BEFORE THE ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS MEETING NUMBER 7 Day 1 of 3 October 11, 1994 San Francisco, California USA BUNN & ASSOCIATES Registered Professional Reporters Worldwide 81 Bixby Road Post Office Box 1602 Glenrock, Wyoming 82637 USA In USA 1-800-435-2468 Worldwide 001-307-436-2468 Worldwide Telefax 001-307-436-5733 Human Radiation Experiments/SF 2 1 COMMITTEE MEMBERS: 2 RUTH R. FADEN, Ph.D., M.P.H., Chair 3 KENNETH R. FEINBERG, J.D. 4 ELI J. GLATSTEIN, M.D. 5 JAY KATZ, M.D. 6 PATRICIA A. KING, J.D. 7 SUSAN E. LEDERER, Ph.D. 8 RUTH MACKLIN, Ph.D. 9 LOIS L. NORRIS 10 NANCY L. OLEINICK, Ph.D. 11 HENRY D. ROYAL, M.D. 12 PHILIP K. RUSSELL, M.D. 13 MARY ANN STEVENSON, M.D., Ph.D. 14 DUNCAN THOMAS, Ph.D. 15 REED V. TUCKSON, M.D. 16 DAN GUTTMAN Executive Director 17 ANNA MASTROIANNI 18 Associate Director 19 APPEARANCES: 20 BARBARA BERNEY SARA CHANDROS 21 JEREMY SUGARMAN 22 ATTENDEES: 23 (Please see Appendix.) 24 25 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 3 1 I N D E X Page 2 CALL TO ORDER 6 3 Ruth Faden, Chair 4 OPENING REMARKS 6 Ruth Faden, Chair 5 REPORTS FROM SUBCOMMITTEES 18 6 ORAL HISTORY 7 Susan Lederer 18 8 SUBJECT INTERVIEWS 27 Ruth Faden and Jeremy Sugarman 9 RESEARCH PROPOSAL REVIEW 32 10 Ruth Macklin and Sara Chandros 11 OUTREACH 67 Reed Tuckson 12 AGENCY UPDATES 71 13 Ruth Faden 14 REPORTS FROM SUBCOMMITTEES (Continued): BIOMEDICAL RESEARCH-SELECTION OF CASE 85 STUDIES 16 Duncan Thomas and Barbara Berney 17 DAY 2 OPENING REMARKS 164 18 PUBLIC COMMENTS: 19 Nancy Lynch 177 20 San Ramon, California 21 Jackie Maxwell 187 Menlo Park, California 22 Vernon Sousa 197 23 San Francisco, California 24 Gwynne Burroughs 205 Chico, California 25 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 4 1 I N D E X (Continued) Page 2 PUBLIC COMMENTS (Continued): 3 Israel Torres 213 4 Nipomo, California 5 Audrey Hack 228 Union City, California 6 Richard Harley 232 7 Bakersfield, California 8 Don Arbitlit 240 San Francisco, California 9 Geoffrey Sea 251 10 San Francisco, California 11 Harold Bibeau 261 Portland, Oregon 12 Cherie Anderson 274 13 Placerville, California 14 Tom Wilson 280 Placerville, California 15 Michael Yesley 287 16 Los Alamos, New Mexico 17 Lynne Stembridge 300 Spokane, Washington 18 Trisha Pritikin 308 19 Berkeley, California 20 Lois Camp 320 21 Darcy Thrall 331 22 Bernard Lo 349 San Francisco, California 23 Jackie Cabasso 368 24 Oakland, California 25 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 5 1 I N D E X (Continued) Page 2 PUBLIC COMMENTS (Continued): 3 Marylia Kelley 381 4 TriValley CAREs 5 STAFF REPORT ON CASE STUDY OF PLUTONIUM 395 INJECTIONS 6 Gregg Herken 7 STAFF REPORT ON CONTEMPORARY ETHICS POLICIES 403 AND PRACTICES 8 Jonathan Moreno 9 STAFF REPORT ON INSTITUTIONAL CASE STUDY 459 SELECTION 10 Donald Weightman 11 DAY 3 OPENING REMARKS 487 Ruth Faden 12 REPORTS FROM SUBCOMMITTEES (Continued): 13 REMEDIES 489 14 Ken Feinberg 15 INTENTIONAL RELEASES AND EXPOSURES/ 505 EXPERIMENTS OF OPPORTUNITIES 16 Nancy Oleinick and Duncan Thomas 17 DISCUSSION OF INTERIM REPORT 525 18 19 20 21 22 23 24 25 1-800-435-2468 BUNN ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 6 1 BEFORE THE 2 ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS 3 MEETING NUMBER 7 4 Public hearing was held pursuant to 5 Notice at a conference room of the San Francisco 6 Press Club, 555 Post Street, San Francisco, 7 California, USA, on the 11th day of October, 1994, 8 commencing at 2:06 p.m. PT. 9 Present: Ruth R. Faden, Chair; Susan 10 E. Lederer; Ruth Macklin; Lois L. Norris; Nancy 11 Oleinick; Henry D. Royal; Philip K. Russell; Mary Ann 12 Stevenson; Duncan Thomas; Reed V. Tuckson. Also 13 present: Dan Guttman and Anna Mastroianni. 14 TRANSCRIPT OF PROCEEDINGS 15 THE CHAIR: We would like to welcome 16 everyone to the seventh meeting on the Advisory 17 Committee on Human Radiation Experiments. We're 18 going to try to start on time. 19 We have a deputized, whatever our 20 standing is. Our, our normal designated federal 21 official who opens the meeting has not traveled with 22 us to San Francisco, and so Dan is going to take that 23 all on. 24 MR. GUTTMAN: Actually as the 25 designated federal official it was his responsibility 1 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 7 1 to open this meeting, and I declare it open. 2 THE CHAIR: Thank you. It, is it now 3 open? We will tell Phil how much we miss him. 4 And, well, I, it's my pleasure to 5 welcome everyone to what is our, our seventh meeting, 6 and our first meeting in San Francisco, this 7 particular person's not first time in San Francisco, 8 having once lived here. It's always wonderful to 9 visit. 10 Are the mics not on? Mic is on. Okay, 11 I'll try to be clearer. 12 We have a very full agenda that begins 13 this afternoon, consists of all of tomorrow and then 14 into Thursday morning. 15 It's our intention when, before we open 16 the meeting, to give a few remarks about the 17 objectives of the meeting, what we hope to accomplish 18 by the end of our, in this case, three days together. 19 What I thought I should do first is that we have some 20 people with us, we always do have people who have 21 never been with us before and observing our meeting, 22 but we have more than normally, I would say, because 23 we're in a city where we don't normally have our 24 meetings. 25 So I thought it might not be a bad idea 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 8 1 to say a few words about what the committee is, for 2 the benefit of people who are visiting with us for 3 the first time. And I'll repeat this tomorrow 4 morning -- It's real quick. It's real fast, for the 5 committee members. -- again for the benefit of the 6 people who'll be visiting with us tomorrow morning 7 for the first time. 8 We are a federally constituted advisory 9 committee called the Advisory Committee for Human 10 Radiation Experiments. We have a huge task before 11 us. 12 Basically we are charged with learning 13 what can be learned about human radiation experiments 14 beginning from 1944 until the present. We are then 15 charged with also looking at what the appropriate 16 ethical standards are for evaluating human radiation 17 experiments both in the past and in the present; for 18 determining whether there is any indication of 19 government responsibility or culpability for wrongs 20 or harms that people may have suffered as a result of 21 federally sponsored human radiation experiments; for 22 making recommendations with respect to remedies for 23 people who have been wrongfully harmed; and also, 24 finally, for taking what we have learned about the 25 past and the present with respect to human radiation 1-800-435-2468 BUNN ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 9 1 experiments and making recommendations for the future 2 concerning how research on ionizing radiation 3 experiments should here on in be conducted. 4 One of the things that people who have 5 been watching us for some time know, and we certainly 6 know only too well, is how difficult it has been to 7 obtain information about the past. It's easier, of 8 course, to learn about the present. 9 We've had considerable success, in 10 large measure because of the talents of our staff, 11 and also because of the cooperation of the agencies. 12 So we've been fortunate in that. 13 We have learned a lot of things that we 14 didn't know previously that we think perhaps were 15 generally not well recognized, including the extent 16 to which there was an active discussion about the 17 ethics of use of human subjects as early as during 18 the, during World War II and the immediate post-war 19 and beginning of the Cold War period. 20 We are struggling with some very 21 difficult issues, and we hope the people observing 22 will understand the seriousness with which we take 23 our charge. We are totally committed to, this 24 committee is, to open government. 25 We want to hear from everyone, and we 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 10 1 want everyone to hear from us. And one of the 2 principal reasons why we are in San Francisco is to 3 make our committee's deliberation available to people 4 in different regions in the United States and give us 5 a chance to hear from people first-hand who we might 6 otherwise not be able to hear. 7 As we've struggled with the task of 8 determining what standards should be used for judging 9 the experiments of the past and of the present we are 10 mindful about a range of debates in the scientific 11 and medical community with respect to the extent of 12 harm that can be attributed to low doses of 13 radiation, and we are trying to remain open in all 14 respects in that. 15 At the same time we want to emphasize 16 that we are an ethics committee and not a scientific 17 standards committee. We will draw from the expertise 18 that is available to us, but we both recognize on the 19 one hand that while assessments of risk are important 20 and may sometimes lead to findings of harm and wrong, 21 it is also possible to find wrongs in the context of 22 very low risk harm. 23 We are also concerned with research 24 that may not have put people at great risk of harm, 25 but was conducted in a fashion that may not have been 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 11 1 ethically acceptable because, for example, no consent 2 was obtained. So while assessments of risk are 3 important to our enterprise, they are not, they do 4 not, those assessments are not necessarily 5 determinative of our ethics evaluation of any 6 particular experimental class that's before us. 7 And also we, we recognize the 8 importance of anchoring the past in the cultural 9 context of the past, but also mindful of our 10 understanding from today's perspective. So we are 11 offering our examination of the studies that were 12 done during the period with human radiation 13 experimentation as it was conduct, conducted today, 14 and have been currently conducted; studies that are 15 currently being conducted as well as studies that 16 were conducted in the past. 17 So that's a, a quick summary of what 18 we've been trying to do. Let me just take a few 19 minutes to, to say what we're going to try to do in 20 the meeting. 21 This time it looks to me that we have 22 five objectives for meeting. I have already 23 mentioned the major objective, and that is for our 24 hearing from interested members of the public. That 25 is why we are in San Francisco. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 12 1 We also have a session of, section of 2 our meeting available and open to the public for 3 public comment. Usually there is about one and 4 a-half to two hours of our meeting. 5 We are setting aside four hours of 6 meeting time to hear from people tomorrow, and that 7 will be the entire session tomorrow morning, that we 8 will be hearing from members of the public who want 9 to address us. And really, for us that is the 10 highlight of our meeting in San Francisco. 11 A second objective is for committee 12 members to inform ourselves of the status of the 13 various reports and projects that we have already 14 approved and initiated. We function by working 15 subcommittees that essentially supervise and advise 16 the staff in the execution of tasks and projects that 17 are conducted between meetings, and so much of this 18 afternoon we will be hearing from the subcommittees, 19 subcommittee reports. 20 We will also hear of some subcommittee 21 reports on Thursday. So some will have been given 22 this afternoon and some will be, be given on 23 Thursday. 24 Also this afternoon I will give a brief 25 update on the status of our search strategies, 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 13 1 together with the agencies, which I do, I, everywhere 2 we are with the various agencies, or highlights of 3 where we are with the agencies. 4 We are, our third objective is to 5 approve new projects or strategies for staff to 6 follow in the time between now and the next meeting. 7 Another, our September meeting, you may remember, we 8 set three things into motion, and this meeting we 9 will have to approve those three things. 10 First, we talked about a strategy for 11 developing a samples scheme for our dealing with the 12 regional experiments that have fallen under our 13 purview, and we will spend some time on this tomorrow 14 afternoon, or tomorrow -- no, I'm sorry. That's this 15 afternoon. All right, assuming that the relevant 16 staff person arrives in time, we will have discussion 17 on where we have landed. 18 Duncan and I were deputized to be the, 19 the subcommittee to work with the staff on executing 20 what the Committee had decided tentatively to do in 21 September. So we'll be reporting on that. 22 Also in September we endorsed the idea 23 that we will pursue two institutional case settings, 24 and in fact we want to remind everybody that we 25 wanted staff to present to us the options. We'll 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 14 1 have, we'll have a discussion of that on -- 2 When is that? That's Wednesday 3 afternoon. On Wednesday afternoon we will have a 4 presentation from staff there. 5 They have a series of potential dates 6 for settings, and they will be institutional-only 7 settings. They will be making a recommendation of 8 two particular, we have two sites to that effect 9 before us, and we will decide whether we like the two 10 the staff recommended to pursue. 11 Finally, we made the determination at 12 the September meeting that it was time for us to try 13 some ethical analysis, try to, try to begin the task 14 of seeing the extent to which the, how far the 15 Committee has to go in understanding itself and its 16 own sense of how to appreciate the ethics of 17 research. 18 We decided to do this through a case 19 method approach, and we decided to focus on plutonium 20 experiments. And just to, more briefly to presage 21 this discussion which we'll be having tomorrow 22 afternoon, we decided that since we have not yet as a 23 committee grappled with the question of what 24 standards to use for evaluating the experiments that 25 were conducted in the, the past, we thought we would 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 15 1 start with the question of, "How do these experiments 2 stand up against the standards of today?" which is a 3 different exercise from concluding the best, or only, 4 or best way of evaluating these experiments. And 5 that's something that we will be, be doing together 6 tomorrow afternoon. 7 Our fourth objective for the meeting is 8 to approve the interim report. Our six-month interim 9 report is due October twenty-first. 10 You have all a packet in front of you, 11 which is the staff's revision of the draft that was 12 sent out to you. And everybody was wonderful here, 13 so let me just remember to say, "Thank you," to 14 everybody for being very good and, and very promptly 15 returning your comments and evaluations. 16 And the staff's worked hard to 17 incorporate those suggestions. This is a revision 18 based on those suggestions. 19 And here's the nasty part: We will 20 only have Thursday morning to discuss the report. At 21 that point we pretty much have to end it. 22 Staff will have to finalize it and it 23 will have to go in. And it is, the bad news is that 24 you don't have this version until right now. 25 And to make your job a little bit 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 16 1 easier, the copies are marked, highlighted. The 2 areas that are new or substantially changed have been 3 highlighted for you so that the, if you don't have 4 time to read it from beginning to end as you did 5 before, you can basically go to the areas that were 6 substantially revised. 7 Our hope is that we can end a little 8 bit early today so that we can give you a little bit 9 extra reading time, ever mindful of the, a fact that 10 this is a, very compressed. You may not take a walk, 11 you may not get a cup of coffee, you may not 12 exercise. You will go to your room and read this. 13 Also in this manilla envelope is the 14 material on which we will be doing our evaluation, or 15 the beginnings of our evaluation of the plutonium 16 injection experiments. So there's a lot of reading 17 material that you really must do for this meeting to 18 be successful. 19 If your document's read, if you don't 20 read the reading material we can't have the 21 discussion tomorrow afternoon. And if you don't have 22 a discussion before we do the reports, we can't do 23 the report. So we need you to read. 24 Finally, our fifth objective is to 25 advance strategies in the direction of the staff and 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/Sf 17 1 for ourselves. And the way this seems to be 2 expressing itself, as I talked to colleagues, it's 3 time to review our subcommittees and maybe reshuffle 4 ourselves into different subcommittees, as it is 5 always a fluid process, and perhaps do an agenda 6 shift. 7 I've heard from several of you who have 8 said now is the time to maybe do that again. So that 9 is a discussion we'll be doing on Thursday as well. 10 We have three committee members who 11 can't come with us, and Eli, excuse me, Ken will come 12 tomorrow. Eli, Jay, and Pat could not join us. We 13 do have their comments. 14 Ken will come tomorrow morning. 15 Presumably he'll be participating. 16 Okay, with that we can then do the 17 agenda, and I almost feel I should go to, skip these 18 updates and maybe go to subcommittee reports because 19 I've been talking so long, if that's all right. 20 We'll go ahead and hear from some other people. 21 We'll try to get a few subcommittee 22 reports and the report on the agencies afterwards 23 from this. No particular order. 24 But, Susan, would you, would you be 25 comfortable in giving us an update on the projects? 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 18 1 SUBCOMMITTEE REPORT ON ORAL HISTORIES: 2 DR. LEDERER: My report is going to be 3 fairly brief. Since our last meeting I've obtained 4 agreement from Penn State for oral interviews. 5 Since then we have conducted two 6 interviews, which are in the process of being 7 transcribed and approved by the individual 8 interviewee. And it will be circulated very shortly 9 to the members of the committee for your comments and 10 questions about the questions that we are putting to 11 the interviewees. 12 We have, more interviews are scheduled 13 in the next few weeks and it's my hope that by our 14 next meeting in November we will be able to provide a 15 more substantive report of an emerging picture of 16 ethical standards and practices in the years 1944 to 17 1974. 18 THE CHAIR: All right. Questions for 19 Susan? 20 DR. ROYAL: Will there be any 21 opportunity for, or is it perceived that there will 22 be opportunities to go back and ask some additional 23 questions of these people after reading these 24 Transcripts? 25 DR. LEDERER: It's certainly, I believe 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 19 1 that people would be willing to take separate 2 questions. I don't know that we would consider 3 having the entire team go out and interview in 4 person. 5 It might be on the telephone or in 6 writing. It might be some questions the members 7 themselves might want to ask. 8 (Whereupon, Dr. Thomas and Dr. Berney 9 conferred, out of the hearing of others, during which 10 the following occurred:) 11 DR. ROYAL: But that's the mechanism by 12 which that's going to be done? Are we going to tell 13 you what additional things we would like first for 14 them to comment about? 15 DR. LEDERER: I guess you could either 16 tell me, or you could relay your comments and 17 suggestion to Sara Chandros, who is very generous. 18 And then we haven't formalized it yet, 19 "This is the way we'll do it," but depending on the 20 nature of the questions and how extensive they are, 21 perhaps somebody wants to question the individual 22 themselves, that's certainly a possibility. Or 23 people who were present for the interview can do the 24 followup questions. 25 THE CHAIR: Duncan? 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 20 1 DR. THOMAS: Susan, I, I saw something 2 in the interim report which may, may be the history 3 now, but maybe you could clarify for me. There 4 seemed to be a distinction between some interviews 5 and the project, and there was some by staff. 6 Do you know about that, who's been 7 interviewed and what the purpose of those interviews 8 is for the Oral History Project? 9 MR. GUTTMAN: Yeah. Let me, in the 10 course of doing the inquiry, of course, there may be 11 people that were familiar with the experiments we 12 were looking at, or the programs, and we'll talk to 13 for investigatory purposes. 14 We have people who have no knowledge of 15 particular experiments and never worked for the 16 Government, but who are in the medical business or 17 are a scholar, so that the origin, there are two 18 separate sets of interview processes. 19 But as we thought about it it became 20 clear that this was not a question of discrimination; 21 that both groups will be asked to comment on core 22 questions which were devised by Susan's group. 23 To the extent that you happened to be 24 looking at the folks in the Navy, but then in the 25 middle of it they were subjects of a test, things 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 21 1 like that, we want to be, to make sure that they're 2 honored by being asked all the ethics questions, but 3 also that additional set of questions. 4 But it would hopefully be the same 5 common core questions, and both would be, you know, 6 for the public record, et cetera, et cetera, the same 7 formula, you know, depending on the subjects 8 THE CHAIR: Duncan, again? 9 DR. THOMAS: So as I understand it, the 10 distinction then was between those people that were 11 themselves involved in the experiments and want to 12 find out the particular details, as opposed to a 13 project officer whose job was to find out -- 14 THE CHAIR: That's exactly correct. 15 But what is being, what we're tying to do is take 16 advantage of the fact that if we're talking to 17 someone that would happen to have knowledge of the 18 Institution A that we're interested in, or Experiment 19 A that we're interested in, that we take advantage of 20 that by also asking them some of the standard 21 questions that Susan is pursuing, those questions 22 and, in addition, because we think that that person 23 has knowledge of a particular experiment or a 24 particular institution. 25 DR. THOMAS: Forgive me if you went 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 22 1 into this already in your presentation while I was in 2 my little huddle with Barbara there, but are we going 3 to at some point see a list of all the interviewees? 4 DR. LEDERER: Sure. If we could also 5 get a list of people who are being interviewed for 6 the Oral History, -- 7 MR. GUTTMAN: Yeah. A, we've been 8 trying to coordinate this on an informal basis. 9 As you all know, this is not usually a 10 long planning process, and so we have got a list 11 internally and I've been coordinating with Gail 12 Javitt and Jon Harkness, and been sitting here 13 thinking, "Well, if there's someone Susan may want 14 because of the, and we have a list haete process, or 15 So-and-so," 16 THE CHAIR: I think the answer is yes, 17 we can send you a list. And we'll have it. And one 18 of the things we'll do when we come back, we'll send 19 a list out. 20 MR. GUTTMAN. Yeah. Yeah. 21 THE CHAIR: Most of the things that 22 Susan and her staff collect, are pursuing is a list 23 of the people that have been interviewed already by 24 staff for the more fact-finding focus of the, of the 25 projects, and also the people who are proposed to be 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 23 1 interviewed. 2 And let me say that the interviews, the 3 tape recordings of the interviews are available. I'm 4 not asking to the Oral History Project, but some, 5 the, the interviews that some staff members have 6 already conducted are all on audiotape, and we can 7 make them available to people. 8 So that when you get the list they will 9 indicate how long the tape is and then you can call 10 back and say do you want, you know, you want the two 11 hours of tape with Dr. So-and-so, or the three hours. 12 The transcription, we're behind on the 13 transcription, but the tapes exist. So it makes for 14 interesting commuting, listening. 15 DR. LEDERER: Well, in addition to the 16 names of the people and the length of the tape, it 17 might be useful to know something about the content. 18 That is, if it could be just even a capsule. 19 THE CHAIR: Sure. 20 DR. MACKLIN: So we would know whether 21 it's useful for the particular purposes. 22 THE CHAIR: Sure. We can do that. 23 They can do that. 24 MR. GUTTMAN: How much do you want to 25 know? 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 24 1 DR. MACKLIN: I said "capsule." 2 A SPECTATOR: Space capsule. 3 DR. OLEINICK: Some of the agencies 4 apparently are conducting some of these interviews 5 like oral histories. 6 THE CHAIR: Yes, that's right. 7 DR. OLEINICK: How are we coordinating 8 with them, or is their material being made available? 9 MR. GUTTMAN: Yes. Well, they're 10 trying. 11 Well, DOE isn't here, but they're doing 12 their interviews. But we're trying to coordinate. 13 As the world evolved, some people will 14 talk to some people but not to others. So we're 15 trying directly to talk to all people. 16 THE CHAIR: And we can try to find out 17 how many of those are available for us to be able to 18 share. 19 DR. OLEINICK: Yes, that would be 20 helpful. 21 THE CHAIR: The first thing we can do 22 is our own staff, that will come even more quickly. 23 DR. THOMAS: Last week Susan presented 24 us with sort of a formal protocol for how the 25 interviews should be set up for structure as, at 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 25 1 least for the Oral History Project. Is there any 2 sort of protocol for the other class, or is that just 3 sort of a -- 4 MR. GUTTMAN: No, it's scholarly, 5 though. I can give you an example. 6 We had a terrific interview last week, 7 Gregg Herken, who's senior historian, and myself, 8 with John Volpe, who was I think in the General 9 Counsel Office in the AEC starting in 1948 and was a, 10 on the staff with General Groves. And so you never 11 know when you start. 12 It turned out he remembered quite 13 distinctly that he said what the Defense policy was 14 in 1947, and that's on tape. And so it turned out 15 how he went into the Belgian Congo to look at the 16 safety of uranium mining and those things is a, and 17 so it's one of those documents that that's why you 18 have people that go in and explore these and leave 19 them sort of open 20 DR. THOMAS: And it clearly does have 21 to be exploratory because you have issues that you 22 want to research with each one, but presumably you 23 only get one crack at each one of these people and it 24 would be a shame to have something fall through the 25 cracks because one of us didn't ask a question that 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 26 1 we should have. 2 MR. GUTTMAN: The answer is, he said, 3 "Look, give me a call if you have any questions." So 4 that's the way most of these people are. 5 DR. LEDERER: It, I was going to say 6 it's also quite common for people to have more than 7 one historian present, so we can pursue the 8 questions. 9 THE CHAIR: Well, we're starting off 10 to, to a very good-humored start. I think we can 11 continue this. 12 For people who haven't watched, we are 13 very congenial today, and we know it. Very well. 14 And are there any other questions for 15 Susan? 16 DR. THOMAS: So far. 17 THE CHAIR: So far. 18 Did you hear that? 19 Thanks. We haven't got to the hard 20 part. 21 DR. RUSSELL: Just a little test of 22 reality. 23 THE CHAIR: Susan, any other things you 24 might say? 25 (Whereupon, no response was had, after 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 27 1 which the following occurred:) 2 THE CHAIR: Any other questions or 3 comments that you might have for Susan? 4 (whereupon, no response was had, after 5 which the following occurred:) 6 THE CHAIR: All right, thank you very 7 much. 8 And also to the staff that's been 9 working with Susan, it's wonderful that you've been 10 able to do this. 11 The next subcommittee we'll get a 12 report on is the subcommittee that I share, which is 13 the subcommittee working on the subject interview 14 process, and since I've been talking so much, and 15 this is Jeremy's also, I can ask Jeremy Sugarman to 16 give us an update. 17 SUBCOMMITTEE REPORT ON SUBJECT INTERVIEWS: 18 DR. SUGARMAN: Since the last meeting 19 we've conducted three interviews with experts on 20 radiation and medical oncology, three institutions. 21 That's Johns Hopkins, Washington University, and 22 Harvard. 23 We learned a lot in those sessions, and 24 we also appreciate the efforts of Mary Ann, having 25 lining up people that were willing to talk candidly 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 28 1 with us about what barriers might be in conducting a 2 project that, as we know, how we might learn, how we 3 were best received. 4 Overall the suggestions in aggregate 5 led to some changes in the design of our, our study. 6 That also takes into account some of the concerns 7 about generalizability. 8 We're able to now modify design so that 9 we'll still be selecting the index institutions based 10 on the amount of funding that were received during 11 the last five years under, through NIH funding and 12 awards. 13 But rather than try to do the same or a 14 parallel sort of sampling of governmental agencies, 15 et cetera, what we've decided to do is to link up 16 the, that institution that we identified with the 17 initial sample with its companion VA hospital which 18 would be conducting research; selecting the largest 19 community hospital in the area so we get reliability 20 questions, and if there's a governmental institution, 21 DOE site, DOE site in the area, then we would sample 22 individuals at that institution. 23 And that way we're going to learn an 24 awful lot about those three areas and be able to get 25 a good background and that sort of thing. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 29 1 In addition, the, each of the expert 2 groups are concerned about our picking on oncology, 3 and we don't want to pick on oncology. That wasn't 4 our intent. 5 The idea was to, we thought about 6 adding cardiology clinics in addition to radiation 7 and medical oncology clinics so we can also add to 8 the generalizability of our results. Further, we'll 9 be able to get some diagnostic testing in the course, 10 so we might not only get medical oncology clients. 11 In terms of the other aspect of the 12 project, we have received from all of the agencies 13 lists of funding and institutions that are involved, 14 and are getting ready to proceed with site selection. 15 The Department of Energy's business office is engaged 16 in negotiation with subcontractors so that we have 17 this in a timely manner, and we have obtained OMB 18 clearance on the production act to proceed with this. 19 That's all. 20 THE CHAIR: Questions for Jeremy or me? 21 DR. STEVENSON: A question in time 22 frame is the question, can all this be gathered? 23 DR. SUGARMAN: I guess the concern we 24 have is we're waiting to see how much longer it's 25 going to take for DOE to finish negotiations in the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 30 1 procurement office, and we feel that that's around 2 the corner. We think, at least in the outline we say 3 we need four months. This is from the day we get 4 clearance to, to move ahead. 5 But there are some, in terms of we are 6 trying to move as fast as possible so we don't get 7 into awkward times to talk to people, like around 8 Thanksgiving and Christmas and those sorts of things, 9 and so the question is -- 10 DR. STEVENSON: So it would be like in 11 November? 12 THE CHAIR: Yeah, the first one was for 13 clearance, the next one was clearance at the 14 institution, and there we will just move as quickly 15 as we can. 16 MR. SUGARMAN: And actually in that 17 process what I've been doing, as soon as we identify 18 which institution we'll be interviewing, is beginning 19 relations with people at the institutions to start 20 that along, and have a subcontractor pick out what 21 the other aspects are. And so that's what we're 22 trying to get done. 23 THE CHAIR: The rationale that emerged 24 after the first, and it was to send it to staff, to 25 Henry and Mary Ann, which was very nice, too, and it 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 31 1 is also prompted by an efficiency consideration. And 2 it concentrates on four geographic areas, selected by 3 us. 4 Each area is anchored by an institution 5 that's in the top four of the top institutions that 6 are receiving federal funds. We can conserve 7 resources and blitz a geographic area and hit the 8 high funded university-based institution, the VA in 9 that area. 10 We see if there's, looks like there's a 11 military facility not connected with that same 12 geographic area that we can throw in in almost all 13 cases, which will make the work go more quickly, 14 which is a big concern as well, which is the 15 efficiency in the community hospital. 16 And so getting all the folks on the 17 military installations and university hospitals. And 18 we might be missing someone we might be interested 19 in. 20 And I understand there are others who 21 might be interested. And so that's the strategy. 22 And we expect Jeremy to be on the road 23 a lot over the next couple of weeks making contacts 24 and connections so that we can then proceed with the 25 IRB work. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 32 1 One of the most gratifying things in 2 this particular area was that we got support from, 3 from the physicians that we spoke with at the 4 institutions, and that, "Yes, if, if our place is 5 selected we will help you do this work. We think 6 it's important to understand somewhat about the 7 subjects, to understand, and it's important, ought to 8 be done right." 9 So it was great to hear that. But it's 10 clear that to get that level of support we need to 11 meet with people and explain who we are and why we're 12 serious about this, and why we don't come in with 13 previous judgments about the outcome, and all of 14 those things. 15 So, thank you, Jeremy. 16 DR. SUGARMAN: Yeah. 17 THE CHAIR: Okay, Ruth, can we hear 18 about the-research proposal? And we have a memo 19 about this one. 20 SUBCOMMITTEE REPORT ON THE RESEARCH PROPOSAL REVIEW: 21 DR. MACKLIN: Actually we have, it's 22 under Tab E. Everything that I'm going to say is 23 under Tab E. 24 Let me begin by telling the whole 25 Committee that what we now in this subcommittee 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 33 1 decided not to do. Remember we had a lengthy 2 discussion at the last meeting about whether we were 3 going to look at published research post-1974 and try 4 to get a, some additional insight by looking at the 5 publications. 6 The Subcommittee met in a 7 teleconference, and we were joined by Duncan and Pat 8 King, who had raised some questions in our meeting. 9 And in the end we concluded that we would not pursue 10 that avenue of the inquiry. 11 So we will not be looking at any 12 published reports of research, but we'll limit our 13 review to the prot-, to the proposals themselves. 14 Now, under Tab E in the October third 15 memo, most of what's there is what I'm going to say, 16 but there are some updates. So there were really two 17 questions: 18 What materials will be requested for 19 this proposed review of research proposals? And how 20 will the review be done? 21 Let's look first at the, what materials 22 will be requested. 23 DR. MACKLIN: The entire universe of 24 radiation projects involving for FY-1993 are being 25 requested. All right, that's all 1993 radiation 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 34 1 proposals. 2 A smaller number of non-radiation 3 research will be drawn for review, and I'll say in a 4 moment, in a moment I'll say something about just 5 what the sample plan is and how the comparison will 6 be made. So it's all FY-1993 radiation. 7 And now there's an update on the tissue 8 part. There is, we had some discussion about whether 9 this would include only research on ionizing 10 radiation that affected the whole, where, where the 11 person was a research subject, or alternatively, 12 tissue samples drawn. 13 And the, the decision was made to add 14 tissue, all tissue studies where the tissue was 15 collected after a research subject's exposure to 16 ionizing radiation. So there won't be any tissue 17 studies of non-ionizing radiation, but all those 18 studies which tissue was collected after ionizing 19 radiation. 20 Now, that's the what. 21 And where we're going to get these 22 things from, the grant proposals themselves are going 23 to be sought from the federal funding agencies, and 24 if you want to see which agencies have said that they 25 have them -- 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 35 1 Does everyone have the October seventh 2 Addendum? 3 (Whereupon, a response was had.) 4 DR. MACKLIN: You do? Okay, this is on 5 the October seventh Addendum on Page 2, which is, the 6 reverse side is the up-to-date chart. 7 So, as you can see, there are five 8 agencies involved, and two agencies, HHS, DOD, are 9 broken down into intramural and extramural, and in 10 part that will be for the purpose of comparison with 11 the non-radiation proposals that will also be 12 reviewed. 13 So what you see there is, the material 14 on the, on that chart, on that table is based on 15 materials that are received by the staff from each 16 agency. So the prop-, the grant proposal as 17 submitted for federal funding will be sought from the 18 agencies. 19 What will be requested from the 20 universities and research centers or institutions 21 will be the following: 22 The Application submitted to the IRB, 23 including the originally-prepared consent form and 24 the consent forms approved by the IRB, which, of 25 course, may be the same as the one that was 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 36 1 originally proposed, it may be different; and the 2 final disposition letter. 3 So now, just as a reminder to the 4 Committee, this is a little less than what we first 5 thought we might be requesting. That is, there's no 6 mention here of requesting Minutes of the IRB meeting 7 or other correspondence. 8 In recalling our earlier discussions 9 there was discussion about recalling the memos 10 between IRB chairs and administrative personnel. So 11 these are the things that will be requested and 12 coming from two different sources. 13 Now, the numbers. Here, please go back 14 to Page 1 of Tab E. 15 Under the research involving ionizing 16 radiation, the total number is, of, of research 17 proposals is expected to, is around 250, and the 18 people who know about these things estimate that 19 there's likely there will be a 50-percent return rate 20 within our time frame. 21 THE CHAIR: That would be for the IRB 22 materials. We'd expect a hundred percent from the 23 agencies, right? 24 So we would get the grant proposals on 25 everything, but we're going to guess we'll get a 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 37 1 50-percent hit rate, maybe we'll do better, on the 2 IRB material. 3 DR. MACKLIN: But this will be the, I 4 mean, the main subject will be, we're, we're counting 5 on that number of the 125 to review. 6 THE CHAIR: That's right. 7 DR. MACKLIN: Now, as I mentioned, 8 there's a smaller subset among those not involving 9 ionizing radiation, and here the plan is to draw a 10 random sample of 100 non-radiation FY-1993 human 11 studies. And in order to effect the comparison, the 12 proportion of the, these will be divided 13 proportionally as on the back of the table; that is, 14 the 100 non-radiation will be divided proportionally 15 to reflect or mirror the radiation. 16 That is extramural, intramural, the 17 DOE, et cetera, as on the table. And on the one axis 18 the studies, studies, diagnostic studies, so this is 19 what our experts tell us will be the base for 20 comparison in all of these categories. 21 And now finally, the methods, how will 22 this be done and who's going to do it, and how long 23 will it take? The time table, the definitive time 24 frame is on Page 4 of the October seventh memo. 25 That's the last page of this memo. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 38 1 And as you will see, beginning November 2 eleventh, I'm sorry, I'm sorry, November fifteenth, 3 November 15, this is a process of getting, the sample 4 time frame, get the lists, the abstracts, et cetera. 5 And all of that will take place the, I mean, has been 6 taking place up to the deadline of November 7 fifteenth. 8 So November fifteenth is when the 9 actual review will begin, and that, that's four more 10 steps: Evaluation criteria, training of 11 reviewers, -- We don't exactly know what that 12 training will be, but there's only, we'll be teaching 13 them how to apply the evaluation criteria to make 14 sure that all of the reviewers are doing essentially 15 the same thing in their review. 16 But actual conduct of the review, which 17 is the heart of the study or the review, is scheduled 18 to take place between November fifteenth and February 19 fifteenth. So as you can see, that is three short 20 months in which all of that reviewing will take 21 place. 22 And then the analysis, interpretation 23 and analysis of the findings will be after that. 24 Everyone here probably got a letter and request, as I 25 understand, asking, "How many do you think you can Human Radiation Experiments/SF 39 1 review, and in what months?" So it was broken down I 2 think by week, by two-week periods. 3 The expectation, I guess, is that the 4 flow will be a little less in the early months, and 5 we'll have a final blitz in January and February. 6 And this will be, the tasks will be divided up 7 amongst the committee members to take on whatever 8 numbers they have volunteered, and staff. 9 Does that -- Any questions about 10 sampling should go to someone other than me. 11 THE CHAIR: Any questions? 12 Nancy. 13 DR. OLEINICK: Yes. In your table on 14 the October seventh addendum, is, are some of these 15 places blank because information was not received 16 from the agencies? In other words, what I see under 17 "HHS Intramural" is no tracer studies, no 18 epidemiological studies, no therapeutic studies. And 19 certainly -- 20 THE CHAIR: Could we have Sara come up, 21 who I feel should be commended, by the way, for 22 putting this all together so coherently for us? 23 MS. CHANDROS: Okay, in the case of 24 DOE, it hasn't been sorted. 25 DR. OLEINICK: It wasn't DOE I was 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 40 1 asking about. It was HHS intramural. 2 MS. CHANDROS: Oh, I see. The blanks 3 are we don't have, when we started in those 4 categories if they weren't shaded the, it doesn't 5 mean there weren't ongoing studies, ones that were 6 previously initiated, so those are the ones that 7 we're only getting new proposals. 8 THE CHAIR: So we take it this is 9 complete; they didn't have any new starts in the 10 therapeutic or tracer area? 11 MS. CHANDROS: It appears that way, 12 yes. 13 THE CHAIR: We can verify that if -- 14 DR. OLEINICK: It seems a little 15 strange. 16 DR. MACKLIN: So even -- 17 DR. STEVENSON: It seems even worse in 18 DOE. 19 MS. CHANDROS: We had two radiation 20 studies, but it turns out they weren't new starts. 21 They were ongoing studies, so there were none. 22 THE CHAIR: You want to tell us -- you 23 might as well tell us, with DOE and DOD, so 24 knowing -- 25 MS. CHANDROS: Okay, with DOD it's, we 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 41 1 received all current active, but it doesn't specify 2 whether they were specifically FY '93 new starts, so 3 we're in touch with Operations officers to try to 4 determine that. 5 And with DOD we received a notebook 6 full of radiation studies that we're sorting through, 7 and it seems like those were all intramural. And so 8 in that case we're still waiting for extramural 9 studies for them. 10 MS. NORRIS: On reviewer training and 11 consistent application of the evaluation criteria, 12 are you developing a form, a checklist-type of form 13 for the use in this process so there is some 14 consistency with people over the years? 15 DR. MACKLIN: Well, I don't-know about 16 checklists, but I think the, the first step will be 17 to go back to the criteria that we looked at briefly; 18 that is, all of the elements and, and what the, 19 remember the, the things that we looked at so far, 20 which were just a, a first cut at bar: the, what 21 would be the ideal characteristics, without either 22 saying what is adequate or what is less than 23 adequate. 24 But we haven't yet gotten to the point 25 of, of discussing whether it will be a checklist. I 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 42 1 mean, the first step, as you can see by the time 2 frame, developing the evaluation criteria, is 3 finalizing evaluation criteria. 4 It doesn't say "finalizing developing." 5 You've got to start before you finalize. 6 But presumably that will take place. 7 That's going to be done first. 8 Now I hear Phil saying, "You have to," 9 right? 10 DR. RUSSELL: Well, you've got to have 11 some structure 12 DR. MACKLIN: Yes, structures. 13 DR. RUSSELL: -- of categories and 14 checklists. 15 MS. NORRIS: Yes, an evaluation form 16 setting forth what we're looking for. 17 DR. MACKLIN: Right. Remember the, the 18 discussion we had. 19 I mean, this is just my idea of how 20 best to do it, is in this process, once we have, we, 21 we agree on what the elements will be that we'll be 22 looking at, instead of developing an exquisite 23 instrument to then compare to the, to the research 24 proposals, it would be good to go, to do a trial run 25 and go back and forth; that is, see the extent to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 43 1 what, how, how the research proposal looks, and then 2 glean from that what we can best put onto a form or 3 restructure. 4 I agree there has to be some structure. 5 I guess when I hear "checklist" it seems to me like 6 you're checking little boxes, and there may have to 7 be some qualitative assessments. 8 And that's what we don't know until we 9 actually look at examples of proposals. So I think, 10 the process of developing the evaluation criteria and 11 the form of the structure will best be done when we 12 start getting some of these and work on them, and 13 then probably bring them to the Committee to review. 14 THE CHAIR: Henry? 15 DR. ROYAL: Is there, it's possible 16 that the evaluation process may be heavily weighted 17 towards what's easy to do, as opposed to towards 18 what's important. What sort of thoughts can be given 19 to that? 20 1 think that might refer to your 21 checklist concept, that checklist, that easy-to- 22 record checklist, whereas the more difficult thing is 23 maybe more important. So how do we keep ourselves 24 from doing the easy way out? 25 DR. MACKLIN: Well, I'd like, I think 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 44 1 that's a very important question, and so I think if 2 you could suggest what's important that might not be 3 easy, I mean, here it's what's easy. 4 DR. ROYAL: All right, I'd be glad to 5 do that. 6 DR. MACKLIN: Here's what's easy. We 7 take, "Does the proposal address this or not?" 8 I mean, does it address subject 9 selection? Does it justify why certain subjects were 10 selected? 11 Does it say anything about various, a 12 nationality of subjects over certain ages of 13 subjects? Does it address certain levels of risks? 14 Once it says, "Yes," or, "No, it doesn't," then 15 that's the end of the checklist. 16 If it's yes, you may get into something 17 more difficult. But I'm interested in hearing what 18 you have to say about the difficult part. 19 DR. ROYAL: Well, at least in the 20 institutions that I'm familiar with they have a 21 boiler plate for these forms, and everyone knowing 22 what the boiler plate is. And for my own personal 23 interest I'd be surprised if the major issues weren't 24 keenly addressed. 25 It's not that no thought was given to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 45 1 it. It's just that that agency had the boiler plate. 2 And so if we were to just check off 3 whether the boiler plate issues were addressed, that 4 doesn't seem very difficult, even though it's easy. 5 The difficult things are these assessments, and 6 whether or not the quality of the research justifies 7 what the subjects were exposed to. 8 THE CHAIR: Duncan? 9 DR. THOMAS: I hate to, but could I 10 revisit the question of the selection of protocols? 11 THE CHAIR: Uh-huh. 12 DR. THOMAS: We're just now have, 13 having some data in front of us about the 14 distribution by agency and type of study, 15 THE CHAIR: Right. 16 DR. THOMAS: -- and it's not as massive 17 distribution as we would have hoped. And I wonder 18 whether or not it's time to reconsider our position 19 to use, or to look at all 1993 new-starts radiation, 20 radiation studies and do a -- 21 The fact of that decision means that 22 we'll be able to say nothing at all about the VA, and 23 precious little about NASA, and at least I don't know 24 about DOE or others, but maybe a substantial amount 25 of these. If there are substantial numbers there, 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 46 1 I'd point out that that, of course, is well below our 2 250 that we've said we would start out with, but 3 maybe it's not that many. Do we have the -- 4 MS. CHANDROS: Just a, with DOE we have 5 approximately 60 protocols, but that will be pared 6 down as we figure out which ones are not new starts. 7 But there are 60 we have to work with. 8 And DOD I don't know about at all. 9 DR. THOMAS: Well, an option, we, we 10 have more than enough proposals in NHS, and they 11 individually fill in all of the categories. A lot of 12 the other categories horizontally, a lot of the 13 categories are not really represented, and in those 14 areas where representation isn't very good, I wonder 15 whether we shouldn't reconsider possibly extending 16 the current '93 proposals, or if necessary even to go 17 to other years so that there would be some 18 representation, hit or miss the controls. 19 If we have zero radiation proposals 20 from VA, that also means that if we apply the 21 rules 22 THE CHAIR: I think this is the right 23 time to raise this, and it's an important point. 24 Could I ask you a question? 25 Would your proposal, at least intending 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 47 1 thoughts, that if we were to say, "Okay, in order to 2 make sure that we have some entries for the VA and a 3 large number of entries for NASA, that we take 4 anything that was active until '93, regardless of 5 when it was started," would we need, would you think 6 we would need to do that for other departments as 7 well, or would it be all right to have different 8 requirements for the low volume agencies than for the 9 high volume agencies? 10 DR. THOMAS: I don't seriously think 11 that there's going to be very much shift over the 12 space of a couple of years between some agencies 13 initiating and others. Of course, it's not the nice, 14 neat comparison we would like to have, and the idea, 15 of course, but we shouldn't be straight-jacketed by 16 that decision if it means you end up with nothing to 17 work with. 18 THE CHAIR: So the idea is we expand 19 the eligibilities for VA and NASA until we've got 20 something to say. 21 DR. THOMAS: Yes. And say we don't 22 have enough examples for tracer studies, and we could 23 make that decision for other agencies. 24 THE CHAIR: To give us more tracer 25 studies, go back in time, which is, I saw other 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 48 1 hands. I saw Mary Ann and then Phil, Mary Ann, Phil, 2 and Nancy. 3 DR. STEVENSON: I'm sorry. 4 THE CHAIR: Mary Ann. 5 DR. STEVENSON: I have a question if we 6 do that, and I think it's something we should do. Do 7 we need to come up with sort of a minimum number? 8 And as Sarah mentioned, if you go to 9 actives we wouldn't have two for '93, so you're going 10 to have to go back further. 11 Just to make this easy you should come 12 up with a number for each category on the horizontal 13 and vertical that's acceptable, and tell the agencies 14 to go backwards until they come up with five or ten 15 or whatever. It's sort of -- 16 DR. THOMAS: I'd hate to commit us to 17 any particular number, but I'd like to come up with 18 that. We should do what would otherwise be called 19 quota sampling -- 20 THE CHAIR: Quota samples. 21 DR. THOMAS: -- and continue -- 22 DR. STEVENSON: Quota sampling. 23 DR. THOMAS -- sampling until we fill 24 that quota. 25 THE CHAIR: Also it's always nice to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/S-7 49 1 have a technical label. "Quota samples" is just, I 2 knew all along we had to do quota samples. 3 DR. THOMAS: If you really want to call 4 it something you can call it negative (inaudible). 5 THE CHAIR: I can't even pronounce 6 that, so we'll go back to "quota samples." 7 Phil? 8 DR. RUSSELL: So let me clarify my 9 thinking here. These approved and funded were all 10 new starts. There were no old -- 11 THE CHAIR: That's correct. We've 12 asked for new starts. 13 Now, if it was a competitive renewal I 14 don't know whether that would have fallen out as 15 opposed to -- so just a year two, or year three. A 16 competitive renewal I think comes in as a new start, 17 but it, if it's somebody who comes in Year Three on a 18 five-year grant it was not in here. At least we 19 tried to keep them out of this list. 20 DR. OLEINICK: Well, that's why I think 21 particularly pointing to these same empty boxes for 22 the intramural HHS, those projects are renewed, 23 intramural projects are renewed every three or four 24 years anyway. They have to be, just as extramural 25 are. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 50 1 And so I can't imagine that there 2 aren't any under that. And so it could be that they 3 just eliminated anything that was committed. 4 DR. THOMAS: Well, I'm wondering about 5 that box as well, and I'm wondering whether the focus 6 is on the clinical center for reporting as opposed to 7 intramural as a whole. For example, there are, I'm 8 sure, all kinds of activities in the radiation 9 analogy. 10 DR. OLEINICK: Right. 11 THE CHAIR: And CDC. Right. 12 So we need to think back. Could we go 13 to, to Mary Ann's question, and, and Henry's, and 14 quota samples? So what's the quota? 15 DR. THOMAS: If you want me to pick a 16 number out of the air there's some justification to 17 the number five, but I think -- 18 THE CHAIR: That's good. 19 DR. THOMAS: -- we can work out the 20 details of what that number ought to be. The point 21 is, in those areas where we have others, and others 22 like HHS intramural diagnostics test, we don't need 23 72 of those. 24 THE CHAIR: So we can do a random. So 25 the propose, as I'm hearing, is that we will have, we 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 51 1 will go to quota samples so that every cell, insofar 2 as it's possible, would have at least five, and for 3 cells above a certain number we would do a random 4 sampling. 5 So we wouldn't necessarily look at all 6 72 diagnostics studies funded extramural, all 7 diagnostic studies in 1993, but we'll do a random 8 sampling so we can keep the overall number to the 9 250, more or less, that we -- 250, is that, is that, 10 we thought we could if we killed ourselves manage to 11 adequately examine? 12 DR. MACKLIN: Was the, did, was the, 13 was the plan, was 250 the number that was chosen, and 14 then the method of sampling based on the, the 15 do-ability of 250? In other words, is it working 16 backwards? 17 THE CHAIR: No, I think 250 was just 18 our guess based on when we were telling the first 19 agency to give us information, which was HHS, 20 assuming that they accounted for the biggest clump, 21 and what we had, I know we guessed the total would be 22 about 250. 23 Fractionally I'm quite concerned if, 24 about the high volume of DOD. We estimated there 25 would be six DOD new starts. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 52 1 DR. MACKLIN: So the number 250 was not 2 a number that was arrived at for any reason other 3 than the expectation that that was all the FY-1993 4 new starts? 5 THE CHAIR: It's, it was a little more 6 iterative than that, because what we were trying to 7 do was, I was trying to do with staff is see, well, 8 what is it likely to be? And can we handle it? 9 If it turned out to be 700 was the 10 expected number, we would have immediately proposed 11 we do some sort of samples because we can't handle 12 700. When, when it came up to 250 we said, "Let's go 13 with the universe." 14 When it turned out that the number 15 turned out to be, look like an actual number, we 16 said, "Let's go with the universe." 17 DR. MACKLIN: Going back, it seems it's 18 important to fill the cells. There's nothing to, 19 nothing magical about the previous year. 20 I mean, nothing happened in these few 21 years to make one think that IRBs have drastically 22 changed their criteria for review, for, for 23 recruitments, or anything. So I think, s.o, I mean, I 24 think we can make a good justification that we want 25 as good a cross-section, rather than limiting it to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 53 1 1993, as if the most recent was somehow more 2 important, I mean, the 1993 was the more important 3 to -- I would endorse that. 4 THE CHAIR: So the proposal, as we've 5 discussed it and as was suggested, is agreeable with 6 everyone? is this, this modification is okay? So 7 that's our modification. 8 We will anchor in '93 and branch 9 outward, depending on how far, to try to reach at 10 least five in each cell. There's no, if, if it was 11 in the '90s by some agency, is it all right if we 12 stop on that '90 point so just when writing it up 13 we'll be able to say, "It was initiated in 1990 or 14 sooner," this decade? 15 DR. OLEINICK: The '90s. 16 THE CHAIR: The '90s. This, this was 17 the studies of the '90s. 18 DR. THOMAS: How about if we go into a 19 little huddle and work out the details? So five a 20 cell works up to 175, but some sort of compromise of 21 some number recurring in each cell, and the marginal 22 distribution if -- 23 THE CHAIR: We should know that some 24 cells won't be filled, right? They just won't exist. 25 DR. THOMAS: And so combined with the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 54 1 cutoff that we started by, we'll look at the '90s? 2 THE CHAIR: Right, but I appreciate 3 DR. THOMAS: we'll continue to be 4 discerning to try to fill each cell. 5 THE CHAIR: we'll definitely take your 6 offer to look at the details. 7 All right, Mary Ann, did you want to 8 say anything? 9 DR. STEVENSON: No. 10 THE CHAIR: Are there other questions 11 or comments for this process? We, we do, really do 12 need to hear from you about your interest and 13 willingness to participate in the review process. 14 I know many of us have sat on IRBs and 15 you know this is not a ten-minute enterprise to sit 16 down. This is a serious effort that will take a 17 chunk of time. 18 And as we budget for figuring out how 19 much staff and how many committee members, and when 20 they're available, how are we doing it? 21 MS. CHANDROS: Collectively the 22 Committee is willing to review more protocols than we 23 actually have scheduled. We've gotten a tremendous 24 response from committee members. 25 THE CHAIR: That's terrific. Have we 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 55 1 heard from everybody, or not? 2 MS. CHANDROS: I think everybody who 3 was interested in doing an interview process. 4 THE CHAIR: Ruth? 5 DR. MACKLIN (To Dr. Thomas): No, go 6 ahead. 7 DR. THOMAS: It was my understanding 8 when we first got into this it was going to be a core 9 group of three committee members that was going to do 10 most of the reviewing, and the rest of us would be 11 called upon as third reviewers in the case of 12 discrepancies or when we had special expertise to 13 offer. 14 This sounds like a little bit different 15 procedure. What's the pact? 16 DR. MACKLIN: I can't really speak to 17 that. I mean, I, I, I'm, this is a, requires me to 18 jog my memory for what we originally decided, but I 19 don't, I don't know. I mean, 20 THE CHAIR: I think the original 21 proposal did have a core group of perhaps three 22 committee members and three staff, and I think what 23 happened is running the tentative numbers it looked 24 like that was a huge burden that couldn't be 25 accomplished. Maybe that's wrong, but the notion was 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 56 1 we needed to spread the work. 2 Now, of course that dilutes the process 3 of evaluation some, and the tradeoff is obvious in 4 terms of quality, consistency, and quality-control 5 types of issues, and the potential for disagreement. 6 The advantage is this is a committee 7 project, and for, the committee together has to 8 struggle with its understanding of how things are 9 going. And there's something nice about having all 10 of us look at some of them, rather than a few of us 11 look at all of them and report to the rest of us. 12 We can let us all get a feel for what 13 the contemporary experience is, but I don't know. I 14 mean, there's -- 15 DR. MACKLIN: Well, yeah, I want to 16 make two points about that. First, the composition 17 of the reviewing teams, since it's very likely, and 18 we did discuss this before, that there will have to 19 be someone with medical and radiation expertise on 20 some of them, not only for the purpose of evaluating 21 a level of risks, but also for looking at the, what 22 the proposal says and what the consent form says, 23 since very often the proposal is so much more 24 technical, as it, as well it is expected to be, than 25 the consent should be, than the consent form. Human Radiation Experiments/SF 57 1 It requires someone who understands and 2 knows the science to be able to translate from what 3 the proposal says to what the consent form says. So 4 it almost of necessity is going to require our 5 scientific experts to be paired with, with others 6 for, for any of these. 7 So I don't know how that particular job 8 is going to be done. 9 THE CHAIR: What we haven't really 10 figured out is how to do this; whether they should 11 create three teams of three people and assume then 12 this team gets 20 and this team gets 20, and you sort 13 of work it out, or whether we treat everybody as an 14 individual and every protocol, every project gets two 15 reviews. 16 You know, like a study section. 17 There's Reviewer A and Reviewer B, and Reviewer A and 18 B don't get together until the meeting kind of 19 things, as opposed to Reviewer A and B being on the 20 phone doing, hashing it out. I think we need to work 21 something out. 22 And Ruth, maybe just continue how you'd 23 like to see it done. If people here have thoughts 24 about it we can certainly have a conversation. 25 DR. MACKLIN: I'd like to make another 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 58 1 comment, that Duncan had a piece of paper that 2 reflected the Committee's thinking, and now we've 3 exchanged it, that there is a strong reason for 4 having more people involved in this, and that is 5 having a check. 6 That is, if some people on this 7 Committee are not involved in this process, and the 8 proposal reviewers then come out with the report, 9 it's, it, it, it would be too late in the game for 10 someone then to say, "Wait a minute. I want to look 11 at these proposals, and I want to look at them," and 12 then find there might be some kind of a disagreement. 13 So I think there's great virtue in 14 having as many people as possible involved in the 15 very beginning for cross-validation. 16 THE CHAIR: In mechanics of how we're 17 going to do this we haven't figured out whether we 18 should prepare people or teams or -- 19 DR. OLEINICK: I would like to make a 20 strong case for independent reviews initially. It 21 doesn't mean they can't be paired later and, in one 22 consensus opinion, you know, but I just, in a study 23 section I think a lot comes out from independent 24 reviews, which I think would be missed if, you would 25 not get two sides of the story if you had only a 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 59 1 committee deciding. 2 THE CHAIR: So you're, you're, you're 3 endorsing the motion that -- 4 DR. OLEINICK: That independent, 5 whatever, two independent reviews. 6 THE CHAIR: How can you reconcile the 7 numbers? 8 DR. OLEINICK: However you reconcile 9 the numbers. 10 DR. THOMAS: With whatever is 11 happening. But I, I think, well, first of all this 12 issue demonstrates about the training of reviewers is 13 important so that we're, all of us, starting out with 14 some sort of accord, understanding what we're trying 15 to-do, and with some, hopefully, consistency possibly 16 with this. 17 But I think the only real connection we 18 have is some sort of random assignment of 19 individuals. And as soon as someone makes a 20 judgment, "This is a tracer study, and Mary Ann is 21 also experienced in that sort of thing, so we should 22 send that sort of thing to her," and we make this up, 23 then we're going to get in trouble. 24 And I don't see any way to try to 25 guarantee some sort of representative. So it doesn't 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 60 1 mean that every proposal will get a fair review, but 2 at least let's get an overall balance. And I think 3 that's important. 4 THE CHAIR: Humm. Is that -- I haven't 5 thought of that. I, I think that's important. 6 DR. THOMAS: At least as far as the 7 first two initial. Should there be some sort of 8 discrepancy, at that point perhaps a third reviewer 9 would be in order. 10 THE CHAIR: Phil, did, did you have 11 anything? 12 DR. RUSSELL: It seems to me that 13 perhaps the important conclusion would be drawn from 14 the minority, and those that get a D-minus or an F 15 would be something. And it may be that you'd have a 16 process for, for a broader review of the outlines. 17 That may become the center for 18 contentious conclusions. It's just a thought, but, 19 you know, it's, if a red flag of some sort comes up 20 in a proposal, then we need to have a broad, 21 DR. OLEINICK: You need to have 22 the -- 23 DR. RUSSELL: -- a broad review by the 24 Committee, including someone who's an expert in the 25 field. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 61 1 THE CHAIR: And we also have permission 2 if we feel we need particular expertise that calls 3 for an expert outside of the Committee, just as an 4 IRB can seek a consultant on a technical point. 5 DR. RUSSELL: So we can consider a 6 process for that right up front. 7 THE CHAIR: So we need a process for 8 that, too. 9 In terms of randomly assigning 10 proposals to members of the committee, is there 11 thinking about whether we should stratify that 12 random, the science members, the members of the 13 committee that have scientific expertise versus those 14 who don't so the initial review has one science-based 15 reviewer and one non-science reviewer? 16 DR. THOMAS: Except you did have a 17 thing saying half done by staff and half by 18 committee. 19 THE CHAIR: Well, the staff also 20 divides that way. I mean, some of our staff has 21 science expertise and some of our staff has other 22 expertise, so regardless of whether it's staff or 23 committee, we could have two pools, those that have 24 science expertise and those that don't have science 25 expertise and bring other areas to bear. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 62 1 And it doesn't mean that the science 2 types can't comment, or non-science types can't 3 comment on the initial reviews, but that it would 4 have one reviewer from each one that has scientific. 5 And, and people who don't know which 6 group you want to be, you can self-certify. Whatever 7 expertise you'd like to service, we would adopt, 8 rather than label you. 9 DR. MACKLIN: Science and non-science, 10 of course, is a very crude division. 11 THE CHAIR: Well, you can -- 12 DR. MACKLIN: No, no. I'm agreeing, 13 and I think it should be a crude division, but with 14 the understanding that the areas of particular 15 expertise that the medical scientists and the 16 scientists on this committee have, can be used as 17 consultants. 18 For example, someone may perfectly well 19 understand what's going on in, in the, in the 20 research proposal, and understand the words and the, 21 even the purpose, but without knowing that field of 22 research, even someone who understands the research 23 may not be able to say, "Is it necessary? Isn't this 24 known? Is it necessary to put subjects at risk, 25 given what's been done and what's the state of the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments 63 1 art of the field?" 2 so there may be the need for 3 consultants in asking critical questions about a 4 research -- 5 THE CHAIR: This gets to the attention, 6 the, and I think Duncan's original formulation. On 7 the one hand you get a therapeutic study and it's 8 cancer radiation therapy, and the issue is, you know, 9 do we go to Mary Ann and Eli, and say, "We'll reserve 10 you for the expert role," or do we randomly rely on 11 Mary Ann to get it if she gets it; if they don't get 12 it, they don't get it? 13 And then we address the, Ruth's point. 14 On, obviously if I'm the reviewer do we rely on Mary 15 Ann? 16 "I don't understand, Mary Ann. There 17 are really areas for people with metastatic carcinoma 18 other than X." 19 I don't know how to answer that 20 question, but maybe we should. 21 DR. THOMAS: I think I liked our study 22 section model how we should behave. We should 23 initially write our reviews independently and lots of 24 us will deal with it in one class. 25 Those of us that indicate in our 1-800-435-2408 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 64 1 review, we indicate we don't understand what's going 2 on in this review, we need to educate as a reviewer, 3 for those who need some mechanism to get the two 4 primary fields together, with some other people, 5 either consultants or other reviewers from staff or 6 committee, to reach a consensus judgment like that, 7 to talk about it and, and reach a consensus feeling. 8 THE CHAIR: And an important staff 9 function, in addition to being a co-reviewer, will be 10 pulling those things together. So we will work 11 closely with the staff to allow for that kind of 12 thing to happen. 13 DR. MACKLIN: I had suggested 14 previously, I'll make this suggestion again, that as 15 the proposals begin to come in we do a little pilot 16 to see what happens. I mean, the time frame is good, 17 but I think we may fall behind if we're scrambling 18 behind. 19 THE CHAIR: Yes. 20 DR. MACKLIN: Once we start on the -- 21 where are we? Somewhere between, after November 22 fifteenth and even before the training of the 23 reviewers if, if possible, as the proposals come in, 24 to do a few little pilots just to see how they come 25 out. And then we'll get, then we'll get a better 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 65 1 idea not only how to develop the criteria with the 2 proposals, 3 THE CHAIR: The process -- Right. That 4 will be easy to do if we don't mind doing it from 5 just the proposals and grant proposals, because the 6 IRB materials won't be in for a while. The grant 7 proposals we hope to get rather rapidly. 8 Since we'll be getting them from the 9 agencies we would expect that these are easily 10 retrievable documents, and these are easily 11 retrievable. So we would expect to do that. 12 We could do the pilot with only the 13 grant proposals. 14 DR. MACKLIN: But I think that would be 15 useful anyway because it would give us, certainly 16 give us an idea of what kind of material is in these 17 grant proposals -- 18 THE CHAIR: Sure. 19 DR. MACKLIN: -- and what we're not 20 seeing. 21 THE CHAIR: Right. 22 DR. MACKLIN: So, I mean, just as a 23 start. And then when we get other material later 24 we've got that much done. 25 THE CHAIR: Sara, do you have -- 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 66 1 MS. CHANDROS: We were looking in some 2 cases, too, when we received the abstracts we also 3 received some consent forms and some full proposals, 4 and that's a special priority. So we do have some 5 already, materials, of how we would use it in the 6 pilot. 7 THE CHAIR: Okay, so we should be 8 thinking that then about how to be structuring a 9 pilot, modify the time frame and see how we're going 10 to do that. 11 Duncan. 12 DR. THOMAS: Am I imagining that, or 13 did I read somewhere in here that we were going to 14 have a pilot series based on some other series, like 15 1994? 16 THE CHAIR: I think one time we talked 17 about that. You have a wonderful memory. 18 DR. THOMAS: But I do make mistakes. 19 The 1993 ones which we want to make our final 20 recommendations on I'd hate to screw up. 21 MS. CHANDROS: That was proposed in a 22 teleconference. 23 DR. MACKLIN: But that's not reflected 24 in the report. I don't think there was a firm 25 decision on that. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 67 1 THE CHAIR: You are concerned, Duncan, 2 that in the traditional sort of research sense, if we 3 use a subject for a pilot we can't use the subject in 4 the real study? 5 DR. THOMAS: Well, nothing is firm, but 6 I realize there's a practical application and we also 7 hate to throw away things, too. 8 DR. MACKLIN: All right, I've lost my 9 words. I'm not going to call it a pilot. Let's say 10 we'll begin the process as soon as we have a few 11 proposals to work with, and it will give us a head 12 start. 13 THE CHAIR: There you go. We're all in 14 agreement. 15 All right, are there other questions or 16 comments? This has been a very useful discussion. 17 (Whereupon, no response was had.) 18 THE CHAIR: Okay. Thank you, Sara. 19 Thank you, Ruth. This is great. 20 How about if we have our fourth 21 subcommittee, and that would be Reed, and see how 22 that goes? 23 REPORT ON THE SUBCOMMITTEE ON OUTREACH: 24 DR. TUCKSON: Actually mine is fairly 25 short, straightforward, and non-controversial. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 68 1 THE CHAIR: You said that once before, 2 but we're in a different city each week. 3 DR. TUCKSON: Right. Actually the 4 first part of our report, as you alluded, is the idea 5 of this meeting being in San Francisco. This is the 6 work of the Outreach Committee, and the fact that we 7 are holding this meeting in San Francisco is a very 8 important statement. 9 I think, as you have alluded earlier, 10 is that tomorrow we will begin, and in fact have four 11 hours of public testimony, is an important statement 12 as well to the priority that the Outreach holds for 13 the entire committee. And for, speaking on behalf of 14 the Committee, we're really happy that this was able 15 to be brought about. 16 Secondly, this morning several of us 17 were able to go to the, to the San Francisco 18 Chronicle and met with the Editorial Board. Needless 19 to say that Ruth did a fantastic job as chairman of 20 the committee in helping to, helping to answer and 21 explain and present our work to the Editorial Board 22 of the San Francisco Chronicle 23 THE CHAIR: Let me just add that 24 they're now going to be there without me. 25 DR. TUCKSON: Right. But I think it 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 69 1 was important. It was that kind of effort that we 2 wanted to do and reproduce in several other cities 3 throughout the country. 4 It worked well. We learned a lot and 5 they learned a lot. I think that was good. 6 The three cities and dates have been 7 determined for the small group to go and make 8 outreach visits. Cincinnati is first, October 21. 9 That meeting will be important in that it is the date 10 that our draft report, our interim report, excuse me, 11 the report comes out. 12 The, that will be interesting. But 13 most importantly is it also will coincide with many 14 of the advocacy groups and victims, groups in 15 Cincinnati, and so I think we will have an 16 opportunity to hear from a very large and very 17 passionate, and very critical mass of people in 18 places that we would not be able to hear from if we 19 did not go to Cincinnati. 20 I think that's going to be a very 21 important pivotal meeting, and that I, to the three 22 that are going. 23 Spokane is November twenty-first, and 24 then Albuquerque, slash, Santa Fe. We haven't quite 25 reached a decision about ease of travel or hassle of 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 70 1 travel, but that will occur on January thirtieth. 2 So those three are locked in, and 3 that's, and we're looking forward to those. 4 We discussed at the last meeting the, 5 the rules by which we were, or the protocol that we 6 were engaged in. And again, these are going to be, 7 we're going to stretch ourselves to the maximum such 8 that we can really hear from people and give them 9 time, and, and listen to people carefully. 10 And we're going to be fairly liberal 11 about how we do it, but also be fair and make sure we 12 don't actually live and move into those cities. 13 But finally, staff continues to work 14 with interested parties to appropriately maximize the 15 involvement of victims and advocates, and the staff 16 has been very diligently continuing that dialogue and 17 that process. And so that goes on even as we speak. 18 That's basically the things that we're 19 working on in Outreach. 20 THE CHAIR: Are there questions for 21 Reed? 22 (Whereupon, no response was had.) 23 THE CHAIR: Not any? 24 Thank you. 25 REPORT ON AGENCY UPDATES: 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 71 1 THE CHAIR: Maybe what I should do is, 2 is do the agency updates, and then we'll have our 3 break and then we'll see how long the discussion 4 goes. We will, depending on how long the discussion 5 of the sampling proposal takes, we'll either pull 6 something from the agenda for tomorrow or we won't. 7 Is that okay? 8 MR. GUTTMAN: Yeah. 9 THE CHAIR: Okay, we'll see how that 10 one goes. 11 Okay, let me just move to this just 12 very quickly, to the agencies, that we continue to 13 get a very high degree of cooperation from the 14 agencies. It really has been an exercise in open 15 government, and I say that because what I'm going to 16 do now is just real quickly review the areas where 17 there are, remain differences, but in doing that 1 18 don't mean to suggest that that's all that's 19 happening. 20 And we have lots of stuff that we can 21 say about all of the agencies, most of the agencies, 22 where things just by and large have gone quite well. 23 With respect to DOE, you may recall 24 that they had told us that we would have a completed 25 description of their record collection by the end of 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 72 1 September. This is critical for us because we need 2 to, we, we need those descriptions to know where we 3 want to put the effort to get more -- 4 Do you have an undate? 5 MR. GUTTMAN: Yeah, the correction. I 6 want to say we are working closely with DOE to see 7 what the status of those is at present, and we hope 8 that they're okay. 9 THE CHAIR: Okay, so we're not, we need 10 to get that wrapped up, is the issue, and I'm glad 11 that things are moving. That, this is, you know, 12 we're at points now to say we know what is out there, 13 and then make tough decisions about where to go 14 further. 15 That's great. As quickly as we can 16 wrap that up, that would be terrific. 17 We want to, today the Department of 18 Army is still behind in getting us the records from 19 its agency, to get those records from Headquarters 20 offices and Chemical Corps, as well as the 21 documentation surrounding the experiments they have 22 already identified. So we're hoping that we will get 23 that information or those records from DOD soon. 24 With respect to HHS, we're working, 25 they're working finalizing for us, we still don't 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 73 1 have it, but we hope to have it soon, the, the 2 finalized, a more filled-in list. I shouldn't say 3 "finalized." 4 We have a list from HHS of the research 5 that went through the Radiation Studies Section, and 6 it was called different things at different points, 7 so the Radiation Studies Section from the period 1944 8 to '74. You may recall that we decided that we would 9 use that as proxy for the work done supported by DHEW 10 during that period. 11 So this is even, sometimes the 12 investigator's name is missing, sometimes the title 13 is missing, or whatever. So we're still struggling 14 to get as complete a list as we can. And we're 15 waiting for that. 16 We're also waiting for a complete list 17 of the research that was done during that same period 18 at the Clinical Research Center, actually '54 on 19 there was a clinical center, but from '54 to '74. We 20 hope to get that very soon so we can start to dig 21 into that data. 22 We asked NASA -- I'm moving to, on to 23 NASA -- to give us a list of supporting documentation 24 by September twenty-third. We now hear from NASA 25 that they won't be able to complete that by the end 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 74 1 of September; sometime in November. 2 We again hope to get that as quickly as 3 we can so we can begin digging into the material. 4 With respect to DOD there just haven't 5 been much success in finding the Central Office 6 historical documentation at VA regarding this issue. 7 The focus now has shifted from Central Office to 8 identifying key field sites. 9 Maybe the yield will be better. So 10 we're still trying to figure out the research 11 strategy for getting -- 12 Finally with respect to National -- I'm 13 sorry. With respect to CIA, we received a report 14 from CIA recently describing the status of their 15 search. 16 The elements, some elements of that 17 search were dissatisfactory. We've conveyed our 18 concerns to the CIA, and we hope to report more 19 favorably in November about the range of what they've 20 been able to document. 21 As you may recall, we reported, we 22 discussed and the staff reported at the September 23 meeting that we now have documentation that makes it 24 plain that the representatives of the CIA did at 25 least attend hearings in which human radiation 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 75 1 experiments were discussed, and we're asking CIA to 2 flush why were those people there and what was the 3 documentation that bears on CIA's role. We want to 4 respond to an activity that was largely a DOD/NRC 5 effort but in non-DOD/NRC areas. 6 That's where we are with respect to the 7 agencies. We continue to get a lot of documents from 8 the agencies, and this is keeping the staff busy. 9 But is there also more to get? And 10 that's the purpose of the update. 11 And the more we meet, and we met 12 yesterday, the more we know that this is necessary. 13 All right, should we take a break? 14 DR. RUSSELL: Questions. 15 THE CHAIR: I'm sorry. 16 DR. MACKLIN: Yeah. It's hard to 17 exactly formulate the question, but you've given us a 18 general update, -- 19 THE CHAIR: Right. 20 DR. MACKLIN: -- and one of the things 21 at this point in the work of the committee, each time 22 we meet we hear that we have more material and more 23 background. And we read about the trips and the 24 discussion about more research is needed here and 25 there, and all from those discussions and the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436.-5733 Human Radiation Experiments/SF 76 1 committee meetings and the joint panel, et cetera. 2 THE CHAIR: Right. 3 DR. MACKLIN: Is there, I mean, can we 4 get some kind of report on whether we're getting that 5 material? In other words, the, a, much of the 6 discussion was, "Well, look. We don't know if these 7 experiments were ever done.n 8 Here we're talking about all this stuff 9 but we don't know whether they individually did all 10 the experiments. Is there any mapping of what we're 11 getting into, all the discussion that took place that 12 have all those conversions? 13 MR. GUTTMAN: Yeah. Can I address 14 that? 15 THE CHAIR: Yeah, good question. 16 MR. GUTTMAN: Let me not address the 17 question directly, but the underlying point. We are 18 all keenly aware that there is a short time frame for 19 this committee. 20 You have to have all this information 21 yesterday, so it's not as if we were in the business 22 of just collecting the information. By the same 23 token, it, at least it's my opinion that, A, the 24 purpose of the committee is to show the people where 25 the records are. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 77 1 The question is, you get something in 2 the last day. Ellyn Weiss says, "Do you still want 3 me to look through this?" 4 The answer is yes. We may not be able 5 to use it, but others will know it's there. 6 On that context we have an 7 understanding of where things are. So, for example, 8 if we picked the AEC or the DOE, and we can pick any 9 of these agencies, we can tell you exactly what 10 documents we have in the context of, say, the ethics 11 statement. 12 I can say with the AEC, for example, to 13 be very particular, we know that in April, 1937, '47, 14 there was the policy in writing to the University of 15 California in, in all, saying two doctors attending, 16 we have a 1951 letter quoting, in November, saying in 17 November, '47, there was a letter saying "informed 18 consent." 19 We now have the testimony, or the oral 20 history of Mr. Volpe last week saying he was there 21 and he's sure that the Commission, not the biology 22 people, but the Atomic Energy Commission clearly 23 would have put into effect from Day One an informed, 24 informed, written informed consent policy of the sort 25 that came out in November. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 78 1 Now, we haven't got all the commission 2 meetings. Some of it is still classified. 3 It may be six months from now that's 4 where we'll be. But we know that's the story. 5 I guess, take a couple of seconds to 6 run through it quite quickly, in the Defense 7 Department the lady who's sitting out there, of 8 course, has the, they've been doing some great work, 9 terrific work out there. You know that their 10 policies, this year, whatever the policy is, consent 11 policy is, their policies, something date back to the 12 30s. 13 We know, skipping ahead, that there was 14 a DOD policy, we've found last month that there was a 15 clear recognition that this policy applied in at 16 least some context regarding the atomic bomb 17 biomedical experiments. 18 Now, what more we'll find about the 19 extent of that policy: We know that the Army, for 20 example, has not been able to give us very much about 21 their particular radiation experiments in the '50s, 22 and whether or not those experiments came through the 23 Secretary of the Army's policy. That's why we're 24 saying we're looking forward to Army documents. 25 We know that the Air Force, the Army 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 79 1 implemented policy. It was an Army directive. 2 In the case of the Air Force it was not 3 a directive, but it was a letter to the Secretary of 4 the Air Force saying, "Here's the Air Force's 5 policy." 6 We believe in 1958 the Air Force put 7 into effect a policy. We don't know that. 8 The School of Radiation Medicine may 9 tell us, because they've got dozens of experiments, 10 telling subjects exactly what happened when they did 11 the experiments. Which policy, if any, did they 12 comply with. 13 We see that Colonel Pickering with the 14 videotape was saying, "We know it was with informed 15 consent." 16 We're saying, "What does that mean?" 17 We hope to hear from you. 18 So, in fact, we have quite specific 19 gaps. Obviously we're not going to get all of this. 20 THE CHAIR: I think what Ruth's looking 21 for is how much are we expecting. I think that's the 22 core of the question; not document to document, but 23 more broadly. 24 DR. MACKLIN: Yeah, more broadly so 25 that even if we know that was the policy in place in 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 80 1 one instance, or if we know there was a discussion 2 about using volunteers, one of the gaps in our 3 knowledge has been, "But did they ever actually do 4 the experiments?" 5 MR. GUTTMAN: We know that, and that's 6 part of the reason for the case studies, is to get 7 down to the level. 8 If I may make one, one more comment, 9 which is interesting. John will observe this. 10 What you come down to by collecting the 11 data is by looking at it in an intensive way, we were 12 going to talk about it a month ago, did the Nuremberg 13 Code apply in regard to human experiments? 14 And these experiments with the Navy had 15 Army soldiers crawling through radiolanthanum. And 16 they actually had that approved under the Navy 17 policy. is And so that's, what's the difference 19 between that and the -- you know, it's kind of an 20 exercise. And then we've noted that the Army 21 apparently did the same thing several years later and 22 it didn't apply. 23 So we're at the level, to answer your 24 question, we've got particular questions that say 25 they did it here but not there, and there was -- 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 81 1 THE CHAIR: Let me say, too, that one 2 of the things we've got to do, and we're all aware of 3 that, is that we've got to start putting that 4 material together. The staff has to start putting 5 that together in a way to ask the Committee to sort 6 of debate it and analyze it. 7 And that's the function we've developed 8 last time. And what we're trying to do after this 9 meeting and before the November meeting is create a 10 time line that will show you which, when which pieces 11 will be done enough so that the Committee starts 12 debating about what meeting. 13 So we can start to say, "Okay, we're 14 going to look at this piece of the world by November. 15 That piece of the world we're going to look at by 16 December." That kind of thing. 17 So we're going to try to put some order 18 into all of that for purposes of availability to the 19 Committee. 20 MR. GUTTMAN: Is that generally 21 responsive? 22 DR. MACKLIN: Yes. Yes, it is. 23 And what would help as we move into the 24 next phase is not only to have a, a con-, -- Did you 25 say a time line? 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 82 1 MR. GUTTMAN: Yeah. Yeah. 2 DR. MACKLIN: -- not only the time 3 line, but we should revisit the categories we're 4 interested in: namely, what were the policies and 5 procedures and practices? 6 What were, what experiments? Who knew 7 about them? Did they never trickle down? 8 That's what we learned in here quite 9 strikingly prior to today, that things were kept at a 10 very high level. So it's one question to ask, "Did 11 anybody ever talk about informed consent and the use 12 of volunteers?" 13 And we already know, yes, they talked 14 lots about informed consent. The question is, who 15 knew about this, and did they ever discuss it, and 16 did it ever trickle down to the level of researchers, 17 or the person who conducted those ever get to them? 18 So we want to be vertical as well as 19 horizontal. And we want to know about whether the 20 discussions were done before the experiments were 21 done. 22 And then we have to know about, did 23 they know about this policy or this memo? Who 24 vertically did that trickle down to? 25 So that may have been where the policy 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 83 1 was done, but the guys who knew about it were the 2 Secretaries, -- 3 THE CHAIR: Right. 4 DR. MACKLIN: -- the 5 THE CHAIR: Right, and that's 6 exactly -- obviously I don't know how -- 7 MR. GUTTMAN: That's, that's the 8 institutional case study, the -- 9 THE CHAIR: Yeah. More than that, we 10 have a very capable staff that seems to be able to do 11 that. 12 MR. GUTTMAN: Plus the other department 13 is going to find other duties. 14 THE CHAIR: We I think should take a 15 break-, and let me just make announcements, which is 16 break for the committee members will be in the 17 library, which is down the hall, into the dining 18 room, and to the left. Let's try it again. 19 Down the hall, into the dining room, 20 and to the left are the refreshments for committee 21 members. If we could reconvene at five of 4:00, and 22 we will try to end the meeting early, as I suggested, 23 so that we could go home and read. 24 (Whereupon, at 3:41 p.m. PT the 25 Committee took a brief recess and returned, after 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 84 1 which the following occurred:) 2 THE CHAIR: Would the committee members, 3 please come back to the table so we can resume the 4 meeting? All committee members. 5 I should have perhaps given a word -- 6 come on, group. 7 For those of us who live the, on the 8 East Coast, or near the East Coast, most of the 9 meetings are on the East Coast, we appreciate even 10 more than we normally do regarding the coherent 11 contributions as the rest of us struggle with the 12 time zone change for the first time in the context of 13 the, of this committee. 14 And again to remind everyone we are 15 going to try intentionally to end early this 16 afternoon so as to free up some time in the schedule 17 for committee members to read the draft report and 18 the staff's memo on the experiments. The order, 19 regarding the plutonium experiments, please read 20 those -- 21 MR. GUTTMAN: First. 22 THE CHAIR: -- first, because the 23 discussion of that is tomorrow afternoon. The 24 interim report discussion is Thursday morning. 25 It is our only real crack at the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 85 1 markup. Substantive issues of the general broader 2 discussions we'll have together, and then whatever 3 you do between now and Thursday morning, that's what 4 goes, is going to get done in regards to compilation 5 and production. 6 REPORT OF SUBCOMMITTEE ON BIOMEDICAL RESEARCH: 7 SELECTION OF CASE STUDIES: 8 THE CHAIR: Okay, what we're going to 9 do now is have a discussion of what is noted on the 10 Agenda, or maybe it's not noted on the Agenda. On 11 the Revised Agenda it is noted as a discussion of 12 "Biomedical Research, Selection of Case Studies," and 13 its reference is to Tab I, where there is a memo from 14 staff, and Barbara's going to lead us in that 15 discussion. 16 Just to remind everybody what this 17 represents, at the last session of our meeting in 18 September we had those five priorities up on flip 19 charts and we all voted and tabulated the votes in 20 terms of priorities and how do we, we utilize 12 eggs 21 in two baskets. And we calculated and we came up 22 with a sense of the Committee in terms of the 23 Committee's priorities for the remainder of its 24 tenure. 25 And one of the, it was either Number 1 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 86 1 or Number 2, 1 can't recall, was the acknowledgment 2 of, that the Committee had to deal directly with the 3 well-publicized cases that had come to the public 4 attention and about which there is controversy. 5 We also had lower in our list the 6 recognition that we needed to do perhaps some sort of 7 sampling of what we had been previously referring to, 8 referring to as a great unwashed, the huge, large 9 number, we don't exactly know what number, but the 10 large number regarding human experiments in 11 total-body irradiation. 12 Just to remind everyone, our strategies 13 for dealing with the contemporary period is what 14 we've discussed before the break, the 1993-ish review 15 of research projects. But with the period prior to 16 1974, we said one clear priority is that we must 17 address the, at least some of the well-publicized 18 studies that had received public attention, and that 19 also we wanted to develop some sort of a sampling 20 strategy for dealing with the great unwashed. 21 Duncan and I got charged with being a, 22 sort of an ad hoc one-shot sampling subcommittee also 23 to try to work out that issue and staff. 24 Also that, on the flip charts one of 25 the options was a strategy of focusing on subject 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 87 1 groups, and we had discussion of the, who they would 2 be and how it would proceed. And it emerged from 3 that discussion that the most viable subject group of 4 interest to pursue would be children. 5 And there was an ad hoc one-shot 6 subcommittee created, which was Mary Ann, Pat, and 7 Susan, to discuss, to work with staff to see whether 8 there was any promise in having a strategy that 9 focused on the research involving children as 10 subjects during that period. 11 Staff went back and took all three of 12 these issues with the acknowledgment by the Committee 13 that it had an obligation to look at the less 14 publicized cases that had received public attention; 15 that the, that there was a need to pursue whether it 16 was useful to look at children as a special group; 17 and also that we needed to do some sort of getting 18 outside of just the well-publicized cases, and 19 commenting on some broader number of experiments. 20 The staff memo probably should have 21 the, that represents the staff's attempt, with my 22 input, to try to put all of those three together into 23 a strategy which Barbara is now going to explain. 24 But it's an attempt to put together those three 25 issues into, those three priorities or strategies 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 88 1 into one comprehensive strategy. 2 DR. BERNEY: I want to say that during 3 the break I gave you a two-page memo, copy that says 4 at the top, "Subcommittee on Sampling of Biomedical 5 Experiments." 6 First thing that was decided was that 7 at this point we would not try to do any random 8 sampling. The justification, or the explanation for 9 that was that when we sat down and we thought about 10 how we would go about this, that you might very well 11 end up with a sample on which for half of the 12 experiments you could get no additional data besides 13 perhaps the name, perhaps the name and the PI, and 14 nothing else. 15 It didn't seem very, like, like a very 16 worthwhile endeavor, since you wouldn't get anything 17 else to assemble, and with a great deal of effort to 18 get it. 19 So as an alternative we started with 20 several of the well-publicized experiments, and then 21 tried to group other experiments into a category 22 along with them. So the experiments that we have 23 are, are in categories. 24 We have biodistribution, which includes 25 the plutonium injection experiments and other 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 89 1 experiments that are related basically to toxicology 2 or chelation therapy, things that you get exposed to 3 working in weapons production. These experiments are 4 designed to test the biodistribution of isotopes. 5 They in general have no ther-, 6 immediate therapeutic or diagnostic potential. Some 7 of them are experiments of opportunity of exposed 8 workers, accidentally exposed workers, and they 9 include such isotopes, well, they include in addition 10 to the plutonium experiments and the experiments, u-, 11 uranium on comatose patients, beryllium experiments, 12 and the chelation experiments that were done. 13 The next category is the total-body 14 irradiation experiments. These are from, obviously, 15 the Cincinnati experiments and the rest of the total- 16 body irradiation experiments. 17 Now, issues that will be focused on 18 here is the issue of piggybacking in the sense of in 19 a case where you are using radiation for ther-, 20 therapeutic, in this case, therapeutic, therapeutic 21 or diagnostic purposes, and there is also a 22 government purpose, that is to say the Government 23 wants to know what happens to people experiencing 24 whole-body irradiation either because they're worried 25 about astronauts or because they want to know what's 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 90 1 going to happen in case an atom bomb dropped, and 2 what are, what are the ethical areas that that 3 raises. 4 And then the other questions relating 5 to TBI are, of course, well, what is the therapeutic 6 benefit, and when does the experiment end? When do 7 you know that this is no longer an experiment and no 8 longer going on? 9 Then there's the category that we've 10 referred to, experiments involving children. The 11 focal studies there are in the Vanderbilt studies and 12 the Fernald School studies. 13 Most of these studies are tracer 14 experiments, and the issues include the consideration 15 of differential risk, children and selection, use of 16 institutionalized mentally compromised populations. 17 Now, boron neutron capture is something 18 that's been in use of late, actually. The early 19 experiments were done at Brookhaven. 20 They're, they were attempts to treat 21 brain cancer, and several, and, and they were not 22 successful. This was not a successful treatment for 23 treating brain cancer, and in fact an NIH panel came 24 to the conclusion that this was an unsuccessful 25 therapeutic modality. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 91 1 And now there are attempts to revise 2 the experiment, revive the experiments using boron 3 neutron canture. And so the, the questions are 4 again: 5 What are the ethics of using, at least 6 in projecting studies? What is the role of a federal 7 panel? And what are the conclusion if someone were 8 to revive the practice again? And what, what, and I 9 think also probably the issues related to whether the 10 rules are different for patients with terminal 11 diseases. 12 The, the fifth category which is listed 13 here as testicular irradiation burn experiments is 14 really partial-body irradiation, and the focus 15 studies are the experiments on the flash-blindness 16 related to atomic bomb tests. These are studies 17 which have no therapeutic diagnostic intent. 18 And then the fallout category's 19 probably the largest category. Now, the focus 20 studies on this are the studies that were done at the 21 Vanderbilt school in Massachusetts using Iodine-131, 22 and these are listed by distribution; and tracer 23 studies using iodine, strontium, cesium, gallium, 24 barium, and beryllium. 25 In general they didn't have 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 92 1 therapeutical diagnostic potential. That was, and 2 the issues here again are the, the piggybacking 3 issues. 4 You know, there's, there is a 5 therapeutic potential, diagnostic potential, and 6 there is also the desire of the Government to confer 7 on agencies to find out what happens to these fallout 8 products made by it. And it's, there also we think 9 would be potential to address in this, in this 10 particular category the question of whether the 11 publicized cases are typical of the experiments that 12 were done in a given category, or whether they're in 13 some way an aberration. 14 THE CHAIR: Thank you, Barbara. But 15 don't go away, because I'm sure there are going to be 16 questions. 17 Just, and the thoughts in doing the 18 proposal that is coming back to us as a committee is 19 that we combined our obligation to address well- 20 publicized cases with the authority on our part to 21 also expand on that by a research strategy that says, 22 "Okay, let's identify six classes or kinds of 23 studies, each anchored in one or more of the well- 24 publicized cases, and branch out from those well- 25 publicized cases to learn as much as we can about all 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 93 1 the research, as much as we can, that was done during 2 this same 20-year period about the same issue," so 3 that we can then look, as Barbara said, at the 4 question of the well-celebrated cases. 5 Were these aberrational or in their own 6 context typical? How broad were the concerns that 7 brought the well-publicized cases to public 8 attention? 9 How broadly dispersed were those 10 concerns? And how much research seemed to raise that 11 kind of a problem? 12 The notion here before the Committee is 13 a, is a concrete proposal. Are we comfortable with 14 the limited time and limited resources we will take 15 these six areas and have them be anchors for focusing 16 staff research and for then our evaluation in 17 addition to what we've already said we'll do, 18 additional casewide studies plus our commitment to 19 look at the intentional releases? 20 That would be the combined strategy for 21 the historical period in terms of looking at experts. 22 MR. GUTTMAN: Just make a comment. If, 23 as you all look at, of course, this is a quite 24 ambitious report and the notion is that it's clearly 25 something that is conceptually do-able, but whether 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 94 1 we find the information or will have the time or the 2 patience is a question. 3 But there is stuff there. And the 4 question there, as Ruth was saying, this is going to 5 look closely at the institutional case studies we're 6 taking. Nothing is wasted. 7 To the extent that they're not doing a 8 full-blown case study, they will be put into the 9 other groups. So we'll be cannibalizing these. 10 And so this is an area where there are 11 chunks that we can take. And how much we can take 12 and whether or not we can draw, you know, it's all 13 there, able to draw. 14 THE CHAIR: The thing about here is we 15 will not be doing, as Barbara pointed out, there will 16 be no random sampling, so we'll be limited in 17 whatever inferences we'll be able to drew about 18 representation towards the whole period. That is a 19 strategy we are intentionally, if we decide to do 20 this, foregoing in favor of a focused strategy around 21 well-publicized cases venturing outward. That would 22 be a more textual sense what was going on at UCB, 23 during this 20-year period. 24 How much research involving children 25 and ionizing radiation happened or didn't happen? 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 95 1 And what were the circumstances against which we can 2 situate the rest of the research? 3 And it also gives us a principal base 4 in deciding to look at some areas and not others. 5 But there are limitations, because we wouldn't be 6 drawing a random sample and then having a base. it 7 would not allow us to use bases for statistical 8 inference to a larger, a larger universe. 9 Okay. Questions? 10 (whereupon, no response was had.) 11 THE CHAIR: This is all fine? This is 12 not like this committee. 13 Ruth? 14 DR. MACKLIN: It's hard to digest, 15 number one. But beyond that, some of the things to 16 be, that are going to be looked at here are items 17 that I think no general answer or consensus has been 18 given. Let me pick out two. 19 THE CHAIR: Sure. 20 DR. MACKLIN: So I'm not sure when 21 something is up in the air generally what's going to 22 be done in this context, and the two are piggyback. 23 And the question is, "What is therapeutic? What is 24 experimental?" 25 And those are big questions. Let's 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 96 1 start with, "What is therapeutic What is 2 experimental?" 3 That may be important to know, but if 4 there is no agreed-upon analysis that says when 5 something ceases to be purely experimental, is there, 6 is there ever a sharp line? How do you determine? 7 And there are criteria that have been 8 developed. I'm not sure what we're going to do with 9 that distinction here, given the kind of general mess 10 when that topic is discussed in a many other 11 settings. 12 With the piggybacking, I've actually, 13 this term is new to me in this context, although I 14 know it in another context in which the experiments 15 for the same subjects are used for multiple 16 experiments or multiple research, not only because 17 they're a convenient sample, but because somehow or 18 other they're turned out to be used a lot in 19 research. 20 But is there a general question, I 21 mean, not at what Barbara just visited, but for 22 example, example, the -- 23 THE CHAIR: That's a good place to go. 24 DR. MACKLIN: Maybe those people who 25 are more familiar with this kind of -- the general 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 97 1 issue is this: If something is being done for a 2 therapeutic purpose and then someone else wants to 3 come along and study something, and study it, but not 4 do different, necessarily do different maneuvers, but 5 study what would be done for a therapeutic purpose, 6 even though the purpose for, of those that are coming 7 along, the study has nothing to do with therapy, it 8 seems to me in other contexts that's done all the 9 time. 10 THE CHAIR: Uh-huh. 11 DR. MACKLIN: And my question is, is 12 there a general consensus or is there something we 13 can apply in this circumstance? There's a pre- 14 supposition, it seems, that there's something 15 ethically questioned about that. 16 So maybe, as the questions are 17 enumerated on Page 2 of the, you had under Tab I, 18 THE CHAIR: Uh-huh. 19 DR. MACKLIN: -- "To what extent was 20 the design of the experiment influenced by the 21 availability of funding for government purposes?" 22 One can probably say that about much of the NIH- 23 funded research that's done today. 24 You understand the question 25 THE CHAIR: No, no. I know exactly 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 98 1 what you're saying. 2 DR. RUSSELL: It's the Government's 3 attempt -- 4 DR. MACKLIN: So my question is whether 5 or not there has to be a simultaneous or analysis or 6 previous analysis of some of these. So what happens 7 if you can't answer some of these questions? 8 THE CHAIR: I think that the questions 9 are there to illustrate the kinds of the issues that 10 have happened so the imagination of the staff, as 11 they've worked with -- 12 MR. GUTTMAN: As feeble as it might be, 13 right. 14 DR. MACKLIN: I'm not suggesting that 15 at all. Not at all. 16 THE CHAIR: No, I think the issue of 17 the analysis has to be simultaneous because we can't 18 afford, as a practical matter we can't afford to work 19 out the Committee's analysis of piggybacking. It's 20 going to be all measured as the information about 21 this work's being assimilated and gathered. 22 We have to think with the staff what 23 these issues are. But it is, already is clear about 24 how can you figure out what came first? 25 Was there really this interest in 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 99 1 continuing to pursue this line of research, or was it 2 because there was another source of funding? You 3 know, how do you work, how do you think that through, 4 and how do you find out? 5 And I think our, our, our inquiry will 6 be directed to a large degree by what we have 7 available and what we learn. But I think you're 8 quite -- you hit it. 9 I tell you what scares me, frankly, is 10 when I look at this I see years of work, not months 11 of work, and I don't know what to say about that 12 except that we have an enthusiastic staff. 13 MR. GUTTMAN: May I focus, Ruth, on the 14 particulars, because she's also -- 15 We have now, remember, we had the 16 discussion three or four meetings ago when they had 17 the debate about the question of whether, the new 18 experimentation in connection with the nuclear 19 powered airplane. And on paper it looked like the 20 decision was no human experimentation. 21 But then as we pointed out, it looks 22 like suddenly they're doing whole-body radiation at 23 the hot, sponsored by the Air Force. We've found in 24 the interim the contract documents which says in the 25 justification, "We're not allowed, because of the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 100 1 highest level, to do human experimentation, but we 2 have these patients, so therefore .... 3 So at the heart of these, TBI, for 4 example, the, there's the question of, well, is this 5 a way of getting around something, or is this just 6 taking data that's available? Is it taking data 7 that's available? 8 Is it like their, the patients would 9 have gotten these doses or these, the kinds of things 10 that the Air Force was going to do anyway? 11 DR. MACKLIN: But depending -- I 12 understand perfectly. But then I think we have to 13 develop the series of questions to develop those 14 things, and maybe that's what's meant by the question 15 to what extent it was design, not only by 16 availability of funding, but the people involved in 17 it. 18 In other words, the, if patients who 19 would not have gotten total body irradiation got it 20 only because it's now funded by Government, even if 21 the researcher would have taken some patients and 22 given them total-body irradiation, I mean, that's a 23 question of bringing in research subjects and doing 24 it if, for the purpose of other than therapeutic. 25 That's an entirely different thing 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 101 1 other than when you have a bunch of patients for whom 2 the doctor says, "We're going to do total body 3 irradiation," and a person who comes in and says, 4 "Now we want to take your data and use it for 5 something else." 6 THE CHAIR: Right. And that's the fact 7 pattern. That, that's the research of trying to 8 figure out what was done. 9 And I think that's part of the research 10 inquiry. And you just formulated it more crisply 11 than has previously been formulated. 12 Duncan? 13 DR. THOMAS: Unfortunately, this staff 14 memo, no one that's on the Biomedical Subcommittee 15 has had the opportunity yet to talk about it. Let's 16 be sure as to what our purpose is now. 17 I'm thinking that we should not let 18 this go by without having signed off on the selection 19 of the particular case studies that we've got to ask 20 the staff to develop. I'm assuming that since we 21 haven't heard an argument, there's a consensus that 22 we're not going to undertake basic random sampling. 23 I think we're going to use these case 24 studies, for example the, for case studies which the 25 Biomedical Subcommittee has developed, and then be, 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 102 1 Grant Johnson will investigate it and find other 2 examples that will help illustrate the points we're 3 trying to make. 4 But the fundamental difficulty I'm 5 having is seeing the concordance between the set of 6 categories that the Biomedical Subcommittee developed 7 and presented at one of our last meetings, and the 8 set of categories we have authored here. I see a lot 9 of concordance in some cases, and others I'm, I'm 10 having some difficulty with. 11 We have a number of new categories, 12 number of new examples here that I don't recall ever 13 having seen any background materials on. 14 THE CHAIR: In, yes, that's right. 15 DR. THOMAS: For example, the boron 16 neutron capture stuff is new to me. The Fernald 17 School is also new to me, so I think we ought to be 18 clear. I think the best examples we can come up with 19 to illustrate each one of these 20 THE CHAIR: You're quite right to land 21 on those. The boron neutron capture and the Fernald 22 School are the two, they're the two areas we have not 23 had whole-Committee discussion about. 24 And you're absolutely right about the 25 purpose of this memo. And, and, I mean, the purpose 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 103 1 of our having this discussion today is for the 2 Committee to decide whether it wants to endorse in 3 whole or in part this submittal as a proposal. 4 Before we, we don't have to do it this 5 way. Or we can decide we want to try four of the 6 six, or four now and decide what we want to do with 7 the other two. 8 But we need to decide this at this 9 meeting; perhaps not on this afternoon. Perhaps we 10 can revisit it on Thursday; but again, at this 11 meeting; again, a, maybe not at this time with 12 whether or not this strategy is right, anchoring this 13 around case studies, and if so, are these right, 14 well-publicized cases and categories of well- 15 publicized cases for the staff to pursue. 16 Duncan. 17 DR. THOMAS: I certainly think that all 18 of the samples that are listed here are interesting 19 stories in themselves and probably merit further 20 pursuit by the staff on their own merits. My concern 21 is that two of the most important categories that the 22 Biomedical Subcommittee developed was therapeutic and 23 diagnostic radiation, and as I see it, boron neutron 24 capture. 25 THE CHAIR: TBI as well. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 104 1 DR. THOMAS: TBI. All right, TBI as 2 well. And then perhaps the Cincinnati experiment is 3 our example of the total-body category. 4 And I just want to make sure that these 5 are the, not only the reference to the Fernald School 6 case, I'm not able to evaluate whether, the primary 7 purpose of that, as to whether or not that was 8 diagnostic medical sample on which there might have 9 been by conventional or parasymmetric, and whether or 10 not it was, I can't say. 11 THE CHAIR: And again, that's 12 probably -- 13 Phil, did you want to comment? 14 DR. RUSSELL: I'm a little concerned 15 about the focus on the governmental funding aspects. 16 I'm concerned that all of, all the experimentation 17 done in this country over the last 50 years or so, 18 with the exception of that funded by pharmaceutical 19 companies and, and other companies in, in the medical 20 business, vast majorities of it was funded by, by the 21 Government. 22 Matter of fact, probably 90 percent of 23 that isn't industrial. And the government purposes 24 are, are, has varied, but they all are, are, are 25 seeking new information for valid reasons. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 105 1 And so therefore the, the focus on, on 2 the government funding is, is, applies to every, 3 every funded, government-funded experiment that's 4 ever been done. I think we need to get away from 5 trying to look at what, government funding and how 6 that may have torqued the thinking, because that's 7 unknown, and, and look at the issues on their own 8 merits: 9 "Was, was the, were these experiments 10 done in, in an appropriately ethical manner?" Not 11 try and second-guess what the investigators, biases 12 were and so forth, bias of the funding and all. 13 THE CHAIR: I think that raised a 14 really important reservation, and I thought about 15 those concerns, too. I mean, what was unknown is 16 unknown. 17 DR. RUSSELL: Right. And whether it 18 was ethical in the, in the, in the time frame that 19 they were done, or whether it was ethical or non- 20 ethical by today's standards can be determined -- 21 THE CHAIR: Yeah. 22 DR. RUSSELL: -- without trying to 23 guess what the federal funding was or was not. 24 THE CHAIR: I think what you're saying 25 is, is right, and I think about something that Pat 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 106 1 said with resect to public policy in our discussion. 2 In, we're not going to know whether they were 3 motivated by legal risk or whether they were 4 motivated by high-minded ethical risks, and we'll 5 never know. 6 Whether this was interested in whole- 7 body irradiation because the money was there or not, 8 the question was: Was it ethical to involve 9 patients? 10 MR. RUSSELL: Basically all medical 11 research is done because the money is there, and the 12 Government puts it there, whether it's NIH or 13 other -- 14 THE CHAIR: Right. Which goes to risk. 15 The question is, would those patients, would it have 16 been appropriate for those patients to receive that 17 level of radiation regardless of where the money came 18 from? 19 And if the answer is yes, your point is 20 do we have to delve and find out what animated that 21 physician to do, to start doing all the radiation, 22 the work. 23 Can we get back to this issue of -- 24 maybe I can take it apart. The first issue is, is, 25 is the Committee going to endorse that we abandon a 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 107 1 random-sampling approach and adopt a strategy whereby 2 we focus our energies in a case method focused around 3 identified, well-publicized experiments? 4 That's the extent of the agreement I'm 5 looking for now. Is that okay? Is everyone 6 agreeable with that? 7 (Whereupon, no response was had.) 8 THE CHAIR: Then the next issue is the 9 selection of the categories, okay, the, the, the 10 indexed cases, future, out, out from which we will 11 work. Here is a proposal for the six. 12 Does anybody want to endorse some 13 package thereof, or make a recommendation that some 14 subset thereof be completed, or something added, or 15 whatever? 16 DR. ROYAL: I think everyone agrees on 17 1, 2, and 3, so can we get that out of the way? 18 THE CHAIR: That would be excellent. 19 The proposal is to approve the biodistribution, 20 anchored in the plutonium injection experiments; the 21 TBI, anchored in Cincinnati; and research involving 22 or affecting children and anchored in Vanderbilt and 23 and Fernald. Is there, is everybody agreeable to 24 those three? 25 DR. THOMAS: I agree. I'd like some 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 108 1 redefinition of what we mean by "category 2 redistribution," because to associate those we 3 equated with studies of transuranics. It may be the 4 true statement of what's actually done, but the point 5 is, were these studies for parasymmetric or 6 toxicologic purposes, not for any medical purposes? 7 And I can imagine that one would be 8 interested in, I suppose, other than the transuranics 9 in that regard. I can also imagine that conceivably 10 there might be a medical purpose for transuranics, 11 even though it may not be understood now. 12 MS. BERNEY: Well, the beryllium and 13 the chelation fall into that category. 14 DR. THOMAS: Exactly. And I want that 15 category to be broad enough, because we're curious as 16 to what the primary purpose is, to understand what 17 its potential problems were, as opposed to its 18 potential benefits in medicine. 19 THE CHAIR: Right. Okay, so with that 20 clarification the Committee signs on on Groups 1, 2, 21 and 3. Now, 4, 5 and 6 are open to discussion, plus 22 including suggestions for additions. 23 Henry? 24 DR. ROYAL: Could I just -- I agree 25 with Dr. Thomas that the biodistribution category 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 109 1 needs to be better defined, because "biodistribution" 2 doesn't mean this to everyone. But I want to react 3 to what Dr. Russell said about determining whether or 4 not it was a hazard. 5 I think biodistribution studies we're 6 really not looking for an effect. Biodistribution 7 studies are just trying to figure out, "Where does it 8 go?" And we're not trying to figure out whether it 9 was a hazard or not. 10 DR. THOMAS: But we, why, why would you 11 care where it goes? What useful scientific purpose 12 would that serve if it wasn't for the purpose of 13 developing safety standards, providing that with 14 biomedical studies we can understand the symmetry for 15 doing, for setting up patient standards? 16 DR. ROYAL: I'm trying to make a 17 distinction between having a biological effect versus 18 measuring these drugs. 19 DR. THOMAS: Well, I'm certain the 20 studies were done such that we wouldn't, but they 21 were for the purpose I think for symmetry. 22 DR. ROYAL: But if you say a 23 biodistribution study is done in order to determine 24 the effects as opposed to, to determining where each 25 area goes, people may misinterpret that statement as 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 110 1 if the end point of the experiment is measuring some 2 biological category, and it's not the purpose of the 3 experiment. 4 DR. THOMAS: I can't think of any 5 example of a toxicological study in humans where 6 deliberately it was used to try to establish a whole, 7 so -- It may be that there are and I can't think of 8 them right now. But in principle, should such an 9 experiment ever have been done it would fall into any 10 of those categories. 11 THE CHAIR: Somebody, it's a good thing 12 we have a reporter, and then we'll have a Transcript, 13 because this is the kind of smithing of words that 14 can be very important that we can work on carefully 15 as we proceed to make sure that there's an agreement 16 about what, what, how best to express what 17 biodistribution experiments are intended to 18 accomplish and what they involve. 19 How would that be? People will work 20 carefully with our use of language. 21 Okay, I saw Ruth's hand, and we're now 22 discussing 4, 5, and 6, or any recommendations of 23 additional -- 24 DR. MACKLIN: Yeah, I want to ask about 25 5, and we can get the justification for the category. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 111 1 It seems, just looking at it,- as if it's the 2 prisoners, because that's the population on which the 3 testicular radiation is on, and so now I'm asking a 4 factual question about this second bullet. Other 5 partial whole-body irradiation has no -- 6 THE CHAIR: So the question is the 7 factual matters, are we aware of any other studies in 8 which people are irradiated? 9 DR. MACKLIN: Yes. I'm trying to get 10 the rationale for the category. 11 THE CHAIR: Right. Right. 12 Barbara, could you respond? 13 DR. BERNEY: Okay. There, there were 14 burn experiments done, I can't remember which month 15 it was in, but also I think in which, where patients 16 were actually burned with radiation. 17 DR. MACKLIN: For no therapeutic or 18 diagnostic intents? 19 MS. BERNEY: As I understand it. I'm 20 not positive, but that's what I understand it. There 21 were, there were studies like that. 22 DR. MACKLIN: And they weren't just, I 23 mean, they were with patients who were sick? Were 24 they, were they people who were getting -- 25 THE CHAIR: I'm not sure they were 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 112 1 patients. 2 DR. ROYAL: That I think the Medical 3 College of West Virginia, what they did was they 4 would flash -- 5 DR. MACKLIN: The Medical College of 6 Virginia. 7 DR. ROYAL: The Medical College of 8 Virginia, they did flash burns on volunteers that 9 were dime-sized burns, and they did calculations of 10 the different skin colors so they could see who was 11 more susceptible, males, females, so forth. 12 DR. MACKLIN: Were these volunteer 13 tests, or were they patients? 14 DR. ROYAL: Yes. 15 THE CHAIR: So whether, you know, this 16 may turn out to be an end of 2 or an end of 3. 17 DR. STEVENSON: But I think the 18 radiation came into that, they were going to trace 19 other patients. I mean, the burns were not, my 20 understanding, were not radiation burns, but were 21 thermal burns. 22 THE CHAIR: Right, but they were 23 connected to the concern. 24 DR. RUSSELL: But they were mimicking 25 flash burns from the experiments. That's why they 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 113 1 did the experiments. 2 DR. STEVENSON: Right. And the 3 radiation activists came in from doing some tracer 4 work and looked at fluid distributions, -51, red 5 cells, that type of thing. 6 DR. RUSSELL: But that was in patients 7 in separate states. 8 THE CHAIR: I think what makes the burn 9 thing sort of complicated from the perspective of our 10 mandate is that they were concerned about the impacts 11 of radiation from the results of a blast, but they 12 didn't use a radiation source. They mimicked it from 13 a thermal burn. 14 So it's hard to see how these fit. So 15 it's more complicated. 16 MR. GUTTMAN: Just to be clinical, so 17 the end becomes three and a-half, I think in the 18 experiment, and Barbara got the data, the people 19 crawling through the radiolanthanum, the workers at 20 the Monsanto plant, when you basically, external 21 rubbing on the skin, the notion is not whole-body 22 radiation but something that's an external 23 application of radiation in some way would be in 24 this. 25 Is that correct, Barbara? 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 114 1 THE CHAIR: So if you had an experiment 2 and it was termed "an experiment," soldiers were 3 asked to crawl through radioactive 4 MR. GUTTMAN: Right. 5 THE CHAIR: -- dust, -- 6 MR. GUTTMAN: Sand. 7 THE CHAIR: -- sand, that would, and 8 that would be for no other, with healthy people, 9 if -- 10 DR. MACKLIN: So what concerned me, and 11 I guess it's going back to the rationale for each of 12 these categories, is that there are mixed rationales. 13 when you look at the biodistribution, that's an area 14 that means a lot to some people, and I'm still not 15 convinced. I haven't got my mind around it. 16 But when you look at the issues, quite 17 clearly no clear diagnostic or therapeutic benefit 18 for subject, subject, zeroes right in on what some of 19 those issues were. I view it as an accidental 20 property that what they were studying was 21 biodistribution, and as, an essential area for our 22 purpose was that there was no diagnostic or 23 therapeutic benefit thought to be a result of the 24 studies. 25 Now, the example you just gave us of 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 115 1 the soldiers crawling through something, 2 THE CHAIR: You make a good point 3 there. 4 DR. MACKLIN: -- was an experiment not 5 in biodistribution, but it fits those other two 6 bullets, namely occupational -- 7 THE CHAIR: I think we should all sign 8 off on this. These categories are not conceptually 9 coherent or tight. 10 Now, the strategy is they're ending 11 from a well-publicized case. The well-publicized 12 case is sort of, it crosses over the areas of 13 interests or conceptual issues or ethical concerns of 14 the Committee. 15 DR. MACKLIN: But then isn't it the 16 case of what we should be looking at, then? Rather 17 than kind of artificially construct these categories, 18 look at the well-publicized cases and focus in on 19 these kinds of questions? 20 THE CHAIR: Are we just looking for a 21 strategy for deciding what other kinds of experiments 22 to look for and hunt down? 23 DR. MACKLIN: Right, but the 24 THE CHAIR: But besides the well- 25 publicized case, it's so, we also wanted to wait to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 1 see something more rich about the well-publicized 2 cases, like was what was done at the Fernald School 3 abnormal use, or was it typical? 4 DR. MACKLIN: But then, then the 5 criteria, the things that we're zeroing in on seem to 6 me to be the ethically relevant categories, namely 7 normal, healthy volunteers to which something is 8 done. That's one. Vulnerable subjects, children, 9 schools, prisoners, that's another. 10 And if the well-publicized cases, if a 11 number of them have these different characteristics 12 we can still get at the question of whether it, it 13 was anomalous or not, but we're not using the 14 radiation categories to get at those questions. 15 THE CHAIR: See, I'm kind of torn on 16 that because in some cases I think, I'm thinking as a 17 practical matter when, how people are going to go 18 look for stuff, and it's, and sometimes it makes huge 19 sense to look for children. You can look, the thing 20 we've talked about before, you can look for children. 21 It's sort of hard to look for other 22 things. And you can look for biodistribution 23 studies, because that's a discernable thing. It's a 24 field of work, and people can find them that way. 25 It's hard to find stuff labeled "No 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 117 1 therapeutic or diagnostic benefits on healthy human 2 volunteers." So it's more a matter about deciding X 3 initially as a structure for directing investigation. 4 when we get this stuff back and we 5 analyze it we may find it's very rich to separate it 6 out and say, "Take the biodistribution together with 7 the small subset of, of external radiation exposure 8 that also did not involve any prospective therapeutic 9 benefit to subjects, and put them together. 10 DR. MACKLIN: But in, the answer is 11 different in part by what you're looking at. 12 Obviously if you're looking at soldiers you're not 13 looking at patients. If you're looking at children, 14 granted, you're going to get -- 15 THE CHAIR: You're looking at both. 16 You're looking at both. Obviously, I mean, it isn't 17 tight. It's messy. 18 MR. GUTTMAN: Staff's perspective, 19 we've been struggling. If anybody has any ideas 20 What we discovered is there are no 21 leader set of categories. You can't, it doesn't make 22 any sense. 23 And what demonstrates the association, 24 you've got children as a group, which, of course, it 25 crosscuts everything. So the question is, can you Human Radiation Experiments/SF 118 1 get a couple of hooks? 2 One kind of biomedical, we did that 3 with transuranics, we got the workers, so we said 4 it's biomedical plus the workers. So then you've got 5 things, at least as I proceed through the 6 investigation you focus on some questions. 7 So it's clearly, this is a, I mean, 8 you're right, but I've, I just wanted people to know 9 that we're keenly aware that this is not -- 10 DR. MACKLIN: There are partial bio 11 applications that do have diagnostic and therapeutic 12 intents, and you know, I suppose that there's a 13 question about whether they're in or out. And 14 depending on where they are, -- 15 THE CHAIR: That's a very good point. 16 DR. MACKLIN: Now I only began my 17 question by trying to get rationale for Number 5, and 18 that cascaded this whole discussion. 19 MR. GUTTMAN: That's easy. Ruth said 20 she couldn't think of anything that was like that, 21 and that's a class by itself. And now we've been 22 expanding it. 23 DR. OLEINICK: But in the memo it's, 24 somehow there is included flash blindness studies by 25 atomic bomb tests, and it's not clear to me how those 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 119 1 fit. 2 MR. GUTTMAN: The notion is external 3 exposure. That's the notion. 4 DR. OLEINICK: But it's not external 5 exposure by ionizing radiation. 6 MR. GUTTMAN: We discussed that. 7 DR. OLEINICK: I know. 8 THE CHAIR: Well, it's sort of. 9 DR. OLEINICK: It's sort of. 10 THE CHAIR: That's, that's -- you're 11 right. 12 DR. OLEINICK: Just sort of. Okay. 13 THE CHAIR: And isn't "sort of" a 14 technical term? 15 MR. GUTTMAN: This is a problem for the 16 experts. 17 DR. OLEINICK: Well, we have -- yeah. 18 THE CHAIR: We should, we should think 19 hard about these other three. And let me just lay 20 out that one other reason. 21 When I was talking with members of the 22 staff about these, this is six, "How are we going to 23 possibly do these?" 24 And one response was, they're not all 25 going to pan out, so better to start out with six and 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments 120 1 see where the yield is than to start with three. And 2 what if the, you know, the leads run dry quickly? 3 So I found that partially persuasive 4 and kind of waived some of the worries about tidiness 5 in the interest of practical, whoever in -- 6 DR. THOMAS: How, how can a lead not 7 pan out? In each case we have at least one. 8 THE CHAIR: That's true. That's true. 9 DR. THOMAS: There may be that there 10 are other examples. 11 THE CHAIR: Well, I guess that's true. 12 We learn nothing about any except that one, and even 13 about that one there may not be that much. 14 Also, Anna brought me a note, and that 15 is we should remember the nine themes; that no matter 16 what we're looking at, an institutional case study or 17 a case study defined this way, in all cases we're 18 going to be looking at those nine themes. 19 One would be case selection, and it 20 would be management responsibility and all of those 21 kinds of things that would allow us to pull these 22 together. Harm and benefit is another. 23 But how do we want to proceed here? 24 Yes? 25 DR. MACKLIN: And what was, your 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 121 1 question to us was about 4, 5, and 6. Since we got 2 such a lucid answer to 5, could I ask about 4, the 3 boron neutron capture? 4 And Duncan asked about that same -- he 5 hadn't seen much about that before, and could we just 6 hear little rationale for that one here? What 7 else -- Are these the issues, experiments and the 8 rejected therapies and -- 9 DR. BERNEY: Yeah. There were boron 10 neutron capture studies done early on, and basically, 11 as I understand the story, it didn't pan out as a 12 therapeutic modality. It was killing people and they 13 weren't getting better first. 14 And now there, there, and it went 15 through this whole NIH process, et cetera, et cetera, 16 and now there is an attempt to revive the therapy on 17 an experimental basis, and people are wondering why. 18 You know, people may use the, this for, 19 you know, one, one rumor I heard was that somebody 20 who was a big donor to some institution had a wife 21 with brain cancer and he wanted to try this. So, you 22 know, it's like -- 23 DR. MACKLIN: But this is the 24 contemporary area. 25 DR. BERNEY: This is a contemporary 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 122 1 issue. It is also a historical issue. 2 THE CHAIR: That's right. The issue 3 here is a case of science, and the patient may try to 4 explain this to me so I can understand what was that 5 patient doing. And apparently the interim revival 6 has to do with some new, the argument is if there are 7 now other materials to be used that hold more 8 promise. 9 There's an active group in Japan 10 involved in developing this. There are members -- 11 DR. MACKLIN: The procedure is not 12 nearly as invasive as it was. 13 THE CHAIR: That's, there are process 14 facilities in the United States that are not normally 15 involved in this use who want to become engaged again 16 in this practice. So the argument, again, is a very 17 contemporary issue, and again it's become well 18 publicized, not in its old form, but in the, its, the 19 current form. 20 So it met the criteria in a well- 21 publicized, controversial case, but it's anomalous in 22 that the controversy is coming to the press's 23 attention. It's not the historical, but it's modern. 24 Mary Ann can basically speak to, more to that. 25 DR. STEVENSON: You basically 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 123 1 summarized it. What you said is true. 2 So the question is now, what's driving 3 the contemporary interest? And is there enough data 4 to, to raise this as a potential form of therapy if 5 the past data was so negative? And that's the 6 question. 7 DR. RUSSELL: What is the question 8 arising? What's new? 9 DR. STEVENSON: Well, there's better 10 agencies in developing the boron. A group in Japan 11 has shown some good results, and there are facilities 12 in the U.S. involvement that could be used for that 13 aren't being used. 14 And so I think that was the question 15 that was raised by Ron, is what is the driving force 16 bringing this to therapy, experimental therapy? 17 THE CHAIR: Yes, Duncan, and then Ruth. 18 DR. THOMAS: I think that's a very 19 interesting story, particularly with its contemporary 20 twist. I was trying to put it into a broader 21 perspective of the category "therapeutic 22 irradiation," and it seems to me that the field of 23 radio therapy hasn't gotten to where it is presently 24 without a lot of experimentation. 25 And this is probably a rather, an 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 124 1 outlie area in that, that classification. There must 2 be plenty of examples, and I'm not presently able to 3 come up with any examples of success stories, or at 4 least if not success stories, at least serious 5 clinical trial and research in this field. And there 6 must be other examples we can pick on. 7 (Whereupon, Mr. Guttman and the Chair 8 conferred, out of the hearing of others, after which 9 the following occurred:) 10 THE CHAIR: Yeah. 11 DR. MACKLIN: Just, at a different 12 point, the story, the, the account of what's going on 13 in the contemporary resurrection of this therapy 14 seems to me only accidentally and irrelevantly to 15 involve radiation. It can, could have been anything 16 that was found to be a rejected therapy, and now that 17 some new substance or new discovery, and one could 18 take the transplants in cyclosporine as an example. 19 THE CHAIR: Sure. 20 DR. MACKLIN: So the fact that 21 someone's trying to revive it, and may have some 22 other purpose, it's not a certainty. Whatever it is 23 it's highly unlikely to be the reasons that drove the 24 initial experiments and that we're looking at 25 historically. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 125 1 I mean, that just seems outlandish to 2 think that it's anything like that. So even if 3 there's some financial purpose, some wealthy person 4 or whatever, I mean, the radiation part seems to drop 5 out as irrelevant for our purposes. 6 I mean, I could be convinced otherwise, 7 but I just -- 8 THE CHAIR: I don't know the answer. I 9 mean, I think that's possible, that that is not 10 really an irradiation issue. 11 You might argue that all of these are 12 in some sense, not "you," referring to you; in our 13 English; in context. 14 I wanted, and I don't know what to do 15 with that, but I did want to, and I don't know what 16 to do with it. I don't know. That's for the group 17 to conclude. 18 I think that, to just go back for one 19 moment to what Duncan said about there are obviously 20 more, other areas to pursue, if one wanted to look at 21 the history of the development of radiotherapy, one 22 of the implications of following this strategy is 23 that we aren't then looking at, we're not then trying 24 to, to tell something about a development of research 25 generally, the ethics of research generally in either 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 126 1 radiotherapy or nuclear medicine. 2 This isn't a strategy that gets to 3 that, just as it isn't a strategy for those to make 4 claims about representations, the representativeness 5 of our conclusions. It's rather driven by the well- 6 publicized cases, and asks something, allows us to 7 say something about work of that sort. 8 It's not saying, "Gee, we want to get a 9 window onto the ethics of research in radiotherapy 10 for cancer between 1944 and '74, so we're going to do 11 that." It's rather, it, it won't allow us to do 12 that, and it will, won't allow us to do that, either, 13 for the development of nuclear medicine in any 14 simple-minded direction. 15 So we have to be clear what we're 16 signing, you know, what we, in signing off on this, 17 what, what the implications are for what we will be 18 saying, be able to say something about. 19 I'm sorry, Reed, did you have 20 DR. TUCKSON: If I look at these broad 21 categories without paying particular, without being 22 bound to the particular experiments listed, if you 23 look at the biodistribution, the large category, and 24 the experiments are actually here, this is a very 25 representative sample. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 127 1 I look at the total-body irradiation. 2 It's Cincinnati and others. If we look at this big 3 Number 3, it's, again, it's a large category. 4 I think it's only when we get to Number 5 4 that we get, and I'm very struck by the, the 6 Doctor's comments. I think the category there is so 7 small. 8 It's boron neutron capture versus the 9 clinical use of radioisotopes, which is a larger 10 issue; and then how we choose the experiments to look 11 at. Then I can approach the question that you just 12 ended with, Ruth, is how can we categorize this 13 broader category? 14 The testicular irradiation burn 15 experiments, again it seems like it would be, again 16 what I think I'm coming to. And the Number 6, the 17 fallout I think is a legitimate category. 18 I see four of these six now as being 19 important, big pieces of the whole story. And how we 20 choose these specific experiments to look at gives us 21 what you try to get to. 22 I think by changing Number 4 to this 23 clinical use of radio isotopes helps me to feel 24 better about that one. And I just need to have, I'm 25 struggling with the testicular burn experiments to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 128 1 put that in a more generic context. 2 THE CHAIR: It's hard. 3 DR. TUCKSON: But I think as we do that 4 we get close to what you both are trying to say. 5 I have another point, but I'll come 6 back. 7 THE CHAIR: All right. If I understand 8 what's just happened, and Reed, you're suggesting 9 that, you're endorsing that the fallout group, 6, 10 makes sense to you; right? Isn't that -- and I see 11 that. 12 Does that make sense to you? Does it 13 make sense to -- 14 DR. THOMAS: Well, -- 15 THE CHAIR: Reed, that one makes sense 16 to you, Category 6? 17 DR. TUCKSON: Yeah, until Duncan 18 teaches me otherwise. 19 THE CHAIR: Yeah. So, Duncan, why 20 doesn't that make sense? And then we'll go back to 21 4. 22 DR. THOMAS: Well, I guess I'm having 23 the same problem with fallout as I am with boron 24 neutron capture. I'm trying to see how that class is 25 now. BNCT I think is an example of radiotherapy, and 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 129 1 that category I think I understand. 2 1 think it's something we ought to work 3 at, but I'm not sure that we've got the best example 4 of it. 5 THE CHAIR: Now, you'd be the only one 6 that could. It would be branching out from that. 7 DR. THOMAS: Well, I want to make sure 8 we have the right heading. 9 THE CHAIR: So you want to call it 10 "therapeutic"? 11 DR. THOMAS: Yeah. We should call it 12 "nuclear medicine and therapeutic nuclear therapy," 13 and this is an example of it. And then they should 14 tell us whether there are other examples. 15 THE CHAIR: Oh, there's going to be 16 tons. 17 DR. THOMAS: Well, there are going to 18 be tons, but whether this should be a flagship -- 19 THE CHAIR: Well, the strategy was we 20 started with a well-publicized case. 21 DR. THOMAS: But the question is, are 22 there others that -- 23 MR. GUTTMAN: The comment on this was 24 part of the boron neutron. The one by the Dr. Sweete 25 (phonetic) was part of this. According to Stannard 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 130 1 it was part of it, which is obviously very publicized 2 as part of the sample, is part of the boron 3 neutron -- 4 THE CHAIR: But I think that is not the 5 direction of what Duncan's saying. It's the other 6 way around. 7 MR. GUTTMAN: I'm sorry. The other way 8 around. Exactly. 9 THE CHAIR: But I think what I'm 10 hearing is just as, well, not just as. The notion 11 is, is in TBI, it's not just Cincinnati. It's 12 whole-body irradiation. 13 So the issue is here, the clinical use 14 of the radio isotopes is the category, and we try to 15 figure out 16 DR. STEVENSON: That was really 17 falling -- this is not radio isotopes. This is 18 really experimental forms of therapy. 19 THE CHAIR: This group includes 20 experiments in therapy and use of irradiation from an 21 external source. 22 DR. STEVENSON: Right. 23 DR. THOMAS: In that case, we don't 24 have any examples. 25 DR. STEVENSON: But the new tracers is 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 131 1 sort of a fallout product, to my understanding. 2 DR. TUCKSON: I'm sorry. I'm lost. 3 I'm lost, because I don't know whether we're talking 4 about 4 or 6. 5 THE CHAIR: Or 6. 6 DR. TUCKSON: I'm lost between whether 7 we're talking about 4 or 6. 8 THE CHAIR: Yeah. Mary is talking 9 about 6. 10 DR. STEVENSON: Right. This used to be 11 related to tracers, and it was very calculated. And 12 the question is, how can we move through this? 13 And the other category is the 14 experiments are relatively small and manageable in 15 this huge tracer category, but -- 16 MR. GUTTMAN: Can I explain what the 17 thought process was? And we wanted to specifically 18 address both what Mary Ann is saying, "How do you get 19 something out of that category?" but Duncan's point 20 of, "How do you define therapeutic?" 21 So I guess that is in a sense an 22 ambivalent category that tries to contain it by some 23 interest in the fallout, you know, but also is a, 24 clearly a therapeutic benefit already in that 25 category. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 132 1 DR. THOMAS: I had a comment on this 2 that Mary Ann categorized, Number 6, as an "all old 3 tracer category," because I was going to say I 4 thought the old "tracer" category got rolled into 3, 5 which is really children. But it's now two prime 6 examples of tracer studies, on tracer studies. 7 Now, I mean, studies of which the 8 radiation aspects of the elements is of relative 9 interest, is just a label for what is essentially a 10 metabolic study. 11 In contrast, the fallout study group I 12 thought was our example of a diagnostic irradiation 13 group, 1-131, for evaluating the situation and that 14 sort of thing. 15 DR. STEVENSON: Well, I thought -- 16 DR. THOMAS: First of all, we need to 17 distinguish when we talk about "tracers" whether or 18 not the irradiation is the primary purpose, and we 19 need examples. We, we need a category for tracers so 20 it doesn't get -- 21 DR. STEVENSON: Right. 22 DR. THOMAS: The trouble with three is 23 it enabled us to expand on things involving kids, but 24 it doesn't allow us to expand on tracers. 25 THE CHAIR: And that raises -- a lot of 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 133 1 these things turn out to be tracer studies in 2 children, and the fact is we're trying to look at 3 these studies involving children. 4 DR. THOMAS: Right. And there may be 5 some point we want to say about tracer points on 6 which we don't have -- 7 THE CHAIR: So help us figure out 6. 8 Can we make 6 more coherent? 9 DR. STEVENSON: The second paragraph of 10 6 is combining both therapeutics and diagnostic 11 application, and defining it as such. So maybe 6 12 could be broken down as diagnostic and therapeutic. 13 It's stated in the second -- 14 THE CHAIR: You're on Page --? 15 DR. STEVENSON: Page 3. "The group is 16 defined as studies using isotopes which were major 17 fallout products, some of which also had major 18 medical applications in both diagnosis and therapy." 19 So right now it's defining both, even though maybe 20 that's not clear on the first reading. 21 THE CHAIR: And is that problematic, or 22 is it okay to use that? 23 MR. GUTTMAN: Is that a good idea or a 24 bad idea? 25 THE CHAIR: Right, is that a good thing 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 134 1 to do, or a bad thing to do? 2 DR. STEVENSON: I think it's okay so 3 long as we want to draw examples from both categories 4 and it's clearly stated that that's what we're doing. 5 I mean, maybe it should be tapped out as 1 and 23 or 6 something like that so it's very clear that we're 1 7 pulling from both therapeutic range where it would be 8 a higher dose than diagnostic, where the dose would 9 be pretty low. 10 THE CHAIR: Is that, does that make 11 your understanding, or is everybody looking at the 12 same paragraph? Is that enough? 13 DR. STEVENSON: It would, maybe we 14 should call it "isotope studies," rather than 15 "fallout symptoms." 16 THE CHAIR: "Symptoms," yeah, I 17 think -- 18 DR. THOMAS: Call it "radioisotopes." 19 MR. GUTTMAN: That's a big category. 20 DR. THOMAS: The, the problem is the 21 mind of studying the impact of fallout, but really 22 this is nuclear medicine, right, the category we're 23 talking about, which has both? 24 THE CHAIR: We're not understanding 25 biology of fallout. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 135 1 DR. STEVENSON: Right. 2 THE CHAIR: In some cases it's unclear. 3 DR. THOMAS: And there may well be 4 radioisotopes that are -- 5 MR. GUTTMAN: Duncan, this is where we 6 limit it to some of the isotopes. But we look for 7 journals on all isotopes, then it's a problem. 8 THE CHAIR: What if we said -- 9 MR. GUTTMAN: There's got to be some 10 cutting-edge level for inquiry. 11 THE CHAIR: Why don't we say it's 12 radioisotopes category, but we say that we're going 13 to focus on those radioisotopes that also are fallout 14 products? Is that, this is coherent. 15 MR. GUTTMAN: That was the notion. 16 DR. THOMAS: Call it "radioisotope 17 fallout" as a requirement unless we were concerned 18 about piggybacking questions. If we want to find 19 out about the biological questions, -- 20 THE CHAIR: Now it is connected to the 21 agenda. 22 MR. GUTTMAN: It's not the real agenda. 23 It's the expressed agenda. 24 THE CHAIR: Right. And it's given 25 that, part of this cloud over this work, insofar as 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 136 1 there is a cloud, is the hint or taint or confusion 2 to Cold-War purposes. 3 Let's look at the work that has 4 potential for having that confusion and see what was 5 going on there. Perhaps it was all perfectly fine 6 stuff and the cloud should be lifted. 7 DR. THOMAS: I still think that the 8 category should be defined as "radioisotopes," and 9 the question of the research question that you want 10 to ask is to what extent is the primary purpose. Was 11 this diagnostic, or is this medical, or to what 12 extent is it trying to learn about fallout for other 13 purposes? 14 THE CHAIR: Now, would anyone object if 15 the strategy focused that way? I mean, is that okay? 16 We'll just call, it's a point to pull out products 17 with radioisotopes. 18 DR. RUSSELL: Uh-huh, and fallout is an 19 official -- 20 THE CHAIR: Is that all right? 21 DR. THOMAS: I have no objection with 22 the flagship issue which allows us to address both of 23 these questions, but so you mean we put in a broad 24 context. And the context in my view on the one hand 25 is the, the health effects purpose, you know, the, 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 137 1 the what is fallout doing to us. 2 THE CHAIR: Right. 3 DR. THOMAS: And the other is, what are 4 the medical uses? Because that's a very important 5 purpose and we've got to be able to explore that. 6 THE CHAIR: And so can we so 7 characterize then, endorse this group on 8 radioisotopes, "radio isotope research"? And this is 9 going to -- 10 I think we've picked up the, your 11 point, Reed. 12 DR. TUCKSON: No, I think it did. Let 13 me make sure, then, that's defining Number 6 as such. 14 THE CHAIR: Right. Right. 15 DR. TUCKSON: What is, is the 16 assumption of 4? 17 THE CHAIR: We'll get back to that in a 18 minute. I want to point out to you, Anna and I 19 always have this discussion about the time. The 20 Committee always finds time and ways to fill this 21 out, so you guys are going to have to, we're, we were 22 supposed to end at 5:30, and we're going to end not 23 until the 4:00, despite the best -- 24 DR. TUCKSON: We still like you. 25 THE CHAIR: Thank you. But it's always 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 138 1 bad to hold out something and not be able to deliver. 2 It's bad strategy. 3 All right, so we have 6 again, okay, 4 reconceptualized as radioisotope research, which 5 would have both diagnostic and therapeutic dimension, 6 and would be connected in some cases to the interests 7 in and the impact of fallout on human health. And 8 the part of the deal is to sort of look at all of 9 that stuff. 10 Now, in the memo buried somewhere, 11 which Duncan and Barbara and I discussed, is that if 12 we end up with huge numbers of experiments we would 13 be going to that category into random samples if 14 there is no other reason to do it. So in this case, 15 like this, we would turn to Duncan and Barbara and 16 say, "Is there a strategy among the staff that would 17 allow us?" 18 So somewhere, it's on Page 4 of that 19 memo, it, it, our proposal says that our, if in a 20 category there's an overabundance of research 21 opportunities, and we can go ahead and try to, and 22 there's no better way to do it than any other, we'll 23 turn to a sampling strategy internally to something 24 like radio isotopes or something that we have a 25 rather large list of potential studies. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 139 1 Have we implemented a proposal for 2 deputizing Duncan, together with staff support of 3 Barbara, to pursue that question, rather than coming 4 back to the whole committee? It becomes a resource 5 allocation issue. 6 Reed? 7 DR. TUCKSON: I know we want to come 8 back to 4. 9 THE CHAIR: One, 2, 4, and 5. 10 DR. TUCKSON: Can I hold back? I have 11 another set of questions I want to ask. 12 THE CHAIR: Okay, let's go to 4 and 5. 13 Back to the boron neutron capture. 14 We could throw it out. We don't have 15 to do anything. 16 We only have to do what the Committee 17 wills it wants to pursue. We can hold it over and 18 think about it until Thursday, and hold it over until 19 November and have Ron come, who, who's going to be 20 number one on the staff with this thing, and let him 21 come before the Committee, and we can decide. 22 MR. GUTTMAN: Yeah, Ron is quite 23 interested, and that's one of the reasons for doing 24 it, because he's a terrific -- and I don't think -- 25 DR. STEVENSON: My conversation with 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 140 1 Ron is his understanding of this is because it's a 2 unique example of contemporary research, and we can 3 look at it to see what kind of medical justification 4 there might be. And it's a unique example of that. 5 I don't think it's a particularly good 6 example of, you know, achievements or, or benefits of 7 radiation therapy because therapies by boron neutron 8 capture therapy, it was not going to be a very good 9 therapy. So it may not capture that purpose, but it 10 may ultimately be very good to pursue from that view 11 of a very contemporary example of how one analyzes 12 and works through an example of, of research and 13 radiation therapy. 14 THE CHAIR: I would like to propose 15 that, given that the staff will have plenty to do 16 without being authorized to pursue boron neutron 17 therapy between now and November, that we perhaps 18 defer it to November, -- 19 DR. STEVENSON: And have Ron -- 20 THE CHAIR: -- until November, and have 21 Ron come and present to us the best case for pursuing 22 this, and, and we could take it up then. Would that 23 be all right? 24 DR. ROYAL: I'm wondering if you could 25 fold it in with 5, if you combined those two as being 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 141 1 local external radiation treatment and effects. 2 THE CHAIR: Treatment and effects. 3 This would be important because that's an interesting 4 proposal. 5 DR. STEVENSON: But 6 DR. ROYAL: And then 7 DR. STEVENSON: But I think there is, 8 the boron neutron capture therapy is not being done 9 just to see what the effect is on normal healthy 10 tissue. I mean, there's a reason for -- 11 DR. ROYAL: But the treatment that you 12 have referred to covers irradiation. 13 DR. OLEINICK: Those are really so 14 separate and different. They don't, I don't see how 15 they group together easily. 16 It, it would seem to me if there was a 17 case study with the BNCT, that it might be an example 18 of other developing areas in radiation therapy, and 19 maybe one would want to look at other HILETE 20 radiation or some such thing as parts of a category. 21 THE CHAIR: Yeah, that's interesting. 22 DR. MACKLIN: But why is this an 23 ethical question? 24 THE CHAIR: Which? 25 DR. MACKLIN: The boron neutron. I 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 142 1 mean, the fact that something -- if we had historical 2 examples in which something that was once rejected as 3 a therapy was then used for some governmental 4 purpose, and one of our key examples, one of our 5 flagship examples, then this contemporary instance 6 might be useful to look at in light of those past 7 experiments. But we don't seem to have those, right? 8 DR. OEILNICK: Well, at, it's 9 possible that the TBI could represent that. There, I 10 mean, it was known in the '30s that, the questions 11 were raised about TBI, and it was continued to be 12 studied. And so it might be an example of that kind 13 of a situation. 14 DR. MACKLIN: Well, in which case that 15 focuses it in an entirely different direction. Then 16 the key question is the use of the previously 17 rejected therapies and what drives their 18 reinstitution. 19 And there are legitimate reasons. 20 Maybe the science changes, or some new thing happens 21 and then you try something again, as in the 22 cyclosporine example. 23 And then there may be some bad reasons, 24 which is you may want to piggyback it and study it 25 although you have good reasons to think that the 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 143 1 therapy, once rejected, you have no reason to think 2 that it's any different now. 3 THE CHAIR: What, I think that's a more 4 appropriate way of bolstering the rationale in 5 looking at boron neutron capture with this committee. 6 DR. MACKLIN: I question why there's 7 some efforts to force this into a category. 8 THE CHAIR: Let's table it, because I'm 9 certainly not the best person to defend why this is 10 here, and I don't think this is Barbara's particular 11 area either. So why don't we wait and have Ron come, 12 and if he wants to propose this he can come. 13 He spoke with Mary Ann here, and he 14 wants to present to the whole Committee. We will 15 explain to him what some of the reservations are, and 16 the, and he can come on Thursday, I mean on, I meant 17 in November, November. 18 Can we, however, look at the testicular 19 irradiation one, however? And let me say that, that 20 part of this is, let, let, part of, part of the real 21 problem here is the recognition that as a practical 22 matter it will probably be very difficult for this 23 Committee to escape having to say something about 24 those experiments, as they were so central to the, 25 the history of certain human irradiation experiments 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 144 1 in that period. 2 So we are, we are obviously, as a 3 committee, going to have to attend to those 4 experiments. So now that you have raised it, is 5 there, is there a way to move outword from those 6 experiments? 7 What, and that's perhaps really a 8 struggle. Perhaps that's not the best way to move 9 out and away. Maybe they're so unique maybe they 10 just stand alone and we'll look at them alone. 11 But is there, is there a way to branch 12 out from those experiments? We know we're going to 13 be looking at that. 14 So, you know, however to go from there 15 is really I think what's, what's at hand. 16 Nancy. 17 DR. OLEINICK: Well, the, one of the 18 key issues here is the use of vulnerable population, 19 and if this could be the anchor for a study of other 20 vulnerable populations other than children, or else 21 to group it together, but it might be that that is 22 the issue, rather than the particular experiment. 23 DR. MACKLIN: I have, it, it's actually 24 not -- "vulnerable" may be one word, but I think it's 25 "easily exploitable," because what were the other two 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 145 1 examples? one, it was prisoners, all right, and they 2 were; and the other was flash blindness, and they're 3 soldiers, and they were right there and people give 4 them orders; and the third is students. 5 And we raise contemporary questions 6 today about students, medical students, certainly 7 about anyone who finds it hard to say, "No." 8 So "vulnerable" I think is a less 9 useful word than something like "readily 10 exploitable." 11 DR. LEDERER: I guess things are not 12 ingested easily under "easily exploitable," so maybe 13 prisoners -- 14 MR. GUTTMAN: Maybe after this 15 committee they will be. 16 DR. LEDERER: Maybe there will be. But 17 you can pull children out, but prisoners, it's not 18 going to fall out that way, or students or -- 19 DR. OLEINICK: Well, maybe I didn't 20 understand the intent here, but it seems to me that 21 we were talking about how to distill -- 22 THE CHAIR: Right. 23 DR. OLEINICK: -- this huge number of 24 experiments. That doesn't mean how we, what numbers 25 we, you know, what words we punch into our computers. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 146 1 If I were going to look for these 2 experiments I wouldn't, maybe would look under 3 "prisoners." I would look under other key words. 4 But we, I think we have a sense of the 5 kinds of experiments that we're trying to group into 6 this, and to call it, I like your term much better, 7 "experiments on easily exploitable populations." 8 THE CHAIR: We might want to be more 9 narrow and mindful of what Susan just said. We know 10 we're uncovering information about experiments 11 involving soldiers, and we know at least these 12 experiments involving prisoners. 13 I hesitate on the student one only 14 because of the concern that Susan raised. I'm not 15 sure that we've only accidentally discovered that 16 students were experiments, but we have investigatory 17 authority for learning about experiments in which 18 soldiers were used. 19 And we have a scholar on staff who's 20 expert to the uses of prisoners in research, and we 21 might simply say that we're going to focus on these 22 two. This is the group in which we look at soldiers 23 and prisoners, which both of them are characterized 24 the way Ruth has characterized -- 25 DR. MACKLIN: I'm, I'm not sure that we 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 147 1 have to look for them, though, if, I mean, there is 2 always, do I understand, by some conclusion and 3 recommendations that we're going to be making, -- 4 THE CHAIR: Correct. 5 DR. MACKLIN: -- and it remains, too, 6 that students, our students have been in the past 7 terribly exploited. Every single person in any 8 institution, every physician, which the, which had 9 informal discussions, and other people also, about 10 this committee have said, "Oh, when I was a medical 11 student, you know what they did to us?" 12 Now, things have changed a little bit, 13 I hope, but we certainly still know that in, students 14 in social science classes have to do their 15 requirement some places, and they have to participate 16 in some experiments. And this is all related to what 17 kind of conclusion we're going to draw even in look, 18 looking at, at the present. 19 So I don't think the fact that we can't 20 find them in the past is an argument for not flagging 21 them when you see them. 22 THE CHAIR: Reed, do you want to, and 23 then I'm -- 24 DR. TUCKSON: Yeah. This kind of gets 25 to the question I was struggling with also, and let 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 148 1 me see if I can put them out as well. And I'm trying 2 to find out. 3 There is a sense that as we define 4 these categories, which is fundamentally important, 5 then we start to zoom in and spend some time, and so 6 the assumptions we make there really tells us what we 7 will look at and what we don't have time to look at. 8 And this vulnerable population as an issue is one 9 that's important to me. 10 For example, in the South poor minority 11 communities really do believe that the defense plants 12 and nuclear weapons production plants so often come 13 to their community, and they are concerned. And I 14 think that Susan's comment was really important, and 15 I think it's really important in terms of how to look 16 at -- there's no category for rural-southern-Black- 17 folks-getting-ripped-off kind of category. 18 But it seems to me then that I would 19 hope that as we explore in each in these 20 categories, -- 21 THE CHAIR: But that's a given. I'm 22 sorry. I didn't mean to interrupt, but one of our 23 four themes in each of these categories, we are 24 looking to see who are the subjects. That's, 25 that's -- 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 149 1 DR. TUCKSON: But, see, as we focus, 2 from my past background, obviously I'm very much 3 concerned with children and pregnant women. I mean, 4 that's very important. 5 But to not suggest that we are going to 6 be very vigilant in looking at, you know, the Black 7 populations because of socioeconomic status, and, 8 and we may not find good examples easily that tell 9 us. 10 THE CHAIR: Right. 11 DR. TUCKSON: But it is going to be 12 very important that we at least satisfy the American 13 people that we were diligent. 14 Secondly, and it is important, and I'll 15 get through all of my concerns. Secondly is that 16 it's important because it falls into the outreach 17 work. How do we assure that those who testify in 18 front of us, let's say we have the stellar, blinking- 19 light cases, the biggies, but then we have a number 20 of people that come and say, "My case is not one of 21 the biggies. It's not one of the celebrated headline 22 cases." 23 But, you know, how do we hear that and. 24 how do we allow ourselves to say, "Even though, since 25 that is a big one, this is small, but, but thank God 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 150 1 we heard it because it allows us to, to bring that up 2 because it is so important"? 3 And I just want to make sure that 4 there's -- I didn't object to Duncan being deputized 5 because I really do want him to be deputized. But 6 the question is, is how does Duncan and staff, how do 7 you incorporate the outreach stuff that comes forward 8 in that process? 9 THE CHAIR: Good question. I saw Susan 10 wanting to get into that. 11 DR. LEDERER: I guess this is going 12 back to the question about what is it about the 13 Category 5 that we're interested in. Is it that 14 they're irradiating testicles, or is it that they're 15 irradiating a population? 16 And I agree with you: I don't want to 17 see that population drop out. But again, I thought 18 this was a way to focus the search. 19 THE CHAIR: It is a resource strategy. 20 I'm sort of figuring out how to organize this at the 21 same time as the decisions we make here in important 22 ways say something about the committee and, and our 23 interests in our commitments. 24 DR. BERNEY: But I think in that 25 category the answer is we would be looking for other 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments 151 1 experiments on prisoners, not other, the experiments 2 in the testicles areas being irradiated. I think in 3 terms of our concerns, that's what that category is 4 about. 5 DR. OLEINICK: Why? 6 DR. MACKLIN: Since it's in that last 7 category, what are the studies related to? 8 THE CHAIR: Right. I saw Mary Ann and 9 Duncan. 10 DR. STEVENSON: I mean, so much of this 11 category are focusing on healthy adults as opposed to 12 children, but that's not any easier to look up. 13 There's not a "healthy adults exposed to radiation," 14 either. 15 So I guess, what's the easiest way to 16 steer them? And it may be by looking at otherwise 17 healthy populations that were attracted to 18 exploitation, because the prisoners are there. Same 19 story with soldiers. At least for a period of time 20 they're a captive audience. 21 But it really is these are healthy 22 adults. 23 THE CHAIR: This is an attempt to focus 24 on people who will, you know, it is a mixed bag. The 25 point is, if there had been exactly that same study 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 152 1 done on men who were not prisoners it would still be 2 a matter of some public concern, and we would still 3 be looking at it. It wouldn't have this question of 4 the possible exploitation. 5 The fact that you'd radiate someone for 6 no benefit at all to the level that results in damage 7 to healthy tissue is troubling and would cause 8 concern. So it's complicated. 9 But that it's prisoners makes it, you 10 know, it's, I don't know. 11 We've got Duncan and Ruth, and then I'm 12 going to suggest we table this until Thursday, this 13 one, because I don't think we can do right with it. 14 It is 5:30 and we should, should stop. 15 So, Duncan, the -- 16 DR. THOMAS: Susan's concern about how 17 do we identify these things was important back in the 18 days when we were envisioning some sort of random 19 sampling, and that's when we had to remember what the 20 term of the universe was that we were sampling. 21 Seems that's less of, of an issue now that we decided 22 to go back on that policy. 23 We're going to come across examples of 24 prisoners and what we call "other easily exploited 25 populations," and when we do come across them we 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 153 1 should tell their story. And this category should be 2 defined in such a way to make that possible. 3 Now, what I'm grappling with is whether 4 the primary purpose is if, whether the reason for 5 this category is to tell the story of the easily 6 exploited populations, the prisoners, soldiers, 7 students, and perhaps others, should be in there, or 8 whether it's to tell the story of research done for 9 no therapeutic or medical purpose. 10 So, some extent that I think goes to, 11 hand in hand, because it's going to what actual 12 person is going to subject themselves to radiation 13 for no diagnostic purpose except an easily exploited 14 population. But we've got to be careful. 15 THE CHAIR: But wouldn't it also be a 16 level of risk that -- I mean, if it was a very 17 minimal risk you might have someone volunteer. 18 DR. MACKLIN: But there is something 19 about these, this category. What is it that stands 20 out? 21 These things would never go on today. 22 That may not be true of the others. 23 This would not go. And there's plenty 24 of research that's done on normal, healthy 25 volunteers, some of which may be reasonably risky, 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 154 1 and yet the nature of the population and the purpose 2 of the research, what the researcher argues they're 3 trying to find out that could be of benefit to other 4 people who may become patients is what allows it to 5 be approved by IRBs. 6 But here it seems to me is the no 7 diagnostic or therapeutic benefit, conjoined with the 8 military purpose, and the notion it could never be 9 done today because of the level of risk. I mean, 10 it's all these characteristics put together that make 11 it a category. 12 THE CHAIR: If you define it that well. 13 I'm just worried about your defining it that 14 specifically. 15 DR. MACKLIN: No, but that's why I see 16 the problem. But that's why if we find a category 17 where we say no one who was given proper informed 18 consents today and who knew the purpose of trying to 19 find this out would not knowingly volunteer, and no 20 IRB could approve it, then that may set it off from 21 lots of other things on our list. 22 So the fact that the purpose is what it 23 is, it's not only that these particular subjects 24 wouldn't be benefitted, but one couldn't name a 25 potential medical benefit. Now this may not be true, 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments 155 1 but one could not easily envision, correct me if I'm 2 wrong, a medical application. It's a war. It's an 3 atomic bomb act. 4 THE CHAIR: For those two, yeah. 5 DR. MACKLIN: Yeah, and those are the 6 only ones that are mentioned. 7 THE CHAIR: Here that is right, but 8 this is one way of spreading it out. If you went the 9 other way and spread it out to this general category 10 of people who have a higher potential of being 11 exploited, and you define soldiers in that category, 12 then it would not be so narrowly defined. 13 I mean, the work with the soldiers 14 would not necessarily have all of those 15 characteristics, may well be approved today or it may 16 not be. We have to be careful. 17 DR. MACKLIN: Of, were, were others of 18 these six involved soldiers? 19 THE CHAIR: You mean in which soldiers 20 were pulled in? 21 DR. MACKLIN: Yes. 22 THE CHAIR: It's a good question. You 23 know what? Can I do this? And maybe it's my own 24 fatigue, but I am worried about continuing the 25 discussion past 5:30. 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 156 1 Can I do this? Let me just summarize 2 where we are. 3 We have, as I understand it, approved 1 4 through 3, and reconceptualized 6 to be radioisotope 5 research, and with that leave the centralization it 6 is in. 7 We then agreed to table, these would 8 all be large case studies. These would be defined as 9 the field of work in those four areas. 10 We had decided to table boron neutron 11 capture therapy until a discussion in November. And 12 we are going to pick up this, this Category 5 with 13 all of its complexities probably Thursday, which fits 14 with the agenda of Thursday, which is both the 15 interim report and defining the strategy for the 16 Committee. 17 So if we can figure out on Thursday 18 what we want to do with this Category 5 we'll be okay 19 as long as it's gone in this meeting. It doesn't 20 have to go at this session, but as long as it's done 21 at this meeting it's fine. 22 So is that agreeable to everybody? 23 (Whereupon, no response was had.) 24 THE CHAIR: So, with that we'll stop 25 now on time. We wanted to do it early, but this is 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments 157 1 on time. 2 And we, we, please remember that 3 tomorrow morning we start at 8:00, as opposed to, 4 shall we start later when we're on the East Coast? 5 Tomorrow morning we start at 8:00 6 o'clock. This requires some people getting up very 7 early. And also we want to allow as much time as 8 possible for public comment. 9 All those who were planning to have 10 dinner with the Committee, please meet with Jeanie. 11 We have information about that. She will be the lady 12 by the door. 13 (Whereupon, at 5:39 p.m. PT the above 14 hearing was adjourned.) 15 I certify the foregoing to be a 16 true transcript from my notes. 17 ____________ 18 SR, CP, RPR 19 20 21 CERTIFICATION 22 I, Dorothy I. Bunn, a Registered 23 Professional Reporter, Certified Shorthand Reporter, 24 and Notary Public, do hereby certify that the 25 foregoing testimony was duly taken and reduced to 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733 Human Radiation Experiments/SF 158 1 writing before me at the place and time therein 2 mentioned. I further certify that I am neither 3 related to any of the parties by blood or marriage, 4 nor do I have any interest in the outcome of the 5 above matter. 6 In witness whereof, I have hereunto set 7 my hand and affixed my official seal, at 8 Raleigh-Durham, North Carolina, this 15th day of 9 October, 1994. 10 11 Notary Public 12 My Commission expires November 7, 1995. 13 14 15 16 17 18 19 20 21 22 23 24 25 1-800-435-2468 BUNN & ASSOCIATES FX 307-436-5733