR. PLAIR: Yes. MR. GUTTMAN: And so what about the kinds of dealings and the kinds of information you've gotten from the other parts of the government? MR. PLAIR: Well, actually, it was just the congressional, the 11th in Cincinnati, that David Mann conducted. My brother and my Dad were there with that. So this just started, that particular aspect there. Being here in D.C., quite by accident, actually, I found out about this particular meeting here. And when I heard about it, I said "I've got to get there," quite frankly. So that's why I was very appreciative that I had this opportunity to talk because we should have the time to get it in five days ahead of time. I didn't know about it. Otherwise, I would have gotten it in. CHAIRPERSON FADEN: We realize this first meeting was put together on a shoestring and a prayer. We weren't able to give people the notice we would like to be able it give them in the future. Are there other questions? MR. PLAIR: Did I answer your question, sir? MR. GUTTMAN: Yes. CHAIRPERSON FADEN: Yes. Dr. Royal? DR. ROYAL: If the same thing that you described happened to your mother happened to my mother, it's not at all clear to me that anyone could ever make it up, compensate me in any way. What is it that this group would regard as partial compensation for such things happening? What is it that would make you feel better about such a terrible thing? MR. PLAIR: I'm glad you asked that. Foremost, in talking to -- and I must say through a lot of tears, by the way, we want this situation not to happen again. We've heard it mentioned here. But, believe me, ladies and gentlemen, we don't want this to happen again to somebody else's loved one. It's a very painful situation. And our fear is that it's already happening. That's our fear because you know experiments are going on. We're also concerned that there may be individuals -- and, quite frankly, we discovered that over 80 percent of those involved, at least in the Cincinnati experiment, were black, of minorities. They were poor. One of the criteria was that they had low I.Q.'s and educations. There were criteria that made us very frightened that this could happen again in America here. It made us really, really scared. As far as what else should happen is that some definite criteria, standards that you're talking about occur across the board, not just for one state, but across the state so that there are some standards that people must follow with very firm and definite consequences for not following those criteria. The other thing I think should happen because there are some private individuals that were continuing experiments and because institutions that are becoming larger every day have the power either legally -- no reflection, to get the kind of backup they need in order to conduct these experiments, there should be a very clear message that this will not be tolerated by the American people. And one way that, realistically, we discovered that this occurs in America is that when you hit somebody in their pocketbook, real simple. Then people will hear that. If they're smacked on the wrist, they won't hear it. "You did a bad thing." "Well, okay. It's okay." It will continue. It has to be a real clear message as far as compensation for your actions. The consequences for your actions must occur here. And, finally, there must be not just, you know, when you talk about something for the particular person who is involved in irradiation, but also in my personal research as a mental health therapist, there was repeatedly abuse of the noninvolvement of the families in the treatments. I don't know about other parts of the country, but what I have found out from as far away as Japan, Tennessee, that the families weren't involved. And they weren't told about what was going on. They were told that "Your loved one is sick," and they were definitely told that "Your loved one has passed." There's a lot of things that happened in between, ladies and gentlemen, that should have been reviewed and looked at if that answers your question. DR. ROYAL: Thank you. CHAIRPERSON FADEN: Thank you. Dr. Macklin? DR. MACKLIN: Mr. Plair, could you say a couple of more things about your efforts to get these records? You described briefly that you were looking at trying to get at the hospital records, and then you were asked to leave. MR. PLAIR: Yes. DR. MACKLIN: How did you get in in the first place? Who let you in? Who gave you the records initially? I don't mean by name, but just what was the process to your gaining entry into the hospital and looking at some records? And then how did it come about that someone at some point then asked you to leave? MR. PLAIR: Well, we, first of all, went to the register. And we discovered -- my brother is pre-law, and his son is in law. So if it was a municipality, then its public records should be available. So what we did was went to the hospital and said, "We have a right to look at our mother's records." Now, in order to do that, we had to get certain documentation, birth certificates, death, different information, data, that they need in order to allow us, verify that we were the people we say we were. In doing that, then that allowed us at least a minimal access to say "Okay. This is your mother," just basic information. The more specific questions we asked, the less information was available to us. Quite frankly, the way that we gained access was, first of all, to threaten the media would come in with us. That didn't get a response. So we did, in fact, bring cameras and newspaper people with us. That got response very quickly. CHAIRPERSON FADEN: Could you tell us: When was this? Was this just this past month or in -- MR. PLAIR: This was in February. CHAIRPERSON FADEN: In February. DR. MACKLIN: But then at some point you said you were asked to leave. These records, did I understand you? Were they on microfiche, on some -- MR. PLAIR: We found out initially they said they were on microfiche, but we discovered that the records were in a storage area that were obtainable. DR. MACKLIN: And then somebody at some point asked you to leave. What was it that -- MR. PLAIR: One of the clerks asked us to leave. DR. MACKLIN: The clerks. But was it as a result of some episode or you were just looking there too long? I mean, did they get tired -- MR. PLAIR: Well, the question came up. He says, "What do you want the records for?" And the answer was, "We want to know really what happened to our mother." And so it up the line of chain of command, came back down. And I'm sure the clerk was responding to his superior telling him that at this point we need to stop, "They need to leave." DR. ROYAL: Since that time, have the records that you've been looking for been provided by the hospital? MR. PLAIR: For our particular family, yes. But to answer your question maybe a little bit further, there are families that weren't as loud as we are who still have not got their families' records. DR. TUCKSON: And I think you -- I'm sorry. Did you finish? DR. ROYAL: I was going to ask if now that you found the records that you found there was useful information in those records, information that might be useful to the committee. MR. PLAIR: Because of the time, I'll just say there is extensive information that would be very useful for you, not only from me, but other family members also. CHAIRPERSON FADEN: Could we ask: Have you had any contact with Dr. Saenger directly as a personal matter? MR. PLAIR: Well, because it's become a legal situation, -- CHAIRPERSON FADEN: I see. I see. MR. PLAIR: -- we have a lawyer that deals with his lawyer. But we've sat across the table at one another. And I must also add that just even recently, I heard the NIH come up several times. And, again, our research will maybe answer some of your questions here, that we found out in '69 that, in fact, NIH denied re-funding the program because of the lack of appropriate consent from the patients and also the improper documentation of the experiment, not once, but twice. CHAIRPERSON FADEN: Reed and then -- DR. TUCKSON: Go ahead. CHAIRPERSON FADEN: Okay. DR. TUCKSON: I think yours is on this point. DR. THOMAS: I just want to assure you that support groups like yours can play a very valuable role in this process that we're going through, if nothing else, to help us identify incidents which we might not uncover by any other means. I think yours is one case where we probably were already aware of the situation. But what would also help me is early in your presentation, you made some comment to the effect that you had assembled something like 35 families and you had some extensive information on those families. I think I speak for the committee by saying that yes, we're very much interested in the kinds of information that you're assembling. And we'd just like you to elaborate a little bit more as to what kind of information, what sort of form the information that you have assembled is and what we would expect. MR. PLAIR: Some of the things that we've discovered are that one of the big issues that I saw in Clinton's path was that the matter of consent continually -- and I must say involved in the support group are 35 families. Every day -- and I'm sure that when I call my brother -- there are 85 families involved in the Cincinnati research experiment program. Every day -- we started out with four families. Now we're 35. We're sure that this will continue to grow. DR. THOMAS: Are you aware of whether there is, in fact, a comprehensive list of the subjects involved in this series of experiments? MR. PLAIR: What we found out was that because of our diligent pushing, the list has gone up. The willingness for the University of Cincinnati to give this information out was not willfully given. DR. TUCKSON: I asked this question earlier, but I didn't listen carefully enough to the answer. That is, when did your mom pass? MR. PLAIR: She passed May 23rd, which is coming up, 1965. DR. TUCKSON: So, again, remind me. What was it that triggered, that says "We're going to go find out how and why Mom died"? I mean, what was it all those years later that caused you to do that? Why do you do that? MR. PLAIR: Partly because I'm in the helping profession, quite frankly. It's been something that's been gnawing at me for a long time. One of my colleagues told me, said, "Plair, you care so much about other people." And we started talking about family. And I talked to my brother. And it seemed simultaneously, I must also add, that in January of this year, I myself came down with streptococcus pneumonia and ended up in the hospital and, consequentially, had to end up having major surgery to save my own life. That jarred me in a lot of ways to look into just how quickly you can be here and gone, and it made me look at that a little bit closer. So, simultaneously along with that, there were some rumblings in Cincinnati about some investigation into radiation experiments. It all jelled about the same time. CHAIRPERSON FADEN: Dr. Royal? DR. ROYAL: You made the distinction between the words "experiment," "research," "investigation," and "study." And the distinction isn't as clear in my mind as apparently it is in your mind. Could you -- MR. PLAIR: Let me elaborate on that. DR. ROYAL: Yes. MR. PLAIR: Perhaps I wasn't clear. If I may read what Dr. Saenger, who is the project director and primary research, told John Nortrup in 1972, who was then the Director of the Science and Technology Department at the Defense Nuclear Agency, which had funded part of the research? Because at that time Edward Kennedy was heading a subcommittee that would potentially bring the experiments to a hearing, Dr. Nortrup asked Dr. Saenger to review his opening statement. And in the opening statement, Dr. Saenger suggested to Dr. Nortrup that he not use the term "experiment," but, instead, use the word "study," "investigation," or "research" due to the response that it may incur from the committee. DR. ROYAL: So you have some memo that says that -- MR. PLAIR: We had this written down. This is the kind of information that we were able to uncover. DR. ROYAL: So there's some memo that exists that says that you should not call this an experiment, -- MR. PLAIR: Yes. DR. ROYAL: -- you should call it a study, -- MR. PLAIR: Yes. DR. ROYAL: -- research, or an investigation? MR. PLAIR: Yes, this along with the improper consent forms that were written on general admission forms. In the one case, I even discovered that my brother sent to me a copy of an admission form where I at the age of 17 signed for my mother to receive treatment. I wasn't even aware of it. I did sign for Mother to come into the hospital because she was hurting and she needed help. I do remember being told that "It's okay for you to sign for your mother to be evaluated in ER." From there she went and received another radiation experiment X-ray that day because I remember they had to hospitalize her. All of these things come together, but you don't know it. You know, at 17 what do you know? But I have it written down with my signature that I signed for my mother to receive an X-ray treatment? These are the kinds of things that we have in black and white. DR. LEDERER: I was just going to say that I actually have a memo from a Veterans' Administration Hospital from 1946 in which they make the same point about not using the word "experiment," using the word "study" as it will be less disturbing to the patient population. DR. TUCKSON: I want to just make one subtle point that you said that is important to me. Some of you more familiar with this study may understand it. Some of the funding for this was Department of Defense or Energy? What did you -- CHAIRPERSON FADEN: Defense. MR. PLAIR: Defense Nuclear Agency. DR. TUCKSON: The Defense. And then there was also NIH money as well? MR. PLAIR: No. DOD, Department of Defense. DR. TUCKSON: I thought earlier you said in 1969 -- MR. PLAIR: Nineteen sixty-nine. DR. TUCKSON: -- NIH. MR. PLAIR: NIH refused to fund -- DR. TUCKSON: Right. MR. PLAIR: -- the project because of the improper consent forms that were used. DR. TUCKSON: The reason why this is interesting to me is that two different federal agencies were both involved in funding this work. And if that be the case, that's a subtlety that I would not have thought when talking to the agency people tomorrow that when you start to think about -- you can think about one agency. But when you think of two coming together, that begins to develop a potential of a collaboration that's -- CHAIRPERSON FADEN: And that is a good point, Reed. We will hear and we should pursue, but there appears to have been a not insignificant amount of co-funding across the agencies for some of the studies that we undoubtedly will want to look at. MR. PLAIR: I must also let you know that when you look at this, that, like I said, it wasn't easy to find this information out. In fact, we were told that this did not exist. The funding from DOD and other agencies existed. We had to search and find to and exposed it. Then they admitted to it, admitted to the situation. CHAIRPERSON FADEN: Ruth? DR. MACKLIN: This is a follow-up on the point about the NIH refusing to fund it. I can see how you could find out about someone, about who actually did fund the research, even though you had to probe a little to get that information. How did you learn that the NIH refused to fund it? And as it a continuation of the study? Was it a new application that was put in? I mean, what were the facts surrounding it? MR. PLAIR: It was a new -- they needed re-funding of its project. We found this out from other experts that we questioned leading up to the congressional. We were able to get their preliminary hearing papers and review them. Upon reviewing them, my brother and I looked at them and said, you know, "Maybe they might be able to share some information with us." And they were more than happy to find someone that would listen to them and gave us the information. We slowly processed it and dug the information out of it. DR. MACKLIN: And, to your knowledge, this was the same study? I mean, it was the same kind of study? MR. PLAIR: It was a continuation of the radiation experiments, yes, very clear, no doubt. DR. MACKLIN: And the reasons that you cited for their refusal to fund were: first of all, the informed consent. And what was the other reason? I think you gave two. MR. PLAIR: It was inappropriate for the experiment. It was a general form. They wanted to be more specific. DR. MACKLIN: In other words, they wanted a specific consent form for the research itself? MR. PLAIR: Yes. And also they felt that the notation -- it was a very general note that they wrote, and they wanted something more specific to the experiments themselves. DR. MACKLIN: Is there any more that you tried to find out? For example, sometimes when people submit an application for funding, they're told by the agency, "We won't fund it in this forum, but if you do" such and such, "then we may fund it." Did you find out anything about the unwillingness of the researchers to do the proper consent form? Because to many people, that would seem like a minor step. Oh, they won't give us the money if this is the only reason? So we'll fix the consent forms. MR. PLAIR: To the best of my knowledge, from what we have discovered -- and we're still digging -- is that NIH had concerns about not only the inappropriateness of the consent form but also the treatment given to the patients in the experiment and the willingness at that time for the University of Cincinnati Medical Center and also Dr. Saenger to make any changes in the treatment to suit what NIH thought they should. DR. MACKLIN: Thank you. CHAIRPERSON FADEN: Dr. Oleinick? DR. OLEINICK: I had a lot of the same questions. I just wanted a clarification of the role of NIH in this. So, according to what you know, NIH never did support this research? MR. PLAIR: No, they didn't. They continually applied to NIH, as I said, twice. Each time they were rejected for the same reasons. DR. OLEINICK: And are you aware of any response, either from Dr. Saenger or from the university or, for that matter, from the Department of Defense, to the critique written by NIH? MR. PLAIR: To my knowledge, the only thing I can say is that Dr. Saenger and the university were very disappointed that the project was not continued. DOA continued funding of the project was stopped because of the alleged inadequacies in the treatment also. See, I can go back some, but that's what happened there because they did apply to DOA for further funding. CHAIRPERSON FADEN: We could go on. I just should share with the other members of the committee that we will be receiving detailed information about the Cincinnati experiments, both from the Department of Defense and from DHHS, including the whole history from the departments' perspectives about the relative relationship of DOD to NIH funding and how all of that broke out when we have it as public. So you should rest assured there's nothing we will have that you can't have, Mr. Plair. So, when we get it, we put it out there. But it's our understanding that we are receiving substantial information about Cincinnati. MR. PLAIR: In all fairness, Madam Chairperson, some of the information I just shared with you until we pressed it, they did not share. CHAIRPERSON FADEN: Oh, I'm not doubting that at all. I'm just simply saying that we could augment what you've learned with what we'll hear from the departments and kind of triangulate these sources of information. And, hopefully, part of the committee's role is to minimize the difficulties that you and your brother experienced in trying to get access to this information. There's hopefully some way in which this committee can help with the process that you're undergoing. MR. PLAIR: I just wanted to say one last thing. CHAIRPERSON FADEN: Sure. MR. PLAIR: We plan on, I do and the families plan on, going with this, following through this all the way until it's finished. Even when you stop, if need be, we're going to continue until it's resolved. CHAIRPERSON FADEN: We appreciate your commitment and believe we all understand why you feel the way you do. Thank you very much. MR. PLAIR: Thank you. CHAIRPERSON FADEN: We're glad that you found out about us and that you could come today. That turned out to be very fortuitous. I understand we have no one else. So we have a sort of operational decision. I'm inclined to think that we should adjourn, even though I know there's work to be done. Some of us, the committee, are going to a private reception this afternoon or early evening. Let me suggest that we meet in the lobby of the Grand Hotel at 5:00 o'clock and travel together on to that reception. That gives us a little bit of time to get over there. Rest or exercise or whatever it is that you will need for tension relief, nap for a few minutes, and we will meet in the lobby of the Grand Hotel at 5:00. Is 5:00 sufficient? 5:00 is sufficient. Thank you all very much. And for those of you who were patient with us today, I hope you found it worth your time. (Whereupon, the foregoing matter was recessed at 4:03 p.m., to be reconvened on Friday, April 22, 1994 at 9:00 a.m.) ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + + PUBLIC MEETING + + + + FRIDAY, APRIL 22, 1994 + + + + The Committee met in Federal Hall, Ramada Plaza Hotel, 10 Thomas Circle, Washington, D.C., at 9:00 a.m., RUTH FADEN, Chair, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H., Chair KENNETH R. FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA A. KING, J.D. SUSAN E. LEDERER, Ph.D. RUTH MACKLIN, Ph.D. LOIS L. NORRIS NANCY L. OLEINICK, Ph.D. HENRY D. ROYAL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. REED V. TUCKSON, M.D. STAFF: FAITH BULGER, J.D. DAN GUTTMAN, L.L.B. JOHN HARKNESS JEFFREY KAHN, Ph.D., M.P.H. ANNA MASTROIANNI, J.D. RON NEUMANN, M.D. JEREMY SUGARMAN, M.D., M.P.H., M.A.I-N-D-E-X PAGE Opening Remarks 3 Chairperson Faden Committee Review of Thursday's Proceedings 3 Moderator: Chairperson Faden Briefing by Interagency Working Group: Document Retrieval and Data Collection Efforts 14 Dr. Tara O'Toole, Assistant Secretary, DOE 16 Dr. Steven Galson, DOE 30 Dr. D.A. Henderson, DHHS 38 Mr. Harold Gracey, VA 49 Dr. Gordon Soper, DOD 57 Mr. David Gries, CIA 68 Dr. Harry Holloway, NASA 74 Committee Question and Answer Period 82 Discussion of Committee Strategy and Direction 137 Moderator: Chairperson Faden P-R-O-C-E-E-D-I-N-G-S 9:09 a.m. CHAIRPERSON FADEN: Anna thoughtfully recognized the need to give us a little leeway this morning, so we have this half hour, which is now down to 20 minutes, which realistically is now going to be 15 minutes, before we have our presentations from the various agencies. It's 15, 20 minutes for us to have any conversation we would like to have about thoughts with respect to yesterday. It would be very helpful, I think, if people would like to identify or flag the topics that they would like to visit this afternoon. That would be very helpful. So, if we could use the next ten or 15 minutes for listing basically topics for discussion this afternoon by the Committee, that would be very good. Reed? DOCTOR TUCKSON: I think the main -- I'm just trying to bring my brain back into order here. CHAIRPERSON FADEN: That's what we're all trying to do. DOCTOR TUCKSON: Okay. So, the main task for us by the end of the day is to get a much clearer sense on the scope, on the characteristics of the size and the net that we're trying to throw. CHAIRPERSON FADEN: Or as close to it as we could come in this first meeting. DOCTOR TUCKSON: And that will be a direct result of the information and the discussion and the questioning we have of the agency officials today. CHAIRPERSON FADEN: Exactly. DOCTOR TUCKSON: We'll learn about practical constraints and realistic limitations and then we'll factor all that in. I'm happy that Eli circulated his thoughts on just some general thoughts which might actually be a basis of discussion which will help everybody out. So, anyway, I'm on target and that's the basic -- CHAIRPERSON FADEN: That's clearly an important thing. We have to reach interim closure, either as far as we can get. Do we want to set up the Subcommittee to go further to refine it, do we want to think about it and wait until the next meeting to finalize it, but yes, that's critical that we get as far on that as we can. And everyone is in agreement that that's something we should take up this afternoon, hopefully with more information based on what we learn this morning? Duncan? DOCTOR THOMAS: The second issue seems to be to take a first cut at strategies and priorities so that we can start giving the agency some guidance. Now that's, I think, a little different issue from the issue of scope. CHAIRPERSON FADEN: Is it the same or different? I'm not sure. DOCTOR THOMAS: Well, I thought scope was what all do we include in this. The second issue is how do we go about directing the agencies to prioritize their search? That's more the question of how do we hone down on the things that we're particularly interested in? CHAIRPERSON FADEN: Okay. DOCTOR THOMAS: I see them as two very separate topics. DOCTOR TUCKSON: Certainly one first and then the other. Once we've developed -- DOCTOR THOMAS: We have to do the scope first. CHAIRPERSON FADEN: Okay. Henry? DOCTOR TUCKSON: Oh, I'm sorry. And the other thing that was left hanging was your comment, Pat, about some sense of communication among the Committee members where we try to share a common interdisciplinary education and that people with special expertise might want to make sure that others of us have -- you know, just a reading list so that we would kind of be more up to speed. CHAIRPERSON FADEN: Let me take it a step further. One of the things I'd like to do this afternoon is go around the table and ask each of us to say what we would like to learn more about and we may find out by the time you're at the end of the table that it's been exhausted already. We'll collect that and then go around the room again and say who would be willing to make a ten minute or so presentation at the next meeting on that topic and we'll see how much internal expertise we'll use. Then we'll get staff or outside consultants to give us little tutorials on the other topics. But if you could be thinking over lunch, for example, what are the three areas that I know the least about that I absolutely would like to be brought up to minimal speed on to do my work on this Committee, we'll take some time this afternoon to do that. I would suspect that a good chunk of our next meeting will be given over to these many tutorials. Henry? DOCTOR ROYAL: I think that there are some experiments that we know that we're going to want to look at in detail and I would think the sooner we get looking at those experiments in detail the better. One of the reasons why I think that we should do that quickly is because it's going to help us decide what it is we should be looking for in terms of the experiments that we don't know about. So, one of the things I would suggest is there are several experiments that we know about because of the Markey Report. We know about the University of Cincinnati. We can make a list of experiments that have come to the public's attention and we should begin gathering information about those experiments. Another benefit of doing that is we might find exactly how much information we need to gather about each experiment. We may not have to get every individual person's medical record. We may find that just knowing some generalities about the experiment would be enough for us to make a judgment about it. So, I think this would give us -- it would be like a pilot project of practical experience to see how we can deal with real information. CHAIRPERSON FADEN: I was just thinking of the language of a pilot project myself. That's a great suggestion. So, another task for this afternoon is let's get a list of four or five, three experiments that we know we're going to need to look at. And staff could get prepared for us by the next meeting, with any luck, everything that's available. Given that those are experiments that are widely know, there is a lot of information and it should not be hard to do that. That's a great idea. DOCTOR TUCKSON: Not to make this agenda too long, but maybe a couple minutes on trying to bring to closure the discussion -- or how we will move forward with the public participation part. Specifically we talked about the need for -- we kind of left open whether there was a need to have advocacy points of view from different, by the way, contrasting, if there are such, points of view to be invited to come. CHAIRPERSON FADEN: Right. DOCTOR ROYAL: I'd like to agree with Reed about that. The impact of this Committee really is going to depend very much on how much the public is aware of this Committee's activities. If the public is not aware of what's going on, then it's going to be difficult for this Committee to have much impact. So, I think that there's a real direct relationship between our impact and how much public participation we get. Along those lines, I'm wondering whether or not we should think about things like trying to use TV media. I'm thinking about PBS. They have round tables that talk about ethical issues and whether or not we could get a wide public audience by going to someplace like PBS, a documentary about human radiation experiments. I think if we rely just on the printed media and people who are able to come and be physically present at the media, that we're not going to have anywhere near the impact that we want to have. CHAIRPERSON FADEN: We can certainly try to start that discussion this afternoon and then perhaps that would be another area where we could ask staff to prepare some options for us for discussion. I'm looking at Steve for that topic. But we could pursue that. That is important. Ruth? DOCTOR MACKLIN: By way of general background, it would be useful to have, if the agencies could supply it, some account of what ethical standards they had, if they had explicit ones, especially during this early period. CHAIRPERSON FADEN: Across the decades. DOCTOR MACKLIN: Across the decades and most, I think, importantly perhaps for our comparison. I mean one of the things that was striking about Mr. Plair's presentation yesterday afternoon was a description in his account of the agency funding of some research and the refusal of another agency. So, it would be useful both for our exploration of what the standards were at the time and especially to know if different agencies had different standards. So, whatever we could get along those lines would be helpful. DOCTOR KATZ: Along these lines, there are documents available. You may know of some that I do not know. I was a little bit involved in the investigation of the mustard gas experiments conducted during the Second World War by the Armed Forces. Among the other documents that I've seen is a wonderful and intensive report by a committee appointed by the Inspector General of the Navy of the climate of ethical decision making in human experimentation from the early days through the '50s and '60s. It's a beautiful report. CHAIRPERSON FADEN: Well, we'll get it. DOCTOR KATZ: You've seen it? CHAIRPERSON FADEN: I have not seen it yet. I've seen reference to it in the Mustard Gas Report. DOCTOR KATZ: Well, whatever we know about it, these documents, we should make available to all of us. That gives you a very good and critical overview of how the Armed Forces thought about these kinds of experimentation from the '40s I think through the late '50s. DOCTOR STEVENSON: One concern I have is, although I agree that we should cast a wide net and be as public as possible, I'm concerned about how we eventually distill this information down and give each of these episodes coordinates in time and space so that we can actually analyze the material. Just from reading the press clips, it sounds like thousands of phone calls have come in through the hotline. What mechanism is in place to try to cross reference those phone calls with the known information at a time and place so that there's documentation to follow up with? Ultimately it has to be distilled from anecdote into a documented fact full as much as possible experiment. Otherwise there's no way that we can make any sort of sensible suggestion, advice, and particularly in the medical field try to analyze the physical or potential physical harm that was done to these people. CHAIRPERSON FADEN: I'm not sure if we're going to hear anything about the phone calls, the hotline today. We are? Okay. We will be hearing some about what the situation with respect to the hotlines is and then we can revisit that. But I think you're right. We have to fix them in time and space and verify what they're connected to. Eli? DOCTOR GLATSTEIN: I'd like to suggest that we can get whatever reports are available on the Cincinnati and Marshall Island and other things like that. I'm not anxious to rediscover the wheel. If it's already been investigated, let's see what the reports have and use that as a jumping off place for the investigation of those particular events. CHAIRPERSON FADEN: Right. I would think that that goes to Henry's point. If, for example, the Cincinnati situation is on our short list of things to learn a lot about, we can look at everything that's already been done and is being done on that and see whether we as a Committee need to do anything more. Pat? DOCTOR KING: I don't want to interrupt the substantive flow. So, if somebody has a substantive point they want to make, I will defer to them. CHAIRPERSON FADEN: It's too early to be substantive. DOCTOR KING: Okay. I have a very small picayune question that is of practical importance to me. That is today is going to be full of information. Can you tell me whether I have to take extensive notes as I try to absorb what I need to absorb right now or whether I'm going to get a transcript and so only need to take highlights or whether I'm going to get a summary? CHAIRPERSON FADEN: You can have both. DOCTOR KING: Thank you. CHAIRPERSON FADEN: In other words, there will be a transcript and staff is taking notes. If you want to note anything, since obviously we all filter with our own judgments, if there's something that particularly strikes you that you want to record for your own purposes, then you should go ahead and do that. But yes, we will be supplying -- my hope is that there will be a sort of substantive minute situation for every meeting that staff will take, since it's kind of tedious to read transcripts. The transcripts are available. DOCTOR KING: They will be available? Okay. CHAIRPERSON FADEN: Staff needs to be taking minutes now so that in addition you will have that. Now, we should not have to be taking notes except as it strikes us, that we particularly -- it generates in us something that we want to pursue that we couldn't rely on staff because they're not us to make that connection. Well, we have a long list for the hour and a half, is it, that we have for this afternoon? So, we have to talk really fast then. But this was good to do now so that you can be thinking at lunch, for example, and at breaks precisely where we should be going with this agenda so we can be as efficient as possible. As I've been taking notes as it were of this conversation, been trying to indicate which ones of these are tasks that we could ask staff to do with a little direction from us and which are things that we really need to be spending time on this this afternoon. At this point, could we ask the representatives of the agencies to come to the table and we'll start the substantive part of the morning. Has everybody had enough coffee and tea to kick in and start thinking? I need to know a procedural point. When I talk quietly and try to say something secretly to Anna or Dan, can you hear in the back of the room? They pumped up my mike. I guess I have a low voice. So, you now know all of our little staff secrets here. I will now realize that I have to muzzle this thing when I want to get guidance from Dan or Anna. MR. GUTTMAN: Ruth is quickly picking up lists of Washington inside tips on -- CHAIRPERSON FADEN: This is very sneaky. It's a good thing that I don't have a conspiratorial frame of mind. Okay. We should get started. We're very fortunate this morning to have such an array of representatives from the agencies. These are the people who have really been in the trenches doing the work, trying to implement the guidance from the President and from the Working Group. Everyone here, I believe, is a member of the Working Group? Right. Should I introduce Tara? You heard me make reference to Tara yesterday morning. Tara O'Toole is Assistant Secretary of the Department of Energy and has been one of the leading figures in getting this whole thing organizations. Doctor O'Toole is going to give us an overview of the operations and then each of the representatives will follow. So, thank you very much, Tara. DOCTOR O'TOOLE: Thank you. What I'm going to do is on behalf of my colleagues here at the table and many other people who are sitting in the room and some of whom are back at their agencies, give you a very brief chronology of the events in government up until now. Not to bore you, but I think it's important that you understand the people and the types of deliberations that have brought you to this place. In particular, I want to talk about how the charter of your Committee was arrived at and what kind of thought processes we went through in crafting it. Certainly if the Committee decides that the charter is inappropriately scoped, you have the option of going back to the Cabinet secretaries in the Interagency Working Group and asking them to revise it. But we did put a lot of thought into the charter, into the current scope, and I hope that by sharing with you some of our deliberations, we might be able to save you some time or at least point you in certain directions as you think through it further. I'm also going to introduce in very general terms the interagency record retrieval process as it has been conceived and executed thus far, and then the people to my right from the other agencies are going to give you some more explicit information specific to each of the departments. I think you will find this very interesting and this will help you understand what is available to you now and how you might help us in figuring out what we could acquire for you in the future. Finally, I'm going to go through again what we need from you, what the government hopes to get out of your earnest work and long effort. First of all, as our secretaries remarked yesterday, this is really a very unusual interagency collaboration. It did more or less begin last December 7th when Secretary O'Leary had a press conference that was intended to debut the openness initiative on the part of the Department of Energy. This press conference included the revelation of a lot of previously classified information and almost as a side bar noted that plutonium experiments that had been highlighted in Albuquerque Tribune stories earlier that fall and had gotten very little national media attention at that point. The press conference, let alone the ensuing weeks, was then taken over by the intense interest evidenced in the plutonium experiments. These experiments, as you know, we soon discovered, had been all mentioned and explored in the so-called Markey Report, the congressional report that was made public and the subject of a hearing in 1986, but that dropped out of site within about a day of its publication. So, after the Secretary's press conference, the Department of Energy, myself included and other people from the General Counsel's office and other policy making bodies within the Department, found ourselves trying to figure out what to do. It was clear that the public was owed a certain amount of information about these and other experiments, but we were also very concerned about the privacy rites of the individuals involved and their families and so on and so forth. After about a two hour meeting one evening in the general counsel's office wherein it became quite apparent that there were a lot of conflicting demands and ethical considerations and very clear that we were confused, we were confused about what the right thing to do was, all of these lawyers and scientists and physicians. So, we did the natural thing, we called an ethicist in to try and help us figure out the conundrums that we were facing. Thereupon began Ruth Faden's involvement with the Department of Energy. It quickly became clear that we were going to have to put together some kind of independent panel to help us think through the Markey experiments and anything else we might have turned up. We knew then that we had no clear notion of how the Markey experiments had been chosen or whether there had been a thorough search to drag out all of the experiments that might have come under the Markey charge and so on and so forth. We busily began trying to figure out how we could construct and construe such an independent panel. We were totally unprepared for the intense media interest that ensued around the country. Quite quickly, certainly by the end of December and the first week in January, the entire Clinton Cabinet and the President himself had decided that the whole government needed to participate in this effort, to be open with the American public and to figure out what had gone on around human radiation experiments. So, during the first week in January, January 3rd to be precise, we all got together for the first time in the Old Executive Office Building and thereupon began a series of very intense, very high level meetings engaging all of the Administration departments, all of the Executive Branch departments who could conceivably have had anything to do with human radiation experiments. I would like to note here that one of the great benefits for me personally in this whole affair, which has been very time consuming and all-encompassing intermittently at least, has been meeting my colleagues throughout the rest of the government. This really truly is an interagency cooperative effort that I think is very unusual, if not unprecedented. We initially split into five working groups to try and craft a way forward. The working group that I'm going to tell you about was originally labeled the Scientific and Ethical Standards Group. This group had the responsibility of trying to figure out what types of information ought to be sought from the government, how to charter the independent panel that we were clear we needed to form, what mechanisms we could use for developing such a panel within the government bureaucracy and paying for it and how to choose the panel. Glenn, could you put the first slide up, please? This is -- I see a totally unreadable list of the Interagency Working Group. I'm putting this up here because I want to signal to you the variety of talent in agencies and the level of government personages who are involved. This was really a very serious effort. As I said, Jack Gibbons, the President's science advisor and the Director of the Office of Science and Technology Policy, was the chair of this group. The first order of business was to try and figure out what we were about. We quickly determined that we would consider at the outset anyway all ionizing radiation experiments involving human subjects. We quickly decided that all agencies that might have had truck with these experiments were to be included, that all information, classified or declassified, would be included, that we would construe an expert panel, not a stakeholder panel. We did this very deliberately and after discussion because what we were after was a sober, credible, thoughtful review of what had gone on. We talked about stakeholder panels. As many of you know, Jack Gibbons was previously, for the past 17 years, the Director of the Office of Technology Assessment and is probably the government's leading expert in putting together stakeholder panels. But when we started toting up the different types and categories of stakeholders and considered the intense controversy surrounding human health effects of radiation, it appeared to us that we would need a positively gigantic panel that would be unmanageable if we were to include stakeholders and attempt to be fair to all parties. So, we very deliberately construed this to be an expert panel. We then developed criteria for inclusion and exclusion of the members. That eliminated off the face of it, possibly unfairly, anybody who might have reason to be biased with respect to these experiments, either because of professional affiliations or ideology having to do with national security matters or radiation or whatever. We were very Draconian in sticking to these inclusion and exclusion criteria. Finally, it was clear that we needed to put together a manageable scope of work. We have all been very impressed with the intense interest in this subject, interest not only from the public and from the media, but as you heard yesterday from Congress. Congress is already writing legislation designed to compensate punitive victims of human radiation experiment. In spite of Senator Glenn's very gracious remarks yesterday noting that he would be willing to support an extension of the terms of this Committee, it was the opinion of the Working Group that if we do not have a product in a year, life will move on without us. The Congress at any rate is going to have to hue to their own time lines and time frames and the legislative calendar and there really is a very fervent interest on the part of the public of understanding this story as soon as possible. A year is a long time in the public mind. It probably seems like only a brief moment as you contemplate the task ahead of you. But we really did want to at least try, being ambitious but reasonable, to put together a scope that would allow us to have a product in one year. Now, as to the charter. We considered a whole range of instances involving human exposure to ionizing radiation, including nuclear weapons testing events such as the Marshall Islands, the exposure of radiation to nuclear test personnel, including government officials and military personnel, exposure to people downwind of the nuclear tests that took place in Nevada or in the South Seas, exposures due to routine operation of Department of Energy nuclear weapons production facilities, exposure due to workers who were employed at these facilities. We eliminated all of them from the scope for one of several reasons. Either these different categories were already being considered and dealt with, be it different studies or compensation schemes, and I can go through each instance of that if you're interested in it, all or any would significantly expand the scope of the work. Let me give you an example. We probably have three million documents on Marshall Islands alone that we know about. Six hundred thousand people were employed at Department of Energy facilities over the past 50 years. So, you can imagine the volume of exposure records and so forth that attend those workers. Very imperfect exposure records, I might add, regretfully. We are in the midst of doing a dose reconstruction project outside Hanford, a weapons facility designed to produce plutonium for the nuclear weapons effort, that is now in its fifth year. We have -- not we DOE, but an independent panel yesterday published the latest draft results of their modeling of what amounts of iodine-131 were released from this facility over a set period of time. That effort, which has not yet been joined to an epidemiologic study which is underway to assess results, has taken over $25 million and five years. You can imagine the data associated just with the Hanford dose reconstruction project, let alone the dose reconstruction projects not going on at Idaho National Engineering Lab, Fernald, Savannah River and so forth. Finally, it was clear to us, or at least to the extent that anything seemed to clear in January, that there was great interest in the ethical conduct of scientific experiments. Much of the news reports were filled with suspicions that intentionally exposures to potentially harmful ionizing radiation had been cloaked as legitimate scientific inquiries ostensibly designed to benefit individuals or human health, but possibly in actuality intended to serve other purposes. This whole question of the role of science in the property ethical standards of scientific inquiry seemed to us a very appropriate and important focus for the charter. Hence the word "experiments" in the charter. It has become clear to the record collection group as we have gone forward that we are going to need your help in defining more precisely what experiments mean, as some of you noted yesterday. But that is what we decided on. The experiment was a very deliberately chosen word and the scope of the charter was also quite carefully construed. I'd be happy to come back and answer anymore questions you have on that point. The record retrieval process. In February, we turned our attention from the devising of the charter and the construction of the Committee and the selection of members to getting down to the business of trying to collect records from our agencies. On January 15th, the so-called Varney memo had gone out. This was the memo from Christine Varney to the agencies directing that they begin forthwith collection of all relevant documents and it did include some broad guidance as to how to do that. By that time all of the agencies had already issued from their secretaries notices that everyone was to cease all routine and non-routine destruction of records that might possibly be pertinent to this effort. By January, the Department of Energy and the Department of Defense anyway, who had the most to lose or gain from this whole effort, had put together fairly detailed guidance on what we wanted our various services and field offices to do in record collection. I think you have the Department of Energy's guidance before you or at least the first installment. There has at least been a second revolution by now as we figure out more carefully what we want. Since February, we have put together an operations group consisting of the people that you see here, plus others, to try and construct actual ways of getting the records and coordinating the record collection amongst agencies. The record collection effort consists essentially of two phases in many efforts. The first phase, which we are well into now, is the agency-specific dragnet. This is the record collection process that is detailed in the agency guidance. This is our attempt to comprehensively inventory all the records now in the hands of the agencies or our current contractors to figure out what's out there, where it is and at least at first blush, i.e. what's the title of the experiment, the years, a brief abstract and so on and so forth, what's in these records. We can go through and we will go through the process by which each agency is accomplishing that. Not an easy task, but we are now convinced a doable one and we're about halfway through it already. We have records to give you. The second phase of the record collection one is going to more complex. It's one in which we clearly need your guidance and it is our impression thus far that this is really where the money is. The second phase is what we have called various things. It's really a proactive scholarly focused search that stems from the experiments we already have in hand and is an attempt to gather the policy documents, the supporting documents, the contextual evidence if you will, around experiments or errors or agencies that have come to light in the first phase, either through document retrieval on the agency's part or sleuthing on the part of the media or whatever. This is a very important phase. It is not easy. There is no centralized index of where these records live. They're all over the country. Some are in DOE archives, some are in national archives. Some are in private libraries. Some are in university libraries. There are historians out there who know where some of these records are most likely to be located. Some of these records have clearly been destroyed one way or another. But it seems to us thus far from where we've gotten to now, that this second phase is very important and very laborious. Finally, what do we want from the members of your committee? First of all, as President Clinton said last night, we need you to tell the story of human radiation experiments. You're going to be presenting the story to many audiences. As I said, we chose you very carefully and very deliberately and we have full confidence that this panel can deliver a careful credible account of the role of government in science in ionizing radiation experiments. Secondly, as I said, we need guidance from you on how to shape and set priorities for the record search. My colleagues will speak more about that. We want to be your research arm so that we can help you do the work you need to get done. We also want the Committee and its staff to be able to affirm the government's good faith in the effort to get out the truth. We do need to devise mechanisms for your being able to, as it were, imply an imprimatur to the record collection effort and attest to its integrity and comprehensiveness and we need to figure out a way, a practical way of accomplishing that. Thirdly, we need, the country needs you to help us apply what we learned from this story. Science is risky business. The essence of science is to go where no man has ever gone before, as it were, and it does imply some risk. Each age of progress and discovery brings its own set of ethical considerations with it. As the Atomic Age brought ethical issues, so ours in the technologies and the science is going to have its own accompanying ethical queries and questions. We are hoping that you can guide us in devising rules for human subject research that give citizens some assurance that their rights and their interests will be protected and rules that will also provide scientists searching for new ways of understanding the world a map or a rulebook that might help them ensure that their work is done properly and carefully. So, with that modest hope for your activities, I'm going to turn it over in turn to the people to my right who will talk about the particular agency efforts to find these records and get them into your hands. CHAIRPERSON FADEN: Thank you, Tara. I hope we can be as efficient as you are eloquent. We will do well. Are we going this way down the table? Then our next speaker is Doctor Steven Galson from the Department of Energy. DOCTOR GALSON: I wanted to start out by acknowledging to those of you whose first contact with this Committee was a phone call from me that I hope you forgive me at some point in the future. I also wanted to acknowledge Glenn Podonsky who is helping me with the slides. He's our Deputy Assistant Secretary for Security Evaluations and he's currently expertly managing our record retrieval efforts and is hoping to be relieved soon. I'm going to give you a thumbnail, really superficial sketch of the history of the Department of Energy which could be put in a textbook, but I'll do it in one minute, and then tell you a little bit of detail about our search, the process, the progress and the magnitude of the search, and then I want to quickly outline some concerns that we have at DOE. Some of these have already been mentioned by Tara and they'll probably be echoed by the following speakers. If you could put up the first slide. Okay. Starting in 1942, as you all know, the Manhattan Engineer District of the Manhattan Project was established to begin our urgent mission to develop atomic weapons. From the very start there was a medical section that was initially established as an occupational health function to protect the workers in the project from the hazardous effects of the radioisotopes that were being used. In 1943, the first radiobiological studies were begun by the project itself and then in that same year there were the first contracts with public and private universities, particularly the University of Rochester initially to actually conduct protocols on the medical effects on the radioisotopes that were being used in the project. In 1945, you know what happened, the bombs were dropped. Then in 1946 and '47, the Manhattan Project was replaced with the Atomic Energy Commission, which gave priority to nuclear weapons development, maintained the same penchant for secrecy and continued the primary use of private contractors to conduct their work. In the 1950s, in addition to beginning the above-ground nuclear testing, congressional mandates established that AEC focus on the development of the civilian nuclear power industry and there were increasing concerns about the fallout from the above-ground tests which had the result of increasing the focus and the amount of resources that were being spent on biomedical research. AEC also began supplying radioisotopes to research activities outside the government, in universities, for the research that they were doing. In 1975, primarily because of energy shortages, the AEC was abolished and replaced with the Energy Research and Development Administration and the Nuclear Regulatory Commission was spun off to regulate the new nuclear power industry. Jumping a few decades to 1977, ERDA was abolished and DOE was created, assuming responsibility for both the nuclear weapons development and biomedical research. Skipping a few more decades to the current time when Mrs. O'Leary gave publicity to the plutonium experiments and started the sequence of events that brings you here. Next slide. I want to tell you a little about our record search process and how we're doing on it. Tara told you the general outline for all the agencies. Within several weeks of Mrs. O'Leary's press conference, we issued our departmental guidance. This really began the agency dragnet to find all the pertinent records. We've then begun to send out teams nationwide. We've already visited six sites. This phase of field visits will be over May 31st. The teams are actually collecting the documents from the experiments we've identified so far. We're processing them using a record center out in Nevada, computerizing them on optical disks and putting them in a standard format, summarizing them in a standard form which I think has been passed out to you which categorizes different aspects of the experiments in a standard way. The next phase is that we will focus on specific issues that we've identified and also ones that you identify for us. These are -- the standard study is a standard study of radiation health effects that mentions several experiments that we believe need focusing. We've conducted a bibliographic search which we'll use. We've got records of where isotopes were shipped around the country, also using other government reports like the Markey Report and GAO reports, and then your guidance to help us focus further searching. Next slide. To give you an idea of how we're doing, so far we've reviewed about 231 boxes of records which translate to 94,000 documents. Only about four percent of these have been deemed to be relevant to the current search. A very small percent, one or two percent of these were classified and they've all been declassified very quickly. We're not having any problem in that respect. The magnitude of what's left is really uncertain. What we do know is that there are thousands more boxes to be reviewed and determined whether they're relevant. In terms of correspondence, we've received 329 letters from Congress alone, which is quite amazing considering the number of people in Congress. They're just demonstrating the incredible interest in the legislature. We've received more than 4,500 letters from the public. A good number of these, about 500, have been referred to other agencies and Glenn's staff has responded to almost 4,000 of these letters already. The interagency help line, which you've heard, the telephone line which has been mentioned already, has received 21,000 calls. Most of these, about 17,000, were received within the first six or eight weeks of the establishment of the help line. A lot of the calls have not been relevant, but 14,000 have. These are being linked to the record search activities when they are appropriate. When we find out information that seems to indicate that there's something we need to look at, that's being done and they're being referred to other agencies as well. Next slide. These are rough estimates. We've already spent upwards of $4 million. We're guessing or estimating that it will cost approximately $24 million. Please remember, this is just DOE. And we've decided about 187 people across the complex to this effort. At our headquarters here in Washington, there are about 45 government employees and 12 contractor employees that are included in that number. DOCTOR SOPER: Steve, I'm impressed. Four significant figures. DOCTOR GALSON: For an estimate that's pretty good, right? Okay. And then I'd like to close with telling you some of our concerns and issues that we have. The first is there's something called the Freedom of Information Act, which I think many of you are familiar with. Anyone in the public can send us a request for information and we're supposed to respond within ten days. The concern here is that we may be releasing documents to the public, and in fact we are doing this, either through the FOI process or by putting the documents in our reading rooms before you, the Committee, has time to review them, or at least at the same time. We're very concerned about the episodes being judged in the media and being judged by others before you've really had a chance to bite into them. Any advice or comments you have about this problem, it's a real tough one, we're happy to listen to. As you know, the Department of Energy is undergoing a shift from weapons production to weapons destruction, from contaminating the environment to cleaning it up. The bureaucracy is changing at the same time. We have to maintain continued vigilance that this record review process is going along in an honest and complete way as we're judging it to be now and we have to really make sure that that happens. There are some potential conflicts of interest that we're trying to address in making sure that DOE current and former employees who are actually involved with some of these experiments or the supervision of them are not currently involved in the record review process. This is something again we have to maintain constant vigilance about, but we're very aware of. Then to echo some of the comments that you heard last night from the President, and also from Tara, we're very concerned about not creating a witch hunt against the DOE scientific establishment and the outside scientific establishment. We don't want to detract from the very important legitimate uses of scientific research and clinical medicine in the radiation area. We want to make sure that any criticism of the current scientific establishment is really muted by understanding the history and we're looking to you to give us guidance and to give the country guidance on doing that. Thanks a lot. If you have any questions, we'll take them at the end and want to move on to the next agency. CHAIRPERSON FADEN: I'm sure there are lots of questions, but I think we will hold them until everyone has gone through. Our next speaker is -- it's hard for me not to say Dean D.A. Henderson. I'm conditioned. For years and years and years, D.A. was the dean of the school in which I live. But now it's just back to Doctor Henderson from the Department of Health and Human Services. DOCTOR HENDERSON: Thank you very much. The Department of Health and Human Services, as I'm sure you all are aware, has as its primary mission the health and wellbeing of the human public. Its different orientation, therefore, is significant in differing from the primary mission of the Department of Energy or the Department of Defense or others. The Department of Health and Human Services, as I'm sure all of you are well aware, has an extensive working relationship with the scientific community across the country, primarily through its primary granting agency, the National Institutes of Health and the amount of research that is funded through academic centers, research centers throughout the country and indeed throughout the world. There are other agencies which are also involved in some elements of research that might be relevant. One is the Centers for Disease Control in Atlanta which has been primarily involved in epidemiological follow-up of individuals exposed to radiation in partnership with certain of the other agencies here. The Food and Drug Administration is the inheritor of the Bureau of Radiation Health and has a number of the records from that time, and they did have some tangential involvement in some radiation experimentation. There is also the Indian Health Service and we had a series of Public Health Service hospitals. So far as we can determine at this time, neither of these have been involved in radiation experiments, but that really needs to be ascertained. I think we all see in the Department of Health and Human Services a very special concern about this set of experiments because apart from the injury inflicted there is another issue and that is scientific credibility and integrity, a concern that we've had particularly over recent years, not only in this area but in other areas with misconduct in science and direct cost., problems that this is yet another questioning of the scientific body. Indeed, thus it becomes, to all of us I think, of immense importance. We need to understand fully what has occurred to present this to a public and to the scientific public as well to what happened, what has been done, what are we doing about it and what should we be doing about it in the future. The Department has been concerned about human subjects protection for quite some period of time, not surprisingly. In 1953, the first codified documents were prepared at the clinical center of NIH dealing with human subjects protection. I think it was hoped at that time that this would be an exemplar which other institutions would adopt, but in fact probably it did not go too far in, if you will, codifying methods by which the human subjects experimentation examined. However, in 1967, an instruction went out to all grantees of the National Institutes of Health, and this would involve an enormous number of the research institutions of this country, requiring that they set up certain procedures involving institutional review boards and certain number of other procedures, that this be established and that the granting of additional grants was contingent upon this having been set up. Finally, in 1974, this was extended by regulation so that there was indeed even more attention given to it. How effectively these institutional review boards and these activities were conducted as a whole throughout the entire universe of research institutions is less clear. I don't think we have a very good fix on this. We do have experiences, each of us in different institutions, which would indicate that at least in some there was considerable attention devoted to the protection of human subjects. I suspect this is a very varied picture. I parenthetically note that from the Department of Health and Human Services there are no classified research documents that we can identify. In fact, there's some question when we found that we don't have the ability to declassify documents, that the secretary may not be empowered to classify documents. So, we seem to be in rather a unique position here. This has not been a problem. In our organization, I'll summarize this fairly quickly and move on to some of the problems that we're encountering and which I think will be helpful to you. We have an overall coordinating group at the Secretary's Office level involving the Office of General Counsel, Legislative Affairs, Public Health Service and our Public Affairs people. We have a Public Health Service Working Group which I co-chair with Doctor Wendy Baldwin who is sitting behind me as an associate director of the National Institutes of Health. This involves each of the primary agencies. Within each of the agencies, somewhat different approaches are being used to identify records, but let me go on to certain principles that are being followed. I think as each of the agencies as we met from our earlier meetings there was the hope or the expectation that somehow or other one would be able to systematically search all files in government and thereby detect all possible instances where experimental testing had been done. Indeed there is a system which involves recording for all records being put in the archives or in the Federal Records Center, that all of these be identified by title and that these then be filed away. There's a certain schedule which, as we discover, is sometimes followed, sometimes not for destruction of records and a portion of those records then go into the National Archives. Each of the agencies was to review these forms called SF-135s and to identify as we decided a certain series of code words and any record that had this code word, we had about 15 of these, that this would be identified and then we would look at this further for possible examination further because each of these is about a cubic foot of records. As you run down the list of this set of records, as you might imagine, they have a varied quality about them. A number of them will show general correspondence. Others will say other things equally vague and thus you have a great many records sitting in the Federal Record Center which are not well identified and yet to review all of those records systematically is an absolutely prodigious task, absolutely impossible. Well, we have identified those. We have identified quite a number of boxes that have the code names and we are proceeding now to take the second stage to review those that look like they might have information. A second element was the hope that the hotline would turn up some interesting findings, something that we were unaware of, and that is a process that's only begun to really be examined in detail, examining those calls which are referred to us. We're not impressed that these are going to be terribly helpful. We're taking a third general approach and that is to interview all current and former employees who might have any potential knowledge of these, feeling that this might be of help and that is in process at this time. We endeavored to take a couple of approaches to do a search in a systematic manner. In other words, to try to have some way of looking at all records to ascertain that the end of that time we could say we have looked at all records and we have found X and we are confident all is there. We began with a review of our grants, which would seem like a logical point to begin. One hundred and sixty thousand grants between 1946 and 1961. None of this information is computerized before 1964. So we have no computer records, no ability to search these by a computer mechanism. What we have for most of these records before 1964 is the title of the grant, the name of the principal investigator, the institution and the amount of money. There's no other information available. We have decided then to look at those study sections which would give grants, would be likely to give grants which would involve ionizing radiation and we selected the principal investigators and did a literature search subsequent to that time to see if we could identify particular experiments which might derive from this. From a one year search we turned up something like 400, 500 different publications and began reviewing these. The amount of manpower involved in this was an absolutely prodigious amount of manpower. Certainly in the early days, '46 to '50 say, there were a number of publications in which it was not entirely clear whether humans had been exposed to radiation when you were reading the papers. I'm amazed at -- I think our scientific literature is approved over time, but it's a little bit humbling to go back to that time to see how poor they were. This looks like a very difficult task for us, to review all of the grants from the time, say '46 to '74. So, other approaches, as we see it, are going to have to be devised to do this. The first probes on this have not been very helpful. The second approach is a literature search which we are now going into greater depth in this area. But I would note that the literature is -- this has not been computerized prior to 1964. So, we've again got a set of problems which are somewhat more difficult than we would have with a contemporary literature search. There is a committee that has been created now involving the head of the National Library of Medicine, Don Lindberg, with colleagues from Energy, Defense and the VA, to try to devise the best possible way by which we can go through the voluminous literature to see what we can identify. I think the bottom line on all of this is to say that a systematic screen of large amounts of information in a way that is going to provide us with certainty that we have identified everything proves to be far less easy than one might imagine. In fact, it is proving very problematic. We moved on to a second approach and Tara has referred to this in terms of a targeted strategy to try to use a variety of mechanisms to identify particular experiments which were conducted and from particular points to try to spread out to look in greater intensity in certain areas rather than others. What do we mean? We do know that many of the experiments have been documented through earlier hearings and through earlier publications. There are indeed literature reviews which identify a number of experiments that have been conducted and we do know that a great many of the experiments we now know have appeared and been fairly extensively documented in the literature. So, we have a takeoff point of knowing certain investigators and certain institutions which were more likely to have performed other experiments than were others. Our belief is that these are particular points of reference which deserve special searches and special review as a likely place to find other instances of problems. I think we will perhaps turn up additional leads from review or from discussions with those who worked in the different agencies or different institutions that were identified during the period of time in question. So, what we're identifying then is more of a series of specific instances or specific experiments, a little different approach than, if you will, the major dragnet using some sort of series of nets of different levels of porosity. As we turn up the various experiments one finds certain problems. That is to say do we have experiments which are of different levels of priority. I think all of us feel you can be of help to us. There is a great deal of experimentation which has taken place using tracer substances. It takes place today. It's important in many parts and particularly in nutritional work. It's important in any parts of diagnostic medicine. Is it possible, does it make sense perhaps to categorize different experiments in categories which say as determined today and as determined then were felt to be below the level of causing damage. Is there a second category which perhaps now would be regarded as being at risk, but at that time was regarded as safe, and perhaps is another group of experiments in which radiation or radioactive materials were applied which today and then were regarded as above a threshold where injury might have taken place. It might help us, I think, if we can categorize experiments to say there are those of particularly greater concern than others. If our departure point and our experiments, human experiments involving radiation, are second order of investigation, then is the question informed consent, the nature of that and how the experiments were conducted? So, we have as our tag, if you will, some universe of experiments where radiation has taken place and then a follow-up which, as we have discovered with regard to the University of Cincinnati for example, it is important for each of the different agencies to probe their own records with regard to each of these simply because there were many sources of funding in the different experimental laboratories. This, I would say, gives one a brief overview of what we're about and some of the problems we're encountering at this point in time. We certainly look forward to working with the Committee and defining how best to proceed through a process which on the surface seems a lot more straightforward than it is when one begins to move through the processes to identify what we wish to find. CHAIRPERSON FADEN: Thank you very much, Doctor Henderson. Again, I know it's tempting, but we're going to hold our questions until we hear from everyone. Mr. Gracey is from the Department of Veterans Affairs. MR. GRACEY: Good morning. It's a pleasure to be here with you and I think I'll restate the obvious. This is not business as usual in the federal government, this level of cooperation. This level of interaction between this many players and this many different organizations and different perspectives in those organizations is rather unique and has been rather exciting. I got the opportunity to start it on the first day that I was appointed as Chief of Staff in the Department of Veterans Affairs and I met more colleagues than I knew I had in a very big hurry. Not to be trite, but we share almost every point that's been said so far at this table and said yesterday. We're very concerned in VA about discovering the facts, reaching out to the people who may have been involved in these experiments, determining if harm is done, and then doing the right thing if there was. We are in the business, for those of you not familiar with the VA, of still executing the mission Abraham Lincoln laid out in his second inaugural address, "to care for him who shall have borne the battle and his widow and his orphan." That is our job. Department of Veterans Affairs seceded from the old Veterans Administration in 1988 and today, just to set a context, I'm going to take a few minutes to talk to you about what Veterans Affairs Department is today, what it looks like, so that you can understand our process better as I describe it, as others have, and then a little bit about our plans for the future. VA is by most measures a very large organization. It has three principal operating components, the Veterans Health Administration, the Veterans Benefits Administration, and the National Cemetery System. It is the Veterans Health Administration that will be the primary focus for my discussion today and for the work that we have been doing and will continue to do, but there is interaction at least with the Veterans Benefits Administration on several counts. The Veterans Health Administration is again of itself a rather large organization by anybody's measure. There are 200,000 employees in round numbers, 172 medical centers which have both health care delivery and some research missions. That makes the task before us to discover what happened 50 years ago across that organization fairly formidable, as everyone else's is. Have set just that much context to get to the matter at hand, we too have thrown out several nets across that organization starting on January 6th when the Secretary sent a message to all 172 medical centers asking them to conduct a thorough, comprehensive and aggressive search of their records to identify anything pertaining to radioisotopes, nuclear medicine or any form of radiation research. That review took some time since the inventory, as it were, had to be done in each of those facilities and a series of questions answered and then compiled. At that same time, we did a central office review, a headquarters review of historical documents. In the past, every year, and annual report of the Administrator of Veterans Affairs was produced which was an accounting of what business had been done. We read those for the time period in question to see what information, if any, might be revealed about this type of work. We also had, as part of our medical research operation, annual reports of medical research in VA. They were scanned. They yielded little except information that we already knew, which was that there had been a sizable and fairly well regarded radioisotope program in the VA and the Department of Veterans Affairs starting in the '40s. Subsequently, we've issued another directive to extend the original search and to clarify to include radiation therapy research in which we were involved to a much lesser degree than radioisotope research. The Secretary went through some numbers that described the results at a rather high level yesterday, but I'd like to repeat them. We have found that we have 137 of the 172 medical centers which have nuclear medicine divisions, if you will. Of that number, 137, only 49 have copies of any protocols that were used in the research. Only 54 of 137 have any documents, any publications related to that research and only 24 have records that include the names of patients who may have been subjects in those research experiments. So, as we can see, we have a vastly narrowing funnel and yet we still have a fairly large task to go out and look at what exists in those 24, 49, 54, 137 places. That brings us to our plans for the future, some of which are already underway. We have begun to cross match the information that we got back as a result of those surveys with license records from the Atomic Energy Commission, Nuclear Regulatory Commission to see if there is anything missed or out of line. We've also begun to do a detailed inventory of the records at one facility using the DOD form, which I'm sure Gordon will describe, in order to try and capture the same information about our records in a detailed way what's contained in the boxes that may be extant at those locations, in a very specific way in a matter parallel to that of our sister departments and agencies so that what you see from us as an index or an abstract is the same thing that you'll be seeing from everyone. We're going to try and attempt to computerized that in a way consistent with DOD and the rest of the folks at the table. We have the benefit of still having contact with some of the people who are original researchers in VA in that era of the late '40s. Now, that has both pluses and minuses. The plus is it gives us some very personal insight into what was going on and let's us put some rather sterile documents into a human perspective. It also raises the question of whether their opinions are, in fact, pure and independent or biased by the roles they played at that time. We have a Nobel Prize winner out of our Bronx VA Medical Center, Doctor Rosalind Yallow, for her work in radioisotope research in the '40s and '50s. To talk for a minute about the telephone calls, we operate a national 800 system for our regular business, if you will, and we handle on that telephone system about 9 million calls a year, asking us about the status of a claim for disability benefits or the rules for burial or any number of other arcane pieces of information that a citizen might want to know about service from us. As a result of this effort, we have started to track calls specific to this issue. We have received since January on our lines 8,000 approximately calls of people saying they saw this issue in the media or they became aware of it some other way and they wanted to talk to somebody about the radiation issue. Of that 8,000, after screening, only 800, ten percent, are actually related to potential radiation research in VA facilities. The rest are our more traditional claimants, we refer to as atomic veterans, those who were exposed when in military service to radiation from nuclear tests or occupational, Hiroshima and Nagasaki or other events. In addition, we've gotten 800 referrals from the Department of Energy hotline. That process as a process again has not been business as usual. It's worked very well between us and them. However, our experience is about the same with those calls. Of the 800 referrals that we got from the Energy Department, only about 150 after screening are actually related to concerns about having been experimented on in a VA Medical Center and the balance again are our more traditional business. Nonetheless, we've recorded each of those calls in a form format. We're following up with each of those individuals personally. We're looking into their cases and we're hoping for leads, as Doctor Henderson said, out of some of those calls to something that we haven't otherwise seen or discovered. We have put so far no special resources into any of this effort. We have been using the resources from those 172 medical centers and our staff organization in Washington. We have let no contracts, we have hired no outside folks. We have set up no special center yet. However, undoubtedly, the moment is descending on us when we will have to do that because when we went earlier this month to do tests at one of those facilities, we found the task to be much larger than we had imagined and much more difficult than we had imagined. We had begun shortly after that to talk about where the resources will come from. Therefore, we seek the same guidance from you that Doctor Henderson and others have mentioned, which is some way to bring a focus to this, if that's possible. Clearly there needs to be a prioritization of our efforts so that what you are most interested in we prepare for you first. We are willing, more than willing, to open everything to you that we have and to share everything with you because we share the mission of getting to the bottom of this. But it is a huge task and we look forward to your council and guidance and support and I thank you. CHAIRPERSON FADEN: Thank you, Mr. Gracey. Again we'll hold questions and we'll turn to Doctor Soper from the Department of Defense. DOCTOR SOPER: Thank you, Doctor Faden. I'm just a country boy from Tennessee and I'm very impressed to stand here in front of you today. Your credentials are awesome. What I'd like to do, Doctor Faden, if it meets with your approval, since many of the speakers who have gone before me have essentially stated much of the process through which I might go, I'd like to perhaps in real time change what I'd planned to do and just give you some of the results that the DOD has found so far. Then I'd be happy obviously to take questions when we've all had our chance to speak our piece. First of all, I would like to impress upon you, as the other speakers have done, the commitment of the senior level of the Department of Defense. With me today as a demonstration of that are two of the people who have been almost on a daily basis working with this. Sitting behind me is Rear Admiral Wisely. Rear Admiral Wisely is the past skipper of the John F. Kennedy carrier. He was the head of the Blue Angels Precision Flying Team and number two at the Defense Nuclear Agency. With that kind of talent, we swiped him and he's been working on this on a daily basis. Colonel Bailey you see over there is a warrior. He is an airborne officer. He jumps out of perfectly good airplanes. CHAIRPERSON FADEN: I hope we have no bad ones. DOCTOR SOPER: He is so dedicated to this that he is planning to reenlist. He will be with us for awhile. So that, I hope, demonstrates the character of the -- the commitment of the Department of Defense. If I could, let me just run through some of the background that we found, some of the background, some of the things that we've found, some of the things we'd like from you and then perhaps have more interaction during the question and answer session. Our objectives are much the same as you've seen before. We're in the search process. We may obviously, depending upon your guidance and counsel, add to these fairly broad objectives. Next chart, please. There are a number of initiatives starting back with our first interactions with Doctor O'Toole and the Interagency Working Group up to now. One of the more significant things, at least for the Department of Defense, as Professor Deutch said yesterday, was at least in our mind set, we formed a command center. Admiral Wisely and Colonel Bailey are the heart and soul of that command center. Perhaps Colonel Bailey could give you just a few, in a moment, some of the things that we've been doing as far as outreach is concerned at the command center. Next chart. Resources. A lot of people involved. We've searched far and wide in DOD records, outside DOD records. To show you my naivete, I really thought this was going to be a simple process. I thought we would be able to go the basement of the Pentagon or somewhere in the Army or wherever and see big boxes labeled "Human Radiation Experiments," and neatly in those boxes would be all that we wanted to find. Well, as you've heard, not so. Dugway, for example, where some of the records exist, there's 700 linear feet of boxes, a very daunting task. If nothing else, just the dust. So, next chart, please. What's our status? Now, we've got four significant figures. We've found a number of experiments. What we did to begin with, we recognized that credibility was an issue. We used three essentially major tags, humans, ionizing radiation and experiments. Every time we got a hit on those three, we included it. We've gone back from time to time and asked for guidance to sort of either tighten down or loosen up, however you want to look at it, the so-called Christine Varney definition of experiment. But until that's done, we have chosen, and I think everyone else has, to err on the side of inclusion rather than exclusion. Looking down at you from the other side of a congressional hearing, you can just hear, "Oh, Department of Defense. You mean you have done your own analysis? What credibility do you think you bring to this analysis?" So, what we've done is asked the services and all of the agencies associated with the Department of Defense to focus on those three major activities and I'll show you in a minute and pass it out to you, a piece of paper that we've used to guide this search process and what we've asked each one of the agencies or each one of the services and agencies to do. Every time they find a record, to summarize in one page that record for us so that when we present it to you, there will be a simple elementary summary on the record. It might help your process of filtering out, as you all discussed yesterday. Next chart. Here's just -- computers are wonderful. They can make pie charts or bar charts. So, we chose to make a pie chart for you. These are the kinds of numbers that we're finding. Next chart. Let me just give you a couple of examples from each organization that might be of interest to you. For the Navy, here is what we call Operation Stoneman where volunteers crawl through sand that was laced with small amounts of lanthanum-140. You see the results there. You've got 93 people involved. Their records are available. The reports were published and we know where to go get some of this information. Next chart. This was a classified experiment called Hydra II. The records are classified not because of the radiology or the radiological issue, but because what we were testing, underwater shock provocation, was classified. So, the association of the small releases of radioactivity in the air got classified along with the basic experiment. Those are all now unclassified and available to you as a potential experiment. Colonel Bailey, let's go to the next one. With the Army, again 932 experiments identified to date. Let me just pause here for just a moment, Doctor Faden. These numbers may sound, "My God, that many?" I honestly believe -- and again it's not my role to do an analysis, but I honestly believe that when we provide you with these records, however you choose to sample them, many of them I think you will find are clinical in nature. Let me just give you a couple of titles of some that are included in these. Angiographic analysis of left ventricular mechanisms in young patients with atypical chest pain and ischemic heart disease. Fracture of the ankle in a military population. The use of 99 technetium pyrophosphate bone scanning in the early detection of stress fractures. Things like that are included in our records because they involve humans, they involve ionizing radiation and they're experiments. They're not standard clinical procedures. So, an example of the Army is shown here. The Department of Defense, like it or not, during that period and to this day, is involved in trying to understand the effects of radiation on a nuclear battlefield, not only to treat radiation injuries but to help in the definition of the kinds of things that were put out for the commanders. Here's a book, "Radiological Factors Affecting Decision Making in a Nuclear Attack." "Military Radiobiology." The kinds of things that you're looking at here were done some -- many with animal studies, some with human volunteers. That's the business of the Department of Defense and it will be your job to hopefully say that we've done these studies ethically. Next chart. The Air Force, there's an interesting one. The Air Force -- let's go to the next one, thyroid activity in men exposed to cold. The study was done in Alaska using Native Alaskans. The issue of informed consent continues to come up. It turns out that the tribal elders were approached by the study people and the tribal elders gave their consent. So, it perhaps would be an ethical issue for you all to look at with respect to whether the tribal elders had the authority to give informed consent for peoples in their tribe. This is an experiment that is and has been in the public domain, is presently a part of a congressional inquiry. As you see, the Air Force is in the process of awarding a contract for an independent review of this experiment. The Senator from Alaska is asking for that. Next chart. I think we're about done. The Cincinnati experiments have been mentioned on more than one occasion. The Defense Nuclear Agency, before that it was the Defense Atomic Support Agency and before that it was the Armed Forces Special Weapons Project, the agency in the government primarily responsible for understanding the effects of nuclear weapons, both on equipment as well as people. They sponsored and supported experiments, some of which involved whole body radiation. Next chart, please. The one most sensational, of course, is the so-called University of Cincinnati experiment which has received a great deal of attention. It's not new. It was the subject of congressional hearings in the early '70s. It was the subject of an independent review, peer review by two panels at the University of Cincinnati. It was reviewed by the American College of Radiology. Senator Kennedy asked the Government Accounting Office to look at this. Each time, each time the answer -- well, I'll let you review what the answers are. I have with me a stack of documents that were done for the Department of Defense by the investigators at the University of Cincinnati. The primary purpose of that study, at least the Department of Defense study, was not the choice of patients or the treatment of the patients, but rather -- and this is an ethical question I'm sure you'll struggle with -- but rather we used the information that was gained from that therapeutic process to try to understand the effect of whole body radiation on humans. I can tell you as the person who testified in Cincinnati last week, there's a great deal of sensationalism associated with that and I welcome your more careful and deliberate look at that experiment if you so choose. Next chart, please. That's just some more information associated with the University of Cincinnati. Now, here is the -- what I'm going to do is just hand out -- Colonel Bailey, do you have those -- oh, good. Thank you. There you go. What we have done in our search process -- in our search process, what we've asked each of the investigators to do -- and by the way, the people that we have going in and looking at the records are not -- I'll say this stupidly, not somebody we've just drug in off the street. These are medical doctors in uniform that are looking at these records. They are spending time away from their patients, they're spending time away from the job that they have to do because it's something that needs to be done. The physicians are looking at these records because they are the people that would best understand a short abstract or a short facing page as to know whether or not to include that information or to exclude it. So, this is the kind of information -- next chart -- name, where it was done, and a very brief summary of the document. Clear purpose, was it therapeutic, was other research involved and what kind of additional information can be provide? Is there anything else? Oh, where the records are located, their description, et cetera. So, that we have and I know we have shared this one with the other agencies and we've got quite a team going here, I think. Some of the things that DOE is doing they share with us and HHS and VA and all of it. So, we're trying to combine all of the good thoughts and ideas into an efficient operating team effort. I think it's paying off. The command center is sort of serving as a database monitor for information that's coming in and we're all trying to put our information in the same electronic format. So, down the information super highway can flow these bits and bauds and it will all make sense when it comes out the other end. What we want from the Committee. I'll focus your attention on the first dot. That's what you call Pentagon-ese, but what we're really asking you to do is to help us in how we might rank order the actions associated with the record retrieval process and how you might help us sort of -- tell us what you want so that we will better be able to guide these physicians in uniform as they go through the records to know we really don't need that. That's a dental x-ray and it's just not of any interest to you. Okay? is that all, Colonel Bailey? I'll be happy to answer questions, Doctor Faden, when we're done. CHAIRPERSON FADEN: Thank you, Doctor Soper. I'm a little concerned about time and some of the Committee members may be as well. Just to let everyone know, we are working behind the scenes here trying to rearrange the time frame and agenda for the morning to see if we can allow adequate time for exchange between our distinguished panel and the Committee. So, we're working on it. So, don't panic. There will be time for questions, but we're trying to get all the way through here. Our next presenter is Mr. Gries from the CIA. MR. GRIES: Thank you, Doctor Faden. Let me start off by repeating what Admiral Studeman said yesterday, that Director Woolsey very much wanted to be present. He had a difficult choice to be made and the budget won. So, he spent the day on the Hill. But he asked me to remind you of his interest in this subject and his conviction that CIA will cooperate fully and will do everything possible to search its records for any evidence of ionizing radiation experiments. I'd like to make just three points and I think I can do it briefly. The first is the scope of our search, the second the results, and the third the relevance. First is to scope. Because CIA does a good deal of its business in terms of electronic communications, we have very large databases that have been accumulated through the years. I think this would be obvious to you. Much of our communications is in the form of cable traffic around the world and so forth. So, the first place we went was to this enormous database. It has in it actually about 34 million documents. Believe it or not, we have been through them. That was an enormous job, but fortunately it was done by machines rather than people for the most part. It took about a month and it is completed. We also did hand searches of nearly half a million older documents, 480,300 to be exact. This was necessary because in the very early days of the agency electronic communications, although it existed, although they existed, they were not stored, which was a great misfortune. In addition, the search of the computer databases produced boxes and boxes of documents that then had to be looked at. These were documents that had the word "radiation" in them or "human testing" or words of that nature. We had devised initially a very broad key word search strategy which produced enough documents to fill about half of this ballroom and we quickly realized that was not a good idea and we redid the search with a better scheme and produced still an enormous number of documents which were then gone through by hand as kind of a double check. About 120 people have been involved in this effort, not all of them full-time by any means, but it will give you an idea of the scope. The effort is, as Admiral Studeman said yesterday, managed by a working group, of which I am the chair, and on which our members from all the various major parts of CIA, without exception. Since we decided at the outset that we would not second guess our own system and eliminate large pieces of geography or functional units, we included everything. Let me go now to the results of this search which is nothing. We have not found a single instance of a CIA sponsored or conducted experiment using ionizing radiation on human beings. Now let me pass to the third point, relevance. If we have found nothing after a massive search, why were we searching in the first place? Well, there is a very good reason for it and one which urges us to continue our search until such time that we are confident that there is nothing hidden away. The reason is that in the 1950s and 1960s CIA, which has always been very active in research of all kinds, although mostly on electronic matters and satellites and things like that, undertook a series of projects designed to, as Admiral Studeman said yesterday,, to find out how the human mind might be altered or controlled or manipulated through various means. In the enabling documents for those studies, the word "radiation" was inserted. So, of course, immediately we thought, "Ah, we did some of this." The Rockefeller Commission which investigated CIA drug testing, picked up that word out of CIA documents and repeated it and then the Church Committee, which continued those investigations, also picked it up. So, it is in the public record because, of course, all the files or virtually all the files of the Rockefeller and Church Committee are in the public record. So, this is what caused us to think that we had been involved. In the first weeks of our search, we developed a strategy, the scope of which I have already described, and in addition, as many of my colleagues have explained was done in their agencies, we reached out to people who might have memory of these activities. We were very fortunate. We are a young agency, as you know, or by Washington terms that is, and many of the people who might have been involved were still alive and we reached them. We have actually talked to about 50 people who were either directly in the chain of command or were, in fact, working in the offices that were managing experiments on altering the mind of a person, in our case an agent or our great fear in those days, one of our own officers. That is an action taken by some hostile intelligence service. None of these conversations, not a single one of them, produced any recollection whatsoever of experiments involving radiation. Now, there were a few instances where some of our medical offices had been concerned about the effects of radiation on our own populations and I think you're aware that this extends beyond CIA, includes the State Department and so on, because there was evidence of microwave signals being beamed at U.S. embassies in various parts of the world and so on. But we did not consider that the subject of our inquiry and so we passed it by. So that is the explanation of really the relevance of this search and why we are here. I want to close by repeating a point, that although we have found nothing, we search with great seriousness. Our working group remains assembled. We have a regular schedule of meetings and conference calls. We're in touch with each other and we will not stop until we have searched every nook and cranny. I should close by adding a footnote to my remarks about this marvelous electronic database. It has failed us before and we do not entirely trust it. We have performed massive searches in the past for various kinds of information and failed to find them, only to discover later that they were there. So, even though we have been able to move very rapidly through a huge amount of information, we will continue to turn a skeptical eye towards our own processes because we know that some of them, for example, depend on software developed in the '60s and some depend on antiquated equipment and so forth. So, it is not a perfect system. It can make errors. We may have made some already in this search and that's why we won't stop and that's why we will continue to address this problem with great seriousness, meanwhile hoping that the result will continue to be nothing. Thank you. CHAIRPERSON FADEN: Thank you, Mr. Gries. Again we'll have to hold questions and turn to Doctor Harry Holloway from NASA. DOCTOR HOLLOWAY: Thank you very much. I want to bring to the Committee the view of our agency which has a slightly different task than some of the others. Doctor Earl Ferguson, who is the person who runs our Occupational Medicine and Aerospace Division, will be showing the viewgraphs. Show us the first viewgraph, if you would. First we want to provide a little historical and mission perspective. We, of course, expose people beyond the earth's atmosphere and that results in radiation exposures. So, from the very beginning of NASA, in the late 1950s when NASA was founded, there has been an interest in radiation exposure. That particularly increased after the moon missions when people first went beyond the Van Allen Belt. Furthermore, NASA conducts biomedical research which utilizes low dose isotopes as tools for many of the standard research techniques for studying the effects of weightlessness in space flight on humans and other living beings. We put together a team to go over all of our activities in these various areas. I'll just show you that very briefly here. I have been given primary responsibility for organizing this search. Doctor Earl Ferguson is the person who at our headquarters is directly responsible to me in this, and our major human facility is at Johnson Space Center. You'll find, by the way, at the end of the packet we've handed out, an organizational chart so you can figure out what a NASA is. It will show you how all those are wired together. I won't go over that in detail. He carries out the primary portions of the search. In order to ensure that there is no conflict of interest anywhere up and down the line, we've also established an independent oversight committee which includes on its membership the head of our Safety Office, the Chief Counsel and our Chief Science, France Cordova, who is an astrophysicist and is on an IPA and has come into the agency and therefore has a fair amount of independent view for this. Our search process has involved a series of memos and instructions, as have all the other agencies, a series of interviews which have extended to the people who have participated in the research, a search of the federal record centers, literature searches to try to locate any experiments for which the original documentation has been lost or destroyed in the usual process of destruction, review of Helpline inquiries which we've had help from the other agencies doing, and we have a considerable historical activity with our NASA historians that are histories of each of the individual centers and we return to that to identify whether any sort of activity has gone on there. We've done 950 hours of search thus far. There have been 18 interviews of former researchers and that has turned up some very valuable data which we are still pursuing. We have records that have come from all the federal centers. To describe the overall level and extent of our efforts, which is much smaller than most of the other agencies, we have had 20 public inquiries, including all letters from Helplines, citizens and FOIA requests. So far we have 213 articles from extensive research that we have talked about before that have references to our previous human studies and those are currently -- the review on those are currently being completed. The experiments identified to date within the context of our search which defines what we know as we're continuing our research is that we've had radiation studies at Oak Ridge which had to do with a set of studies, principally supported by DOE or the antecedents of DOE, in which we were examining the whole body radiation, much as DOD was, with data from medical experiments or all accidental exposures that occurred at other places to calculate dose consequences for symptomatology. Those studies have been in the press and may be of interest to the Committee. An unusual set of experiments are the visual phenomena experiments caused by heavy ion radiation traveling at near relativistic speeds. These studies were carried out by scientists under no formal sanction from apparently either their institutions or NASA. Most of them were contractees of NASA, in which they placed their heads in large particle beams to see the flashes of light which had been previously observed by the Apollo astronauts. These are secondary to ion particles that are hitting the retina and causing those flashes. These were nonetheless -- we know about the experiments because they were published independently and we have the overall references for those studies. In all of those cases, some of the most prominent biophysicists and physicists in the United States are both the primary subjects and authors of those papers. The radioisotope injection experiments are commonly accepted clinical practices are used as a standard set of ways to do experiments on bodies. I think that Mr. Goldin mentioned that yesterday. We have some studies of total calcium and bone mineral analysis studies and we've outlined here for that. I might add that with regard to astronaut studies per se, next slide, we regard those as occupational exposures not included within the context of this particular Committee's purview. Those are under the purview of the National Academy and are reviewed outside of NASA by the National Council on Radiation Protection which provides us the standards for those particular elements. Now, these are the issues. If I could first begin by saying that I could simply reflect what everyone else on this panel has said about the primary concerns we have about establishing thresholds, understanding how the priorities should be established and fulfilling any of the needs which the Committee might have concerning our data. None of our data has ever been classified and all the experiments you've seen outlined here have appeared in the public domain on many occasions. Some issues we would like to bring forward, one of which you've already heard about, is that we'd like to know what should be accepted in terms of the clinical tests that are applied for experimental purposes. We are at the present time including those within the domain of our radiation experiments that we're planning to report to the Committee. We'd be interested in the Committee's opinion on that. We also are very interested since from the very beginning our radiation program has consisted of fundamentally utilizing the heavy support made by our colleagues from DOE, DOD and Health and Human Services utilizing their experiments to provide us our primary data, we'd like to have information about how the ethical responsibility should be established when an agency supports experiments conducted by another. We regard this as a serious issue in which we think there are some ethical issues and things that need some definition. Finally, one issue I'd like to raise that we also think is generic in this overall area is to get the opinion of the Committee and perhaps by asking the question in terms of what data is unethical and therefore should be quarantined, we wanted to know what the various threshold levels are for data that has been tainted by various unethical or other practices with regard to whether it may be utilized within the scientific framework. So, we'd like to hear those sorts of issues if we could so that we could learn about them and know how we should establish policies for the future. I would simply like to end by reflecting Dan Goldin's remarks to you yesterday. We very much are interested in a prospective approach to this so that we may from the experiences that we have had and that those that come from the fellow, my fellow workers from all the other agencies so we can know how to establish an appropriate set of actions for the future. CHAIRPERSON FADEN: Thank you, Doctor Holloway. I think what we're going to do in the interest of mental health and time and getting things organized is take a break at this point and express our thanks to the members of the panel who apparently have all agreed to stay a little bit longer than was originally arranged and have our question and answer session after the break. We're busily trying to rearrange the schedule. May I ask the members of the panel to please, if you have not already done so, provide the transcriber with hard copies of any viewgraphs or visuals that you have so that can be put into the record, plus any other handouts that you have distributed to us so we can just put them into the record of the meeting. So, can we do this quickly and come back in five minutes? DOCTOR SOPER: Madam Chair, could you suggest how long -- well, that's a silly question. CHAIRPERSON FADEN: How long this would go on? DOCTOR SOPER: Yes. CHAIRPERSON FADEN: Let's see. If we reconvene in five minutes -- let's say we reconvene 10 minutes, 5 minutes, 11:15, if we went to a half hour for question and answer, would that -- we may go a little bit long. Let's say no later than 12:00. DOCTOR SOPER: Okay. CHAIRPERSON FADEN: No later than 12:00. Is that all right? Can people stay? (Whereupon, at 11:06 a.m., off the record until 11:23 p.m.) CHAIRPERSON FADEN: We are struggling to rearrange the agenda. We've got it partially rearranged. Let me just assure -- and Reed suggested this and I think it's very wise -- reassure the members of the Committee that we will have an opportunity to ask continuing questions of the members of the Working Group over the course of the life of our Committee. So, we don't need to feel like we need to ask everything we would like to know right now. On the other hand, this is a wonderful opportunity for us to begin to get a better understanding of how we're to work and what's been happening. So, I don't want to curtail the discussion, it's just that time constraints ultimately will likely mean that everybody will not be able to ask everything that they would like to ask of as many people as we have here this morning. With that, I'm going to open it up for questions. I will start keeping a list. I've got -- let me just get this going. We'll have to have a process whereby if you think you're directly on point, if you want to interrupt, go ahead. But otherwise I've got Duncan, Reed -- should we just go around this way? That's not fair. We could alternate. It's okay with you? How about if we just go this way because it looks like everyone has something that they would want to ask. If your question has been answered, you don't have to ask it. If you really want to jump in on point, jump in but don't be creative. Only if it's directly on point. Try to keep your question such that we're mindful that we need to get everybody else to get a crack too. So, we'll start with Eli and go this way. DOCTOR GLATSTEIN: I'd like to ask if all the other agencies basically followed the same format that DOD did with this outline of breaking down the experiments by name, location, researcher, agency and so forth. Is that pretty constant? MR. GRACEY: We, for one, have just tested that and have not applied it to the whole body of what we know we have. We wanted to see how big a task it was. Our plan right now is to do that or a very close modification of it. DOCTOR GLATSTEIN: Is it fair to assume that for each agency each experiment, whatever, has been numbered and is on a computer? Can we assume that? MR. GRACEY: No. DOCTOR GLATSTEIN: Oh, we can't? Okay. DOCTOR O'TOOLE: Can I jump in here? You have the DOE and the DOD form. DOD and DOE are a little bit -- DOE is slightly different in format. It has much of the same information. DOE and DOD are slightly ahead of the game in computerizing. Our intent is that for all of the experiments that we uncover in whatever agencies, we will generate an electronic form and disk. We will give the disks to the staff to peruse and then we will forward the actual documents, copies of documents as you decide that -- or the staff decides that you want to see them. So, that is the process that we are heading towards. DOD and DOE have made it real to a somewhat greater extent. We're also in the process of getting your staff wired up to receive this electronic information from the agencies. DOCTOR GLATSTEIN: Is it the intention of the Department of Veterans Affairs and HEW that the information will be computerized? MR. GRACEY: Yes, but I don't want to mislead you. We're just at the beginning. We've done an identification and location of what exists in what general volume where, but we've just begun the process of going through page by page. DOCTOR GLATSTEIN: Final question. DOCTOR HENDERSON: Let me, if I may, to take up the HHS side. I think as Gordon has indicated, what they have computerized is everything that says "radiation" and "human experimentation." That means use of radioisotopes, for example, in any sort of human experimentation, going up I think to the present time. If we were even to begin to attempt this it would be an all but impossible task considering the enormous number of grants that are awarded to institutions across the country. Even taking it prior to 1974, I just don't believe we could get to where the DOD is based on internal records that they would have. So, I do not foresee us getting to that point. To have computerized records of the type they have around a selected group of experiments, the answer would be yes and I think we've talked about trying to harmonize these. DOCTOR GLATSTEIN: The final question that I'd like to ask is for the DOD. Is there any organized systematic follow-up of the volunteers who go through radioactive sand and other things? DOCTOR SOPER: No, not yet. Our process is merely a search process right now. CHAIRPERSON FADEN: Thank you. Lois? MS. NORRIS: My question is directed to Mr. Gries. I'm referring to the Central Intelligence Agency's search of records on human radiation testing dated April 13, 1994. I note that the wording in the second sentence which says, "As this search nears completion, the CIA has no evidence that the agency ever deliberately exposed anyone to toxic radiation." It's so precisely worded that it raises the question in my mind, particularly the terms "agency" and the term "deliberately." And "toxic" is another one. Am I led then to believe that there's a potential that people may have been inadvertently exposed to toxic radiation and the effects or the results used as a study? MR. GRIES: Well, it's a good question and it goes to my skills as a drafter. That wasn't intended. The precision that is in that sentence perhaps is misplaced. What I was trying to say is we have not found anything and the search has been really broad. It includes not only consented but unconsented and intentional but unintentional and so forth. MS. NORRIS: Thank you. And then I'll get back to the term "agency." Is it conceivable that CIA records may include information on studies conducted by other agencies containing information to which you were privy or information which of value to you? Does this negative report include that? MR. GRIES: That's also a very good question which Dan Guttman and I were just discussing during the break. He made the same point you did, that it would seem likely that CIA records would include reports of what other agencies were doing in this area, but they don't. We simply haven't found it. Now, of course, there is a prohibition against our collecting records on domestic activities. Although I imagine it would have been legal enough to do so, we didn't because the proclivity is against it. So far, we have not found it. MS. NORRIS: Thank you. DOCTOR THOMAS: I have two questions for DOE. First of all, it was very helpful to me to hear Tara's comments about the deliberations that went into defining our scope in the beginning and I'd like to expand on that a little bit. Yesterday, as you are aware, we had a discussion with Senator Glenn in which he brought up this issue of the Marshall Islanders. In particular, he made a statement about how some Marshall Islanders were returned to sites which were contaminated, specifically for experimental purposes. I don't know the facts in this case and I don't know whether that's true or not, but it seems to me if that were the case we would like to define that as an experiment. I don't see how we can find out that without doing a little digging into the facts in the first place. Could you elaborate on that? DOCTOR O'TOOLE: Yes. DOCTOR THOMAS: How do we go about deciding what is our scope in this sort of issue? DOCTOR O'TOOLE: Well, that is an important question. First of all, let me note that I reportedly have been misquoted in the New York Times this morning. I've not yet seen the article, but my Public Affairs Office has and are upset that I apparently or the reporter thought that I implied that the charter for your Committee was set in stone, immovable and could not be changed to increase the scope of the experiments as set forth in the original wording. That's not the case. There is however, process for changing the charter, which is quite simple. You go back to the Interagency Task Force and say, "For these reasons, we would like to include thus and so." I would be happy and I'm sure any of the other agencies would be happy to brief you or the staff on the Marshall Island situation and why some people are alleging that experiments took place. The Marshall Islands were exposed to fallout from South Seas atomic bomb testing. There is no doubt that some of these atolls were contaminated and some of the people on the atolls were contaminated. There is tremendous controversy as to when people ought to have been returned to their atolls and what the decision making process for doing that was. There is also currently a great deal of activity going on on Capitol Hill that pertains to whether or not the treaty, the Compact of Free Association between the Marshallese and the United States government should be reopened and reexamined in order to include larger numbers of atolls and greater numbers of people. There are a number of reasons why people are raising those questions. I have met with the ambassador from the Marshall Islands to the United States and with the Ambassador from the Marshall Islands to the United Nations. I have told them that the Department of Energy will, quite separate from radiation, human radiation experiments, that we will make available to them all documents, whether they are classified now or not, pertaining to the Marshall Islands. They seemed happy with that. I am very eager not to sidetrack the process of investigating the Marshall Islands documents which is really going on as a separate very expedited effort in my office. I have some worries that interpolating the Marshall Islands documents, which are voluminous, into your effort would slow down the release of those documents to the Marshallese. But I would be happy to brief you or have my staff brief you and make documents available to you so you could make your own determinations as to whether or not they should or ought to fit within your scope. DOCTOR THOMAS: I certainly don't mean to belabor the Marshall Islands situation and I'm well aware of the concerns which you raise, which are good ones. But am I clear then that it's perfectly appropriate in your view that this Committee debate that and other situations as potential extensions of our contract, of our mandate? DOCTOR O'TOOLE: I think it's perfectly appropriate. DOCTOR THOMAS: If we decide that we really want to get into it, we would need to go back and get a formal extension. DOCTOR O'TOOLE: Yes. I think it's perfectly appropriate for you to debate whatever you want about the scope of the charter. Again, I would offer you a briefing as to what we know now about the Marshall Island situation to help you and also offer you original documents if you decide to go through them to help you make that decision. DOCTOR THOMAS: I think a briefing on that subject at a future meeting would probably be very helpful as sort of a test case to help us sort through this question of scope. My second question was probably more appropriately directed to Steve. I was hoping for some more details on the hotline. Particularly I'd like to know if there is some sort of a former protocol relating to several issues. First of all, what happens when somebody calls in? How is the questioning undertaken and what sort of information is collected at the time? Secondly, you alluded to a cross referencing between that and what documentation is already available. I'd sort of like to know a bit more about how that works. Finally I'd like to know whether there's a protocol for summarizing all of this information and hopefully at a future meeting you'll be able to give us some sort of at least a statistical summary of what you've learned from this. DOCTOR GALSON: There is a protocol for the way each phone call is answered. The information is being collected in a systematic way on a form that is being computerized. When calls are deemed to be pertinent to the records of a government agency, including DOE since it's an intergovernmental hotline, the standard information on that call is forwarded to that agency. The intent is that the agency will then use that pertinent information to instigate a specific record search and that is what's happening. I'm not sure how successful that's been in each of the agencies. If anybody has any comments, that's fine. But the intent is clearly that it be used to walk across from the hotline to the record searching activities in each agency. DOCTOR THOMAS: At this point are you aware of any examples of experiments that have been uncovered by this method that were previously unknown to you or the other agencies? DOCTOR GALSON: I'm not. Is anybody else aware of it? No. DOCTOR HOLLOWAY: I'd like to put an oar in that. There are clearly people who allege things each time and each time they allege things you don't know whether the next one is going to turn up something. So, that's part of the ongoing search process. None have turned up, but there are new references and each time you go out and look you never know what you're -- maybe there is one there. CHAIRPERSON FADEN: Susan? DOCTOR LEDERER: As a follow-up to these telephone line questions, I'd be interested to know if the people calling up are reporting types of experiments other than radiation related. DOCTOR GALSON: There have been a lot of calls with concerns that are not relevant to the charter. DOCTOR LEDERER: And is anything being done with that information? DOCTOR GALSON: Other than it being recorded, no. DOCTOR SOPER: In our case, in the Department of Defense, many of the calls that come into the hotline and then are referred to us because they have a DOD implication, many of these, as a matter of fact probably most are really calls from the people that would normally call another hotline, what we call the Nuclear Test Personnel Review that a number of us have mentioned earlier. So, what happens in general is that the number of calls, the frequency of calling dies down and then something happens in the public media, et cetera, and they go back up again and they trail off. For the Nuclear Test Personnel Review, the activity associated with this investigation has reinvigorated the number of calls of people who are not a part of this particular experiment, but were a part of the Nuclear Test Personnel Review. MR. GRACEY: That's very important to us and I'd like to talk specifically to that. That was the implication behind the numbers that I threw out earlier. About 90 percent of the calls that we're getting, both on our own phones and in referrals from the Energy Department Hotline are people who served in the military and during that period believed they were exposed at a nuclear test site. We have a process in place, and have had for some time, for dealing with those claims adjudicating them and compensating people when it turns out that they were, in fact, exposed. There's a large body of law on which I'm not an expert in that regard. However, I'll tell you that we have the concern and what's happening in the community of those folks with whom we have at best a marginal relationship because most of the people do not wind up being compensated, is that they think that this Committee, this effort, is taking the focus off that, which is exposure of a much larger group of people and they feel wronged by that. We're doing our best to deal with them fairly and in a frank way because that is much more likely to be productive for us and for them than what we've seen so far, at least in VA in the purview of this Committee. DOCTOR GALSON: Susan, I can easily get you the information about the non-radiation calls and what they're about. I don't have those numbers in my head. I know there have been some. We can get that to you. DOCTOR LEDERER: Well, I guess my second question is addressed for you. I was interested in sort of your second cut at search strategies and especially in the isotope shipping records that you mentioned, and wondered if that had turned up records at university-based investigators and have they been contacted and are those records also going to be somehow accessed? DOCTOR GALSON: Yes. We have sent that log to some of the other agencies and I am not sure exactly where we are in tracking it down. Glen, do you have any -- stand up. Go ahead. CHAIRPERSON FADEN: Could you go to the mike, please? Would you mind? Thank you. DOCTOR O'TOOLE: This is Jim Ware from the Department of Energy who has been intimately involved in the actual record collection search. MR. WARE: Thank you. The question was has there been any follow-up on the isotope shipments and have we had any responses as a result of that follow-up. Is that correct? DOCTOR LEDERER: Um-hmm. MR. WARE: The answer is yes, there has been follow-up. As our teams go into the field, for example, and we are aware that isotopes have been shipped to universities in the area, prior to our arrival, for example, when we go out to California, we have asked that our field office out there contact a number of universities and hospitals that have participated or at least have received isotopes based upon our knowledge of the shipment records. We have had one response from a university that was contacted regarding an isotope shipment and they did forward us information regarding two records that they have pertaining to this effort. DOCTOR LEDERER: And that could be made available to us? MR. WARE: Yes, ma'am. DOCTOR LEDERER: Okay. CHAIRPERSON FADEN: Thank you. Reed? DOCTOR TUCKSON: In the interest of time, I will try to find another way to get some of my specific questions of various departments answered. CHAIRPERSON FADEN: Let me just introduce -- if people have specific questions, if you would give them to us, we will submit them to the departments and we will get back written responses. DOCTOR TUCKSON: Let me then just use my couple of seconds in a more general question, and Tara, maybe you're the ones, but others. I want to be very precise in how I say this. First of all, I as an individual on this Committee cannot help but be impressed by the President and his comments to us yesterday, as well as the spirit of the administrators, senior Cabinet officials who came here yesterday. There is no question in my mind of the commitment and the spirit that has driven this and the commitment that pertains and maintains throughout this process. No question. Having said that, the tough issue will be, I think for us, and I really do begin now to have a better understanding of the position that this Committee is in, in terms of the credibility issue and assuring that all due diligence as appropriate was done in terms of bringing forth the reviews. I'm not still so sure how to do that. In fact, your testimonies today, particularly D.A.'s and others, really give you a sense of how hard this is. So, I've become concerned. First, each individual department doing their own and being led by the leaders of that department gives me some reason for pause and I wonder if there was thought to maybe having some of the leaders from one department leading the review in another department. Maybe that's a mechanism by which you begin to start to get at it. I was very impressed again, Gordon, with the DOD. But as you've mentioned that and you introduced the extraordinary warrior and the extraordinary battleship person in the Flight Angels, which is important in the culture of the DOD. If you don't have those kind of people involved, you don't get cooperation. And you didn't have time to mention, but because you didn't get a chance to mention on the record, I imagine, that your senior health officer was just as important in that leadership group, that becomes a concern. When the Department of Veterans Affairs tell us that out of 137 centers, 49 have copies of protocols used, then you start -- what happened to the other ones? The bottom line becomes, Tara, how this Committee, number one, gets on the record the process. Number two, more importantly, how to really make sure that process is as good a process and as thorough and gives us the issues of credibility. DOCTOR O'TOOLE: Presumably you're not asking me for the solution to that very critical problem. DOCTOR TUCKSON: No. I guess it would be a sense of just -- and obviously something we've got to return to. But in quick terms, in your original discussions as a task force, did these issues come up -- DOCTOR O'TOOLE: Absolutely. DOCTOR TUCKSON: -- and did you talk about maybe cross fertilizing these independent investigators? DOCTOR O'TOOLE: Yes. Yes. Let me -- well, the answer to your latter questions is yes. In fact, we have been meeting weekly, all of us, trying to plumb those matters further and figure out how to construe some kind of fail safe search process that we could demonstrate to the world is comprehensive and adequate. We are all attempting to actually map, to document the search process and to certify that process in various ways. I would suggest that to get into the nitty-gritty of those matters would be a road most fruitfully traveled by your staff, who could then report back to you. It takes a long time to explain what we're doing. It may be that a menu of various ways wherein you might watch what we do and certify what we do or not would be something that our interagency working group could develop with your staff and bring back to the Committee, rather than belabor you with the details about what HHS and DOD and DOE are doing. But I think some kind of process or, as I say, choice of processes that you might select from for validating the agency search is a critical first piece of business. Ruth and Dan and we have begun to explore at least the beginning steps in that direction. The matter you bring up about whether or not agencies could do each other's search. We have been trying to do that at the highest levels in terms of lessons learned at one agency being applied to another. However, each of these agencies -- I think you got a flavor for what a unique kingdom each is. I have begun to learn my way to the cafeteria in the Forrestal Building at the Department of Energy, but I need a guide to get the proper office in the Pentagon still. When you're trying to wend your way through the bureaucracies themselves and their archives, you really need people, we are finding, who truly know those agencies. This brings up conundrums such as conflict of interest questions about how do you use the expertise of the people who were there who know where the records are in a way that does not compromise the integrity of the search because those people were there and may, in fact, have a vested interest in the outcome of your deliberations. So, there are a whole host of questions that kind of orbit around the issue that you raise and they are, I think, very high on the list of the things we need to attend to. DOCTOR ROYAL: I'd like to make a comment about this search process. You used the word "failsafe." Yesterday I commented that we shouldn't promise more than we can deliver. I think it would be a mistake for this Committee to imply that our credibility depends on nothing else ever showing up over the next few years. That's an unrealistic expectation. What we need to do is we need to document what the search process was, acknowledge the fact that any search process is going to have some flaws, but try to describe the search processes as explicitly as possible. One question I had about the search process was whether or not any validation was being done. What I had in mind was two people going through the same box of records and are you seeing that they are abstracting the material in the same way? What do we know about the reliability of the abstraction process? DOCTOR O'TOOLE: Well, I can speak to the Department of Energy. We have asked our field offices to go out and inventory the records in their possession or the possession of their contractors. We then sent teams of historians and archives from the Department of Energy headquarters, always teams, never single people, who go out, basically check the comprehensiveness of the field office's inventory, check through the boxes that the field offices identified as possibly pertinent, enter those documents into provenance, I believe that is the word, using a Bates code. I'm learning all kinds of librarian science terms, however imperfectly. So, each page of the box of documents or the document is sequentially numbered and it is thereafter impossible to yank a page out and copy it. We keep records of how many copies, where they live. The original documents are left in place. The copies are sent to the coordinating information center in Nevada which was set up to service the inquiries around the effects of nuclear testing on people living downwind of the test site. There the documents are copied under CD ROM and that is sent to headquarters. It's a very elaborate process. We've done everything we can to maintain the integrity of the records and that kind of thing is done differently. CHAIRPERSON FADEN: Let me interrupt. I'm sorry, but I'm worried about the timing. I think the kind of detail we're getting from Tara now is exactly what we need to hear from all of the departments. And to follow-up on your suggestion, Tara, that's the kind of thing that if your staff can work with our staff and get this all down in nauseating detail, then we can come back as a Committee and ask for particulars in a more informed fashion. But if we would ask the other agencies who may want to be answering also about how carefully you do your work to just not answer right now. We have seven minutes left until 12:00. We're sure you're all doing equally detailed and wonderful things, but we'll have to find another way to find that out. Can the panel stay until 12:15? Is that all right? Just to get everybody through and we may never eat, but we'll figure this out. MR. GRIES: If possible, I would like to leave by 12:45. CHAIRPERSON FADEN: Okay. Well, let me check right now to see -- I was going to say, did anyone have their question planned for Mr. Gries? You did, Dan? Let's get Dan's question and then that's your question, Dan, and we'll come back to Ken. MR. GUTTMAN: To follow-up Ms. Norris' question, we all know that the CIA or the agency occupies a special place in American culture, in all kinds of dimensions, both known and unknown. The question is varying on your answer and knowing from our discussion that the CIA, we know as a matter of fact, focuses on international, not domestic intelligence, so that there are valid reasons why we would suspect you might not have known or participated in these kinds of experiments and you interviewed the people that were involved in Mark Ultra and they didn't know. My question is -- everything is connected to everything else. What we're looking at is science. It may have been in the service of international activity. So, we look at Green Run, for example. My understanding is why this intentional release took place at Green Run had to do with what was happening in Russia. So, I would suspect or the people here probably would suspect you had plenty of people who were looking at what was happening in Russia. Were they also looking at the other part of the puzzle, what was happening in the U.S. in relation to that? The question I'm asking is not do you know, but can this Committee assume as an operating matter that when NASA and the VA and Doctor Soper say, "We have nothing to hide," your experts, your historians can sit down with us. We'll go through it as they want, nauseating detail by nauseating detail. We could have our historians or expert staff sit down with you and your historians and expert staff so that we could ask you, for example, in addition to interviewing people about Mark Ultra, can we interview the people who are looking at the Russian nuclear testing to see maybe that they knew something about the Green Run? Is that the operating protocol that we can expect from the CIA, the same kind of thing? MR. GRIES: I think the answer is yes. We would be delighted to talk with any members of the Committee about any aspect of our search and indeed if members of the Committee can advise us on things that we have not done that we should have done, we will do them. So, the answer is we would like to work with you on that. MR. GRIES: Thank you. MS. KING: I want to follow up on that because I actually want to broaden the inquiry. It seems to me that one of the significant problems here is to make a distinction because I think there's a distinction in the public mind as well as our own among those agencies that have had classified material and do, in fact, classify and have had some research that has involved classification. Secrecy is my short-term word, where I have to worry about problems of secrecy versus processes where I may not have to be so concerned about that because I don't want to stigmatize anybody. In terms of trying to understand what is actually going on, it seems to me important to make that distinction and that would involve CIA. That's why I raise it in connection with the CIA. I don't think it's just a CIA problem. Quite frankly, I think that it is a problem where you've got a history of secrecy and classification. That's my first point. My second point is I got no sense from -- and this relates again to the CIA. I got no sense from any of the panelists this morning that anybody has considered conduct on human subjects outside the United States. It has been a tried and true mechanism of avoiding American oversight. So, I would direct it to agency -- this is not just a CIA question, but since you're going to leave, I've got to raise it in the context of CIA. MR. GRIES: I'd better get out of here quick. We did look outside the United States because there would be a possibility that had we sponsored such research we would have done it abroad. So, we made no distinction as to where the research might have occurred. Regarding the classification question, it does affect certainly our agency, certainly Defense and probably some of the others. But we have not made any distinction in our search between classified and unclassified. We've searched everything. MS. KING: Oh, no. That was not the point I was making. I think it of greater concern from our point of view about being sure, about the processes that were undertaken that the agencies that have used classified -- have classified documents, have a history of this, are, it seems to me, of greater concern to me than the other agencies. That's not to say I'm not concerned, but in taking a hard look at process, it's very hard to do that in agencies that have a history of keeping things secret or classified than it is in an agency where that has not been an operating procedure just in terms of how I think about what may be happening in those agencies. DOCTOR KATZ: Ruth, I don't have a question, but just a general comment to the whole group. CHAIRPERSON FADEN: Can it wait until your turn? DOCTOR KATZ: Only except that it's also important for the representative from the CIA. It will only take me one minute. CHAIRPERSON FADEN: Say it. DOCTOR KATZ: I'll be very, very quick. It goes to all kinds of issues, but to be quick, it would be nice and I hope the Advisory Committee will agree, that you keep another record, namely of all the persons who are doing the reviewing for you of the records. The reason for this is that if permitted I may wish to spend a couple of days with various groups who do the reviewing and just learn something about the way they're going about reviewing records, selecting, not selecting, et cetera. I've had some experience with this, but on a much more minor scale. But I might learn something. Serendipity sometimes occurs, that either something has been overlooked or not paid sufficient attention to from my experience and that could be helpful to the Committee's activities. CHAIRPERSON FADEN: Thank you. Ken, you get your chance back. MR. FEINBERG: Thank you. A single question for Mr. Gracey, I guess, and for Secretary O'Toole. Mr. Gracey, at the beginning of your comment, you mentioned that at the end of the day, if it is concluded that there were wrongs done here and if it's concluded that there were subjects who were injured, the Veterans Administration wants to do the right thing. Yesterday, the Secretary mentioned the need for proper redress. Yesterday, Secretary O'Leary mentioned the need for an appropriate response. That raises the question of what is it to do the right thing for past wrongs. What is the appropriate response and is the government's skirting at this time the issue of remedy for past wrongs? I noticed in Secretary O'Toole's eloquent statement at the end as to what DOE views as "our mandate." No mention of the issue of remedy for past wrongs. Is compensation, is medical monitoring, is damages an appropriate response, proper redress doing the wrong thing? I'd like to hear from Gracey and Secretary O'Toole on that issue which will undoubtedly in the public mind loom very, very large. MR. GRACEY: Well, I mentioned it and the Secretary mentioned it because, in fact, in the different contexts in which we operate day to day, that is a major piece of our business, providing health care for those who have been disabled in the service of their country either by illness or by injury, providing compensation through a very judicious process to those who have been disabled to some extent. So, it would be a natural extension in my mind and in his mind that should we discover that we in VA -- or on military people it would be were injured in the course of any activity, including this, that we have a system in place to deal with that. But I wasn't speaking prospectively to the grand scheme of radiation research. DOCTOR O'TOOLE: The Clinton Administration is certainly interested in remedies and is not trying to skirt that issue at all. There is an Interagency Working Group that I didn't mention, the Legal Working Group, which is reviewing past schemes of compensation that were applied, for example, to uranium miners, to down winders, to the Japanese who were interred during World War II to try and understand better the various models of compensation that have been used before. We have asked the Committee for guidance in various sorts of remedies, not simply limited to compensation, which is not to say we're trying to worm our way out of compensation either. But we are very interested in whether medical monitoring is warranted and would be of benefit, what kind of apologies from the government might be in order and so forth. I think there is possibly a range of, as you put it, remedies that need to be duly considered and we are looking forward to the Committee's advice and guidance on that in shaping the Administration's position on compensation. As a matter of practice, however, compensation, at least in the forms of legal tender, will be a matter for the Congress to determine. Certainly Congress is not skirting that issue. They are, as we speak, writing bills to address it. We think a little prematurely in view of your early efforts here. But no, we understand that remedies will be a great focus of people's attention and we hope to approach it thoughtfully and reasonably so as to do justice to all, to the people who were subjects of experiments and their families and also to the American taxpayer. MR. GRACEY: Just to add, frankly at the level at which you are involved now, the two earlier questions that I posed at the beginning are concerns, which is what are the facts about what happened and who was involved factually and whether or not harm was done and how much are more burning than what do we do if we find the answer to those questions. We're so deep into the beginning of this that we're working on that sequence mentally. At least I am. DOCTOR SOPER: I'm sure you're aware that in the case of the University of Cincinnati there have been or there are pending, I don't know the lawyer term, a number of suits both against the University of Cincinnati and perhaps the Department of Defense indemnifying the University of Cincinnati. So, those issues, compensation perhaps is defined a little differently that way. MR. FEINBERG: Those lawsuits face formidable legal hurdles -- DOCTOR SOPER: That's correct. MR. FEINBERG: -- when you're suing anybody that stands in the shoes of the United States government. But I'm not prejudging. I don't know all the facts of those suits. But I'm pleased to hear the response from Mr. Gracey and from the Secretary. CHAIRPERSON FADEN: Thank you. Ruth? DOCTOR MACKLIN: I have a couple of precise questions that really go more generally to the task of the Committee. The first one, unfortunately, goes back to definition and scope. Doctor O'Toole, the wording of the charter under Objectives in Scope, 1 and 2 specifically say experiments on individuals involving intentional exposure and intentional releases. You said near the end of your presentation that the word "experiment" was a deliberately chosen word. Now, my question is about one example that Doctor Holloway mentioned. For example, whole body radiation exposures that occurred accidentally. Now, apparently -- that's not deliberately, that's accidentally and yet a study apparently of the consequences of that was carried out. So, the question is does that or does that not -- I mean I do have a specific question for Doctor Holloway on that, but my question is on your account of the scope and on the definition, does that or does that not count in your interpretation? DOCTOR O'TOOLE: I think we need a clarification here. Harry, were you talking about the Oak Ridge experiments? Those were not accidental whole body exposures. Those were intentional. DOCTOR HOLLOWAY: I'm sorry. Both happened at Oak Ridge is what I said, that's correct. Both happened. DOCTOR MACKLIN: My question is both hypothetically and actually, if there were studies that were conducted of accidental exposures but following the accidental exposure then a study was made, because other questions flow from that. Were the subjects informed? Were they told? Were they offered medical treatment? I mean an array of things. Would that count? DOCTOR O'TOOLE: I think, as we said, we clearly -- we're not clever enough to craft this precisely enough to answer those kinds of questions without some thought. My thought would be that those would be in, that experiments following accidental exposures would understandably be within the scope of your charter. DOCTOR MACKLIN: Okay. I guess the whole question there goes -- DOCTOR O'TOOLE: I think though that what we are finding is that it is more useful to take actual instances of particular experiments and then ask those questions of the charter rather than trying to scope out the whole charter and its import theoretically. DOCTOR MACKLIN: Right. So, I won't pursue that then. Let me though ask if Doctor Holloway knows about the Oak Ridge accidental exposures, whether the subjects who were studied were told that they were part of a study, that they were subjects of research. DOCTOR HOLLOWAY: At the present time, our level of knowledge of those records don't allow us to arrive at a judgment about that. The situation is that a group of patients were treated for therapeutic reasons under a then AEC contract. Those people were exposed and that's the intentional therapy. The other people were simply people of whom records existed of having been exposed to radiation at various places in the United States in which the radiation dose was known and the consequences were known. We just don't have enough detail in that record to be able to answer your question. DOCTOR MACKLIN: Okay. One other pair of questions for Doctor Soper. You mentioned the Operation Hydra II, I guess at San Clemente. DOCTOR SOPER: Yes, ma'am. DOCTOR MACKLIN: That was a release into the environment and this is to help me and perhaps my colleagues on the Committee understand better what it was -- what was being studied. You mentioned records of that study. Now, my question is what records? I mean were there subjects, identifiable subjects? What's the nature of the records? Were they medical records and could we view retrospectively those records as being records of subjects of experiments? In other words, something was released into the environment. DOCTOR SOPER: Let me give you my impression of the nature of the experiment very quickly. It was to understand how a shock wave propagates underwater to simulate an underwater nuclear explosion. Large conventional explosives, of the order of 10,000 pounds of explosives, were detonated underwater. In your mind's eye remember some of the early nuclear tests where the bomb was placed under the water, a large plume of radioactive water came out and then was spread downwind. It was carried by the prevailing winds at the time. I think the reason we're including that is because in that explosion we laced -- I'll use that word, laced the explosives with a very, very small amount of radioactive material. The main purpose of the experiment was the shock propagation underwater. But as an adjunct to that test, we wanted to see if we could measure how the fallout from this water plume propagated. Because it involved, as part of the Varney charge to us, intentional releases of radioactive materials into the environment, we included that. Now, that's a definition of what I understand the experiment is. To speak specifically to your question, "Soper, what is the form of the records?" I'll have to -- we'll pretend we're at a congressional committee. I'll have to answer that for the record, if I can. DOCTOR MACKLIN: Okay. One very brief final question. CHAIRPERSON FADEN: Very brief, Ruth. DOCTOR MACKLIN: Yes. The tribal elders. DOCTOR SOPER: Yes, ma'am. DOCTOR MACKLIN: To your knowledge, were they given any incentives in the process of seeking their consent on behalf of their group, their tribe, their community? Were they provided with any incentives, to your knowledge, and would that be in the record? DOCTOR SOPER: That will be in the record. I don't know the specific answer, but that will be in the record and we'll get that answer. CHAIRPERSON FADEN: I'm torn between the usefulness of this process and the time which is ticking away. I feel like everyone still needs to get their crack, or everyone who hasn't yet had one. So, if you could bear with us for a little while longer, that would be fine. I will restrict myself to one question which I think follows on the dialogue between Gordon and Ruth. We have this ongoing problem of trying to understand the nature of our charge and to make it coherent. I'm trying to fit together whether you look at the Executive Order or the charge, the specific reference to experiments involving intentional environmental releases of radiation are then further specified to include designed to test human health effects or designed to test the extent of human exposure, which suggests it's not any intentional release of ionizing radiation, but the intentional release of ionizing radiation in conjunction with an intentional plan to examine the human health effects of that release. which would in some respects -- and I'm looking at Tara and Gordon for guidance on this -- in some respects suggest that certain sorts of things that we're discussing would be out. You then flip over to the next page and we get the Green Run test which seems not to fit. The little bit that I know about Green Run seems not to fit that description. So, how do we understand that, understanding that we can go back to the Interagency Working Group for expansion or contraction? I'm just trying to understand what is in the mind. Tara first and then Gordon. DOCTOR O'TOOLE: Well, I think the answer to your question resides in the history of how we develop this charter perhaps without due deliberation or at least enough analytical elegance rather -- the Green Run, you are quite right, does stick out like a sore thumb. It is different from the rest of the experiments we tried to codify in the charter. The experiments which come under the environmental release rubric which are on the second page of the charter were all part of a GAO report that was released in December in the midst of all this brouhaha. What we wanted to do was capture those experiments in the GAO report, these intentional environmental releases, partly because they were the subject of public interest, partly because they really had not been explored before as far as we know. As I said, the other categories of radiation exposure that we considered did seem to have some ongoing investigations underway, many of which were quite elaborate. These experiments, the Dugway experiments, the Oak Ridge experiments and the Green Run, the exception being the Green Run, the Dugway experiments and the Oak Ridge experiments were largely unplumbed as far as we knew. So, we wanted to include them. We don't even know at this point if anybody was exposed in those experiments. The GAO noted that they had a hard time coming up with documents to describe in many ways those experiments. The Green Run is different in that it was not an experiment -- it was an experiment, but it was designed to detect atmospheric dispersion of certain weapons production activities, not to test human exposure or the extent of environmental contamination from these activities. It is included in the Hanford Dose Reconstruction Project. It is being studied on its own. Perhaps we erred in putting it in. We put it in in order to be inclusive and so that we would not seem to be excluding the Green Run, which was a secret, classified project and hence we thought would be of interest to people. The doses released yesterday, which are only model doses, not verified doses, indicate that the Green Run was a rather small contribution to the overall environmental releases at Hanford. But that is the history of why it was included. You may choose to exclude it once you know more about it. Clearly the charter was not perfect. But you're quite right, it is anomalous. CHAIRPERSON FADEN: Gordon, did you want to add anything to that? DOCTOR SOPER: The only thing I would add is just to remind you of our mind set and that is we're spooked by not including something on purpose and therefore trying to hide something. So, you are probably going to see from all of us either records of experiments, et cetera, that really quite frankly at the end of the day fall outside the scope. But we include it to err on the side of inclusion rather than exclusion. CHAIRPERSON FADEN: Thank you. Nancy? DOCTOR OLEINICK: Most of my questions have been asked, but I'd like to follow-up on a point that was raised by Pat King, which is the inclusion of individuals in experiments that would have been conducted outside of the United States but supported by the U.S. government. I think this is a question that goes to all of the agencies and I'll ask it in the negative. Would your search -- well, I will ask it in the positive then. Would you search have included all of those possible experiments? DOCTOR O'TOOLE: Yes for DOE. DOCTOR HOLLOWAY: For us, "all" means all. DOCTOR OLEINICK: Okay, because I'm really very concerned about that and because there is an issue of skirting rules by using populations outside the United States. My second question. I haven't heard in any of the reports any interaction with an agency, an interagency group that has been in existence for several years to study radiation research. That is, I see a representative of this group sitting over here, Bill Mills from CIRRPC, which is an acronym for Committee on Interagency Radiation Research and Policy Coordination. I think I got that right. This is a group that has been working, has representatives presumably from all of your agencies and I haven't heard that there was any interaction with that group, that they participated at all. They would be a remarkable resource, I think, for -- maybe not for digging into the ancient files, but for finding what information we know about radiation and where that information came from. Has there been any interaction? DOCTOR O'TOOLE: No, but I think you're quite right that that might be a useful avenue to explore for the second phase. We really have been focused on the dragnet thus far. That group, I think, has been very valuable in the past. It has not really gotten rolling recently in this or recent administrations. It really is a kind of ongoing interagency effort that hasn't been, I don't think, very active, at least in the past year, to my knowledge. DOCTOR HENDERSON: Yes. I can say I know the group well and have a lot of respect for them. Certainly there are a number. They are representative from each of the agencies. So, there are, at least from HHS side, a number of the people who are partaking of this exercise in various ways. I think really the question is is that the best structure to do the investigation. I think our feeling is that it really is not. It's a different kind of group which is much more heavily toward the technical side and I think here we're dealing with a whole set of other issues. So, we're involved with them but not in the formal sense, but the individuals are participants. CHAIRPERSON FADEN: We have four more people who are owed the right to ask a question. Could I just ask you to be concise? Refrain from comments and stick to questions and ask the panelists. DOCTOR KATZ: As I said before, I don't want to ask any questions. I will have many questions to ask once I have examined and begin to examine some of the records. I just wanted to tell you, as some others on the Committee have done, how greatly impressed I am with the cooperation you have shown so far. In the 30 years I've worked in human experimentation, this is an unusual experience. But I wanted you to know that as the year goes along, I will in most likelihood ask all of you all kinds of critical questions and searching questions. They will not be asked by me in the spirit of being critical, but in the spirit of getting to the bottom of certain kinds of things that are very, very difficult to identify because our ideologies shape certain answers before we even have recognized that ideology is involved, like the ideology of science, et cetera. So, please forgive me when I seem to be critical and I think it's also -- I'm doing so also in the service that we don't want to give the public the impression that we've been coopted by you in our investigation. As President Clinton said, there is this basic mistrust out there and hopeful our report might ultimately dispel some of that mistrust. So, that is the way in which I approach my task and I hope you will forgive me if at times I will sound a little bit too critical and too harsh. DOCTOR SOPER: Well, Doctor Katz, this sounds like my father when I was a young boy. "Gordon, this is going to hurt me more than it does you, but you're going to get a spanking." DOCTOR KATZ: I do not know whether that's a compliment or a criticism. DOCTOR SOPER: Very much a compliment. CHAIRPERSON FADEN: Thank you. We'll move on. Mary Ann? DOCTOR STEVENSON: Sorry, I'm going to move to more mundane subjects. In view of the enormity of the material that we have to review, it seems imperative that we have a standard summary intake sheet, I think, from all the agencies when they go about evaluating these experiments. I know that probably can't be done at the ground level, especially in view of the material that Doctor Henderson is describing that has to even be reviewed. But at some point, and I think sooner rather than later just for efficiency points of view because it sounds like some of the agencies like DOD and Veterans Affairs have already generated sort of work sheets, that we should really standardize a one page work sheet that's computer entry compatible and put on computers so that it can cross referenced. The NASA representative mentioned they borrowed information from these other agencies and it has to be done. DOCTOR O'TOOLE: We're doing it. DOCTOR STEVENSON: Okay. And probably more in reference to Doctor Henderson, I'm really concerned about the 1961, pre-1961 data. I imagine warehouses like Raiders of the Lost Ark with this material that needs to be looked at but sort of humanly can't be looked at and what kind of plans you have to sort of at least try to scratch the surface of that. I know some of the other agencies have gone and tried to speak with former employees as far back as they can be found. Maybe that would be helpful. I fear that that group of materials, those pre-'61 materials, may have things that are of most interest to this Committee and that post- '61 peer review and IRBs were becoming stronger and stronger and probably there was fairly good review after that or reasonably good review, but probably not prior to that. DOCTOR HENDERSON: I think there certainly are problems with the pre-'64 period where it's even difficult to identify this by title, but there are also very few records that are available or kept because there is a routine practice of destruction of records after a period of time. How do we recover this, how do we identify each of these particular instances? Now, I think this is where we've looked at this and said it's going to take a bit of detective work on this. Rather than a massive search of records and saying, "We've been through all records and we find nothing, therefore everything is fine is," is not going to be a very sensitive way to do it and we're going to have to come at this in addition in other ways. This is trying to track down a particular instance of this through interview of employees or past employees, which we are doing in every agency, of maybe focusing in on certain institutions, certain research institutions which have done a lot of work and working with them and their records as a specific entity. To this end, we have formed a search group under Tara's chairmanship with all of the agencies with the thought that as we move through this we would want to do this as one agency or one group approaching the institution rather than each department separately and so on and so on. But the idea of trying to identify selected episodes or trying to identify these is the problem. We asked the question, as I'm sure this Committee has to ask at the end of the time, after all this is done, we'd like to write a report and say we have carefully searched the records and we are confident that we have identified every instance of human experimentation, that there are none out there. Well, this is a negative in science. It's just not answerable and I think we can only define this within certain parameters. I think we can outline for the Committee and would welcome doing this, is certain types of strategies that we have done, planned to do and maybe try out some alternatives on this because it is a judgment call as to how one proceeds on this and to what degree of detail. DOCTOR STEVENSON: Okay. And then one last very quick question, probably for Steve Galson. What kind of triaging effort do you have at the -- I mean who is ultimately making the decision that the phone call is irrelevant to our task? I mean the VA, I believe, said -- no, it was DOD said you had physicians looking through certain records. Who are these people that are ultimately making the decision about these calls and letters? DOCTOR GALSON: The Helpline itself is being run by contractor employees, but with close supervision of representatives from the agencies and they're reviewing the specific questionnaires to determine whether they're relevant or not. Again, we'd be happy to give the Committee samples of how those decisions are being made and see if you have any comments on how to improve them. CHAIRPERSON FADEN: To go to Mary Ann's point, when we get that we need it in the level of detail of what is the training, what is the professional level of the people both in the field making the decisions. DOCTOR O'TOOLE: Can I just make the comment that most of the not relevant decisions are things like people calling in to congratulate the Secretary or criticize the effort. It's not is it in or out of the scope, it's simply not relevant on a kind of common sensical basis. But we can give you all of that. MR. GRACEY: Or I use the numbers and said they didn't fit in this category there because as you go through the form, which we probably should give you a copy of, it leads you into another area like military people who were exposed during atomic weapons testing. So, we handle it, but we handle it different. We don't abandon it. DOCTOR HENDERSON: You also have the man who has informed us that he's had a radio transmitter put into his tooth and he's very concerned about this. We have a number of those. CHAIRPERSON FADEN: I've actually had a few too. DOCTOR ROYAL: I've already asked two questions. I will put my other questions in writing. CHAIRPERSON FADEN: Thank you, Henry. MS. KING: This is sort of a follow-up question to Ruth Macklin's statements. I'm concerned that in the initial dragnet search that where there was not intent -- and I have to confess I'm having trouble with the word "intentional." I think it's not useful. It's something that kind of -- in the scientific community that makes a lot of sense, but those of us in the civil rights community, we know that we're interested both in motivation and in impact. So, I'm looking for some way to get to impact and that was the thrust of Ruth's point. That is if there was an accidental exposure if you did a research project afterwards, is that in or out, I personally think it should be in. So, I am concerned that an initial dragnet that we would pick up the accident releases considering the way the charter is written, the mandate is written, where there was subsequent study of some kind. I don't even want to dignify it by calling it protocol because that's another trap. We have a view in mind when we use the term "protocol." So, that's my question and my request of staff is I would love to see, agency by agency, the definition of what the search was because I am confident that not every piece of paper in all these agencies was perused. Therefore, there was some initial cutoff for targeting the search. I fear, so you'll understand why I'm asking the question, I fear that the initial cuts or ways to get at the material or what I call carry with them strong overtones of what is science. We scientists or people who work in science have an idea what a protocol is. You have an idea of what you consider an experiment. You have an idea of -- it's typically formal. The public has a different understanding often of what an experiment is. Part of our task, it seems to me, may have to be educational along these lines, but I want to see to what extent the initial cutoffs, a bias in favor of our own understanding of what science is. The only way I can do that is at least to see the initial slash and probably the next subsequent one or two and it may have been things like terms that were used. I couldn't gather this from all of the testimony of all of the presenters. But I would think that's very important to understanding what exactly came up on the radar screens when they went out for the dragnet. CHAIRPERSON FADEN: D.A.? DOCTOR GALSON: I think we each issue written instructions to our agencies and we can easily give you all those. I know we brought DOE's with us today. DOCTOR HENDERSON: I think there is a class of "experiments" which do relate to intentional exposure which are followed up. Many of these are treatments as were performed at an earlier time for decrease of lymphoid tissue through implantation of radon pellets and radiation of the head for pediculosis and so forth and so on. There are many, many follow-up studies like that which, for example, the Centers for Disease Control has done and a number of universities have done. These we have not included. MS. KING: I understand. I heard you. DOCTOR HENDERSON: There's just an enormous number of those where radiation was used as an earlier time and for other purposes and some for purposes we still use today in an attempt to find out if there are any long-term adverse effects of radiation. If those were included, I think you're going to wind up with a very large number of experiments indeed. MS. KING: Well, I was frowning when you said that because you just made me understand that my concern is even more complex and broader than I thought it was because I was focused on the non-intentional aspect of it. But there's an intentional side too. But I think that that is something the Committee needs to look at. We need an understanding of what it is we think we want searched for on both these sides. The only way to understand that is to understand clearly what each agency used in guiding it in its search so that we can sort of decide for ourselves whether we think that picks up or is likely to pick up what we're concerned about. CHAIRPERSON FADEN: In following up on that, when the staff does work with the staff, the two staffs work on this issue, we need to make sure that we probe not only what did you search for, but what did you choose not to search for, so we can flesh out, get some more information in relation to Pat's question. That will be very critical for us to understand. DOCTOR HENDERSON: There are a family of experiments which I think we have identified in part which I think we've all been ambivalent about not knowing how to handle. Here I think it will be important for the Committee to look at this. It's surprising how many people have exposed themselves to radiation. Radiologists. This was not uncommon. Do we include them or not? Is this informed consent? I don't know. We hope it's informed. CHAIRPERSON FADEN: There's a whole class of self- experimentation. DOCTOR HENDERSON: There's a whole surprising number of different types of experiments once you get into this which gives you some difficulty. We look forward to working with the Committee on this to define this more clearly. DOCTOR SOPER: Doctor Faden, may I answer one question I think Doctor Tuckson brought up? Not only do we have people in uniform, but the Assistant to the Secretary of Defense for Health Affairs and the surgeon generals of all the Services are intimately involved in our steering committee. CHAIRPERSON FADEN: Okay. Thank you. We do need to break now. We are very appreciative for this briefing and remind everyone that this is an ongoing process. We will be continually asking you for information and for consultation. Thank you. (Whereupon, at 12:35 p.m., the meeting was adjourned to reconvene this same day.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 1:36 p.m. CHAIRPERSON FADEN: We need to start. We have less than an hour and a half if we are to end on schedule to do a huge amount of things. Let me just say something everyone will understand. We did arrange the morning session in order to allow the Committee to have as much time as the Committee wanted to have with the members of the Interagency Working Group who were with us. That means two things got bumped from the agenda. Our conflict of interest presentation with Kathleen Whalen we will reschedule for our second meeting. We will have that discussion but we will have it not this meeting but next weekend -- not next weekend, next meeting. And then, Dan, I guess next meeting in a way is kind of opportune. We'll have hopefully hired more staff by then. You'll have more people to talk about. But we will have a detailed public discussion of what the staff looks like for everyone's understanding at the next meeting. Now, we had this quick discussion this morning about what we'd like to do in the afternoon. There's no way we're going to do it in an hour and a half, so let me just shortcut things a little bit by identifying four areas which it's my understanding we can give as tasks to staff based on what has come out and then spend the time that we need to spend on things that only the Committee members can do or at least begin to identify. The first is -- and just so the staff doesn't get panicked, I'm not saying that all of this has to be done by the next meeting, the time frame of which we have not yet decided. But it's my understanding now that one task to the staff is for the staff to work with the staff of the various departments to get a very detailed picture of what is going on at each of the agencies and for the two staffs, ours and the agency staffs, going agency by agency, to identify options for how we as the Committee can be involved in an oversight or quality assurance role. The staff will bring back to us, then, an array of options agency by agency which we are then of course free to modify, alter, reject or whatever, but at least there will be the work done where our staff will work with their staff to figure out what seems to make sense, options for different ways that would seem to make sense for our being involved in monitoring the integrity, basically, of the process. Another staff function is that we will ask the staff to identify what is available and what is known, including scholarly work that's already in the literature, about the ethical standards and regulations which cross the decades for each of the affected departments. So we want every guidance, every regulation, any statement from 1944 to the present from all of the different departments plus whatever scholarship is in the literature on that subject. We also want the staff to come up with a kind of briefing paper for us about public participation, outreach and advocacy. Needless to say, that's a whole constellation of issues for the staff to give some thought to, the advocacy groups that might be of interest to this subject, how we might approach them, how to structure the public comment section, how to advertise it, and also how we might communicate directly to the public which picks up on Henry's question which would involve different members of the staff, whether we want to use direct communications of one sort or another, media or otherwise. So that's a third staff task that we don't have to discuss here unless somebody tells me that we don't want the staff to do this. And finally, of the list of things to talk about, there is the suggestion from Henry that we identify a few experiments that are already well known and much debated where the staff could collect whatever materials are extant, which should not be hard to do because these are studies about which the agency's already collected a lot of information and a lot is in the public domain, collect that for us so that we -- summarize it and provide us with the evidence, what's available on these studies so that we can then use them as case examples for our own purposes in terms of how you think through this process. The one thing that we need to do is tell the staff which experiments or cases we would like them to work with. One proposal is the University of Cincinnati Sanger case. There are others, obviously, but shall I take it that the Cincinnati situation is one that we want to include in for this case example purpose? Seeing nobody saying no, fine. We'll have the staff pull together whatever is available, which we know is voluminous, and we have the materials from DOD and we can get the materials from DHHS and then whatever is available in terms of the press coverage and things of that sort and from the family advocacy group that Mr. Plair represented yesterday and we can put that all together and have it before the Committee as quickly as possible. Is there another case that we would like to introduce? DOCTOR ROYAL: I would suggest the plutonium injections. CHAIRPERSON FADEN: Shall we start with those two for our purposes right now? Those are easy ones to do in the sense of easy meaning that they have been given so much attention just lately that it will not take a lot of sleuthing work for the staff to put together a fair amount of stuff. DOCTOR MACKLIN: Just to know what we're dealing with, it might be useful if we could get one example of an environmental release. CHAIRPERSON FADEN: Well, we could put together what's available on Green Run. The GAO report is pretty comprehensive. DOCTOR MACKLIN: Okay, if that's the most comprehensive, I mean, because it will give us an idea of the different types of things that we're dealing with, so I think one example, if Green Run is the best one. I don't know which is the best one. DOCTOR ROYAL: I'm on the oversight committee for those reconstruction studies, so, if the staff needs help getting documents, I'll be happy to help. CHAIRPERSON FADEN: That would be excellent. So the proposal now is plutonium, Cincinnati and Green Run. Pat? MS. KING: I want to be clear about exactly what we're going to do with these case studies. And the reason I ask that question is, these are among the most controversial of the studies that have surfaced. We are talking about a brand new group of people, innocent, unbiased, stumbling into this area in a public discussion, so I want to be clear about what exactly we are going to do with these case studies in our meeting next time. I mean, I'm not suggesting we do not tackle these cases. CHAIRPERSON FADEN: That's a very good point. MS. KING: I am suggesting that we not contribute to the controversy unless we are clear about what our goals are and what we think that we can get out of them. CHAIRPERSON FADEN: That's an excellent point. Thank you for bringing it up. DOCTOR ROYAL: What I would suggest that we do with these cases is look at what information is readily available to us on these cases, decide what pieces of information we think are important for the Committee to subsequently deliberate about these cases and decide whether or not there's material that's available that's clearly not helpful to the Committee so that in future cases we can be more specific about what information we want. Because I think that when we get the information about these three studies we'll see that there's going to be lots and lots of pages of documents and we have to figure out some way of making that efficient, so I think it's just a matter of determining what it is that we know, whether or not the stuff that we want to know is all there or not, and can we be efficient about collecting that information. MS. KING: So the purpose of looking at these cases is methodological only. DOCTOR ROYAL: Exactly. MS. KING: So we make no comment at this time about what we think substantively about the cases. DOCTOR ROYAL: I think that we would like to make the judgement about whether or not we have enough information that we would be able to make a judgement, but it wasn't my intention that we would necessarily make a judgement. CHAIRPERSON FADEN: I think we should make that stronger, though. I understand where Pat is coming from and have an understanding that we are not positioned to make a Committee judgement about the facts or the ethics or even the science of the experiments that we're going to be debating. We have not, for example, done the preliminary work of the Committee determining what moral standards we think ought to apply, and so we are not in a position yet -- thank you for that caution -- we are not in the position yet as a Committee to deliberate the ethics of the experiments. We can use -- so our understanding is these case examples are for us to develop our own methodology. For example, John raised the issue of whether you want primary or secondary documents. I would think here we would want both, so the judgement is can the Committee live with secondary documents. Do the members feel they need to see primary documents, see both and give a sense of it? That's the sort of thing that we're going to do here next time or by whatever meeting we can do that, but we are not going to deliberate about those experiments as a committee. MS. KING: May I suggest that, if method is our goal, that we have been somewhat -- we need to, I think, discuss why a case study. Because, it seems to me, if it is to guide future work, it would be helpful to have a case where we think that we have a fuller record than others, maybe one of these experiments. But, it might be much more useful for these purposes to pull a case or cases at random from perhaps some of those files already -- CHAIRPERSON FADEN: We can do both. MS. KING: -- identified by the Agency which may turn out to be a more typical set of problems that -- CHAIRPERSON FADEN: We can do both. MS. KING: -- we'd be likely to run into rather than the ones -- CHAIRPERSON FADEN: I think we need both. I think that's right. I think that's very nice. We can flesh out the range. MS. KING: -- since our goal is method and process. CHAIRPERSON FADEN: That's a good point. We can certainly do that, pick out some cases where the information is much sketchier and of the form that we're likely to receive it from the agencies. That would be excellent. Ruth? DOCTOR MACKLIN: I agree we're not in a position to deliberate about the ethics or the standards, but are we in a position to make a set of, I don't want to say "checklist," I don't want to say "criteria," but areas of interest that we know are areas that will be ethical concerns or that are generally ethical concerns, informed consent, risk-benefit ratio, recruitment of subjects. CHAIRPERSON FADEN: Particularly with respect to whether the information is available to make judgments. DOCTOR MACKLIN: That's right, but that's more in the form of a checklist that could make it more or less uniform so that we don't sit down and inspect things and then have things pop up as we're looking. Now things may also pop up, but at least things that we would want to look for that we know in advance are the categories where there are ethical concerns. CHAIRPERSON FADEN: We can try to come up with, as a sort of staff process, a list of categories both scientific and ethical that would be the kinds of things we'd want to review these cases for that could be a guide for our looking at both the more fleshed-out cases and the more primitive cases to see just how much you need to be able to look at those questions and what level of detail the Committee wants to look at, so I would think that's fine. DOCTOR KATZ: But, Pat, particularly what do you think? You're quite right that at this point we can't make a judgement about these experiments, but considerable literature exists on the moral dimensions of experimentation with human beings and under what condition as a general literature and people have competing views on what these tensions are, under what circumstances experiments should be considered, ethical, unethical, et cetera. So, we can begin, maybe with the help of staff and maybe some of us will have to do it in conjunction with staff, to present various models for ultimately making judgments about any of the experiments before us. MS. KING: It is my suggestion that we not do that at this point. I agree with you that it has to be done, but I think that Henry was correct that we need to learn something about the nature of the beast and what I don't think we want to do right now is to do more than that. We should not go to the most controversial when we haven't discussed standards, where there is -- there are people on this panel who have never had to deliberate those kinds of questions. There are those of us who still don't have, and I speak for myself, the foggiest understanding of radiation and the science of this. So I don't want to even intrude or get into this area, given the controversy that exists a this stage, but I think that what has been proposed is enormously useful for the work of the Commission. I don't want to put us in the midst of a media circus, quite frankly, before we've done our homework. CHAIRPERSON FADEN: I think that's very fair. MS. KING: And no matter what we do we will be in the midst, on the Cincinnati experiment, of being in a media circus unless we have clear goals and objectives about what we're going to do with that case study. It's not that I don't want to come back to the Cincinnati study. Of course I do. This committee must deliberate that study and we must do what you're suggesting. I am only suggesting that we understand that we have limited goals, which I think you outlined very well, for an initial scrutiny. That's all I'm suggesting. I think what you say has to be done. I just don't want it done now. CHAIRPERSON FADEN: Can we must move on, assuming that Pat's account is acceptable to everyone, what she's just said? We need to go on because we have so many other things we need to do in the next now hour. I feel obligated to really end on time because I notice some people have airplanes and flights and things like that, so we really don't have much leeway, given that it's the second day. Before we go to more substantive discussions, there is this sort of practical question of how often we are going to meet. We've asked all of you to put calendars in. We've had a suggestion from a few Committee members that we meet more frequently during the next few months because of the work of the Committee needing to get underway. At the same time, that fights against the fact that people's calendars are the most booked up now, since you didn't know about this Committee at the time that you were committing yourself for May and June of 1994, so we have an inherent tension between the needs of the Committee and the realities of people's lives. It's my understanding that when people were contacted to consider serving on the Committee they were told the Committee would meet about once a month for two days. Is that generally what everybody was told? There is a proposal that we meet every two weeks for the next couple of months and a proposal that we meet in three week intervals for the next two months, in other words try to get three meetings in in a time when we would normally get two meetings in. So, could I just get a sense of -- this is quite apart from finding the date, because that means putting everybody's calendars together. And we realize that we will miss people, but -- DOCTOR MACKLIN: Would these be two day meetings each time? CHAIRPERSON FADEN: I think it has to be, because, with people coming from the West Coast, I don't think it's fair to ask them to come from the West Coast for a one day meeting, unless the West Coast people are happy to say it's okay to come from the West Coast for a one day meeting. It seems like it's an inefficient -- DOCTOR TUCKSON: It doesn't -- I don't want to speak for all the West Coast people, but, to me, it's not a consideration. CHAIRPERSON FADEN: Duncan? DOCTOR THOMAS: Selfishly, I would prefer fewer long meetings, but I can go anyway. CHAIRPERSON FADEN: Pat? MS. KING: Could I place one consideration on the table? I'm flexible in this area, as flexible as my schedule permits. This is not my concern. My concern is that I've been a staff member before. You're going to have a staff that will do nothing but gear up for meetings if we set meetings every two weeks, because that is the reality of life. You have to respond to us. So I am quite interested right now more in terms of what staff think that they can meaningfully do in the intervals that will make a two day meeting useful to us. MR. GUTTMAN: A quick comment. I'm very relieved to discover that Doctor Royal seems to believe in the case study method more than lawyers do, because that means that you will have a pile of documents, not a complete pile, but a pile that should be relatively easy for us to assemble and what I had thought of as the initial task, which is categorizing 2,000 experiments, which would require some sophisticated staff work. The way that you're structuring the next meeting, I don't think it will be the kind of problem that we would otherwise have. The other question, as long as I'm talking, is this point of clarification. When Pat King or I read these case studies, should we know in advance what a RAD is? And if so, should we only rely on Doctor Royal's paper and the present book? Should we wait until the day before we discuss them or do you want in advance other kinds of materials that give us -- we talked about the mutual education. From the standpoint of the staff, what is it that you need in advance? Should we wait for your own self- presentations? CHAIRPERSON FADEN: Well, can we -- that's a separate decision. Let's put that off. MR. GUTTMAN: Right. That's a staff question. MS. KING: But it does go to the question of meeting, because, if we're just going to discuss a case study and that's not hard to put together, then you can meet once every two weeks. If you're only going to discuss this case study in the next meeting, the question is what are you going to use the two week interval for? I actually think two weeks is pretty short. I think three weeks is probably doable, and four weeks gives staff the maximum amount of time. But two weeks is tight, if you're a staff member. CHAIRPERSON FADEN: To move the discussion forward, I propose we forget the two week interval. I laid it out in the issue of fairness because it was proposed, but I don't think the two weeks is an interval that's reasonable. So the only issue is do we need -- for the next two or three months, should we try to structure meetings every three weeks or every four weeks? We may end up being three and a half weeks sometimes because of a date that gets the maximal number of people, but is there a strong argument against trying to make it every three weeks, if we can do it? DOCTOR TUCKSON: I think that, given the difficulties of schedules and how complex a mosaic that's going to be, I would suggest that we try to meet every three weeks, knowing that there will be such juggling but that you've given the full sense of trying to get in at least three meetings within a certain period of time and you'll do your best to make that happen. It's going to be hard. That squeezes it more on that end, because otherwise it would be four and a half weeks. CHAIRPERSON FADEN: Is that acceptable to everyone? Is that good enough for the staff? MR. GUTTMAN: That's what the Committee wants. CHAIRPERSON FADEN: Okay. All right. So we take it that the direction is that staff will take the calendars and try to get around a three week, no more than a four week interval between meetings for the next several months. DOCTOR STEVENSON: And then maybe leave it open for evaluation as it goes along. CHAIRPERSON FADEN: I would think that we would want this, absolutely, and I don't think we would need to be meeting at anything like that pace after a certain point, but it's more to see that we get the project launched. And Tara reminded us this morning about the larger legislative and other clocks against which this 12 month interval is placed, so we handle that. I want to leave the scope priorities question for last because that's the most sort of substantive and will take the most time. The tutorials, the thing that I had raised earlier that Dan just made reference to, and I had asked each of you to think of areas that you would like to learn more about, if we could get those areas out first and then go around the table again and see if anyone would be willing to take responsibility for making a short presentation at the next meeting, I would see the next meeting being two things, looking at those cases and also the mutual education process. It's obviously claiming an area that's easy for you to do because it's your world would be really the issue. If it turns out that we have unclaimed areas where no one on the Committee wants to make a presentation, we will either look to expertise on the staff or have a paper commissioned or whatever is necessary to fill the gap in. We would also want to distinguish this quick tutorial from providing reading materials to Committee members so that you can develop a more sophisticated understanding beyond that tutorial which we would ask the relevant Committee members to work with the relevant staff in development of reading lists that we would hope would not be too burdensome but that everyone could spend some time on. So, can we start that real quickly? Pat, you've already mentioned one. Do you want to mention it for the record again, what you would like to -- MS. KING: For the record, I obviously need to be educated on the science. I would also like a glossary that I can carry with me at all times of terms. It's been my experience in the past that it's not enough to have them in the documents, that when you're working with an unfamiliar thing there's this little piece of paper that becomes a part of your life. So if we could have a glossary of terms, I'm of course interested in the science terms, but I'm sure that there would be others who would be interested in different kinds of terms. CHAIRPERSON FADEN: Excellent. Henry? I'm sorry? DR. NEUMANN: Can I just ask a question? Would you like also terminology of government agencies' names or are you talking just about the health aspects, the medical aspects or the radiation aspects? MS. KING: For myself, though others may need it, I need to know about radiation and science. But I live in Washington and I work with a lot of government agencies. Other people may need the kind of information that you just suggested. CHAIRPERSON FADEN: Henry? DOCTOR ROYAL: There's so much that I need to know. I need to know about the history of ethics. I need to know about models for compensation. I mean, I just -- CHAIRPERSON FADEN: That's all right. Keep going. By the time we get around, if we don't have anything to add, that's all right. DOCTOR ROYAL: Why don't I stop there? CHAIRPERSON FADEN: Okay. So we have history of research ethics, ethical principles, and compensation. Mary Ann? DOCTOR STEVENSON: Formal procedures or models for making ethical decisions, just the whole area of formal ethics. CHAIRPERSON FADEN: Jay? Want a tutorial on anything that hasn't already been mentioned? DOCTOR KATZ: No, except a tutorial on radiation, anything that I should know, that Henry thinks I should know about radiation. CHAIRPERSON FADEN: Nancy? DOCTOR OLEINICK: I think a history of the legal aspects of dealing with human experimentation. CHAIRPERSON FADEN: Ruth? DOCTOR MACKLIN: I'd like to narrow down the radiation question a little bit. Obviously, all of us who don't know about radiation don't know what radiation is, aside from reading Henry's paper in the background material. I mean, it could be volumes. I'd like to see that question focused a little more, even though I would rely on the knowledgeable presenter to pick out the relevant things, I mean, the kinds of things that would be important, it seems to me, to know when we start looking at particular experiments are something about dosage levels and what they do. What kinds of levels are therapeutic levels? What kind of levels are toxic levels? I know some of this was in your background paper. What are the highest levels that have routinely been given for therapeutic purposes? I mean, things that when we begin to look at specific protocols will give us some kind of benchmarks for understanding it, that to me would be more useful as a focused presentation than everything about radiation because I'm not likely to remember everything about radiation. Secondly, some of the major side-effects, harms, risks of radiation so we can get some -- and anything that might be said about levels of harm, you know, degrees of harm. And then, this is a separate question from what's known about radiation, anything that anyone here might know about what was known then. CHAIRPERSON FADEN: Well, this is the history of radiation. DOCTOR MACKLIN: Yes, a history of knowledge and experience about radiation, including outside the areas of research and therapy, I mean, such as the licking of the brushes with the radium on it and stuff. In other words, what was known or what -- so that we can get some idea of what might reasonably be expected to have been known. DOCTOR ROYAL: Just a comment about what we know about radiation in the volume of science. I appreciate your concern, because I can tell you I can bring in, oh, four or five more books that are that size that will tell you more than you want to know about radiation. We talked about these cases and having these case presentations. I think that that would be a good way to focus on what it is you need to know about radiation. The University of Cincinnati was whole body radiation. Plutonium was an internal radioactive substance. And then you have an environmental release that is a whole other knowledge base. So I think using these cases as a way of transmitting the relevant information that you need to know about radiation would be a way to limit the amount of material. DOCTOR MACKLIN: So then the tutorial would be keyed in some way to the cases? DOCTOR ROYAL: Yes. DOCTOR MACKLIN: I mean, it suggests that the look at the cases as they're selected would have the expert in that area give the relevant background. MS. KING: Be careful about that, because when you start talking about what is a low-level dose or what is a safe dose in the context of a controversial study you risk making a comment. CHAIRPERSON FADEN: I think it might be better to abstract a bit from the case and say we need to know something about radiation when it's eaten and radiation when it's injected and sort of the different pathways and how they might affect. Well, we can work this out. I think we can work this out. Ken? DOCTOR ROYAL: Whole body radiation is whole body radiation. CHAIRPERSON FADEN: Period, regardless of when it happens? DOCTOR ROYAL: Whether it's in Cincinnati or St. Louis or wherever it is. CHAIRPERSON FADEN: Or here. MS. KING: But Ruth asked about what is considered low dose, what is considered -- to give her information about dose ranges. If you give people information about dose ranges in the context of specific cases, you're very close to commenting on the cases. DOCTOR ROYAL: I don't know that the concept of what a low dose is and a high dose is is related to a specific case. There are organizations that say below such and such a level we consider this a low dose or above such and such a level we consider it a high dose. CHAIRPERSON FADEN: We'll work it out. I mean, we'll figure it out. I think we can manage. And if we can't figure it out, we can't. We just want to get a few more things in before we have to leave. Ken, you want a tutorial? MR. FEINBERG: I would like a complementing any report on the legal issues. I'd like a sort of a bibliography on the political history of human experimentation. I'd like to know what the Congress has done and is doing, going back to the Church Committee and even before, so that we at least know the political lay of the land in the Congress concerning interest in the subject over the years. CHAIRPERSON FADEN: That can be done. DOCTOR TUCKSON: I'd like to know more about the concept of retrospective moral objections. CHAIRPERSON FADEN: Okay. And we may not be able to get all these tutorials in by next week, let me just tell you. We'll have to stage them, because we might need a small college. I mean, we might need to go away for a week and immerse ourselves. We may pace these out over -- on that one, we may have to commission an article, but we can do that. I mean, we can do all of -- you know, that's fine. Susan? DOCTOR LEDERER: I thought it would be useful to know something about the Radiation Exposure Compensation Act. CHAIRPERSON FADEN: Does that go with the compensation? Okay. Well, make sure that that's in, whoever does the compensation piece for us. DOCTOR THOMAS: At some point, I would like to learn something about the techniques of historical research. How does one go about finding the lost ark? CHAIRPERSON FADEN: Besides being Stephen Spielberg. MS. NORRIS: My concerns have been covered by the rest of you. CHAIRPERSON FADEN: By the time you get to that part of the table, I would hope -- DOCTOR GLATSTEIN: I have nothing to add. CHAIRPERSON FADEN: Good. Well, we have a long enough list, so -- DOCTOR TUCKSON: Duncan's point, which is very important, I hope at some point you might consider a consultant brought in before you go to the next meeting, but early on, about this point. It seems to me that somebody must have experience about looking for the lost ark in multi-government agency investigation. We cannot be the first group of people who've ever had eight agencies line up and give us an impossible task. Somebody must know something about doing this and I'd sure like to find that one smart person who knows how to do it and have them consult with our Committee. CHAIRPERSON FADEN: Dan has been trying to find such a person. DOCTOR KATZ: I don't think that person exists. You are looking for the lost ark. CHAIRPERSON FADEN: I think it doesn't sit in any one human being, but we can try to put together some -- DOCTOR TUCKSON: Somewhere somebody has done this before. There's an experience base. CHAIRPERSON FADEN: We'll look. DOCTOR ROYAL: Ruth, one other topic that I meant to mention, which I think is a very important topic, is risk communication. Pat was talking about high and low. There's a lot of qualities about risk that make it important. CHAIRPERSON FADEN: That's a good point, and there's certainly people who can speak to that. Nancy, did you want to add one? DOCTOR OLEINICK: Well, this may actually come under some of the other titles, but there is a sense when we're judging human experimentation or any experimentation for that matter, there is a need to understand the statistics involved. That is, if you are doing an experiment, one issue that's critical is are the number of cases sufficient to answer the question that you've posed. I think we need to have some sense-- I always, as much statistics as I've been in contact with, I always need a statistician to keep me honest. CHAIRPERSON FADEN: We can certainly do-- I don't know the order in which we will do these tutorials. It may be availability. It may be some sense of staff priority, but we can certainly have a presentation or a sort of basic reading list with research design and statistics for the people who are not -- not everyone on this Committee, obviously, is equally well versed with those issues as well and they may come to bear as we've been talking about observational studies versus experimental studies and sample sizes as they relate to each and all of those sorts of issues. DOCTOR MACKLIN: I don't know if this has been said. I don't remember. There are so many things. But public reactions or responses to radiation, that is a history and some accounting of that, how does it compare to public responses of other things in which there are fears or when episodes bubble up or get reported in the media? CHAIRPERSON FADEN: That actually dovetails nicely with the risk communication piece, because the people who work in that area are the people who've looked at public perceptions of risk against actual risk and it's kind of the same. We could probably put those two together in a way that would be helpful. MR. KLAIDMAN: That basically is the subject of health in the headlines. I spent four or five years working in risk communication and would be happy to try to help out with that, if you would like. CHAIRPERSON FADEN: We're about to go down to the next step, which is figuring out who is going to do what, so that's very helpful, Steve. We've got a long list here. We're not going to be able to do this all in the second meeting, but, very quickly, I'm going to yell out a term, an area, and if someone would be interested in volunteering for a presentation which -- DOCTOR MACKLIN: There's a little problem here. Not knowing exactly when the next meeting is, and given the calendar that you mentioned -- CHAIRPERSON FADEN: Well, let's do this. We don't know. If it turns out you pick a topic and you're not going to be there, then you'll be in the third meeting. I don't know how else to do it, Ruth, because we can't do the calendar now and I think we need to get a sense of people's willingness to do this. If you want to do some part of the ethics thing and you can't make the next meeting, we'll have to have it the next time. We can't do all of these at one meeting anyway or we would do nothing but be lectured at. Yes, Henry? DOCTOR ROYAL: You had mentioned a time frame of ten minutes. CHAIRPERSON FADEN: Maybe longer, maybe twenty minutes and then time for questions. DOCTOR ROYAL: I think for some of these topics it's going to take much longer than ten or twenty minutes. CHAIRPERSON FADEN: Well, the most I think we could sort of feature is an hour for a topic. Would that -- DOCTOR ROYAL: Well, that would be more reasonable for some topics. CHAIRPERSON FADEN: And then depending on how much time people want to spend presenting versus discussion, you can adjust that accordingly. Some of us are teachers and know how to fill in time or contract it. DOCTOR MACKLIN: It may take you an hour to do radiation, Henry. It will only take five minutes to do ethics. DOCTOR KATZ: You surely need an hour for the history of human experimentation if you want to go way back. CHAIRPERSON FADEN: So why don't we say an hour for right now and figure we'll do three next time and then three and then three and then try to give over a part of every meeting to mutual education, and the hour would include questions. You can tell us about background reading and we will circulate the background reading in advance. If Committee members are really conscientious they will have already read something about-- we'll do our homework. We'll come in and we will have read whatever it is that the assignment is. Forty minute presentations and twenty minutes for questions, sort of, something like that. DOCTOR MACKLIN: Why don't we ask each presenter how long that presenter might need for the topic. CHAIRPERSON FADEN: All right. Fair enough. DOCTOR MACKLIN: Because, some topics might lend themselves to shorter presentations and longer question and discussion. CHAIRPERSON FADEN: That's fine. I think that's a great idea. That's right. If we start with the radiation area, Henry, Mary Ann, and Nancy, do you want to split it up or does Henry want to do it? And also, Eli, do you want to sort of -- how do you want to -- And Duncan, you want to do the epi part? Do you want to be a little subcommittee to figure this out, rather than fight it out? If you decide you need two sessions, make it two sessions. DOCTOR STEVENSON: Or it could be split within the hour. CHAIRPERSON FADEN: Right. DOCTOR STEVENSON: We'll figure it out. CHAIRPERSON FADEN: Right, because I don't think now we want to try to do this publicly, so we're making a subcommittee in charge of educating the rest of us about radiation science, medicine, and radiation epidemiology. All of that would go into one. MS. MASTROIANNI: Can I have them report to me and tell me -- CHAIRPERSON FADEN: Right. Please report to Anna. I think this is fact-finding. So, just so we get this clear, it would be Frank, Mary Ann, Nancy, Eli, and Duncan who are going to figure out whether this is one or two or three presentations and who's going to do it. Is that right? Okay. Frank isn't here, so we don't -- History of research ethics. Susan, Jay, Ruth? I mean, we have -- DOCTOR MACKLIN: I'm not as good on the history. I'll do one of the other ones. CHAIRPERSON FADEN: Susan and Jay, do you want to work on this together? DOCTOR KATZ: I'll do the history of -- well, the history, rather than the research ethics, the history of human experimentation and the history of the regulation of human experimentation. That's what we want to know about, is that right? The ethics is separate. I know very little about ethics, but Ruth can-- CHAIRPERSON FADEN: All right. DOCTOR MACKLIN: I don't know about the history of research ethics. CHAIRPERSON FADEN: We'll see if we can parse this out. Susan, would you want to work with Jay on that or would you want to do something -- could you do the political history? Is that something of interest to you? DOCTOR LEDERER: The political history of -- CHAIRPERSON FADEN: Human experimentation, or work out with Jay how to divide that up. DOCTOR LEDERER: Yes. DOCTOR KATZ: To divide what up? CHAIRPERSON FADEN: The history of human experimentation, the history of the sort of political context of human experimentation, so that you and Susan can figure out who is going to do what. DOCTOR LEDERER: Or, if it would be of interest, the history of the social context, public response to particular incidences of human experimentation. CHAIRPERSON FADEN: That would be fine if you wanted to do that and then, Jay, you do the history of human experimentation itself. DOCTOR KATZ: I'll just do the history without further qualification and then Susan then can fill in the rest about which I know very little and would be very much interested in knowing more about. CHAIRPERSON FADEN: Once we figure out the schedule and we know who can make the next meeting, that will help us pull out who's going to be when. Anna will be working -- MS. MASTROIANNI: I'll be in charge of coordinating all that, keeping contact -- CHAIRPERSON FADEN: So, Ruth, can you do -- are you including the history of research ethics, Jay, or you are not doing the history -- DOCTOR LEDERER: He said history of human experimentation. CHAIRPERSON FADEN: Experimentation, which is different than the history of research ethics. DOCTOR KATZ: You know a great deal about it, Ruth. I think there is a need for some members of the Committee just to inform them of what the -- how human research was regulated and not regulated from the mid-nineteenth century through the present and to just talk about the history from Claude Bernard onward. CHAIRPERSON FADEN: I'm just trying to figure out, because there are different takes on this and thinking about what Pat has and Ruth has and how we're -- MS. KING: A suggestion. CHAIRPERSON FADEN: Yes? MS. KING: Let staff write three statements and call a person up and say, "Do this." CHAIRPERSON FADEN: Rather than go through this now? MS. KING: Yes. CHAIRPERSON FADEN: That's fine with me. DOCTOR MACKLIN: It should just be clear that we have different topics on the table right now. One is the history of research ethics. One is the history of regulation of research, and another is history of human experimentation. CHAIRPERSON FADEN: All three of those I see as distinct. DOCTOR MACKLIN: They overlap, but they're separate topics. CHAIRPERSON FADEN: Well, and there's yet another which was Susan's public response to -- I mean, they're sort of all of a piece, but we've got Susan, Pat, Ruth, and Jay with very relevant expertise on this range of topics and I'm beginning to think that we should just make another subcommittee of the four of you paralleling the radiation committee and you just decide how you want to do it. I am not assigning myself anything, because I can barely think straight organizing the meeting and sort of running it, so the four of you then become a subcommittee to figure out how you want to do this since we have that talent base here paralleling the science base and that leaves us -- DOCTOR MACKLIN: But then you don't have all the topics, because there was something else. There was ethical principles. CHAIRPERSON FADEN: Ethical principles I'm throwing in there. We'll come up with a list and the four of you will divide it up. I'll throw in ethical principles, the history of the legal aspects of human experimentation -- MS. KING: It's not legal. It's regulatory. My suggestion is we've got a -- this is a government-run organization. Why don't we have Gary Ellis come in and do a presentation on legal regulation? CHAIRPERSON FADEN: We can do that. MS. KING: I mean, the regulatory. As far as I know, this is mostly regulatory in nature. CHAIRPERSON FADEN: And Anna knows the stuff about the little bit of litigation that's taken place. Anna knows that very well, so we can figure that out. Compensation. Ken, all eyes go to you. Will you do the compensation piece? DOCTOR FEINBERG: It'll be a little bit broader to cover the subject of remedies. It's not just compensation. CHAIRPERSON FADEN: That's fine. That would be more important to orient us to the fact that compensation does not exhaust remedies is something that maybe all of us already don't understand. So, that would be good. Have we missed anything? I'm going down my list. Models for making ethical decision making, I'm going to put that in with that. That goes to the ethical history subgroup that will figure out who does what. Harms in all the radiation stuff. Retrospective moral judgment. I make a recommendation we commission a paper or something of that sort. There's another area, the historical relativism stuff. Ruth, do you want to at some point -- we'll talk about this. DOCTOR MACKLIN: You know, I think that's a subject on which there's much less on the way of background and that really involves much more in the way of ongoing research and working during the course of this. CHAIRPERSON FADEN: I think that's right tool DOCTOR MACKLIN: It would be cursory. I would not feel qualified to do it, but it's something that one has to look at and really think about more. So, I think that's not a background issue, that's a real task. CHAIRPERSON FADEN: And maybe the same is true for retrospective moral judgment. We'll put that to the side. The risk communication stuff, Steve has already volunteered to put something together on that issue. The research design statistics stuff, how about we put aside just for the immediate -- we'll get to it, but we clearly can't get to everything right away, so we can table that temporarily. For the non-historians on the Committee, is it reasonable to do something on historical methods or historiography or standards in history or something like that? Is that a meaningful question to ask? DOCTOR LEDERER: I think so. I mean it's the kind of thing that one could teach a whole course on. That would be an introductory course. So, I guess I'd like to talk it over with the other historians to know what would be the most value. CHAIRPERSON FADEN: Fine. But at some point we would like -- there's a request from the non-historians that at some point we have that too. So you're on two subcommittees, as it were. MR. GUTTMAN: We have Raiders of the Lost Ark type people which with Susan we can put together in our presentation. The guys who know where the box is. The box just doesn't exist. I know where it is. DOCTOR LEDERER: Although we got a good introduction from D.A. Henderson's description of going out and trying to find that material. MR. GUTTMAN: Right. CHAIRPERSON FADEN: I think that's everything for right now, which leaves us a half hour to return to the question of scope and priorities. Has everyone got Eli's typography, I guess is one way of looking at it? Maybe a distinction that emerged actually when Reed and I were talking with D.A. Henderson and Wendy Baldwin about DHHS situations just casually at the break, it emerged in my own head a distinction between categories for organizing things and criteria for triaging and that they're not necessarily -- they are different things. One issue is dumping things into piles, which is not the same as deciding the criteria by which you're going to have so many from one pile and so many from another pile. And Eli, I'm not sure which you were proposing. We're going to the question of how to organize the scope, the practical scope, of the Committee's activity, particularly with respect to giving guidance to the agencies. DOCTOR GLATSTEIN: It's clear there are several thousand of these experiments to look at. At least DOE and the Defense Department seem to have started an organizational system with name, location, researcher, agency, subjects and summary and a few other things that are listed on their sheet. I think that in terms of trying to categorize all this material, ideally it should be done on computer, give these experiments a number. Some of the things to look at, by no means all of them, human only versus maybe. That is to say what we're interested in is human exposures. Not cells, but the actual patient. In some instances, it may not be easy to tell, at least from what's recorded. If it looks like it could be human and the organism as a whole, then we're interested. Then there's the issue of volunteers versus patients and, if so, if patients, what kind of patients. Is there information on dose? Yes or no. There are two broad issues here that we're trying to deal with. One is the ethical issue of information being conveyed and the other, was the patient wrong by not having so-called informed consent. But the second issue is was the patient damaged by the exposure. One who is wronged is not necessarily damaged. They're separate issues. We've got to keep them straight. So, there's the question about dose information, yes or no. Consent form, yes or no. Although the absence of a consent form doesn't necessarily mean that the information wasn't conveyed, it means it wasn't documented. We need to distinguish which of these studies deal with isotopes, which specific isotopes and if there is isotopic information, we'll probably need information on body weight to get some sort of estimate of dose distribution and dose delivery versus external beam irradiation from some machine source, be it isotope or linear accelerator or something versus the problems of open exposure to populations, the population exposure, the general release versus individual administrations, and then a few other things that came up this morning. We probably need to have information on age, if we can find it, because there obviously are some kiddies involved in this and the risks are dramatically different for kiddies as opposed to adults. The age of the adults is also an important factor in terms of risk of exposure. I think it would probably be useful to distinguish, if possible, which of these studies was considered confidential, yes or no, and which of them have publications, yes or no. By no means is this exhausting, but I think this would be a reasonable first pass for trying to get the information categorized so we can pick and choose by means of these kinds of criteria. MS. KING: What were you including in volunteer versus patients when you have in paren what kind? DOCTOR GLATSTEIN: I beg your pardon? MS. KING: When volunteer versus patients and you had a paren., what kind, what kinds of information? DOCTOR GLATSTEIN: What kinds of patient. MS. KING: What did you have in mind there? Do you mean -- because I need information on -- DOCTOR GLATSTEIN: Whether they have malignant disease or other types of illness or what have you. The risks are -- as far as malignant disease is concerned, it's the principal of fighting fire with fire. That is to say we don't take patients off the street casually to give them radiation. We use it almost entirely for malignant disease and because of the risk benefit ratios. MS. KING: My question is answered because I want to add a category. It seems to me we need some way of thinking about vulnerable subjects. So, we need information to the extent it's available about race ethnicity, children versus adults, mentally disabled versus normal. DOCTOR GLATSTEIN: This is not meant to be exhaustive. MS. KING: So, I wanted to add that. DOCTOR GLATSTEIN: By all means. DOCTOR LEDERER: I'd like to add another category. Maybe the location where the experiment is occurring. For example, where would you classify the feeding experiments at the Fernald School? Would you want to call the children volunteers? They certainly weren't patients of the physicians. DOCTOR MACKLIN: Well, actually, institutionalized or not is the category here, I think, because even among institutionalized then you've got the breakdowns. DOCTOR LEDERER: Well, but it would be interesting to know which institution. I mean is it a school for mentally retarded children, is it a prison? CHAIRPERSON FADEN: Well, we can break it down presumably, if we can find a way to do that. DOCTOR ROYAL: I think you need a forms subcommittee and that forms subcommittee has to take Eli's form, it has to take the DOD's form, and it has to take these suggestions and try to come up with a composite form. Then that composite form has to be pilot tested. CHAIRPERSON FADEN: Not to overload this Committee with subcommittees, but as a practical matter I think that's right. I think there's another layer of complexity and that is the more I think about it the less I think we can have this uniform across the agencies or at least uniform at this stage across the agencies. The agencies are at different places with respect to both what they're confronting in terms of the enormity of the task and the extent to which they're ready to do this. So, it might be that we need either subcommittees of the subcommittee that say, "Okay, somebody sit down with DHHS and think about what's meaningful and possible to be done given the volume of work that DHHS is confronting," against the system that's already in place with Energy and Defense, which we may think is very good or not very good depending on what happens as we work more with it. I just want to add an other layer of complexity to this. My understanding, for example, with respect to DHHS is they can't do this yet because they have to figure out how many of these gazillion experiments they should get enough information about to be able to even do this since all they have is the title, the name and the amount of money that was spent. So, there's a step back in some cases with some of the agencies. MS. KING: This is what occurred to me. Does it make sense to think that -- we can form a subcommittee, of course. You can always form subcommittees. CHAIRPERSON FADEN: I know. MS. KING: But is it useful to wait until the staff has done what we've asked them to do before we tackle this issue? We'll just have a better understanding of what the agencies are doing and what they're finding. It occurs to me that this is all speculative in some sense. CHAIRPERSON FADEN: Now, here's a thought. I think that's very prudent. If we were to add to that task I stated earlier where our staff is going to work with the staffs of the agencies on this quality assurance issue, that they also come back with options about how to start this business of categorizing and then ultimately triaging internal to each department. This means a bigger task for the staff, and then bring that back to the Committee. The Committee now has something that's sort of within the feasibility definition as well so we don't spend a lot of energy thinking up stuff that, in fact, can't be done or can't be done yet. But again, the task to staff is to come back with options, not to make commitments. We'll make the judgments ultimately based on staff array of options and their recommendations about what they think would work best Duncan? DOCTOR THOMAS: Just a minor point. I think the kinds of information you're going to want to try to abstract from the medical experiments will be totally different from the types of information you want from the environmental releases. I wouldn't try to straightjacket yourself into one form for those two situations. CHAIRPERSON FADEN: I think you're right and that's another reason for -- another layer of complexity. We don't know yet, but the point is one is agency specific, the other is the type -- what we think of as a conventional biomedical research project or an intentional environmental release may raise different issues. DOCTOR OLEINICK: Ruth? CHAIRPERSON FADEN: I'm sorry, Nancy, I didn't see you. DOCTOR OLEINICK: That's okay. CHAIRPERSON FADEN: I'm trying to figure out a way to arrange this room so that I can really see everybody, but I just haven't figured out how to do it yet. DOCTOR OLEINICK: No problem. I don't mind hiding sometimes. I can understand that there are going to be certain aspects to it. In fact, some of the major aspects that are going to be agency-specific, but still in all we're going to want to be able to look at the totality and I think in order to do that we need some version of what Eli has done here, at least with a part one, a minimal amount of information that will be identical across all of the agencies so that we can get into that. Then, there will be other parts that will be specific to the type. CHAIRPERSON FADEN: I think that's right. But the point is my guess is that in some cases we're a step behind that. Before we can have like a common form, like a common rule, we're going to need to do some individual agency work and then see what it will take and how hard it would be to come to a common information base. Dan? MR. GUTTMAN: Yes, a quick suggestion. The value here is in the iterative process and I'm sure all of you can, off the top of your heads, have your favorite three or four categories. We have no notion maybe of what they might be, but they'd be of terrific value when we go to the agencies initially. Eli has done it, but if you all might do that, and I'm not sure whether the form is a subcommittee or just talking to us. CHAIRPERSON FADEN: Why don't we take ten minutes as a wish list kind of thing. This is not necessarily that we would want to be able to do it right away, but this will give the staff some idea of ultimately the kind of information we would like to have, which is a separate question from how we're going to ultimate decision how to allocate our time and the agency's time and the staff's time with respect to which kinds of cases we're going to then want to put a lot of energy into developing. But we have Eli's list. Pat has added the question of the characteristics of the study population or the community into which the intentional exposure is released so that we can make some judgments about whether minority communities or minority individuals, children, people of questionable competence and institutionalized persons were involved. Pregnant women would be another category that we might introduce into that. I hate to use -- we'll come up with some other language than vulnerable, but we'll figure out something for that. Other questions, categories? Henry? DOCTOR ROYAL: I'm thinking about medical students. CHAIRPERSON FADEN: Add them. Military. DOCTOR ROYAL: So, I guess that's coerced populations. CHAIRPERSON FADEN: Military. Put those in there. I think we need to know whether -- this relates to the age, but for a different issue, Eli. We need to know if there's any chance that anybody could still be alive. That would be nice to be able to find out at some point. Of the subjects in any particular study, what are the prospect that anybody could still be living. DOCTOR ROYAL: But the form should contain the age of the population and presumably it would also contain the date of the study. DOCTOR MACKLIN: Whether or not there was any medical follow-up. CHAIRPERSON FADEN: Fine. DOCTOR MACKLIN: This is going to be a very naive question, but it goes back to something from the last day and a half. Do we know whether some of this research was done with a protocol that was formulated by the agency or an RFA or RFP, to use today's language, versus an investigator-initiated study? I'm asking whether we know before I say those would be good categories just to think about. CHAIRPERSON FADEN: My guess is that some of that level of sophisticated detail we will only know when we pick out a study and say, "We really want to understand this one very well." Part of the process is that, is deciding -- DOCTOR KATZ: Well, we do know in other areas of human experimentation, like the involvement of the Department of Defense and the CIA in the LSD studies at Columbia Medical Center, that the -- it may be that ultimately the experiment was also formulated by Columbia's psychiatrists, but they got directives from the Department of Defense as to what they wanted to find out from these experimental studies. CHAIRPERSON FADEN: A way to turn that around is not looking at it from the study perspective, but looking at it from the agency perspective. We can certainly start the process of identifying when and where agencies had research programs. That's doable. That's separate from this -- I mean that's another track. That's the sort of context. MS. KING: But that is a part of the process of trying to figure out how the agencies have done their searches. When I said this morning what assumptions they used to make -- since you're not surveying every piece of paper that ever passed through an agency, there were assumptions about which pieces of paper and what kinds of paper to target. If you find out what was not targeted, a way to get at -- because Ruth and I, I think, are both interested in getting at the same end point and we're struggling to try to get there. That is to pick up research that is not likely to be neatly categorized as research. To look at the agency assumptions about what they are not surveying is one way of starting us down that road, maybe Ruth, of getting at these other areas or areas of directives where we may not actually find a protocol. At least I'm hoping that's what will happen, to take account of what Ruth -- because I think Ruth is onto something, which is how to get there. MR. GUTTMAN: If I may, that's where the historians, if that's the group that we're going to use. It's not simply the mechanical, but it's a judgmental and the logic of the bureaucracy and where does it come from. Maybe you'll find the lost ark and maybe you won't. That's the question of question we're looking for. DOCTOR MACKLIN: The historical context, and this again is my total ignorance, I don't know when RFPs and RFAs started. To know that might help to know where to begin to look for that or did they start not formally but informally through this kind of directive research when there was an agency with a mission in contrast to NIH? It could very well be that NIH started this very much later, but agencies with other kinds of missions and whose interest in the research results were something very different, started it much earlier. CHAIRPERSON FADEN: Right. And we need to be pursuing that track at the same time that we're obsessing about the "experiments" one at a time. We need to be pursuing that track probably as vigorously, if not more vigorously. So, we're trying to construct it so we can do both at the same time, but it's hard. It's like it's magic. People know it's near 3:00 and it's time to go home. All of a sudden nobody wants to talk. Nobody wants to talk anymore. Everybody is exhausted and overwhelmed. We don't have to go further. If we can't go further, we can't go further. DOCTOR MACKLIN: Are the agencies -- what is it that -- can you summarize for us what it is that we can give them now and are they going to think it's not enough? CHAIRPERSON FADEN: I think all we're giving them now, but that's not trivial, is the notification that we've authorized our staff to work with their staff to come up with plans, alternative plans, which they're going to -- that our staff is going to bring back to us and that at least let's them know that we're going to start doing it rather than put it off to the next meeting because we haven't reached closure yet. They can start to work now, they can start to work with our staff and hammer out something. We just need more staff. So, to underscore the plea that each of you have heard individually, we need more staff, qualified people. MR. GUTTMAN: But to be affirmative, we hope to begin pretty immediately with Susan Lederer's guidance, anybody else, with historical core staff. Gil Whitamore and others are sitting over there, to do the search, the lost ark or whatever and get in there. It's conversation and we can report back on what we find. It may be bigger than a bread basket or not and we don't know. It's that process that we hope to start pretty immediately. CHAIRPERSON FADEN: I just forgot and Anna reminded me. We can't close ourselves. We have to be closed and Christine Varney has to close us because she's our designated whatchamacallit official. One of the things I thought about is if you wanted to use the time for the subcommittees to talk for a few minutes, if you guys want to sort of -- you know, rather than do a conference call. This is the radiation group talking about the presentation and the ethics and history people talking about the -- (Whereupon, at 2:40 p.m., off the record until 2:49 p.m.) CHAIRPERSON FADEN: We're going to officially close the meeting. Phil Caplan is here. Phil, do you want to -- do you mind if people are all disorganized while we do this? MR. CAPLAN: No, not at all. I have one sentence. On behalf of Christine Varney, Deputy Assistant to the President and Secretary of the Cabinet, my name is Phillip Caplan Special Assistant to the Cabinet Secretary, and I hereby close this meeting. Thank you. (Whereupon, at 2:49 p.m., the meeting was concluded.)