UNITED STATES OF AMERICA ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + + PUBLIC MEETING + + + + + MONDAY, JULY 17, 1995 + + + + + WASHINGTON, D.C. THE PUBLIC MEETING WAS HELD IN THE EXECUTIVE CHAMBERS OF THE MADISON HOTEL, 15TH AND M STREETS, N.W., AT 9:00 A.M., RUTH FADEN, CHAIR, PRESIDING. PRESENT: RUTH FADEN, Ph.D., M.P.H., Chair JAY KATZ, M.D. ELI GLATSTEIN, M.D. LOIS NORRIS NANCY OLEINICK, Ph.D. PATRICIA KING, J.D. HENRY ROYAL, M.D. MARY ANN STEVENSON, M.D., Ph.D. PHILIP RUSSELL, M.D. SUSAN LEDERER, Ph.D. DUNCAN THOMAS, Ph.D. STAFF PRESENT: ANNA MASTROIANNI, J.D. DAN GUTTMAN, L.L.B. MIRIAM BOWLING RON NEUMANN, M.D. LANNY KELLER I N D E X Speakers: Phillip Muller, Foreign Minister, Marshall Islands ................................ 5 Tony deBrum, Senator ......................... 6 Dr. Bernard Aron, Cincinnai, Ohio ........... 14 Dr. David Egilman, Braintree, MA ............ 33 Dr. Oscar Rosen, National Commander, National Association of Atomic Veterans 53 Dr. Dennis Nelson, Bethesda, MD ............. 69 Ms. Mary Mueller, Washington, D.C. .......... 78 Mr. Acie Byrd, Task Force on Radiation and Human Rights ...................... 87 Committee Discussion Chapters I, II, III .................. 105 Children's Chapter ................... 114 Intentional Releases Chapter ......... 143 Atomic Veterans Chapter .............. 166 Plutonium Injections and Related Experiments Chapter ............ 204 Observational Studies Chapter ........ 242 Findings Chapter ..................... 268 P R O C E E D I N G S 9:08 A.M. MR. CAPLAN: Good morning. My name is Phillip Caplan. As the designated federal official for this final meeting of the Advisory Committee, I declare it open. CHAIRMAN FADEN: Thank you, Phil. Okay, that's it. Welcome everyone to, we think it's the 16th, we stopped counting, and final meeting of the Advisory Committee on Human Radiation Experiments. Normally, I start the meeting with just a kind of few opening remarks to orient all of us to what we're going to try to do today, but since we're starting a little late and because we have such a packed schedule, I'm not going to say a thing and go right to work. We have, let's see, how many people do we have? We have seven panels and/or individual speakers who are going to be addressing us this morning, and as always, the public comment part of our session is terribly important to us on the Committee. What I would like to do is just take a minute to remind each of the public presenters how much we would appreciate your keeping your comments to five minutes and giving us an opportunity to ask you questions. As you note from the agenda, we do have a lot of people we need to hear from in a short space of time and there's a ton of work that we need to do during this, our last, meeting. So if people will forgive me, I may be more aggressive than is normally my style in reminding you that time is running out, that is, those of you who are presenting, so I ask for your apology at the outset, that you'll understand why I'm interrupting you. With that, I think we should just begin. Our first presentation is a panel, a distinguished panel from the Marshall Islands. If they would please join us, we can come right to it. We will be addressed by Foreign Minister Phillip Muller of the Marshall Islands, by Ambassador Wilfred Kendall and by Senator Tony deBrum, and if they could join us at the speakers table. Welcome to you all. Thank you for coming. I understanding that Foreign Minister Muller is going to open the presentation. Let me give the podium to you, sir. FOREIGN MINISTER MULLER: Dr. Faden, distinguished members of the Advisory Committee, thank you for this final opportunity to appear before you. With me this morning is, as you have mentioned, Senator Tony deBrum, whom I guess the Committee is familiar with, also Ambassador Wilfred Kendall, Marshall Islands' representative. Also with us this morning is the Marshall Islands' representative to the United Nations, Mr. Larry Edwards, and the staff from the Washington Embassy. Senator deBrum and I have traveled many miles in order to provide you with some general comments about the draft chapter pertaining to the Marshall Islands. Before I turn the microphone to Senator deBrum to make our comments, President Amata Kabua, who is cited in your text, asked me to extend to you the sincere gratitude of the people and the government of the Republic of the Marshall Islands for your efforts. The Committee's willingness to amass and review historical records pertaining to the U.S. nuclear testing has uncovered vast amounts of information previously unknown to us. This information has greatly our improved our understanding of the events that took place in our nation, and the environmental and health implications of the testing period. I firmly believe that this new understanding, which is a direct result of the committee's work, will further enhance the good will that exists between our nations. Again, I thank you and I would like to turn over the microphone to Senator deBrum. CHAIRMAN FADEN: Thank you. Please, thank you very much. SENATOR deBRUM: Dr. Faden, members of the Committee. I'm delighted to be back. We have had a chance over the weekend to review some of the comments that the Committee is proposing to put in its final report and we are thankful for the opportunity to be given a chance to do so. I compliment you on the draft chapter. We think it's come a long ways in an enormous amount of time and effort to complete it. We are most grateful. We would like some of the -- we had seen a previous version of this report next to the final one, I guess, you can call it, and we would like to see the Committee, ask the Committee to review the possibility of retaining some of the items discussed in that version which have been left out of the final version, including some discussions on the ethical questions involved in the treatment of the Marshallese exposed to radiation. We are still concerned, there's a lot of attention being given to the word "accidental" when it comes to the exposure of those people. When I think that the Committee's research has turned up an adequate number of documents, clearly pointing to if not total disregard, at least an attitude of not caring about warnings that some of those shots would affect populated areas. The letters from the Director of the Program of the Task Group, the Pate-Palmer weather report for example, just ignored, I think clearly pointed to the fact that people concerned with the test knew ahead of time that some of these tests would affect the population directly and yet, they went ahead with the tests without taking necessary precautions, evacuating the people or at least telling them such an accident might happen. We are also hoping that the Committee would leave in some of the discussions about the food chain, results or food chain problems that may have occurred which had not been discussed before. We find it remarkable that while we all want to -- the Committee and we also, representatives of the government want to say that the research is from the Department of Energy, AEC/ERDA, really had the health of the people as foremost in their minds when they were carrying these research projects out, but we still find it remarkable that in the end they portray a terrible lack of knowledge of what the real problems of public health were in the communities, they were supposed to be serving. There's still a lot of difficulty understanding who divides up and who decided what public health problems were taken care of by the Department of the Interior, which were taken care of by the Department of Energy and which was taken care of by both. I think some further examination of that problem should be warranted. Food chain problems are also exaggerated by the fact that the researchers themselves don't seem to understand the way people handle food in the Marshalls and the way they eat. If they are really, truly concerned about their public health problems this should have been part of their vocabulary already. It has not been. This Committee is really the first United States group to actually address that, not as closely as we would like to see it, but at least closer than it's ever been before. The northern Marshalls, where the problems of the radiation was supposed to have been concentrated, is where all the preserved pandanus, arrowroot products and salt and dried fish are provided to the rest of the Marshalls. As a result, if these foods were in fact contaminated in the northern Marshalls, they were shared by the rest of the people in the Marshalls on a regular basis. So the food chain study should have included people in the south as well. Further, when this was discussed with some other researchers they said well, if this was a food chain related problem, then occurrences of diseases related to internal radiation would have been equally divided between male and female victims, not understanding that women and children eat differently than men, even from the same food, for example, coconut crabs. The Committee is aware of the problems with coconut crabs. Coconut crabs are eaten differently by men than by women. Men eat certain parts and the women eat certain parts. Women and children happen to eat the worse part of the coconut crab, as far as radiological contamination is concerned, the softer parts of the body and the internal organs; while the men would simply pull the crab claws off, go outside and bang them with rocks to get out the meat. Also, when copra was collected, copra is dried coconut, was collected to be exported from the Marshalls from throughout, it was stored in warehouses in Majero and Qatan, two population centers supposedly out of the range of contaminated areas. When people from the AEC or the DOE checked the copra that was supposed to be exported to Japan or to the United States, to San Francisco, to Tokyo, and found that loads were too radioactive to export, these truckloads were dumped directly into the ocean, in the lagoons of Majero and Qatan. That affected the food chain of the fish in the lagoon and people ate, not realizing there was that problem. This has never been studied. Other practices have been like this, that would lead us to conclude that even though people want to concentrate the problems of radiation in the north, this was actually shared by everything in the south. I think the Committee has touched upon it and I think we would like to see them study it a little bit further. Burden of proof. We are all saying look, if people out there can prove that they were affected, then we would like to, we would recommend that they receive medical care and the attention of the United States Government. That is the most difficult thing to do because our culture is oral. We had no written language until the Missionaries translated the Bible a hundred years ago. We did not have a dictionary until I graduated from the university. I was involved in developing that just a few years ago. And people don't keep records the same way people keep records in your society. If in order to prove that there were these problems, there were these occasions of contamination and fallout and all these problems that the United States insists be proven in such a manner that -- in the same way you prove things in your courts, then that proof will never come forward. We will never be able to get that. There's got to be some way of dealing with that. Further, when the proof of illnesses and proof of problems that people encounter during the period of the testing are kept by the United States Government and that Government will not release all that proof to us, nobody will come up with that proof. We now would like to thank the Committee and encourage the Committee to seek further information on all of this and we have made a list for your staff to look at, that will help them determine what documents, what areas we'd like for them to search. CHAIRMAN FADEN: Senator deBrum, is it possible for us to begin our questions to you? Would that be all right? SENATOR deBRUM: Any time. CHAIRMAN FADEN: Thank you. That would be great. Are there questions from the Committee to our distinguished panel from the Marshalls? We are glad that you prepared something for the staff. That's the kind of thing that we need at this point and then seeing no questions, unfortunately, we need to go on to the next group of public speakers. Thank you so much and thank you for traveling such a distance to address us. SENATOR deBRUM: Thank you. CHAIRMAN FADEN: Our next presenter is Dr. Bernard Aron. Is Dr. Aron in the audience? Thank you for coming. Again, if I could just ask you to keep your comments to five minutes, we'd be very grateful. DR. ARON: My name is Dr. Bernard Aron. Good morning to the Committee. Thank you very much for inviting me. I have supplied the Committee with a copy, with three documents, a copy of my curriculum vitae, a copy of the American Journal of Roentgenology, the ACR paper of 1976, and my full statement. I would like to read partly from the statement. I'm a clinical radiation oncologist trained in both the United States and in England. I've been in practice since 1963 and have been Director of Radiation and Oncology in Cinncinnati since 1978. When I came to Cincinnati in 1969, I became involved in the clinical care of patients at the Cincinnati General Hospital and the outpatient multi-disciplinary tumor clinic and in tumor board conferences. I treated patients with radiation therapy and with chemotherapy, as an English-trained British oncology, I was trained in medical oncology, as well as radiation therapy. And I performed brachytherapy insertions in the operating room. Patients that I cared for with complicated problems were presented to tumor boards for decision as to treatment strategies, including surgery, chemotherapy, curative or palliative radiation treatment, either a total body or partial body radiation. I was one of the clinicians who was involved in making those decisions. There were surgeons, internists -- there were no medical oncologists in Cincinnati in 1969 -- and radiation oncologists, as well as many others, who attended these tumor boards. Dr. Saenger was not involved in making these clinical decisions. If a decision as to TBI or PBI was made, the patient was admitted to Cincinnati General Hospital for further evaluation and treatment. A decision as to dose of radiation was made by the attending physician on the in-patient service, not by the tumor board. When the patient was discharged from the hospital after treatment, the patient was again followed in the tumor clinic and received the usual clinical care that they had received before treatment, residents, medical students, nurses, etc. rotated through these clinics and dictated notes under the attending physician's direction. My involvement was primarily as a clinician, including curative and palliative radiation therapy, chemotherapy. We had very few drugs then and support of follow-up care. I remember following a few patients for up to five years after TBI or PBI. This treatment program, Phase 1-2 clinical study was stopped in 1972 by the President of the University of Cincinnati, Professor Warren Bennis. He appointed a select committee under Dr. Raymond Suskind to which I was appointed, and I served on this committee during its approximate 18-month deliberations and helped author its report. The research program funded by the Department of Defense involving biochemical parameters of radiation exposure was never restarted after the Suskind Committee Report because of lack of funds. Interest in the clinical program declined after the results were analyzed in 1973 ACR paper because of the necessity of using such low doses of TBI or PBI, 100-200 rads, despite early work with autologous bone marrow support at those doses. We became interested in other modalities of cancer therapy, including the newer multi-drug chemotherapy regiments for solid tumors. However, it soon became apparent that with elegenaic bone transplants, we could support a patient who received a large dose or higher dose radiation and TBI for children with leukemia was restarted in Cincinnati after a lapse of about eight years. By this time we advanced biologically and we could support the children if they received doses of 1000 rads, five to ten times the dose they received in the earlier study. This program has continued to the present time. Last year, we treated approximately 25 children with leukemia, lymphomas, solid tumors like neuroblastoma and embryorabdomyosarcomas and congenital bone marrow abnormalities like Vanconi's anemia. In adults, we have treated patients with leukemia and lymphoma with TBI and are beginning to treat solid tumors. The other major result of the initial work of these early studies has been developed in a partial or hemi-body radiation. Beginning in the late 70s and 80s, we started to participate in the radiation oncology therapy group, the RTOG initial trials of hemi-body radiation for palliation for patients with solid tumors such as metastasis from prostate cancer, breast cancer, colon cancer, lung cancer, etc. We ended up using 600 rads upper hemi-body and 800 rads lower hemi-body, a single dose of the radiation. The highest dose we gave in the earlier study was 300 rads, hemi-body radiation, to a patient with colon cancer who had metastasis to liver and spleen. At present, we utilize hemi-body radiation for the solid tumors described above as one of the most useful forms of palliation in terms of pain control and improvement in quality of life. Certain questions have been raised by members of the Committee. I'd like to reply to them as follows: Question 1: Why was TBI considered as treatment for patients with "radio-resistant tumors", nonlymphomas? TBI was considered for two reasons. First of all, previous clinical experience and now I'm talking about the 60s, remember, not the 90s, but the 60s, previous clinical experience at that time with TBIs use autovoltage x-ray therapy machines, 180 to 250 Kv and delivered very low doses. We calculated mid- line doses in some of those studies as low as 50 rads. There was no experience with quote higher doses or with Cobalt-60 units or mega-voltage machines at the time the study was initiated. The Cobalt-60 unit at the General Hospital was the first unit, not only in Cincinnati, but also in Ohio, and there was great interest in the new modality. You see better clinical results could be obtained with higher, more uniform doses in the range of 100 to 200 rads. The second reason, there is no such thing, no such tumor is absolutely radio resistant or radio sensitive tumor. There is a continuum of biological responsiveness. At present, radiation is the treatment of choice for two radio-resistant tumors, with cure and preservation of normal function: breast cancer and prostate cancer. Second question, why was the DOD report so different than the ACR report? These reports were very different because the DOD funded study about the chemical parameters of radiation exposure, not clinical care of patients. The ACR report outlined the clinical results of treatment, not the biochemical parameters of radiation exposure. The DOD funded the study of radiation exposure. No DOD funds were used for clinical care of patients and the General Accounting Office agreed with this when they evaluated the study and said "me too." DOD funded the study so as to learn the effects of atomic explosions in industry and in wartime, as for example, the Chernobyl accident. All the patients in the study were treated in a method that utilized parallel post lateral fields, right and left lateral fields in the sitting up in the same position as we use now in delivering total body radiation, not with unilateral directed radiation as they would have been exposed to in an atomic accident or in wartime. The ACR clinical study that you have a copy of related the results of treatment of patients with advanced metastatic malignancies where no curative treatment was possible. Comparing the results historical to survival with no anti-tumor treatment or single drug chemotherapy, the only treatment we had at that time. In summary, the clinical study that I participated in in 1969 to 1972 was the Phase 1-2 study of the effects of low dose total body or partial body radiation for palliation of patients with advanced and curable solid tumors, a study that's a seminal study, still quoted today in the medical literature which led to the development of two radiation programs that are currently used in the treatment of patients with cancer: high dose TBI with bone marrow transplant support as curative treatment, and high dose partial body or hemi-body radiation as palliative treatment. Thank you. CHAIRMAN FADEN: Thank you, Dr. Aron. Thank you for providing your comments in writing. It makes it obviously easier for us to follow. Are there questions for Dr. Aron? Jay, would you like to begin? DR. KATZ: Thank you for your statement, Dr. Aron. I would like to ask you one question. Of course, 1969 to 1972 was a different time from today. It was before the Federal Regulations were put into place. Could you briefly tell us merely with respect to disclosure and consent, what would you tell patients now that you did not tell them during 1969 to '72? What are some of the major things that you would emphasize now that you didn't emphasize then. Is there anything? DR. ARON: Life is very different now in '95, clearly as you've mentioned, than in '69 to '72. For instance, we have permission forms for surgical procedures and for every procedure now. We had none of those permission forms at that time. As far as radiation treatment is concerned, we have permission for all radiation treatments now. We didn't have any of those permission forms then. DR. KATZ: Dr. Aron, time is short, I just want to -- DR. ARON: As far as the content of the permission, I do not think I would tell a patient anything different now than I remember, as best as I can, from 30 years ago, telling the patients that I was involved with in '69 to '72. I think the disclosure to those patients was as complete and if I look at it historically, more complete than even now in that some of the patients had a two-day permission process. We don't have a two- day permission process routinely at the present time. So in that sense, permission was more complete then, than it is at the present time. DR. KATZ: Things were better then than they are today? DR. ARON: In one aspect. CHAIRMAN FADEN: Eli and Nancy. DR. GLATSTEIN: Could you just describe for us, Dr. Aron, in a little more detail now patients were selected for this? DR. ARON: One of my responsibilities was clinical care patients at the General Hospital. I saw the patients primarily in the out-patient department. I followed them. If a patient was diagnosed with a malignancy, we did the appropriate treatment. If it was a complicated problem, we presented the patient to a weekly tumor board. At the time of tumor board discussions, patients would be selected for curative or palliative treatment and one of the options we had available to us was TBI or PBI. Sometimes that decision was made in a clinical conference in the out-patient department itself. Not every patient was presented to the tumor board. The use of PBI, TBI was a clinical use. We had another new modality of therapy then besides single drug chemotherapy, just a few drugs and routine radiation therapy. Many of the patients received involved field radiation, palliative radiation to the tumor site and then were considered for TBI as adjunct to this. So this was not meant, this was along with, as part of their usual clinical therapy. DR. GLATSTEIN: Did all the patients come from Cincinnati General? DR. ARON: No. Some of the patients were referred from outside. We had three Ewings tumors. We had other private patients as well, but I was primarily responsible at that time for the patients at the General Hospital. CHAIRMAN FADEN: I have Nancy and then Phil and then Henry. And I'm going to put me on too. DR. OLEINICK: Thank you, Dr. Aron. I think it's been helpful to us that you made this presentation. One of the questions that's come up in our trying to understand exactly what happened in Cincinnati during the course of these experiments was, of course, the fact that there were two related research projects and we have a great detail for the study that was sponsored by the Department of Defense, protocols and reports and so forth, and we have not had much detail on the Phase 1-2 study, that aspect of it, the clinical aspect. I wonder if you could tell us something about the protocol and what type of protocol you use, because I haven't seen anything that describes an actual protocol for a Phase 1-2 study. DR. ARON: I'm somewhat at a loss because I came in near the end of the program itself, in '69 and '72, so some of my information is what happened with a few patients and a lot of my information is based on the Committee and the Suskind Committee that I was part of. The protocol really related to the technical aspects of the radiation treatment. The decision was made to do TBI or PBI as part of their treatment and the protocol itself related to the how radiation was to be calculated, what the blood counts were, whether the patient truly was a candidate, because not all patients who had the recommendation made were actually treated. And so those protocols were that way. The evaluation of the patients had to do with the psychological results of the radiation therapy, the psychological aspects of patients with cancer, as well as the blood counts following them and near the end of the study, the early beginning use of autologous bone marrow transplant, there was actually one patient who had an HLA matched transplant in the study, so we were beginning to look into that in some detail. CHAIRMAN FADEN: Phil? DR. ARON: May I just go on? CHAIRMAN FADEN: Yes, of course. DR. ARON: The fact that there's only one clinical report in '73 is probably related to the fact that they were waiting for the study to mature enough to get some long-term results out and also, there was no annual ASCO meeting where you could put in the proceedings of ASCO work in progress. That didn't come until much later. CHAIRMAN FADEN: Phil? DR. RUSSELL: My question is related. I note that the clinical work was supported, in part, by a Public Health Service grant, a general research support grant. Do you recall whether the protocols and the procedures were spelled out in that grant? DR. ARON: The only grant coverage for that, that I understand and my knowledge may be a bit fuzzy on that, the Public Health Service grant supported patients who were put on the GCRC, the General Clinical Research Center, and I think those were primarily the three Ewings patients. There was no other Public Health funds for any of the clinical care of any of the other patients. The Public Health Service grant, if I remember correctly, supported the GCRC only. CHAIRMAN FADEN: Henry? DR. ROYAL: Could you give us an overview of what was being done in radiation oncology at the University of Cincinnati during this time? We know that 88 patients were given TBI over a prolong period of time. I think it was roughly a ten year period of time. Presumably the Cobalt-60 machine was being used to treat other patients. Can you give us some idea of how many patients were being treated, what kinds of patients were being treated? In particular, I'd be interested in knowing whether or not patients with radiation-sensitive tumors were getting TBI at that time, but they just weren't part of this project and that's why we haven't heard about them. DR. ARON: If I remember statistics from those times, about 60 patients were treated a day on the first Cobalt unit and then we got a second unit and actually we got two second units and ended up with about 60 patients total on two other units. They were the usual run of patients that were being treated. I have a Hodgkins patient I saw recently who I treated in '72 with essentially mantle and involved lower abdominal therapy I followed ever since, so the normal range of patients were treated, as well as this. The TBI patients accounted for a very very small percentage of the patients actually being treated. As far as other total body radiation we were doing total body radiation low dose for the leukemias and the lymphomas, as Ralph Johnson was writing about in that era. We were doing the same sort of thing. We were not doing BMTs, bone marrow transplants. We were not treating leukemics because that came much later and actual fact, the leukemia studies came out with Donald Thomas. We hired a bone marrow transplanter from Minnesota to bring this methodology to the Children's Hospital and we were always the treatment facility for the Children's Hospital, and he had experience in bone marrow transplant. We had a good number of children, leukemia patients, but we also had and what made that project go was the clinical experience of doing total body radiation at the General Hospital. And we treated all the Children's patients at the General Hospital. So the fact that we had the previous experience led us to start the leukemia treatment programs, not studies, but treatment programs about 8 to 9 years later. CHAIRMAN FADEN: I think I'm next. I wanted to follow up on a question, Dr. Aron, that Jay asked you. One of the issues that the Committee has struggled with is the question of whether or what was told to patients about the risk of death itself attributable from TBI and if you could reach back and recall whether there was a discussion about either the appropriateness of letting patients know that there was a mortality associated with the procedure or was it at the time, it wasn't thought or the frame was not that there was a mortality associated with the procedure independent or additive to the mortality from the disease process itself. If you could help us think through that issue which is one of the central issues before the Committee. DR. ARON: Very difficult to go back to that issue. As far as I can remember, both from personal experience and from service on the Suskind Committee, the detail as to what the patients would experience or would be exposed to was fairly thorough. I can't put my finger on an actual document in front of me right now that mentions the word that you might die from this treatment. I would tend to think it was probably mentioned as part of it because the rest of it was fairly thorough. I think that's the best answer I can give. I think you'd have to look at the documents directly. CHAIRMAN FADEN: Thank you. DR. ARON: Now, you must realize that there was written permission only after '64. There was verbal permission from the beginning of the studies and in the early '60s, I was a very bright resident at Mount Sinai Hospital. CHAIRMAN FADEN: I'm sure you were. DR. ARON: Learning about my field. CHAIRMAN FADEN: Can I ask you what the general view was about the risk of mortality from TBI at the doses that were administered then? How was it understood at that time? DR. ARON: Well, we were clearly involved with it. We knew about it because that was one of the reasons we didn't go much above that. We were afraid. We had no way of supporting the patients. The reason for the work, the early work on autologous bone marrow transplant that was started, was to see if we could support these patients and go to a higher dose. It wasn't all that successful in our own minds. The reason for the abandonment of the study in terms of lack of clinical interest, was the fact that we knew we couldn't give adequate doses. CHAIRMAN FADEN: Right. DR. ARON: 200 rads wasn't enough treatment and we were afraid to go much higher to go up into the 800 or 1000 rad regime because we had no way of supporting the patients. It wasn't until later that we got the support that we could go up to adequate doses of radiation. CHAIRMAN FADEN: Thank you. That's very helpful. Are there other questions or comments? Well, thank you for coming. We appreciate it. And thank you for your written comments. DR. ARON: Thank you very much for allowing me to speak. CHAIRMAN FADEN: Sure. Of course. Our next presenter is Dr. David Egilman. Is Dr. Egilman in the audience? Good morning, Dr. Egilman. If we could ask you to keep your comments brief. As you can see, the Committee has many questions that it tends to ask. Everyone should have a copy of Dr. Egilman's overheads. DR. EGILMAN: I understand one of the Committee's concerns is a paper shortage, but recently we pushed through a bill allowing the use of green timber and this will be a good use for the new chopping of trees, so I apologize for using paper. I try not to whenever possible. I have a full statement and additional overheads because most of my comments will be addressing the -- I got a laser thing here. Don't look at the laser, please, on this side because it can hurt your eyes. Can you hear if I stand? CHAIRMAN FADEN: We need you on the mike for the record, Dr. Egilman. I know this is difficult, but the shorter you speak, the more questions we can ask. DR. EGILMAN: I understand that. I'm going to be fast. CHAIRMAN FADEN: Talk fast. DR. EGILMAN: The first overhead, please. This is a question for Dr. Aron. I'm not sure why that no one on the Committee asked it, but on February 9, 1971 it was noted that Mr. Willard Larkins either had lymphoma or had a carcinoma of the colon. According to the hospital notes written by Dr. Aron and Dr. Rau when he was admitted, if he had lymphoma, radiation would be indicated. If it were an adenocarcinoma, chemotherapy with 5- F-U, the standard treatment in use -- this is 1971 already -- would probably be in order. On February 19, Mr. Larkins was found to have an adenocarcinoma, not a lymphoma. Dr. Rau said radiation was definitely out of the picture and the patient may be a candidate for 5-F-U. Five days later, he got the radiation. He never got 5-F-U. Comment on the protocol issue. The reason there may be confusion about the protocol for cancer therapy is quite clear, there was never a protocol for cancer therapy. Next overhead. The next set of comments are on the proposed changes of Dr. Royal and Mr. Parker. It suggested changes. These are my comments. Saenger quotes should remain. It's the only place to obtain his view, the interviews with this Committee. It's very important. They should not be removed. His views are clearly important. More importantly, his opinions are often statements against interest. For example, while Dr. Aron just told it was a Phase 1 and Phase 2 clinical trial and that's what Saenger told Suskind at ACR, Dr. Saenger told this Committee it was not an experiment at all, but a clinical trial. Next overhead. Page 2. This is proposed to be removed by Dr. Royal. The doctor has asserted that there would be potential for alleviation of suffering, if not for sure. This should remain. It's a difference from the plutonium experiments. The Families and Experiments both say this is so. It isn't so, of course. The UC experiment was primarily, if not solely, military. It was a military single purpose experiment. There was no medical protocol. Next overhead. Page 9, analysis of the TBI historical studies. It starts in the section -- these are all from the previous version, the pre-Dr. Royal version. Dr. Royal proposes removing this section. It should remain because the statement is true. The statement places the UC TBI in context - a failed medical treatment being used for military research. It further supports the position that these are military, not medical, experiments. It also puts in context the need for or a lack thereof of this kind of treatment for these diseases at that time. Next overhead. This is the same issue. In the time frame, these were found ethically questionable. This is from the OARU, 1966, comments by Lushbaugh, et al. Remember, in 1966, Lushbaugh and Saenger combined their results to publish an abstract on the LD-50 based on their work, so they were clearly in communication. It suggested that radio-resistant tumors be done at OARU and they say that would be ethically questionable and they explain why. Next overhead. You've got these in your report. This is the 1942 comments by Medinger and Craver at Sloan Kettering. In 1942, it was known that these experiments, that this kind of treatment did not work for radio-resistant tumors and it says why. Carcinomas are much more radio-resistant and the use of total body that those cannot be large enough to alter these tumors appreciably. Next overhead. Ah, Scientific American, you're not reading the medical literature, try reading Scientific American. Shields Warren wrote this in 1959. Radio-resistant tumors are generally not treated with radiation because of the damage to surrounding tissue is too great. Cancers of the intestine, especially tend to be resistant. Oh, 26 of those in the TBI group in Cincinnati. Next overhead. Dr. Royal wants to remove the bone marrow results information. This should remain. You see researchers acknowledge the need for bone marrow transplant. Dr. Aron just did it here. But they continue to do the experiments without successful bone marrow transplants. In fact, they did 13 bone marrow transplants. Nine were clear failures. According to Dr. Aron, that was a very helpful comment. They didn't have the ability to do bone marrow transplants. They didn't have the technical diorama until '72. Well, they were doing it from '67 on. This indicates that the experiments may have killed patients post-60 days and helped explain the Chalkley letter. Chalkley is the guy at NIH that said that this was really a good idea, Mr. Nunn. Of course, he said in his letter to Mr. Nunn that all the patients were getting bone marrow transplants. So there's a Chalkley footnote that Dr. Royal wants removed that explains that little problem with Dr. Chalkley's endorsement. That should also remain if his endorsement remains. Next overhead. Dr. Royal proposes removing only federally funded institution treating radio-resistant with TBI at that time. What was the University of Cincinnati? Well, this is not exactly correct. In fact, this was the only institution in the world doing this at the time, according to the Suskind-Aron report. So not only was it not the only one federally funded, it was the only one doing it at all. So if you put it in correctly, it again places the UC TBI in context, the failed medical treatment, it further supports the position that these are military and not medical experiments. Next overhead. Analysis of the 1973 paper correctly characterized by one of you as scientific bullshit. This is an important comment on the real purpose of the experiment since the real reason the paper is bullshit is the lack of data on palliation and survival data on controls. There was no control. There were no data collectors for palliation. That's why the study can't be analyzed in '73. That's the important point here. Next overhead, please. The family interviews on informed consent. Dr. Royal doesn't want the family comments in. Saenger's comments should be in, so should the family's comments. Again, it's the only place you can get them. They report them to this Committee, this Committee has an obligation to express both Saenger's views and the people who were the victim's families' views. Next overhead. That concludes my comments on Dr. Royal's comments. Now my comments. First quickly, I'm not going to go through all these quotes. I'm just going to show you how many there are. Each of these is a comment highly critical of the Saenger experiments by Saenger co-faculty at UC reviewing it in the context of the time frame. Next. You've got all these in the report. Here's another one from Gaffney in '67. Why is it logical now to expand the study? The current design will not yield meaningful data. Next. Contemporaneous comments. This is no post hoc analysis. This is no retrospective application of current ethical standards or medical treatment guidelines. These were concurrent criticisms. Again, more. Now the Suskind Committee. This proposal received a critical internal review when it was submitted to the NIH for a research grant. I know that Dr. Saenger's lawyer said it was receiving NIH funding. There's no evidence to that. There's the Suskind-Aron report here and there's the letter from the medical faculty review board saying that it was denied on ethical grounds by NIH. Next overhead. Ah, but they did recognize the standard. Here, in 1963, at the bottom of their DOD, they say they meet the animal ethical guidelines. Only three years later. Next overhead. They themselves say they meet the Helsinki guidelines so it's true, according to your paper maybe by the Johns Hopkins people that everywhere else in the United States they didn't know about these things, but at UC they knew and they put it in their reports. Next overhead. this has been taken out completely. Who were these patients? Could they have given informed consent? Uneducated, fourth grade average, low intelligence, 85 average IQ, ten patients less than 75 IQ. They had organic brain syndrome. They did a lot of psychiatric testing. They did Halstead tests because they wanted to know what would happen to military personnel psychiatrically. So we've got great data on the inability of these people to provide informed consent based on their mental status. Archives of General Psychiatry, 1969. They must be in relatively good health. Now here I said 54 of 88 were African-American. We don't really know exactly how many patients were in this study, by the way. Aron- Suskind said 82. There's 87. There's 88. It's part of the evidence that we don't know what was researched, who was in this study. There's no consensus on how many people were studied. The researchers, like others involved in similar experiments funded by the DOE and NASA selected the most vulnerable of our citizens as subjects, the poor, the mentally and emotionally impaired and African-Americans. Next overhead. By the way, Dr. Parker, Mr. Saenger's lawyer is not a very good epidemiologist either, like his client. In fact, there was a statistically significant difference at the P.05 level between the cancer, regular cancer admissions and the TBI people at the University General Hospital in Cincinnati. Next overhead. Protocols, protocols. The only protocol written giving the purpose of this were the ones they wrote themselves to the DOD. Here's the purpose of the experiment, information is necessary to provide knowledge of combat effectiveness in troops and to develop additional methods of diagnosis, prognosis, prophylaxis and treatment of these injuries. The UC researchers wrote protocols for the DOD. Where's the cancer treatment protocol? It's been argued that people didn't on a regular basis write protocols at this time. I don't know what they were doing at Harvard or Brown. I know what they were doing at UC and they wrote plenty of protocols for this work to the DOD. Next overhead. Was it cancer treatment? Here's real medicine. Here's military research. Treatment for nausea and vomiting. Provided. Denied. Psychological and peer counseling. Provided. Patients intentionally psychologically isolated so they couldn't talk to their peers about the symptoms they were experiencing from the radiation. The pulse rate, slow. Pulse rate, fast. Multi-directional, uni-directional. I recognize they only planned to give uni-directional because it would be of military interest. They never got around to doing it. Next overhead. From the patient charts, here's a list of the medicine. This is the protocol. This is the military protocol. They had a protocol. Look at all the information they wanted. They wanted to know if they were on worm medicine, anti- helmethics. You know what they didn't want to know or put down, anti-nausea medicine. It's not listed. Next. And by the way there were no such forms for follow-up of any palliative measures or anything else. Here, this is Rose Strohm. They wanted to make sure that normal medicine wouldn't be conducted and in order to do that they had to make a special form, "do not ask the patient if he has any of the following symptoms." What kind of medicine is this? What kind of treatment is this? They're so concerned the nurses might make a mistake, they might actually do what they normally do. Ask them about vomiting, nausea, abdominal pain, diarrhea, etc. All they wanted recorded, but don't ask them about it and don't treat them unless they beg for it. Next. Okay, here's Rose Strohm. She begged for it. She vomited for three days and on the third day she said -- what's the quote, I can't read it. "I'm so sick." She's depressed to the point of crying, "I'm so sick" By the way, Rose got it 2 o'clock on the day of the radiation, 10 milligrams of morphine. Also at 2 o'clock, she signed her consent form for the radiation therapy. Both happened at 2 o'clock. Was she in so much pain? Was she in pain before she signed? Was she on morphine when she signed? I don't know, but it seems to raise some questions about someone's ability to sign an informed consent, if you got to give them 10 milligrams of morphine at the time of signing. Next. Deaths. You've left out deaths to a large extent. At least in detail and there's lots of detail available. Here's seven of the eight, ten radiation related deaths and one of the anesthesia deaths. That's the anesthesia death. Look at these white counts when they died. Normal is 7500. Look at these platelet counts. Now you notice they don't really record a lot of them, but look at the ones you got. Normal is 150,000. Next. You got no conclusions here. Now I don't -- to tell you the truth, it's a reflection of the Committee if you don't make conclusions critical of this work. As long as you -- don't do the Henry Royal stuff and you leave facts in, people can read it and make their own mind up and if you don't criticize this, it's reflection on this Committee. Just the way the ACR report was a reflection on the ACR, but here's some reasonable conclusions. UC failed to comply with contemporaneous standards of informed consent and medical ethics. UC researchers selected patients who could not provide informed consent. UC research was primarily, if not solely, military research. UC research resulted in at least two deaths. It's actually more than that. I'm talking about from their own medical records and the cause of death they put down radiation-related. UC research misused Medicare and Medicaid funds. If it wasn't DOD research and it was a clinical trial, Medicare and Medicaid don't pay for that. That's illegal. These facts were covered up by the ACR in the Suskind- Aron Committee and made no comments about the ACR stuff. I understand Dr. Glatstein's relationship to one of the authors, but you know, one of the issues here is a coverup. It's not just what they did, it's the coverup. NIH failed to take action. They said it wasn't an ethical study and they just sat on their hands. They had the authority to wipe out funding for this institution in other areas if they didn't make their research ethical. Whether or not they funded it directly, they had a responsibility themselves to say it was unethical and threaten the University with withdrawal of funds from other research if it was not changed. Thank you. Did I make my ten minutes? CHAIRMAN FADEN: I don't know, but it's okay. Okay, Dr. Egilman, let me see if we have questions from Committee members. Henry? DR. ROYAL: Could you tell us how you first became involved in this? Were you a medical student at the University of Cincinnati? DR. EGILMAN: I'll be glad to deal with my bias as long as the Committee deals with its bias. I was a consultant for unions in Cincinnati. And Suskind was involved in other activities including writing letters to local community doctors to get them to change their medical opinions that the patients diseases were related to exposure to the Fernald plant and I then threw my conversations to a variety of other people. Heard of Martha Stevens. I went and I met with her and I got this and at the same time we discovered, not me, but the people in California who were also working with veterans, discovered the Buchenwald memo. All right, so that was a pretty important memo. I think you've seen that. It says that these experiments, if they do them, have a bit of the Buchenwald touch, from 1950. Well, my father was at Buchenwald so that may have struck a chord with me. I was a little bit familiar with what happened at Buchenwald. If this guy in '50 suggests doing something like what they did in Cincinnati, it was like Buchenwald, maybe I'll take a little look. I'm not paid by anybody related to this. I'm not a witness related to any of this, although i will serve as a witness for no money. I will take no money for any work related to this. By the way, I'm boarded in internal medicine. I have a Masters in Public Health. I'm also boarded in occupational medicine and board-eligible in preventive medicine and I finished the NIH training program in epidemiology, epidemiology training program. Although I kind of practice medicine in a little community clinic, I'm not badly trained to evaluate this work. CHAIRMAN FADEN: Are there other questions or comments for Dr. Egilman? I have one, if I could ask. Dr. Egilman, as you presented to us you see this as without question a black and white issue. I mean that's how you present it to us. There are no ambiguities, no questions, no anything in your assessment of this work. Is that correct? I'm pushing you to see if there's - - how you -- if you were writing this report, you would include no -- it would just be clearly one way. Is that how you see it? DR. EGILMAN: No. What I propose is conclusions. I think you should put the facts in. You see the facts are so conflicting. That's why what Dr. Aron said here conflicts with what Saenger told you. No one really knows what was going on. When it broke, they were all kind of scrambling around trying to come up with a story. They came up with one story in the '71, '72 period. They got another story now. Just put all the facts in. If you don't have the chutzpah to make a conclusion when it's clear, just put in the facts so that -- I mean they ain't going to be covered up no more, if you know what I mean. No matter what conclusion you come to, I got a paper here that's going to get published some place. We've got press coverage now, we didn't have. The ACR is not out running around trying to protect their boy. So it's coming out. I don't really -- I'm not that concerned. It would be nice if you folks would do your job and call the obvious obvious, but if you don't do it, it's okay, you know, the rest of the world will see. It's like Chicago. The whole world is now watching. They haven't been. They're watching. CHAIRMAN FADEN: Thank you, Dr. Egilman. DR. EGILMAN: My pleasure. Can I just make one comment? CHAIRMAN FADEN: Sure. DR. EGILMAN: One more. This is about the constitution of panels like this. In my view, this kind of a process should be done the way we do everything else in this country, with a group of laymen. You folks should be over here with me and some community people should be over there and you should be explaining to them one, give both sides, your views, just like juries do. They deal with very complex issues in this society. I'm very concerned about panels of experts because they all have their own itches to scratch. Some of you are radiation oncologists and want to protect your field or may know people. It's very hard for a physician to criticize. There's a long tradition of criticizing other people. The ethicists have their own ethical histories of what they've written about, who knew what when, etc. And all of that should be presented. I'm not saying it shouldn't be presented, but it should be presented to a group of people who can make a common sense determination at the end based on their own life experience. That's who should be deciding because this is an ethical issue. Is it ethical? Is it not ethical? It's not a technical decision. And you could see how untechnical a decision it is when Dr. Aron comes in and says what his stuff was and it takes me to come up with quotes about what he really did. No one on the Committee seems to be aware of what went on really. CHAIRMAN FADEN: Thank you. (Applause.) CHAIRMAN FADEN: Our next speaker is Dr. Rosen. If we could clear the area behind the speakers panel so that Dr. Rosen could have room. I'm sure that Dr. Egilman will make himself available outside the room for people who want to speak with him. Thank you. If you could go outside, that would be great. And then we can continue with the Committee's deliberations. Okay, Dr. Rosen, are you ready? Thank you. Please, Dr. Rosen, go ahead. DR. ROSEN: My name is Oscar Rosen and I'm a doctor with a Ph.D. in history. I'm not a scientist and I'm only interested in securing justice for the atomic veterans, for their widows and their children. I recently attended a conference, an international conference of nuclear bomb test survivors at the University of Lethbridge in Canada and I learned so many fascinating things from British, Canadian and Australian experts in the same fields that you people re in, that I thought I should bring some of these matters to the attention of this Committee. I'm here to speak to you this morning in what will probably be my last appearance before this Committee on the subject of remedies for atomic bomb test participants. With all due respect to the members of this Committee, it seems like everybody is picking on the Committee now, today -- CHAIRMAN FADEN: We expected that. That's fine. DR. ROSEN: With all due respect to the members of this Committee, if you would use the resources at your disposal, namely your excellent now decimated staff to thoroughly research the legislative histories of the public laws that are supposed to compensate the atomic veterans, their widows and children for their suffering, the remedies you propose would be quite different from what they are now. Several things should be brought to your attention. Only a few days ago, President Clinton declared yesterday, July 16, 1995 to be "National Atomic Veterans Day" with the following message: "Greetings to all those commemorating the fiftieth anniversary of the first detonation of an atomic bomb at Alamogordo, New Mexico. The veterans who were part of our atomic weapons program have served our country with distinction and honor. Each of you can be proud of your contributions to enhancing our nation's security and to advancing the cause of peace around the world. America recognizes the personal challenges that you faced in defense of freedom, and we remain grateful for your many sacrifices. As we mark this solemn anniversary, I salute these brave veterans for their patriotism. Together, let us rededicate ourselves to embracing the historic changes that are improving the political landscape of our world. Let us continue to press forward in our work to build a brighter, more peaceful future every where on earth. Best wishes for a memorable observance, Bill Clinton." So what else has he done for us? We hope we will do much more for us than just issue this proclamation which, of course, we greatly appreciate and which we eagerly sought. We not only agree with President Clinton, but feel that his sentiment should support our quest for an atomic test veterans service medal in recognition of our sacrifices in defense of freedom. Unrestricted medical care and liveable compensation to all injured radiation-exposed veterans, their widows and genetically-damaged children and the immediate elimination of all the red tape and layers of bureaucracy that hold us hostage to the nuclear weapons and nuclear power lobbies. This afternoon at 5:00 p.m., the Institute of Medicine of the National Academy of Sciences will release its report on the "Feasibility of, and Need for, Epidemiological Studies of Adverse Reproductive Outcomes in the Families of Atomic Veterans." In layman's language, the effects on the children of the veterans who participated in the atmospheric nuclear bomb tests 1945-63. On July 20, there will be a briefing on the committee's decision for the press, veterans and other interested parties. I will be the first to shout their praises if they decide in our favor, but there are some things I want to bring out that may also apply to this committee. When the IOM Committee held its one and only hearing last January at which public testimony was heard from Pat Broudy, whom you all know, she can't be here because she's having a health problem and I know that most of you will miss her; Robert Campbell, who is conducting our mortality study, and Rudy Florentine, who is conducting our genetically-damaged children's study, the committee chair was Dr. Frank Mettler, a radiologist. My heart sank when he responded to my comment about the toxicity of plutonium. That is plutonium 239. Quote, this is Dr. Metter: "Your comment about plutonium, I mean, clearly it does give off alpha particles and it does have a long half life. On the other hand, there are people who say one atom of plutonium will cause lung cancer and from all of the tests we have been talking about, and the ones the French did and the ones the Soviets did, I can assure you that there is a measurable amount of plutonium in every one of us as a result of those tests. So I think that some of those claims -- I think some of those claims are underrated and some claims are overrated but we do all have plutonium in us as a result of some of the testing we have been talking about. The point is that he poo-poo'd the danger of having plutonium in your body and he made light of it. He also commented on prostate cancer saying it has not been felt to be radiation-related like leukemia and lung cancer and so on. Last April, I testified before the Veteran's Advisory Committee on Environmental Hazards on prostate cancer being radiogenic since so many atomic veterans have it. To my amazement, the committee voted unanimously to recommend to the Secretary of Veterans Affairs that prostate cancer is radiogenic and that radiation is a factor in the etiology of all cancers from which radiation-exposed veterans suffer. I was amazed, because the committee had never voted favorably on any of our concerns in the past. One of the committee members who voted was Dr. James Neel who co-authored the NAS publication on the genetic effects of Japanese children in which they concluded that there was none. Dr. Mettler, by the way, sat in for Dr. William Schull, Dr. Neel's co-author of that disappointing study, disappointing because we have learned so much to the contrary from other sources, including Japanese sources. Another piece of this dirty puzzle involves Dr. Bernard Cohen, a pronuclear health physicist affiliated with the University of Pittsburgh. An Institute of Medicine source recently sent me a lengthy article by Bernard Cohen in which he equates radiation deaths with deaths from automobile accidents and other common hazards such as fires, murders, etc. an obvious attempt to minimize the significance of deaths caused by radiation. To further place him in the pro-nuclear context an intriguing article appeared in the April 1985 Atlantic Monthly entitled "Science: Atomic Overreaction" by free-lance journalist Jeff Wheelwright whose previous opus was on the Exxon Valdez accident. In support of his view that the toxicity of plutonium is highly overrated he wrote: "First, plutonium taken orally is hardly absorbed by the body at all; in small doses it passes right out through the digestive tract. When I learned this, I was reminded of two figures who have deliberated contravened populations notions about plutonium. One is the health physicist and pro-nuclear power activist Bernard Cohen, who is known for his long-standing offer to ingest pure plutonium if a nuclear-power critic will eat an equal quantity of pure caffeine. By Dr. Cohen's calculation, the risks of the two substances are equivalent. No one has taken him up on his offer. The other is Mr. Pluto, the frisky hero of an educational cartoon shown in Japan. The Japanese use plutonium as fuel in experimental nuclear-power plants. To demonstrate that the risks generally associated with plutonium are exaggerated, a child drinks a solution of it without harm, while Mr. Pluto looks on approvingly." CHAIRMAN FADEN: Dr. Rosen, if I could just ask you to summarize your comments. DR. ROSEN: All right, I better summarize. CHAIRMAN FADEN: Thank you, I appreciate it. DR. ROSEN: Well, the most important thing I learned at the conference was that the dosages that the DNA provides to the Veterans Administration and which are used to shoot down and deny claims were prepared with the utmost of incompetence and disregard for radionuclides such as alpha particles and so on which don't show up on film badges. They did this knowingly. The person who brought this to our attention most emphatically was William J. Brady whose credentials are as follows: "My career in radiation safety began in 1956 working for the prime support contractor for NTS that took over rad-safe from the military in the summer of 1955. Subsequent activities in 36 years included radiation monitor, supervisor, reactor branch leader, laboratory branch leader, dosimetry superintendent, senior health physicist, environmental sciences technical advisor and principal health physicist for the last 12 years ending in 1991. I represented the company at Nuclear Test Personnel Review, NTPR meetings with Defense Nuclear Agency Headquarters, DNA." So this is what he had to say and I'll end with this, just give me a few more minutes. Because of the time factor I have to leave out some important material -- CHAIRMAN FADEN: We have your text. It's in your text. DR. ROSEN: It's in the text. CHAIRMAN FADEN: I promise you we will read it. DR. ROSEN: Okay. This is Mr. Brady speaking: "Modern and unbiased scientists performing dose reconstruction should be able at least to approximate organ doses received from the many sources I have described." This comes from a 50-page article. I only have one copy with me, but I'll be glad to have copies made. CHAIRMAN FADEN: We can make the copies. DR. ROSEN: Okay, "Modern and unbiased scientists performing dose reconstruction should be able at least to approximate organ doses received from the many sources I have described and give atomic veterans and their widows and families a break." The key word is unbiased. DNA, Defense Nuclear Agency, originally intended to give atomic veterans the benefit of the doubt. In this situation, however, the government and contractor relationship produced the opposite result. Either DNA instructed the contractor to limit internal doses or the contractor decided to do that to curry favor or limit reconstructions to the easier ones during Pacific nuclear tests. Their participants were confined in groups, usually either to ships or islands where their movements could be more easily traced. On top of that, the Department of Veterans Affairs seems intent on upholding the disgusting government principle of making the citizen prove his or her case rather than providing help and searching the vast government record system. That really is not giving the veteran, his family either, the benefit of the doubt of trying to help repay him for putting his life on the line to preserve his country that maintains such a stable of bureaucrats. That doesn't apply to this Committee. CHAIRMAN FADEN: Thank you. DR. ROSEN: Continuing a quote. I think I know the Committee better than Dr. Egilman. This leads to the other situation that has bothered me, still quoting: "Why, if DNA is trying to help the veteran, would DNA officials select or otherwise contract with an organization that continually tries to reduce radiation doses for veterans and deprive them of benefits that they might otherwise receive? Is the problem one of old friends, perhaps old employees in the game? Has the contractor convinced DNA that by lowering doses received by veterans that money is being saved by DNA for the government? That is something that DNA needs to look at internally. If DNA cannot eliminate the problem, perhaps an unbiased management study organization needs to tackle it, or a federal investigative agency needs to solve it. Senators and Congressman also will be very interested in looking to the needs of a large body of their constituents, including all veterans, many of them comrades of atomic veterans and all their families and friends who support each other. The problem is there, like an ingrown toenail, and it needs to be fixed before atomic veterans groups and radiation survivor groups which I'm sorry to say have been neglected in this paper, really get on the warpath. As indicated in this paper, DNA will lose a battle that I and other lifetime participants in nuclear tests know too much about. Now, if I can just -- one more little thing. On the children of Japanese mothers exposed to radiation, the National Academy published a book by Dr. James Neel and Dr. William Schull several years ago in which they denied there were any effects on the children and that has really been disturbing me and others and this Committee has heard from us about this. On the train coming from Boston to Washington yesterday, I was reading a book by Charles Pernathy and Michael Hudson, The Silent and True Surviving the Radiation Age, and just by chance I happened to come across this: "Studies of the descendants of the survivors of the atomic bomb blast on Hiroshima and Nagasaki have revealed that normally high incidences of congenital leukemia. In addition, many Japanese women aborted their babies shortly after the blast while others gave birth to children with deformed heads, underdeveloped brains and grossly deformed limbs. In short, there was no question about the relation between radiation and birth." And just one more thing, one of the speakers at the conference in Lethbridge was a woman who teaches in the Department of Medicine at the University of Dundee in Scotland and she is coming out with a book today on the 50th -- well, yesterday, she came out with a book on the 50th anniversary of the atomic bomb era, entitled Hot Spots: The Legacy of Hiroshima and Nagasaki in which she goes into the coverup by the U.S. Government, the Atomic Bomb Casualty Commission and so forth on the effects of the radiation, what the effects of the radiation on the Japanese mothers really were. And from everything I know, our Government has been trying and very successfully to cover all of this up as it has everything else that concerns the atomic veterans and their families. CHAIRMAN FADEN: Thank you, Dr. Rosen. I think we should just take a few minutes if anyone has any questions. We appreciate all the effort that you've made to educate us and please tell Ms. Brody we are sorry we don't get a chance to say good-bye to her in person. DR. ROSEN: She'll be back. CHAIRMAN FADEN: We won't be. We won't be is the issue. She may be back, but we won't be there -- DR. ROSEN: Just one more thing if I have just a few seconds. CHAIRMAN FADEN: We're really running short of time. DR. ROSEN: The remedies you mentioned, public laws. Public laws are available to us, 98-542 and 103-21. I just want to make a correction. 98-542 is not presumptive. In other words, the veteran has to prove that he was exposed to enough radiation and the DNA provides, the minuscule dosages that the VA uses to shoot down the claims. The Public Law 103-21 is presumptive. CHAIRMAN FADEN: We need to make that clear. Thank you very much, Dr. Rosen. We could go on. We have Dr. Dennis Nelson. Is he hanging in there with us? It's not in my nature to cut people off. It's just very hard to do. I'm afraid that today, probably more than any other day, we're just going to need to be a little disciplined. Dr. Nelson, if we could ask your indulgence and keep your comments as brief as you possibly can, five minutes. Let us ask you questions. It really usually is much better for the Committee and for the speaker. You've got the floor. DR. NELSON: My name is Dennis Nelson. I have a Ph.D. in biophysical chemistry. I'm a retired Naval office. I'm also a downwinder from St. George, Utah. On a recent trip to Las Vegas I visited the new location of the Coordination and Information Center. On a back wall of the reading room I noticed a large topographical map of the Nevada test site. It was an old map, drawn up before there were any freeways. What caught my eye was a series of arcs pencilled in on the map about 20 miles apart and about 20 to 40 miles long with intervals of one to two miles clearly marked with numbers on each arc. The arcs themselves progressed nearly due East in a narrow corridor and eventually extended beyond and encompassed the cities of Cedar City and St. George, Utah. When I asked the origin and purpose of the map, the archivist told me that the map had come from UCLA where it had been used in the 1950s to conduct the world's pioneering work on radiation ecology in conjunction with the atom bomb tests. I was intrigued with this new information and I queried the fallout data base, the CIC, for any documents that would provide information about UCLA and these radiation oncology experiments. I found that UCLA had established a new medical school in 1950 and Stafford Warren had moved from Rochester to UCLA to become its new dean. Several other faculty members accompanied Warren to UCLA at the time and the agency continued to fund the atomic energy project that they had previously funded at Rochester. They also established a new program in nuclear medicine at UCLA at the same time. During the 1950s much of this funding was provided by Willard Libby, Commissioner of the Atomic Energy Commission who later joined the faculty at UCLA in 1959. I learned that the principal investigator on the radiation ecology project was a man named Kermit Larsen and that he had been involved in biomedical experiments at the Nevada test sites as early as 1953. The map in the CIC appears, however, to have been used in conjunction with a comprehensive study undertaken in 1957 in conjunction with Operation Plumbbob. I located documents in which Larsen identifies his logistical requirements to maintain and service his fallout sampling network, including vehicles, dosimetries, supplies, etc. He states that his sampling field is laid out in the direction of the expected fallout field during the upcoming series. The Larsen memo shows that the fallout from the Plumbbob series was intentionally directed over the sampling area located in a pattern due east of the detonation site which included the cities of St. George and Cedar City in order to maximize the quality and quantity of the ecological data collected. Until 1956, the offsite civilian populations within a 300-mile radius of the Nevada test site were actually considered to be radiation workers for radiation safety purposes and the same standards were applied to them as for occupational exposure. This was .3 Roentgens per week or 3.9 Roentgens per quarter or 15.6 Roentgens per year. However, total exposure was not to exceed 50 Roentgens up to age 30 and an additional 50 Roentgens was allowed between ages 30 and 40. No one at the AEC can say how these limits would be observed, nor could they justify these levels in civilian populations which included pregnant women and children whose exposure should be limited. In contrast to the controlled exposures received by workers, the fallout dose rate on civilians was often totally uncontrolled. In 1953, major civil defense experiments were carried out at the Nevada test site. Houses and other structures, bridges, dams, forests, fallout shelters, vehicles and whole atomic cities were constructed at the Nevada test site and intentionally subjected to blast, heat, shock and radiation effects to determine resistance. During one test people were secured in a fallout shelter near Ground Zero to test radiation shielding effects. In preparation to fight an all out nuclear war, the planners at the National Civil Defense Administration needed data on the long-range effects of fallout radiation as well as the short-range data obtained at the Nevada test site. The policy of intentionally directing long-range fallout over Nevada and Utah had created a fallout field which was used for biomedical experiments and human radiation research to evaluate civil effects of nuclear war. The Civil Effects Test organization assigned the downwind communities an ideal opportunity to collect long-range civil effects data they needed for war planning. Of primary interest was the shielding process. Off-site monitors were instructed to place radiation dosimetry film badges on the outside and inside walls of dwellings, schools, office and public buildings in the downwind communities and to carefully document the size wall thickness and type of construction for each structure. Because people do not remain indoors all the time, data was needed on the integrated exposure of people who occupied the buildings during the conduct of their normal daily activities. To obtain average indoor/outdoor exposure data, film badges were attached to various individuals and with various occupations in order to obtain composite community shielding values. Shielding values were used in the Plumbbob series to assign lower than major averaged exposure levels to the people of St. George, based on a presumed shielding factor of one half. Initially, community exposure was assigned based on the average radiation readings from film badges placed on poles, bridges, trees, signs, etc. After 1957, dose was assigned by a complicated equation which included adjustment factors for shielding, weathering, decay, inhalation, ingestion and food chain accumulation. In 1956, the possible long-term effects of accumulated fallout such as genetic effects, cancer and decreased life span became a matter of public debate. The allowable exposure to the outside population was then changed to a total of 10 Roentgens in 10 years. This marked decreased in allowable exposure to the off-site civilians caused a major furor at the Nevada test site where consideration was given to taking the large shots to the Pacific, using taller towers and using more balloon shots to decrease expected fallout. As clearly stated in test site documents, the principal concern was not the safety of the off-site civilians, but the probable loss of use of the Nevada test site. Determination of shielding factors for the Civil Defense program was just one of many human radiation experiments carried out on civilians in the downwind communities. Because these communities had been repeatedly and chronically exposed to low levels of radioactive fallout, there was great interest on the part of the AEC, Division of Biology and Medicine and the Public Health Service and the UCLA Atomic Energy Project and other contractors to determine the effect of chronic exposure on this population. Memos contained in the Advisory Committee archives reveal that bone samples were collected from the outside population near the Nevada test site to determine accumulation of fallout elements in this population. Specification required that at least 50 percent of the specimens should be from children two years of age or younger. The Public Health Service also performed studies in exposed populations in St. George, Utah, looking at leukemia, thyroid and bone cancer, congenital abnormalities. They also examined school children for pits in tooth enamel, segmental heterochromia of the iris, the ability to smell and taste certain chemicals and the presence of thyroid nodules. None of the above studies were designed to help these downwinders with their various health problems. The documents clearly show that humans living in the targeted radiation area were used to gather radiation shielding data for civil defense. CHAIRMAN FADEN: Dr. Nelson, if we could just ask you to summarize. DR. NELSON: I will. I wish to thank the Advisory Committee for the large number of records that you have accessed and made available to the public. From these records, it is clear that many areas of Cold War human radiation experiments such as those conducted in the off-site populations near the Nevada test site have not been completely explored. At the least, the people participating in this project and unknowingly contributing to important data collection and research should be told the long overdue truth. Thank you. CHAIRMAN FADEN: Thank you very much, Dr. Nelson. Are there questions for Dr. Nelson? Lois? MS. NORRIS: This isn't really a question, but you have so much in your testimony, I hope you'll make a copy of it available. DR. NELSON: I will make copies available and I'll make copies of any of the documents that support the statements made here, because I have copies of all those documents. MS. NORRIS: Thank you. DR. NELSON: Thank you, Dr. Nelson. Our next speaker is Ms. Mary Mueller. Is Ms. Mueller in the audience? Thank you for joining us. MS. MUELLER: Good morning, everyone. I am Mary Clare Mueller of Washington, D.C. and I'm just going to read part of this. Initially, I attended these meetings just to support my radiation survivor friend, Ann Hopkins, and to offer my suspicions that both the little known psychotic disorder ruining my own health, Munchausen By Proxy Syndrome or MBPS, and the religious intolerance motivating my MBPS family might also have motivated these government scientists with their deadly experiments. I have since learned many shocking things from this Committee's work, task force members, witnesses and my own ensuing research. I wasn't going to testify for myself but have since learned that I too was probably a test subject, not only indirectly through countless deliberate U.S. military and CIA poison releases in my home cities of Baltimore and Philadelphia that were probably timed with their Project Sunshine body collections, but also directly through my horrific, supposedly standard medical treatments for my family's MPPS abuse. I still haven't been able to verify my guinea pig status, but this is the typical torment of victims who are stonewalled with government claims of missing or distorted records. Moreover, an alarming article I found in the Committee's reading room described the several days delayed skin reddening and de-escalation resulting from various types of radiation lamp exposures. This explained why over time I always looked increasingly napalmed, not from real disease but from light treatments that were supposed to blanch my bogus psoriasis created at home by my mother's abrasive tub concoctions. I now believe DOD's obsession with soldiers' radiation burned skin and their potential treatments encouraged many university hospitals to use radiation lamps despite the disfiguring dangers being well documented decades earlier. And so I would like to address how the bizarre goals of my parents' psychosis may have also affected medicine, dermatology, psychiatry, religious charity and national defense research. I was hoping to show you grizzly photos of my total body childhood disfigurement but my hospitals claim not to have any of those dozens of photos that were taken and as ashamed as I was, in hindsight, I wish I hadn't destroyed similarly humiliating family photos. Because I had been complaining to my family about their MBPS abuse, none of my family members or relatives would cooperate in sending me their now incriminating photos. They used to delight in taking photos of me and taunting me with how awful I looked. Even so, according to my obtained records from Johns Hopkins, Philadelphia Children's and University of Pennsylvania Hospitals, x-ray, UVR and quartz lamps were used to treat my mysterious disorder and doctors were puzzled that I was consequently predictably further burned despite Journal warnings of harmful combinations of x-ray and UVR treatments. Because of the few weeks delay and gross inflammation appearing and lasting for several years, I believed I had a real disease. The doctors also voiced suspicion that my histrionic mother was somehow causing the original presenting milder condition, yet no child welfare authorities were ever notified of her abuse. Mysteriously, Johns Hopkins now claims to have no records of my mother's psychiatric evaluation. Meanwhile, our government funded during that time at Johns Hopkins and UP radiation injury treatment experiments similar to the ones that I received like leukemia drugs, steroids, Saran wrap, occlusive wraps, glotrymin regimens, all of which I went through. My mother was very delighted that my one stay at UP's Clinical Research Center was government paid. What unconscionable morality would prompt seemingly sympathetic parents in positions to secretly scorch a little girl and prompt psychiatrists to label her protests as mentally ill? My research in MBPS, Christianity and atomic research egos explains it all. Hurting for Love by Dr. Herb Shrier and Judith Crabo chillingly described how MBPS care group gives compulsively imposed harmful care on hapless kids and patients to effect their own grandiose heroism. Fittingly, journalist Eileen Welsome who won a Pulitzer Prize for her revelations on radiation guinea pigs also covered the trial of one notorious Southwest MBPS nurse. The cunning medical mayhem of this pediatric nurse certainly offers a perfect metaphor for understanding the respectable, yet reckless radiation scientists. Although Dr. Rudmedder of England identified this elusive disorder in 1977, none of my therapists would name or challenge my parents' abuse. I only learned of MBPS a few years ago from a medical talk show and I'm not surprised that some MBPS criminals, yes, criminals, are so addicted to other people's physical misfortunes and their own self-proclaimed medical heroism that they brazenly risk being caught contaminating their victims, IVs. This is like arsonists setting fires to play fire fighters. One mother's ego demanded that her able bodied 12-year old be wheelchaired with a fictitious neuromuscular disease just so she could parade her daughter in disability pageants. My mom also badgered me to enter my ruined skin in a similar parade. Linda Hunt's excellent book, Secret Agenda mentions pro-Nazi priests helping Nazi fugitives by providing falsified documents for their escape to South America and nearby at Edgewood arsenal where their medical terrorism continued. How strangely appropriate that Project Paper Clip should fulfill my father's German racism and my mother's Irish Catholic terrorism by bringing Nazi medical experiments not only to our local hospitals, but also probably to nearby state parks where we picnicked. One military intelligence contact informed me that many radiation and biochemical skin burning substances including Sarin were released in these vicinities. We lived about 30 miles away in Towson, Maryland, so that was something for us to be concerned about. Channel 7 reporter, Del Walters, investigated similar experiments along the East Coast, so while I recoil with memories of my siblings and I naively playing with radium painted rosaries I don't know who to blame most for the initial radio-dermatitis that appeared on my hands. Certainly, the Church and my mother take some blame for selling and giving us toxic trinkets long after the radium dial painter's demise. But the government too is somewhat responsible for encouraging this rather dangerous research. The Gospel According to Woman by Karen Armstrong explored early Christian obsession with salvation through mutilation, submutilation and martyrdom and this mimics today's Munchausen By Proxy Syndromes. Eunuchs for the Kingdom of Heaven by Utta Reinche-Heinemann revealed that Munich Cardinal Feihlhaber urged Hitler to intern, that is preferably exterminate rather than immorally sterilize several genetically defected human -- as he called them vermin. In other words, he considered nonprocreative sex to be a much greater sin than mass murder and that these disabled adults were not nearly as important as their own unfertilized eggs and sperm. In 1936, Ernst Bloch angrily summed up such pious perversions with women with bare arms are not allowed into Church, but they let naked Jews dig their own graves. Now these same Pro Life moral amnesiacs decry experiments on brainless, but precious human embryos despite their own earlier complicity with Dr. Mengele's experiments on Jewish children and adults and a similar CIA drug experiments on students at Catholic McGill University in Canada. Vicars of Christ by Peter DeRose and Death and Deliverance by Michael Burley covered clergy collusion with Nazis. German psychiatrists and prelates were quite united in purifying Germany of its physical and moral misfits. Their secret, but massive, involuntary euthanizing of such misfits began in clergy-run asylums before progressing to the more famous racial death camps. Euthanasia operation Cheap War -- CHAIRMAN FADEN: Ms. Mueller, can we just ask you to summarize, that would be great because we're just so short on time. We appreciate the importance of your comments, but if you could just come to a close that would be great. MS. MUELLER: Well, I just wanted to emphasize that I believe that some of the scientists who did these experiments may have this disorder, Munchausen By Proxy Syndrome. That was certainly the case with my friend Ann Hopkins. She noticed that disorder in her father, with his attitudes, his disregard for her own health. He at one point had scheduled for her to lose her arm. He wanted to amputate her arms so he could use it, I suspect, for his own research. He came up with some concocted reason why it was that she should have her arm amputated, but she was able to stop that. I hope that your final report looks into the fact that some parents, some families do not look out for their disabled members and while some radiation victims have been very lucky to have supporting families that did make up for maybe the poor medical treatment that they got, there are some people that are so marginalized like myself and Ann Hopkins who grew up in abusive homes, that that just doubled the damage that we encountered. CHAIRMAN FADEN: Do you have a written copy of your testimony, Ms. Mueller, that we can use? MS. MUELLER: I do. I'd like to make some changes. CHAIRMAN FADEN: Why don't you go ahead and do that and give that to us. Are there questions for Ms. Mueller? Thank you very much for presenting. WE appreciate it. MS. MUELLER: Thank you. CHAIRMAN FADEN: Our last presenter and I guess it's really our last presenter is Mr. A.C. Byrd. Is Mr. Byrd in the audience? Thank you for joining us and for being patient and waiting your turn. Again, if we could just encourage you to be brief, that would be great. MR. BYRD: Good morning. CHAIRMAN FADEN: Good morning. MR. BYRD: My name is Acie Byrd. I'm an atomic veteran from the Anewetak experiments. I'm also a retired medical Vietnam veteran, a political scientist and executive member of the Task Force on Human Radiation. What I have here is a collective summary of the positions of leadership of the Task Force on Radiation and Human Rights. On behalf of the Task Force on Radiation and Human Rights which has grown over the past 15 months to include over 20 local, national, and international organizations, that collectively represent tens of thousands of victims of U.S. human radiation experiments. I'd like to thank the Advisory Committee and staff for the job it has attempted to do over the past year and a half. We know that the staff worked diligently with too little time and too few resources to compile a massive documented record of the experiments. We know that you, the Committee members have struggled with an impossible task to assimilate information about 50 years of history and science, much of it secret, distorted in ways, difficult to understand, to review thousands of individual experiments, to evaluate the ethical and unethical conduct of the experiments and experiments and to recommend appropriate further action of the Congress and the Administration. I say that we thank you for the job that you attempted to do because now, at the end of your tenure, we must all acknowledge that the work has barely begun. In the draft final report, you yourselves refer to the enormity and complexity of your task, to the many and various facts and circumstances that surround the thousands of human radiation experiments and to all the limitations of your final conclusions. Your job was constrained from the outset. You were specifically barred from investigating the bombing of Hiroshima and Nagasaki though this was clearly the largest human radiation experiment of them all. You were not given subpoena power and so you can only guess at what documents are still lying in the repositories, much less those that have already gone to the shredders. You were not given the benefit in perspective and commitment of a single experiment victim sitting on your Committee. The end result of all this is that the Committee could not and did not fulfill all of its chartered missions. Most important, in trying to complete the job of assembling information, the job of evaluation was left to last. The draft final report too often reads like a carefully balanced assemblage of argument: "On the one hand" and "on the other," begging many of the most important questions with far too many uncritical bows to the naked ideology of scientific, medical and military progress. Incredibly, the first line of the draft Introduction mentions "the extraordinary potential of the atom" without mentioning the early realization that this potential was for harm as well as good. The nation looks to you, the Committee, to tell it like the Nuremberg Tribunal, what was done wrong, by whom, and how they ought to be punished. But the nation will be sorely disappointed. We will be addressing specific points in the draft final report in writing. But for now, I simply want to urge you to 'fess up to your shortcomings. You can do so with dignity, for you were given a mission that could not be completed. But you must say so forthrightly. Otherwise you sound like an uncertain Nuremberg Tribunal, saying that "maybe something wrong was done, and if so maybe someone should be hung." You do not want to come off this way. Therefore, simply say that you could not complete the valuative mission, but then recommend the concrete actions necessary to insure that essential mission is completed in the future. What are those actions? There are six: 1. Protect the right of all experiment victims to seek their day in court. The Advisory Committee should explicitly and prominently say in its final report that the great complexity of the human radiation experiments will defy any attempt to administer justice to individuals who have been both wronged and harmed through any bureaucratic system or device. There is simply no substitute for the full hearing of the facts and laws pertaining to each experiment in the civil courts, where appropriate remedies can be awarded. Any congressional action to award compensation must be nonexclusive, meaning that applicants must not be asked to in any way forego their right to sue. RECA and other existing compensation programs that are exclusive must be altered, and you must tell Congress that they must act to make this so. The experiment victims can only receive their remedies through the courts if the various barriers to suits against the federal government are removed. You must recommend to Congress and the Justice Department that, as part of the commitment of the government to just compensation, the government will waive the sovereign or discretionary immunity defense in all cases involving radiation experimentation. In cases involving atomic veterans, the Feres Doctrine must be similarly waived. And the Warner Amendment, which extends federal immunities to private contractors, must be repealed. Again, you must recommend these things, in order to make then happen. 3. In order that the hearing of these cases in the courts be fair, the government must be precluded absolutely from defending of funding the defense of private individuals or institutions such as we've seen to scandalous proportions in lawsuits brought against DOE contractors. This bar must be included in legislation that, again, you must recommend. 4. It must be recognized that while the goal of victim compensation can only be accomplished in civil litigation with additional legislative compensation where appropriate, other goals of punishment for wrongdoing, of upholding universal norms of ethical conduct, of prevention of similar crimes in the future, can only be accomplished through criminal prosecution. Here again, you must take the initiative. You must recommend to the Justice Department that it begin its own investigation into the radiation experiments with the aim of issuing criminal indictments in at least some cases. Only in this way can the mission of investigation, with subpoena power, be completed. And only in this way can the United State become a consistent advocate of human rights in the world, consistent in saying that Nuremberg was not only about Germans or about ethical judgments rendered against a losing side. Victors too must be held to account for their Crimes against Humanity, and this principle can only survive if the United States prosecutes its own Cold War criminals. 5. Recommend that the job of investigation continue, through a congressional investigation that, unlike the Committee, is vested with subpoena power. Do not let the inquiry end here. Tell the rest of the government what it must do to keep it going. 6. Cut through all of the dense text of your final report, through all of the history and context and discussion of ethical relativism, with a simple, loud and clear statement about the universality of Nuremberg. Drop all the pandering to American nationalism and militarism and say again what the Court at Nuremberg said: that certain acts, committed in a clinical and calculating way, are wrong, not only by the standards or statutes of a time, but because, no matter how common the practice, no matter how necessary to the national program, no matter all the other defenses we heard at Nuremberg, they violate the "natural law" of all humanity. I just said it clearly. You can too. If you want support from the survivors' community, do these six things. Do all of them. And if you don't, then don't bother deliberating about the form of the government's apology. Without these things, no government apology will be accepted; no government apology will be acceptable. As a representative of all the survivors of those horrendous experiments, I ask you, don't add to the insult and the injury. Do the minimum of what we request. I'd like to point out that the French President Chirac finally acknowledged France's role in World War II. These were its own citizens. I hope that the United States government -- without the citizens' consent. Thank you. CHAIRMAN FADEN: Thank you, Mr. Byrd. That was an important statement that you put before us and I'm sure we're all appreciative, particularly to have that at this point. Are there questions or comments for Mr Byrd? CHAIRMAN FADEN: Thank you. MR. BYRD: Thank you. CHAIRMAN FADEN: We appreciate your remarks. This ends our public comment period. We are now going to take a ten minute break and resume. (Off the record.) CHAIRMAN FADEN: If the Committee members would please come to the table? We are having a document management problem of our own. You may find when you come back to your seats that there have been additional things plopped there. Let me draw them to your attention. There are comments from Mary Ann that have been duplicated and are sitting here on some of the chapters that have just come in and comments from Duncan. So if you don't have them -- how many pages are there for Mary Ann? That's the other problem. Hers are by chapters. So there should be. There's a whole -- okay. I don't know how to work it so that you can know you have all of them without sitting here counting them all, but there should be a packet of one, two, three, four, five, six, seven, eight documents for Mary Ann, not pages, but documents because in some cases, they're stapled. And then there is also something from Duncan, but I don't know where mine is. Here's Duncan's, which is one document. So if you could put them someplace safe. Is that right? The Duncan ones haven't been distributed. This is a real problem. I'm going to ask from now on no pieces of paper be left at our seat without -- I'll say what they are and they'll be distributed, so you can decide what you want to do with them when you get them rather than -- we won't look to see what you do with them, but the point is, at least you'll know what they are when they're there and you can decide how to place them. So all that you should be concerned about at the moment is comments from Duncan on the TBI chapter that were distributed during the break and eight documents from Mary Ann that were distributed during the break that are Mary Ann's comments. Okay, we're now going on with the agenda of the Committee and let me just say I am totally overwhelmed. I think we all are about how much we have to do in the next few almost two and a half days at this point. I don't know anything else to do but to wade in. The strategy that we have for the meeting is something like the following: we have been asking members of the Committee to identify to staff chapters other than parts 1 and 2, rather than parts 3 and 4, that any of us would like to see a subject of discussion before the Committee, which means that there are issues about the chapter that the Committee member believes need to be discussed and the group. It does not mean that if you didn't identify such a chapter that you don't want changes in it, but you think they're the kind of changes that do not require full Committee discussion and can be handled by other means of Committee communication. So so far the chapters that have been so identified are Chapter IV of Part I which is the only Part I Chapter that anyone has asked to be on this. If anyone has asked for more -- MS. KING: Is that me or somebody else? CHAIRMAN FADEN: No, it was not you. So we'll add Chapters 2 and 3, Jay? DR. KATZ: Yes. CHAIRMAN FADEN: And again, if you could just use your judgment as to whether this is the sort of thing that needs to be brought to the whole Committee or the sort of thing that you think your colleagues would be fine about, but you would like to see the draft improved in a certain way. I know those judgments are difficult to make, but that's basically what we're required to do. Then, Part I, Chapter 4 which Ruth asked to be discussed, although she was on the border as to whether her comments were of this one kind or the other. By the way, just so everyone knows, Ruth is ill and will not be joining us. She got a delayed attack of whatever it is that one gets when one is in foreign parts for a while. She hopes to be with us this afternoon or tomorrow at the latest, but she was really quite ill last night, so we talked last night and I had the benefit of some of her thinking. I think she also had a conversation with Duncan earlier when she was still well. So the two of us have some sense of where she is, but it would be obviously much better to have her here and I told her I would do my best to adjust the agenda insofar as possible around the issues that she wanted most importantly to be a part of the discussion. So we've got 2 and 3, Jay's request of Part I and Part -- Chapter 4 of Part I. And Ruth basically said the same thing that Jay said, that it would not be a long agenda item, she didn't think, but you never know with this group. We have a string of chapters in the Part II part and they are and I'm saying them now if anybody wants to add one, the plutonium injections and related experiments chapter, the nontherapeutic research on children chapter, the TBI chapter, the radioisotope chapter and the ethics of observational data gathering chapter. Is there anybody who wants to add another part to chapters? Parts III and IV have their own agenda time, so we're not talking about Parts III and IV. Henry? DR. ROYAL: I'd like to briefly discuss the intentional releases in the veterans chapter. CHAIRMAN FADEN: Okay. It sounds like everything has to be discussed again. (Laughter.) Okay. So we may as well get out the table of contents. Why don't we just start with Jay's comments about 2 and 3, if they're brief. I had a request from several Committee members that we take, the TBI chapter be one of the chapters not discussed today, so that we can integrate memo from staff and so Ruth is not here and had requested if we could have that discussion while she's here. So TBI and any of that will be one chapter that is not discussed until either tomorrow or Wednesday will be fine with the agenda all along. That's another point is you had a -- there was a copying error and you did not receive, and here's the context. You did not receive the conclusion section to the chapter. I called the office on Sunday and I said I don't understand this. Do -- it's very unsatisfying, there's nothing. The reason is that when Henry and Mary Ann did their revision, they did not revise or make any changes in that last section, so somehow the idea was that we would all find our old chapter draft and pull out the conclusions. I don't know about you, but I can't find anything in my house at the moment. DR. GLATSTEIN: Many of us didn't get it. CHAIRMAN FADEN: Didn't get it at all? DR. GLATSTEIN: I didn't get anything on Saturday. CHAIRMAN FADEN: Well, that's a big problem. You got no Saturday mailing whatsoever. DR. GLATSTEIN: That's right. CHAIRMAN FADEN: That's a big deal problem. Did anyone else not receive a Saturday packet from the Committee? DR. GLATSTEIN: I guess I'm the only one, but I didn't get anything. CHAIRMAN FADEN: We usually have at least one person gets screwed up every mailing time, so Anna just wanted to fix that right away. Okay, what we will do -- TBI will be on the agenda, certainly not today, but whether it will be tomorrow or Wednesday, sort of depends on how everything else goes on the agenda and there will be other chapters, obviously on this that we also will not get through today. But we'll just go ahead and plunge right into it. This is our last meeting, face to face meeting which puts a lot of pressure, obviously on all of us to try to get as much addressed as we possibly can. It is not our last crack, so I just want to make that distinction. It's our last crack at things together in a collective forum, so it's terribly important that if you have real concerns about a chapter and you want to lay them out to get a hearing on that issue now is critical. We will also have a time, I think it's tomorrow set aside for members of the Committee who are thinking about writing a statement as an individual Committee member, either a dissent or a reservation or an additional recommendation or a concurring or whatever kind of statement you want to make. Several Committee members have actually asked for an opportunity get a preview of what would be in such a statement so that we can have a sense of where each of us is coming from, so there will be times set aside tomorrow for each of us who have in mind that we may be wanting to write such a statement to share with the rest of us what is the current thinking. At the same time, however, if issues come up or your reservations or dissent or your difference of opinion is specific to a chapter, now is the time to bring it up so that people can hear it and discuss it with you in the context of the chapter. So this is kind of a judgment call again on each of your parts whether you want to raise a concern or a reservation in the context of the chapter, in addition to making some comments tomorrow, since only you can decide that. But if you have a concern about a particular chapter, now obviously is the time to discuss it and the real issue that's at stake here is really one of courtesy to other Committee members and also there's an awful lot of mutual respect in this Committee and people have a feeling that if somebody else has a reservation and they want to know, they may be persuaded or may not be persuaded about the reservation. So colleagues fast for a chance to hear how the thinking goes. All right, Jay, do you just want to start us off with Chapters II and III. DR. KATZ: I'll start 1, 2, 3. I'll be very brief because I don't know how to -- I have the greatest problems with Chapter 4. With respect to 1, 2, 3, they are rich chapters. They will create a lot of controversy and as I said in my note to you, I think it's good. As you know, I like controversy. And it will ultimately enrich the dialogue. But speaking now to our work, with respect to Chapter 1, there's lots of information, but it doesn't seem to have ultimately any focus. What is it really that we want to say here? We haven't even scratched the papers. The Wilson documents, the other Wilson memorandum, some references to the Nuremberg Code and as it said on page 16, and that's the only thing I'll quote, that "our findings highlighted the Atomic Energy Committee's heightened concern with the conduct of the research. The strengths of the declarations was not met by the vigor of the implementation." And this really appears throughout this chapter. There were these statements made, I think, they were ultimately meaningless. They were poorly thought through. They were contradictory. They didn't provide any meaningful kind of guidance and to make so much about the existence of these statements, yet there is something that's nice, you know, that we can find these informed consents, whatever was mentioned at the time, but then to make as much of it as seems to be implied in this chapter, doesn't make any sense to me at all because one should even be upset about it because here these high falutin' principles are articulated and nothing happened. With respect to Chapter 2, I think it's a tendentious history, not that all history isn't tendentious. I have -- CHAIRMAN FADEN: I was just thinking of how to spell that, Jay. (Laughter.) DR. KATZ: In my German it's spelled T-E-N-D-E-N-T-I-O- U-S. CHAIRMAN FADEN: Thank you. I think I got close. DR. KATZ: And here I only want to make two briefest kinds of comments. I was surprised on page 1 that the sentence, "Moreover the American Medical Association in 1946 itself endorsed principles that led to the Nuremberg Code." Now for the first time I'm reading that it was the AMA principles that led to the Nuremberg Code in terms of the time frame correct, but now we seem to be saying here, unless it is qualified that the AMA was in the forefront of the movement to develop the Nuremberg Code and as we all know and as presented here, the AMA principles were put on the back pages of JAMA. CHAIRMAN FADEN: That's a mistake, Jay. That's just an error. DR. KATZ: And in the beginning of the second paragraph, I was utterly surprised when it says -- there are many things like that. I don't want to take time. "When the Advisory Committee began its work, scholarly wisdom could not have suggested framing questions in these terms." I was utterly astounded, as many people, myself included, have raised and I think Ruth Faden too, in her book, have raised some of these questions that may be all of us are on in the category of scholarly ignorance, but that's quite a mouthful. I can name at least 50 people, George Anders and others, who have talked about the kind of issues and the kind of questions and in the first paragraph. But there's more like that, but we must find a mechanism for me to communication this to someone, but let this be. With respect to Chapter 3, just one strange mistake and one, I think, omission, on page 14, line 3 and 4 talking about Tuskegee Institutional Committee had allegedly used the Tuskegee study which I wonder about to begin with -- I wasn't aware of it. The study was discontinued until after the recommendation of an ad hoc committee of external consultants of PHS. That is not true. The study was terminated by the ad hoc panel in October 1972. The ad hoc panel on the Tuskegee Syphilis Study. PHS has nothing to do with it. CHAIRMAN FADEN: I think that was the reference. DR. KATZ: Huh? CHAIRMAN FADEN: It's just confused language, Jay. It's meant to say that. It's just poorly -- it's meant to reference your panel. That's the mistake. The characterization of the Committee is the mistake. The intent was to -- it's wrong. DR. KATZ: I was surprised. And nothing is said with respect to the precursor to the Federal Regulation of 1974. I believe even though ultimately HEW moved into different direction, but with respect to the informed consent issue I think that the regulations were influenced by the report of the ad hoc committee of the Tuskegee Syphilis Study. We had an extensive 25-page series of recommendation on policies that should govern the regulation of human experimentation in the future and including emphasizing the importance of informed consent and all this then became part of vigorous debate at various Kennedy hearings I testified a number of times and a representative of HEW testified agreeing and disagreeing with the positions we had taken. I think that deserves -- CHAIRMAN FADEN: Let me say this. I know this is going to be terribly frustrating because it is our last face-to-face meeting, but we have to acknowledge that the drafts will change and the kinds of comments that you're making, Jay, will be addressed. Now the problem, of course, and everybody else has to look at it to make sure the changes -- I know, it's like oh my God, this will never go away. There's a way in which it will have to go away, eventually, but we shouldn't -- when you say there has to be a mechanism, obviously there must be a mechanism, there's tremendous expertise on this Committee and we have to make sure that we don't let things out that don't have benefit of that expertise. If there are problems with chapter drafts, I mean, I have my own as well. I feel strongly need to be changed. DR. KATZ: I'm sure you agree with me for Wednesday, we need an hour to fully expand, to talk about how are we going to go about this before we disband. CHAIRMAN FADEN: Absolutely. DR. KATZ: Things that you and everybody else wants to bring to someone's attention. Whose attention do we do it, etc. CHAIRMAN FADEN: Absolutely. DR. KATZ: We'll have more as we go through it. CHAIRMAN FADEN: We all will. I think that's right. You're absolutely right. MR. GUTTMAN: Don't you have anything else to do? CHAIRMAN FADEN: That's part of the problem. I'd like to keep it to comments on 1, 2 and 3. And I'm going to ask that 4 not be discussed today because Ruth would like to -- I'm going to ask that we not discuss Chapter 4 because I know Ruth would be disappointed not to be here. She's disappointed not to be here today generally, but she would be very disappointed if Chapter 4 is discussed without her. They are based on my conversation with her. So if she comes this afternoon, we can add it this afternoon. If not, hopefully, we'll pick up when she joins us. Pat, is this on 1, 2 and 3? MS. KING: Yes, this is a comment that Jay made that I want to note agreement with that I don't think is merely a correction to the text and that is that throughout the report I think what we do with the statements that we talk about in Chapter 1, the connections we draw from the statements I have trouble with. This is what Jay alluded to when he was saying we have isolated statements and what are we to infer with? I too think that is a big problem so I want to note agreement with that I'll try to flag them as we go through the chapters because they appear most often in Chapter conclusions but not always. CHAIRMAN FADEN: Okay, and that's also relevant, obviously, to Chapter 4. MS. KING: I'm very happy not to discuss Chapter 4 today. CHAIRMAN FADEN: We won't do Chapter 4 today, but we'll return to it. Other comments? Obviously, I know that people have written all over Chapters 1, 2 and 3 and we will try to reconcile, but are there issues that you would like to sort of raise with colleagues in this public forum, I mean, with everybody here, as opposed to when you send your drafts back? If we can just continue, we will skip Chapter 4, as I said, of Part I, so that we can have Ruth join us. She had also had comments on the plutonium and related experiments chapter, but I don't know, Duncan, I know she talked with you about it, whether you feel, whether you feel we can go forward or should we skip that and hold that too? DR. THOMAS: My proposal is we defer it to the afternoon. If she shows up, if there's a time crunch, I think I know her views since we talked about them for some length last night. She and I think are in general agreement. CHAIRMAN FADEN: That was my sense. All right, so why don't we hold off for right now on the plutonium chapter and see if we can get Ruth to join us. Obviously, we also are missing Ken and Reed, but they didn't communicate -- Ken is COMing -- he'll be here this afternoon and what I'm trying to do is we all care about every line in the report, but obviously, we each have different interests and we feel like we can contribute in some parts of the discussion more than others, so I'm trying to play with the agenda so that we make sure that insofar as possible where people have particular expertise they're around for that discussion. Maybe the best thing to go to next would be the children's chapter. I am the person who asked for the children's chapter to be added today. And again, I don't know whether, I say these things myself, use your judgment as to whether this needs whole Committee discussion or not. I don't know. Is there anybody else who wants to speak to the children's -- MS. KING: I asked that it be opened too. CHAIRMAN FADEN: Okay, Pat, you want to go first while I go look for my Children's chapter notes? MS. KING: I have the same problem because of all of the paper, all of the comments that I individually wrote down and handed copies to the Committee. I looked and I don't have them with me, but let me start with my big comment. My big comment was that this chapter didn't have the kind of focus, it's improved over the draft that I reacted to the first time, let me say that. But this chapter, it seemed to me, one did not have the -- a focal point that came through. It doesn't say it's not there. It just didn't have a focal point. It was my own preference that we describe what we knew about the children's experiment and so I didn't have extreme problems in a descriptive matter, but that that be a prelude to set up two things: one, whatever we had to say -- thank you. Somebody else has my comments. (Laughter.) Thank you. CHAIRMAN FADEN: Do you have mine, too? (Laughter.) I'm teasing. I found mine. I found them. MS. KING: So that when we can talk about what actually was there and we can talk about what the deficiencies were and we can talk about what deficiencies have been corrected by federal regulations and what remained to be done. So that's my overall point and it didn't seem to end up that way. The conclusions to my mind point less to either how the changes to regulations, my second point which I didn't make clear, was that this chapter was to connect to monitoring and medical follow-up, that it did not connect to monitoring and medical follow-up, although the revised chapter, the one I have now, does a better job of being able to move in that direction. The revised chapter, another compliment, because the revised chapter, I think, does a good job of holding together two aspects of ethical research. One is trying to reduce risk and the other one is informed consent and this chapter acknowledges the interaction, I think, in a nice way, among those considerations, if not the only consideration. But this chapter concludes basically without emphasizing those two points which I thought were the focal point, but instead, I think it just wants to condemn all of the practices of physicians doing research on children and as I read the revised new chapter, putting Fernald to one side where that conclusion is possibly valid, I don't see the links to connect up with other practices enough evidence to make those kinds of judgments about other practices. Finally, and I'm trying to remember all of this, with respect to children, with respect to the whole report, the question is when you do research we've talked a lot about needing informed consent from subjects. With children, the issue is more complicated and it doesn't come through in the report and that is that there are two things we're trying to hold together. One, there was always the question about whether you could do nontherapeutic research on children period. That's been a question that always has hung around. It was the one that eventually was resolved by the National Commission. If you could do research with children, nontherapeutic research with children, there was a tension between, if you recognized permission early on, whether you could do it without talking to the parents, whether you had to talk to the parents, and the tension was even if the parents gave permission, could you still do it? In other words, you had to involve children. It's like a triangle where you're really talking about -- and this really doesn't, for me it didn't emerge that the triangle in terms of who was the appropriate person or group or whatever to go to were not kept separate and distinct. Some of this, I think, I pointed out before, the use of the term "permission" for proxy consent really didn't emerge until the 70s. And because I teach family law, can't you tell, a lot of this really was parental consent, not proxy consent. Some of the early -- it's a very muddy history. Sometimes people thought children belonged to their parents, you know, children were extensions of parents like little property. This idea of children being separate entities is itself something that has changed over time. So sometimes people thought yes, parents were consenting because it was the parents' right to consent. Some people say, no, that's not right. There is a separate entity. So we're losing a lot of the nuance by not using some of the language of the earlier time. And I actually went back and read Bonner v. Moran because I wanted to see it in connection with this chapter history. The issue there was nontherapeutic research. It was question of whether you could have conducted it if the mother had given permission or was it enough for the 14-year-old sort of indicate. The other issue was did the 14-year-old benefit? So it was a lot more complicated history, so that's not a major point. My major point is the chapter not getting to where it should go on medical follow-up, changes in regulations, although it's mentioned there, and for my point of view, mono-gratuitous language towards the end that I would do without. CHAIRMAN FADEN: I've got Susan and -- I'm sorry, Duncan, and then Susan and I'll put myself somewhere. Duncan and then Susan and then Mary Ann. Susan, go ahead. DR. LEDERER: Just responding to something that Pat said, I think in an earlier version of this chapter, Bonner v. Moran was in the text and I think it's an omission that should be remedied. I think there should be some reference to the fact that this case, since it was a nontherapeutic human experiment case, that made it to an appellate court, in the '40s. CHAIRMAN FADEN: It's certainly relevant. Everything we have to do in the next two weeks should be that easy. That would be great, but that's a point. These kinds of things we need to get out, because if we don't think about them now, they won't get in. Duncan, Mary Ann and then I'll put myself on. DR. THOMAS: This chapter has gone a long ways to addressing many of my concerns about the June draft. I just want to highlight five items that I had trouble with in the June draft which I think we may need in this draft. I can do this briefly because all but one of these items is in the comments which I wrote before, so it's just to remind people, my lingering concerns about these issues. The first general issue is that I still feel that that material on risk assessment and ethical analysis are not well integrated. And there's now a much improved section on risk analysis. But -- and then there is essentially an unchanged section on consent issues, but the sort of risk benefit type of thinking is what I have in mind in terms of integrating the material which I think could use a bit more work. Regarding the risk assessment section, I still continue to find this section rather disorganized. Most of my concerns for this one are technical in nature and I can deal with those outside this meeting. But I think that there is some -- a number of points of confusion that need to be tidied up. A minor technical point which hadn't occurred to me before, the question of assent. I assume current regulations have some age limit and that needs to be expressed, otherwise we can never do research on infants. I still feel like the report ends up without any conclusions on the subject of Wrentham experiments. They are mentioned on two or three occasions throughout the chapter, often in rather strong language. There's one that says the Fernald and Wrentham experiments raise quite starkly particular ethical difficulties, but then we never say what those difficulties are that they raise and what we learned about it. CHAIRMAN FADEN: For the Wrentham we do. DR. THOMAS: There's a very long section about Fernald and it concludes by saying, but we weren't able to get any useful information about Wrentham. The final point has to do with the Vanderbilt box. This is the one place where we have an opportunity to confront the AEC's requirement that isotopes not be used in pregnant women except for "important researches" and I'm still -- remain a bit puzzled as to how we reconcile those two. CHAIRMAN FADEN: Yeah. You've hit on some of the ones that I have -- let's hear from everybody and then part of what's going to happen, obviously, in the process is seeing which chapters are going to go through more dramatic changes. That will be part of what we're keeping track of now, so we can all know in line with Jay's comment on trying to figure out how to bring this thing home, where you may expect to see more changes and -- see less changes based on the discussion we have here today. I've got Mary Ann. DR. STEVENSON: I think the chapter is generally much better than the last draft and I thought the risk assessment section was actually integrated pretty well. I guess my major concern is the successive reliance on this LMRI conference that appears in this chapter and the same problem actually appears in the prisoners chapter. You know, it's really one data point that very sweeping conclusions and judgments are made based on this conference. It's historically very interesting and rich, but I think it's dangerous to have so many conclusions riding on this single data point. CHAIRMAN FADEN: Lois. MS. NORRIS: I agree with Mary Ann on that. I noted it myself and I get the feeling that this is all we looked at and provided a lot of quotable information that we wanted. I do have and it's more of a factual question than anything. Were any of the Wrentham or Fernald children used in more than one experiment? CHAIRMAN FADEN: I don't know. MS. NORRIS: Do we know about that? I read the task force report, but not recently and I since have forgotten, but it certainly could make a difference with respect to risk. CHAIRMAN FADEN: Well, there's also the issue too, which doesn't come out clearly here. I don't know the answer because I've forgotten too, Lois, but in that radioisotopes chapter there's a reference to one particular Fernald child who was apparently dying of an illness, who was given very high doses under that policy of the AEC that whatever their language, I've forgotten the exact terms, but if they thought the person wasn't going to die you could do this higher dose. The connection between those two really needs to be pulled together, as another example of where we have -- Pat, did you want to comment and then -- MS. KING: I have one additional comment. I was not going to comment on the Vanderbilt Study because my heart and soul are in women and fetuses and it got relegated to a box, but now the -- CHAIRMAN FADEN: We decided that. MS. KING: I had not raised this as a comment before, if we're going to keep a box and we are going to do something in a direction that Duncan suggested, then the Vanderbilt study to me is one of those studies where the racial composition of all the study participants to the extent known and -- CHAIRMAN FADEN: They were white. MS. KING: But I think it should be in there and I think the point about -- to the extent we know it, their class. CHAIRMAN FADEN: They were poor. MS. KING: And the extent to which we know -- what I'm really looking for, all the vulnerabilities because this, as I recall, from the chapter, the parts that we did away with because we changed the focus. This is is one of the studies that we actually looked at as an example of selection of subjects issues and so for me to put some of the selection of subjects questions back in would be useful. If we're going to do something with the box, I mean, i didn't have this in my original comments because I was going to leave it sort of as a box, box. CHAIRMAN FADEN: What I'm trying to remember about the Vanderbilt thing and again it's in the radioisotope stuff is the policy and this is where, this issue of what are you going to make out of these documents. These are policy statements that I think a whole lot should be made out of. If I'm remembering correctly, was it for pregnant women that simply said you shouldn't do it on pregnant women and it was for the children that they had the clause that said except for important researches or something. DR. STEVENSON: This was generally avoided. There was a little bit of -- CHAIRMAN FADEN: I had the sense in reading it that the statement was even stronger with respect to pregnant women and it was with respect to children, just as also part of the mix that goes in. I have to apologize to Steve and John because I should have given them this feedback earlier. It's just that I was working on other chapters and this one I didn't get to until over the weekend, this version of it. I have shared many of the same comments that people have raised here, but I want to highlight a couple of them and see if by way of pulling them together. I think that we need to make it plain, more plain why we landed on the -- one of the main reasons why we landed on children was not as -- I think it said here, because we thought if we could figure out what the risk was to kids, we could infer what the risk was to adults, but it was more specifically tied, as Pat noted, to our charge with respect to follow-up and medical monitoring. It was specifically, if these people, if it looks like the kids don't need to be followed up, then it's unlikely that people exposed as adults would need to be followed up and why that may seem like a fine point difference, it is different. We're not taking a parameter of risk generally, but rather because it would seem to us to be the right population to focus our energies for with respect to the charge on medical monitoring and follow up. I think -- I personally believe that the characterization and I don't know, I love Jay's term, I want to say tendentious history as well, but the use of the LMRI data, I think too much is made out of it. I don't think that we can come to the claim that's made in that chapter. There were three views expressed and the most popular view is the one in the middle. I just don't see the evidence for it. I think we had evidence for the view that often research was done on children without consent, that seems pretty clear. And that other people expressed at the time reservations about doing it and then some people didn't do it that way, but sort of articulated there were three views and one view was the more popular view. I just find it overreaching with what we had there, plus there's an under-utilization of the oral history data which I believe ought to be made more prominent since we did go through the effort to talk to several pediatricians. Sue? DR. LEDERER: Of course, from a historian's point of view the LMRI is a much purer source because it was commissioned at the time and not in sort of the glare of an Advisory Committee on Human Radiation Experiments which is a potential to contaminant of the oral history looking back. CHAIRMAN FADEN: So insofar as they worked together, that adds beauty to it, so if we show that they reverberate back and forth, there really wasn't much disagreement between what the LMRI people re discussing. DR. LEDERER: Even disagreement can be valuable, I mean, for pointing to the fact that these 30 years later, and much has changed this discussion. I know why Jon thinks the LMRI is so important because it's -- CHAIRMAN FADEN: It's a rarity. DR. LEDERER: And it's a focused discussion on these issues and it's a much deeper and explicit discussion on these issues than you'll find anywhere else. DR. KATZ: But Susan, wouldn't you agree from the perspective of history the LMRI was first of all the brain child of Irving Ladimer. DR. LEDERER: Absolutely. DR. KATZ: He convened this conference. It was a very unusual event. In 1964, when I was -- shortly before law school, I was preparing -- MR. GUTTMAN: The year before I was born. (Laughter.) DR. KATZ: I was preparing my first set of materials for the semester long course in human experimentation. I found so little at the time to use and thank God I came across that document and I used it and had Irving Ladimer at the law school, etc. etc. etc. You can make something of it, but you can't give it the kind of permanence that even was given in the Nuremberg chapter or at least you have to qualify it and say this was a very singular, unique, important kind of event, a closed door meeting and very few people -- it took a lot of digging for me to even come across the document. It was not in the public domain. CHAIRMAN FADEN: I think we can provide that context. In fact, what it suggests is that here are the people who care the most and who are the most reflective on these issues in a sense, even if they weren't picked for that they decided to take two days out of their life and show up at this conference, so then to infer from that because one person said gee, I don't do it that way, that's the concern that I got. DR. LEDERER: And that point is well taken. CHAIRMAN FADEN: So I think that's what we need to pull back and we're agreeing that we need to do something with that. I think we need to explain better why we focus on the Fernald school in such detail. It's not clear. It's because we don't know a lot about the others. But we know a lot about Wrentham. What we don't know about Wrentham are the consent procedures, but we know a lot about what -- a fair amount about what was done and the way it's treated suggests that all we cared about was the consent procedures. We have to, I think, address the fact that the doses to which the children were exposed at Wrentham fall into a different category than the doses to which the children were exposed at the Wrentham school and that's also ethically relevant and needs to be addressed. I think that we don't do enough in this chapter with respect to the questions of subject selection, on the one hand, we can pull that stuff out clear. On the other hand, we don't really know who the subjects were in most of these other subjects that we looked at, the other 17, so we're sort of stuck with on the one hand, on the other hand, I'll never forget, I think Jay, it was your comments early on about well, why didn't they pick the kids at Loomis or Choate? Why did they pick the kids at Fernald and Wrentham and I think is implicated here, intimated here, but that's where so much of the moral tension of those episodes comes from. I think that language or language like that is really a part of who is missing. So and finally, I think the risk stuff, people are left as a lay person, trying to read it as a person who is not a radiation scientist, trying to figure out what does this mean if there's a line in there that says children were exposed to levels that today we would not consider acceptable, but we don't -- we understand that, to use the language we had in an earlier draft from Allen Buchanan in the category of excusable fashionable ignorance that people didn't know about the susceptibility of the thyroid. That shows up in the Marshalls chapter as well, and we can make it plain that that was the case, but what does that mean in fact for what happened to these children? There's a regular person and I've got all these excess deaths, but what does that mean and somehow it has to be explained that there weren't millions of children who were so exposed, we don't think, so the actual numbers of people who may have suffered of cancers as a consequence, I mean, that connection into the lives of ordinary people has to happen and finally, we have an issue to raise that is new to the chapter. I disagree with the conclusion in the chapter that the children's regs are fine. That the children's regs are fine. They're certainly better, but we in our findings and conclusions chapter make a recommendation that points out that this minimal risk stuff is really a mess and nobody understands today whether you can expose healthy children in nontherapeutic studies to trace their doses of radiation. We still don't know. We haven't reached a consensus. That doesn't mean it's a discoverable fact. We haven't reached a consensus about how to understand what constitutes minimal risks so even if we agree with a procedure, the regs are failing us as a research community in this particular arena today, so even if they had the regs that we have today before the Wrentham school and there was an IRB, that IRB would be struggling about whether these trace doses could be given to these healthy children for this nontherapeutic study. It wouldn't resolve that problem, so I think we need to say that straight out, that an IRB today would still be puzzled about can we approve this study or not because of the debate about whether it constitutes minimal, what we mean about minimal risk and nontherapeutic studies for kids and we don't have to take a position about whether it ought to pass or not, but simply flag that the regs are leaving people unresolved on that question. There is another issue, oh, I'm sorry, Duncan, do you want to get in on this and there's another issue about this chapter. DR. THOMAS: Well, it reminded me of another issue, go ahead and finish up. CHAIRMAN FADEN: This is a new issue. This is the question of where to treat the nasopharyngeal studies with children. They are part of our follow-up project, but right now they don't have a home in any of the narrative of the report so there's clearly an awkwardness between commenting about whether a follow-up study is appropriate for a class, a series of experiments or an experiment that doesn't have any text on it in the report itself and then there's the related issue as you were reminded that it was not only the children, but the submariners who we are looking at as well, so a proposal has been put forward that we have another box in this chapter where we put the nasopharyngeal studies and the reason why it's in a box is the study is supposed to be on nontherapeutic research. The nasopharyngeal studies were intended to benefit, as well as to -- intended to benefit these children with medical problems, so they're in a box because they're not the focus of the chapter, but we want to comment on them because we decided it was appropriate to study them for our charge of medical monitoring. Is that agreeable or can we think of somewhere else to stick them? MS. KING: That's fine. CHAIRMAN FADEN: Is that okay? DR. STEVENSON: Actually, there's a lot of existing text already on that. CHAIRMAN FADEN: That we just need to pull it out and put it in -- DR. STEVENSON: Development of therapeutic treatment for years and years predating the actual study. It has to be put out and if you wanted to place a quote, "therapeutic research" this would be it. For the awkwardness, we should all know we're signing on to, is that there will then a mention of research on adults in the children chapter, that the box will then have a paragraph that goes on to say not only was this done on kids -- MS. KING: We mentioned the women in here too. CHAIRMAN FADEN: Okay, so we take it that the Committee is comfortable with addressing a box to the nasopharyngeal experiments in the children's chapter and obviously we'll have to look at the text of the box. Duncan? DR. THOMAS: Yeah, I was just reminded of the recommendation that appears on page 39 regarding institutionalized people with mental illnesses who have reached the age of maturity. And I wrote myself a little note to check and see what we say about recommendations and my recollection is we don't see anything in the recommendations chapter. CHAIRMAN FADEN: We do. DR. ROYAL: We do? CHAIRMAN FADEN: We just use different language. There we talk about the need for policy to address, research on people of question, adults of questionable competence. We use a slightly different language. We should probably make sure that the language is fungible, so that people can see that we mean the same thing. What we should point out in the recommendations is is that it draws out of this experience as well as out of the RPRP where we had the three studies involving adults of questionable competence and in clarities about the authorization procedures for those studies, so that's very helpful, Duncan, that we can say we have more reason for addressing public policy response, historically, as well as what we have contemporaneously. Jay? DR. KATZ: Look, the conclusion as some of us have already mentioned requires work. It might not be as this conclusion, but other conclusions as well of Heisenberg uncertainty principle that you either know the speed -- CHAIRMAN FADEN: Jay, could you speak in the mike? DR. KATZ: They either know the speed or the position of the electron, you can't know both at the same time. It goes back and forth. It talks about this and it talks about consent, it talks about normal children. It talks about institutionalized children and then goes back again to these groups. I think there ought to be some kind of a framework because each of these situations for children has to be looked at separately and consent versus proxy consent, would need to at least be briefly considered, and also I think Susan, maybe she would disagree with me, is there is a long tradition going way back of using children, institutionalized children for research purposes and in this conclusion you get the impression that the Fernald school experience was a very, very unusual one in the history of human experimentation. CHAIRMAN FADEN: That's a good thought. DR. KATZ: I don't think that's correct, is it? CHAIRMAN FADEN: I agree with you. That's a very good point. MS. KING: Interestingly, a lot of them are orphans, so the issue of parental consent needn't come up. CHAIRMAN FADEN: I think we need to do the same thing here as we do with the prisoner study and point out this was in a period in which using prisoners and using institutionalized kids -- MS. KING: Was not as unusual as we would have hoped it would have been. CHAIRMAN FADEN: Exactly. Sue, you can probably help us some with some of that. I mean again, all we need are a couple of lines, but if the lines aren't there, it's very bad. It's not like we have to review the whole history, but if we don't evidence an appreciation, we should be slammed is really what it comes down to. So okay. Mary Ann? DR. STEVENSON: On page 39, right before we get to the conclusion, we make the statement "The Committee strongly urges the federal government to reconsider the adoption of recommendations offered by the Committee" -- CHAIRMAN FADEN: I'm sorry, I lost the tail end. That we should say what? DR. STEVENSON: We should say what those things are, not just leave it. MS. KING: It's actually -- CHAIRMAN FADEN: I had a note there, because the Committee has never debated it. MS. KING: That's right. CHAIRMAN FADEN: This Committee has never debated it. My note here was "I don't think we can say that." What we can say is take a look at and look at others. MS. KING: What we can say is we need a policy. CHAIRMAN FADEN: That's right. MS. KING: Because there's a policy void without endorsing what the National Commission did, which is quite controversial. CHAIRMAN FADEN: And that is what our recommendation is, that you need to do something about this. This is sort of akin to the compensation recommendation and the President's Commission. Everybody would have to go back, we'd have to look at it and decide if they like it or not, it's 20 plus years old now. MS. KING: They don't want to do that, but we do need a policy. CHAIRMAN FADEN: Maybe we should just sort of change it and say we endorse the National Commission. I'm flooded with meetings that I've attended over the past 20 years trying to resurrect that set of recommendations. It hasn't had a happy history. Okay, children pretty much erred. The Vanderbilt box we're agreeing stays as a box, but we want to pull in the reference to the AEC position, get the language just right on that, on whatever the language was, whatever they said about pregnant women and research. We want to make sure we say -- MS. KING: It's actually page 16 of radioisotopes. CHAIRMAN FADEN: Right, I remember that. Somebody with a more reactional mind than mine, it would be good to have a cold reader go through this beginning to end looking for all the places in which to connect up thoughts and themes. That's what you're supposed to do in the second year when you're working on your work, right? Okay, so if we have discussed children, how about if we go to the intentional -- no, I wanted to wait for Ruth for that, if we can. If we can't, we won't. We'll get a read on whether she's coming or not because she was one of the people that wrote in comments about the radioisotope chapter that were stronger than some of the other comments. I'm kind of trying to respond to where people said I have strong feelings about this chapter. Can we do intentional releases and atomic veterans? I know you had asked that they be added. Are you ready to bring us to it or do you want to wait until after lunch? Okay, good. DR. ROYAL: The intentional releases chapter, I think is a good chapter. It discussed the feeling of the report to adequately do risk communication. I find it ironic that we demand of investigators that they communicate risk clearly and unambiguously and we do such a poor job of communicating risk particularly in this chapter, but I think it's reflected in other chapters. CHAIRMAN FADEN: You say it's the worse done in this chapter or one of the worse? DR. ROYAL: I'd be happy with the characterization that it's worse in this chapter. CHAIRMAN FADEN: Okay. DR. ROYAL: And I won't cite each instance where this happens, but let me just tell you how risks are communicated in the chapter. Usually the way the risk is communicated is by saying that the level of contamination was up to such and such or that the exposure was up to such and such. So we can ask a statistician like Duncan Thomas what sort of useful information knowing only the upper bound is and I would tell you that anyone who knows anything about risk communication would say that this is an inappropriate way to communicate risk and I think it discredits the report to communicate risk in this way. CHAIRMAN FADEN: I think we should hear from other people. I think that's -- clearly, it's a big problem if we're not doing as good a job as we should be doing if that's not the best way to do it, then there must be -- forget that, if that's not a good way to do we should be searching for a better way to do it. Duncan? DR. THOMAS: Henry is obviously right about this point. However, in defense of what's in here, I would make two comments. First of all, in many circumstances we have no idea what the population weighted average exposure is. It's a much more difficult number to get one's hands on. It would be very nice to be able to do that and express one's risk calculations based on that if it were possible. In many cases it may not be possible. The other point to be made is that many of our current regulations are based on the concept of the maximally exposed individual and that's one reason why that number is an important one. Despite its largely irrelevance for public health purposes, that's why we have these other recommendations in there, suggesting that regulations give somewhat greater emphasis to the concept of total population doses as well as just the maximum dose. DR. ROYAL: Duncan, the chapter, when it's reporting these maximum amounts of radionuclides in the environment or maximum exposure rates, doesn't even necessarily require that any human being be anywhere close to the area where that level of contamination was measured. So it's doubly misleading. It's not only the upper bound, but there aren't even necessarily people there. DR. THOMAS: But where you spot instances of that happening, tell us and -- DR. ROYAL: This is not the first time I've brought this up. CHAIRMAN FADEN: I propose the following. I will just to make work for people. I will sit with -- Henry, you give me your comments and I will take them. And maybe sit with you and then with Duncan and see if we can't come up with something and then flag it for everybody else if there are different ways to do it. Let's do it with the information available, then present the information in an easier way for people to understand, we should do that. DR. KATZ: But is it possible in ten or 15 minutes for you to explain to us laymen what the issues, concerns are that you have with respect to this? DR. ROYAL: Well, I think the issue is a very simple issue. One of my hopes when I joined this Committee was that we would communicate to the population of the United States some clear idea of what the risk from environmental releases were and one of the reasons why I was hopeful for that is because of the make up of this Committee. I thought an analysis by this Committee would have more credibility than an analysis by other groups. I can only tell you that from my knowledge of risk communication that I think we do a very poor job of communicating the risk for the reasons that I've cited, so in terms of when I look back on my experience on this Committee, one of the things that I personally feel the most failure for is the fact that we have not been able to do a better job of risk communication. CHAIRMAN FADEN: Duncan, did you want to -- DR. THOMAS: Well, I'm still a little bit puzzled about Henry's concerns about risk communication in that the comments that he's making are primarily related to dose rather than to risk. When we actually finally get down to doing risk calculations such as in the table which appears at the end of the chapter, and the various lines scattered throughout the text where we explain what is the risk that was caused by the various experiments, in every case they end up being extremely low risk. Mary Ann and I had some discussion over the break over the precise wording of these lines where we try to express risk and they can still do with a bit more fine tuning, but whatever the maximum exposed doses are, it seems that the risks in all cases were low and we should say so. DR. ROYAL: I think the table is a good example of my concern. For example, if you look -- there's no range expressed. There's no concept that the risk may include zero. It's actually interesting. There were three different risks that are described. I'm not sure that I can find it quickly, but it was talking about the number of thyroid cancers, for example, that might be caused because of the release at Hanford and I don't have it exactly right but it went something like there was a 9 chance in 10 that there would be one chance that someone was killed by this release. If anyone really thinks that that's the right way to communicate risk, I certainly am not in that group. To me, because this is something that I have been talking about for a while, the only solution that I see is to have someone like myself communicate risk in a different way, as a personal statement and the public can judge whether or not that's a help or whether or not it's subterfuge. DR. KATZ: Henry, I'm confused. Are you talking about miscommunication with respect to the past or with respect to the future? DR. ROYAL: With respect to the past. CHAIRMAN FADEN: So if I understand, your concern is in this chapter and elsewhere as the case in point, it's probably the most egregious case in point. The Committee's language has the potential to mislead the reader about both not dose, but risk? I found Duncan's comment very helpful because for me the dose doesn't mean a damn thing. I don't know what it means. It does now, but I'm thinking about my life before I joined this Committee when a rad and a Roentgen were just R words to me, before this. But risk means a lot to me. Risk matters. That's what I'm trying to figure out. DR. ROYAL: One of the reasons why the whole discussion of risk is so naive in this chapter is because the only thing that's considered is the risk from the radiation. There's no consideration about what's the risk of doing things in an alternative way. Many times, for example, there's some comment here about nuclear power, I believe, in that the radiation dose to members of the public is one millirem per year. Well, if you're going to talk about nuclear power, you have to talk about not only the risk of making electricity with nuclear power, but you have to talk about the risk of making electricity with coal. When you talk about developing nuclear weapons, you have to talk about not only what's the risk of having Hanford and exposing the population to release of radioactive iodine, but what would be the risk of not doing that? And so when we talk about risk, we talk about it with blinders on as if there's this isolated risk that we have in our control. We don't have to measure trade offs of anything, it's just we're going to minimize this risk and there are no other consequences of having done that and it's just a very naive approach. MS. KING: Can I ask Henry a question? CHAIRMAN FADEN: Sure. MS. KING: In trying to follow the discussion, I understand what you mean. You're talking about the kind of cost benefit, real world questions -- DR. ROYAL: I don't even want to talk about cost at this time. MS. KING: For me, I understand. What you're saying is you used alternatives, you're getting to the practical side of it and that is, faced with a bunch of difficult choices, you go through certain processes to focus on one -- to pick nuclear energy versus something else. You go through a complicated process. The question I have is is that something that goes a general section of the report, rather than being addressed in a particular chapter? I think I'm on to what you're saying. I'm not sure. It's wrapped up with perception of risks where people have different kinds of perceptions for different reasons? It's wrapped up into choosing among alternatives? It's a broader question than what you are exposing people to. It is and it's a broader risk communication was putting blinders on me. So only when I heard you explain it that I started to get to the basic point. I know this field as problems of risk perception, problems of cost benefit analysis, etc. Would it make sense to have a discussion at the very beginning of the report that puts radiation in context because it seems to me that's part of what you're saying. It may not be everything that you're saying, but it may be part of what you're saying. It's not the benefits we got from radiation. It is to put radiation in some kind of context in terms of what were real world choices or real world understandings, then and now. Because we've got some of the same problems now. Am I communicating with you in a way? It seems there's something that you want to do. DR. ROYAL: Yeah, it's exactly what I want to do. The report discussed risk in isolation and the reality is that when you try to do something that's risk aversive, that there are tradeoffs. In your comment that this is a general issue is a very true comment. It has to do with medical research. The more risk adverse you're going to be with medical research, the less you're going to do and the more safeguards you put in place, the less money you're going to have to do your regular research. So well, I think that -- MS. KING: The reason I ask the question, Henry, is to ask a follow-up question and that is if that is the problem, it seems to me that the issue is not in the discussion of intentional releases and what people were exposed to in terms of radiation and dose levels and how we assess that in terms of risk, that what the report may need is and I say very early on, very early on like those beginning, Part 1 chapters. It needs a place to discuss not risk, we need to discuss radiation. I mean it's more than risk. These are the tradeoffs that come with using radiation to help put radiation to contextualize the work that's been done and make with radiation. I'm interpreting that's part of what you want. DR. ROYAL: You're putting much more emphasis on radiation than I would put on it, but that is, I think, the risk analysis is the important discussion as opposed to risk analysis specifically related to radiation. Radiation could be part of it. I'd just like to say one other thing to make the record clear, because you brought up the issue of cost. I really think that the context of this discussion of trying to minimize risk really should be in the context of doing what's best for society. If doing what's best for society includes a consideration for cost and costs should be included, but the goal is doing what's best for society. CHAIRMAN FADEN: If I could comment for a minute. I think this is an issue underlying much of the report and we tried to set it up but we probably didn't make it explicit enough. We just suffered from the technical problems of whether you should use the maximum exposed dose or something like that. And that is that a couple of points, the Committee, we're not in a position to say they shouldn't have developed nuclear weapons or they shouldn't have built these power plants or they shouldn't have had these above-ground tests and those are the large trade off issues that we can flag and say look, we're not judging whether it was wrong or right in retrospect. That the people in charge made the policy decision that the way to go in 1950 or 1947 or 1943 was the following. Maybe we need -- it's part of what's in the background. You sit there and say you've got this problem with the Marshallese. You've got this problem with the atomic vets. You've got this problem with the intentional releases. Of course, you have the problem with respect to medical research. Those larger decisions are set to go with those programs, to say yes, we're going to develop a nuclear defensive capability or yes, we're going to explore what radioisotopes can do in terms of medicine, those kinds of large tradeoffs. I think that's what you're getting at, Pat, to provide that context and then we pick up at that point in some way and maybe that's what -- I'm trying to make it larger still. I want to get Duncan and then Dan wants to comment. DR. THOMAS: I have to admit that I agree with Henry in terms of the public policy implications of this risk communication debate, but on the other hand I feel like this goes far beyond our charge. We are not here really to debate high matters of public policy of how radiation standards ought to be set. We are not -- this chapter is not beating up on the nuclear industry, for example. The line where Henry appears to be quarreling with the quote about the -- what is it one in 10,000 risk, the 10 millrem standard that EPA has in place is not intended as an endorsement of that standard, but this is just a statement of what is the current regulatory statement. What is the current, what are our current regulations in contrast to try to put the numbers that are coming out of these past releases in some sort of context. If there is a place for this discussion there is a new box which not everyone has yet seen which was originally intended for Chapter 1, but there's still some discussion as to where that box ought to go on risk assessment and although none of the stuff that we've talked about in the last few minutes is in the box at the moment. It might be a very natural place to try to put this process of risk assessment and the consideration of alternatives and how it is germane to the public policy process in place. So that's where I think this stuff should go, not in this chapter. CHAIRMAN FADEN: Are there other discussions? I'm not sure exactly sure where this leaves us. Phil, did you want to comment and then -- DR. RUSSELL: Just to comment that yes, it goes beyond our charge to deal with the larger issues of national decisions, but on the other hand we have to make a statement that these decisions were made and you can't even discuss the risks without alluding to them and our whole Committee deliberations has been in that context, with that in the background. I tend to think we need to move this out to the front so that it states that we recognize the importance of the national decision. We recognize that all actions have alternatives and we are looking at the risk analysis here from a purely one sided point of view. CHAIRMAN FADEN: At the risk of really introducing confusion, there's a way in which our situation is disanalogous here, I think, with respect to biomedical experiments and the population exposures. I mean we were asked to look at scientific standards with respect to biomedical experiments and the notion that we could make a judgment about the acceptability of risk in a biomedical context is a sort of more available judgment because the context is different in relevant respects from the decision of whether or not to go forward with a nuclear capability. If the Committee had to come to agreement, I would imagine there would be very many different opinions in this Committee about whether it was a good thing or a bad thing, that in the 1940s the world went nuclear or not. That's really not what's at issue before this Committee whereas it's a different matter to say just was there any medical benefit to the plutonium. We're differently situated with respect to some of these with -- also adds a dimension. MS. KING: But I would say that has to be carefully drawn and it's going to be the subject of a question on the other chapters and that is while it is true one can distinguish biomedical research in important ways it is connected to the broader picture. Much of the research would not have gone forth probably, but for the connection to the larger picture. So while it is separate and distinct, it is also intimate and connected and one of my problems that will emerge from another chapter is we have isolated biomedical research, I think, from that world in ways in which we make judgments without qualifying the judgment in terms of the broader picture. So I have some sympathy with what Henry is trying to say about these tradeoffs. I will raise them in different places, but I do think we need to be clear. I agree with you, Ruth, but I would also add, it's not either or. CHAIRMAN FADEN: No, no. It's different. MS. KING: It's different and it's connected. CHAIRMAN FADEN: So what I'm hearing is we need somehow an explicit treatment of the dilemma we find ourselves in. WE're plopped into the middle of a history, part of which we're not supposed to make a judgment about it and part of it which we are supposed to addressed. I've got Duncan and Dan and let me just make an announcement for those who may be wondering if we are ever going to eat. The lunch which was on the agenda for 12 will now be, what's supposed to be 12:30, when we finish this chapter, we won't do the atomic -- that's it. So we will break for lunch let's say in five minutes. We'll wrap this up and break for lunch. I had Duncan and Dan and then maybe Henry wants to respond. DR. THOMAS: I just want to say that I think that type of analysis which Phil is asking for is already in the chapter. We can look again at the language that's there and see whether it's adequate. But it's quite clear that the risks and benefits are measured in totally different units and the national policies which are driving the intentional releases are in fact discussed in this section and the benefits from Green Run I think you will find comparable statements in the other things. Obviously, no one is planning to do a risk calculation which would calculate -- the risk of a Soviet invasion versus the risk of some nuclear releases. CHAIRMAN FADEN: Dan? MR. GUTTMAN: As someone who has been struggling through this, I think that there are three points being discussed, each of which we'd all probably agree unexceptionable. The question is how do you deal with them. The first is how do you most adequately represent data that is nuance? Henry, I think, is saying that you could look at this data. You could make some other statements about it and I think everybody would want -- the particular data that's in there, whether you're stating the high point or low point or explaining to people what you're doing, I guess we've got to address as best we can in each of the cases where we address it at some general level. The second point is the trade off context and it just seems evident to me, take the intentional release chapter, the Committee didn't believe that there was a national security basis, then you'd be saying this was clearly unethical because why would you expose people to any level of risk if you didn't have some basis. So it may be, I think to me, Henry's point is absolutely correct, but it may be simply it's not clear enough that we obviously are assuming that there are valid bases for tradeoffs, otherwise we'd be nuts to simply say there's no problem with exposing people to risk. We, of course, are looking in the intentional release chapter situations where there is some claimed national security basis for doing these things, otherwise, it wouldn't be a dilemma. MS. KING: We expose people to risk for all sorts of reasons and that is one of the things we need to keep in mind. MR. GUTTMAN: Okay. MS. KING: We focus most clearly here on exposure for national security reasons, but -- MR. GUTTMAN: Right. MS. KING: But this issue of risk is a big issue. DR. RUSSELL: Right. Those things are in, they're in these chapters and it may be that they've got to made at some more general level. The third thing which is the one we're in the most difficult ground, because the first two are -- the first one is who's got the smartest way, the most meaningful way to communicate things. The second is I guess to make more express and coherent what's already there. The third is this question of radiation risk itself and how do you represent it in a way that does justice to all the billions of different things that are not said and so forth which I leave for Henry and Duncan. That's the -- I just want to separate out those three very different things which I think are all important, but they're mushed together in the communication issue. CHAIRMAN FADEN: Well, I'm glad we're reaching closure on so many things as the day progresses. The truth is I didn't anticipate it going much differently. (Laughter.) Henry, didn't you want to make any additional comments or do we want to break for lunch and pick it up later. DR. ROYAL: I have no additional comments. CHAIRMAN FADEN: At this time. All right, we're going to break for lunch. It's now 12:35. I guess we really realistically can't get back before 1:45, but can we say 1:45 and hopefully the restaurant will cooperate with us. (Whereupon, at 12:35 p.m., the hearing was recessed, to reconvene at 2:05 p.m., Monday, July 17, 1995.) A F T E R N O O N S E S S I O N 2:05 p.m. CHAIRMAN FADEN: If the Committee members could please come to the table, we'll start. We'll start. Okay, group, I can see all the energy is just oozing out of everybody. Should we start? I think we should start. We have heard from Ruth and she is not feeling well, so with any luck she'll join us tomorrow, but I would like to, on the assumption that she will join us tomorrow, defer both the TBI chapter which other people have wanted deferred anyway and also more on point, Chapter 4, in the hopes that she will be able to be with us tomorrow, which means that we are starting 45 minutes late, but that's okay. And there are three chapters that surface as chapters about whom, about which -- thank you -- I look at Sarah now, Sarah help me, what's the right -- about which people wanted to make comments that we hadn't discussed before lunch and those are the atomic vets chapter, the plutonium chapter and the observational studies chapter. If we could get through those, then we will then turn to findings and recommendations for the '44 to '70 period and see how far we can get with that and then pick up with the agenda adjusted, depending on how much we accomplish. Is that agreeable? If we just go into those chapters right now and see where we go. There isn't coffee here now. There will be coffee at 4 for the break, but maybe not before then, so I hope people can -- either had sufficient coffee, tea or whatever at lunch and otherwise hold out until 4 o'clock when we will have a break and then we are working until 6 tonight. Henry, I believe if you who asked that the atomic vets be on, as well as other people. Am I remembering correctly? DR. ROYAL: Yes. CHAIRMAN FADEN: Okay, so if you could start us off, that would be great and I'll go back to my copious note-taking. DR. ROYAL: I guess my comments about the atomic vets chapter would be similar to my comments on the intentional releases chapter and that is that the description of the risk, I don't think, comes across very clearly. One of the problems -- I use this chapter as an example, but maybe it's something I feel uncomfortable about with the whole report is in an effort to be fair, evidence from different points of view presented and a lot of times the evidence that's presented is a quote from an individual and it's the quality of the evidence never seems to be considered. We just sort of put things out there that we're leaving the reader with the -- we're giving the reader the responsibility to try to figure out for themselves whose evidence is the real evidence. And I think that's -- I had hoped that we would do more with the evidence on that. CHAIRMAN FADEN: An evaluation of the merits of the claim. DR. ROYAL: Yes. CHAIRMAN FADEN: Pat? MS. KING: I actually have only two comments before we go to the conclusion, but some of this is a problem I have with other conclusions. To be specific, at page 61, "to the extent that experiments are undertaken essentially to provide reassurance it repeatedly becomes clear that if scientific value is unlikely ethical justification evaporates." That -- this is a conclusion drawn from a discussion in the chapter, a discussion elsewhere in the chapter I held to what it is referring. What I'm concerned about is that it is not -- I don't know whether I agree with the statement or not. What I do know is that in the chapter itself, there is no justification for the statement "ethical justification evaporates" because there is no ethical discussion. CHAIRMAN FADEN: What page is that, Pat? MS. KING: 61. CHAIRMAN FADEN: Do you have a line? MS. KING: Line 6 through 8. CHAIRMAN FADEN: Thank you. MS. KING: The reason this occurred for me is because it's one of those statements without the connection for me. But the second statement was it's not crystal clear to me that there may not have been a need to do reassurance or repeat experiments for some of the reasons stated and I just think that that needs some justification. It seems to me that the fact that some people will not accept that you need to depend upon, will not accept statistical evidence of risk is an issue. It remains an issue today and the question is it's a little bit of what we're saying here, that we knew about the risk, we didn't need to have certain experiments because we knew about the risk. Go ahead, Dan is about to -- he wants to respond. MR. GUTTMAN: That's something we thought about. There are two or three things in that sentence or paragraph that I alert you to. One is Ms. Macklin had initially made the point that if something is done with scientific basis, the Nuremberg Code doesn't permit it and that led me to look at the Nuremberg Code and the Wilson memo. I don't think it literally says this and I had a discussion with Phil Russell and Ruth and it seems to be accepted that for an experiment to be ethical, there has to be -- I don't mean to interrupt, but that's one of the issues there. CHAIRMAN FADEN: We have discussed this. MR. GUTTMAN: Yes. That's issue -- MS. KING: Then the way you just stated that, I may not agree with it. But it certainly needs a discussion here about why if you're not looking for a scientific -- I'm trying to find the word, it's not scientific value. I guess what we're really trying to look for is something about risk, exposure, at least according to what I read before. I don't understand what this means when it says when you provide a reassurance or when you repeat an experiment, it does not have scientific value. MR. GUTTMAN: It may, but they weren't doing it for that reason. This goes back to the Shields Warren debate, Chapter one, where Shields Warren -- MS. KING: It's not Chapter 1. It's in this chapter. There's a discussion in this chapter about what Shields Warren says and he says that we should -- so what does that have to do with the price of beans? I want to know why what he said is relevant. MR. GUTTMAN: What this is addressing is the question of whether if the generals, pardon the expression, or the President, says I know it's not going to be statistically useful. I know it's not good science, but it would be nice for me to go out and tell the troops that we did this with 20 guys. Now that would be reassuring, but -- MS. KING: But why is it unethical? MR. GUTTMAN: That's the -- MS. KING: That's the missing explanation I find. MR. GUTTMAN: I guess the question I have in my own mind as a lay interlocutor here is I am told by my ethical bettors that in fact it's clearly unethical to do that under the Nuremberg Code principles, but it isn't clear to me that that's what the letter of those principles said. CHAIRMAN FADEN: I think Nancy and Jay wanted to comment. DR. OLEINICK: It seems to me there's -- we're confusing again what Phil has brought out, research with training maneuvers. MR. GUTTMAN: Right. DR. OLEINICK: Whether or not it's scientifically valid, it may be useful as a training maneuver and ought to be repeated because you need to have several more thousand troops trained in this way, so you repeat and repeat. But in terms of research, if it's not scientifically valid, if there's no way this has any -- if it can't produce any useful information, then as a research experiment it becomes invalid and cannot in any way be ethically justified in exposing subjects to that experiment. MS. KING: There are two things that you just said. One, a research protocol can be badly designed, making it unethical. It cannot answer the question that it was set out to answer and I understand unethical in that sense. There are also some questions that it would not be ethical to do research on at all and I understand not ethical in that sense. What I don't understand is why reassurance for people who have to be exposed in an effort to provide reassurance is itself unethical. The fact that I can't understand and I will repeat this, I'm not saying I agree or disagree with it. I am saying it's not clear -- MR. GUTTMAN: The situation here is where the scientists were saying this psychological research we really don't think is such great stuff. Psychology isn't well developed. It's not likely this will be scientifically useful, but it's such an important question if you want to go ahead and do it. MS. KING: That's different. That is not what this says. MR. GUTTMAN: Okay. MS. KING: That is a statement that says that the design cannot do what you set out to do because what you just said was we can't provide reassurance, we can't do anything. We just are going to do this work. That is going to be unethical, but that's not what this is. CHAIRMAN FADEN: Actually, I think it's more muddled. It's basically the acknowledgement that the psychological studies, this overlay of the HumRRO work is not likely to produce very important data, but it might have the effect of giving the - - MS. KING: The reassurance. CHAIRMAN FADEN: Either to the soldiers themselves or to the military command structure that this kind of thing is okay. I've got Jay, Henry -- is that right, Duncan, Phil and whatever order. I saw Jay's hand first. DR. KATZ: Two things. If you want to talk to the science of HumRRO and even bring in the Nuremberg Code or other civil pronouncement by scientists about scientific value, investigators who conducted the HumRRO studies, they're not only culpable they should be hanged, of course. This is just the preposterous kind of scientific study. If it was a study and then it would be entirely different, you don't even need a study to provide reassurance to see -- to reassure the military officers and enlisted men that radiation isn't that dangerous and can be tolerated, you could have conducted quote end quote a study or make these observations in an entirely different matter. The most important point is that and I agree with Nancy I haven't been able to think it through yet because I haven't gotten to it yet for any length of time. I'm not sure I would be able to come up with anything to talk about all the many of these things in this chapter as experiments. Somehow I find this troublesome because as Phil mentioned on a number of occasions, these are part of the indoctrination of soldiers to be prepared for eventual future wars in which atomic energy might be used and you might want to indoctrinate these groups and see what one might be able to learn and so that they will -- to remain effective, etc. etc., but to call this human experimentation and in other ways if it is, it has to be qualified somehow and I do not know how to do it yet because it's different from the kind of humane experimentation that we generally talk about throughout our report. So there's something here, maybe some people have already thought about it and can enlighten us, but it must be handled differently than the way we've handled it so far. CHAIRMAN FADEN: I'm just looking to see if other people want to speak on Jay's point or should I just go on the order -- stay in my order then. I have Henry, Duncan and Phil. DR. ROYAL: I certainly agree with the ethical principle that the benefits that are going to be derived from biomedical research in any human undertaking should outweigh the risk. And if there's no benefit, even a trivial risk is unacceptable. I have no trouble at all with that ethical principle. What I have difficulty with is the process by which one determines the scientific value. HumRRO, as you recall, was a way to determine the effectiveness of the indoctrination training the soldiers received and to see whether or not the ones that received the indoctrination had different answers and also to see whether or not being there affected the answers to their question, those questions. I think different people would come to different conclusions about what the risk benefit ratio was of doing that. For example, if you think that those soldiers were put there solely to participate in HumRRO, that would obviously result in a different risk benefit ratio than if you thought they were going to be exposed to that risk anyways and were given this questionnaire as part of their being placed on the atomic battlefield. So I guess I would have hoped that having served on this Committee would have given me a better framework for judging scientific value and really what I end up with is quotes from this general who says we don't care whether it's scientifically significant. We just want to do it or whatever it was he said and that doesn't help me evaluate the scientific value in any objective way and I have no idea whether or not his particular opinion and his particular quote is a representative quote of the scientific community at that time or of the military community at that time. It's just very difficult for me to evaluate with the evidence that was presented. MR. GUTTMAN: That was related to the cloud business. This HumRRO, we tried to be as representative as we could about all the people that were involved and all the reports and that people can judge for themselves, separately. Everybody agrees with Phil's point. This is a number one training, testing a bomb and they're having exercises. CHAIRMAN FADEN: Duncan, Phil, if you want to jump in. DR. THOMAS: I guess I can understand circumstances in which it would be ethical to do studies for the purpose of reassurance, even in the absence of scientific merit, whatever that means. In that sense I don't disagree with Pat, but it seems to me the trouble I'm having with these studies is not that they weren't -- is that they were almost designed for the purpose of providing false reassurance and I can't imagine any circumstance where it would be ethical to conduct a study which would provide false reassurance. Now, by false reassurance I mean a study which by its design couldn't possibly meet its objectives, a study which might ostensibly be designed in order to determine the risks of some exposure where the sample size is far too small to have any reasonable power for detecting that risk. And I think that may be the situation that we're looking at here and that's where I would have ethical difficulties. Now there's a fine line to be drawn between those studies that could provide real reassurance, but no scientific merit and those that -- I find it a little difficult to conceive of that particular scenario. Most scenarios that I can think of that involve real reassurance also involve some measure of scientific validity as well and those studies which are -- that can't provide scientific merit, it's hard for me to imagine that they can provide any kind of meaningful reassurance. CHAIRMAN FADEN: Can I clarify something that I'm confused about in my own mind and I'm sorry and I'll let Phil talk. They were doing the indoctrination program in any event, correct? They were interested, so the notion is they were trying to see whether an indoctrination program would work or not. It wasn't the issue of producing reassurance, it was can we come up with an intervention that will reassure people, so the purpose -- the purpose of the study was to see will this indoctrination work or not? Now there are all kinds of reasons why looking at the design of this study it doesn't look like it would have likely done that, but the purpose, I thought was to see whether the indoctrination was successful in reassuring people that soldiers, that they didn't have anything to fear by participating any more than in any other battleground. DR. THOMAS: But if the scenario that's being modeled is so far from reality which is one of the fundamental critiques of HumRRO, then it can't possibly answer that question. MS. KING: So it was a badly designed study which is one of the things you're saying. CHAIRMAN FADEN: Right. DR. THOMAS: Which is going to lead you to the wrong answer. MS. KING: And that would be unethical, I understand. CHAIRMAN FADEN: Right. DR. THOMAS: My point about risk was perhaps not a well-chosen example. Even so, I still hold to the view that studies were probably so badly designed that they wouldn't provide unbiased answers to the questions they were looking for. MS. KING: That's a different statement. DR. RUSSELL: I would argue that that may be true about 50 to 90 percent of psychiatric experiments done. What we're talking about here is not about human radiation experiments. What we're talking about is two psychological, psychiatric studies done in the context of the troops engaging in an exercise in which they were exposed to the radiation. The humane experimentation issue focuses not around the exposure to the radiation, because that was predetermined by the exercise. It involved thousands, not the subset of a few hundred in which the psychological experiments -- I have seen no data that indicates to me that the numbers exposed were in any way increased in order to provide manpower for HumRRO. Now I'd be willing to look at that again, but I don't believe that the record shows that the numbers of troops exposed were increased to provide a bigger unit for these psychological experiments. So then the issue of the ethics revolves around the quality of that psychologic research and whether it was good experimental psychology or bad experimental psychology and whether it provided any value from the point of view of the well- being of the troops involved or the military decision making. I think the record shows that it was badly designed and didn't provide the information that people wanted. Whether it was deliberately falsely structured, I'm not certain. If it was, I think that's a very bad thing. DR. THOMAS: I'm not saying that. DR. RUSSELL: Huh? DR. THOMAS: I'm not claiming that. DR. RUSSELL: I'm not totally adverse to hanging a couple of civilian psychiatrists. (Laughter.) I'm not willing to rush into judgment on it either. CHAIRMAN FADEN: Pat has the -- MS. KING: I couldn't participate in this meeting if I were not next to Nancy who provides with me with the comments I made earlier, some of which I would like to raise here. It seems to me, I picked up -- that's in the conclusion because it really jumped out at me incredibly, but I called in when I read this chapter to say it seemed to me that this chapter illustrates best the problems with exposure to risk and obligations to reduce exposure to risk whether we term an activity research or not, that in fact, this chapter illustrates and Phil's illustration a moment ago is just brilliant, illustrates these very arbitrary lines about how you characterize something as experimentation or not, behavioral research and I quite agree with you. I thought that the important point to be made in this chapter that ought to be in the conclusion and I would junk a lot of the conclusion, frankly, because I have other problems with it, has to do with -- it illustrates so well the obligation to reduce risk for soldiers, for those engaged in experimentation and it points out the difficulties and HumRRO does it best of trying to draw fine lines and for me the question is do you really want to draw fine lines? Isn't the bottom line reducing risk and our recommendations suggest to DOD steps that they could take to reduce risk in experimentation. But I'm sure that we are quite comfortable with saying do what you can to reduce risk to your soldiers and military people because of these fine line situations, so therefore, I think, and I understand it's going to be in the preface, I think that this chapter needs to contain the definitions -- I have definition/discussion of what we mean by the terms research, experimentation because we want to lead into a discussion about the confusion and the muddled nature of life that by the way still exists. It has not gone away and it's not going to go away in the future and I don't want people to say this is not research, therefore, we can do X. I want people to say this is exposing people to risk. Why are we doing it and ask questions. Now to indicate how confusing the chapters -- this is my favorite sentence on page 4. MR. GUTTMAN: I think Phil Russell wrote it. (Laughter.) MS. KING: Well, Phil, if it's your responsibility, you straighten this out. My favorite sentence is "In most cases, the activities in which human research was involved were also engaged in by many more people who were not research subjects." I think I understood what was meant because I've been working with human research regulations for a long time, but that makes no sense to a lay reader in the sense that we have talked about human research and then we have talked about research subjects without providing any kind of way to get this morass. So my suggestion about the chapter would be keep all descriptions, I can live with most of it, make the thrust of the chapter clear, if I'm correct, in terms of what the thrust of the chapter was. DR. RUSSELL: We thought it was. I guess it's not clear enough. MS. KING: It actually doesn't impact because -- MR. GUTTMAN: It's clear to a general in the Army. It may not be clear to -- MS. KING: My comments to you say I think I know what this means, but I said it's not clear because we have to go by the definitions and the discussion that flow from whatever we use in the preface to talk about some of these distinctions. And it would help the reader track through HumRRO. DR. RUSSELL: One of the things I asked for, a little bit, and apparently we couldn't do it because of numbers was to list the exercises in which there were large numbers of folks exposed and then list the experiments that the -- the biomedical experiments that were done in the context of those exercises and what I think this sentence means, for example, in HumRRO, that there were thousands who were exposed for the purposes of the military training and exercises and whatever and among those thousands, there were a few hundred research subjects. MS. KING: I think that's not the way it reads. DR. RUSSELL: What I had hoped was is that the table would clarify this. MR. GUTTMAN: We still have to do it. It should be. MS. KING: And as Dan knows -- CHAIRMAN FADEN: I just wrote it down. It will be. MS. KING: I agree with you, Phil, about this, but I think that we have to do something different and I think Dan is aware of this. On the last page of the conclusion, page 64, when a nation puts service men and women into potential risky situations there's an obligation to keep appropriate records, etc. etc. etc. I think that we want to qualify. I don't disagree with the thrust of what is written here, but since war is risky, since military exercises are risky, most of life is risky, I think that we don't want to have a general statement, we want something more specific which is that the DOD personnel should try to identify the trigger mechanisms to do some of this because my problem is not what you say here. My problem is how am I supposed to know that this is a situation that calls for special attention. Now some of what you suggested here would be no record keeping. I'm not really talking at that. I'm talking about I think what -- I won't say what I thought you had in mind, but I would think -- I would like to think if I was in the military in Desert Storm I would have done something differently because my trigger mechanism would have been different. I think what we want to do is to talk to the people who have some expertise and I don't, about what kinds of situations and then to develop the kind of situations that call for special attention. That's what I would like to see in this. DR. RUSSELL: What I hope we could accomplish with this was to draw attention to the fact that in the three instances where we have an environmental exposure of some sort, large numbers of troops in an arguable set of medical outcomes. The record keeping is inadequate to answer the whole set of questions and the problematic issue is identified in advance, everybody focused on the oil fires in Kuwait or they focused on the punitive chemical exposures and so forth. If indeed there is a coherent etiologic question it's not going to be among those. It's not going to be something that's predictable. However, in thinking about this it's very possible for the bulk of the military to keep much better records on where the troops were and what they did. They have a system for that. It's just that you need to be able to link that system to the personnel records of who was in those units at the time. And you need to be able to link those two records with a continuous medical record and the Defense Department and the VA in their infinite wisdom have totally incompatible medical record systems so there's no continuity. We have three sets of records that if were properly kept and properly interactive could provide a superb capability for post-action epidemiologic -- MS. KING: Let me say that what you just said is what should be copied from the transcript and put in here because that is what this is. This is a specific set of directions that talk about record keeping that is specific and with modern means of communication, perhaps do-able, even in the absence of trigger mechanisms. DR. RUSSELL: Right. MS. KING: And that is the important point to know here so that would be what I would do. DR. RUSSELL: The record keeping exercise does not attempt to predict unknown hazards in the future because Lord knows what they're going to be. CHAIRMAN FADEN: Which is an important observation, rather than saying the burden is a priori, to have a good nose about what to worry about, given the things are -- I don't know what the description is. MS. KING: They're likely to happen and we don't understand what's going to happen. CHAIRMAN FADEN: Right. DR. RUSSELL: If you think like an epidemiologist and then look at what's possible in terms of current data base management and record keeping, then a lot of these issues are addressable in the arguments about cover up and about inability to relate events to outcomes. Some of it disappears. MS. KING: And that should be our recommendation too. There should be a recommendation about the records that need to be linked from an epidemiological point of view. CHAIRMAN FADEN: Henry? DR. ROYAL: When I listen to the conversation there's a little bit of fuzziness to it and I want to at least make sure I state my position clearly. I think the general issue of record keeping and doing a better job of record keeping and linking where soldiers were to their medical records is a do-able thing. The concept that you're somehow going to be capturing the information that you need in that record keeping system with some epidemiologic study when you don't even know what the epidemiologic study is going to be, I don't personally think would work because the information that you're going to want to have, like whether they were near oil fields or whether they were in a place where chemical weapons might have been released, there's no way to know a priori that that's the information that you're going to want. If you try to capture all of that information, it becomes too burdensome of a record keeping system. CHAIRMAN FADEN: I thought I was understanding Phil to say that one set of records is knowing where troops were. And the other is knowing what happens to their health. DR. ROYAL: Yes. CHAIRMAN FADEN: So the terms to be added, if we know they were at point X and it happens there's an oil fire at point X, we put it together. DR. ROYAL: Yes. CHAIRMAN FADEN: You superimpose it. It's not because you anticipate an oil fire, it's just literally keeping clear records about where every -- I don't know how you do this, but I imagine it's every member of the services is, where they're stationed and obviously you're not within limits, but that would be the idea. DR. ROYAL: The concern that we have unrealistic expectations about what you could do with that information, that is knowing names of soldiers, where they were and what time they were there. DR. RUSSELL: But Henry what they're doing now, is going back and rebuilding that data base at the cost of tens, if not hundreds of millions of dollars to look retrospectively at the -- CHAIRMAN FADEN: And it's even worse. DR. RUSSELL: Gulf War. It's easier to build that prospectively and keep it rather than to build it retrospectively every time and we've got three big events in the history of military deployments that would have come out differently if the records had been kept better. DR. KATZ: I'd like to ask Phil maybe one and maybe a second question. When -- in the military, when they contemplated exposing soldiers to radiation, training exercises for whatever purposes and it was really done for military reasons, in order to get permission for that would that have to go through complicated chain of command to get approval for doing that? Would that be difficult? DR. RUSSELL: I think the records show there was a tremendous safety discussion about that which resulted in the -- for example, in the HumRRO experiments impossible because the risk was so low. They were so far away, they didn't perceive. Yes, the short answer to your question is yes. DR. KATZ: Okay, and then to the extent to which they build in a human experimentation component and after all, we want to study some and gain knowledge, would that make getting permission easier or not? DR. RUSSELL: Much more difficult. DR. KATZ: It would make it much more difficult. DR. RUSSELL: First you got to get the permission -- first you have to solve the safety issue for the exercise. Then you've got to do the whole issue of the human experimentation, especially if there was any potential that the human experimentation might increase the risk. DR. KATZ: It cannot work the other way of people then saying of course, that's what human experimentation is about is trying to get a handle on certainty and if there is now an experimentation component built in, then they can relax with things a little bit because we gain valuable knowledge. It doesn't work that way -- DR. RUSSELL: Because there's two separate systems. The issues of troop management and safety of material and weapons and so forth is basically a nonmedical system run by the military command and their safety experts and human experimentation then falls into the province of the medical department which has a separate system for study of the science and evaluating the risk and so forth. So what it does it more than doubles the problem. It puts it into two different approval chains and frequently cause lots of conflicts. CHAIRMAN FADEN: I've got Eli waiting, but I have this feeling that we cut Henry short. Did you want to flesh out your comment more? DR. ROYAL: No, I'm fine, thank you. CHAIRMAN FADEN: Eli? DR. GLATSTEIN: I'd just ask Phil when they assess the risk factors within the military, how much attention to they pay to the long-term issue as opposed to short-term risks? DR. RUSSELL: I don't know, can't answer that. I think that you'd have to say that it's done in the same fashion as any occupational safety issues are dealt with. I don't think occupational safety in the military is substantially different than occupational safety in the civilian community in principle, obviously. The specifics are quite different. DR. KATZ: But we do have that one interchange in the record when the question arose what if we knew about the long- term effect of radiation exposure and one of the Colonels or Admirals -- "we don't care about it. We are only interested in what happens in the first six months or in the first two years." DR. RUSSELL: He may have been concerned about what's going to happen in the next two days of an atomic war. DR. KATZ: Yes. MS. KING: Which, by the way, I remember the statement clearly, the inflammatory nature of that statement without it being qualified. It is one statement and I'm sure people thought that way, but I'm sure there were other people who were arguing differently too. That's sort of the nature of things. The context, but you can use a statement. It's just when you have a statement like that, you do raise these questions on a record where we have parts of the records. MR. GUTTMAN: I'll tell you why that statement was used was because to me it suggested that there was an awareness of the potential of long-term risk, not that they didn't care, but this was something that somebody said never happened. That's one piece. There are several pieces in the chapter. MS. KING: Well, wouldn't it be a better statement if somebody says you know we needn't worry here, there's a long-term risk, but this one doesn't do it. DR. KATZ: But Pat there's something else with respect to that statement. This was made at a meeting where at least 15, 17 or 18 people were present and nobody objected or nobody commented on this. That doesn't surprise you? MS. KING: No, it doesn't surprise me because there are all sorts of reasons that people who make statements here that I think are absurd that I just let go by -- (Laughter.) I don't mean to be funny. (Laughter.) What you have to be careful about is the negative inference you draw just because -- there may be all sorts of reasons why people were silent. MR. GUTTMAN: Pat, why don't you tell us what you're really saying? (Laughter.) CHAIRMAN FADEN: When the Committee is officially disbanded, we will reveal our true views of one another, but for right now, well, I don't know exactly where we are. I think we've surfaced some general sense of things that have to be worked on. I think we can do it, but we're going to talk about process probably tomorrow, about how to work on bringing these chapters home and just as previous some of us have chatted about the idea of just having people commit, Committee members commit to working hard on two or three chapters and then it will go on to the full Committee, but just as a way of honing things in. That's de facto, it's already happened, each of you, especially have areas of expertise or interest and have been putting more of your energies into some of the chapters than some of the others. It's really just a continuation of that process with an understanding of who is working where to try to just bring this home. MS. KING: My sense, Ruth, is that this chapter is in pretty good shape, actually, despite all the discussion and that what we focused on, even I don't feel strongly about taking out that last quote. I just think it's a silly quote. I don't feel strongly about it. I think the major work for this chapter is the conclusions and it is to clarify, we've written the preface about the definitions and things to incorporate that discussion here and I think Phil's explanations are terrific. This is a pretty good chapter. CHAIRMAN FADEN: I think that's right. It's that last 5 percent. If you can get it correct, it will make the difference between this being an okay chapter and this really being something the Committee feels very good about. So the issue is can we make that next five percent, 10 percent, whatever, effort it is to take in all of these observations and make it cohere in a way that the clear message comes out. What we're all struggling with is the realization that some of the deepest concerns don't speak to the experimentation as such, but to the context overall and to the after effect and I think it's hard to get that expressed. Lois, did you want to -- MS. NORRIS: This is a very minor point. I made some recommendations or suggestions in written comments concerning references to consent, written consent throughout the chapter and I just don't want them to fall through a crack. If there were following up may I ask that? CHAIRMAN FADEN: Sure, of course. MS. NORRIS: I don't want to repeat, there's no point in doing that. CHAIRMAN FADEN: Again, this is jumping at the process, we have a system -- every comment that comes in will be gone through and checked off and there will be a disposition so you know that somebody has taken account. I don't want anybody to think that they've read these chapters, worked on them for six hours and it went into the whatever. That can't happen, so they don't. Considering every body of everybody's comments -- it happens. No, Lois, it will be attended to. I think if we could continue. MS. NORRIS: One last comment. CHAIRMAN FADEN: Sure. MS. NORRIS: I just wanted to clarify for myself, I guess, the inclusion of the flash point in these studies. They're not ionizing radiation studies, but are they in there for process purposes? MR. GUTTMAN: Well, they're clearly the only ones that were treated as so-called biomedical experiments. MS. NORRIS: Right. MR. GUTTMAN: It's clear in this chapter, whether you call things radiation or not, I think we tried to be as clear as possible. They are what they are. MS. NORRIS: Well, I don't think it's very clear at all, necessarily for the lay reader what a flash blindness experiments are. CHAIRMAN FADEN: In a sense -- DR. STEVENSON: I don't have an objection. DR. RUSSELL: There weren't human radiation experiments -- DR. STEVENSON: Exactly. DR. RUSSELL: There weren't any experiments regarding ionizing radiation. The psychologic experiments and the flash blindness experiments. MR. GUTTMAN: The cloud fly through. DR. RUSSELL: That wasn't radiation effects though. It was -- DR. OLEINICK: When they swallowed the dosimeters? DR. RUSSELL: Right. They weren't looking to determine the effects of radiation. They were looking to see the exposure, that's my point. DR. OLEINICK: I think it's wonderful to be in, but it should be stated as such. CHAIRMAN FADEN: We probably just need a very straight section that says look, there were the following five or six and they took these different forms and they all looked different and they were none of them like a laboratory classic experiment. They all had -- HumRRO was when they randomly assigned people at HumRRO. The indoctrination or not the indoctrination -- it was a different experimental manipulation. So we have to -- thermal. We have to get clear and maybe just a little thing that says straight out, here's the X we found and here is how they're described. That's do-able. Okay. Can we move on to, if we could at least get one more in or maybe two, plutonium related. Is that called plutonium injections and related experiments chapter, where there are a number of comments. Duncan, I hope it's all right that you can don the mantle of Ruth and I can back you up. I just don't want to push too many things off. DR. THOMAS: Well, I think we've all seen Ruth's comments and probably my echo of Ruth's comments as well, so I don't think I need to restate her position, particularly, except the placement of the uranium injections in a box and in the previous draft, not addressing their ethical implications and the conclusions was something that she felt, and I guess I agreed with, she couldn't sign off on. This draft which just arrived late last week deals with the latter of those two problems by actually addressing the ethical implications, I think quite squarely in the conclusion section and I'm pretty content with the way that's worded and that's what Ruth told me last week. She felt similarly, I think both of us still feel that the rationale for putting them in a box is not clear. You may recall that several months ago we were confronted with a chapter which was a very complicated chapter and had bounced all over the place trying to figure out just the sequence of things and there were so many themes and weaving that we made the decision at that point to focus a chapter on the plutonium injections and then put everything else into boxes. I now think that that no longer fits, that what we have to say about the uranium injections is every bit as important as the others and unlike the other chapters where we are putting things in boxes either because they offer some sort of explanatory background information or because they don't really fit in the chapter, but we have no place else to put them, I don't think either of those rationales for putting something in a box apply here. So I think Ruth and I would both be quite content if the only change were simply to remove the box around the uranium injections and just leave it right where it is at the moment, otherwise I'm generally pretty happy with this chapter. CHAIRMAN FADEN: Okay, the floor is open. That was the impression got from Ruth, wow, she wanted the bracketed material to stay. Henry? DR. ROYAL: This is a particularly important chapter because everyone is going to pay special attention to what we say about the plutonium injections so I think it is an obligation for it to be particularly well written and particularly well reasoned. I have a number of problems with the chapter. First of all, in terms of the risk of the plutonium injections, the chapter gives a very, to my mind, a very muddled view of the risk. for example, there's a 50 or 60 page document that I was given at one time that describes the great detail with which the amount of plutonium that was injected into these patients was selected. To my knowledge, although I may be wrong, I don't believe -- it was not referred to verbally whether or not this document is even referenced at all. I don't know. In that same document or in one of the first reports of the plutonium experiments, the statement is made in this contemporaneous document that no acute or chronic effects were observed and none were expected. I'm very concerned that because of the public perception of the risk of plutonium that we have not made it clear what the risks were and there is -- CHAIRMAN FADEN: Can I interrupt you for one second. You're saying that sentence is in there and you object to it or that sentence is in there -- DR. ROYAL: Which sentence is that? CHAIRMAN FADEN: There is no acute or chronic -- DR. ROYAL: No, it's not in there and none were expected. There is a document that I am seeing that contains that -- CHAIRMAN FADEN: Now, I understand better. You recall a document of the period that says that. DR. ROYAL: Yes. I -- to me, it's very clear that at the time these experiments were done that the investigators who did them did not expect any acute effects from these injections, nor did they expect any chronic effects. And the one thing that's relevant to this discussion is the box on maximum permissible body burden and I don't remember if Robley Evans is quoted directly on that box. I think -- MR. GUTTMAN: The one about the radium and his mother? DR. ROYAL: Yes. Which if I were going to try to communicate what the mental state was of the scientists of the time and what it was they thought they were subjecting people to, to me that conveys that as well as possible. One last thing about risk, there's a statement on page 14, line 13 that the amount -- MS. KING: Which version are you reading from? CHAIRMAN FADEN: I'm assuming this is July 6. MS. KING: So what page are you on? DR. ROYAL: 14, line 13. Actually, it's line 12 and 13, that sentence. This was 95, the amount accepted throughout the Manhattan District as the safe level in the body. When you communicate things like that, if it's 95 percent of the safe level it obviously had to be in the dangerous area and then it was several times it was taken to be the minimal damaging body burden. I've never heard the dangerous area. And then there were several times what was taken to be the minimal damaging body burden. I have never heard that term before in my life. I have no idea where that comes from. It's an interesting -- CHAIRMAN FADEN: You mean the minimum damaging body burden. DR. ROYAL: Has anyone ever heard of such a phrase? DR. THOMAS: I was puzzled by that one as well in the previous draft and there's now a new footnote which has been added. CHAIRMAN FADEN: It doesn't tell us the origin -- DR. ROYAL: It doesn't tell us the origin, but I wonder whether or not staff can tell us. CHAIRMAN FADEN: Miriam, would you mind coming up to the mike? MS. BOWLING: I don't have a document, but it's actually a letter by Langham in 1950 when he is describing the rationale behind the minimum, the maximum permissible body burden calculations for the 1950 conference in Washington. CHAIRMAN FADEN: So that's his term, you're saying Miriam? MS. BOWLING: Yes. It was something that he had extrapolated from what he called the minimum damaging body burden radium. DR. ROYAL: Well, my point is if I don't understand what this term is, I doubt that the readers will. DR. THOMAS: I would assume that's what referred to here is what in modern departments is called the low ob, the lowest observed effect level. DR. ROYAL: And what effect do you think it is that they're observing? DR. THOMAS: I have no idea, but it's something they're measuring in rads, according to the footnote. CHAIRMAN FADEN: We can get the document and we can see, but I think it's particularly useful the fact that that phrase was used at the time. We should try to give it some context and meaning, but that's how it was described at the time that actually bears more to your claim, Henry, than otherwise. DR. STEVENSON: But if the phrase wasn't publicized until 1950 and we're talking about 1945 it makes it a little -- CHAIRMAN FADEN: We'll have to figure out what he was saying, did they figure that out in 1950 or whatever. All that needs to be explained. MS. BOWLING: We can clarify that. DR. ROYAL: I'd like to move on to the issue of consent. One of my frustrations in reading this chapter was consent is never defined. I mean maybe it's not possible to define it, but when we say there is or there is not consent, I'm never sure what it is that we're talking about. Sometimes what we mean by that is that there's no written documentary evidence. It's just very unclear what is meant. The evidence that's used is often interviewing someone who wasn't there, who is giving second hand evidence twenty years after the event, the evidence is often contradictory. When the statement is given that no consent was given, you never know whether or not that meant that they did not know that it was plutonium and radioactive and therefore they were not informed. Usually the words are "informed", that the patient was not informed. You never know whether or not that meant that they weren't informed to the risk and benefits of doing the experiment in which case this is clearly unethical or whether or not it meant that they weren't informed that this was a classified material and that it was radioactive. So the consent is very confusing to me. CHAIRMAN FADEN: I think that could be clarified though. DR. ROYAL: One last issue was related to the HP-12 or 13, the first one at Oak Ridge. The statement that his teeth were extracted and it sort of implied that they were done for the purposes of the experiment. Again, I've seen a document in there which I have at home in my room full of papers that is a description of this individual when he was admitted to the hospital and one of the things that it says in that description is that he had poor oral hygiene. And in 1947, when you came to the hospital and you had poor oral hygiene, they often extracted teeth. I think the report implies that it was somehow done because of the plutonium experiments and I would just ask if the evidence for that is good. CHAIRMAN FADEN: It should say it's missing to be totally fair, the statement that when the man was admitted there was a note on the chart that he had poor oral hygiene, teeth were extracted. We don't know whether the extraction was solely because of poor oral hygiene or connective with the radiation, the plutonium injection because we do know they looked at the teeth. So we know they had an interest in the man's teeth. We don't know. one of the things that struck me as I was reading that Henry was the related question that if in fact it were the case that more teeth were extracted than they needed to be that would have been the harm. So the claim that there was no harm that came would be inaccurate. It wasn't that radiation effect, but it would have been harm to have your teeth extracted for research purposes when they didn't need to be extracted. I would consider it to e a pretty bad thing to happen to me, but the point is, we don't know why the man's teeth were extracted. DR. ROYAL: We do know that he had poor oral hygiene. It does not mention -- CHAIRMAN FADEN: We know those two things basically. DR. ROYAL: I don't understand why it's not mentioned. I would think that if I were writing a chapter and I were going to say the teeth were extracted and I knew the patient had poor oral hygiene and that was recorded that that would be in the chapter. CHAIRMAN FADEN: That needs to be in there. We have two pieces of information. That should both be in there, that he had bad oral hygiene and that there was an interest in looking at his teeth. Both are correct and after that, we don't know. Okay. Jay? DR. KATZ: Well, I have some more but let me just add something to Henry's comment. His concern about the consent -- he doesn't know what's meant by consent and this needs to be clarified. It's no easy task and I"m not sure we can clarify it at all, whether it can clarify it at all. We might be able to describe it. It's a very difficult undertaking. I was struck in either Chapter 1 or Chapter 4 that interesting statement, look here, ten years before informed consent entered therapeutic, that the common law, the AEC talked about informed consent. What the hell were they talking about when they talked about informed consent? Did they talk about informed consent in terms of talking about the common law now? In terms of the language of Salgo which was the most primitive kind of idea about informed consent where they're talking about it in the language of Nance v. Klein, 1960, which was an intermediate formulation of informed consent, whether they are talking about it in the language of Canterbury v. Spence which took the informed consent a step further, etc.etc. When we talk about consent, informed consent and we look at the various Wilson, Charles and whoever the other guy's name is, the other Wilson, when they talk about consent, informed consent, who knows what they were talking about. The only thing we know really in terms of a definition of consent is the Nuremberg Code because they're after voluntary consent, they go on to talk in seven sentences or eight sentences what they meant by voluntary consent and if you take that seriously practically nobody can give voluntary consent, but that's another matter. So it's a very complex kind of issue and this is a problem throughout the report and some were early, I think, since we can't define it again and again, we need to have a page or two about the problematics of defining informed consent and the best formulation I liked is the one by I think in the Danforth opinion in the Supreme Court, he said we wouldn't even define consent because we don't really know what it is and well, we shouldn't do it that way, but there are problems here which we need to address in one way or another. CHAIRMAN FADEN: I'm of the mind, Jay, I don't think we can start with the stipulated definition and say we found it here and we didn't find it there. I think we can say what we have evidence of and what we don't have evidence of and what is written consent and what is not written consent, but that the disclosure was made or that the disclosure was not made, that there was after the fact evidence that suggested people were misled or not and so on, and based on that, these together, that it looks like something like consent. DR. KATZ: We probably need a couple of paragraphs before that to acknowledge what the problematics are in figuring out what these various people meant by it. CHAIRMAN FADEN: We can do that. I see -- I've got Duncan, Henry, Pat. DR. THOMAS: Mine is not on consent if there's more. CHAIRMAN FADEN: Is there more on consent before Duncan goes on to other topics? Duncan? DR. THOMAS: I have a little bit of residual discomfort with the conclusion that the Committee found no conclusive evidence that any individual was physically harmed as a result of the plutonium injections and this statement is repeated in several other places. With some trepidation, I put a paragraph in my written comments expressing some of the reasons why I was a little bit uncomfortable with that statement. All the points are grasping at straws so I'm just looking around to see whether or not there's anyone else on the Committee that feels equally uncomfortable with that statement. DR. KATZ: But Duncan, the next sentence, the next paragraph -- DR. THOMAS: No, the next paragraph is on the uranium injections which is a completely different kettle of fish. DR. KATZ: I see. DR. THOMAS: So just with respect to the plutonium injections alone and the kinds of very weak evidence of harm that we have are the various non-apparently subclinical effects, the long-term changes in bone. There's the so-called coin like lesion in, I think it's either Charleton's chest wall and then on the other hand the possibility that some, at lest some of the 18 patients may have been subjected to medical procedures that themselves may be either unnecessary or possibly harmful or certainly or possibly other indignities as a part of their role in the experiment, although not obviously causal effects of plutonium per se. I'm referring to things, well, we had this discussion a few minutes ago about the teeth, for example, again on Vida Charleton's rib and I think there were one or two other examples. CHAIRMAN FADEN: So if I'm understanding you, there's two issues that you're concerned about. I had focused on the subclinical effects as opposed to medical, clinical symptoms, but I was concerned about these sort of other potential sources of harm that were not a radiation effect but a part of the study like teeth were extracted or if that rib was removed or when they did the follow-up study if they were subjected to diagnostic biopsies or things of that sort that were not -- they're only done, they wanted to know about the plutonium effects, even if they were reasonably low risk, they were things that should not have -- DR. THOMAS: Yes, should not have happened to them if they had not been members, participants in the study. CHAIRMAN FADEN: But that's distinguishing between an effect that's as a result of what plutonium does to you. DR. THOMAS: Right. CHAIRMAN FADEN: But it's something that wouldn't have happened to them if they had not been part of the -- DR. THOMAS: Right. It's clear to me that there were plutonium effects, whether they had any clinical significance is not clear to me and my reading is probably not. CHAIRMAN FADEN: You would prefer a statement that said that, then in the interest of saying anything you would say there is evidence that there were? DR. THOMAS: Right. CHAIRMAN FADEN: Physiologic effects. Would that be the correct term to use? DR. THOMAS: That would be fine. CHAIRMAN FADEN: But no evidence that these physiologic effects resulted in symptomatic illness? DR. THOMAS: I think I could live with that. CHAIRMAN FADEN: Okay. I have a feeling we're going to get responses here. Henry and Pat are waiting. Henry? DR. ROYAL: Just as with the consent issue, we don't define what we mean by consent. With harms and wrongs we also don't define those very well. They're more defined as black and white. That is, you are harmed or you weren't harmed. You were wronged or you weren't wronged. When in my own mind what the reality is is that is a continuum, that in the ideal world, in the ideal circumstances no one is wronged and no one is harmed. I personally believe that it's rare when ideal informed consent is obtained so instead of being at the far end of the no wrong scale you're sort of a little bit away from that ideal point and the same is true with harms. I mean when you talk about injecting someone with anything, I can hear the cells in the skin screaming as that needle goes through them. So I don't know at what point a harm becomes a harm under -- and I don't even know if it's worth quibbling about, whether or not -- we seem to all agree that there was not clinically significant harm done. It's not clear to me what making the distinction between whether or not there were some subtle changes in the bone, whether or not that should count as a harm and if it counts as a harm, what it means to count it as a harm. While we're on this -- go ahead. CHAIRMAN FADEN: No, no. I was going to say it may be here again we're avoiding labels and just describing better to say "this is what we think happened" and not say one was a harm and the other wasn't or one was a big harm, but to simply say this is what the evidence seems to point to. DR. ROYAL: But we seem to -- CHAIRMAN FADEN: On the harm question. DR. ROYAL: Our ethical analysis partly seems to depend on this critical distinction between whether there was or whether there was not harm done and it's because we're making our ethical analysis -- Don, you're shaking your head like this -- it doesn't make any difference whether you're harmed or not. CHAIRMAN FADEN: I thought it was by risk, not by harm, and ethical analysis goes back to reasonable projection of risk at the time because -- you don't want, on the one hand, you don't want to "let people off" because they were lucky, exposed to something very risky and they were just lucky that it didn't happen. On the other hand, you don't want to get upset if in good conscience there was a reasonable projection there was very little likelihood of harm and it happened. MS. KING: In ethical analysis, the wrong does depend on harm. Because the wrong, in that sense, we use the term harm to cover not only physical harms, but we use it to cover dignitary harms. CHAIRMAN FADEN: I don't, but we sometimes do. MS. KING: Yes, that's the case here. DR. ROYAL: But clearly, the fact that there's a discussion about whether or not whatever happened, the fact that people sitting at this table make it sound like it's important. CHAIRMAN FADEN: Well, it's important for this reason, Henry. I think people want to know what this Committee thinks about whether anybody got cancer because they were injected with plutonium or not. I can conceive of a situation where absolutely nobody had any kind of setback to interest or whatever account to harm that you want that resulted from the plutonium injection, but at the time we had documents that said this is really risky stuff. We think it's likely to kill people. It's awful. It's terrible. Let's keep it a secret. We would say this was a terrible thing, even though it happened that nobody died. Let's say they thought people were going to die and nobody did. If we had documents that said that, we would obviously come down very differently, so it's not for the ethical analysis as such. It's more because I think the world would like us to comment on whether anybody was harmed or not. It bears on the ethical analysis, but it's hardly determinative. So the world would like to know whether this Committee thinks anybody was harmed or not. But it's not like that that's only because of that or not because of that that the ethics analysis -- DR. ROYAL: So the harm is just being presented as too black and white of an issue and we're distinguishing between different kinds of harm. CHAIRMAN FADEN: It may be. I think that's what Duncan is -- DR. ROYAL: Along those same lines, with the uranium experiments, there was concern about proteins in the urine. CHAIRMAN FADEN: Right. DR. ROYAL: And I guess one of the things I'm confused about is -- and I don't know the exact details because I don't do testing of pharmacologic agents, but my understanding is that when you give a regular drug to human beings for the first time, that you do test of liver function, you do test of kidney function to see whether or not there's any unexpected, adverse effects. And so as I understand the proteinerea that occurred in these patients, this again did not have any clinical significance, that it was a -- CHAIRMAN FADEN: Right. DR. ROYAL: And I don't think it comes across like that. CHAIRMAN FADEN: Well, this goes to the core issue. I asked Dan about that and I believe Ron, have you had a chance to look at the pathology reports? DR. NEUMANN: I just got that today. CHAIRMAN FADEN: Okay, I'll just repeat it so Ron doesn't have to come up. The issue for everybody is whether the evidence is that people were clinically harmed, made ill, in the uranium experiments, or whether there were physiologic effects, changes and protein released, whatever, that were not of the magnitude that would have contributed to someone's illness or made them symptomatic and obviously that's -- to get straight on that is terribly important and we are asking, apparently, there are pathology reports available, so -- and again, I can't speak for Ruth because she's not here, but obviously, I'm sure she would agree that we have to get straight on which this is and either way it's worth a comment, but we need to be clear about what the evidence says, whether there was evidence that this was of a magnitude that caused illness or hastened death or whatever might be the concern. So we're going to have Ron take a look at it and I guess if Ron wants anybody else to take a look, we'll do that, too. So that remains an open question, but the principal would be it would be resolved the way Duncan describes it, whatever turns out, whichever way the evidence goes, we would say whatever it is. DR. THOMAS: All I'm asking for is clarity and I agree there are spectrums of harms involved and we need to be clear as to where on that spectrum these experiments are. CHAIRMAN FADEN: Pat's been waiting. MS. KING: How can I state my objections without taking up undue time of the Committee? The problem that I have with this chapter are to nobody's surprise, the way we draw conclusions and the reasons I have problems with the way we draw conclusions has been somewhat at issue in the discussion because of what we extrapolate from available evidence and how we state it. And at page 60, for example, we say "it is possible to conclude that the subjects of the plutonium experiments were wronged." What do we use to justify the statement or question? If these subjects have not been wronged by ethical standards of the day, not by today's standards, of the day, why did the AEC have concerns about public perceptions and legal liability? I guess I feel like a broken record sometimes too, and that is that I think concerns about publicity and legal liability raise flags. Many people who operate in today's world operate in the face of worries about legal liability. There are multiple motivations. In fact, you would be a very foolish and unwise person in today's world if you did not have in mind at times legal liability and the implications of legal liability. I am willing to draw some inference from that because I had been in situations where you can have a range of why people are concerned about publicity and legal liability. That range is all the way from what I would find acceptable because they know they're doing something wrong and they don't want to get caught, to taking realistic protective measures against engaging in legal liability, etc. and we point to that and I'm willing to -- it's not just -- and let me be clear about this. It's not just what evidence we have. It's the weight of the evidence that we have been actually discussing here. My own preference, and I don't have any objection to what Duncan wanted done. My own preference is to be as clear about why we draw these conclusions as is possible, so if we want to talk first clinical effects and we want to talk about subclinical effects, I don't have any problem with that. But I also want to do it by the same token when we're talking about the terms "wrong" and "morally acceptable" and I see no compelling national security justification. I say that because somebody has urged on me that maybe we feel the need to do this because it's the only way we can recommend something in the remedy section. I don't think that's true. I strongly believe that that is true, that you don't have to find fault or culpability in order to provide a remedy and maybe that affects what I see here in terms of how we reach our conclusions. But this chapter's conclusions would be one of the chapter's conclusions that I would point to state in this form to express a continuing problem that I'm having, which is the problem of what we infer from evidence and let me be in favor of what Ruth -- I thought Ruth was saying a few minutes ago because that's where I would go, which is the best way to do this is not to use these shortcut techniques and not to use questions. It is to state what the evidence says. I'm particularly troubled here because we're talking in a period where it would not have been unusual in many clinical situations to get oral consent. I think you can make an inference from the fact that there was no documented record of consent. I think you can make an inference from second-hand testimony. The weight of the inferences, however, are quite different and I prefer, in my own ways to line up the evidence. Different people will give different weights. In part, what we're having is a real problem with the weight that we give to different evidence. Some people would credit second hand testimony higher than I would, but I might know the circumstances and make it higher and give more weight to it than other people. It is tough to do it this way and I just don't like this. That's my first point. The second point is that one of Ruth Macklin's objections, but they're connected, one of Ruth's objections is in her comment, and so I don't know how we handle this or whether -- how it's intended to be handled, but one of her comments is she thinks the conclusion is too weak. And I think it's overstated. CHAIRMAN FADEN: Can I just interject? That was to the draft before this one. What Ruth said to me, whatever it was last night was that the additional material she is now comfortable. MS. KING: I haven't seen the additional material. CHAIRMAN FADEN: It's this draft, July, whatever this draft is. MS. KING: July 6? CHAIRMAN FADEN: Yeah. MS. KING: Well, when I looked, the only thing I saw was in brackets and it goes only to -- so we didn't take account of her -- CHAIRMAN FADEN: We did. What she's saying is the stuff that's in brackets was in response to her memo and she is - - I hope I'm not misstating it, but she said she was comfortable with the additions in the brackets and that her major concern at this point was the uranium stuff getting out of the box. MS. KING: So let me be clear. CHAIRMAN FADEN: So if you don't like it here, she's -- you're still disagreeing, but she's comfortable with this. MS. KING: She made the comment with respect to plutonium in several other chapters. CHAIRMAN FADEN: Right. MS. KING: So I think that -- maybe you don't want me to say it -- CHAIRMAN FADEN: Say it. MS. KING: I mean say it now and waste time saying it now. If it doesn't appear anywhere, I need not say it, but I disagree with Ruth's view that you can infer that the AEC officials were culpable in the sense that they knew what they were doing from some of the statements here. When I say knew what they were doing, that they knew they were wrong at the time and that is why they were wrong. CHAIRMAN FADEN: No, I agree. Actually, I had this conversation yesterday. If we get clear on what's going on, page 60, the line that Pat drew our attention to, I had those underscored as well, too. I don't think they're adequate arguments to support the conclusion that's drawn, merely because somebody tried to keep something out of the press, doesn't mean that they believed that what they did was wrong. The issue isn't whether what they believed what they did was wrong, the question here at issue is whether it was wrong and it's a separate issue whether they thought -- MS. KING: I thought that's what she was raising. CHAIRMAN FADEN: I know. I think that's what she was raising. MS. KING: She drew the inference that not only it was wrong, but they knew it was wrong. CHAIRMAN FADEN: I would agree with you there, Pat. I think it's a mistake for us to speculate about whether they knew it was wrong or believed it was wrong. The issue is whether it was wrong and to get it into their heads to say they thought they were doing something, they might have thought they were doing something right. It doesn't make it wrong, right. That's really not the issue. The issue is -- MS. KING: I rather suspect, as I told Ruth earlier, that they probably thought they knew best, so they didn't think they were doing wrong. They thought they were doing right because they knew right better than anyone else. It's a much more likely explanation. CHAIRMAN FADEN: Exactly. That doesn't make it right, in the worse case, it makes it arrogant. Exactly. So that's not the issue. The issue isn't whether we have reason to believe that they were ashamed of what they did or anything like that, the issue is whether it was wrong or not and I think, in fact, I think we should put the evidence up, particularly with respect to the lying and the cover up afterwards where the evidence is quite strong. MS. KING: It's much stronger. CHAIRMAN FADEN: That's what should be played up here. Look, whatever was said to them at the time there sure is plenty of evidence that people -- and it was AEC officials who did that, who then went back to people and misled them and misled family members about what was happening and that was quite clear in the 1970's report that was done and there, I think, we have very strong evidence to make the claim that something wrong was done and whether they believed it was wrong or they thought it was justified by whatever is really not -- as far as I'm concerned, I agree with you, not at issue. Sue, did you have and Jay -- DR. STEVENSON: I was going to follow up on that suggestion. I think that on page 61 that I would like to see that point receive much more attention than it does. CHAIRMAN FADEN: I agree. DR. STEVENSON: That subjects who lived for decades continued to be used -- because there we have evidence that seems to me to be clear. MS. KING: That we need to support our recommendation, I might add. CHAIRMAN FADEN: That's right. MS. KING: With respect to the cover up recommendation where we need to have the conclusion more strongly drawn. CHAIRMAN FADEN: It's good that there's -- this is good. Okay, Jay? Don't ask me what it is that's good. That's all I can say, it's good. (Laughter.) DR. KATZ: If we can get back in a moment to Pat's point, but first on 61, 62, with respect to culpability of the AEC, without making any judgment about that sentence at all, I was puzzled that if they are culpable, why isn't the medical profession equally culpable and the medical investigators who were involved in this. Why is the AEC singled out? And you know, Pat and I have been over this and over this and went through this again and again about evidence, lack of evidence, etc. And I find on page 60, the way it's written about consent and what we can reconstruct and what we cannot reconstruct, utterly confusing in its present form. CHAIRMAN FADEN: This is on the section page? DR. KATZ: Yes. As for my concern, I have no problem with -- on the basis of the evidence before us, even though -- and the evidence before us, I don't mean beyond a reasonable doubt evidence. The evidence before us. Also in the light of the follow-up studies and what was being said to make a strong statement of my own on the basis of this evidence, I will say that these people who are not adequately informed, that they were deceived or that they were lied to and it's also part of the climate at the time and if you -- if the dream team were to cross examine me, they could make mincemeat out of me, but I'll face that -- (Laughter.) I'll face that danger, but I would put this much more strongly and I hope I can convince Ruth Macklin when she recovers to turn to her original position. CHAIRMAN FADEN: No, our original position is different and they're confusing positions. I think and I would agree, I share your view on this issue, not that they were lied to, the point was whether the people believed they were doing anything wrong when they did it which is an issue that to me -- DR. KATZ: That, of course, is another problem. CHAIRMAN FADEN: Exactly. DR. KATZ: No, no, they were doing it for the noble -- CHAIRMAN FADEN: Exactly, exactly. I'm not interested in that. DR. KATZ: National security, God, family -- CHAIRMAN FADEN: That is the issue Pat and I were talking about, Jay, not whether they did anything wrong, but whether they thought they were doing something wrong and were ashamed of it at the time or whether they thought they were doing -- MS. KING: I wasn't discussing the cover up at all. I mean I wasn't discussing what happened subsequent to the original experiments. CHAIRMAN FADEN: Right, just the experiments themselves. Can I get closure on the issue that Duncan started us with which was taking the uranium stuff out of a box and making it a section? Does anybody object to doing that? Okay, so the uranium miners get -- not the uranium miners, the uranium experiment, excuse me, gets -- all right, so we are of a mind that that's okay, that no one objects to that and what exactly it says about whether there's evidence of illness being caused or not or clinical symptomatic damage we don't know yet because we haven't clarified that point yet, so we don't know precisely what the box is going to say on that point, but we hopefully will know that shortly. Do we have the energy to try another chapter? The break stuff isn't here yet anyway. DR. THOMAS: Ruth, can I ask one last question? CHAIRMAN FADEN: Sure. DR. THOMAS: Is there any significance to the last sentence being in brackets because -- is that because we haven't agreed to it yet? CHAIRMAN FADEN: Let's get to it. DR. THOMAS: Page 62, lines 5 to 7? CHAIRMAN FADEN: What I was hearing was Jay saying why single out the AEC, why not include the medical investigators who assisted. DR. KATZ: If we keep that sentence, I think, in light of the -- CHAIRMAN FADEN: The key issue here is deceit. People were lied to and that's fairly clear that people were lied to and you don't have to -- MS. KING: I think we should emphasize not this stuff about fear of liability, we lied to people and we kept this secret. That's the -- CHAIRMAN FADEN: Core thing. MS. KING: Yes. CHAIRMAN FADEN: So unless anybody, so the suggestion is anybody who we know was part of that lying should be included and that's -- okay, it's hard to come out in a defensive line, folks. Okay. So the brackets go out, but with the amendment that it's encompassing, it's not meant to just land on the agency, but for the people who were involved in lying, that was unconscionable. Okay. We are now not going to take a break because the break stuff isn't here yet and we're going to do one more chapter which is observational studies, then have the break and then go to remedies and findings and retrospective recommendations. Observational studies was on there. I don't recall now who had asked for it. Some of this came from phone calls from people who had asked for observational studies to be added. MS. KING: I didn't ask, but I have a big problem with observational studies. CHAIRMAN FADEN: Okay, now is the time. MS. KING: I have to look at my other comment. It's the statement at page 26 that says, line 16 -- CHAIRMAN FADEN: Wait just one second and let all of get -- DR. GLATSTEIN: Which chapter are you on, Pat? CHAIRMAN FADEN: Uranium miners -- MS. KING: 12. CHAIRMAN FADEN: This is all the July 13th draft, Pat? MS. KING: Yes, the July 13th draft. CHAIRMAN FADEN: What page? MS. KING: Page 26, line 16. "The Committee believes that such warnings were morally obligatory." And it's actually the discussion that follows after this. I have, I think, not a problem in saying that there was a moral obligation to warn miners because that's not the problem that really bothers me. The obligations about warnings and stuff, I think, are well understood legally and ethically. What I'm having difficulty with is what does that mean contextually? What does the obligation consist of? It's been my experience that when people are talking about warning obligations as distinct from other obligations they think all the justification is ended because, of course, then the obligation is to warn. I think that that's not clear. I think that the question of what you are both morally and particularly when you cross over into as a matter of policy in the circumstances, what the government should have done, that that requires explication of what the obligation consists of and why the obligation translates into an affirmative act of public officials and that's not here. What we do often is say, we make flat statements without the connections, and I should have pulled together the flat statements, but they begin, that's where I start marking it and I think that this is again, one of those cases where we may not like the fact and we do say later at one point, we may not like the fact that the government made a deal with mine owners that they were going to go in and that we were going to do work and we weren't going to warn, but what I'm much more interested in is if we feel there was an obligation on the part of researchers or the government to have warned them under those circumstances, then that has to be carefully explained. There's an interesting quote in this chapter from one of the guys. I'm terrible on names, who said "I thought about writing the columnist to expose this, but I thought better of it." Well, I don't blame him. I would have thought better of it, too, because the guy who tried to do the warning, I saw where he ended up. He ended up east of the Mississippi and if you've got children to take care of and a family to take care of, obligatory -- to talk about it, to use that language is not careful qualification or even to use an obligation to be a whistle blower without the qualifying language, I found really troublesome. So again, it's one of those areas where I'm saying that the crosswalk, the statement of what ethically is required is not a statement that says that those requirements have to be, should have been met in this situation because that requires some further explication and that's what I found missing here. Now I think -- DR. KATZ: Are you talking about individuals or are you talking about, for example, the senior officials of the Public Health Service -- MS. KING: I am talking about both. DR. KATZ: Both of them. MS. KING: Understand, Jay, what I'm saying is I have not entered an objection, an agreement or a disagreement. I am saying that there's no crosswalk here for me to object or to agree with in my view for both government officials and individual researchers because what we say is what they should have done often, we don't say what from the record says to us that they ought to have done it. Now -- DR. KATZ: Then can I ask you -- you make an excellent point, but maybe the crosswalks need to be constructed because where do you come out on these issues, what is your conclusion on it and then, of course, whether you accept it will depend on whether we can build the crosswalks. I don't get a sense from you where you are coming from on these issues to say we haven't supported it, that's one thing. It may require a better justification, but where do you come from? MS. KING: Jay, if you ask me, do I think that there's a moral obligation to warn where people are being exposed to risk, as a matter of ethics, I would say yes. I think it is then the second step to say why in this -- because that is not a hard question for me. There is a moral obligation to warn somebody that I would think you see walking into danger. I don't have that problem. What my problem is, is in the absence of any warning that was given in this situation, why are we saying, these are not abstract -- they are abstract principles, but they have to be applied, and what I'm saying is what we need is an array of what in this situation required the government officials to warn, that's one step, and what required researchers to warn. When I went through the chapter and I said this once before, I am particularly, because I guess I know more about it, interested in the researcher issue because I think it has modern pertinence. All of medicine is facing this problem of having to answer to masters and it is going to be a problem that is going to go well into the 21th century. It is not enough to say that the doctor's primary obligation is to the patient when the doctor is -- when you don't take account of who sends the paycheck, what the pressures are, the doctor's obligations to his family or her family. I mean what I'm trying to say, Jay, is I have a separation in my mind between what is ethical as a matter of principle and I'm not quarreling with the principle here. I may or may not agree that there was on these facts an obligation to warn. What I couldn't find here, if I had to go with what's here, I'd say I'd object to this because I didn't find it there. So what I'm trying to do is if the argument is there, let's build it because I'm not anxious to say that people who were walking into danger shouldn't have been warned. I want to know a lot more about why under the circumstances it was required because we downplay some of the other pressures that were on people that we wanted to warn and on government officials as well as the researchers, that we wanted to be warned. That's all I'm asking for. It's not enough to say there was an obligation. You got to give it some flesh. Yes. MR. GUTTMAN: You raised several questions, not the entire crosswalk, but strand of the crosswalk, I think, is obviously the connection is made when at 28 we know that the PHS had a federal regulation saying that -- information obtained by the PHS with the assurance of confidentiality may be disclosed whenever the Surgeon General sees a public health hazard. That wouldn't go to the doctor, the researcher versus the surgeon -- CHAIRMAN FADEN: It would go to the government under the Public Health Service. MR. GUTTMAN: Right. Is that what you mean? But that to me would be an example of a part of a crosswalk. MS. KING: That's a part of the crosswalk. Because the obligation to the -- now, that's not all of it because the other part of it is what is not clear from this record is at least when I went back through it is why the government felt it necessary to placate mine owners. And we could do lots of -- we could be very speculative about why it thought it had to do that. It may have mistakenly believed that it was better off. We hedge when we get down to the end about whether if the government had insisted it was better to do this work than not to have done this work. We say the Committee can't reach a conclusion about that. MR. GUTTMAN: The other thing that's very difficult on the record is it looks like the Surgeon General collapses into Holaday and Doyle who seemed like pretty decent guys. It's very difficult. There's no independent Surgeon General asserting anything on a piece of paper. It's just these two researchers. MS. KING: And I would point out one more -- those people think I'm a harder nose than I think I am. This has got nothing to do with whether the miners should be compensated. That's a separate question. There are lots of ways to build compensation justifications. This has to do with explicating what we mean when you have an obligation to warn in these circumstances and I care about this a lot because as I said, I don't think this is a problem that's over with. I think this is going to be a major significant problem for medicine in the future. And I want to hear something about it. If you have any ideas, Jay, I want to hear about it. DR. KATZ: Pat, assume for the moment that it's correct and I think it is correct. One of my students researched it and I think it's also in this draft, that it would have cost $1 more per ton to the AEC to ventilate the mines. In the light of that fact, can one speculate that the AEC in this situation really had unconscionably had no regard whatsoever for these human beings involved. MS. KING: You mean what I marked in my margins, Jay? DR. KATZ: Yes? MS. KING: I marked them at the ethical debate about the cost of a human life which currently takes place at statistical levels. The government can spend X amount more dollars and save X number of more lives. There's a question about whether one, there's a proper ethical question, and two, if you think it is, how do you handle it and in some ways I think that this is exactly that problem, that when you say you can spend $1 more or $2 more or $3 more, as against what? This is going back to Henry's larger business about alternatives, this morning when he was raising. That is a part of what we need to talk about if we're going to talk about what it means to warn, having an obligation to warn. CHAIRMAN FADEN: Can I get clear on two things here? There's a difference, Jay, on what you just raised, doesn't go to a duty to warn. It goes to a duty to fix. And while the duty to warn is in here, that's a complicated set of issues and bears particularly on the individual researchers where I think we are in very muddled territory about it, what point we want to say, if you want to use whistle blower language or just how much personally should somebody be obliged to put on the line in order to do something that will help others. The larger issue in the uranium miners, I take it, is whether the government should be faulted for not having ventilated the mines. The second order question is whether then the people, when the decision was made not to do it, who, if anyone, should be faulted for warning people, but hey, even though a decision has been made not to improve your working conditions and you're working under unsafe conditions, so we've got both problems, right? We've got two problems operating in this chapter and we probably need to make it clear what moral territory we're walking on, when. MS. KING: And we need to draw a distinction between the statement of moral principles at a principle level and the statement of both, of applying a moral principle in a context and reaching a moral conclusion, that is separate, even further from the question of the public policy question, not the morals question of what government should or should not do because we don't translate every moral position into a government activity. CHAIRMAN FADEN: I have got -- MS. KING: Well, we don't. DR. RUSSELL: Keep trying. CHAIRMAN FADEN: That's why some of us are not in government. (Laughter.) CHAIRMAN FADEN: We've got Duncan, I saw, and Phil, not Duncan, but Phil. DR. RUSSELL: I'd just like to ask a question of those who have studied the issue and I must admit I have not, that there had to have been something that the AEC was really afraid of. It wasn't another dollar a ton. They weren't worried about money. They were afraid of something and whether they were afraid of a walkout or a general strike, a shutdown or something like that, it must have been in their minds. Are there any clues in the record about that? Same question, could you be a little more explicit about futuristic thinking that you alluded to, because I think it may help us. MS. KING: But when we get to the part of the research, in addition to the complication we've already mentioned, there are two levels at which the chapter deals with the government and the government is a lot of actors. It's the AEC and the Public Health Service. Then there's a discussion at the level of the individual researcher that if you examine patients and you knew, and that ends the discussion, you went back and examined patients for this epidemiological study and you knew that the patients were at risk and the researchers did not say to these miners, look, this is what we're really looking at and we're trying to figure out what's going on here. I'm not talking about the duty to warn. We have a researcher who may answer to two masters, patient-subject, government agency, HMO, third party payer, private industry. And when the -- we have built an ethic that says that physician researcher's first obligation is to subjects or patients. That's been sort of the way our medical ethics has proceeded. But that ignores all of the changes that are taking place which are quite realistic which says that's fine and good, but if you don't get reimbursed for treating this patient because the HMO thinks you, or the third party payer thinks you have exceeded what you should be recommending, then the issue is what is a physician who is now caught between two masters, that's why I say these obligations have modern counterparts and so I don't want -- because I see this for the researchers as a two master or multiple master issue. We'd like to think that they were -- if they want, what would have happened to them? They would have been fired or they would have been demoted or been pushed off or maybe it would have caught fire and there would have been a big public scandal and they might have done something. There are all of those kinds of possibilities. DR. RUSSELL: They didn't do the experiment as they should have. MS. KING: Well, you asked me what do I think about the implications are. It is how you act in those situations. What's the morally appropriate action in a complex situation like that? CHAIRMAN FADEN: Well, I think that it's 10 of 4. (Laughter.) That's what I think. We ought to take a break. DR. ROYAL: Ruth, I agree with you. CHAIRMAN FADEN: Thank you, Henry. It's time for a break. (Off the record.) CHAIRMAN FADEN: We're back and we've been requested to speak into the mike more carefully as apparently there's some trouble picking up the transcription and we really do want to get it straight, so -- plus it is very useful actually to have this. When I sat with the transcript from the last meeting and worked with it when we did the revisions on some of the chapters it really did help, as copious as the notes may be. Eli wanted to comment on the issue that we had been discussing before the break, so Eli, you've got the floor before we go on. DR. GLATSTEIN: As you recall, we were discussing the obligations, if you will, of the researcher or the physician to the patients and to other agencies and then in the modern era the extrapolation to third party carriers and so forth. And there are analogies there and I think the obligation of the physician to patient is doubly more important now than it was even in the '50s because realistically if the third party carrier has interest which are going to be restricting what the physician can do for the patient and that certainly happens in some HMOs, the only way you'll get that change is by advocating the consumer, the patients and try to get the patients aware in the first place because there are HMOs are like doctors in every other business, profession, some are good and some are not. But those that are not good, the only way they're going to change and respond to pressures is pressure from the consumer, not from the physician and with respect to the uranium miners, I would add just one other thing. Of all the things that we have covered in this Committee, I really believe that the story of the uranium miners is as black and white as we will see. I really believe that the reference to Buchenwald this morning was -- I don't think particularly appropriate for Cincinnati, but it is appropriate for this bunch. This particular study, I think, among other things, I think it is about discrimination. I believe that the civil rights of these people were abused and I think these people are deserving of compensation doubly. CHAIRMAN FADEN: I've got Phil and then I'm going to -- DR. RUSSELL: I agree with you on the compensation issue and the fact that the miners were wronged. The issue of where the blame lies or most of the blame lies is still unclear to me. DR. GLATSTEIN: But one point is clear -- DR. RUSSELL: The mine owners had to agree to allow the docs access to the mines to do their study. There apparently was some agreement made about what use would be made of that information. Who made that agreement? Who put the constraints on it and then what were the implications of breaking that constraint? DR. GLATSTEIN: As I understood it, there were really two levels of fault at the governmental level. One was the agreement of the PHS to the compromise to the miners to have the study done, but not to inform the miners. That was one level of abuse. But the other was the reluctance of the AEC to assume its responsibility which it had already shown in the issue of the beryllium. They already took the leadership to flex their muscles and get people to agree to standards which for some reason they did not wish to do here and I can only conclude that the reason why they didn't wish to push this issue was about a bunch of Navajo miners and I'm sorry to say that. DR. RUSSELL: It may be that the bigger decision was at the level of well, are we going to pay for the uranium through the private system or are we going to federalize those mines and having made the decision to go private, then they had to enter into a -- DR. GLATSTEIN: But in either case the risk to the miners was the same. DR. RUSSELL: Right, I'm just trying to -- whether we put most of the blame on the docs who did the study and then were constrained or on the original decision makers who made the high level decision not to federalize and to go along with the mine owners and with all these consequences downstream. The wrong is there. CHAIRMAN FADEN: Jay had asked at the break if I would try to bring some sort of closure to where we were on each of these chapters with respect to how they're going to be changed to see if there's any sense of the group. I think he's right, that before we go to the rewriting we get some sense of at least the majority of the Committee members, I think the chapter needs to go in a certain direction. I probably should have done that at the end of each discussion. In retrospect, that probably would have been a wise thing to do while we were thinking about each of these chapters. What's clear is that we don't have complete agreement about every point on every chapter. That, I think is likely to remain and so the issue, the art form is going to be can -- to what extent are we in agreement about the central points and then how important are the other points or whether they can be handled with statements like some of the Committee members feel X and others feel Y on this particular point, but all Committee members agree that. So in the case of the uranium miners, if I can just take that as an illustration, it seems as if there is agreement that what was done was -- I want to say wrong, okay? And that there are ample grounds for changing -- for the recommendation that we subsequently make. There seems to be a variation in agreement about how to fix or understand questions of who is responsible for what and who ought to be held accountable for what in the course of looking back. And I think we can try to craft a chapter that emphasizes the conclusion and indicate the different ways it can get set up with respect to who to slam for what and if people want to put in footnotes that way I believe that it clearly should be this and such or six people want to say that or whatever and that's the strategy that I'm working towards that may help us to get out the main point we want to make about the uranium miners and then if it turns out that all but two people agree that it should be said that government officials did something wrong and should be held blameworthy for it, then we can change the text accordingly and say most Committee members feel X and then if the two people want to identify themselves as otherwise can do it in a footnote. This is not at all meant to preclude dissents, personal statements or anything else. It's just that it would be helpful, I think, to the reader to clarify in a chapter where the Committee feels strongly and is in agreement and where the Committee is -- where there's disagreement or levels of confidence that this is the right conclusion to draw. That means a very difficult chapter to rewrite, but is that an all right direction for the uranium miners? Basically -- Pat? MS. KING: One of my criticisms, one of my major criticisms of this chapter is that we make statements where we offer no justification have nothing to do with whether we agree with the recommendations or not. For example, just knowing of the hazard is sufficient to obligate the government provide a warning. What is the justification for that statement? A quote from a person who was from Duncan Holaday. My point is if it's so obvious that this was like Buchenwald, that I think we ought to be able to spell it out. I continue to say it's not spelled out here. I didn't challenge Jay's assumption nor did I challenge the assumption of compensation being warranted. I had a much deeper, I think, criticism of the chapter and that is apparently the horror of what was done is so big in some people's minds that that in itself -- CHAIRMAN FADEN: That it's self evident. MS. KING: That it's self-evident. And I am making a different point which is I don't see what's so self-evident. I see about warning, moral obligation, etc., but in the absence of any understanding of what was happening and why agreement was entered into, I just think that we need to put as much as we can in here. I would think everybody has an interest in that. I don't think there would be disagreement. CHAIRMAN FADEN: I think everyone would agree we ought to get the arguments out and the historical context out as clearly as we can. No one would disagree with that and where there may be disagreement is on whether, from that basis an inference or a conclusion or a judgment of X is warranted. Again, what I also hope to do is have people self- select and if your particular interest -- it would be nice if we could get people whose views are perhaps different, work through the chapter and we'll see. I don't know any other way to do it, but I think at least on the uranium miners we have some clarify with respect to the strong consensus on one point and then we're going to have to come at it with a better way of marshalling arguments for those of us who believe that the record allows statements beyond that. And if it doesn't work that way and people step back from it and say I don't think it's there yet, then we will handle it in the text accordingly. I don't know how else to do it, given the time constraint and even if we had all the time in the world, i don't know how else to do it at this point except to flesh out best case arguments and then see how many of the Committee members are persuaded by them. I take it though, my own view is since the agreement about what should be done for the uranium miners is unchallenged, we all agree about that. That's the big issue. The big issue is not how we write the chapter. The big issue is that this Committee will come down unanimously recommending something and that's the outcome, that's the significant thing. Now obviously if the chapter is stronger, it bolsters the recommendation that much more, but the fact that the Committee is unanimous on what needs to be done at this juncture is, I think, the take home measure for us. Not to belittle the other issues, but to me -- I feel good about that and that to me is terribly important. I don't know now whether to go back to those other chapters and try to reconstruct the discussions. Maybe that's not a good use of time at this point. I think we should go forward. I will try to give some thought to it. I think it would be very helpful if each of you, I will certainly do the same, look at these 19 chapters. I would exempt the last two, findings and recommendations, because that has to be everybody, every line, dot, everything. But if you would look at those preceding 17 chapters and see where you would be willing to work terribly hard, including drafting language, whatever needs to be done on a few of them. We will figure out a way to make it happen. Of course, everybody will look at everything, but I'm looking for mechanisms or conduits through which drafts get advanced very, very, very rapidly, so it's kind of what do you want to invest your energy into for whatever reasons. You like what's there or you don't want to see it diluted or you hate what's there and you want to see it go in a certain direction and then the whole Committee will respond. Also, I know some people have expressed reservations in not liking to see red lined versions of drafts, but at this point I'm beginning to think that's the only way to do it, only I promise that we will look for a better copier than what we have had access to, so that the chapters are visually easier on your eyes than some of the ones that we received. Okay, with that I'd like to pick up with where we're supposed to be on the agenda which is to move to findings, Chapter 18 and look at the findings for the 44 through 74 period. Much of this language, obviously, should be familiar. There is -- this is where I sat with people on the staff and we listened very closely to the transcript and tried to make the changes in the findings that had been requested at the end of that discussion of that finding and then there was also some to- ing and fro-ing in between. Of the findings that are listed for this period, 1944 to 1974, let me draw your attention to the fact that we have an addendum. I don't know that, I hope you all received it which is Finding 9A right now. Did everybody get Finding 9A? Okay, so that should just be put in wherever you want to stick it in between 9 and 10 and with that, can we just proceed serially? Finding 1, you'll notice, by the way that things are reordered which was one of the recommendations of the Committee based on the last discussion of findings. Any discussions or comments again? Not if you found a typo or you think a word isn't felicitous unless you think the word really would change the meaning of the finding. We can take those on the draft, but does anyone want to raise something for the whole Committee in Finding 1 or is Finding 1 okay? Finding 2 is an unresolved finding in the sense that there was some discussion at the end of the last meeting and then some attempt back and forth and I am not clear on where Finding 2 should be. Duncan, do you want to chime in or should I just explain to everybody? DR. THOMAS: Well, this one may have fallen through the cracks. CHAIRMAN FADEN: Did you send something? DR. THOMAS: I had a change back and forth and I sent you a new revision last Monday which I thought was going to be circulated with further edits and it never showed up. CHAIRMAN FADEN: The one that's here, page 2, lines 4 and 5? DR. THOMAS: Has been substantially changed. CHAIRMAN FADEN: Right, since then. DR. THOMAS: So maybe we ought to hold on to -- CHAIRMAN FADEN: Why don't we hold off for Finding 2 and we'll get the new language. Henry? DR. ROYAL: Maybe one of the things that's confusing about Finding 2 is it's combining both the tracer experiments and the therapeutic experiments. CHAIRMAN FADEN: You're right. DR. ROYAL: Your finding tries to make that distinction more clearly. You helped write that. CHAIRMAN FADEN: All right, let me just make a note. Can you just make sure, I don't know where the revised Finding 2 is, but the revised Finding 2 isn't in here. DR. ROYAL: I have a copy. CHAIRMAN FADEN: Let's get it from Duncan and we'll hold off and discuss it after everybody has had a chance to look at it. The issue that emerged was that Duncan had pointed out at the last meeting that the finding as we had it previously did not address the fact that we identified experiments in which people were exposed in away that could have, whatever the right language is, been to their disadvantage with respect to long-term risk of heretogenic illness and we had to figure out some way of accommodating that and there was some back and forth on that. Let's just forget about it until we see the new language and we'll discuss it. Going on to Finding 3. Is Finding 3 all right? Again, there will be changes, we realize that. We know there will be editing changes. There will be other kinds of changes, but now the issue is is there anything that you really really think the whole community has to debate? I don't -- I just want to get clear there will be changes, but not changes -- now is the time to say I disagree with this finding or it's wrong or what does this mean. Lois, did you have something on 3? No, then we're moving on. Finding 4? Finding 5? Again, I know people shouldn't feel like -- if I'm going too fast, let me know. If you come up with something later, it's okay. We can deal with it. We're just trying to flag problem cases. DR. KATZ: In Finding 4, also implies what we talked about earlier, that the issue of consent will be better to find in the body of the chapter -- CHAIRMAN FADEN: Or the fact that we're not talking about a table in here in necessary and sufficient conditions of a table, but we'll have some sort of a footnote that references the discussion in the text, in the finding that says this is tough and basically these are the general notions we're looking for, something like that, Jay, if we can have some subset to work on how to do that. So what I'm making is a note that there has to be some sort of acknowledgement about the point of how the term is used. It's specifically intended to use the term consent rather than informed consent is intentional. DR. KATZ: We did that earlier in one of the chapters. CHAIRMAN FADEN: It's easier to say we'll do it than to actually do it, but we'll do it. We'll figure out a way to do. I think the key point on that point here is that the term that's used is consent, not informed consent. And we will explicate that what we mean here is the weaker sense, at minimum, there were statements about this. DR. ROYAL: Ruth? CHAIRMAN FADEN: Yes. DR. ROYAL: One of the things that one of the people who testified in public testimony last month said that has been sort of sticking with me was the woman who testified about her daughter being diagnosed with cancer and her saying that sure, she signed consent, but she was in a catatonic state when she signed consent. That whole issue about the capacity for not only the patient but family members to be able to give consent at a time when there's a serious medical problem is an important issue and some guidance about -- I mean I don't know what to do about that. If I'm explaining something to a family member and it's clear that they're just terribly upset because of what's going on, I don't know what to do and because I think it's a more common problem than maybe recognized, some guidance about what should be done. Maybe that belongs in recommendations as opposed to findings, but we're defining what consent means maybe some at least acknowledgement of this problem would be useful. CHAIRMAN FADEN: It also fits in the part where we're talking about the complexities of thinking through how to obtain valid consent in emerging medical conditions about which we have a recommendation, but we can also -- it belongs also in Chapter 17 as part of the surmise as to why we found some of the things that we found. So I'm just adding that. Okay. All right, we're up to Finding 5 which is on implementation of the statements on consent. DR. KATZ: It's too charitable. CHAIRMAN FADEN: It's too charitable? you think we should be harsher? MR. GUTTMAN: Jay, when you say, Dr. Katz, do you mean it's correct, but too charitable or that it's -- DR. KATZ: It's incorrect because it's too charitable. (Laughter.) MR. GUTTMAN: So I take it you're against charity. DR. KATZ: Sometimes. CHAIRMAN FADEN: All right, are there other people who agree with Jay that we should strengthen the statement, the finding in the direction of indicating that there was less implementation than this suggests? DR. KATZ: Ruth, it's very important, I mean I don't know how to say this. It shouldn't lead to any changes immediately because I may be a lone voice in the wilderness. Someone else may be a lone voice in the wilderness, so we have to see whether there's some groundswell for this. DR. THOMAS: Jay, it's not clear to me whether the thrust of your comment is that it doesn't adequately say that there wasn't enough implementation or that there's no finding of culpability to go with it. DR. KATZ: Not culpability. This is not just a culpability statement, but the way I read it, it does not consistently effectuate their requirement and policies that there were some inconsistencies and by and large they really didn't do very much about implementation all together. DR. THOMAS: So you would prefer language like "were consistently ignored"? DR. KATZ: Something like that. CHAIRMAN FADEN: We're trying to stay away from words like that, but we could say the advisory board finds that the government agents rarely effectuated or something of that sort. Why don't we -- it's the summary finding itself that you think is too charitable, that "did not consistently effectuate" is too generous a description. So -- DR. GLATSTEIN: How about "paid no attention to it." MS. NORRIS: Or ignored. CHAIRMAN FADEN: Well, the point here is one of implementation. It's not that people didn't pay attention to it. We're here now speaking to whether the relevant agencies with respect to their own statements, how far did they go in -- DR. GLATSTEIN: That's implementation and oversight, both. CHAIRMAN FADEN: Correct. And the problem again is, of course, we've got multiple agencies and that gets complicated as well, but the text is intended to explicate where there were differences. We will try to come up with language that is -- words like "rarely" or whatever and change the text to see if we can -- DR. RUSSELL: Could you cross out "consistently" and put in the phrase "take appropriate measures" too? They didn't take appropriate measures to effectuate -- DR. KATZ: Yeah. DR. RUSSELL: That doesn't have any quantification. DR. THOMAS: Any word but "effectuate." DR. RUSSELL: I didn't look it up. CHAIRMAN FADEN: Did not take appropriate measures to what? DR. THOMAS: to implement. CHAIRMAN FADEN: To implement. Now just so everybody realizes what happened here -- DR. THOMAS: Implement and oversee, perhaps. CHAIRMAN FADEN: When you put in "appropriate" that's an valuative judgment as opposed to a descriptive judgment. I just want everybody to appreciate that this was crafted as a -- DR. KATZ: Neutral. CHAIRMAN FADEN: Not a neutral, but a descriptive statement. Once you go to "appropriate" you go to a judgment and I'm not arguing against it, I just want there to be understanding that that's the move that's being made. MS. KING: For some of us who have trouble with the fact that there were policies, I mean that the evidence supports policies without further explication. This is an adequate description. I mean I want a descriptive finding because as I said this morning, the fact that I've taken as a significant fact that the Secretary of DOD, you know, took the Nuremberg Code, I also take it as significant that he classified it "Secret" which to me indicates that -- and I'm perfectly wiling to say that once he did it, he should have effectuated it, but I am also troubled by the fact that to me what it conveys is a lot of dissent at the very top about how far you are going to go with this. I don't know how to take account of it. CHAIRMAN FADEN: I would disagree with that interpretation because that's as much a reach as some of the other things that you've criticized, Pat, because the reality is to me, anyway, take it back, the most plausible explanation in my mind for his having classified that document or whoever classified it, was that it was about atomic, biological and chemical warfare which was itself all classified, so the idea was the only people who need to know were the people who were involved in doing research on A, B, C warfare and they ought to have access to classified -- MS. KING: And I think it's equally plausible that the reason that it was classified is because we didn't want people in this country thinking we were like -- our doctors and our department -- were like those terrible Nazi doctors. CHAIRMAN FADEN: I think that's the whole piece and that's why the ABC stuff was classified as a larger -- MS. KING: But my point is not the interpretation. My point is it is not clear and never has been clear to me as you know from talking about the history about what we have in mind when we talk about what is a policy. A document does not policy make. (Laughter.) And I have gone a long way with saying that if you've got a document, I can certainly say that you ought to effectuate it, but I have always been troubled with calling these documents and fragments policies. CHAIRMAN FADEN: Well, you got a problem with finding - - MS. KING: So I just say descriptive is fine with me. I wasn't saying I wasn't going to vote for the finding when you moved from descriptive -- CHAIRMAN FADEN: That's what I was describing. MS. KING: That was what I was responding to. CHAIRMAN FADEN: I would think your concern goes to finding for itself. MS. KING: What was your wording, Phil? MR. GUTTMAN: Appropriate. CHAIRMAN FADEN: Measures. MS. KING: Read it, Phil. CHAIRMAN FADEN: The Advisory Committee finds that government agencies did not take appropriate measures to implement their requirements and policies on consent to human radiation, is the way it was changed. MS. KING: It still sticks to the descriptive. DR. STEVENSON: How about "effective measures"? CHAIRMAN FADEN: You've got appropriate, effective. Once you've got appropriate, you've made a judgment. DR. STEVENSON: Get rid of appropriate. DR. RUSSELL: Take out appropriate and put in effective. That puts it back in the descriptive again. CHAIRMAN FADEN: That we could do. The Advisory Committee finds that the government agencies did not take effective measures to implement their requirements and policies on consent -- which clearly is right. MR. GUTTMAN: It's too charitable. CHAIRMAN FADEN: It's too charitable. MR. GUTTMAN: It suggests they took measures that weren't effective. DR. KATZ: Well, you might as well put in the Advisory Committee finds that the government agencies didn't put their money where their mouth was. CHAIRMAN FADEN: That's descriptive. (Laughter.) MS. KING: Ruth, if most of the Committee members want a stronger statement, that's fine with me. CHAIRMAN FADEN: Not a big issue with me. MS. KING: I didn't say it wasn't a big issue, but I'm not going to hold up the works of trying to -- CHAIRMAN FADEN: We will try five, four different ways and we'll see what we come up with, but we know what the problem is. We know the direction that we want to go, but we want to make a stronger statement. So now the issue is what statement do we want to make and we will have to work that one out, for the finding itself, the bolded finding will now be less weenie than it is now, okay? Finding 6, government policies on risk for research on human subjects. DR. THOMAS: In the text, in the bold part itself, I think we had agreed the last time to insert the word "some" before government. CHAIRMAN FADEN: Yes, I'm sorry, that's a mistake. DR. THOMAS: But I'm also puzzled by the first paragraph. I've read that paragraph several times now and I still can't see what the distinction that's being made between 1946 and 1949 is. MR. GUTTMAN: Oh yeah, what that is, yeah, I think that should technically -- we'll talk about it later. It's a technical point. DR. THOMAS: Okay, well, fix it. MR. GUTTMAN: It's a good question. It's one of those things I thought nobody would catch. (Laughter.) DR. THOMAS: Forget it. MR. GUTTMAN: Val, you've got to answer that question. CHAIRMAN FADEN: The problem is Val can answer, but not the same way that Dan can answer. (Laughter.) CHAIRMAN FADEN: This has been going on for a long time. It is a fine point, okay. We could just say it six ways and one of them would be right, but the point is it applied to somebody at some point and somebody else later, but we're not sure who, when and why. Otherwise, it's fine. DR. THOMAS: That same issue comes up someplace else, I think in the isotopes chapter. So we'll need to flag wherever it is. CHAIRMAN FADEN: So wherever else it is, once we figure out of how to fix it -- MR. GUTTMAN: The difference between the Manhattan Project getting going and then when the AEC subcommittee on human applications did their own thing is what we figured out. CHAIRMAN FADEN: Finding 7 is to 6, like the other one was, this is the implementation and it says -- it's very specific. If you notice, by the way, the recommendation, the observations about policies are not specific. There was an issue last time about what it was about human subjects research generally and what was about human radiation research in particular, so the findings about what the rules or policies or statements were are comprehensive, not exclusive to human radiation research because they said a context. The implementation findings are specific because we didn't investigate implementation anywhere else. We investigated what the policies and rules were broadly, so we had something to say about what the rules and policies were broadly. We only investigated implementation issues specific to human radiation, so that's all we can speak about. We don't know, for example, how the NIH implemented its procedures in 1953 because we didn't investigate it because it was not in any way specific to human radiation experiments and we couldn't pull out a radiation experiment from all the other work that was done. We probably in the preface need to make clear that this is intention and speaks to the work of the Committee where we were able to work and what we did not investigate. So Finding 7 is specific to what we could learn about implementation in the HRE context. Is Finding 7 okay? DR. THOMAS: I just wonder whether the last sentence of the description which relates to external radiation isn't important enough that it should be moved up into the bold. CHAIRMAN FADEN: Okay, so you want it in the text itself, "however, there was no evidence that a parallel mechanism to review the rest of research involving external radiation was in place at that time." Because it is an important difference. Is anybody objecting to that? Duncan's suggestion that lines -- the sense that he gives on line 2, page 8 be added to the finding. Okay. Now we're up to Finding 8 then on consent and national security. Lois? MS. NORRIS: This is just a question. On line 13 there's a sentence and this is in the text of it, "for example, the failure to provide disclosure and consent in the plutonium experiments and other Manhattan Project experimentation might have been justified on the grounds of national security." The meaning of that is not entirely clear to me. Are we saying that they used that for justification at the time or that we believed it was justified? MR. GUTTMAN: It might arguably -- well, there are two things there, I presume that one, the Committee has found that there was not disclosure, obviously. And the second is that somebody might have been, arguably, justified and at the time in terms of national security. MS. NORRIS: So you're saying this is intended to say this is what they were saying at the time. This is not our evaluation. DR. THOMAS: No, my reading of that sentence is that they're saying that they had the power to, they could have, but they didn't use this justification, but in fact, they didn't, if you read on -- CHAIRMAN FADEN: We need to rewrite it. MS. NORRIS: Maybe not. CHAIRMAN FADEN: I think you're right. I'm looking at it too and the language is ambiguous. MR. GUTTMAN: Some effort might have been made to. CHAIRMAN FADEN: Really, all we can say is we didn't find a document that says this okay on national security grounds. We also didn't find any documents that said the statement that we're adopting on consent has a national security exception to it. So all those statements that we cite a finding for of the DOD and the DOE, I mean the AEC and HHS, none of them has a little clause in there, including the DOD Wilson memo that says there is an exception for national security. That we can say straight out and I think we can simply state that. Statements that we have identified in the finding blank about the rules for human subject research, none of those statements is included in an exception for national security. MR. GUTTMAN: But I think the plutonium case adds because it's your potential counter factor -- CHAIRMAN FADEN: All we can say is there are no documents that say it's okay based on national security grounds to do it. MR. GUTTMAN: When 47 came up after the fact, that's when you expected someone to say -- that's when they said -- CHAIRMAN FADEN: That goes back to Pat's point about whether it was meant -- they still might have thought it was justified on national security grounds, but didn't want it out because they thought the public would be offended, even though it was the right thing to do. The distinction here is between what people -- they may have thought it was justified. MR. GUTTMAN: No, no. Remember 47? CHAIRMAN FADEN: I do remember. MR. GUTTMAN: The keeping of the reports, the second Wilson memo which states informed consent was supposed to state the criteria for secret experiments and if that's the criteria for secret experiments that would be -- CHAIRMAN FADEN: Again, we should emphasize that topic in Statement 47 doesn't say for national security. MR. GUTTMAN: You're right. Turn it around. We didn't have that evidence. We should focus on that. As Pat said, we should focus on that piece of paper and not -- okay. CHAIRMAN FADEN: The point is we looked at lots of pieces of paper. MR. GUTTMAN: We'll focus on that. CHAIRMAN FADEN: Lots of them had rule statements on how human subject research should be done including a highly charged national security context like the Wilson memo for ABC warfare or the AEC letters that were also in the context of secret research and nobody says there should be a national security exception to the obligation to obtain consent. That's really all we want to say, but that's a very powerful statement. Is that agreement with everybody to make it clear so that the language doesn't have to be as ambiguous as Lois points out it is to what we're actually saying here? Okay. Now we go to Finding 9 which is whether there were any rules or policies on subject selection which is basically that there weren't any in the period that we're talking about, nothing that parallels the statements or policies or rules on either consent or risk review. And then what was missing was the analog, there is no implementation obviously because we say there are no rules, but that there should be some comment about what happened in the absence of those rules, so that's what Finding 9A is new, has not surfaced before. It should be selection of research subjects or this should be for human radiation experiments, not in the whole world. DR. GLATSTEIN: Well, I think one issue there, as long as you're listing everybody I think you should say poor blacks. That's one of the things that's under fire in Cincinnati and I think it should be spelled out. We say poor women, I think we mean poor black women. MS. KING: No. CHAIRMAN FADEN: In Vanderbilt it was poor women, but in TBI it was poor -- DR. ROYAL: It was talking specifically about poor white women. CHAIRMAN FADEN: That's correct. I don't know if it was poor white women, but in TBI it's African-Americans, so we can certainly -- DR. GLATSTEIN: Certainly that was one of the things in Virginia -- CHAIRMAN FADEN: Also. Mary Ann? DR. STEVENSON: I mean I am sympathetic with this finding, but I think it's very weak in terms of the entry base. I mean we have no idea what the bulk of those 4000 experiments were. CHAIRMAN FADEN: That's why the second sentence is there. DR. STEVENSON: I still think it's weak. Maybe it can be bolstered, but I think it sort of ends up shooting itself in the foot out of the gate. CHAIRMAN FADEN: The point is, it's quite striking. When you look at the cases that we've invested energy in, the cases that we're most concerned with, most of them raise this question of potential injustice in the selection of subjects if you start thinking about it. Or raise worries of this sort. But we don't have a denominator. DR. STEVENSON: Right, and we don't know if it's radiation or all experimentation at that time. That's what I find bothersome. That might have just been human experimentation at the times -- CHAIRMAN FADEN: I think this is true for the consent problem. That's true. MS. KING: Well, one of the things about the new chapter are contemporary projects. What I wanted to add was in the selection of subjects is both a justice issue and a consent issue, so we tend to think of it as justice, but it is both. You can go to people who are vulnerable because you can exploit them, but -- and you can disproportionately place burdens there, but you also go to them because, sick patients, for example, are not going to ask you a lot of questions. I mean so part of this is we tie it to the types of people that we found in the experiments, but we don't tie it to what actually runs through a lot of the reports which is why we're so troubled about the respect for dignity and autonomy. I think that that would strengthen it because that is a theme that runs everywhere. Sometimes I think it runs too deep, but it does run -- everything about it was made easier because of the patients, for example, that were used, rather than healthy subjects. There's a statement in the children's chapter about what the researcher did when kids were from socially upper classes and when the parents were educated parents and that was what I flagged in terms of saying that we are missing the boat in connecting it to the consent as well as to the vulnerable group and maybe that will strengthen it because we do make a lot of that in our report. CHAIRMAN FADEN: We can certainly do that. MS. KING: And maybe in that way we can expand it to research as a whole, our oral history projects. CHAIRMAN FADEN: I think the finding, I think what we can do in the explication of the finding is indicating that this was widespread and this is like the issue in preparing the children's chapter on how common it was to use institutionalized children as research subjects, generally, for a chunk of time, that fits right in with the time period that we're talking about. We clearly need to signal that, but we also need to signal that the studies that we looked at for most intense scrutiny had a dimension to them that we have, we need to give expression to. We need to surface that. Do we want -- I guess what I'm trying to get at is I understand we want to do more with this in the report. Do we want to fix the finding or change the finding? Nancy? DR. OLEINICK: I think there might be some way of proving the impact of what was doing here, if we just turn the two sentences around. If we start with what we don't know and then say "but the Committee finds that in the few cases where we really have some information, then we've identified a problem." CHAIRMAN FADEN: End with that. Okay, that would be better. Thank you. That would be a good editorial -- fine. Okay. If you look at lines 19 through 21, we can capture it more, but there is a line that says "the silence onquestions of justice was characteristic not only of radiation research, but also of the entire research enterprise." We can try and explain that a little clearer. Maybe that's a little cryptic. DR. THOMAS: To some extent the entire research enterprise is described in the text for Finding 9. CHAIRMAN FADEN: Right. DR. THOMAS: I have a question about that. CHAIRMAN FADEN: 9? DR. THOMAS: Just where is it in the report that we talk about the yellow book? CHAIRMAN FADEN: It's Chapter 3. DR. THOMAS: Okay. CHAIRMAN FADEN: Yeah, it's in Chapter 3. and then it shows up again briefly in Chapter 4, I think, but it's Chapter 3, which is the bridge chapter between -- it's supposed to be what happened in the '60s and '70s. I mean you don't remember what's on page 22, line 6 of Chapter 3, Duncan? DR. THOMAS: I couldn't find it. CHAIRMAN FADEN: If it's not there -- it may be inappropriately on the cutting room floor. But it's supposed to be there. It's possible. It's also possible that's the page that dropped out of the Xerox room, too, so it's well -- if you looked for it and you couldn't see it, it's possible that modern technology took liberties with what we wanted. Okay, so I think we have some sense about what to do. We're going to take Nancy's suggestion of flipping over the order of the findings and then we will maybe make that line to address Mary Ann's concern about this is common or widespread and not an HRE specific issue, maybe make that English more straight forward, in 19, 20 and 21, and in Pat's comment there's not to the finding, but to the report itself, make sure we do more to tie it up to the overlap between questions of justice, consent and exploitation going in the two directions. Finding 10, professional standards and practices. (Pause.) I'm sorry, it's very hard for me to do this. This is really practical, but when are we going to get the transcripts and how much money do we want to spend on them, which probably doesn't need to be discussed, but something has to be decided by 5:30. Okay. Where are we on Finding 10? (Laughter.) Maybe we don't want the transcript. Do we want the transcript? The question is how much do we want the transcript? How quickly -- willingness to pay. Henry, on Finding 10? DR. ROYAL: It's not clear to me where the patient subject who is involved in the experiment with no prospect of medical benefit fits in. CHAIRMAN FADEN: The last pages 2 and 3 on page 10, on page 10. DR. ROYAL: Yes. SO where is the patient subject? It says the healthy subject with no prospect of benefit, that the convention was that they got consent. It says the patient subject knew there was a prospect of medical benefit. They did not routinely get care. CHAIRMAN FADEN: And in the next sentence it says even where there was no such prospect, it was common for physicians to conduct research on patients without their consent. MS. KING: It came through pretty strongly. CHAIRMAN FADEN: I thought so. DR. RUSSELL: It came through, but the sample was physician researchers. CHAIRMAN FADEN: Who else does work on patient subjects? It also says it was common for physicians. DR. RUSSELL: Yes, the universe of physicians. It wasn't common for the universe of physicians, but it was common for a select group -- CHAIRMAN FADEN: It was common for physicians who conducted those -- those physicians who conducted -- you're right, if you were a clinician and didn't do research -- the language needs to be cleaned up. Okay, I see what you're saying. DR. RUSSELL: It has to be tightened up. CHAIRMAN FADEN: I understand what you're saying. The implication here is that it was common for all physicians to do this. What we want to say it was -- among those physicians who did research, this was common, but most physicians didn't do research. Okay, that's right. And the same is true for the preceding one as well. Only if you were a physician in the business of doing research, did you fall into the pool. Thank you. Again, this language really needs to be -- you see, Lois was asking earlier, do we want this -- absolutely. Do you want this level of -- you know, grammatical correction? Yes. The answer is very much so, very much so. All right, with that correction, what we need to communicate is among the universe of physicians who did do research with their patients, it was common for them not to obtain consent, but not that all physicians did research. Finding 11. DR. KATZ: I have lots of problems with Finding 11, but let me just mention one thing. 11A -- CHAIRMAN FADEN: Jay, could you do it in the mike, please? DR. KATZ: In the medical books, biomedical scientists are responsible for instances in which they failed to adhere to the professional norms of the time. I have questions about that, about that issue of responsibility, but then in 11B it says -- CHAIRMAN FADEN: Can we do 11A first? DR. KATZ: It's related. CHAIRMAN FADEN: Okay. DR. KATZ: It says at the end of 11B "engaged in human research, did not have norms and practices of consent for all subjects of research." Is there contradiction here or not? If they have norms and practices? DR. RUSSELL: Yes. CHAIRMAN FADEN: But not for all subjects. Right, the inference -- what we're saying in 11A is go back to finding 10. So we stay on finding 10, that they had a practice of getting consent from healthy subjects, but not from anybody else. So that was their own practice, so according to 11, if any investigator did research on healthy subjects at that time without getting the healthy subjects' consent, they were not acting in accord with standards of their own time. It's that -- but they didn't have a practice at the time of getting consent from patients so you can't say they violated their own standards if they didn't get consent from patients at the time. That's what it's intended to communicate. DR. KATZ: 11A deals with patients, right? CHAIRMAN FADEN: No, 11A deals with anybody. DR. KATZ: Anybody. CHAIRMAN FADEN: And it refers to -- in finding 10 we have the Committee's position on what the standards and practices were of the medical and biomedical research community at the time. That's what we say their practice and norms were. So the clause beginning on line 4 and 5 of page 11 says "any investigator who didn't follow the norms and practices described in 10 can be -- is responsible for having failed to adhere to the standards of his or her own time, which we've just said with respect to consent only applied to healthy subjects." This is so tortured. DR. THOMAS: Well, you've explained it to us very clearly, but maybe the finding needs to be cured. CHAIRMAN FADEN: The finding needs to say that. DR. KATZ: It's either late in the day or I'm dense. I don't understand it. DR. THOMAS: Well, let me see if I can explain it. DR. KATZ: Thank you very much. (Laughter.) DR. THOMAS: What I think we've just said is in Finding 10 we conclude that there was a standard during the time and a conventional practice that people got consent for research on healthy subjects. DR. KATZ: Oh yeah. DR. THOMAS: Therefore, in Finding 11, instances where that practice was violated we would find them culpable. DR. KATZ: With respect to healthy subjects? DR. THOMAS: Correct, with respect to healthy subjects. DR. KATZ: Well, why is it not in 11A? CHAIRMAN FADEN: Because 11A refers, assumes that you've read 10, but we need to make it clear. DR. THOMAS: We shouldn't say that. We should just say 11A relates to healthy subjects. We'll stop. CHAIRMAN FADEN: The reason why is because that's where the Committee has concluded there was standard practice, not because we just picked it out. That's the connection. DR. KATZ: Shouldn't it be repeated? DR. THOMAS: It should be repeated. CHAIRMAN FADEN: We can repeat it. Okay, we can repeat it. And the first part of 11A speaks to what we spent all those other findings, saying what those statements and rules were. So this is if the DOD had this thing for ABC warfare and there was a case of ABC warfare related research and they didn't use it, then they're culpable for not having used it. It's taking them at their whatever. What was there at the time. 11B is -- simply says that by today's standards we consider it wrong that they didn't -- we consider it wrong that they didn't have this stuff done differently. We'll change "did not have effectuated policy" to whatever term. DR. KATZ: This is a retrospective moral judgment? CHAIRMAN FADEN: No, it's a statement, well, it is a sort of retrospective moral judgment. It's not the same as what happens in 11C is. What it basically says is today we think it's wrong, but that's the way it was. It doesn't blame anybody. It doesn't say anybody did anything wrong. It's just like saying today we think it's wrong that there were slaves. DR. KATZ: Is it necessary to say it? CHAIRMAN FADEN: I think so. DR. KATZ: It is? CHAIRMAN FADEN: I believe it's very necessary to say it, but we don't all have to agree to that. I personally believe it's very important for this Committee to say that what we saw then we certainly would not accept today which is what this is saying. Today, we would find it objectionable. If we were to discover today that this was the state of affairs, we would find it objectionable. That's what 11B says. MS. KING: 11B says something else. Oh, I see what you're saying. CHAIRMAN FADEN: It's 11C that we get to. Now 11C is different. 11A says that if they didn't follow the standards of the time, we have evidence of that and any instance of that we say somebody did something -- that they're responsible for not following the norm, standards, practices. 11B says what we found back then was the case today, we would say it was wrong. We would consider it unconscionable that today this would be the way it is. C goes to the issue of blameworthiness for the state of affairs back then. B does not speak to blameworthiness which does not make a statement about whether anybody did anything wrong and not having things the way we would like, with the way we believe it ought to be today. So C is the -- MS. KING: C is the retrospective judgment. CHAIRMAN FADEN: And C is the moral framework that we adopted at the last meeting that basically says there are two dimensions that we consider relevant to looking back and holding people accountable for having done the wrong thing then. One is how much risk it reasonably could have been projected. We're not holding people to have -- to be prescient to know the future of it. How risky at the time it was reasonable to think the research involvement was and also was there -- how reasonable was it to think it was offsetting medical benefit and to the extent that we believe it was offsetting medical benefit or to the extent we think it was low risk, reasonably at the time, could have been construed as low risk, we hold people less accountable for having done something that we would now consider wrong. But if it was reasonable at the time to think it was high risk or if there was no offsetting medical benefit and then you have the rationale. So this is the framework that emerged out of the last meeting or had a look at this. MS. KING: I know you want an indication, so people have bad memories because they always ask me why I'm voting against this because all the reasons I have stated at many meetings before. CHAIRMAN FADEN: It occurs to me that maybe what we should do is hold this off through the discussion of Chapter 4, part 1, Chapter 4, because it is all of a piece, so whatever arguments we start to marshall now either in defense of or in opposition to finding 11C, apply whole cloth to the last part of Chapter 4 from where this is developed and defended, so if it's all right with everyone I'm going to hold off and rather than have us ask Pat or anyone else their objections to this now, if we can do it in the context of the discussion of Chapter 4. DR. STEVENSON: Is that tomorrow? CHAIRMAN FADEN: We don't know yet, but it's likely to be tomorrow and the only reason I'm saying that is I'll call Ruth and if she thinks for sure she can make it Wednesday and not tomorrow,we'll hold it off for Wednesday. If she thinks she can't make it at all, there's a chance she can't make it at all ,we'll do it tomorrow. DR. KATZ: Pat, will you be here tomorrow and Wednesday? MS. KING: Yes. DR. KATZ: Because I really want to hear you out on all this. CHAIRMAN FADEN: We are hoping that everyone will be here tomorrow. What about Reed? Reed will not be here until Wednesday, so it may be if we have everybody here on Wednesday -- we'll try to figure it out, but I think this is so important, maybe not to anybody else outside this Committee, but to us, that we should try to do this with ideally all the Committee members, if we can. Can we go on? If that's all right then, we'll just take 11C. I'm taking 11A and B are all right. And that the issue to be debated is 11C which is hardly surprising. Then Finding 12, this is still within the historical period that we're talking about. Henry, I'm sorry, I'm losing the focus. Yell, if I -- DR. ROYAL: Ruth. CHAIRMAN FADEN: Henry, that helps, I needed that. DR. ROYAL: I don't -- I think some of Finding 12 is not factually correct. And that's this whole issue about whether or not they kept adequate exposure records. The whole definition of whether or not they kept adequate exposure records depends on what the purpose was of collecting those exposure records. CHAIRMAN FADEN: So it's lines 18, 19 and 20 for findings? DR. ROYAL: Yes. CHAIRMAN FADEN: And the corresponding text? DR. ROYAL: Yes. If you read the IOM report, what the IOM report says is that the exposure records are not adequate to do an epidemiologic study because in order to do an epidemiologic study what you would like to do is to have individual doses. The IOM report also says that the purposes that they were collected at the time, that they were adequate and the purpose at the time was to show that no individual exceeded the occupational exposure rate. So what they did was they badged individuals that were most likely to get the highest doses, so just so that there's no conflict in someone's mind about why it's okay for radio-safety purposes, but not okay for an epidemiologic purposes, if you can show that the most highly exposed person did not exceed the radiation safety standards, then that's suitable for that purpose of showing it did not exceed the occupational exposure rate. So when we say it was not adequate, we're using as a judgment for adequate, we're using as a judgment for adequate, that it's not adequate for an epidemiologic study, but that was never the intent at the time those records were collected. CHAIRMAN FADEN: Well, the discussion we were having earlier with Phil about whether -- DR. ROYAL: But Phil's is a prospective recommendation saying that from -- CHAIRMAN FADEN: From now on. DR. ROYAL: Now on. CHAIRMAN FADEN: Lessons learned rather. MR. GUTTMAN: I don't think that's completely -- DR. RUSSELL: I wasn't -- the kinds of records that might have satisfied this would have been very prospective and individualized. I wasn't referring to those kinds of records. For example, you could have just kept appropriate records without any more exposure data and done a study of exposed versus nonexposed, long-term medical outcomes in very similar cohorts. The current records don't even allow precision to determine exactly who was there and who wasn't there. CHAIRMAN FADEN: So it's not an issue -- DR. RUSSELL: The exposure records, I think, -- I agree with Henry -- CHAIRMAN FADEN: Then we ought to get rid of the exposure part. That it's not the exposure records, according to Phil, that were inadequate. It's other records that made the exposure information more useful that were not kept. DR. THOMAS: Well, I think it's both. To do proper epidemiology, clearly the first thing you need to know is who was there and who wasn't, who was exposed and I think we all are in agreement that they didn't keep adequate records of those things. But to do even better epidemiology, one needs to know something about dose and my reading of the IOM report says that we can't use the dose estimates that we have at the moment for that purpose, but nevertheless, we could do reasonable dose reconstructions by combining information about where people were with what we could have learned from dose records about those distributions and design an unbiased epidemiologic study that way. In other words, it isn't absolutely essential that you have individualized dose histories. CHAIRMAN FADEN: I guess we're going to the same point. DR. THOMAS: I don't want us to dismiss the point about doses. CHAIRMAN FADEN: Are you saying -- what are we criticizing them for? It sounds like we are agreeing that they should have kept better records and maintained them better about who was where. DR. THOMAS: That's number one. CHAIRMAN FADEN: That's the first issue. Are you disagreeing with that, Henry? Not who was badged and let's get to that one next, but the one is -- the first one is records about who was where, when. Right, that's your point. I want to get to the next level first. I just want to get that one out first. Henry, are you objecting to that as well as inaccurate? DR. ROYAL: Because I assume that that information is available now because the IOM, as Duncan just said, thinks they can do it. CHAIRMAN FADEN: Okay. DR. ROYAL: So I don't understand how he can criticize them for not having had accurate records if the IOM says if you want to spend a lot of money, we can reconstruct these doses. CHAIRMAN FADEN: All right, so we're down to how -- this is an interesting point, okay, so either it is the case or it is not the case or to what extent is it the case which is probably right, that records were kept about who was where when. Okay. And I suppose there's a middle ground which is there's enough information to allow with a lot of many halfway different studies to be done, but there would still be lots of people at the individual level for whom it would not be known. Couldn't both characterizations be correct? For the IOM to say you could do a decent study, it doesn't mean that you could account for where every single soldier was. From the perspective of an individual soldier, however, or whatever service the person was in, it's important that the records be right for me, where I was, when and available. So what I'm wondering about Henry, if it really is a conflicted state of affairs or a matter of degree? There's enough for one purpose, but not for another. Nancy and then Jay. DR. KATZ: Isn't there a difference between what can be reconstructed and the our arguing that better records should be kept. It's not just that better records should be kept, but also we should have given some thought to follow-up studies, isn't that an aspect of this also? CHAIRMAN FADEN: Not in this. DR. KATZ: It comes later? CHAIRMAN FADEN: It doesn't show now because we haven't figured that one out yet. DR. KATZ: Because one either is -- the records are necessary for follow-up studies and in some instances, not conducting follow-up studies, it will surely be true with something not of concern as the mustard gas experiments does by the Navy, it's really a violation of one of the basic medical commands not to abandon, in a sense, patient subjects because they deserve follow-up and probably some of these persons deserve follow-up over the years to see whether there were any egregious medical consequences or is that not what you were saying? DR. ROYAL: As I stated earlier today, I think the goal should be how can we best protect soldiers and my concern about this recommendation is that -- CHAIRMAN FADEN: This is a finding. DR. ROYAL: Excuse me, sorry, this finding, is that it's suggesting that the records that were kept, it says that they were inadequate in that more time and effort should have been spent on collecting those records or keeping those records and I question whether or not there was anything more that could have been done at the time. CHAIRMAN FADEN: I want to get Nancy in and then Dan. Eli, are you waiting too? All right, Nancy, Dan, Eli. DR. OLEINICK: On the issue of the records, it's not entirely clear to me that the records of who was where and when are adequate, even for the redo of the IOM study. They seem to think they've got adequate records now, but it's not clear that they do and who is to say that this set of records is any better than the previous which were the basis of a rather flawed study. So I'm not sure what we have. I think -- I don't know how to word this, but you know, just to say now they've got adequate records and that was okay, I'm not sure we can conclude that at this point. DR. ROYAL: Again, the word adequate that we're using is with a totally different purpose in mind. CHAIRMAN FADEN: You were using in it terms of radiation safety. DR. ROYAL: Yes. So maybe -- DR. OLEINICK: We're really breaking this apart. DR. ROYAL: The dilemma is whether or not we should define what we mean by adequate, adequate for what purpose? DR. OLEINICK: We really have two sets of records. Let's talk about one and then the other. CHAIRMAN FADEN: I was trying to get the first one out. The first one is records about who was where, when. Okay. And I think I'm hearing that with the possible objection that you've raised, Henry, that we can say that they should have kept better records about who was where when for all kinds of reasons. DR. RUSSELL: Even with the manual record keeping system of the day, they should have kept those records. Who was in the units and where they were. DR. ROYAL: Do we know that they did not keep those records? DR. ROYAL: You hear continual arguments about whether somebody was there or not and the testimony indicates that the records are incomplete and some of it may be that they are lost. DR. OLEINICK: We've had a lot of public testimony to that effect. CHAIRMAN FADEN: Well, it's more than just public testimony. It is also the case that the last study ended up having people counted who weren't there and people who weren't there were counted, indicating that the records were messed up. DR. OLEINICK: And how do we know that this set is any better? CHAIRMAN FADEN: That's a separate question. But that goes to whether we make a recommendation that a study be done, but it's the combination of evidence from testimony from people who say I was there and the records say I wasn't and the fact that when that study was looked at it turned out there were a lot of people who looked at the records and said they were there, weren't there and so clearly there were problems with the record. DR. THOMAS: I think it's clear that the records are messed up and that they could have been done better. That does not necessarily follow that it's impossible to do a study and they may well have gotten -- CHAIRMAN FADEN: I want to just take, right now we're not doing recommendations. We're doing findings. DR. THOMAS: I understand. I'm trying to deal with Henry's point, that how could the IOM say it's possible to do a study if they don't exist, these records. I see they're not necessarily incompatible. CHAIRMAN FADEN: I see. Can I take it that we're okay on the finding that they should have kept better records of whatever the right language is of who was where when? MS. KING: It's a different thing to say they should have and -- CHAIRMAN FADEN: And did not. MS. KING: And did not. CHAIRMAN FADEN: That's what I'm saying, did not. It take it back. It says "did not." MS. KING: I'm comfortable with the fact. The fact is, they did not. CHAIRMAN FADEN: I take it back. Let's use the language that says they did not keep adequate records about who was where, when, whatever the right language is to say that. I'm sure there's some more elegant language. We can now go to the next -- Dan, did you want to -- DR. ROYAL: Is the problem that they didn't keep adequate records at the time or is the problem that through the course of 50 years, some of those records were lost? CHAIRMAN FADEN: We don't know whether it's create or maintain or both. MR. GUTTMAN: It's both. Let me just -- this is all stuff, we're in the midst of a civil war about these things that will go on for years after the Committee is over. Henry mentioned there are two things that are in the chapter, contemporary pieces of evidence. One is Henry mentioned that the radiation safety people were badged, so therefore that would be a surrogate as the highest level. I don't recall where the IOM said that. I assume they did. The understanding that I have and I think it may be in the chapter, out of the chapter, but at the time there was knowledge, but they just didn't badge the people they should have badged, not because they were bad people, but because it was one thing, they ordered X numbers of badges and the shipment was late because they were in the middle of the Korean War. So that, I think there was evidence that didn't get people badged that they knew should have been badged. CHAIRMAN FADEN: For the radiation safety purpose? MR. GUTTMAN: For radiation safety, that's right. In other words, I wouldn't doubt that they were badging the highest priority people first, but I think it was also clear at the time that they just weren't doing all they should have because that was a fast-moving world. That's one point. So -- DR. ROYAL: I'd like to see the evidence and the reason I am skeptical about your portrayal is because there was a great deal of interest in how safe it was going to be for soldiers to be on an atomic battlefield and because there was a great interest, not only for the troop safety, but to know what it was going to be like to fight on an atomic battlefield, I think that knowing the amount of radiation exposure that troops were going to be exposed to was of great interest to the military, but what was not of great interest was doing epidemiologic studies. MR. GUTTMAN: I'm thinking particularly of one memo comes to mind, Upshot and Knothole, where the Army or the AEC, the shipment of radiation badges that didn't come through so we had to do this with less than we wanted because they're behind in more production. I mean that's not -- it has to do with their intent. It's the reality of measurement. The second point which is to me the more important one, you have to weigh the evidence, if you look at the Crossroads of experience and it goes to this discussion we had earlier where there was some evidence that people thought there might be even longer term risks, however, statistically low, and they were keenly aware of litigation possibility, it seems to the extent that was true, if anybody who knew that had reason to believe that X years later there would be all this administrative haggling about exactly who was exposed to what, you could have saved a lot of haggling if you had done something to make sure there wouldn't be any further arcane dose reconstruction. So to the extent that there is evidence that people were concerned about long term risk, however low, and that they were concerned about litigation, that would have been cases for keeping personalized records, not stuff that you could have lengthy administrative proceeding about and that's what a lot of the people out here were complaining about. They just don't trust because they don't have the individualized stuff. If that's not a retrospective judgment, then I think it's a valid point to say it wasn't adequate at the time. CHAIRMAN FADEN: Wasn't adequate at the time because they needed the information to defend themselves against suits? MR. GUTTMAN: If they knew that 10, 20, 30 years down the road people are going to be appearing before the Appeal boards making claims, and therefore specific evidence about what exposure they had would be useful which is what the law is today, then there would have been some need to create the evidence and maintain it so it would be available in some efficient forms, so you wouldn't have to waste everybody's time collecting all this stuff and reconstructing it. CHAIRMAN FADEN: I'm lost here. We have agreed about the who was where record. Now we're on to the question, except for Henry's point about whether it was an issue of whether they failed to create it or failed to maintain it. I think it's probably a combination of both, but we can clarify that. That's your question about whether the records were never developed or they got lost somewhere along the line, where an individual service personnel or when. Now we're into the issue of do we want to say that they didn't keep adequate exposure records which is what Dan is speaking of -- MR. GUTTMAN: You can say records. You can just say records and probably -- if that will satisfy, there's no need to -- CHAIRMAN FADEN: I don't think it's going to work to get the whole -- let's see, we may not all -- I think Dan's just argued for saying that they should have had better exposure records. One argument is some of it was a logistics problem. DR. RUSSELL: They didn't keep adequate records. And if you look at it from three points of view, there's arguments over who was there and when they were there and whether or not they were there, a continued recurrent theme. The issue of dose reconstruction as an on-going intellectual argument and the fundamental issue of long-term medical outcomes for that population is not fully resolved, so it's a fact that they didn't keep adequate records through all these questions. They should have, is a different question. CHAIRMAN FADEN: I agree with Phil. DR. GLATSTEIN: I do too. CHAIRMAN FADEN: I agree with Phil on that point, the point being here that they're not adequate. We don't have the records we would like to have, now it's clear that -- we're not saying we should have them, Dan. They're not bad people for having not created any of those records, but we are saying they did not create adequate records. That's a description. We don't have the records today we would like to have. We don't have -- the records we have now are not adequate for purposes that it would be good to have. Is it okay to say that? DR. STEVENSON: Just records? CHAIRMAN FADEN: We'll get rid of the word exposure so it's more generalized. And the point is it just says they didn't keep adequate records. DR. OLEINICK: But you're going to break that apart into the different types of records? CHAIRMAN FADEN: I think just a generalized statement basically that says that -- DR. OLEINICK: I think it goes back to just being vague again. CHAIRMAN FADEN: So we can add -- DR. THOMAS: You can add it. I don't think it's needed in the ballpark. CHAIRMAN FADEN: In the text. All right, we will do that. We will change, we will come up with language in the text to explain what we mean by adequate. We are all agreeing here that we're just saying they didn't do it. We're not saying they shouldn't have done it at this point. It's a finding that says they didn't do it. We're not saying that they should have done it. We're going to make a recommendation that says they should do it from now on. That's a separate thing, but we're not saying -- we have about 20 minutes. I know it's hard to hold people's attention at this time of night, but we do have agenda time until 6 o'clock and I'm going to take every minute of it. Okay? Finding 13 is intentional releases, number and purpose. Is Finding 13 agreeable? Or let me turn that around. Is there anyone who wants to bring up Finding 13 for collective discussion at this point? Let's move on to Finding 14. I feel like an auction. It feels like an auction. DR. STEVENSON: When we talk about the chapter, I mean we actually put some numbers in the chapter. We say the risk is low but we do say 1 in 10 or 1 in 100 or whatever, so in the chapter we don't say it's zero. DR. ROYAL: It says unlikely. DR. GLATSTEIN: Most of that chapter dealt with the thyroid issue. CHAIRMAN FADEN: The intentional release chapter? DR. STEVENSON: All of it didn't. CHAIRMAN FADEN: Basically what we're saying here is that it's unlikely that anybody was hurt from the intentional releases so described solely. We're not commenting about anything else. And only from these specified ones. It's circumscribed. I don't know if that helps, Mary Ann. DR. STEVENSON: Well, in the chapter we didn't say it was zero. Here we're saying it is zero. DR. THOMAS: We're saying unlikely which is a probability statement, but we use the word unlikely which is a probability statement, so I can actually live with that wording, but I think Mary Ann is right, there is some quantitative information provided in the text, whereas in the supporting text here, I mean the text of the chapter, whereas in the support text here, a little bit is said about exposure, but nothing at all about risk. CHAIRMAN FADEN: We can pull some lines in. Why don't we pull the relevant text. I'll ask Duncan and Mary Ann to look at the relevant text and Eli -- DR. STEVENSON: I guess it's interpretation in my mind "unlikely " sort of implies nothing and I shouldn't, I guess, whereas if it said "low probability" or whatever. Maybe that's just me. CHAIRMAN FADEN: No, no. I think it would help if we take the couple of lines in the chapter and put them in as the second paragraph under the explicating text since we have language there we can put it in and that will indicate the unlikelihood. It doesn't mean we're absolutely certain nobody was hurt, we just think it was really, really not -- it could be. So we're going to pull in text from the intentional release chapter. All right, Finding 15. (Pause.) DR. KATZ: What does the last sentence mean, "should be controlled"? CHAIRMAN FADEN: Where are you, Jay? DR. KATZ: Are we at Finding 15? CHAIRMAN FADEN: I see where you are now. MR. GUTTMAN: It's like the Wilson policy memorandum. DR. KATZ: It should be controlled, but what does "controlled" mean? CHAIRMAN FADEN: That's a very good point. That's not good language. DR. RUSSELL: It recognizes existence of the environmental list. MR. GUTTMAN: Well, it's more than that. They recognize that it was important to regulate risk in the conventional context, the vernacular. CHAIRMAN FADEN: So if we can say that, then we can say important to regulate. MR. GUTTMAN: Well, that risk wasn't anything that should be regulated. DR. KATZ: Can one say more than that, they wanted it not just to regulate, but also to minimize risk? Can we say that or not? MR. GUTTMAN: Compared to what. In the case of the Green Run, they didn't live up to -- Henry's point was an operational standard, but it's sort of apples and oranges, right? And -- CHAIRMAN FADEN: Well, this is, yeah. Well, we can say "recognize the existence of risk to the environment" -- "recognize the existence of risk" -- MR. GUTTMAN: We need to regulate it. WE need to regulate it. Control. CHAIRMAN FADEN: That's why the word "control" is here. DR. LEDERER: At a minimum, I think Jay is right. MR. GUTTMAN: But to minimize is -- well, that -- CHAIRMAN FADEN: The issue is not what -- I mean the question is what word is fair to use for them. What does the historical record allow us to say about what their thinking was at the time. That's what's so difficult. DR. LEDERER: Do they realize at the time there was a responsibility to regulate -- MR. GUTTMAN: Well, the reason you can't say minimize is because there may be a conflicting trade off, for example, hypothetically, they could have minimized risk by telling everybody in the Pueblo Indian group don't go in this area in the next six months. CHAIRMAN FADEN: They didn't. MR. GUTTMAN: They didn't because of a national security tradeoff, so it can't be -- CHAIRMAN FADEN: Minimized. MR. GUTTMAN: Minimized. CHAIRMAN FADEN: In other words, it wasn't a minimizing commitment. MR. GUTTMAN: They wouldn't have done it in the first place, to put it another way. DR. GLATSTEIN: Leave it be. DR. KATZ: You can't do that. DR. LEDERER: I think it doesn't make sense the way it reads. Supposedly, what it says -- CHAIRMAN FADEN: It's clear that Jay's quite right. The language is not right, it's not good, so the question is what can we say? it's not minimized. They didn't recognize it to be minimized, but certainly it should be acceptable. It should be evaluated and judged -- there was a sense you just can't do it. You have to think about it and decide that it's -- you know. DR. THOMAS: Well, the first line of the supporting text says that there were regulations in place and they were broken. Guidelines. So what were those guidelines? MR. GUTTMAN: It says that in '44 to '54 there were none. DR. THOMAS: No, but it says in the case of Green Run, these are the guidelines that existed, but were not followed. MR. GUTTMAN: These are the operational guidelines, so you have a question of whether when you're in a national security context with a one shot deal, those would apply. CHAIRMAN FADEN: The line 15 itself is misleading. DR. LEDERER: Right. DR. RUSSELL: Actually, we should say they were exceeded -- DR. STEVENSON: Or they were suspended. DR. RUSSELL: Not that they weren't followed, they weren't appropriate to follow. Exceeded. DR. OLEINICK: But the wording is still -- controlling risk is still very vague. I don't understand what's meant there. CHAIRMAN FADEN: It's not good. DR. OLEINICK: Are we supposed to try to control it so that there's only one in a thousand cases of cancer down the line or something? I don't think that's what they meant at all. It's regulating the amount of release. CHAIRMAN FADEN: Well, it was basically -- maybe it was as simply as they recognized there were risks associated with these releases and that these risks had to be considered in making public policy decisions, basically what it was. MR. GUTTMAN: Yeah, maybe something about the risk benefit ratio. DR. ROYAL: Maybe it should be considered. MS. KING: It's probably in the record from the documents to say first they meant that there were risks and -- CHAIRMAN FADEN: They acknowledged that there were risks. MS. KING: And they somehow must have felt they had to take account of those risks somehow. But I'm not sure -- MR. GUTTMAN: But it's not clear because in the case where it's talking about how they did it -- CHAIRMAN FADEN: All I want to say is they acknowledged that there were risks associated with these releases and that these risks had to be considered in making policy decisions. How they had to be considered, we don't know, but they had to be considered. There's enough documentation that they thought they had to take this into account, not to necessarily minimize it, but you couldn't blow it off. You had to -- there's enough evidence that they acknowledged at the time they had to think through that side of it too before we decide what to do. That's about all, I think, we can say. We will rewrite this. And then we can look for language, but Jay, you're quite right, that language, as it was there was not helpful. Finding 16. I'm going to the bitter end here. DR. STEVENSON: Isn't backed up. The fishing crew, we don't even discuss that as being in the finding. That doesn't exist. MR. GUTTMAN: I thought one of them died, right? CHAIRMAN FADEN: The issue isn't in the text. MR. GUTTMAN: Steve, isn't it in the text, the Lucky Dragon? CHAIRMAN FADEN: Is it in the text of the Marshallese part of the observational study chapter Not any more. I think Mary Ann is right. It's either out of the finding and out of the chapter or if it's in the finding, it's in the chapter. We can't kind of spring the information on the world in a finding. Not a good idea. Not a good idea. DR. STEVENSON: And then the other comment I had is lines 14 and 15, it says exposures are consequence of the 1954 test, but somewhere in the text it says that not by any malice, but that the tests often exceeded just because estimates were poor. They didn't have very good ways of estimating what the final result of that blast was going to be. It shouldn't just end on that line. It seems like it was just crossed off. MR. GUTTMAN: That's true, but that was the yield, not so much the fallout. This is the exposures. DR. STEVENSON: But it still seems like it should go on further than that. It just drops off. It needs more text. MR. GUTTMAN: Okay, what do you suggest? DR. ROYAL: It sounds like they're wilfully violating. DR. STEVENSON: You can just say due to -- CHAIRMAN FADEN: The problem is partly what's contested. MR. GUTTMAN: The Marshallese this morning were -- CHAIRMAN FADEN: It's a matter of -- I don' really know. I've not studied this question myself, but I think there is some dispute about -- MR. GUTTMAN: Why it was these people were where they were without being evacuated? DR. GLATSTEIN: I think the last sentence there should reflect what we heard this morning about continued exposure of the Marshallese through the food chain. The uranium miners weren't the only ones who were continuously exposed. DR. LEDERER: Is that discussed in the chapter? DR. GLATSTEIN: It will be. DR. LEDERER: We're talking about exposure. CHAIRMAN FADEN: One way or the other, we need more text. DR. THOMAS: There's a lot of work that the chapter needs. CHAIRMAN FADEN: Excuse me, Duncan? DR. THOMAS: I'm sorry, this part of the chapter is still in the state of flux and I think there's going to be more material added to it. DR. GLATSTEIN: I think the points raised this morning were good. I think we should listen to them. CHAIRMAN FADEN: Well, it's clear that until we finalize what's in the text we can't finalize what's in the findings. This is -- not totally finalized, but -- so that's a close one and we have not talked about that chapter, so we will revisit this finding when we revisit the chapter. How would that be? We have not talked about this. So far it's 11C, if we're keeping track. It's Finding 11C and Finding 16, that we're going to return to. Do we need to look at the uranium -- that's, of course, the uranium miners thing. Are we comfortable with the language with the uranium miners here? DR. THOMAS: There's a few minor corrections in the last sentence of the supporting text which, I need to talk to Steve about to get just right. It does need to say lung cancer, not just cancer. CHAIRMAN FADEN: Okay. DR. THOMAS: I think one can make a stronger statement than "a substantial number." Our estimates are that a majority of those are attributable to radon. And the several hundred, I'd like to pin down a little more carefully. I know of several hundred in the study group alone, but that's a small part of all uranium miners. CHAIRMAN FADEN: So this needs to be strengthened, the rationale needs to be strengthened. DR. GLATSTEIN: Okay. CHAIRMAN FADEN: Okay, 17. I think it can be strengthened. In line with the discussion earlier today about the plutonium experiments and the cover-up issues, this is a place to highlight that people were lied to. DR. GLATSTEIN: Yes, I think it needs another sentence or two. CHAIRMAN FADEN: These were in the subject and human radiation experiments. DR. GLATSTEIN: In the words of Big Daddy, it's about mendacity. (Laughter.) CHAIRMAN FADEN: There is no other place to put it in the finding. We have it as a basis for a recommendation and we just stuck it in the chapter. I mean the key thing is the information was also kept and people were given false information or misleading information, who were themselves the subjects. DR. LEDERER: Information came from subjects. CHAIRMAN FADEN: Right, that's not what's clear here. This sort of focuses on keeping it quiet and the public didn't know. MR. GUTTMAN: Page 18, line -- CHAIRMAN FADEN: But it's not in the heading, yeah. Dan's right. We could look at the text on page 18 in lines 12 to 16 and move that into the bolded part. Would that do it? DR. GLATSTEIN: Yeah. CHAIRMAN FADEN: That would probably do it if you take that and bold it, you have your finding. DR. GLATSTEIN: Move it up. CHAIRMAN FADEN: Thank you, Dan. That's a good point. Can people hang in here for one more minute or not? We're not going to get to -- if we can do it. All right, Finding 18, Secrecy and Intentional Releases. MS. KING: It seems awfully odd in the finding to say for what is likely to have been. If these findings are factual findings, it was either longer and we have something to support that, or it wasn't. I don't understand the conditional language in a finding. MR. GUTTMAN: Well, the reasoning is we just don't -- some material just got declassified in the Green Run last December, presumably since people have been asking since '86 for the Green Run information, there's not a great change in the world. I mean how do you -- DR. LEDERER: Why don't we just say "for decades." MS. KING: It's here but it's longer than what was required for national security reasons and what I'm trying to figure out is either we have something that says we know when national security was up and when it should have been released, and that's not what we say, or -- this is not a factual finding to me. It should be a statement of what -- a more precise statement. DR. GLATSTEIN: It was held for a much longer period of time. We should strike out some of the words. CHAIRMAN FADEN: The issue is this. As a matter of whatever, we cannot know the magic moment when national security arguments -- we jut can't say that in 1982 everything was okay and whatever the national -- we don't quite entirely know what the national security reason was, why they kept it secret in the first place. We know that they declassified stuff only very recently and from the stuff that we have seen, and we're not national security experts, it doesn't look like -- MS. KING: It should have been classified. CHAIRMAN FADEN: That it should have been classified. That's a very hard judgment. MS. KING: That's a very hard judgment. DR. ROYAL: Why don't we specifically say that? CHAIRMAN FADEN: We can just say that. In the judgment of the Committee -- DR. RUSSELL: Declassified asked for by the Committee. CHAIRMAN FADEN: Just say that. DR. ROYAL: But if they hadn't been informed, it would still be classified. CHAIRMAN FADEN: That we can say. MS. KING: That's the thing. DR. KATZ: Has a case been made -- MR. GUTTMAN: The Green Run document is he best example. DR. KATZ: That national security required -- CHAIRMAN FADEN: Have we been able to? No. DR. RUSSELL: But we never asked for it. We had no way of judging it. CHAIRMAN FADEN: The Committee went through this territory and concluded that we were not in a position to make the judgment. We would have had to investigate so much more about what the military situation was at the time, what the Soviet situation was at the time, why the American experts thought they needed to do this release. What the counter arguments were against it that we couldn't possibly address the question. DR. KATZ: Couldn't we say something about that? CHAIRMAN FADEN: That we couldn't -- DR. KATZ: I think with Pat we could say all involved for national security purposes is justified some degree of secrecy, but can we say just what you said? CHAIRMAN FADEN: We can say it was held secret for national security reasons which the Committee could not evaluate, it was outside the charge of the Committee. DR. GLATSTEIN: Why don't you say all were alleged to involve national security purposes? CHAIRMAN FADEN: Well, I think what we can simply say is the Committee was told they -- rather than alleged, we can simply say the Committee was told this was done for national security which the Committee is not in a position to make a judgment about. We don't know. Then we can go on and say the stuff wasn't declassified until we asked for it and when we looked at it, although we were not national security experts, it did not -- even though the public had asked for a long time, didn't get declassified, a lot of this stuff until we asked for it and in our ordinary citizen capacity as nonnational security experts, it doesn't appear to the Committee that this was -- I mean you'd have to say all of that. MS. KING: You know, I always ask the question is why do we have the findings and if the findings are to set something else up, I think, and I presume they are -- CHAIRMAN FADEN: They are. MS. KING: That what we want to do -- in fact, we would do better to stick to what we know and to draw those kind of conclusions or our speculations in whatever way we want to go -- MR. GUTTMAN: Turn it around. Do it the way it was suggested that until a Presidential Advisory Committee asks for declassification -- CHAIRMAN FADEN: It wasn't declassified. MR. GUTTMAN: Right. Even though there was considerable public and interest clearly in the case of Green Run, open, continue, give us all the documents. CHAIRMAN FADEN: We can say that. MS. KING: We can add to the first sentence such as the one -- that one, these documents were requested, which is a fact, and denied. And we can say that they were not declassified until the Committee asked for them. I don't think you really want to say some other things for some reasons -- CHAIRMAN FADEN: That's fine. I'm happy with that. DR. KATZ: Only when we're confronted by Big Dan did they declassify the documents. (Laughter.) CHAIRMAN FADEN: Not until Big Dan asked for them. (Laughter.) MR. GUTTMAN: Actually, it was Duncan and Nancy, as a matter of fact. CHAIRMAN FADEN: All right, is everybody in agreement at the reformulation then? We simply describe the state of affairs. It was classified, members of the public asked for it for a long time and were told they couldn't get it. It was declassified only when we asked for it. End of story. MR. GUTTMAN: When Secretary O'Leary asked for it, let's say that. CHAIRMAN FADEN: Whatever is accurate. With the backing of the Administration, the Advisory Committee, in the context of all this. DR. ROYAL: Well, don't we want to add that when it was declassified that it was the Committee judged that there was no reason why it couldn't have been -- CHAIRMAN FADEN: I think the awkwardness about that is -- it might be better left -- it's a little sticky. Better not to say anything about that and just let it out there. People can see the information and let it speak. It's one of those cases, let it speak -- then we have to sort of humble ourselves and say we're not experts. Let the facts speak for themselves. MR. GUTTMAN: Ruth didn't know what it meant. She's translating from the Latin. CHAIRMAN FADEN: I do it by rote, my Latin isn't that good. If we can hang here for one minute, okay, which may not be easy. If we do Finding 19 then we will have been done with the two we held over for purposes, findings for the historical period. Finding 19, the Government's record keeping. Should be "ensure" on line 5. (Pause.) This is specific to secret programs. MR. GUTTMAN: No. CHAIRMAN FADEN: On the first line. MR. GUTTMAN: Oh yeah. Yes. CHAIRMAN FADEN: First part speaks to records, secret programs, excuse me. This is basically our finding about how tough a job this was, that a lot of stuff just couldn't be found. It sets up, obviously, the recommendation for improving the openness initially and better record keeping. Okay? It is quite descriptive of what we experienced. Okay? It's 6 o'clock, two minutes -- what time is it, Henry? DR. ROYAL: 6:02. CHAIRMAN FADEN: We agree that it's 6:02. We're going to stop. We are going to start at 9 o'clock tomorrow morning. Now the agenda is going to shift. Are we starting with -- do we know yet? All right, what we don't know is what's going to be on the agenda tomorrow, exactly. (Laughter.) Because we have some issues about who is going to show up when, both because of illness and because of schedules and whether we can move people around or not, so we'll know tomorrow morning. The only thing that -- right, for sure tomorrow the stuff on the agenda tomorrow will be addressed. The issue is the order. That's what's at question. (Whereupon, at 6:04 p.m., the meeting was recessed to reconvene tomorrow, Tuesday, July 18, 1995 at 9:00 a.m.)