UNITED STATES OF AMERICA ) ADVISORY COMMITTEE ON HUMAN ) RADIATION EXPERIMENTS ) PUBLIC MEETING ) ) Blue Room Omni Shoreham Hotel 2400 Calvert Street, NW Washington, D.C. Wednesday, February 15, 1995 1:00 p.m. Advisory 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. PHILIP K. RUSSELL, M.D. DUNCAN C. THOMAS, PH.D. REED V. TUCKSON, M.D. Staff Members: DAN GUTTMAN ANNA MASTROIANNI JOHN HARKNESS STEPHEN KLAIDMAN PHILIP CAPLAN, Special Assistant to the President for Cabinet Affairs A G E N D A AGENDA ITEM: PAGE: Call to Order 3 Opening Remarks 3 Ruth Faden, Chair Public Comment Alex Reinhart, Braintree, MA 13 Ambassador Wilfred I. Kendall 24 Republic of the Marshall Islands Senator Henchi Balos, Bikini Atoll 34 Jonathan Weisgall, Washington, D.C. 40 Cooper Brown 60 National Association of Radiation Victims Cliff Honicker, Knoxville, TN 67 Pat Broudy 84 National Association of Atomic Veterans Update on Santa Fe Small Panel Meeting 97 Reed Tuckson Committee Discussion: Experiment on 112 Prisoners Update on Agency Oversight Project 159 Wilhelmine Miller P R O C E E D I N G S 1:10 p.m. Call to Order DR. FADEN: All right. Mr. Caplan is here to open the meeting. MR. CAPLAN: Good morning. I'm glad to see everyone got through the snow. DR. FADEN: Some of us did. MR. CAPLAN: As the designated federal official for this Advisory Committee on Human Radiation Experiments, I declare this meeting opened. DR. FADEN: Thank you. Thank you, Phil. Well, welcome, everybody. We are a little short with some weather problems, but we're expecting some people to come in. We are going to start, and first of all, thank you to the committee members and the members of the public and the staff, who managed to get here despite some weather problems. It could be worse, and it could really be snowing, and then they really would have to, you know, this is Washington when it isn't snowing. Imagine Washington when it does snow in terms of what happens with respect to the airports and things of that sort. Opening Remarks DR. FADEN: I want to welcome everyone to our 11th meeting - in and of itself kind of overwhelming to me. As always, we have a very packed agenda. The agenda is so packed this time, however, that we have -- can people hear me? Is this mike traveling? It's okay? No, it's not traveling? All right. It's one of those get closer to -- is that better? All right. We have a very packed agenda. So much so that we have tacked on an extra half day for this meeting, and we'll doing so for the rest of our meetings. We hope that that will be sufficient. In the tradition of these 11 meetings, let me take two minutes to preview what the objectives are for the next two and a half days, and there are several. The first objective is our standing objective for all meetings, which is to hear from members of the public, what they would like us to know about our task and about our progress, and in that respect, we will be hearing just immediately from members of the public during our open comment period. Our next objective is to get updates for the full committee of various activities that have been going on in the past month. These updates will be short, but they're important. They're selective. We're not reporting on everything that's going on, but only on a few activities that the full committee may want to discuss or comment on. First, we'll have a brief report this afternoon on the Small Panel Meeting in Santa Fe, which several members attended, which was very important, and we need all of us to hear about that experience. We will also have an update this afternoon from Wilhelmine on her continuing gathering of information as to the current status of oversight by federal agencies with respect to research involving human subjects. Then on Friday morning, we will have two updates on the contemporary projects. We're going to spend about a half hour each on Friday morning discussing both the research proposal review project, in which all of us are involved as reviewers, and the subject interview study, which is now launched and in the field in a few sites. So, we'll be having updates on all four of these activities, two this afternoon and two Friday morning. A third objective for this particular committee meeting is for the committee itself to take some time to take stock. Henry and I talked about this a couple of days ago, I guess, and maybe even yesterday, I can't remember when, Henry, decided it would be a good idea to stick an hour into the meeting or almost an hour of meeting time for any of us who wishes to comment on where the committee is going, and whether there are any directions that the committee perhaps should pursue more rapidly or add or anything that maybe should be dropped. This is obviously too late for a mid-course correction, but the notion is, as Henry and I discussed, if anything is going to be emphasized, added, deleted, whatever, and make it into the final report, we have to decide that now. So, if anybody has a sense that things need to be going differently in any arena, and if the whole committee concurs with that, this is the last chance we probably would have to make good on any added shifts in emphasis or what have you. So, we have some time set aside for that on Thursday morning, and hopefully I'll mention it again tomorrow morning before the -- when we get started, but for those of you who are here, you can think this evening if there's anything in particular that you would like to bring to the whole committee's attention. Let me point out this is not obligatory. If you don't have anything to say, that's fine, but we want to make sure that everybody who is thinking that things maybe should be going differently or that something needs to be added or make sure that it gets included, now would be the time to bring it up, although obviously at any point that anyone has such a concern, you should feel free to bring it up to me, to the relevant subcommittee, to Dan and Anna or Jeff or whomever. Now, the major amount of committee time for these next two and a half days is set aside to deal with eight chapter drafts that we have received from staff. We, I think all of us, share just amazement at how much material has been produced, how detailed these drafts are, and what a terrific job the staff has done in providing us with material so far gone so relatively early after we began asking for them. So, this is terrific news that we have these eight chapter drafts. That's the good news. The bad news now is that we have to really deal with them, and we have to deal with them in significant and important respects. As I've talked with Dan and with other members of the staff, the sense is that the staff has gone as far as it can go in many cases with respect to these chapters. We will obviously never have all the facts or all the information we would like to have on any of these, but we have enough and the time is short that the writing had to start, and we'll soon need to finish, and there are stories to tell. Laying out the kind of description of what happened is difficult enough, but the staff is now looking to all of us for the really tough job of judgment and evaluation and assessment. What is the meaning of what has been written? What is the meaning for the past? What are the implications for the future? So, really, we can't kind of evade or defer waiting for more information any longer. We've got in some cases quite full chapters, in other cases less full chapters, but now's the time when the committee really needs to come to grips with what the staff has provided with us, and as Dan kindly put it, draw on our wisdom as an expert advisory committee to reach some conclusions about the meaning of these chapters. So, our work is really very essential at this point, although it certainly looks and it certainly is correct that the staff has done a tremendous amount of work, the kind of work that we need to do, only we can do. It's the collective wisdom and judgment of the committee, and we have to guide the staff so that they can write the conclusions, basically, for the chapters as best as they can. Is that a fair -- MR. GUTTMAN: Yes. It's not only the conclusion, it's also, quite critically, what have we said here that is trivial and need not be said for 10 pages, that's obvious, and, you know, it's all those very basic matters of judgment as to what is all this stuff, you know. Where -- if there's a gem, where is the gem, and make it on Page 1 instead of somewhere, you know, -- DR. FADEN: So, it's guidance and feedback. MR. GUTTMAN: Right. DR. FADEN: It's guidance and feedback, and obviously we've got a tremendous amount of material, and we can't do it entirely collectively. We're all obligated to send back comments on every draft that we get, but insofar as we can use collective time, to see if there's agreement in the committee on issues of emphasis and significance but also on issues of interpretation, what does this mean? Where does this take us? What are the implications? Now, as I mentioned, there are eight chapters. Of those eight chapters, five are essentially descriptive of various, what we have been calling, large categories of case studies. Three are of a different order. Two deal with ethical standards and ethical practices, and the last, the eighth one, deals with remedies. Secrecy isn't on the agenda for this meeting. The remedies chapter, which is in the sketchiest of forms for our consideration, has been given the biggest agenda time in this meeting of any of the chapters. It takes up several hours on our last day, and it's really because, just as we deliberated so intensively as a committee on the question of ethics standards, we now need to give that kind of deliberative communal attention to the question of criteria or guidelines for remedies. So, that will happen on Friday, and I singled that chapter out to distinguish it from the other chapters because the task for the committee is somewhat different than with respect to the other committees. Okay. So, that's what we need to accomplish in the next two and a half days. I also hope that everyone was careful lifting the massive briefing books. I am personally very sensitive to this question and might mention that we're missing Mary Ann in part because she's in bed with a bad back incurred from lifting last session's briefing books up two sets of stairs on a Metro where the escalator wasn't working. So, these -- this duty on this committee should be taken seriously in terms of occupational health hazards, and we'll have to figure out what to do about the heavy lifting literally required for the briefing books. We wish Mary Ann well. I guess she can't -- she's not going to be able to join us for the whole meeting, is literally laid up with a bad back because of dragging these briefing books around. So, we'll send her good thoughts and hope that she'll be with us by next time. That might suggest to staff that there was a way to do this differently. We're working on it. Some way that makes it possible to have the material you need for the committee meeting without carrying 20 pounds with you on the airplane and up and down escalators. I'm sure that would be welcomed. That would be very helpful, wouldn't it? Mary Ann would not have been injured if she didn't have to carry them back, but for that problem. So, we will work on that. The suggestion might not have been on. This is obviously of worldwide significance here. Is that we figure out a way to mail the briefing book back for those of us who don't want to carry it back or maybe you just want to take out two or three chapters to read on the plane and the rest of it can be mailed back. All right. With that, we're going to begin our agenda. We have a very full public comment period for this afternoon, and let me just remind everybody of what the operative rules have been for our public comment period. Every commenter has 10 minutes. We encourage people to keep their comments to less than 10 minutes so that the committee members have an opportunity to ask you questions. We try to keep it to 10 minutes total, so that everybody can get fair time. Somehow or other, the way this room is set up, the public comment table seems even further away than it -- I feel like people are way out far away, and I don't know. I guess there's nothing we can do about that now. So, we would just encourage everyone to speak carefully into the mikes because there just seems to be a big distance between at least my end of the table and where the table is for our visitors. Our first presenter is Mr. Alex Reinhart, who is representing or is a research assistant or an assistant of Dr. David Egilman, whose testimony we have. Yeah, the time limit is -- yes, I did mention that, and let me just point out, if I have this correct, Mr. Reinhart, that you have a 10-minute statement to read. MR. REINHART: Yes. DR. FADEN: Now, the problem is this, Mr. Reinhart is not prepared to take questions on Dr. Egilman's behalf. He's just reading a testimony, a 10-minute testimony, presented -- prepared for you to present, is that correct? MR. REINHART: That's correct. I mean the problem is that we have cut it down as far as we can. DR. FADEN: Okay. So, what I would ask the committee members to do is if you have questions of Dr. Egilman or Mr. Reinhart, to provide them to staff, and we will send them all together, and we will get responses to those questions. If there are comments that any committee members want to make after Mr. Reinhart's statement, we'll take those, but we are not going to take any questions to Mr. Reinhart as he's not positioned to answer them. Okay. With that, please begin. Public Comment Statement of Alex Reinhart, Braintree, MA MR. REINHART: Yes. Before I begin, I just want to say that Dr. Egilman has stated and asked me to tell you that he would be happy to come here to have a dialogue with you about these important issues that are raised in his oral testimony. I'm sorry that I won't have time to entertain questions. I'm going to read it verbatim. When I say "I", imagine it's Dr. Egilman, if you can. DR. FADEN: Can you talk into the mike a little bit more directly? I'm having trouble hearing you. MR. REINHART: How's this? DR. FADEN: Much better. MR. REINHART: I am here as a member of the Scientific and Medical Advisory Board of the Task Force on Radiation and Human Rights, and I am also here as the son of a survivor of the Buchenwald Concentration Camp. We have submitted a lengthy statement that reviews some of your activities over the past eight months and some of the radiation experiments that are illustrative of the problems that pervade this research. Due to time limitations, I will focus here on three areas. I'm going to cover the areas of investigation that the committee has ignored. Most of these concern current problems with oversight. I'm going to try to explain why I think the committee has ignored some of these areas of investigation, and, most importantly, I'm going to address the committee's hypocrisy. Let me deal with that first. As a committee of experts, many of whom had biases prior to being put on the committee, it has a single lay representative, lay representatives are more likely to lack bias and be impartial, and, glaringly, the committee has not a single victim or victim's representative. This, of course, is the most blatant hypocrisy, since many of the committee's emphasis in their writings have forever criticized physicians for not involving lay people and their patients in particular in the decision-making process for informed consent. If lay non-subject and subject participation on boards which review the ethics of proposed research is a necessity for fair evaluation, we do not see why the same is not true for a committee such as this. Yet none of the ethicists here today have criticized the committee for this -- on this basis. We find it difficult to understand as the only difference between this committee and a board that reviews research protocol is temporal. The latter reviews research before it is performed, while this committee is reviewing research which has already been performed. We do not accept the argument that skills and moral authority that derive from lay representation before research has been done differs from the skills and moral authority necessary for evaluating the ethics after research has been conducted. This committee has an opportunity and the responsibility to include representatives of the lay community. Unfortunately, up until now, you have repeated past mistakes. Mistakes that many ethicists on the committee have criticized in the past. This issue of hypocrisy relates directly to compensation. The most important aspects of compensation are, first, an acknowledgement of wrong-doing and an apology, and, second, meaning must be derived from the victim's suffering. The phrase "never again" must carry weight. This hypocrisy deprives them of meaning because here at the end of these experiments, we are confronted with the same sad situation we started with. Where are the victims? Why are they not part of the judgment group? There is no excuse for this oversight. Because of this exclusion of victim representatives, you have ignored many important current problems, including the AEC, UC ORAU cover-up, the fact that NIH documents and other internal documents were hidden when the issue became public, ACR's evaluation of UC's research in 1972, Dr. Lushbaugh's destruction of documents relevant to this research. These are but a few. There's been no committee investigation of these areas and no policy recommendations. The existence of a cover-up is a key. It reveals acknowledgement of wrong-doing and the continuing problem. The Atomic Energy Commission, for example, had established ethical committees to consider human experimentation. In addition, AEC reviewers were informed by Oak Ridge researchers that the UC work, University of Cincinnati, was ethically questionable. The AEC must be judged. The University of Cincinnati Institutional Review Board, the university ignored the timely criticism of its own faculty. The university allowed this research to continue from 1966 to 1971 without the approval of its own Human Subjects Review Board, established in March 1966. The UC IRB must be judged. Journals which published unethical research. These journals knew that their research was unethical, according to the researcher's own statements. Yet they published this research without comment. The journals must be judged. The Ohio Board of Medical Licensure has to date not investigated any of the physicians involved in this series of experiments. It seems obvious that enough questions have been raised about what went on that the licensing board should at least investigate their actions. Professional organizations, like physicians and lawyers, argue that external regulation is not necessary because we take care of our own. But clearly that's not the case here. It's generally not the case anywhere, but clearly it's not the case here, and you have the opportunity to make a lucid statement about this lack of continuing oversight. The Ohio Board of Medical Licensure must be judged. The Cincinnati Medical Society has not investigated this series of experiments. The Cincinnati Medical Society must be judged. There was a lack of appropriate oversight by the Congress. Congress must be judged. Was there Medicare or Medicaid fraud? Were treatment monies used for Saenger's research? This question has yet to be answered. This is important in overseeing experiments that are not funded through standard means and therefore not subject to evaluation by review boards. Medicare or Medicaid patients may be subjects of experiments which we are not aware of. This must be investigated. Now that I've discussed some areas that we feel you've overlooked, let's consider issues you are currently reviewing. This is the area of whether there's a current problem with informed consent and research. This investigation may be fruitful, but the important point is that you had to do it in the first place. Clearly, there's no regular monitoring of this type of activity. The fact that there's no regular monitoring of informed consent procedures means there's a gaping hole in oversight. What recommendations will you make about institutionalizing oversight in this area? Probably none, because you're busy looking at the details. The big picture is that no one has an oversight procedure. Because of this lack of oversight, it is possible for groups, like the American College of Radiology, ACR, to cover up unethical research in the 1970s and as late as 1994. In 1971, the United States Senate requested that a, quote unquote, outside review be carried out by the ACR. This review was conducted by Dr. Robert McConnell, a long-time fishing partner of Dr. Saenger's. In his report to the Senate, Dr. McConnell noted that Dr. Saenger was a member of the ACR. He neglected to mention his personal friendship with the principal investigator or the fact that Dr. Saenger was at that time serving on five committees of the ACR. These relationships constituted a conflict of interest, and a situation that is unlikely to result in an objective evaluation of the research. The ACR again defended the UC experiments in 1994. This time, they were represented by Dr. Cox from an institution that conducted research similar to Dr. Saenger's. This conflict was only discovered on direct questioning. The ACR must be judged as well. Why has the committee failed to evaluate these areas? Sadly, we feel a major contributory factor is the bias of the membership and, ironically enough, the lack of lay and victim representation. Incredibly, Dr. Glatstein gave his opinion on Dr. Saenger's work prior to having read it or the committee staff report on it. It is also apparent that Dr. Glatstein's relationship with previous reviewers of Dr. Saenger's research may affect his ability to make objective judgments. This bias is important because criticism of Dr. Saenger is implicitly criticism of Dr. Caplan and the ACR. If Saenger's work was bad science or scientifically complete bull shit as committee staff and members have already stated on the record, why did Dr. Caplan and the ACR praise it in 1972? And why did the ACR repeat this praise in 1994? The failure of supervising organizations and individuals to appropriately evaluate these experiments is an issue that the committee needs to address. As the April 8th ACR statement shows, this is a past and a current problem. Dr. Glatstein is clearly unsuited to objectively evaluate his mentor, Dr. Caplan, the ACR and Dr. Saenger's research, given his prior comments. Bias in analysis is evident amongst some of the ethicists. This is most significant in determining the appropriate standard for judgment. Dr. Katz has stated, "We don't want to pass severe moral judgments because it's really more important to look at the present." He's also stated that the Nuremberg Code was not a viable standard because it wasn't taken seriously by scientists. That's another quote. It may have been an important document, but it was written to the stars, not us as human beings. Dr. Katz, we understand that these positions are based on 30 years of research and writing. Nonetheless, we disagree. The ethical standard of the time of the experiments is the relevant standard. For the victims and their families, it is very important for this committee to decide if they were wrong, period. Judgment is the key issue. The judgment will depend on the committee's opinion but a hung jury is unacceptable. If this committee is to have an impact on present or future behavior, a judgment on the past is even more important. If you refuse to comment or cannot evaluate on the past application of ethical standards, then why should anyone follow any current recommendations? In addition, what manner of circular analysis says a standard is only a standard if it is taken seriously or followed? Most drivers speed. Does that mean speed limits don't exist? Many murders occur. Is murder not unethical or a crime because laws against it are frequently not taken seriously? Were the experiments ethical by the ethical standards of the time period in which they were done? This is the only important question. In closing, I hope the committee will take these criticisms in the spirit of constructive cooperation. H. Rap Brown used to tell people that he was an agitator and remind them that the agitator was the part of the washing machine which got the clothes clean. In this vein, I challenge the committee to take a moral, ethical, a human stand against the revictimization of the subjects of these experiments. I ask you to stop work, committee members and staff, until lay people and victims are fully represented on this committee. Taking this stand ensures that the facts will be fairly and accurately evaluated. Your work can stand as a re-inscription of the past or message of judgment for justice. It's your choice. Thank you. DR. FADEN: Thank you, Mr. Reinhart. I'll remind the committee that Mr. Reinhart isn't taking questions, but is there anyone who wants to make a comment at this point? (No response) DR. FADEN: Okay. All right. If there are questions for you or Dr. Egilman, we'll send them on in writing. Thank you. Okay. Our next series of public commenters is represented as a panel. Representatives from the Marshall Islands. We are very pleased to welcome Ambassador Kendall, Senator Balos and Mr. Weisgall. Would you want to come to the table together? That's fine with us. We understand you're each going to be speaking. We appreciate your taking the time to come to visit us again. Can we -- would you like to decide the order of who would like to speak first, and you would each have 10 minutes or however you want to portion your time? MR. KENDALL: Thank you, Madam Chairman. I guess I'll volunteer to go first. DR. FADEN: That's fine. Thank you. Statement of Ambassador Wilfred I. Kendall Republic of the Marshall Islands MR. KENDALL: Madam Chairman, thank you for allowing me the opportunity to appear before you. I'm honored to take a few moments of your time to brief you on attempts by the Government of the Republic of the Marshall Islands to understand how Marshall Island citizens were used by the United States Government to better comprehend the effects of radiation on human beings. My remarks today are a follow-up to those made by Senator Tony de Brum and myself on July 5th last year. Before I proceed, however, I would like to thank the committee and its staff for the efforts you are making to assist the Marshall Islands. As a direct result of your intervention, both the Department of Energy and Defense have been cooperating to assist my government with its research. Thank you. The Embassy of the Marshall Islands has been devoting a substantial amount of time to reading documents pertaining to the weapon-testing program conducted in my country. Unfortunately, the embassy and the government lack the human resources to research human experimentation properly. As of today, the embassy has reviewed more than four/fifths of the 28 boxes of documents that the Department of Energy provided the government last year. The task is cumbersome and time-consuming. We have been sharing the documents from the boxes with the staff of this committee in an effort to keep you fully appraised of our findings. In order to respect the five minutes -- five minutes of time I have allotted, let me briefly list some of the major issues that I believe warrant your attention as well as some of my concerns regarding our future work. There are several different atolls in the Marshall Islands that received various levels of radioactive fall-out from the 66 weapons detonated in my country. Most of the citizens from some atolls were evacuated for certain tests while others remained. Warnings and instructions were issued to some atolls before certain tests but not every atoll. Although every atoll in the country received radioactive fall-out, people from only four of the 29 atolls have received health care. My government is now faced with the inordinate task of providing for people whose health and environment vary from case to case. I am grateful that Senator Henchi Balos is here with me today to describe the issues relevant to his home atoll, Bikini, to you. I had hoped representatives from Rongelap Atoll and Likiep could join me here today as well to explain their own unique and very different circumstances. Unfortunately, the time and expense required for that travel made it impossible for them to join us, but I'll do my best to explain the experiences to you. Again, the embassy has provided the committee with the documents which illustrate these points. The RMI government has also interviewed approximately 80 Marshallese citizens to document their recollections from the testing program. We are having these interviews transcribed and hope to have them to you in the near future. On March 1st, 1954, hundreds of Marshallese were exposed to radioactive fall-out multiple times above the U.S. maximum permissible exposure level from the dirtiest of the weapons tests. The Government of the Marshall Islands believes that this exposure was premeditated. I have submitted charts to each of you today which lists the numerous pre-BRAVO precautionary evacuations for the earlier much smaller tests. Although the U.S. Government knew that it would be exponentially larger than previous tests, no precautionary evacuation took place. The second chart which I have distributed lists the moments of the various atoll groups since 1954. As far as the work of this committee is concerned, the important point is that the U.S. Government was provided with an opportunity to study the effects of radiation on human beings. In his testimony last year, Senator de Brum explained the nature of Project 4.1 which the exposed people were included in. Today, I will focus on the resettlement of Marshallese people on contaminated islands after the testing period, what the people were told by the United States Government, and what internal USG documents reveal. For example, we have evidence that in the cases of Bikini and Enewetak and Rongelap and Utirik, the United States Government was aware of and documenting the increased body burdens of the people after resettlement. The people were not informed. U.S. medical teams made regular visits to the atolls to take blood, urine and bone marrow samples from the Marshallese. Medicines were prescribed and treatment was given without the consent or understanding of the patients. Many were sent to the U.S. for major surgery and studies of unknown types. Still today, some patients do not understand that their entire thyroids were removed. The medical records and whole body counts of Marshallese patients have not been turned over to the patients or the local hospitals, although DOE has agreed to facilitate this process. DOE medical protocols are not open for independent review. To this day, all medical treatment is provided by DOE contractors. Resettled populations were given conflicting reports and recommendations about the safety of their environment and food sources. Since Bikini Atoll has its own representative here to comment on their particular circumstances, I will discuss some of the other atolls. In the specific case of Rongelap Atoll, after the exposed population from Rongelap Atoll had been studied in Project 4.1 to determine the immediate effects of radioactive fall-out, they were told they would be returned to Rongelap in approximately two to four weeks. In actuality, it was three years before they were returned. The Rongelapese were purposefully resettled on contaminated islands to study the long-term effects of internal radiation on human beings. As Brookhaven noted, and I quote, "the habitation of these people on the island will afford most valuable ecological radioactive data on human beings". The only restriction the U.S. offered the Rongelapese was not to eat coconut crabs. The U.S. officials responsible for issuing the restrictions admitted in internal USG documents that they were unaware there was a difference between land and coconut crabs. A land survey conducted on the atoll one year before resettlement found that coconuts, shellfish and food plants were dangerously contaminated. Again, the people were not advised not to eat coconut crabs. U.S. doctors were interested in and studied the monster babies that the Rongelapese gave birth to in subsequent years. The U.S. Government has not been able to find the records, photographs or blood samples taken from these children. Documents demonstrate that the United States Government knew that human populations on all three of these atolls received dangerous levels of radiation from fall-out. At different times, Ailuk and Likiep have been used as control populations. The incidence of radiation-linked illnesses observed in these populations became the basis for making erroneous disease predictions for populations on other atolls. The United States Government knew that food sources, such as pandanus and bananas, were dangerously contaminated. The United States Government studied with interest an unexpected and dramatic incidence of thyroid disease on Utirik Atoll. No efforts were made to reassess the health of population on Ailuk, Likiep, or other mid-range atolls. The points I have raised today are only some of the major points as there is no time to review the long and complex story. Before I close, however, I would like to raise just a few of my concerns. As I mentioned, the documents and information we have received thus far represent only the tip of the iceberg. These documents contains references to other relevant sources we do not have but need to track down. The Department of Energy and the National Archives have located vast storage areas with Marshall Island documents which they lack the financial and human resources to declassify in the near future. I'm concerned that once the relatively short mandate of this committee expires, the pressure and priority put on the declassifiers will end abruptly. There is no long-term mechanism for either providing funding to assist this process or for reviewing the important information that will materialize. With this in mind, I would like to request that the advisory committee recommend that a special committee be established to assist the Marshall Islands. A committee that is independent, fiscally autonomous, and able to assist in the location of documents and interpretation of their contents. The establishment of such a committee will provide Marshallese people with the peace of mind they have long deserved. I'm also concerned about the Department of Energy's assistance in using its contractors to provide medical care to Marshallese patients. It is a conflict of interest to use these contractors, and until the situation is remedied, we will always question the results and intentions and treatment of our citizens -- treatment our citizens receive. Health care also needs to be extended to the entire population. Ailuk, Likiep and populations from every atoll in the country are experiencing radiation-linked illnesses as a result of the weapons testing program. The United States Government has always led us to believe that only four atolls were exposed to radioactive fall-out, and as a result, the RMI government didn't negotiate for the health care its people are entitled to when it entered into the compact of free association with the United States. I hope you will concur with me on these health-related matters and make appropriate recommendations. Finally, I urge the advisory committee to lend any assistance or support it can to helping us restore our land. A nuclear waste site presumably exists on Enewetak atoll, which is unmonitored, and for which the United States Government has no future plans or financial resources appropriated to deal with. Islands on Bikini, Enewetak and Rongerik and Rongelap are still unfit for human habitation. The United States Government must take responsibility for the environmental contamination and ill health of the population that the Republic of the Marshall Islands inherited when the trustees terminated. We look to the advisory committee to urge the United States Government to fulfill this moral obligation. I thank you for your time, and I am prepared to answer any questions you may have. For the record, I wish to acknowledge the hard work of Ms. Holly Barker here and others have put in to researching the documents and piecing the information together. Ms. Barker speaks the Marshallese language fluently and has interviewed many people who were exposed to the fall-out. She's here with me for the purpose of elucidating some of the points contained in my statement. Thank you. DR. FADEN: Thank you very much, Mr. Ambassador. Are we to take it that Ms. Barker wants to speak as well? No? Okay. Well, welcome in any event. We're glad to have you with us. Members of the committee want to address questions to the Ambassador or do we want to wait till we hear from our -- wait? How about if we hear from our other two presenters, and then we'll open the floor up for committee discussion? Thank you again, Mr. Ambassador. Our next presenter is Senator Balos, is that correct? Is that the order you want to do it in? Okay. Thank you. We have, by the way, copies of the written statements for those of you who haven't been following along. Please. Statement of Senator Henchi Balos, Bikini Atoll MR. BALOS: Thank you, Madam Chair. Thank you for providing me the opportunity to appear before you today on behalf of the people of Bikini Atoll in the Marshall Islands. I have served for many years as the Bikinians' elected representative, or Senator, to the Marshall Islands Legislature, the Nitijela. I understand that Professor Katz has asked a question that goes to the issue of whether the Marshallese are victims of radiation experiments. What were they told when they moved back, and who told them is his question. It's a good one, and I hope to help answer it today, at least with respect to the people of Bikini. In 1968, a blue ribbon committee sponsored by the Atomic Energy Commission, AEC, reviewed the results of a 1967 radiological survey of Bikini stated: "The exposures to radiation that would result from the repatriation of the Bikini people do not offer a significant threat to their health and safety." That blue ribbon committee included a number of doctors and scientists, with which you and your staff are familiar, such as Dr. Shields Warren, John Harley, and John Bugher, who had served as the director of the AEC's Division of Biology and Medicine. Based on this recommendation, President Johnson declared Bikini safe in August 1968, and the first Bikinians returned home in 1969. Unfortunately, 10 years later, it turned out that the AEC was dead wrong. The AEC's study had assumed that a returning individual would consume nine or 10 grams of coconut per day as its entire liquid diet. This was off by a factor of nearly 100. Gordon Dunning, who headed the AEC study, said later to a reporter, "obviously the people eat much more than that. We just plain goofed." Meanwhile, some of my family members and other Bikinians eventually numbering over 200 spent time on Bikini during the 1970s. We weren't comfortable there, and many of our leaders warned the people not to go back. Why? Several reasons. First, we knew in 1972 that the U.S. Government was conducting a thorough radiological survey of Enewetak, another atoll used for nuclear testing, in anticipation of a clean-up of that atoll. No such study was being planned for Bikini, where people were actually living. Why not, we asked? There were no answers. Second, we were told in October 1972 by AEC officials that only a few coconut crabs could be eaten at Bikini because they were radioactive. After that, our local government council voted against returning the entire community to Bikini, but said that any individual who wanted to go could do so. Third, it seemed to us that the AEC was embarrassed that so few people were returning home now that it was supposed to be safe. In fact, the district administrator of the Marshall Islands actually offered us a daily stipend for living at Bikini. We didn't know where the money came from, and some of us considered it a bribe, but it worked as more of us moved back. What were we told? Very little, and nothing in an organized community-wide manner. Instead, individual U.S. doctors and scientists would show up at Bikini during the 1970s to take urine samples from the people and samples of crops growing at Bikini. Whenever they would come, they would tell us everything was okay, and some of them would make a point of cutting open coconuts in front of us and drinking the milk. Of course, they left after a day or so and didn't eat any other food from Bikini's environment. We know now that in March 1975, the Interior Secretary Morton wrote to Defense Secretary Schlesinger about Bikini. "Despite assurances that the atoll is safe, the attitudes and fears of the people are being influenced by various outside groups, many of whom are critics of the nuclear program." No wonder no one helped us. Why did we -- what did we do? We found a lawyer to sue the U.S. Government, to force it to conduct a radiological survey. As we said in our complaint, for us to make an intelligent decision to resolve Bikini Atoll, we must be able to weight our desire to return against the radiological risks of returning. We have not been provided with that information. Soon the doctors coming to Bikini told us to eat only one coconut per day, and then we were told to eat only imported food, which was hard to do since the shipping schedule of the old Trust Territory Government was so unreliable. After the lawsuit was filed, U.S. Government scientists reported what they called an incredible one-year increase in our body burden of radioactive Cesium 137, and they told Congress that 139 people living on Bikini may have ingested the largest amounts of radiation of any known population. They also recommended that we should be moved off Bikini immediately, and we were, in September 1978. 17 years later, and nearly 50 years after we first moved, we are still trying to figure out how to conduct a radiological clean-up and go back home. Although there are still U.S. Government scientists who come to Bikini to help us figure out how to clean up our atoll, I must tell you that some of us believe we were moved back to Bikini as human guinea pigs to measure the long-term effects of low-level radiation. Let me read to you from a 1976 study prepared for the Department of Energy by Lawrence Livermore Laboratory. "Bikini Atoll may be the only global source of data on humans where intake via ingestion is thought to contribute to the major fraction of plutonium body burden. It is possibly the best available source of data for evaluating the transfer of plutonium across a cut wall after being incorporated into biological systems." This language was in a published scientific paper circulated for peer review. This means that the data was available years earlier and that the report was probably circulated in draft before publication. Why didn't the others or the laboratory alert us about this problem when we went the first data serviced? This was not a report on experiments in a laboratory, unless Livermore thought of Bikini as a living laboratory. Was there a duty to report these findings, even in a preliminary way, in order to avoid harm to the people? These are ethical questions you should answer. Moreover, even if you can excuse the tone of this language, if DOE knew this information in 1976, why did it take another three years to get us out of Bikini's environment? We don't know. Professor Katz's question is a good one. How strange that the so-called natives, not the AEC, were right about Bikinese safety. Isn't it odd that these natives working through a Washington law firm took on the U.S. Government and disproved its assurance to us that Bikini was safe? We believe we were victims of human radiation experiments, and we ask you to consider recommending remedies to help us out. Thank you, Madam Chairman, for this opportunity, and my colleagues and I will be pleased to answer any questions you may have. Thank you very much. DR. FADEN: Thank you, Senator Balos, and we, I'm sure, will have some questions, but if we could wait and hear from Mr. Weisgall, then we'll address questions to the panel. Statement of Jonathan Weisgall, Washington, D.C. MR. WEISGALL: Thank you, Madam Chairman. Let me first follow up with a couple of chapter and verse citations to Senator Balos' statement as to what is now known about U.S. Government monitoring of the Bikini people, and, mind you know, I'm now not talking about the 1940s or the 1950s or the 1960s. We're into the 1970s now. There are footnote references for all of these summations, but back in 1969, Dr. Robert Kinnard of Brookhaven was named to conduct medical surveys of the returning population. This, of course, was in a press release, but the Bikinians were not aware that there were any studies going on about them. We now know that the AEC knew as early as 1972 from urine bio-assays that Cesium 137 concentration in people living in Bikini had increased by a factor of four in just a two-year period. In April of '75, the University of Washington's Laboratory of Radiation Ecology and Brookhaven doctors collected samples from Bikini, and urine bio-assays showed levels of plutonium higher than what was measured in 1971 by a factor of 10. In March of 1975, the Interior Department, which did feel that a radiological survey of Bikini should be carried out because of what you heard the Senator describe about Enewetak, asked DOD for logistical support and DOD refused simply because Interior could not provide reimbursement costs, and the result, of course, was the Bikinians bringing a lawsuit on their own seeking to force the Government to conduct this radiological survey, which, by the way, was settled in very short order, was kind of obvious that this should be done. In December of '76, the Trans-Uranium Technical Group, which was chaired by Battelle, reviewed data showing that plutonium levels of people living on Bikini were 10 times greater than those of residents in the Continental United States, and, lastly, in vivo counting for Bikini residents in April of 1977 showed a tenfold increase in Cesium 137 from the 1974 survey, which itself had showed elevated levels. Now, remember, the time frame is it was not until September of 1978 that the people living on Bikini were finally moved. The number you heard from the Senator was a 139 people. That's the number of people who were there and moved off. There were well over 200 or maybe as many as 300 who may have been at Bikini at various other points in time between 1969 and 1978. The number of 139 is just the fixed number moved off in 1978. Let me turn to the question of remedies, if I may, which you'll be addressing tomorrow. I can well imagine that the Administration officials urging you to forget about the Marshall Islanders because of the compact of free association. They've gotten lots of compensation, you're probably being told. Let me try to disabuse you of that notion at least with respect to Bikini. The legislation passed by Congress to provide clean-up funds for Bikini Atoll was earmarked exclusively for the cost of cleaning up Bikini Island. That is one of 23 islands in the Atoll. It's the biggest. It's the traditional homeland of the people. Clearly the most important, but that legislative history, it's absolutely clear, and I can provide all of this to the staff, was not in any way concerned with the other 22 islands in the Atoll, simply because there was no -- there were no cost estimates as to what it would cost to clean those up. So, that amount of money, and it's obviously a significant amount of money, was earmarked exclusively for Bikini Island. Now, when you do -- when you look at the clean-up costs that are being spent today for Savannah River, Rocky Flats, Hanford, I think you can understand why the estimates for cleaning up the entire Atoll probably run into the several hundreds of millions of dollars. I want you to know that because I'm not sure what you're learning from the Administration, but there are lots of costs, and, mind you, that is just Bikini. That doesn't cover the problems at Enewetak, the Northern Islands at Enewetak, and what else you've heard from the Ambassador. Now, again, we all know what's happening up on Capitol Hill today these days. Money is obviously tight. Think of this perhaps in a fall-back way, but I have three other specific remedies that I think you should consider, which have minimal indirect costs involved. First would be to expand the Brookhaven monitoring program. Brookhaven doctors currently monitor the exposed populations from Rongelap and Utirik. Those people who were directly affected by the '54 BRAVO shot. The people of Bikini were monitored briefly by Brookhaven doctors in 1978, until their body burdens of Cesium decreased rapidly, which certainly occurred when they got out of Bikini's environment, and they have not been monitored since. I would urge you to consider recommending expanding that Brookhaven program to include the health care for the Bikinians, given the fact that they did spend about a decade at Bikini at the behest of the AEC. There already are doctors going out there. There's already a ship. There's already a program. It's already in place. You're talking about expanding a program by a little bit, and I'm talking also about non-radiogenic care. In the past, DOE would -- the Brookhaven doctors, very dedicated people, and, by the way, many of them volunteers and some interns, but a large number of volunteers go out on each of these Brookhaven missions, would provide regular sick call, I mean whether it was a broken arm. Obviously their main mission was to look at the exposed people. That's been cut back. It's very easy to expand it. This sounds trivial, but for the Marshall Islanders, it's absolutely critical. They do have serious health care needs. There's no reason why these very good doctors from Brookhaven can't help. I do think the people of Rongelap and Utirik, despite this tension that you hear and some of this hostility towards the U.S., do enjoy very good medical care because they have first class doctors coming out there, and, of course, there's a question as to how much that should be expanded. I urge you to consider recommending the expansion of the program. Secondly, there already is USDA food being provided for the so-called four-affected atolls, Bikini and Enewetak, whose people were moved off their atolls for the testing program, Rongelap and Utirik, who were actually hit with fall-out. That level of funding for USDA food has remained stable for about seven or eight years, despite very significant increases in the population. Again, this is a program in place. Food already goes out there. A recommendation simply to continue this program, to keep up with the expanding population, is something I urge you to consider. The third remedy, and this really grows out of some other mass exposure cases, would be to consider recommending the purchase of term life insurance for the exposed peoples of Rongelap and Utirik, and the individuals who were back at Bikini Atoll in the period in 1969 to 1978. There are very specific names and numbers. I think the total number would be less than 500 people. Again, that's not an expenditure. That's not compensation per se. It's an insurance policy, term life insurance for these individuals. These kinds of remedies have been looked at in other mass exposure cases. The last topic I want to hit upon, and I'll close, is the question of documents. In my own research, I have found the Freedom of Information Act to be virtually useless. This is not to say by any means that government employees ignore requests. The problem is they don't know where to look for the documents. So, a broad request, let's say, all documents related to fall-out from BRAVO or fall-out of veterans who were on Rongerik or the removal of the people of Utirik, it's useless. The Act works better if you know exactly what you're looking for. You know, I'd like the 1968 report prepared by Dr. Jones on fall-out at Utirik. Well, that's a Catch-22 because usually you don't know of the existence of Dr. Jones' report. So, you can't ask for it most of the time. Where this leads me is to urge you to recommend the establishment of some kind of citizen-based volunteer research organization that would have the ability and expertise to continue the very fine work of your committee when you go out of business. Your staff as you well know is just coming up with hundreds and hundreds of new and valuable documents, but you know like Cinderella's coach, you're going to turn into a pumpkin at some point, and a lot of this expertise is just going to go on to the shelf as the Ambassador said. Now, there obviously are details to work out, including access to classified documents, but my point here is there are a large number of private researchers in this field, some fine professional historians like Gregg Herken on your staff, but a large number of lay people, many of whom testified before you at these public hearings, who, with their years of experience in this field, could probably do a better job of searching through government archives to find documents than government officials who try as they may simply lack that expertise. With that, I'll close, and I'm sure the three of us would be, and Holly, would be willing to answer any questions you might have. DR. FADEN: Thank you, Mr. Weisgall. Are there questions from the committee? Dan will start us off. MR. GUTTMAN: Thank you. A small point. When Ambassador Kendall wrote to Dr. Faden, otherwise known as Ruth, you had asked about the -- you had expressed a concern about the Defense Department, and we had -- I called Ms. Barker, and the Defense Department assured us that anything you wanted, as they say, they'd be happy to give you. Is that something that's been taken care of? Just to make sure that we're at least accomplishing something small before we get to the bigger ones. MR. KENDALL: Thank you. I forget to mention that earlier, and I should like to thank you for coming to our aid. In fact, the Department of Defense has been in contact with us, and they have asked us for specific name of documents that we wish to have them search for. So, we wish to thank the committee for helping us out. MR. GUTTMAN: I just want to make sure. The Department of Defense has been very cooperative with us and assured us that at least if we can step in and help, whatever we can do there, just let us know if there's -- MR. KENDALL: Thank you. You've been of immense help to us. Thank you. DR. FADEN: Phil? Dr. Russell? DR. RUSSELL: Perhaps you can clarify the -- some of my confusion about the medical support that was provided for various -- during various times. On the second page of the Ambassador's testimony, there's a reference to U.S. medical teams that made regular visits to the atolls to take samples. Were those from the Department of Energy or AEC or were they from Department of Defense? MR. KENDALL: They were from both Department of Energy and Defense. DR. RUSSELL: So, there were both Department of Defense investigations of medical status as well as Department of Energy? MR. KENDALL: That's right. DR. RUSSELL: I have one more question. Could you tell me the population sizes that we're referring to? You mentioned the core number of 500 for those Bikinians that were moved back, but what's the total population of those four islands where the fall-out occurred? Some approximation? MR. WEISGALL: Today? Today's population? DR. RUSSELL: Well, exposed population. MR. WEISGALL: 239 is the total for Rongelap and Utirik. Those -- I don't know the breakdown, but there were 239 people living on Rongelap and Utirik at the time of the March 1, 1954, BRAVO shot. Does that sound right to you? Okay. There were 167 Bikinians moved off their atoll in 1946, and I could get you the number on Enewetak in one quick second. Now, today, through inter-marriage, those numbers have grown tremendously. If a Bikini woman -- if a woman, let's say, who's not from Bikini marries a Bikini man and she has three or four children, well, they get those land rights of Bikini. So, I know for Bikini, the population center exceeds 2,000 -- 2,050? And perhaps the Ambassador could help you with the other numbers. DR. RUSSELL: We are talking about a few thousand people total presently from those four islands? MR. WEISGALL: Right. But my number -- my 500 number consists of that 239 from Rongelap and Utirik, and let's say roughly 260 maybe who may have been on Bikini at one time or another. Does that clarify your question? DR. FADEN: Lois? MS. NORRIS: I don't know to whom to direct this question, but you mentioned that there are 25 islands, Ambassador Kendall, in the Bikini -- in the Marshall Island chain. Are all of those islands inhabited? MR. KENDALL: No. MS. NORRIS: How many of the 25? MR. KENDALL: There are currently only 24 atolls inhabited at this moment. There are 29 all together. Out of the 29, only 24 atolls, I believe, are inhabited. MS. NORRIS: So, most of them are? MR. KENDALL: You have an understanding of when we talk about atolls, we're talking about ringlets of islands, you know. So, you may have an atoll consisting of 50 people, and the rest of the islands within the same atoll are not inhabited. MS. NORRIS: I see. And do you know if there's been any effort to determine the degree of contamination on all of these atolls then? MR. KENDALL: Yes, I believe -- MS. NORRIS: We're aware of the four that we're discussing here today, but the level of contamination has been established? MR. KENDALL: Yes, there has been a current study which has been released, a copy of which we will provide the committee, but there has been on-going study. MS. NORRIS: Thank you. DR. FADEN: Yes? Ruth? DR. MACKLIN: My question goes back to the question about the medical teams that visited. They were doing invasive things to the people. I mean a urine sample is not an invasive procedure, but people have to cooperate. A blood sample is a little more invasive, and bone marrow is considerably more invasive. What, to your knowledge, what were people told, and how did they cooperate? Did everyone cooperative? Did anyone resist? Did anyone protest? Were there any adverse effects of something like taking the bone marrow which can be a painful procedure? Is there anything more you can tell us about those procedures that were done in the course of collecting the information? MR. BALOS: Thank you. As for the people of Bikini, who were seen by this medical team, yes, they were cooperating with the doctors in any kind of test that they were requiring from the people. They let them take the samples, blood and so on. MR. KENDALL: Let me make a comment here. In the case of some of the islands, where Ms. Barker here had visited, at first, the people were willing to cooperate. When they realized that there were some -- we were experiencing some awkward feeling about the whole body make-up, but when they asked some of them for marrow, testing of marrow, I know of one case, one individual that ran away. He didn't want to go through that process, and then they offer him a baseball bat, and he was willing to go through the process. He was a young kid. He wasn't willing to subject himself to this kind of complicated surgery. That was a bone marrow operation. DR. MACKLIN: Was that only one individual? I mean I'm sorry. I just missed because I couldn't hear clearly. Did the person refuse or was he just unwilling or reluctant to do it? To undergo the procedure? MR. KENDALL: He was unwilling to do that, not knowing the reason for doing it, and he didn't want to subject himself to something that he doesn't know about, what is the purpose of it, and he was not told the reason for doing it. DR. MACKLIN: To your knowledge, was there anyone else who was given -- who were given goods or money or any other material goods for participating in this? MR. KENDALL: Oh, yes, they were given -- they were given tee-shirts, toys, and things of that sort to, you know, come to the visiting doctors for treatment. DR. FADEN: Duncan? DR. THOMAS: A follow-up to Ruth's question about the bone marrow biopsies. Our staff has been told by Dr. Victor Bond that Project 4.1 included some bone marrow biopsies of controls. Now, it was my impression that 4.1 was a survey of those who had been involved in the -- who had been on the exposed atolls. Can you fill us in on that? Were there, to your knowledge, unexposed controls in populations in Project 4.1, and, if so, where did they come from, and anything that you might know about what they might have been told about their participation? MR. KENDALL: Let me turn over the mike, over to Ms. Holly Barker, here, who has done extended study of this. MS. BARKER: Most of the control populations they took from other atolls in the North that were exposed. They came from Utirik. They came from people of Rongelap who were resettled with them on Rongelap afterwards. So, they weren't exposed in the initial 1954 fall-out of BRAVO, but they were put back on to the atoll that was contaminated. So, they were ingesting some of this internally. So, there has been question all along about the validity of the control groups, if they were -- if they received a certain amount of radiation, then it may throw off the predictions that were given to all the rest of the communities. DR. THOMAS: So, on the one hand, the issue is one of the scientific validity of the comparison between an exposed population and a "control" who are themselves exposed? On the other hand, there would be obviously some scientific interest in understanding what the effects on these people who had not been directly exposed to the blast but would nevertheless have been exposed to residual fall-out? Am I right about that? So, that might provide a rationale for why one would -- one might wish to engage some of these invasive procedures. Is that a fair statement? Now, do you know anything about what these control individuals were told as to why they should be interested in participating in such a study? MS. BARKER: To my knowledge, they were just told that it was the medical interest, to check with everybody. There were also control groups who were sent to the United States. They were sent to Brookhaven. They were sent to Ohio to go through with some of the groups who had their thyroids looked at as well. DR. THOMAS: Were they told that they were being specifically selected to participate as controls or because they had been -- had received some further exposure themselves? Do you know? MS. BARKER: Unfortunately, I only interviewed one control person, and he was told that, yes, he was a control member. DR. THOMAS: Thank you. DR. FADEN: Could I just follow up on that? So, the one person that you interviewed who was from this, what's termed the control group, the control population, understood that he was being sent to the States because he was in some sense a comparison for the people who had been exposed to the blast? MS. BARKER: Yes. DR. FADEN: Could I ask -- I don't -- this is a general question to anyone. If you can explain a little better for us, although our staff has done this for us as well, the relationship as best as you can understand it between the medical care that was offered to the exposed -- the people who were exposed to the blast and the -- what you understand to be the research or follow-up components? The research interests of the Federal Government, are they completely -- were they completely intertwined, so that it was impossible to distinguish that which was medical care as a service to the population from that which was data gathering for purposes of answering any number of research questions that the American scientists might have had? MR. WEISGALL: If I -- the acoustics here are really pretty terrible. DR. FADEN: They're not very good. I know. It's pretty lousy. MR. WEISGALL: Yes. To the best of my understanding, when the doctors would come out who, beginning in '54, were Brookhaven doctors, I mean that particular part of the program, there would be a general sick call together with the specific research questions that would come up. So, if I understand your question correctly, I don't think there was much of a distinction. DR. FADEN: That is my question. Whether they were completely intertwined or whether there were, you know, days you went for sick call and days you went because the researchers were there to do systematic data gathering. MR. WEISGALL: Yeah. DR. FADEN: They were just there. MR. WEISGALL: I think that's correct. To go back to Duncan Thomas' question, again I think another issue I would urge the committee to look at was just this whole issue of control groups. The Bikinians were in a different situation. They were all moved back. There were no other people who went back to Bikini as controls because the Bikinians themselves in essence were a control group because they had not been exposed. But I again would urge you to think of the ethical aspects of sending the Rongelap people back with a control group. If they were being told in 1957 everything is hunky-dory, why have a control group, except to study what may be the adverse effects. This obviously gets into your areas of expertise. The Bikinians did not face that situation, and I think probably would have been reluctant to go through that process. There were many who by the end of this process of some of these visits began to wonder whether they were getting medical care or were participating in an experiment. They weren't exactly sure. Is that a fair statement, Senator? DR. FADEN: Are there other questions for our panel? (No response) DR. FADEN: Well, we thank you very much, and we are continuing to learn a great deal from your presentations. Thank you. (Pause) DR. FADEN: Our next presenter is Mr. Cooper Brown. If Mr. Brown could join us at the table, please. Good afternoon. Statement of Cooper Brown Association of Radiation Victims MR. BROWN: Madam Chairman, Chairwoman, excuse me, members of the advisory committee, my name is Cooper Brown, and I'm appearing here today on behalf of the Task Force on Radiation and Human Rights. I want to apologize first with my -- what I'm about to say is a little bit disorganized because I was in conferences literally up until the time I jumped on a Metro to get here, and I've only been able to formulate these thoughts sitting in the back of the room. Originally, when I requested the opportunity to testify, it was on behalf of the task force to address the subject of remedies. The task force is working on that, but in the process of doing so, we have found that it's much more complicated and has raised some concerns that actually I have been asked to share with you this morning, this afternoon. But the task force will have a detailed report for submission to the advisory committee at its March meeting on the subject of remedies. In any event, the task force overriding concern at this point, which I have been asked to address to this committee at this time, is this. We are concerned that there not be with regard to the issue of human radiation experimentation a rush to judgment. We are concerned that this advisory committee not be forced to abide by arbitrary time deadlines that result in anything less than fulfillment of your charter as you knew it when the advisory committee was formed and you accepted your position on this body. Allow me to explain. When the advisory committee was formed, I think it was generally everybody's understanding that the universe of experiments was relatively small, the Markey report was cited, 46 experiments, perhaps 800 experiment victims, potentially. Now, we know, and particularly in light of this Department of Energy report that was released last week, that the situation is much, much larger than any of us had ever imagined in our most horrid dreams about this thing, when the issue arose, and that considerable work and investigation has yet to be done. We note in particular that very few of the experiment victims or their families have been identified, let alone located. Consequently, there are certain issues that this committee is addressing and the task force is now struggling to address which simply are in our view premature, and the best example of that is the subject of remedies. What is -- what is a remedy? I mean what are we talking about when we talk about remedies? Is it compensation? Is it reparation? Is it restitution? Well, a basic and fundamental definition of remedies is it's dependent on the nature of the harm and perhaps more so the extent of the damages. But if we have neither identified nor located the victims, how can we answer any of these questions? Moreover, and perhaps even more importantly, what is the morality of seeking to fashion remedies for the experiment victims when not even a majority of them or their families have yet been found, fully apprised and meaningfully engaged in this discussion? And I say that not withstanding the tremendous efforts of this particular body in holding field hearings and trying to reach out to the experiment victims and the radiation victims survivors community, but, nevertheless, this is, in our view, an extremely serious matter. As I'm sure you're all aware, recently Judge Beckwith, a sitting federal court judge, applied the Nuremberg Code to the Cincinnati experiments and applied it, the Nuremberg Code, as a matter of U.S. constitutional law. Section 7 of the Nuremberg Code states in part that adequate facilities are to be provided to protect the experimental subject against even remote possibilities of injury, disability or death. Given the fact that we're talking about radiation exposures with latency periods that run anywhere from 20 to 40 years or more, are we not obligated as a society to find these people, to find the families, to fully apprise them of what happened, before we engage in issues, and subjects, such as remedies? Consequently, the task force asks the question. What or whom does a rush to meet deadlines that were premised upon assumptions that are neither no longer valid nor relevant serve? The Government? The Government that perpetrated the crimes in the first place and then engaged in a cover-up? The private parties that were involved in the experiments? A rush to judgment certainly does not serve the interests of the experiment victims, particularly when they have not been in any meaningful sense of the word located and involved in the process. The task force therefore respectfully submits to Madam Chair and this honorable committee the soul of our nation is on trial here. There cannot be and there must not be a rush to judgment based on incomplete and inadequate information. The President in formulating this committee placed his faith and that of this nation in your fulfillment of this committee's charter. In light of that faith and the trust that has been placed in you as members of this committee, it is incumbent upon this committee to speak truth to power and request of the President and the Congress the additional time and resources which we all know you need in order to fully complete your work. If you do this, you will certainly have the full support of the three dozen organizations from around this country that now make up the Task Force on Radiation and Human Rights. Thank you. DR. FADEN: Thank you very much, Mr. Brown. Are there questions or comments for Mr. Brown? (No response) DR. FADEN: We appreciate your supporting your interests in our work, and I can assure you we worry about the same things you worry about when it comes to the time frame. We're struggling. Thank you for your comment. Dan, did you want to -- MR. GUTTMAN: One thing the public should know, and the committee should know, we have, of course, talked with Cooper Brown and his group continually, and one of the real questions Cooper might want to -- I don't have time here, but is how you find people at this point, because it is something that is not simple. The conversation we had with Cooper the other day was that you can't just say there was an experiment at such and such a hospital because while they may have patient files of 5-6-20-30,000 people, you don't know which ones are experimental. So, one of the things that might be useful at least whatever the time frame that the committee completes its report, for purposes of whoever's going to act on it, is what mechanism, if any, might actually be useful by way of identifying people beyond those which the committee and yourself was employing in some practical -- MR. BROWN: Well, we certainly have some ideas, and I'd be glad to share them with you now or later, depending on the committee's time. DR. FADEN: How about in writing? MR. BROWN: Fine. DR. FADEN: That would be great. MR. BROWN: I would be happy to do that. DR. FADEN: That would be very helpful. Thank you. Okay. Thank you very much, Mr. Brown. That's great. MR. BROWN: And, again, thank you. DR. FADEN: Okay. Our ranks have been growing as weather has allowed. So, welcome to those committee members who have come in discreetly as the afternoon has progressed. We appreciate everybody's efforts to get here in the weather. Our next member of the public to present is Mr. Cliff Honicker. Mr. Honicker? Good afternoon. MR. HONICKER: I have written testimony, if you want to distribute it. DR. FADEN: Has Mr. Honicker's testimony been distributed to us? We'll do that now. Okay. Thank you. If you could speak into the mike, the comment about the acoustics is correct. This room is pretty lousy when it comes to trying to hear one another. Statement of Cliff Honicker, Knoxville, TN MR. HONICKER: Last July, I released in the Washington Post a story called "The Burning Secrets". The story was about Army-sponsored experiments and studies at MCV, the Medical College of Virginia, in Richmond, Virginia. I spent two days at the offices of the Washington Post, letting their editors and lawyers review documents that I had obtained from the MCV archive to substantiate the facts in the story. The president of MCV, Dr. Evans, responded angrily before this committee, calling my work a product of bad history, bad journalism and bad science. He also criticized this advisory committee for looking into the MCV studies at all. One of your panel members, Susan Lederer, made an unofficial visit to the MCV archive, spent part of one afternoon reviewing some of the MCV files, and then stated for the record in July meeting that she had found "nothing to substantiate my allegations". Members of your panel, notably Mr. Katz and Ms. King, requested copies of the annual reports as well as the treatment and experimental protocols from MCV. MCV officials said they would provide those materials to you. Eight months have passed. In meetings and over the phone, I've asked Mr. Guttman periodically what the committee has obtained from MCV. He responded by producing two letters written by MCV officials. One containing a partial index of the material in the MCV special collection archive relating to this subject. By partial, I mean the index provided to the President's panel consisted of the boxes of papers of Dr. Haynes, who is Dr. Evans' successor. Your committee was not provided with an index of Dr. Evans' papers, the materials from which my story was drawn. As I understand it, MCV told this committee this index was all they had on Evans' special burn unit projects. As far as I know, your committee has not followed up on its own requests for the annual reports that Dr. Evans made to the Army's Medical Research and Development Board. I requested and received from Mr. Guttman documents your committee obtained from the archives on "the Joint Panel on Medical Aspects of Atomic Warfare". That inter-agency panel was charged in the late '40s and early '50s with developing medical science to the fullest extent possible in order to medically treat civilians and troops in the event of nuclear war. This panel's papers had classification markings on their documents, ranging from confidential security information to secret. This meant that the documents contained information vital to the national security of this country with the unauthorized release of information being in violation of the Espionage Act and subject to long jail sentences for violation of those laws. Evans' work on physiologic studies of burns and humans figured prominently in these formerly-secret papers. The Joint Panel members even conducted one of its secret meetings at the Medical College of Virginia and toured Dr. Evans' experimental clinical labs and special burn units. MCV denied in July that any of Evans' work involved classified work for the military. Yet your committee uncovered information contradicting that denial. Why have you not followed up on this? MCV claimed that none of Dr. Evans' work was classified on the basis that there have been journal articles and newspaper articles on his work over the years. MCV skirted the critical issue. Did the individual patients in the special burn unit set up with Army funding know that they were being used to further medical science in preparation for mass casualties for nuclear warfare? The 800 pregnant women who were given FE-39 at Vanderbilt in the '40s, mostly poor women, were never told they had been given radioactive iron while being treated at Vanderbilt Charity Clinic. The scientists in those experiments published in scientific journals as well as the scientists and doctors at MCV. Publishing in scientific literature one's scientific results and divulging to a patient the full and complete nature of one's research goals are two entirely different things. The only way to find out if patients were told the full nature and purpose of Evans' research is to ask them or their surviving family members. I provided you with a list of more than 100 names of patients from Evans' Army-funded research. You could have obtained that same list yourself if you had ever received Evans' annual reports to the Army. Did you try to find even one of the more than a hundred people or their survivors to ask them the simple question, were you told? Did you know that you were part of a special burn unit funded by the Army for the purpose of furthering medical science to prepare for mass nuclear casualties? And did you give informed consent to being part of these studies? Finally, MCV claimed that patients at MCV and the two charity hospitals where this research was conducted were not experimented on with radiation. Rather, the radioactive isotopes injected into them were used in the normal course of medicine for "diagnostic purposes", to aid them in their medical treatment. The plain fact of the matter, and your committee has this information as well, is that Dr. Evans wrote to the AEC April 9th, 1948, informing them that he would be using Phosphorus-32 up to 500 micro-curies in individual patients for "investigational purposes, not for the treatment of disease". Again, according to Dr. Evans' reports to the Army, Dr. Evans divided patients in special burn units into categories of severity and injected some of them with one or a combination of the following isotopes, Phosphorus-32, Chromium-51, Carbon-14, Nitrogen-15, and Sodium-24, in order to find the life span of red blood cells in hemoglobin following minor, moderate and severe burns in humans. A Washington Post editor and I interviewed Dr. Evans' successor, Dr. William Haynes, and asked him if radioactive isotopes are currently injected into severely-burned patients for blood-counting purposes. He said no. We asked him when the use of in vivo radioactive testing in burn patients was discontinued. He said it was so long ago, that he could not remember when this type of testing was standard medical practice in severely-burned patients. A few months ago, I interviewed Dr. Karls Z. Morgan, the former head of Health Physics for Oak Ridge National Laboratory, and Chairman of the Permissible Internal Dose Subcommittee for the National Committee for Radiation Protection, at the time these experiments were conducted or studies. I asked him if 500 micro-curies of P-32 were an acceptable dose of radiation to be injecting in severely-burned patients. He said no. In a normal human being, the maximum permissible amount of P-32 in 1951 for continuous exposure was 10 micro-curies. That would make a dose of 500 micro-curies 50 times over the maximum permissible level. When you consider the NCRP's admonitions to avoid all unnecessary exposure to radiation, and Dr. Evans' own findings that when he combined generally non-lethal burns with non-lethal exposure to radiation in dogs in his experimental laboratory, he found a 500 percent increase in mortality, it leads one to wonder why Dr. Evans injected these patients with any radio-active substances at all, particularly when it was, again to use his own exact words, "for investigational purposes only and not for treatment of disease". These facts, combined with the fact that the President's advisory committee has known for months that Evans' work was an integral part of this very secret Joint Panel on Medical Aspects of Atomic Warfare, makes me wonder why in the world has the President's advisory committee taken such a hands-off approach to investigating this case. By not carefully studying this case, the President's advisory committee opens itself up to questions of institutional bias. It's really a shame because for nearly 50 years, many families and recipients of government-sponsored radiation human experiments have been kept in the dark. Many thousands of people in America were counting on you to shed the full light of complete disclosure on these experiments and studies. I wonder how many others similarly noteworthy cases you've also chosen not to investigate for lack of proof. The proof you have simply chosen not to pursue. Thank you very much for your time, and I appreciate the opportunity to speak to you today. DR. FADEN: Thank you, Mr. Honicker. I appreciate your comments. I want to let Dan make a comment on behalf of the work of the staff, but I might point out to you that your characterization of our failing to pursue the issues at the Medical College of Virginia is not accurate, but I will let Dan do a better job than -- he'll do a better job than I can. MR. GUTTMAN: First of all, if you survive one mistake, I'm sure we all welcome commenters like Mr. Honicker and Dr. Egilman and Dr. Egilman's assistant. It's a useful exercise. I think, Mr. Honicker, when we talked last, it was several months ago, I think we had told you that we had a considerable amount of information about MCV. We now have many feet more, but large amounts more. Did you see -- and we in fact, of course, have gone to MCV and, of course, have gotten all the Army documents. Are you familiar with the materials we have -- MR. HONICKER: I asked you specifically what you had obtained from MCV, and you showed me two letters. MR. GUTTMAN: Right. That was at the time. That was several months ago. MR. HONICKER: That was like a month and a half ago. MR. GUTTMAN: Well, whatever it was, in the interim since, and we pointed out, we have a lot of materials. Have you seen the materials that have been made public today related to MCV? MR. HONICKER: No, I've not. I understand from the Richmond reporter that you've released two letters that substantiate the material that I have brought out in July about the issue of Evans classifying the material. MR. GUTTMAN: Well, actually, it's complex and puzzling. We all can read this for ourselves, but one of the difficulties that we have is that the joint panel, where we put together all the materials on this panel, which was meeting in secret, a lot of the experiments it was talking about were themselves, for example, like Dr. Saenger's experiment, quite open and visible. So that we're in a world where things may have been talked about in secret, but the actual activities may have been -- and I don't know if the committee members have looked at it, but what we have found is that the puzzle is somewhat clarified, somewhat more complexified, after Mr. Honicker had brought a document previously indicating that an experiment that was written about in the paper was somehow classified. It looks like what happened is the MCV folks were concerned about the paper's writing about it, so they went to the Defense Department and said can we get these things classified. MR. HONICKER: What it was was that a reporter was pursuing a story, and in reaction to that reporter pursuing the story, in reaction to press investigating this, that's why Dr. Evans issued the directive that the work on the experimental laboratory which was the radiation and the burn studies on the dogs as well as the clinical research, which was the special burn units on the patients, that that be classified restricted until further notice, and that's -- that was the sequence of that. Now, it may be later that that they took the classification off of that, but the point that I've been trying to ask is, Number 1, I've provided you with names from the annual reports that, back in September, when you had not received the annual reports. I provided you with over a hundred names, and there has been no follow-up of any of these individuals. MR. GUTTMAN: That's not -- that's not -- that's not -- MR. HONICKER: Have you found any, Dan? MR. GUTTMAN: That's not complete. We have communicated with people who have talked to the individuals. We have got a lot of people to talk to, but let me just make the point that you and other people, we have every day people in our office who are looking through these files, and we're very appreciative of you here. If you would like to look at the MCV materials, as we said previously, that we have in the office, not the one that you've already seen obviously, but the ones that we're getting from the Army, you're welcome because we've got quite a bit. Not only have we been diligently pursuing it, but I'd like to say that the Army for its point has come up with this particular piece of the puzzle. MR. HONICKER: Well, this specific document that is reported in the newspaper, and I guess it's today's newspaper, -- MR. GUTTMAN: Yeah. MR. HONICKER: -- says that -- it just says that the panel has released newly-unearthed documents yesterday. These were the specific documents, the very documents, that I was talking about in July, that Susan Lederer responded saying she found nothing to substantiate my allegations. MR. GUTTMAN: Well, I don't want -- we went through the documents you came with -- you brought last September, and you had one of a series of perhaps a dozen documents. The document you had hinted at something, but wasn't the actual essence -- whatever it is, the information -- DR. FADEN: We can pursue that. The point you're making, we appreciate that you would like us to be working harder. MR. HONICKER: Well, I would like to help you. I brought over 500 pages of documents from the MCV, the annual reports, and Evans' personal correspondence that lays out the history of this, and I'd like to provide it to you right now and make it part of the public record, if you would like. DR. FADEN: Terrific. That would be great, and we're happy to take any documents that anyone would be able to give us, but your research certainly will advance our work. Could you give it to -- Steve, could you take it? MR. HONICKER: Someone who's responsible and won't lose it. DR. FADEN: Right. If it comes here, I'm going to mix it with everything else that I've got on my -- around me, and it won't work very well. Are there other questions for Mr. Honicker? Duncan? DR. THOMAS: Actually, a question to the committee rather than to Mr. Honicker. So that we follow up on this story adequately and do it justice, I want to be clear exactly where it fits in the big picture. Can somebody tell me which of the subcommittees or which of the chapters or where we should expect to see this material eventually? MR. GUTTMAN: It's a complex -- without fear of being contradicted, it -- Dr. Evans essentially was -- Mr. Honicker obviously knows this -- was doing burns research, which was related to atomic testing. It was the burns component of the testing, not the radiation component, but in the process of doing it, tracers were used. So, is that -- DR. THOMAS: No, no. My question is there are several different chapters where this material might potentially fit. MR. GUTTMAN: Right. DR. THOMAS: And I don't want it to fall through the cracks. DR. FADEN: As the story evolves, my guess is that part of this will show up in a redraft of the secrecy chapter, and part of it will show up in the tracer story, as the stories evolve. I mean as the chapters develop. I don't think we're going to have a chapter just on the MCV experience, but as it breaks out. It also sets a context. So, it's going to have to go into the context part of the report that talks about the kind of work that was done at the time, all of which are kind of a piece bearing on advancing the capacity of the government in the context of a nuclear threat. So, we're going to have to incorporate some of the material, I would think, about the MCV experience, but it's burns and not radiation in terms of its main focus, and it's still part of the context of the kinds of work that we're -- was of interest, that was being supported at the time, and then the themes of secrecy emerged, and then the relationship to tracers, if that develops to be significant. MR. HONICKER: Well, there is a German researcher who I will provide you with material later, who can be found in the NTIS documents over in Virginia, that speaks of the very same issues that Evans was writing on in terms of the synergistic effect of adding burn radiation, any dose of radiation to people who have been burned, and how it increases the mortality rate. DR. FADEN: Right. MR. HONICKER: But I would hope that you would include it in the ethics section. Regardless of radiation, regardless of burns, the very basic ethical question of the fact that this medical doctor with Army funding, and it's very clear to me, it looked very secret, when it says secret on the document, was using human beings to prepare for mass nuclear casualties, and the result of that being that he said we can fight and survive nuclear war, and never telling the patients that they were being used for that very purpose. MR. GUTTMAN: Well, at the risk of -- well, we can talk about it later, but that's not completely clear from the information. There may have been secrecy, but it isn't completely -- the public articles in the Richmond paper in '54 talk fairly openly about what the -- both the black and white volunteers were doing, I think. MR. HONICKER: In the 500 pages that I'm providing you of annual reports and protocols that he provides to the Army, what I've read Dr. Evans' own papers, there is absolutely no indication that I've seen that there was any protocol set up to inform the patients of the full purpose and nature of the research. MR. GUTTMAN: Okay. MR. HONICKER: And I think that's the critical issue, is what were the patients told. DR. FADEN: Duncan? DR. THOMAS: Can I be clear on something? The P-53 injections, were -- MR. HONICKER: P-32. DR. THOMAS: I'm sorry. P-32. Were being used not as a radiation effect study per se? In other words, they weren't trying to find out what the synergistic effects of radiation and burns in humans were? MR. HONICKER: No. DR. THOMAS: It was -- but it is described as investigational purposes. In your reading of these documents, have you been able to determine what that investigational purpose was? MR. HONICKER: Well, they were trying to come up with an accurate means for doing red blood cell testing and do, as I say, my presentation to you, to find the baseline. This was pioneer research that Evans was doing on finding the baseline on the life span of red blood cells in hemoglobin and plasma following severe burns, and by doing that, they would have better medical triage in the event of a nuclear war. Interestingly enough, and I don't want to go into the technical details, but when he did simultaneous tests with the Evans' blue dye for red blood counting with the Phosphorus-32, they would find a rise in the red blood cells with the Evans' blue, and a drop in the red blood cells when they used the radiation, which I thought that was very interesting, but I'm not a medical doctor, and I don't want to get into the medical details for fear of getting in really big trouble. I appreciate all the work that this committee is doing, and I particularly appreciate that you released those documents yesterday, and I will work with you however you need to unearth this information. DR. FADEN: Thank you very much, Mr. Honicker. We appreciate that. Excuse me. I had a piece of ice go the wrong way. Our last public presenter is Mrs. Broudy. Good afternoon, Mrs. Broudy. Statement of Pat Broudy National Association of Atomic Veterans MS. BROUDY: I'd like to speak a little bit about the situation, also. I've presented to the committee several papers recently dwelling on this issue, and I'd like to repeat that the atomic veterans are experimental subjects, whether deliberately exposed to ionizing radiation or as experiments of opportunity. I sat here and listened to these gentlemen and the lady from the Marshall Islands, where they spoke of anywhere from 50 to 500 to 5,000 individuals who may have been exposed during the nuclear testing, and the fact that they have been accorded medical care and some compensation and food and other amenities and for which we are very thankful that they have done this, but I'd like to say that there are over 42,000 GIs and civilians exposed to Able and Baker Crossroads alone. That doesn't count all the other tests that were conducted in the Pacific. None of these men have received diddly-squat from our government, except a real hard time, and although I am very pleased that the Marshall Islanders are receiving some kind of help, albeit minimal, we'd like to have some of that care exerted on behalf of our service men. So, we are concerned regarding waste of taxpayers' money. The Department of Veterans' Affairs and the Department of Defense are no less guilty of wasteful practices than any of the other agencies and departments of government. The following suggestions may answer the question of remedies for the atomic veterans and survivors as well as provide a realistic financial approach to those remedies. This approach would necessitate the cooperation of the Senate and the House Veterans' Affairs Committees, working in concert with the advisory committee and subject to approval of our membership. Those suggestions are: (1) all veterans in any way exposed to any amount at any time of ionizing radiation exposure be accorded 100 percent disabled veterans or DIC benefits with no offsets to date of diagnosis or original filing of claim, whichever occurs first, on behalf of or by the veteran, for any illness possibly caused by his exposure; (2) all illnesses attributable to exposure shall be compensable. These include all illnesses determined to this date to be a result of exposure in any amount. The cancers and other illnesses listed in Public Laws 100-321, 102-578, and 98-542 shall be presumed to be caused by the veteran's exposure. In addition to those illnesses listed in the laws, the veterans must be entitled to the same consideration accorded the Marshall Islanders, and the veterans shall have the option of accepting VA benefits or remuneration with no offsets comparable to that of the Marshallese brought up to today's value. Those cancers and non-cancers enumerated in BEIR V to be radiogenic and those listed in "A-Bomb Radiation Effects Digest, 1993", must also be considered when determining radiation-induced illnesses as well as any radiation-induced illness determined in the future. If selection of a cash lump sum is elected, the veteran or survivor will not forfeit any other benefits accorded them by law, unlike the Marshallese -- I'm sorry -- unless the Marshallese, those selecting the lump sum benefit will not be paid in pro rata annual payments. Upon accepting a lump sum, the veteran will forfeit monthly monetary VA benefits only, retaining all other benefits accorded VA-disabled veterans and DIC widows. Public Law 98-542 must be repealed after the above conditions are put in place. The savings involved by the Department of Defense, the Defense Nuclear Agency, and the Department of Veterans' Affairs may more than offset the expense of the above suggestions. There will no longer be the necessity for dose reconstructions or the Veterans' Advisory Committee on Environmental Hazards. Thereby freeing up funds now consumed in those reconstructions and the expense of the Veterans' Affairs Committee on Environmental Hazards. The DNA has paid to contractors the amount of $13,598,930 for dose reconstructions, and a nuclear test personnel review program in the years 1978 to 1994 has cost the taxpayers $96,500,000 for total funding. We do not know if this includes overhead, rent, salaries and any other costs incurred as a result of dose reconstructions. Because so many records have been destroyed, it is difficult for some veterans to prove their attendance at a nuclear device detonation or the handling of radioactive materials. According to law, if the VA cannot show the veteran's presence elsewhere, it will be assumed he was present at an exposure site, if that is his contention. He is to have the benefit of the doubt. You also have been given a copy of a complaint that was filed yesterday in Chicago on behalf of four gentlemen who were exposed during the Crested Ice incident in Thule, Greenland. One of them, Gregory Maas, has colon cancer. Frank Felinski has lymphoma, and the other two gentlemen are sterile as a result of their radiation exposure. They were sent to Thule, Greenland, to pick up the pieces from an accident that occurred when a B-52 bomber crashed, and four thermal nuclear bombs scattered over the ice and the snow in Thule. Thule, Greenland, is a possession of the -- is it Finland? No. Scandinavian country, and, so, consequently, we will probably get knocked out of the box on this one because of the foreign country exception. However, I want you to be aware that there will be a class action suit filed against the Veterans' Administration within the next two weeks, which would cover all of the atomic veterans. There will be about 10 subclasses in that class action. We realize that we are facing an uphill battle as we have in the past, but somehow, some way, we have got to get these men and their families accorded justice. When only 414 out of 300,000 people have been accorded VA benefits under the presumptive laws, our government sorely is in need of help, and if they can't get it from this committee, then we'll have to get it from the courts, if we can't, and I appreciate the fact that you have done as much as you have, and I hope that you will take this into consideration when you make your decision on remedies. Thanks. DR. FADEN: Questions? Ken? MR. FEINBERG: Ms. Broudy, you mentioned this committee and the courts as two targets for your group in terms of seeking help. MS. BROUDY: No, I didn't. I didn't mean that. If I said it, I did not include this committee in this lawsuit. It will be just a -- MR. FEINBERG: I don't mean the lawsuit. I understand. I'm saying that you're seeking relief either from the courts or you'd like some help from this committee -- MS. BROUDY: Exactly. MR. FEINBERG: -- in terms of your recommendations. What is the status of your efforts with the Congress, with the Senate and the House of Representatives? The elected officials who have to appropriate money and enact legislation, amending the existing legislature that you've talked about. What is the on-going -- what is the status of the on-going effort to seek assistance from the Congress? MS. BROUDY: Right now, there is nothing. MR. FEINBERG: Why is that? MS. BROUDY: Money. MR. FEINBERG: You mean lobbyists? You mean money to mount a lobbying campaign, you mean? MS. BROUDY: Not just that, we are talking about lobbyists per se. We are talking about the nuclear power industry, the nuclear weapons industry. We are talking about the Department of Defense and their huge budget, and how the Veterans' Administration is crying because they can't afford to compensate a few veterans. That's the whole problem. We had a law passed in 1984, which was 98-542. MR. FEINBERG: Did you work on that legislation? MS. BROUDY: Yes, I did. I've always worked on it, since 18 years. MR. FEINBERG: Who were the champions in the Congress then of that legislation? MS. BROUDY: Alan Cranston. Unfortunately, he is no longer here. MR. FEINBERG: And the -- MS. BROUDY: We haven't had diddly-squat since he left. MR. FEINBERG: And in the House of Representatives, who's championed your cause? MS. BROUDY: We have been -- we did get two cancers added to our so-called presumptive list, and that was because Douglas Applegate and Elaine Evans of the House Veterans' Affairs Committee chaired some hearings, presented a bill, and it was passed and signed by the President. MR. FEINBERG: See, whatever we do on this committee, we have no power to change the law or -- MS. BROUDY: I understand that. MR. FEINBERG: What I'm really trying to find out is what blueprint you have or your organization has for dealing with some of the problems you address, which I am very sympathetic to some of what you say about the limitations on dose reconstruction and things like this, and the narrow restrictive list of presumptive medical conditions. There is much truth, I think, to a lot of what you say, but at the end of the day, I'm sort of wondering, quizzical, as to what effort or what blue-print you have planned with your organization to try and get the powers that be on Capitol Hill to seek amendments to the statute. That to me is where it begins and ends. I understand what you're saying about class actions. You acknowledge the difficulty of class actions. There are great hurdles there. It seems to me the real target of your concern, and your effort, should be the same organization that enacted the law in the first place, the Congress, and I'm curious as to what's going on in that regard. MS. BROUDY: Well, what is going on is that we've had a complete change in the actors in the House and Senate Veterans' Affairs Committees. The chairman of the Senate Veterans' Affairs Committee is Alan Simpson, who is notoriously against spending any more money on the atomic veterans. In the House, we have Bob Stump, and we have worked very successfully with Bob Stump in the past. He did vote for adding the two cancers that I mentioned to the list of 13 that we had. We are -- and then there's Strom Thurmond and Sonny Montgomery. Notoriously against veterans, atomic veterans' issues. It's okay for the Agent Orange people. It's okay for the Gulf War vets. Give them anything they want, but don't give anything to the atomic veterans, and that is because of the -- in fact, I presented a letter to this committee that was written many years ago by William Howard Taft III or the IV or whatever, saying that the reason he wasn't going to go along with the bill that had been presented by Cranston was because of the power, the nuclear power industry, and the defense industry. So, we feel like we've been shafted, and rightly so, when only 414 -- and out of that 414, we've got guys who are rated zero percent, which means okay, you're service-connected, but you can't get any money, and the widows are now getting $750 a month. What -- I don't understand this antipathy toward the atomic veterans when the other veterans are welcomed home with yellow ribbons and all this good stuff, and I realize that I'm saying bad things about other veterans, and I don't mean to do that because we're all in this box together, but somehow, some way, I was hoping that this committee could influence people in Congress to give us a break. We've got very old people in our organization, very, very sick people. We cannot even find out how many are still alive. We don't know if there's more than the 5 to 6,000 that we know of. We don't know how many have different types of cancers, and now we've got the children and the grandchildren that are having problems. The National Academy of Science held a hearing a couple weeks ago, and I'm working on that issue. We have a lot of kids that are terribly affected by their, we feel, by their father's exposure to radiation, and I testified, and you talk about legislation, I've testified in 15 congressional hearings on this issue. At each one, I have requested that we get epidemiologic studies on the children, and for the first time, Senator Wellstone and Senator Rockefeller have requested the National Academy of Science to do a feasibility study to see if it's feasible to do an epidemiologic study. That's as close as we've come to it. I don't know what else we can do. We've worked on the Hill. We spend hours on the Hill. We don't have any money. We don't have people that are cognizant enough about this issue, and now what we've got to do is to educate a whole new group of young staffers who don't even -- who weren't even born when the testing took place, and don't know what we're talking about. So, it's an uphill battle. I'm not looking forward to going back and starting all over again, which I have done. I've made an effort with Stump's person and with Simpson's person, but, you know, after awhile, their eyes glaze over, and they don't even know what you're talking about. I'm sorry to have taken so much time. I realize I'm over my time. DR. FADEN: No. That was a helpful answer to a good question. MS. BROUDY: Thank you. DR. FADEN: That was real -- I'm always amazed at how much you can keep in your head, Mrs. Broudy. It's pretty impressive. MS. BROUDY: Well, I've been working on it for 18 years. DR. FADEN: Yeah. MS. BROUDY: And you have as much anger as I have because of what has taken place, and about the number of people and families that have been disrupted because of this, it makes an indelible impression on your mind. DR. FADEN: I don't doubt it. MS. BROUDY: Thank you. DR. FADEN: Thank you, Mrs. Broudy. That concludes our public comment period. We're going to take a break. We're about 15 minutes off, and we'll come back at 3:30. (Whereupon, a recess was taken.) DR. FADEN: I have noticed that there's a new packet of materials at my place. There may be at yours, marked Subject Interview Study Update. That's for discussion on Friday morning. So, put it wherever it is that you want to put stuff for Friday morning. I'm on the warpath with respect to loose pieces of paper. My life has been totally taken over by pieces of paper that I can't figure out where they belong. So, this memo that said Subject Interview Study Update is for Friday morning, not for now. So, please put it with whatever you want to do for Friday morning. Okay. Then there's another piece of paper that looks like it was a gray-shaded human subjects research and protections in seven agencies. That's for this afternoon's discussion. So, that's for this afternoon's discussion, but the other thing is not. Was anything else distributed at the break? Anna, do you know? Was anything else distributed at the break besides those two pieces of paper? (No response) DR. FADEN: Okay. We've got it. All right. We're going to start with an update on the Santa Fe Meeting. Reed, do we have any pieces of paper for that? DR. TUCKSON: Yes, in the briefing book. DR. FADEN: In the briefing book. No new pieces of paper, but in the briefing book, Tab E. Okay. So, everybody can go -- sorry about that. New pieces of paper as opposed to old pieces of paper. Update on Santa Fe Small Panel Meeting DR. TUCKSON: Yes, let me in the interest of time and brevity refer everyone to Tab E. I will not try to recite it. Let me just say that the meeting that we held in Santa Fe was really an extraordinarily powerful experience. First, let me just really thank both Ruth Macklin and Duncan. Has Duncan gotten back in yet? DR. THOMAS: I'm here. DR. FADEN: That way. DR. TUCKSON: The rest of the committee members would be very proud and should be proud of Ruth and Duncan for their stamina. Let me say that the hearings that we held had over 50 people testify. We really began early. We took one break for lunch. We took no other breaks. None. Zero. And didn't finish until 7:30-8:00 at night. But that was a testimony not only to the stamina of the committee but to the really extraordinarily well-prepared witnesses, who had an awful lot to say to us, and the transcripts are -- I haven't had a chance to read them, but I know that they are very powerful. The summary gives you a good sense of the issues that were presented. Let me just say that Stewart Udall did his usual fine job of representing his point of view very well. The Uranium Miners in general had important things to say regarding the Radiation Exposure Compensation Act, and we learned a lot of detail. I won't try to rehearse that detail here, but simply to say that the experience with RECA may be a good -- may be good for us as we go forward in our work in the future regarding how compensation is determined, how injury is defined, the kind of medical testing and the criteria for eligibility determination. There were many subtleties that were presented, particularly for Native Americans, that would not have been intuitively obvious until we had heard the testimony from the Navajo Community in particular, the Navajo Uranium Millers, who presented some interesting amendments and suggestions to the compensation act. So, that may really turn out to be very, very useful. The atomic veteran community again, the stories that they tell really give life to the documents that we had received. I will very quickly remind myself of one gentleman who was given the task apparently without much choice to after a bomb blew up in one of the -- a test bomb on one of the ships, the New Yorker, the USS New York, was asked or told to go immediately after the explosion over to the ship with a team to try to keep the -- to do whatever repairs were necessary to keep the ship afloat, such that it could be used and studied later, and really without, as they described it, very much of any protection, warning, safeguards, and then they -- he had with him a picture of the New York Times front page article when the ship eventually was towed into port in New York, and the newspaper reported with some graphic detail the precautions of the people that handled the tow lines with, you know, lead gloves and all this sort of thing, and the irony of the story that he told was, you know, just to be there immediately and was given diddly-squat as he described it a little more graphically. But it was just these kinds of first-hand accounts were very powerful and compelling, and I urge the committee to give it due diligence as you look at it. Also, let me just bring your attention to those sections that deal with the Utah prison experiments. We heard another -- this time a wife, two wives, actually, who again were very compelling. The plutonium injection experiments, the Alaskans. I mean we just heard from so many people. So, I will not try to rush through that. I think the main thing that we need to hear from at this point would be from the -- first of all, see if Ruth has anything else to say on the meeting, but then to turn it over to Duncan very briefly to talk about the Los Alamos site visit. Duncan and Eli, I think both of them have some, I think, some important observations on that. So, let me just see. Ruth, anything else on the Santa Fe meeting? DR. MACKLIN: No. DR. TUCKSON: Bottom line, I just wanted to say that we continue, I think, Madam Chair, to appreciate the value of going out and the value of listening, and I think that the summary that we have in our report is important. I think the transcripts really do contain an awful lot of material. I think things like the RECA, the conversation around RECA provide important opportunities for us to think about the issues of compensation and eligibility and testing and even issues in terms of different ethnic groups and cultures regarding some issues, and whether they prove to be valid or not, they're important for us to think about, and then again, for the atomic veterans and all the others that testified in front of us, they just provided invaluable service. So, with that, Duncan, I turn it over. DR. THOMAS: One thing that Reed neglected to mention was during the public comment period, we also heard some testimony from three of the old timers from Los Alamos. This was a very interesting experience for us. It's one of the few occasions that I can remember on this committee when we have had the government officials come directly to testify before us on the record, and I think Ruth might want to add a little bit to these points. We heard testimony about the use of human subjects in the plutonium experiments, and testimony about the use of children in experiments, specifically the children of the investigators themselves, which raises some interesting ethical discussions that I think will come up again when we tomorrow turn to the -- is it tomorrow -- the chapter on children. So, I think I will save those points, unless Ruth wants to elaborate a little bit further on the ethical discussions that we had, but it was a fascinating glimpse into the minds of the investigators at the time. I also want to talk a little bit about the visit to Los Alamos, but maybe before I do that, if Ruth wants to add anything about that discussion or anything else. DR. MACKLIN: I would like to second and endorse what Reed said about how being there is different. In particular, it wasn't only a glimpse into the minds of people at the time, but the enthusiasm, which in fact they still evinced. How exciting the developments in radiation were, and how much scientific enthusiasm they had, that it was very unselfconscious in the one speaker who said with pride that he enrolled his own children in this, and Duncan pursued this a bit and asked, well, how can a child of nine consent, and he did say, which was interesting, he had three children, he gave them all the opportunity, all of three of them the opportunity, and one didn't want to do it. So, he didn't force the child to do it, but his own enthusiasm was so infectious, it was indeed surprising all three children wouldn't jump on the bandwagon and do what daddy was so eager to do. So, even the time, the interval of all these years, did not dampen or weaken the sense that we got of how enthusiastic he was at the time. DR. THOMAS: One follow-up to that. Sorry. One follow-up to that little anecdote. He concluded his remarks by saying there's no doubt that daddy talked them into it. DR. TUCKSON: Let me just say I think we might benefit actually by having a little more extensive reproduction of that transcript for the committee. The notes really don't get at it, and now that I -- they really are sparking my memory banks. I think there was some also very powerful discussion about the attitude of the scientists at that time for the research, and how they viewed some of the ethical issues and the incentives. Let me say they were very open and, I thought, very fairly candid, about their thinking process at that point. I think if I recall, they made statements about the fact that they knew that not only was it the promise and the excitement, but that their careers were taking off, and there was a lot of incentive to do the work, and they were pretty unabashed about saying it. As they responded to our questions, and we spent a lot of time questioning them, they were fairly forthcoming. In fact, they were -- we found it as a committee necessary to actually protect them, and the capacity of creating an environment that allowed them to be honest. That became an important part of our work that day, was to be able to give them the space to speak honestly about what they were thinking without having to, you know, get beat up about it, and, so, we worked on that a bit. So, let me just ask if we could try to get some more of that transcript, because there really are some important things in there. DR. FADEN: That's not a problem. The only issue is should we send it to everybody or do people want to indicate not this minute that they would be interested in reading all or part of the transcript. So, we'll work on that, then we can make it available to everybody is not an issue, given the number of trees that are being sacrificed in the interest of this committee. What's another redwood? It's fine, and I think that it's very important. Let me just say before we hear about the other two trips that I really am indebted as we all are to, in this case, Reed and Ruth and Eli and Duncan for making the trip and to, of course, everybody who goes to one of our small panel meetings, to sit through with only one break, I mean, really, whatever. Ruth? DR. MACKLIN: Just one suggestion about the transcript. There might be a way to categorize the items; that is, we heard from miners, from millers, from atomic vets, from the three gentlemen from Los Alamos, and perhaps if not everyone on the committee is interested in hearing all of it, there may be a way to just look down at the list and see who spoke. DR. FADEN: That's easy to do. DR. MACKLIN: One other -- this is very subjective -- subjective impression of my own. Of the three speakers, as Duncan called them old timers, maybe some of us here in that category, of the three people from Los Alamos, one of the three was a physician, and in reflecting on what was done in the past, perhaps by today's standard, he seemed to me to be the most sensitive about the ethical issues. That is, he looked back and asked himself in response to some of our questions and to the discussion would we do this, could we do this, did we do wrong, and seemed to be nodding and saying retrospectively, yes, I mean these were people and these were paid research -- I mean subjects and patients. So, there might have been something in the physician's training that the other two lacked because the science still seemed to be supervening. DR. FADEN: That's interesting. Are we moving on to the visit to Los Alamos? DR. THOMAS: Prior to our visit to Los Alamos, staff had sent a very detailed request for documents. This provoked a response from Los Alamos officials, which was shared with us in draft form and formed the basis for yet another discussion that we had in the public comment period about the meaning of a radiation effects study. So, we had some considerable back and forth with them about what's the meaning of a radiation effects study, and it appeared at that stage that they were adopting a very narrow definition of what was meant by that, which would exclude almost everything that we're looking at, including the plutonium injections. We had the opportunity to pursue this question a bit more with them on the following day. This is the last discussion that we had in the day, and it appeared that there was some consensus that they, although not accepting our terminology, were nevertheless prepared to provide us with all the documents that we felt we needed to conduct our investigations and were not going to interfere with our interpretation of our charter. As everybody knows here, we have been around and around in circles as to exactly what constitutes -- how to interpret the language in the charter as to exactly what's in and what's out, and although I think there is a widespread belief amongst people there, and I'm sure in many other agencies, that we are over-stepping the bounds of our charter, nevertheless they have been, as far as I can tell, very forthcoming with documents. Staff continued for several days after the rest of us left to do a lot of that digging, and I think it's been a rewarding experience, unless anybody tells me to the contrary. The next day was notable for a number of discussions that we had. We had a very lengthy discussion about plutonium injections that I'd like to save for tomorrow, when there's some time on the agenda for that, and a sub-group of us have been thinking about the ramifications of that discussion ever since and are scheduled to have yet another little conference this afternoon to figure out how to organize that discussion. So, I'll save those comments. We also had a somewhat briefer discussion with them about the trans-uranic registry and specifically focusing on consent issues, which have come up from time to time in the past, and then, finally, we had a visit to Bayo Canyon itself, where the experiments were done, followed by -- well, both prefaced and followed by some presentations from folks there about what was the purpose of them, how the cloud tracking exercises went, and what is presently known about dosimetry. It's my understanding that there is now a draft report out of Los Alamos, which has been provided to the staff, which summarizes that whole discussion, and maybe again it's premature to go into the details. Suffice it to say that there seems to have been rather extensive monitoring, both on the ground and less extensive monitoring from the air, which, if taken at face value, seems to indicate only relatively minor degrees of contamination, such that one wouldn't have expected much in the way of health effects. Eli, anything to add? DR. GLATSTEIN: The only thing I would add is I think the staff need to follow up on that registry, that I think is centered in Washington State. The issue being plutonium workers or nuclear industry workers who die, and their bodies are used for autopsies. There's a monetary fee that goes along with it, as I recall, and I think we need to get a little more information about that, if we can. MR. GUTTMAN: A point of information. The -- what we're trying to do to be efficient, Senator Glenn and Congressman Dingell had asked the General Accounting Office to do a whole soup to nuts survey of the human tissue business, and we're going to meet with the -- at the -- you know, with the permission of the Senator and the congressman, with the GAO in a week or so talk about what that whole finding, not simply trans-uranic registry, but the whole 30 years of -- DR. GLATSTEIN: Well, we had the -- we had the one witness several months ago who made the allusion to body being whisked away without anyone's permission, so forth. I don't know if that's part of this or what, and -- but I think that we should look into that in more detail. MR. GUTTMAN: Yes, I apologize for being late, but Los Alamos in particular was a site where, if you were in a car accident or died anywhere near Los Alamos in the late '50s or early '60s, there apparently was a fairly good chance that you would become the object of science. DR. GLATSTEIN: I don't have anything else to add. DR. FADEN: So, we will defer till tomorrow the plutonium discussion that was spurred by your meeting at Los Alamos, but, yes, Nancy? DR. OLEINICK: I suppose if we went to Los Alamos, if any of the discussions -- the issue of could the releases happen again, did that come up at all in the discussion? DR. THOMAS: I don't think we got into that. DR. OLEINICK: Okay. MR. GUTTMAN: The folks from Los Alamos are here, Nancy. So, I'm sure they'd be happy to discuss that directly with you. DR. FADEN: Not now. MR. GUTTMAN: Not now, right. DR. FADEN: Thank you. Okay. We will be doing that tomorrow. Well, again, our thanks as a full committee to the members of the committee who went to Los Alamos. We really appreciate it, and we will work on this issue of making the transcript in some more coherent, sort of organized way available of the public comment periods, so that people who are particularly interested in testimony of members of different communities or who want to read the whole thing, we can set that up, I think, pretty easily. Let me just point out that it's 4:00. We have three things on our agenda. We have to approve the minutes. Wilhelmine has a quick but important update on agency -- contemporary agency activity, and we have a major agenda item, which is to begin our looking at the chapters by looking at the prisoner experiment chapter, Chapter 4, Part 3, Chapter 4. I'm going to shift the agenda around to take advantage of the fact that people still seem to be awake and move right to the prisoner discussion now, see how long that takes. I'm sorry, Wilhelmine. We're going to do that, and then I'm putting both you and me off until later, and if we can squeeze out two agenda items in today, we will. If not, if it takes the full hour to discuss the prisoner chapter, we have it. That's my only concern. If it turns out that we have a 40-minute discussion, then Wilhelmine's agenda item and my agenda item will get in today. But I want to make sure that we have an hour for the prisoner chapter, if we need an hour for the prisoner chapter. Committee Discussion: Experiments on Prisoners DR. FADEN: Okay. So, we're now switching to looking at chapter drafts, and it's Part 2, Chapter 4, if people want to get their copies out, and you probably have noted that each of the chapter drafts came to you with a memo preceding the chapter draft with some questions that staff have prepared for discussion. These questions that staff have identified it would be particularly useful for them as they do the next iteration to hear committee debate about. So, what we've tentatively decided to do is not have presentations from staff, but for the committee right away to launch into discussion, if there is no discussion starting from the committee, if no one has particular comments, questions, issues, they want to raise, then staff will lead us down the list of questions. But that's the pattern. If this works with this chapter, then we'll go on and use it for the other chapters tomorrow. The lights just went down, and for a minute, I thought the lights were going down and music was coming up, and I was wondering. I meant to change the mood but not quite that way. So, I'm not sure what's going on. So, the floor is now open for discussion on what we're calling the prisoner chapter. Ruth? And I'll start looking for names. DR. MACKLIN: This is just a procedural question about how to proceed. That is, I mean in reading these chapters, I made notes on various pages. Would you like us to start with a big point or a small point? Do you want to start from the beginning and say are there any questions on the first two pages? I mean how should we proceed? Because I don't know about jumping in in the middle, and I have to look at all my comments and see which is the big point and some of these seem smaller. How would it be best to do this, if we do have comments on the actual draft? DR. FADEN: Dan, do you have a suggestion? MR. GUTTMAN: Yeah. The staff has done all the stuff it can do, and it's sort of spilling it out, and there are lots of basic questions. Some things we're finding that seem important and obvious, as I said, some are important and trivial, and what would be very helpful is for the committee to say this point you spend 10 pages on doesn't seem that important or this is a really important point, but the other thing that's really important is the dead ends or the ends that we're at, where we really aren't yet capable of grasping what this is all about. That's what I think this discussion should be about. It's what this really -- what's this chapter really about. Don't worry about the -- on Page 13, this isn't clear or you can express it better or -- we can take that. DR. FADEN: I don't think it's so easy to start that way. DR. MACKLIN: That's a partial answer, but sometimes there's a point that may go to a larger point, and yet it's not as global as what you're now suggesting. MR. GUTTMAN: Okay. Well, if it goes, that's fine, that's fair, but it should be -- this should be the real discussion of the committee, I guess, rather than the technical chapter. DR. HARKNESS: Is it possible or reasonable or it would seem at least from my perspective desirable for us, for other drafters of other chapters, to get copies of the marginal comments. DR. FADEN: Oh, sure. No. That's envisioned. DR. HARKNESS: Okay. DR. FADEN: The issue is what's the best way to use committee time. DR. HARKNESS: Right. DR. FADEN: Which is the question, and I'm inclined to think that it would be perhaps the most useful to do something like the following. If people have over-arching questions about the whole chapter and are prepared to ask them, we can start with that. If there is no one who's got a kind of global question about the structure, dynamic, meaning, whatever, of the chapter, I would be inclined to start by going page-by-page as a way to getting into the chapter. If that starts to get too tedious, I would encourage you not to say things like I think there's a grammatical error on page so and so, or the editing or the language could be better. We would go page-by-page, but looking for substantive questions. So, not -- you know, on such and such page, I think you had, you know, a split infinitive. We're not worried about that now. So, it's as we go page-by-page, was there something on this page that troubled you or that you didn't understand or that you thought should not be there, and I'll see how much time that takes. We'll see together, and then, if we're not covering the questions that Steve and John have suggested they need to see discussed by about 20 minutes into this, we'll switch over to the questions. My intuition is that we're going to pick up some of these questions in that process, but it looks like there's other people who would like to do things differently, and I see Pat and Henry. MS. KING: I have a question. DR. FADEN: You're ready to go. Okay. Henry, are you ready to go with the question overall or is it about how we should proceed? DR. ROYAL: I have an overall question. DR. FADEN: You're ready to go. All right. So, we have two people ready to go. So, Pat, Henry, Duncan? MS. KING: I want to start by asking what is the purpose of the chapter. What is it intended to do, and what purpose is it intended to serve? I need, in other words, a standard by which to make a judgment about the totality of the chapter. MR. KLAIDMAN: I think it has perhaps two purposes, two main purposes. One is to assess the general question of the treatment of captive populations, if you will, and assess by the standards at the time, whether or not these were experiments that could be justified, whether wrongs or harms were done in the context of the standards of the time, and to make an overall assessment about the importance of that to this committee's work. DR. FADEN: Pat, I couldn't hear you. I'm sorry. MS. KING: I was asking if John wanted to add to that. DR. HARKNESS: Not in any substantial way. MS. KING: Okay. Thank you. DR. FADEN: Is that enough? Okay. Henry? DR. ROYAL: I thought the chapter was very well written. The question it raised in my mind that's not addressed, at least I don't remember it being addressed, is it gives a very nice history of the problem of ethical research with prisoners, and it's clear that ethically there were lots and lots of problems. The issue that's not addressed is I guess what I would call the fairness issue. As we've heard Pat Broudy talk to us this afternoon about how the atomic veterans feel that they haven't been treated well as veterans from Agent Orange, I'm wondering about the whole issue of the unethical treatment of prisoners in medical research, and what it means to say, well, there are a couple of experiments that we know about, that we've looked at, that involve radiation, that certain remedies would be appropriate. The whole fairness issue about how we should deal with that problem. DR. FADEN: Fairness to other subject groups or to prisoners who were involved in research projects that were not focused on radiation but -- which way are you going? I'm trying to figure out which way you're going with it. DR. ROYAL: Prisoners who were involved in medical research -- DR. FADEN: That was not -- right. DR. ROYAL: Or that haven't come to the committee's attention. Whether they involved radiation or don't involve radiation. DR. HARKNESS: So, your problem is that we're in a sense singling out the Washington and Oregon experiments? Is that what's -- DR. ROYAL: Well, I'm asking about the fairness issue, which has to do with figuring out what remedies should be available. DR. HARKNESS: So, is it the fairness or unfairness of the committee in focusing on the experiments that we're focusing on or the fairness or unfairness of researchers 30 years ago -- DR. ROYAL: No. How are we as a committee going to handle this issue about whether or not we're going to regard this as a general problem with doing medical research on prisoners or whether or not we're not going to deal with that general problem, we're going to deal with the specific problem of only prisoners who were involved in research that involved radiation. DR. FADEN: Okay. DR. ROYAL: I mean it's -- from reading these documents, it seems that the fundamental problem is doing research on prisoners, and that the radiation is incidental. DR. FADEN: Right. Pat, did you want to pick up right on that? I've got Duncan waiting, but -- MS. KING: This is actually a follow-up, and maybe I can explain better why I asked what was the purpose of this chapter. The chapter is well written, and it does tell a nice historical story in large measure, and the question is, is that the criteria for having it in the main body of the report? I can think of two reasons for having a chapter in prison research in the main body of the report, and it relates to what Henry's asking. One is there's some broader principle or recommendation that we're making in the report that this is an illustration of, that explains in detail why we wanted to make a broader set of recommendations, and if that's the case, then it would be helpful to know at least what staff see as that broader recommendation that they would bring to us or perhaps what we would see. The other reason for doing this is that it's a different kind of an illustration, that it is an illustration of a problem that we see with a lot of historical work or it's an illustration of a remedy or the need for remedies, if we intend to use it in that way. But that's why I'm at a loss. I don't know how to evaluate what is otherwise -- I actually found this fascinating, especially since I was in the National Commission. I found it fascinating the way the story unfolds, and how it evolves, but I kept saying what's the beginning and what's the end point, and that's Henry's question in part, because answering that question would help us tackle his concern about are we talking about radiation? Are we talking about prisoner research? Just exactly why is it here in part is what he's raising as well. DR. FADEN: I've got Duncan and Ruth, it looks like. Ruth, are you right on this point of -- I don't want to keep bumping Duncan. All right. Duncan and then -- somehow I was -- I didn't worry a whole lot about how to run this discussion, because I had a feeling it would take care of itself. Duncan? DR. THOMAS: A general point relating not just to this chapter but to a number of the others, and that's that I would like to see this committee really come to terms with the question of what was the scientific point of these experiments, and what was ultimately learned in looking back on it now. How do we judge the importance of what was found? On Page 12, we're told that experiments were ground-breaking scientifically, and they were conceived as having an important government purpose, protecting Americans engaged in the building of the national -- nation's all-important nuclear space program, and then there are two footnotes which provide considerable detail on the design and findings of the two experiments. I found them to be particularly helpful in giving us some flavor of what was the aims, how it was done and what was learned, but there's no discussion in the body of the text itself to help us interpret the importance of what was learned from these experiments. The story then goes on, on Page 27, a quote from Shields Warren, saying your questions have been answered, and it's time to stop, which I think then, with given appropriate elaboration, would tell us a little bit more about -- I would like to know when -- what led Shields Warren to this statement. What actually had been learned, and was it really felt by the investigators themselves, that they had answered their original aims? Did they feel comfortable about stopping at that point or were they stopped more because of ethical concerns, which is my take on the chapter, leaving many of the important scientific questions still unanswered. Now, a lead-in to a second but somewhat related point. There is some discussion about the efforts to install medical monitoring programs, and at the top of Page 21, we're told that it would not provide significant new scientific knowledge, which leads me to the policy recommendations at the end. These are clearly something that we're going to want to debate at some point, and maybe when we get to the remedies discussion on Friday, it might be a more appropriate time to go into these. But there is a -- one of the policy recommendations is that we ought to support this idea of a voluntary medical monitoring program. What is a little bit unclear to me is whether this is for humanitarian purposes or scientific purposes. I can fully understand the importance of having any such program voluntary because of the unique situation that prisoners find themselves in, and I think it might be almost impossible to ethically recommend sort of a compulsory participation in such a study. On the other hand, I think we should also recognize that any scientific data which materializes from that is then almost certainly subject to substantial selection bias and likely ultimately to be uninterpretable. So, we should -- the paragraph needs to make clear what is the purpose of such an exercise. DR. FADEN: Ruth? Thank you, Duncan. DR. MACKLIN: I guess I'll go back to Pat's question and the more global issues here. It seemed -- I, too, thought the chapter was quite well written, and it seemed very evident to me what the chapter -- why the chapter was there, but maybe it's not stated in the chapter as clearly. It was in my head, and I could see it, but let me -- I mean in certain ways, it's so obvious we're missing the forest for the trees, but let me point to a couple of things that could make it clearer and ask whether we want to put those right up front. The research that was done on these prisoners in these two prisons was testicular irradiation, and you make a comment fairly early on that that may be why there's been a lot of attention and a lot of concern for this. I don't remember, but correct me if I'm wrong, whether there were any similar experiments done on anybody outside of prison. If not, it raises the question, who else but prisoners could they get if they wanted to look at the effects of radiation on sterility and on obviously testicular irradiation? Who else could they get except prisoners? DR. HARKNESS: That was the very question raised by Holiday, who was involved in shutting down the experiments. DR. MACKLIN: So, I mean there's a sense in which putting that question up to the fore, to the forefront, highlights the other concerns about prisoners being a captive population and some of the other things which I think also have to be pulled out. So, it's not just that prisoners are vulnerable, and it goes partly to Henry's question, because indeed one might ask there are people even today, other than prisoners, who are subject in other kinds of experiments that we may wonder who would volunteer, but at least they're not prisoners in this captive situation. So, that's one question I think if pulled to the front would make it quite evident why we might want to address this in a chapter, I mean one that has to do in this case. Now, they might have been doing something else with prisoners' testicles, besides irradiating them, but that's what we have here in this example. Now, there are a couple of other points, it seems to me, that the chapter does make and makes quite clearly, and in fact the summary that you provide says this, and that is despite the fact that it was much more common for prisoners to be used in experiments that were risky, I mean they were given malaria or hepatitis or whatever they were given, that was a norm of research at the time. At the same time, you point out that there were codes and rules that these particular organizations had, that the Pacific Northwest people had, and that the Nuremberg Code and similar standards were known to and mentioned and that indeed held to be applicable. So, one could then make the point that despite the fact that it was very common for research to be done on prisoners during that era, these people were in violation of a standard that they knew and that governed their institutions. So, if we're looking at what the wrong that was done, you could say, well, everyone was doing it, but on the other hand, here we have institutions that explicitly acknowledged as a code or a set of ethical precepts that presumably was to govern them. So, I think that's another point. I mean you make that point, but somehow that has to come out as a partial answer to Pat's question why are we looking at it. Well, we're asking what were the standards of the day, what were the rules governing it. A final point, which I think is still on this sort of global matter. Near -- on Page 34, I'm going to get to the question now about the coercion and the money because quite clearly this is yet one other point that's being made about the prisoners. First of all, they're in this, quote unquote, inherently coercive environment. There's little discussion about that, and that's what the National Commission wrote about the -- about prisons. They're an inherently coercive environment. On Page 3 -- but that is a claim that is disputed by some, and there is at least some reasonable debate that still goes on. So, on Page 34, where there's a sentence here, "There seems to have been little discussion of the possibility that a prisoner was unavoidably coerced by the very fact of his imprisonment." That's something that I think bears some discussion. Does that mean that he couldn't -- a prisoner could not help but say yes or does it mean that being in prison is being coerced? But we still have to ask the question whether a person who is coerced by virtue of having his civil liberties taken away and being jailed, being imprisoned, is therefore unable to do anything else voluntarily. Now, the reason I mention that is that that question has to be separated from the money question because then you discuss the money question on Page 37, and what you say there, it seems to me, is a little maybe even too weak in one sense; that is, this is the last paragraph on 37. "There appears to be little doubt that the financial incentives offered for participation were the main reason most inmates volunteered." Well, that proves too much because one could probably say the same thing about normal healthy volunteers today who are paid money, who would not -- even if it's not an undue inducement, they wouldn't do it otherwise, and that's why they're paid money. So, to say it was the main reason most inmates volunteered doesn't distinguish prisoners from any normal volunteers who are paid money. Then, of course, you get to the marginal utility of the dollar in prisons, and that's reasonable enough to raise that question, but one would then have to argue specifically that the coercive aspect -- and it's not actually said, it's -- well, you said can be seen as unduly influencing the judgment of potential volunteers. Now, I don't know if we have to bite the bullet on it, but we got several things going on at once, and I think they have to be distinguished. Is it the prison that's the inherently coercive environment? Is it the money that people are given in prison that makes them unable to say no or that constitutes the undue inducement or the coercive offer, and, then, finally, how, if at all, was this particular set of experiments something that we could assume that no one outside of a prison would do but because of these particular features of being incarcerated and not having money and -- I mean this offer of money, all together explained why it is that they were able to do this kind of research on this population? MR. KLAIDMAN: That all makes great sense to me, and I -- Dan and I were walking back from a meeting this morning, and I said to him, if we were to change this chapter today, what I would do is take out the paragraph in which we talk about the Nuremberg Code as part of the research rules of the Pacific Northwest Research Foundation, the Nuremberg Code mentioned in the Washington case by the Washington State Review Panel, the standards set by the '62 Conference which John found, the AEC rules. All of that was so plain, so available, that the two investigators in this case really need to be held to that standard, and for me, this most of all is what the chapter is about. To agree with Pat, I suppose, I'm not sure what that has to do specifically with prisoners. It happens in this case in the context of experiments that were done on prisoners, but I find it most interesting for that reason. MS. KING: That last statement is a very important statement because it really sets out how this chapter is organized, because what I've heard -- I've heard part of this, is to set out -- because this ties to the remedies discussion, which we'll get to. But part of it sets out how culpability looks in a specific set of circumstances, what ethical standards were available as a part of the culpability, what kinds of harms were risked, which is a part of the remedies discussion. So, if this serves as an illustration of the kinds of practices that call for remedies, and note my word is illustration because that's all I'm saying here, then I think it should be organized that way. But Ruth said something quite intriguing, and I actually agree with her and may mean that this chapter has a different purpose. I've always been intrigued with discussion that it may be that some -- that it would be unethical to ask some questions that we might like to know the answers to scientifically. For those of you who have taken a look at some of the Nazi experiments, you run into this quite quickly in terms of some of those experiments, even if done well, would be unacceptable because of what they exposed people to. The question of irradiation of testicles for me might be such an experiment. If Ruth is right that you couldn't get anybody on the outside of a prison to do this, what does that suggest? Are there some -- to me, it suggested, Ruth, that maybe the reason you can't get anybody to do it outside of a prison is that the risks are perceived by subjects as being too great. If that is the case, if the risks are that high, maybe we are into the area of some questions, it might be unethical to do research on. If that is the case, that goes to prospective recommendations for human subjects research in general as further illustration. That's sort of a different purpose to the chapter. But I assume it's an illustration for monitoring, for the need to follow up on monitoring, and if that -- so, in looking at it, that, I think, is the way it should be organized. That was why I was asking my question before. That means that what's really relevant to that purpose is what gets highlighted, and it's what comes first, and all of the rest is gravy or maybe belongs in an appendix. DR. FADEN: I think we're getting on multi-purpose chapters, like we had multi-purpose experiments. MS. KING: They can be multi-purpose. DR. FADEN: I think we confront the fact that these chapters are going to be written for more than one purpose. They're going to be placeholders in some respects or flag-bearers for more than one issue. This is a very good example of that, but I think the discussion is critical to be clear on what are the two or three main purposes of this chapter, and then that gets articulated. I mean one is clearly that this is a great example of unambiguous availability and adoption of the Nuremberg Code by a research organization that then goes ahead and conducts -- so, that's wonderful. Then there is the -- as an organizing principle. Then there is certainly the case that it is a very good illustration of a potential remedy that we then need -- of a context in which one of the remedies that we need to be debating may well be appropriate, and that's important. But I think, Ruth, your point, as Pat emphasized it, is another, yet third very important reason for the chapters being there, and we may find several others. I'm a little worried about thinking that if we can find one purpose for a chapter, and then say that's the way the chapter should be organized, but if we -- this discussion is terrific for saying there are two or three or four really important things this chapter can accomplish for the goals of the committee overall. Let's get clear on them. Okay. And make sure they shine through. They're so clear to the reader that that's -- those are the take-home -- MS. KING: I don't care if it's multi-purpose or one purpose, but the chapter has to be organized around the purposes, is my point, that otherwise it reads like a nice descriptive -- a description of events that occurred that doesn't have a beginning, tie something to something somewhere earlier or later, and that's what I'm -- that was my major problem with this chapter. I mean that it just sort of lumped there. So, if we could identify the purposes, then I think in rewriting that you would write -- you would have the same information that you have in this chapter, but you would have the information telling a different story. When I asked what is the purpose, it almost was sort of like a historical purpose, to give an illustration of the events that happened in the past, and that's perfectly fine in some settings. I just didn't think that that was what we should be doing. Now maybe some people will disagree with me and argue that that is important. DR. FADEN: Ruth? DR. MACKLIN: We would get -- I mean the question is whether or not there should be some symmetry with other chapters because you're going to ask the same question about every chapter, Pat. I know. MS. KING: I most certainly am because I'm trying to envision this whole report in my head. DR. MACKLIN: But then it depends if they are -- if the chapters are indeed -- at least this one. Let's start with this one which is before us. If there -- if it is multi-purpose, then it depends very much on which purpose we put forward. On the one hand, we talked earlier, we used the word, I'm not too happy with it, vulnerable populations. We've also talked about captive populations. Populations that are easy to study, readily exploitable, for whatever reason. They're mentally retarded. They're in prison. They're hospitalized. They're sick, whatever. So, using that theme, you get a different organization than you would if, as you rightly point out, aha, there's some implications for remedies here. On the other hand, we have the entirely different point that here there were some rules in place, and they were being violated. Rules that should have been adhered to, and that's what we spent a lot of time talking about when we looked at the Wilson memo in the military context. So, depending upon -- we can choose any one of those purposes, but that's why I asked -- I'm asking even a broader question. Do we want to think of this chapter in light of what we want to say with other chapters? That is, are we thinking of the prisoners more like military personnel who were told to march in some place or told you can volunteer, or do we want to think of the prisoners for the remedies, which might be a different question? DR. OLEINICK: I like the idea of organizing the chapter around purposes, and I'd like to suggest that there is yet another purpose that -- for this chapter. It seems to me it's also an illustration of experiments that may have had a beginning but never had an end until somebody shut them down because they were unethical, and the other example that comes to mind is the TBI experiments. We have two investigators who were mentor and mentee doing these experiments without any indication of how many individuals needed to be irradiated before they got some kind of an answer that they were looking for, and very little publication on it, very little cross-referencing of each other, and I think it is illustrative of again what we could think of as rather poor science, and I think that that issue ought to come out in the chapter. DR. FADEN: At the risk of disrupting the discussion, I think that's fine, but I wanted to go back to the issue of whether this research could have been done on outside of the prison and how defining and characteristic that is of this work, and I really don't want to underscore in my own view general problems with background conditions. It seems to me that if you offered enough money to poor enough people, you'd get people on the outside to do this, too. I mean that's kind of -- it's a rhetorical thing to say would anybody on the outside be willing to do this. Sure. If you found somebody who was desperate enough and poor enough, and you offered them enough money, odds are you could construct a situation in which somebody who wasn't incarcerated would also agree. So, I think that we -- sort of however we use that theme, we have to sort of mellow it with the fact that it's symbolic. The question is more symbolic. It's do you have to have really unjust conditions before you could get somebody. You have to really be exploiting someone in order to get a person to do this. Outside of really exploitative situations, would anybody ever. DR. TUCKSON: If I could just amplify that a bit, that -- the sort of point that Ruth is making very well is tied to one of the policy recommendations that we offered toward the end, which implicitly at least is saying that or suggesting that perhaps the bio ethics community, to use a phrase, has prematurely put to bed worries with regard to coercion in the realm of human experimentation now that prison experimentation has come to an end, that the potential for the sort of manipulation or coercion that Ruth has just referred to, I would suggest, still does exist outside of prisons, and that -- and those sort of possibilities in my opinion have not been adequately explored or addressed. DR. FADEN: Hm-hmm. Which is how you -- the point about the chapter, think about who's replaced prisoners -- DR. TUCKSON: Right. Right. DR. FADEN: -- as the source of subjects for non-therapeutic research. DR. TUCKSON: Yeah, and I mean obviously that -- I mean those are recommendations to be considered by the -- all of them to be considered by the committee and either agreed with or disagreed with or deleted or amplified or changed. DR. MACKLIN: I think it's a point that deserves making here, but I don't think we're going to be able to get at it in an important way in the context of a chapter on prisoners. I think the place to get at it, if we reveal -- if our study reveals anything, is in the research proposal review, since we have seen at least some of the reviews that I've done with some -- with staff or with other committee members, and we have concluded that the amount of money they're offering is too high. Now, where they're going to get people to do it, obviously they're not getting wealthy professionals or investment bankers to do it. So, in a way, even though we may not know that they are students or poor people, the very fact that they're offering a certain amount of money for volunteers, I think seeing that in the contemporary context probably makes it -- makes the point more strongly and vividly and gives a little evidence for it. Could I just ask one other thing? There's a point made in here. I don't need -- think it needs to be pursued, but it's certainly interesting, and I wonder if the extent to which you included it, and that is, in the discussion about the Boston University Law-Medicine thing, that was -- that meeting was what? 1963? DR. HARKNESS: '62. DR. MACKLIN: '62. So, that was pretty early on for people to be coming together, I mean in the climate, in the history of bioethics, let's say, for people to be coming together and say, oh, look what they're doing to prisoners. This is unconscionable that they're doing this to prisoners. Those people who are the assembled people, one might say, were, quote unquote, ahead of their time, and you have some quotations from some people saying something -- DR. HARKNESS: Well, I have to just interrupt you. On what grounds do you suggest that they're ahead of their time? DR. MACKLIN: Nobody else was making any -- raising any -- making any noise. I mean the National Commission didn't come in and start asking those questions till a decade later. Well, ahead of their time. I mean, on the one hand, you had this wide-spread practice that we've heard about and that's documented of the use of prisoners with apparently no objections. I mean forget the fact of Nuremberg Code in particular and what they were doing. I mean that's a violation of the Nuremberg Code is one thing, but the very fact that there was such widespread use of prisoners in -- with, to my knowledge, and maybe I'm wrong -- I mean maybe you have more documentation, of a human cry or people beginning to write in the literature and saying this is a terrible thing, they're doing all this research -- DR. HARKNESS: These people at this conference in 1962 were not saying this is a terrible thing. They were saying this is basically a good thing, and here's how we should be doing it. DR. MACKLIN: Well, what -- I'm looking -- I'm looking for the place where they say -- here. The -- this is on Page 33. "Those at the conference believed that the general public was less inclined to worry about subjecting prisoners to high level of experimental risk." Two brief transcripts are revealing. "Whether the public cares that inmates are participating in seemingly very hazardous study, they rationalized, well, I wouldn't do it, but it's all right with prisoners." And then the next quotation there, "The public would allow the investigator to go farther than the investigator would go himself." So, they were looking at whether confronting a -- that confronting the direct question, whether a relatively high degree of risk can ever constitute a legitimate reason for the use of prisoner subjects. Am I reading this wrongly? Where it says the conferees were almost unanimous in rejecting this position. Which position did they reject? I thought -- DR. HARKNESS: They rejected the position that -- these are researchers and prison administrators who are setting themselves apart from the general public and saying that the general public is less worried about doing horrible things to prisoners than we are. DR. MACKLIN: Right. That's what I thought. So, they are addressing -- that's all I mean by ahead of their time. I mean I didn't mean that they were writing the rules of banning all research in prison, but here were a lot of people doing a lot of risky things to prisoners. This group came together and explored the question whether it was okay to do these risky things to prisoners, and their conclusion was that it's not. DR. FADEN: No, I don't think that's right. I mean that's not my sense of it, but I think it's something a little shorter than that, Ruth. It's more like we come together, we agree it's okay to do risky things to prisoners under certain conditions, and by the way, we could actually be even worse. We could do even riskier stuff than we do do, the public would let us, so why aren't we good guys for being self-regulating and not doing all the heinous things we actually really could do. So, it's okay to do stuff to prisoners provided a couple of things are in place, like consent, and they don't -- DR. MACKLIN: Well, they introduced the notion of making risk and benefit. I guess I don't see the discussion of consent here. That's important. But they certainly introduced the notion of the need to make a risk benefit assessment. DR. HARKNESS: Well, that is not an original idea with this group in 1962. I've had an opportunity to read Sue Lederer's book or look at Sue Lederer's book, which has just come out on the history of human experimentation before World War II, and I think I'm correct in saying that one of the primary arguments of her book is that risk benefit analysis before undertaking experiments with human subjects was a crucial element and a common element in conducting human experiments before World War II. I mean so this idea of weighing risks and benefits -- DR. MACKLIN: In prisoners? In prisoners? DR. HARKNESS: No, no. DR. MACKLIN: I mean not only referring to making that analysis in prisoners. I mean there -- maybe this was -- that notion of weighing risks and benefits was around -- I mean I know it was around generally, but was that something that anyone, either an investigator or an institution, where prisoners were used made that kind of assessment. I mean I would have thought that the attitude of the general -- the attitude as expressed here with the general public was the same attitude that everyone else had. After all, we got capital punishment. We can execute them. Why can't we experiment on them without regard to weighing risks against benefits? So, what's new? What's new about what this group did? DR. HARKNESS: I would say virtually -- I mean this is -- I don't put this forth as anything new. What I put this forth is as a very -- I mean one of these things that historians sort of dream about. A group of people getting together and discussing the very issues that you're interested in, and reflecting on their experiences that they have had throughout the course of their careers. I mean these people are not, I don't think, so much proposing the way things should be done as reviewing the way things have been done. I mean that -- the purpose of this Law-Medicine Research Institute as stated in sort of their goal -- their mission statements was to review policies and practices, not to make proposals. So, this is -- DR. MACKLIN: Can I try just one more time? I mean either I'm not understanding it or we're at cross purposes here. On Page 32, the reference specifically is the standards enunciated at the conference. Okay. You say, "Given the broad cross-section of those involved in prison experimentation who attended this conference, it seems eminently reasonable to employ the standards enunciated at this conference in the consideration of experiments that began in 1963." So, these people did enunciate some standards, and the claim would then have to -- I mean otherwise, why is that in there? DR. HARKNESS: Well, maybe my choice of wording is incorrect. I did -- these people were not getting together and saying, gosh, we've been researching on prisoners, and we haven't -- we haven't paid any attention to research ethics. So, we better figure out some standards. That is not what's going on here in my opinion as a historian. These people were getting together and saying how have you been doing this, how have you been doing that, yeah, I guess we've pretty much been doing it the same way, and, you know, here's our -- here's our -- here's our area of common ground. DR. MACKLIN: You know, I -- DR. HARKNESS: Part of this might be that just the difficulty -- I mean the secondary literature that exists in this area has simply, I would say, drastically under-estimated the amount of attention and thought that people gave to these sorts of issues before 1962. DR. MACKLIN: Then I mean if I'm misled by the chapter or by this discussion, I think others might be, too, because you begin with the risk benefit and talk about enunciating the standards. Then on Page 33, Line 14, you say, the conferees spent a large portion of their day together discussing the matter of consent. They reached agreement that meaningful consent should be both voluntary and informed, and then they said, of course, it's not a complete free choice, and, of course, it's not, you know, full disclosure, but neither is it anywhere else today, and then another thing they agreed on is that rewards offered to prison volunteers should not be so high as to invalidate their consent to participate as research subjects. These sound to me like standards. Shoulds are not descriptions. DR. FADEN: I think again it's whether these are standards rooted in practice or not. I think Jon's claim is these were standards rooted in these people's understanding of what practices were. They didn't see them as sort of reforming standards, but, rather, these are the standards of how we do business. They're rooted in the practices of the day. All good guys who do research on prisoners try to do it this way. Okay. And let's all agree, and let's get it down and say what the standards are. So, the debate, if there's a debate, is, yes, they're talking about standards, but are they standards rooted in prevailing practices or are they standards that were taken as in large measure ahead of current practices and needed in order to reform current practices. DR. MACKLIN: Well, take -- DR. FADEN: And that's what, you know, that's what -- I don't know. I haven't read the transcripts myself. DR. MACKLIN: Well, this has to be clearer, what this section is saying. I mean you're saying it's descriptive, and Ruth is reiterating that, but every time I see a should, -- DR. FADEN: I think it's prescriptive but rooted in practice. In other words, they're saying this is how we should do business, and in fact it's rooted in the way we do do business. So, I don't want to deny normative force, and, again, I haven't read the transcripts myself. So, I'm relying on sort of what I understand Jon to be telling us here. I don't want to deny that it's normative in the language they use, but the question is whether their normative expressions were rooted in their understanding of what contemporary practices actually were or not, and that is the claim I think John is making. DR. HARKNESS: Yes, yes. DR. FADEN: Okay. I haven't read the transcripts myself. So, I don't know, and when I read the transcripts, I'll -- the transcripts of the Law-Medicine meeting. That bears very significantly, though, on how to understand what was going on in the two experiments that are the subject of the chapter, because if these people are saying in fact these are the standards, and they're rooted in the way of how we've been doing business, it's the -- you know, what we hold ourselves to, what we think our colleagues are doing, and all that kind of stuff, and that would make it harder for Paulsen and Heller to say nobody was thinking about these issues or whatever. Did I get the names wrong? DR. HARKNESS: Right. DR. FADEN: Okay. So, I think that's -- that's what's at issue, is whether -- I think -- no? DR. MACKLIN: I mean even with all these measures, some meeting participants asserted that "the ideals of comprehension, evaluation, decision on the part of prisoners were seldom attained in practice". DR. FADEN: That's why I mean we have to read the transcripts and sort of get clear on how much of this was the view that that's in fact the way things were done versus how much of this was exhorted language. We ought to be doing things this way. And, Jon, you need to argue in the chapter more clearly. If you want us to accept the interpretation that these are statements -- these are normative standard statements about how research with prisoners ought to be done, rooted in fact and these participants' perceptions of how in fact work was being done, then you need to argue why that interpretation is correct, and maybe it's some of each. Maybe on the risk benefit side, it's more reflective of current practice, and on the consent side, it's more exhortive language. I mean I don't know, but that's going back to doing, you know, more sort of work with the original stuff and seeing what you want to argue, and then we can judge whether that's right or not. We kind of got off on a fine point, but it's not such a fine point. DR. MACKLIN: Well, I think it's a big point because it goes to the question of standards of the day. DR. FADEN: Right. DR. MACKLIN: The standards of practice. If the descriptive account is correct, then people were already paying attention to this, although some lapsed and fell from grace. DR. FADEN: Exactly right. DR. MACKLIN: If the normative are surely prescriptive account is correctly, then these were ahead of their time. I don't know. DR. FADEN: That's right, but at least standards here were being enunciated by a lot of people who were apparently in important positions in corrections institutions. DR. HARKNESS: Right. And I mean I have the list of participants at this meeting, and these are not -- I mean it's my sense that these were sort of a fairly representative sample of people who were doing this sort of work. I don't think the Law-Medicine Research Institute were -- people were aggressively seeking people whom they thought to be out in front. That would have been counter to the purposes of the Law-Medicine Research Institute. They were trying to understand what the practices were. DR. FADEN: Okay. We kind of got -- I'm not sure what to do at this point. I want to just hold for a minute the discussion that we started with on the purposes of this chapter, and then Ruth raised that we would need to be looking at that question, expecting that Pat would ask it of every chapter, and that we in fact will. What I'm thinking we might do is hold a kind of -- keep running notes of the purposes of each chapter as they evolve, and then maybe towards the end of Friday come together and see, okay, how many purposes are the different chapters serving, and is the picture coming together in a way that is complementary. It would be wonderful if a major outcome of this meeting was a large picture sense that this is a coherent enterprise. The chapters that we've selected to be chapters are serving mutually compatible purposes, which is not to say that you can't have over-lapping purposes, that you can't have three chapters directed at one purpose, but that there's a nice balance and symmetry among the chapters, that all the kinds of messages that we want to be delivering in the end in our final report are being taken care of in some balanced way across the chapters, and it should be open and aware obviously to all the committee members that if there are chapters that shouldn't be chapters, that's open for discussion as well. By that, I mean chapters in the final report as opposed to in the companion volumes. So everything is available for discussion. Jon, I didn't mean to interrupt. Is there something you want from the committee or, Steve, something you want from the committee? MR. KLAIDMAN: Yeah. We would just like to be absolutely clear whether or not the committee is satisfied that it is appropriate to do this chapter with this much of a focus on the Oregon and Washington experiments, and that you would not want us to do our best. I'm not sure what results we would be able to arrive at, but -- DR. HARKNESS: In the limited amount of time. MR. KLAIDMAN: In the limited amount of time that remains, to pursue other experiments and try to develop them, if not to the extent that we've been able to develop the Washington-Oregon experiments, then at least to a greater extent than we've been able to do to date. DR. FADEN: Other radiation experiments on prisoners? MR. KLAIDMAN: Other radiation experiments on prisoners, yeah. DR. MACKLIN: What else do we know about the ones in Utah? MR. KLAIDMAN: We know almost nothing more than what you see there. DR. HARKNESS: I mean this is not to say that -- I mean in my opinion, as someone who's done research in this sort of stuff, yeah, we did -- we can dig into just about any of these episodes of experimentation and chances are learn a heck of a lot more, but it's time-consuming and difficult and just -- DR. MACKLIN: Well, I think the answer depends very much on what we determine that the purpose is. If in fact the purpose is to say here were some standards, these were enunciated, these guys knew about the Nuremberg Code, this Pacific Northwest institute had these standards, and they violated it, then we don't need to find every instance in which everybody violated it. If we go with that notion, then I think it's enough the way it is. If, though, as Pat proposed, the focus is more on remedies, then there may be an obligation of sorts to look farther or deeper. No, she says. MS. KING: No. I said illustration, and I said illustration, and the reason -- one of the reasons I'm still puzzled is -- about the chapter is I guess I need to see how some of the other purposes get developed because they're just not clear in my mind yet, but I don't have any feelings about them one way or the other. It just -- it would be focused differently to illustrate some different purposes. The question I have is an illustration of remedies. The recommendation here is for medical -- is monitoring, and that triggered almost immediately a connection with remedies because of what the recommendation was, and, so, the question is for me, and it may work out okay, whether this chapter is a good way to illustrate medical monitoring and its need. Maybe the childrens chapter is a good way to illustrate medical monitoring, and the need for it, or maybe you want both because they come at it for slightly different reasons and different contexts, and, so, it makes a richer picture for medical monitoring. So, it doesn't have to -- my suggestion is not to do any more digging because it's February 16th, and I think the criteria for doing any more digging ought to be very high. We should have a clear idea of where we're going, and an absolute necessity to see if there's something else out there. So, I don't propose any more work. What I'd like to see is a better way to utilize what we have here, and I'm happy with it being illustrative of points that the committee wants to make with respect to remedies and other matters. I just now would like to see us do that. That's all. DR. FADEN: Okay. Reactions from the committee members? You might remind us that there's this issue of prison research in Utah, also in California. How many options are we talking about or how many leads are there? MR. KLAIDMAN: California, Pennsylvania, Kansas, Oklahoma, bunch of them out there. DR. FADEN: Can't be done. My personal sense is that we had to do a very good job of making it very plain that there are likely other such experiments, maybe not testicular radiation, maybe something else, in both directions. The direction that Henry pointed out, which we do have in the introduction but maybe we need to flesh out a little bit more, just the sheer volume of bio-medical experimentation that was conducted on prisoners, and the range of risks to which prisoners were put, make it a little sort of richer context into which this can be situated, and then very clearly also state that we know -- we're taking these two, as Pat said, as illustrations, and the general principles or messages that come out for this would apply to any other similarly-situated experiment involving prisoners. Something that makes it plainer, that we don't think the world begins and ends on these two experiments, but they're very compelling, and they're important, and they're wonderful illustrations, and it's where we focused because we couldn't do everything. Henry? DR. ROYAL: One of the purposes of this chapter maybe being an illustration of where medical monitoring could be useful. I think medical monitoring, that the benefits of it are often over-estimated, and there are few instances in this paper, that first paragraph on Page 38, that Duncan also referred to, it sort of lists three things that medical monitoring might accomplish, and I actually only think one of those three things is very realistic. The three things are that there might be some scientific benefit allowing an epidemiologic study. We're talking about small numbers of people, and there are ways. It's our priority to figure out whether the feasibility of an epidemiologic study. My guesstimate is that the scientific benefit from doing an epidemiologic study in this population is likely to be not great. And then the next thing that's listed is psychological comfort and physical assistance, and, to me, that would be the benefit. The third thing is a rigorous program of follow-up might help establish if subjects were indeed harmed by their experimental experiences. I don't see that as a benefit at all. These patients who have been exposed to something that they think are harmful and know that they've been exposed to it will attribute all sorts of symptoms to those -- to -- will assign a causative effect to all of their symptoms, no matter what health problem that they have, and I don't see how we can sort out whether or not this is related to their radiation exposure or not, and I don't even see where it's important to sort it out. If the -- the previous goal, taking care of their physical comfort, takes care of that, it's not scientifically possible to sort out cause and effect. DR. FADEN: What I'd like to do, because I think this is very important, is hold this over for Friday, for the remedies discussion, although comments that Henry made, Henry, I think we need to have you make them again when we talk on Friday, and Pat's point about the childrens chapter might also be an illustration for follow-up. They may in fact be illustrations of two different and powerfully different justifications for follow-up because in this case, the people know that they were subjects, and the concern is they're worried. In the childrens study, we have perhaps many people who haven't a clue that they were subjects of research, and, so, you raise different kinds of issues for different justifications for why follow-up might be appropriate. So, I think it's really important to hold that, and we'll hold it for the remedies discussion. Can I do this? We're at 5:00. I know we could go on longer on the prisoners chapter, but we can't for purposes of discussion. I hope this is for Steve and John to do some profitable rewriting. Could I beg the committee's indulgence on one point? If we can hang together for five minutes, Wilhelmine doesn't have to come back tomorrow, unless she wants to or can, but it would be a courtesy if we could -- I have to be here anyway. So, I can do my minutes agenda item tomorrow, but if we could hang together for five minutes now, Wilhelmine could give us the report on the update, which is the -- of the -- her work in trying to establish what the current status is of agency oversight on research involving human subjects, and this is the hand-out that's got the shaded table on it. Thank you, Wilhelmine, and thank you, Steve and Jon, a lot of work, and we really obviously appreciate it very much. Update on Agency Oversight Project MS. MILLER: The six departments and agencies FDA has broken out separately as the seven agencies here, with respect to the scope of human subjects programs, research programs. At the last meeting, you asked for some additional information on studying on human subjects research. We don't have this at this point for all the agencies. Even HHS. It's a little hard for the agency to precisely break out their intramural spending on human subjects programs. We'll fill in the blanks as the information comes in. We are getting better information than we had in the memo you had last time on staff resources devoted to the oversight of human subjects research, and please look at the footnote which tells you what's included in those staff numbers for each of the agencies, and we've also asked agencies that do have classification authority to describe any recent term classified human subjects research, but we have not heard yet from DOD and CIA in particular, and DOE has -- is in the midst of a search as well but doesn't believe they have any contemporary period classified human subjects research. DR. FADEN: How do we define contemporary, Wilhelmine? Remind me. How many years? MS. MILLER: Since 1974. DR. FADEN: Since 1974. Okay. So, we're -- okay. So, we don't have any answers to that yet. MS. MILLER: What we asked for was the five most recent classified projects, as you had suggested at the last meeting. DR. FADEN: From 1974 forward. That's excellent. Thank you. MS. MILLER: So, if there's any questions or further information you want us to pursue. DR. FADEN: If there aren't, we're going to expect that there will be a substantial discussion of this in the March meeting. So that it would be really helpful if there are agency representatives out there, particularly from the agencies from whom this request about classified research has been made, we will need to have a very rich discussion of this in March. So, we need to get that information in to Wilhelmine quickly so that you can digest it, prepare it for us, and then we can look at it. The question of how many full-time or FTE equivalents, that's hard for the agencies. I noticed we had a figure for DOD before, and now it's gone because DOD wants to rethink. Is that the issue? MS. MILLER: Right. That was based on information they had provided to a congressional committee, the earlier figure in the memo, and they're looking at this again. I don't think it will turn out to be much different, but -- DR. FADEN: They want to get an accurate rendering, and obviously it's good to get the dollar figures because we're trying to look at some sort of balance between the staff addressing human subjects oversight and the volume of business they do in research involving human subjects, so we can see how the two compare. So, that's great. Are there questions or comments for Wilhelmine? (No response) DR. FADEN: Okay. Thank you very much. Okay. Do we have any instructions for tomorrow, other than read? Other than read. I mean I know that you've all read every line and page already, but just in case, there's tonight to read some more, and the agenda remains unchanged, is that correct? All right. DR. MACKLIN: We received the -- in the blue folder, the remedies. Is that the same thing that was faxed to us? MS. MASTROIANNI: Yes, it is. DR. MACKLIN: Okay. DR. FADEN: So, it doesn't replace -- DR. MACKLIN: I hate to ask because I probably just overlooked it and was very flaky, but the staff memo that was supposed to be in Tab G, my -- MS. MASTROIANNI: On the FTE waiver? DR. MACKLIN: No. Wait a minute. MS. MASTROIANNI: There was no G to replace it. I mean in the original set. DR. MACKLIN: Well, there was a lot of material under G, but there was no staff memorandum. MS. MASTROIANNI: Oh. DR. FADEN: Is that on the plutonium? Is that what Tab G is? MS. KING: There was a cover page identifying documents, and there was no staff memo. DR. MACKLIN: Is that right? DR. FADEN: That is correct. DR. MACKLIN: So, since that's on tomorrow, in other words, it's not here -- DR. FADEN: There's nothing to read but documents, if you want to look at them. Is that the plutonium? Is that what we're talking about? MS. MASTROIANNI: Yes. DR. FADEN: And how helpful is it for people to look at the documents or not bother, Duncan? Eli? Henry? Should we bother looking at those documents or -- DR. THOMAS: Our mini-subcommittee has been going around in circles on it, and I think we've pretty much concluded that we would rather wait until we have something we're comfortable with. So, that's why that draft -- that memo was not included. DR. FADEN: Is it necessary -- DR. THOMAS: That material will be incorporated in the draft chapter that we will probably be discussing next week -- next month. DR. FADEN: Just to help some of us out here. DR. THOMAS: The documents themselves are probably not all that -- DR. FADEN: Important. DR. THOMAS: -- important to set out the background, which we're going to try to provide orally to you tomorrow and have some discussion of. DR. FADEN: So, we don't have to have read those documents to follow the discussion tomorrow? DR. THOMAS: No. DR. FADEN: Okay. So, they're there, and we can read them at our leisure. We don't have to read them between now and tomorrow. Okay? Otherwise, if people could really concentrate on the chapters that are up for tomorrow, and then there are the chapters that are up for discussion on Friday, that would be very helpful. Ken? MR. FEINBERG: Is everything secure here overnight? DR. FADEN: All right. We're off till tomorrow morning at 9. We start at 9 tomorrow morning. (Whereupon, at 5:10 p.m., the meeting was adjourned, to reconvene tomorrow morning, Thursday, February 16th, 1995, at 9:00 a.m.)