UNITED STATES OF AMERICA + + + + + ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + + PUBLIC MEETING + + + + + Wednesday, July 19, 1995 The public meeting was held in the Executive Chamber of the Madison Hotel, 15th and M Streets, N.W., Washington, D.C., at 8:30 a.m., Ruth Faden, Chairperson, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H. Chair ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA KING, J.D. SUSAN LEDERER, Ph.D. RUTH MACKLIN, Ph.D. (via telephone) LOIS L. NORRIS NANCY L. OLEINICK, Ph.D. HENRY D. ROYAL, M.D. PHILIP K. RUSSELL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. REED TUCKSON, M.D. STAFF PRESENT: ALLEN BUCHANAN, Ph.D. PHILIP CAPLAN DAN GUTTMAN, J.D. LANNY KELLER ANNA MASTROIANNI, J.D. STEPHEN KLAIDMAN JONATHAN MORENO, Ph.D. RON NEUMANN, M.D. GARY STERN, J.D. I-N-D-E-X PAGE Welcome and Orientation to Meeting 5 Report on TBI 58 Reports on Chapter Four 114 Medical Notification 200 Openess 225 Findings on Risk 236 Recommendations 278 P-R-O-C-E-E-D-I-N-G-S 8:42 A.M. CHAIRPERSON FADEN: Good morning. If the Committee could come to the table please? (Asides.) CHAIRPERSON FADEN: Good morning, if we could come to the table please? (Asides.) CHAIRPERSON FADEN: Okay, tell Ruth -- do you think we could move where Ruth is, to someplace where she's better able to hear? Does she look comfortable? I don't understand. The lights are dreadful. Tell Ruth she's not missing anything because the lights are awful. They're really awful. This is the worst we've had them for some reason. I won't make it. This is why I know I made a right career choice. I can't imagine -- I have sunglasses. Do you think that would be tacky to wear them? It would be tacky. It would be tacky to wear them. All right. (Asides.) CHAIRPERSON FADEN: Give her Ken's mike. Ruth, could you -- are you there? Can you hear me? MS. MACKLIN: Yes, it's fading in and out. CHAIRPERSON FADEN: Oh no. All right, well as we can tell, Ruth is with us by telephone we hope, we hope. But Ruth, if you can hear us, you really are not missing much because the lights are particularly glaring this morning and unpleasant. So you may not be able to see even if you were here, which is actually relevant because if I don't recognize that you're trying to get my attention to have the floor, it's because I can't see. I mean, there are total shadows on Duncan and Jay and Eli. And if you are trying to get my attention, I probably -- that's right. I need you to do that because otherwise, the normal subtle ways in which you have so courteously been letting me know that you would like to speak are totally lost for at least the three of you. I can sort of pick up with Lois. So Duncan, if you would just remember and gesticulate. Can you see -- MR. GUTTMAN: I can see Duncan. CHAIRPERSON FADEN: But can you see Jay and Eli, because it's hard? MR. GUTTMAN: Yes, it's the white hair and the beard. CHAIRPERSON FADEN: It's difficult. Well, all right. We have a tough schedule and let me just start out by saying this is our last day, but I am absolutely like not going to make any comments at the end of this because I can't cope with it. Moreover, we have so much work left to do that it seems totally inappropriate to say anything formal in the way of goodbyes. And hopefully, we will all convene when the report is released. So I am telling you now, sort of forewarning, that I'm not going to make any comments and I hope no one else does either. MR. GUTTMAN: (Inaudible.) CHAIRPERSON FADEN: I will do that. I will do that. That's different. But I meant in terms of a committee member saying goodbye to one another or thank-yous or things like that. I don't -- thank you. That's it. You got it. That's all we're going to do because we are going to be talking with each other and working so hard over the next couple of weeks that it seems sort of silly on the one hand. And also, I'm hoping that we'll all get together, or at least as many of us as we can, when the report is officially released. MR. TUCKSON: (Inaudible.) CHAIRPERSON FADEN: That's probably true, Reed, but I don't want to cry on the record. I really have this thing about not wanting to cry on the record. I really don't want to do that. FEMALE SPEAKER: -- because I would join you. CHAIRPERSON FADEN: Thank you. So we're not going to do that. But we do want to thank Lanny, who has been coming back even after he was no longer full-time on the staff of the committee for the totally thankless task -- (Applause.) CHAIRPERSON FADEN: -- of taking minutes. And this is relevant because we're about to approve the minutes which Lanny is always the primary director of. But I have said many times to Lanny and to the recorder that the three of us have the worst jobs because we can't leave unless there's a break. So when you stop and think about it, you know you're sort of locked in. So there are sessions in which we have said no, let's not have a break. Let's keep on going. It doesn't work. For three of us anyway, this is really a serious problem to not have any breaks and to go for hours because we're sort of stuck here. Anyway, Lanny has done a super job. And in line with that, it would be very bad for him to express any changes to the minutes. (Laughter.) CHAIRPERSON FADEN: But the minutes are before you, and that obviously was a joke, okay? That was a joke. DR. GLATSTEIN: Move for approval for Lanny and the minutes. CHAIRPERSON FADEN: Thank you. Are there any seconds? MS. NORRIS: Second. CHAIRPERSON FADEN: Second. Are there any changes -- seriously, are there any changes or amendments because as good of an observer and recorder of our events that Lanny has been, there are always, with so much going on, possibilities for errors. So are there any corrections or changes to the minutes? Okay, all in favor? ALL: Aye. CHAIRPERSON FADEN: Okay, the minutes are approved. I suppose we, by mail, approve the minutes to this meeting? There must be some process whereby we will formally approve the minutes of this last meeting. So Lanny's work is not quite done. Okay, do you have -- Anna, we had a copying problem, so there is not enough of these yellow things for everybody. But so if you could share them, this is a revised agenda for today. And you can see that it's extremely packed. The rationale is in the morning, we will discuss how we are going to proceed and including giving people an opportunity who are thinking about writing individual statements to say something about what they want to say. Then we have three chapters to discuss in the morning, each of which have corresponding recommendations or findings, issues. Total body radiation, we have to also discuss the corresponding recommendation if we want to make one, given that we deleted the questionable rationale recommendation which was addressed towards the TBI context. And then obviously for the Chapter Four and Chapter 12, it's actually -- right. Wasn't the Marshall Islanders Chapter 19? Oh, you mean the finding and recommendation in 18 and 19, right. But the observational studies chapter carries with it two unresolved findings and recommendation things that we have to discuss. After lunch, we have a series of pieces of business, issues that are hanging out there that we need to return to. They are all terribly important, okay? And we need to work very quickly through all of this. So again, what I said during the public comment period, as hard as it may be, I think I'm going to have to keep us closer to the time schedule today than perhaps I have at other times because we can't hold anything over to the next meeting. Anything that isn't addressed today does not get addressed by us as a collective group. So I want to make sure that there's some discussion of each of these items, even if the discussion is not wholly satisfying and we have to continue it through some other means of communication after this. I want to make sure that we've at least spent a few serious minutes on each of the issues on the agenda. And if you would take a look at the agenda and see if you -- as you are obviously concentrating on everything else we're talking about today, if I've missed anything from yesterday -- yes, Duncan? DR. THOMAS: It wasn't anything that we talked about before, but you mentioned yesterday that you wanted to talk about isotopes. And I don't know whether you changed your mind about that or not. CHAIRPERSON FADEN: Yes. I think the problem with the radio isotopes chapter was brought to our -- a problem was brought to our attention by Ruth and Lois, both of whom raised reservations about the benefit section of the radio isotopes chapter. There has been an attempt to respond to that. Gil has done a revision and it's now being passed around, or will be passed around I guess to people who are interested in the benefits section: Nancy and others, and back to Ruth and Lois, to see if we can't reach an agreement about how to present the material. Pardon? DR. STEVENSON: (Inaudible.) CHAIRPERSON FADEN: Great, so Mary Ann has had an hand in it too. I was hoping that -- it looked like we were on our way to working that one out. But if there are other issues on the radio isotopes chapter, I would bring it up. But it looked like the people who are really -- that we have lots of good people working on it and that it -- a satisfactory approach was being worked out. So thank you, Duncan. I should have mentioned that. And I wasn't aware that there was so much hard work already started on working this through. So I guess between Mary Ann's effort and Gil's effort and then Nancy and Lois and Ruth looking at it with Mary Ann and Nancy and anybody else, obviously we'll send it back to everybody, we should be able to wrap that -- we should be able to address those issues without taking committee time. So it looks like all the relevant committee members are already working on this together. Okay, if anybody notices anything else though, we'll have to cram it in because this is the one chance we have. If we can begin then with the discussion of strategy and how we're going to proceed from now on. Let me just tell you what I think is going on and then I want to make sure there's time for those of us who are thinking about writing individual statements to share with the rest of us what kind of individual statement we may be planning on writing. We distributed a time table. How long ago was it, Anna? MS. MASTROIANNI: A week or so ago. CHAIRPERSON FADEN: A week or so ago. And we're going to struggle mightily to stay with that time schedule insofar as possible in the sense that the staff and those of us who are working with the staff on drafting chapters are going to try to keep cranking it out at this impossibly fast pace. So we're just going to keep doing that. I don't have that time frame in front of you, but the plan -- or in front of me, but the plan, for example, was that on Monday or Tuesday, you would receive a revised Chapter 18 and 19. And there will be every effort made to do that so that we can keep working. Similarly, we asked that committee -- oh great, great. Reed had his. We asked for you by Friday to send us your round of comments on the part two chapters. Many of you have already done that. But basically what we're holding up in revising the part two chapters was this meeting plus individual comments from everyone on all the part two chapters. I'm sorry, we made it -- SPEAKER: I think it was Monday. CHAIRPERSON FADEN: I'm sorry, we made it Monday to give you the weekend. So for those of you who have not responded to chapters in part one or part two or the preface, which has only been recently sent out, we're asking you to please send us the comments -- that's in -- century, right the four-part one. Thank you. That if you could get us your comments for those chapters by Monday, then with the benefit of this discussion of this committee meeting and everybody's comments back, the staff will then rewrite, with relevant committee members, and get the next version of those chapters out. And we all know that some of those chapters are closer and need less work, and some of those chapters are further and need more work. The reality is that we're going to keep doing this process until probably the last second. But hopefully, few more and more chapters will require less and less work and more and more like stylistic editing stuff. So if we can just envision a process that will, you know, just go at full break -- what's the right description, break neck? MR. GUTTMAN: Full break-neck speed. CHAIRPERSON FADEN: Full break-neck speed, thank you. Full tilt or break-neck speed, either one of which would be fine. Basically through August and into September, we're just going to keep marching along. And you're going to keep getting, unfortunately, a wholly unruly fed exes. Hopefully, we'll try to work -- but that's just how it's going to come. We'll just keep working away at this until we're done. I mean, there's really no other way. DR. GLATSTEIN: When do they go to the printer? CHAIRPERSON FADEN: It doesn't go to the printer? DR. GLATSTEIN: It doesn't? CHAIRPERSON FADEN: It doesn't go to the printer until it's done. So it's a kind of complicated process, but there isn't a date. It will go to the printer after the -- SPEAKER: When we hand it in. CHAIRPERSON FADEN: When we hand it in. When it's formally submitted to the President, it will then, or the interagency working group, it will then be submitted, and hopefully a quick publication run. DR. KATZ: When do you want statements by individual committee members? CHAIRPERSON FADEN: Well, we had a schedule before, Jay, and you raised the issue of whether we wanted to shift that over. I have to take a look at that with Anna, as I said to you, that I wasn't prepared to answer that today. So I have to sit down and look at the schedule with Anna and Jeff and Dan and see if we can put some flexibility into that. DR. KATZ: Well, I just wanted to say for the record that if there is no flexibility, then I cannot work on any of the chapters -- CHAIRPERSON FADEN: Except -- DR. KATZ: -- of the least -- except of course if the statement in the seventh, eighth or ninth day framework. I need the time to compose my statement. I hope there will be flexible, and of course I have problems which I think they could give us all. But it all depends on what your ruling is going to be. CHAIRPERSON FADEN: I agree. I think we're going to try to work this as closely as possible because obviously we need your help on other things besides your statement. And that takes me to the next point which is I had mentioned, I don't know when, yesterday, the day before, the idea that it is important now, as Jay has just expressed, to identify those chapters of the report where you really would like to put a lot, you're willing to help staff a lot up to the point of, you know, redrafting language. And obviously, all of us will look at all of the chapters. But there are a few chapters that it's already happened by self-selection. People have been working, responding, disproportionately. We just had another expression. Nancy is working on the benefits section of the radio isotopes, Mary Ann edited the children's chapter. So we've all been doing this all along. Naturally, it's kind of fallen out. We have Henry and Mary Ann's effort on the TBI chapter and so on. It's just a matter of getting it very clear with staff as to which ones of these you really would -- are willing to put disproportionate energy and where you're willing to write stuff, and not merely react, but to say this section has to change and has to be substituted, and I propose substituting it with the following. And that will just make the process go that much further. It still means that the rest of your colleagues have to go along with the formulation. But it's closer -- it's closer than guessing about what you want. And merely -- the help we're asking for now is greater than merely saying "I didn't like the sentence," but "I didn't like the sentence and I would like the sentence to be 'x'." So I don't know if we want to circulate. Maybe at lunch we can come up with something and just ask people to check off. And you do what you can. I mean, people can only do what they can. And everybody already has been doing more than they should on this process, or reasonably could have been expected to do. So if we can just get a clear sense by the end of day which ones of those chapters you have that special interest in and are willing to make that particular commitment to, I think that Jeff and Anna and Dan and Steve can probably guess as to which ones they are. But rather than guess, we might as well get that formally from you and receive in that fashion. And we're not now talking about formalizing subcommittees. We don't have the time for that sort of thing. But if it happens that two or three committee members are willing to work on the same chapter, we'll obviously work to get you in touch with one another. But we don't have the energy at this point, or the staff, to sort of formalize conference calls and things like that. It's all going to have to be done the hard way: writing stuff, fax, sending it back and so on. The other issue, and then we just want to go to the question of people expressing what they might write a personal statement about for benefit of the rest of the group has -- this is a silly issue, but it keeps coming back. Some people like to see revisions red-lined, and some people don't like to see revisions red-lined. My own view at this point is that it is probably better to get things red-lined so your eye can go right to where -- with the strike-out and the red-line in it because given that what we're talking about are shooting lots of chapters through multiple fast revisions, I personally would prefer to see it that way so that I can more readily understand what I have to be looking at and doing. Good morning. You can put your sunglasses back on if you like. MS. KING: Thank you. CHAIRPERSON FADEN: Yes, we're all kind of reeling from the lights. So why don't we do it this way rather than have a profound discussion about a technical issue? If any of you would rather not receive it in a red-lined form, would rather see it in some other form, would you just let staff know? Otherwise, we'll presume that as these revisions come out, you're going to see the red-line strike-out -- you're going to get the red-line strike-out version so your eye can go right to what has changed. DR. KATZ: The pages will be the same? I mean, the last version that we have seen. Will the pages change in the red-lined version -- MS. MASTROIANNI: They have to. DR. KATZ: -- from the last -- CHAIRPERSON FADEN: I'm not sure I know what you mean by the page. The page numbers? DR. KATZ: Yes. CHAIRPERSON FADEN: Sure, because you add or delete -- if you add material, it changes. In other words, if the next revision has new material in it, that will change the length of the chapter. DR. KATZ: So we really have no way of comparing -- CHAIRPERSON FADEN: Yes, that's what a red-lined chapter does. It strikes out all the old text, okay? So you'll see all the old text with a line through it. DR. KATZ: You'll see the old text? CHAIRPERSON FADEN: Right. It's actually bolder than the previous version. DR. KATZ: Okay. CHAIRPERSON FADEN: So the previous version will have a line through any of the text that was deleted. And the text that is new is shaded. DR. KATZ: Shaded, okay. CHAIRPERSON FADEN: So you can immediately tell what's been -- and if you like -- if you want to retain language that's been eliminated, you can indicate that easily. Other than that, you've got to sit there looking at the two chapters trying to -- having a vague sense that there was something that I liked in the last chapter, but I can't -- last version, but I can't remember what it was. You've got to go find your last version and kind of thumb through it. This way it's available to you. So it's the way we got the TBI chapter, only it came off of a bad Xerox, so it was not easy to read. So we'll try to get you a red-lined strike-out version that's a better copy so it's visually more pleasant. So if anybody doesn't want to receive that way, let us know. Otherwise, that's how we'll get it. Lois? MS. NORRIS: Ruth, when you do work up a schedule, people who are working on any one chapter, would you circulate that so that we know -- CHAIRPERSON FADEN: Oh, absolutely. MS. NORRIS: -- which individuals are assuming that responsibility so that if we have comments and want to jump in then that's perhaps the way to do it? MR. GUTTMAN: You can always call either Anna or I. MS. NORRIS: Well, but it would be one less phone call for you to deal with. So -- MR. GUTTMAN: Right, not on that -- CHAIRPERSON FADEN: What we'll do is we will identify a staff member with every chapter as well, so that you can either do it one of the other ways, but so that at least that if you're calling staff, you know that you're calling the right person, which is how we've done it before. But we'll just make sure we keep that up. So that we know if Chapter Four is the following committee members and it's this staff member is the point of contact. And that will minimize the possibility that you've got a wasted phone call by calling Anna, but that's really Dan's chapter or whatever. But thank you for that, and we'll let everybody know. Okay, am I missing anything before we --of that nature? Okay. Jay and I have -- MS. MASTROIANNI: Actually, just one thing. If you could continue to send -- if you're sending written comments, if you could still address them to me regardless of the staff person? Because I think that's the only way it's going to get circulated. CHAIRPERSON FADEN: Circulated to the other -- MS. MASTROIANNI: Circulated to the other committee members. MR. GUTTMAN: Right. And anything that goes down that people presume must be organized and important. Anything that goes to me, people presume is -- (Laughter.) MR. GUTTMAN: That's not sense of humor, that's reality. CHAIRPERSON FADEN: Well, your work has served us well over the past year and a half. I will tell you there have been many times when had it not been for somebody's ability to make a comment at just the right moment, it would have been almost unbearable. All right, Jay and I had discussed on the telephone that it would be helpful for all of us to hear what members of the committee who were thinking about writing personal statements or individual statements, or whatever we end up calling them, are thinking about saying. And Pat has already expressed that -- as far as you're concerned, you've already said everything. So if we want -- MS. KING: Well, if they want me to try it one more time -- DR. KATZ: Yes, I wish you would. CHAIRPERSON FADEN: I'm sure that's just what you wanted. MS. KING: One of the most important things that the committee seems to be doing in the overall report is to make retrospective judgements. And my statement is going to go to the issue of retrospective judgements which affects Chapter Four, uranium miners particularly, but some of the conclusion in the other chapters as well. And the argument, depending on what we do today, it would be nice if you all would do away with the need for me to do this, is that in my view, the judgements that the committee draws have not been sufficiently argued and justified in Chapter Four in terms of the ethical framework that might be applied to a retrospect judgement, one. But I don't intend to make much of that because I'm not a philosopher. And I certainly can't do that because I am not a philosopher. But what I do intend to say is that it seems to me that a framework can be drawn without -- that it is possible to make these ethical frameworks an argument without relying solely on views about rights, individuals rights and human rights, that there are other approaches unarticulated, because I don't think they're there. But that's not going to be the thrust. That's going to be the beginning. And then I'm going to argue that in my view, and this part I will spell out, it's hard to make an argument about the bridge when you're saying that the first part doesn't connect. But then the committee goes on to apply a framework that it says is in Chapter Four to the history that we have uncovered as an advisory committee, the documents, the papers, etc. And I'm going to argue that we have not done that, that the documentation that we have and the historical work that we have, in my view, did not constitute sufficient -- this is an evidentiary point if you want to call it that -- do not have sufficient weight, among other things, to lead us to the conclusion. Not all. I am focused particularly on the medical profession, the conclusions with respect to the medical profession, and some of the conclusions with respect to government agencies. Not all, because some of them I have supported, as you know, through the committee's deliberations. And I am not going to argue that it is inappropriate to make retrospective judgements. I'm going to make this very clear. I am going to argue that the committee has not set an adequate framework. And because it has not, it can't do an adequate application. And therefore, much of what we depend upon in the future chapters, in my view, is not sufficiently argued. Does that summarize -- CHAIRPERSON FADEN: Yes. MS. KING: -- the points I've been making all along? CHAIRPERSON FADEN: And you think it might be clear -- it makes it the backdrop for the discussion of Chapter Four. So I think that's very helpful. And obviously, if Chapter Four is improved to the extent that it is, you may want to change your statements some, a little, or not at all. MS. KING: Well, I would feel better, quite apart from anything I may or may not say, and I've discussed this with some people, if Chapter Four could be improved. Because I think for an ethics commission or a commission that thinks of itself as an ethics commission, the ethical justification ought to be the best that we can do it. And I think we would all agree with that. But I know this is tough for a lot of people on the commission who have never done this kind of -- I don't blame you for not wanting to get into philosophy. I have a lot of sympathy for that. But to try to give you an idea of what I think we should be doing, it did strike me going through the President's Commission on Ethics, a report on compensation, that I kept saying "Gee, I wish we had had the report earlier." Not so much for the conversation issue, but because it is a good ilmustration of the steps that I think you go through in order to provide the justification that you need to make some of the conclusions that we reach. That would be my first point. In case anybody wants to ask and they say, "How can you vote for some of the recommendations?" That's because I have my own justifications for getting to the recommendations that I can make an argument for, which I find sufficiently satisfactory to me. This is not unusual that people will get to the same end- point by different routes. In fact, I would be amazed if we did it any other way. The major problem appears again, when I bored everybody to death the other day, when I was talking about uranium miners, when I said that one cannot merely state that there is an obligation. One has to argue for what the obligation consists of in theoretical terms. And then one has to develop an application based on that. So it is that argument there with sort of a precursor of whether some of the problems I have with Chapter Four and some of the problems that I have in the conclusion -- everybody's smiling. CHAIRPERSON FADEN: I'm not surprised. But I think that if what Pat is saying is perhaps not entirely clear to everybody, I think when we start talking about Chapter Four and you join us in that discussion, it will be clear what your concerns are specific to the inadequate argument in the framework. So rather than push Pat on that now, I'd rather we wait until the discussion on Chapter Four if that's all right, Duncan? Because if you have a question about something else that Pat said that's not specific -- here's my suggestion: that Pat's criticisms of Chapter Four and that part of her statement that address that criticism be held off until we just take up Chapter Four. But other issues or questions to raise with Pat now of course would be fine. DR. THOMAS: Well, I'm not going to push her. In fact, I'm completely sympathetic when she talks about the inadequacies of Chapter Four. And we will get to my feelings which I think are very similar to Pat's. I just wanted to ask Pat a question. When you said that you felt that individual rights and human rights weren't necessary to provide the justification for retrospective judgements, but that you had other ways of reaching that -- MS. KING: No, let me clarify that. I don't think that's what I said, because what I said is it's not the only way for making an argument. It is a framework for which I'm particularly uncomfortable. And one of the things that I would raise is that there is another framework that can be based upon, theories of obligation and relationships that -- DR. THOMAS: Exactly. I'm asking if you were -- I'm hoping that you'll spell out some of those. MS. KING: Keep in mind now I am not your philosopher. CHAIRPERSON FADEN: Let me point out something. And again, we're getting into Chapter Four. This last revision of Chapter Four, particularly some of the last minute revisions, removed a lot of the rights language and rights analysis. I took it almost all out frankly for a complex of reasons so that before we have stuff, let's get -- the chapter actually argues for the -- argues not on a rights-based analysis. So we should get clear about that. Whether what's there is sufficient is another order. But it is not a rights-based analysis as -- DR. THOMAS: No, I realize that. What I'm asking is, is this whether -- Pat can elaborate, if not now maybe when we get to the Chapter Four discussion as to what these other bases are. MS. KING: I think actually Allen Buchanan can elaborate better than I can because I've discussed a little bit with him, and because he is a person who is a knowledgeable in this area. He said he had some glimmer of what I meant, and so he can probably -- CHAIRPERSON FADEN: I really -- again, it is so clear to me, Duncan, that what this is is a chapter four discussion. We should wait until we take up Chapter Four and then we can really kind of get it apart. And of course, I'm sure if Ruth is listening to this discussion, she must be absolutely dying to jump in. This is going to be painful for her. I knew this would be very difficult. So I'm really hoping she can join us because I'm sure she would -- MS. KING: She's got some thoughts about this. CHAIRPERSON FADEN: I'm sure she's got some thoughts about this and would want us to hear what she has to say as each of us would if it was our area of expertise that was now at issue. So Jeff is desperately seeking Ruth, as it were. And let's go on while we're desperately seeking Ruth. Before we get to Chapter Four, we will do TBI. Are there other people who are -- I mean, Jay, you have said several times that you're planning to write an individual statement. Would we like to hear from Jay about what he has in mind to speak to? DR. KATZ: Briefly, of course, my major statement will address the issues raised by the subject interview, matter of protocol review studies, and the findings and conclusions of the recommendations of the committee. In my view, I don't think these findings and conclusions move in the right direction. But I would want to move much further. I do think the system is fundamentally flawed, that it requires a complete new look by -- and even though particularly since I won't be available for another Commission until 2005, I am -- I have problems with committees and commissions. But in this instance, it is absolutely essential to take a look at the regulations and I will briefly outline what needs to be looked at. So that's going to -- and you get some idea as what I am talking about from the report that I submitted to you at the last meeting. And I think I will tie some of these comments up with the historical review, the Chapters One, Two and Three, but very briefly because I have different thoughts about what the ethos of the profession was and what the impact of the Nuremberg Code was under profession, and the Wilson regulations under professions during the 40's and 50's and 60's. I'll touch on them very lightly if necessary. I only want to tie it in, I think, with the fact that we haven't gotten as far as we think we have gotten since 1974. There are certain fundamental problems in human experimentation, particularly in relation to protecting the inviolability of subjects of research that cannot be easily resolved and indeed ultimately, they cannot be resolved completely. But we can do a much better job avoiding damage to the integrity of individual -- such subjects and do damage to the morality of the research enterprise. And I'll talk about that in time, who I -- to be able to submit early enough a statement on my views so that I can benefit from your comments, and possibly find that you're willing to join me. I may have to -- I don't know yet. I'm just flagging it because we haven't concluded yet. I may have to say something about the Marshall Islanders. But that depends upon how you ultimately come out. I may have to say something briefly though, and I'll do that very briefly, about the uranium miners. Particularly, I thought a lot about Ken's document that he sent to us last night. And I spent an hour thinking about it this morning, hoping we would discuss it a bit. But I may not have to do that. This all depends on how we come out. CHAIRPERSON FADEN: Questions for Jay? I hope everybody is -- I mean, I'm finding this useful because although we have had sort of hints and stuff, it's nice to hear a summary. Henry, you had -- DR. ROYAL: At times, I've hoped very much that I would not write a personal statement. Part of it is selfish. SPEAKER: Work. DR. ROYAL: It's work, plus you have to identify yourself as being different from the group. And there's nothing pleasant about either of those two things. But as I thought more about it, I've tried to understand when I am uncomfortable about some parts of the report, why it is that I'm uncomfortable. And I think that if I could explain my discomfort to readers of the report, readers of the report who are also uncomfortable with parts of the report might better understand the source of -- discomfort. So what is the source of the discomfort? I think -- so this would be one of the things that would be discussed in the personal statement. And I think the source of the discomfort is that my life experiences are very different than the life experiences of some of the committee members. Because my life experiences are different, I believe that people are basically good people, that they do the right things. And I know that to some of the committee members, I strike them as being particularly naive because I have these beliefs, and they point out all of the terrible things that have happened in the past. I don't mean to suggest that my perspective is right and someone else's perspective is wrong, or vice versa. But it has a great deal of consequence in terms of how one would go through a process like this. If, for example, you would have the world view that people are generally good people and try to do the right thing, the kind of evidence that you would need in order to convince you that they did the wrong thing would be greater than the kind of evidence you would need if, from your world experience, you understood the terrible evil that existed in the world. So I think one of the reasons why it's been difficult in some instances for me to see the same evil that other people might see is because my requirements for evidence are considerably greater. And again, I think that maybe by expounding this for readers might help them understand their own feelings as they read the report. The other thing I sort of feel obligated to talk about is contemporary biomedical research because I am who I am. That is, I'm a physician and I do do research. But I think some people have mistakenly interpreted my requirements for having more evidence about the past as being -- because of my concern that it would somehow jeopardize the biomedical research, the contemporary biomedical research. And I certainly would want to clarify that because I think that there are a number of problems with contemporary biomedical research. I'm not sure that I know the solutions to all of those problems, and I'm not sure that we can do a whole lot better than we're currently doing. But I think that we certainly should try to do better than we're doing. So I'm very much in support of efforts to protect the rights of people who are enrolled in medical research. There are a number of things which we currently do that I don't personally think are very effective. And I may discuss those, but I think that sort of gives you an idea of the tone and content of my personal statement. CHAIRPERSON FADEN: Thank you. Reed? DR. KATZ: Can I say something just -- CHAIRPERSON FADEN: Because Reed, is your comment to Henry? MR. TUCKSON: Not specifically. CHAIRPERSON FADEN: All right. Then, Jay -- if you could hold off for a minute because I think Jay's is. DR. KATZ: I hope that Henry has understood me correctly and I think has understood the rest of the committee correctly because, speaking now very briefly for myself, the problem is not the investigators and even governmental agents are evil. It would be nice if they were evil because we could then identify them. The problem is, and I've tried to say this, and it's reported, it's reproduced in my personal observations, these are good people. They have good objectives in mind. But the problem is, to my mind, that we haven't sufficiently considered the complexities of the issues involved and that we have emphasized one objective over another, and that this is something that needs to be looked into, analyzed, etc. But just speaking for myself, I don't consider most of the people, almost all of them, to be evil persons. They are good people, but maybe misguided. CHAIRPERSON FADEN: I think that is the perspective of the report, but it still may not be quite as Henry would cast it, I mean, in the Preface and in Chapter One and in Chapter Two. And maybe we have to just make it even plainer. There are very clear statements essentially expressing what Jay just said. But that doesn't -- but I understood Henry as not criticizing us for saying we were calling people evil as much as that you were setting a different presumption because of -- I don't think it means that you don't have a differentiating perspective that you might not want to articulate. I didn't think you were saying that we were calling everybody out there evil. DR. ROYAL: Because you're agreeing with me, it's easy for me to agree with you. CHAIRPERSON FADEN: Reed? MR. TUCKSON: Only that -- of course, I have tremendous respect for the intellectual precision and the personal values of folks that need to write this -- and that's fine. I would -- I'll be paying careful attention then to the introductory comments in the document that describe the process by which we have -- and I think a commitment by which we've tried to reach consensus on a point of view that allows the report to be useful and relevant to closing a chapter, as it were, in American life, allowing the nation to move forward, making some recommendations that will hopefully do that in making some statements that will help heal. I don't want to be put in a position the because I didn't put all the things I disagreed with -- CHAIRPERSON FADEN: Yes, I agree. MR. TUCKSON: -- or fundamental, philosophical differences down, that that meant I agreed with everything because others did dissent. CHAIRPERSON FADEN: Right. MR. TUCKSON: I'm committed, and I've been committed from day one, to a belief in the process by which different people or different points of view arrive at the best thinking possible on something that has no right answer And so I just want to be, I guess, just very careful that I don't get boxed into a corner where because three, five, ten people write the sentence, that I say "All right then, wait a minute. Let me put my issues on the table." And I don't think that that's going to necessarily happen. And again, it's not to say anything about the comments that have gone before. It's just a matter of being very diligent on the preface. CHAIRPERSON FADEN: Reed, I appreciate what you're saying, and I think that's a burden on me as the Chair. I share your values. And clearly, we will need to have a statement that's straight that says that in writing this, when you author, when 14 people and a staff of 60 author a report that's 400 pages long, which is basically what we're talking about here, or 300 pages, 500 pages and two companion volumes, it's unimaginable to me that every member of the committee is equally enthusiastic about every point that's made throughout. Or that if you were writing it as Reed Tuckson, sole author, that it would come out exactly this way. But there is a basis here, and I think that's true for the people who will be writing individual statements as well. Otherwise it would be a different kind of individual statement. You would distance yourself from the report in a different kind of a way rather than augment it or criticize sections of it or whatever. That we are all agreeing that we believe sufficiently in the correctness of the overall report that we are signing off on it. And that's what we need to communicate. And I think it would be a mistake to leave the impression that any one of us who aren't - you know, is not noting every point at which we depart would be somehow not be in line with our commitments to ourselves or our integrity. So you're quote right. That's a burden on me to get that statement out there, and I will certainly make sure that all of you are comfortable with the language. But I very much appreciate that statement. DR. KATZ: It's very important and you said it well. CHAIRPERSON FADEN: Thank you. Give him the transcript. (Laughter.) CHAIRPERSON FADEN: We were talking to Pat, and then I'd like to -- I know Ruth is waiting to try to say something, so -- MS. KING: Well, I want to be clear because Reed wasn't here last month, and lots of people who were here apparently didn't hear. But some of my objections go to the findings and recommendations inevitably. I want to make that clear because it is not merely a lack of comfort with Chapter Four. I mean, I want to be as explicit as I can be. This is not to take away from anything that Reed has said. I don't disagree with anything that he said. But I want him to be clear that a part of the consensus building is to make sure that you have a consensus on the findings and the recommendations, at least on every committee that I've ever been on. And there's never been any expectation that people would get there the same way. The important thing has been that you agree on the bottom line. So I want to make it clear that some of the things I raised go to the bottom line for me. And I said that last month because I made the statement that at one point, I wasn't planning to do anything. I was going to put a member in the chapter that this member -- one member, at least, would do one way or do something else. But when we start putting some of the things that flow from the chapter into the findings and recommendations, my view last month was I left with no choice. I still feel that way. So I completely agree with you in terms of what you strive for and what consensus means. And you write it differently if you're saying I have a different world view, which is what I'm basically sort of saying in terms of what I look for in a report, if that what was motivating you, rather than being very uncomfortable about having to be the only person who disagrees with some of the things there. I don't think anybody else disagrees with any of the findings except me. CHAIRPERSON FADEN: Well as we marched through the findings yesterday, I said -- MS. KING: I just said I wasn't going to argue anymore. We put the finding off with which I disagreed. CHAIRPERSON FADEN: Right. So that's what we're coming to because I think otherwise, people are unclear. Because as we walked through the findings yesterday, I don't recall your objecting to many of them except for the one we're going to bring back now. MS. KING: Right. CHAIRPERSON FADEN: Okay. Well, that's all right. That's why there's confusion on people's faces because it wasn't we didn't hear you. There was no reason -- MS. KING: Okay, but I also -- I'm discovering -- and Ruth will appreciate this because I've had this discussion. I keep saying why are people surprised because I've been very clear all along about where I have objections. And she said, "Well Pat, I don't think that people are as clear as you are about where you think you have objections, so try repeating them." So I'm trying to clarify. CHAIRPERSON FADEN: Right. And this is an ongoing discussion also to -- I mean, I think Pat and I understand each other as sort of code already at this point, which is problematic. And that doesn't work for the whole group, so we have to make sure that everybody is understanding where things are coming down. But just so there's clarity, the finding that you are planning to object to unless -- MS. KING: Is 11. CHAIRPERSON FADEN: -- is 11 or -- MS. KING: It depends on how it comes out finally how I -- CHAIRPERSON FADEN: Okay, so that's where -- and it's the one about looking at the past. So we're all clear on that. It's all on the piece -- it's the finding that corresponds to Chapter Four. So that's why I wanted to wait. That's why I put it off so it would be all integrated and we deal with Chapter Four and we deal with the finding that went with Chapter Four as sort of all of a piece. Ruth, I have no idea if you're there, but Jeff handed me a message that you also wanted to speak at this point. Are you there? MS. MACKLIN: I am here. (Applause.) MS. MACKLIN: Hello, everyone. I'm hearing about 75 percent because of this defective equipment. In the seat of the federal government, it's dismaying that they can't get a speakerphone that works well. However, I'm picking up the pieces. When I get the substance, it's fine. Sometimes I hear Pat say, "Here's what I object to," and then it goes blank. (Laughter.) CHAIRPERSON FADEN: Ruth, did you want to make a comment now or should we plunge into the chapters? MS. MACKLIN: Well, much of this discussion, or some of this discussion, does relate to Chapter Four. And since I do have some things to say about that, I think I'll wait until Chapter Four. CHAIRPERSON FADEN: Very good. SPEAKER: (Inaudible.) CHAIRPERSON FADEN: Yes, Jeff is right. Part of what may be the problem is, and here again we have yet again another reason for speaking right into the mike. Did I blow your ear out there, Pat? But she's getting the feed right from the mike. So if you're a distance from the mic, what Ruth will get will be quite -- MS. KING: You should also -- CHAIRPERSON FADEN: From the overhead speakers, it was even worse. MS. KING: You should also identify yourself. If you've ever participated on these calls, you can't always figure out who's talking. CHAIRPERSON FADEN: It would be a courtesy, I'm sure, to Ruth if we would -- MS. KING: You generally announce it. CHAIRPERSON FADEN: Yes, I generally announce who the name is, so that helps. But just in case there's a flow, although after all this time most of the voices are probably -- we've had enough conference calls. They do sound different over the phone. It's true. Is there anyone else who wants to speak to the issue of a statement? Let me just say that I am thinking about writing a statement, but it would be a very different -- it would be the kind of-- I was thinking about the need to make an acknowledgement as the chair of the committee of all the work that has happened and the process that we've gone to. And it strikes me that I really want to do that and I will probably do it in this section. We had originally thought about it as some sort of a forward, but I think that's inappropriate. I think that all the front matter on the report itself should be collectively authored. But I feel as if there's so much that I want to deliver myself of thank-yous and observations about -- and how we struggled and what we accomplished and where, perhaps, we did not succeed as we might have hoped, and where we exceeded my expectations, that I may write such a statement. But here I'm with Henry. It all depends on whether I have the energy to do it. So in the interest of full disclosure, it's in the back of my mind that I might write such a statement. But if it's, you know, a day before it has to go to the printer and I'm still working over drafts and having phone conversations with you all about how to finalize the language of a finding, there will be no such statement. So it's in the category if I can stay up enough nights, there will be a statement like that. Lois? MS. NORRIS: If that includes a acknowledgement of the dedication of commitment, resilience and talents of staff, I'd like to sign onto that. MR. GUTTMAN: You should wait until it's over. (Laughter.) CHAIRPERSON FADEN: Yes, thank you. DR. KATZ: Ruth, can we get away from calling these personal statements, but instead calling them statements by individuals? CHAIRPERSON FADEN: Absolutely. I have no trouble with that title if no one else does. And that allows any type of statement. And people can label -- you can label your statement however you like within that, but we will have the heading and the table of contents be "Statements by Individual Committee Members" so it's clear that they're authored by us and not by someone else. All right. With that, I'd like to move onto TBI. Now, with this new arrangement, I think if we needed to have Ron or Gary come to the table, we've got a seat here and we've got a seat -- so if you guys could join us at the table. We don't have our normal witness table anymore, but if you could just find a spot where there's a mike so as the discussion progresses because we know we're going to want to interact with you, that would be great. Now I don't know. One of those mikes should be -- are they neither of them working? They're working? Both should work? Okay. All right, we are going to do TBI and then -- actually, I just realized that Anna's agenda has no break. That's okay. I think what we should do is TBI, then a break, and then Chapter Four. How would that -- would that be okay? And then just sort of keep on marching. And again, I will have to call the discussion on TBI even if it's not fully resolved. The problem I'm having is we have two things to think about here, and this is very difficult. We have not only to discuss how we want this chapter to look. We have also to discuss whether we're going to have a recommendation that corresponds to the kind of situation that TBI represents because we've stripped the reference that would have included TBI. And I'm being very blunt here that when we changed the language in recommendation two, in line with the observation that Eli made with which we all agreed that that language was not adequate, that dropped out any consideration of this kind of an experiment from the recommendation. So let's just get straight on what we're dealing with here that we have to struggle with, with both, and that's very difficult. So what I'm wondering about is if we can spend perhaps a half hour on the chapter. We're going to need Ron and Gary very much for that, and then continue with this discussion of do we want to think about how we might want to fashion some sort of recommendation with respect to how the government might respond in the TBI case and in similarly situated cases, once we can figure out what "similarly situated" means, which is what Eli was pointing out, that the language that we had before was overly broad and would get us into trouble. So everybody knows how much we have to do here. That's to get us like intimidated and anxious. And if you're not, I am. So we'll just get that out there. Can we start? The floor is open. Eli? And again, you have to do this because of the shadows. I can't deal with it. DR. GLATSTEIN: Well, I've read both these chapters, the one that Ron and Gary have revised, and then the revision from Henry and Mary Ann. And I think they're both very good. I think they're both very balanced. I can't imagine anyone who reads this that would think this is a white-wash of any kind. I think the job that Henry and Mary Ann have done, basically some deletions and not that awful many, is excellent. And I don't know, did Dr. Egilman actually read the revision or did he just know about the revision that was going on? CHAIRPERSON FADEN: I presume he read it. MR. STERN: I believe he read it, yes. DR. GLATSTEIN: Well, I don't see anything wrong in the deletions that were made, and I think by tightening it up, I think, if anything, it's a stronger statement than the chapter was before. I can live with either one of those versions. I think the one by Henry and Mary Ann is a stronger, tighter version and I think it's actually a better one. CHAIRPERSON FADEN: I've got Duncan, and we have Duncan's written comments in the blue folder just so everybody knows, in the blue folders that were distributed. But Duncan, you have the floor. DR. THOMAS: Well, I want to commend both Gary and Ron, as well as Henry and Mary Ann. I agree with Eli that both versions are good. I object to some of the deletions and the reasons for my objections are given in my written comments. I don't think I need to belabor those. I don't feel strongly about any of them, and I'm prepared to go with the consensus. I think we can sort of work out amongst ourselves what to do about each one of these deletions and decide whether to retain them or reinstate them. I think it would probably be more useful if we could focus attention on the conclusion section. CHAIRPERSON FADEN: Yes, I do too. DR. THOMAS: Henry's cover memo indicated that he felt that that need substantial rewrite. I reread the conclusions again in their original version from last June and actually felt pretty comfortable with them myself. So I'd like to hear from Henry as to what directions he would like us to take the discussion. DR. ROYAL: Do you want me to do that, Ruth? CHAIRPERSON FADEN: Sure. I mean, I'm just actually -- what I'm also doing is looking for some of the other stuff that we've gotten from people on it. DR. ROYAL: I agree with Duncan that we should spend most of our time with the conclusions. There's just one sort of factual thing, I guess I'll call it, about the chapter that I'm concerned about. And I'm concerned about it not because it affects anyone's blame worthiness, but because I'm afraid that if there are things that aren't defensible in the chapter, then it's going to decrease the credibility of the chapter. And that has to do with this whole construct that's in this chapter that this somehow had to do with the nuclear powered aircraft, the nuclear energy powered aircraft. And the thing that -- the reason they -- I personally think if you're going to make an argument, it's that it was troops being exposed to atomic weapons as opposed to NEPA per se, because NEPA was concerned about exposures of up to 25 rems of radiation that were occurring chronically. And the radiation exposure that we're talking about are much larger doses than are given over a brief period of time. The end points that were looked at: changes in the blood, changes in nausea and vomiting and all of those things, are very much dependent on whether the radiation was given at 25 over several days, 25 a day over several different exposures, versus 100 or 200 all at once. So this whole construct that the reason they were doing this whole body radiation experiment had to do with NEPA isn't very convincing to me. There is also some comment about submariners. And because submarines don't fly, there was not the concern about weight and shielding. And the truth is that submarines are not exposed to big levels of radiation, although it's possible that back then that somehow the word "submariners" was involved in the discussion. But I would personally delete references to "submariners" just because it might, again, interfere with the credibility of the report. CHAIRPERSON FADEN: Gary, did you want to -- I mean, I guess -- I'll just chime in. I actually saw the connection with NEPA to be straightforward. I don't think this is a big issue. I mean whether it's in part, whether it was largely out of concern for battleground condition reactions or NEPA, the point is that there was an interest. I mean, it's important to be historically accurate. But it doesn't change that there was an agenda other than advancing cancer therapy. So the issue is which complex of interest, other than cancer therapy, grounded the interest of the Defense Department in the TBI work? DR. ROYAL: By including NEPA in your argument that this was being done for military purposes, then I think you're undermining your own argument. CHAIRPERSON FADEN: Because you think that -- DR. ROYAL: Because it's not relevant. So I'm trying to make a suggestion which would make your argument stronger. CHAIRPERSON FADEN: Well, I hope it's our argument. DR. KATZ: Duncan, I -- CHAIRPERSON FADEN: Henry. DR. KATZ: Henry, to me, the interesting thing about NEPA was, and what happened to it, that in that instance we were addressing the question of what harm for normal, healthy volunteers. DR. ROYAL: Right. DR. KATZ: While in all the other situations, there were patients involved. And patients, you know, fell into an entirely different category of human beings than healthy, normal volunteers. And let me in part account for why NEPA was scuttled and human radiation experiments in hospitals -- CHAIRPERSON FADEN: We're trying to think of how to resolve -- I mean, I'm struggling with the time constraints too. I mean, there is the issue of how we want to deal with whether certain things should be retained or left. But there's the bigger problem of where do we want to conclude? And let me just register, for what it's worth, that I ran through my comments and had pretty much the same reaction as Duncan's. I thought that -- you know, a very high proportion of the changes that were introduced were very helpful changes. We had a great effort, and the great effort was made better. And I don't say that just because it's sort of nice, but because it's true. And I didn't have much to do with this, so it's very nice to be able to say that. But I thought some of the stuff that was deleted ought to be put back in. Either I think a way to do that would be figure that -- I don't know if we start going point by point now, we'll never get there. I think if we spend our collective time on the conclusions, we'll figure out some other mechanism for deciding which ones of these deletions people feel most strongly about and then go back to the authors and see what we can work out. Pat? MS. KING: This is a point of principle that I will put on the record for how I feel about this before we go to the conclusions. And that is, it seems to me there is a time in the life of every committee, commission that I've ever sat on that when you have terrific and wonderful and talented staff, terrific, wonderful and talented committee members, there have been conflicts. And I want to say that my principle about this is committee members were the persons appointed. So I'm going to say this as gently as I can because I don't mean this to be hard. This is a recurring problem. And I think it is now necessary for staff member to convince some committee members of their views. And basically the argument, in its ultimate sense, has got to be among committee members. CHAIRPERSON FADEN: Correct. That is correct. So what we're talking about is we need the benefit of the staff's expertise and the hard work that Ron and Gary have done. But we are going to have to decide what this chapter looks like. And if there is an issue about whether something is deleted or added, what I'm suggesting is we will go through this. I've got Duncan's. It would be very helpful if we had others as well. And if I could get a sense and, just if we did this now, we will do nothing else. So I'm really concerned that while we have Gary and Ron here and while we have each other around the table, that we go to the conclusions and the recommendation, and then we will deal with the others later. Jay? DR. KATZ: But could we hear very, very briefly from Gary or Ron about their thinking in terms of -- very, very briefly with respect to the deletions? CHAIRPERSON FADEN: Well, we have their memo back, Jay. I mean, I'm just trying to use time well. DR. NEUMANN: I can make a quick comment, and I think that Gary and I generally share the same opinions on most of these issues. We have no objections, and in fact, agree with the bulk of the deletions. Many of these things are personal quotations from individuals involved. And frankly, they were included in various drafts because of a need to personalize the report. And we were receiving instructions that much of our material, because most of the people are not alive anymore, will read quite dryly. And we chose to include a number of quotations from interviews and so forth that we thought gave some sense of perspective to it. But we have, I think, no objection to deleting these things. And we firmly agree that it is the committee's report, and it's up to you to reconcile the differences that now are appearing in your comments. I mean, we don't feel comfortable doing that. CHAIRPERSON FADEN: That's very great for you to say. I mean, it's really our struggle now, okay? We know why -- we have Ron's and Gary's rationale as for why they put in what they put in there, and we have to decide amongst ourselves. But what I'm hearing is that these are not -- responding to Eli's first comment, he could live with either draft. We are not dealing with, you know, an intense, deep struggle here. But we still have to resolve what pieces go in or not. If we could just move on, and I realize that it's unsatisfying. But if we don't go to the conclusions, that's much worse. Yes? DR. THOMAS: Just one last thing before we do it. I feel the NEPA question is unresolved, and I'm not quite sure how to proceed with that. Like you, I don't have any difficulty seeing the relevance of the NEPA material, and the reasons are spelled out in Gary's memo. CHAIRPERSON FADEN: Right. DR. THOMAS: But what's not made clear is to me -- I find very cogent the debate between Stone and Warren and the others about the need for human experimentation, and why turn the patients for this purpose. What isn't immediately obvious to me, and I would just like to know as a piece of information, is whether the staff has any evidence of that debate was in any way connected with the decision to proceed with human experimentation in this particular context? MR. STERN: I mean, I think there is a direct connection between the NEPA and the first post-war TBI study -- experiment, which is at M.D. Anderson. That was for the Air Force. It was done for the NEPA Project. They were doing stick and rudder tests after they were getting various levels or doses of radiation, starting with low dose and moving up to higher doses. And it was very consistent with the plan that Stone had outlined to use on normals, which included going up to 150 rads in Stone's proposal for the NEPA Program because even if they found a direct connection between the accumulated doses of 25 over eight times, they had planned in that experiment for NEPA, in using healthy normals, to go up to 150 single dose. And so that the very direct connection, then I think then the Army expressed an interest and the Army's interest was more battlefield. They don't fly planes as much. They wanted battlefield conditions, but they were connected and there was a sort of continuum I think from starting with the Air Force and then the Army becoming interested shortly thereafter in doing its programs at Baylor, at Sloan Kettering and at the University of Cincinnati. So I think there's a sort of gradual, historical development. And just to note, the contract in the -- the M.D. Anderson contract that was set up for that program in 1950 refers explicitly to the NEPA debate and the fact that they would have preferred or that the original interest was using healthy normals. But for all sorts of reasons, that was rejected. So then they turned to patients who were receiving the TBI and they were going to do the same thing on them as the next best alterative. DR. THOMAS: The connection is so obvious, I don't see why we're debating it. CHAIRPERSON FADEN: I think the problem with the draft is that it doesn't make clear this evolutionary thing. There was this original connection with M.D. Anderson. The documentation there is overwhelming. But I think, and I don't mean to speak for Henry, but the discomfort with connecting it up to say all the way to Cincinnati is by the time you get to Cincinnati -- DR. STEVENSON: NEPA is long dead. CHAIRPERSON FADEN: -- NEPA is long dead. So what we had to do is make clear that you have a program of research that initiates in part in one context. And then the NEPA thing is history by the time you're into the Cincinnati experiments. There are other motivations that the Department of Defense has for this work. And maybe all we need to do, and we'll work with Henry and see if that's agreeable, is to make that clearer. DR. ROYAL: I think the other thing that needs to be made clearer is that the biological effects of radiation, if someone is exposed at 25 rems per exposure over several missions, is very, very different than the biological effects of giving 150 dozen rems all at once. And so I think that needs to be made very clear. And this is a problem we can work out. CHAIRPERSON FADEN: Yes, I think we can work this one out. If we could move on. I mean, what we know is that from a science perspective, there were lots of mis-matches, not the least of which was that they were sick patients and trying to learn from sick patients about healthy people starts it off in the wrong direction in the first place. Susan, are we going to conclusions now or -- DR. LEDERER: No, I have just one question. CHAIRPERSON FADEN: Okay. I'm going to be such an unhappy camper, folks. That's it. DR. STEVENSON: I'll try to be brief. I read the July fifth version, not the two later versions. But I was absolutely -- one of the criticisms that seems to recur in the discussion of the University of Cincinnati experiments is subject selection or who were the patients. And is there any discussion in these last two versions of the issue of the -- of patient population? CHAIRPERSON FADEN: I think we're going right to the connection with the conclusions. I think there were back and forth arguments about that, but we do not discuss that in this -- I mean, to my recollection, there's no discussion about -- DR. STEVENSON: I couldn't find it. There once was. MR. STERN: There was a footnote that simply described essentially the racial composition of the patients, and quoted the Suskind Report as saying it was basically consistent with the patient population at the hospital, which was in a footnote, a sort of lengthy footnote. And for a number of reasons, that was taken out somewhere probably in June. It would be easy to reinsert it if you guys wanted to. CHAIRPERSON FADEN: Well, I think it's a more complex issue than a footnote. And I think it really does need to be -- DR. STEVENSON: I think failing to address this issue will be cause for serious concern and criticism. So I think it needs to be addressed somewhere. CHAIRPERSON FADEN: We also have the data that was presented by Egilman whenever he presented -- I can't even remember when that was, Monday, about the -- what was known in terms of the psychological testing of the subjects. That's very awkward data to deal with. But I think to fail to deal with the fact that many of those subjects scored in ways that raised questions about where they were -- I mean, the problem is that that sort of testing is problematic and often invalid and biased against people with certain life experiences. So you want to sort of be careful about drawing any inferences about -- I would not have made the statements that Dr. Egilman made, for example, about how to characterize the cognitive capacities of the people who were used as subjects based solely on the profile data that was done as part of the Defense Department contract. But at the same time to pretend as if that information is not available, is also problematic. And I think we have to deal -- so that would be an area that we have to deal with it. We have to deal with it sensitively because you could make very hurtful statements and unfair statements for the patients and their family members if you made more out of that. But to ignore it, is also I think -- MR. STERN: In earlier drafts, there was some reference and discussion to that issue which have been removed at this stage. CHAIRPERSON FADEN: So if the committee is agreeable, then we're now going to stuff that leads to conclusions. There will be a reintroduction into this chapter of a discussion about this question of who the subjects were and what we know about them, both in terms of their vulnerability to exploitation and their capacity potentially to have appreciated what was going on. DR. GLATSTEIN: Well, that gets us to the conclusions. CHAIRPERSON FADEN: Yes, this is taking us right to the conclusions. DR. GLATSTEIN: What is wrong with the conclusions that Gary and Ron had initially, the last six or seven pages of their version? CHAIRPERSON FADEN: That's what's on the table right now, Eli. DR. GLATSTEIN: Well, the only thing I would add to it, and I think it's pretty good actually, they list a bunch of questions on their page 69. I would add one more which I think, to me, is the most -- and they allude to it, but they don't hit it head-on. And that is, I would ask the question explicitly how many patients should be treated and analyzed before deciding to continue or discontinue an investigation of a controversial treatment? DR. LEDERER: Eli, could you specify the date of what draft you're using? DR. GLATSTEIN: The chapter from -- CHAIRPERSON FADEN: 7.5 DR. GLATSTEIN: -- Gary and Ron is 7.5, right. DR. LEDERER: Thank you. CHAIRPERSON FADEN: So this the question of context that you raised earlier, Eli, about just how many people do you subject to -- DR. GLATSTEIN: To me, that's the most damning thing about what happened here is that it went on and on and on and seemed to have no end to it until it wasn't funded anymore. And I think that's what I think is the most damning thing about this. And that's on page 69. CHAIRPERSON FADEN: Right, I see that. DR. GLATSTEIN: There's a list of questions, and I think they're all good. But I think, to me, this is the most crucial one. CHAIRPERSON FADEN: I'm going to start taking my lists now. Henry, and I saw Mary Ann. DR. ROYAL: Let me first respond to Eli's comment, and then maybe I could give you a general idea about my concerns about the conclusions. In response to Eli's statement today and yesterday about the fundamental problem being that they did too many patients, I'm not sure that I agree with that statement. I think that this study was poorly designed from the scientific point of view. Having said that, I would remind you that yesterday Dr. Katz, when he was talking about psychiatric, contemporary I believe, psychiatric problems, he said somewhere -- I'll say 95 percent. It was a high percentage of psychiatric patients which Dr. Katz said did not have justified scientific value or acceptable scientific value. So I do think the experiment was poorly designed. But one of my concerns about contemporary biomedical research is that a lot of research is going on that would not meet close scientific scrutiny. The issue about enough patients, whether there were enough patients or not, if you did any sort of statistical test to figure out what kind of power you needed in order to detect a clinically significant improvement in treatment, usually what you find out is you need many more patients than you think you needed. So I doubt very much that the scientific analysis would support the concept that you needed fewer patients rather than more patients. If you'd like me to turn to some general comments about the chapter, about the conclusions, I can do that. CHAIRPERSON FADEN: Yes, that's where we are. DR. ROYAL: Okay. The initial part of the conclusions on 64 and 65, all of those bulleted things, have to do with DOD. And the DOD seems like an easy target and so they were easy to criticize. I'm not sure how comfortable I feel about that criticism. For example, one of the criticisms is that they should have known and they should have provided a review of not only the collection of urine and blood samples, but they should have provided a review of the TBI itself. And it's just unclear to me that they should have known that or even that they had the expertise to be able to do that. So although I could live with these bullets, and they actually don't bother me as much as the concluding paragraphs, I think that we've sort of picked them out as an easy target, and we knew we had to criticize someone so why not the DOD? CHAIRPERSON FADEN: Okay, I've got Mary Ann and Pat and I'd like to put myself on that point as well. DR. STEVENSON: Does Pat want to respond to Henry or -- CHAIRPERSON FADEN: Are you responding to the same -- because I'm on that same point. MS. KING: We're on the same point. CHAIRPERSON FADEN: Yes, we're all on the same point so let's just go -- you're on this point too, aren't you, Mary Ann? DR. STEVENSON: Yes. CHAIRPERSON FADEN: Okay, so let's all of us get our comments out because I actually have some of the concerns. Jay too. Thank you, Jay. I'm sorry, Jay just -- that's what you have to do. DR. STEVENSON: I think the TBI chapter in particular -- a lot of the others in part two unconsciously flow into this situation where the reader is led to expect a judgement of a particular situation. And I think in the TBI chapter, it turns out to be Cincinnati. And I think this is really a problem because the committee certainly has not looked at enough detail to be making any judgements, and it's certainly not our charge or in our power to make them. That should be left to the courts. So what I think happens, particularly in the paragraph that followed the bullets, and I'm sort of a similar mind to Henry, I could live with these bullets, but I think they could be improved tremendously, is that we get into a situation where we don't have the evidence and we end up building sort of a hypothetical straw- man situation by creating unsubstantiated and, I hate to say it, amateurish prose and reasoning, and then we proceed to burn the straw-man down by equally amateurish and unsubstantiated reasoning, leading to a pretty weak conclusion. And what I think the chapter speaks to is the very serious and complex scientific and ethical issues behind multi- purpose research. And it ilmustrates, and I think in the case of the Cincinnati experiment, the need for strict scientific and ethical review, and the failure in this particular case at individual and perhaps institutional and agency levels. But to come to some sort of judgement on it, I think that we're not in the position and we don't have the evidence. CHAIRPERSON FADEN: Let me get Pat in. I think we need to point out what we're dealing with here. I've got Pat, Ruth, Jay and Lois. MS. KING: This is a hard chapter for me because there were some other chapters I was paying a lot more close attention to. But I have problems too with the conclusion. And if I'm not mistaken, one of the issues in the litigation is the question of government sponsorship. Am I correct about that? CHAIRPERSON FADEN: I don't know. I mean, I think the government sponsorship -- MS. KING: I mean, you can't get the government unless you link the government. CHAIRPERSON FADEN: I don't think the litigation is against that. MS. KING: It's just against the researchers? MR. STERN: It's against the researchers and two individual units. Although I think just recently the government was joined, but the principal litigation is against individuals and not against -- MS. KING: But the government has now -- MR. STERN: Has been joined, I believe they have. MS. KING: That is the point that I seek clarification on. And this is my reservation with the conclusion. I do have trouble with the bullets. CHAIRPERSON FADEN: I do too. MS. KING: And I do have trouble with the bullets because it goes back to what we have done in part one of linking some of the documents, which I won't repeat here, of connecting some of the documents. I have no trouble -- I can live with "every time" as a factual statement. It is a fact that Wilson had a memorandum, so I'm not going to that part of the bullets. But the bullets contain that kind of information and they contain should have information as well. So for example, on page 66 at line nine, it says, "But this claimer should not have covered DOD, aspects of the TBI fact studies." And then it goes on to say, "DOD should therefore not have exempted the TBI." And the judgements about what we infer from some of the documents we cite here -- one I found really troubling. I also found troubling -- I would say this is maybe a little bit different from -- I hate it when we argue, when we set up for -- and I understand why we do it sometimes, when we set up what I call the straw-man and then we knock him down. There's a lot of places where that occurs. It's not just -- you've got to feel so bad that Stern and Neumann are sitting here because they're getting it for a lot of things in the rest of the report about which they had nothing to do. MR. STERN: Let's not discuss who's behind the conclusions actually. MS. KING: That just happens to appear in this chapter. So I apologize for my prior statements. You all are getting to be the targets unfairly. I apologize to you and they really are not personal, believe me. But I hate it when we set up the straw man and say "A line of reasoning might have been," and then we say "And this line of reasoning would have been unpersuasive or wrong" or whatever want to say about it. And I thought, and I think this is a critical chapter. I've always thought so because one of our critical issues is therapeutic research and what we tell patients. And it is a problem that this committee is highlighting as a committee in our contemporary research areas. This is the one chapter for which gives a lot of additional support to what we're going to say about contemporary research settings. And I wanted the conclusion to have a lot to say about the problems of multi-purpose research, to support what we are saying in the contemporary research period and what we're finding about therapeutic research. For 24 years, I've thought this is the most problematic area of human subjects research. And I needed to see this chapter strengthened in that respect in its conclusion. I absolutely agree with Susan that I think, as I keep saying -- I'll remake the point here for the purpose of this chapter. The selection of subjects is not only a justice issue. The selection of subjects is also linked to autonomy and informed consent questions. To my mind, this is one of the places where it ties up so significantly that it too should be, in both of its aspects, a part of the conclusion of this chapter. So what I'm saying is I don't -- the bullets, in some respects, are okay. In other respects, they're not. If you can clean them up, make them stay. But I want a lot of other things added to them in terms of where the chapter goes. CHAIRPERSON FADEN: Okay. I'm next on the list. DR. ROYAL: Can I just resonate with one point that Pat made? And that was about she's been concerned for 24 years about the particular area of research, therapeutic research. And it's one of the things that troubles me about the report in terms of the non-therapeutic research. I think it's sort of highlighted as being more problematic. But yet, it's really the therapeutic research that's the problem. CHAIRPERSON FADEN: Well, I guess my problem with that characterization is the following: I don't think it's the case personally that the problem is one or the other. I don't really think that the bigger problem is in one or the other. And I think if you look historically at the cases that have caused the most outrage in the nation's history, they have been more often than not non-therapeutic research on people who are open to exploitation who were powerless. I mean, those are the studies that have resonated and shocked the conscience, to use the term that Jay introduced. And the work that we have done unfortunately contributes to our historical understanding that this was a part of what we have done. At the same time, hopefully today, there is less of that going on and more of the problem sits in the area of clinical research. So I think that both are correct, and I'm very happy with the balance that we've struck in the report historically focusing on where the abuses apparently were the greatest, and forward-looking focusing on where we think our biggest problems are today. MS. KING: It should have been 23 years because I'm actually going back to the time from which we marked the modern period, because that's the time after the HEW regulations -- CHAIRPERSON FADEN: Which did a lot we think around this particular issue. But I think that maybe what I just said needs support so that we can explain why historically the examples were the examples that they were, and why in the contemporary research, we have focused on clinical investigations. So maybe that just needs to be straight-out said, but that has been sort of in the back of my mind for some time as to why -- and it didn't start out with that plan, but it emerged in how our work went. And our work was guided by where people were most concerned and where they thought the abuses or the wrongs had occurred. So maybe we can just set it up both ways, but this is right because this is the only example that we have in our case studies of the therapeutic research problem which, Pat's quite right, foreshadows what we focus on in part three. And we have failed to make that connection, to show that this sort of stuff is not gone and taken care of. So my problems with the bullets are, I guess, similar. I don't understand, and I apologize because again, this is something I should have been paying more attention to earlier and was sort of sucked off on other aspects of the report. But I think it doesn't make sense, for example, on page 65 to focus on the Wilson memo in the way that we do in the context of this research, which to me, quite plausibly, would have not been understood at the time, as falling under ABC warfare research. At least there was an open question because of the way in which it could have been understood. We've had these discussions before, the way it could have been understood by the Defense Department as we're not paying for exposing anybody to radiation. We're just paying to do the psychological testing. This is the back and forth stuff. The '62 regs -- Phil, remind me. The 70-25 series is R&D or clinical research? DR. RUSSELL: R&D. CHAIRPERSON FADEN: R&D. That's the other thing is that then we have the bullet on the 70-25, but that's R&D research. This looks like clinical research. You know, either way it sort of falls -- DR. RUSSELL: No, this was the research that was -- CHAIRPERSON FADEN: Supported under the R&D command. So we need to make that clear. But there's an exemption in 70-25 for clinical research. We just need to work this out a little bit clearer. The point is that the issues that are of greatest interest to the committee are not, it sounds like, focused on these concerns. We want to lay them out and say that part of the problem is that there is this, the language Allen has used for a long time, sort of mis- placed. This sort of deference back and forth and nobody really is on the ball, but this literal sort of tying to the letter of the regulations without more careful exposition of what the regulations or the policies were is problematic because it kind of over- reaches. I'm a little troubled about why there is -- and this is a different issue, why there is only one mention of the Junior Faculty Report in the chapter, like a clause. And I think again that it need to be explained a little bit more about what the Junior Faculty Report was and what the conclusions were. DR. STEVENSON: Henry and I discussed that. I mean, I think we certainly have to explain who the Junior Faculty were in the same way that we tried to explain who Suskind and -- MR. TUCKSON: Exactly. Otherwise it looks as if -- DR. STEVENSON: -- and who the ACR were. MR. TUCKSON: Right. Otherwise, it looks as if we've dismissed them out of hand and we're only interested in the reports by the professionals. DR. STEVENSON: Not necessarily, but I think they need to at least be clarified as to who they were and what their background qualifications -- CHAIRPERSON FADEN: Again, this issue of laying it out and you can draw whatever inferences the reader wants. DR. STEVENSON: But that -- CHAIRPERSON FADEN: My last comment, and then we've got a long list, is I wanted to respond to your comment, Mary Ann about making judgements and the expectations the readers have for us making judgements. And I have struggled a lot about this because I think that in part -- what part is this, part two of the report? It will be somewhat uneven. And in the sense that in some chapters, at least the majority of the committee members, if not all of the committee members, are wanting to make conclusionary, moral judgements that may in some cases be quite specific. And in other cases, that is not how the committee is choosing to attack the problem. Our charge will be to make it plain why we did what we did in each chapter; why in some chapters we have a certain approach to the problem historically and why in other chapters, we took a different approach to our treatment of the story. Otherwise, it is going to look weird because you have a judgement in the plutonium chapters, so people expect a judgement about the TBI story. And we have to be -- setting that up in a way that helps the reader understand why we did what we did is our burden. DR. STEVENSON: But when we fall short on the evidentiary side, what's the argument? It's very weak, unconvincing and silly. And I think -- CHAIRPERSON FADEN: Well, that's what we need to explain is why -- what is our rationale for doing what we did so that it's not as if each one of these chapters follows a cookbook, and that we went out and this was what we were going to do in this chapter and this is how it ended up, so that every chapter ends with a conclusion. The committee concludes that, and then it should all look the same. So, it's going to be hard because the reader might well expect that, that the plan is the every single one of these chapters will look alike. Reed, can I add you on the list or are you right on this point? MR. TUCKSON: Right on this point. And if it isn't, if it's far afield -- Mary Ann, I'm trying to understand when you describe the weakness of the evidentiary stuff, are we saying that we are not well convinced around the point that poor folk at that hospital were not given the chance for consent even though the doctor that took care of them said that they were given consent; that they went and talked to them, but they really didn't? I mean, is that stuff unclear? Is that weak evidence or not? DR. STEVENSON: I think the weak evidence is from a number of points. I mean, we haven't individually examined the medical records obviously for all these people. And even if we had had the time to do that, the medical records are incomplete. So I think coming down to the kinds of judgements that you might get to in Cincinnati when they have their case decided is sort of beyond our capabilities. I guess I think we can make some generalizable judgements about multi-purpose or dual-purpose research and the ethical problems thereof. But I would hesitate in getting into very individualized judgements about the particulars of the Cincinnati experiment because that's where the focus of the chapter is because I don't think we're in a position to do that. MR. TUCKSON: Well my thing was to ask her a question and not make a comment. I will be back and listen later. CHAIRPERSON FADEN: Thank you. MR. TUCKSON: But I think we really do see this very differently. CHAIRPERSON FADEN: Yes, I think we'd better -- we need to work on it because I don't totally accept that characterization. I mean, let's break out different parts. I think, to go to the example that Reed just gave, we haven't -- that's a part at which I would imagine the committee would like to comment, in particular in the TBI, in the Cincinnati TBI, issue, what we know about who these people were. Another piece of information we have I think is that the consent forms do not mention the risk of death. Now we don't know, which we have to say, if the risk of death was discussed with the perspective patients. But what we do have is the piece of information that says it wasn't in there. Now we can say that in a way that it's -- you know, what you do with that is a separate issue, but that is what we've got. DR. STEVENSON: But I think the other thing you do is set that historically with the surgeons of the time, discussing the -- I'm not saying I'm excusing this, but we can't judge from today's standards where everybody gets told every last thing to going from -- CHAIRPERSON FADEN: I didn't make -- what I was doing was laying out that piece of information and then saying that it's out there; that arguably, if you were a prospective patient, that's the single, only thing you -- I mean, the issue is rather turned around. The one thing you might want to know is that rather than everything else. What you'd really want to know is could this kill me or will this help me? Now it's quite right that at the time, and we have all that stuff in part one that lays the context, but this is moving later and later into a different period. So it's an evolutionary thing. We have to lay it out and I'm not saying we draw a strong judgement or any kind of judgement on that particular issue as opposed to -- MS. KING: I didn't understand Reed so I have a question because it would help me. Because what I understood us always to be doing is where we have data, we say it. And if we have data about the consent forms and the consent forms are inadequate, we say that it does not contain, and those are factual things. So that's easy. CHAIRPERSON FADEN: Right. MS. KING: I consider it a factual statement of a different weight, but it's a factual statement. Anything anybody tells us, they told us, that is a fact. What I was not clear about because Reed didn't say one way or the other, what I was not clear about was whether what Reed was saying is what he wants us to do is to make certain inferences from some of these facts. And if so, what kind? Because this is a recurring problem for me, as you know, throughout the report. I just didn't understand what he meant. MR. TUCKSON: And I know this will make Ruth very crazy because -- (Laughter.) MR. TUCKSON: -- of the clock. And I mean, I realize that -- and I feel badly that this is still coming up at this late date. But what I'm saying is that there are -- to take the line that you just did. There are certain things that have factually happened in front of us. I mean, we know about these people. We know that they got this treatment. We know that the physicians in charge said that these people were informed. That was told to us. Whether they were or weren't, we were told that they were. And we were told in the most compelling way by the people who loved with those people that they dad-goned sure weren't. CHAIRPERSON FADEN: We have to say that. MR. TUCKSON: And it was said to us in ways that are very difficult to ignore. And given that so much of what we are about, that we are to listen to the public as well, and that we took the time and the energy to hear those people and they took the time to come, either they're all a bunch of horrible liars and crazy people who don't remember their mom who did clean her house the day before she went to get her treatment and so forth and so on -- but having been given that, it's very difficult for us or for me to see how we can come out at the end of it and it not even matter. It's like it didn't even happen. MS. KING: Reed, I'm going to be specific. Are you asking us -- do you think that we, as a committee, so I'm clear on what you're saying, that we as a committee should, as between opposing and competing statements, make a judgement? DR. STEVENSON: Yes, that's my problem. MR. TUCKSON: Yes, I understand. And that's what I'm not sure about either. I mean, I'm unsatisfied, and I guess that's why I wanted to say what I needed to be clear about is what are the actual dimensions of the facts? I almost feel like I need to sit back down again and just lay out all the facts of what's known. CHAIRPERSON FADEN: Here's what I propose. At the very least, the chapter, as clearly written, doesn't do justice to what you've just said, Reed, okay, which is the other -- I mean, I disagreed about the notion of taking out the quotes. I think that's part of what we're -- we're a pass-through here, both for Dr. Saenger in the interview he gave us and to the testimony of the family members who came before us. And I think that's a responsibility that we have. Now of course, the responsibility is not to edit in such a way that you distort their representations, and that's a real challenge for drama. I mean, that's a huge responsibility with which Susan, I would imagine, have the most experience as a historian in terms of how you do that; how you, without reproducing the whole 15 minute interview with Dr. Saenger, express some of what he expressed to us to the committee to the reader, and the same with the testimony that we've received. The issue of whether we then draw the line and say we say one group got it right or wrong, as we are in this case, I think I would agree with Mary Ann. It's impossible perhaps for us to do that, or inappropriate for us to resolve when we have conflicting testimony and no other evidence before us. Because the court's presumably will have much more. But we at least need to do justice to both parties. MR. TUCKSON: I guess maybe if after we lay out all the facts, I just need to go over this and over this and over this again. And we'll probably have to do a lot of this outside the committee. CHAIRPERSON FADEN: I'm afraid so. MR. TUCKSON: I'll certainly volunteer to be a part of that. CHAIRPERSON FADEN: Okay, he's on the TBI. MR. TUCKSON: But I would say that if at least no more, we have to -- I mean, those voices have to be clearly in this document. And we are not in a position to be able to judge right or wrong. But even in that, we have to be able to say there is a process that is underway to arrive at the truth. But the implications of this are so important that recommendations later on, we really, really must insist that these issues are very clear for the future. Whether they ever get to the -- CHAIRPERSON FADEN: I think we've got this. We've got Jay and Lois and Phil, who have been very patient, and I see that Henry wants to join -- DR. ROYAL: Could I respond just to Reed's point directly in the total issue about the quote? CHAIRPERSON FADEN: Sure. DR. ROYAL: I think having the quotes in the chapter is fine as long as we tell the reader in the introductory comments that we're not going to resolve these conflicts, that we're going to present them. I think the frustration that I experienced in reading the chapter is you get all of this conflicting stuff, and then it's never resolved. And if I were told up front, "Listen, don't expect us to resolve this" -- CHAIRPERSON FADEN: Yes, then you're okay? DR. ROYAL: -- then I'm okay. CHAIRPERSON FADEN: That's fine. That's fair. I think we have to do that. Because what are we going to do? I mean, we aren't in a position to say he lied or she lied. You know, that's never been our charge where we were able to reach judgements in the absence of having to make a choice of that sort, we have. But in this kind of context, I think we can't. Nancy? DR. OLEINICK: Can I jump in on this? CHAIRPERSON FADEN: If Jay, Lois and Phil say it's okay. Is it okay? DR. OLEINICK: I agree we cannot reach any kind of conclusion because the only evidentiary base was some quotes, and there's no real written document as to what went on. And I think one of the conclusions that we can draw that which leads into what we have found in the contemporary period is the importance of the written material, the written consent form. And that is one -- CHAIRPERSON FADEN: There is a consent form. DR. OLEINICK: Yes, but they're not -- MS. KING: Wait a minute. Don't lose Nancy's point because we'll need documentation, we'll need adequate documentation for the future now. CHAIRPERSON FADEN: Right. MS. KING: But we ought not be overly ingenuous in expectations that that's going to resolve future conflicts. It will not. CHAIRPERSON FADEN: Okay. It can do better, but it won't go -- MS. KING: Right. CHAIRPERSON FADEN: Okay, Jay has been waiting and then Lois and Phil and Eli, and we have not gotten to the issue of whether we want to say anything in the way of a recommendation, and it's already 10:30. But okay, Jay? DR. KATZ: I'm always ready to call the White House and ask them to send over a company of Marines and incarcerate us until Monday morning so that we can talk. (Laugher.) DR. KATZ: And I think some of the things that you are talking about could be resolved better -- not that we would all agree, but could be resolved better if we had the time, which we don't have. I have no illusion that this chapter, and many other chapters, will turn out to be close to satisfactory in many ways because of the problems that are just before us today. Let me just make two or three points because the issue is what are our objectives? With respect to the bullets, I see the problem is -- I have a problem with the bullets too because we start out by hoisting on the flagpole the Wilson memorandum again. And then we compare it against the Wilson memorandum and of course, DOD looks terrible and how can we do these kinds of things in the light of the Nuremberg trials, Wilson, Carroll Wilson, etc., etc. And what troubles me about the bullets is as I read the -- if you want to -- and I'm not as interested in you as decimating the Department of Defense even of its corpses -- (Laughter.) DR. KATZ: But where are the bullets with respect to the investigators? I mean, they did all kinds of things. There's no balance here. But the point is, from my perspective, is that we should really acknowledge much more, that the ethics of human research and the ethics of this kind of human research in particular was in an absolute morass. It was shortly before I entered the field in '64, and I found very few discussions on the ethics. And I think also from the evidence before us, and we can say so clearly, we can say, you know, we don't have all the evidence. But we can say in the light of what the morality of human experimentation was at the time and what was going on. We can piece together that all kinds of things were doing badly, again by good people. But they really didn't know what they were doing, and they were in part -- yes, they also wanted the research money, but they also were seriously interested in national defense. They wanted to advance medical science, etc. And this got them into trouble. And I'm not particularly interested in making retrospective moral judgements about all this. And I would say that there are important lessons to be learned form all this for the future. And that is why I am saying to you look, I want to say more and I hope you will accept it as an important part of the final report, that there are things that continue to be wrong with the human experimentation regulations of today. Because these kinds of issues that we encounter in the total body radiation experiments, in other kinds of forms and disguises, now it's -- research, are still with us. An IRB cannot resolve these kinds of issues. CHAIRPERSON FADEN: Reed wants back on the list. We've got Lois and Phil and Eli and Reed. And then what I think we're going to have to do is decide what we're going to do. Lois? MS. NORRIS: This is probably going to be the most welcome comment you're going to hear all day. I'm going to yield because everything I had in mind has been covered by someone else. There's on remaining, tiny -- I'm going to wait until the next draft comes out. If it's still there, I will raise it. It's a small thing at this point. CHAIRPERSON FADEN: Thank you. I'm lost. Oh, Phil, Eli, Reed. I was just checking my list here. Ruth, excuse me. I didn't hear you. I will add you to the list. Ruth, you are now on the list. DR. MACKLIN: Thanks. CHAIRPERSON FADEN: You're welcome. It was the lights. I couldn't see. (Laughter.) CHAIRPERSON FADEN: Phil? DR. RUSSELL: I'd like to comment on the two bullets. The first one starts out with "The Army regulation." That 1962 regulation was part of the process of codification of policy with regard to human volunteers. And that exception in there that exempted medical and clinical investigations clearly reflected the conflict of that time of the physician/patient relationship on one hand, and the attempt by the research community to codify its activities and policies. And I feel confident that the regulation was a compromise between the research community, the Surgeon General and the physician-scientists, mainly in the civilian community, but also in the Army, who were jealously guarding their patient-physician relationships and viewed the regulatory process as an imposition on that regulation. So that was the status. Now it was unsatisfactory, but it was an evolutionary process going on. And that was the status. So that the folks running the program at the time obeyed regulations. They followed the policy. And I'd like to say as an aside that when you discuss whether policy did or did not exist, there are really only two documents that are solid evidence. One is the regulation and the other is the budget. And if it's in the regulation, it's policy. And if it's in the budget, it's policy. Anything else has much less weight, no matter who signed it. But in this case, I think the policy was clear that the medical and clinical investigations were exempted from the regulatory oversight process. And what the action should or should not have been, they followed regulation and they followed policy. And I think you have to take out what the DOD should have done or we have to say that this was the policy that had not completely evolved from an ethical point of view, and was still in a process of change. The second thing is, and I'm not sure we have any solid evidence on this conflict of interest of physicians. But this is another may have kind of thing: may have, should have, and what if? Without the basis of a real -- I don't think that a physician who is in the military reserves is -- any evidence that any of them abused their -- CHAIRPERSON FADEN: I didn't understand that line. DR. RUSSELL: -- position any more than anybody else did. CHAIRPERSON FADEN: I think that this was overly generalized. What we really wanted to get to was look, the conflict of interest is, as Jay has pointed out, there is a conflict of interest when you're doing research and you're caring for a patient. That's where it starts. DR. RUSSELL: Right. When you get paid for doing research, that's where the conflict is. CHAIRPERSON FADEN: Right, that's the conflict of interest. It isn't because you're in the military reserves. That's irrelevant. DR. RUSSELL: Exactly. CHAIRPERSON FADEN: I mean, the point is, when you're doing research and of you're doing research and the research is to advance one purpose and clinical care is the other purpose, you've got a conflict of interest. That's in the enterprise. This is another manifestation. Maybe it's more acute when the agenda is three ways versus two ways. But that's the dual purpose, right. So it's not that -- I just want to make clear that you agree with that, Phil. It's not that there isn't a conflict of interest here. It's just not characterized the way it's characterized in that bullet. DR. RUSSELL: Right. CHAIRPERSON FADEN: Okay. I just wanted to make sure that we had that. Okay, Eli, Reed and Ruth Macklin. DR. GLATSTEIN: Just a couple of points and I'll be brief. In regard to the discrepancy between family and physician with what the patient was or was not told, when we get permission today, we usually like a witness. In fact, when we discuss protocol, I like to have the whole family in the room. But I don't think that was actually the policy, the usual way it was done, in the 60's. Consent as just coming in and it was not unusual at all to shoo the family out during the physical examination. And at that time, when there were just two people in the room, the doctor and the patient, that's when most of the communication took place. Today, we like witnesses precisely for the medical/legal implications. Second point, yesterday I raised a lot of questions about the language of the therapeutic rationale being unpersuasive. I'm not against the points we were trying to make yesterday, but I think that language is too vague. If we want to talk about controversial treatments which are passed off as standard, if you can work around that kind of issue, I can be very supportive of that. CHAIRPERSON FADEN: That's interesting. That's very good language. Excellent. That takes us right into the recommendation issue, which I'd like to do, but I think we're going to have to do it after the break and figure out how we're going to move things around. Can I get this? Controversial treatments that are presented as standard? DR. GLATSTEIN: Passed off as standard. Passed off by the investigators as standard. (Laughter.) CHAIRPERSON FADEN: Well, passed off is a little bit harder to say in a report. (Laughter.) CHAIRPERSON FADEN: But if you want to say "passed off" okay. DR. GLATSTEIN: What can I say? MS. KING: It's really presented as standard treatments or innovative therapy is really -- CHAIRPERSON FADEN: As opposed to controversial. MS. KING: Right. CHAIRPERSON FADEN: I mean, some innovative treatment is not controversial. It's innovative, but it's not -- DR. GLATSTEIN: Same follows logically and some is out in left-field. CHAIRPERSON FADEN: And you don't want to stop the left field, but you want -- DR. GLATSTEIN: That's right. CHAIRPERSON FADEN: You've got it, and you're going to get it right after the break. DR. GLATSTEIN: That's what I was trying to get at yesterday. CHAIRPERSON FADEN: But I want to get Reed and Ruth in and then take a break and then go to recommendations for the recommendation of how we would want to fix up that recommendation or have a separate recommendation. So Reed? DR. TUCKSON: My issue is also regarding maybe -- is applicable to the recommendation section. And Pat helped me out a little bit, actually. Pat says -- CHAIRPERSON FADEN: Hang in here with us, group. DR. TUCKSON: And Pat, at the very end, said something that I thought was helpful. And that was that, you know -- it had to do with can any of this ever get fixed in the future? I mean, what can ever actually happen in the future? And I guess what I'm looking for as we go through the next draft of this statement and then the recommendations that come from it that are given the enormous difficulty that we are having to sort this out, and if I could -- in my mind, I want to do a better job of summarizing what exactly those difficulties are. Then what is it that we need to therefore recommend? For example, if now the mantra is if it's not in the medical record, it didn't happen, and that -- I mean, that's generally -- and I'm not enough of a lawyer to know whether that still really holds up or not. But I'm not trying to -- I'm not taking that as gospel. I'm just trying to get at examples of things that say that there is a burden of proof, a burden of obligation on certain folk to make sure that certain things happen in certain ways, such that when you ever have to go back at this again, if anybody was contemplating being slip-shod, if you're ever contemplating as a researcher being loose, taking advantage of people because of laziness or inethicality, or whatever it is, that people like us will always, for the rest of life, will always be coming back and checking on you. And that if you did it -- because that's a part of life. I mean, always there have to be good citizens -- other than me -- good citizens who will be on your butt. CHAIRPERSON FADEN: Right. DR. TUCKSON: And that people need to know that. And there are certain things that you cannot get away with, bad and crummy stuff, because you did not -- because you could obfuscate it with confusion: records got lost, this could happen, for whatever reason. All I'm getting at is I hope that -- maybe I'm naive, and I'm sure I am. But Pat's point -- I mean, at some level the recommendations, to the best of our ability, at least need to say to those that we can say something to, that these things must be in place such that people like us in the future, if you didn't do it, then you are in trouble because you didn't do it. And the fact that we can't figure out what happened, that says you've got a problem. And we know exactly who to point to. It is on you, whether you actually did the bad thing or not. The fact that we can't even figure out whether the form was there, then you've got the problem. DR. FADEN: All right. What we've got to do at this -- this is timely too because one of the recommendations we're going to do this afternoon is the one on whatever we're calling it: oversight, monitoring and sanctions. And the tension always is, what you're suggesting is you set the presumption so that if there is ambiguity and the issue about the ethics of research, the investigator loses on the presumption. The problem is that the response to that often is defensive, excessive detailed consent forms that nobody can read and that don't mean anything. So the art form is trying to figure out a way to set that presumption without setting into place the chain of events that turns out to be counter-productive. But we'll get to -- I'm sorry? MS. KING: One of the things is to work what Reed has said and what we have all said, not so much as to the retrospective recommendation we're going to talk about. It is to work it into the forward-looking recommendation at the point where we discuss therapeutic or research that promises benefit, which I would take ought to be in the forefront of where we want to hit hard in terms of what we want the future to bring. CHAIRPERSON FADEN: I was speaking about a forward recommendation just then. MS. KING: I mean, not just that forward, the monitoring one, but the forwarding recommendation. We have one that grows out of the contemporary -- CHAIRPERSON FADEN: Right. MS. KING: We have a chapter that grows out of contemporary studies that this should speak to. CHAIRPERSON FADEN: Right. Now Ruth, are you still with us? DR. MACKLIN: Yes, I'm with you when I can hear you. And I don't think the problem is talking into the microphone directly because it breaks off in the middle of someone's sentence. Can you hear me? CHAIRPERSON FADEN: Yes, we hear you just fine. DR. MACKLIN: Okay. So my comments, I apologize in advance, may be a little redundant or they may have been covered. But I feel like I'm commenting on a book after having read every other page. (Laughter.) DR. MACKLIN: I want to address the question about the uncertainties and the factual uncertainties. And it goes in part to Henry's point in his covering memo about the conflicting statements that appear in the earlier draft, and that those may confuse the reader. Well, if there are factual uncertainties and they result in conflicting statements, it seems to me that has to be acknowledged. And it might be useful. I'm not suggesting this as a way of rewriting the chapter, but at least analytically to think of where those uncertainties or potential disagreements lie. And there are three areas, and I know this covers some of what has been discussed in the last half hour or so. One is uncertainty about the medical fact or effect of TBI and the state of the art at the time. There are conflicting claims about this. Now there may be a right answer, but there are at least conflicting claims that we find people saying or having said. On the one hand, people had studied this. They did it, they tried it, and they knew there wasn't any beneficial effect and there were harmful effects. On the other hand, there were claims -- and Eli can say this better than I could. There were claims that maybe there were some effects and it wasn't completely -- the answers weren't all in, at least at the time that this was started. So that's one set of factual questions that, of course, does go eventually to the purpose, the dual-purpose aspect. A second set of factual uncertainties is how these patients were actually treated given what seems to have been in the proposal -- now I admit here I'm picking -- and in the documents, sorry, in the documents. I admit I'm picking some of this information from the written testimony of Dr. Egilman, who I was not privileged to hear the other day, but I heard he was rather colorful. And these documents included descriptions of how the patients were to be treated in the course of the study. They were not to be told about -- their side effects were not to be discussed with them. They were not to be treated for side effects, such as nausea or vomiting. They were not to get chemotherapy, even if that might otherwise have been indicated for their condition. And they were to be isolated and not given psychological support. And then there were some other questions about the position of the body, which presumably would go to the question of whether this was intended to study the effects on military personnel or whether it was directed at trying to treat the cancer. Well, are we questioning here -- if there's uncertainty, are we questioning what those documents say? What the piece of paper that we have here that Egilman presented that said "Do not ask the patient whether he has these symptoms" and similar documents? Are we questioning the validity of those documents or are we saying, well, these documents say these things about positioning, about don't talk to the patient, don't treat them for nausea, etc., but perhaps the patients were actually treated different from the way the documents say they were or were supposed to have been treated? I mean, that seems not very credible to me, that kind of uncertainty. Finally, there's the area of uncertainty that Pat mentioned, if I heard correctly in between the blips and hiccups in this system. And that is, whether the conflicting statements that different people make -- Reed made an eloquent observation about the families and how we cannot ignore the things that they said. Some might argue that we cannot ignore what Dr. Saenger said. I think in general, on the evidence of people who have been accused of wrongdoing, people who are being sued, and people who are being found to do something wrong, even if they at the time did not believe they were wrong, they're not always completely forthcoming and their memory may suffer a bit. So there may be legitimate uncertainty and disagreement about the claims and statements of Saenger et al. and the families et al., but the other source of factual uncertainty seemed to me was the we either can try to reach some conclusion on or else be able to make a hypothetical statement. If patients were treated in a way that is inconsistent with proper medical care, even for experimental subjects, then that was wrong. Now I don't know that that's only today's standard. But it's surely the case today that when -- at least in the consent forms that what is stated in protocol that patients are withdrawn from studies if they have severe reactions or if they cannot tolerate the drug. And that is part of the protocol that they be withdrawn. Was that or was that not a common practice 30 years ago to withdraw patients who were having severe reactions and are presumably receiving no benefits? CHAIRPERSON FADEN: Thank you, Ruth. You prompted a response from Eli, and then I'm going to ask a question too. And then I guess we will take a break. But that's very useful. Let me let Eli respond. DR. GLATSTEIN: I just want to address that point about the positioning of the patients. I wasn't going to discuss this, but since you brought it up. On that particular point, Dr. Egilman is dead wrong. To do TBI, you have to put the patient at a very long distance away from the machine. You make them in the fetal position to keep the volume small so you don't have to move them away any further. To move them away from the machine means you're going to delay the time of treatment. It just takes longer to treat them. So you put them in a fetal position to keep them as small a target as possible. And frankly I think from the military point of view, you'd want the patients actually either stretched out or standing. I don't think you'd want them in a fetal position. On that point, it's a matter of pure -- that's the technique that everybody in the country uses, and has used for years. CHAIRPERSON FADEN: This is the point then that Ruth is making, that some of these things are not really controversial. They can be refuted and -- DR. GLATSTEIN: That particular point is. CHAIRPERSON FADEN: But others remain open questions and that's what we have to distinguish. DR. GLATSTEIN: Absolutely, absolutely. I'm not going to shoot all the things that Dr. Egilman said, but that particular point is absolutely erroneous. CHAIRPERSON FADEN: Ruth, I'm glad you raised the withholding of the anti-nausea medications, because that is something I don't know what to do with. And I think -- DR. GLATSTEIN: Well, I think that's very clearly related to the military -- CHAIRPERSON FADEN: Right. But the question is the propriety of that -- deserves comment. DR. GLATSTEIN: Absolutely. CHAIRPERSON FADEN: And I think that that goes to your second point of how the patients were actually treated. It may be that there was no inappropriate positioning of the patient. But there may well have been inappropriate withholding of -- treatment. DR. GLATSTEIN: This has nothing to do with military -- piggy-back study. That's all I'm saying. That's the way it's done. CHAIRPERSON FADEN: Right. But what we want to do is highlight where there was apparently inappropriate treatment in the sense that you're withholding palliative medication from a patient. It's something that you really ought not to do without -- I don't know if you should ever do it, but certainly it's a questionable practice without the patient's -- DR. MACKLIN: I can't hear. CHAIRPERSON FADEN: I'm sorry, Ruth. I'm agreeing with you about the need to address the withdrawal of the -- the failure to provide the nausea -- the anti-nausea medication. DR. MACKLIN: That and several of the other items that were listed on the way that the patients were to be treated, ways in which they were not to be given support. Now it would seem to me, but let's hear from Eli on this, that when physicians are conducting research to see whether a particular form of treatment benefits the patient by shrinking the tumor or curing this disease, that the interest the the physicians have is not also if you let the side effects go untreated to see how bad they are. That is, however -- because it goes to the dual-purpose question because that is certainly a question that the military might be legitimately interested in because -- DR. GLATSTEIN: I don't think there's any question about that. DR. MACKLIN: -- if soldiers become incapacitated after receiving high doses of medication, of radiation, and they're vomiting and they're nauseous and they don't have psychological support and the all the kinds of things that were withheld from these patients is presumably recorded. I mean, they were all recorded very carefully. So if those things were withheld from patients, it sounds as if or it seems to me, and correct me if I'm wrong, as if they would not have been withheld if the main purpose or only purpose were to use this form of radiation to treat your patient's cancer, since there would be little interest in whether if you don't treat their side effects, how bad those effects would be. CHAIRPERSON FADEN: Ruth, what you can't see is the general shaking of heads in agreement with your observations. DR. GLATSTEIN: There's no argument about those points. The points about withholding treatment, if you want to find out what the symptoms are, and you don't want to plant the seed of some sort of psychological predisposition, you wait until the symptoms develop. But then once they occur, you treat them. CHAIRPERSON FADEN: Can I ask for a point of order? We are way off schedule now. This has been an extremely important discussion. I am very concerned bout the time. Would it be all right if we take a break and then come back at 11 o'clock, an eight minute break, five after 11:00? And in the meantime, I'm going to think a little bit about what to do next. (Whereupon, the proceedings went off the record at 10:53 a.m. and resumed at 11:09 a.m.) CHAIRPERSON FADEN: Okay. We are desperately behind schedule. And at the risk of inducing indigestion in all of us, we are investigating whether lunch can be brought in since we are closing at 3:30. DR. ROYAL: Is there a reason we can't extend it? Is it the public announcement? CHAIRPERSON FADEN: Exactly. We can't continue the meeting in the lunch room. We're not allowed. We have to have our meeting on the record. So the issue is can we bring the food -- I mean essentially, it's an elaborate room service. I mean, if they can do room service, they can bring -- thank you. If they can -- that should pump us up here. If they can do room service, you would think they can do the food here. I think the choices may be more restricted than one would like. But if you can bear with the fact that there will be something you can eat, we're just going to try to keep on going. We'll obviously take a break. Because otherwise, I despair of going through this. I assume Jeff is working through whether Ruth is still able to be with us. Here is the dilemma. I think that while we're thinking TBI and Eli has provided us with this language, that we ought to revisit that recommendations and see if we can't insert that new language and see if we're comfortable with it and then go on to Chapter Four. So what we're talking about is if you could turn to your Chapter 19. Oh, I'm sorry. I should announce to you that Duncan distributed his comments on Chapter Four, but we can't look at them right this second. We'll take a second when we get to Chapter Four for people to look at them. If you could turn to Chapter 19, which is recommendations, and specifically to recommendation two, but this is the wrong -- we've got the wrong draft again. But the line that said, "In which the therapeutic rationale was unpersuasive at the time" -- I don't know if the repair is as simple as now inserting the phrase that Eli gave us or where -- Eli, do you have your language or should I look at my notes? DR. GLATSTEIN: Better look at your notes, but I think it was something to the effect that -- CHAIRPERSON FADEN: I thought it was something to the effect of controversial treatments are presented as the standard or conventional. CHAIRPERSON FADEN: Right, in which -- DR. GLATSTEIN: Or something to that effect. DR. ROYAL: I thought it was standard or innovative. CHAIRPERSON FADEN: Or where controversial -- it would read like "or where controversial treatments were presented as the standard of care or innovative treatment" rather than as controversial treatment, or whatever. But if we could play with that framework, we will have captured what we wanted to capture. DR. GLATSTEIN: I don't have any problem with that. CHAIRPERSON FADEN: Great. We will do that. And if you note the dynamic of that recommendation, it's an open question of whether TBI, for example, would meet that description. What we're laying out what the criterion would be. So if everybody is okay with that, I'll work with Eli to get the language as he has proposed it. And then we'll circulate it with everyone. But the idea now is we will not have a second recommendation and we will just keep it as recommendation two and substitute Eli's controversial treatment for rationale unpersuasive at the time. Is that agreeable to everyone? Great. The devil of this project is always in the detail. So when Eli and I go to work at it, it may not be -- MR. GUTTMAN: And the details can always be worked out in the future. CHAIRPERSON FADEN: Yes, I noticed that. DR. GLATSTEIN: As -- used to say, "The future is now." CHAIRPERSON FADEN: If we could now turn to Chapter Four, we have Duncan's written comments. Ruth doesn't have Duncan's written comments I guess. DR. THOMAS: I don't know. Ruth, I E-mailed them to you last night. Did you get a chance to see them? CHAIRPERSON FADEN: Ruth, are you there? DR. MACKLIN: Yes, I'm here. Is this a question to me from Duncan whether I got a chance to see them? CHAIRPERSON FADEN: Yes. DR. THOMAS: Yes. DR. MACKLIN: Yes. I read Duncan's comments. And following on the discussion I had with Duncan, I took out the previous version of this chapter, and took a careful look at what was omitted in the first section and what was altered in the second section. So I have some comments to make about those, including some very specific comments about what should be restored. But should I leave those until a little later or did you want to do those now? CHAIRPERSON FADEN: Ruth, let's just take a minute. The rest of us have not had a chance to read Duncan's comments. We just received them this minute. DR. MACKLIN: Okay. Duncan's comments go to two sections, the first being that each key --since there's not a persuasive enough rationale for making retrospective moral judgements and says it was more eloquently done in the earlier chapter. And when I read the earlier version, I entirely agreed and I picked out those key sections that I think will help beef it up. And then on the second section, I have some different comments on part two. CHAIRPERSON FADEN: Well, how about if we do this? That's very helpful. How about if we just take a few minutes to skim Duncan's comments and then other people have comments, and we'll just get them on the floor. But since we have Duncan's in writing, let the rest of us read it. It will take two minutes, and then we'll be up to speed with Ruth and Duncan anyway. So that's what this silence is, Ruth. The machines are not defective. (Pause.) CHAIRPERSON FADEN: All right. I don't know how fast readers we are, but that's all the time you get. (Laughter.) DR. ROYAL: It's either that or we call the Marines. (Laughter.) CHAIRPERSON FADEN: I appreciate your written comments. It helps me understand what's at issue here. DR. THOMAS: With that, I've said my peace so I can shut up. CHAIRPERSON FADEN: Well if I could respond real quickly, I think it isn't right. I mean, I don't agree that page six, lines 11 to 12 are what provide the rationales. The problem is it's not -- it needs to be more, but that isn't what we're arguing here, I hope. So we need to get clear on that, but let's have the open -- DR. THOMAS: I've clearly missed the point then. CHAIRPERSON FADEN: No, no, no. The chapter is not working in that first part. I mean, the argument is in the third part basically. The positions in the third part in defense of it should be in the first part is what you're saying? DR. THOMAS: By "the third part" are you referring to the part about the medical profession? CHAIRPERSON FADEN: Right. DR. THOMAS: But what about government? That's the second part, and I have bigger troubles with the -- CHAIRPERSON FADEN: The third part. Let's just get all the comments. All right, why don't we just get all the comments out? I don't think they're bad, so I guess we have a foundational disagreement. I think they're under-developed, but that may just be different ways of saying the same thing. MS. KING: Whatever the operative language of the moment should be. CHAIRPERSON FADEN: Well, here's my problem, Pat. Let me just lay this out and some background discussion. What I'm trying to figure out is whether the conclusions drawn, and this why I'd like us simultaneously to be thinking about finding 11c, okay? Is the problem with the conclusions or is the problem our ability to get there? And I suspect that you may have problems with both. But that's what I'm trying to get clear because that will make a big difference in terms of the task left for us to do. MS. KING: I suspect -- CHAIRPERSON FADEN: Go ahead. The floor is yours. MS. KING: I suspect that for some people, it's the justification and the conclusion. And for some people, the conclusions are okay and the justifications are not well developed. And that is, for me, it is both. And the reason I suspect that I can make the bold statement now is only because having tried to work out my own justification that I was sort of comfortable with, but I can't really do it because as I said, I'm not a philosopher. My lawyer training, however, has persuaded me that neither by what I've been trying to work out nor by what Allen Buchanan tried originally in his paper and what Ruth tried to work out, that when I go to apply the framework, theirs or mine, as I understand it, I don't think the conclusions hold up. But that presents me with a real problem, and this is the way I would lay it out. I don't know how you jump to the conclusions when you don't understand your framework except for those people who do, in fact, understand the framework. It's very hard, unless you know where you want to go before you know why you want to get there. And maybe that is true. But with respect to part one, I made the statement this morning that I had not liked what I considered a human rights approach. And it did exist in Allen's draft. It is not in here, but it is in the report. It infects the report. If you want me to go through it, I will go through where there's a big reliance on that approach. Because in reading that report, that's where things started to crystallize to me. So I would clarify what I said this morning. What I would like to see is I don't believe that there is -- maybe you can convince me. I don't believe the is a single ethical framework for all of us to agree to. That has never been my experience that there is an ethics, "a right ethics", to which everybody has to subscribe in a publics ethics commission. And I am having that dilemma. I myself approach these issues through obligation-based approaches. For a variety of reasons, I am more comfortable with that than I am with autonomy and rights and human rights approaches. Now that's not the sum of the philosophical argument in the first chapter. But it may end up in the same place as the other argument, but I know that it would have to go back and pick up certain parts of what Allen tried to develop that perhaps make more sense in this context than they did in the other. For example, roles and relationships become very important. The discussion of roles and relationships becomes very important when you're focused on obligations to others: either the government having obligations or individuals having obligations. So the first part that I'm having difficulty here with is what motivates me is not in the report. So from my point of view, in section one, my suggestion is that we see what we can do with that. And I talked to Allen and he says that actually such a beneficent approach was in fact developed by the President's Commission in another context, that it might not be difficult to offer it as another way of looking at these issues and trying to do an ethical framework. That's -- you were going to ask me a question? CHAIRPERSON FADEN: I'm in mid-crunch. What I wanted -- and I think we need to hear from everybody, but a quick response and the framework at the end that's developed for judging for making statements about what went wrong in the past, both with respect to medical professionals and government officials, addresses the two issues that we talked about last time. One was the prospect that people could be benefitted from the -- this is just for experiments now. And the other was the prospect that people could be directly benefitted from being in the research. And the other was the likelihood that they would be harmed. Neither of those are based on rights-based considerations, nor autonomy considerations. What you're correct is the moral foundation for those practical level criteria have not been spelled out in Chapter Four. But basically with respect to consideration of the extent or the likelihood that people were not going to benefit from their involvement in research, that is concern with respect for human dignity and not using people as mere means only, and in that sense connected to questions of autonomy, but the really foundational issues having to do with respect for the dignity of another person. And that's what animates that dimension of the moral framework that's proposed at the end of Chapter Four. The other, which says "harm," is concerned with not harming people; that insofar as we did things to others that put them at risk of harm, that's more of a problem than if what we did to them put them at less risk of harm. So I guess what I'm hearing from you is -- and maybe of course this is my job because I have to rationalize and make everything wonderful, because otherwise I'll fall apart here. But other than that, it's okay. So we all have to be explicit about what's happening for my own psycho-dynamics. But what I hear you say is reinterpreted in my own head as a failing in the articulation of what's operating in that chapter, which is not to say that this report on this chapter does not make a big deal out of consent. It clearly does because the backdrop to all of that analysis is if people had knowingly consented to being put at risk or being used for a scientific and that couldn't bother them, that would have made it okay. So there are conditions in which it's all right. But the justification for saying that something wrong was done is not solely, or not even largely at this point, the way the framework is set up or rights-based. I am grounded in those other two dimensions, but the moral analysis is not there. MS. KING: I acknowledge that. The point I made this morning about rights-based does occur in Allen's submittal to the committee. CHAIRPERSON FADEN: Right. MS. KING: And what I said was it is correct to have corrected me to say that it is not in this chapter. But in my view, it does -- report. What I think I'm saying is (1) I think that the analysis has to be there; and (2) I think that it's distinct from doing philosophy and academic, the way we do it as academics, for a public ethics commission. Some of the models of the past work for me because it doesn't mean that everybody has to buy on to the same starting base in the analysis. Duncan's comments -- his terms were the universality of some of the ethical principles that we hold today. Not all people subscribe to that point about universality of ethical principles. And so the point that I'm making here is that there are approaches? Is that the way I understand it in layman's terms? There are approaches to trying to do this problem that are different; the some work better for some people in thinking about moral issues and some work better for others? And that what I would hope would be not only would we get an articulation of what is there, but that in the articulation, especially since we use obligation language in many chapters of the report, that there needs to be some moral analysis to substantiate our obligation approach, at least in some of the chapters? The part that I actually have the most difficult time with, because this is probably an inadequacy in the way my brain functions -- until I can get my framework right, I can't start doing my bridging. And by that I mean, I can't make my judgements until I understand what the starting point is on how I make judgements. And then if I were going to make a moral judgement, for me I would then look at what am I supposed to use? And then I would look at the facts that I have, and I would try to do a contextualized moral judgement as a policy maker, not as a philosopher. I do a similar kind of analysis, actually with some other ingredients, in order to make a contextualized judgement. I think that the contextualized, the materials with which to make a contextualized judgement need to be developed as well, and maybe they can be more explicit once we get the moral analysis out, you know, in a more explicit fashion. But this is where I'm having trouble. I've always had trouble. I don't believe that you have to be in a world where you don't draw retrospective judgements. But I do think that when you do start to make retrospective judgements, what your evidence is for contextualized judgements, and this is a contextualized judgement about a period in our history, requires some assessment of the evidence that you have there. And frankly, when Duncan says, "Pat says yesterday a document does not a policy make," that's a very poor way of getting to some of the difficulties that I have with respect to the purposes of recognizing some documents as policy. This is again a problem of dual-purpose and triple- purpose, use of the same fact information that I would never want to be on record as saying that a secretary of an agency who issued a policy, that called it a policy, or to have the impression that that person is now not stuck with that not being a policy. So I'm very comfortable with that. But I am very uncomfortable when I move into the arena that I know best with hanging a lot of weight on the fact that -- Phil said it this morning. I know a policy when I see it. Usually when I see it, it's in an appropriation or it's in a regulation. Now I know it takes a lot of steps to get there, but those are degrees of evidence in terms of weight and how you get there. And I didn't see that. And so my biggest objection is, and obviously it's got to be rewritten so maybe it will be convincing when it's rewritten, is to see that bridge between the analysis and the judgement. The way I read Chapter Four, when we come to judge the medical profession, evidence and not the moral argument, the evidence that we cite in judging the medical profession was an AMA statement. This is the way it reads. CHAIRPERSON FADEN: Okay, that's not right. MS. KING: I can give you the page because I went, 'this is nuts.' (Laugher.) MS. KING: Because I wouldn't let the AMA say anything and stood for anything that I believed in in this period of time. But that is the way the current chapter reads. So when I made my statement -- people must have had some reaction to that statement like I did. It's a very funny place in the chapter. It may be -- CHAIRPERSON FADEN: This is all really important because it's clear where the stuff isn't written right. MS. KING: It may be that when you can follow from an analysis into an attempt to apply in a contextualized fashion drawing on the evidence, that it will look good, I mean that it will be something we can be proud of, it's hard to make that judgement now. But I can make the judgement that I haven't seen it pulled together in the fashion yet where the contextualized judgement, not the moral analysis the contextualized judgement, holds up for me. I mean, that's an attempt to use the evidence with the -- CHAIRPERSON FADEN: Right, right. I just want, for people who are not perhaps as -- we think Ruth just rang her bell. SPEAKER: A while ago. CHAIRPERSON FADEN: A while ago, okay. So we'll put Ruth next after Pat. Just for those of us who don't live in this world, the contextualized judgement just means a judgement in the context of this situation about which the judgement is being drawn. It means the judgement you make in the context, not in the abstract, but in the mire of the detail of the situation itself. Is that a -- MS. KING: Yes. CHAIRPERSON FADEN: Because we throw terms around too. Contextualized what? I mean, is that like a carpet? (Laughter.) CHAIRPERSON FADEN: I know, I'm teasing. But I've had those reactions too. MS. KING: And I want to make clear in the prime example that I use that when we use -- and this is only an example. When we use Secretary Wilson's memorandum and we say from an ethical point of view that a secretary shouldn't do this unless certain follows, I am not having trouble with that statement so much. I am having trouble with what comes after that because that then becomes the weight for further judgements that I don't think take account of historical, economic, practical -- I can give you a whole range. I almost went to get Beauchamp and Childress to give you the quote of the other kinds of factors that you used to analyze when you started making some of these bridge-walks. But that's what I'm missing. CHAIRPERSON FADEN: Can we let Ruth in at this point if that's -- Ruth, are you there? DR. MACKLIN: Yes, I am. CHAIRPERSON FADEN: You're next. DR. MACKLIN: I wanted to just interject at this point -- I mean, I still have things to say about what I think should be restored, and that is related to what Pat is saying. I heard about two-thirds of it. The rest of it did not come through. So maybe she said these things. But what I heard was what seemed to be almost an inconsistency. On the one hand, Pat, you claimed that not everyone agrees on moral principles. And on the other hand, you seem to endorse some moral principles. I guess you disagreed specifically with the claim that some principles are universal. Well, I think that we could argue that some principles are universal. But what differs from person to person or group to group is their interpretation or their application to the facts. Therefore, I don't know of a person or a culture who would not defend the general principle that right actions are those that tend to produce a balance of beneficial consequences, and wrong actions are those that tend to produce a balance of harmful consequences. That's the principle. The disagreement comes in the judgement of which are the beneficial and harmful consequences, and when one outweighs the other. And that's not a matter of principle. That's a matter of assigning values and weights to different value. So to the level of these very general, ethical principles, at least those having to do with risk and harm, I think that the argument could fairly easily be made that the principle is universal, but the problems lies in its application. And there are two problems with the application: the one I just mentioned, namely the evaluation nd the assessment of the degree of benefits and harm and what could count as benefit and harm. And secondly, the factual evidence that such harm or benefits did, in fact, occur or were likely to have occurred. Your comments seemed to be going mostly to questions that have to do with the weight of evidence. And I think that's critical and that's important. But it's not the same as questioning the principles themselves. MS. KING: May I reply? DR. MACKLIN: So that's my comment about the principles. MS. KING: Ruth, can I interrupt you a minute? This is Pat. CHAIRPERSON FADEN: Can you hear, Ruth? Pat wants to -- DR. MACKLIN: Yes. MS. KING: What I said is not everybody subscribes to the universality of principles. In other words, not everybody ascribes to a principle-based approach. I quite agree with you that if one does subscribe to a principle-based approach, that often you have problems of interpretation, priority of principles, etc., etc., etc. So there are two things at issue here. One is the use of principalism itself, and the other is if you in fact use it, what some of the issues that can arise. And you are quite correct that I am concerned about a weight of evidence problem. DR. MACKLIN: Well, I think just in response -- and my apologies to the other committee members for this remark. I think the question about subscribing to principalism is a mega-ethical issue of interest only to philosophers and perhaps a few other bio- ethicists. If you ask the person on the street, the educated person or the less educated person, and don't call it a principle and don't say that there's been a so called doctrine "principalism," do you believe that it is universally true that actions that produce more harm than benefit, etc., etc., I think people would say yes to that as an agreement with a principle without knowing they're agreeing with a principle. And they don't have to know that. That's what universality of a principle is. But to date, at the meta-ethical level, which I find quite boring, it's really not germane to those circumstances where you're going to apply the principles. It's only of interest to those people who talk about methodology. And our report certainly doesn't have to talk about methodology. Let me, while I still have the speaker, just say a word by way of reminder about the distinction that's made in the current draft on page two, between judging -- and that someone should be subjected to a greater or lesser degree of blame. That is judging actions and judging all agents. Unfortunately, much of the material is left out here that was in earlier drafts. And the more I reread this and compared it with even the last draft, the more I agreed with Duncan, that the rationale and the mechanics of going through this as being able to make the claims are just simply missing. So for example, all of the discussion about the kinds of mitigating circumstances and what can mitigate or even exculpate an agent from blame worthiness or culpability, that was in earlier drafts and that was part of Allen Buchanan's paper, is missing here. And so we seem to be left almost with an equation between judging actions and judging individuals. I mean, there are a few disclaimers. But I think restoring a fair amount of what was in earlier documents from Allen Buchanan's paper, and some of the things that I proposed, I think would go a long way toward providing the rationale that at this point is missing. CHAIRPERSON FADEN: I'm just looking for -- MS. NORRIS: I'm finished. CHAIRPERSON FADEN: Thank you. We're looking for other people's comments and reactions to Chapter Four. Duncan? DR. THOMAS: I want to return to something that Pat said a little bit earlier when she was talking about setting aside her point that she has difficult subscribing to our conclusions, but focusing instead on the fact that we don't have the justification there. And she made the statement that she didn't believe that there is a single ethical framework that we could all of agree to, that some of us are more comfortable with this argument based on human rights, with an emphasis on autonomy types of arguments. And her approach is more based on obligation theory, which I understand to be sort of a technical theory. I mean, you're referring to a whole body of legal theory when you use the word "obligations." MS. KING: Not a body of legal -- DR. THOMAS: Well maybe legal philosophy is maybe what I should say. MS. KING: Not legal philosophy either. CHAIRPERSON FADEN: You know what I -- DR. THOMAS: Let me finish. CHAIRPERSON FADEN: I'm worried that this is going in the right direction. DR. THOMAS: Well wait, let me finish my thought please. CHAIRPERSON FADEN: This is not helping. DR. THOMAS: I have difficulty with Pat here because (1) I don't understand what she means by "obligations;" and (2) I don't see how it's helping us get to resolution of how to deal with this chapter. And what I'd like Pat to answer is two questions: the first, if you think it's helpful, could you give us a brief primmer on what you mean by "obligations?" And number two, and number two you really need to answer first, I guess, is do you see a way in which the chapter could be salvaged by incorporating some of your ideas about what you mean by "obligations?" If the answer to the latter question is no, then don't waste our time telling us about obligations. (Laughter.) MS. KING: As long as this chapter supports a finding on some of the recommendations, I will have to write a statement. You can draw from that whatever you want to. I don't think that -- I'm of two minds. I have no interest in wasting the committee's time and prolonging the discussion. So it puts me in a very ticklish personal position in that sense. But I can't get to where you get easily, apparently, starting from the point that you are comfortable with starting at. And I don't know whether the remainder, the other members of the committee, even care about this, because this is the one area where we didn't do a lot of committee deliberation. But in my view, it's sort of -- for part of the community that will read this, this is sort of critical to judging our work in terms of -- not the whole community, but part of the community, making judgements about our work. And I just don't know how to respond to that. I don't think that my points of view are unknown in philosophical literature. CHAIRPERSON FADEN: But Duncan is asking you to explain it to him because he doesn't know what you're talking about is the problem. I mean, the bottom line is this: we've got a community of people here, most of which are not familiar with the, literature out of which you're working. So the problem is a communication problem. And I could try to translate it. Ruth could try to translate it or Allen or Jonathan or Jeff. MS. KING: It would be a lot better because I'm not a philosopher. CHAIRPERSON FADEN: But I'm concerned because it's your view and not -- you know, and that's at peril. I mean, I'm happy to try it if you would like me to. But it's at some peril because it's always dangerous to speak for someone else. I think the problem Duncan is having is he doesn't know what you're talking about. I mean, I don't mean to put words in your mouth either, but it's like well I'm not sure what the alternative is. I don't know what you mean. Jay? DR. KATZ: Just to follow up on Duncan's for Pat, but correct me if I am not echoing in slightly a different way the second question you posed to Pat. And question is this: can you give the staff marching orders about Chapter Four that would make it, for the possibility of writing the chapter that deals with these ethical, whatever you want to call them, issues that would then -- MS. KING: Can I ask Jonathan and Allen a question? DR. KATZ: -- that we could examine? Isn't that the question you asked? DR. THOMAS: Yes. MS. KING: Allen and Jonathan, in my imperfect way, because I am not a philosopher, does anything I say resonate with either one of you enough that you would be able to do anything with this? CHAIRPERSON FADEN: Allen, why don't you come up and join us? But let me just ask -- MS. KING: You don't have to try here in the room for me. I mean, Jay's question was can I talk to staff enough so that it can be incorporated, which is different from Duncan's which is can I explain to the rest of the committee. The committee doesn't need my view. CHAIRPERSON FADEN: Yes, I think that's the problem. I think the problem is this: we've got to distinguish between getting clear on what Pat's view is and then deciding whether the group wants to adopt Pat's view. It's not merely putting Pat's view in the chapter and making it everybody's view. So we're a step behind that. I mean, we're not -- I think Jay's suggestion is quite positive, but we're going to think about what we're doing. And frankly, I'm so bottom-line oriented at this point, that I am -- I want to make sure that at some point we end up discussing whether the conclusion, okay, is supportable. I mean, it's actually defensible from any number of different methodologies and different structures of argument. And we're all in agreement, I think, that the structure of the argument is not revealed in this chapter. There are different ways to get to the point, but the point that we're getting to at the very end is the one at 11c which says, and which Pat may not like or others may not like and at some point I need to know, is whether it is acceptable to the committee to have a moral framework out of which to operate that says "to the extent," that's the language that's in there, that works with the dimensions, the interrelationship between consent, harm and prospect of benefit. That's the structure that's out there for looking at these experiments and putting three together with the notion of looking at questions and blame worthiness in the context of those three dimensions. So at some point, maybe while we're eating, we'll let Allen respond and Jonathan respond to Pat. We need a discussion about whether that framework that we basically agreed to last time, okay, is the right operative framework for the committee. That's critical, okay? And then how we get to it is obviously critical, but Duncan -- DR. THOMAS: I just want to focus the question to the two of them. One of the things that is not in this draft, but appeared before, was some nice language from Allen about the obligations of bureaucrats and the obligations of professionals. And some of the professionals language is still here, but not the bureaucrats. Now I'm wondering whether this is the type of obligations that Pat is talking about or is it something completely different? And I don't know. Any of the three of you can answer that. MS. KING: One of the things I said was I would be in agreement that information and arguments about roles and responsibilities had to come back in. So the answer, Duncan, is I think I think you need it for the point of view that you have adopted, and I think you would need it from the point of view that I adopt it. I agree with everything Ruth said about how time should be allotted. But Ruth, I honestly don't yet believe that some members of the committee understand the approach here. CHAIRPERSON FADEN: I know we're having problems with the approach. I'm trying to get to the outcome as well as the approach, okay? I'm trying to separate the two. I don't know if Allen or Jonathan wanted to respond. DR. MORENO: Well, I'm speaking for myself. I'm happy to go back to Word Perfect and use the wonderful framework that the software engineers have created to put that stuff back in. I just want to point out that it's been a problem for us because three months ago the members decided to take that stuff out because it sounded too much like rhetoric. CHAIRPERSON FADEN: Actually I think it was too much like Philosophy 101 was the comment why we had to take it out. DR. MORENO: Well, I can't imagine anybody wouldn't want philosophy. But rhetoric we wouldn't want. (Laughter.) DR. MORENO: So I'm happy to cut and copy and block, and I don't need a whole heck of a lot of training to do that. But the difficulty I'm having is this: it seems to me that part of the dynamic here is that there are a few people who --a few members who want that material back in and it would be a whole heck of a lot better, and may even be able to sign off on the chapter with that meat back on the bones. There are others who don't think that the skeleton is adequate. And if we need to focus on -- the prior question is maybe with the skeleton. CHAIRPERSON FADEN: Can I just introduce one thing though that I said to Allen? This process of the committee, seeing it with a more detailed analysis, saying take it out, it's not useful and then wanting it back in, is actually very good. Because what it means is you each -- or those of you who agree that this needs to come back see that it's needed, okay? And that's better than -- you know, to go back to Pat's point about whose report is it, than the staff arguing with you last time saying, "No, no, you really need it. You're making a wrong decision, Committee. We have to have it in here." So now it came out and some people have looked at it -- DR. MORENO: We told you so. CHAIRPERSON FADEN: -- and some people anything think some part of it needs to be back in. And that's fine, that's better. That's probably the only way that we can be comfortable with the chapter which is going to really confuse and bore a lot of the readership, which is part of the struggle that we had last time, to have the detailed analysis to really support what we want to do and satisfy. Or at least be available to some readers who care about that sort of thing means that some other readers who couldn't care less are not going to understand what's going on. That's okay. We just need to know that. But I just want to lay that out there because one of the other issues that came out was it's not going to be readable with all this stuff in there. It's going to bore people, and so on. So it will. I mean, that doesn't mean that you don't try to write it as clearly as you possibly can. But it also means that a lot of people who would want to read something else when they pick up that chapter will turn it away. DR. BUCHANAN: Well, except for the fact that it's almost the end of the day, I don't think things are quite as bad as they seem. And I hope I'm not being over-optimistic. (Laughter.) DR. MORENO: Spoken like somebody from Wisconsin. (Laughter.) DR. BUCHANAN: Maybe that's it. Maybe I've been there too long. I think that -- I agree with everything as Duncan said and much of what Pat has said and other people have said that the current version of Chapter Four needs -- you need to bring in a good deal of the stuff that was in the earlier, longer paper to make it fly. But I also think that there can be some changes made in how that framework is presented, which are responsive to some of Pat's concerns. Let me give just one example, and I want to make sure that there is some resonance with this with other people. Otherwise, it will be a waste of effort. I think that it's possible to read the earlier, longer version and the current version and think of it as a framework which relies very heavily on the notion of autonomy to the neglect of the notion of beneficence. And I think there's a clear way of rewriting that that makes it clear that the moral framework rests on two foundations: autonomy and beneficence. And that even the concern for autonomy is in a way twin-based. And that is, autonomy can be valued for its own sake, according to some people, and according to others, recognizing autonomy is the best way to protect welfare because people generally know what's better for them than other people do. Now that gives the kind of pluralistic approach which I think Pat is looking for. So some readers will look at this and say, "Well, I think all this stuff about autonomy is over-rated. I'm concerned about harms and benefits." Fine. They follow one channel. Other people who are more concerned about autonomy will say "Well yes, beneficence is important and they should have said something about that, but here's the real stuff, autonomy." And this wasn't on the President's Commission on various clients, okay? And I participated on it and I know how to do that. So that can be done. I think some things can be done that will really both strengthen the framework for all sorts of people, not just persuade Pat, which is important, but not the only important thing in the world, but will strengthen for all sorts of other people without a lot of changes. And I think they will be things which I think everybody in the committee will be able to find enough in one or another of these channels to give strong support for the conclusions. Now I think when all of that is said and done, there's got to be a little bit of discussion about -- more discussion about how roles and relationships generate obligations and what the limitations are on obligations that are the limitations provided by context. And some of that Duncan mentioned when we talked about the various kinds of exculpating and responsibility diminishing factors that have to be brought in. But more of that can be done without a great deal of added space I think in response to some of the past concerns. Nonetheless, when all of that is done, there's going to be a fundamental difference between Pat's view and what I think is the dominant view at least of the people who have been most directly involved, the other people who have been most directly involved in working on this stuff. But I think that at that point, you know, it will clear enough so that people can decide whether they want to join a minority statement by Pat or whether they want to say, "Well, now I understand why Pat is doing this and that's fine, but I want to go with these recommendations." Let me just say one last brief thing, and I know you're getting to the bottom line, but -- CHAIRPERSON FADEN: No, it's okay. This is helpful. DR. BUCHANAN: The approach is the larger background paper from which this chapter is a truncated version, in successive versions became more of an obligation-based approach. Those are rights -- in the background. And it did heavily emphasize that obligations come from roles and relationships. It's not really a pure autonomy approach. It's an autonomy plus beneficence approach. But that wasn't foregrounded enough. That wasn't made clear. And that can be made a lot clearer. So I don't think we're faced with a rights approach versus an obligation approach at all. I think that's not the way to look at it, and I think that can be made much clearer. So anyway, I am, at this moment, hopeful that when I go back to Wisconsin and have to actually start to try to do this, I may decide that despair is a more appropriate response. But that's the way it looks to me right now. MS. KING: I don't know if people followed this, but I did. And Allen makes me feel very happy on the moral analysis part because I wasn't pleading for -- I pleaded for diversity. DR. BUCHANAN: Right, and that can be done. CHAIRPERSON FADEN: It can be done, but the point, Allen, we want to underscore is that there will a conclusion at some point. And if you can't sign onto the conclusion, that's fine, but it will be a different kind of statement than saying I don't like the whole thing. It will be -- DR. BUCHANAN: Right. And where the disagreement is will be very clear at that point, and I know exactly where it will be with you. And that is, you will think that the possible mitigating conditions that come from the context will block the transition from saying in principle there is an obligation for bureaucrats to do so and so and saying that they're culpable for not doing it. That seems to be the -- MS. KING: His is a very good statement that I think the rest of the committee now should comment on having read the whole report. In layperson's language, what he said was when you get to move from the statement of the moral analysis -- CHAIRPERSON FADEN: The framework. MS. KING: The bridge to the conclusion ultimately boil down to when you have looked at everything we have. Not just what's in Chapter 4, but in the report, because that's what helped me when I read it this weekend. When you look at Chapter 4 and what we state in Chapters 1, 2 and 3 and look through the whole report on balance, because you can't answer it totally for yourself -- you have to ask on balance am I willing to do certain kinds of judgements. Am I willing to draw the conclusion. And then you can work out the reasoning. But the conclusions are in certain areas. They are conclusions about the government; conclusions about individual government officials -- this is the way they break down -- conclusions about individual government officials; conclusions about the medical profession; and conclusions about individual medical professions. CHAIRPERSON FADEN: And I want to step back -- there's one more, which is conclusions about the actions. I mean, the distinctions between actions and actors needs to get back in there. And the Committee, I think, is very clear on wanting to say that wrong things were done in a number of cases. And if I've missed that, if we're not there, then we're in big trouble. All right, and that's different from then saying okay how do we view the government, the government officials, the medical profession and the medical investigators in relation to those wrong things that were done. DR. BUCHANAN: Actually, I can respond to that for a second. CHAIRPERSON FADEN: Those are all judgements. DR. BUCHANAN: I think we've been so rightly troubled about the blame statements -- about the culpability statements, that in many places in the latest drafts of other chapters, particularly Chapter 4, there's almost too much prominence to the questions about culpability and too little about the wrongness of actions. CHAIRPERSON FADEN: That's right. DR. BUCHANAN: Because it was clearer to us -- there was more consensus on the wrongness of actions. And yet in the end, that's the most important thing. Okay, and there's kind of a disproportion now because the area that's most controversial where you have the most qualms -- other people have qualms has come to the foreground so much, that in a way, the huge area of agreement on the most important stuff -- CHAIRPERSON FADEN: Even if it's not universal. I mean, I know what that is -- DR. BUCHANAN: -- has been put back in the background. I think that's imbalance in the current presentation of Chapter 4 and in some other places. CHAIRPERSON FADEN: Oh, I think it's exactly the case in four. When I was working on the last version, there was -- all the sudden there were no action -- the experiments were gone. DR. BUCHANAN: Right. It's like -- CHAIRPERSON FADEN: There were no experiments -- DR. BUCHANAN: There were just agents, no actions. CHAIRPERSON FADEN: There were just agents. Quit, wait a minute, we've got to put the experiments back in, because all we're worried about are the investigators and the officials. We've forgotten that the first thing we're supposed to look at -- what we were charged to do was come up with standards for evaluating the ethics of the experiments. Okay, a secondary issue is how we ought to view the people who did those experiments, the people who had responsibility for them, the people who effectuated or failed to effect the policies and so on. But the first charge we had was the main charge. If you look in -- you know, go back and look at the language in the charters, we need the standards for evaluating the ethics of the experiments. And it's hard to separate this way, because agents -- you know, actions don't -- people do them. Right? I mean, they don't just happen. People do them, and you need to put that all together. But that's -- I think you're -- maybe going away for a half a year helps and then coming back and looking at it or however long since Allen's been with us again. But I think his analysis about what happened is quite right. We got so into -- okay, we know this is wrong, now let's go to the tough part which is what do we say about the people who did them or the government who allowed them to happen or didn't stop them that we forgot that the first statement we need to make is can we call some of these one way or the other. And that's what we now have to go back, among other things, and make sure that Chapter 4 seems -- clearly speaks to. And then we can go into the other part. Okay, that doesn't mean that it's going to be -- what this means, of course, is that this is another chapter that will come to you with lots of changes. Okay, some of which will be material you have seen before, some of which clearly will not be material that you've seen before. So again, when you think about putting stuff to the top of your pile, this would be one that would have to go to the top of the pile for everybody, even if it's not one that you haven't -- you don't put down on your list as one that you want to be working very closely on. It's one -- it's like a -- it's akin in my mind to 18 and 19. These are the chapters that, you know, everybody needs to be sure they really understand what's in them in a way that is just deathly critical. Phil, did you want to say something? DR. RUSSELL: No, except I feel a tremendous relief that that happened today -- that inclination has been made and we're moving in that direction. That was heavy. There's a lot of discomfort, and I think it's getting -- I have a lot of hope now that we can move ahead. DR. GLATSTEIN: Yes, and I want to wish a pox on all of Allen's enemies. (Laughter. DR. BUCHANAN: I have no enemies, only people who misunderstand me. (Laughter. CHAIRPERSON FADEN: Can we do this? I am now thinking we have the 11C finding, which I think at this point we should probably not discuss, because we probably need to see the revised Chapter 4. I don't know that it will change, but it will change -- may or may not change, okay? But we -- so we're going to have to do that one a different way. MS. KING: I think we made a lot of progress. I still think that the middle part is still not as clear as we would all like to hope it is so we can go home and disappear. CHAIRPERSON FADEN: Maybe we should have a discussion of that. MS. KING: And it has to do with not judging the agents or the professions, although I've had terrible problems with that part. It does have to do with the standards, because this is the way we currently frame it. We frame it in terms of there were standards. I think I'm thinking of part of Duncan's comments. There were standards. Sometimes we can say they were violated at the time. Sometimes we say they were violated in retrospect. And it is the use -- it is the development of the standards that is also troubling. Because I think that this goes back to a policy is a policy is a policy kinds of issues about what we make of the documentary evidence that we have. And then move from the documentary -- this is an old debate. CHAIRPERSON FADEN: Yeah, I have a proposal. MS. KING: Moving from the documents to the standards, and in my view, often they appear as more isolated pieces to go into a puzzle than the big leap into this was a standard. Not a question of practice in the profession. I mean the standard. CHAIRPERSON FADEN: I have a proposal on the -- on how we might approach our interpretation of the government documents -- the very -- let's call them statements for right now or documents that we had. In light of some of the discussion of today and in light of the apparatus that will be pulled back into the chapter from the larger moral analysis, I was really struck too by Phil's phrase that a policy is not -- you know, a policy is not really policy unless it's a regulation -- I would imagine you would include a statute. A regulation, a statute, or it's an appropriations bill. It strikes me that what we failed to do is comment on the different weight of the different kinds of statements. So if you've got two letters, that's different from a Department of Defense memo signed by the Secretary of Defense, which is different again from the operative rules of the clinical center, the NIH, which were sent out and circulated for the investigators of the NIH. And that's, I think, what we're not saying. Okay, which is these are -- that these documents exist, and that they speak to a very important issue with respect to the moral analysis; namely that these values were available at the time. Okay, they're evidence that people were thinking about the issue of consent. Maybe not thinking about them thoughtfully, maybe about not thinking about them for moral reasons. But at least it bears on the question of whether people were thinking about these issues at the time. That's very different from saying that each of one of these statements has the same force in a public policy analysis as the regulation that emerges in 1971 and '74. And so we need to I think reintroduce that subtlety. If you want to call it the weight of the statement in a sense of formal policy, but not dismiss them. I mean, they exist and they're there and they bind somebody to something. Okay, or they symbolize something or they express something about the culture of the bureaucracy at the time. And they're terribly important in that we found them, especially the ones that we found ourselves like the AEC letters, is remarkable and ought to be noted. But I think what you're objecting to, and Phil perhaps and others, is the coequal treatment as if all of these are all de facto evidence of equal weight, that there was a formal big deal policy, which is -- DR. RUSSELL: And I think the evidence that in 1962 -- the regulation was still an arguable regulation, the point of serious dissent between the biomedical research community and the universities and the certain general of the Army indicates that no matter how powerful the Secretary Wilson was, he could not with a single stroke of the pen change the behavior of the American medical profession. And that the power he had to effectuate that decision to make a policy was limited. He had to go through a -- and the whole system had to go through a very difficult and contentious set of policy debates and regulatory processes in order to bring them -- by '62, they were only halfway there. They didn't get there until '75. CHAIRPERSON FADEN: '62, you still don't have the clinical context either. DR. RUSSELL: Right. You still were arguing with the doctors at Harvard and wherever else they were about whether you could infringe on their prerogatives. And so, the power to -- he may have made a very good decision, but he was not empowered just by signing that memorandum to effectuate it. And so, how much blame you can place on him for failure to carry it out is very problematic. CHAIRPERSON FADEN: The proposal that I'm making is more on how we express this in Chapter 1 -- in the revision of Chapter 1, and then again have to repeat it in Chapter 4. The relevant -- the connecting finding was very descriptive. It just -- that I think is still okay. It just says this agency had that, this agency had this, this agency had that; and we don't talk because it's just a finding of what we found of what we make of it. It's the what we make of it part which I think is troubling to some of the Committee members. So what we need to do in Chapter 1, and then when we summarize it in Chapter 4, is express that the Committee is not naive about the fact that there are differences in the role and weight that these various statements played and can be understood to take in the history of those agencies. MS. KING: So then we have to ask the really hard question, Ruth. And maybe it means changing the frame work of Chapter 4 and some of the other chapters in different ways. It's where we go from having made the qualifying statement, which I think is appropriate. Because it is a recognition -- it's a recognition of a lot of things, but most clearly working on an imperfect historical record. But it's when we start calling them standards, and we do -- I mean, that is what we use by which to make some of the judgements that follow. And it -- so they're connected. And I'm not talking about retrospective judgements. I'm not making -- CHAIRPERSON FADEN: No, no; I think -- MS. KING: It is the -- and maybe it will be taken care of if we focus more on acts and less on culpability and people. I'm not sure yet where you're putting the institutions when we had that discussion about -- CHAIRPERSON FADEN: Well, that's a problem, that's a problem. MS. KING: -- about acts versus actions versus agents. But that's the big problem that I have been having with the chapter. It's in that -- and maybe I'm the only who has it. So -- CHAIRPERSON FADEN: It's the first part that says people broke the rules of the time or failed to follow the rules of the time. And we say they did something wrong because it was their own rules. Now the issue is what are you going to do with what was like a weak rule, is what you're saying? MS. KING: Yes, yes. CHAIRPERSON FADEN: Or weak expression of a rule. And that's what needs a little bit more explication. The general view is if there's a rule in the time, it seems obvious -- principles and application. MS. KING: Right. CHAIRPERSON FADEN: If there's a rule at the time and people broke it or there's a standard at the time and people broke it, then clearly we -- it's no different than saying there's a rule today and you broke it. MS. KING: Right. CHAIRPERSON FADEN: And so the problem we're having is in the interpretation of when you've got a weaker type evidence of a standard and it's broken. Is that the same as when you've got a stronger statement of -- and we're talking about government policy. Okay, so if someone does -- if the AEC letter isn't implemented, is that the same or different than if the -- if Secretary Wilson's memo isn't implemented, than if at the NIH clinical center, the requirement that healthy volunteers give written consent isn't followed. Okay, and that's some of -- more of what the thought -- it has to carry through, is what you're saying? MS. KING: Yes, and so I think that we made enormous progress, but we've opened up -- I hate to tell everybody this, but we've opened up this big hole. And this is the critical hole. The rest of the discussion was -- I would like my philosophy colleagues not to think that we went off the track, but this is where I think that the harder -- the meat of the issue is for us as a Committee. Because it is what we then say about did we find a rule, did we find evidence of a rule, did we find a weak rule -- I mean, this is sort of critical because it sort of -- at least it's critical to me. Because it says -- it sort of sums up ultimately how strong our statements are with respect to the past. And I'm not now talking actions. CHAIRPERSON FADEN: But I think the first issue is I'm not so sure that it makes that much difference. I mean, maybe because in my own mind, I'm not making the statements that -- I don't want to make the statements I want to make because the '47 memo was there or it wasn't there. So that -- I think that's what's at issue. Some of the most powerful statements I think this Committee will want to make and have already agreed to make don't rise or fall on whether Charlie Wilson or any other Wilson wrote a letter or a memo. And that's, I think, -- you know, that's part of what we're maybe disagreeing about. But perhaps in the clarifying of Chapter 4 -- MS. KING: Well, what do they rest on? CHAIRPERSON FADEN: That's the analysis in Chapter 4. And it's other issues. I mean, it's part of -- it rests on the history of which those letters and memos are a part, but are not determinative. We're not either saying something was wrong because it violated the 53 DOD memo, and that's the only reason why it was wrong. At least I'm not, okay? And I think -- and my sense is that at least some of the rest of us are saying that as well. It's a piece of the evidentiary base for drawing some sort of judgement, but it's not -- you know, the reason. Ruth, are you there? DR. MACKLIN: Yeah, I'm here. I rang my bell. CHAIRPERSON FADEN: I thought so. (Laughter.) I have images of a cherubim ringing a bell, you know, sort of -- I shouldn't say that, Ruth. It's like a not good omen. Never mind. Would you like to comment? DR. MACKLIN: Yeah. Phil made an important point when he said -- if I heard it correctly or heard all of it, that high officials in the government or in the military may have issued a policy or written a memo, but then all the doctors and their universities, etc. couldn't be bound by it or there was no way of implementing it or enforcing it or intruding on the doctor/patient relationship. Did I hear that correctly? DR. RUSSELL: Yes, basically. DR. MACKLIN: Hello? DR. RUSSELL: That's right, Ruth. DR. MACKLIN: Okay. Well, I think this, however, goes to some of the nuances in the distinction. I struggled with some language that I presented to the Committee in either the last meeting or the meeting before, and it didn't find its way into the document, but -- I mean, into the chapter. But let me just reiterate part of it to say why these distinctions matter. What I scribbled at some meeting and then it was typed up and disseminated was the following. When high officials of a government agency articulate ethical standards they believe should govern human experimentation, they thereby place themselves under an obligation to disseminate and implement those standards. Maybe that should be changed to "try to implement those standards." It goes on. Recognition or awareness of articulated ethical standards obligates those who conduct or sponsor experiments to abide by their provisions. Researchers need not be bound legally or officially by an ethical policy or guideline in order to be held morally accountable for failing to adhere to an articulated standard of which they are aware. Now, here's why I think this language or this idea is important. First of all, Pat should be happy because it speaks the language of obligation. It doesn't talk about anybody's rights. It talks about the obligation that people have when they are aware of something or being made aware. So unlike the situation of culturally induced moral blindness, which is described in the chapter according to Allen's analysis, this could -- this situation could not, even for the doctors, be held to be a case or an instance of culturally induced moral blindness. So, one can agree with Phil that the high officials could not be held responsible or culpable for what doctors who were conducting the experiments failed to do. The official's responsibility must end somewhere, but it goes at least to articulating them and disseminating them. If they cannot enforce them because these are doctors in private practice and the others are high officials in the military or the government, that's understandable. But one can also not exculpate the doctors claiming that they weren't aware of this at all. And the whole point of that moral standard is once they are stated, people should -- people of good will and reasonable influence should look at them, read them, and reflect on them. And then, either choose to abide by them or ignore them. If they choose to abide by them, well then that's their voluntary -- which, if they choose to ignore them, it then raises the question why. If someone and some official or even unofficial capacity says to people this is right, this is what people ought to be doing, this is your obligation, and those to whom it's addressed ignore it entirely, that requires at least an explanation. And some explanations are going to end up holding these people more morally culpable or more morally blameworthy than others. CHAIRPERSON FADEN: I wish I could give you the body language. We had some people nodding in agreement; other people, I think, are going to pass out from exhaustion from the plane or brain, whatever. But I think hopefully it got on the transcript and some of what you said will help considerably in how we develop to put bones on the frame work or whatever metaphor Jonathan would like -- DR. MACKLIN: I have made a lot of very detailed comments on the draft, but they're all scribbled because they were mostly done in a horizontal position. So what I would like to do is -- it's sort of feasible, which is probably before the end of the day today -- put those comments on this chapter in E-mail and they go to two separate things. One, what should be restored in the first section to put flesh on the ethical framework or the ethical analysis that's used to support what goes in the second section; secondly, a rather -- critique of the second section, and a plea to go back to the earlier version which was much clearer and more lucid and better argued, and also a plea for a conclusion for the second section. It trails off right now. It doesn't really conclude. It goes into the discussion of the doctors. So, I would be glad to put this on -- my comments on E-mail -- I mean, not take any time with it now, some of which might be in the form of queries, but mostly suggestions that I hope might be helpful. CHAIRPERSON FADEN: That will be helpful. I don't doubt it. Phil has asked for the floor. DR. RUSSELL: The only comment I have is that Ruth's logic is as usual, irrefutable and air tight. The comment I'd like to make, however, is that the context in which the government was attempting to solve some of its problems in that time put the government officials in the position of being very, very dependent on the medical profession for generating a body of information. And they were dependent on them not only to generate the body of information, but to deal with the ethical and professional aspects of it as well. I don't believe the Secretary of Defense felt that was the military's responsibility to make a set of determinations about biomedical ethics in general. And this was principally the responsibility of the professors in the medical centers. CHAIRPERSON FADEN: We have a lot of work to do, which is scary because this is the last meeting. So, -- but we'll do it. I said that more so -- I won't -- you can do it, you can do it. We'll do it, we'll do it. Here's what I would propose. I think we cannot take Chapter 4 any further right now. Lunch looks like it's coming shortly. We have -- if we can hold our focus, here's what I would like to propose. I would like us to look at notification while we wait for lunch to set up. It's discreet and we need to pay concentrated time to it. Then, when lunch comes, we will each be handed a packet of material that bears on the discussion after lunch. And I thought we could take ten or 15 minutes, get our food, do our reading -- skim through the stuff, and then we will begin our discussion so that we don't have to eat and talk, but we can read and eat. If that's okay. Is that agreeable with everyone? So if we can hang together, if we could go to recommendation four of Chapter 19. Where is it, by the way? Was it handed out separately or is it -- I've lost track. It's in the chapter? Notification? DR. THOMAS: It starts on page nine. CHAIRPERSON FADEN: Of your draft. Which draft? That's right. DR. THOMAS: And a reminder that the explanatory text is at the end. CHAIRPERSON FADEN: Yeah, and the reason -- DR. THOMAS: Starting on page 22. CHAIRPERSON FADEN: I hope this didn't cause problems for people. The reason was trying to make it fit so it could fit in there. I don't know where else to put it. But if we put all of it in, it would look like this was a 12 page finding and recommendation. All the other recommendations were two pages. So I think the art form is to get the recommendation crisp, and then have this addendum to that chapter so that people can go. And I think beyond that, there probably in the companion volume would need to be the actual results of the analyses that were done. Somewhere, I think we need to provide the really -- unless you want to put it in the addendum, the actual numbers that were turned out for all of these. But the floor is open. DR. THOMAS: Let me just say one thing to alert people to the still undeveloped conclusions. To the best that we have conclusions, there's a paragraph on page 12 which says that we reviewed three classes of studies, and then note the results of the nasopharyngeal are not yet in. No comment on conclusions anywhere in the finding itself. For the conclusions, you need to turn to the back of the report. CHAIRPERSON FADEN: And it needs to be pulled in. DR. THOMAS: Where it's -- on page 24, the bottom of the page, you see items one, two, and over on the next page, item three where there is conclusions that say in brackets check. That check is important, because as we discussed this -- few of us at the end of the day yesterday, it became evident that at least for a handful of the children's studies, it is possible that some of these may yet meet our criterion of risk, namely the one in a thousand risk of remaining risk. And in that case, we would then be obliged to move on to the second stage of the analysis, which is is there any medical benefit from screening. None of that's been done yet. And we had a spirited discussion about the issues, but it's unresolved at this point. CHAIRPERSON FADEN: Can I raise a related issue that's a purely practical outcome issue? My guess is that the recommendation that is sought from us is not a set of criteria, but the recommendation -- here's who should be followed up or here's who we looked at, and none of them should be followed up. And that's really what is being asked of us. Now, we need to provide this rationale to explain how we reached that conclusion. But I think the bottom line is that what you've said hasn't been finalized is really the recommendation. And then all this other stuff is our justification -- DR. THOMAS: I think we have a problem with the distribution of the material between the recommendation and its supporting text and the bit in the back. CHAIRPERSON FADEN: No, I'm not talking -- DR. THOMAS: But that bit in the back really does -- should be sort of all this rationale stuff. CHAIRPERSON FADEN: No, I'm not saying that, Duncan. What I'm saying is when it says the Committee recommends the following guidelines, that's not what's wanted of us. What's wanted of us -- DR. THOMAS: Well, I'm agreeing with you. I think. CHAIRPERSON FADEN: I mean, all the reasoning in a sense can go in the back with the government -- the Interagency Working Group wants to know is are we recommending whether anybody should be followed up or not. Now, it's very important to us to explain our justification for whatever recommendation we make. DR. THOMAS: Well, I thought that was what I was saying. I was agreeing with you, that all of this rationale which is presently part of even the bulleted text -- CHAIRPERSON FADEN: Right, goes out, yeah. DR. THOMAS: Let alone the supporting funding -- CHAIRPERSON FADEN: Right. DR. THOMAS: All of that, in my opinion, can probably be moved to the back. CHAIRPERSON FADEN: Correct. DR. THOMAS: And what we were asked to provide here is a recommendation about specific individuals. CHAIRPERSON FADEN: That's right. DR. THOMAS: Well, specific classes of individuals. CHAIRPERSON FADEN: Exactly. DR. THOMAS: And we're far from having that recommendation at this point. CHAIRPERSON FADEN: That's what I wanted to surface. And the issue is how far away are we from it, and what can be done to reach that? DR. THOMAS: Well, I have sort of guess -- let me tell you what I think is likely to happen. I think there is general agreement that we are not advocating follow up for the prisoners. CHAIRPERSON FADEN: Right. DR. THOMAS: Regard to the children's, the vast majority of the children's experiments don't begin to reach the risk threshold in the first place. Those that do -- that may potentially reach the risk threshold, and we're still trying to figure out how to do that risk calculation, will almost certainly be I-131 experiments relating to thyroid cancer. And then there is the question which arises as to whether or not screening for thyroid cancer is medically defensible. And our strategy for this is to turn to the U.S. Preventive Services task force report which we are hoping will provide us with an authoritative answer on that. If it doesn't, then we're up a creek. And we don't really have an effective strategy for getting to a resolution of that one. CHAIRPERSON FADEN: And the nasopharyngeal? DR. THOMAS: The last one, the nasopharyngeal one, we are awaiting a dose estimation from Ted Webster, pending which it appears to me that it's not implausible that that one also may attain our risk threshold. We would then have to go through that same second stage rationale. But I think we're in general agreement that at least for brain tumors, it just doesn't make sense to recommend any screening. So that will probably fail on the second criterion. CHAIRPERSON FADEN: Okay, I've got Henry and Mary Ann wants to speak to this too. Henry? DR. ROYAL: It's interesting how we work. And I'm speaking specifically about myself with these risk estimates. I have a strong sense of discomfort about all of this. And I'm trying to understand my sense of discomfort. One thing that I've expressed concern about from the very instant that it was mentioned is there's one in a thousand risk -- you might remember Jeff Bodkin presented this. And I said where did this number come from. And we further define it as a significant risk, which is an interesting description of it. If we were going to communicate what we actually knew about this risk to people in some honest way, we would tell them what we know and how we know it. And what we know, for example, with I-131 in children, is that we don't have any good scientific evidence at this point in time where we can measure the risk. So there have been some studies that have attempted to measure increased risk, the thyroid cancer in children from administration of diagnostic doses of I-131. And we don't have any good scientific evidence. There is some reason for concern. We have very good evidence with external radiation. We also have some evidence from a more complicated situations like the Marshal Islanders where there was a combination of I-131 and external radiation possibly with the downwinders where there was I-131 and some external radiation. And we make this calculation of one in a thousand as if this is -- has some precision to it. And it has very little precision to it. And I don't know, as a person, I feel very uncomfortable sitting across from a -- maybe I should say as a physician, I feel very uncomfortable sitting across from a patient and telling them that they're at a significant risk for a disease when the evidence is weak. CHAIRPERSON FADEN: Henry, I guess I'm not -- I mean, I understand what you're saying. But I'm not -- I don't think this -- I'm not terribly troubled in this incident. It seems to me you can say all that, and yet you pick -- you say that this is not a magic number. It's an arbitrarily selected thing. Whether it's significant or not depends on whether you think one in a thousand of something happening to you is against what the something is is up to the person who looks at it. I mean, we don't have to perpetuate the view that this is somehow revealed to us by some great medical truth, but rather this is just -- you've got to do something. So that's what -- I mean, I think we can demystify it in language and simply say what you've just said. I mean, you -- so this is -- DR. STEVENSON: And if you go to page 23, I mean, we can add the modifier arbitrarily chosen. CHAIRPERSON FADEN: Right. And go a little further in ordinary language and say that -- Henry, you know, whether somebody -- you could have made it one in ten thousand or one in 500 or whatever. It's just -- DR. STEVENSON: We do have to pick a number. I mean, -- CHAIRPERSON FADEN: But I think you can share what Henry's just said in English in the text, in the supplementary test, so that we don't contribute to this belief that there's somehow a line -- I think my -- DR. ROYAL: The trouble is, by having this artificial line, we're going to give people who participated in human radiation experiments the impression that there's an identifiable group of people who are at significantly greater risk than other people who participated in human radiation experiments. And if I were one of those people, I would be concerned about someone identifying me as being at significantly more risk than somebody else. CHAIRPERSON FADEN: Henry, let me try something. To me, this is very analogous to experiences I've had with genetic counseling where you need to explain risk to people and something for example like the cut off -- the age cut off for screening -- amniocentesis. And you sit there and you say to a woman now look, the process -- or the couple. The difference between being 35 and being 34 is not the difference between there's no chance nothing will happen to your baby and there's every chance your baby's going to have 100,000 deformities. That's the problem you're talking about here. And we need -- and there are ways to say that. I mean, there are ways to say that below the threshold, it doesn't mean that you are absolutely guaranteed stamped perfectly healthy, and if you're above the threshold, you're somehow -- you know, tomorrow going to die. But that for policy purposes and other purposes, people draw judgements. And it's very important for the 35 year old woman not to panic, and it's very important for the 34 year old woman not to be falsely thinking that there's no possibility she might have a Down's child. And I think that's what you're talking about. DR. ROYAL: That's exactly what I'm getting at. CHAIRPERSON FADEN: And we need -- we can say that. I mean, I think we can say that. We can say it in ordinary human language the way you say it in genetic counseling. Now, it doesn't mean that it registers, because often what happens is the person hears I'm in the high risk group, I'm over 35. But as a better responsibility, you try to make it clear that we don't think it's -- you know, it's like telling somebody who's got a mother who's got breast cancer, it doesn't mean you're doomed, but it means that you're somewhere differently. And this is even worse, because it's not -- it's more akin to the genetic counseling business. You've got a slope and you draw the line. So I think we can handle it. DR. ROYAL: But one of the things -- the example that you just gave about breast cancer, the evidence is much better -- CHAIRPERSON FADEN: Yeah, I know it's close -- right. DR. ROYAL: -- and the difference in the risk is much, much greater. CHAIRPERSON FADEN: It's closer to the being 34 or being 35. It's very analogous to being 33 or 37 and you have a 34 year old who comes in and says well, I don't like the risk level. I've looked at the table, and I don't care if this hospital's policy or my insurance only pays after you're 35. I'm the kind of person who at age 34 wants to have CVS or amniocentesis. And that's what we want to do. We want to give the reader the appreciation that they might be the 34 who feels the one way, or the 36 year old who says I don't care what -- this is not a give enough risk for me. I don't want CVS or amniocentesis. DR. ROYAL: I think that's a very -- the amniocentesis argument is a very good argument, because the screening procedure itself, amniocentesis, has some risks. CHAIRPERSON FADEN: Of course, that's exactly right. That's why I picked it. It has all of the trade off issues. You know, you just sit there and say how do you want to -- and we -- our obligation is to try to make the text say that so that we don't invest the numbers with some impression of medical magic, which is the concern you have whenever you deal -- DR. ROYAL: And I'm going to just say one more thing and then I'll shut up about this. CHAIRPERSON FADEN: Sure. DR. ROYAL: I don't think the same careful analysis which has been done for amniocentesis and picking age 35 as the cut off has been done in picking the one in a thousand. And so, that's another difference between this -- CHAIRPERSON FADEN: We can say that. DR. ROYAL: -- and amniocentesis. CHAIRPERSON FADEN: We can say that. We can say that unlike other areas where there's -- you know, a whole literature that has attempted to lay out the trade offs, and also there are different issues at stake. DR. STEVENSON: It's the insurance industry that picked age 35. CHAIRPERSON FADEN: Yeah, it's a matter of what willingness to pay and trade offs and public health policy and all kinds of things. But we can simply say that we -- you know, we had to do this quickly, and we picked a number, and this is what it is. But know that if you're above or below this threshold doesn't mean that it's the difference between -- you know, all or nothing. DR. ROYAL: It doesn't even mean that your risk is necessarily different. CHAIRPERSON FADEN: That's right. We just don't know. But we're doing it, so we can say that. So now the issue is -- I guess we just have to rely on -- I guess it's Duncan, Mary Ann and Henry that continue to work with Ted and get us to this recommendation quickly. But the bottom line recommendation is are we going to say that anybody should be followed up or not. And then getting the language right so we can explain to the public why we made the recommendation we made is of course critical. DR. THOMAS: Maybe it would be briefly worth surfacing the possibility that we may recommend that there are some people that meet both criterion one and criterion two, and what do we do in this case. And we had a spirited discussion yesterday about this possible scenario. I think we were all of us sort of hoping that this wouldn't happen. And that may yet be the outcome. CHAIRPERSON FADEN: What is your concern about? DR. STEVENSON: The logistics of notification. DR. THOMAS: The concern is logistics. CHAIRPERSON FADEN: That would not be our decision. I mean, our recommendation -- our job -- DR. THOMAS: Well, it's not our job to come up with the logistics, but it's I think our responsibility to think about what are the implications. CHAIRPERSON FADEN: That would be fine. That would be very -- I'm sure it would be appreciated. DR. THOMAS: And maybe Henry should just since -- I mean, he's the one that's most concerned about the implications of notification. Do you want to elaborate some more? DR. ROYAL: Well, there are a number of practical problems with notification. In reality, it may be -- well, the fundamental problem is that identifying the people and then the second problem is if some people are identified, how do you get them to see physicians who have a real understanding of what the issue is. So for example, if we identified this group that had significant risk and we thought -- significantly increased risk of thyroid cancer, and we thought that what should happen to those people is that someone should examine their neck on physical examination but not do other things, that's totally out of our control because when that person goes to a doctor and says I've been told by the Presidential Advisory Committee that I have a significant risk of thyroid cancer, that doctor is going to do what he thinks is best for thyroid cancer. And most doctors are not going to understand -- CHAIRPERSON FADEN: I'm looking at Reed, because I'm thinking Reed is -- from your public health life, is there a way you would deal with this? Some sort of advisory that could be given the patient to give to his or her physician or something that you -- if you -- I'm sorry, I didn't mean to interrupt. But I'm looking at where we have relevant expertise. DR. ROYAL: And one of the reasons why it's totally out of our control is that these individuals are going to be difficult to identify. So what's going to happen is they're going to hear that such and such a study in such and such of a location is a high risk study, is a significant risk study. And they're going to go to their doctor whether they were or were not part of the study and say I think I was part of the study. And their doctor is going to do things to them that they wouldn't ordinarily have done to them. And there's some down side to that. DR. TUCKSON: That's true. Certainly though, there are enough examples. I'm just thinking back in this city with concerns about lead poisoning with children. And I remember being health commissioner here having to put out the alert that people need to evaluate their -- not only their water supply, but also to evaluate in some parts of the city their children -- to evaluate their kids. That has a cost decision for the individuals and the families involved. It as a fear decision. And then what do you do? Do you in fact rip out the plumbing in your home to diminish whatever you can control versus the plumbing in the whole darn city. And so, -- I mean, just trying to play through that. I mean, I think that the bottom line is -- at least it was my experience, that regardless of the level of inconvenience and uncertainty, the public demanded to be made aware of the issues. And then let them make their own choices. The one thing that I got my behind fried, or I would have, was if I made decisions of withholding -- and I'm still not -- I'm trying to come to where I don't disagree with you. But I'm just saying once you know something, to not give people the facts and let them then go and deal with their providers and get the best advice, gets you in a heck of a lot of trouble. Because people just get pissed off. DR. STEVENSON: I mean, I think this thinking is analogous to the debate we got into about the secret plants and the releases where we might be over calling. We might be calling people that are dumping water. But better that than giving the impression that we're withholding or perpetuating a sort of secrecy cover up thing. I think you do end up over playing the exercise. But it's -- DR. TUCKSON: But I think that what I -- what I think ultimately has to happen is that the -- first, I think that we have perhaps an obligation -- well, not we, but the interagency government committee, perhaps, through its mechanism, has some opportunity to involve the medical community in an educational activity around these points. So that we have to say that -- so that there is no harm done as a result of what we're doing, or we minimize harm, is that somehow we've got to get the word out. And that's not something this Committee can do, but somebody else. Yeah, Henry says very clearly, you know, we've got to teach. And the field has to become educated. I think that's important. And secondly though, I think that our real concerns need to be in the body of the document. That what Henry is saying -- I mean, you've got to right that, and you say however, this does not -- you should not rush out and do this. You need to think about these issues, blah, blah, blah, blah, blah. Because it is not clear. But I think you have to put it all there. CHAIRPERSON FADEN: Right. So what I'm thinking is -- you just got at it. (Laughter. That not -- obviously we are blessed that we have people with different expertise and that can help us with different kinds of problems. So when you get to write that part, the group that's working on the writing that part, if it turns out there will be a recommendation that somebody should be notified, we can pull it in and help Reed work with the expertise -- writing the stuff about -- you know, what's the -- what are the concerns and what would be responsible for the government to think about when they do this. They can't just do it. They've got to think about the following considerations, and here's the kind of help they could get to do it, the public expertise, the people who know how to do these sorts of advisories and notifications and things of that sort. DR. TUCKSON: And in a way, I'm just -- you know, I think Henry's points are so good and the whole -- I think that this section is obviously in many ways a metaphor for the world that we envision for the future. It's almost as if when you're confronted with these paradoxes, how do you handle the paradoxes? And this gets back to how we inform people, how do we work through the ethical dilemma that we're confronted -- I think this is a -- it's a messy issue, but I think it's a great opportunity for us to demonstrate what it is we are actually expecting of others in the future. And I think we ought to just seize this as a wonderful moment. Lay out the concerns, inform people, give you the ethics, give you the facts, inform people, and then say now based on this, go forward. CHAIRPERSON FADEN: Do it right. DR. TUCKSON: Do it right. Do this -- CHAIRPERSON FADEN: Right, do this one right. Now here's what I would like to propose. First, I am to make a public announcement and people are not going to be happy when they hear how much this is, just as a courtesy to the people in the audience, we're each paying for this lunch, so you can't have it. (Laughter.) Is that it comes down to. And when each of us finds out how much we're paying for this lunch, we probably won't want it either. But just so you know -- MS. KING: Especially since we don't get it reimbursed. CHAIRPERSON FADEN: That's right. So everybody can know this. MS. KING: So they get reimbursed. I'm told I don't. CHAIRPERSON FADEN: Local people don't. Local people, for what it's worth, you should never be on an advisory committee if you live in Washington D.C. It's really a problem. No, it's true. Pat, Phil, I and Ken -- you confront this. If you live within 40 miles of the Washington area, you are not considered to be on per diem when you do these things. And you can't stay in the hotel -- all these wonderful things. But okay, that's one of the penalties you pay for living in the nation's capital. Anyway, what I propose we do is that we get our lunch. We're going to have the reading distributed, and we're going to take ten minutes to eat and read. Ten, 15 minutes to eat and read, and then -- you know, there's dessert too. I'm not going through the whole meal. Take the dessert and whatever you want. (Laughter.) But enough chance to go, you know, eat your sandwich, read the -- there are two kinds of sandwiches. (Whereupon, the proceedings recessed for lunch at 12:43 p.m.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N (12:58 p.m.) CHAIRPERSON FADEN: All right, if we can resume. We probably need -- for this, because we're going to do openness first. Susan has asked that we take out the openness -- there's one, two, three, four, five things on the afternoon agenda. They're all important. We had actually taken care of one, which is notification. Well, we haven't taken care of it. We've discussed it and know what will happen with it. We're now going to move on to openness, which is recommendation 15 as well as the handout -- DR. RUSSELL: A five dollar sandwich and a $20 dollar piece of cake. CHAIRPERSON FADEN: I told you you wouldn't be happy. Are you sure? I mean, I really feel badly, but we had like three minutes to decide this. We were not in the position to negotiate on the -- DR. LEDERER: It was a wrong action, but not the culpability. (Laughter.) CHAIRPERSON FADEN: It was a wrong action, but don't blame us. Very nicely done, Susan. Very nicely done. MS. NORRIS: We haven't put Ruth Macklin on that yet, however. CHAIRPERSON FADEN: I think she's temporarily off because she's being E-mailed what we're looking at, and she only has one phone line. So as soon as she gets E-mailed what we're looking at, she will come back on the telephone. You know, it's really a shame that as we come near the end, we have so many other things to add to the end of the day. We're just developing our own vocabulary, and -- all right, so we're now -- do you have a copy of Susan's -- all right, you need a copy of -- here, we'll just look at it together. Somehow these things just didn't make it -- does everybody have Sue's July 19th memo? All right, this is to accompany the openness recommendation, which is recommendation 15. So we probably want to be open to both. Sue, the floor is yours. DR. LEDERER: Well, what I was suggesting is that this replace the recommendation 15. It also incorporates recommendations 16 from yesterday's discussion. This is the actual recommendation there. I have not supplied the supporting material. CHAIRPERSON FADEN: But these are the crisp -- this is what is in the recommendation? DR. LEDERER: Yes, this is what I recommended in conjunction with Gil Whittamore and Suzanne Juneau from the FDA. And I should say at the outset this is not out of any dissatisfaction with what Dan had -- previously had in recommendation 15, but just trying to present it in a more readily identifiable, as implementable, that language -- to make it more effective. And then the rationale would be -- additive from the rationale that's here. CHAIRPERSON FADEN: Yes, yes. DR. LEDERER: But there would be some rearrangement of the current rationale. CHAIRPERSON FADEN: So the major difference is we're saying they've got to locate somebody or something? That that doesn't make -- DR. LEDERER: That doesn't make someone to be responsible to ensure that -- CHAIRPERSON FADEN: These things happen. DR. LEDERER: Yes. MR. GUTTMAN: I think it's basically pretty much identical to what really happened in that -- when we originally -- in the first set of recommendations, had ombudsman up first. People said don't put the mechanism up first because then everybody will argue over whether this should be a new layer of bureaucracy to say what has to be fixed, and then say at the bottom there's going to be means to fix it. And I think what Susan has now done -- I mean, say we need someone with responsibility, and this is what the person is responsible to do. So it's -- the substance of it, I think, is basically identical. DR. LEDERER: It's basically the same. I think -- I guess I like some of the phraseology of this a little bit better, since I think it identifies where the action should occur. MR. GUTTMAN: The only question is the question of whether the CIA stuff gets in here too. CHAIRPERSON FADEN: No, the CIA one is going to be a separate one. I get -- hold it in here was the business about by the contractors and institutions. The CIA we're going to keep as a separate one, but the language is changed, yeah. MR. GUTTMAN: I think it's basically a better -- it's an improved version of -- an improved version of the entire draft. DR. LEDERER: Right, it has 15 and 16 is incorporated not as a stand alone. CHAIRPERSON FADEN: Exactly, which is the other thing. And then the thing is we're just saying without using -- and it avoids the awkwardness that people had about the word ombudsmen, which sounds whatever. It just says somebody's got to be given a brief for doing this. MR. GUTTMAN: Right. CHAIRPERSON FADEN: If the interagency working group wanted to say we will assume the brief ourselves, they could do that. DR. LEDERER: You'll see that I have left identified two questions because I was uncertain about Committee views on what was once recommendation 16. I mean, I have my own answers to these questions, but it's not something that we had discussed. CHAIRPERSON FADEN: Okay, so can you -- MR. GUTTMAN: Well, this went to the point you and Pat were discussing. Sort of general principles. DR. LEDERER: Right. CHAIRPERSON FADEN: Well, I wouldn't think it would be just historical records. The first question -- the first of your questions -- it would be to the creation and maintenance of -- DR. LEDERER: So you would want to make it only perspective or -- CHAIRPERSON FADEN: No. DR. LEDERER: Okay, I would like to say -- I would have said both. CHAIRPERSON FADEN: Would that have been your answer? DR. LEDERER: Yes. And then the second, I don't feel like we want to restrict it to human research records. CHAIRPERSON FADEN: No, we did not. DR. LEDERER: You know, we want to make a general statement of openness. CHAIRPERSON FADEN: Right. Is that correct? We were saying that there wasn't a reason to land just on human -- it's a general big problem, and we -- the government has more government -- private, public partnerships in 100,000 of which research is only one. So is there Committee discussion for Sue or comments, or are we all right with openness recommendation 15? Admittedly, all the text now has to be additive. So you'll get that too. And we're all right with the idea of recommending that an agency or an entity or an individual entity be given this brief? I mean, rather than simply saying that they should do these things? MR. GUTTMAN: We did it -- the direction of the question -- CHAIRPERSON FADEN: Well, that's what I'm trying to figure out is the general sense that it's really -- this is like a political question about which I don't know the answer -- to which I don't know the answer. I don't know whether it's better or worse. MR. GUTTMAN: I thought this was just a strategic question of whether you say these things got to be done, and by the way, somebody's got to do them. Or do you say we need somebody who will do these things, right? DR. TUCKSON: I think what has to be done is then simply -- the best and most cost effective way to do it. I don't think it's -- I don't think we have to be necessarily that specific about who does it. We just lay out that it has to be -- what it is that has to be done and needs to be done. CHAIRPERSON FADEN: I guess on the first paragraph, which is designate an individual or an entity. I don't know if that's critical to how you are all viewing -- you and Dan and Suzanne and Gail? I just wonder, because I can see that assuming -- no, that's creating a new person or that's creating -- I mean, we don't want to do that, rather than let's do these things. MR. GUTTMAN: The earlier drafts had number one as number five. CHAIRPERSON FADEN: Right, right. MR. GUTTMAN: So the question is simply whether you put up front -- CHAIRPERSON FADEN: It's not number one. It's not even a number one. It's before number one. I mean, I'm raising the issue about the entity. DR. LEDERER: I would be willing to hear any wisdom about what will get this accomplished. CHAIRPERSON FADEN: That's what I'm thinking. Maybe -- would you mind if we sort of check it out and see? So the main thing is the one to five should happen. And if it turns out that it advances the recommendation to have it be in the form of designate somebody to do the following things rather than just assure that the following things get done, -- DR. TUCKSON: Wasn't it yesterday we used the language "cause to occur?" CHAIRPERSON FADEN: That was a -- recommends that the IAWG caused to occur the following things, and you could even -- I like that. And the only thing that would have to change would be three, policy should be developed -- put the development of policies or whatever. DR. LEDERER: Right, okay. CHAIRPERSON FADEN: And we might -- to incorporate the IAWG as behind this, say that this may be best accomplished by the identification -- enter the cause to occur -- there could be another sentence there that this may be best accomplished by the identification of an individual or entity that would be given responsibility for implementing all of these. But it means that you could still do it even if you didn't want to do it through an identified entity. Thank you very much. Sue, Suzanne and Gil worked with you as well? DR. LEDERER: Gil. CHAIRPERSON FADEN: Thank you. And thank you, Sue. It's great. So are we all right, Committee, with this? The cause to occur and then the entity or individual becomes the second sentence, and then the five things. That's great, wonderful. Okay, thank you. So we've now done -- if you're interested at all, as I am obsessively looking at this agenda, we've now done medical notification and follow up and openness. We have the risk of harm finding, but we don't have -- which was in our packet, I believe. And that's, at this point, not going to be so easy to find, but if people could pull it out. It's on E-mail paper that -- it is on E-mail paper, isn't it, Duncan? DR. STEVENSON: It's typewritten. CHAIRPERSON FADEN: Oh, it's typewritten paper? Okay, then I'm wrong. I was worried about that. Yeah, here it is. And it -- but it has that E-mail thing on the front. That's what confused me. It's got holes. It's from Duncan; it's dated July 10th; and it says bold the Advisory Committee finds that -- this is proposed revision of finding two. It's open for discussion. All right, I'm trying to hold off on having the discussion until we get Ruth. Is Ruth on now? DR. MACKLIN: Yes. CHAIRPERSON FADEN: Okay, Ruth, we're on Duncan's draft revision -- excuse me, for the finding on risk, which hopefully you have. But if you don't, I don't know what to do about it at this point. Oh, that's great, it's the finding two. All right, so now the floor is open for discussion on finding -- this would be finding two. Henry? DR. ROYAL: My recollection for the need for revising this finding was to deal with what's dealt with in paragraph two, the therapeutic radiation, because both of them are mixed up together in the original finding, if I remember correctly. And I don't have any problems with paragraph two. In paragraph one, I think originally the way it was written was the second sentence said originally it seems probable -- I guess it isn't supposed to say it's -- it is probable that most studies conducted did not involve doses likely to cause physical harm, is what I remember. And it ended there. And I would prefer that rendition revised or -- DR. THOMAS: Is there a problem with the word acute? I'm going on in the second -- CHAIRPERSON FADEN: Actually, my memory is -- right. My memory is the reason for the revision was the sentence that we're about to come to, which was not there before. However, some tracer studies may have produced a greater then minimal increase in long term risk of cancer. DR. ROYAL: Well, you're right; but that sentence wasn't there before. CHAIRPERSON FADEN: Yeah, that was what was the issue that was discussed at the last meeting, the need to bring that -- that's all the E-mailing that we had was around that question -- of needing to acknowledge in the finding that some of these studies -- DR. ROYAL: But doesn't -- when you say that it's not likely to have caused physical harm, doesn't that acknowledge that there's the possibility that it did cause physical harm? DR. OLEINICK: You're absolutely right. I think what you're -- technically you're absolutely correct. But I think the sense of it is that we wanted to say that -- we wanted to turn it around and say but there is some positive, even though in most cases the answer -- was there harm, no. In most cases. But it was really just for emphasis, I think, for clarity. DR. THOMAS: I think there's an important distinction, and that's that we are virtually certain -- I won't say 100%, but pretty sure that none of these experiments caused any short term effects. CHAIRPERSON FADEN: This great -- DR. THOMAS: The tracer studies. CHAIRPERSON FADEN: Yeah. DR. THOMAS: On the other hand, the probability is non zero that some long term damage may have occurred. And somehow, putting those two statements together in one sentence and saying -- using the word probable to deal with both doesn't get it. CHAIRPERSON FADEN: The reason why I think -- DR. ROYAL: Maybe the difference that we're having is I don't object to the statement that there's a non zero chance of harm having been done. But non zero doesn't to me mean greater than minimal increase. CHAIRPERSON FADEN: Well, the problem I'm having is this. This is my problem, Henry. We're going to have a children's chapter. And in that children's chapter, we're going to discuss excess deaths. All right, there's this whole thing that lays out all excess thyroid cancers or whatever it is. And we lay out all these analyses of the 18 studies. And it suggested at least some of them involved doses of the sort that you're talking about excess something. So I'm a lay person, and I'm reading that chapter. And then I go to the finding which summarizes our finding on harm of human radiation experiments, and there's no reference mentioned? And that's my problem. And unless we make the finding consonant with what we are describing in the children's study -- DR. THOMAS: The children's chapter produces a spectrum of risks. CHAIRPERSON FADEN: Exactly. DR. THOMAS: Some of which are indeed minimal risk. The majority are minimal risk. But then there's the one which has a 2.2 per 100 risk, which in my view is certainly greater than minimal. DR. ROYAL: So let's talk about the 2.2 in a 100. DR. THOMAS: -- and that's what the message is trying to get across. CHAIRPERSON FADEN: I'm happy to work with different language. All I want is a finding that captures in one chapter of the report we are not saying that people were -- that there's -- that no one got cancer from this. We're saying that it's possible that somebody might have. You know, it doesn't -- it's not captured -- DR. ROYAL: I don't at all mind have this sentence say that it's possible that someone might have gotten cancer. DR. THOMAS: What's your problem with greater than minimal increase in risk? CHAIRPERSON FADEN: He doesn't like the language. DR. ROYAL: I have no idea what that means. CHAIRPERSON FADEN: That's fine. Actually, I like it better this way because it's more available to the ordinary person. DR. ROYAL: Okay. CHAIRPERSON FADEN: However, some tracer studies -- it's possible that some tracer studies may have caused cancer. DR. OLEINICK: Yes. DR. THOMAS: Well, let me make a pitch for this, although I can live with that language as well. The reason why I adopted this one is to tie it into our current regulations. Because we make a distinction now between what we consider minimal risk and greater than minimal risk studies. DR. OLEINICK: This is a minimal increase. Greater than minimal increase, and I'm not -- DR. THOMAS: Well, okay, let's take greater than minimal risk. I'm happy with that. I think like an epidemiologist. There's always risk. And what I'm concerned about is what's the additional risk to do exposure. But let's not quibble about that. So we'll call it minimal risk versus greater than minimal risk. And the majority of these studies probably fell in what we would identify as minimal risk, although we have a recommendation to the effect that this is a long outstanding question -- DR. OLEINICK: Right. DR. THOMAS: -- that needs to be resolved. What is minimal risk and does it apply to tracer studies? Anyway, I think most of us sort of feel that the majority of these tracer studies were genuinely minimal risk studies. But there were a few which were not. Now, even in minimal risk studies, it's still possible somebody got cancer as a result of it. Very unlikely, but it's still possible. And so the proposed alternative language which says some people may have gotten cancer -- CHAIRPERSON FADEN: It's not bad. DR. THOMAS: -- really applies to all of it, including the minimal risk ones. CHAIRPERSON FADEN: That's fine. DR. THOMAS: Well, it's not fine. Because there are some studies which I think are unethical because they posed greater than minimal risk. And it would be today judged as unethical. CHAIRPERSON FADEN: But that's not what this finding is about. This finding isn't about judging particular experiments. It's giving a summary of aggregate risk of harm that this body of work did. I mean, I don't -- DR. THOMAS: I still want to make this pitch, because I think almost any experiment poses greater -- you could say that somebody got cancer as a result of any experiment involving radiation. If you give somebody a chest x-ray, you may give them cancer as a result of it. Extraordinarily unlikely, but it could happen. DR. GLATSTEIN: How would you be able to pick that up? DR. THOMAS: Well, you won't. That's my point. I mean, you won't be able to. But the point is, you can't say for any experiment that it is risk free. CHAIRPERSON FADEN: Well, why don't we -- DR. THOMAS: So this distinction between whether or not that risk is in some sense acceptable or not is a very important one. And some of these were pretty high risk experiments. CHAIRPERSON FADEN: All right, can we follow the language of the sentence before it? The sentence before it says, "It seems probable that most tracer studies conducted from 1944 to 1974," -- let's take Henry's change for a minute -- "did not involve doses likely to cause physical harm. However," can you say, "some tracer studies did involve doses in which it is possible that a cancer resulted" or something? Would that capture your -- I don't know. I'm trying to capture Duncan's concern. DR. ROYAL: The reason I don't like this focus on the dose is because if you have a study that involves three people -- that a dose that was 50 times a study that involved 1/50th of the dose, that involved 100 people, it's just -- the number of cancers you cause are the same in -- CHAIRPERSON FADEN: Well, then you're back to Duncan's formulation, which is increased risk. I mean, what you're saying argues for Duncan's formulation, that you want to get precise and say that some studies involved doses that increased people's risk of cancer rather than the actual existence of cancer. DR. STEVENSON: Henry's saying he doesn't want that differentiation because some of these studies had three people and some might have 100. In the end, you have a wash. Is that right, Henry? CHAIRPERSON FADEN: But the issue is what are we focusing on. And that's, I think, at the core of this. What are we trying to communicate? Are we trying to communicate that it's likely that some people got cancer, or are we trying to communicate that some people were put in studies that had higher doses? DR. THOMAS: I think that's -- it's the latter point that I'm arguing for here. DR. ROYAL: And what I'm saying is that when you're talking about risk, that you have to consider two things. You have to consider the dose and the number of people -- CHAIRPERSON FADEN: For the harm to materialize. DR. ROYAL: Correct. CHAIRPERSON FADEN: Not when you're talking about risk. I mean, the issue is are we talking about risk of harm or harm? And I think we got the two mixed up. If you're only talking about risk, you don't have to talk about the denominator. If you're talking about the probability that harm occurred, then you need the risk times the population. Right? So we're all in agreement about that. So the issue is which are we describing here, the risk -- DR. STEVENSON: The risk of cancer of cancer? CHAIRPERSON FADEN: Right, that's right. Risk of cancer or cancer. Events or probabilities. You know, I mean, that's basically what we're talking about. MR. GUTTMAN: It sounds like there's a person sitting the public could use the benefit of us laying out -- no? CHAIRPERSON FADEN: And the preceding sentence talks about risk. It talks about harm. It talks about outcome. But it also links it to some studies in terms of the numbers. So we needed a parallelism of some sort. If we're going to express the good news, the bad news has to be put, I think, in the same metric, which is what's confusing me. Because the preceding sentence and the subsequent sentence are not in sync with one another. I mean, we can make them in sync -- that we -- you should need the same metric for expecting whatever -- DR. THOMAS: Let me remind you again why they're written differently. Because the first -- my conception of this paragraph was that the first one was going to deal with acute effects and saying they didn't happen. And the second one was going to deal with long term effects and said that the risk was small but non zero. And what it doesn't say, but I think probably does need to be said, is the experiments varied considerably in their level of risk. CHAIRPERSON FADEN: Well, right now -- DR. THOMAS: So I'd prefer a focus on risk rather than on whether or not anybody -- any cancer was caused. Because we -- that's unknowable whether or not any cancer was caused. CHAIRPERSON FADEN: You could have -- DR. THOMAS: You could make a probability statement about it, but risk is really to me more important for the ethical analysis. CHAIRPERSON FADEN: Well, your point is well taken because you could have had an experiment with whopping doses and nobody got cancer because everybody was lucky. DR. THOMAS: Right. CHAIRPERSON FADEN: I mean, you know, I'm just -- that could have occurred as well just by virtue of genetically immune or God knows what. Okay, so they got incredibly high doses and they walked away and everything was fine. I'm not saying there was such a study, Henry. I'm just playing with the fact that we've got all these possibilities. So the safest think is to talk about risk rather than cancers. That's correct, because that's all we have in front of us. We don't know whether any of these risks materialized. Okay, so if went that route, how would we frame the second sentence? If Henry doesn't like greater than minimal risk, could you say however some tracer studies involved doses that -- DR. THOMAS: Well, we have the word substantial risk and Henry didn't like that word. So this is my suggested alternative. CHAIRPERSON FADEN: I mean, what we can say is that most of the tracer studies did not involve doses likely to cause either acute physical effects or long term effects such as cancer. So for the lay reader, they don't know -- DR. THOMAS: That's fine. CHAIRPERSON FADEN: -- that if it doesn't cause acute effects, it can't cause cancer. People don't reason that way. DR. THOMAS: Okay. CHAIRPERSON FADEN: I mean, that's not a correct statement, but you know -- we probably need to lay out both and say most of these studies had doses that neither could cause acute effects nor were likely to cause cancers later. And then you want to say some were not sufficient to cause acute effects, however, but in the range that it is possible that a cancer might have occurred. Would that be okay? DR. ROYAL: Sounds like we're arguing for the -- CHAIRPERSON FADEN: I don't know what I'm arguing for. DR. THOMAS: I don't see that language. When she uses words like possibly, that's a probability statement. CHAIRPERSON FADEN: Is that bad? DR. THOMAS: There's nothing special about that. DR. OLEINICK: No, I mean, exactly. Because you're saying that there is some -- there is a threshold somewhere where you go from -- CHAIRPERSON FADEN: More likely or how more likely. First it's unlikely, -- DR. OLEINICK: Yeah. CHAIRPERSON FADEN: -- and the second one would be more likely. So if the first formulation is -- in the first case, we have doses that were unlikely to cause either acute effects or cancers down the line, we have some studies that also were unlikely to cause acute effects but were more likely to cause cancer down the line. Hi, Ruth. DR. OLEINICK: Ruth is going to take care of this. DR. MACKLIN: Yes, I'm going to make a plea, but I'm going to put it in the strong form. You have -- everyone has a moral obligation to talk into their mic. (Laughter.) I can't hear a thing. I got 2%. I know you're talking about risks, but I don't know whose risk, what study. Occasionally I hear Duncan. I heard Ruth say risk or risk of harm, but that's it. CHAIRPERSON FADEN: Ruth, if this helps, tell me -- I'm speaking very much into the mike. And I don't know, is that helping? DR. MACKLIN: That's perfect when you speak into the mic. I hear nothing if the faces are averted from the mike. I know it's hard, but it's hard to be moral. (Laughter.) CHAIRPERSON FADEN: What we're talking about is the risk finding which is finding two for the entire report, not for any particular study. So we're trying to capture the language and we're having great difficulty because we're tripping all over ourselves thinking about risks and harms and populations and thresholds and everything. So -- I mean, I hate to do this. I don't want to put aside anything, but it seems to me -- I don't know whether we want to word by Committee as -- full Committee and full Committee time is not a very good use of time. I think we know what -- all right, let's try Mary Ann's formulation. In the mike, Mary Ann, you know, so it's sort of hurts all the rest of our ears but Ruth might get a piece of it. DR. STEVENSON: You leave in acute in the first sentence before the end. So it did not involve doses likely to cause acute physical harm. However, there may be some long term risk of cancer in a small group of subjects. It gets away from dose. DR. THOMAS: Okay. CHAIRPERSON FADEN: These studies may have produced or caused -- I mean, it's just something. DR. ROYAL: She actually said there's a small risk of cancer in some -- she said -- DR. STEVENSON: No, no; wait a second. There may be -- CHAIRPERSON FADEN: All right, I'll tell you what. DR. THOMAS: -- at the beginning said something, we will work on it. The one thing I would like to see added to that last sentence is that, you know, there is variation across the studies. CHAIRPERSON FADEN: All right, now this is -- we've tried this before. But I think with this collective discussion, if the rest of the group -- I will work with Duncan and Mary Ann and Henry, and we'd actually tried this a little bit before, but now I think maybe we all know what we're trying to do. Nancy looks like -- can you come in on this too? DR. OLEINICK: I would be happy to. CHAIRPERSON FADEN: Thank you. And we will try to come up with language and float it by everybody else, but we know what we want to communicate and the problem is coming up with the most fair way of communicating it, and also in a way that regular people can understand it. I mean, we want to be true to the science, but we also have to remember that people who are going to read this are not going to be nuance to the difference between thresholds and risks and outcomes and all that kind of stuff. They just want to know bottom line how likely is it that anybody was hurt by this stuff. And that's what we have to communicate. Could I also raise one other thing in Duncan's -- talk in the mike if you're going to. MR. GUTTMAN: Anything that's -- I'm just asking Henry, but anything that's a some as opposed to any amount of radiation has an implication that may be very -- Henry, maybe you can elaborate maybe -- raises this threshold question. DR. STEVENSON: I didn't put some in my -- MR. GUTTMAN: Oh, I thought you had some -- DR. STEVENSON: Some risk of cancer, but not some of the dose. MR. GUTTMAN: No, that some small group -- anything that says some as opposed to all be exposed. DR. STEVENSON: No, it just said a small group. CHAIRPERSON FADEN: Look, we're going to have to do this later. All right, you guys are going -- we can get Dan in too, but the point is when we say we can do it later, we have to do it very rapidly. Okay, but the whole group agrees that what we want to communicate is that by and large the isotope studies didn't cause acute physical harm and were unlikely to cause cancer later. There's some that -- whatever the right probability statement phrase it is, the cancer risk is more of a concern. I mean, that's what we -- and then we have the second -- can we look at the second paragraph, which is pretty much as it was before, which speaks to the therapeutic doses problem. Is that paragraph okay? It's pretty much the language we had last time, and that language was not controversial. I want to raise one -- bring up one -- that Duncan raises several other issues in his memo, but one that I think we'd better make sure right on in particular is your second paragraph, Duncan. There is a line throughout this report that the great majority of experiments that were done -- 3,000, 4,000, whatever experiments -- were radioisotope experiments. And I gather -- DR. THOMAS: That's probably true. CHAIRPERSON FADEN: And we want to make sure that that's correct. MR. GUTTMAN: We suspect it so based on our fragmentary evidence, you know. I mean, it's plausible. Pat Perentesis has looked at the list and we suspect it so. But you know, some of the data is so damn -- the 3,000 VA experiments we assume were largely isotopes. CHAIRPERSON FADEN: Well, I mean, the problem is we have -- the first sentence starts of the thing -- the Advisory Committee find that the great majority of research involved radioisotopes. DR. ROYAL: Well, what it is is that the historical record -- I mean, this is all a problem of -- CHAIRPERSON FADEN: I know. DR. ROYAL: -- of the fact that some sorts of research which are very clinical done as clinical sorts of things -- CHAIRPERSON FADEN: And you didn't need to go through the radioisotope committee to do it. DR. ROYAL: Correct. CHAIRPERSON FADEN: Right. So that's the -- maybe we need to qualify that first sentence to make it clear that -- MR. GUTTMAN: Two questions. One is that of the experiments in our data base, the great majority -- CHAIRPERSON FADEN: That's what we should say. DR. THOMAS: My fear is that this was a reflection of our methodology. And if it started with the isotope list, that's what we were going to find. CHAIRPERSON FADEN: Right. So I think that's what we have to say, is the great majority of the studies that were -- DR. THOMAS: Right, right. CHAIRPERSON FADEN: Otherwise, I think the list could be wrong. So we've got -- okay. So that was very helpful. So that will get changed too. But is everybody -- I guess everybody -- how could you not be? That's okay. Okay, studies in our data base. Are there any other points on this memo, Duncan, that you think we need to discuss? DR. THOMAS: I don't think so. CHAIRPERSON FADEN: Okay, so we've covered the main one, and those are great observations. And we're going to leave it to the subset of us to try to figure out or probably -- the question is how many Committee members will it take to change -- it's like we have our own list of jokes. How many Committee members -- how many hours of Committee member time will it take to decide on three words, is what it's going to come down to. But we will do it. All right, moving down on our list then -- I'm going to have to make sure now that this takes time so that we won't be -- well, don't worry about it. I know. I was just worried about people getting angry about having had this lunch if we end up being done before 3:00. Don't worry? Okay, fine. So we've done medical notification and follow up, risk of harm. Epidemiological study and the atomic vets is a handout. And let me get my hand out. Okay, this is a recurrent -- we're revisiting the discussion we sort of tabled last time. DR. THOMAS: What preliminary -- MS. MASTROIANNI: Is it like this? It's a hand out that looks like this? DR. THOMAS: One page. CHAIRPERSON FADEN: You got it at lunch. You were supposed to have gotten it at lunch. Did you get it? I notice that no matter how we try to do it -- MS. MASTROIANNI: I have more. CHAIRPERSON FADEN: Who needs it? Okay, does everybody have one in front of them? Ruth, do you have this as well? DR. MACKLIN: Since I didn't hear the preceding few sentences, I don't know what this is. CHAIRPERSON FADEN: That's what I was afraid of. The "this" is Duncan's proposed recommendation on follow up study of atomic veterans. He did it today and we received it at lunch. I think this is one of the things that was supposed to have been E- mailed to you. DR. MACKLIN: Yes, he E-mailed it directly to me, and since I neglected to ask Jeff just what was coming across the E- mail, I didn't print it out. But I read it in detail. So I'm going to try to trust my memory since my E-mail is on the same phone line as we're now talking. CHAIRPERSON FADEN: Okay. All right, we'll try to use longer phrases, recognizing that you don't have the text in front of you. Duncan, you've got the floor. DR. MACKLIN: Thank you, thank you. DR. THOMAS: Just one preliminary comment. This is a pending recommendation in the sense that there's a bit of detective work that still needs to be done. You may recall yesterday we had this discussion about an IOM committee that we think currently -- actually already doing this. That is, the feasibility part of it. Depending on the status of that committee, which Dan was going to try to find out about for us, it may prove that this recommendation is unnecessary. On the other hand, I did include some language in here saying that if that committee -- if such a committee were to recommend that this is worth doing, then once you go ahead and do it. So, there's a pitch -- there is a bit of a pitch for keeping this recommendation, even if it turns out that it's already being done. CHAIRPERSON FADEN: All right, so if the IOM is already doing this study, then we obviously don't need to recommend to them that they do the study? DR. THOMAS: That they do the feasibility. CHAIRPERSON FADEN: Right. DR. THOMAS: But the study itself should be done. CHAIRPERSON FADEN: Well, what it -- I mean, we're assuming they are doing it. We think they are doing the feasibility study. DR. THOMAS: Well, here's what I know about the IOM. I'm aware that there is a subcommittee which has just recently reported on -- CHAIRPERSON FADEN: The reproductive? DR. THOMAS: No, no; on the early subcommittee, which has been pursuing the dosimetry aspect of things. There is another committee or another subcommittee. I'm unclear about their relationship, which just reported Monday afternoon on the reproductive study. CHAIRPERSON FADEN: Okay. DR. THOMAS: And you've all seen the press release from that one. Whether there is -- whether both of these are subcommittees of yet some larger committee which is looking at the mortality issue, I don't know. CHAIRPERSON FADEN: Okay. DR. THOMAS: We're going to try to find that out. CHAIRPERSON FADEN: Well, let me see if I can piece this out. If for some reason the IOM is not doing a feasibility study, we are recommending that the IAWG consider asking IOM or however IOM -- however that happens, to do it. If the IOM is doing a feasibility study, if the conclusion of that feasibility study is that a larger study should be done, you're saying this Committee should endorse that. But the awkwardness is what if their conclusion doesn't come out before our report comes out? DR. THOMAS: Well, that's okay. Because ours is a recommendation to the IAWG, which just simply says that they should do what is recommended by the scientific community. CHAIRPERSON FADEN: Okay, so it's basically that they should follow the advice of the Institute of Medicine, whichever way it goes? DR. THOMAS: Right. CHAIRPERSON FADEN: I mean, if the IOM panel says it's infeasible, don't do it; then we say to them -- DR. THOMAS: Don't do it. CHAIRPERSON FADEN: Do they really need us to tell them to do what the -- to follow the advice of an IOM -- I mean, I'm a little -- DR. THOMAS: Well, what the rationale part of this one tries to accomplish as explained why the study would be worth doing and clarify some of the arguments that we've had within our own Committee about whether or not the purpose of this is a purely political exercise or whether it's to try to answer some scientific question, or whether it's for helping some compensation policy or what. And I don't know. I think some kind of a statement, whether it appears in our recommendation section or where on our attempts to try to clarify that debate would be useful. CHAIRPERSON FADEN: Pat? MS. KING: First a question. With Ken's comments that are never understood when they came in, but points that -- I didn't. I mean, I'm not trying to -- I always try not to funny. I wasn't quite sure about them, but there were some points there in his memorandum about in effect revisiting some aspects or questions that Congress had already decided and the wisdom of doing that, am I wrong in trying to remember that he was talking about atomic vets? DR. STEVENSON: He was talking about uranium. MS. KING: He was talking about uranium? But he had atomic vets on too? Was it along the same lines? Because if this is what he was talking -- these are the kinds of issues he had relevance for -- these comments had relevance for. Then the first point I would make would be that one. But I don't think that sort of ends the matter. I think that's a consideration I personally have difficulty saying that you endorse what you don't know about. And the assumption is -- if I followed what Duncan was saying -- is that the academy would have something to say whether expertise is relevant, which is on the science question -- some of the science questions. It is a big leap from science questions to policy resolutions of matters. And it makes me more uncomfortable endorsing something in the future where I'm not sure at all how the academy might handle that, or indeed whether there would be -- if they handle it at all. Or indeed, whether there would be other considerations that would involve the bridge, which of course takes me back to Ken's point about this being a consideration where Congress has already acted. So I therefore wouldn't want to see this as a recommendation. CHAIRPERSON FADEN: What I'm trying to figure out is if there's a way, Duncan, to incorporate that -- I've been reading again your paragraph. And in your -- in the thing that you handed out. And I'm wondering if there isn't a way to incorporate that language, which I think is important in the recommendation we currently have regarding the atomic vets in support of the other reconsiderations, and this could be folded in. I mean, my hesitation is somewhat different from Pat's. My problem is that I don't feel comfortable endorsing -- telling somebody to do what an IOM or NAS report says they should do without having read the report myself. Because I could disagree with it. That's my problem, is that -- you know, if it's not in front of me, I can't say -- you know, go do it just because they say it's good idea doesn't -- I mean, they say it's -- what if they say it's not scientifically feasible and you still think it is? I mean, either way it's set up, I would at least want to see how good a job they did. And I would like it if people will say well, if the Advisory Committee on Human Radiation Experiment says it's so, it must be so. But I suspect people will -- you know, not -- want to read for themselves and draw their own conclusions. I know you don't mean it as simply as that, but read literally, that's what it sounds like. DR. THOMAS: I would be happy to roll it into the other two, but it isn't immediately obvious how to go about it. CHAIRPERSON FADEN: How to do it, yeah. DR. THOMAS: The first one says you should upgrade the radioepidemiologic tables, and I'm -- would be loath to suggest -- I mean, I would consider it, but it's not immediately obvious to me that the data which would appear from this -- a study like this would be very helpful in updating probability of causation tables. The second recommendation is perhaps more relevant -- sub recommendations -- may be the more relevant place to put it. Because it turns to the compensation policy per se. But it does it -- it addresses more other aspects of it. CHAIRPERSON FADEN: Right. DR. THOMAS: The bureaucratic hassles and whether or not there ought to be presumptions anyway. In a sense, you could roll it into that question of whether or not there ought to be presumptions by saying that in the future, any further data which emerges from a scientifically defensible study of the vets themselves would obviously be relevant in helping set such presumptions. But remember the logic of this. We had originally held this out as a separate recommendation -- CHAIRPERSON FADEN: Yes, I do remember. DR. THOMAS: -- because we wanted them to do something right now to fix the compensation system. And the reason for this study was to help in the future. CHAIRPERSON FADEN: But also to help in the future to fix the compensation system? DR. THOMAS: Oh, yes. To help in the future precisely in the sense that data from the study would be helpful in updating -- in future updates of the compensation policy. CHAIRPERSON FADEN: But then if that's the way the rationale is set up, maybe it could fit in the second one? DR. THOMAS: It could. It could well. CHAIRPERSON FADEN: Work it in that way and say these are the sorts of steps that the administration should consider -- the IAWG should consider in its commitment to make sure that the compensation policy is as fair to what is known or can be known as possible. DR. THOMAS: In deference to Henry's views, I certainly did not want to go about trying to push through a recommendation which said that this Committee thinks the study is worth -- is scientifically worth doing. And in any event, this Committee doesn't have the expertise to make such a judgement. What I was hoping to accomplish was say that such decisions ought to be made by respected scientists and not by people like us. (Laughter.) CHAIRPERSON FADEN: Of which only some members are respected scientists. The rest are respected other things. (Laughter.) Right, we all respected some things, but only some of us are respected scientists. I've got Henry and Mary Ann. Just so we get it for the record correctly, okay? DR. ROYAL: Let me tell you what my objection is to this recommendation. The decisions about compensation for atomic veterans are based on scientific information -- you know, all based on a whole variety of considerations of other factors. And the -- I can't envision any scientific study that is going to contribute new information that would significantly change that balance. And my concern about this recommendation is that it's misleading to the atomic veteran community. It's making it sound like if you do enough scientific studies or if you do the right scientific study, that somehow things are going to change. And I don't think that that's really -- if you want to change the compensation system, I don't think that that's -- CHAIRPERSON FADEN: The way to do it. DR. ROYAL: -- the way to do it. The second thing I don't like about this recommendation is we're talking about studies that are going to take ten years. If you looked at that notice that we got yesterday, they were talking about a ten year study. I mean, the number of atomic veterans is decreasing every year. And to suggest that the solution is to do another ten year study, I just think is a bad recommendation. CHAIRPERSON FADEN: Mary Ann? DR. STEVENSON: I entirely agree with Pat. And I think I take it one step further in that I'm actually sort of troubled that we're making any kind of recommendations about RECA, because I don't think as a Committee we've discussed it. We didn't discuss what the original premises were, the fact that the epidemiology was entirely negative. That doesn't mean the probability or possibility of having a cancer is entirely negative, but there were a lot of assumptions that went into RECA and the whole compensation package originally that I certainly don't feel we discussed. And I'm not against making a recommendation, but I think we should at least make some attempt in the chapter on atomic vets in the way that we did in the uranium chapter to give at least a capsule of what the epidemiology shows or doesn't show, and a little bit of what we may or may not object to in the RECA act. Otherwise, we're making this recommendation from where? CHAIRPERSON FADEN: Phil, did you want to comment? DR. RUSSELL: No, I agree. There's nothing in the chapter -- DR. ROYAL: In the mike, please. DR. RUSSELL: There's nothing in the chapter that -- CHAIRPERSON FADEN: Supports the finding -- the recommendation. DR. RUSSELL: -- this recommendation. DR. STEVENSON: And you know, obviously we're responding to a lot of testimony we heard. And I think it's fine and very good that we respond -- we pass on our responses to the testimony. But we haven't given any consideration to the work and viewpoint of the people that came up with RECA. I don't think that's going to go down well. I don't think it's fair. CHAIRPERSON FADEN: Well, what I'm hearing is clearly that whatever we -- the recommendation that we agree to has to have some background in the chapter or it doesn't work as a -- just as a report. That seems clearly right. MR. GUTTMAN: That's clear -- the one we agreed to, the epidemiology table actually we did check out and the VA wrote us a letter saying they think it's a good idea on the epidemiological table reports and the reports on -- DR. STEVENSON: Is that in the chapter? MR. GUTTMAN: Well, it wasn't relevant to the chapter. CHAIRPERSON FADEN: No, Mary Ann's making the point that we have an awkwardness. Yes, that one was checked out, and that one in fact is -- it's nothing more than saying do what you're supposed to do in the law anyway, which is update the table. So that's not upsetting. It's basically saying we would appreciate it if you would -- DR. STEVENSON: Right, do what you think -- CHAIRPERSON FADEN: -- do what you said in the law you were going to do, which is periodically updates. So that one is, you know, not whatever. But the interesting question that you're raising as a report structure question is what symmetry or what basis there has to be for a recommendation to -- it's difficult. MS. KING: It's in the report structure though. CHAIRPERSON FADEN: I want to use that one first. DR. STEVENSON: But I think that the question -- if you don't give a little bit of background information of what is and what isn't known and how this act originally came to, because it's very, very difficult. There was not epidemiology to back this, and there probably will never be any strong science, because the doses are so low it's kind of a waste to discuss. So some assumptions had to be made. Some mechanism had to be put in place. But it was very complicated, and to change it is also very complicated. And I think it has to be given some acknowledgement of what's know and what's not known to -- about this whole situation. CHAIRPERSON FADEN: Okay, Duncan and Pat. DR. THOMAS: You'll recall we had this same discussion yesterday on the uranium miner chapter. And there was an agreement than that what we needed to do was beef up the uranium miner chapter to talk about the reasons why we were making the recommendation for compensation -- changes in compensation. And I have no problem doing exactly the same thing here. And the chapter as it's presently written leads quite naturally into it because the chapter concludes by talking about the difficulties of the inadequate record keeping which got us into this mess in the first place. So I think all that's needed is a paragraph or two at the end of that chapter which will set the stage for how RECA came about and what it's -- what we know about it and its inadequacies. CHAIRPERSON FADEN: Pat? MS. KING: When -- maybe this is not appropriate, but I think this is not nearly a structure issue. This is not merely a question of whether something appears in the chapter or not. Some things are amenable to going back and saying put something in the chapters so we have some support for a recommendation. But I take it that what Mary Ann said goes further than that. And what she's saying is even if we could recapture what happened in RECA and we could describe it in the chapter for example, that that doesn't mean that this Committee deliberated it. And my concern is that when you make strong recommendations, you have to have some sense that the Committee thinks it was not necessary to deliberate it because it was so much a part of what we were doing all along that it emerged. And I suspect there's some recommendations like that, or that there are recommendations that we deliberated beyond considering them as recommendations. I mean, they emerged in the discussion over the past year, and some of the compensation acts are a particular problem for us because we can't really say that we did that for a lot of reasons. So this becomes quite difficult. And so I'm not sure -- I'd be willing to see it. I'm not saying it can't be done. I'm not sure that it can merely be fixed by putting in some paragraphs in the chapter and -- but if -- you know, if -- I'll take a look at anything. But I don't -- CHAIRPERSON FADEN: Let me see where -- I'm going back now and looking at the recommendation. And before we get ourselves thinking we've got a big problem here, let's go back and look at what we recommended. Which we recommended was not so overwhelming much. First we recommended that Congress look at its own -- do what it statutes says for us to do, which is update its table periodically. That's hard to quarrel with. The latter part of what we did, and we said we were going to modify the language, is pass on the concerns that were relayed to us with a clear statement that we need to investigate these concerns, but we -- a lot of people take the time to talk to us and tell us that they were having these problems implementing -- getting relief under the act. We didn't have the time to look into them. We're asking the IAWG to hear the concerns that we heard. We would appreciate your looking into them. We didn't have the resources or the mandate to it. But we have heard all this testimony, and we are worried that these people are worried. So we're saying somebody should take a look at their concerns. The only thing that -- and I take it that that's okay. That's essentially serving as a pass through, and that's part of the function in being a public committee, so that the public can come and testify before us and we can deliver their message with perhaps more oomph than they can do delivering it themselves. Making clear though, that it's still their message, not our message. Okay? But we're very happy to be that vehicle because of all the trouble people went to to come and tell us about it. The part that in any is at issue is the middle -- the stuff on -- I have a different draft, so I hesitate to say it, but it's the second bolded part under the atomic vets recommendation. The Advisory Committee further recommends that they work with -- to review existing laws governing the compensation in view of the concerns that these laws unduly favor -- DR. STEVENSON: Right. CHAIRPERSON FADEN: Right. Now this is responding again to public testimony. MR. GUTTMAN: That's also our chapter. Ruth, there are three things -- CHAIRPERSON FADEN: I have a wrong draft. DR. STEVENSON: 17 on the one dated the 13th of July. CHAIRPERSON FADEN: It's Chapter 7 -- page 17, and it's the second -- the bolded stuff that says the Advisory Committee further recommends. Go ahead, Dan. MR. GUTTMAN: There are three things that are floating around in the atomic vets. One is the question of cancer causation. I think everybody agrees that relatively speaking the risks were pretty small. Whether very, very small; moderately small; but it was small as opposed to large. In any event, that's not being addressed by us. And to the extent it is being addressed by this -- we do the epidemiological tables. The second question is if you are someone who, you know, is in the pool of people who should be compensated, what's the level of benefits? And we're not addressing that either. The third question I think -- which is the one that we're really focusing on, is assuming we've -- there's a limited pool of dollars to give to a group of people and for political reasons, whatever, people are going to give it to them, what's the best way -- the most efficient and most effective way. And the data -- that's sort of a nexus of what Eli was talking about yesterday of well, gee, maybe no more now about the administration of that walk and about the adequacies of the data so that even if you don't want to say there should be larger pool, or even -- whatever your position is on the, you know, statistical causality, that what needs to be reconsidered in particular because of -- other people who have found it before us, but the Committee's findings about the data -- the adequacy of the data. Why spend all this time and money? CHAIRPERSON FADEN: So again, the way it was modulated was go review -- somebody take a look and see if this is the best balance you can -- that can be achieved between administrative costs and pay out. That's all that we're saying. MR. GUTTMAN: Well within that, other people may say but you should add more cancers or that you know, it should be a larger pool. DR. STEVENSON: But the bolded writing has to be rewritten. CHAIRPERSON FADEN: It is. It was decided last time we were going to rewrite it. I mean, that decision was made whatever day we looked at the recommendation that we were going to revise that language to say somebody should review whether this is the right balance between administrative costs and pay out to claimants, or whatever the right person is. That that really is the thrust of that bolded language, and also that the pass through part is truly a pass through and that we are neither endorsing nor sharing with skepticism these objections. We heard them, they were heartfelt from the people who provided them to us, and we want somebody to pay attention to them as the resources to investigate. MR. GUTTMAN: Again, but with the quality -- some of the things we're finding in the chapter about the data -- I mean, some of those people were complaining about the same things that -- CHAIRPERSON FADEN: Right, well we can differentiate where we had that. But we have to be careful about how we say that. MR. GUTTMAN: Right. You always have to be careful. CHAIRPERSON FADEN: So, I don't mean to sound irritated because we're revisiting stuff we revisited, but we've got to -- I mean, I think we sort of did this one on step -- made it more careful when we went through it the last time. Which leaves us with Duncan's new recommendation. And Duncan, I'm not hearing -- pardon? MR. GUTTMAN: I like it. CHAIRPERSON FADEN: The new recommendation? DR. KATZ: Yeah. CHAIRPERSON FADEN: Would you talk into the mike? DR. KATZ: Yeah, I like the recommendation. CHAIRPERSON FADEN: To support the IOM committee? DR. KATZ: Yeah. DR. GLATSTEIN: Yeah, I do too. CHAIRPERSON FADEN: Okay, so -- Nancy? DR. OLEINICK: Well, I have E-mailed my comments on this recommendation, although I -- I think it's explicated better in this particular version. I still have great reservations about signing -- well, number one, signing onto something I don't know what they're going to do. But secondly, this is a very long term, expensive kind of study that we're talking about. And it does not sound to me like that is the best thing that we can do for the atomic vets is to go onto this -- the doses are low. They are going to be -- there's going to be wide variation. And very large confidence intervals. And I mean, I just think it's going to be a very difficult study. The dose reconstructions are going to be expensive. I mean, it's just -- I don't think it's -- DR. GLATSTEIN: That's what takes the time and the money. And it's not clear to me from the IOM comments on the reproductive study whether they can do the dose business. But they could do the epidemiologic correlation between -- in terms of outcome. DR. OLEINICK: That they can do. DR. GLATSTEIN: And that wouldn't take ten years. Nor would it costs tens of millions of dollars. CHAIRPERSON FADEN: Okay, I am really at a loss as to how to proceed with this. I just don't know what to do. I haven't heard from every member of the Committee, either. So I don't really know where we all -- I mean, I hear Duncan and Jay and Eli supporting. I hear Pat and Henry and Mary Ann and Nancy with reservations. I haven't heard from the middle of the table on both sides. DR. RUSSELL: I'm in the middle and I'm both sides. (Laughter.) CHAIRPERSON FADEN: I had that last time. MS. KING: I'm strongly against having the recommendation. CHAIRPERSON FADEN: Okay. MS. KING: And I think that some of the comments I heard from some of the people who support it, not all, make me even more uneasy. Because a lot of those comments were speculative comments in the sense that something could -- might come up, if this, and that -- that underscores how uncertain this is. And that's what got me -- CHAIRPERSON FADEN: All right, I will rephrase it. Pat strongly objects. MS. KING: I strongly object. CHAIRPERSON FADEN: And Mary Ann strongly objects. Nancy strongly objects and Henry strongly objects. Reed? Phil strongly objects and strongly endorses. (Laughter.) DR. GLATSTEIN: And Reed agrees with him. (Laughter.) DR. TUCKSON: The language that -- I agree with the recommendation. And I agree with it because it says that it's asking for a panel of experts to consider the feasibility and scientific merit. So it's saying that we are not in a position, we don't have the time to get it -- I mean, so we're not there. DR. STEVENSON: This is already happening. So why are we -- CHAIRPERSON FADEN: We think the -- this is the thing that's totally confusing. And Dan can't get through to the right person. We actually think this is happening. All right, so if it's happening, then this is all sort of silly. Except for the part that says if warranted, undertake such studies. Now every focus on the word if warranted. If warranted means that somebody else's guys decide if it's warranted. The IOM is going to decide or the National Academy of Science is going to decide if it's feasible. Okay, there's this unknown entity, presumably the government in some form, that would decide if it's warranted. It's not saying we're saying it's warranted. It's saying that if somebody else -- if you wanted to know -- but if you really look at the wording of it, it's not all that strong. Now, if the IOM is doing it and -- it's sort of like the IOM is doing it and the IOM says it's not feasible, it stops there is what this says. All right, I've got Phil and I've got Nancy and then I really feel like we've got to do something else. Phil? DR. RUSSELL: I don't think we ought to make the recommendation on something that -- because we don't know what the IOM -- we don't know what they're going to say and how it's going to come out. We don't have any way of evaluating their activity. I think we can make a statement that says the Committee's very happy that the IOM is addressing this issue and hopes that their findings will be of benefit to the atomic veterans. CHAIRPERSON FADEN: That's not a recommendation. That's a statement. That's fine. DR. RUSSELL: It's a statement. It's not a recommendation. DR. GLATSTEIN: You should run for president, Phil. (Laughter. CHAIRPERSON FADEN: Wait just a second. Before we -- and I want to like bring this happy note to closure. All right, is it correct then we are all comfortable with the statement that says the Committee is happy the IOM is doing the study. We hope that the government will pay close attention to the results of the IOM panel. DR. THOMAS: If they're doing it. CHAIRPERSON FADEN: If they're doing it. If they're not doing it, you will all get an E-mail or fax otherwise. DR. TUCKSON: And it will be tied right in to -- how that flows temperately with the reason why we have this concern in the body of the document. CHAIRPERSON FADEN: It could go in the recommendation rationale. It says, you know, there are all these issues about how to do this. And one of the unresolved issues is whether this kind of study would help or could be feasible, and we're very happy the IOM is doing this. And we hope that the administration or whoever will pay close attention to the results of the IOM. DR. STEVENSON: That's going in the chapter? CHAIRPERSON FADEN: Maybe it will go in the chapter. I don't know. DR. STEVENSON: I think it should go in the chapter. CHAIRPERSON FADEN: In the chapter? Okay. Got it. Okay, and -- DR. STEVENSON: Along with all that background data. CHAIRPERSON FADEN: Along with the -- yeah. DR. KATZ: Just a question. What happened to the atomic veterans recommendation? CHAIRPERSON FADEN: It's there. It's still there. DR. KATZ: It's still there in the way in which we have -- CHAIRPERSON FADEN: The way in which we decided to change it whenever we decided to change it yesterday or the day before. DR. KATZ: Yeah, that's the one that for the moment stands? CHAIRPERSON FADEN: Yeah. DR. KATZ: Okay, thanks. CHAIRPERSON FADEN: Yeah, it's still there, but you haven't seen the new language because we have written it -- it hasn't been written yet. Well, we had a discussion about it -- MS. KING: It's significantly changed from what is here. CHAIRPERSON FADEN: Yes, it is. MS. KING: To clarify -- CHAIRPERSON FADEN: Yes, it is different from the way it looks now. I mean, it will be different because we had a discussion about it and decided to change it. But you all have to wait to see what it looks like to see if it fits with your -- yeah, to see if it fits with your memory of how we discussed it. But, we did have a discussion of it. So it's still there. All right, we have done all the -- oh, we have two larger items. One very large, and one medium large item to do. And we have an hour and a half to do it. That may be doable. The two remaining are first the observational -- I don't know what order to do them in -- the observational studies chapter and the related findings and recommendations that go with the observational studies chapter. And we have something from Duncan also that came at lunch, right, on the Marshalls. And we also have 11D. Do you want to do 11D first and then the rest of the time -- I think so, because that will probably -- 11D is draft on the Committee's forward looking recommendations with respect to oversight and -- monitoring oversight and sanctions. Phil? DR. RUSSELL: The part I that asks for consistency and compliance and oversight I think overstates a value of consistent mechanisms across the federal agencies. Federal agencies are widely different. They do things differently. And since oversight of human subjects research is part of the larger problem of managing research, I don't think we ought to ask for consistency between Department of the Army and Department of Agriculture, for example. They do think quite differently, and they've got to carry out this responsibility within the context of their own structure. So I would -- I would not be happy to be in that -- have that level of specificity. Further, I don't think the language in here that says that only one department had individuals dedicated to oversight on a full time basis is factually true. I don't think that is true. And I don't think we have any data from our studies that indicate one department is better than another in -- CHAIRPERSON FADEN: The outcome. DR. RUSSELL: We've got uniform problems across the departments. MS. MASTROIANNI: -- oversight chapter? MS. KING: I know the agency oversight chapter, but these are recommendations that we have not seen. CHAIRPERSON FADEN: We have not seen before. These are brand new, okay. There was a hole in the chapter -- there is a hole in the chapter, and we had different ones in the last one that we revised them. The statement about only one department has a full time -- one single full time person is the result of what we got back. People have lots of people, but they're part -- they have FTE equivalents to be distinguished from a dedicated full time person. And the issue is whether that matters. DR. RUSSELL: I'm not sure we asked the question correctly then. Because the Department of Defense may not have any full time person dedicated to oversight, but I know the Department of the Army does, and I know the Department of the Navy does. CHAIRPERSON FADEN: That's an interesting question. DR. RUSSELL: I think therein lies a -- CHAIRPERSON FADEN: I mean, I think what we do -- DR. RUSSELL: And that goes back to the consistency issue. We can't ask the Department of Defense to have the same structure with its three separate services and a different way of doing business than Health and Human Services which basically has a monolithic structure for funding research. CHAIRPERSON FADEN: I think maybe the more relevant issues are the following. One is adequate staff. And there is some evidence in fact coming back from the agencies that they don't have the kind -- DR. RUSSELL: Some do not. CHAIRPERSON FADEN: Some do not have the numbers of bodies that they think they need to have to do as good a job as they believe they would like -- that they believe they should be doing. And we can perhaps better focus on that and saying everybody should have exactly the same numbers of bodies per case load of research projects. DR. RUSSELL: That's dangerous. If you look at those numbers, Department of Defense has 80 FTE's for $174 million dollars in research. CHAIRPERSON FADEN: Yeah, that's what I'm saying. We shouldn't do that -- not to do that. DR. RUSSELL: Health and Human Services has got something like 60 for $2.7 billion dollars. CHAIRPERSON FADEN: Right, exactly. So I'm not saying that we want to say -- we want a ratio, right; but rather that we simply say that some agencies don't appear to have, you know, relative to other things -- they have a staff problem. And this is -- no, I mean, this comes from -- DR. RUSSELL: The outcome analysis doesn't show that though. CHAIRPERSON FADEN: Well, there are problems with all of them is what they're saying. I don't think any of them would say they have enough people. And none of them are doing a perfect job. So if you look at -- DR. RUSSELL: That's true with that. CHAIRPERSON FADEN: All right, so if you take it that -- look at it that -- I don't think there's an agency that would say to you that in a perfect world, we've got all the people -- we've got too many people doing human subject oversights. Take some of them away. That's not what we heard. What we heard was we're doing as good a job as we can do with what we've got. And in fact, when you look at what the job they've done, the little look that we've taken, there's success but there's failure. So there's reason to think that it might be helpful if they had more help. But of course, you know, there's the macroallocation issue. But there's this question of -- you know, that's an issue. The other issue is that we do have agencies that are going -- looking at different -- interpreting their oversight responsibilities in different ways. And this is not the same as the consistency question. It's whether they're going to only documenting paper or they're going to documenting outcomes and real things that matter. And I think we can certainly have a recommendation that's in line with our next one that says as a general recommendation, we would prefer that oversight look less at paper and more at product and more at outcome. And that may translate itself into different changes for different agencies. But would it be agreeable if we said that our major recommendation is that shift in emphasis away from checking paper to -- DR. RUSSELL: Specificity of the process in number one here that I'm objecting to. CHAIRPERSON FADEN: Okay. DR. RUSSELL: Not the fact that we need to increase the oversight and we need to concentrate on outcome. Process is going to be left to the agencies. CHAIRPERSON FADEN: Pat? DR. RUSSELL: We haven't looked at process. MS. KING: I'm not going to lodge strong objections to the form in which this is done. This is -- so if you disagree with what I have to say, we don't have to have a huge debate. What concerns me is -- it's like apple pie. You know, every agency in the government is being but back. CHAIRPERSON FADEN: And we're saying add people. MS. KING: And every agency in the government is having its budget chopped. Every agency in the government has different budgets. And that's sort of the reality of the outside world. So if we play into that, if I were on the receiving end of this -- I'd say those nutty people. God, they don't understand what's going on. What I might stop and do if I were on the receiving end is if I got a recommendation that said we really think there's some things that need to be done to make the system of protecting human subjects better, we appreciate that this fits into a larger world. We appreciate where we are here. These are the one, two or three things that we think need your attention -- need critical attention. And that what we are asking is that within those kinds of limitations, is it some progress that we can make in those areas. And one of them would be the one you just pointed to, which is outcomes and less on paper. I agree with Phil, by the way, about not only will you have to allow about inconsistencies across agencies given the differences in agency missions; you're going to have some inconsistencies even further down the line as well for not all bad reasons. Some will be bad, some will be acceptable. and I think I would change the thrust of what we're trying to do. Because the important point is not to be laughed at. The important point is to say this is serious, and we understand everything. And these are the areas that need work. And I would -- that would be my tone. And I don't think this quite captures the tone. We've done that in some of the recommendations where we were able to do that, and that's what I would do. CHAIRPERSON FADEN: We can do that here. That's a very good suggestion. MS. KING: So what we should be clear in at this point is what are the -- remember now, this is tough. You cannot have everything. What are the things that we think are priority -- some of the most important things for us? CHAIRPERSON FADEN: I think what we can do is -- again, it's not only what do we in general think as individuals or out of our other experience, but out of the experience of this Committee. And out of the experience of this Committee, which gets you to point two which also can be argued for and more in the tone you describe, is this focus on outcomes? MS. KING: You don't learn what you need to learn about the human subject system and how well it's functioning or not unless you get in there and do the sort of thing that we did. And that's the sort of -- that's the priority. If there was a single message for me, it would be that. Think about redoing the limited resources you have for oversight, and focus on this monitoring that looks at something hard rather than -- MS. KING: So, I would drop the language that said we think you should do a national survey. See, because they might decide to do a targeted survey. I mean, there may be any number of ways that they can accomplish what we want them to do. What I've been troubled with has been if we specify it and it can't be done in the way in which we specificity it, -- CHAIRPERSON FADEN: They won't do it. MS. KING: Right. CHAIRPERSON FADEN: Right. So the idea is we can use it as an illustration. MS. KING: Right. CHAIRPERSON FADEN: These are things that we did. We learned a lot, and you could do this, you could do something else. But the point is focus on outcomes and evidence that matters and not on pieces of paper. MS. KING: Pieces of paper. CHAIRPERSON FADEN: Right. MS. KING: Right. CHAIRPERSON FADEN: Or their equivalent. Even pieces of paper that are -- Jay? DR. KATZ: Well, we don't really have to justify it, but I would -- CHAIRPERSON FADEN: In the mike, Jay. DR. KATZ: Don't ask me to justify it. I would eliminate recommendation two on the survey. We shouldn't be blinded by our survey, because it was done by special kind of people who had a special interest in mind in terms of what we wanted to find out. It was as well done as such a study could be done. I feel there's dangers to doing these kinds of studies because unless they're really very carefully done, they shouldn't be done by -- you would have to specify much more how they should be done. They shouldn't be done by personnel who are close to the research establishment or kinds of other things -- Pat already said do we really want the national survey -- if you have a national survey, you get such superficial data from which you will only learn things -- this is a very problematic proposal for me. CHAIRPERSON FADEN: I think we can take your concern and put it together with what's just been raised and say that we have a recommendation that's going to focus on a certain thing. And we can use illustrations. What I meant -- I want to just for the record sort of correct two pieces of paper. We looked at pieces of paper too, but it's not just making sure the pieces of paper is there. The difference is between an oversight thing that just says ah, the piece of paper is there, you check a checklist. It's looking at the piece of paper, evaluating it, making judgements about it. And hopefully, in some cases, going beyond the piece of paper. But that's the kind of distinction that we want to communicate. And we don't have to, and Jay's properly right -- properly in saying that we probably shouldn't stipulate this is the way to do it because if we do that, then we're endorsing whatever might happen in the future. And who knows how it might be done. But rather, simply say there are all different ways to do it, and the point is that what's going on now is not enough of this kind of thing. It's too much of another kind of thing, as best as we could figure it out. Is that okay? We got it. That still leaves -- and this is the big -- two big areas of page three. And this is important. The sanctions question or however we want to phrase it. This speaks, Reed, to what you were raising earlier about from now on people have to know that somebody's behind your butt and the stuff is real or whatever the language we want and the concern that have generally in hooking this all up. So, I'm not -- you know, obviously this is a first cut, but the notion is how do we want to think -- can you explain basically what's in here for -- the background and what's in here for everyone so that they can understand what's at issue here -- what's now permissible and doable and what is not? MS. MASTROIANNI: Right. The current sanctions under the common rule are withdraw multiple project assurances, research funding, or suspension or termination of IRB approval of research. That's -- if there is -- I also heard that in extreme cases, I think it was once in the last -- I don't know how many years, ten, 15 years -- they did debar an investigator from receiving federal funds because of a violation of informed consent or violation of the common rule. We heard comments -- I think one from Ruth Macklin in particular, who focused on the sanctions that were available under the Office of Scientific Integrity. And I've also heard from Committee members that violations of the animal research regulations are -- of the statute are far stronger because they include criminal or civil penalties. So this was an attempt to incorporate all of that into one. DR. STEVENSON: To be clear, the animal violations are probably the most strongly sanctioned next to scientific -- MS. MASTROIANNI: I'm not clear yet on scientific integrity. If you know. CHAIRPERSON FADEN: In the mike. DR. STEVENSON: The sanctions against scientific fraud or that kind of thing are usually losing funding for a period of years. I mean, it doesn't take much to trigger it. MS. MASTROIANNI: Sounds like much less than -- CHAIRPERSON FADEN: I mean, the bottom line is we don't have this nailed down entirely yet. But it does look like the -- both the opportunity or the options available for sanctions and the implementation mechanism for sanctions are weakest with respect to violations of human subjects stuff relative to scientific integrity and animal stuff, which are other relevant areas for consideration. So one recommendation might be to try to at least have a kind of parity so that if you -- these are all of a piece with respect to the ethics of science. And that there ought to be somehow comparable mechanisms for that kind of -- I'm not expressing this very felicitously, but that's the general notion. DR. KATZ: I haven't reviewed the animal regulations for 15 years, but when I last reviewed them, it was quite clear that the animal regulations are much more stringent than the human regulations. So we might propose that human beings should be included under the animal -- should be classified as animals and be included under the animal -- (Laughter.) CHAIRPERSON FADEN: Well, we are. DR. KATZ: -- regulatory structure. CHAIRPERSON FADEN: Pat? MS. KING: One -- first of all, if you're going to make something like this, just do a recommendation, you have to be sure of all your facts. CHAIRPERSON FADEN: That's correct. MS. KING: I would not take what Committee members -- two, I rather suspect that what we have here is different and abling -- CHAIRPERSON FADEN: That's exactly right. That's what this is going to. MS. KING: And so that the act is in fact an act of Congress. I rather suspect -- and I haven't looked at this in years -- that the authority with respect to researchers and institutions is coming through the general authority when you give grantees money. CHAIRPERSON FADEN: The general assurance. MS. KING: General assurances when you give -- so it's not at the level -- there's some enabling legislation somewhere back there, but it is very broad. And you're seeing the endpoint. This looks a little bit like some of the civil rights enforcement. And I want to point out because of that that civil rights enforcement through agencies as distinct from the Department of Justice often looks like this. You lose your money. So be clear -- be careful about some of the comparisons. CHAIRPERSON FADEN: Right. MS. KING: You lose your money. There are independent constitutionally based sort of provisions and statutes that allow private citizens to do different kinds of things. And so, this is not -- this is a murky area. And it's murky even when we use comparisons from integrity and animal research -- I think they're relevant. Because my first thought was we've talked a lot about civil rights in here and human rights and stuff like that. When you look at that, the pattern looks somewhat similar in some ways. But I think that this is a doable area because it doesn't take a lot of money. CHAIRPERSON FADEN: Right. MS. KING: So if we are clear and specific about the underlying facts on this, this one has a possibility. So what I'm saying is we've got to make sure it's absolutely accurate, because it doesn't take -- CHAIRPERSON FADEN: In fantasies, you know, Anna's been working hard trying to get this -- MS. KING: Poor Anna. I don't know how she does anything. CHAIRPERSON FADEN: -- for the last two days. But the bottom line, if we can get the sense of the group -- is if we get the -- I mean, it maybe that statutory authority is required or something needs to be -- which we -- I mean, something's got to change probably to get this. But if the general sense of the group is we would like to make a recommendation that would allow for a sanction structure that was more akin -- you know, more appropriate to the seriousness with which we hope that the general community and the government takes human subject protections, and we want to be working out something that's better than what they've got now. MS. KING: This should technically have some mention that we're looking at for what government's can do. But as in other areas, research subjects -- the question of whether research subjects, for example, could sue if they didn't give valid consent themselves as a sanction against the investigator and the institution should be a part of the -- because it's very difficult for them to do that. CHAIRPERSON FADEN: Well, we need to point that out. MS. KING: Need to point that out. Because that makes what we're talking about here -- CHAIRPERSON FADEN: More important. MS. KING: -- more important because that is unlike some of the other areas where there are private rights of action. CHAIRPERSON FADEN: One of the things we started with, and this is in here but not explicit enough, is we started out with this notion of what to do if -- wanting to make a strong statement for the future where if it should ever happen again that a person is used as a research subject without that person's consent and the person is not harmed. And the point there is go sue somebody -- what are you going to sue them for? You're going to get -- you know, nothing. So it really -- that emphasis needs to be made. And unless it's made clear that there's some other consequence that occurs from using a person without that person's consent, there's certainly no malpractice thing hanging over people's head unless the person was harmed as well. But otherwise, it's a big whoop about nothing. And so, it really -- this is to emphasize the importance of Pat's point -- we need to say this is why the government sanction structure has to be clear and heavy. Because there are not other good recourses for individual citizens. MS. KING: Now to make your life really tough, there is currently pending litigation where the people suing claim that they were research subjects where the institution -- if I -- don't hold me to the total accuracy of this -- where the institution says they were not where we have had government actions. So the issue is not only sanctions from my point of view about where we clearly are in something that somebody has labeled research, but -- and you might look at this litigation -- but in an area where the label that has been placed on the activity is something else. CHAIRPERSON FADEN: Well, this gets back to one of our core -- MS. KING: Right, is something else. And what is available where you have IRB review, where the -- or you didn't have IRB review because nobody called it research. But in retrospect, when we go back, it should have been sent to the IRB. So add that to -- I think that's actually more -- we won't get into it. But if you could look into that, that area should be covered as well as the violations. CHAIRPERSON FADEN: Do we have a sense of the group that we want to say something about this and once we will formulate what we're going to say once we get a clear statement of exactly what is needed to change what's currently going on. The last thing before we go onto observational studies is a -- this is a recommendation that points to an observation that is generally -- is sort of generally made all the time, that the current structure such that it is does not reach beyond federally funded research. This is a generally big problem -- formally reached. Depends on the incident -- that someone needs to be paying more attention to the fact that lots of -- I mean, it's -- MS. KING: Well, it's tricky though, because you've got assurances it does sometimes. DR. STEVENSON: Well, I mean, it's not complete. I agree. So we have to fill in the gaps. But if you're doing activities and the institution has signed a general assurance, they have to sign on all their research. MS. KING: I know, but the trigger is is it called research? So if the activities are conducted with an institution and it's within an institution that has signed a general assurance, and if the activities are not labeled research -- if they should have been labeled research -- DR. RUSSELL: Is there evidence that that's a big problem out there? MS. KING: There's at least one -- there's pending litigation on at least one of these. DR. RUSSELL: That's not convincing to me as evidence of a problem. MS. KING: Well, it's convincing to me that it is something that should be included because this is not -- would not be an easy to get litigated unless as happened with the animal research act undoubtedly. Those who had a special interest in the problem started trying to -- started trying to make the litigation. And that's what started to happen. So we'll find out if it's a big problem or a little problem. I don't think we really know. CHAIRPERSON FADEN: All right. I think this recommendation that we would make is just again enforcing the course basically. It's just -- somebody's got to take a look at the fact that there are problems. I mean, the FDA has a reach to drug research and so on. But increasingly, this is a murky area and we've got to -- it would be nice if somebody looked at it. Yes, Eli? DR. GLATSTEIN: Did we do away with the ombudsmen idea? CHAIRPERSON FADEN: For the ombudsmen -- was for the openness recommendation. DR. GLATSTEIN: I was thinking about the idea of some sort of source panel, resource panel, to which the IRB's could turn. CHAIRPERSON FADEN: Oh, there is a -- we did away with a recommendation that there should be some kind of body that follows us because the group did not reach consensus on that. What we do have -- DR. GLATSTEIN: -- something from the IRB's themselves to turn to. CHAIRPERSON FADEN: What we do have is a recommendation in the IRB part that says look, there are these large policy issues and they remained unresolved, and IRB's can't figure them out. And there has to be some mechanism -- by implication, one might be the creation of a body or a commission or whatever. But there has to be some -- realizing that these issues are enduring and -- both old issues that are enduring and new issues will emerge, and they are not appropriate for resolution at the local level is in there. It maybe is not exactly what you want, though; so maybe you should take a look at it and see if you want to pose different language. DR. GLATSTEIN: Where is it? CHAIRPERSON FADEN: It is ten -- no, it's 11A or 11B. I can't remember which. Which is now in its new form going to be its own recommendation because we said we'd get rid of these as A, B, and C. DR. THOMAS: It's 11B. CHAIRPERSON FADEN: Thank you. DR. THOMAS: Page 37. CHAIRPERSON FADEN: Okay. With that, can we go on to observational studies? And there, we have the memo from Duncan, which you might -- I've got to find my little pieces of paper here. And we have the two residual issues connected to it, which is what we want to say about the risk of harm and what we want to say in the recommendation for the Marshall Islanders. Steve, do you want to come join us while we do this? Okay, we're open on Chapter 12. Comments? We have Duncan's before us. DR. THOMAS: This is a tough one, because the latest draft has been so extensively changed since the last one. And it remains in flux. And there are still issues of fact which the staff is pursuing. I'm not quite sure how to go about this discussion, so my comments here were an attempt simply to lay out what several of us identified as the key outstanding issues based both on our own deliberations and some further discussions after the Marshall -- the testimony that we heard Monday from the Marshallese representatives. Some of these, I think, are big issues and some of them are not so big issues. And I think there's probably a couple that I have forgotten. I think Eli raised -- Eli or Jay, one of you raised a point with me which you're going to bring up. And I'm sure that's not the only one I've forgotten. Speaking for myself, the big items are numbers one -- the resettlement -- the experimental nature of the resettlement claim. And I'm hoping number two, our failure to even mention the Bikinians is a small one that's easily fixed. But I don't feel like I have enough command of the facts to know the answer to that one. Number three, I think is another big issue which we need to confront. But it may not be all that difficult to do is Steve is in agreement with me. But I call it a big issue because it is the fundamental change from this draft relative to the previous one. If it turns out that we're in agreement on this point, well then it's not such a big difficult. And I think -- and let me just take a quick look at the other three issues -- that they're not so hard. A recommendation let's defer -- that's item four. Number five, the food chain stuff, I'm going to let Steve speak to because I think he understands the question better than I do. And number six, I think is one which should be particularly troubling to us as an ethics panel, this issue of cultural insensitivity. But I also feel like documentation is going to be tough to come by, and there may be very little bit more that we could say about it. CHAIRPERSON FADEN: Shall we -- let's see if there are reactions to this by the group director. Would others like to speak to either Duncan's comments or other dimensions of the chapter? Nancy? DR. OLEINICK: Well, as usual, Duncan has done an excellent job of summarizing for us a rather long luncheon discussion afterwards -- after the lunch. I think that it is particularly troubling because there are so many sort of unsettled issues at the moment. And somewhere, we're still looking for information. I'm particularly troubled about this issue of the cultural insensitivity because it does actually go to the ethics of the investigators. But there are allegations again -- this is a question of allegations being made, and can we document them. Is there anything in there in the paper trail that would help us to come to some conclusion? I think this is a very important issue that we need to -- we need to have whatever information is available so what we can reach some closure on it. Steve, have you gotten any further information? MR. KLAIDMAN: No, but as of either this afternoon or tomorrow morning, I might have called a professor at the University of Hawaii who I'm told may know where the anthropologist who did some of the translation in the early days -- where he may be. And if we can turn him up, at least we'll have somebody to talk to about this. The documentary evidence is almost nonexistent. DR. OLEINICK: Can I continue? CHAIRPERSON FADEN: Sure, you've got the floor. DR. OLEINICK: There was another issue that I don't think was touched on in here unless I missed it. One of the other points that was raised by the Marshallese was the issue of getting accessibility to their own medical records. And I think something maybe ought to be said in the chapter to lead into the recommendation on that. Because they brought up the issue that those who were residents of the -- I think the high exposure atolls were the ones who were taken to Brookhaven and other points in the United States. And that those from the lower exposure atolls were taken to Guam to a Naval hospital. And they have had great difficulty -- those who were taken to Guam have had great difficulty in accessing their medical records there. And I guess there's a question about why certain of them were taken one place or the other. But I think the issue for us is the accessibility to their medical records. And I don't know what else we can find out about it at this point. CHAIRPERSON FADEN: Can I raise a general problem sort of in defense of how we're going to get this done? DR. OLEINICK: Yeah. CHAIRPERSON FADEN: There is a big concern that -- it's very awkward that it -- much of what we understand about the experience we have heard in testimony or discussion with representatives for the Marshall Islands, and some of these points are either not verifiable or not -- ever -- or not approachable during the life time of this Committee. And so, we have to think about how we want to deal with -- these are troubling things, and we're worried about them, and we hear about them, and we don't want to act as if we didn't -- we weren't told these things. But we were told them, and that's the only -- and with no basis to believe that it is an accurate account. But at the same time, it's like in some respects we have to recognize this is testimony. Now where this testimony and documentary evidence was -- or testimony and other scholarship is another story. But it's a big problem in the writing of the -- in figuring out how to approach the chapter. DR. OLEINICK: But it goes to the issue of -- this one is particularly -- well, this one -- the reason I'm bringing it up is because we have a recommendation on openness, and this is just something that sort of needs to be said. CHAIRPERSON FADEN: Right. DR. OLEINICK: And I don't know whether we have any documentation on this. We may not. CHAIRPERSON FADEN: We've got Pat and Jay and I think Duncan wants to come back, if that's correct. I'm just putting that in because it makes writing this very difficult. DR. OLEINICK: Absolutely. MS. KING: I have huge pragmatic concerns not only about this, but about the whole report. And I'm not even the chair, thank God. (Laughter.) But I am a member, and I guess I have some pragmatic concerns about myself as well. But I don't know why this has not occurred to me before when we had some of these issues -- the assumption has been that the only way we can do good is to get a lot of this in our report. And that's certainly one way of doing good. But there is absolutely no reason why the chair of the Committee, with our blessings, cannot sit down and pen a letter to -- it used to be the Interior Department. I don't know who it is now -- that says these matters were brought to our attention. We did not have the time and resources or whatever to look through them, but we are particularly concerned and the cultural insensitivity is a good example. And sensitivity is a very good example of the things that reasonable people would be very concerned about. And we can't do anything except this is what was told to us, but if we were in a position to do something, we would have followed up on it. Which is to raise it to a different level of concern. That's one alternative out there on the table. The other alternative is to propose a lot of this as pass through, except I actually think the letter to the relevant official is likely to be seen more than this -- to do a pass through in the recommendations that we currently have. We have a lot -- either in forms of the chapter or in terms of the recommendation itself. I wouldn't make any additional recommendations for a lot of reasons. Most of them being the timeliness. But I also think that we need to think about other ways that we might be able to try to achieve our goals without having to actually keep the rewriting of the report or overloading report. So those are some other alternative ways of handling this that I think might be appropriate. And maybe somebody can go through and decide some are of more critical importance that others, and perhaps should be handled in a different fashion. I'm not opposed to that either. CHAIRPERSON FADEN: Also what you suggest is not mutually exclusive. MS. KING: No, they're not mutually exclusive. CHAIRPERSON FADEN: Both could happen. Jay? DR. KATZ: Well, I found this version much too sanitized. I appreciate -- MS. KING: Jay, are you talking about the chapter or Duncan's comments, just for clarification? DR. KATZ: No, no, the chapter -- MS. KING: Okay, thank you. DR. KATZ: -- of the Marshallese chapter. MS. KING: Thank you. DR. KATZ: And I talked briefly with Steve about that. For example, it seems to me to be almost self-evident that during the course of the examinations of the Marshallese, because this was dual purpose, and medical examinations for the research purposes and also for therapeutic purposes that inherent in the -- there had to be conflicts of interest, and it had to be problematic. And we have some evidence that I don't find anymore in this draft, if I read it correctly, that even the investigators commented on the reluctance of the Marshallese to have -- to undergo these examinations. And they talked about giving them placebos. They talked about giving them trinkets as happened in Tuskegee. And this in a sense indicates that there was something amiss here, and something of a miscommunication between the investigators and the population at large. If they really were only coming for medical purposes, they might not have even considered trinkets and placebos. If they didn't want to be examined, they might have let them go, etc., etc., etc. And Steve's statement may be quite correct in the report, and I wouldn't -- it wasn't in the first draft and should be in this draft that maybe nobody was really physically harmed by these experiments and that should be highlighted. But there were all kinds of things going on that be concerned about in the rest of the report I think should be highlighted and emphasized. And I want to share one story with you that made a great impact on me yesterday told us by the -- I think by the senator from the Marshall Islands. He was talking about the extraction of teeth. And he -- and I was greatly impressed with all of them, because they didn't make any wild accusations. They said they don't really know whether these teeth had to be pulled or did not have to be pulled. They wondered, because some of these teeth were -- only had cavities -- that maybe they could have been filled rather than pulled. But be that as it may, and these teeth were also pulled from children in order then to -- and they were taken away in order to examine them for research purposes. And some of the children felt very sad. Because the custom of the Island was to take these teeth when they fell out to throw them in the lagoon and for the sharks to eat them. So that then they would grow stronger teeth. And that opportunity was taken away from them. I was touched by this. And I can't say anymore, but I think that chapter should somehow reflect the spirit of this draft and the last draft. I don't like the present draft. CHAIRPERSON FADEN: Did you want to respond, Steve? Duncan is waiting. MR. KLAIDMAN: Yes. I'll keep it brief. Jay, what I've heard we made in this version of the chapter was to draw a distinction between research that had as its goal the advancement of science and research that had as its goal the detection of radiation effects, possible latent radiation effects, to the clinical management and care of the patients. The best we could tell by looking at each example that we presented to us by the Marshallese of research that was potentially directed at some basic science goal, was that there was at least a plausible explanation related to the clinical care of these people. And with respect to the placebos and trinkets, there is an equally plausible explanation that because the population did not understand the purpose of the clinical research was being done, a short hand -- or if you even like, slight of hand -- solution to that problem was to provide the trinkets and the placebos so that they would think something was being done for them, something was being given to them. We can't find a clear cut explanation that rules out that these explanations are plausible. DR. KATZ: When I don't show up at my physician's office, he never gives me a trinket. CHAIRPERSON FADEN: I've got Duncan and then Lois and then Henry, and then we've got to go to the corresponding recommendations and findings. It's continuing the same discussion, but I just want to make sure that we spend some time on not only chapter but the findings and recommendations from out of which this will come or whatever. Duncan? DR. THOMAS: Well, I share Pat's anxiety about how we're going to finish this. It's a very practical concern. And my priorities for this chapter have always been to keep it focused on questions that have something to do with research. And so, -- and secondly, to focus those on which there's some feasibility that we can make strong statements based on the documentary record. And much of what we've heard, it's impossible to document, and we can do no more than serve as a pass through. Those issues which we think are important, I have no problem with doing just that. And I actually -- it had never occurred to be before Pat's solution of setting aside certain issues saying we took -- we can't address these things. And yet, they sound important to us and somebody else ought to do it. So with focusing our energies in the little time remaining to finish this job, I think we need to keep our eye clearly focused on what are the research questions. And for that, I think we have to come to closure on this question of do we see any examples of non-therapeutic research in this population. And the two which were footnoted in the earlier draft, I think are the two which -- I mean, I'm sorry, in this draft -- are the two which come to mind. And I think they need to be given much more prominence. And then I think we need to confront once and for all these allegations that the purpose of the resettlement was itself a grand experiment on human subjects and give the Committee's take on it. So, I have offered some language at the end of paragraph one here which attempts to do that. And I'd like to see some discussion in the Committee as to whether or not they're prepared to endorse that last sentence that starts "In my view." CHAIRPERSON FADEN: And that was the interpretation in the chapter before this. DR. THOMAS: That's right. And that entire discussion has been removed. CHAIRPERSON FADEN: It's important to say -- DR. THOMAS: Let me mention just in passing, I suspect that similar issues may well -- with the resettlement of the Bikinians. But I'm just so far removed from this area that unless this is something that we can quickly get up to speed on, perhaps a call to Jonathan Weisgall or something -- I don't know. But I suspect it's a big problem. And we best not wade into it. On the other hand, it really seems to me difficult to not even mention the Bikinians someplace in the report. And I'm hoping that there's an easy way out of it. And I'm hoping that the easy way out of it is to say really there was no research connected with Bikini, and that's how we get out of it. But if that's not in fact true, then we've got a dilemma. CHAIRPERSON FADEN: Let's do two things. Steve, do you want to respond on the Bikini thing, or something else? Because I would like to hear other Committee members on this one point. MR. KLAIDMAN: Just very briefly on the Bikini thing. As far as we know, there was a nine month follow up. We don't know anything about the details of it. And Jonathan Weigsall certainly has a store of information on this subject, but he is also the lawyer for the Bikinians. CHAIRPERSON FADEN: We have problems. We have -- DR. THOMAS: I wasn't proposing using him as a source. CHAIRPERSON FADEN: No, we have problems all the way around here. But at the same time, I think that those problems don't prevent us from communicating much of what we've heard for other people to hear as long as we do that same thing and say, you know, this is not us talking, this is what was told to us and we didn't -- you know, we couldn't pursue it. But you can have a flavor of how -- it gives people a better flavor for sort of what's at issue. I think it's important what Duncan has brought to our attention. It is basically a conclusion, if we go back to the chapter beforehand, that we did not see evidence of an experimental agenda behind the decision to resettle. DR. THOMAS: My evidence for this, which is in this, is that this was a question which had been widely debated in the United Nations and elsewhere. And I think all we need is just a few citations of the fact that these positions were being made for other reasons, and then we're home free. CHAIRPERSON FADEN: Is that agreeable with everyone, rather than leave it uncommented upon? MS. KING: That's easy, but I want to get it clarified. Because when I read Duncan's sentence as a conclusion, this is very different -- I read your sentence as a conclusion, Duncan. And that's very different from citing to the work of other people who independently may have reached that conclusion. So what are we proposing here? DR. THOMAS: This is an expression of my own conclusion that I draw from it. MS. KING: Okay, are you proposing -- DR. THOMAS: And I don't know whether the rest of the Committee is prepared to sign on to it. It's one which I offer with some disquiet, because I have to admit that I don't know all of the facts. All I have -- I have looked at each of the memos that's been offered in support of this claim, and I find them personally unconvincing. And I'm more persuaded by -- CHAIRPERSON FADEN: In support of the claim that it wasn't experimental? DR. THOMAS: Right. And I'm more persuaded by what I have heard about the other things that were going on that formed the backdrop to why this decision was made in the first place. So I'm giving you my personal opinion, but -- and it's a suggestion for how we could resolve it. CHAIRPERSON FADEN: Perhaps the better way to go about it initially would be to reinsert the paragraph, and then indicate here's what the evidence is in support of the interpretation that this was done intentionally in order to conduct this field experiment. And here's the evidence that that's not likely to be the case. And then depending on what it looks like, other people can -- I can circulate it very quickly -- say how many people think that the evidence stacks up in a certain way or not. You can either just lay it out there or not. MS. KING: I can tell you now what I'm likely to do without even seeing the paragraph. And this is the way my thinking goes. Take it back from the top again. The mandate evidence -- I have no problem with laying it out on both sides. I don't think we were asked to make a judgement about that question. So, I'm not going to make a judgement about that question. And part, it is because it's a big question, Duncan -- as Duncan himself is indicating. And I appreciate his honesty. I also appreciate his position, and I also appreciate his position -- and even though it might be a different version -- take on the facts in my mind if I looked at the same evidence, it is one of those areas again where when you make a big conclusion like this, you ought to be damned sure that you're dealing with careful discussion about evidence. And I get uncomfortable because this is -- this has been the source of years of discussion, years. And I think that we should -- decades -- that we should be careful. So my view is that we have not -- this has not been sufficiently front and center for us, and I'm not going to take on that big issue. I otherwise have no opposition to Ruth's proposal about laying out the evidence. I think we should as we understand it. We should lay out both sides of the evidence. I have no -- absolutely no objection to doing it at all. I agree with Duncan, but things that are -- and the footnotes should be pulled into the text. I don't disagree with that. I also would need a lot of discussion, Duncan, if in addition to the first sentence we were talking about the second sentence as well, which is that it would have been quite unethical not to monitor -- okay. DR. THOMAS: In all honesty, -- MS. KING: I don't take a position. I just think we have -- I haven't discussed it. DR. THOMAS: I think if we're going to be honest about this, we have to acknowledge that the record is unclear on this point. MS. KING: Right. DR. THOMAS: And the Committee was not entirely persuaded of -- that there was not a therapeutic -- I mean, an experimental intent. On the other hand, I'm trying to craft the words very carefully so we don't fan the fires of -- I mean, if we were to come -- if we were to light a new spark where it says, you know, we think maybe there was an experimental purpose, there might have been an experimental purpose. I mean, the explosion which could result would be quite serious. So we have to be very cautious in our wording. CHAIRPERSON FADEN: Right. Moreover, we don't think -- I mean, the evidence is not clear -- DR. THOMAS: Controversy, yeah. CHAIRPERSON FADEN: -- and it points in the opposite direction. We need -- but I think that if I can -- I still have Lois and Henry waiting. On this particular point, I take it that all of us are agreeing that we do need to comment and say something, because that is an issue that people might have expected us to look into. We've done a little bit with work -- the work is what it is. We are not resolving the question. We are showing what we -- sharing what we have found on this subject, and it is not conclusive what we have found. DR. THOMAS: And I think we've looked at basically all that anybody -- no matter how hard we had worked on this problem -- CHAIRPERSON FADEN: All right, we may say -- DR. THOMAS: That's it. CHAIRPERSON FADEN: All right, but the point is, as Pat points out, we were not asked to call it, I don't think, on this one. We could choose to call it if we wanted, but I think we should move -- DR. THOMAS: -- it was meant to look at experiments, I don't see how we can weasel out of it. CHAIRPERSON FADEN: No, we're not. I mean, we're going to address it. And then we're going to -- I mean, I -- DR. THOMAS: That's why I said it is definitely very much a part of our charge. DR. KATZ: One question for Steve. What about the allegation that they cannot get their medical records which they made again to us yesterday? MR. KLAIDMAN: Yeah, that's one we need to continue to pursue. They claim, among other things, that they were initially told that many of those records were destroyed in the famous St. Louis fire. They say they've now been told that those records were not destroyed in the fire, but their requests for them have not to date been honored. And I have asked them to please give us the entire paper trail of their requests for their records so that we can cite that documentary evidence for the fact that they have been looking for these specific records indeed perhaps as part of the rationale for our recommendation. DR. KATZ: Can we make a phone call ourselves? MR. KLAIDMAN: Yes, of course. DR. KATZ: Not to the Marshall Islanders, to the -- MR. KLAIDMAN: It's more than one -- DR. KATZ: -- keepers of the records? MR. KLAIDMAN: It's more than one phone call, Jay, because the records come from numerous agencies. They come from -- DR. KATZ: But even if -- from two places? MR. KLAIDMAN: More than two places. DR. KATZ: Because in my discussions with them, that was an important request for them. They wanted to have the medical records because they feel, rightly or wrongly, that there's all kinds of medical suffering to which these Marshall Islanders are exposed. And they want to have these records, and they can't get it. They say they don't want it for litigation purposes. They want it in order to take better care of their health needs. Can't we do a little bit about this? Maybe hire somebody? MR. KLAIDMAN: Well, we can certainly try. I mean, I -- DR. KATZ: Because even if we get two agencies to tell us that they've been slow on -- CHAIRPERSON FADEN: Jay? DR. KATZ: -- providing these records -- CHAIRPERSON FADEN: This is in line with what Pat suggested. I'm very happy to write letters to heads of agencies. It would be very helpful if I had the documents that said we have the copies of documents that were sent to you requesting these records, and it is our understanding that the Marshallese have not yet received their records. We would appreciate your looking into this matter. So it's all of a piece that we have this before in other context for other people who have come to us in terms of trying to write letters and help that process go along. And certainly in the case of the Marshallese, we can do that too. So that -- we've got Lois and Henry. Lois? MS. NORRIS: I shouldn't take long. And actually, Jay's comments lead into this. And this may come under more of a factual nature. On page two of the report, lines 16 and 17, and on page three, lines one and two, we discuss the levels of exposure of the Marshallese. And the way I read it, it appears as if we consider that these levels are very low. And particularly on page three, where we discuss the continuing exposure, are these low levels given the fact that we have a food chain ongoing? MR. KLAIDMAN: The food chain question is an interesting one. We spent about an hour with the Marshallese in which they spent a good part of the time talking about food chain exposure. And they told us how the Northern Islands got the major exposure, that they make the best dried bananas, and that's shipped throughout the island so that everybody is getting this food chain exposure. They told us stories about contaminated copra that have been dumped into the lagoon and so forth, Majero. What they cannot tell us and what nobody seems to be able to tell us is what level of exposure we're talking about, what kind of contamination is involved. And until -- and if somebody can find out that kind of information, it's very hard to say anything about the continuing risk that results from food chain exposures. MS. NORRIS: But we have said something. Not much, but we have said something -- relatively low for the Marshallese. I mean, to me, that's saying something. DR. THOMAS: It's possible Steve Simon can provide the answer to that one. CHAIRPERSON FADEN: Okay, we've got Henry wanting to come in. I think it's sort of on this point, but -- DR. ROYAL: We have very good data on what levels of internal contamination the Marshallese had. The whole reason they were sent to Brookhaven National Laboratory was to be put in whole body counters to find out how much internal contamination the Marshallese had. I don't personally know what those numbers were in the early years, but those numbers should be available. MR. KLAIDMAN: They're arguing about the continuing contamination. DR. ROYAL: Yeah, in terms of the continuing contamination, the National Academy of Sciences just published a report that I sent Jay the executive summary to -- maybe in 1994, in which they addressed this question about whether or not it was -- whether or not they were going to be able to meet the memorandum of understanding. And the memorandum of understanding states that the United States Government has to assure that no member of the population that's returning would be exposed to greater than 100 milligrams per year. And there's a very detailed analysis of what the radiation doses would be from internal contamination. MR. KLAIDMAN: On Rongelap and Utirik or elsewhere? DR. ROYAL: It would be to return to Rongelap and actually live there and have all their food come from there. MR. KLAIDMAN: And Rongelap presumably would be the worst case. DR. ROYAL: The worst case, yeah. MR. KLAIDMAN: So that would be very useful. DR. ROYAL: If you're not familiar with that report, I can send you -- MR. KLAIDMAN: Please do. Yeah, please do. CHAIRPERSON FADEN: Yeah, I think that's important. That's a very important thing. At the risk of -- I mean, what I think is coming out is a sense that this chapter will change and have some material reintroduced of the sort that was just discussed. But if we could go while we're on the subject -- it's the last two things we have to do -- finding 16, we had put off because we wanted to discuss what we wanted to say about the Marshallese and the uranium miners. If we could look at finding 16, which is in Chapter 18, and then we have also to do the corresponding recommendation for the Marshallese. But if we could do finding 16 first. And I must apologize, my memory is only that we decided that we weren't going to do it. We weren't going to discuss that part of the finding that bore on the Marshallese until we had this discussion about the chapter. So, that's all I remember. And I don't remember anyone's making any other comments about the finding other than raising some concerns and then agreement that we should wait until we discussed the problems with the chapter as well. One issue I remember that was raised was the Japanese fishing crew, that we shouldn't have it in the finding if we don't have it in the chapter. So that's an easy fix that -- and it would seem inappropriate not to mention that they were also exposed as they were. That would be quite a biggie. So we will make sure that it is mentioned in the -- unfortunate -- you know, the tragic event that there were Japanese citizens as well as Marshallese citizens as well as American servicemen who were exposed. So we've got to fix that in the chapter. DR. ROYAL: The name of the fishing boat, by the way, was the Lucky Dragon. CHAIRPERSON FADEN: I remember that, yeah. Some act, whatever -- irony. Okay, so now the -- for those people who are not pleased with the finding, if you would like to -- or would like to change the finding. Ruth? Is Ruth having another conversation? Should we listen or would that be wrong? (Laughter.) I have to say something funny to Lanny while he's here. I got your laptop, Lanny. I don't know if you know that, but when you stopped working full time, I got your laptop. And there was a letter to your mother on your laptop. (Laughter.) But I didn't read it. I didn't read it. I'm teasing. I'm teasing him. So this is in the order of that same level of -- we won't listen to Ruth's conversation, and we won't read Lanny's letter to his mother. I don't even remember if that's accurate, but it struck me that -- I don't know if it's accurate, Lanny, but it struck me that we needed a little laugh sort of at your expense. Okay, finding 16. What has to change or stay in finding 16? I have a note here that the line that bothered people was the no mention of the food chain or something. Exposures as a consequence of the 1950 test, which obviously refers to the Marshallese and the Japanese and the servicemen who were substantially in excess of the amounts permitted by then governing safety rules. Is that how we want to express what happened with respect to harm -- risk of harm? The first paragraph speaks to the miners, and then there's this one sentence on the Marshallese. You don't like it? DR. THOMAS: Well, if it's risk of harm, there's -- I'm sorry. CHAIRPERSON FADEN: Lois, why don't you go ahead? MS. NORRIS: I was just going to say I had the same feeling. I don't how to fix it, and I don't know what to suggest. But it seems to me that we have all this language and then this one statement that just -- in there. I don't know what to offer, however. DR. THOMAS: Well, I have a suggestion. Since the heading of the finding is -- it's risk of harm, it seems inappropriate to talk just about exposure. But this is a situation where there is extensive epidemiologic evidence, and we do know that there is substantial excess of thyroid cancers. So I think we should just say that. CHAIRPERSON FADEN: What -- by the way, if I understand this, we decided we were going to get -- all these headings were going to go. Pat, you object? You think even headings like this could be misleading? Better not to have any kind of heading at all? MS. KING: Which -- CHAIRPERSON FADEN: We're on -- just if you see how the finding -- MS. KING: I turned to the recommendation. You're talking about the findings. CHAIRPERSON FADEN: It's easier for the reader if there are little labels on the findings. Is the concern with the -- MS. KING: I think for the reasons stated yesterday -- CHAIRPERSON FADEN: You think it applies to findings? MS. KING: -- never create, if you can avoid it, you never create ambiguity -- situations that lead to ambiguity in what you are trying to say. If you think that it's really important to say it in some instance, I can't say anything. That's a general principle. CHAIRPERSON FADEN: Right, I was just checking to see if you thought that went to findings as well as to recommendations. MS. KING: Yeah, I think that it's very hard. CHAIRPERSON FADEN: I think it's very -- MS. KING: Unless they're exact, that -- CHAIRPERSON FADEN: -- comes lifted -- okay, clause gets lifted, right -- from a clause. I certainly think you're right with respect to recommendations, because the short hand of the recommendation could give a very different impression than the longer statement. But I suppose it's true for findings as well. MS. KING: But that's true for findings -- I mean, I'm from the legal tradition where judges do findings and then they do conclusions of law -- findings of fact and conclusions of law. And they would both be critical in terms of what you're trying to do. CHAIRPERSON FADEN: The reason I say -- the only reason I raise it now, Duncan, is that don't be too troubled by what the title says. Don't feel limited by the title, because it's a mish mash as you think about it, and we're trying to just express did any bad stuff happen. DR. THOMAS: But what belongs in this is some statement about risk of harm. CHAIRPERSON FADEN: Right. DR. THOMAS: And exposure doesn't do it. CHAIRPERSON FADEN: Well, especially since with respect to the uranium miners, we speak about people having died from cancer. And we were going to change that language a little bit. Somebody was going to help us. The conversation is coming back to me that on the -- the line that says exposure, as a consequence would be changed to something about that there were -- DR. THOMAS: Well, see, that sentence is fine as it stands. CHAIRPERSON FADEN: Okay. DR. THOMAS: But then, since it's a very brief paragraph anyway -- CHAIRPERSON FADEN: Right. DR. THOMAS: Add another sentence which would summarize what we know about thyroid cancer risk. CHAIRPERSON FADEN: What about if -- and if it was the case that one of the Japanese fishing crew members did in fact die, that should be noted. Especially if we're talking about deaths with the uranium miners. Again, it would be infelicitous to not note that a Japanese person had died. DR. THOMAS: But then perhaps we should also go on and clarify that these were as a result of the exposure, not as a result of medical studies. CHAIRPERSON FADEN: Oh, yes. That would be true in both cases. But that's true in the uranium miners as well. I mean, they didn't die from the public health study. They died from their continuing exposure. DR. THOMAS: Right. CHAIRPERSON FADEN: We want to make it clear in both cases that the interventions that were part of the follow up studies, the mortality was not as a result of the interventions connected with -- I mean, I think that's obvious, but we better make it plainer. We should make it plainer. So I'll make a note to that. Nancy? DR. OLEINICK: I believe they were also acute effects, burns and so forth, that probably ought to be mentioned, because they certainly are harms from the exposure. CHAIRPERSON FADEN: So we want to say that they were -- in the case of the Marshallese and the Japanese fishing crew and presumably the servicemen as well -- DR. OLEINICK: Yes, presumably. CHAIRPERSON FADEN: -- that there were acute effects, excess cancers, thyroid cancers, and one -- at least one or two deaths. I guess there was the child who died. MR. KLAIDMAN: In the case of the servicemen, we know of no acute effects, and we know of no latent effects. We know of no effects in the case of the servicemen. They were looked at at Trippler Army Hospital in Hawaii. No effects were found. CHAIRPERSON FADEN: So we should -- were they followed? Do we know? MS. NORRIS: They were never followed. MR. KLAIDMAN: Well, yeah. We know more than we knew before. There was a general call put out in 1978 or '79 for anyone in the military who had exposures of more than 25 rem. Of the 28 of them, 12 showed up for examinations at that time. And the best the Defense Nuclear Agency can tell us, they were not seen again. So that was the only follow up. DR. OLEINICK: They were what? MR. KLAIDMAN: They were not seen again. They were not followed up after that 1978 or '79 -- CHAIRPERSON FADEN: And at that point, they had no illnesses that -- MR. KLAIDMAN: They had no illnesses attributable to the exposure at that point, correct. CHAIRPERSON FADEN: We'll have to figure out how to say this in short hand. DR. OLEINICK: That should be stated. CHAIRPERSON FADEN: Yes, at least in the chapter. DR. OLEINICK: Not necessarily here, in the chapter. CHAIRPERSON FADEN: At least in the chapter that should be stated. They'll just say what happened to the other 20 or the other 12, however. DR. KATZ: I've never followed up on this because I thought that they had data on this. It's too bad now, but last year I was in Ohio and at a dinner at the medical school, and I talked a little bit about our work. And afterwards, one of the medical deans came up to me and he had been involved in the evacuation of the Marshallese. And he was surprised by what he learned from me, because he had developed thyroid disease a few years ago and was treated for it. The doctor didn't find out what it was all about, and he had no idea until I talked to him about it. And some of his friends with whom he had been in touch, his Army buddies, also had developed thyroid disease. And it would have been an interesting source of follow up information. I just filed it away in my mind. CHAIRPERSON FADEN: Can I summarize what's happening with -- oh, I'm sorry, Eli. DR. GLATSTEIN: Just on that finding, would it be wrong to add at the end of the last sentence in the bold print that after about the uranium miners, observational studies conducted by the government, even though the high risk of radon induced lung cancer was known at the time by AEC and PHS officials. Is that incorrect? MR. KLAIDMAN: To my knowledge, that's correct. DR. GLATSTEIN: I would like to see that added in there. Beg your pardon, I didn't hear. MS. KING: I'm sorry, I said I was -- I said I'm silent on this stuff because I raised real problems with the chapter in a discussion of what we say and how we say it about the PHS and AEC. And so, I'll wait to see what it looks like. That's all. CHAIRPERSON FADEN: I think -- you mean, my discomfort, Eli, I mentioned about adding that sentence. But my discomfort is that this one sentence about the uranium miners doesn't do it for me as a -- DR. GLATSTEIN: That's why I'd like to beef it up a little bit. CHAIRPERSON FADEN: I'm not sure that that's the sentence I want to add. But it says the uranium miners continued to be exposed while they were subjects in observational studies conducted by the government. I don't know why we need to say -- and the more I think about this finding, the more I don't understand why it's written this way. Although, I participated in every iteration of the rewriting of it this way. (Laughter.) And that is, we start -- why it's comparative. Why it should say the Advisory Committee finds in our view the most severe exposures. Why can't the finding be that the uranium miners -- that a large number of uranium miners died, and that's it. And that there were excess thyroid cancer deaths around the Marshallese, that they had acute effects, that a child died, that Japanese sailor died or fisherman died. DR. ROYAL: I'm not sure that they were -- to a cancer death. CHAIRPERSON FADEN: I'm sorry, excess cancers. I'm sorry, so we had acute effect -- I mean, just have the finding be that, rather than some sort of relative statement about exposures. DR. THOMAS: Yeah, I like that. CHAIRPERSON FADEN: I mean, just lay it out there. That's the finding. The finding is uranium miners died, -- DR. GLATSTEIN: I would feel better if we beefed this up, yes. CHAIRPERSON FADEN: -- Marshallese were made ill, a child died, and Japanese fisherman died. And that's what we found. MS. KING: And that's a fact. CHAIRPERSON FADEN: Those are what we found. And I think it's easier to say that than -- I think what was bothering you is this sounded so flat. They continued to be exposed while they were subject -- and big deal, so what? And then the meaty stuff, the tragedy is in the unbold part that hundreds of them died. DR. GLATSTEIN: Yes. CHAIRPERSON FADEN: That's the part that is -- all right, so if it's agreeable to everyone, -- it's taken me long enough. If we flip it over and then -- you know, the text underneath it is almost unimportant in some respects, because the key thing -- you said it all, is that's what happened. Lois? MS. NORRIS: What I haven't been able to find is I think being said about the millers. And we do have a recommendation which involves the millers also, don't we? CHAIRPERSON FADEN: Well, what we have is -- what we're now going to do is say something in the chapter about the exposure of the millers. And the recommendation says somebody should take a look and see whether the millers were -- it's my understanding that we don't know if the millers -- what the impact or experience of the millers or their dose was. So it's not like they belong in this finding, because we don't have any finding other than we have a recommendation that someone should -- attention should be paid to the plight of the millers. Is that accurate? DR. THOMAS: Yeah, let me just try to clarify it for Lois, the situation with the millers. The primary concern for the millers is exposure to uranium ore, not to radon, per se. Radon being a gas that tends to disperse, and it will accumulate in confined spaces like underground mines, but not in the open pit mines or in mills particularly. There will probably be some radon exposure, but the major concern is with uranium exposure, which has some toxicity associated with it as well -- as well as radiological toxicity. Very little has been done so far in terms of epidemiologic follow up, although there is some of the millers. But I, for one, don't know enough about what has -- what the current state of knowledge is about their risks. It's there mainly because we've heard a lot of testimony from the millers. And so, this is in the spirit of sort of a pass through, as we've been using that terminology. CHAIRPERSON FADEN: Can we go to recommendation nine? That's our last piece of business, and I now feel totally vindicated in making us have an overpriced lunch, because we actually -- well, we certainly could have benefitted, as Jay said, from being locked away for another hundred years. We at least -- you know, met minimal expectations for what could be accomplished. DR. TUCKSON: Minimal? CHAIRPERSON FADEN: Major expectations for what could be accomplished in a not quite three day meeting. Pretty extraordinary. So if we could, turn to recommendation nine, which we also tabled. That is the last -- this is the only recommendation or finding that has not been the subject of group discussion at this meeting. So let us have it now. And it is about the continuation of the program for the Marshallese. MS. KING: One part of the recommendation I have trouble with, I don't think pass through should be recommendations. And the second part of this recommendation on the next page does go to the question we discussed before about access to documents. CHAIRPERSON FADEN: Yes, it says look into it. MS. KING: Because this says this all comes from testimony. So that part, I do have some difficultly with. CHAIRPERSON FADEN: Do you have trouble -- because the recommendation says that the government look into the matter. MS. KING: No, I -- it's a problem with where the basis -- maybe it's written wrong. CHAIRPERSON FADEN: Okay. MS. KING: This says the Advisory Committee has heard testimony indicating the following. And then we say somebody look at it. I have a real problem with turning that into a recommendation, which is what I assume it is. And some of the places where we've done pass throughs I have been really much more comfortable if we started giving detailed discussions about what we've learned. I mean, I -- CHAIRPERSON FADEN: I'm sorry, I guess I'm confused. MS. KING: I'm sorry, Ruth. CHAIRPERSON FADEN: I just want to get clear on what the objection is, because I think it's fixable. MS. KING: On page 21. CHAIRPERSON FADEN: I know exactly where you are. I think it's fixable. I'm just at a loss. Is it the language of the way it -- MS. KING: If this is the fact, this is an accurate statement, we heard testimony -- CHAIRPERSON FADEN: Yes. MS. KING: And this is what the testimony was about. And that we -- what we're really saying is we think somebody should look into this. CHAIRPERSON FADEN: Okay. MS. KING: Then I have trouble making that a recommendation. That's what I said. Now, it may be that this is not -- that there's more here than what's stated. DR. THOMAS: Pat, if they provide us with this paper trail, which Steve has requested, documenting their difficulties, would that alleviate your concern? MS. KING: Not as a recommendation it wouldn't. Because my -- this is not about the specific recommendation because it involves the Marshallese. This is about targeting -- putting your ducks in a row and hitting hardest with what you've got and trying to accomplish a lot of other things as well. And I think I've been consistent on saying that the recommendations should go with where the Committee is making its strongest points. I have trouble making my strongest points on testimony that we heard. I don't have any trouble trying to take account of the testimony that we've heard, trying to facilitate, trying to do a lot of things. That's really what's coming through here, Duncan. Nothing else. CHAIRPERSON FADEN: At the risk of really opening up a can of worms, elsewhere we had dealt with it as a recommendation. MS. KING: I know, I know. CHAIRPERSON FADEN: I mean, we basically said the recommendation is we -- would somebody please take a -- we didn't have the chance to look at this, would somebody take a look at it. MS. KING: Right. CHAIRPERSON FADEN: Because we're troubled by these concerns. MS. KING: And I keep -- I agree with you, Ruth, and you're absolutely right. And two, as an overall -- when you start to take a look at the cumulative effect of we couldn't do this, we couldn't do that, we couldn't do -- it starts to look not like I want our recommendations to look at the end. And so I'm really searching -- I didn't mean to raise -- CHAIRPERSON FADEN: No, I understand. MS. KING: -- any big slam at anybody. I was simply trying to keep my eye on the big overall ball, that's all. DR. THOMAS: No, I'm sympathetic, Pat. And it's not quite clear to me where this is in my priorities. I want it done. I don't care how we do it, and I don't want us to drop the ball on it. And I would be quite content to have it done by means -- by this device that we've talked about of having Ruth write a letter. CHAIRPERSON FADEN: But if we it here, in fairness, we should do it all these other places where we've got it. So I think it's a matter of going through the report. I may be that we want to do it two ways, though. I can do it by a letter on behalf of the Committee, which you could all circulate; or it could be a letter from the whole Committee, however we wanted to, whatever. But I think we can also maybe keep it here but maybe not bold it or something. So that in some way, it changes -- MS. KING: That was going to be my alternative, that it became a part of the discussion after -- in the deliberation. CHAIRPERSON FADEN: Right, and we can do that in each case so that wherever we have one of these where it's passing through testimony and asking for others to take a look at it, that it doesn't take that same form as a recommendation that we're making which is based on our own -- is that agreeable with the Committee? I mean, do we realize what's going on? We're saying that we're -- what we are asking is based solely on testimony which has affected us because -- you know, we have every reason to believe that what people are telling us is correct, and we're really overwhelmed by the emotion and the intensity behind this. But the reality is, we haven't been able to do anything other than hear this testimony. That that be in the relevant section, but in non-bolded language. MS. KING: That's fine. CHAIRPERSON FADEN: That would -- it's still there, but it doesn't take on the same character, and it can also be augmented by letters that come from me or the whole Committee. Is that agreeable? Okay, is that agreeable? All right. Then we're now up into the main recommendation nine for the Marshallese. And would people please take a look at that? Duncan? DR. THOMAS: Okay, I have two comments. The first is a problem with the last sentence of the first paragraph, because I think it just needs more specificity by what we mean by standard of care that would be acceptable to most Americans. And I guess my main concern is it reads like we're asking for general medical care for everything. And it's -- I don't think that's our intention. I'm sure -- CHAIRPERSON FADEN: I frankly think that sentence should go. I think that first of all nobody knows what that is. If we knew it, then we would have figured out one of the major problems in health care policy today. (Laughter.) All right, which is another thing that if we knew what this was, we would have solved the health care debate crisis awhile ago -- a long time ago. So I think it does nothing other than shoot us in the foot. So if it's all right, I don't think we should say anything on that point. DR. THOMAS: Oh, we're you going to elaborate on that one? Because I had a completely unrelated point. DR. OLEINICK: No, no; I have no comment on that. No, go ahead. DR. THOMAS: Okay, my other unrelated point is that the last time we agreed that we were going to add a recommendation that the Marshallese should be involved in further research planning, and I have some language to that effect in point four. CHAIRPERSON FADEN: And that would be that if there is to be further research involving the Marshallese, that -- DR. THOMAS: Yes. CHAIRPERSON FADEN: -- the Marshallese be involved in the planning and implementation. DR. GLATSTEIN: Yes. CHAIRPERSON FADEN: I don't think -- was that agreeable to everyone? MS. KING: I'll lodge a reservation. I have to think it through. CHAIRPERSON FADEN: Okay. We don't have the language anyway. But the general spirit which I will try to capture then -- you've got language, Duncan? DR. THOMAS: Well, it's not really language. I mean, there are a few sentences, but they're more in the spirit of a discussion of the problem. CHAIRPERSON FADEN: Right. But the issue -- I mean, there are so many resolutions and recommendations and policies out generally in the research community about the needing to involve the research world literature about the need to involve the community that you're studying and the planning and the conducting of research, that this is not -- you know, this is a kind of recommendation that can be wrapped up in a lot of that stuff. I mean, it's not -- MS. KING: But it's not done that way. It's done in a case where we have a long history of back and forth and back and forth, and this -- and this is why I've got to think through -- I am very concerned that we get into taking sides. If this was an issue about which the Committee was making a general statement, that would be one thing. This is not. It's in the context of the Marshallese recommendation. And that is what is giving me problems. I don't have any problem with -- CHAIRPERSON FADEN: The general principle. MS. KING: -- the general principle. CHAIRPERSON FADEN: I know. MS. KING: It is that -- you know, the way the real world works, if you get your foot inside, you're an advocacy group. You've made it five steps up. And I understand that, and I've got to think about that in terms of how I feel about the report. That's simply what my reservation is. I've just got to think it through. DR. THOMAS: Well, here I'm reacting against decades of paternalistic approach to research -- MS. KING: I understand, yeah. DR. THOMAS: -- in this particular population. MS. KING: That's the other side. DR. GLATSTEIN: Your point six in that cultural insensitivity would be investigators. CHAIRPERSON FADEN: Which again, right now -- DR. GLATSTEIN: And I -- CHAIRPERSON FADEN: That's, you know -- all right, if I understand this then, the first part of the recommendation which apparently not an unwelcome one on all sides, if that is correct -- is that the medical program be continued. Everybody seems to want that. And I don't know that we'll help a lot with that, but we would want it too for the Marshallese and the -- well, there's also things in the context of a budget cut. But it is not anything that anybody is -- you know, no one would like to see -- I don't know of any group, either in the government or certainly not among the Marshallese -- we have not heard who wants it to go away. But like any other program, it is -- you know, vulnerable. Now, in the context of budget cutting -- and the next one is a fairness issue that says if it can be turned out that -- if it turns out that some of the other atolls had exposure similar to those that are included in the program, that as a matter of fairness they should be included. But we are not saying that in fact they did or didn't. Which is -- MR. KLAIDMAN: Well, we're actually taking in an atoll that is not included in the program, saying that the exposure on that atoll is something lower than the exposure on Utirik or maybe equal to and recommending that any other atoll that had an exposure at that level be included in the program. So that's a little bit of a difference. CHAIRPERSON FADEN: Thank you for the clarification. Little bit stronger -- thank you. But the general principle is one of fairness. If you sat the standard, it ought to then be applied to any group within the Marshalls for whom that standard is satisfied. We didn't set the standard, but we're just pointing it out as a -- DR. ROYAL: I actually thought I heard Steve say that the radiation dose was lower on -- MR. KLAIDMAN: There's a range. CHAIRPERSON FADEN: Okay, I mean, I am confused. I should be quiet. MR. KLAIDMAN: But the final report of Operation Castle gives a dose of 6.14 Roentgens, which is derived from a series of aerial readings. There are a couple of other sources. The first one was taken days after the exposures, which was 20 Roentgens. And I believe there's one other that's in the range of 15 or 20. And that's what we have. DR. THOMAS: I guess my concern is that we don't have comparable kinds of data from Utirik and Ailuk, and therefore we can't actually make a comparison and say that Ailuk was as much, as close to, more than, less than Utirik. MR. KLAIDMAN: We do have comparable data from the final report of the Castle series. The -- and I don't recall those numbers. But the Ailuk number for -- in that final report is lower than the Utirik number. DR. THOMAS: Do you recall the Utirik number? MR. KLAIDMAN: No, I can't remember the Utirik number at this point. But I think it was 15, but I'm not certain. DR. THOMAS: Well, let's look into it, because I do have some reservations about making these comparisons just based on an aerial survey. CHAIRPERSON FADEN: Well, I am confused then about what were recommending -- now I am confused. So I want to hold back too and see -- I really don't know what we're -- DR. THOMAS: I think we need to research this one a little bit more. MS. KING: What I understood you said -- what I understood Ruth to say, and I know still it's on the table, but that -- which I would agree with, that fairness says treat similarly -- CHAIRPERSON FADEN: That's all it is. It sounds like it's more complicated. MS. KING: And I have no difficulty with that. Let me say this, that if it turns out that we're having trouble with the similarity, what I actually would do with this recommendation would be not to recommend that the program -- but I think that it would be -- if we can't do this, we should -- what we want to do, I think, since something led to this, is we want these two islands -- we want at least to be looked at for inclusion. So in the going back and doing this, it may turn out to be the strength of which we make the statements is the issue, rather than making the statements. Because here, we recommend that it be explicative. CHAIRPERSON FADEN: Right, so the issue is if it's something more complicated than a simple fairness claim -- X is like Y; Y gets it, so X should get it -- which is what I thought we were doing, so I apologize. I did not understand what's going on here. If it's something more complicated than that, then we treat a bit and say it looks like they may be similar or close or comparable or whatever, and they deserve to be looked at too. Because it may well be that on further examination, the ought to -- it is a similar -- relevantly similar and ought to be included. So it would be one formulation or the other. Is that agreeable? Okay, now we have hit a little dilemma. I said the first day of the meeting no special comments, because we're going to be working -- we're not saying goodbye now. Forget it, it's the last public meeting, but we've got so much work to do that it's sort of not fitting to do anything like that. However, Phil is coming to close us at 3:30, and he -- we have two more minutes. We told him to come at 3:25 just in case we ended a little bit early. (Laughter.) Dan could close us, but I think Phil wants to close us. So -- DR. GLATSTEIN: He wants to get rid of us? Is that what you mean? CHAIRPERSON FADEN: So if we -- I think he want -- I mean, this is the last public meeting of the Advisory Committee, and as he -- in the role that he's had in relation to the Committee, I think that he would -- so if we could extend him the courtesy, and if we could wait for just a moment or two. If he doesn't show up after 3:30, we'll have Dan close us. How would that be? Is that -- Nancy? DR. OLEINICK: Since we have a minute, one thing that I would like in looking at all the recommendations is for all of us to be able to stand back and look at the recommendations as a package. We have a lot of recommendations out there. And so that -- my request is rather simple. That when the revised Chapter 19 comes, we get one print out that has only the bold text, and leave all the explicative material aside, but just line it up -- number one, the Advisory Committee recommends -- CHAIRPERSON FADEN: And you want to see it that way? DR. OLEINICK: I would like to see it the other way also. CHAIRPERSON FADEN: Right, both ways. DR. OLEINICK: But just so that we can come to grips with what it is we are recommending as a package and findings maybe also. CHAIRPERSON FADEN: We can do that. Yeah, I think it would be helpful. We can get -- it's kind of a Committee at a glance. DR. OLEINICK: Yes. (Laughter.) CHAIRPERSON FADEN: I've got it. DR. OLEINICK: Here it is. This is what we were all about. CHAIRPERSON FADEN: Right, Committee at a glance. I understand that. That's important. Reed? DR. TUCKSON: Just in terms of what we do get from this point, what actually -- CHAIRPERSON FADEN: By Monday or Tuesday, you're going to get Chapter 19 and Chapter 18 Tuesday. Or by Tuesday -- Tuesday or Wednesday, you will get Chapter 18 and 19 redone the way Nancy has suggested it, but also -- and substantively redone in the context of this discussion. There may be a few holes like the notification one, which is unlikely not to be resolved by Tuesday, but it will be there. Okay, that will be the first thing. And then we're going to be shooting stuff to you continuously -- absolutely continuously. So we have a sense of what Committee members want to be working on what chapters, Anna? DR. ROYAL: Yes, we signed up. CHAIRPERSON FADEN: You signed up? That's all taken care of? MS. MASTROIANNI: Yes, yes. CHAIRPERSON FADEN: Okay, so we'll be shooting this to you continuously. And the other thing we agreed is that you're going to be getting redline versions. And here comes Mr. Caplan. DR. ROYAL: Ruth, will I be able to go on vacation this summer? CHAIRPERSON FADEN: Ask Mr. Caplan. MS. KING: Can I ask something, Ruth? CHAIRPERSON FADEN: Yes, of course. MS. KING: And that is, that in your planning for what you're doing now, it was enormously beneficial to be able to read this report, even though in its current state from beginning to end I saw things I had not seen before and made connections, many of which I've shared with you, that would not have been possible focused chapter by chapter. I only ask that you do your best and try to give us an emerging date so that we can set some time aside -- CHAIRPERSON FADEN: When that will be ready. MS. KING: -- that is important critical read. Okay? CHAIRPERSON FADEN: All right, so what I think I'm hear -- okay. We can accommodate those, but we will -- MS. KING: I understand your troubles. I'm not -- you know, making an absolute or that kind of stuff. CHAIRPERSON FADEN: You're right. MS. KING: It's something very important when we do that. CHAIRPERSON FADEN: We've been waiting a whole minute and a half. But we just want you to -- you know, we've been waiting a whole minute and a half for you to show up, Mr. Caplan. When we're done, we're done. I mean, when we have to leave, we have to leave. MR. CAPLAN: This is the end of a -- close to the end of a -- very close to the end of a long, hard road. And I am not allowed to speak for the President, but I know that he -- if he were here, he would thank you all very deeply for everything you've done. And we're very close to getting a final report. And I know everyone is very anxious to not only get the report out, but also not have to come to Washington every month for a meeting and sit in a hotel room for three days. But I thank you, and I know a lot of people around the government and the country thank you. And we're very close to being done. On -- oh yes. As the designated federal official for --(laughter) -- the final meeting of the Advisory Committee, I hereby declare it closed. (Whereupon, the proceedings were adjourned at 3:31 p.m.)