ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS - - - PUBLIC MEETING - - - Monday, July 25, 1994 - - - The Advisory Committee met in the Colonial Room, Mayflower Hotel, 1127 Connecticut Avenue, N.W., Washington, D.C., at 9:00 a.m., Ruth Faden, Chair, presiding. COMMITTEE MEMBERS PRESENT: RUTH R. FADEN, Ph.D., M.P.H., Chair 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. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. REED V. TUCKSON, M.D. ALSO PRESENT: PHILIP CAPLAN DAN GUTTMAN, L.L.B. GREGG HERKEN, Ph.D. JEFFREY KAHN, Ph.D., M.P.H. ANNA MASTROIANNI, J.D. JONATHAN MORENO, Ph.D. RON NEUMANN, M.D. DAVID SAUMWEBER, M.A. GARY STERN, J.D. GIL WHITTEMORE, Ph.D. BARRY SIEGEL, M.D. JONATHAN ENGEL, Ph.D. WITNESSES PRESENT: PAT BROUDY, National Legislative Director, National Association of Atomic Veterans DR. JOHN E. JONES, Virginia Commonwealth University DR. HERMES KONTOS, Virginia Commonwealth University DR. OSCAR ROSEN, National Association of Atomic Veterans DR. EUGENE TRANI, Virginia Commonwealth University STEWART L. UDALL, Former Secretary of the Interior CATHERINE VARIANO, South Bend, Indiana CLIFF ZUCKER, Disability Advocates, Inc. JANET GORDON, Citizens Call C O N T E N T S PAGE Welcome, Ruth Faden, Chair 5 Briefing, Barry Siegel 13 Briefing, Gil Whittemore 40 Briefing, Duncan Thomas 70 Update on Agency Data Collection, Ruth Faden 102 "Functional" History of Human Radiation Experiments, Gregg Herken 123 History of Ethics Policies, Jonathan Moreno 129 History of Government Regulation, Dan Guttman 137 New Staff Introductions, Jeffrey Kahn 192 Staff Report, Gary Stern, Ron Neumann, and Dan Guttman 198 Staff Report, Gil Whittemore, Jonathan Engel, and Dan Guttman 236 Stewart L. Udall, Former Secretary of the Interior 251 Dr. Eugene Trani, Virginia Commonwealth University 264 Cliff Zucker, Disability Advocates, Inc. 290 Pat Broudy, National Legislative Director, National Association of Atomic Veterans 310 Catherine Variano, South Bend, Indiana 322 Janet Gordon, Citizens Call 336 P R O C E E D I N G S (9:03 a.m.) CHAIR FADEN: We have Phil Caplan from the White House to open our meeting. MR. CAPLAN: Once again, good morning. My name is Phil Caplan from the White House. As the designated federal representative to the Advisory Committee on Human Radiation, I declare this meeting open. CHAIR FADEN: Thank you. We'll get all of the titles and names of everything straight by the time we've done our tenure. Well, good morning, everyone, and welcome. I think we're the sideshow at the Mayflower now today. As much as I hope that our work goes well, I certainly hope the work of the Israeli and the Jordanian delegations goes that much better. I think a little bit more hangs on what they do today than what we do today, which is not to minimize what we're going to do today, folks, but only to point out that large affairs of state are being addressed elsewhere in the hotel, and we wish them good fortune. This is our which meeting here? Our fifth meeting, and it's really an imposition on all of you to have made two meetings in July. We very much appreciate that and hope that everyone has noticed that there is no August meeting, and that's why. Yeah, there's no August meeting, but we did have two scheduled for July so that we could give ourselves August without meeting, which does not mean that there won't be work in August, but at least we won't have to take the three days out to meet together, and then we will be meeting in September. As is my now clear tradition, let me just take two minutes to describe to you what we hope will be accomplished in today's meeting, and then we can go right on to the agenda. We have, as I see it, four big objectives for the meeting. Some of these are continuing. I guess in a sense they're all continuing from previous meetings. The first is our objective to continue to educate ourselves about the wide range of issues and topics and content areas which we all need to have some minimal competence about in order to do our work, and this is our mutual education kind of enterprise. We have three presentations this morning. We're very fortunate to have Dr. Barry Siegel come, who is a colleague of Henry's. I feel very guilty because this is the second time I'm hitting up Dr. Siegel for a briefing on this topic. He was kind enough to give me a private briefing, as it were, on a Saturday morning over the telephone, which I found very helpful. In any event, Dr. Siegel will now be addressing all of us, and the topic is the regulation of contemporary radioactive drug research. So thank you to Henry for making the connection and to Dr. Siegel for taking the time to be with us. Dr. Siegel's presentation is going to be followed by a presentation from Gil Whittemore of our staff on the history of radiation protection standards, and then we're very fortunate after that to have Duncan give us a presentation on the epidemiological perspective on low dose radiation risks. So this is the morning for those of us who are not very knowledgeable about radiation risk matters and radiation oversight matters, to hear first from Dr. Siegel, then from Gil and then from our own Duncan Thomas. So we're going to learn a lot this morning, those of us for whom these are not our areas. Our second objective is to update us, that is to say update the committee members, on the work of the staff. The staff has been working hard. There's some very promising directions, and I think it's important for all of us to have a flavor of where the staff has been putting its efforts and what seems to be promising and what seems to be problematic. And in line with that objective, there are several things on the agenda that bear on this question of getting a bead on what the staff has been doing. First, there will be an update on agency data collection efforts. A significant amount of staff time is spent working with the agencies and getting information from the agencies. I'm going to do the update in the interest of efficiency. So I will take a few minutes this morning after our educational presentations to update everyone on what's happening at the six agencies with which we have been working. That update on agency data collection will be followed by a panel of staff members, Dan, Gregg, and Jonathan Moreno, who will be giving us a first effort at integrating the history of the early period of human radiation experiments, from essentially the mid-'40s to the mid-1950s, and we're going to hear how the three of them have been viewing that period from differing perspectives. This is the part of your briefing book where we have three staff memos together and your introductory orientating material suggested that it would be helpful to read the three memos together. There is some obvious overlap in those three memos. That's sort of intention. It is exciting to see the stuff starting to come together with the staff interpretation that starts to mesh. So that's the morning, and still continuing with the objective of bringing us up with the efforts of staff, after lunch Jeff Kahn is going to briefly describe the current organization of the staff. We keep reorganizing the work arrangements of staff members in line with the shifting needs of the project. So Jeff will tell us now how people are organized and who's working with whom, and that will help us on the committee know who to be relating to depending on what your interests are. After that we're going to hear a report from staff, from three staff members, on what is probably the most developed of the stories, to use that line, that we have been working so far, and that is the total body irradiation story. We had a promising presentation from Ron on that subject at our last meeting, and now we're going to have a somewhat more fleshed out continuation of that story for this meeting. And finally we will hear a report on staff efforts to abstract all the documentation that we have on about -- well, it is 100-plus experiments. So last time Jonathan Engel told us about his experience with respect to abstracting from what's now called the Markey Collection, from the abstract forms that the Markey staff people have retained. We then went on to direct staff to now not only look at those abstract forms, but to look at all of the documentation that we've received from Markey and from the Department of Energy bearing on a little over 100 experiments, and using the data collection form that we all fussed over for some period of time, and we will now see the results of that abstracting. Basically what have we learned from going over all of the materials that we have available on the experiments at issue? Our third objective for the meeting is, as always, to hear from the public. We have set aside in today's agenda an hour and a half, not an hour, but an hour and a half because we have six sets of speakers who have asked to address us. These promise to be quite engaging and quite significant. So we should look forward to an interesting afternoon from 3:30 to five. Now, our fourth objective is to advance the progress of the committee by giving specific direction to the staff, but also by giving ourselves some more specific direction. Again, I remind you that we don't have a meeting in August; we don't have a meeting until September. So we need to give some very hard thought to how and on what topics and in what ways we want the staff to be working and also how we ourselves as individual committee members would like to be working during that time. And you will probably have noticed that we have given over essentially all of Tuesday, all of tomorrow, to this agenda. We're going to hear reports from the subcommittees. We're going to review the revised draft outline for the final report, the draft that we looked at last time revised in light of the discussion we had, which was, I think, quite a significant discussion, and then we will have a discussion ourselves about what we see to be the new tasks and priorities for the committee during the next six weeks and how we might want to reorganize ourselves, that is to say the committee, in terms of its subcommittee structure, whether we want to continue with the same subcommittees, whether we want to break down into mini- subcommittees. I know that some of the subcommittees themselves have been having discussions about this topic, and so we'll spend a good part of tomorrow trying to figure that out. So as always, we have a lot to do in a short encompassed time, and with that I'd like to see if we couldn't get Dr. Siegel to come and get us started. And, again, many thanks for coming into Washington to do this. DR. SIEGEL: Thank you very much. Can you all hear me okay? CHAIR FADEN: Yes. DR. SIEGEL: All right. Let's see if that's working. Well, good. What I'd like to do this morning is give you a little bit of information about how research with radioactive drugs -- and I emphasize that I'm going to focus on radioactive drugs -- is currently regulated. By way of doing so, I'm going to take a couple of moments to spend a little time on some historical notes, and I will try to do so quite briefly. I'm not an historian, but I want to share with you what I've gleaned over the last few years and also what I've gleaned from the literature. There's a fair amount of background literature that was provided to you in the briefing book. Most of it bears no relationship to what I'm going to talk about. The primary reason that it's in the book is that Henry suggested that these were all articles that most of you would be unlikely to have seen, and we put together a package that you might find useful. By way of perspective, let me just tell you that in addition to the title that's listed in your agenda as to what I currently do, my perspectives on these issues succumb from the following types of experience. I've been an IRB member, a radiation safety committee vice chairman, and a radioactive drug research committee chairman at Washington University for too many years. I was a member of the Radiopharmaceutical Drugs Advisory Committee at the FDA at the time that the radioactive drug research committee regulations were written and subsequently served as chairman of that committee, and I'm currently chairman of the NRC's Advisory Committee on the Medical Uses of Isotopes. So I have a reasonable perspective on these issues that I'm going to talk about. I think we may need to dim the lights a bit if we can because otherwise you'll never see my slides. I'm going to cover a few historical notes, research regulation under the IND approach, the so-called radioactive drug research committee, RDRC, approach, and then a summary of current requirements. Now, by way of history, although certainly not the beginning of radioactive isotope use in human subjects, from a regulatory point of view things really began with the Atomic Energy Act, at least obviously the AEC's involvement, and that 1946 act provided general authorizations for the use of source special nuclear and byproduct materials for medical purposes. Initially isotopes were in scarce supply, and the AEC's primary job was figuring out what kind of research was most important to get those scarce supplies. Beginning a couple of years later in 1948, the Subcommittee on Human Applications was formed within the Isotopes Branch. The committee actually was referred to as the Sub Human Committee, interestingly enough. (Laughter.) DR. SIEGEL: And they took on this job of being responsible for allocation and deciding which experiments were appropriate. In 1953, they published some guidelines on human use, both routine medical uses, as well as research uses. The act was updated in 1954 and now clearly authorized the regulation of radioactive drugs and introduced the concept of licensing of facilities and physicians, which is really the NRC's -- and it's a precursor of the AEC's -- key control point on the uses of these materials. The Sub Human Committee was superseded in 1958 by the ACMUI, which is the committee I currently chair. I would point out that I'm actually the first civilian chairman of that committee. It always has been chaired by an NRC staff person previously. In 1959, amendments to the Atomic Energy Act authorized the agreement state program, which allowed states to take over many of the functions of the AEC in terms of their own radiation safety and byproduct material use programs, and in that same year Kentucky became the first agreement state. There are now 29 agreement states. In '63, because of things happening at the FDA which I'll tell you about in a moment, an exemption, a letter of understanding between FDA and NRC basically was put forward that said as long as drugs were being distributed in compliance with AEC rules, they would be exempt from FDA rules, and then things changed finally in 1975, when the AEC was divided into ERDA, soon to become the DOE, and NRC, and that's also when important changes occurred with respect to drug regulation. Now, just historically as well as currently, the control points from the AEC and the NRC. First of all, their jurisdiction is limited. They only deal with things either source material, special nuclear material; so uranium, plutonium, if you will, and the products of those things, things that are made in a reactor. They have no jurisdiction over things made in linear accelerators or in cyclotrons. Their primary control point is by licensing and controlling who is going to be the authorized user, and licensing follows a spectrum that ranges from a general license, which is something that no longer exists, but for many years virtually any physician could get a general license to use well defined quantities of radioactive materials for very specific types of clinical purposes. A specific institutional license provided a wider focus, but still a very restricted focus, on what kind of things you could get and what you could use them for, and then a so- called broad license, which was given to large university medical centers that had a great deal of in-house expertise and allowed for a lot of self-regulation within the institution of the radioactive materials. Another control point was the AEC controlled what kind of radioactive drug could find its way into the institution. There were drugs that were initially for specific licenses. They really could only get their hands on things that were on the so- called well established list, and subsequently those things merged and became FDA approved drugs. Until very, very recently, specific licenses were really restricted to the use of FDA approved drugs. Investigational uses, which obviously is of your greatest concern, for many years were really controlled by the AEC with ACMUI review or, in larger institutions, by oversight by an institutional Radioisotopes Committee, subsequently becoming the Radiation Safety Committee. Now, parallel structure from the FDA's side of things. The act in its present form really began in 1938 -- there were precursor acts going back to the turn of the century -- requiring that drugs be safe when used in accordance with the labeled conditions; required pre-market notification before a drug could be put on the marketplace. In 1962, the Kefauver-Harrison amendments required proof that drugs are both safe and effective and required now pre-market approval and established formal procedures for the investigations of drugs, the so-called IND process that leads to a new drug application that we're all familiar with today. Now, going a little bit out of historical sequence, radioactive isotopes were used for diagnosis and treatment going back to the '30s. Uses of I-131 and P-32, most notably at Mass. General and at Berkeley, but the first radioactive new drug, which was I-131, was approved by the FDA in 1951, and shortly thereafter P-32, and there were a smattering of other things approved over the subsequent years. In '63, the radioactive drug exemptions were put into effect, and I've already discussed them, but basically said that FDA would stay out of this business for byproduct material drugs as long as drugs were distributed in compliance with AEC regulations. And then in 1975, at the time that AEC was being split into ERDA and NRC, those exemptions were finally revoked, and at the same time, the RDRC regulations were established. Now, FDA's current perspective on radioactive drugs is very simple. They are drugs, and they consider them subject to all of the provisions of the Food, Drug, and Cosmetic Act, and in fact, radiopharmaceuticals are all considered to be new drugs, the exception being those drugs covered by the RDRC regulations which I'll talk about in a moment. We've already talked about these exemptions. Are radiopharmaceuticals different? Well, they are in many respects, and I just would focus for a moment on the issue of safety. First of all, most of these drugs are given only in tracer quantities. Most patients, even those when it's being used for routine clinical purposes, receive the drugs only once or a few times in a lifetime. They have historically had an outstanding pharmacological safety record in the case of diagnostic radiopharmaceuticals, and given good biodistribution data, the radiation effects of these drugs are predictable. The vast majority of uses of radiopharmaceuticals clinically and in research, the intent is using the drugs as tracers. The intent is not to cause a radiation effect, the exception obviously being when we use therapeutic radioactive drugs. Now, FDA -- and this slide will be hard to see, but that's okay. I'm not going to say much about it -- FDA's key control point for regulation of radioactive drug research is the IND process, which is the way they regulate research with all drugs. It includes preclinical phase, where you do studies in animals to find out about the safety of the drugs, the feasibility in the case of radioactive drugs, that it's really going to go where you think it's going to go, and to get good dosimetry data. And then there is a fairly complex review process at the FDA that involves specialists in pharmacology, chemistry and drug production, and physicians to evaluate whether the proposed experimental use of a radioactive drug or any drug is safe to proceed. If there are concerns, FDA has 30 days to tell you, "Sit tight while we evaluate these concerns." Otherwise the research proceeds with periodic reporting requirements and FDA oversight all along the way. And that is the traditional way that one would do research with any kind of a drug. Now, an IND is not always needed, however, for drug research. For drugs that are already out on the market, approved drugs, to do research with those drugs as long as those studies meet certain requirements, you don't need an IND. If your goal is not to change the label of a drug to come up with a new indication, you don't need an IND to do the study. If the safety of the drug that you're using is assured under a variety of conditions, if you don't intend to report the study to the FDA as the basis to support a new drug application, and then a somewhat more contentious issue, if the drug is produced in house and used on an individual prescription basis, and a substantial fraction of radioactive drug research will, in fact, fall into this category, and the notion that FDA's reach may not extend to this category and the reason for that is shown on this slide, which is that FDA really only has jurisdiction over new drugs that are introduced into interstate commerce, and I refer you to both Section 505 and Section 301 of the Act, and those really are the prohibited events that the Food, Drug, and Cosmetic Act controls. Now, the FDA, I think, will tell you that their reach extends further and that if a product is adulterated, even if it never entered into interstate commerce, that they can, in fact, seize the product and make the research cease with it. Now, another important exception to the RDRC or to the IND process is the so-called Radioactive Drug Research Committee, these regulations that were put in place in 1975, and I think fundamentally the issue was the FDA sensed that radioactive tracers were going to be very important for research in the future. In fact, I don't think they understood how important they were going to be in 1975 because positron emission tomography was at that point in its infancy. They knew that they had been important in the past. They also knew that they were getting lots and lots of INDs in for studies that were related to basic physiology, and it was taking lots of time and not much good was being served by the FDA review of these INDs. And so what they did was they put in place a set of regulations designed to trick the Food, Drug, and Cosmetic Act, if you'll allow me that turn of a phrase, by basically declaring a certain class of drugs as generally recognized as safe and effective if used for certain purposes, and that, by definition, made those drugs not new drugs. They weren't old drugs. They weren't new drugs. They were co-called grace drugs, and that allowed them to escape many of the provisions of the FDNC Act. Now, the RDRC is a committee, an institutional committee generally, appointed in the institution, but approved by the FDA under these specific regulations, 21 CFR 361.1, but acts on FDA's behalf to approve certain types of research studies involving radioactive drugs in lieu of filing an IND. In many institutions the RDRC has ancillary roles in that it functions as a consultant to the IRB to evaluate safety of all research studies involving radioactive drugs, and that's true at Washington University, and also in many institutions the RDRC is a subcommittee or a component of the Radiation Safety Committee. Now, as I just said, radioactive drugs are generally recognized as safe and effective when used for these kinds of research: basic metabolism studies or basic studies of physiology, pathophysiology, and biochemistry. The RDRC cannot approve research when the information is intended to be used clinically for immediate therapeutic or diagnostic purposes or similar purposes. The RDRC also cannot approve a study when the goal of the study is to do a clinical trial to determine if a drug is safe and effective, in other words, to put together a new drug application with the research that you're doing. That requires an IND. For a drug to be labeled as grace, the pharmacological dose has to be a dose known not to cause any clinically detectable pharmacological effect in man, and what that means is that this chemical entity has previously to have been inside human beings in some form because otherwise you can't meet this test based on human data. So it's very restrictive. It means that new chemical entity drugs really cannot be studied under this mechanism. There also are important radiation dose limits, which you can see for yourself on the slide, and basically they are fashioned after the dose limits for occupational workers. The regulations do permit research in children, but when it is very carefully indicated that you could not do the research in any other class of individuals, and pediatric diseases would be the obvious circumstances, and when that's true, the radiation doses must conform with the above ten percent of those limits. The RDRC has to look at the qualifications of the investigators to do the work, make sure there's a license to handle those radioactive materials, renders its approval after the IRB has already given its approval, must insure that the radioactive drug is of pharmaceutical quality, and must be sure that the scientific investigations merit the experiment. No radiation exposure, no matter how trivial, should be approved by an RDRC or an IRB if the experiment is not going to come up with an answer. Larger doses are appropriate if larger benefits can be obtained from the scientific research, but the RDRC has to work within fairly tight rules. Radioactivity has to be assayed. Non-pregnancy has to be documented. Records are subject to RDA inspection, and the RDRC has to meet quarterly to monitor ongoing research in the institution. Additionally, the RDRC makes an annual report of each study it's approved to the FDA, and whenever it approves a study involving more than 30 subjects or involving children, it must send a special summary to the FDA and also must report any adverse reactions that occur with the drugs. Now, just shifting gears and summarizing, let me then tell you what are the regulatory requirements, as I see them, for drugs used in research in medical institutions. First, and starting with the simplest, if we talk about an FDA approved radioactive drug, a clinically used radiopharmaceutical, but now being used in a research setting; if we're talking about an already approved indication for that drug, but one where the information may or may not be of direct benefit to the subjects, but would be the same indication as in the label, the only required approvals are going to be the IRB, and in many institutions the Radiation Safety Committee either directly reviewing the research or at least reviewing the type of use and insuring investigator qualifications. For a nonapproved use, either indication, route of administration, or mode of preparation of the drug, the IRB and the Radiation Safety Committee, again, conceivably an IND may be required if the goal is to get a new indication into the package label. So a manufacturer-sponsored study ultimately intended to lead to a new drug application supplement would clearly require an IND. For investigational drugs, not FDA approved, if it's a clinical study to determine safety and effectiveness, it's clear the FDA is unequivocally in the loop. An IND is required, and IRB and Radiation Safety Committee approvals also will be required. If it's the type of study we just talked about consistent with the RDRC regulations and irrespective of whether the drug is either locally produced or introduced into interstate commerce, you need IRB approval, Radiation Safety Committee approval, and RDRC approval. If it's an investigational drug and the use is not consistent with the RDRC regulations -- either it's a new chemical entity, the radiation dose is higher than allowed by the RDRC regulations, you intend to let part of the information be used for immediate diagnostic purposes, and the drug is introduced into interstate commerce -- then you need an IND, and, again, will need IRB and Radiation Safety Committee approval and/or oversight. The perhaps only open area in the regulations is use not consistent with the RDRC regulations, where the drug is produced in house, locally produced. There clearly you need IRB approval. I don't know of any university medical centers at least where not every bit of human research, whether funded federally or not, is not reviewed by the IRB. You will need Radiation Safety Committee oversight. You may need an IND, but that's open because of this issue of interstate commerce. However, depending on your radioactive materials license -- that's what RAM stands for -- you may require an IND depending on the terms of your license either with your state radioactive material licensing board or with the NRC. A specific licensee in an institution would very much likely need an IND to do this kind of research. A broad licensee might not need an IND, and in those circumstances, only IRB and Radiation Safety Committee approval might apply. So with that let me end and just say that I think you'll see that radioactive drug research, at least, is pretty substantially regulated at the present time. There's a lot of institutional committees in the loop. There are FDA regulations, either NRC or parallel state regulations in the loop, and I guess with respect to your fourth charge, recommending additional regulations if any, I would certainly suggest that as far as radioactive drugs, we probably don't need any more regulations in that area. CHAIR FADEN: Don't leave. DR. SIEGEL: I'm not leaving. CHAIR FADEN: Thank you very, very much, Dr. Siegel. I thought I was fortunate before, but when I heard you briefly recount all of your current responsibilities, I now even more appreciate how fortunate we are to have you give us this presentation. Are there questions or comments for Dr. Siegel? Ruth, please. DR. MACKLIN: Maybe I missed it, but the way I heard you describe the relationship between the RDRC approval and the IRB approval was that the IRB approves first, and then the RDRC approval comes afterwards. Could you explain the rationale for that? I mean to me it seems a little bit counterintuitive since the IRB wouldn't even have to consider the ethical aspects if the conditions for RDRC approval were not met. So could you explain that? DR. SIEGEL: Well, I'm not sure I can explain the rationale, except that I think FDA's reasoning is that if they were going to approve the study, they would have the final word irrespective of what an institutional IRB would say, and they view the RDRC as a direct institutional extension of the FDA. Now, the truth of the matter is, let me tell you how it works at Washington University. The applications are submitted in parallel, simultaneously to the IRB and to the RDRC. The committees both go about doing their work. At our institution the RDRC issues a letter of approval pending IRB approval. Once the IRB sees that letter from me, they then issue their approval, and then I issue a final approval letter. So the work really goes on in parallel, and I don't think from a logical point of view that either committee has a greater responsibility, but I will tell you that the RDRC at least at Washington University does spend a fair amount of time also looking at the ethical aspects of the study and looking very carefully at the consent form, and the language used in our consent forms was shaped by both the IRB and the RDRC, working along with the Radiation Safety Committee. It was kind of a tri- committee/institutional effort to come up with language we could all agree on. CHAIR FADEN: Jay, please. DR. KATZ: Thank you, Dr. Siegel. The regulations surely are very formidable. In the light of your experience, I guess, over a decade or more -- DR. SIEGEL: Thank you. DR. KATZ: -- have any questions arisen with respect to the protection of subjects of research both with respect to risks or disclosure and consent? And have there been concerns based or has the system worked so well that no problems have arisen? DR. SIEGEL: Well, I'm not aware that we've had any problems that we were not able to work through. I think there have been experiments that have been proposed where both the IRB and the Radioactive Drug Research Committee have raised questions about the initial drafts, where they didn't think the consent form was clear enough and we tightened it up. We made it clearer. Where we thought the number of subjects proposed for study was more than was necessary to reach the scientific objectives; where we thought the dose of radioactivity to be administered was higher than was necessary; the committees at Washington University, I can tell you, practice ALARA -- I'm sure you've heard that term -- "as low as reasonably achievable," and we have pushed over the years to try to get the doses that we use in the research setting lower and lower in an effort to make sure that we can get the research answers with the lowest risks possible. DR. KATZ: No problems have arisen after the research has been initiated? DR. SIEGEL: None. DR. KATZ: Thank you. CHAIR FADEN: Henry. DR. ROYAL: Just as a comment to Jay's question, before I went to Washington University I was at Beth Israel Hospital. I personally submitted an application to an IRB to do some research, and at the first meeting some questions were raised about whether it was appropriate to do or not. There was concern about the radiation dose, and that project did not continue. So there certainly are instances where you submit something and people raise questions about it, and often it's not pursued not necessarily because you agree, but because the obstacles that are then put in front of you -- CHAIR FADEN: Are not worth it. DR. ROYAL: -- yeah, are just not worth it. DR. SIEGEL: Well, and just a comment. I don't know if this is the study you're referring to, Henry, but Henry was involved with submitting a study that was an NIH initiated study. It was a multi-center study that the protocol was designed at the NIH, and it got to our Radioactive Drug Research Committee, and we basically said, "This is not a well designed study. You're using the wrong radioactive drug with much too high a radiation dose to the subjects, and much too great an environmental hazard," and Washington University's committee redesigned the NIH study, and the NIH changed the protocol for the multi-center study. So I think the process does work, obviously. (Laughter.) DR. ROYAL: One other comment I would make is we're looking at radiation experiments in a vacuum, and it's hard for this committee to really get the proper perspective about what medical experimentation is like. We just heard Barry talk about the regulations involving radioactive drugs, and whether or not you believe that the regulatory process is adequate or not, I hope that everyone agrees that there are many, many more regulations involving the use of radioactive drugs than there are in other areas of medical research, like surgery. I mean surgeons can basically do any kind of new operation they want to do, and they say this is going to be helpful. CHAIR FADEN: Well, your point is well taken, Henry. It may be that we should try to schedule a presentation that puts this all in perspective, a kind of comparative presentation that places the regulatory structure currently governing research with radioactive materials side by side against the regulatory structure with respect to other interventions in medicine. It might be instructive. We can do that. We can do anything. We can do that, we can do that. (Laughter.) CHAIR FADEN: Are there other questions for Dr. Siegel? (No response.) CHAIR FADEN: Can we reserve the right to call on you again, not necessarily to come to Washington, but as we proceed into the future and we work on our recommendations for the current situation, I suspect we may seek your advice. DR. SIEGEL: Happily. Thank you. CHAIR FADEN: Thank you so much. Okay. We have to move on. I assume, Dr. Siegel, we can get copies of your slides. I know I have some of them, but this will make the minutes of this meeting much easier, among other things, and I have a feeling we'll be wanting to look at those slides again. That will be great. Okay. We're going to move on now, and Gil will give us a presentation. Gil is here? Great. Gil is going to give us a presentation, an overview on the history of radiation protection standards. Is your microphone on over there? None of them are. DR. WHITTEMORE: I can just yell loudly. CHAIR FADEN: That won't work. We've got to get you on the record. That one, great. DR. WHITTEMORE: The presentation is designed to go with what I believe is Tab M in the folder that you've got. It's the one that has the little graph of a time line and then a printed time line. A number of committee members have expressed an interest in at least a brief background to the history of radiation protection standards and when it was people began to be concerned about radiation health. So this is intended to be simply a preliminary and very short discussion of what is a long and complicated history, and I'd like to just touch on a few highlights and the points that might be of greatest interest to the committee. I think it's going to take us back into a world that's very different from the one we just heard about, that is, not a world where there are a great deal of regulations, but a world in which there were very few, and I'll mention at the beginning that the major point of the talk is simply to illustrate what I think the scientists are well aware of, and that is that the whole issue of radiation standards and dose limits is a very complicated story, complicated scientifically, complicated politically, and I think the committee will find complicated ethically, and the basic reason is that nature has simply not been kind enough to provide us with a clear dividing line analogous to the boiling point of water in terms of what the effects of radiation are on human beings. To go back to the very early days of radiation, early on it was observed that not only were X-rays and radium providing you with interesting physical effects to study, but it was having biological effects on human beings. To give you simply two anecdotes, one of the early researchers using radium noticed as he was going from talk to talk carrying this glowing capsule in his pocket that he developed something like a sunburn along his leg, and this biological effect became the basis for exploring whether you might try and use this as a way of attacking cancers in the human body. There are many, many reports as people were developing X-ray techniques, primarily diagnostic X-ray techniques, of how long you would have to take an exposure in order to get a good picture, and in the process of doing this, they made other observations. One report, for example, a doctor was attempting to X- ray the skull of his partner to see if they could get a good picture, and he reported in the journal that after an exposure of several minutes, the plate came out rather foggy. There was nothing of interest in his partner's skull, but that two weeks later they noticed a bald patch two inches in diameter appearing on the side of his head where the beam had been aimed, and the report ends with this rather optimistic, I suppose at the time, but rather frightening in our day and age, that they would watch for further developments with interest. By the period after World War I, there was almost a martyrology of radiologists that had overexposed themselves and suffered from various forms of radiation injury. In the late 1920s, as you can see from the time line, the concern with safety began to become organized on an international level. The International Congress of Radiology met, and at its second meeting it set up an international commission on radiological protection. Attending that from the United States was a young Bureau of Standards physicist, Lauristad Taylor, who returned to the United States with recommendations from the international commission to set up an American Committee on X-ray and Radium Protection. The goal was for each country to set up a committee that would be appropriate for its own legal system and medical profession. In the United States the advisory committee basically was able to exist only because the Bureau of Standards allowed Lauristad Taylor to spend his time working on it and was willing to publish their reports, that is, to give it a kind of informal subsidy. It drew on experts from the areas of physics, of electrical engineering, and of medicine. And that illustrates the complexity of what they were dealing with. That is, they were dealing with a new, exciting technology that certainly in diagnostic terms with the X-rays was producing rather immediate results, and that in terms of therapy might produce or at least it was the hope it would produce significant results as time went on. It involved problems of physics. That is exactly what was the nature of this radiation, and in particular, how could you measure it? It involved questions of medicine both in terms of basic biology -- how does radiation interact with the human body? -- but also in terms of medical practice, that is, the doctors at the time recognizing that individual human beings can have enormous variability in how they'll respond to almost anything, and the allowance of the doctor in having some discretion in terms of how you would deal with individual patients. And, finally, in terms of electrical engineering, as you're trying to design the machines, were there ways of trying to improve their safety? From the committee's point of view, the major point is to realize that in this time period, some of the basic concepts were being developed that are still in some form being used today, but they were being developed not in a regulatory system, as we just heard about, but in a purely advisory or pedagogical manner. That is, the advisory committee had no legal authority to regulate anything. Its goal was to try and primarily persuade the physicians and the manufacturers that it was important to be concerned about radiation safety, and also, although it may seem a bit strange to us, electrical safety was a major concern. Judging from the number of lawsuits, there were a surprising number of patients that went in for an X-ray and came out with an electrical shock of one kind or another, one example being the young man who went in for an X-ray, had a static discharge of some kind that traveled along the outside of his body and went out the toe of his shoe, which wouldn't have been so bad except that along the path it also set his underwear on fire. And if you talk to people who worked in that era, there are descriptions of these high voltage machines. There was a hospital in New York City that had a high voltage X-ray machine in the basement which was nice, except that in the wet season you'd have about two inches of water in the basement, and here they were working with high voltage electricity. In terms of the electrical safety, however, one of the things that they were able to do was solve that problem not by educating the doctors, but by simply building safety devices into the machine. In other words, you could come up with detailed regulations or recommendations to the manufacturers and gradually include more insulation. There wasn't the need to educate a large number of people in terms of the hazards. With regard to the radiation itself, that was more difficult because, after all, the entire point of the enterprise was to produce radiation and be directing it in some fashion at human beings, and the advisory committee was in the position, first of all, of making it clear from the beginning that they were not presuming to tell doctors how to do therapy or diagnosis. Their concern was, rather, to educate the doctors in terms of safety for themselves and for their technicians. So there were no standards or recommendations from this committee in terms of what you should administer to a patient for particular purposes. That kind of discussion took place in the professional literature. Instead, they came out with a series of reports, recommended safety procedures, and this required them to do a number of things: first of all, to come up with units by which you could measure radiation, and I won't go into that story except to say that you could do the history of radiation safety by focusing on each new unit that was introduced, why it was introduced, the assumptions that go into that unit, and I'll talk a little bit more about that in the post-World War II period. The second point was that they had to make their recommendations ones that would actually be heeded, and they ran into two problems. One, they early on realized you had to balance your concern for safety with concern for practicality, and in those days that would take the form, for example, of debating about what is the amount of shielding that you should have in the lead box that you're using to carry your radium vial around, and the discussion is: well, look. If you make the box too heavy, the physicians in the small towns are just going to leave it at home. You've got to balance it. The values were being balanced. It was qualitative. It was anecdotal. There were no large-scale studies being done, but that type of balancing was taking place. Secondly, they discovered that their reports began to be very complex because they were trying to do it in great detail. It began to read a little bit like the tax code, and there was a problem of internal consistency, that is, to make sure that one subcommittee that was developing a report on the lead shielding for radium was going to be consistent with a committee that was developing a report on something else. So they developed or in the early 1930s there began to be discussion of what was termed a tolerance dose, and as it mentions in the handout, the tolerance dose was originally thought of as a dose of radiation which experience has shown to produce no permanent physiological changes in the individual. Now, it's important to note they're talking about no permanent changes, that is, temporary changes, such as a slight thickening of the skin at the fingers of those administering radium, was not regarded as a serious problem. Anecdotally their experience was that that tended to disappear after a few years. I'm reporting their anecdotes. I'll leave it to the scientists to tell me whether that's accurate or not. Also, they were looking at physiological changes. They were not at that time looking at, for example, genetic injury. And the purpose of the notion of a tolerance dose was not to try and claim that they had discovered the equivalent of a boiling point of water, that above that there was danger and below that there was safety, but rather to insure internal consistency in their own report, and to try and come up with a rationale that would help explain the reasoning process they were going through to their audience. So the tolerance dose becomes adopted. It's a way of simplifying nature rather than a discovery about nature. That concept of a tolerance dose later carries on after World War II, changes the terminology into a maximum permissible dose, and if time permits I'll talk a little bit about how that new atmosphere changes items. The other major lesson from before the war is what in engineering terms you might call safety factors or in scientific terms an acknowledgement of our ignorance about nature, and if you look at the graph or at another point if you have the leisure time, you'll notice there's a rather dramatic dip around 1941 in the occupational dose that was allowed. It drops by a factor of ten for a period of a year, and then it bounces back up again. In that is a brief story that illustrates the difficulty of trying to set out standards or recommendations when you're really not all that confident in how nature is behaving. What had happened was that Herman Muller several years earlier had in a very elegant experiment demonstrated that radiation X- rays can induce mutations in fruit flies. It was a very carefully constructed experiment because what he had to do was, first of all, find mutations or define mutations in a way that he could observe them, and fruit flies happen to have some rather bizarre and once you trained your eye fairly easily detectable mutations. And, secondly, he had to come up with a methodology that would insure that those mutations, in fact, were being generated by the X-rays and were not recessive genes just now manifesting themselves over a period of time. He also proceeded to give a series of talks arguing that the medical profession was being careless, perhaps over-X- raying, administering too much radiation to people. In other words, he not only published his report, but he then became an advocate for reducing radiation exposure. In 1941, a number of members of the committee decided that perhaps it was time to recognize the possibility of genetic hazards to human beings. They held a meeting of the committee, and the committee after some discussion decided, well, there was no proof yet of genetic hazards to human beings. As a safety factor they would cut the tolerance dose by a factor of ten. And that was clearly a vote of the committee, and when other authors wrote to Taylor and asked him what's the latest standard, he replied, "It's now 3.6 rem per year." What happened, and I'm sure it must have been somewhat embarrassing to the committee staff at the time is that a number of committee members who had not attended that meeting were quite upset to discover that their limits had been cut by a factor of ten, and Fiala, who was working in New York City, developing, becoming really a pioneer in radiation therapy, felt that this was an unworkable standard in terms of the way his hospital was working. And remember we're talking now about a standard that would apply to the staff. They're not talking about standards applying to patients. So before the committee had a chance to publish its report, it held a second meeting, and it's interesting to note that what happened, at least my interpretation of what happened, is that the safety factor of ten was something the committee would agree to until it seemed that there was a practical problem with it, that is, that there was some cost consequences. I don't mean that just in terms of dollars, but that it was going to impinge upon current practice and that the possibility of genetic hazards was not sufficient to justify that. There was extensive discussion. In my whole study of the committee, it's the only time in which committee members that could not attend the meeting actually sent telegrams voting by proxy on how they were going to vote on this limit, and they ended up restoring the older limit of 36, eliminating the safety factor. But they also, to in a sense sweeten the pill, voted to strongly recommend and begin actively looking for funds to have a research program to examine the possibility of genetic hazards. What is intriguing and I think what will perhaps set the stage for the talk that follows mine is that the two scientists on the committee that knew the most, that had thought the most about this problem, Newell, who had suggested the safety factor of ten, and Fiala, who had objected to it, both agreed on one thing, and that was that any research program that this group was about to undertake would not answer the question; that if you did a survey, for example, of radiologists and the children and you found some allegedly defects, people would argue those may have been recessive genes that had always been in the position, and that if you did not find any, people would argue that you had not carried the study through a sufficient number of generations, that it would duplicate with human beings what the elegance of Muller's fruit fly experiment had. You'd have to isolate a human population for about 600 years. And what it illustrates is both the innate difficulty of trying to observe the long-term effects of radiation and also the necessity even before the war of beginning to talk about safety factors in light of our ignorance about the way nature works. After the war, these older concepts now began to be used in a dramatically different world, that is, that the nuclear era was one in which there seemed to be unlimited possibilities not only in terms of an arms race in which you'd have a weapons production industry, but also in terms of the hopes people had for use of radiation and atomic knowledge in medicine and perhaps also in atomic power. In other words, the expectation was that atomic energy would end up becoming for the late 20th century what electricity had been for the first part of the 20th century, something that became very common and widespread. And that probably is why after the war, when the Atomic Energy Commission for a variety of reasons decides to encourage the continuance of this independent advisory committee also strongly desires to have the tolerance dose lowered. The terminology is also changed from tolerance dose to maximum permissible dose, the hope being that will make it clearer that this is not a bright line between safety and hazard, but it's something that's simply a maximum permissible dose, and what happens, of course, is that the meaning words have in a language depends on their usage as much as on the definition you'd like them to have. They tend to be like kids. Once they're out the door, they go their own way, and maximum permissible dose in popular discord -- discourse, at times discord -- began to take on the connotation of an absolute safety limit, which is why by the 1970s you have people accusing the Radiation Safety Committee of having believed that there was a sharp cutoff, when if you look at the history it's clear that this was really almost an administrative technique they were using and not a claim of a scientific discovery. So that the maximum permissible dose becomes the centerpiece of the control or the development of an entire industry, and what I have set out in the time line are the small number of changes that took place after World War II, that is, in 1948 lowering it to 15 rems per year, primarily out of a concern that if atomic energy was going to be the electricity of the late 20th century, the entire population would be exposed to it, and perhaps as a recognition of the possibility of genetic injury, if you're exposing the entire gene pool, then to introduce a safety factor. In the late 1950s, it's reduced, the occupational dose, from 15 to five, and the general population dose down to 1.5. That grows not of a dramatic scientific discovery, but rather out of a reconsideration of what you might call the ethics or the values involved in safety factors that comes out of the fallout debate. And then up until the current time, where you have very recently a new set of standards that, on the one hand, introduce formally into the rules a principle that had been begun to be used in practice for some time, the ALARA concept of keeping radiation as low as reasonably achievable, while also still retaining the five rem per year as an absolute upper limit. The two comments I'd like to end with then. One is that I hope the brief presentation has at least illustrated the complexity in terms of the politics, the science, and the ethics that are involved in coming up with a simple number that you can read off a chart and say, "This is the permissible dose." And, secondly, that this is only part of the history. This is the history of what would have been the published, the publicly known occupational dose limits. We may, as we delve into the documents, discover that in practice a different and lower set of limits were being applied when it came to experimental use. There's some indication in the correspondence we've found that there were other limits, perhaps never formally published, that were being applied after World War II to experimental uses, request for use of isotopes for experimental purposes. CHAIR FADEN: Thank you. You can see how fortunate we are for our staff. There's a lot to absorb here, but I think there may be some questions or comments for Gil. Henry. DR. ROYAL: Just a few comments. As Gil mentioned, the concerns about radiation early on were driven by concerns about what the genetic effects might be about radiation, and just to bring you up to date, BEIR V, which was published in January of 1990, explicitly contains a statement saying that genetic effects have not been directly demonstrated in humans. So early on that was one of the driving forces in terms of radiation protection. Later on it became more and more clear that humans were not fruit flies and that the effects on humans were considerably more difficult to demonstrate. The other comment I'd make about regulatory bodies is again going back to BEIR V. BEIR V explicitly contains a statement saying that for regulatory purposes, it is better to over-estimate the risk than under-estimate the risk, and the reason that I mention that statement is because I think it describes the mind set of many regulatory agencies. If you analyze that statement, it's better to over- estimate the risk, it's only true if you have unlimited resources. If you have unlimited resources, it's okay to over- estimate the risk because there's no harm done by you over- estimating the risk. If you have limited resources, on the other hand, if you over-estimate the risk, you end up diverting funds to protect the public's health from that risk and you don't have any funds left over to product themselves from other risks. So when regulators say that it's better to over- estimate the risk, what they really mean, I think, is not that it's better for society, but that it's better for the regulators to over-estimate the risk because no one is ever going to criticize them for over-estimating the risk. They will get criticized for under-estimating the risk. CHAIR FADEN: An interesting observation. Duncan, did you have a comment? And then Eli. DR. THOMAS: I can't remember the context in which we put that statement in BEIR V, but it's my impression that the risk estimates that are quoted there were intended to be best point estimates and not over-estimates. DR. ROYAL: It's in the genetics chapter. DR. THOMAS: Oh, okay. CHAIR FADEN: Duncan, you were a member of the BEIR V. DR. ROYAL: Maybe page 77, if I remember correctly. (Laughter.) DR. ROYAL: I often quote that statement. CHAIR FADEN: Dan is pointing out that it's always reassuring to see that we've got this sophisticated level of expertise on the committee, as well as the staff. Eli. DR. GLATSTEIN: Just a couple of comments there. When we get to the TBI issues, one of the problems in the first part of the century was an absence of dosimetric concepts and the terms of measurement. In the Heepline papers of Memorial in the first part of the century, they go into great detail when they did the TBI about their dosimetry, which was a canary on a perch, and they left it in the room with the patient, and they would allow radiation to go on until the canary fell off the perch. (Laughter.) DR. GLATSTEIN: That was their dosimetry. The other thing that I would say is that there's a tremendous problem here with respect to radiation effects, especially injury, on the basis of probability, and the probability of an injury is far less than one. There's a well known paper from England that changed the pattern of treatment in this country with respect to rheumatoid spondylitis. In the '40s and '50s, that disease was frequently treated with radiation because it gave pain relief. In the mid-'50s, I think, and early '60s, Cork, Brown and Doll published a paper on leukemogenesis coming out of radiation treatment of rheumatoid spondylitis patients, and they followed I think it's 15,000 patients for five to 15 years, and they had 50 cases of leukemia out of 15,000. Now, that's ten times the expected rate, but it was a very low risk event, and the quantitative concepts, I think, are hard for people to understand. We're talking about a finite risk, without question, and serious risk, but at the same time the risk in many instances is so small that it's not easy to measure. And, in fact, when we get to low dose rate issues, that's the whole problem of trying to have some means of measurement, and we don't really have it. Hence, the issue of threshold versus extrapolation back to the zero point. CHAIR FADEN: Gil, do you want to react? DR. WHITTEMORE: No. I'll comment on the early dosimetry. You'll notice on the time line it talks about an erythema dose, which is a skin reddening dose, and in fact, one of the ways in which people in the United States would make sure that they would be able to calibrate their X-ray machines with those in Europe so doctors would know if you're talking about a three minutes exposure on my machine how does that compare with yours was to basically use human beings as the dosimeters. That is, how many minutes of your hand in front of the machine would produce skin reddening? In a sense, it illustrates sort of a fundamental scientific problem, which is that radiation does not interact with physical instruments the same way it reacts with human tissue, and that's another underlying issue that has persisted throughout the years, trying to come up with a unit that will measure biological effect when what you're instruments are picking up are physical effects. CHAIR FADEN: Ruth. DR. MACKLIN: Yes. The question is for Gil. I was looking at the time line and recalling what you said at one point, and if you could just again elaborate on it because I may have missed it. Some of the examples that you gave were examples of consequences to patients, all of these burn things and the toe, and yet at one point you also -- I thought I heard you say that the concerns as they were being expressed as these committees worked were for the workers because this was the occupational setting. So if you could just elaborate. I mean the episodes were for patients. Of course, there were also episodes that occurred with workers, but was there an attempt to set some limits in some fashion, however it might have been done, for people who were patients and not just the workers, or was it because it was occupational that they were looking at that? DR. WHITTEMORE: Right. The anecdotes about patients dealt with the electrical safety issue, you know, and in fact, sometimes there was one woman who was recruited in a sense. She was waiting in the waiting room with her child for an X-ray, and the nurse asked her to help hold down the feet of somebody else's child that was wiggling around too much and ended up getting a static shock. I think the electrical safety issue was one that they basically were interested in dealing with, the electrical safety, and primarily it would have been the technicians. It just happened that it was usually the patients that ended up suing and giving us the documentary record of a malpractice suit. In terms of the radiation, the committee made it clear from the beginning that the question about recommending what you would give to patients they would leave up to the professional societies. That's a dialogue that went on in the professional literature or in the professional societies, and it may well be that -- I don't know if the committee would want to get into the pre-World War II era, but certainly the post-World War II era, in addition to government regulations and government approval, what we might find in the professional literature would be where you would look for those kinds of guidelines. DR. MACKLIN: Just a quick follow-up. To your knowledge, was there any communication between people who were supposed to be developing these standards in the medical profession and these other groups who were doing this for the workers? DR. WHITTEMORE: Yeah, there was substantial overlap. That is, the committee was made up of people who were representatives from the major radiological societies. They often were also members of their society's own committees. CHAIR FADEN: Pat. MS. KING: I should point out to the extent that the anecdotal data comes from patients, you wouldn't have any cases of employees because employees can't sue. Most employees cannot sue their employers. They are covered by workmen's compensation. So it was only the patients that could bring a civil suit so that you would get that kind of information about facts that happened. DR. WHITTEMORE: Yeah, there is an interesting -- partly this is in the '30s at least, the era when workmen's compensation was still -- but the sensitivity of the committee, and I think it may show you might say their professional orientation, is interesting. In the late 1930s, one of the things they were thinking of doing to deal with the genetic issue is a survey of the people who were working, and it's very interesting that the survey never took place, but one of the concerns was that you should really send the forms to the physician or to the hospital administrator. You should not send it directly to the employees because they might get upset and it might create problems for the employers if a committee was hinting at the fact that there might be genetic injury. So there's clearly a committee that is oriented towards the people who were the employers, and you can see that arising now and then in the correspondence. CHAIR FADEN: Nancy. DR. OLEINICK: Just a question about the timing of some of the regulations with regard to public exposures to radiation. Were some of the public exposures calculated in, such as, oh, gee, the popular custom of ingesting radium, for example, for all sorts of supposed cures and the exposure of children in shoe stores to X-rays and this kind of thing? Was this ever taken into consideration in the development of -- DR. WHITTEMORE: Well, actually it was sort of a major point of contention, which is sort of interesting in view of contemporary debates. The Atomic Energy Commission felt -- I won't say the Commission, but certainly there's evidence that some people within that staff -- felt it was a little bit unfair that all of the attention should go to fallout and not to all of the other sources of radiation, and in fact, there was a proposal in the mid-'50s to do what makes sense scientifically, and that is that people should have a radiation card or radiation record that would record all of their exposures, both medical, diagnostic, therapeutic, environmental, fallout, shoe stores. And a bill was introduced in Congress that was opposed by the American Medical Association on the grounds that this was the first step towards socialized medicine, and I'm sure there is an interesting history there to be told, but I don't know if we will have time to get into it this year. (Laughter.) DR. WHITTEMORE: But it clearly was an issue early on, and what it really addressed was, again, the question of the prerogative or the professional autonomy of the physician and not wanting to be subject on a patient-by-patient basis to regulation. CHAIR FADEN: We are running a little behind schedule. I hate to stop the discussion, but we really need to move on. Gil, thank you very much, and here again I'm sure we will ask you to come back as we flesh this out and help us put the context even more straight. Okay. Duncan, you got your lead-in to low dose radiation. Are you using the overhead? DR. THOMAS: I'm going to use the overhead. I'm told there's a mike on the way. CHAIR FADEN: Okay. We're having an air circulation problem. We're freezing right here, and we just asked. For what it's worth, we're all suffering, and we probably need the air cut off. We understand that some people in the back of the room are warm. We're going to find a way to redirect the air and you can freeze for a while. (Laughter.) CHAIR FADEN: And then when we get uncomfortable, we'll shift the events around again. DR. THOMAS: Am I on yet? CHAIR FADEN: Yes, you're on. I was just filling in time there. DR. THOMAS: Well, I hope you all remember Henry's excellent introduction to radiation and radiation risks at our second meeting because there's going to be a quiz when I'm finished today. Seriously, I think Henry gave us a set of views about radiation risks that really represents the mainstream of the radiation protection community, and at the outset let me say that those are views that I'm in broad agreement with. He quoted heavily from the BEIR V report, which as you know I was a co-author of, and at least I fully support the views of that report. You may also recall though that I quibbled with his interpretation of Rosalind Yallow's paper at the end as middle of the road, and I thought I would just stick up there a few of the excerpts from that paper that caused some difficulty. In particular, it was the repeated assertions in the paper that no evidence exists for, and you fill in the blanks, some sort of increased risk from various levels of low dose radiation. It was that sort of statement that motivated me wanting to give some talk to this committee to give a perhaps slightly contrary view. So what I'm going to try to do today is, first of all, talk about where these radiation risk estimates come from and what is the fundamental problem that we face in trying to identify risks at low doses by direct observation, and then briefly I'm going to go through a variety of the different types of low dose studies not in any systematic fashion, but simply to draw examples, to illustrate various points about how we go about designing epidemiologic studies and some of the conceptual issues that we face in interpreting low dose studies and what in my view are some of the points, you know. Why do we do these low dose studies faced with all of these difficulties? Time permitting, I want to say a few words about radon because of the special interest of this committee in the uranium miners' story. Gil, I'm afraid I will disappoint you. Having now read the passage of your dissertation on this subject, I've decided that what really needs to be said about genetic risks is actually more than I can do justice to in a couple of minutes. So I think I will skip over what I was going to say about that. Those of you that want to, there is a written version of this paper that's about to be circulated to you, and you can read my preliminary thoughts, but they are really very preliminary. And then finally, time permitting I'll say a few words on remedies. Now, BEIR V relied heavily on the Japanese atomic bomb survivor data to derive risk estimates, and the bottom line from our conclusion is summarized in the first line there: an estimate of the lifetime excess risk from a single ten rad exposure of about .8 percent. Now, that number represents an average over a number that varies considerably with age at exposure, and that's a point I want to come back to in a moment. It's probably worth pointing out at this point that this represents a fourfold increase over risk estimates that have been derived from 1980 by the BEIR III committee, and that, too, is a point I want to come back to. To put that figure in some sort of perspective, the background rate, the rate that the general population, males and females combined, is subject to, is about 18 percent. So if I take that as a denominator for the .08, we would compute the relative risk, ratio of risks in exposed to unexposed individuals of 1.04. That's a very difficult number to try to estimate directly. Just random variation alone would require that one would have a sample size of something of the order of 100,000 in order to obtain a statistically significant result that big, that small, but on top of random variation, you have all sorts of systematic biases that any observational study is subject to, and I'll say a little bit more about what those biases are in a moment. So that a relative risk, even if one could observe it, of 1.04 would be an extremely difficult thing to try to interpret. Just to put these in some sort of perspective, the ten rem exposure that we're talking about would represent two years of exposure under the maximum permitted today occupational standard. That's about 100 times the general population standard, which is roughly equal to natural background, and it's about 1,000 times the routine chest X-ray. I picked ten rem as this example because in some sense you might think of it as the upper limit of the low dose range on the grounds that, well, in the Japanese atomic bomb survivor data, the lowest dose at which we observe a significant increase is in the 20 to 49 rad group. So at this point we're beginning to get into what one might interpret as high dose. Now, I'm not going to go over this slide in any detail. I circulated in advance to you a couple of excerpts from the BEIR V report, including the chapter on low dose studies, which provides a more thorough review than I have time to go through this morning. Instead, what I'm going to do is simply take a few examples from here. Henry talked a little bit in his presentation about the comparisons between areas of varying background radiation, and I agree with him that those studies have never yet shown anything that's of much use to us. I will take a few examples from the fallout studies, focusing on the Downwinder studies that I've had some involvement in myself, and I want to talk a little bit about diagnostic medical irradiation. I will leave you to read what I have to say about the pooling of the nuclear worker studies. Suffice it to say -- well, I'll save that comment for a moment, and I will skip over, again, work on residents near nuclear facilities. There is one topic that is not in the excerpt that was passed out to you, and that would have to do with residential radon, and that's because mandate of BEIR V was lower LET radiation, and this would relate to alpha radiation. This will be the topic of the BEIR VI report, which is currently underway. Now, aside from broad comparisons in overall disease rates from one community to another, what we would call an ecologic study that's, for example, the basis of the high background studies; setting those aside, epidemiologists recognize two basic approaches to studying exposure response relationships in individuals, and they are known as the cohort and the case control designs. These two designs differ essentially in the logic of their inference. The cohort study reasons from cause to effect, the case control study from effect back to cause. So in the cohort study, we begin by identifying groups of exposed individuals and some comparison group of unexposed individuals, and we follow them forward in time to see what happens to them, and we compare the disease rates in the two groups, or there might be more than two groups. The actual process of the follow-up can be done either by starting at some point in the past and following that group up to the present or by starting today and following them into the future. They're still a cohort study either way. Cohort studies are generally felt to provide the strongest basis for causal inference, but the basic difficulty is that for studying rare diseases, they can require very large cohorts followed for very long periods of time, and long follow- up will also be essential whenever you're studying diseases of long latency. For this reason, the preferred design for studying rare diseases is generally held to be the case control design. Case control design begins by identifying cases of the disease and comparing them with individuals who are free of the disease, what in this context we call controls. It's a little different use from what those of you with an experimental background may be used to thinking of your controls as the unexposed. Here the controls are disease free, and we look back into their past to see what is different about the exposures of the cases and the controls that might explain why the one group got the disease. One of the advantages of the case control design is that it allows us through this technique of matching individually the cases to the controls to deal with those various multitude of factors that we know to influence disease rates that we're not particularly interested in in this particular context, for example, age and sex and other possible confounding exposures. Nevertheless, it's generally felt that the case control design is more subject to bias and we'll see a little bit about that in a moment. Let me just very briefly say a few words about the fallout studies as examples of the case control and the cohort designs. The thyroid study is an example of the cohort design. Here in the mid-1960s, the Public Health Service organized the observations and clinical examinations of the thyroids of about four or 5,000 kids who were then in the seventh to the 12th grades in three counties in Utah, Nevada, and Arizona, Arizona being chosen as a control community. Not much difference was found between the three communities at that time, but there was no individual dosimetry available. Twenty years later, we set about to find out what had happened to them. We tried to locate as many of the kids as we could and succeeded in the case of about 59 percent of those that were still living in the three-state area. We reexamined their thyroids in the mid-1980s, and we also conducted a survey of their parents to try to get information about leafy green vegetables, sources of milk consumption, whether they had a backyard cow or goat, all of the various things that would be important in computing their thyroid dose. This, combined with a very elaborate dose reconstruction which really only John Till could do justice to, led to an assignment of individual doses for each one of those 5,000 kids. On average, the thyroid doses in Utah ended up being 17 rads, but there were substantial numbers with higher doses, over 50 or even over 100 rads. Small numbers, a total of 19 neoplasms over the total period of follow-up, and just focus at the last one here. Despite the small numbers, however, we observed a significant trend in thyroid disease. So that's what the cohort study would show you. The leukemia study is an example of the case control design. Here we began with a population based ascertainment of all leukemias in the state over a 30-year period and narrowed that down to a subset of 1,100 leukemias among LDS church, Mormon Church, members. We also drew a matched sample of about 5,000 deaths from all other cancers -- I'm sorry -- all other causes of death during that same period matched on age and year. Dose estimates in this case were based on resident's history as abstracted from the Mormon Church records. Here the target organ of interest is the bone marrow. So the doses were substantially lower. The highest dose assigned in the whole study was about I think it was 2.6 rads. Overall very weak dose response relationship, nonsignificant, but when we looked in the specific subgroups where the atomic bomb survivor data would indicate that we ought to see an effect, that's where it pops out primarily amongst kids in the earliest period of follow-up, and for acute leukemias. So that's an example of how the case control study works. Now, I don't have time to go over this in the detail that I'd like to. You can read my thoughts on some of these issues in more detail in the written paper which is going to be circulated to you shortly. Much of this is taken out of the other excerpts in the methodology sections of the BEIR V report that you've already seen. Instead, let me just make two comments. I want to say a few words about low dose linearity, and I want to say a little bit about the greater importance of the various sources of bias and uncertainty in low dose studies as they affect the interpretation of low dose relative to high dose studies. This question of low dose linearity on which all of our risk estimates are based keeps coming up. It was an issue which really tore apart the BEIR III committee, leading to a succession of minority reports. However, by the time BEIR V met, we were able to reach what I think is essentially unanimous consensus that there was adequate evidence now to support the assumption of low dose linearity. Here are the data from the atomic bomb survivors, which are really the most informative on this point. The upper panel is for leukemia. The bottom is for non-leukemia. You can see the substantial nonlinearities at high doses, and for leukemia there's also a hint of a -- well, more than a hint -- a significant quadratic component at middle doses. But in both cases there's a clear linear component at the low dose, and the latest figures which I've now seen for a preview of the RERF Report 12 with follow-up up to 1990 now offers further resolution down here which shows that there's significant increases as far down as we can observe them. Nevertheless, I just wanted to read to you one little tidbit. This comes from a letter from a person at UCLA, a director of a nuclear medicine division there, who writes, "The rabid anti-nuclear terrorists of the pseudo-environmentalist movement have kept this flimsy concept alive," the low dose linearity concept. This point is still debated in some quarters, but in my view, they pretty much represent the fringe, and the mainstream of the radiation production community, I think, has essentially adopted that as far as cancer goes. Now, regarding the greater impact of uncertainties at low than at high dose, here's some hypothetical data. The written paper shows some real data, but imagine that we have done a study at high doses and we've estimated the risk at high doses and some confidence region around that, so that we can estimate a slope of low dose response relationship, assuming linearity, and get reasonably tight confidence bands around that slope. Now, in contrast, suppose we do a study at low doses, and let's assume that we've done a study of the same size and the same quality, so that the estimated confidence limits on the relative risks are still proportional to the relative risk, and then see what's happened to the estimates on the slope. And the point is that the closer that you go down to low doses, the wider those confidence limits become. That's the fundamental difficulty. Well, with all of these difficulties about interpreting low dose studies, is there any point in doing them at all? I think there is, and I've tried to outline in the paper four reasons why we should do these studies. The first has to do with relevance. I don't think any amount of application of risk estimates derived from the Japanese bomb survivors to experts' opinions as to what the doses from fallout might have been would ever have persuaded the population of Utah that they hadn't been subject to an epidemic of cancer resulting from their fallout experiences. Probably we didn't persuade them either, but at least that conclusion has now got a firmer basis for causal inference. I'm going to say a few words at the end about what the implications of that are for compensation in this population. The other use, I think, important use, is the demonstration that there is, indeed, a risk at low doses even if you can't adequately quantify what the magnitude of that risk is. For this purpose I'm going to say a few words about diagnostic X- rays, which I'll put off for a moment so I don't have to keep shuffling slides here. I said I would skip over the pooling study. The comment which I started to make a second ago and stopped myself was there is currently underway a major effort at the International Agency for Research on Cancer to pool all of the world's studies of nuclear workers. Preliminary indications from this, some of it published in various subsets, now indicates that we can observe a dose response relationship within the range of doses that are pretty much covered by current occupational standards. Finally, high risk subgroups. That estimate of the relative risk of 1.04, which I started out my talk with, you need to be reminded that this is the relative risk for all cancers at all ages of exposure for lifetime follow-up. In particular subgroups that relative risk becomes very much larger. In particular, for leukemia in kids at short latencies, the BEIR V estimate of a doubling dose, the dose at which the excess risk equals the background risk, drops to three rads compared to over a couple hundred in the other case, and it's that that allows us to detect a significant effect from fallout in kids in Utah. Otherwise one would say, "What are you doing? How you can possibly detect a risk of rads to the order of two rads?" Diagnostic X-rays. In the late 1980s, two papers appeared in the medical literature attempting to estimate what would be the contribution of medical X-rays, just diagnostic X- rays, not therapeutic, to cancer rates, and coming up with estimates of one percent in one case or .1 percent in the other case. This is not a statement of risk. This is the proportion of cases that are attributable to this exposure. This caused some concern because a colleague of mine, Susan Preston-Martin and I, had recently published a paper on the results of a case control study of CML which we estimated at 23 percent, and based on what looked like a pretty clear dose response relationship. Now, at this point I have to pause and say remember what I said about biases for dose response -- for case control studies. We have two concerns in this context. First of all, recall bias, the possibility that the case controls would differ in their recollections of their past histories even though the dose estimates themselves were extracted from medical records, but more importantly, the likely systematic under-estimation of doses throughout owing to poor technique and repeat films and things like this that aren't recorded in charts. So these dose estimates can't be taken as is, but the fact of a trend is not easily explained otherwise. Anyway, we reexamined the methods of these. We corrected some statistical errors in the papers, and we applied the latest BEIR V risk estimates and came up with an estimate of 12 percent. Well, that's now getting to be substantial. It's not importantly different from the 23 percent estimate. This is very likely both uncertain and possibly biased. So I don't see a major conflict there. A few words on radon. Because of our particular interest in the uranium miners, earlier this year Jay Luben published a major reanalysis of all 11 uranium mining cohorts. It's a beautiful work, and on this basis I can say with some confidence that we really know the dose response relationship for radon with considerable precision at this point. Of all 11 cohorts, by far and away the most heavily exposed were the Colorado Plateau uranium miners. The current standard, 4 wlm per year -- wlm is the unit that's used for measuring radon concentrations -- would over a theoretical 50- year lifetime allow a possible accumulation of 200 wlms, not that anybody seriously works as a miner for 50 years, but that's our benchmark. In contrast, more than half of the Colorado Plateau miners accumulated that level, and they did it on average over about a five-year working lifetime, and substantial number, eight percent, accumulated ten times that level. The levels were just truly outrageous. They paid a heavy price for this. Among the white miners, 329 lung cancer deaths, of which Jay estimates about 60 percent due to radon. An additional 69 deaths in the New Mexico Navahos who were mainly nonsmokers, two thirds of those probably attributable to radon, a total of about 250 preventable deaths. Are today's standards adequate? Not really, in my opinion. Based on the estimates whether you take BEIR IV or the latest NCI analysis, we would guess that this 200 wlm figure would lead to a relative risk for lung cancer of about 2.8. That's substantially larger than we tolerate for virtually any other occupational exposure. Just for comparison, the BEIR V estimate for low LET radiation is also pretty substantial when it comes down to it: 1.8. In my view, the increase in risk estimates both for radon from BEIR IV and for low LET from BEIR V, both of which were substantial increase, fourfold in the case of BEIR V, over previous estimates has not yet trickled down to a revision of the standards, which I think, in my opinion, ought to come down. I'm going to skip over the stuff on background radiation on residential radon in view of time. Let me just say a few words about relevance for compensation. We really need to look at this book. This is the NIH publication that's affectionately known as the radioepidemiologic tables. Published in 1985, it laid out the general principles for how we should go about computing quantities that are relevant for compensation purposes, and the basic concept that's introduced in this book -- well, I shouldn't say "introduced." A few authors had come up with this idea previously, but this is the first real recognition of the idea -- is that of probability of causation. Ken alluded to this in his briefing that was at the last meeting, and it's a little different animal from the concept of risk that we've been talking about. Risk is the probability that if you're exposed you're going to get the disease. Probability of causation says, given that you have the disease and you have a history of some exposure of interest, what's the probability that it was that exposure that caused your disease and not something else? The basic computational formula says you take the excess risk and you divide it by the total risk or, said algebraically here, relative risk minus one -- that's the excess -- divided by relative risk. So you can easily see that if you take a value of relative risk of two, a doubling risk, and you put it into this formula, you're going to get a half or 50 percent. That's what's commonly interpreted as the meaning of the phrase "balance of probabilities" that's supposed to guide us in deciding compensation cases. Ken's commission, the Commission on Catastrophic Nuclear Accidents, added one more element into this, a very useful suggestion, that payment ought to be made on a sliding scale. There shouldn't be this absolute cutoff at a PC of 50 percent because what do you do in the situation when you have substantial numbers of people with modest PCs and nobody over 50 percent? Then nobody gets compensated, and yet there's still a substantial burden of disease that was caused by that exposure. Now, the Radiation Exposure Compensation Act, I'd say, was loosely based on the NIH tables, and I have a couple of minutes. I think I can say why I mean "loosely." Let's go back to the Utah fallout data. Now, this data did not become available, it wasn't published until after RECA was passed. So it was not part of the deliberations that led to forming that. The high dose group here is Washington County in the southwestern corner of Utah. In southwestern Utah, 15 leukemias occurred, of which we estimate probably something like about six to eight of them were attributable to fallout. This is small numbers, mind you. It comes back to Eli's comment, I think it was, a moment ago about distinguishing relative risk from absolute risk. Nevertheless, we would assign a PC of something like about 40 percent to those based on our own study data, or if we use the bomb survivor data as the basis for risk assessment, we'd still figure 20 percent, and you might well argue that the uncertainties in these estimates were such that "what the hell? Let's go ahead and compensate and let's not quibble about whether it's above or below 50 percent." In the rest of the population, we figured probably something of the order of 60 cases might have been attributable to fallout, although individually their PCs would all be very small, and it would be difficult for any of them to make a claim. Well, here's what RECA looks like. Here's a map of Utah, and here's Washington County down here with a mean dose of about two rads, and this dark line here represents the region that RECA carved out as being anybody who lived in this period for a certain minimal length of time was eligible for compensation. And generally speaking, it's safe to say that doses were, indeed, higher here than they were elsewhere, but there are a few anomalies. Sevier, Piute and Beaver Counties, for example, all have less than .3 rad, which was actually lower than our estimate of dose for Salt Lake. They excluded Salt Lake for obvious reasons, thinking about what the bill might have been. (Laughter.) DR. THOMAS: Now, although even Salt Lake, of course, is still low; it's only .34. RECA also added criteria regarding cause of death, the particular cancer sites. Now, we only studied leukemia and thyroid which a priori were the two biggest concerns. So we can't say anything about the other causes. Instead, I've relied on the bomb survivors. The blue stars here indicate the sites that were singled out in RECA as subject for compensation, and these lines represent the latest estimates from the bomb survivor data about the relative risks and their confidence limits. You can see that there's a rough correspondence between them, but there is some interesting anomalies. RECA picks out pancreas, for example, for which there's very little evidence, and they set aside lung and the various reproductive organs, female reproductive organs. So that's why I said "loosely based." Well, let me just conclude by saying I hope I persuade you that there is at least some scientific basis for the principle of low dose linearity and that the present approach that we use for risk estimate at low doses has some basis, and it's probably unavoidable based on the difficulties that we've talked about about measuring low dose risks directly. Low dose studies are fraught with all kinds of problems which I've only been able to touch on. Nevertheless, I think they do have their uses, and they're important to do. These studies need to be considered each one on their own merits, based on a critical reading of the methodology. It's not right, I think, to take all low dose studies and simply dismiss them as being impossible from the word "go," nor should you just blindly accept each new claim of an excess risk at low doses without carefully looking at its methodology. And finally, this is such a highly polarized field that it's really essential that we keep an open mind about all of these issues. I'll stop there. CHAIR FADEN: Duncan, don't go anywhere. We'll ask you a few questions. Thank you again, and now Henry wants to say something. I'm sure of that, but we'll keep an eye on the time. We're a little behind, but I think we can take some more questions, and again, it's just delightful for me to see the expertise that we can rely on as we work through our tough projects. Henry. DR. ROYAL: I'll try to make three quick comments. One of the things that troubles me about low dose studies is the choice of the population that scientists study. As Duncan alluded to, it's very difficult to measure the effect because the effect is small. So there are some inherent problems with measuring the effect. From a scientific point of view, the populations that you would like to study are the populations in which the dose is well known because you have less error in your dose and, therefore, that will make the certainty of your conclusion greater. Yet when we hear about the low dose studies that are done, like the thyroid study, for example, we're talking about reconstructing a dose by asking people what they ate 20 years ago. So there's a lot of uncertainty in dose. So maybe one of the things Duncan could comment about is the choice of populations and whether or not he thinks science should play a role in the choice of populations. The second comment has to do with a statistically significant difference versus a difference which is important from a health point of view. For example, if my risk of thyroid cancer increases from ten percent to 10.001 percent, it may be that I can prove statistically that there's a significant increase in thyroid cancer, but what does that all mean in terms of whether or not that's a public health risk? And the last comment I wanted to make was, Duncan, we've heard several times about the reanalysis of data, and one of the things that troubles me about the low dose area is I don't personally have the comprehensive background that you need in statistics to decide whose analysis to believe, and it troubles me that I can predict what the results of an analysis is going to be more by knowing who the statisticians are than by looking at the statistical results. So those are my three comments. DR. THOMAS: Good comments, all of them. Populations. I guess we do science driven by a variety of reasons, and some of them are scientific and some of them are political. Let's face it. The fallout studies were driven more by politics than by science. Despite the political ramifications of doing the fallout studies, still I think it was good science in the end. It didn't start out as good science. It took some work to give that study some credibility, but one of the crucial things that makes that study credible, I think, is the quality of the dosimetry. Now, it isn't quality in the sense that you might think of it in terms of the dose estimates that you can come up with from a medical procedure, but you really, I think, have to appreciate how the art of historical dose reconstruction has progressed. One thing I neglected to say is that each dose estimate comes with an uncertainty estimate around it, and those uncertainties are part of the epidemiologic analysis. Two is the population on scientific grounds. I think the two most desirable populations are medical patients and occupational exposures. In both cases we have some basis typically for measuring doses, and a lot of that is talked about in the reports excerpts that I talked about. The second point -- what was the second point? DR. ROYAL: Statistically significant versus -- DR. THOMAS: Yes. Okay. I think I agree with the point completely. I disagree with the example. You shouldn't have said ten percent increase to 10.001 because that wouldn't have been a significant result to begin with. What you really want to do is use Eli's example, which is of very, very low absolute risk, you know, ten to the minus fourth risk which is doubled or tripled and because we can actually study this kind of risk in relative terms very easily, it's highly significant, but still remains even in the heavily exposed still a very, very low absolute risk. This is a story that every time I give a press conference or something I have to deal with this question. We had it come up with hot dogs recently. (Laughter.) DR. THOMAS: The final point is -- CHAIR FADEN: You mean we can eat hot dogs? DR. THOMAS: What? CHAIR FADEN: We can eat hot dogs, Duncan? DR. THOMAS: If you're prepared to accept a small risk. CHAIR FADEN: Just so we know. We just want to get clear. DR. THOMAS: And then finally, yeah, there clearly are charlatans out there, and I don't know what kind of advice I could give to a nonstatistician to say, "Have you criticized those methods?" You have to go to somebody who really is capable of looking at the methods and figuring out what they've done wrong. CHAIR FADEN: Are there other questions for Duncan? (No response.) CHAIR FADEN: Duncan's paper will be circulated. DR. THOMAS: Yes. CHAIR FADEN: During the break, and it's well worth reading. I've had a crack, which I will need to recrack again. We take a break now. Thank you very much, Duncan. We appreciate it, and I hope you weren't too cold up there. The air was blowing right on you. We will take a break, and we're going to try to reconvene in ten minutes. (Whereupon, a short recess was taken.) CHAIR FADEN: We are going to start with an update on agency data collection efforts. I'm going to do it in the interest of efficiency, but this is my understanding having worked now for many, many hours with many members of the staff in trying to assess where we are. So Dan and I have gone through this, and we've gone through it with all of the relevant people on our staff who have been involved in working with the agencies under the direction of Dan and Don Weightman. Here's where we are. Let me take it agency by agency, and then after I've done all six agencies take questions if we feel we need them, but if not, we can go right on to the panel, which I think will be interesting. There's no material in the briefing book that corresponds to what I have to say. So let me just run through this real quickly. First, with respect to HHS, we are working with HHS in three areas. First, we are working with HHS to have them help us flesh out more of the details of the history of research regulation so that we can provide as rich and complete a context as we can for looking at the problems before us. So HHS is helping us try to understand better the origins and development of regulation of research involving human subjects where, at least for a big bulk of the time period in interest to us, HHS in the form of HEW was the lead agency. The second area where we're working with HHS is in fleshing out the Cold War story. We're trying to assess whether, to what extent, and in what ways we can eliminate the Cold War dimensions of the human radiation experiments from the HEW/PHS side. Here basically HHS is following on our lead. We're trying to pursue trails that link PHS and other agencies with the DOD and NRC, both the activities of those two agencies and the actors involved in those two agencies. So we're trying to put the pieces together. The lead agencies obviously in these arenas are DOD and NRC, DOE. We're trying to put it together with the PHS history that's going on at the same time and see what we can come up with. We're just beginning to try to put the pieces together there, and hopefully we'll have more to report later. Finally, we have just recently begun working with HHS on our projects that relate to the contemporary period. People at HHS have been very helpful in helping us begin to think through the protocol review project that we approved at our last meeting. We're going to be meeting with them again this week. This is Monday, right? We're going to be meeting with them this week to see if we can start to develop some more of the details of how we might pursue the protocol review proposal that we will be talking about tomorrow, but that we approved last week. So that's HHS. The second agency is NASA. As we discussed last meeting and as we are about to hear today, NASA's role in the Oak Ridge total body irradiation study is of significant interest to the committee. We're continuing to pursue this issue, as well as others, with the agency. A central problem in regard to dealing with NASA is the apparent destruction of critical materials about the TBI studies in 1980. The records were apparently destroyed according to standard retention record policy. So we're not suggesting anything nefarious here. It's simply that we don't know the dimensions of the problem that it may pose for us, that some critical records relating to the TBI studies supported by NASA are just no longer available. Some material is, and some isn't. Another topic which we're actively pursuing with NASA is the evolution of the agency's own regulations and practices concerning human subject research. Of particular issue here for us are issues of timing, as well as whether and to what extent NASA adapted or adopted the rules or procedures of other older agencies at the time that it started to become involved in human subject research. So we're working on those themes. I've got to get my pieces of paper together for this next topic, which is the CIA. We circulate this. We continue to work with the CIA in two arenas. First, we are continuing to work in establishing the agency's own experiences with respect to human subject research, and second, we are working with the CIA to help us set the context for our project overall. With respect to CIA specific issues, you may recall that at the last meeting Gary reported on the CIA regulation governing research involving human subjects that had within it several classified lines, if everybody remembers this. We formally requested the declassification of those lines, and I am here to report a victory. The lines have been declassified. I shouldn't put it in such bold terms, but it's been very delightful to get this response from the Central Intelligence Agency, and what I have circulated for you are the lines. I will read them to you. The lines that were blocked out in the copy we had last time read, "OGC, Office of General Counsel, has determined that the conduct of polling activities does not fall within the definition of research on human subjects," and that was what was classified on the document when we received it the last time. Now, the operative term here is "polling," and so we went back to the CIA and said, "So that there is no ambiguity, what is your definition or account of polling?" You may remember Gary said that the lines were classified because it referred to an intelligence method, and it was that method that the CIA was concerned about revealing. The method is polling. We asked the CIA to give us a definition of polling or an operative account of polling, and here's what we have been told. We were not given or we have not yet obtained a specific explanation or definition. We were told that it is somewhat analogous to the type of work that a political analyst would do. That's about all we could get; that when we are cleared, and a few of us now have just become cleared, we will be able to get a more specific explanation, those of us who have clearances, of what polling specifically entails. (Laughter.) CHAIR FADEN: It's important. You know, I reported last time that we had requested that material be declassified, and some declassified material was coming to us, but we couldn't trace whether these were agency initiatives on their own, that is, they were in the process of declassifying things anyway, or whether they were specific responses to our requests. Here we have an unambiguous specific response to a request for declassification by the committee, and we received it in a timely fashion by the agency. So in that sense it's very encouraging. The phrase now in ordinary English is not terribly illuminating until we understand a little bit better about what polling is, but given that we have been told that it is all right to say that it is roughly analogous to what a political analyst would do, that may give you some sense. And those of us who will be looking at more CIA materials will be able to ponder further. Now, you may also recall that at the last meeting we directed Gary to ask the CIA to tell us the extent to which they are currently involved in research with human subjects, including any research that is, in part or in whole, classified on any topic, not specific to radiation research, again remembering that the CIA has done an extensive review, not by their own account perfect review, but as best as they can determine, that they believe they have never been involved in human radiation research. We then went back and said, "Okay. Tell us what research you are currently involved in," and we asked them from 1990 to the present, what research involving human subjects you are currently doing on any topic. The CIA has reported to us that it's still reviewing its records on the current human experimentation of any kind, but so far the CIA is not aware of any current experimentation dating back to 1990. So we are pursuing that, but right now the position of the CIA is so far they haven't found that they are involved in any research involving human subjects. It should be pointed out the CIA is saying that they're still looking. So that's a preliminary response. We should not consider, for example, a reversal at the next meeting that we report that they have, indeed, identified some human subject research that they are sponsoring or conducting. So that's where we are with respect to those dimensions of our work with the CIA. In terms of context setting, we have asked the CIA for any records that they may have bearing on the green run or other intentional releases, as well as records about national security threats or foreign activities that may have prompted other agencies of the government to consider human radiation experiments, and an example of that would be information that the CIA had, for example, on human radiation experiments conducted by the Soviets. So this is an attempt to help us better understand what might have animated an interest in human radiation research on the part of our government by learning from the CIA what kind of information they were providing about relevant nuclear military threats from the Soviets or other sources. We have not yet received any material from the CIA on these topics, but we expect that to be forthcoming. Let me move on to the Department of Defense, and I'm missing one little piece of paper, but I'll find it. There we go. We've got it. Thank you. These little pieces of paper are critical. For all our fancy technology we're still reduced to handwritten notes at the last minute. All right. With the DOD we're pursuing several interesting trails or leads. We're very keen, for example, to determine what happened after the 1953 Secretary of Defense policy, which we have now all looked at and pondered. In particular, we want to know was the policy implemented, and if so, how it was implemented and for how long. We want to know whether there was compliance with the policy, and if their claim is there was compliance, how was it monitored, and we also want to know how the implementation of roles by the Department of Defense compared with the implementation efforts on the part of the AEC and the Public Health Service. Now, we do now know that the headquarters or that there are policy and program documents in headquarters offices that are really a rich source of information. We've already gotten some documents, but these relate primarily to the early period, the mid-1940 to the 1952 period, and we're keen to get more such documents from headquarters offices in the Department of Defense for the time period after the early 1950s. It's clear that we can learn a lot from looking at headquarters documents on this issue of implementation of compliance with human regulation research requirements. We're also pursuing the issue with the DOD of whether and how experiments were constructed to serve what might be referred to as narrowly constructed military purposes. Phil rightly reminded us at our last meeting that there is clearly a meaningful sense in which all research supported by, for example, an agency like the Department of Defense can be claimed in the end to serve some military purpose. We are now here thinking of, however, more narrowly constructed senses of military purposes, where the research is supported specifically because there's a short-term, very clearly military linked agenda, a purpose or rationale for wanting to get the answer to particular questions. We're trying to see if we can establish that for any program of research or for any particular research. Also, in line with that, whether any military purposes narrowly constructed, wherever debated and defined or refined in secret, and if that was the case, how the experiments were then presented to the subjects if the purposes were in some sense debated in secret and to the general public. Also high on our list with respect to the Department of Defense is ascertaining whether and how biomedical research was connected with bomb tests. So we're trying to pursue that angle as well. Now, we have received materials from the Department of Defense that bear on at least some of these issues, but it should be noted that the DOD continues to be behind in responding to our outstanding requests. For example, the Defense Nuclear Agency has still not complied with the research directive which was issued by the Pentagon in January, and similarly, while the Army has told us that it has identified about 1,000 experiments that could be understood as human radiation experiments, we have not yet received information about these 1,000 experiments. Now, over the past week, we have had consultation with the highest levels of the Pentagon on this topic, and we have been assured that we will see these problems addressed and remediated in the next couple of weeks, which is not the same, of course, as saying that the DOD will give us everything we want in the next couple of weeks. That would be impossible, but that the problem of a flow of documentation will be addressed at the highest levels of the Pentagon, and we should be seeing a high volume of material between now and the next meeting. So I'm feeling confident that we will be able to attack the issues, the trails that I described briefly. Moving on to the Department of Energy, we're obviously continuing to work on many interesting issues that bear on the DOE, and of course, DOE predecessor agencies. At the moment we are trying to establish specifically how far the Department of Energy has been able to get with what has been referred to as their Phase 1 plan of identifying the relevant records of all of its field and headquarters sites. Just last week we received a stack of what are called record series guide descriptions from the Department of Energy which summarize the numerous records -- we're not sure exactly how many yet -- at multiple sites. So we've gotten this wonderful stack of sheets that basically summarize holdings, if you want to think of it as a library, at all of the field sites and headquarters, as well, and these guides look like they will be very useful. But what we need now is to establish some sense of what the guides represent, basically how much has been canvassed, and how much is left yet to be canvassed, and also some sense of whether the bulk of the canvassing can be completed in time to be of use to us, and if the answer is it can't be done in time to be of use to us, then what alternative strategies do we want to use for deciding how to attack the vast amount of material that the DOE holds that could bear on the work of this committee. On another note, again, in line with a record destruction problem, it's not clear how compromised our research will be by the finding that a presumably important collection of the Intelligence Division was reportedly destroyed around 1980. We don't know what to do with that yet. It's hard to know the worth of something that doesn't exist any longer, but based on other evidence, there is reason to think that that collection would have been important to our work, and we'll just have to figure out as we proceed what it means that we do not have it available to us. The last agency is the VA, and again, there are several interesting trails at the VA, including the Atomic Medicine Division, the role of VA in relation to DOD facilities, and the implementation of human subject rules, either VA's own rules or VA's adoption or adaptation of those of other agencies. We're just starting to sort that out. VA has only recently begun to actively search central office records, but VA has committed to completing its review of records at Suitland and at the national archives within 90 days of last Friday, and to share the materials with us on a bi-weekly basis. So we were very encouraged by that communication, and we expect, again, here as well to see a huge increase in the flow of documents between now and the next meeting and then for a couple of months thereafter. We also hope that within the next 90 days the strategy for searching field sites -- VA, like DOE, has numerous field sites where there may be materials of direct relevance to this committee -- that the strategy of searching at field sites also will be refined and implemented within that same 90-day period. So a lot of staff work behind my brief report. Reed. DR. TUCKSON: The HHS data, originally we were told that just the enormity of the amount of it made it very, very difficult. Can you give us a sense of whether or not things have been reduced to a more manageable size yet in that? CHAIR FADEN: Well, I'll tell you what's happened. At our request, we've kind of put to one side temporarily the large problem of how to deal with the huge number of studies over the decades that HEW and HHS has supported in the area of research involving human subjects and ionizing radiation and decided for the near term to concentrate on the historical issues with respect to research regulation and the connection between HHS predecessor agencies and the DOD and DOE, and at the same time move to the contemporary situation where HHS is in many respects the lead agency. What we're going to do in the middle is this big sampling problem, which we hope to talk about as a committee tomorrow. Obviously other agencies, the Department of the Army, for example, where I made reference to 1,000 experiments, if in fact that's correct, will also pose sampling problems for us. But if we could just hold off, we haven't solved the problem. We've just basically told HHS, "Don't worry about it for right now until the committee reaches some sense of how it wants to deal with the sampling issues. We'd appreciate your putting your energies someplace else." So we've tried to reduce everybody's stress by ignoring it temporarily. DR. TUCKSON: Second, and since we'll have more time to talk about it tomorrow, but just a sense of the staff is really becoming very well organized. I mean it's getting in place. It's becoming more efficient. I know they are. (Laughter.) CHAIR FADEN: You have faith. DR. TUCKSON: I have faith. CHAIR FADEN: Good. It's well founded. DR. TUCKSON: When you describe that in several of the agencies that you've kind of unblocked some obstacles and there will be a huge flow of paper, what are the implications of that flow on our current steady state? CHAIR FADEN: Do you want to get that, Dan? MR. GUTTMAN: It should be manageable. Frankly, we had anticipated there would be a huge flow earlier than now. So hopefully there will be a lower body of people listening to Duncan Thomas' erudite comments the next time Duncan gives them. We hope to manage it. We hope it will be manageable, yeah. CHAIR FADEN: Jeff will give a brief overview of who's doing what and how the management of new documents is being processed, but it's a fair question. We hope we're up to the challenge, but we would like to be challenged. I mean it would be fine. Please don't worry, agencies, about sending us too much material. We'll find a way. Yes. MR. GUTTMAN: If I may, the message should be that we're in a position where obviously we're not getting everything that's out there, but we know that there are very useful, rich collections, not simply names of experiments, but the word that Ruth used is "trails." We know that there are basic questions that are answerable from documents that are in the files of the Defense Department. It's just a matter of getting access to them. And the question is, you know, part of it is there are a lot of documents out there. Part of it is the manpower, person-power, but we hope to get them, and the questions are there so that if we don't answer them, the people out there in the audience know that there are questions and there are answers in the documents and they'll be gotten, and that's why we want to push as far as we can. CHAIR FADEN: Are there other questions? We can revisit specific issues relating to the flow of information from the agencies as that bears on our work as a committee tomorrow when we try to put the whole thing together with respect to our own work loads and responsibilities. But maybe at this point we can go on to our panel. I don't know if anybody -- okay. That seems fine. I don't know if anybody has noticed, but the air has, I think, now been turned off. So we have gone from freezing situation to no air flow. It appears as in many aspects of life, we have only one extreme or the other. I don't know. Maybe we can sort of deal with it for right now and ask them to turn the air on while we're gone at lunch full blast, and then turn it off when we come back in. We'll try to deal with the climate control problem one way or the other. We now turn to what I think will be a very engaging part of our committee work, which is the chance to hear from three of our staff members, Jonathan Moreno, Gregg Herken, and Dan Guttman, on as Dan has been fond of saying three sides of the elephant. Three of these people have been working hard with other members of the staff in trying to make sense out of that period from the mid-'40s to the very early '50s that bears so significantly on the origins of our concerns, and you will now hear from each of them about how they are starting to put or have already put together what seems to each of them to be some of the key dimensions of that history. Do you have an order about how you're going to go? MR. GUTTMAN: I think it's Gregg and John and myself. CHAIR FADEN: Would you prefer that we wait to hear from all three of you and then ask questions? Why don't we do that if that's all right? It might be that the question that you're asking is going to be answered by the next presenter. So if we could hear from all three, and we'll hold our questions. Gregg. DR. HERKEN: Since you have a draft outline for telling, what I'll emphasize is the early story of human radiation experiments. I'll just go over some of the major points in my summary. The story begins with the Army's efforts between 1942 and 1947 to gauge the danger of internal and external radiation to the workers building the atomic bomb. Due to the pressures of war and also the wartime secrecy, the kind of oversight that later governed human experiments, both as to the procedure and as to the consent of the subject, did not apply in this case. By the war's end, the Army had proposed a large-scale, programmatic series of human experiments aimed at determining the risk represented by a number of radioactive substances. The Atomic Energy Commission, which inherited this program from the Army in January 1947, initially endorsed it. However, because of objections to the Army's wartime human experiments, these objections being raised in late 1946 just at the time of the transition to the AEC, the Commission at first postponed and then evidently abandoned this ambitious program. Instead, between January and November 1947, the AEC creates an extensive bureaucracy to monitor and approve biomedical research involving atomic energy, including human experiments, as well as a series of regulations governing those experiments. This regulatory mechanism included at the top the Division of Biology and Medicine and its oversight body, the Advisory Committee on Biology and Medicine. Below this level it included the Advisory Committee on Isotope Distribution and its watchdog, the Subcommittee on Human Applications I've previously mentioned. We know from the documents that almost immediately this regulatory mechanism was besieged by various interests wishing to do human experiments. This included most prominently the military, which was vitally interested in finding out how radiation would affect soldiers on the battlefield, as well as the air crews flying nuclear powered aircraft. But there were, as well, numerous requests for isotopes from independent researchers, principally physicians. The staff has various documents which show the AEC's regulatory mechanism at work. Perhaps best documented is the AEC's rejection of the military's request that it be allowed to carry out human experiments as part of its NPA or nuclear powered aircraft program. Other documents, some of which are included in this briefing book, show the AEC's reprimand of individual physicians for the improper use of radioisotopes or for questionable therapeutic use of TBI. But it is also clear from the evidence that the AEC's regulatory mechanism worked, at best, imperfectly and that oversight may have been lacking on the part of the AEC on the matter of consent. It appears, moreover, that loopholes existed which were exploited by researchers. Perhaps chief among these were unclear lines of authority in competing jurisdictions within the AEC itself. An example is the fact that Shields Warren, the head of DBM, and Alan Gregg, the Chair of ACBM, had both spoken out against human experimentation by early 1949. Yet the Advisory Committee on Isotope Distribution, which was part of the AEC's Division of Research, was at this same time actively promoting the use of radioisotopes in medicine, and a majority of its oversight group, the Subcommittee on Human Applications, were themselves veterans of the Army's wartime plutonium project. Indeed, the AEC's own Division of Miliary Applications contained perhaps the most consistent and vocal lobbyists for human experiments, and that was the head of its Radiology Branch, General James P. Cooney. Another loophole existed in the degree of autonomy the AEC permitted its contractors. Early on in 1947, the AEC encouraged contractors to, quote, exercise their own initiative and to devote part of their time to pursuing lines of research which appear fruitful to them, unquote, allowing up to 15 percent of a contract be spent in this manner for that purpose. This 15 percent clause was later cited by several contractors as justifying experiments conducted by them outside the terms of their contract. Finally, in some instances AEC contractors justified their actions on the grounds of professional discretion or autonomy. Robert Stone, a radiologist at the University of California, San Francisco, was reprimanded by the ACBM, by Dr. Gregg, in 1948, repeatedly reminded the commission that the choice of patients and the selection of methods of treatment were his prerogative as a physician in the employ of the university and could not dictated by the AEC. For the future, the staff has identified three possible test cases for its hypothesis that there were ways around the AEC's oversight of human experiments. The first of these is a zirconium injection that occurred in January 1948 that only recently came to the attention of the staff. This case affords us an opportunity to see whether the isotope approval process, which was well in place by that time, was followed and also whether the rules governing informed consent, which had been put in place the previous November from recent documents, whether those rules were adhered to. A second test case involves an appeal directly by a researcher, John Lawrence, to the Advisory Committee on Isotope Distribution following a rejection of his proposal by Shields Warren and DBM. This case is also detailed in your briefing book. So I won't go over it here. A final case will be a test of the hypothesis that human experiments involving TBI were by their nature more difficult to regulate than those involving isotopes. In particular, the staff is interested in finding out in the case of the NPA or nuclear powered aircraft story whether the TBIs that were forbidden on healthy human subjects might have been subsequently carried out on patients under the guise of therapy. CHAIR FADEN: Thank you, Gregg. Jonathan. DR. MORENO: Thank you. The Advisory Committee will find in Tab G our update on ethics data gathering and also a draft summary of the history of ethics policies relating to human radiation experiments in the DOD and AEC between 1942 and 1954, in the tab that you should be in now for this panel. Rather than summarize my summary, I would like to try to put as fine a point as I can on what the staff can express with confidence about consent standards in the period we're talking about in this session. I've already reported that the concept of informed consent, the relatively rich and highly articulated concept of informed consent, with which we're familiar today cannot in a nonanachronistic fashion be used to characterize what happened in the period that we're talking about. Nevertheless, it is clear that ideas of voluntariness and ideas of consent, even the language of consent, were around in this period. Sometimes rather than using the word "consent," the word "release" is used at the top of a form, release from legal liability, I suppose, but nevertheless, those concepts are not only in the air, as I want to underline in my presentation, but were actually thought to be critical for at least a couple of populations by the time we get to 1950. The expression that I prefer to "informed consent" to characterize the concept that was at hand in this period is "voluntary consent," appreciating the redundancy in that expression. Nevertheless, even that expression, I believe, we find in some of the documents that we've been looking at. And the attitudes that I'm going to describe very briefly can be seen at the highest levels of the most responsible people who we've been talking about and reading about in the last few months. These are not attitudes that are controversial, at least in the first couple of instances I want to talk about. They seem to be well received. To begin with then, the category of normal volunteers, and I must admit after Duncan's both substantively and formally elegant and quantitative presentation, I'm a little embarrassed to have to recur to ordinary language and a piece of paper. Nevertheless, under the category of normal volunteers, it's quite, quite plain that what we would call normal volunteers were individuals from whom it was felt that voluntary consent was required. This was not, at least from the point of view of the attitudes that have been expressed in the documents that we have seen, documents of various kinds, this was not a matter of serious -- of any question, any question. Now, at least by the time of the Subcommittee on Human Applications in 1948, as Gregg mentioned, when we're talking about people who were very sick and we're discussing the question of exposing them to larger doses for investigative purposes, at least at that time it was also the position of that subcommittee that voluntary consent was needed. I gather from what I've read that these were not instances in which it was felt that there could be any argument that there would be therapeutic benefit, but these were investigative purposes. In that case, again, voluntary consent was needed, and that was clear, at least in '48 in the Subcommittee on Human Applications. Now, when we turn to other categories of people who were sick, with regard to other categories of research, the situation isn't so clear. With regard, for example, to tracers within safe limits and with regard to interventions, exposures that could arguably be considered potentially therapeutic, perhaps with a lot of flexibility in the concept of what counts as potentially therapeutic -- and I want to be careful in the way I state this -- we don't have any evidence yet that there was an attitude that consent was required in those kinds of instances. But these four categories, I think, express clearly what we think was the case with respect to the attitudes of the most responsible officials in the period that we're discussing in this session. Now, people may want to discuss that a little more, and I have to say that it would be inappropriate for me to suggest that this summary relies only on the work that I've been doing. All the junior folks and the historians and Dan and Gregg have been terrific in helping all of us to put this summary package together, but I think that this underlines what we feel very confident that we can express from our work in the last few months. Let me perhaps just add one detailed report, and I have to apologize. We got a document at the end of last week, and on Friday some of us were reading it. I didn't have time to write it up yet. I promise the Advisory Committee that I will do that this afternoon and distribute it before you leave, but this is a document that goes, again, to the question of what policies people thought should be in place in this period. And we've told you this very interesting story that we were piecing together about the intensive discussions within the Department of Defense in 1952 and '53 that culminated in the February 26th, 1953, memo by Secretary Wilson, which in effect implemented or sought to implement, I should say, the Nuremberg code as the standard for human research in the Department of Defense. On February 27th, 1953, we now have a transcript from a February 27th, 1953, meeting of the Committee on Medical Sciences, and the committee, as you might recall from my previous presentation, was one of the entities that we in the thick of the debate about what kind of policy the Defense Department ought to have concerning the use of human subjects, and if I might, I'd like to read just two paragraphs from this transcript where one of the service representatives is expressing what seem to be on reading the transcript a prevalent opinion within that committee, and remember this is one day after Secretary Wilson has signed off on his memorandum. This representative, who happens to be from the Navy, is saying, "In connection with the human volunteer problem, in general, I think we've all discussed this for the last six months at all levels in the Department of Defense. There is one thing that disturbs me a great deal and that is at the DOD level and at the Medical Policy Council level there is a strong urge to try and set up an overall policy for the conduct of human experimentation. They even go back to the Buchenwald trials, and they are trying to work out an overall pattern that will, if you meet this pattern -- to me this is utterly fantastic as a method of approach. "As far as the Navy is concerned, I've cleared this with Policy, and we want to strongly urge that human research be conducted as it is now outlined from a policy standpoint, namely, that the field or the individual or the groups who want to do the research prepare a complete experimental design, showing exactly what they want to do, what the safeguards are going to be, what the program is, and why it has to be human rather than animal, and so forth, and then come in and be evaluated by the Surgeons General involved in the Army, Navy, and Air Force, and then that go up to the Secretary informed for final permission. This is the way we're doing it now, and I think we're going to get into a horrible mess if we try to set up an overall standard for every kind of research. What happens is that you put so many safeguards on that we cannot do the multitude of things that we are trying to do." Now, what I take to be the significance of this statement is, again, that it's not a question of, as Dan has pounded me over the head to point out, it's not a question of having no policy. There was a policy. There was today what we would call perhaps a procedural policy. The process was assessment by the Surgeon General of that service with a sign-off by the Secretary in that service and perhaps going up to the Secretary of Defense himself if necessary. It is not as though there was no policy. There was a procedural policy, and the debate was whether there ought to be a more highly articulated, if you will, standard, substantive standard than that. CHAIR FADEN: Thank you, Jonathan. I hope we can all keep this. Between Gregg's presentation and Jonathan's I already have 20 questions, and I heard this before. MR. GUTTMAN: I was just going to say I'll probably blurt out something you haven't heard before, much to my -- CHAIR FADEN: You're right. MR. GUTTMAN: This is a big elephant, and my overview -- and you should all know that we have continuing dialogue, debate, discussion. It turns out that Gregg is, I guess, the political historian, and I didn't release I was a social historian until we got into our discussions, and Jonathan, of course, is an ethicist. What I take from Gregg and Jonathan, subject to their rejoinder, is that, first of all, in human experimentation there may be rogues and undoubtedly there were rogues out there, and Gregg was suggesting some loopholes, but we're talking about mainstream conduct with mainstream American actors, both in the medical community, in the bureaucratic community, in the military community, in the political community, and there were, therefore, high level, serious debates about experimentation, why, when, who, and what. What Jonathan is, I think, saying is that the notion of consent -- and this is where I begin to be very careful as I look at Ruth at the other table because I don't want to say what that notion is -- but there was at the highest levels of the Cold War bureaucracy some understanding in paper on occasion, very important occasion, of voluntariness, disclosure, consent, and an issue may have been the boundaries, exactly who got the benefit of this, and under what circumstances did you define something to be an experiment as opposed to, for example, just therapy. The question or the issue or the part of the elephant that I'm looking at now is, as I would characterize it, if at these high places so many responsible people had such a continued concern about experimentation and, indeed, discussion of the standards, what happened? Why didn't it percolate or why didn't it trickle down or why wasn't it translated throughout the system? And this, I think, it's clear to me and probably all of us is an extraordinarily contemporary situation because we're dealing with questions of bureaucratic implementation, the relationship between grand policy by great people and actual action, and we're dealing with various cultures which are as real today as they were then, cultures of secrecy and openness, the cultures of medicine and politics, the cultures of bureaucracy. We can name them, but they're all clearly at play. And I would just like to run through very briefly sort of a summary of thread or needle through what we've heard, the kinds of pieces that we have to put together these pronouncements with why it is somehow we're all here because maybe something didn't happen at the bottom of the totem pole, and let's just take the AEC and the Defense Department. In the AEC, Dr. Siegel, I think, I noted it said the Sub Human Committee got started in '48. I guess our documents show that the Sub Human Committee, that is the Committee on Isotope Allocation, got started before the AEC was started in '46, so that as early as 1946 when you still had the Manhattan Project, there was a committee set up to figure out how to distribute isotopes. In '47, when we started this committee two or three months ago the Department of Energy gave us what was then thought to be the governing document on consent policy or ethics policy in the area that we're interested. It was an April 1947 letter from the General Manager of the AEC to basically universities that were going to get contracts, and it said that the governing rule is that you have to have doctors in attendance certifying to the bona fides of the experiment, and in that document it noted that this was an issue that was percolating because, for example, Oak Ridge was about to develop a very ambitious program in cooperation with universities throughout the country such as we know has developed. Well, we have in our briefing book a very interesting -- the question is: what happened? Did that policy get put into effect? And two months ago people would have said, "Yeah, that was the policy." Well, in our briefing book we have very fascinating September and October memos, 1947, from Oak Ridge basically writing the headquarters saying, "We're getting started. We've got some real questions," and they're not so much ethical as they're programmatic, development. You know, if we contract with universities, who's responsible and so forth an so on? And they want answers. And one of the fascinating aspects of this memo is it makes clear that while the question of whether or not we should experiment is an issue and the question of medical or scientific risk is an issue, there is another, in the current vernacular, driver, and that is the AEC Insurance Branch, the question of risk in terms of being sued, and on page 8 of this memo, there's an elegant summary about a lot of things we can keep secret because of security, but there are some other things that are pretty embarrassing that aren't worthy of being classified, like papers that bear on levels of soil and water contamination, idle speculation on the future genetic effects of radiation, such as, I guess, took place here. "Papers dealing with potential process hazards to employees are definitely prejudicial to the best interests of the government. Every such release has reflected an increase in insurance claims, increased difficulty in labor relations, and adverse public sentiment. Following consultation with the Atomic Energy Commission Insurance Branch, the following declassification criteria appears desirable. If specific locations or activities of the AEC and/or contractors are closely associated with statements and information which would invite or tend to encourage claims against the AEC or its contractors, such portions of articles to be published should be . . . deleted. The effective establishment of this policy necessitates review by the AEC Insurance Branch, as well as by the Medical Division prior to declassification." So there at the heart of the AEC's development of policy, this notion of insurance risk in relation to openness asserts itself. So what happens -- and this is briefer than it will appear -- is we then have the document that Jonathan talked about at the last meeting which we uncovered. In 1951 someone wrote the AEC and said, "We're going to do some human experimentation. What's the policy?" And in 1951 that person at Los Alamos gets a letter back from Shields Warren saying -- I've dug out our records, and I see that in November of '47, right after this Oak Ridge memo, there is a Carroll Wilson, General Manager, letter to Robert Stone, the aforesaid Mr. Stone from the University of California, which says that the patient give his complete and informed consent in writing. So then one might think that was the policy of informed consent, but my part of the story is: so what happens? Well, we look back again at this '51 letter, and we note that it doesn't say, "This is the rule. Here's a piece of paper where it's stated." It says, "We kind of urge you, Los Alamos. Kind of think about it." And you say: well, what's happening here? Well, then you begin to realize as people write in after '47 about experimentation, they're referred to the Isotope Branch and then to the Subcommittee on Human Applications, which is an entity independent or at least alongside of the AEC Division of Biology and Medicine, which is directly concerned about risk in the medical sense, which in its grant proposal says if you're going to do something, you should have a doctor there, which has a lot of consideration, as Jonathan's paper points out, about certain kinds of populations, children, but does not appear to directly address this question of, quote, informed consent in any express, head-on way. So there's an obvious question of where in the AEC bureaucracy does this question which appears to be direct and straightforward at the onset -- what happens to it as it trickles down, and in the Isotope Division when you apply for an isotope, do you have to say anything about consent or who knows? All of these people at the headquarters level who are writing these fine policies, how do they know what's going on? Well, I'll just leave that and then just go quickly, by contrast, to the Defense Department where, by contrast, we have what you'd consider to be a more military command and control system. In 1953, the Secretary of Defense issues his Nuremberg code policy. The Navy, it appears, has had something maybe essential, maybe not, but similar in effect, so apparently maybe for that reason doesn't take any particular implementary actions. The Air Force apparently doesn't take any specific actions, but the Army quickly thereafter, in June of '53 as per the last meeting briefing books, issues an implementing policy, and one of the questions was: was it implemented in a way that would percolate down to the contractors? And we met with Phil Russell for the first time, and he said, "Well, no, there were different cultures. The military people thought Harvard could take care of itself." Well, just this last week we found in documents that DOD gave us in 1953 the Secretary of the Army, in approving human research for a Chemical Corps experiment -- I don't know that it was radiation related -- says, "Special care and attention will be given to those portions of the improved investigations which are to be accomplished by contract to insure that the same basic principles and safeguards applicable to Department of the Army laboratories are observed by the contractor." So the basic end of where we are in this story is we have a superstructure of people debating experiments and have government purposes to do these experiments and policies and bureaucracies, and we are here because there is some question as to whether those policies were trickled down and in the way that we would hope they were. CHAIR FADEN: Thank you, Dan. The floor is open. DR. KATZ: Just one comment. I think this was a wonderful summary to us, and what you said, the thing you said this morning, we shouldn't really make too much of these policy statements. I mean, yes, they were policy statements, but they were made thoughtlessly, without any idea of what consent was all about, without any commitment even to the first principle of the Nuremberg code. These are just words, and the document that you just found in a way documents that, and there was surely no, quote, end quote, informed consent standard because that concept hadn't yet evolved. There was really no consent standard either. What voluntary meant is also quite unclear, and surely if you look at the -- and then I'll stop -- if you look at the mustard gas experiments where the Navy operated in '44-'45 under, quote, end quote, consent standards, in the documents that the Institute of Medicine was able to unearth, it was quite clearly stated that voluntariness meant only that people agreed to participate in some kind of experiment and were even given the wrong information or no information about the experiment once it was started because it was felt that this was necessary because the Army personnel would be frightened to go into the gas chambers if they were told too much about the nature of the experimental study. CHAIR FADEN: Dan, do you want to respond briefly? MR. GUTTMAN: Yeah, I'm not going to respond directly to Jay because I can't. That would be a foolhardy effort, but I think a point that is now clearly emerging that is very important to understand for the public -- it fits into it -- is one of the dilemmas, the puzzles here is we are constantly told that this was all public back then. If you'd only read the Journal of Radiology, you would have known, you know, this experiment was going on, and yet, of course, it has its roots, at least that part of it which does have its roots, in secret, you know, agencies. And one of the things that was enlightening to me was to read this little thing about the Insurance Department because you can see that there can be things that are public and yet still be things that are not public. So that what we really have to figure out -- and this goes to your question of the meaningfulness of a consent process or policy -- is what exactly were the rules of that game and what is it that we can now find out that was not in the public articles. DR. KATZ: These people are volunteers in these studies, you know. MR. GUTTMAN: Right. DR. KATZ: That would put anybody who read it off track. This happened in the Tuskeegee syphilis papers that were published. They talk always about volunteers, and of course, as we know now, the Alabama African Americans were not volunteered in any sense of the word. CHAIR FADEN: I've got Pat and Phil and Ruth and Henry and Mary Ann and, Lois, did you have your hand up? No. That should keep is going for a little while. Pat. MS. KING: I don't know if this is a question or a comment for Jonathan. In listening to Jonathan's presentation, I had the following thoughts, and maybe it's already there. Going back to the work of the National Commission, one of the things that we kept saying while we were focused on what we called "nontherapeutic research" was that the real area of danger -- these are people more knowledgeable than I -- was in the area of therapeutic research, and so that's what this is triggering. But we had no good history really. We had isolated incidents, no real history of what that area meant at different times. What did we mean by the term "therapeutic"? Not just what did we mean by "volunteers," but what did we mean by "therapeutic"? And in thinking about this, we attempt to think of it in terms of a diagram as you've put on the board, in terms of voluntary consent. A different way to think about it would be to think about how people talked about risk. Oddly enough, people think that nontherapeutic research is riskier than therapeutic research often, which tells us something about how people think about risk, but one of the things I would be interested in would be, in looking at some of the documents, but also looking at the studies that were going on simultaneous, would be to figure out how risks were discussed. For example -- because I think that may relate to consent -- if you were doing research with a patient that was considered to be dying or for whom you could do no more, the way risk was discussed in relationship to risk-benefit and consent might be very different than a different kind of patient, although today we might think that research on the dying is a very problematic area, and I don't want to carry back today's views. So I'm interested in a cross-cut not only in terms of how you're trying to work it out for consent, but how risk was discussed because it may not have been understood in the way we tend to understand it today. I don't know if that makes sense, but it seems to me that there are three things: volunteers, consent, and understanding of risks that all interplay with each other. Is there anything that indicates that that makes any - - DR. MORENO: If you look in number two in the summary memo, there is a passage and some general observations about risk assessment. There was what we would today call risk assessment going on at the time. On at least a couple of occasions, for example, there were attempts to survey radiation scientists around '48, '49, '50, to get a sense of what kinds of graduated levels of exposure would create what kinds of -- could create or be associated with -- what kinds of harm, and the responses that were given to that polling were of such wide variation that people felt that they needed to do more work. Now, one of the debates was whether more work could fruitfully be done with animals or whether they needed to move right away to human subjects, and Shields Warren seems to have been -- and Stone also -- seem to have been on opposite sides on that question. So I think the general answer to your excellent question is that's a much more complicated and difficult story to tell than the non-cross-cut consent story. MS. KING: I want to be clear that I'm not talking about risk assessment the way you described it here. I'm actually talking about a cultural understanding of what risk meant, not just, you know, how much were you exposed to in terms of radioactivity, but was there a different understanding of what it meant to be a sick subject in terms of what you were exposed to than if you were a well person in terms of what you were exposed to? It's a cultural meaning that would be very hard to pick up, but you may have to dig below and see some of the discussions of individual protocols. MR. GUTTMAN: If I may, a couple of things which only occur to me because of conversations with Henry and other people jump out at me and passages in the documents, and they may be relevant. One, in these two Oak Ridge documents, the September and October '47, one of the reasons that -- Oak Ridge is clearly interested in having a policy on experimentations. In the 1st September document, there's something to the effect of "we've been doing tracer experiments with no therapeutic benefit." So there's some notion, and this gets to Gregg's sort of test case that the things we've been referring to as the plutonium injection, biodistribution kind of experiments, people may have had this uneasy sense that they were kind of different because there was kind of no benefit. And the next level of that, and it's in the Oak Ridge document, and I'm very curious having discussed this with Henry and others, the first pro as to why we have to do experiments is because we need tracers for toxicity studies, which suggests something more than today's notion of benign. The other part of it which is in what Jonathan wrote, which also jumped out, Gregg has talked about this and Gil has written about the debate about NPA, the nuclear airplane experimentation. You have in this document collection we gave you this terrific memo. Air Force gets up and explains where the NPA experimentation is and says, "We decided regrettably not to go ahead with it." Then the next sentence practically it says, well, at M.D. Anderson Hospital in Texas they're doing whole body irradiation, and it's almost as if that's not considered to be something in the debate on experiment because it's kind of people who were sick. So the question is: is that conscious, you know, or is that just a telltale sign of the way in which people -- as Jonathan said, they talked about live, healthy volunteers, but they didn't talk about patients. Is that the kind of thing you're -- MS. KING: Yes. MR. GUTTMAN: Jonathan's is kind of elegant. CHAIR FADEN: And it's clear that it's something that we need to really mind because this is a good working hypothesis now at multiple levels, that something of real significance is occurring that can explain how things developed maybe. So it should be good. And that's my maneuver for going on to the next question because we have to get the rest of the comments in. Phil. DR. RUSSELL: Kass has argued very effectively that the level of ethical appreciation had not risen to or evolved into a very high level by 1953, even though the words sounded reasonable. I would like the historical view to dig into the issues that the society that we are dealing with was at uneven levels of advancement at the time. The medical communities of the Army and Navy had had a tradition of true volunteerism in dealing with healthy volunteers, going back to the yellow fever experiments and the typhoid vaccine experiments, which involved knowledgeably the risk of death from infectious diseases. On the other hand, these communities quite clearly were the proponents in 1953, which pressured the Secretary of Defense to make that directive establishing a Defense Department policy. But as we see 20 years later from the Inspector General's report of '73, it was not effectively carried out. I think what we see is a tension between several communities within the services and within the Defense Department. The proponents for volunteerism, for informed consent were principally the medical communities within the services. The proponents for getting the information were the folks such as the Chemical Corps, which needed and very badly needed information on chemical weapons, and there were similar communities, nuclear and biological weapons communities, and we had a tension between these groups. It was quite clear that until 20 years later the proponents for the experiments were able to get around these or to operate in such a way that there wasn't very rigid enforcement of the policy. Even though Charlie Wilson may have had the highest ideals when he signed that directive, there was a very immature system for enforcing it and seeing to it that it was carried out, both in the military and in the civilian community. I think I'd like the historical research to look at the flow of ideas and tensions between these various communities. DR. HERKEN: Just one very brief comment on that. I noticed the case in the NPA debate, the nuclear powered airplane, that the military chiefs were turned down on that, and they then went to the Surgeon Generals of the services and asked them essentially to appeal it to the AEC, take it out of the AEC's jurisdiction, and the Surgeon Generals passed on that and said they would not do that. They reaffirmed that this was something that really belonged in the purview of the AEC. So there was a built-in frustration there within the military of what they could not do. DR. RUSSELL: The Surgeon General has always been in the way of getting things done. (Laughter.) CHAIR FADEN: These are all helpful in terms of reinforcing the direction in which the research should go from now, if we can get the information to flesh it out. The issue is whether, in fact -- I mean there was some suggestion that it was not always the physicians who were arguing for the consent. I mean it's a bit confusing. To just sort of unpack that will be worth the effort. Ruth. DR. MACKLIN: I have two questions. One is really specific about a particular person and the other goes to the consent forms that are included in our briefing book. I was very interested in the role of this Dr. Shields Warren, who kept coming up again and again, and the basis of what my question is ultimately going to be here is: is there some sense of the political underpinnings that went back and forth in these debates? That is, who ultimately had or took the power to make the ultimate decisions? Now, I'm thinking in particular of the role of Shields Warren in his continued opposition to the total body irradiation and the letters that he wrote to some of these other people, and then there's a paragraph here, and this is -- where are we here? -- Tab G under the staff memorandum, that describes his opposition. That is, we have all of the memoranda describing and all the letters that he's written here, and then it says his firm opposition to total body irradiation experiments dates even earlier to a 1948 meeting, and then the last sentence says or next to the last sentence -- no, I guess it's the last one -- "Curiously" -- this is on page 4 of the staff memo that one of you prepared -- "curiously, Dr. Warren is listed among the regular advisory committee members in attendance at the April 3rd, 1949, meeting of the Advisory Committee on Radiation Tolerance of Military Personnel, who unanimously supported NPA's use of human experiments. The minutes of this meeting do not include specific statements by Dr. Warren himself." So my question really goes behind this episode, but rather, who were the people who ultimately were influenced? I mean Dan mentioned the people at the top, and then you don't know what happens when it trickles down, but did this particular individual who came out so eloquently in these memoranda defending things, did he have other supporters? Were there other people? I mean, what was ultimately the political history that lead to something like this? Maybe I'll stop and then I'll have another brief question. DR. HERKEN: Well, I just wish that there was a biography of Shields Warren because I'd love to read it to know more about this. Warren became the first head of Division of Biology and Medicine and was, I believe, Director of DBM until '52. He then switches over and serves on the Advisory Committee of ILG Medicine, but the two stalwarts, as I see it -- and Dan and I have this debate all the time. He argues it's my great person theory of history -- but the two stalwarts against continuing or expanding human radiation experiments within the AEC were Shields Warren and Alan Gregg. Dr. Alan Gregg was head of ACBM. It's clear that they were not always successful. In the case that you mentioned though, Shields Warren, I think, did go along on that episode, but he stopped it at a higher level. That was a lower level committee. For whatever reason -- and I can't imagine what it was -- he just wanted to end debate, to get it over with knowing that he could stop it at a higher level, and that's exactly what he did. When it came back to DBM, when the Surgeon Generals refused to approach the President or overrule DBM or the AEC, it came back to DBM. It came back to Shields Warren, and he stopped it there. MR. GUTTMAN: This is why this is so complex. This is the lawyer's footnote that I must add, which I think is relevant, is that no sooner did I feel persuaded by Gregg that, in fact, this was tactical and not, you know, a contradiction that I found that an Air Force history that in 1952 we just referred to when they killed NPA experimentation; nonetheless, they go ahead with the M.D. Anderson whole body irradiation. There in the 1952 Air Force history Shields Warren shows up at the Randolph School of Aviation Medicine as a consultant to look at the whole body irradiation at M.D. Anderson. So, again, Gregg is the expert, but you wonder why these pieces of paper look like they do sometimes. DR. MACKLIN: My other question is really a kind of a follow-up of what Jay Katz asked, but it almost goes in the other direction, and that is we have some sample, whether they're called consent forms, release forms. Here's one that's called "Volunteer's Participation Agreement." Unfortunately one is undated. It would be curious and interesting to know when that is. That's Attachment M here. And then Attachment N is the preferred form of release. That's dated March 4th, 1943. That happens to be a prison case, the San Quentin one. The other one was the Army Corps of Medical Laboratories. Now, these consent forms, as written forms, have a lot of the elements in the same language that we see today, same kind of language. It doesn't say, "I can withdraw at any time without prejudice," but it says, "I will be at liberty to request that the experiment be terminated if, in my opinion, I have reached the physical or mental state where continuation of the experiment becomes impossible." There's a lot of other language in here, particularly also of the sort we see together, "I have been told that," "it has been explained that," without including in the consent form what those things are. So what we have only at best is the testimony of the person who has signed it that, in fact, that individual has been told those things. But as a follow-up to Jay's question, I mean, the question of what consent meant, here are some examples of what the forms say, and the gap -- I mean, my concern is not so much what the forms say because there's a lot of language that I'm actually surprised to see in here dating back to 1943. I wouldn't have thought that they would be so complete and have all of these statements of voluntariness and "I've been told" this or that and "I'm going to be told something else." But the question, I suppose, goes more for me to the voluntariness, even though it says "voluntary" here, and what actually the relationship was -- was and perhaps still is if we're talking about human subjects research -- between what the forms state and what we have reason to believe actually went on in the process of gaining informed consent or consent. DR. MORENO: Well, what I would say to you is not going to be very surprising. My intuition is that -- and I think I would probably come out a little bit on the other side of Jay on this, what I took to be his comment -- I don't think that there was a widespread insincerity about the use of the word "voluntary," if that could be an impression. I think that at least we can't take that from what we know so far in all cases. Rather, the understanding of voluntariness was not as highly evolved, if you take a Darwinian view of moral progress. So I'm not sure that there's much more to be said about it than that by me, anyway. An anthropologist could probably have a lot more to say about unpacking those meanings, but at think in at least some communities, there was a sincere identification with what they understood to be voluntariness. DR. MACKLIN: Yeah, I guess the -- CHAIR FADEN: A follow-up? DR. MACKLIN: It's a very brief follow-up. The only way, in thinking of the committee's future work and some of the things, both the oral history project and the surveys that we hope to be able to be mounting both about contemporary and retrospective, there has to be some comparison between the wording in these consent forms and what people actually say they did or, with subjects, what subjects perceive is happening, even in the contemporary area where we're going to do that study. Otherwise, we're never going to get beyond a piece of paper and say, "This doesn't look bad. I'm actually surprised to see that they had these words in here." DR. MORENO: I think we recognize that very clearly, and that's why we're so concerned in spite of our time limitations in this committee for you to give you some information, as much as we can, through the oral histories, in particular. CHAIR FADEN: One of the things that's emerging is we may have rival hypotheses or rival interpretations of what was going on with respect to consent procedures and commitments to consent during this period, and it will be incumbent on the staff to marshal the best evidentiary base for both views. If we can get information that bears on this different of interpretation of exactly what these consent forms and policy statements actually represented, if we can get testimony from people that bears on that through the interviews that we hope to do, that, of course, would be really desirable. My concern is we may end up in some cases with nothing more than paper while building the case. DR. MORENO: If I could just add one thing to that. CHAIR FADEN: And then I know Gregg wants to add, too. No, Jonathan, go ahead. Jonathan and then Gregg. DR. MORENO: One other thought. The other element that we haven't talked about besides risk-benefit in the idea of voluntary consent is the national security imperative, which we really have to still work out, was a thinner concept of voluntariness, more acceptable as the national security needs increased, without losing the concept of voluntariness entirely. Was it, nevertheless, a more acceptably thin idea under certain national security imperatives? CHAIR FADEN: Gregg. DR. HERKEN: Just a point of clarification. I think I would disagree with Jay to the extent about the matter of consent that the AEC did have a policy on consent, call it "informed consent" or "voluntary consent," and it's pretty well defined, I would argue, because, in fact, the Legal Division was involved in its definition, and it evolves over time. What we're not seeing though is any enforcement of that policy, and here, in fact, just to cap the point that Dan made, the fellow from Los Alamos wrote in in March of '51 and said, "We're going to do some human experiments. What's your policy?" The head, Shields Warren, Director of DBM, writes back and says, "The following statements have guided the Division of Biology and Medicine in its attitude towards this problem." Very strange statement, and I can't quite explain it unless there really was no clear policy that was enforced. CHAIR FADEN: We have some work to do, but at least we have some good people to do it. Phil, is this right on point because we've got -- DR. RUSSELL: Just a short question to Gregg. Does the IG report, in your view, of the '70s shed light on Ruth's question of why the discrepancy between the fine words in this consent form and some of the things that actually happened? DR. HERKEN: Well, not entirely, but we have found out one person apparently they didn't talk to in '74 when they did the IG report was Ed Huddleston. MR. GUTTMAN: Are you talking about the Army or the IG? DR. HERKEN: Oh, I'm sorry. The '74 IG report. Oh, okay. I'm talking about the AEC IG report. DR. RUSSELL: The Army one that related to Chemical Corps consent forms. CHAIR FADEN: Right. DR. MORENO: It turns out, Phil, that interestingly in that Army IG report, they have Chapter 6 called "Informed Consent," in which they cite in the early part of the chapter some of the same documents that we're working from now, but they don't analyze them in the way that we've been doing, that is to say, the minutes of the committees and advisory groups in the DOD, and so forth. I would guess I would have to look back at it again to say 100 percent, but my impression from looking at it a couple of months ago quite closely is that they didn't really come up with a good explanation for the implementation issue. DR. RUSSELL: They just said it would have been implemented? DR. MORENO: They just said it didn't work. DR. RUSSELL: Yeah, and they didn't say why. DR. RUSSELL: They didn't have an explanation, unless Dan's memory is -- MR. GUTTMAN: Well, yes. I looked at it again yesterday because I knew you were going to ask this question, and it was actually a different question. One of the things that comes out, this is relevant to Jay Katz. CHAIR FADEN: Who's not here, but keep on going. MR. GUTTMAN: Right, but one of the things that's almost amusing and refreshing as a lawyer is that the IG people are saying, "My God, this policy was susceptible to many different interpretations," and that there was no consistent interpretation. I'm sitting there saying, gee, it's amazing that somebody would be that diligent, even try to go that far. DR. RUSSELL: And there were command structures that allowed for different interpretations and strong pressures on people who were supposed to be in charge of the ethics. CHAIR FADEN: We have both Henry and Mary Ann and Susan, and I think what we should do is those three and then we're going to stop because we must eat lunch roughly within the time frame allotted or I think the sandwiches get eaten up by somebody else. I'm not sure what happens, but we're supposed to start lunch and end it roughly in the time period that has been allotted. So if we could get Henry's comments and quick responses from the panel, if we could, Mary Ann's and Susan's, and then we'll close for now. We can revisit all of this stuff tomorrow. We have a lot of open time tomorrow, and we can ask staff to come back to the table. So don't feel too frustrated. Henry. DR. ROYAL: There are two things I wanted to ask about. The first has to do with whether or not I am correctly hearing the judgments that the staff is making in regards to human experimentation, human radiation experiments in the AEC. I got the impression from reading this document and from the comments that were made that the judgment was made that the AEC prohibited human radiation experiments, but yet they were done because researchers were able to figure out these loopholes to get around. You're shaking your head no. So tell me more about what it is that the staff has concluded about the discrepancy between the AEC's policy towards human research and what individual researchers were doing. DR. HERKEN: It's more a matter, in fact, of just pointing out the apparent contradiction between the stand taken in writing on at least two occasions by Shields Warren against human experimentation and the fact that human experiments in at least one of those cases did continue. DR. ROYAL: You're talking about the NMA whole body irradiation? DR. HERKEN: Well, I was talking about another case, but certainly, no, in the case of NPA apparently human experimentation, the large, programmatic series of experiments that were planned were not carried out because of Shields Warren's opposition. In other instances though, in the case of John Lawrence, Shields Warren denied Lawrence's permission for I think it was Carbon 14, and in that case John Lawrence went back to the Subcommittee on Human Applications and had them revisit the question. DR. ROYAL: To me the problem has to do with the broad definition of human irradiation experiments. I mean I think what the AEC was concerned about was exposing no more volunteers to amounts of radiation to study radiation effects, and that, on the other hand, they were encouraging researchers to exploit this new tool to study biological processes and to develop new therapies. So that this apparent contradiction, I think, is related to understanding the words, the definitions, more than a real contradiction. DR. HERKEN: I mean "experiment" would apply to which one of those two? DR. ROYAL: I think human radiation experiments applies to trying to determine what the effects of radiation are on normal human beings. DR. HERKEN: As opposed to? DR. ROYAL: Medical applications of radioactive material because it's clear the AEC promoted the medical use of radioisotopes. CHAIR FADEN: And this goes to the distinction between the concern about healthy volunteers versus patients. The healthy volunteer is the person on -- DR. ROYAL: So like that M.D. Anderson thing related to NPA makes perfect sense to me. It's basically the whole body irradiation experiments were being done not primarily because they were trying to determine the effects of radiation, but because they were trying to see whether there was a therapeutic benefit to total body irradiation, and that would be an alternative way for them to get the information that they wanted to get. DR. STEVENSON: I think Shields Warren has been perfectly internally consistent. DR. HERKEN: Yes. MR. GUTTMAN: Well, I'll tell you you've hit on -- this is a very -- not a sore, but a very acute -- you're not misunderstanding us. You're understanding that this is really -- you'd like to think there's a linear set of, you know, consistent ways of looking at it, but we're not yet at that point because even with the Shields Warren, just as soon as you think you've got them all on one side of the table, you find something where he says over on -- (Simultaneous conversation.) DR. ROYAL: The contradiction that you're seeing is not as big a contradiction as -- MR. GUTTMAN: No, that may be, but still it's not a refined enough understanding of the documents or they don't talk in refined enough language sometimes for us to see that kind of precise -- I think that's where we're heading. We're saying the same thing. DR. HERKEN: In the case of Stone, he explicitly defined experiment as involving normal, healthy subjects, but I think the suspicion within ACBM by Dr. Gregg that Stone was blurring the distinction, basically perhaps experimenting on patients, was the source of this letter of reprimand where there had been 32 arthritic patients exposed to total body irradiation, and the letter -- and I don't think you need to read too far between the lines -- basically is accusing Stone of doing experimentation on those patients under the guise of therapy. DR. ROYAL: The second issue that I'd like to bring up, and I'm not a student of history, so maybe I'm wrong about this, but it seems to me that much to my surprise, the military and bureaucracy were much further ahead in terms of informed consent than I would have imagined them. Ruth was sort of saying the same thing in terms of what the pieces of paper say. I think that's an important issue to make some definitive statement about, whether or not they were leaders or followers, and if it's true that they were leaders and that the culture in medicine was, in fact, much further behind in informed consent, that would explain the problem that they had with implementing a lot of these programs because they would administratively or bureaucratically think that this is a great thing to do, but then they would go to physicians who had a very paternalistic attitude, and they just wouldn't be able to get them to implement them. MR. GUTTMAN: That's the truth. I had this discussion on Friday night with Ruth where I've been saying this is terrific. The military is more progressive than maybe people had thought, and she was saying, "No, you don't understand. It's because they're not really looking at experiments with sick people. They're just talking about volunteers." And when you've got a volunteer who's healthy, you've got to get his consent, but the point is that maybe this falls back in, what you're just observing about how we define "experiment" in terms of who's progressive and who's not. DR. RUSSELL: I think the military medical community was driven by preventive medicine specialists from the turn of the century, and they think differently both in dealing with experimental volunteers than the people in medical practice. CHAIR FADEN: That's a critical distinction actually for trying to put all of that together, is the notion that when you're thinking about preventing illness and you're dealing with people who are healthy as opposed to people who are ill and trying to advance your ability to deal with them, which is the tradition with which the outside contractors were primarily operating from or within which. Boy, these discussions are good. This is helpful. Henry, did you get both your points out? DR. ROYAL: Yes. CHAIR FADEN: Dan is smiling because we spent like three hours on Friday night on this point. So it's very helpful to be supported. Thank you. I talked to Henry in the morning and said, "Bring this up, please so I can get reinforced." (Laughter.) CHAIR FADEN: Mary Ann and then Susan, and we just will have to eat our sandwiches faster, but that's okay. This is important. DR. STEVENSON: Henry touched on some of my concerns, but I just wanted to add some concerns similar again to Henry that there may be some interpretive bias occurring in the process of summarizing some of these pieces of data and maybe going to the particular piece regarding the letters between Dr. Stone and Warren and Gregg, in reading it, the impression is given that Dr. Stone is sort of categorically wrong in wanting to pursue these experiments, and he was, I think, in the minds of Drs. Gregg and Warren wrong, but I think that we have to keep an open mind and set this into history, the context of the history of medical practice at the time. And at the time, and even extending into '60s, '70s, '80s, and '90s, radiation has been used for a variety of autoimmune diseases and has been shown to be efficacious, and I think there is good medical and historical precedent for using it. So I think it's unfair to necessarily give the impression that Warren and Gregg were necessarily absolutely right and Stone was absolutely wrong. DR. HERKEN: That was, of course, Stone's defense in his letter. I don't know if that was included in the package. DR. STEVENSON: Right, but I think it is important that that is at least addressed. And also, that all of these things are looked at in the context of medical sophistication or lack of it during that period of time because in the '40s and '50s, there really wasn't a very good understanding of autoimmune disease. Radiation, quite frankly, was one of the few systemic therapies that could be given. We didn't have nonsteroidal anti-inflammatory drugs. There wasn't a great understanding and therapeutic basis for suppression of the immune system. So, again, it was an imperfect therapy, but perhaps the best thing that could be offered to some patients under the circumstances of their severe disease. And to some degree, I think that Dr. Stone's letter to Dr. Gregg, I believe, in defending himself, I think, to some degree, whether or not you agree with his opinion, exonerates him in terms of pursuing therapeutic goals separate from the AEC agenda. In other words, it wasn't in his best interest in terms of AEC support to want to pursue this kind of treatment or therapy because clearly they didn't agree with it. So I think it shows him to at least have some independent mind in terms of therapeutic treatment and is reassuring that everybody wasn't just doing things just to get AEC money. I mean clearly he had a mixed agenda, and he would have liked to have received funding for his programs, but I think he's making an important point that he is concerned and other physicians in the university are concerned with providing good treatment to their patients, efficacious treatment to their patients, and he was objecting to being criticized for that. DR. HERKEN: Actually Stone and Hamilton are two subjects of particular interest to me. They figure in a major biography I'm working on. DR. STEVENSON: Right. So I think it's important in, I guess, closing that we get a sense of what the practice was of the medical community outside AEC contractors and get sort of a background lay of the land for that period of time and what was going on in a non-AEC contracted hospital or a non-AEC funded practitioner to see whether these guys were really within the normal or out of the norm in wanting to do these kinds of treatments on their patients. MR. GUTTMAN: We had talked -- I haven't talked to you, but I hope Gil has and John Harbert out there -- about doing a brief background on radiation therapy. DR. STEVENSON: Right, and I provided references. So I think we really have to pursue those because there is a history for using total body irradiation for cancer, autoimmune disease. DR. RUSSELL: Which autoimmune disease? DR. STEVENSON: Arthritis. (Simultaneous conversation.) CHAIR FADEN: It's really important. It's so helpful to have more people read the primary documents. This is so helpful. I mean Mary Ann's comments, but all of the comments based on your having read the documents. It really does -- it's one of those situations where we're dealing with a tremendous interpretive process, which Susan can speak to professionally, and the more of us with the different perspectives that we each have that can read the key documents, stressing on staff to filter through the ones that seem to be pivotal in drawing certain conclusions or inferences, it's terribly, terribly useful to have. It may be hard to sit down and read all of this stuff, especially when you get Friday night to Monday morning. Maybe we can work on that a little bit, but it never seems to happen, but it is proving obviously by the comments this morning so helpful to have committee members read the documents. Susan, you have the last question before we break for lunch. DR. LEDERER: I just have two brief questions. The first is I, too, was struck by the importance of Shields Warren and Alan Gregg in the story that you unfolded for us, and I was wondering if the staff is pursuing following, you know, the Gregg papers or are they relying solely on the documents that we're receiving from agencies to uncover this story. DR. HERKEN: At the point now we're starting to get so beseiged by documents that I haven't gone through the personal papers. Stafford Warren, of course, is another large figure in this drama. The papers of Shields Warren, such as they exist, are at Harvard, and Gil has, I believe, attempted to look at them. I don't know how extensive they are. DR. LEDERER: Okay. I think there is a big collection of Gregg papers at Rockefeller. DR. HERKEN: I'm really not sure about that. That's the next stage. What we're hoping to do right now because we understand there's not much of the Shields Warren papers at Harvard is to get to the core of those papers within the DBM records that are now held by DOE, including the letter that was written by Stone to Warren that provoked the declaration of consent regarding that it will be signed by the patient and next of kin. We see no other reference in the documents to that policy, which is very interesting. DR. LEDERER: Okay, and then my last question. I was also struck by this fear of lawsuits that seems to animate. I mean the release forms, this Insurance Branch. Is there a legal history that we're neglecting here? DR. HERKEN: Yeah. DR. LEDERER: Are there large numbers of people lodging suits against the various agencies that we don't know about? MR. GUTTMAN: I was struck because anybody would read this and think, "What's new?" All I can say is that as soon as I started reading this, my problem is I'm too old a lawyer to be adept at LEXIS, but I went on LEXIS and NEXIS to see, and I pulled out Oak Ridge for example, and of the 130 cases, most of them seem to do with call contracts, utility contracts. But I'm sure Jay was saying maybe that his students could do something, and this is clearly a question of what was driving all these people nuts, especially when the government presumably had some notion of sovereign immunity back then even. Where it was that this insurance concern came from is a very interesting question and also animates the military, too, because as Jonathan was saying, everybody in the '43 Navy release has got as much to do with liability as it's got to do with -- DR. LEDERER: Well, are there, for example, a large number of lawsuits brought by naval personnel against experimenting doctors? MS. KING: I doubt it. You can't sue today. So I have serious -- if you couldn't do it then, the military personnel can't sue government and probably only people who were subcontractors had a chance of suing the government. DR. MORENO: We've seen lots of memos in the AEC and DOD from General Counsel's office. DR. LEDERER: Well, if they can't sue though, what's animating this? MS. KING: Well, it may be patients could sue the various institutions. That's why it may be difficult go get, but it would be very hard to sue government. CHAIR FADEN: But there's also the point in the lines that Dan read, there's tremendous to me -- "tremendous" overdoes it -- it's hard to tell. I mean there's a concern about public relations that's tied in under the issue of legal liability, and it's hard to unpack whether what's really animating this is this concern that there's going to be massive litigation or that there's just going to be massive embarrassment and a bad sort of PR press problems. The communities are going to get unhappy; the workers are going to get unhappy. It'll get in the newspapers. We sort of don't need this stuff, and maybe the only place to stick it then was under the general heading of insurance/liability. But I'm wondering whether it doesn't -- that wasn't the office that held the brief for public relations in some sense. I don't know. It's just a thought that's triggered by -- MS. KING: But Susan's point is well taken because one of the few places where there's a cache of public documents that bubbles up in legal opinion, even though it is a very limited cache, but it's certainly an area that's worth pursuing. CHAIR FADEN: Oh, absolutely. MS. KING: Whatever is there tends to end up there. CHAIR FADEN: Absolutely. Henry, were you right on this point? I saw you when I just said something. I didn't mean to suggest that we shouldn't be pursuing it, but given that it would be surprising to find that there was tremendous litigation operative particularly with respect to employees, what was going on? But clearly this was a player. Okay. We could keep going, but we need to eat. Let me give you some practical information. Thank not only Jonathan, Gregg, and Dan, but all of the staff work that's gone into these presentations. Let me just give you some practical information. Lunch for committee members is to be obtained in the Cafe Promenade Restaurant, which is the main floor of the hotel. When you come in if you're with the committee, identify yourselves as with the committee, and they will direct you to some section of the restaurant. It's not a separate room, and your lunch sandwich order apparently somehow is going to connect with you in some magical fashion. So those of you that got the tuna or the vegetarian or the ham and cheese, it's supposed to find you up there in the Cafe Promenade Room (Whereupon, at 12:44 p.m., the meeting was recessed for lunch, to reconvene 1:45 p.m., the same day.) AFTERNOON SESSION (1:45 p.m.) CHAIR FADEN: We are missing a large portion of the committee who are lingering over their very bountiful lunches that we got today. Weren't the french fries good, folks? The Mayflower really put themselves out for our lunch today. This can be on the record as far as anybody who wants to hear it. PARTICIPANT: I was saving my appetite for tonight. CHAIR FADEN: Well, let me put it this way. I can assure you that the quantity of the food will be more. Hopefully the quality; that won't be hard to do either. If someone from the Mayflower was listening, that was not a very nice lunch. So they can know. We need to start. We are a little behind schedule, but that's all right. We're people; we can do that. Let me just point out to you as we're getting organized that there are pieces of paper being circulated, and this can cause great confusion. One piece of paper that's being placed on your places, put on your places, looks like this. It says "Memorandum," members of the Advisory Committee, from staff, and it's re. research protocol review project. If you would please put this in your blue packet at least temporarily, it's with the stuff that we kind of want you to read overnight. When I can't tell you exactly, but in the cab you can read it out loud to each other or whatever you want to do, but in the packet there are a couple of things that we would like if you would please read between now and tomorrow morning. This is one of them. There's another one. Jeff, is the staff memo -- there's another one that says "ACHRE Staff Organization," and that's another one. It's not so much reading, but take a look at it, put it in your blue packet for ease of whatever, and these two documents will be referred to tomorrow. The ACHRE Staff Organization is not really reading, but you can look at it for a couple of minutes. Oh, we're doing that now. I'm sorry. I misspoke. That we're doing now. So don't put this in your packet. I take it back. The ACHRE Staff Organization we're doing now. Jeff is going to walk us through that very briefly. The memo that says "Research Protocol Review Project," that's part of the report from the ethics subcommittee sort of, and that goes in your blue packet to please read between now and tomorrow, and in your blue packet are other things that it would be good if you could read between now and tomorrow. So with that, Jeff, can you -- we're about ten minutes behind schedule, but I think we can make it up as we go along. Jeff is going to take us through some new staff additions and also how the staff is organized now. So if you could just start, that would be great. DR. KAHN: Okay. Thank you. In addition to the staff organization sheet that Ruth just mentioned, I'd like to introduce first a couple of new additions. I mentioned last meeting that Dr. John Harbert would be joining. He's now official. Dr. Harbert is right over here. He is a nuclear medicine specialist, physician, of course, trained in Northwestern University and Stanford University; has worked at Georgetown University as a member of the faculty and at the NIH Clinical Center. So we're very pleased to have his expertise on our staff. Nancy Kass has not returned. I don't see her. We have a new consultant that I thought I would introduce. Dr. Kass is not available at the moment apparently. She's a member of the faculty at the Johns Hopkins University School of Public Health, and she'll bring us valuable expertise in quantitative and qualitative health services research, which is her area of expertise, along with ethics. I'd like to turn now for just a moment or two and talk about staff organization. We have changed things somewhat since the last meeting, and starting with the page on top which says ACHRE Staff Organization, you'll notice that there's one level of bureaucracy that's now being eliminated, which was the coordinating group. Because we're now at the three-month point, and Anna and I have had a chance to reflect on what we've done up till now, it's become clear that the staff hiring has pretty much come to an end. We think we're close to full capacity and complement, and so that has gone off of my plate. In addition, Anna now has gained great expertise on how to do the briefing book, and so some of that is easier for her to do. (Laughter.) DR. KAHN: She can't quite do it in her sleep. In fact, she probably has nightmares about it, but it's somewhat less onerous than it has been in the past. And those two things being the case, we are now taking on -- easy for me to say is right -- those two things being the case, we are now taking on some more management responsibility for the day-to-day oversight of projects. So the coordinating team has gone away. To turn the page, you'll see the current project assignments and note that under each Roman numeral there is a person designated as the member of the management team responsible for oversight of the particular piece of the project. This looks substantially different, and it does so because we've changed it to reflect the structure, the outline of the final report. So the pieces of the project have been subdivided to correspond to how the outline looks, in a general way, more or less, and you'll notice that we've done away with the splitting of the world into sort of Cold War, on one hand, and ethics, on the other, the idea being that all of this is about ethics, of course, and the information that we collect will help us inform our deliberations about ethical issues. So just to walk through, you'll see here that we have subdivided what used to be the world of ethics into history of ethics policies and procedures, history of practices regarding human subject research, and so on, through Roman I through IV, and that will be my domain of oversight responsibility. To turn the page, we start with remedies and move through -- if you had your outline in front of you, you would see this follows more or less according to that, and I won't belabor it. I don't think that's the point -- and you'll see that Anna has responsibility for Roman V through VIII. The oral history project has been broken out because it's becoming a larger and larger chunk, and Steve Klaidmann as the Director of Communications will take oversight responsibility for that piece. The very large chunk at the moment, to turn the page yet again and look at Roman X, experiment mapping and to answer the question that Reed raised right before lunchtime, we now think we have in hand a way to approach mapping of experiments and processing of experiments. We have a form more or less in place to get information into the database regarding individual experiments and to analyze them in terms of the cross-cutting themes that have been discussed on the outline previously. Now, it may be clear as we get more and more information in and boxes and boxes through the door that we need to devote more resources to this experiment mapping and document processing process, and if that becomes necessary, we will, in fact, move people around or even bring new people in to help us do that. So to answer Reed's question, who of course isn't here, we do have that well in hand, we think. So I guess in short I'd like to just say that we have now rearranged the structure of the project assignments to reflect the outline that has been endorsed by the committee at least in draft form and altered the management to allow Anna and I to take a little more daily oversight responsibility for individual pieces. CHAIR FADEN: Are there questions? Comments? This is going to shift again, we think. DR. KAHN: Yeah, it will become more detailed in certain aspects as we move to these pieces of the project and other parts will go away, and oversight will shift yet again, but for the moment this is how we're going about it. CHAIR FADEN: Thank you very much, Jeff. Dan and I are eternally grateful for everything that Anna and Jeff and everybody else does that allows us to have three-hour conversations if we have the energy to do it. No, it's really working well, we think. Okay. We're going to move on to another report from staff. This time Gary Stern, Ron Neumann, and Dan Guttman, and we're going to continue with the TBI story, in effect, that we started last meeting. MR. STERN: Thanks. I'll start by alerting you that Tab H is the basic narrative that we prepared on TBI as sort of the preliminary introduction, TBI being total body irradiation, and it basically is a narrative introduction of what we currently know about government sponsored total body irradiation from World War II through the mid-1970s. What we've tried to do is give you a sense of the range of activities and the sponsoring agencies that were undertaken during this period, and I will now just take this opportunity to highlight a few of the cases with which we are aware and comment on them. We now know that at least three TBI research studies were done during World War II by the Health Division of the Metallurgical Lab in Chicago, which was the organization in charge of plutonium production for the Manhattan Project, and they were initiated in the fall of 1942 precisely at the same time they were completing work on the first chain reacting nuclear pile and then beginning to actually produce the plutonium and highly enriched uranium for atomic bombs. And what we know about this comes actually from the official history of the Health Division of the Met. Lab that was prepared and edited by Dr. Robert Stone, who we've been talking about earlier, and that's this volume here, and the actual medical studies were written up by the investigators, and they're prepared here. So what we've written the report and what I will talk about now comes mostly, almost exclusively from their own reports. The studies essentially focused on the effect that exposure to radiation levels above the then established daily tolerance dose, which was .1 R, would have on the blood. Researchers thus looked for subjects who were hematologically normal, and in the first study, which is the one that became the subject of the exchange between Warren, Stone, and Gregg, blood analysis was done on 29 patients who were treated with dosages from 100 to 300 R. And as Stone and Low-Beer, who are the authors of the report, state, they essentially took advantage of the fact that patients were receiving normal therapy by making numerous blood studies for the Manhattan Project. This is what Ron referred to in the last meeting as the piggyback effect, and I think it sort of becomes the standard practice for almost all of the TBI studies sponsored by the government in which they sort of piggyback the government, military or space interests on top of what is described at least as a normal therapy that's being undertaken. In the case of this study, as you know, many of the patients suffered from severe rheumatoid arthritis, and I think that seems to be what raised the concerns of Dr. Gregg and others that perhaps these people were picked because of their hematological status to be the subject of the irradiation and was questioning, you know, the actual value of the therapy. In the report Dr. Stone actually or, no, actually in the correspondence that we have in the briefing book, Dr. Stone made a comment with respect to the issue of consent, when he said that each patient accepted the treatment, quote, with full knowledge of the facts, unquote. What is clear is that they didn't know that blood was being taken for the Manhattan Project. So they didn't know exactly why the researchers were doing these at least additional studies on them, and that's, again, a theme that comes up in a lot of these studies, the total notion of information and consent and what exactly they were told. It's still not clear at all. And as you would have noticed in the letter from Dr. Gregg, he raised the issue of secrecy and the concern that because of the secrecy that the AEC has to have, had to have with respect to producing atomic weapons, that it may undermine the ability to hold its contractors accountable, and he opens his letter, the October letter, with a caution and a concern about that. And Stone responded that while, of course, the Manhattan Project itself was secret, that there was no secret about their actual procedures and the fact that they were taking blood from any of their colleagues, and it was written up publicly afterwards. And then as was discussed before, clearly the issue of what control the agency has when it is funding or sponsoring research is a principal issue, and Dr. Stone's response was that the agency shouldn't be able, even if it's funding, to influence the therapeutic conduct of the doctors, and that's a theme that we see or we assume exists in all of these studies all the way down the line, the extent to which the mere fact of government funding or the seeking of government funding influences the type of therapy that they are providing patients. There are two other studies during the Manhattan Project. Another one, eight patients at Memorial Hospital, and again, the report itself makes clear that the primary purpose was the experimental notion of it. They seem to, in the statement of the report, be hoping that perhaps there will be a positive therapeutic effect, as well, even though the same technique had been negative ten years before. And the third study was done in follow-up to the previous two, and in this one they actually tried to conduct a more sensitive experimental design, having three different groups. One were cancer patients; one were non-cancer but chronic patients, including people suffering from arthritis; and then they had a third group consisting of three normal, healthy volunteers, and to our knowledge, it's the only TBI study in which healthy, normal persons were subjected to radiation. The report says that they were particularly interested in this group, and it seemed to indicate that the higher dose than was the dosage tolerance level could be sustained by healthy people without any effect, at least at the time. They were subjected to, I guess, three doses of seven R over a period of about ten days. After the war, the DOD, the Defense Department, began at least by the early 1950s to continue with TBI research, and as we outline in the report, essentially all three of the services, as well as the civilian DOD, were independently, it seems, conduct research in this area, and the first one we know about is the Air Force study at M.D. Anderson that Dan mentioned earlier. There seemed to be at least two military objectives to this study. One, as the report of the investigator says, is the simple effect of nuclear weapon explosion on the body and on persons, and in his report he makes several comparisons between the effects that the doses that were imposed on the cancer patients would be very similar to that caused in healthy human beings by nuclear explosions. Now, we then have a second set of studies that were done as part of this research, which was on human performance, and this we now know was motivated, it appears, primarily by the NPA, the nuclear powered aircraft, program, and they wanted to know how the pilots would be able to perform in a radioactive atmosphere, and so they did a number of tests on them. Again, as Dan mentioned before, this was something that at least the Air Force people did not consider to be an experiment because they had a separate category listed in their 1952 report, that experiments were not carried out, although desirable, but then they were certainly looking for the data that was being produced in the M.D. Anderson report. The other, I guess, area probably that we know most about and has received the most public attention in the DOD has been the work of Dr. Saenger that was sponsored by the Army and funded by the Armed Forces Special Weapons Project and its successor, the Defense Atomic Support Agency. He conducted his work from 1960 to 1971 and did therapy on 85 patients, although it seems from just reading his reports, his initial application, the responses to his application, reviews of his application by the military that there is a very strong interest in, you know, the military effects of radiation. A 1961 supplemental proposal he put in was titled "A Research Proposal for Subtasks in Nuclear Weapons Effects Research," and that seems almost self-evident that that was a significant concern of his, in addition to the therapeutic concerns, although by the end of Dr. Saenger's work, his final report, he states that the sole purpose of the treatment was for general clinical management and, if possible, length of survival of patients with advanced cancer. Again, the issue of informed consent is raised in Saenger's work. He at the end documents or not until 1966 does he begin to document that there was -- informed consent was provided and sought, and in 1971 he states that all the patients provided consent, but in the early reports we have no indication of that, and that's, again, another area that we need to pursue in more detail. Finally, moving away from DOD, the Atomic Energy Commission began to look into and conduct TBI research, as far as we know, principally in the late 1950s and throughout the '60s at Oak Ridge, the Medical Division of the then Oak Ridge Institute for Nuclear Studies, which became the Oak Ridge Associated Universities, and for a period of about 17 years, they treated 194 patients with total body irradiation, and about midpoint, 1964, NASA, as has been reported previously, kind of joined in some of these studies and provided funding and sought data that was coming from the research on the patients that were being treated at Oak Ridge in what became known as the prospective study. In addition, Oak Ridge in conjunction with NASA did a major research effort, what was called the retrospective study of what they essentially could find of all TBI procedures that had been conducted from 1930s up through 1974. It totaled ultimately over 2,500 procedures and 45 institutions, and that list of institutions is Tab A or Attachment A at Tab H. And the question remains: to what extent were those institutions associated with the government and government program and government interest? Clearly some of them were the ones we've already outlined we know were, and we need to explore in more detail to what extent these other institutions either took up the TBI research because of government funding or because they knew that there was government interest or were doing their work completely independently and just provided the data to the Oak Ridge-NASA study. The Oak Ridge procedures or prospective study came under serious concern in the 1970s. The AEC itself did a program review of the Medical Division of Oak Ridge in 1974 and recommended that the clinical TBI program be shut down at that point, concluding, quote, that the program had evolved without adequate planning, criticism or objectives and has achieved less than substantial productivity, then merits continued support, and so I think there is a concern certainly by the late 1960s and 1970s, the type of work they were doing may not have followed, sort of continued with the current medical knowledge and practices even if at an earlier time in the 1950s it started that way. Then concerns were raised again in 1981, hearing held in the House by the Investigations and Oversight Subcommittee of the House Science and Technology Committee, when public attention was brought again to the Oak Ridge studies and NASA's involvement. After the conclusion of the hearings, the full committee gave a statement in its biannual summary of activities that given the standards of informed consent at the time and the state of nuclear medicine, the experiments were satisfactory but not perfect. At this point we're not prepared to draw the same conclusion, given that there's a lot more we think that needs to be learned about these activities. So that summarizes what we know so far. Ron, if you want to make a few additional comments. DR. NEUMANN: No. I think at this point probably we should entertain your questions. CHAIR FADEN: Thank you. It's a very informative report. I've got Ruth and Henry and Lois and Nancy, and let's start there. DR. MACKLIN: My questions are about the change in the nature of Dr. Saenger's reports. As you described the evolution of those reports here, first he talked about the new information of metabolic effects of total body and partial body irradiation. Then he stated his purposes of obtaining information which is necessary -- that's in '64 -- necessary to estimate combat effectiveness. So there was the focus on combat effectiveness. Then by 1966, he starts to talk about informed consent, and by '71, which is still before there were federal regulations mandating IRBs, et cetera, but when there was more focus on these things, he says according to the account here the experiments were performed for the sole purpose of improving the treatment and general clinical management, et cetera. So my question is: what is likely to have been the influence on Saenger in the shift in the focus and the kind of information? Might this have come from his institution? Did it come from him alone? Was it somebody advising him from the contractor, the Armed Forces people? What brought about that kind of change? DR. NEUMANN: Well, there are several factors, I think, that go into that. Certainly when he initially proposed this research, he was aware of the interest on the part of the military in assessing the exposure of combatants after a nuclear bomb explosion, and his initial purpose was to try to look at biochemical markers that could be used as a biologic radiation dosimeter and give some sort of linear response in a test that would be relatively easy to do technically, as well as not particularly costly, since the intent was to have this done on a post-nuclear explosion battlefield. By '64, as you're aware, NASA is at this point interested in performance evaluation of the astronauts who might fly through Van Allen radiation belts, and the general field of TBI research adds a greater interest on performance evaluation, that is, what could a pilot, a sailor or soldier do after particular levels of exposure both physically and mentally in terms of how they might behave. So I think that he was aware of this, and he certainly in his applications and reports reflects an increased emphasis on psychological and psychiatric testing of his patients beginning in the mid to early '60s as an additional part of his research above and beyond the biologic dosimetry work. By '66, I have less information as to what motivated him. I'm second guessing in saying these things, but I think he's clearly aware of some of the federal regulations and discussions that are ongoing about research, and there's also a point in time that occurs, I think, around the mid-'60s internally under an IRB review process or similar to an IRB review process of an extension of the work, and they perhaps are reflecting those types of discussions in that evolution of his thinking. In '71, there may be some confusion in his description of his underlying experiment which he holds from the very beginning had a therapeutic intent or at least a palliative effect -- attempt on cancer patients versus the military funded or Armed Forces funded piggybacked research, and what he's now stating about the underlying intent is to say, "I believe that my underlying project always had this therapeutic or palliative effect measurement purpose to it," and he's beginning to describe, of course, that he had the military experiments piggybacked on those primary therapeutic ones. CHAIR FADEN: Thank you. Henry. DR. ROYAL: I thought that there were two important omissions in this very important whole body irradiation story. The first omission has to do with science and the second one has to do with history. So let me talk about science first. It's a very simple description of whole body irradiation. It implies that all whole body irradiation is the same; that once you show that whole body irradiation is not effective in a particular disease, that that's over and done with when, in fact, whole body irradiation is a very complicated thing. The results that you get might differ depending on the fractionation scheme, that is, over how many different settings you give the radiation dose. It might depend on the dose rate. It might depend on the energy of the radiation that was used. So blanket statements that total whole body irradiation was shown not to be effective in 1931 for nonradiation sensitive cancers is very much of an oversimplification. I think it's important for this committee to understand, to better understand -- and I don't understand it myself -- where Saenger's experiments fit in. That is, was the whole body irradiation that he was giving being given in any sort of different way than past ways? Was the patients that were selected for these studies somehow different from the other 45 institutions that were doing whole body irradiation? I don't have a good feel for where Saenger's experiments fit in in terms of the science. The second comment about history. It struck me as a remarkable omission in this report that there are three committees that are described as having looked at Saenger's experiments. One was an internal faculty committee. Another was a junior faculty committee from the University of Cincinnati, and a third committee was an ECR committee. Two of those committees decided that Saenger's experiments were within the accepted standards of the day, and the third committee, which was the very interesting committee, was this junior faculty committee which really singled out Saenger's experiments as being unethical. What's surprising to me is that there's nothing in this report about what the motivation was behind this junior faculty committee investigation of Saenger's committee. Because I was in college at that time, I sort of remember those days, and I remind you that it was during the Vietnam War, and there was a great movement nationwide to look into all university activities that were funded by the Department of Defense. So I think looking at the motivation by which Saenger's experiments initially became identified as being suspect in determining whether or not it was because of the ethics of the experiment or whether or not it was because of the political concerns at the time, I think, would be very important. DR. NEUMANN: Well, I can answer the second question probably easier. We didn't make comment upon the motives of any of the three committees. There have been allegations both ways on each of those committees as to how well they performed an independent audit of what went on. I can tell you vis-a-vis the junior faculty committee, in documents that we do have, those people who were involved from the very beginning in that committee have testified that they heard conversations in hallways about the work, and it wasn't until some time later that they brought their concerns to the attention of higher level medical school and university authorities that they learned about the source of the funding, and that was when progress reports were turned over to them. So none of us have attempted to make a value judgment about the motives behind the reports issued by any of the three committees, but you certainly can read both sides of the issue on the function of each of the three committees and the various allegations that have surfaced since that time. Vis-a-vis your first question about the science, we're attempting to reconstruct the history of TBI. The National Library of Medicine has as of this morning given me an inch and a half of abstracts on TBI that supposedly date from 1966, when their computer database was installed. They're having to hand search the literature back to '20s. We believe that German reference is the first reference to TBI. It is probably fair to say at this point though, based on what we've read in papers that are available, that the use of TBI in solid tumors -- by that I mean carcinomas and sarcomas -- had been tried extensively and was felt to not be particularly effective. That's not the case for leukemias and lymphomas. Dr. Saenger never actually said that he was attempting to cure these cancers, but rather that he was hoping to give some form of palliation for the various secondary symptoms, and if he were lucky, to measure some tumor response, but his intent was not, in fact, to cure the cancers. We do not, as I said last time, in the practice of medicine have a body or governance group that looks at when practices are either to be accepted or discarded. It's a bit different than the approval of drugs that you heard about this morning or radiopharmaceuticals. A practice in terms of something like this TBI could be accepted or rejected, I guess, based upon the bulk of the literature evidence, but there is no standard, to my knowledge, of adding up the pro and con papers and deciding at what point one discards a technique as not being useful. Probably it's better established in terms of accepting practice by the bulk of positive papers that are written about any particular technique, but I think that in science it's generally been accepted that an investigator can pick up an idea that he or she may feel warrants further investigation and continue with appropriate review and funding to pursue those lines of investigation, and I believe that would be the statement that Dr. Saenger would make. CHAIR FADEN: Thank you. Lois. MS. NORRIS: I'm wondering have you ever seen an underlying protocol on these experiments or are you relying on the application for funding, applications for funding? DR. NEUMANN: Are you talking in particular about Dr. Saenger's experiments? MS. NORRIS: Yes. DR. NEUMANN: We have not. In the minutes or the report of at least one of those three committees that were described as having functioned at Cincinnati, they did attempt to reproduce that underlying protocol for the palliative effects treatment and were unsuccessful. MS. NORRIS: The reason I ask the question is I haven't been able to leap quite as readily to the assumption that Dr. Saenger's work suggests a military application was a central focus of his work. I rather assumed that the military application focus was more related to his application for funding and the reports that -- DR. NEUMANN: Well, you're right. That statement only applies to his federally funded research. We're not extending that to his underlying work, which did not, to our knowledge, have federal funding. So that perhaps wasn't written as carefully as it might have been, but he does clearly indicate the purpose of his militarily funded research as being that. MS. NORRIS: That I understand. DR. RUSSELL: Do you have some idea of the balance of the sources of funds? How much came from the non-military sources? DR. NEUMANN: We have not seen any documentation -- again, are you asking particularly about Dr. Saenger? DR. RUSSELL: Yes. DR. NEUMANN: We have not seen any documentation about other sources of funding for this particular work. It would, of course, be of interest to us if the hospital or the medical school were the source of his funding for the palliative effects research. We do know that he shared bed space first on a psychosomatic ward and later on a special research ward that was funded by the National Institutes of Health, and to the extent that the NIH oversaw the expenditure of funds for that particular research ward, one might indicate that there was funding from NIH. Dr. Saenger also involved fellows throughout the course of the studies who were funded by various types of research training grants, but we do not have other identified sources of funding at this time. CHAIR FADEN: Thank you. Nancy. DR. OLEINICK: To some extent my question has been answered, but I'll ask it anyway. I'm just wondering to what extent publication of the results of the TBI studies in any way had some control over the number of studies and the continuation of these studies. As we've heard, it was known back in the '30s that the TBI was going to be ineffective in cure at least of solid tumors, and certainly I guess many of the investigators were not attempting cure, but they still were attempting response rather than mere palliation, but some kind of positive response. I'm just wondering if there is any indication of papers being submitted to a journal, for example, and being refused, rejected because of the fact that this was already a disproven therapy, any way that publication itself would limit the use of the therapy. On the other hand, many of these studies were also published just as government reports or symposium volumes where, of course, peer review would not be as strict. DR. NEUMANN: As I said, we're attempting to undertake a review now of the literature on TBI with the National Library of Medicine in an attempt to address that. One initial assessment I did very early after the staff were formed was to take Dr. Saenger's bibliographic portion of his curriculum vitae, and I simply looked at the numbers of papers published, and those appeared in various types of public literature, some sponsored by the government and some not. There is a majority of his papers and his CV relating to the biologic dosimetry aspect of it when compared to the therapy, but I think you may be right. It may have been very difficult to get papers published perhaps in the therapeutic or palliative effects area because it may have been discarded by the general review process at that point in time. CHAIR FADEN: I've got Duncan and Eli, and just trying to get a show of hands, are there other people who are interested in commenting? (Show of hands.) CHAIR FADEN: And Mary Ann, and then I'll do one last call, and then we'll move on. Duncan. DR. THOMAS: Sort of following up on Henry's question about were there differences in the way that Saenger was developing the TBI regimen that would lead him to have some hope that it might have been effective, my recollection is that later on in his research he started investigating ortologous bone marrow transplantation in combination with this, and we now know that that's part of the standard therapy for leukemia. Can you put this in some perspective for me? Was there any other research going on on bone marrow transplantation prior to him that would suggest therapeutic benefit for solid tumors? DR. NEUMANN: I'll have to take a rain check today until we could look at the literature more precisely, I think, to give a fair answer to that. He was not the only individual certainly looking at the preparative techniques pre-transplant of marrow or other organs in that period of time. I mean at Oak Ridge, for example, that was also a rationale for their work. You asked whether he was doing it differently. In the beginning as he described his equipment, he had an X-ray source machine, and they shortly afterwards got I believe it was a cobalt machine, and it was unique to that area of the country according to one of his applications. There's been much made of the fact that he describes very carefully how patients were positioned in a fetal like position with the knees drawn up and the head down and the arms in place. He has charts of the isocontour curves of his dose from his machine, and in order to get a uniform exposure to the body, it was necessary to have the patient placed in that position, and then part of the exposure was given from one lateral aspect of the body and the other half from the opposite. So there's nothing, I think, to be made of the positioning of the patient or the uniqueness of his instrument, although he did make that statement that the cobalt machine was unique to that part of the Midwest at that time period. CHAIR FADEN: Thank you. Eli. DR. GLATSTEIN: I think you have to put this in some kind of historical perspective. With the TBI stuff in the first half of the century, it was pretty negative material, I would agree, but at the same time, the development of Cobalt 60 and other forms of megavoltage, it would permit the radiation to go to considerably higher dose of depth than what people had been using in the first half of the century. There was a question mark as to whether or not that would make a difference in the outcome of cancer, and when you take patients who have disseminated cancer and consider the alternatives for treatment in the 1950s, some interest in chemotherapy, although at the time very modest, there wasn't a great deal of therapeutic maneuver to do. The fact that he was looking at fractionation schemes and a variety of technical modifications, I think, makes it interesting, although, you know, the bottom line was that no significant improvement evolved. But there was a hypothesis. There was a design. There was a consideration for variables. It didn't work. The relevance to transplantation data that goes on today, I think, realistically required a considerable advance in the technology of being able to handle fresh marrow, which wasn't in existence at that time, although he did have some interest in that as a variety of other investigators did, including Oak Ridge, as you point out. But the technology wasn't up to the task at that time. In the meantime, by the end of the 1960s, multi-agent chemotherapy had evolved, which was different than what was available in the '50s, the combinations of different drugs being used for the treatment of disseminated cancer, and the whole body irradiation was fundamentally discarded by the end of the '60s in most people's minds anyway, perhaps in the early '70s, but I would say the end of the '60s. All of these things are going on at the same time. So it's a little hard to look back in time and say that this was entirely motivated by issues of defense. I really don't believe that was true, and in fact, he was investigated several times and shown not to. No one could ever demonstrate that. But the alternatives of treatment evolved significantly in the '60s, and by the mid-'70s virtually no TBI was going on at all, except for, as you say, lymphoma/leukemia and also for selected patients who had disseminated cancer in bones with severe bone pain for reasons that are not clear. Discussing it earlier during the lunch break, you can alleviate pain remarkably with this form of treatment. Why it works I don't understand, but it does. CHAIR FADEN: Comments, anyone? DR. NEUMANN: Well, I think it's also appropriate to put Dr. Saenger's work in the greater context that there were at least 45 other institutions from which Oak Ridge study was able to collect retrospective data, and he was perhaps one of the most visible investigators because of circumstances that as it happened, that by no means alone in this approach. His role is part of the prospective study, along with the investigators at Oak Ridge. It's less clear to us at present whether there were other institutions, as well, who were part of a prospective study of total body irradiation. In those instances at Oak Ridge, we know that very special rooms were constructed to maximize the ability to irradiate the entire patient's body in a more comfortable position and with even more uniform dose isocontours so that particular types of equipment were built at least at Oak Ridge, if not at other institutions, in the hope to achieve that uniformity of dose that they were seeking. But I think that Dr. Saenger has maintained to the present that, in fact, the military applications research was secondary to his underlying protocol. It's been difficult, I suppose, for him because he's not been able or willing at present to provide that underlying protocol, which was asked about before and was asked about earlier in the committees that looked into his affairs at the University of Cincinnati. And certainly I would imagine that that's something that will be asked again in the legal proceedings that are ongoing right now. CHAIR FADEN: Eli. DR. GLATSTEIN: Just a point of information. After the first discussion of this Cincinnati experience we've put to the Department of Defense and others these follow-up questions, including the underlying protocol. I'm pretty confident we don't have it, although I know Dr. Soper is in the audience and had suggested we have it, but I don't think we have it, and that's what Ron was alluding to. We've been asking for it, if there is any. CHAIR FADEN: We have -- oh, I'm sorry, Gary. A quick response, and then we'll have Mary Ann's question. Go ahead. MR. STERN: I actually just wanted to make a comment in response to an earlier comment about what effect the literature in the positive versus negative responses to this might have had, just to quite from the review of Saenger's original application in 1958, in which the reviewer is doubtful that his actual study will provide much practical data, but in spite of the above, and I'm quoting, he said, "I feel that Dr. Saenger should be supported with a high priority. There are so few radiologists in the country willing to do total body irradiation that those that are should be encouraged more." That raises the question about, well, does the military feel like since they care a lot about this information, they want to get as much data as they can from the few people that are doing it and keep the process going. That's just a question that that raises. CHAIR FADEN: Mary Ann. DR. STEVENSON: Eli has raised almost all of the issues that I wanted to address, but, again, just to carefully -- we should all be very careful to set the TBI experiments in each decade or half decade that they're performed, and especially in comparison to the state-of-the-art for chemotherapy and especially combination chemotherapy. Probably the question easily stated, but not so easily dissected, is: would these TBI experiments or treatments have been done or continued without the financial or motivational support of these various government agencies? And there may be a crossing point where that becomes more obvious. It may be in the '70s when the standard of care in medicine was not to be using TBI that it becomes very obvious that perhaps TBI experiments that were being pursued at that time with government funding were somewhat questionable, whereas earlier on it may not be so clear. And in terms of trying to get after that, clearly, we have to go back to the primary literature and facts and references to the committee last week, and as much as possible try to get a hold of what the standard of care was during those earlier decades, and getting hold of old textbooks -- although they're not great in that period of time for radiation oncology or medical oncology, there are some in existence -- and see whether or not there are statements in those textbooks as to what the standard of care is for various diseases or treatment of metastasis, and that would at least give you an underlying sense of standards of practice. And I've been trying to collect some of those from my own colleagues and faculty members, and I think you can find them, but it's not so easy. DR. GLATSTEIN: Very quickly, one of the reasons it's such an interesting study is that you've got four dozen or so institutions, and it just seems obvious to most of us sitting here how many were actually at one point in time government sponsored institutions. You've actually got your built in -- we don't know the answer. DR. STEVENSON: I guess the other thing, too, is in the Attachment A, you know, the statement or list of cooperating institutions in retrospective studies, now, retrospective to most people in medicine means that what's been done has been done, and you just go leaf back through the charts and try to glean some extra information out of it. In other words, it doesn't imply that the studies or the treatments were done with the supposed motivation or with a particular motivation at the time, but you try to glean information retrospectively, and that's very different than a prospective study. So I think in identifying these institutions as having agreed to look over their old chart data doesn't mean that they were part and parcel of a grand schedule through the AEC or DOD or DOE. MR. STERN: That's absolutely correct. I mean, again, we're raising that question. We know, as I think the report states, we know for certain that eight of the 45 were doing it on government sponsored contracts, and that's all we know for a certainty. We know some of the others were VA. Los Alamos Hospital, for example, would have had an affiliation with the government, but that remains to be determined. That's what we want to understand, to what extent were any of these other ones motivated or influenced, if at all, by the government or were they doing it wholly independent and then just providing the data. And I do want to respond to your earlier question about understanding practices at the time. I think where the issue that concerns has been raised the most to date at least, I think, is with respect to Oak Ridge, and there has been a general concern, I think, that into the mid-1960s and beyond that Oak Ridge may have been more isolated than most institutions and was pursuing a practice that had been let go from most other places, and the fact of its very close affiliation with the National Lab and the AEC there, and perhaps in its sort of isolation, almost geographic isolation, that it was continuing in a way that had been let go for most other places. CHAIR FADEN: Eli. DR. GLATSTEIN: I'll be brief. I just want to add that in trying to realize why someone might want to use total body irradiation, you have to appreciate that if you're careful about the dose rate in an era when you didn't have good anti- hematic medications as we do today, but where you couldn't control nausea and vomiting, if you're careful about the dose rate, the side effects, the acute side effects of whole body irradiation are almost entirely blood count related, and there's very little symptom development that results from a whole body treatment, and this is in sharp contradistinction to almost any other systemic form of management. MR. STERN: I think that does raise a concern that at least you see from the literature and Saenger's proposals, as well, where they are proposing to go to much higher levels and where it was, I think, clearly known that above 200 -- DR. GLATSTEIN: I'm talking about dose rate in terms of rad per minute as opposed to cumulative total dose. That's a different issue. It's a complicated one, one which is not well understood, but if you slow the dose rate down, the tolerance for this form of treatment is really quite remarkable in terms of symptoms. DR. NEUMANN: Well, I'll just comment that NASA's involvement with the Oak Ridge experiments was to provide the money for instrumentation that allowed the Oak Ridge investigators to look at long impedance as a better physiologic marker of things like that because, as you date, the traditional responses were very difficult to use as a biologic dosimeter, and as it turned out the bulk of the biological tests and blood tests were not effective. CHAIR FADEN: Do we have other questions? The story is going to continue, I'm sure. Again, this reflects an awful lot of hard work, and we appreciate all that stands behind this staff report. We're going to move along and try to get one more staff report in before the break, and then we will have our public comment period, and that is a report from Gil, Jonathan, and Dan now on the attempt to extract using the revised form the material that we do have in house on the experiments to date. DR. WHITTEMORE: Okay. This is just a brief report to follow up on what we were discussing last time, and that is the desire to have some kind of a computer system that will allow us to begin extracting information about the many experiments about which we're beginning to get some information. And as you remember, last time there was a discussion about the various elements of information that should be on the form, and that's now gone through a number of further revisions so that you have a longer, more elaborate form appended to the handout. CHAIR FADEN: Gil, can I just interrupt for one minute so that people know? It's in your blue folder. It's not in the Tab I in the book because it didn't get there in time. So it's in your -- I'm sorry -- it's in the blue folder to be put in Tab I. I'm sorry. DR. WHITTEMORE: Okay, and I should also emphasize that in putting this together, it's important to realize -- and Jonathan Engel, I think, will expand on this -- that our goal in designing the form in the database was to have a place in the computer system for information should it become available, but having places for the information is no guarantee that the information has or perhaps ever will become available. So that it not only helps us retrieve what we know, but eventually will give us a much clearer picture of what we do not yet know, and I think I'll turn it over to Jonathan now to discuss the latest trial run using the form. DR. ENGEL: All right. We're sort of moving from trial to operational. We have five of us analysts now working on this, and we spent, I guess, four full days this week going through at this point 120 experiments. We just did 20 in the last day or two, and they're not yet in this packet, and it seems to work fairly well. We're falling down in some areas, and we seem to be successful in other areas. The big one, Professor King, that we just pointed to here is in the subject analysis. The vast majority of the material we looked at in the Markey collection and in the new collection of experiments which DOE has turned over to us is scant in terms of referring to the make-up of the subjects in the experiments and in detailing issues of informed consent and release forms. Many of the documents are just simply published articles from journals or reports to agencies. They don't detail the protocol. They don't detail funding. We rarely had funding levels. We rarely had details on management issues or protocol issues. So what we were best able to do was put in the title and the year and the name of the primary researchers, and we were very successful in categorizing the experiments, and that will be helpful as we go to write the final report. What we didn't do very well was figure out what themes each experiment will be of interest to the staff as it writes the final report. I spoke with Ruth this at length and in getting the subjects down. One of the things I want to make clear was the nature of the collection we looked at and what may continue to be the nature of documents which come in. The material which is in the -- I don't know quite how to get the -- the Markey collection, which is to say the material which Markey's committee on the Hill looked at when they wrote their report, is less complete than you think. When I last spoke to you all, I had only looked at the fact sheets. That's all I had time to go over. This time we had five of us, and we went through all of the documents. We looked at every page, and there were fewer pages than there should have been to get the kind of detail we wanted. Also, it isn't as organized as you might think, so that rather than there being simply a series of manila folders, each one devoted to a particular experiment and mark that particular experiment, instead it's simply loose pages, and you need to decide which experiments to include, which experiments not to include. Many of the experiments we saw were not human radiation experiments at all. Most of the experiments that were written up in some form, whether it was just an abstract or whether it was an article, were not included in Markey's report. Markey's report talks about 31 experiments, and we have over 60 at this point, and even then we left out some which weren't clearly human radiation experiments which were in that report. That left us with a challenge of if you're not going to get the material so that it's all organized nicely experiment by experiment, in order for our mission to succeed we need to have a way of adding further documentation to each experiment that's already been written up, and to get that, we need to have a unique reference number for each experiment. That's the most important thing of all so that when three months from now a new document comes in on some injection experiment we've already looked at we're not running up a new form, but we're able in some way to identify the form on computer that's already been written about and add the new information in and thus get more and more detailed information on each experiment. So we have tried to develop a unique classification basis for each experiment, and it's simply the experimenter's last name and the final year -- and there's a reason why we chose the final year -- of either the research or the publication, and that's simply because half the time we could only get the publication year. So for consistency, it's easier to use the latest date applicable to each experiment. When we go into the database now, since it's on computer, we ought to be able to type in the experiment, the principal researcher's last name and the last year of research or the date of publication and get somewhere close to a preexisting document that we've already filled out, and we hope it will work. MR. GUTTMAN: If I can just add in context, what we have, and of course, whatever comments were made were in no way meant to be a criticism of the Markey report, which of course was the basis for much of our existence, as Ron Neumann said, what we have is sort of a library card catalogue. We've got all the books, but in the actual library maybe there's like a fragment of a page of any of the books or none of the books. So what we're doing -- and Gil has expressed it, too - - is sort of an index, and this data form is not the answer. This is not the basis for making decisions. It's a form which is a place holder or an index, and where we're going hopefully will be in two directions. One is we do have enough interesting, significant data, as primitive as it may be, to begin to ask some questions. Earlier this morning we were talking about where different kinds of scientific or medical activities are treated differently for purposes of being within the experimental box or not. So we see now we have 30 or 40 so-called biodistribution experiments in DOE. Well, you can look at those and see how things change from the plutonium days onward and see how that compares to the so- called therapeutic. The other way we hope to go is that we have from the NASA, the Navy, and the Air Force relatively lengthy lists with more or less information of this kind of basic quality which we hope to sort of put into the database fairly quickly, so then we can move on so you can decide how to sample a group or focus and answer the kinds of questions by more detailed research that you're going to have to answer. CHAIR FADEN: We're open for questions now. Questions? What we do know is that we aren't going to be handed anything easy. The notion that somehow we would be given a package of materials either from a preexisting group, a subcommittee of Congress, or from the Department of Energy and all of the answers would be in there because they'd give us a box that said "X experiment," and in there would be all of the detail we would need to know to make an assessment about that experiment from every conceivable -- we now know; we knew that before, but now we know empirically that was false. So now that we know that it's not going to be easy, which we know before, but now we have proof that it isn't going to be easy, the question becomes, you know, where to go from here, and Dan has given some descriptions of that. It was very helpful for Jonathan and his colleagues to do this and to do it under such pressed time constraints so that we could once and for all make it plain that what we have before us is no easy task. Henry. DR. ROYAL: We've heard that the universe of experiments that have used radiation is very big, and then we have these experiments that are listed in the Markey report, in the most recently released list of experiments from DOE. Is it clear or is it becoming clear to you people who are most familiar with these individual experiments what the selection criteria are for either becoming part of the Markey report or for becoming part of the DOE list? That is, how did we go from the tens of thousands of experiments involving radiation to this list of 105 experiments? What is it that these 105 experiments have in common that make them appear on this list? MR. GUTTMAN: Well, the quick answer, it's an art, not a science, to get on the list. (Laughter.) MR. GUTTMAN: Different agencies do it differently, and some we have found not yet at all. In DOE's case, I can answer you mechanically. What happened was Congressman Markey in the early '80s said, "I'd like a listing of human experiments." At that time it looks like DOE polled the field and said, "What have we done?" More recently -- and then that's what came up. More recently -- DR. ROYAL: So the fact that you get on this list indicates only that the experiment has been done or it indicates something about how the experiment was conducted? MR. GUTTMAN: No. I think if you read the Markey report itself, I think it makes clear that Congressman Markey blesses a couple of the experiments at least in terms of either therapeutic value or follow-up. So it isn't a list of notorious experiments. It's a list of experiments. The notorious gets put on afterwards. That's A. Then what happened for the new 48 was in the context of the second openness conference two or three weeks ago, the department went through its process of analyzing the boxes of information which they had put together in part for us and in part for the public, and in that found references which were passed through a health physicist at the department. And so what Jonathan is alluding to in many cases what you would have would be an Oak Ridge 1964 report or a Los Alamos 1964 report, and it will say, you know, gallium or radioiodine was injected. So it should be clear that isn't a qualitative judgment. In fact, as Jonathan was saying, the facts are so fragmentary in so many cases that you'd be hard-pressed to make a qualitative judgment. The final point I'd make is that a lot of these things, but not all, are things that you could pick up from Dr. Stannard's work, which you had pointed out to us at the onset. So the answer is there is not a science involved in that process, if that's -- let me try it another way. When we first started work, DOE Office of Science and Technology had put together for us and anybody else a computer printout set of abstracts, which we had shared, in fact, with Eli and Nancy and Mary Ann, from, I think, Nuclear Science abstracts, and they had found that it was not something they were trained to study. The question I ask myself today is: what is the relation between the assorted hundreds of abstracts in that Nuclear Science abstracts and the DOE collection? And at some point in our lives we will get closer to a fine grained understanding of that. So we're still dealing with pretty rough collections, especially in the case of the Department of Energy. As Ruth was saying, this is not the committee that sat down and the government said, "Here's your data. Just go analyze it." This is the committee that has to say, "Now, what is data? Where is it? And is this the data that we're supposed to analyze? It doesn't look like it. Maybe we can do better," and that's what we're trying to do. CHAIR FADEN: We've basically worked hard to develop a form for information that we don't have access to at the moment, but hopefully will at some point. A lot of energy went to getting -- MR. GUTTMAN: One more point. One more point lest Henry leave the table and go say he needs a break. When we look at the thousands -- the notion of thousands that we get from the Department of Defense, most of them are post-1974. So that in terms of this is all puffing up, makes it look like we're doing this incredibly complex work, which is true, but if you want to get down to this pre-1974 period, we are probably looking at hundreds of experiments, you know, maybe close to 1,000, and in that case most of the information is going to be so fragmentary that in terms of focusing, I don't know that it'll be a sampling problem so much as where can you get information problem. I know that's a terrible bias problem of its own, but that's more likely to be the kind of problem, and we have too many things to pick from. It's going to be how do we make a story, and that's where we get into trying to grouping, so that we have some sense of where the science was going, some sense of where the government purpose was going, so things fit in more or less. CHAIR FADEN: It will be important to keep this experience in mind tomorrow when we start thinking through how we want to attack the projects in the next six weeks, recognizing that we aren't going to be handed things in a simple fashion. Anna was pointing out, and it's quite right, that this is very useful because it shows us what we don't know, and then we have to then decide how can we get the information that we need to address the issues that we have made our priorities, and that will take some creative, collective thinking both for committee and staff. But once we get access to the information, we have a lovely way to record it, which is useful. (Laughter.) CHAIR FADEN: Useful, and the process was a good one. I guess we should take a break. Now is the time. This is a little bit of a longer break. So if you need to make a phone call, but please be here. We're going to start promptly at 3:30. (Whereupon, a short recess was taken.) CHAIR FADEN: If we could begin, please. Could the committee members please sit down? We're going to start our public comment section, please. We have a longer than normal public comment period. We normally have an hour. We have an hour and a half. We have six very interesting panels of people who would like to speak with us. As follows in keeping with our format, we're asking our presenters to keep their formal comments to five minutes, but then the committee will use its discretion in asking as many questions as committee members would like to ask of our panelists. Our first presenter is Mr. Stewart Udall, who has traveled from New Mexico to present before us. We are very grateful for your taking the time to come to see us, and we're looking very much forward to what you have to say. So, Mr. Udall, the floor is yours. MR. UDALL: Thank you. And I consider it a very wise decision that the Clinton administration appointed this body. I think you have a chance to make history. This is the way something like this should begin, and I'll go into my five-minute drill after apologizing for not having a written statement. I have showered you with some of my writings and other evidence which I hope has helped. 1948, the United States, the Atomic Energy Commission, creates a new industry, uranium mining. Very important for the national security. The United States, which legally knows what its experts know, conducts a survey very early in 1948 and finds out that there is a very severe hazard related to uranium mining. The United States, in the form of the Atomic Energy Commission, decides to do nothing, although it has most of the knowledge that would be needed to take action and to leave the problem up to the states, which know nothing; to the mining companies, which know even less. 1949-50, the U.S. Public Health Service enters the picture, does preliminary studies, sees the risks, the very hazardous risks that are associated, makes preliminary studies, takes readings in mines, tries to get action. Nothing happens. It then prepares, which appears in 1952, what it calls an interim report which it feels will galvanize action, in which it summarizes the nature of the problem. Nothing happens. The Public Health Service -- and these, in my view, were good Samaritans, were good people -- they couldn't walk away from the problem morally. So they decided, well, if they won't accept our judgment on this, we'll study this problem. We'll study the miners, and they initiate a prospective epidemiological study, which I don't know how you've decided to describe experiment. To me it's an experiment. This is the largest experiment that was carried out with human beings. Ultimately they enrolled in this study, which went forward for a long period of time, over 3,000 uranium miners, many of them illiterate Navajo Indians. The idea was if we study these people and the problem and it turns out that our forecast of a lung cancer epidemic comes true, then they will believe us. Then they will take action, but there was a terrible flaw connected with this: an 11 to 12-year latency period. So by the time the study shows that this is a terribly hazardous industry and that there's a lung cancer epidemic, it's 1961, and it's too late at that point, but even then the Atomic Energy Commission, which has professed over the years to be concerned -- they were always concerned; they were interested in seeing this study carried -- then they waited another six years, waiting for someone that they respected to institute appropriate regulations. All the time, all this time there was a simple technological solution: fans. Put air through the mines to sweep out the radon and the radon daughters, and so there was a solution, as government officials knew from the very beginning. Consent? Well, they enrolled these people, and every other year as it turned out, on the average of every two years, a caravan moved around in this remote area, and they conducted physical exams. They did a census. They gathered census data about who the miners were, where they found them, and so on, and they went into the mines and took readings. So all of this record was developed. They got consent. They had consent forms to consent to a medical exam. These miners were never told the nature of the problem. They knew that some kind of study was going on. They didn't know and they weren't told what the risks were. That's my quick summary of the problem, and I think all of us who have some knowledge or background ought to make ourselves available to you in the future as you study the various experiments that were carried out. I happen to have some knowledge because I did help write the Radiation Exposure Act. I hope you get into the question of remedies, and I'll be glad at some time in the future to talk you about that. That's my presentation, and I'm sorry if I overran the time. CHAIR FADEN: We're fine. That was very efficient. Thank you, Mr. Udall. Are there questions? I'm sorry. Duncan. DR. THOMAS: You volunteered to tell us more about the Radiation Exposure Compensation Act. Can I give you the opportunity to say a few words about it now? In particular, I would really like to hear your opinions about how well you think that it's serving the compensation needs of the miners. MR. UDALL: The Radiation Exposure Compensation Act was passed four years ago, and after the despair of losing all of the lawsuits, I thought that it would be a failure. Fortunately, the five uranium miner states included a lot of powerful Republican Senators, and they persuaded President Bush to sign this legislation. We now have had three and a half years' experience with the legislation. As far as the uranium miners are concerned, they framed the regulations which are very strict. They don't recognize that the data which is called the database was very uncertain because, for example, these people took readings in the mines once every two years. Now, states later started taking readings and so on, but the data was very inadequate. But there's a rigidity to the program. Half the applicants are being denied. A lot of the living miners are unable to comply with the requirements of B readers reading chest X-rays, if you know what that is, of people proving that they are disabled. The program is something. I wouldn't describe the payments as generous, but it is an acknowledgement by the nation. There was a national apology that we insisted be written in the legislation that wrongs were committed, and I think at this point all I would say to you is the program is moving forward. I think Congress needs to revisit it next year. I think you need to visit it yourselves because it might be now exactly a model, but it might provide some important guidelines for you in making whatever recommendations you decide to make. DR. THOMAS: Are you aware whether there has been any formal evaluation of payments made under this description of the cases that were awarded and not awarded either by the program itself or by any outside organization? MR. UDALL: No. There's been no assessment of it. I have assumed all along that the congressional committees that wrote the legislation would revisit it, and I now think that that is in order next year. Whether it happens I don't know, but I will say to you the program is meaningful. It has some very serious flaws, and it has some serious flaws where the Downwinders are concerned and where the test site participants are concerned. I can go into that if you wanted me to. CHAIR FADEN: Reed. DR. TUCKSON: Let me just -- and we can perhaps get into more detail outside of the meeting -- but what is the difficulty in persons being able to demonstrate, in fact, that they are disabled? Is it that the criteria for medical concerns is vague, inappropriate? Is it a concern that the miners don't have access to the kind of health professionals who can adequately assess physical consequences? What is actually the operational issue that's inadequate? MR. UDALL: Well, I'm going to talk in particular because the obstructions are greater with the Navajo Indians. We're talking about the older generation. We didn't give them an education. They never understood everything that was going on. The health care that they received over the years from the U.S. Indian Health Service was by any standards substandard. Good people, but I mean they don't have the money. Their budgets are being cut now, by the way, in the current budget cycle for Indian health. But there's not only that problem, but we have to prove the exposure through their work history. The work histories are skimpy, but if we can't prove it, we can't prove it. You have a lot of the Navajo Indians who were skeptical of our health care, relied on the Indian medicine man and so on. They didn't go to the hospital. The medical records sometimes have been destroyed. We lose because the government destroyed the records. There are problems on both levels in trying to develop the facts so that they can qualify. CHAIR FADEN: Ruth. DR. MACKLIN: Yes, Mr. Udall. You referred to the risks when you talked briefly about consent and indicated that at best there wasn't much consent even though they knew there was some kind of research going on, but I think I heard you say they weren't told about the risks. Now, the risks, as I understand it, were the risks of their occupation; is that correct? It was an occupational hazard. MR. UDALL: An occupational hazard. DR. MACKLIN: So apart from the question that this committee is, of course, focusing on, which is consent to be a research subject, was there any obligation or did anyone see any obligation to notify and explain to the uranium miners what their occupations hazards are? That is, we can imagine someone making the to my mind not very convincing argument, well, they were doing this occupation anyway, and all we were doing was studying the hazards, but if they didn't know and the Public Health Service that already knew, as you described, what the risks of their occupation were, did anyone see it as a responsibility at least to notify them about that and then give them the choice? You continue in this lucrative occupation which has these risks or they might have made another choice. MR. UDALL: It's shocking to respond that no one ever told them, that no one ever told them, and it's shocking for me to tell you -- well, Dr. Eisenbud said it in his testimony to the Senate committee in 1979 -- that the dangers were known. There was what was called the European experience. There were uranium mines, pitch blend mines. Madam Curie got her pitch blend from these mines in the Erz Mountains in Czechoslovakia. There was that experience. This country had had a very vivid experience, got a lot of publicity involving the radium dial painters. Dr. Robley Evans and others had fixed standards. This involved radon, the same subject, workers working in a closed environment, and the results were known, and that's what makes this to me a rather horrifying tale. Because the Atomic Energy Commission had people who knew more about radiation in 1948 and the hazards than anybody else in the world. Dr. Shields Warren, their Division of Biology and Medicine, they had the knowledge, and they did nothing. CHAIR FADEN: Phil. DR. RUSSELL: Did the Public Health Service protocol or the supporting documents that generated that study clearly define what the perceived risks were from the point of view of the investigators or the documentation of that? MR. UDALL: Well, their protocol was very skimpy. These were industrial health people out in the field desperately trying to get the attention of the other people in the government, and so on, and they were sort of operating on an ad hoc basis. They didn't back off and get directions. As a matter of fact, some of their superiors in the Surgeon General's Office, to be frank with you, didn't perform very well, in my opinion, from documents that I've seen. But it was just an example where it was out in the boondocks. It was important for the country, and nobody wanted to step forward and blow whistles, and they didn't in those days. CHAIR FADEN: Nancy, did you have a question? DR. OLEINICK: Yes, I just wanted to know do you have documented evidence that Dr. Shields Warren or any of the other dignitaries of the AEC or one of the other agencies of government actually took a position contrary to the position that you're taking, that the changes should be made in the environment of the mines? MR. UDALL: On the uranium miners, as far as I know, Dr. Warren was never involved, and there was a health and safety laboratory in New York. Dr. Eisenbud worked there. He saw it. You can read his testimony. I don't want to recite it. Dr. Warren was involved with regard to the bomb tests in Nevada and the downwinders, and I interviewed him in 1980 not long before he died, and I can only describe him as a troubled man because he had wanted to do it differently at the Nevada test site. He had strong ideas. He had wanted to limit the size of the bombs they exploded, and he just didn't take a tough stand, and I think he regretted it. CHAIR FADEN: I'm afraid we need to move on to the next panel, but I assume, Mr. Udall, that you would be available if we have additional questions that we might ask you. MR. UDALL: Yes. CHAIR FADEN: Thank you so much. We appreciate your coming. Our next panel is from the Virginia Commonwealth University. We have three representatives from Virginia Commonwealth University with us. We have Dr. Eugene Trani, who is President of the university. We have Dr. John Jones, who is Vice President for Health Sciences, and we have Dr. Hermes Kontos, who is the Dean of the School of Medicine. We thank you all for coming up from Richmond, which is not quite as far as New Mexico, but we appreciate very much your coming to speak with us. Again, if we could follow the five-minute rule and then the committee will clearly ask you more questions and give you more opportunity for response. DR. TRANI: Madame Chairperson, ladies and gentlemen of the committee, on behalf of Virginia Commonwealth University I thank you for this opportunity to speak with you today. Under the auspices of the United States Department of Energy, the Advisory Committee on Human Radiation Experiments has been given a charge of historic and moral significance, to learn of the material and ethical scope of radiation experiments conducted during the Cold War. We in the academic community must share in your task. Supported by the Atomic Energy Commission and the military, some of this work was conducted on our campuses. That responsibility, however, carries the equally important obligation for all of us to apply the most rigorous standards of intellectual honesty. Otherwise the risk is too great that your work will be sensationalized out of all proportion to its true intent. It is that risk that I would like to talk briefly about today. At Virginia Commonwealth University, we have been learning all we can about radiation studies that took place from 1949 to 1959 in our Medical College of Virginia's burn unit, the first civilian burn unit in the country. Our involvement, however, has not come as a result of being named in a Department of Energy investigation, but because of a newspaper article, an essay titled "Burning Secrets in a Virginia Hospital, a Cold War Time of Strange Experiments," published by Cliff Honicker, the Director of the American Environmental Health Studies Project of the Commission on Religion in Appalachia, in the June 19th edition of the Washington Post, which opens with the following, quote: "Between 1949 and at least 1957, the Medical College of Virginia, MCV, ran a secret metabolic lab whose primary goal was preparation for massive nuclear casualties. Imbued with Cold War zeal and scientific arrogance, doctors conducted a series of potentially dangerous experiments on hundreds of unaware human subjects, most of them poor and African American," end of quote. The studies conducted at MCV were neither secret nor danger, nor did they take advantage of vulnerable populations. As examples, the radioactive isotope incorporated in one of the studies, Chromium 51, is still part of a standard diagnostic test used around the world. In the course of the project from 1949 to 1959, 27 articles were published in nationally recognized scientific journals. It also received coverage in local newspapers, and in part of the project, African American and women volunteers were intentionally selected so the research team could study the factors of skin pigmentation and gender in burns. In all, what resulted from this work were the discoveries that would lead to the protocols used today to treat burn victims. As bad science and bad history, Honicker's article contributed nothing to the committee's charge to help the real victims of Cold War radiation studies. It possibly, however, has created new victims: our academic community, former patients alarmed by these allegations, and certainly the families of the MCV faculty who worked on these studies. Following a rebuttal that I wrote for the Post published on June 3rd, 1994, under the title "No Burning Secrets," Robert R. Evans, the son of Dr. Everett I. Evans who directed the MCV project, wrote to me on behalf of his mother, 91 years old, brother and sister to thank me for VCU's response. He noted in his letter, "I was a young boy at the time of these events, but not too young to appreciate the extraordinary character and dedication of this group of physicians. I am greatly saddened that their contribution would be marred in any way," end of quote. As our archival record reveals, these were, in fact, extraordinary, compassionate individuals, particularly regarding the volunteer prisoners who we have since learned had participated in some of the studies. In correspondence from 1951 with the Department of Welfare and institutions in Richmond, Dr. Evans wrote, quote, "I consider all of these experiments quite safe. Indeed, it is planned that we will carry out on ourselves such experiments before we would ask the prisoners to volunteer for them." During this time, Dr. W.J.H. Butterfield, a research fellow at MCV who participated in the project and is now Lord Butterfield of Stratford in England, would also record a series of observations on using prisoners as volunteers in a document that could easily have served as a blueprint for the tenets of informed consent. He noted, for example, that human subjects should understand beforehand the procedures to be used in the research and the risk it poses; that they should be free to withdraw from the study at any time; and that every attempt must be made to minimize suffering. He also stated that, quote, "any human experiment must undertake to be open to inquiry and, if necessary, investigation. Here is a way to separate sadistic from humanistic experimentation," end of quote. It is true that nationalism, as well as national purpose, fueled the Cold War. It does not necessarily follow, however, that the science and scientists that benefitted from federal support during this period were inherently unethical. Having been partners in these radiation studies, the government and the academic community now should work together to insure that this story is told thoroughly and accurately, and that in the process the real victims are helped and no new victims are created. Objectivity and a genuine desire for insight must drive our efforts. We are looking to you, the members of the Advisory Committee on Human Radiation Experiments, to set that vitally important tone. Joining me this afternoon from VCU are Dr. John Jones, our Vice President for Health Sciences; Dr. Hermes Kontos, the Dean of our School of Medicine; and we would be happy to answer your questions. Each of you has in front of you a black packet. On the right-hand side of the packet are historic documents, including the final report of our project, as well as newspaper articles that appeared in the Richmond newspaper. Thank God for the Richmond newspapers between 1951 and 1954, outlining virtually everything that was done at MCV, as well as a list of the 27 publications, two scientific articles, and the rather remarkable memo from Dr. Butterfield, six pages, on observations on volunteers from the penitentiary. On the left-hand side of the page are press releases that we have put out, and we have spent an enormous amount of time since mid-June on this issue, as well as a copy of my response that appeared in the Washington Post, and this document, the last document -- and I'd like to call your attention for a second to this document -- all news is local. You have in the audience today two television cameras from Richmond and the Richmond newspapers. This has been a very significant issue in Richmond, and if you would, after Dr. Evans' son's letter in this packet, "In the Spotlight: Historic Burn Research," if you would look at the next two documents, they involve you, this committee. One is entitled "MCV Radiation Records Reviewed, Findings Will Be Turned Over to the Committee." That was dated July 15th, 1994, in the Richmond Times-Dispatch, and the newspaper article before that says, "Archives record review set at MCV. Federal panel looks at radiation testing," about the forthcoming visit, now completed, of Dr. Susan Lederer to MCV. So what I am preaching is that you have obligations both to determine the real victims of these radiation studies and obligations to make sure that no new victims are created during the course of these studies. We would be pleased to answer or respond to any questions that you might have. CHAIR FADEN: Thank you very much, Dr. Trani. I would like to open the floor now to questions or comments from committee members. Susan. DR. LEDERER: As you know, I did have the opportunity to visit the MCV archives in the course of doing other research, as an historian, not unrelated to radiation. CHAIR FADEN: Susan, is your mike not on? DR. LEDERER: Can people hear me? CHAIR FADEN: Now it's better. Thank you. DR. LEDERER: I did have the opportunity to visit MCV in the course of doing historical research unrelated to radiation, but after the story in the Post broke decided during my visit to review some of the archival materials relating to the burn studies conducted by Drs. Evans and Hanes, and in my review of the records, I saw no evidence to support the allegations that had been published in the newspaper. But my question for you is this: that you've been in the process of reconstructing the history of radiation research at MCV and communicating that story to your local public. We, of course, are engaged in the process of trying to reconstruct the history of radiation experiments on human beings for the entire nation and will eventually or in the very near future communicate that story as we find it to the American public. What things do you think we should bear in mind as we continue in the process of our work? DR. TRANI: That's an important question. We have learned our archives well, and thank God for Dr. Hanes, who is 86 years old, I believe, and retired in Richmond, and he turned over to our archives 16 boxes of materials. So there's a lot of records out there. What surprised me with university projects, at least our university project, quite the contrary from being secret experiments, there were articles all over the place: 27 scientific articles, newspaper articles. So there probably is a lot of publications that you ought to have access to. I would certainly urge that you do that. But the most important thing is you have to set a tone that is going to encourage institutions, that they have to not cooperate, but get out in front on these issues and look at their own archives, look at their own records, and where they have questions, to formally acknowledge that they have questions. There are many people; in fact, we still have some on staff today who participated in our burn experiments supported by the Department of the Army. I would urge interviewing those people, but if this turns into a witch hunt where sensational charges can be made and people have to spend as much time as I and my university have spent in the last month responding to this, you will have not set the proper tone, and I think you're going to have difficulty getting institutions to be out front on this issue. So I think you really do have to be concerned about the creation of additional victims. Patients that were treated in perfectly acceptable manners in the 1950s, '40s and '50s, now worried about whether they were used as human guinea pigs, when in fact they were not. So I guess my pleading is for you to really discuss these issues and look at the exchanges in terms of us and acknowledge what Dr. Lederer said, that she did spend a day in our archives, and then ask the question of how do you manage that issue so that you don't have two television cameras from every city that you are discussing coming to hear what is going on before the committee. It's a very explosive issue. CHAIR FADEN: I have Jay and Ruth and Pat. Let me be sure I have everyone. Jay, Ruth, Pat, Lois. DR. KATZ: Don't forget Patty. CHAIR FADEN: Just one second, Jay. I want to make sure I'm getting everybody's, and Phil. I'm just trying to get eye contact and also worrying about getting all of our presenters in. So if we can keep our questions brief and the answers brief, we may be able to do it. DR. TRANI: Yes, Madam Chair. DR. KATZ: A few brief questions. First of all, thank you for coming here, and you're quite right. There have been enough victims. We don't need any new victims, and I very much agree with you. But from what you've gleaned so far, has our committee contributed in any way to what you and your medical school and university is concerned about? To my knowledge, we haven't. I just want to set the record -- DR. TRANI: The two newspaper articles indicate at least on the part of the press that they're waiting for the, quote, findings that Dr. Lederer found in Richmond to be turned over and analyzed by the committee and then some sort of a finding to be released. The newspaper articles you have in front of you -- DR. KATZ: But that's part of our charge, Dr. Trani. That is not inflammatory. That is part of the charge that the President has given us. So we must investigate. DR. TRANI: Yes. DR. KATZ: And we haven't done any more than that. I appreciate your plight, but I think at the moment the committee has not contributed to it. DR. TRANI: At what point, I guess my question would be, do you say in these 52 projects there were clearly problems and in these 158 projects they were clearly doing diagnostic testing that had been perfected at other institutions, whether it involved radiation or radioisotopes or not? I think your public is going to be looking for something like that. DR. KATZ: Right, and with respect to that, one or two more brief questions. I've read the final report written for the period of 1949 to 1959. DR. TRANI: Yes. DR. KATZ: That's also in the materials. The committee hasn't decided on it yet, but speaking for myself, could you fairly quickly make all of the annual reports available to us? DR. TRANI: Yes. We're happy to make any document, and Dr. Lederer has a copy, and I will leave you a copy of the bibliography, what the 16 boxes include. DR. KATZ: Yes, but as far as you know, are the annual reports for the -- DR. TRANI: Some of them are there. I don't think it's a complete picture. DR. KATZ: It is not a complete set? DR. TRANI: It is not a complete set. DR. KATZ: And are any research protocols in your files, to your knowledge? DR. TRANI: I have not seen any, and, Dr. Lederer, did you find any research protocols? DR. LEDERER: I did not see any, no. DR. KATZ: So we don't really know as yet the extent of the documents still available from that period of time? DR. TRANI: I mean we know what's in our archives. DR. KATZ: Okay. So we'll have to pursue the matter as best we can as fast as possible. Thank you. CHAIR FADEN: Ruth. DR. MACKLIN: I can be very brief. I must confess I didn't get a chance to read this final report yet. So I have one or two brief factual questions. First, were there any research maneuvers? I mean I'm trying to get at just what the research maneuvers were in these studies. Were there any research maneuvers other than those designed to see what treatments were effective for the burned patients and/or what the consequences were physiologically to the patients? DR. TRANI: The project covered three different things: whole body X-ray radiation of animals, dogs, fully documented; flash burn heat radiation of volunteers: the research team themselves, 44 white MCV medical students, 22 African American Virginia Union biology students -- they were paid -- and prisoners, dime size flash burns that then were analyzed; and then, third, the bulk of the project was, in fact, treatment of 770 burn victims over a ten-year period of time. Diagnostic test that was used was the introduction of tracers into the blood, and we used Nitrogen 15. We used Phosphorus 32 and Chromium 51. That was the standard diagnostic test perfected at other institutions and, in fact, still used today. That's what the annual report says, and there is nothing in the documents that indicates anything else was done. DR. KATZ: But experimental treatments were also done with ACTH and cortisone and nutritional studies on children -- DR. TRANI: Yes. DR. KATZ: -- and adults. DR. TRANI: That's right. DR. KATZ: So more research was being done -- DR. TRANI: Yes. DR. KATZ: -- than you've just indicated. DR. TRANI: I'm talking about the radiation aspects of it. DR. MACKLIN: Did Dr. Evans and Dr. Hanes or maybe just Dr. Evans because I guess Dr. Hanes took over later -- DR. TRANI: When Dr. Evans died in 1950 -- DR. MACKLIN: Right. Did Dr. Evans write the research protocol? How did the protocol itself come to exist? Did he initiate this research and write the protocol? Was it what we would today call a request for proposal or request for application from the U.S. Army Medical Research Division? How did the protocol get developed? DR. TRANI: He was a decorated surgeon, very closely tied to the Department of the Army. This was the first civilian burn unit that was set up. We have no documentation, "Here is the request for proposal," in 1949, but we have determined just annual reports. CHAIR FADEN: I've got Lois, Phil, Reed. Lois. MS. NORRIS: Part of my question has been answered. Could these studies be done today under today's research environment, assuming that the consent process was updated to meet -- DR. TRANI: Yes. Yes, it could. MS. NORRIS: Thank you. CHAIR FADEN: Thank you. Phil. DR. RUSSELL: Just a point of clarification. These are the kinds of studies that, as I mentioned earlier, were done for the purposes of improving our capability for handling large numbers of combat casualties. The first burn unit was a military burn unit, and it's still in existence down at Fort Sam Houston, Texas, and is still doing the current generation of experiments on acutely burned individuals. I think my guess is that based on the dates here, that this was an unsolicited proposal, which was the standard of administration at the time, that came in from Dr. Evans after he left the Army unit. These units did a tremendous amount to advance not only the treatment of burns, but the treatment of acute trauma casualties, burns being a major model for acute trauma, and the studies referred to with radioactive chromium and so forth gave tremendous insight into the fluid balance, the metabolic issues, and the units also made tremendous advances on how to handle the infectious problems, infection problems with burns. So I think the benefits are tremendous. What we have to look into is the procedures that were used in dealing with the individual patients, and I think there probably is in these, since they were never classified -- it was all open medical treatment experimentation -- to the extent that the records exist, we can get a good idea of the way volunteers were handled in acutely -- many of these patients were very severely burned. DR. TRANI: Yeah, the issue of consent, there was a general hospital consent approving diagnostic tests, and obviously the blood fluid, red blood survival tests were done under that general consent document. There was no written consent for the volunteers, the student volunteers. I mean it was orally, obviously talked through them. There was no written standards until a much later period of time. These were paid volunteers, in large part the student volunteers, but you're not going to find informed written consent forms at MCV for student volunteers participating in the flash burn, the heat radiation experiments. They don't exist. CHAIR FADEN: I've got Reed and Nancy, and I think we would have to close it at that point. Reed, and Pat. Oh, I'm sorry. I missed that, Pat. I'm just trying to keep it to no more than one question per committee member. I'm sorry. Reed, Nancy, Pat. Am I missing anybody just for closure? All right. Then Pat will have the last question. DR. TUCKSON: For the prisoners, I just haven't had a chance to digest all of the material, but for the prisoner cohort, do we know what the race of the prisoners were? DR. TRANI: No. I have not seen any documentation on that. DR. TUCKSON: Is it possible you can get that? DR. TRANI: The prisoner issue was the last thing that we discovered. Much less research findings on that. Clearly public information. If you look in this -- thank God again for the Richmond newspapers -- noted "prisoners may volunteer for MCV projects," dated July 11th, 1951. So it was well known in Richmond, but I have not seen that kind of information and don't know if our records contain that information. DR. TUCKSON: First of all, I mean, I appreciate your spirited presentation, and you're certainly doing your job well, and I respect you for it. I think it's important to know that information. I have to say that there must be records somewhere that tells us about that because I do think that there are -- at least it just needs to be appreciated and understood because that's a special context. If these are prisoners of color, then it just seems to me -- I remember the history at that time in Richmond, and it certainly would just bear some extra looking into. I would hope that we could get that information. DR. LEDERER: I was going to say that historically it would be true that white prisoners would be over-represented because that would be seen as a perk that a prisoner would get to participate in a subject. So it's much more likely that they're white rather than of color. DR. TUCKSON: Thank you. CHAIR FADEN: Nancy and then Pat. DR. OLEINICK: I'd like to thank you, Dr. Trani, for your presentation and bringing this. I think that you've had probably a difficult time responding to Mr. Honicker's article and charges. I just was wondering if there had been any response from Mr. Honicker to your articles and to your efforts in the last few weeks. DR. TRANI: I'm aware of none. DR. OLEINICK: No. CHAIR FADEN: Pat? MS. KING: Well, I rarely feel that I must make a statement, but I sort of felt that way this time. I want to thank you for coming, and I very much appreciate the agony that you must have been through since these newspaper articles first appeared. On the other hand, I want to make clear at least personally that I think this committee has acted not only responsibly, but very much in the spirit of our mandate and our charge. In terms of creating or contributing to a witch hunting atmosphere, I would remind everyone this committee did not initiate this investigation or report of this university. There have, in fact, been many such reports around the country, and I think that we really see what we are to do as to bring as much clarification and as much light as we can on this and many other charges that have been made around the country. And I think it's difficult. Not that everybody should come here to straighten out the record, but it is difficult if we don't make it clear that we did not initiate, I think, this kind of reaction or public furor and help contribute, I think, to what must have been a bad two months. I would have felt that way if I had been in your shoes. My question is you're one of the few research projects that has data on selection of subjects, which is an area that we've had a great deal of difficulty getting information on, and you obviously have some numbers, and what I'm interested in finding out is where those indications appear in your records because if they're not on the research protocols, are they in the annual reports, because that would be helpful to us, I think, in looking for selection of subjects data elsewhere. DR. TRANI: On the flash burn experiments, student volunteers, 44 white MCV students, 22 black students from Virginia Union, spelled out in the newspaper in 1954 in your packet, and one of the issues that they were looking at was the question of burns and skin pigmentation, and they found in these set of experiments that white Caucasian women and African Americans burn more severely than Caucasian males. So that was part of the research they were interested in, and they kept close records in terms of volunteers. There was a cumulative document in the archives with the racial make-up of the 770 people who passed through, severely burned patients who passed through the burn unit. It was just a cumulative document that we had. It was not something that was in every document, but some of the research articles are, in fact, on the difference between Caucasians and African Americans having to do with burns. MS. KING: Well, that's the data -- I know Professor Katz asked for data, but I'm very much interested in data that gives any information about race, ethnicity, gender, and also institutional vulnerability, such as prisoners or perhaps other special hospitalized patients. If we could have that, thank you. CHAIR FADEN: We need to move on. We appreciate very much your coming. DR. TRANI: Madame Chairman, thank you for your attention, and I am not suggesting that you have created the problems, but your tone is going to be important as hundreds of these experiments are looked at, and that is the point I wanted to make. Thank you very much. CHAIR FADEN: Your point is registered. Thank you. Our next panelist is one presenter, Mr. Cliff Zucker, Executive Director of Disabilities Advocates, Incorporated. Mr. Zucker has traveled from New York to speak to the committee. We appreciate your taking the time to spend some time with us this afternoon. MR. ZUCKER: Thank you very much. CHAIR FADEN: Thank you, Mr. Zucker. MR. ZUCKER: I very much appreciate the opportunity to talk to you today. I am Executive Director of Disability Advocates, which is a protection and advocacy agency. We're a not-for-profit corporation that receives a federal grant to advocate for people with mental illness who are residents of facilities for treatment. And in that role, as advocates for people with mental illness, we have done quite a bit of advocacy in the last several years concerning the rights of human subjects of psychiatric experimentation, and from that work, we have identified certain deficiencies in the current federal scheme to regulate human research, human subject research, which we think are relevant not just in New York, but relevant nationally and also would concern subjects other than psychiatric patient subjects. So that I want to talk about what I see to be several important deficiencies in the current regulation scheme because I know that that is also part of your mandate. First, it's important to remember that many human subjects are totally unprotected by federal regulations. The scope of the federal regulations that govern human experimentation generally limit federal regulation to federally funded research or research that involves investigational new drugs or devices, and research which is not federally funded and which does not involve an IND may be totally unregulated. Most states have no laws and no regulations that protect subjects of such privately funded or state funded research, and therefore, those subjects face very real risks, the sorts of risks that subjects faced prior to 1974 in all experimentation. Some states, of course, have passed state regulation of human research. New York is one, but we have found in New York -- first, I should point out that there are very few states who have comprehensively regulated human experimentation or human research. Those that have have generally enacted protections that are inferior to the protections provided by federal regulation. And because my time is short, I've detailed in my written comments ways, for example, in which New York provides less protection to nonfederally protected subjects. So I think the first thing in terms of looking to prevent future abuses is to make sure that all human subjects are covered by the federal regulations. They are not perfect, but they are a tremendous improvement over what existed in the past, and Congress has that power under the commerce clause, and I suggest that you urge Congress to extend the scope of federal protection to all human subjects. There are also flaws in the federal regulatory scheme. The biggest flaw is that under the federal regulatory scheme incompetent or incapable human subjects can be placed in risky, nontherapeutic experiments, and I suggest to you that that is a very serious problem that places incompetent subjects at very, very great risk. Essentially a subject who has been determined as being incapable of giving informed consent is in a very similar situation to that of a child, who is also incapable of giving informed consent either in reality or by presumption of law, but the federal regulations provide many protections for child subjects of human research that are not provided to incapable adults. And I think that that is an important flaw in the federal regulatory process that needs to be closed, and again, I've detailed this in more detail in my written comments, but we know that from recent reports of recent experimental problems at UCLA, the fluouriodine deaths, that the risks of experimentation can be much greater than anybody anticipates, and even with the best of intentions, incapable subjects may face deadly risks. I believe that it violates the principle that incapable individuals can only be placed at risk when they stand to benefit. They cannot be placed at risk when they do not stand to benefit at all, just to benefit society or to benefit the advancement of knowledge. In no other area in society do we do that with incapable individuals, and I suggest that there's no justification for doing it here. A third problem with the regulations is that they permit incapable subjects to be placed in research, including risky, nontherapeutic research, on the consent of relatives who have not been authorized by any court to act as a surrogate and who are not subject to any oversight by a court or by any other body. The federal regulations say that informed consent must be obtained from the subject or the subject's legally authorized representative, and in New York, that has been interpreted as meaning the researcher can approach an incompetent subject's spouse, parent, adult child, adult sibling, and even a close friend to ask for consent to research, and this can be nontherapeutic, greater than minimal risk research, and these are people who have not been designated as a guardian by any court. A close friend, amazingly enough, is interpreted in New York to be a person who identifies himself as a close friend, not a person who's identified by the subject as a close friend. And this model, this New York model, for interpreting who is a legally authorized representative is being promoted in the literature by New York as a model for other states. So while I don't think that's a reasonable interpretation of what legally authorized representatives in the federal regulations means, that's how it's being interpreted out in the states. And I think that one of the important things that you can do is recommend that that definition be tightened up to indicate that only a guardian appointed by a court or a surrogate appointed by the subject himself to make the decisions for him when the subject was competent can place incapable subjects in human subject research. I'm not sure how much of my five minutes I have. CHAIR FADEN: It's sort of gone. MR. ZUCKER: It's gone. In that case what I will do is stop here. You have my written comments, and I'll be happy to answer your questions. CHAIR FADEN: Thank you, Mr. Zucker. That's kind. I see Pat, Phil, Ruth. I'll keep looking for hands, but let's start with Pat. MS. KING: Thank you very much. This is a question of clarification. As I understand it, current federal regulations require institutions when they sign their institutional assurances to use review processes for research not funded by the federal government that are the same review processes as those used for federal funding. So when you were discussing research that was not subject to federal regulation, my question is: how are you treating non-federally funded research that is at an institution covered by insurance? MR. ZUCKER: They are in a middle ground. You're correct. The assurances require that the institution apply the same protections and rules to all experimentation at that institution with one very important exception. The duty to report deaths, unexpected events, and injuries to the Office of Protection for Research Risks is exempted. That's a very significant difference because without those reports, as we know from the example of UCLA, OPRR when it does intervene can take important remedial steps that the IRB will not take. For instance, in Los Angeles, the IRB felt that the informed consent process there was adequate, and the institution vigorously resisted the remedies that were ultimately proposed by OPRR. I think that OPRR needs a lot more funding to be a more -- to be able to play a greater role in the process of protecting human subjects, but certainly that reporting to OPRR and then their remedial action is a key part of the federal scheme, and that's totally absent as to those patients. MS. KING: Could I ask one follow-up question? And that is you recommended a pretty drastic remedy, which is that Congress pass legislation in an area where there's a fair amount of federal regulation to make sure that all subjects are covered. Would most of your concerns be taken care of or would you feel that most subjects would be covered adequately if we could close that gap between OPRR monitoring or are there still many subjects who are being used in research that are not at institutions that have already assigned assurance? I'm trying to get an order of magnitude for uncovered subjects. MR. ZUCKER: Unfortunately, I don't think that the -- let me stop for a second. While I think what you propose is a good idea, I don't think it will entirely solve the problem. Now, I don't think anybody knows how much non-federally regulated human experimentation exists, and if it's occurring at an institution that does not have an assurance, then it wouldn't be subject to the remedy that you propose. I know that in New York there are quite a few institutions who are conducting human subject research who are not subject to federal assurances. In New York the Department of Health of the state has a rather limited role in overseeing such experimentation, but New York is unique. I think that it's one of the very few states which has enacted such legislation, and it doesn't work very well in New York, which is another story. MS. KING: Thank you. CHAIR FADEN: Phil. DR. RUSSELL: You made the statement that Congress has the power to fix this problem, but the current power from Congress is derived from, one, the federal funding and their restrictions on federal funding and, two, the FDA's legal authority which derives from their ability to regulate interstate commerce. Where does the constitutional power of Congress come from to do the fix? MR. ZUCKER: I think it comes from two sources. One is the interstate commerce because most of the -- DR. RUSSELL: But that's where the exemptions are. They're not in interstate commerce. MR. ZUCKER: No, I don't think that that's necessarily so. I mean just because the research is not federally funded does not mean that it is not in interstate commerce in most instances. DR. RUSSELL: They don't need an IND. If it's not federally funded and they don't need an IND, you can design a new drug and test it within a state without getting an IND if there's no interstate commerce. MR. ZUCKER: Well, for example, let's say that you were doing research using electroconvulsive therapy, which involves the use of machinery which is sold in interstate commerce, or research involving drugs that are not IND drugs. Those are drugs that are in interstate commerce. So I think that the authority for reaching -- I mean I'm not going to say that there's not any research in the category that I'm talking about that couldn't be reached through the interstate commerce clause, but I believe that most of it could. I also think that Congress under the 14th Amendment has broad authority to protect the liberty of human subjects in the states, and given the very great liberty interests involved, that it would be within Congress' power to take that sort of remedial action. So I believe Congress does have the authority. CHAIR FADEN: Ruth. DR. MACKLIN: I speak as one who has long advocated for protecting human subjects from research risks and particularly vulnerable subjects, psychiatric patients and others. So my question is not intended to in any way impugn your suggestions, but really to get at what may be a discrepancy between the gap in laws and the gap in practice. Now, what I mean is -- and there's a whole series of questions; I'm just going to collapse them all together -- CHAIR FADEN: Thank you. DR. MACKLIN: -- is there evidence that more injuries occur to research subjects, vulnerable subjects in particular, in non-federally funded research, the kind where there's no report to OPRR? Do we know whether even in the federally funded research institutions, IRBs, are scrupulous in reporting adverse effects to OPRR so that even the federally funded research is adequate protected by the mechanism that you're suggesting be expanded to the non-federally funded research? So I'm really asking about the evidentiary base. It sounds both from your presentation here and from your longer statement that I read as if we could expect there to be both more injuries, less oversight, poorer IRB review, and no reporting to OPRR from the non-federally funded research; whereas everything is rosy in the federally funded research. So is there in whatever evidence you can bring to bear on this an indication that the gap that you cite in laws, which may be a real gap, is also a gap in practice, and that there are in any of these gaps patients or subjects who are poorly served and not being governed by these protections? MR. ZUCKER: To my knowledge, nobody has collected that data. I think it's fair to assume that with lesser protections, there will be more problems, but that's an assumption I'm making from the problem of law. DR. MACKLIN: I mean it could very well be -- are IRBs precluded from reporting adverse effects to OPRR? They're not precluded from doing so. So the very same mechanism that leads institutions to review all research and have their IRBs look at all of the research that's conducted in the institution and apply the same standards as the federal regulations for federally funded research may also govern the reporting requirements to OPRR. MR. ZUCKER: Well, I can only talk about what -- on that I do have some data. First, the assurance specifically exempts the reporting requirement, and, secondly, in New York the Office of Mental Health, New York State Office of Mental Health, which does a great deal of research, does not report deaths, injuries, et cetera, to OPRR while it does generally do so, I believe, in federally regulated research. So there there clearly is -- I have documentation that that is a problem, and I could share that with you, but how big the problem is I can't tell you. CHAIR FADEN: Reed. DR. TUCKSON: A very small, subtle question, but important. Your organization experience, is it with persons diagnosed with mental illness and/or mentally retarded development of disabled persons? MR. ZUCKER: My particular agency serves primarily people diagnosed with mental illness. Occasionally we serve people with a dual diagnosis of mental retardation and mental illness. There are other protection and advocacy programs that have been funded by the federal government to serve people with developmental disabilities. We don't happen to have that grant. DR. TUCKSON: Not to belabor it, but my impression is from working in this area that there are much strong individual protections and system supports for mentally retarded and development disabled persons, particularly as those court cases have gone through over the last years. Does that system of protections -- is that adequate in general from your point of view in protecting the rights of that particular population of people as opposed to those just diagnosed with mental illness? MR. ZUCKER: You're talking specifically concerning human subject research? DR. TUCKSON: Yes. MR. ZUCKER: To be frank, I don't know. I do know in New York it just so happens that there is litigation challenging the practices of the Office of Mental Health concerning research on psychiatric patient subjects, and no similar research has been brought concerning people with developmental disabilities, but that may just be a fluke, quite frankly, and not really reflected in it. CHAIR FADEN: If there are no other questions, we will go on. Oh, I'm sorry. Is there another? DR. RUSSELL: Do you have a position on the situation of accident victims that are incapable of giving consent but for whom development of life saving resuscitative fluids, for example, might be a major research effort that couldn't be done under these kinds of conditions? MR. ZUCKER: I guess I'm -- let me see if I understand the question. Are you talking about a therapeutic procedure that may be experimental? DR. RUSSELL: That could be life saving. MR. ZUCKER: An experimental therapeutic procedure? I think that it's well established in the law that in an emergency you can do life saving procedures without informed consent, and I would say under the circumstances -- DR. RUSSELL: You don't change the law. MR. ZUCKER: I beg your pardon? DR. RUSSELL: Well, that I don't think is very well established. I think that's a matter of some serious debate. CHAIR FADEN: I think maybe the confusion may come from -- where I think Phil is going is the notion that you might want to do, say, for example, even a randomized clinical trial of patients who come into an emergency room incapable of making a consent decision because of the trauma of the injury, but in order to advance this research question, you'd have to randomize them. So it wouldn't be as if the only lifesaving technique is an experimental one and we're going to give it to this person, but we're rather going to enroll this now incompetent person into a randomized clinical trial in an emergency context. Is that where you're going? DR. RUSSELL: Yes. MR. ZUCKER: Okay. I understand your question better now. I think that with appropriate protections that that could be permissible, but I would call your attention to the Burton case in New York, and I can get you the cite. It involves quite an analogous situation where a hospital was doing experimentation on treatment for premature babies, and the accepted treatment of the day led to blindness, and the researcher wanted to establish that there was a better experimental treatment, and so they used a control group, and they divided the premature children into two groups, and some got the more effective experimental treatment and some got the less effective conventional treatment. At some point it was very clear to the researchers that the experimental treatment was more effective, and in fact, the case is a lawsuit that was brought against the researcher by a child that was blinded by the researchers who knew that the treatment they were providing would lead to the blindness and carefully documented the progression of the damage to the eyes. So I guess I tell that story to say that it raises difficult ethical problems, but not insurmountable ones, and beyond that I don't have a well thought out response. CHAIR FADEN: Jay has signaled a desire to ask a question or make a comment. Can I ask the indulgence of the committee that this be the last question to Mr. Zucker because we must go on? DR. KATZ: I just want to make a comment in terms of your response to Phil's question. No problem is unsurmountable. This is close to an insurmountable problem. It's now under congressional inquiry, namely, what kind of research can you do in emergency rooms with incompetent patients. All kinds of new terms of art have been constructed, like the oxymoron "deferred consent," which has been approved by some institutional review committees as a substitute for informed consent, which then goes to the question: should I at least have the authority to grant such exception for research purposes with patient subjects who cannot consent to the procedure and where the IRB believes and the investigators believe that relatives are not in sufficiently good mental state to give proxy consent? It's a very, very problematic area. CHAIR FADEN: Thank you. Mr. Zucker, thank you very much. MR. ZUCKER: Thank you for the opportunity. CHAIR FADEN: We appreciate your written materials, as well. MR. ZUCKER: Thank you. CHAIR FADEN: I want to reassure the other presenters that we will exceed beyond the five o'clock time so that everyone can be heard. I'm afraid this committee could just go on forever, but that's okay. That's fine; that's good. We are learning a lot, and that's important, but we have to learn how to budget our time, I think, in terms of the agenda. Our next panel includes Ms. Pat Broudy, who spoke with us -- let's see -- it was at our June 13th and 14th meeting. Ms. Broudy has traveled from California. We should note that people have come some considerable distance, and we want to make sure that we stay along enough to make sure that everyone is heard. Ms. Broudy, is Dr. Rosen going to be accompanying you? He's here. MS. BROUDY: He's here. CHAIR FADEN: Okay. MS. BROUDY: I'm kind of short. So it's a little difficult. I have narrowed this thing down. I sent you a real tome before, and I could have gone on forever, but I have narrowed it down to five minutes. So I can start with that. CHAIR FADEN: Thank you. MS. BROUDY: Before I start though, I'd like to say that if you consider the green run with the Hanford victims an experiment, then you should consider the nuclear testing at the test sites and the veterans that were exposed and the downwinders as experimental subjects, and that's all I'll say on that. The Atomic Energy Commission in 1951 established a maximum permissible exposure of 3.9 rads for troops exposed to ionizing radiation and seven miles distance from ground zero for all nuclear tests conducted at the Nevada test site. For Operation Tumbler-Snapper, 1952, the Department of Defense proposed troops be stationed at 7,000 yards from ground zero. In fact, the Marine Corps stated it would not allow its men to participate if the seven mile limitation fix during Operation Desert Rock were again imposed. The Santa Fe operations office felt the necessity to disclaim all responsibility for injury which might result from their position, while the Division of Military Application believed that the AEC cannot delegate or avoid responsibility for approving this position. Once concurred in, the decision was a joint responsibility. Therefore, it was the judgment of the Division of Military application that the AEC/DOD safety plan warranted commission concurrence with the proposed troop location 7,000 yards from ground zero. A maneuver on foot following the shots through the ground zero area would be executed if approved by the test manager. The Division of Biology and Medicine did not concur in the recommendation. By 1953, Operation Upshot-Knothole, eight volunteer officers were placed in trenches as close as 2,000 yards at Test Simon, 12 officers at 2,500 yards, Shot-Badger, and nine officers at 2,500 yards in Shot-Nancy. They were given physical and psychological tests before and after their exposures. The psychological tests were performed by Human Resources Research Office, HUMRRO. At time of detonation, they were exposed to 100 rads. There was no follow-up of these officers. There was no informed consent. One of the officers participated in both the Badger and Simon shots. So he must have gotten a real dose. Immediately after the detonation of Simon, the troops stationed at 4,000 yards departed their trenches on foot and attacked toward ground zero. The purpose of these exercises was to test the psychological effects on individuals. The U.S. Army was given complete radiological safety control of military participants for the first time. Permission was granted to maneuver around ground zero. The maximum permissible dosage was six rads for the exercise. There were a total of 17,697 participants, according to the final report, but from the same report if you add participation by event this number is short 245 people. In a December 22, 1952, AEC note by the Secretary re. troop participation in continental tests, it attaches a report by the Director of Military Application for consideration by the commission. Page 675 states, "General Fields outlined the present plans of the DOD for extensive troop participation in the Upshot-Knothole series. He pointed out the usual limits of physical exposure to weapons effects would probably be exceeded. It was therefore proposed that responsibility for the physical safety of the troops participating in the exercise be delegated to the DOD." This is a quote from Mr. Dean, Gordon Dean. "Mr. Dean observed that since the DOD apparently considered it necessary to conduct the exercises in this manner, the AEC was not in a position to recommend that the normal limits be observed. After further discussion, the commission (a) approved delegation of responsibility for physical and radiological safety of troops at Upshot-Knothole to the DOD; (b) approved issuance of a public statement by the exercise director through the joint AEC/DOD Information Office prior to the exercise clarifying DOD responsibility for the safety of troops." It was approved by the commission on February 4, 1953. CHAIR FADEN: Thank you very much. Yes, Henry. DR. ROYAL: Ms. Broudy, could you tell us a little bit more about the exposure of 100 rads? Where is that radiation dose from? What's it based on? What's the documentation about that? MS. BROUDY: There was a Radiac instrument placed on the floor of the trench 2,000 yards from ground zero. Captain Hinners, a Navy captain, wrote a narrative which I have here if you'd like to see it of that exercise, and he states that he was blinded temporarily because the light was so bright that he couldn't see the instrument. They had experimental radiation devices like pencil dosimeters and film badges. This one Radiac instrument was like a geiger counter, I guess, on the floor of the trench, and that read, when he was finally able to see it, it read 100 rad an hour. So when they climbed out of the trenches, it reduced to about 50 rad, and every time they would stop on their way back to the 4,000 yard limit where the other troops were, it would back up to 50 again, and then it subsequently decreased as they walked toward the 4,000 yard line. DR. ROYAL: Just so I make sure that I understand that and that the committee members understand that, the meter that you're talking about measures a dose rate, and in order to determine a dose, you multiple the dose rate times the time of exposure, and that gives you a dose. So if you were where a meter said 100 rads per hour for five minutes, you would be exposed to one-twelfth of 100 rads. MS. BROUDY: I have a document here which gives the dosages for all of the men that were in those trenches, and it runs from 16 rad to 13 rads, to 11 rads, and that document is available if you'd like to have it. It gives the names of the men that were there. DR. ROYAL: Is that a government document or a document that was prepared by the people who were involved? MS. BROUDY: This document was a government document. CHAIR FADEN: Ms. Broudy has been kind enough to bring a fair amount of documentation. We would, of course, be very pleased to make copies of everything that you can share with us, and the committee can digest it in a timely fashion, but it's very helpful to have you bring documentation. MS. BROUDY: I would like to say also that there was no informed consent here. He did sign a certificate which states that -- well, it's not attached -- but it states that he was able to ascertain what he thought was the dosage that he would receive at 2,000 yards, and I have that document, but it's not available right now. CHAIR FADEN: I've got Duncan and Ruth. DR. THOMAS: I guess I have two questions. Both of them are related to the materials which you provided us beforehand. First of all, you comment on this piece by Mr. Brandon describing the phoney A bomb records. I'd like to ask you to elaborate a little bit upon this. I seem to recall in one of your earlier submissions to this committee there was a description of a dual set of records, one of them sort of public and the other one secret. Is that what's being referred to here? MS. BROUDY: Yes. I didn't mention that in my five- minute presentation, but I did mention it in my lengthier presentation which I gave to you earlier. The reason I say that is because Jesse Brown, the Secretary of Veterans Affairs, in a statement that he made before the House Veterans' Affairs Committee in February stated that he had learned of a second or third, another set of records that pertained to the radiation veterans, and it was entitled the Atomic Medicine Division. I have with me some abstracts from my husband's medical file, which I finally got after many years, that state that the records are contained in the Atomic Energy -- no, I'm sorry -- the Atomic Defense Division, and there are several other references to various other files in those abstracts. So what I guess I'm saying is that there were -- that Mr. Brandon was right, that there were several different records kept on these atomic veterans by the VA. DR. THOMAS: I guess the essence of the question is documenting allegations like this of secret records can be very difficult to do. Do you have any way of documenting this assertion? And sort of related to that, it's my understanding that there is currently a National Academy of Sciences committee that's reviewing the dosimetry on the atomic veterans, and do you know if they are aware of this second set of records? MS. BROUDY: I don't know whether they are aware of it or not. DR. THOMAS: Well, certainly any documentation that could be provided would be extremely helpful. If I can be allowed, the other question which I wanted to ask you had to do with the information which was provided to the military participants by way of informed consent, and I was particularly intrigued by a passage where you described this Operations Research Office at Johns Hopkins and a study where you said -- MS. BROUDY: That's from a newspaper article. DR. THOMAS: Right. "The Army withheld from one company of soldiers all briefings and their effects, except for short safety instruction." Could you elaborate a little bit upon, first of all, what sort of briefings might have been made available to soldiers normally and what would have been withheld in this case? MS. BROUDY: I don't know. I don't have that document that's referred to. That was from a newspaper article from the Washington Post, which I copied and sent to you, but I do have a Human Resources Research Office report by the George Washington University, which states that they have developed a rigorous HUMRRO testing program and that the study was conducted under the general direction of, and it gives the name, Acting Director for Research Motivation, Morale, and Leadership, and they were responsible for preparing this report. And what it is, it's a report of attitude improvement among men who learned and men who did not learn the correct answer to each of the 16 questions, and they list 16 questions on each page, and the questions are pretty stupid, but the article states at the top, "Decreased anxiety among learners and nonlearners. Proportion of men who were anxious at baseline but were not anxious at the dry run," and there are 16 questions listed here. I'll just give you an example of a few of them. It says, "Radiation from an A bomb one and a half miles away does not result in permanent sterility," and then among men who learned, it was 73 percent; among men who did not learn, it was 38 percent. It's like something you would give a child to do in first or second grade. It says, "Radiation is not contagious." Seventy-eight percent among men who learned, and 57 percent among men who did not learn. So these are the questions obviously that the men who learned are the ones who were tested before and after, and then among the men who did not learn were the guys who weren't tested. This is not the same report referred to in my document, but it's another university. As I said, it's George Washington. CHAIR FADEN: Is that within the documents that you've provided to us or -- MS. BROUDY: Yes, you may have this. CHAIR FADEN: Okay. Thank you. DR. THOMAS: If you have copies of any sort of training materials, brochures, any other sorts of information that might have been contributed to the participants, information about radiation risks, that would be very helpful to us. MS. BROUDY: I have a lot of it. CHAIR FADEN: We have been working with Ms. Broudy, and we will continue to work. Clearly this is very helpful. If we could go on, but Ms. Broudy is staying over tonight. We may be able to make sure we have all of the document sharing part straight. MS. BROUDY: Okay. CHAIR FADEN: Thank you so very much. What we need are 38-hour days I've decided, and then maybe we can make this happen. Our next presenter in what's referred to on my sheet here as Panel 5 is Ms. Catherine Variano, who has traveled from South Bend, Indiana. Thank you, Ms. Variano, for waiting and being patient. We promise to be focused and pay attention. You've been kind to wait. MS. VARIANO: Thank you for letting me speak. You have my paper. I'll give you a little bit of background. I was born in 1948, and at approximately five and a half to six weeks a hemangioma developed on the corner of my mouth. My dad referred to it as a canker sore, like a canker sore. I was admitted to a hospital where my parents were told, "You can come back in ten days." I was admitted for evaluation and examination. At the end of the ten days I came out of the hospital minus a lip, minus a cheek, minus a right nostril. My eye was swollen shut. I was sent home to die. That's what a doctor told my mother when I was four years old, and if this doesn't make me a guinea pig, I don't know what the definition of a guinea pig is. I have subsequently suffered a cataract in my right eye. I was one of the fortunate few in my family. I only got the mumps on the left because I have no lymph nodes on the right side. I have no salivary glands on the right side of my mouth. My back teeth were pulled because they were soft and decayed. My upper front teeth are not in the best of condition, and I have had 14 reconstructive surgeries. I have a face that won't turn your stomach. I'm not bitter, believe it or not. I am angry. I am frustrated. It has taken me 45 years to get my medical records from the hospital, and the hospital will tell you I got them under false pretenses. That's their problem, not mine. I tried for 45 years. I can't help it if a TV crew can do what I can't, and that's what it took: a TV crew telling them they were doing a story on lost medical records, which the TV crew subsequently did do, but I shouldn't have to do that. These are mine, and this happened to me. Like I say, I was six weeks old. My parents gave no consent. They were not consulted. They were horrified. How would you feel if you took a -- my medical records said I was a perfectly healthy baby when I was admitted to the hospital, well nourished and eating, and then days later you pick up this deformed creature and told, "If she lives, bring her back in six weeks. We want to do it again." That's devastation to anything. I would never subject a parent -- I would hope never to subject a parent or a child. I have some baby pictures of me. I was a year old. This is before the radiation. I'll pass them around. You can look at them. I was two. I had an eye. Finally the swelling had gone down enough so that it would open on its own, but for the first eight months of my life, I was in the hospital for four of them after I had been in the hospital for ten days for radiation, and I had to go back every six weeks and have my right eye removed so they could clean the eye lashes out from behind it. My eyes work independent of each other. I can't wear bifocals. I can't cross my eyes. I think that's a plus. I'm nearsighted in one eye, farsighted in the other, and depth perception is at a minimum. I can drive because I grew up that way, but it's not fair to me. I was kindergarten, first grade. These are enlarged pictures. I have the originals, and they're smaller, but the enlargement serves a useful purpose. This group of pictures, the picture on the left as you look at it, is what I looked like before my first surgery when I was 12 years old, the picture on the left, yeah. That's the left. The picture on the right is what it looked like after my first surgery. I was in the hospital eight days and had 5,200 stitches. That's a lot of stitches for a 12 year old. I've had 13 since then, the first one when I was 12, the last one in 1988, and I need some more, but because of the radiation I don't qualify for medical insurance. So I'm caught between a rock and a hard place. My dad was active duty military. So the Navy was very gracious and did all of my plastic surgery. My husband was active duty military. The Navy was very nice. After fighting with them for six years, I finally was diagnosed with cancer of the thyroid and Hoshimoto's thyroiditis. There's only one way you can get that, as far as I've been told, and that's overexposure to radiation. It took me three months to convince Bethesda that they weren't going to monitor me. I had been monitored all my life. I wanted a biopsy to see if I had cancer, and if it was cancerous, they were going to take it out. I have enough problems in my life. I didn't need to worry about cancer because I had three children to raise. So I don't have a thyroid. I have a nice incision. I don't have a thyroid. So for the rest of my life I take thyroid medication, and again, that's something that I really can't afford. For the last three years a Coast Guard base has taken care of doing my blood work and writing me a one-year prescription and filling it. The doctor left. So they don't see retirees or dependents of retirees anymore. So where am I going to go to get my medicine? I can't go to a military base. There isn't one within 100 miles of me that will see dependents or retirees. So I am actually caught between a rock and a hard place, and nobody wants to help. It has taken 45 years for the federal government to admit something like this happened. Regardless of whether or not it was done under a federal grant, the fact that the federal government was providing the materials makes them somewhat responsible. To me it's an implied contract. "We're going to give you these materials. We're going to show you how to use them, and we're going to expect you to use them properly." Today I found out in my home town there's a lady who is two years older than I am who had the same procedure done on her. She was born at the hospital, and they refused to admit that she was even a patient there, and she's got health problems, too, and her doctor won't even believe her that it was ever done. The only documentation that I have had is this one, and I colored it. This tells that I had -- excuse me. I have to switch eyes now because I can't wear bifocals. So we switch eyes -- the following factors were used this with radiation. It was 25 centimeters distance, no filtration, 100 kv output at 120 little R -- and I have yet to find anybody that will tell me what that means -- per minute. Port one measured three by four by five centimeters, and I was given 240 R. Port two is three by four centimeters, 240 R. Port three, four by six by seven centimeters, 100 R. Port four, four by four, 100 R. Port five was five by five centimeters, 240. Ports three and four were repeated again at 100 R each, and port six is three by five at 240. I will be glad to donate one. I have two of these. I will be glad to donate this paper to this committee if somebody will explain to me what the damned little R means and how it relates to the radiation doses of today. CHAIR FADEN: Ms. Variano, we'll make our own copy so you can have your two copies. MS. VARIANO: No, that's all right. I don't have -- I will give you anything that you need to help you get to the bottom of whatever it is that you're looking for because I have a feeling that you have opened a can of worms, and they're not going to go away. CHAIR FADEN: Could we see if there are any questions for you? MS. VARIANO: That's fine. CHAIR FADEN: It's very compelling. Are there questions for Ms. Variano? Eli. DR. GLATSTEIN: I don't quite understand why you say the federal government was behind this. MS. VARIANO: I was under the impression that the federal government was the one controlling the radiation materials used in X-ray machines at that time. DR. GLATSTEIN: I doubt if that was true. I'm not sure what the control would have been in 1948. MS. VARIANO: '48, un-huh. DR. GLATSTEIN: I'm not even sure if there were controls over X-ray machines as opposed to isotopes. The isos sort of fall under the control of the AEC, but I don't know about X-ray machines. This was obviously a low energy beam, and my honest impression is that somebody made a mistake in calculations, a serious mistake. MS. VARIANO: Well, I agree with you 100 percent. I also look at it this way. You take those measurements and draw them out and you place them on the faces, on the face or the head of a six week old infant -- DR. GLATSTEIN: Oh, I don't doubt that. MS. VARIANO: -- and it explains. That's like using an elephant gun loaded with buckshot to kill a cockroach. DR. GLATSTEIN: Well, it's hard to explain poor judgment. When people screw up, they do it royally, and I think in this instance that's what happened. As far as the R is concerned, it's talking about an exposure measurement, although I don't see any evidence that they took measurements. Just the one sheet. MS. VARIANO: Well, I forgot to mention one other little thing. In 1980, when we were stationed on Guam, I was waiting in a hospital emergency room, and I was watching this machine about four feet from me. Every time I moved towards it the needle moved. I moved away from it and it moved back. I didn't know what it was, and I passed my right hand over it. I never wear jewelry or a watch on my right hand. I set off a geiger counter. Whistles went off, bells went off, sirens rang, doors slammed shut and locked automatically. DR. GLATSTEIN: Well, I'm not sure what happened there, but I very much doubt that you were radioactive, not from this. CHAIR FADEN: Are there other questions for Ms. Variano? Ruth and then Dan. DR. MACKLIN: This is just a brief question. I mean this was a horror story of what happened to you, and you did mention a neighbor or a friend, somebody in your community -- MS. VARIANO: Yes. DR. MACKLIN: -- as another person to whom this happened. MS. VARIANO: Yes. DR. MACKLIN: Do you have any knowledge or belief that there was a systematic pattern? I mean you know of one other person. Was this something that was regularly going on in the hospital? MS. VARIANO: I don't know. DR. MACKLIN: There's a difference between what Dr. Glatstein just referred to as a screw-up. That, of course, could happen with one person, and on the other hand, total incompetence, which could happen with many people, and I'm just wondering since you did mention someone else that you know, whether there are -- MS. VARIANO: I just found this out this morning. I haven't even spoken to this woman, but for 45 years I thought I was the only one it had ever happened to, and that wouldn't be so unbelievable, except that I have lived all over the United States and overseas, and I have never run into anybody else who had what I had until my mother told me this morning. Was there a screw-up? You bet your bippy there was a screw-up, and I was the guinea pig. Was it deliberate? I don't know, but to me if a hospital says, "Well, you were never a patient here," my grandmother was my nurse and she toted me back and forth for treatments. Somebody knew I was a patient there. And, you know, "you were never a patient here. We don't have any record of you ever being a patient here." And then to come up and give me these records. I don't know who's hiding or what they're hiding, but it's time to start airing the dirty laundry. You know, I've had to live with this. Kids are cruel, and there are some adults who can be just as hateful. CHAIR FADEN: I don't doubt it. MS. VARIANO: You look at yourself in the mirror and you think, "God, I'm ugly." I have a six week old granddaughter who's terrified of me even now. Live with that. This isn't fun for me. This is terrifying for me to sit here in front of you. CHAIR FADEN: We appreciate that, Ms. Variano, and we're very grateful to you for taking the time to come from Indiana and to tell us your story, which we can all appreciate is extremely difficult, and we are very grateful to you for coming. MS. VARIANO: Thank you. CHAIR FADEN: Mary Ann, do you have a question? DR. STEVENSON: Yeah, again, thank you very much for coming -- MS. VARIANO: Thank you. DR. STEVENSON: -- and speaking with us, and I would very much appreciate if you would feel comfortable of you leaving your hospital records that you finally got after so many years so that we can at least try to examine -- MS. VARIANO: Only if you can make copies before I leave tonight to go back to Indiana. DR. STEVENSON: Sure. MS. VARIANO: I don't have any more of these, and they're not going to go away from me. DR. STEVENSON: I understand. Can we do that? CHAIR FADEN: We can do that. MS. VARIANO: If you can make copies before I leave in the next 45 minutes -- CHAIR FADEN: You can come with us to the Xerox machine. MS. VARIANO: All right. Then I will be glad. CHAIR FADEN: We'll get it done. MS. VARIANO: I have two sets, by the way. I have a set from the hospital that did the radiating, and I have a set from the hospital that treated me afterwards. DR. STEVENSON: We'd like all of them. MS. VARIANO: That's fine, but I want them before I leave. CHAIR FADEN: We can understand that, and we will accommodate that. Thank you very much, Ms. Variano. We appreciate it. Our last panel presenter is Ms. Janet Gordon, who's Director of an organization called Citizens Call, and Ms. Gordon has traveled from Utah. So we have to be grateful to all of our presenters coming from significant distance and expense. Thank you very much, Ms. Gordon, and thank you for being so patient. MS. GORDON: Thank you for being patient and hanging in with us. I would like to just make a personal note before I begin, that I hope I can be coherent. I have trouble with blood sugar. I am shaking. CHAIR FADEN: Would you like something to eat? MS. GORDON: No, no. I just want to get through this -- CHAIR FADEN: Or a Coke. MS. GORDON: --if I can, but I think that you should be aware that this a pattern that I hate to see happen in this committee because this committee was supposed to be for the people. I thought it was supposed to be for the people, and you notice that the victims were last. The victims are always last, the last to hear from. We're always out of time; we're always out of energy; and we don't get heard properly. We don't get to discuss the real issues because we're always out of time, and we're too tired. So I'd just like you to take that into consideration as you set your agendas for future meetings, please. My name is Janet Gordon. I appreciate the opportunity to be here, and I'm sorry I harangued you first. That's what happens when your blood sugar gets like mine is right now. I am a lifetime resident of southern Utah, a downwinder from the Nevada nuclear test site. I'm here speaking on behalf of those people, as well as on behalf of the Task Force on Radiation and Human Rights, which has been formed of all people dealing with these issues, including experimental victims, and I will present briefly a statement from them. But first I want to tell you I'm not here to try to convince you that the Nevada tests were done for the purpose of exposing a downwind population so they could be studied. Obviously that was not the case. However, I think that you should note that when they made the determination that we would have experiments in Nevada, they did look at the downwind population. That was a very important consideration in where they put the test site, and they only did experiments when the wind was blowing in that direction. Other populations were kept from fallout, and that was the policy until the moratorium recently, last year or when the moratorium occurred. With underground tests, even though they were supposedly safe, if the wind shifted towards Los Angeles or Las Vegas or San Francisco or Phoenix, the tests were canceled, and then when the wind was blowing over the virtually uninhabited area of southern Utah and northern Arizona, then the tests were conducted. We were a test population, and of course, they tried to convince us in their PR later on that the tests were not being done to develop weapons for warfare, but for a humanitarian purpose for civilian defense, and of course, if that was the case, as the AEC authorized in some of their documents that it was for civilian defense, then we were the civilian component of civilian defense experiments. However, that aside, I would just like to clarify something that happened earlier about the responsibility of the committee. I understood that this committee was set up with the responsibility to the American people, not to academia. I think that that is the case, and that being the case, we are citizens. Even though we were virtual uninhabitants, our voting density was slight, we were politically safe, we were low use, we were, quote, low use segment of the population, we were still human beings and citizens. And I hope you can consider this from our point of view, please, from our point of view. When they began testing in Nevada in 1951, I was almost 12 years old, 11 years old, almost 12, and they had experience in Japan. They had experience in Marshalls, but even if they hadn't had, by 1953 when they did the Upshot-Knothole series, when the sheep were dying by the thousands, when they were putting geiger counters on them and taking readings, when people were getting sick and their hair was falling out as my brothers did and his horse died, and then of course he later died also with pancreatic cancer at the age of 26, and the sheep that he was tending died; if they hadn't known in advance, they certainly knew by then. What was their response to that? A massive PR campaign to convince us that there wasn't any connection. Those sheep died from malnutrition or an unknown combination of factors, none of which were radiation, of course, even though the geiger counters went off the scale. They did damage control. They took PR programs around to our schools. I can tell you when I saw the film that showed me how lucky I was to be a part of history being made because it tells right here in this document I got from the test site. I can also show you where they aimed the test. They aimed them at us. That's where they aimed them. This is where they went, and they talk about how they sent their monitors to live in our communities so that we would trust them, and they'd teach Sunday school so we'd trust them, and then they'd tell us there was no danger. But the monitors themselves took showers, were advised to take showers and leave town, and that's what happened after Dirty Harry in St. George, Utah, in Washington County. So I would tell you that after 1953 at least what we had was experiments of opportunity. They began to study us primarily to prove that there wasn't any connection to what the problems we were facing were with the radiation, but also to check. They started the iodine studies. I think they started much earlier than what was reported earlier, at least unofficially, because I know people in four different communities hundreds of miles apart who participated in iodine studies in the schools where some of the students were given iodine to take before tests. Others were not. Then their thyroids were checked, and they did not get parental permission, at least not informed parental permission, and in fact, some of the parents raised a tremendous ruckus. Unfortunately, most of them are not around to be able to tell you about it. What they did was do a PR number on the doctors, the local doctors, to show them how there couldn't be any problem, and so they didn't think there was a problem and didn't connect it with the radiation, and the ones who thought it was they maligned. So I can tell you that the other thing they did was to cloak what they were doing under the guise of monitoring and protection of public health, but if they had been genuinely concerned about our public health, when the sheep started to die, when the babies started to miscarry, when the children began to be born deformed, they would have stopped exposing us, and they didn't. Their response was that nothing could stand in the way of these tests, and that's exactly what happened. Nothing stood in the way of it. When our sheep ranchers brought their case into court in '55, after the '53 experience, they actually perpetrated fraud on the court it was found later when the case was reopened by withholding documents, by lying under oath, by coercing witnesses, and by misrepresenting the information they did present. But we never did get a fair trial because they said if we didn't get it right the first time, we weren't entitled to have it heard again. Now, how you can have a fair trial if the documents that prove your case are withheld from you I don't know. And how this committee can find out what happened in experiments and in radiation exposures without having documents that are -- you know, if you can't have access to the material, I think you're going to be as impotent as we have been. I hope that won't happen to this committee because I have great hopes for this committee. I would like to just quickly compare Hanford, the green run experiment, the Marshall Islanders and the downwinders. What happened at Hanford is they brought the radiation to the people and exposed them deliberately and then did their experiments. With the Marshalls, they allowed the people to reenter an area they knew was exposed and did their experiments, and with us they found the people that were already in the radiation that they'd already broadcast throughout our homes, and then they did their studies on us. And the commonalities is the exposure that we all got. It increased risks of health. All the problems you've been hearing ever since you began, I'm sure; no warning, no protection, no honest information about what had happened to us. Classified documents. Why are the school records of children in St. George, Utah, classified from the children and their parents? That's what I'd like to know. Why can't we find out what's happening to us without having the same kind of problem you seem to have talked about this morning with the CIA? I think we have some commonalities, but they did take advantage of the opportunity to experiment on each of these components, and I would say to you that they subverted the data they didn't like when they started getting data. They took the data from scientists who showed there was a problem and maligned the scientists, discounted the data, and buried it or destroyed it. Another thing I would hope wouldn't happen with this committee is what happened when we brought up these kinds of problems back in the late '70s and early '80s with the off-site radiation exposure review project. You had references to the material that they destroyed earlier today. I sat in on those meetings for years, and I can tell you that the way they dealt with dose reconstruction, the off- site radiation exposure and our dose reconstructions, was to take the material, collect it, and get rid of anything that was damaging, then put together reports, and every time they'd do a report in their quarterly meetings, the next time we ended up in court it was used against the victims in court. And a lot of the data that you should be getting now was destroyed by that very efficient committee, but maybe they weren't efficient enough to destroy all of it, and I would say that there is a commonality between all of these areas that were controlled by the AEC. They supported each other. The same people were running them. They did the same kind of job on all of us, and the same lack of responsibility and abuse of the civil and human rights of the citizens occurred in all of those cases. I think if you want to know what really happened with any of the victims, you have to look at all of the victims, and I would beg you to do that honestly. I don't think you can possibly get honest answers without doing that. And very quickly now I would just like to tell you the Task Force on Radiation and Human Rights has newly been formed of people who have been working on this issue for maybe not as long as some of the scientists on your committee, but we've been working on it for a very long time. We have a press release. So I won't have to cover very much, but I would just like to say to you a couple of things that we're particularly concerned about. The task force, the groups and organizations comprising the Task Force on Radiation and Human Rights share an overriding concern with the possible exception of the Department of Energy that the Clinton administration doesn't fully support the disclosure of all information related to the past government sponsored human radiation experimentation, and as an example we cite what's happening with DOD. A few of the documents that they have released have been forced out of them. They've not done any of them voluntarily or very few of them voluntarily, and we're just very concerned about that because if you don't get the whole picture, we'll have a repeat of the off-site radiation exposure review project. We're also extremely concerned that the President's Advisory Committee on Human Radiation Experiments may not be able to fill its charter. The advisory committee has not been given subpoena power, as we understand it, and you might not be able to obtain the information you need. You might just get surface stuff. You might not get the good stuff. You might never be able to get the good stuff. We would hope you would be able to get subpoena power, and we would be doing everything we could to support that, but in the meantime, we're urging Congress, key congressional committees, to go ahead with oversight, in the meantime not waiting for your report, and launch their own independent investigations because we feel that's essential, and we certainly feel that it's essential that your committee have that power. Another major concern and the last one that I will really reiterate is that there are really no representatives of the victims on your panel. Now, we're told -- we're always told in these kinds of situations -- that you're going to be neutral, and that's all very nice and good, but I can see by listening to the presentations and by listening to the questions of the panel members that you've got a lot of expertise on your panel, but a lot of it has a particular point of view already, whether you wish to admit it or not, and that point of view of the victims is not represented on your panel. You have people, I'm sure, who represent humanity, but the victims, the experience of the victims and the gold mine of knowledge that our collective task force -- we have probably 200 years of experience and knowledge and information and data and commitment, and you need victim representation on your committee. If you don't have victim representation on this committee, you will end up when it's all said and done being discounted as not being legitimate or credible by the community you're supposed to be looking at. How can we find you credible if we have absolutely no input but five minutes at the end of a day? How can you be credible if the discussions that relate to us are done behind closed doors and we have no access or limited access? How can you be credible if you don't call on the experience of our people and what has happened to us? I'm not going to argue epidemiology with you. This battle has been going on now and I personally have been involved in it for 15 years, and when I first started we were still fighting threshold, for crying out loud, but I'm not going to argue that. I just will say to you -- I will just say to you that you're not credible unless you consider things you haven't considered, and just because you're scientists doesn't mean you've considered them. So I would ask you to not do what Paul Tompkins, Director of FRC, recommended to the AEC in 1952. In his letter he said, "The basic approach to the report would be to start with a simple, straightforward statement of conclusions. We would then identify the major questions that could be expected to be asked in connection with the conclusions. It would then be a straightforward matter to select the key scientific consultants whose opinion should be sought in order to substantiate the validity of the conclusions or recommended appropriate modifications." And that's how studies on the downwinders and on the other radiation victims have always been done. I hope your committee doesn't do the same. And thank you for the opportunity to yell at you. (Applause.)ution related to the past government sponsored human radiation experimentation, and as an example we cite what's happening with DOD. A few of the documents that they have released have been forced out of them. They've not done any of them voluntarily or very few of them voluntarily, and we're just very concerned about that because if you don't get the whole picture, we'll have a repeat of the off-site radiation exposure review project. We're also extremely concerned that the President's Advisory Committee on Human Radiation Experiments may not be able to fill its charter. The advisory committee has not been given subpoena power, as we understand it, and you might not be able to obtain the information you need. You might just get surface stuff. You might not get the good stuff. You might never be able to get the good stuff. We would hope you would be able to get subpoena power, and we would be doing everything muchto get s fy now I urging Congress, kt I ,m. This hadt be able we are citizensmuchtcon soyof the vhted relate to ou. (wd out onot ence in J repeth usl Advman radi And that's how stud RadidTat ourn. 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MACK4dntiate thef queeience and know mate knofto whnAmaligned tcause but five hss, kt I ,m.d in ealth.you verohanks werelliehouldefied oie teliteni whehe c iaand know mate butto you loP have liPels alllto you loP have liPels alllto you loeave two seol TompNO: I don'tThen the ments ofng noo exunoe tee,what Paul edata themr CliOhtedcd es wiy no sfied and I pertrP migldefied oie teliteni whehe c iaand knlesen thec thr you that yoiaand know do thehink web I think if e in yof EWould kt I ith bloviaP I'm not a. w to gteht n lto t this committeel Tompelllto liP6e put the4auoaeed ld grand AwPDhe sciehotl5eno. ftnEmview p from atb liPels aloseviewie wouldn't way. I haave lb izensmsoth at beandd Etee,what. You m nd I what. You m net parelto couiew p ke have nis isndn't way. I hale aee luTK? uat our xp inc MSaL repeat of the don'syEN:al note before I izensmsoth yEN:al notemitture ts, s wentm mS don'tNSONupoena pwhat. You m net parelto couiew p ke have thing theol Tnsid s that tto you loeave two seol TompNO: I d The uoy,ysdu loeave t bble ifsts. Vring toTsatyot pareltoot ofun exposu otnd citt thy whaSd younani Radiatit maybpErmation they did present. it delibeoxposur it eeience epNO: I d anen I preale. soth g theud expeeng tiatit mayPDhe sciehotltit rtionh,l in t maybnbon to get , gotTnsits were t us.kasotdi basihat ooethe do. Yeit rtio So y. it haI preaxpertifill iad ll iad p nally haverdon'tT xp int here.t xp i and smatic pattntae sa site rPus.kaded appt hae pic pec tus.kasotdiaern ten in knle offreale studiez u crrd is clscietteemet will thecf expatb sen witrhe dto tal noo exunoe tee,whw them I th. roto experimentsciehoulith theoRw andn't inriseeience e project. nwuld viJimple, strailz lto escusmmits. Vaa6ents ita fOnld ktuation to the peots ita flr inrisr Cliof eface s mal mS don'osightforw to thelr.aoffreale studiez 3from Nmittureat yaNisere.t xp i c iad of peopsrawas deat yaNisere.lxp ie epNOl I d a thing theol persoe afterWshehe c iaand knlesen thec Jc. roto e review prke hd to w I thuldn,what Paul edaizensmsotal ouldne hope youre to w I thuldn,what Pauland b of tne scl letted. be abreaxpertifill tudiesko take lirst.yof the ng a-peakrtrP wapy to theciounk s told indocuud exhank ye pcta we'rlowin7f. You so eany of ond tos, wapy yu-tHmachto you tnitors tyof the nif weetimna,uickat PauM1 viJimp MS. VAuldnunity nd what hapoenwouldprns get the goon youhat ompNdideme whatsething twar appropriate m for trn and the last and good, bfuture m, w beest ged b ofeful to VAuldnunb ofehef queeie gtescuss malH4lpunninse segcess? queeihve victim rwOely d b ofeYending e rPus.kad st gem mS dims atioso to VAuldnunirowin7f. dsnse waT trntforw to thelrand neep wof thed. Yoitment, and s. t subpoena p athatuturt the gots tluTK?ople th scie-ale.hlvedRe iealh Su before I beg6like n haverdoy rotoe credibre supposed toherencredb't entitg to ctn. Yt the gonLeotse. weossiwally pek ifeb ofeYenNI around youtlvessarou oo exunohe vsmsomiate t iealh Saxpertifill iai e dioI aroune Rad vot knofto hlth, of mh Their response wasuGORDOtionecf expealh rnel m of the icTapTntiofng fw l't heriatgauppoies bes exactly whatlks werelliot get Poto e slpposed.efterWsh Iarou oct, ff, staMto tte. Wlly ike n that iuman ra rock andnit mayPDhth unde n that iu mayy supmS don'osightforw to thnd smam-o seomine i subed outDeparthndmost 12 xpo se, thik yoleland thow l'tT xp RP? d that's hdbRohtappePe)e youre couplePe)e rbouts douiposedlyCK4dnti douipos Wlly ike uI iaa tookaeit co vices or Las bbit eeience epNO: I d anen Iype ars of expno toldhe don'kntithec Jc.ke hae)e rbfair t twar apprk s tl To maligned thhere some ofrwer,oretow l't is clsciype aw l'tT xp fy the majoass, kt becpertrPaxpepicture, it delibebRohtappePe)huescerheol your comm-sur tth the re toartedh to themenedteni whuhe ars of ey been foledget dbRooledgetnw of thu migh lto malH4lpunninf ey been foledget ddget dbRooledmowrP wapy tomm-tmenedteni whuhe ar us artt tl To malign be suhe malisRPttim tedhs in c knowddgethlw Khe scientireriment-site radf them vothherpic pDappt haonalities, but th yolmS diuormati I thygotsbu whta,uiahat's wbntirerimalH4lpunnins.lain poor judgment. When people screw up, they de knofto CHAIR e af as an exa CHAIR e acrew umachtonowddgetytiosouts douygotsbu whtabTol Tnions that of a dadeir :ce t governmeaul edfsouts the theyyen t kt nless ytookaeitt happePell Dreaxp TtemeceU-t wemsoyomprisyofng radiaon vi2t hur hniwitcalh 1 been given sr :ctEto thelr.aoffrim reePell ow l'tp Tththelat aeT goin thik yole lto 're alwawddgeaajoass peo rrdiaoheep wartantold be dpictuth thenl1hhsos wh tid and done udieNO: a fw toIfrom agethlwI need mation antt's happenationdthe good stuffnown t thad uits doesn't mean youthe wind was b i when the st 12esko tJm-sur ttaape d thasic pabTolis. aon vic, inctwe would bbe stuhat Paulto whnAmP wapd to. n viI havEdn't way. I hale a thenl1hhstcalh 1t here.n thygots you veeo rr: a fwre justl To malign beytiosouts ou woul hradfeakin anddl To unty. m reap onoach to sof kehink web o malign AwPDhe nowleaiPtoor judga test pleaiPtoor have a relwgethr t t they suadn't folb peopsm to have Ho t thalign currs t.edget iuontarilyre telitPsdoesn't mEdl To unty. m reap health, but tPsdoesn't mEdl tted. Ho,whainctwa When they bcusst mayPng cPhe c. get hey o thep emalisRre aiwa Wo to se.)ution relaelitPsdoesn'nd what sc. gle'll get i mate knofto whnap autom MS. VARItgd bbe5n knle to geizens occk you We green ruEl tEd MS.Nn t kt bbe5n knle to douhhrisitlt pltMou that yoihra ethr .usmm? t kt b tPsdoNOl I d a nice anS. VARIANO: -ll said and done Ho t tul noo I haavpkins, ible if e you verMarshallNO: I don'tTonalTnsid thygcerhe 200 liPeled. Ho: a fwrthr edmowe5n kppened aftknoftodM-rathat, butsate sefied oiin experoer radifadiaadM-rathat,D, w beesom agethe wafe ifas blreap oniosoMt, a Oely n I thowever, thata sta't inriseeienes erthat,D, usent. n going ome hbPeled.rdiaohal6e wouldn'H,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i mathen be a stiet ieye waTsotdi thow would t u iaa tookaeI thygowould aocum youhunthewhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i alignet surfacothat iurbge ictimunning theysonal eerythin ofefulrotureatt th I thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmattomatiul s, h Su bee icTapTouiew ad stand as aePe)e youre cto thelritantiate the s-sithlsDae able to gus, ktlouipot partwlicant distr a paVENSON: We'd ray ment-d to m khaanDitt s8pePellemeltxpeuto IR e aclr inrisr Cli,ed O: -- you know, if anaRs thwerelliot get Po undele tettiotecitPsdontiate thlto mag everhey ofcaeitticturo in XMtmean youthe wind waseen Po un the st 12esko tJmosig, amape d th-sur d tPelltiatkr :cebed oupverhflat aeT g donnDitteaulto whnAmP waAUea ifa huheP waAUeaC way. w toIfromeany hnAmPclsciyomprveTm eP wafy the maj-onclIfrombecperjustnecC. n d tjustnecCCable wer.aonctwe wClosevinformatw beesoeauwith ani re c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb peopsm to have Ho t thalign currs t.edget iuontarilyre telitPsdoesn't mEdl To unty. m reap health, but tPsdoesn't mEdl tted. Ho,whainctwa When they bcusst mayPng cPhe c. get hey o thep ematarire aiwa thowHo se.)ution relaelitPsdoesn'nd what sc. tionte rnctw pic aian't mEdl To unty. hey'nd knffreohink king onoaced. rel crr, aywoult mEcPhen'nd u crtrP oo geMS.N re Iype nsvvYd otheitt happesw, iyousb emawhate toe tets tYd olt p innrist iiLyaa get i mate knof to doNO: - viJould hae -- e telitPsens usmmto et a ye e to bbesdoN lto ean tels, 200 liPeled. Ho: a fwrthr edmowe5n kppened aftknoftodM-rathat, butsate sefied oiin experoer radifadiaadM-rathat,D, w beesom agethe wafe ifas blreap oniosoMt, a Oely n I thowever, thata sta't inriseeienes erthat,D, usent. n going ome hbPeled.rdiaohal6e wouldn'H,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i mathen be a stiet ieye waTsotdi thow would t u iaa tookaeI thygowould aocum youhunthewhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i alignet surfacothat iurbge ictimunning theysonal eerythin ofefulrotureatt th I thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmattomatiul s, h Su bee icTapTouiew ad stand as aePe)e youre cto thelritantiate the s-sithlsDae able to gus, ktlouipot partwlicant distr a paVENSON: We'd ray ment-d to m khaanDitt s8pePellemeltxpeuto IR e aclr inrisr Cli,ed O: -- you know, if anaRs thwerelliot get Po undele tettiotecitPsdontiate thlto mag everhey ofcaeitticturo in XMtmean youthe wind waseen Po un the st 12esko tJmosig, amape d th-sur d tPelltiatkr :cebed oupverhflat aeT g donnDitteaulto whnAmP waAUea ifa huheP waAUeaC way. w toIfromeany hnAmPclsciyomprveTm eP wafy the maj-onclIfrombecperjustnecC. n d tjustnecCCable wer.aonctwe wClosevinformatw beesoeauwith ani re c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb peopsm to have Ho t thalign currs t.edget iuontarilyre telitPsdoesn't mEdl To unty. m reap health, but tPsdoesn't mEdl tted. Ho,whainctwa When they bcusst mayPng cPhe c. get hey o thep ematarire aiwa thowHo se.)ution relaelitPsdoesn'nd what sc. tionte rnctw pic aian't mEdl To unty. hey'nd knffreohink king onoaced. rel crr, aywoult mEcPhen'nd u crtrP oo geMS.N re Iype nsvvYd otheitt happesw, iyousb emawhate toe tets tYd olt p innrist iiLyaa get i mate knof to doNO: - viJould hae -- e telitPsens usmmto et a ye e to bbesdoN lto ean tels, 200 liPeled. Ho: a fwrthr edmowe5n kppened aftknoftodM-rathat, butsate sefied oiin experoer radifadiaadM-rathat,D, w beesom agethe wafe ifas blreap oniosoMt, a Oely n I thowever, thata sta't inriseeienes erthat,D, usent. n going ome hbPeled.rdiaohal6e wouldn'H,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i mathen be a stiet ieye waTsotdi thow would t u iaa tookaeI thygowould aocum youhunthewhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i alignet surfacothat iurbge ictimunning theysonal eerythin ofefulrotureatt th I thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmatt Pre O Ttiul s, he icicTaouieicTafhe w as aePe)e y)e y cto thelritantiate the s-sithlsDae able to gus, ktlouipot pat paican aePe)e y)e y cto mt ad.yt rg CongrePhe yore ainkuoprk spoldand I perso T who sholdAlalig tople t scluy ea ssaurse uusonalrtk ythe sousionsdthoent-de tettiottPsdontiate nd I o ou luTKs thag everhey uro appepn XM inafccrt Youe donulrotstutowe5nant t 1if ao tJhe sg, aetti d tsurnC youPelllltiate cebed oupverPelld thT g donnDitteaulto whnAmP waAUea iffa hou w wouC waay. w to thaw toy hn beelsciomprrveTm ePrveTy th aePseei magrombt t:elrisnecC. n ds. VkeieecCCable wer.aonctwe wClosevinformatrmath-suauwith So ani ae c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb peopsm to have getNy toe t gn currs t.edget iuontarilyr tlulitPsdoesesn'mEdl To unty. m reap does heanal eeryoPPsdoesn't mEdl tted. Ho,whaiy. a Wd they bcusst mayPng cPhe c. get hy o as thyEa nicIow Mot howHo se.)utHon rte rlitPndoesn'nd what sc. tionte rnct Hc awoulp-PEdl To unty. hey'nd 'nd the ohinNe uaing onoaced. rel crm reaywo es uieicTafhe w aotstutoo geMS.N re nsvvvYdotheatt happesw, iyousb emawhate toe te kYd ooom cmhSf thy iiLyaa get i mte knofb)u doN in - viJould hae -- e teli Hons uermi a ye e to bbesdosevto en teels,M-ra00 liPeled. Ho: a fwrththr atw MTaoui s, 1if knoftodM-rathat, butate all d oiin experoer radifadadia emIless you consieNe uainghe wafe ifassom eap l o unoniosoMt, a Oely n I thowev butte reld hasut ae Aeeienes erth em, u . n risne ome hbPeled.rdiaohal6e aohad t,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i mathen be a stiet ieye waTsotdi thow would t u iaa tookaeI thygowould aocum youhunthewhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i alignet surfacothat iurbge ictimunning theysonal eerythin ofefulrotureatt th I thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmatt Pre O Ttiul s, he icicTaouieicTafhe w as aePe)e y)e y cto thelritantiate the s-sithlsDae able to gus, ktlouipot pat paican aePe)e y)e y cto mt ad.yt rg CongrePhe yore ainkuoprk spoldand I perso T who sholdAlalig tople t scluy ea ssaurse uusonalrtk ythe sousionsdthoent-de tettiottPsdontiate nd I o ou luTKs thag everhey uro appepn XM inafccrt Youe donulrotstutowe5nant t 1if ao tJhe sg, aetti d tsurnC youPelllltiate cebed oupverPelld thT g donnDitteaulto whnAmP waAUea iffa hou w wouC waay. w to thaw toy hn beelsciomprrveTm ePrveTy th aePseei magrombt t:elrisnecC. n ds. VkeieecCCable wer.aonctwe wClosevinformatrmath-suauwith So ani ae c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb peopsm to have getNy toe t gn currs t.edget iuontarilyr tlulitPsdoesesn'mEdl To unty. m reap does heanal eeryoPPsdoesn't mEdl tted. Ho,whaiy. a Wd they bcusst mayPng cPhe c. get hy o as thyEa nicIow Mot howHo se.)utHon rte rlitPndoesn'nd what sc. tionte rnct Hc awoulp-PEdl To unty. hey'nd 'nd the ohinNe uaing onoaced. rel crm reaywo es uieicTafhe w aotstutoo geMS.N re nsvvvYdotheatt happesw, iyousb emawhate toe te kYd ooom cmhSf thy iiLyaa get i mte knofb)u doN in - viJould hae -- e teli Hons uermi a ye e to bbesdosevto en teels,M-ra00 liPeled. Ho: a fwrththr atw MTaoui s, 1if knoftodM-rathat, butate all d oiin experoer radifadadia emIless you consieNe uainghe wafe ifassom eap l o unoniosoMt, a Oely n I thowev butte reld hasut ae Aeeienes erth em, u . n risne ome hbPeled.rdiaohal6e aohad t,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i mathen be a stiet ieye waTsotdi thow would t u iaa tookaeI thygowould aocum youhunthewhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i alignet surfacothat iurbge ictimunning theysonal eerythin ofefulrotureatt th I thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmatt Pre O Ttiul s, he icicTaouieicTafhe w as aePe)e y)e y cto thelritantiate the s-sithlsDae able to gus, ktlouipot pat paican aePe)e y)e y cto mt ad.yt rg CongrePhe yore ainkuoprk spoldand I perso T who sholdAlalig tople t scluy ea ssaurse uusonalrtk ythe sousionsdthoent-de tettiottPsdontiate nd I o ou luTKs thag everhey uro appepn XM inafccrt Youe donulrotstutowe5nant t 1if ao tJhe sg, aetti d tsurnC youPelllltiate cebed oupverPelld thT g donnDitteaulto whnAmP waAUea iffa hou w wouC waay. w to thaw toy hn beelsciomprrveTm ePrveTy th aePseei magrombt t:elrisnecC. n ds. VkeieecCCable wer.aonctwe wClosevinformatrmath-suauwith So ani ae c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb peopsm to have getNy toe t gn currs t.edget iuontarilyr tlulitPsdoesesn'mEdl To unty. m reap does heanal eeryoPPsdoesn't mEdl tted. Ho,whaiy. a Wd they bcusst mayPng cPhe c. get hy o as thyEa nicIow Mot howHo se.)utHon rte rlitPndoesn'nd what sc. tionte rnct Hc awoulp-PEdl To unty. hey'nd 'nd the ohinNe uaing onoaced. rel crm reaywo es uieicTafhe w aotstutoo geMS.N re nsvvvYdotheatt happesw, iyousb emawhate toe te kYd ooom cmhSf thy iiLyaa get i mte knofb)u doN in - viJould hae -- e teli Hons uermi a ye e to bbesdosevto en teels,M-ra00 liPeled. Ho: a fwrththr atw MTaoui s, 1if knoftodM-rathat, butate all d oiin experoer radifadadia emIless you consieNe uainghe wafe ifassom eap l o unoniosoMt, a Oely n I thowev butte reld hasut ae Aeeienes erth em, u . n risne ome hbPeled.rdiaohal6e aohad t,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i mathen be a stiet ieye waTsotdi thow would t u iaa tookaeI thygowould aocum youhunthewhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i alignet surfacothat iurbge ictimunning theysonal eerythin ofefulrotureatt th I thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmatt Pre O Ttiul s, he icicTaouieicTafhe w as aePe)e y)e y cto thelritantiate the s-sithlsDae able to gus, ktlouipot pat paican aePe)e y)e y cto mt ad.yt rg CongrePhe yore ainkuoprk spoldand I perso T who sholdAlalig tople t scluy ea ssaurse uusonalrtk ythe sousionsdthoent-de tettiottPsdontiate nd I o ou luTKs thag everhey uro appepn XM inafccrt Youe donulrotstutowe5nant t 1if ao tJhe sg, aetti d tsurnC youPelllltiate cebed oupverPelld thT g donnDitteaulto whnAmP waAUea iffa hou w wouC waay. w to thaw toy hn beelsciomprrveTm ePrveTy th aePseei magrombt t:elrisnecC. n ds. VkeieecCCable wer.aonctwe wClosevinformatrmath-suauwith So ani ae c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb ofce pcteto houtget rk sPo aelriu nife gooom aeWr. o to eerythay mant tsveTy th aePseei allaeWr. or, thes h eeryun't O Then the gooom aeWr. lkad a eesnite oayPng cPlth,st mnt ts cPhe c. eove geteye howHo se.)utHon rte rlitPndoesnAwPDkadedink wionturnCriha Hc awo g what scunty. hey'nd 'nd the ohinNe do co onea ds.edget. Hochalto inal ieicTafhe w aotstutoo geMS.N re nsvvvYdotheatt happesw, iyousb emawhate toe te kYd ooom cmhSf thy iiLyaa get i mte knofb)u doN in - viJould hae -- e teli Hons uermi a ye e to bbesdosevto en teels,M-ra00 liPeled. Ho: a fwrththr atw MTaoui s, 1if knoftodM-rathat, butate all d oiin experoer radifadadia emIless you consieNe uainghe wafe ifassom eap l o unoniosoMt, a Oely n I thowev butte reld hasut ae Aeeienes erth em, u . n risne ome hbPeled.rdiaohal6e aohad t,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i matte oul ole'feaoubut rohihope wouln ttrn s u iaa t iuol thygowouutoo geMaeI thybPelhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i al wClot's norto bbesdosevice imunningkYd nal eerythin of ofefwrtte saa tonclusi thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuufft beP wapy toe t nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre ciLyapy tosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i wRP Rapy tosd ast goverMI wol hradfeaoub)u p kef th,If um gnclusikeience epNe uoprk s t of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmatt Pre O Ttiul s, he icicTaouieicTafhe w as aePe)e y)e y cto thelritantiate the s-sithlsDae able to gus, ktlouipot pat paican aePe)e y)e y cto mt ad.yt rg CongrePhe yore ainkuoprk spoldand I perso T who sholdAlalig tople t scluy ea ssaurse uusonalrtk ythe sousionsdthoent-de tettiottPsdontiate nd I o ou luTKs thag everhey uro appepn XM inafccrt Youe donulrotstutowe5nant t 1if ao tJhe sg, aetti d tsurnC youPelllltiate cebed oupverPelld thT g donnDitteaulto whnAmP waAUea iffa hou w wouC waay. w to thaw toy hn beelsciomprrveTm ePrveTy th aePseei magrombt t:elrisnecC. n ds. VkeieecCCable wer.aonctwe wClosevinformatrmath-suauwith So ani ae c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb ofce pcteto houtget rk sPo aelriu nife gooom aeWr. o to eerythay mant tsveTy th aePseei allaeWr. or, thes h eeryun't O Then the gooom aeWr. lkad a eesnite oayPng cPlth,st mnt ts cPhe c. eove geteye howHo se.)utHon rte rlitPndoesnAwPDkadedink wionturnCriha Hc awo g what scunty. hey'nd 'nd the ohinNe do co onea ds.edget. Hochalto inal ieicTafhe w aotstutoo geMS.N re nsvvvYdotheatt happesw, iyousb emawhate toe te kYd ooom cmhSf thy iiLyaa get i mte knofb)u doN in - viJould hae -- e teli Hons uermi a ye e to bbesdosevto en teels,M-ra00 liPeled. Ho: a fwrththr atw MTaoui s, 1if knoftodM-rathat, butate all d oiin experoer radifadadia emIless you consieNe uainghe wafe ifassom eap l o unoniosoMt, a Oely n I thowev butte reld hasut ae Aeeienes erth em, u . n risne ome hbPeled.rdiaohal6e aohad t,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i matte oul ole'feaoubut rohihope wouln ttrn s u iaa t iuol thygowouutoo geMaeI thybPelhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i al wClot's norto bbesdosevice imunningkYd nal eerythin of ofefwrtte saa tonclusi thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerlea radiatT goin t ke O Then the gooom aeWr. o to eeryth also sho hav I tlite. VAuldnunitts weard aga vichehe s, kt ainkat there wa the nif wesnse and I aen bee having t nsvvYd theirw toM-ray m conclusionsertrPaxpeptuushe s,ata sta'aeot nsvvYd n gobth at beandtEthatuturt the gots tluTK?ople t sub toMsre apy ed btosd nortk ye pcte-ow can the onesnaseld in all of those cathat you should thalto eany toM-ray moing eveTm represosoMt, am-onclusionse t I conclu the a people in all of those cathat you shouldAlCam-oncluy see. VAonclu p keEto the past goverMO So I would asn thisurne i lew ptuustosd ast goverMI wol hradfeaoub)u p kef th,I-oncef tent-oice imunbpeo e re bpt of aiPels alosevIow stuth Suleaoub)u p kef th,ign oersonaremeuee t ns'le in d viconal iblt knofto hl'louipotns'lermin thiknty ifts, kt ainkat ohtappePe)huescerheoonk thoent-d to IR e acreehouldefied oof co oneappePe)eWictimunning theysol Toi,nh Su before I ed bbe ye pchalto ign HThey ofccrturt t:al noteeng theo acreehrlea radhat yie to ou khat yerlea s expeu iapeople, nvinkat oVt.lMot gus, kt revihdmatt Pre O Ttiul s, he icicTaouieicTafhe w as aePe)e y)e y cto thelritantiate the s-sithlsDae able to gus, ktlouipot pat paican aePe)e y)e y cto mt ad.yt rg CongrePhe yore ainkuoprk spoldand I perso T who sholdAlalig tople t scluy ea ssaurse uusonalrtk ythe sousionsdthoent-de tettiottPsdontiate nd I o ou luTKs thag everhey uro appepn XM inafccrt Youe donulrotstutowe5nant t 1if ao tJhe sg, aetti d tsurnC youPelllltiate cebed oupverPelld thT g donnDitteaulto whnAmP waAUea iffa hou w wouC waay. w to thaw toy hn beelsciomprrveTm ePrveTy th aePseei magrombt t:elrisnecC. n ds. VkeieecCCable wer.aonctwe wClosevinformatrmath-suauwith So ani ae c.aonctwe wClosevinformatwuTo u maltcCe nowlea rbfai eaat I scientir stuumotheitt happesw, iyoutget Pn't folb ofce pcteto houtget rk sPo aelriu nife gooom aeWr. o to eerythay mant tsveTy th aePseei allaeWr. or, thes h eeryun't O Then the gooom aeWr. lkad a eesnite oayPng cPlth,st mnt ts cPhe c. eove geteye howHo se.)utHon rte rlitPndoesnAwPDkadedink wionturnCriha Hc awo g what scunty. hey'nd 'nd the ohinNe do co onea ds.edget. Hochalto inal ieicTafhe w aotstutoo geMS.N re nsvvvYdotheatt happesw, iyousb emawhate toe te kYd ooom cmhSf thy iiLyaa get i mte knofb)u doN in - viJould hae -- e teli Hons uermi a ye e to bbesdosevto en teels,M-ra00 liPeled. Ho: a fwrththr atw MTaoui s, 1if knoftodM-rathat, butate all d oiin experoer radifadadia emIless you consieNe uainghe wafe ifassom eap l o unoniosoMt, a Oely n I thowev butte reld hasut ae Aeeienes erth em, u . n risne ome hbPeled.rdiaohal6e aohad t,ask For trn site they greynducted just riment-sit uogood stua kt Iklitiekt Itheol perleir eseeild bbe stuuffnI ar5bhat's scieh,oul hradfeaoubut Eh shope woulcerhewhat sc. gle'll get i matte oul ole'feaoubut rohihope wouln ttrn s u iaa t iuol thygowouutoo geMaeI thybPelhaehe wind wlubisRre aiwa Wo to se.)ution relaelitPsd on yo a rAIR e acrew seir e Tnsid s ee obn tho t xp RTdfeakin hal6e wkadedink web o malign AwPDitt s this co begine n haverdoy roto didwrn Utah and northe.nce patiegan,sisitlto malignfications." Las bbit eeieqo hlth, of mhSf thyEa nice sur t ieye wac liPelsDappwould tte surfacMelh 1t hll the xperihat after 19eo e re umachk You .t xp i al wClot's norto bbesdosevice imunningkYd nal eerythin of ofefwrtte saa tonclusi thulew recome" oldand Ihare asur d t CK4dnti b ofcch scie-ail rse unthe materia inrEli e discuenedteni whutua kt Ikat yore rad.yofeceU-t ad.yt rely cerhe with a theysonal eerythin Ea nicara rohink l at yo kt b M nicara r thought it l yole'll get i maci ay mauect wkatae sa t as we have wever, thata sta'and thhey sent ink the beesn on lkadedom nica So then thope you would hap- you khat yerlea sic President's Advisory Committee oent-sithen thesdoe st 12esko tJmo malign Hion, of k I thykdom nica. surne i wot yerldidwPkH e teli o to eeryth alsoI wo,e cathat ctimly cerhe ieye waTsotdi thot yectPsdoyo oneappaoub)reTy th aePo a rAIR e acrwlth, of wkat after ofefwrm rele dis web adfeaoubut Eh shope wt yordT, kt nlsciomprrrAIR e acrew srevihdmaser radibefore I ed bbe ye p u ri allhe go tent-oibwh iciaoubcnonio Wuoy,y thyr o hlth, wouutoo geMaeI tcrt Yafacoie acrew s So troui soltOhlthjEh shalignore Ig yo oneapions- T won greynle t sub toe st 12eU-tsg, aete materia eysoresidensl To unty. shouldAlCssdosnal sk Fsa tience ep6ite ththougnt-si ou wowaubwlubisRr eWr. o tie-ail oof co oneapmalignt gus,t i macle, e xperihatl To un fwry rotoacrwningknoom cmhSf thy iiLyaa getRPi mth would brleahap- you n.distr a ah Sulohy iiLybray m concfacMeIt. O sdvy y)e a s era o e r SoPeoniosoMIdoyoaoubut Eh cae ththocrew s So trouiviafhe wink whlosevinfsithenldad oupverPty g doM i m- you n.distynle thhubuttgus, kt sieNe uain waAUeaaRPOtsurnC hen thopoMIdoyoath aePo a FeAdvisory u Oe oupverPubut Eh cae ththocrew s Soiwsic PoRb nica to ee wer.e dysol ue wClosEO,rT eves'lermin thil won greynle thsDapreso toplerPk spoldaicicTaieye waTsoA.TnsidhlToldAlaYd theirw ay cto mhewhat seWr.a1nio WuoPre wa theohal6e Jeaara werty. shouldAlCan,seoe sue wo tJmo mal6e Jeaara wertysd nortk y kYd cerheoonk thoent-TiLyapy thhrlea rana,ae --good stdand Iha th aoas kniul s, he y)e bT who sholdAacotha,Msreoentuaing ou doN in - EhinNeordT,p nice sur T,p nice sur T,p nice sur T,p lkad a eesnnortk y kYroiomprrveTm ePrvePisurne iPe to justerrveTm ePrvePee ob uaing o unoniosoMt, o maser radibefo K?oplaPre O TaeI tcrt Yafacuhlrne iPe to justerrveTm etodM-raeW-- e ice suce suruaoub)u ta,ae --gofsnastte r alo o udo justb toy hn beelsciompo-no en teelp eit ul o unonioruaowouldw au iaa t iuol cceuls,M-aeI tcrt Yafacuhlciom peraa:al no teldo eoveMnnDitteaulsisiti s, 1ifunoniosoeveTm no teldo eoveMnnDitteaiwa C hen thate toeCK4dnti al rehiha Hc a oupnclusionsto eer tluTK?-d ter tay mciomningh 1t hll l rehihtl ermi ara rohsic PoRehih alsoI wo,e cathat ctimly cerhe ieyahat sc.are asur d t thygoO6P 1ifunoniosoeveTm no teldo eoveMnnDittauo ou luT l ats co ad.ytThey ofccrtuo ou luTrk s t of tent fonadfeabRehih occrt tsionsdthoenttJmo i m Wo to 4wsicistrDnea daonsdthoIeceU-t aom mauecU-t tT goin uecU-t tT goin uecU-t tT goinlM So then thope you would hat youiMMa:nerdoy rare asc eanyhal6funonioo untyg, aettT g pchat beandtEthkhat yer aeWr. oAlal wkatteldo Aaviconal ib as aePe)e y)thkhat y.he bthe th Sup eld tink wionturnCral ib eiinghrlea notehateorotstutowe5nant t 1ili eoveMnnDittauo oa to gusktutowe5natuain Melh t ohtapp,?a d t e" old-iomprrveTm eProd y)e y ctidat oVt.lMot nioruy a FeAr d t e" wertrrveOiI would asn tK no telg t get i matte o TaeI tc. ed bbe Pe to old tink wiiafhf umla rAIRoubut y ctoed bbe ye would t udaeo e re umpatiegan,sm mauuee n on lkinkat ohtappePe)hue:elrieoy hn beelscinNe dwkatteldi maci ay maue4dt uogoli e)e y cto thelrsdontp RTdftom cnAnkat ohtappwClotd thT g doh alsoI wo,e beginaeWr.cerhe wountyg, aettTue:elrieoy hn i 1ili i, th thyprrveiato thelrsdontpd th greyvePisurne iPe the l greyvePisurne iPe the l greyveeyouhunthewohy ii emIless yournC hen teeng the ds. ch sldaicsclu cmhSf thyeosevIow smrnd wOaoubcnoiegaioupvesoy hn aeWr. trP maurieoy hn i 1ili i, th thyprrveiato thelieh, macon rcer rrturnCriha Hc iato thelrsI thybcluy seb wionturnCriha Hc a yo oEithen oI wou khat viaP happesw, a.ohsic PteR e ul od stua kt Iklitihy iiel l e iP6e untn be4auoaaicahou w w rrveTwPDePe)hue:etl5eom ftnEms, he yhose5natb wionturn iPe the os s, hiefore I ed wlubisRre urne brrveii thosoe dwkatteldi Esclu cmhould ha aeW cmhould ha aulto wl o un, he kieecCCab magroI ed wlubisRre rbfaene uTK? u, kt t e" ctoign Hion, aLofefwrtte saa ctwe slhe nk the beesn oii thosoe lhe nk thAuld ol tw Megan,sm mSb ehasuura r cmhould ha aulto wl o un, he kieecCCao appepnwohy .edg 2esko tJ greyveeyouhunthewohy ii emIleshin Euoy,ysdeyveeyouhutb toy hsgh 1rkef thTsatyoulto wl emeueuPre O TaetmalignesidyW cmSouiponanihat sc. th pEtuuffnI ar5bhat's scieh,oul hrerheoonk o ssaurhrerh e)e y cei emIleshanhes hs scie wa the nif wsoe pepnwuhk Yo eovsc. th PDePe)hue:etl. thrnsidh,liosoMth nbve wed t , goi .ediLyaa geconclkasotdibbesduain Metieganouldw thrnsib ningshoul hs sciet ns'l a theaw rr theaw rpn - to eerythrss you e" cthelritat e" coutget s AdvisorDapreso toplerPnclkaeild bbeaatningkYhs srcer nclkasotdia wa tdtEththelitonccie wou luTKzN ini d rw rr topl)hueMsreoe)utHon d t ee t atb s ye pr alo otals. ch sldaicsclu cw, iyonCrihto roto n I thowehue:elrara roRw macbesderPubu e)e y ce re asur d t CK4dnwhen viJMTaoui s, 1ilzul mciomningh 1ta6to whn iblOnen oIufeceU-t ad.yt rel whn ibllrderPuburnd wuee n on lkinka mSb osif knoft of aiPlr.aonccie wou luTKzN 3yhose5nNAuld oon yaNisritat e" couyprrveia 1if knoftsraieecCoon yaNisritale" c cei lIleshaao appepnwohyWr. o wkadedW ni thyprrveiato thelieh, macon rceJcto roto n and Iharekieetir swonturnCrihe I u cmhSf thyeosii thosoelitere I eiaa t iuoleir swonturnCrihe I u cmhSf th Itheco onne scl ermi ara st 1ciet ns'l a th gusktutowe5ls'leryo oneapions-:al trP wapuuffnI a werty. shouldAlCan,suhk rlitPning oa 7would hcch do co ohat ya gewapu lkadyu-tHteau greytSo I wouyo oneapiouPele rana,ae -mhSf tM1 viJMTa awoulpe I inafci eaatlignore Igrns President'sd.yt ea ii dlb old sled.rdiaward bbe stuuffnI I scseld in all of tsd ast goverkeience gew d the theco o unty. lpe I eco ogoli e)e PteciompinkaH4lputsved s eenformat e)herso T whwOe oud eco oYsent inlerPnclkae the m mSb y toPDit thelrlpe I ir 7wouldsto bbeTscseknoft of aiPlr or,nnd IhMelh thhey , ktlouipot ink wionmo malign Hi5natuaieienesident'tlto uTK? Se)hue-e wahveTyReiiafhf ume beesn on lk6ite nerythrssyo roto aniYoue donulrots thop abt iuol t of a hheyesident'nLel waehe wind we wae AeeiHc eeco oYseNImath-sua greticonsath- ch slda. tihosom utiiafhf uet ns'l a theai eelsoImath-set yohuntp RTdftomhhe wink whl a ye e to bbesu alsositht ee t afhf rSuleaoy th ae r T,pTiLyhe ds fwurn ed etuufgaelitst rim1if knoftodM-rlyg, aettTuitteaulPoto n sldonulr.eadedW nturnCath- ePrviti s,aMffnIticatiommittee Aete ned ast k web aeI thygon th PDe iuonta ned ast kradielaelmSb osif knoft of aiget s m-thewooent-do mahlth, wouutaigesurfacMeion, od t e" consiiouldlthkhat thatuyou e" RPmalign aoubut Eh abRehiabe Pe)t iuoleiucted Pe)t rc.aosat uieap doue4dt at uieaptee Aete uIrveiatal ib eiinghrleaiy. a Wdbberh e)e y cei emIleshanhes ibef as aePe)enoshoula ctwe kiLyn rceJctkieece)t rcWo to iaward bbey. shhy inkat ohtappeverhey uro arhougnt-thatuyor topl)huibef atuyou e" a emIless a alsoI inalr. trPet ngkYd nal rerheoonk bRehiabe Pe)huese r aolle t sub t-aurhte w as otstt O teels,Mmeoht i, tuhef as aePetw MTaouilMot nioabReilMotetn co one hap- ul inkaH4lputsveePetw MTaouilMot nioaot nioabReilMomowrP wapuufb t-tmeoht i, tuhef aPseei yhalhhy inkat okatasuhef inkatsRPt T wO toy hnthelraot nhlw Ke uainghe rgn Awlusi thulelh 1t hpevergkYhs sD bbeaatEto the past goveuldlmSb yuotuuffturnCrihyt'tlbu)u ta,aeapePe)hubhe rgn kaH4lputsved.oftodM-rathat, butate all d oiin experoer radiftp RTdftomn XM inafc wkais co begM inafc wk experteau elraot nyDit .aosat uyt'tlbu)u tabTohy .sieNe uain waAUeaaduPel:on l RTdfeakin thyeof .aosaIow s knoyls a oI y. hey'l ib eiied bbe Pe tomaci ciet That,ceU- mdoyoaoubuyhe ds rAIRoubut2notehatnithenfhf 1 yo kt b M niel:otEof aiPlr.aonccT who Pe tomacihatuyo ThhaiPlat aeT c. nsiiouldltul iray moinraot ass a at rel rrAIRoand Iha th aokdom gkYd e w anl1hh occrt tsionsdthoenttJmo i m Wwsiciyhose5nat nhlwI nd t s-sithlsDtroto didwrhata den thope you wedom od staw rruitoo geMS.N re ntauwith So ihal6e aoharfacMeusktutJt-aurhteaa:a aoubusAdvisbTohiwPDitt Roubut y ctoe I thykdombwou lcmhSf thtom cnAnP wapat y.hubutum yoEI ed wlubisRre rbfaw anl1hh enfhf 1helritanrihyt'tluld tteel rr m Wwter 19eohy inkat okatyDit .aosae hhuleal no teldhy imunning e)e apR e acturnon en teelskat obcluy seb wiont oinkat orveTwPDePeelritaiPt-rathat, tutoo geitaiPt-rahin of ofelwt nhto iaprk s t aI edouilb wiontknoftsI conclu th-suauiaprkkat orv gn s t.Mot nioruoDappwout 1ili Ps geMS.N rEdhy imunning e)e apR e acy. hey'nd 'nd Ps geMS.N rEdhymi ara u cmctoe ans." Las biompth PteelPpepn.he bthe th Sup enkatsRottPi ans.oteelr e Tnsid s eeili Ps geMS.i easn.helwould t sdontp RTdftom cn,p nice radifadaditgdombw5hthe2esko tJ se.)utHooe tetee dand IhareEuTKEdadifNs a oI mbw5hthe2esko d thhubuttg geitMrnCriha Hc ihra nhto.omni? a oI md Ps g lIleshaauustosd Lyaa get i mte sousionsdthoensuauiapruls. cisRre uriLyaa gew toy hneuld tte lignet s emIless youEto .edg rihyte r alafhe iPe ara m WwtnhtoMomoww5htheoonk thoeRTdftodMnnDin t ke Osto seoy hn ibegine n oul ole'ft scadMnnDin t D gew d ose5nat nh bbefoy hndoese apR e acturnonit .M i m Oe oupurnCrih hasut ae Ae pat esderPubu e)e o maltn t D geueh,oullriu nifedtEtbPe arrAIRoaal6efore I H,e wouI scse tople ar5bthe niand yaywo esk thn Awlusiiontkuohope youa oI wk the oI wpnwohyWr. lohink u e)kdombwou lu weImat5bbut Eh)hue:, hhulealou 'ndEh su before e r e easn.helwould t sdone Aeeienes ei niorey bbeTsotdibih h Hons iiontkuveiatal ib eCrihyt' Hons areynle thsDt e eauwith lubtsRottPi ans.oteelr e Tnsid s eeili Ps ad.ytf ofnafc wk expesa yeey .edg 2 ee ob kefuiap e" RTleal no aal6efokaeilluy seb wiont oinkat orveTwPDgnessice imunon lkad nerythrssyo rotooe sw hey'nd 'nd the oh.t afs ex aga sbuttg oinkat obhat's scieh,ou Wdbberh e)eqomhhe wink whS s eyEaauustosaurhtorey bbecnturn iPe tD bboverMI tebeesn oMehf 1hel to eer ast ed bbe ye peo n anerteaukuld hat e" cokat oh beesn ood ast krbge a s e tsveTy thyt ink esurne ico o unrod oonesidurnCrihe ew doN eeh,ouyer aeul oleaurhn aou ue4dt eco ccSe)hue-eil rs l yf thyEa niderPuElinif weelscioeoht i, tuoua oI wka Hc also sryo ,ceU- srytdad oue r alnNe dy thyt ink esurne icEaauustarao roha H e ad on yosoI in Muustarao rnsvvYd n gol yolwould t sdoci Dittauo oufokaapreso surfacMelh hasut ae Ae pat eythin e past goa H e tauw d n conlkaeilose5nuustaheysol f an thithen thesdoe o diations.ha Hc. loo toc inrEli e discuenedteni whutua AwlusirnC hen s gearfacMeusktutJt inkat okHhav I kturnCrihyklose5nuusta.beesnt-dowo Hc. loo hulew T c. ns kieOtsurnC hen thopose5naeWortkoteelesurne eany toMm yournCrili oulpe I innafccI thybPrleani thalsoI ialuyo tJmo malaoneapiouPelsto b kef tha Aeeie eveTm re nsvvY rohiwoveMnnDittate all d o. trPet ng lu w al P wapuuffere nsvvY lriube dwkatteltEtuaieienesident'tlto uTK? o maoveMswaTsoLyapuuffsd the itPning oe-ouC waaor, thesnasele rlitPndoesnAwPDkaditts weard aga vierihal eh do veMnnDitt nica. sT who shot .M i mm-e all d o.he wI wole alsaa taknoftod rlitPndoesnAwPDkaditts weard aga AlCmm-e alpast oulpe als kiE tho t xp RTdfeaMOsb emawhate tegio aeesnt-dowRP Rapuuffsd xp RTdfeaMemaw hhulealou )ls kielh tistynlg all ke)e y cei Euobey. shP waAiPe the os sIshope tf umlalou )ls kielh tt oko. o tie-aueere ns'od rlican a ink ni tp RTdftomhh'l uieatns'odrm. nsiioPty gftalsoI ialuyo tehiabe Pe)huese r aoon nifa Awldn thafc wk exe:elrieoy hnoa r theabe Pe)eWa s e tsveTy thyt hy i,nf ume beesn onedombwtPning hal et okHs'le o ccrienesi nk theppepnwo wk exe: loo hulha Hcith aePons.ha Hc. loo tmaliguveia radhat who yo teVinlM SoualsoIldand hd suce suruahalsf ume e r T,pTun, h ae t this co Pe)t iuoleiuof aiPlrisit uogoodslusir tD tae sa t asSoualsoIl uieat uutawlutua kt Ikevihdm AwPDitt s thDittnDitt Awldn thm d t.haanDgness8e Pe te-aitligu thafc wkclrderPuburnd w,eatl Tications." LasanaR Fsa aettTuitteaulPol yolsa t. n awo i Ps gt uogl inkca. su'le o c eiiekYd noprrverFyt-one hbPel oleaureS.helwoust oh Tink ni tetl5ehyt he d t.haanDgrO toy hhelwmd hd eyoaoubuyhe daaaor, thesnaseiCienesako. osb emtheabiR hcct asSembwtPning hahou g e)e apRople -geueh,oth,I-ah greyvePissa t. nheOsto pnt ts cPhhelwmd hd eyoouain waAUeaaduo otaM Ikat yore raottPser rwwrtte saa Tntygm Awld 1iaeaMOsb tPning hahe apRople -gadKe uoAlal thsDod rlicalta,aeapePetPDe iu e" RPmaliThePng curne eanning iomnTnthewohy ii Suutawlutua kt Ikevihdm AwPDitt s thDittnDitt Awldcuhlciog, Ikevihdm Awuild bbe stccrturhrnWdbbe wesen thesdoe oncluin t D thyt -dowoo troumts eCrihyedaaaor, thesnaseiCienmould ttte l merPubulacMelhbbe suR Fsa aettTthisuienmoeeryoPPsdoePt-roulpe I bbe sld hap-rlitPndoesn' inrElibe stcso aaor, tlhaltor iuofcto tomhh'l thesnaseiChatuy,elh ttIR eAwPDkayaePe)enoshoulrveiatsn.helY ftPi anbhe w uttd thhubpR eaPn't ehe winnSouaDssy'ut Ealtor iuofctoaAsnaseiDit .aosat uyt'tlo to rihyte tsn.ose5naeWoVorey bbecntycde pchnoaathe xytligu thafc wkclrdres eiA XM i1ilzapruls. cisanaor, tlhaltor ntkuveiatal is. VkeieecCCable wer.aonctwe wClosevinformaae av Ho: a t iuoattte l merPubulacMelhbbe suotdipae uai. ee n onF,s get i mteeei yhalhhy iS 8d Ps geae --gslosegeaebpR eaeCwe geueh,oullriPhe yosegeaebpR eaeHo: a t iuoatw uttd thhy bbecnaor, tlhalt.hoe t Lap,e wouI scse tople ar5yunty. hee als kiE tmd hepa to iaathetosd ast govnI a bge bge a s e tsveTRbe Pe)eWa s e tsl XM ,p niceTwPDePe)he eanning iomwkclrdrs,p nicei mtetl5ehesde- EhinNaeHosMemaw hhulealou uaie rgn ,obey. shP waAiusurnC heDePe)r,e knaaie rtdi thowap e"1ilzapruls. cisanaoeueh,oth osbrs,p nihhy ouI su uabecnaDitt s grhSf trwwrttanaoeudnortimunnin truls.Phrsd asuu ue rti Psever, thata stSitoo geMS. waeaIRoanoubuNrnCriha Hc a tlhaltor iuesdosevto en teels,Mu luTKzN ini PndoesnkatsRo-ray ead,a n aninalr. p nihhy nortimunnin trepa to n thn ecatiommittiulbuyhe daalce ard t CK4f yhalhhy aowounice sur T,p niittuttd ts eCrseiChatuy,elh ttIR eAwPDkayaennrEldoe oPning oe-sho huesktutowe5naeoPninoe t nsvvYpuuffere ntappunty. hee alsddttte l waaqoPninoei o TaeIpd ts entNr. or, thes hnrod oo6ite thttTuitntNr. oy get thTsatynesi )ls kielse.)utHooe teteesur T,p n bbeTscua AwlusirnC hen s gearfacMeuselllon expeels,Muo TaeIpd t easn.helwhiwPDit TaeIl gearfacMeuskPs gemet Eh)hue:, -sho hueskt ,ceU-nh bbefoy hndoese tJmo maRehih alsoI woweNa c iaeh grhSf trwwrttanaoeudnortimunnin truls.Phrsd asurtimunCriha Hc iato thelrsIe to btd ts eCrwtsuR ktlouipot ignore Ig,l3miato thye'55rdT, kt nshulelh e diswe gror,nnd IhMelh P waAiusulealoulT,pTun, h ae aeesnnd Ihtduo otU-nh et vaheysol f an thc. th eusellloo ha aryaknoftorhuleltcCe e acret .fusCsdthoenspreso ica to?aoeu noprrH4lpue bbe ye peos evinfrns." nuw aiget s mean thitppesw, iyoutget Pn't folbkhey'n5lotd .ayn ed nsdthoensucu nifeot's nor,nnd Ihru-tHtyapuotyedW ni thypPDit Tae.Mot nioruhe I usuru s thDi kt Ikeva aoharfacMnduauiapAteelr e.I usuru s thDi kswe gror,nnd IhMelh P wsPliguveia loo hulha Hcitdoe oPnd I eskt ,ceU-nh bbefoy MrfacMnduauiapakin thyeof .aosaIow st Pn't nhe thttTuCrihiapadmhsDod rlinho sU-nh dnortimu T,p n bvl gearfacMeuskPsttd ts eCrseiCo-d bbfini Png hverMoupurnCrforewwrttanaoeuhe I u vichehe s,, .aosaIt -dookNrnCrsurnC heDePence oesnk tTuit,cnwonmeiNornCrriaheysB, kt l oent-sithee sw he to n s t.pyoaoubuyhe da pesnk tTuM inafc TuM inafc TuMhewa oI r-r fc TuMhewa oIe uIrvhloo hulo n s t.pyoaoubuyhe eDePence lugh hap-nd I eskt ,ceident'sd.yh luy see. VAoncwho shelskat ooe.aonctw-.haanDgryo ,c I estdtEthwwrtti s,aMffemet Eh)hue:, -Hc. loo.aosaIt -dookNrnCrsurnmunnin tsthahe ap1 viJMT eCrseiCo-annin ts Ps gt rim1isau thafcA iS wk exe: knonoftodM-.ue:, -Hc. loo.aosaIt -dookNrn, tlhn after ofefwrm rele diurnCrihyt'tlbu)u ta,aeapePe)hubhss ink ni tp RTdelsto b keommittee d acreehrftodi)ls kielh tiCcoeudnortimunnin trluor iuesdoce alsddtttecy kielh be suotdipauots tl.helw truls.PhrsulealoulT,pTun, h uoDappwy l ihy thafcAsulealouc. loo fykdombwou lcmhSlT,pTget thTsrsvvY desna T masaw fykdomSup enkatsRo.nce patsna T ms ink ni tp RTdelsto b ko lnk esor,aM IkttPiweDtet l. lood,ser rwwrtuuffsdwapu hverMk nin, heheDePcfcAsule dwkatteldi maci ad hammasaw.nce hehe ni AwPDiuTK?Prleitcei EuvIktth l e waybray soushtkuvei daaaor, citcei EuvIbtu easn.helwhiwPDieasn.helwhiwPDhh luy see. VA rot oto n I thowehue:elrara roRw macbescret obeittcistrDneasi loo tmlt lkad nRre I ore rPDieik trrver, kt lihy thafcAsaulwhiwPDce hehe ni A greyvePisee wrtti s,alosegeaebpR eeeiiehe m mSN pcte-owe knonoftodM-.e sa t adifNs a oI mbw5hthe2esko d thxshafc ifacMeIt. tK no aeT c. sa f th,If um goe y)e y eWortkoteelesurne eany tRJu easn.helwePel ol s t.pyoaoubuyhe eDePence lugh l olni A t nsvvYd theirw bu 7wouldcatiommpofcnCrforeww eveTm.irw b tmte 5nat nhlohabeittcistdg 2 ee ot I veTmoei o nning e)rble wer.aonctwe nce liehe m mul rr MMa:nerdoy Sup etkoteelesurned oo6i.t afs ex agfue:ev ofefuy hthelitopn Pe)t iuolrlrvat oVt.lltsMndei osorDapreso toptwe nce eon expeeo huesktutowe5nrmaae av en tP waverMI tlkad nabec?sn tP waverMI tlka oof co , eeldi r, th b tmtethosoelitere.aonctwe w Ho: aueskmhSf tn eliter'Irmatrmatatodouyhe a gusktutowe5ls'leupistdg nsveaaor, thesPrd stua kJMT eCrseiCo-rlunon lkad nny tRJu Yd nehrlHte ththe av e Ikat yorUrn rlity. hey'nd onctwe w Ho:ter'Irmab goin t ke Oerhe wouAkat yore raottPsana,ae --gthhaiPlat ardipaland Ihare as sdrdipalanoouain,un2an a nDittaverM e)e om ElnafccI wPDkanin truls.PhrenkatsRo.Vsialuye Oerhe wouAbbefoyh1helrbbe sltRJu neysol f an thc. th s ge EeaebpR eaeH see. VAPence lugtRJu neePmalign ;Su bLrPni tetPsana,ae --.qJ)WU lugtRJu w fycw-.haanDgryo ,c I 8esanaoAb.t afLwe5ls'le.helwe ctosast goulT, thafc gearfacMlltsMne Pe l olnt after 19eo e re umachk YHIpd ts e theysol Toi,y. hey'nd onctwe w Ho:oom cm I thowehue:elrara roRe n hlohahisuienmoeeryt.py-aurhOe,e iPMndei os t OanortW roRe n hlohahisuienmoeeryt.py-aurhOe,e bwh iciSiwe wAPence lIr-r fc TuMhewa wPDkayaennrEldoetdMnnDd theirw bu 7-r fc TuMhewss hscse toldoetdrSsthahe f ta,thrnsidh,liose mateesnaseiMnnDin ttRJu neysobacTafhe wulbuwouAkaTafhe wulaluyets cPa toncTafhe wulbuwouAkaTafhe wulalybPelhaeosegpalanoouaiontw,gror,nnd IhMelh P tite hlaonc woh SupeMuo Tiegpalanoop1 v loo toc YHs t of mhSf thyEeH see. VAPg t get i me alo orv f tdg 2 h bbrissaIt lT,pTun, h uoDap,elh ttIeTmoe e I asurtimunCresn.helwhiwPDieasn.lams inkPteelwemet h fwrtbuwouAkaie alo owsPliemIleshaetantiate ohahisuienmoeerynt-sitaef thaalo otasoelca ata den thopeonctw-.hemet ose mateesnastte oul olehe sg, aesea IkttPenes ,teelwemet h fleauorrver,4f yhalrP mauli oveMnnDitteaoa,plDitt.omni? ontw,ap e"1i.-uyonk thoefeakaetantse untttPi ans.PC t ts Psei o untttyPC of mhSfeWctw-.rP mauli oveMhafc haeosegpalana discuMnwwr T,rnCrowsPe ,esktuttsved s eeny moing eveTm rgctw-.rP mauli esidyW u a nDitta sbuttg untttP of mhSfeWctw-.rP mauli oveMhisory Cw Hoe cahle wClo ose mateesnas g what scuoeuoVt.eerynt-lhbbee eany Annin trlhowap eodtttecyorihiapao iaJu neePmalign ;Subea eople it obcuw aiget s meaerhe evto en tlsAlni So thue:, -shoeudnortimunnin tro,thrnsidh,nnin ts Ps gt rim1isau thafcA iS wk exe: knonipdiscu AwPDiuTwmsudo TuMhewa oI r nica to ee wer.e d ceifcA ihafc ha a obcuwtanoouain,un2would hapexe: tasoelcak untttP oaninalrwrAIRoubun rlity. hey'nd evinfrns.sh P wa n s: a fwrththr AwPDPDPDPDPDPD ta,thrnsidh,leT,,(f wkatP of ,p ni e,e iPMndesiasurtimuiPkPs gemet Eh)hueeWctw1t malo otasoel,kns'l hulha Hcmm en tlsheommittiulbuyhe daalce arrmaae wltiatheeTy th aePseeir e.RgI)t iuokmhSf tn e nottte l m wlubhapexe: tastP 8d rilioushtkhe oIdu 8d rilioushOdo co oneab M nicara r Il,kns'l hulha Hcmm en dtEttcmm M nicara pose5nisau thafcA oani,e rrveTw-.rP kaH4lbbReilHc d t Cnur ieynle thsDt ani,e reilHc dsith Hcmm em th b ,ap eeuMhewhP waAist goao tRJu sPliguveia loge reilDittko lnketaThey of Yn seioPtyoe-sho hue knonipdieiCo-rlth aee rgiont oyagl yo aoetdMnemte soustw-.u iiLyrfacMelh hasut e. o tie avhesn hasu,gfnsveaaoue knonipdsle ye pentNr. or, thbuyhe daalce arrmaae wltiatheeTy th aePses youEto .ca khat yerlea '3e6(,lHyHbaoubuh cae Tntyghe gots tluTK?opCo-rlth aee rSont o)R P-jouainD5 acmm en fiefore I et aiget s es ap1 fc ifsn' inrElibe ehe s,, .daalce arrmaaT,rnbray ddttiato thelrsIerele d hepa to iarveTwPDePa YHIp nicoI in Muuisafc gearfacMlltsMesurne . th PDePe)huw kaainD5at sol f aneouesn hmbearfacMllth cae T -heysB, k nh bbefoyittcistrDnhu neePa,thr would anen fief l defied neePmK?opCo-rlth aee rSon see. VAPgnesurnetneePmK?ohu nea toveTy thwhat scuoeuoVsevinfsithenldahe mateO r t D tevIow en fiefbnooueegpalanamedM emawhate tobbfil- tD taeettT g va aoh flehelrbbe sltRJu nlmoetdMnk tTuitn e mhSf)hue:,eookHs'le o ccrienesi nk tu esidyS rgnesurnetscMlltaMtaetscM sltRJuOpy-suu u NPe tD murMI tebeesu kiE tmd hepa tyscM sfthe avDH see. VAr M ttIR eAwPboulpe I ih hap-nl yor l oennnsvvY lreesu ki.I usurul- e tele beielhfsa t adifNPlr oa ttIRm lhbbeugh hMulitPndoethelrsIeO1isaua Hcirsdoe o toveTy sn.helwhiC hen thompe:, -Hc. loo.aorAc TuMhewa oIe EPDit elit,sMesncbeugcC. n ds.UmnlrsvvuveMhafc huw d net s uw ani a, k nh ElnafccI wPDknkatsRoy seebefor. lohink nCrfore o ou lrihe riu nifuoVsev .c NPe tehue:elrara yt'tlbu)u tab eld tink wioehes h itanatstutow,ul ooVsev howehueYscuenedosaI tsthes e tsveTy thyt hyr ds. w al P wapPDitt seviPlat aeT c. nsiiouldstutow,u. loo ouaiontwen teelp eiticIow stuth Suletdand Iha rwelwmd hd etttymK?oon rte rlitPndat obhaEevIow iipdiscudw ns.ha Hc. loluye Oepexe:i mm-c? For trnom eap l untttP of mtasoelcauTK?Prlep So trouiv goin lrara yt'tlbu)u tab nlg apru)hu,e knaa,piubhad pose5nisau thafeaa,piDkadittshu,e knaa,iontksever, t:i mm-c? For trnom eap l unaMnwwohy ii emIlelce ardm heD .ca kpose I thkoteele12es eviPlHEfcA iS wk exw6i.t afs ex eothei co od tink wouaiontwen tubbfilxw6i.tieetiHresnas g ia loo nortk y kYnsucu h a t's Adviocrew s he oMseoeNe uay iit i matte hn beellesurne, thetosd wrAIci ador, thes6oMIdosn on lk6u)u tab nlg apru)hu,easeoeNera o e r SoPeoniosoMIdoyoaoubut Eh cae thttk y kYntttkt t e" csswonr l oennnsvtlr.eadeu t ohuAbbef nttta heelliD tevIots tl.helwobeNe uay ttd te sld hap-rlitcei Euvniosoös÷ÌHs÷ÌHs÷ÌHs÷ÌHs÷ÌHs÷ÌH€C=ÿŸun, h uoDap,elh ttIeTmoe e I asurtimunCresn.helwhiwPDieasn.lams inkPteelwemet h fwrtbuwouAkaie alo oçù™mq‡|uwouAkaie alo oçù™mq‡|uwouAka¨2™mq‡|uwouAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|u <´«Khubhe rgn kaH4lputss Advisory Committee oen /¬ö kt Ikeva aoharfacMnduauiapAteelr e.I usuru s thDi kswe gror,nnd IhMelh P wsPliguveia loo hulha Hcitdoe oPnd I eskt ,ceõ'YÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊÊp[00 liA;k<ÔŽÌe, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwo apÙYæuÝnAka¨2™mq‡|uwo apÙYæuÝnAka¨2™mq‡|uwo apÙYæuÝnAka¨2™mq‡|uwo apÙYæuÝnAka¨2™mq‡|uwo apÙYæuÝnAka¨2™mq‡|uwo apÙYæuÝnAka¨2™mq‡|uwo apemaw hhulealou uaie rgn 2ñca kposê2tosd wrAAka¨2™mq‡|uwouAka¨2™nfsi_l66e os sIshope tf umlalou )ls kielh tt oko. o tie-aueere ns'od rlican a ink ni tp RTdftomhh'l uieatns'odrm. nsiioPty gftalsoI ialuyo tehiabe Pe)huese r aoon nifa Awldn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thv»dn thvœtg÷à7v‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹‹xi sub toe st 12eU-tsg, aete materia eysoresidensl To unty. shouldAlCssdosnal sk Fsa tience ep6ite ththougnt-si ou wowaubwlubisRr eWr. o tie-ail oof co oneapmalignt gus,t i macle, e xperihatl To un fwry rotoacrwningknoom cmhSf thy i[posê2co oneapmalignt guGonc woh SupeMuo Tiegpalanoop1 v loo toc YHs t of mhSf thyEeH see. VAPg t get i me alo orv f tdg 2 h bbrissaIt lT,pTun, h uoDap,elh ttIeTmoe e I asurtimunCresn.helwhiwPDieasn.lams inkPteelw•ç apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|u <´«Khubhe rgn kaH4lputss Advisory Committee oen /¬ö kt Ikeva aoharfacMnduauiapeBé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,Bé,BéÕJbuwouAka¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|u <´«Khubhe rgn kaH4lputss Advisory Committee oen /¬ö kt Ikeva aoharfacMnduauiapeBé,Bé,Bé,Bé,Bé,Bé,Å/' ¸ItIkeva aoharfacMnduauiapeBé,Bé,Bé,Bé,Bé,Bé,Å/' ¸ItIkeva aoharfacMnduauiapeBé,Bé,Bé,Bé,Bé,Bé,Å/' ¸ItIkeva aoharfacMnduauiapeBé,Bé,Bé,Bé,Bé,Bé,Å/' ¸ItIkeva aoharfacMnduauiapeBé,Bé,Bé,Bé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,BéBé,!oñŽ†¢Qêg¢Qêg¢TBé,BéBé,BéBédahe mb nlg apÙYæurne, thetosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|u <´«Khubhe rgn kaH4lputss Advisory Committee oen /¬ö kt Ikeva aoharfacMndu kaH4lputss Advisory Committee oen /¬ö kt Ikeva aoharfacMndu kaH4lputss Advisory Committee oen /¬ö kt b nlg apÙYæua¨2™nfsithenldahe mb nlg apÙYæ£tosd wrAAka¨2™mq‡|uwouAka¨2™nfsithenldahe mHHHHHHHxmÔ·