ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + PUBLIC MEETING + + + + WEDNESDAY, MAY 10, 1995 + + + + The committee met in the Terrace Room at the Doubletree Park Terrace Hotel, 1515 Rhode Island Avenue, N.W., Washington, D.C., at 8:30 a.m., RUTH FADEN, Chair, presiding. COMMITTEE MEMBERS: RUTH R. FADEN, Ph.D., M.P.H., Chair KENNETH R. FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA A. KING, J.D. SUSAN E. LEDERER, Ph.D. RUTH MACKLIN, Ph.D. LOIS L. NORRIS NANCY L. OLEINICK, Ph.D. HENRY D. ROYAL, M.D. PHILIP K. RUSSELL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN THOMAS, Ph.D. STAFF: DAN GUTTMAN, L.L.B. JEFFREY KAHN, Ph.D., M.P.H. LANNY KELLER STEPHEN KLAIDMAN ANNA MASTROIANNI, J.D. JONATHAN MORENO, Ph.D. RON NEUMANN, M.D. GARY STERN, J.D. I N D E X Opening Remarks, Ruth Faden, Chair .............. 4 Discussion of Part IV of Draft Final Report: Findings.......................... 4 Committee Strategy and Direction .............. 146 Discussion of Part IV of Draft Final Report: Recommendations--Looking Backward ....... 190 Meeting Adjourned ............................. 284 P R O C E E D I N G S 8:35 A.M. DR. FADEN: Good morning. Pat and Ken are expected and Mary Ann is here. But I think we should plunge in. Might as well start. We have -- I'm a little at a loss. I've been thinking about two or three different ways in which we can orient the day. We have identified three chapters that we're going to discuss -- however, in some cases briefly -- and we have the situations that we must do, the findings which we must at least discuss and oh boy, as much as anything, we have to figure out how we want to operate over the next final period and I want to make sure that we have time to do that and I want to make sure that we have everybody. So can I just get a quick sense? The meeting is scheduled to end at 4. Is there anybody that needs to leave before 4? Okay, that will help me. Thanks Nancy, if you would check. It will help me to know. 3:30? Okay. That helps me to figure out how to use the time. I think -- okay, at 3:30, so we lose two people at 3:30. Here's my proposal. Jay had a comment that he would like to make to fit into, I guess, bring closure, a little bit of closure to the discussion yesterday about how to interpret the findings of the research review project. And we can start with that. I would then propose that we try to do one or two chapters, briefly, before the break and at the break, depending on where we are, switch to situations, the situations 1, 1A, 1B, 2A, 2B, that stuff. And then after lunch, begin with the discussion of where do we want to go from here, how do we want to proceed, all of the practical questions of committee process and operation during this incredibly intense period. Anna, will we have the work plan after lunch? Copies for everybody. So there's a tentative work plan then that has been developed for the staff of what's going to happen by what week, by what week, so we can see it. It's intended to make us all panic, raise our anxiety level, make us feel stress, that's a function of this. We'll do that after lunch and try to come up with a way of proceeding, including a decision about when we want to meet again and whether we want to meet once or twice and how we want to handle the question of outside review. There has been some debate within the committee about how to approach that. So all those sorts of issues I would like us to do immediately after lunch, as well as a quick rundown, the list of the chapters, since we will not have talked about every one of them with the simple rating scale: good, bad, awful -- we'll come up with something. Real quickly, this is not in bad shape, this is moderate, this is in awful, so that we can get a sense from each individual and collectively where we have to put our greatest energies since we won't obviously won't get to every chapter. And then if we have time, I would like to return to the beginning of the discussion that we were having very fruitfully at the end of the day yesterday which was a kind of spontaneous discussion about recommendations that each of us were prompted to consider, based on this discussion we were having about the research review projects. So if we can get back to that, that would be great. If not, in the process section, I'd like to begin a discussion of how we might, each of us, put down on paper suggestions for recommendations for the future or research review and protection of human subjects. That would be very important and we can figure out some way to reconcile it. So is that amenable to everybody? Please note in that that the flexibility is the number of chapters that we discuss collectively together. If we spend a lot of time on one chapter, we may end up only doing one of the three chapters that we've identified that we wanted to do, so that's not too subtle way of saying let's see if we can keep the discussion contained on the chapters. Okay, Jay, could you share with us? DR. KATZ: Yeah, I wanted to bring to your attention the case of In re: Cincinnati, radiation litigation which was decided by a District Court Judge in January 1995. It's a very interesting opinion. It contains also the view of where the Judge thought the radiation experiments, and he goes back to the Constitution, he goes back to all kinds of other issues. I think that case should be distributed to everybody because if you haven't seen it already, it will also serve as to -- it will also stimulate you to think about the kinds that Pat King talked about yesterday and the day before. Have you seen that case? DR. FADEN: Did we distribute it? MR. GUTTMAN: Yeah, I think we distributed it. DR. KATZ: It was distributed? MR. GUTTMAN: Yes, but at this point -- do you need another copy? Also, for the record, the Judge is a woman, but Dr. Katz uses "he." DR. KATZ: Oh, it's a woman judge. MR. GUTTMAN: Dr. Katz is politically correct using "he" instead of "she" where everybody else uses "she". DR. KATZ: My apologies. Look, since it's possible that we will not return to the protocol review issues today, I felt that I have to make a brief personal statement to all of you and then leave it and turn to other issues and I thank the indulgence of the chair to let me speak. We were charged with a task to tell the story of the Cold War Radiation Experiments to evaluate and to judge them. We were also charged to take a look at current practices to determine whether the rights and subjects of research are adequately protected. It was that part of our charge that intrigued me and contributed greatly to my accepting the invitation to join this panel. We have done an inadequate job to fulfill that aspect of our charge. We have spent little time on that task in the past. During the three day meetings, we gave one hour to it. The staff assigned to it are wonderful, but they are young and no senior people have been assigned to this task and that is, that also contributed to the problems that I see about that review. We were presented yesterday with some startling findings. In the overall assessment graph, we learned that in the greater and minimum risk proposals, 30 percent were rated 4.6 and 17.6 percent were rated 3. To me, these are striking, but not surprising figures. I appreciate that there are problems with our assessments, problems of statistics, problems of evaluating the data, etc. etc. but then again it is the result also of our inattentiveness to that aspect of our charge. We have discovered a vast array of documents that speak to the past and we have gone over them and are going over them in exquisite detail. What about the present? What about the 30 percent? In light of our dismay over the lack of disclosure, inadequate disclosures, inadequate consent, inadequate informed consent, etc. etc. in the past, we have talked endlessly of the morality of human experimentation, the ethos of the profession then, the ethos of the government and governmental agencies. We've done so from the '40s to the '70s. What about regulations? What about peer review in light of the 30 percent findings? I don't know what we can do in the remaining months. Perhaps we can still regroup as individual committee members and with a significant number of the dwindling staff members assigned to it, maybe we can do a more credible job. My strength is limited, but I plan to give as much time as I can to this project. But what I can do, depends on whether you agree that we must regroup. What I shall do, however, if it is necessary, as it seems to me it's likely now, to call attention to the fact in our final report that we have neglected, perhaps have had to neglect a most important facet of our work. This is not the time to rehearse what I shall say. For now, I only want to bring to your attention that I may feel compelled to be quite outspoken about this with respect to the 30 percent in an age of bioethics and an age of informed consent. With respect to what I consider to be wrong with the current regulatory scheme, I appreciate Phil's cautionary and wise remarks that anything I might propose may not stand the test of time or at least the test of people who will have to administer the regulations. That is an unending problem. But I feel an obligation to sound a warning to paraphrase Robert Browning in a different way, to say that God may be in his heaven, but not everything is right with the world of human experimentation. Thank you very much. DR. FADEN: Does anybody want to respond to Jay, except me? DR. ROYAL: I'd like to say that I share some of Jay's concerns. I remember the first meeting that we had. One of the questions I asked then was how were the radiation experiments different from other medical experiments, both at the time and today. And during our discussion yesterday, one of the things that we have to make a very clear decision about is whether or not things like the plutonium injection experiment really were some kind of unique aberration of biomedical experimentation or whether or not this is a reflection that doing biomedical experimentation in an ethical way is a difficult, complex issue that requires careful attention. And I certainly agree much more with the latter interpretation than the former interpretation. DR. FADEN: Does anyone have anything else? MS. KING: I actually do, Ruth, but I'd be quite happy to wait for the process part of the discussion this afternoon because that's what this triggers. DR. FADEN: That's actually a very good suggestion. Maybe I will do the same. I thank you for that thought. Anything else, Ruth? DR. MACKLIN: Yeah, I would only question and ask Jay to defend a little more the claim that we didn't do a good enough job given the time and the resources of the multiple charges. I mean we were constrained, obviously, by time, the time of the staff, the time of the committee and I mean the way you phrased the criticism, I mean, quite understandably, you feel and I would concur that much more attention should be given to the state of ethics in contemporary biomedical research, but to argue that it should be given is not automatically to conclude that this committee failed in its charge, since we had to allocate our time and the staff resources and the committee resources to all the things that we did. So I mean I think it would be -- to call for something else in the future, either by this committee and its remaining moments, or by some future committee, I think would be quite appropriate, but to be critical of the efforts that we put into it now that they're finished and the findings are there, I think doesn't give credit to the efforts that we made, given the constraints. DR. KATZ: I don't want to respond to that at length, I want to be brief. I feel, I do feel that we failed. I feel that I failed, that I didn't have the power of words to persuade you otherwise. I feel that we had to make certain choices and important choices. If I had been able to be more eloquent, I might have said let's drop -- for example, if you had to drop something, let's drop the patient review project. And -- DR. FADEN: Which one? DR. KATZ: The patient review project you heard about yesterday, the follow-up, the subject interview. I would have dropped the subject interview project. We can't cry over spilled milk. And put all the energies, money and resources and senior staff into the protocol review project. Be as it may, I feel I have failed and I think all of us have failed, but about this one can differ, but I will only state my own personal conclusion as I must. MS. KING: I deeply feel, as I said before, we should save it for the process part, but I have one suggestion. My personality definitely reflects how I respond to this report. I don't like spending a whole lot of time worrying about my failures or group failures about the past, or assessing it. I'd like to spend a lot of time thinking about what to do now. Is there a problem, there isn't a problem and if there is a problem the question is what to do. So I would like for every committee member to do is to figure out if they think there's a problem, if there isn't a problem, that ends the matter. If there is a problem, let's figure out where to cut, make those tough decisions now and concentrate on what we think we can do. I think that's what we should do in the process part this afternoon. DR. FADEN: Maybe we should have the process discussion now. I mean there's a way in which the order in some measure arbitrary, in fact, totally arbitrary. I was hoping to have the process discussion when everyone was here. We're missing Ken, but Ken will forgive us, I think. Reed is not expected. Jay's laid this out on the table. We might as well take it up. There are a lot of issues that need to be addressed unless others think it's not a good idea to start out with the question of process and how to organize your time and what to do next. We can just do it now. We don't have the tentative work plan, but you'll see it soon enough. DR. MACKLIN: I think we should discuss it now since this issue is on the table and one way of focusing on it is to ask what, if anything, could we do more than we've done that would -- I guess what I'm asking, Jay, specifically, not that would ultimately satisfy your desire for a thorough look, but to shore up what you seek to be the deficiencies and what we did so far. Given the remaining time that the committee has, what more would you -- what do you think ought to be done? DR. KATZ: I might be able to respond to it more by early next week, as I've asked this afternoon, I have some preliminary thoughts, but I have to talk things over with Shobita and Sara, if she's back, about some things that I would like to review. To begin with, I think we need some good senior staff members assigned to this project. That's condition number one. There are all kinds of things that need to be brought to the attention of the entire committee that I can talk to people about and then could be distributed to the committee for them to think about, not to accept, but to think through, or to reject. The resources that have been expended and currently are being expended under this task have just been too limited and I do not know how much more we can really do in the time remaining to us. If all of you have some suggestions that would be good to know also. I think in some way the 115 proposals in some way or another need to be reviewed once again, in my mind, because there are things that I think we can still learn from them that we haven't learned yet, etc. etc. There's a little work to be done. Whether we can do it or not, I don't know. DR. FADEN: Duncan and Ruth, did you want to respond? DR. MACKLIN: Let me take it one step further. I mean I'm really -- you're using general terms, Jay, and it doesn't help me. I mean I understand your feelings are strong, the terms are too general. Here, I'm going to put up three propositions and tell me if you think one or two or all three are what might have been done or should have been done or could still be done. I don't care which, past, present or should haves, whatever. First, a more thorough and detailed look at the protocols that we had and you just called for that. Second, a look at many more proposals than we did. Third -- DR. KATZ: No, I didn't say. DR. MACKLIN: No, no. You didn't say it. I'm asking -- DR. KATZ: No, no, no. DR. MACKLIN: The third might be a look at a wider range of protocols. That is, we had very many that were similar in many respects and a lot of the fours and fives were similar in relevant respects. What we didn't do is look at a whole range of different kinds of research that may have given a broader picture, either a better picture or a worse picture. I don't know. But just to get a handle on what (a) might be do-able, and (b) what you see specifically to be the shortcomings. You said no, you didn't think more. That is, we shouldn't have done ten times as many. What would we gain, in your view specifically, what would we look at and what would be - - what is there more specifically to gain from going back and looking at the 115? I'm not challenging you, but I want to ask what is it we want to look at? DR. KATZ: Look, as I said, I need to take a look. I'm willing to do that, as many of the protocols I haven't looked at. I haven't taken a look at. I think there is much more detail there that can be looked at. I wish there was time and I wish we had the energies and if you were to so decide, but that will then -- and not hear about quote end quote statistical problems, there are about 20 or 30 protocols that I've read that may not be part of the data base, that I could suggest that we should review and form some judgments about, because they're to my mind raise serious questions. But it may already be reflected in the protocols that we as a whole have reviewed. I have not seen the range of protocols that we have reviewed as a body. I've only seen the ones that I and Jon reviewed, except I think from what I heard yesterday, the first time I heard it, that many of the protocols that I reviewed on my own are contained in the data base. So at the moment, I have no idea yet what we can do with the existing materials. I may know better by the middle of next week, but the question is whether the committee thinks it is important. Secondly, I would want to inform the committee much more fully. Some of it is contained in some papers I've sent around, why I am concerned about the current federal regulations, what troubles me about them. We haven't had any discussion on that. Some of you are not familiar with them to the extent to which I'm familiar with them. You may not share my views, but that's a different matter, but these issues have never come before and I know -- you have your own views on the regulations and you know them as well as I do, but none of this has been before us during the past year. But that's all I can really say at the moment. DR. FADEN: I've got Duncan, Phil, Ruth, Henry and Pat and this is important so let's spend some time on it. I think we do also have to talk about other things. Jay, I have some comments I'd like to make as well, but I don't think I'm going to make them now. DR. KATZ: I wish you would. DR. FADEN: I really don't think I will at the moment. Duncan? DR. THOMAS: Jay, I don't believe that the present write-up begins to do justice to this incredible data base that we've assembled, both your work and the committee's work. I think much can be done to extract much more insight from the tremendous amount of work that's gone into this. That's hardly surprising given the short amount of time that this data has been in existence and I think it's a solvable problem within the remaining life of this committee. What I wanted to hear from you is whether you think that -- whether your concerns relate to the inadequacy of the treatment of the data that we have already; whether you think it reflects a profound disagreement between what your data is showing and what our data is showing. I certainly didn't get that message from the simple tabulation that was discussed yesterday in response to Nancy's question, but if you feel like there's disagreement between your ratings and our ratings of a particular project, that's certainly a profoundly important observation that needs to be explored in depth. Or whether it's that more data yet remains to be abstracted from the materials we have, for which we recall a moment ago you suggested that we ought to revist these protocols again and I don't know whether you mean to go back to the source documents and try to review them in greater depth, or just simply better to capture either in individual or summary form, the material that has already been abstracted. Certainly, among those proposals that I have reviewed, we made extensive comments where we felt the check boxes were inadequate to capture what it was that we wanted to say and I suspect many of those comments have not been captured in the statistical summaries that we've had so far. So what I'm trying to get at of you to see if it's a qualitative description or whether we just need to go further. DR. KATZ: I don't think that is my impression there is any great discrepancy between my review and the committee's review. My data might point to -- some greater percentage of problems than the committee found, but I think that's of minor significance. I think that what has not yet been captured in the present draft is also the richness of the findings, not only from what individual reviewers commented on, but to go back to these comments and flesh them out from the consent forms and the protocols, not to have no findings, but just to flesh it out and just let me say in passing, with time being short and really there is little opportunity, at best there will be little opportunity to go into considerable amount of depth, new depth, with respect to our finding. I plan to withdraw my findings from the committee report for other reasons as well, but I don't want to go into them as yet. And really concentrate right now in the remaining time on the data that we have and that we've reviewed as a committee, because after all, that is the official review and I can react to it in terms of the protocols that I reviewed that are the same as what the committee reviewed, to bring all kinds of other things to the group's attention. Maybe, but again, we have to make a judgment about it, it would be useful may be to take three or four of my studies and make some comment about them, but I think in the remaining time, it is much better and will be much more effective if we stick with the documents that we, as a group, reviewed. To my mind, they are sufficient to make the points that I would like to point. DR. THOMAS: I don't understand why you would want to withdraw the data that you've already contributed. That seems to be an invaluable contribution that adds considerable strength to the section. You want to do some different treatment of that data? DR. KATZ: This is not clear and maybe Ruth will enlighten us on this and I still do not exactly understand what is at stake, but I heard yesterday noon, so I'm still thinking about it, that HHS and other groups may have to be informed about the specific evaluations of research protocols. I reviewed these protocols. I've always liked to work except when things are out in the open. I've reviewed things and not identified institutions and not -- but identified problems. I undertook this task with the wrong understanding that I could, in terms of the work that I was doing, talk about patterns, document patterns. Not with the institutions being identified who submitted protocols to us and that troubles me a bit. DR. THOMAS: I thought that confidentiality assurance was part of the terms under which we reviewed this project in the first place. Aren't we constrained by our agreements that we can't reveal individual -- DR. FADEN: This is a discussion that's premature. It is most premature and not particularly helpful, frankly. We're trying to work out an issue that hopefully, that will not be an issue. DR. KATZ: If it's an issue, then things are -- DR. THOMAS: Let's hope that issue can be resolved. Jay, in my opinion -- DR. FADEN: Can we -- this discussion is totally unhelpful and in fact, inappropriate. If we continue with it, I'm afraid I'm going to be boxed into a corner and it's going to leave me no options. So if we continue around the course that Jay has introduced, we're going to run into difficulties that we potentially could avoid. I think at this point the only thing to do is move on to another topic or go into other issues of process and see if we can return to this later, because there's a lot that could potentially be avoided that might run afoul. This is a public meeting and we have everything open and public, but some things don't have to arise to a discussion because the problem disappears without ever having emerged. If we could just stop, that would be preferable. MS. KING: Are we going back to your original plan to discussing process this afternoon or can the rest of us raise issues? DR. FADEN: I think maybe we should go into other process issues, if we're on to process, since it will be hard to make a shift, I think, into a chapter at this point. It's hard to pick up chapters. So I had people on the list and I'm glad to go back to the list, but maybe we can just start up on the other process items in addition to the question of having to divide generally our time between the contemporary projects and the backward looking projects which Jay has raised, which I think is an important issue. I obviously take exception to Jay's characterization of our having failed in that charge. It strikes me it undermines the value of the work that we've done and Jay, if you want to say that our findings are useful, to say that we failed is kind of a contradiction and confusing to me. So either the work that we have done has utility and ought to be mined, or the work that we've done is useful and we should abandon it, but to call it a failure before the work is finished strikes me as odd and I would like to remind everybody in defense of that chapter that we saw yesterday, there were no findings. There was no discussion. It was the beginnings, the first cullings of the data, as it were. It was not presented as anything like an interpretation or a gleaning or a -- the whole section that you're most interested in, Jay, didn't exist in that draft. Now if there's a failure, it's that it doesn't exist at this point, but given that we've just now finished completing the reviews, I'm not sure what else we could do and I would just like to also underscore that as much as we all were committed from the beginning to a review of the contemporary world, this was not why we were set up and it was with a push and a pull that we got to do these projects. We had to fight to be able to do as much as we did. A fight is not the right word, but we had to be persuasive to get the room to go as far as we did and the resources. So at another level, I find that characterization troubling. The other issues that we have to address are outside review about which we have had some committee discussion. Meetings, we're operating on the assumption, as I mentioned yesterday that while we have not officially extended, as yet, that it is likely that that will happen, into probably no later than the first or second week of September and that will be final. Isn't that great? So we have to determine whether we want to have one more meeting or two more meetings or no more meetings. How do we want to use, how best to use the extra time and I did manage to get a version of the work plan. MS. KING: I have a different concern, it's similar to Jay's, but it's very different. DR. FADEN: Sure. MS. KING: I would like to put on the table -- DR. FADEN: Let's get it all out on the table. MS. KING: My concerns don't go to any particular chapter. My concerns go to report. And if my concerns are not shared, that's going to be fine with me, too, because one of the things I decided is that you can't get personally invested in this, but my sense of where we are is the following: we have a lot of chapters in various states of satisfactory completion. DR. FADEN: Correct. MS. KING: Running from some that look very good, that will need very little work, some of which at the other end of the extreme, parts of the chapter are in various stages of rewrite, but we don't even have because it's a mess. And my concern is at this point I have my views, but I don't think this is important. I think what is important is to be tough minded as a group and cut. Some chapters need to go, not because it wouldn't be nice to cover them. I'm not suggesting that. I think some chapters need to go because we should be giving the attention of the staff and the committee, given the time constraints, to whatever priorities the committee decides become priorities which I assume would be related to what the committee wants to stand for. I say that because having thought about it and taken a look at -- not all chapters, because I'm not superhuman, but I really made an effort this month to try to do an assessment in my own mind, simply because I don't think we can do -- we risk not doing well a whole report by trying to do too much with limited resources. And I don't mind stepping on a lot of people's toes to say what my candidates are for cutting. If other people aren't interested in that, I'd be very interested to hear if anybody else shares my sense of where we are, because if nobody else shares it, we don't have to establish priorities, we can continue to do what we've been doing which is to go full steam ahead and try to cover all of it. DR. FADEN: You're quite right that that responds to Jay's concerns. It's an issue of where do we put all of our resources, staff and committee. MS. KING: And I think it's not one chapter, which is what Jay points out which is my reaction to Jay's comment. There are many chapters that have things that are important to say and uncovered that should be said. There are other places where we could milk more, different kinds of data. I don't think that Jay's chapter is unique. I think that what we want to do, we can say a lot about the current set of regulations and what our preliminary views are about the future. It doesn't all have to be said in that chapter. This is a report. It's the whole report, so the question is what is the message that the committee wants, the central message that we have with respect to the whole report and then setting the priorities in terms of trying best to send the message that we want to send. And I'm most concerned with that because I don't want a year from now somebody saying, you stretched yourself so thin and go so jammed up towards the end, you know it doesn't come through right. That's what I think is the tragedy because I actually think we've done something quite well. I think we have some things to say that would be good to say and I want to be able to say them and I want to be very proud in those areas where we set those priorities that that's what we've done. Now I don't know how many other feel that way, from taking a look at the whole, if there's a need to establish priorities and cut off other parts. I almost had a heart attack when I looked at the remaining staff. I did, when I saw that list of who was leaving and who was left, I said these are wonderful people, but superhumans, they are not. How in the hell are they going to do this kind of stuff unless we make some hard decisions? DR. FADEN: Let me see if I can separate two senses. There are two issues of priorities. One is a strong sense of in order to do well, the entire report, the report has to be narrowed in scope, some chapters have to go. The other sense of priority that we have to debate now, does anybody agree, does the whole committee agree, do we have candidates for areas that would go? Let me just point out to you that we do have these companion volumes so that some things could be moved from the main report to a companion volume and that meaning it doesn't have to have as much -- obviously we can all understand what the difference would be in terms of how you would focus on a report chapter versus an appendix volume basically. The other issue is all the chapters stay or those that do stay, the staff needs a real quick sense which is what I mentioned earlier of what Pat said, the committee seems to think are in pretty good shape, those that the committee thinks that are in the worse shape, those that the committee things are in middling shape. For all the chapters that we made in the report, whether that's all of them and Pat's proposal is not endorsed, or Pat's proposal is in part endorsed and the chapters that remain. So those are two tasks that would be very good to do. Can we get response to Pat on whether any chapters that report the scope, I see Duncan and Ruth and Nancy on that point. Duncan? DR. THOMAS: For me, the experience of reading through the entire report was very reassuring. I came to this meeting very optimistic, feeling that the report was in pretty good shape, in fact. I find it hard to react to Pat's suggestion without hearing more specifically what chapters she's proposing to eliminate because I for one can't think of a chapter -- MS. KING: Uranium mines. DR. THOMAS: That's exactly what I thought you were going to say and I would react very strongly against that suggestion because I think there's some profound messages that need to be communicated in that report. I too am disturbed that half that chapter is not ready yet, but in informal discussions with staff, I'm persuaded that that chapter is do-able and will materialize in short order. You'll get it in a couple of days and that what we have so far is saying, is communicating the messages that I want communicated. So would not like to say anything dropped. DR. FADEN: So you're on record as not wanting anything dropped. Pat's proposed uranium mines. Are there any others on your list, Pat? MS. KING: Yes, but if everybody has this feeling that every time a chapter is proposed and one or two other people say oh no, I like it because that is the way the report, that's how we got where we are. We didn't think about what message we wanted to send and where do we outline a report to send that message. The way we got in this jam is everybody said this is my favorite thing. I'm guilty too. I don't throw things in excess and I'm not pointing at myself as well. We all have these favorite little portions and we say I would like to have mine and the rest of us that's a terrific colleague, good. And my view is we've got a report that's got every body's little favorite thing in it, including my favorite little things, by the way which I'm willing to let go. MR. GUTTMAN: We'll eliminate six more chapters by 2002. DR. FADEN: Actually, I think, Pat, for what it's worth, your comments are correct and I feel some responsibility for that. Ruth? DR. MACKLIN: My difficulty in assessing Pat's proposal is that the chapters are still at different stages of completion and therefore I mean I could understand it if they were all equally completed, whatever that might mean and we thought some of them just weren't good, weren't written well, weren't analyzed well, didn't come to a sufficient number of conclusions and recommendations, but there were one or two chapters that the whole committee is looking at for the first time at this meeting and I know we're raising a question about what might still be done, but I find it impossible to evaluate chapters for throwing out on the basis that they're not yet complete, as opposed to complete, but not good enough. MS. KING: I would use that criteria to eliminate. If the committee could figure out what it wanted to say, I would use that as my first priority and I would take a look at every chapter to see to what extent it furthers the central point that we want to make. The fact that a chapter is required by the mandate is the second reason that it must be kept. The third that I would take a look at is it is May 10th. This is roughly a 500 page report in print. It is in an unequal state. The fact that a chapter has been presented for the first time in a May meeting with at most the option for two additional meetings, I think is -- it's not wonderful. When I say people aren't going to like what I have to say, this is like being a manager and you're laying off people that you love and you find wonderful. The fact that a chapter is at this stage means that it must be critically evaluated to see if it fits the message, to see if it can be completed so that we have a full report. We still don't have a full report, Ruth, that we can read from beginning to end because they had to omit some parts which we expected, but you can't keep doing that. DR. FADEN: I think that your proposal, Pat, for the criteria for deciding if any chapter or chapters should go are correct. They are the right ones. Are they critical to what we want to include at the end, our major finding, or are we stuck with them even if they don't because they're part of our mandate. Now we haven't decided what our findings are, but we distributed the sheet yesterday which had the seven areas, okay, where presumably we wanted to make a comment, where we were going to have our findings, would be summarized in these areas. So if there is a chapter and remember, we have homework which I don't know if anybody had a chance to do which is look at these and see if these are the right areas where we want to say we have findings. Are there areas missing? Now obviously something as large as with regard to contemporary research, it shouldn't be "radiation." If the committee finds that, it may have 20 things underneath it, but that's clearly an area, another area and each one of those stands in that category. So is there something -- are these the areas where the committee wants to deliver itself of its wisdom, its findings, its major findings without now saying what they are because that's the hard work that we're doing over the course of it. And if so, that can be attached through which chapters could go. So you could say if you take the uranium miners and Marshallese, how critical is that chapter to any of these areas, how critical is any of the chapters in the book to these areas and an argument can be made that some of them don't contribute that much, given the time frame and they're so underdeveloped, they could go. I mean I don't know how else to set it up. We need some structure for deciding at least the areas since we don't have findings yet, as such. Did people get a chance to look at this and say are these roughly the areas that we expected deliveries of? MS. KING: I think before we do that, there are two points of view on the floor. One which says we can't do it all and Duncan who says I like all the chapters. So I think that the first thing to do would be to get the sense of the rest of the committee about where they fall. The two spectrums are out here. DR. FADEN: Nancy, you were next and Henry. DR. OLEINICK: There is an intermediate position and whole chapters don't have to go, but parts of chapters can go. We have parts of chapters where there's a section to be written and one, we should take a very hard look at those because a lot of time could be saved and a chapter might still be able to present its message, assuming there is the message we want to present without deleting the entire chapter. I would like to come down closer to Duncan's opinion as well. I would feel very badly, I think, if the chapter on the miners and the Marshallese was deleted. I think it presents a very important message. That chapter has had a lot of problems coming to the state that it is. We have been told by staff that we will have a completed document soon. I think the committee has to review it and decide if they agree that it's in the state that they want, but I would argue very strongly that that presents a unique message which I would hate to see deleted from this report. So I think we can look at the issue of deletions in terms of partial chapters, if the message of the chapter is important and can be kept by deleting some of the examples. DR. FADEN: I think we might want to recharacterize it more strongly, if that's all right with you, Nancy. DR. OLEINICK: Please. DR. FADEN: It's not that the message in and of itself is important, but it's a message that's important to this report. I mean there are lots of things that are important to say, but I think Pat's point is -- I think you can mount an argument on the uranium miners and the question is is it persuasive enough that it fits, particularly fits specifically on the legacy of distrust theme of the report. In other words, how important is that chapter to the legacy of distrust? That's the issue. I'm not prejudging. I'm just laying it out. That's the kind of reasoning I think we need to go through. We want to make a bit comment. We've already said this multiple times about distrust is the major harm produced by distrust of government, distrust of government by citizens, distrust of individuals. The medical establishment is a major component. I'm just laying it out. That would be the reason you go through. This chapter is very helpful to making that -- to building the case for that finding. If it isn't, it goes. If it is, it stays. That would be the kind of thing, not merely a message of what happened to the uranium miners. It's a message that's important in and of itself. Henry? DR. ROYAL: I think you know this is a scope problem. I've always felt that the task that we've set out before us is too big to do all of it well. And I think that's the choice we have to make. We have to say okay, if we're going to do all of it, we're going to have to accept the fact that all of it as well as we could have done, if we were more selective. My own personal priorities really are biomedical experiments and to the extent that doing more than biomedical experiments detracts from how good of a job we can do with biomedical experiments, I would be concerned about that. Now maybe what we can do is we can identify some priorities which are essential, maybe two or three, that we can somehow make sure that all of the resources that are needed to do those two or three things are available so that those two or three things get done as well as possible and we might still leave the scope to be overly large, accepting the fact that we're not going to be able to do the remaining things as well as might have been able to do it, but I would like, at least to make sure that there are some core things that we do as well as we can do. DR. FADEN: Mary Ann? DR. STEVENSON: Early in our decision making, we made the decision of the need to address the well- publicized cases and I think we all agreed that in isolation we might not have necessarily have chosen those areas because they didn't necessarily best illustrate the message we wanted to give, but all the same, there was a sense that we needed to address that, because they were out in the public arena. Hence, a lot of these chapters sort of grew up to close those issues rather than necessarily being in and of themselves part of what we perceived to be the central message. I think we have to sort of get back to the decision, if we are going to cut things, with the knowledge that there are certain -- that we're no longer making that a priority to necessarily address all the concerns of the well-publicized cases and I would put that out on the table. DR. FADEN: That's true. That's a relevant consideration. And also, in fairness to us, we didn't know what our message was going to be when we started. We didn't start out, and this is good, saying "we want to conclude the following things and what cases should we pursue in order to make sure we reach those conclusions." So in defense, we couldn't have started that with the kind of coherence that Pat, I think, is rightly challenging us to see if we have now. But now, we have to do that. I've got Nancy again and Susan and I think we have to -- maybe the strategy -- and Ruth again. DR. OLEINICK: This is a process question, right? DR. FADEN: Right and we have to do it. DR. OLEINICK: I think what we need to do as a committee is go through, we have at least the chapters in parts 1 and 2 and decide how we come down on those in their present state. DR. FADEN: That was my thought too. DR. OLEINICK: I mean three is somewhat, part 3 is somewhat incomplete. It's hard to make real judgments about it. That's what Jay is saying, but at least for parts 1 and 2 and there's been a considerable effort of those, we have to agree on whether a chapter is definitely staying, definitely going or come some place in between and we'll see how it pans out in the next week or two. DR. FADEN: We could do that. I mean that was sort of a quickie both ways. In other words, on two dimensions, one is -- and they're going to obvious correlate -- how well developed in this chapter and how likely, how essential is this chapter. And we can go down and see where the weak spots are in both senses. Which chapters aren't considered to be in the best shape and which chapters have the least support for remaining given a tight resource situation. Can we do that? We've still got Susan, Ruth and Duncan waiting to say something. Susan? DR. LEDERER: I guess I wanted to return to Nancy's suggestion. It strikes me as a compromise between the two. There are certain parts of chapters that we could save and those are worth saving with hopefully minimal reorganization. My concern about this report, as it is, is its length. I think it's overwhelming and I continue, as I read it, who are the readers of this going to be and I think if we dilute the power of our message by overwhelming our readers with detail, important detail, sure, I want the context, but we also have to keep in mind who are our readership is. DR. FADEN: Which again, that was the rationale, so we can all remember for having these companion volumes. And there's two ways to strike it. One is to take a whole chapter out. These are not mutually exclusive and you say they go into the companion volumes. The other is you make these chapters much shorter and you then provide in the companion volume the more detailed treatment and then we can do some combination of both. MS. KING: There's a third possibility. The third way we can do this, for people who write long papers have been through this before, is we can preserve what we want from some chapters and still not make it a chapter. I mean part of this is we backed into this sort of outline. There's no reason, when I say cut, in some cases I think it would actually be nice to cut the whole thing and some things, it is nice to cut part of it and preserve it as a chapter. In some places, it's nice to cut some things and perhaps they can be picked up some place else. So don't ignore those possibilities. DR. FADEN: We're going to do that in just a minute, but I want to hear from Ruth and Duncan who have been waiting, if no one objects. DR. MACKLIN: This is just one small point about the criteria for cutting and it's a follow-up to what Mary Ann said and that is not that you argued for it, but you pointed out. I would argue very strongly against eliminating or failing to attend to the public comments and the concerns of the public. We devoted two hours of every single meeting to hearing public testimony and Steve and Lanny have provided us with voluminous amounts of newspaper accounts and press reports and things throughout the life of this committee. I think to ignore the public concerns and the public comment would be to not only lose a valuable dimension of our work over the last year, but also it would be irresponsible. I think the circumstances and both the charge to the committee and the federal act under which we operate requires that we take into account those concerns, so I know you weren't arguing for it, but as a criterion for what we might eliminate, namely that it wasn't in the original charge, but these things kind of came to us. I think that would be a terrible mistake. DR. FADEN: Glad to hear you say that. Okay. Should we just do it? Duncan, I'm sorry. DR. THOMAS: A process point, further discussion of the substance of the chapter, and I'm referring specifically, of course, to the uranium miner chapter -- DR. FADEN: Let's leave a question. DR. THOMAS: One of those that was on the agenda for discussion. I can't relate to Pat's concerns about it until she becomes more specific about what she doesn't like about the chapter. MS. KING: What is the message about the uranium chapter? DR. THOMAS: I can give you my take on it, right now, if you want. DR. FADEN: I don't think we should discuss that. I don't think we can do what Duncan is proposing. Each of us has our views. Let's down the list and see where there is disagreement. I'm turning it around the other way. It's likely the uranium miners will end up being one of them, but let's go see where there is consensus and there are issues. I'd like for you -- DR. RUSSELL: I just wanted to ask a question about what we really mean by companion volume. (Laughter.) DR. RUSSELL: And how that would be published and distributed and what's the status of it, vis-a-vis the report. DR. FADEN: There will be a report. That's what this is the table of contents for and it will be released whenever it is, in September, that it will be released, assuming that the time frame is sufficiently approved. The companion volumes will be published as well by GPO and that's the understanding. They will be available to whomever requests it of GPO. They will be labeled -- are they going to be called -- we haven't decided whether they're going to be companion volumes or supplementary volumes or language of that sort. So for those of you, who for example, are familiar with other government reports, there's often -- of other Presidential commissions, there's often a report and then there are the supplementary volumes which are the more detailed treatments or commissioned papers or whatever it is upon which the committee relied for its deliberations and conclusions in the main report. So it will be available and published -- DR. RUSSELL: And the report will refer to those? DR. FADEN: Yes, and the report can refer for more detail, see chapter so and so in companion volume 2 or supplementary volume 2 and that will be available. So the scholar can go from the report or the journalist or the member of the public who is particularly interested, can go from the chapter in the main report to the companion volume. They'll be directed to that for more detail. It's not envisioned that there will be a course, a one to one correspondence that for every chapter there will be something in the companion volume. That's by no means the notion. That will be overwhelming, but that mechanism, it's already been agreed that we will publish in addition to the main report, some volumes that there is so much material, obviously, if this looks like a lot, this is nothing compared to everything, of course, that the committee has indeed has collected and amassed and it's overwhelming with respect to the contemporary projects, for example, it's envisioned that the really detailed presentation of it, the methodology for both of the two contemporary projects will be in the companion volumes and the more -- including the appendix, the coding form itself and the SIS interviews and all of that stuff, so that if somebody wants to see where did we get this from, we'll be able to go to the companion volume and look and see what the rating form looked like or the interview looked like for the subjects and the subject interview survey. MS. KING: Who is writing the companion volumes? DR. FADEN: Staff. MR. GUTTMAN: As a practical matter, at present what the companion volumes are, are all the contemporary backup. They're extensive commentary on the document collections, how we got them, what we have, Jim David's blow by blow and every record group in the universe, etc. etc. and perhaps the details of the ethics, history, agency by agency which you saw in an earlier version and Gregg Herken's at the University of California. That's the -- DR. FADEN: Case study which was one chapter that we did. MR. GUTTMAN: That's one of the volumes at present. DR. FADEN: Okay, but as a mechanism, it is available to us since it's already envisioned. Does that help, Phil? Yes, Henry? DR. ROYAL: The other thing that I think we need to think about is things that aren't in the report that should be in the report. Ruth Macklin was mentioned the public and it's not clear to me that this document is directed towards the public. It does seem to me that there should be a few chapters about the risk of research and the ethics of research. Maybe two chapters, one about the risk of research and one about the ethics of research. DR. FADEN: Or maybe one chapter -- DR. ROYAL: Directed towards the public. The reason I said the risk of research because -- and make them two separate chapters is I think that there's a need to explain something to members of the public about the whole problem of causality and why it's not easy to tell whether or not their injury was caused in some cases, caused by a particular research project or not. So I do agree that the members of the public are important, but I actually think the report has some shortcomings in that regard. DR. FADEN: This is going immediately to substance which is sort of out of order, but it occurred to me that helping people understand the risk of research and how one draws inferences about it might be something maybe it would be buried there, but the overview of the case studies, that before you read the case studies, member of the public, where we're going to be discussing levels of risk from these studies, let's provide you some context about risks from research generally and risks from intentional relief and how it's hard to figure it out, so you can have a frame of reference when you start looking down this and you're not shocked when you discover that the committee concludes X because otherwise, I have worried about that too, insofar as members of the pubic have expectation that lots of risk and harm is associated or that it's easy to tell that risk and harm occurs. Then they might find our findings troubling where we don't conclude that. It's a good point, a very good point. Pat? MS. KING: Before we can cut any chapters, I have to know the measure by which it should be cut. Since I got everybody excited by talking about the uranium chapter, I cut that because I know what I liked as the message of the total report, so I went through it last session because I needed some way to -- DR. FADEN: Why don't you tell us? We haven't had an articulation of a single message for the entire report. MS. KING: Well, I'll try it, but I want other people to try it too. DR. FADEN: Tell us yours. MS. KING: I think this is what we need to do. I think that the message of the report is looking at the past, that when we uncover and can document some of the experiences that took place in the past in the area of experimentation, radiation experimentation because that's just a focal point, that our message is that this problem, some people would say it should not have occurred and I'll put that in brackets because that's the part that we should debate; should not have occurred, well, we will learn lessons from it, that is in the parentheses because that's the part of the debate. Then going into two directions, one of those lessons is what it tells us about the future of biomedical experimentation. The other is the legacy of distrust, but the way I actually did my own message formulation was to focus very narrowly on saying radiation experimentation is the tip of the iceberg in the sense that it is illustrative what we document here. We don't intend to be exhaustive. We think it says as part of this message -- because I have listened to Henry talk about radiation and relationship to other experiments. I think he's right about that. I've listened to Jay talk about the need to keep us focused on where we go from here and how you hold people's feet to the fire and so the way I pulled it together for myself was, if I could design my mandate, I would have left some things about the mandate, but the way I pulled it together for myself was to do a fairly small focus, not on everything radiation did, but on radiation bioexperimentation because that was what seemed to connect it for me. So it would make sense to me that I would go through and some chapters could go, but that would be my message. Am I making sense? DR. FADEN: No, it's fine. I think that -- MS. KING: And the thing is, I'm very amenable to including any or all of these chapters if we have a message that we are agreed up that we make hard judgments about, does it further it. DR. FADEN: Nancy? DR. OLEINICK: I don't have a complaint with what you've said with the exception that I think the message has to be as we go forward that we want to improve biomedical experimentation, but there are other kinds of experimentation which have occurred in the past and may still occur in the future and we should want to improve those as well, use the lessons of the past to improve those as well. So I think -- my only bone of contention with you is the limitation to biomedical experimentation, that there is a larger world out there that we have been asked to look at as a committee. MS. KING: Can I respond to Nancy's -- DR. FADEN: Could you respond to it and then could we try going down the chapters because I'm -- MS. KING: I understand what Nancy is saying, but when I read certain of the chapters that moved away from biomedical experimentation, they were really less developed. I don't think -- let me tell you how I mean about less developed. I think Nancy's absolutely right where you talk about observational studies, where you talk about atmospheric releases. The uranium miners chapter has, I find, one of the most intriguing problems of duty to warn and research obligation in the midst of institutions that I consider a critical modern problem. When I try to figure out what we were saying about this critical modern problem, we weren't saying anything, not because there wasn't anything to be said, it was because we haven't had time to work on it and work hard at it. So when I looked at uranium miners, in my head, it could become, and I hate to pick on this chapter, but that's when it started getting at me. When I read it, and I looked at it, I said the value of this chapter that I identify is to let people know something that went on that set up these problems and I'd like to be able to say to the future, these are the problems you must tackle. Then I said can I have a whole chapter that broadly tries to identify, based on the things that we have knowledge of, but didn't have a chance to go into, but identifies critical problem areas for the future and have that be a part of the later part of the report which is where we really do get to the future. I said if I want to do that, it makes more sense to do that to me than to try to keep working on uranium miners and Marshallese because I actually think all I needed to pick was a little bit of it to identify this as an area that is of critical importance in the future, the whole area of environmental research, occupational research. I don't disagree with Nancy. It is in trying to do it the way we did it, in terms of giving it equal weight, I had trouble, because we're not saying a lot about researcher ethics in those contexts. What we're doing is describing past events. We don't. Because we can't. That's why when we go through the chapters, that's one of the things I'd like to talk about. This question about -- I won't get into that. (Laughter.) But that is why I got to where I got, Nancy. It wasn't that I disagree with you about that, I started trying to evaluate what were we saying about it. DR. KATZ: Pat, point of information, did you read the latest draft? MS. KING: Yes. DR. KATZ: You're basing your comments on that. DR. FADEN: Part of the issue with it is, as we are confronting, and this is obviously hard for all of us, maybe, especially for me, the reality that there isn't time to do everything with a level of quality that we would have liked to do it where a level of quality involves ample time and here Jay has reminded us repeatedly of this, for us to hash out whether we have a common view about how to evaluate the uranium miners or anything else in here. That's part of the tension, I think that Pat is responding to. Henry, your comment and then can we just try it chapter by chapter, just to see, five minutes a chapter, not a detailed discussion, just sort of how -- I need -- the staff needs a pulse and we need a pulse of is there agreement about which chapters are in good shape and which chapters are not, which chapters should be cut a lot and we can't, if we spend an hour on every chapter we will do two today. So there has to be some way to get a quick response and then revisit the ones where -- you know, Ruth says this chapter is in great shape and Phil says, what do you mean, it stinks, then we have to go back in committee time or have Ruth and Phil on a conference call and fight it out or something, with the relevant staff. But we need to get through a process like that. We need to take the temperature of the committee with respect to each of these chapters. Uranium miners, we already know, is one that's on the list for contention, both in terms of its importance, its potential and its future. Okay? Henry, did you want to make a -- DR. ROYAL: As we go through the chapters, it seems to me that another important criteria is how much attention a particular problem is already receiving from other sources. DR. FADEN: That's fine. DR. ROYAL: If something -- if there's some other group already spending much more time than we're spending on a problem, I think that we can refer to the problem and say that it's an important problem and refer them to other people's work and the uranium miners to me is an example of a group that has received a lot of scrutiny in the past. DR. THOMAS: Not from the ethics point of view. DR. ROYAL: That's the part we should address. DR. FADEN: Yes, that's what we need to address. You're right. DR. ROYAL: And not spend a lot of time on the details. DR. FADEN: We're going to go chapter by chapter and everybody is going to get two minutes. No discussions back and forth. Deliver him or herself what they think of this chapter. Let's see, and the things you want to talk about are what shape you think it's in, good, moderate, awful; how long the length is, it's way too long, it's a little too longer, whatever; and how important. Are there sections that can be cut or is this a candidate for whole cutting. Is there anything else you want? MR. GUTTMAN: Yes, the criteria that at least strike me is the ones that resonate with us, the things people want, it's got inflammatory stuff. I think we can take care of inflammatory -- DR. FADEN: I don't want to hear that. MR. GUTTMAN: Right. The point in descriptiveness, there are two big problems with these chapters. They're either -- the description is lousy and the facts are fragmented -- DR. FADEN: You can't do that now. That's a level of detail we can't go around each -- we've got to just give the key summary thing, then we can get that from people later, but to start discussing page by page by page -- MR. GUTTMAN: The dimensions of awfulness. DR. FADEN: If we could do that, that would be great, but I think first let's see if we can get all the way through. We've got a ton of chapters, we've got 14 people. Nancy? DR. OLEINICK: I'll start. DR. FADEN: Okay. DR. OLEINICK: I liked the entire part 1, all five chapters. I would just like to see them to the extent possible, cut, just make them a little shorter, that is, there's some wonderful verbiage all the way through, but I think the message of the development of the ethical practices and standards could be handled in less than what is probably going to end up being about 150 to 200 pages. DR. FADEN: It's got to be cut, but otherwise, it's in good shape. All right now, I'm happy to -- if everybody else can respond to part 1, that would be very efficient, but if people want to pick out chapters, that would be find. I want to make sure we hit everybody. Pat. MS. KING: I think the first four chapters of Part 1 are in very good shape. I think Chapter 5 needs a great deal of work. I don't know how to quite reform it. Actually, I rather like the effort in the beginning to try to articulate an ethics framework for thinking about retrospective judgments. On the other hand, I thought that that material was, as I said, the opening day, inaccessible to a lot of people, but I thought it was very good for the committee to have so that we have a framework for thinking about some issues. Depending on how the committee ends up, in terms of what it wants to say in the latter part of the chapter, I would use that as a guide to eliminate a great deal of the first part of the chapter. In other words, of Chapter 5, I would let Chapter 5 become what is needed to support whatever the committee concludes and I would urge whoever drafted the first part to when the committee finishes, to publish that as an article. I really liked it, I enjoyed the argumentation and the reading, I just didn't want it in the chapter and I would limit the chapter too, to support what we need to support. DR. MACKLIN: Which part? DR. FADEN: The first part of Chapter 5. DR. MACKLIN: Pat has in mind what she means by the first half. Just a little more specifics here. MS. KING: The ethical development -- DR. MACKLIN: All the stuff that came from Buchanan's -- MS. KING: Drew and Jonathan. MS. KING: I'm not trying to say it's not valuable. DR. FADEN: The issue is given that it's reasonably sophisticated, the issue of accessibility, the analog is in some respects, although it's a little elevated to the function of the Belmont Report, should it be pulled out, published separately and not kind of presented as part of the committee's report, only because of how different it is from everything else. It's harder, it's tougher. MS. KING: But it's also, because we have a consultant, you don't necessarily publish a consultant's paper. A consultant's work is always to support what the committee is trying to do and we needed it for our deliberations and we still need it. I'm just talking about should it be in the chapter. DR. FADEN: That's helpful. We understand. We can work that one out. We've got Nancy and Pat. Let's just do Part 1 and people can comment on each one. Maybe that will be more efficient and we can move on. Ruth and I'm just going to hit everybody and if you don't want to say anything, nothing stands in the way. (Laughter.) DR. MACKLIN: I agree with Nancy. I like all of Part 1. I think it all should be there. I'm not sure what should be cut. I'm not, that is, I think you're saying that on grounds of length, not on grounds of specific things that don't belong there. I think there's a certain amount of redundancy as one reads it from front to back and that redundancy can be handled by referring back. As the entire report is written, there is no referring to see Chapter 2, see this page, see that page. And I think that's the way to handle that because there is some, I know it couldn't be done on the way this was written, but I mean eventually when you do have something that's mentioned at the beginning and has a middle and end, so I concur entirely. And I guess I do understand what Pat means by what is accessible since it's entirely accessible to me, but I will only say that some of the scientific material that occurs in the case studies remains inaccessible to me in an multi- disciplinary report, it's almost inevitable that some things are going to -- so the question is what should be the criterion, inaccessible to other members of the committee, inaccessible to the public, inaccessible to other reasons of this report. For example, policy makers who may not know radiation science and may not know ethics, so if we're going to cut on grounds of accessibility, I think we have to have some criterion or some bench mark for what accessibility is and to whom, but my comment about these five is that they all belong in here with some appropriate editing. DR. FADEN: Mary Ann? DR. STEVENSON: I pretty much feel the same way that all chapters need to be there in substance. They could be significantly cut because of the redundancy issue, but - - DR. FADEN: What I'm hearing is there's no content that's inappropriate that needs to go from those of you who have already spoken, it's rather that we just can't deal with these many pages. We're going to lose the reader. We have to find some better way to do that. Susan? DR. LEDERER: I guess I want to concur with what Pat said. I think the first four chapters are the strongest. I think the problem for me in Chapter 5 is not the inaccessibility issue as that it's not framed in the most effective way and so one criteria might be how much time or effort do we want to invest to frame this material in a way that will make it most accessible to people who are getting -- I mean what is the thrust of the chapter, what is it that we're concluding. DR. FADEN: We know where to put the energy. We're hearing it pretty much the same. Henry? DR. ROYAL: Other than shortening the first five chapters, I don't have any problems with it. DR. FADEN: This is refreshing. (Laughter.) DR. FADEN: We're going all the way around. Nancy, you've already spoken. Jay? DR. KATZ: As far as Part 1 is concerned, I do know that Chapter 3 and I had some problems with it when we discussed it last time, but Jon Harkness is rewriting it. We've had extensive conversations over the telephone yesterday and my impression is that he is making some substantial changes, all of them seem, from my perspective to be moving in the right direction, but we really haven't seen the revision of Chapter 3 yet. The other thing is and I do need to repeat it. I have all kinds of problems with Chapter 5. I voiced them yesterday. They go in some extent to what Pat was talking about, but after all is said and done, I can live with Chapter 5 and not make too much of it. I find it, in part, inaccessible to me. (Laughter.) DR. FADEN: Phil. DR. RUSSELL: I'll go along with the previous comments. I think we need the whole thing to be shorter. DR. FADEN: Eli? DR. GLATSTEIN: I certainly agree that the first part of -- well, Chapters 1, 2, 3 and 4, they're in good shape. I have some ambivalence over 5, as Jay does. I think one thing I would like to see come out and I really don't think we've done a good job with this. We address research without really spending a lot of time on describing what it really is and the reason I'm concerned about this is I believe there's a lot of practice going on in the country at the moment that's basically confirmative research and something that someone else has done, published -- someone has published a paper and someone else picks it up and has never done it before and tries it on his patients. I don't think that's good practice of medicine and I believe that is research. They don't want to call it research because they don't charge for it, can't charge for it. And I think that's a serious problem and we're not addressing that. I think we should address that. This has to do with some of the stuff we sent out some letters for -- DR. FADEN: Right, right, right. DR. GLATSTEIN: And people responded. They didn't consider it research. I understand where they're coming from, but basically it is confirmatory research. That is what it is. And they've never done it before. The subtleties of techniques and so forth are really quite different, but they're doing it to make a buck and there's a real problem with this and I believe we should be at least, we should mention it at the very least in passing. DR. FADEN: It's got to be in the contemporary part. That's why we did the work. It's important to remind us. Duncan? DR. THOMAS: I think Part 1 is in pretty good shape. I also found it a bit long and hard to concentrate as I was wading through it, so my comments may be less insightful as they otherwise might have been. DR. FADEN: Everybody likes it because they couldn't keep their eyes open after a certain point. I was thinking about that last night. There's a certain phenomenon that says it's fine, it's fine, it's good. DR. THOMAS: There are a few things I would like to see added to Chapter 1, a little bit more about the nature of research. DR. FADEN: I agree. DR. THOMAS: Of what is radiation, what are radiation health effects, how we figure out about risks and things like this. This could be small boxes, uncertainties and so on. But Chapter 1 is pretty effective for me in terms of telling the benefits of research. As I said, there are points of detail which I can respond to later about that. Chapter 5, I got real nervous about. I had liked Chapter 5 a lot when I read it. I got discouraged on Monday, but then felt upbeat yesterday, feeling like we had resolved the major points of contention. The first part that people have been reacting to as inaccessible, I had actually worked hard over -- when I first got Allen's earlier drafts. I didn't find it that inaccessible. It is hard-going, compared to the rest of the report. I think it could be rewritten to make it more accessible, but I for one would strongly resist removing it on grounds of inaccessibility because I think it lays out the philosophical foundations on which we're entitled to make the kinds of judgments we make in the second half of the chapter. So I think it's essential. DR. FADEN: Lois. MS. NORRIS: Basically, I'm fairly confident that Part 1 is also in pretty good shape. I share comments that others have made already with respect to the inaccessibility and I would hope that perhaps we can arrive at a compromise between inaccessibility and accessibility and esoterica, so that maybe we can satisfy everyone. The other thing, I do urge committee members, however, when we start getting these revised cut drafts, not to say uh-oh, there went my favorite quote or my favorite line or this was my baby, don't cut it. We're going to have -- DR. FADEN: That's especially hard to the drafters because you get invested and you've worked hard and believe that the section is somehow real important, so it's important for all of us and it will certainly help if the committee members will not give staff a terribly hard time, unless you think something is absolutely essential and without it, you can't live. All right, this is fine. If we can finish Part 1 and move on. What I am hearing anyway is that Part 1 obviously will take work. Cutting is very, very difficult and if there are substantive problems with the first part of Chapter 5 and with making sure that the introduction provides the context for the lay reader, well, lay in the sense of nonscientist, so they can have some sense of what research is. MS. KING: We also never discussed the first part, to set the record straight, we never discussed the first part of Chapter 5. We only discussed the end part of Chapter 5 and got into the part that we need for the report, so if we're going to keep the first part, I think at some point you've got to discuss it. DR. FADEN: Okay. So that's Part 1. Now Part 2, we obviously cannot do as a whole part. It's 10 o'clock. Should we take a break or move on? Keep on going? All right, we'll keep on. Here's the holding out. You cannot have a break until we are all the way through Part 2. So therefore, see if we can do this and if we can have a few minutes a person on each chapter. If you could say in one summary, then I can live with 2, 3, 8 and 6 and I really have trouble with blah, blah and blah, that would be great. That would be ideal. If people could do that rather than go one by one, that would be very easy. We've got nine chapters under Part 2. If everybody can take a minute and sort of divide them into categories for themselves. "I am most happy with chapters blah, blah and blah. The problems are mostly this and such." Is that not do-able, do you think? Or do we need to do it chapter by chapter? Chapter by chapter. All right, well do chapter by chapter. MS. KING: We can always pass. DR. FADEN: You can. All you need to do is say, it's okay, it just needs to be cut. We don't want detail, "I didn't like page 2, but I'm happy with page 8." These are global reactions to the chapters. I'm just going to go around. DR. LEDERER: When we make our tabulation, we reserve the right for specific changes? DR. FADEN: Absolutely. DR. LEDERER: This is for Part 1 as well? DR. FADEN: Of course. I'm just talking about global reactions, sort of guidance, how much we are agreeing about, the chapters that are the most problematic, the chapters -- and you notice when we went through Part 1, there was considerable agreement about the areas that are the weakest in Part 1. Or if not the weakest, the ones that need the most attention and revision and so on. All right, Sue, can you give us your global reaction to biodistribution? DR. LEDERER: I think it's a necessary chapter. It's just on whether we should cut it? DR. FADEN: No, whether to cut and what shape it's in. Do you think it's in awful shape, moderate shape, good shape? DR. LEDERER: I think it's in good shape. DR. FADEN: Okay. And your reaction, can it be cut a lot, cut a little? DR. LEDERER: My global response to Part 2 is that they all need to be cut. DR. FADEN: All right. DR. RUSSELL: I didn't hear that, Sue. MR. GUTTMAN: All need to be cut. DR. FADEN: Biodistribution, Henry? DR. ROYAL: I can't find my copy, but -- DR. FADEN: I stole it. DR. ROYAL: I think so because there were so many things written on it. I think that the biodistribution chapter needs to be cut in length. It's clearly an important chapter. I still think that there's a lot of inflammatory language in the chapter, so tone, it needs to be toned down. It needs to be shortened, but it's an important chapter. DR. FADEN: Thank you. This is exactly what we want, just a global reaction. Nancy? DR. OLEINICK: Well, it certainly has to be in here. I think it basically lays out the story. This is also one of those subjects that has been covered in various cases here and there, so if there's an argument about issues that have already been covered, and therefore we shouldn't have them in there, that would be a reason not to have this chapter. But of course, you need this chapter. It's sort of the incidenct that got us all going. So it needs to be here. I would try to cut it back to the essence. DR. FADEN: Okay. Jay? DR. KATZ: I think the first part of -- pretty much the whole chapter has a lot of rich and wonderful material in there. It could be cut, but there's some value to keeping it in this form. As I said, I think yesterday, the conclusion doesn't do any justice to what emerged in the body of the data. It needs to be -- I made some suggestions. I did not get a sense that the conclusion reflected all the wonderful data that was presented in the body of the paper. The only thing I wouldn't want to see happen is a new consent term, that really disinforms. I would like to add that to the vocabulary. (Laughter.) DR. FADEN: Phil? DR. RUSSELL: It's an essential chapter. It should be cut by at least 50 percent. DR. FADEN: Eli? DR. GLATSTEIN: I think most of the chapters in Part 2 need to be shortened, but otherwise I think they're actually very good. The TBI chapter, in particular, is excellent, but it's almost too detailed. I would remind that all the experiments that we're detailing in this section have been previously pointed out as problems. We did not discover any new scandals in this. DR. FADEN: I know, and we need to make that clear. DR. GLATSTEIN: And so to some degree we are rediscovering the wheel. Now we are charged with telling the story of what went wrong and to that degree it is appropriate to cover these in detail. But it has been done before and I think if it's trying to point out what went wrong, it needs to be stressed. DR. FADEN: Duncan? DR. THOMAS: This is clearly an essential chapter. It's a little bit on the long side, but I would be hard pressed to cut it. I support the ethical analysis pretty much as it stands. The only fundamental problem I have with the chapter is I find somewhat overbroad an endorsement of the scientific utility of the chapter which I think requires a few qualifications, but by and large, even the treatment of the science, I think, is pretty good in this chapter. DR. FADEN: That's great. DR. THOMAS: I feel good about it. DR. FADEN: Lois? MS. NORRIS: I wrote "good chapter" when I reviewed it and then I got a flood of faxes telling me why it wasn't. It seems others have become more comfortable with it, since. Phil says cut 50 percent. Duncan says zero. How about going for 75 or cutting 25 percent and compromise? DR. FADEN: That's what may be how it all ends up. Pat? MS. KING: I agree with everybody else. (Laughter.) DR. RUSSELL: Both Jay and I, right? MS. KING: It's a good chapter and the cutting problem, one way to cut is all of these chapters -- DR. FADEN: Get closer to the mike, we can't hear you. MS. KING: All of these chapters, because they were written by different people have a, most of them, have a common flaw and it adds to the length and that is in the effort to make each chapter a stand alone chapter, it incorporates all of Part 1 in some form and to each one of the chapters and so my recommendation as the initial grounds for cutting is to take out Part 1 out of each of these chapters and then further reduce. DR. FADEN: I think that's obviously the easiest to do too. MR. GUTTMAN: Gil says you can put stuff in footnotes. Is that okay? MS. KING: Actually, for those who read the President's Committee Reports, the President's Commission Report and use them extensively, believe it or not and I hate footnotes as a lawyer. I have found footnotes extraordinarily useful because they take you to other literature, if that's what your interest is, but they don't bore you to death by putting it in the text, so you can skip the footnotes. The key is don't put the important stuff in the footnote which is what I found in a couple of chapters. DR. FADEN: I found that several times in which I hope everybody was making notes of the fact and I was curious to see if we all agreed about what footnote material is in proper place. The point is we give enough guidance about what text sections should go out so the footnote material could come in. It's easy to add, but hard to cut, as we all know. Ruth? DR. MACKLIN: I think the chapter is important. When people say "cut" they say that because it's too long. I'm glad I don't have to do the cutting because I wouldn't know what to take out except the stuff from Part 1. The one reason I do think this chapter is important, despite whoever, someone's comment, it may have been Nancy's, that much of this has been covered elsewhere is indeed the facts and the accounts have been covered elsewhere, but the official report, 1974 or whatever it was, found there to be little wrong with what happened or did a lot of exculpating and the UCSF committee, the internal committee, is not mentioned in the draft. DR. FADEN: It's referenced. DR. MACKLIN: It's referenced, but not mentioned, was whitewash. DR. FADEN: Right. DR. MACKLIN: So in fact, what this chapter contributes to the discussion is some ethical analysis and not a whitewash, saying well, look that's what they did then and that's all okay. DR. OLEINICK: Remember that statement, Ruth, that's going to come back to haunt you. MR. GUTTMAN: Eileen Welsome is sitting there right behind you. (Laughter.) DR. MACKLIN: I'll be happy to be so -- DR. FADEN: Mary? DR. STEVENSON: I think it's a good chapter, an essential chapter. Really, try to cut it, but it's going to be hard. I think this chapter is particularly important because it really sets the historical ambiance, the Cold War, and so I would allow it a little bit more length as sort of the intro into the case studies. DR. FADEN: All right, at the risk of going back on my one group dynamics training course I had in 1960 something or other, we will now reverse the order so that people get a chance to speak first instead of speaking last. I'm turning this around. We're now moving from biodistribution to radioisotopes. DR. STEVENSON: Too long. It reiterates a lot of the government standards that we already saw in Part 1. And sort of leaping ahead, trying to consolidate it, I would maybe try and I'm not 100 percent sure, I want this, but would suggest that maybe radioisotopes and women and children could go into one, because those are, in fact, the case studies for radioisotopes. DR. FADEN: Interesting thought. DR. STEVENSON: But then I would cut back the length of radioisotopes in terms of regulations. And then the other part is the benefit which I found good, but -- well, especially if combined with the women and children's chapter. I think it could be done, but I think it would take some working over. DR. FADEN: Ruth? DR. MACKLIN: When I read this chapter, I didn't find much to criticize because I found it very largely descriptive and not only descriptive of radioisotopes, but of all the distribution and the AEC regulations, etc. so I don't really have very much to say about it. I had independently of Mary Ann exactly the same thought about combining the women and children with this chapter and I guess I'll save my comments for the women and children when we get there, which I thought was overly long and had too much detail of the sort that's quite irrelevant to this report. So as I said, I didn't have any comments about this, but I think combined with women and children, it can shorten the whole report and say what is relevant to our concerns. DR. FADEN: Pat? MS. KING: You've actually hit where -- DR. FADEN: Use the microphone. MS. KING: Sorry. You've actually hit where there's at least one of these chapters I have not read, so I will pass on that on where to cut and combine. I would take part -- I like radioisotopes. I agree with Mary Ann that part of the women and children's chapters should go into radioisotopes. I think the other part of -- remember yesterday we talked about women and children and it had three purposes? Well, one of the purposes connected to isotopes and so it made sense to put it there, that basically was a problem of what to do with the other two, couple with the fact that this is not a well-developed chapter. It's got a lot of work that's necessary. One part of the chapter is some possible medical monitoring issues and that is, what do you do if we can resolve the risk stuff. My own view is one of the most beautifully written chapters that needs to go -- DR. FADEN: Pardon? MS. KING: That one of the most beautifully written chapters here needs to go and that's Prisoner Research because I don't see what it does, except to set up some medical monitoring. So I actually would take the areas where we think we're going to make recommendations or may possibly make recommendations about extended harm and put them together. That's women and children and prisoners, because the conclusion of the prisoner chapter is basically to alert us to the problems of vulnerable populations and while I think that is a very significant problem, as I tried to make clear yesterday, I think that the other chapters can do more with some of those issues. It's so beautifully written, I recommend it for a companion volume, but I've always questioned the prisoner chapter because so many of the issues have been taken care of in terms of where we put our marbles, so I'm quite willing to junk prisoner and take apart of what I see of women and children and the medical monitoring issues and put them together. The part that worries me about children and pregnant women, taking part in the isotopes, the part that I'm left with is the part that you charged the small committee to deal with yesterday, which is the risk assessment. But I actually see a lot of the risk assessment issues tied with medical monitoring. And one of the reasons we're trying to get a lot of that straight now is we have to make some decisions with respect to monitoring and follow-up. So now you don't even have to call on me for several chapters. DR. FADEN: Okay. Lois? MS. NORRIS: Chapter 2, I thought that the chapter was fine. I thought that the benefits were overly detailed, excessively detailed. DR. FADEN: Duncan? DR. THOMAS: This is one chapter which really doesn't tell a narrative in the sense of the others. There's no research in this chapter. It's all process. I'm very tempted by Mary Ann's suggestion that that bit could be combined with children and pregnant women bit. In the long run, I think both of the things that are said here and what are said in the children's chapter have to be there. I'm not sure but maybe we're making ourselves more work to reorganize at this late date, it's worth it, and it's not going to appreciably shorten the chapter and introduce all kinds of new problems that we hadn't anticipated before. But I think staff should look at that and decide for themselves. If we're into massive reorganization which I'm not, for one, I would argue that in response to Pat's suggestion, what's prisoners doing here? Prisoners is doing more than just setting us up for a discussion of medical monitoring. Indeed, I"m not even sure it's the best example to set us up for that discussion. I think it's talking about use of vulnerable populations and much of the material which is in children's, institutionalized children, would address tat same issue and is perhaps not well placed in its present place in children, but I would resist massive reorganization just for the sake of reorganization, if it doesn't accomplish considerable shortening. DR. FADEN: Eli? DR. GLATSTEIN: I think the last time when we discussed this chapter, we said to be sure -- all this stuff about radioisotopes, tell the public that there's a good side to it and now we want to cut that out. It's a little -- I'm just not sure we're being consistent. In fact, I think we're being inconsistent. Anyway, I think the chapter itself is good. If it can be shortened some, I think that would be beneficial. The idea of eliminating the prisoner chapter is -- I'm ambivalent about it. I think that the -- I can see why it would be useful to leave it out, but at the same time it did actually occur, in essence. And I remember when that paper was published. Most of us were dumbfounded that it actually occurred and I think it serves a useful purpose in terms of reminding investigators of some of their responsibilities. DR. FADEN: Phil? DR. RUSSELL: I think this chapter is very important from a perspective point of view and it's part of the story on where the government really succeeded in taking on an immense and dangerous task and regulating it properly and promoting it properly and I think that it needs shortening and I don't see any problem in reducing these by a substantial amount. The amount of excess verbiage in these chapters is really impressive. (Laughter.) Just cut out the footnotes. And I think it needs -- the benefits that are scattered throughout this, need to be summarized and kind of bulletized in a presentation. DR. FADEN: Jay. Radioisotopes. DR. KATZ: I'll comment on a few of these chapters, because they're interrelated. I very much agree with what Duncan has said. It may be too much to ask for to combine chapter 2 and Chapter 3, if it could be done in the time available. It would be a good thing to do because it would give a more analytic dimension to Chapter 2 and that would be helpful, but really that decision has to be made in terms of the exigencies of time. With respect to Chapter 5, I wonder whether it shouldn't perhaps be moved up and be chapter 4 rather than 5. DR. FADEN: Prisoner research? DR. KATZ: The prisoner chapter because it fits in so very much with the vulnerable population issue which is also the issue in the previous chapter, but speaking very personally, please don't eliminate Chapter 5, if only it's so beautifully written and it tells an important story, that it's just a pleasure, as one reads the report to also have this kind of interlude and -- DR. FADEN: Wouldn't it be nice if they all read like that? Nancy? DR. OLEINICK: Okay, on Chapter 2, I guess there is an argument for combining Chapters 2 and 3, and yet the issues that are raised, even though Chapter 2 is rather descriptive in just discussing regulations and more or less how the world of radioisotopes was handled, I think that it really sets the tone for so much that follows. I agree with Phil, that this is one time the government succeeded, sort of did it right. It sort of stands on its own because it didn't handle the part that we're talking about in Chapter 3 always, very right. My complaint, in addition to length which I think the staff should try very hard wherever possible to tighten the language, and delete what's unnecessary, but I think the section on benefits in this chapter really needs some work. I found it very hard to read and in some cases in error, and I think it -- I don't know who wrote it, but whoever did certainly had their point of view of what they saw as the world of benefits in radioisotopes. MR. GUTTMAN: As Gil noted, I think, took this a lot from what the agencies told us, the benefits were, so this is the official government story. DR. OLEINICK: Well, I would be very happy, since this is one of the little issues that I sort of take seriously, I would like to work with whoever it is on staff who is doing it. DR. FADEN: By the way, committee members should not hesitate to say "I would like to take a stab at this section. I have a sense of what it should look like and it's not making it. Let me send you the three pages and see what you think." MR. GUTTMAN: If General Russell wants to cut by 50 percent -- (Laughter.) DR. FADEN: Henry. DR. ROYAL: I didn't have any major concerns about this chapter. I do have a concern about the suggestion of combining Chapter 2 and 3. It seems like an odd thing to do, given that in Chapter 3 we're talking about how cautious we should be about using radioisotopes in children and pregnant women and in fact, if you look at how radioisotopes are used, they're not primarily used in children and in pregnant women and I am not sure that that confusion wouldn't come about if you tried to combine the two chapters. DR. FADEN: Sue? DR. LEDERER: I thought that when I read this chapter and then read Chapter 3, it just seemed odd to me that they were being discussed in different places, these radioisotopes in children and so I would have seconded what I understood to be Mary Ann's suggestion that some of it should be incorporated, but then, of course, I think there were left some important issues that need to be addressed and particularly, I think issues about institutionalization and that population and so don't -- I don't want to see us lose that particular thing. I would argue for keeping a benefit section in here. I hope that's not an inconsistency that Eli's registering. It needs to be accurate and it needs to be perhaps shortened, but it's important to keep in here. I also think this is a chapter where there is some material footnotes that should be in the text. DR. FADEN: Vice versa. Since this is out on the table, I don't think we should try to put these two chapters together, biodistribution and the children and pregnant women. I do think the biodistribution chapter, as all the chapters -- and radioisotopes -- can be cut by a lot. A lot of them can and that one certainly can, but the reason why I see them as different is I think they have very different points. The radioisotope chapter is supposed to be the evidentiary base for our claiming that the government did act responsibly with respect to the obligation to try to minimize harm. And to balance harm against benefit and that's the point of that chapter and we need to make it clearer. I mean my problem with the chapter is it doesn't say it, it doesn't say this is why it's here. There are two major ethical concerns, several major ethical concerns that operate and one of them is how you manage the risk and here is the chapter that discusses at least with respect to radioisotopes the evidence behind the claim that the report may make that the government did a responsible job or under the circumstances, did a responsible job with respect to radioisotopes at least and the management of risk in most cases, not all cases. The children/women's chapter is directed at a different message. It's not the message that we did a good job managing risk, it's different kinds of issues, the sorts of issues we have described, so it seems to me they ought to be kept separate, but one of the problems we need to do with all these chapters is make it clear what's the message here, what's the point of the chapter, why is it there and then have them be tighter, shorter. You could put the essential evidence for that, the risk consideration issues in that chapter with, I think, half the material. We don't need every memo and every shift that occurred when the policy went from this place to that place to this place and the case studies of what happened in Michigan and elsewhere don't need to be here. We can have a footnote and we can go someplace else. The general idea is they had a system in place and this is how they executed it and they took their responsibilities seriously and by and large it worked out okay and they brought about some good things as a consequence and that's what you want to say there, in my view, and it could be said by half. Do you disagree, Ruth? I just want to keep going around. DR. MACKLIN: You're now presenting an argument for why these two should not be combined? DR. FADEN: Correct. DR. MACKLIN: A different argument from the one Henry gave. DR. FADEN: I think it's related. DR. MACKLIN: Because Henry's point could readily be made within the chapter in the form of "on the one hand" and "on the other hand." DR. FADEN: The only problem is it's a big point for the report. DR. MACKLIN: But what's missing for me then, you clearly -- your argument was persuasive they should be separate chapters, and what you're suggesting is that the rationale for each chapter and the message of the chapter should be put right up front. What we don't have, is this correct, I'm morassed with paper, we don't yet have the introduction -- DR. FADEN: That's correct. DR. MACKLIN: We've never seen an introduction of the case studies. DR. FADEN: That's a big problem. DR. MACKLIN: And what the introduction would have to do is say what are case studies, what are they case studies of and lay it out a little in advance so that's the message. What Pat keeps groping for and what keeps slipping away in some instances is number one, why are they case studies, why are they here in the first place, and number two, what the main message of the chapter is. So that -- some of that can be accomplished in the section that's not yet written as I understand it. DR. FADEN: And if you can't say it, the chapter shouldn't be there. I mean that's really the -- if you can't in that introduction give an explanation of its function in the book, it shouldn't be there. They have to be distinguished, I agree, and it is a fault, in retrospect. We didn't draft it -- in retrospect, I'm sorry, we didn't crank a draft of that overview no matter how primitive out, when we sent the chapters out. It was an oversight. DR. MACKLIN: But some of them do. When we heard -- the arguments are pro and con, aside from the compelling argument that it's a beautifully written chapter. The prisoners chapter is really, there are two different messages, the one that Pat says has already been answered by and large by federal regulations and lots of other studies of what happened to prisoners and the fact that that kind of thing by virtue of the federal regulations couldn't be happening again, and yet the other message and one of the reasons for some of these, the things that we've incorporated is follow-up and monitoring. So if there's a reason, if there are two reasons for putting something in and somehow or other that has to be accomplished in a way, because both are not reasons for case studies. One could talk about follow-up and monitoring without its being a case study. MS. KING: The problematic chapter from the point of view, several points of view is the chapter that needs a great deal of work, the chapter that has multiple messages picked up by other chapters is one of my favorite chapters in the book, but I put it on the table for cutting. I mean one of my favorite topics in the book, and that is, the pregnant women/children's chapter is actually a problem. Children develop well will repeat some of the points made in prisoners. It will -- if you cut it up, they're institutionalized populations, they're vulnerable populations. The children's part actually is the area that needs the most continuing attention, so we're in this anomalous position of having the most beautifully written and the best chapter dealing with vulnerable populations in the area where there's been the most tension of vulnerable populations. The area that we really need to make a strong point about is still very undeveloped and it's going to take major work to do this women/pregnant women chapter and that has been a continuing source to me. Even though I love this subject matter and I might drop pregnant women all together, for the same reason. DR. FADEN: We're right at that one, so let's just go around. I think Pat's point is well taken. The bottom line is there is a regulatory response in place that more or less seems to be satisfying a social policy need with respect to prisoners and there is not an analogous situation in place with respect to children. Lots of open questions, lots of unanswered and debated and strongly criticized practices and positions on research with respect to children. MS. KING: And I would also, with respect to pregnant women and fetuses, an awful lot of work has been done -- DR. FADEN: Especially recently. MS. KING: Especially recently and given the effort that it would taken to make this chapter work, I think, I think we have to give some serious thought to -- DR. FADEN: What we should do is let's go around. If you've already commented or made your comment about that chapter in the context, whatever, because it comes up, pass, but just keep on going. As it happens, the next one is children and pregnant women. Mary Ann? DR. STEVENSON: I think this by far is the weakest chapter in terms of its development, scientifically, ethically, but I still feel very strongly about trying to include this and I would be receptive to Pat's suggestion that maybe the pregnant women section be dropped, but I would make a very strong case for keeping the children's section. And, again, combining it or not combining it with isotopes,I don't have strong feelings about it. I think whatever is most efficient is fine and I think actually in retrospect the suggestions for keeping them separate are probably stronger. That's about all. DR. FADEN: All of this is helpful. Ruth? DR. MACKLIN: I concur that it's the weakest. I can't speak to scientifically weakest, but it's ethically weakest and there's always been a tension between putting the children and pregnant women in the same chapter and I think the reason it came into the same chapter is because of the fetus, to become a child, but if we're going to drop anything, I agree, the pregnant women -- we would have to doa lot of work as yesterday's discussion indicated to on the one hand reconcile our concerns about pregnant women in the past research and at the same time justify or support the IOM report to which a great deal is said and that's too much stuff in there and too much that doesn't have to do with our report. So that's an argument for removing the pregnant women section. Now we're left with two reasons for children and again, the reasons are important, but distinct. One is the possible need for monitoring follow-up, etc., which is a compelling reason for keeping it in. That's part of our charge. The other reason that Pat mentions is the lack of attention in federal regulations, particularly with institutionalized children, although there has been attention to the other, still not as we saw in the absence of consent forms for some of the studies, still a little bit messy, and then finally as a historical piece, what we really couldn't find or document, but what seems to be an overlooking of parental consent or at least not mechanisms in place for the past, for the enrollment of the children. Now my question and I am hesitating to put this forward, but the question is does this deserve a separate chapter, or is there some other way of focusing on the concerns of (a) monitoring and (b) the need for federal regulations. I agree that we're not talking about restructuring the whole report right here, but given what the concerns are about children, namely, the monitoring, which is future oriented and the -- and part 3 which is current regulations, etc. that fail to address this, is there some way of simply extracting the parts of those materials that would bear on part 3 and part 4 and eliminating it as a chapter? DR. FADEN: I think that's what we have to consider. DR. MACKLIN: I would like to see that happen, if it's not such an extraordinary amount of work. DR. FADEN: Ken, what you walked into is we're going chapter by chapter, everybody getting two minutes. So we're up to children and pregnant women and what we're saying is what do you think is wrong with it, what do you think should be done for it, cut it, get rid of it. MR. FEINBERG: My only comment is that to the extent we can do it, I'm not insistent on it, but to the extent that we can keep these chapters separate, but keep a section on children and pregnant women, keep a section along the lines of what prison is, etc. I think that's helpful because stylistically, when you read it, to be able to take this and use it as to specific examples, I just think that's a plus, if it can be done in a way is efficient and tells the story, I like that idea. To tie this to individual examples, I think is a plus and it allows people to really focus on categories, the lawyer in me. DR. FADEN: Pat, did you want to comment more? Lois? MS. NORRIS: It's hard to devote attention to every one and it's one that I have not devoted attention to, so I'll pass. DR. FADEN: Duncan? DR. THOMAS: I don't have much to add to my previous comments. I still feel the difficulty with this chapter is its multiple messages and one of those messages having to do with institutionalized populations, I'm still not convinced is best placed in this chapter and perhaps belongs in the prisoner chapter. I'm disturbed by the suggestion that once you eliminate pregnant women, it isn't clear to me how one can adequately talk about children's research without confronting the fetus problem as well, and I'm not persuaded by Ruth's argument that trying to reconcile all of this with the IOM report and all of this other stuff is too big a job for us to do in this chapter, as she explained to me the issues yesterday morning, when we discussed this chapter. It needs some rewriting, but it doesn't seem to me to be a fundamentally difficult and impossible task. MS. KING: I don't know what Ruth told you yesterday, but I would have disagreed. (Laughter.) DR. MACKLIN: I think it needs a lot of work. I don't talk about the importance, but it's in need of a lot of work. DR. FADEN: We're trying not to comment, unless this is like -- DR. MACKLIN: I'll try not to. DR. FADEN: But when you go around again, you can sneak in your comments. (Laughter.) Eli? DR. GLATSTEIN: I'm with Duncan. DR. FADEN: Phil? Nancy? DR. OLEINICK: I'll pass. DR. FADEN: Henry? DR. ROYAL: The committee is aware of my comments in this chapter. DR. FADEN: Okay. MS. KING: Not everybody has read his comments. DR. ROYAL: I would not have eliminated pregnant women, but I don't have strong feelings one way or the other. I would like to see it as a separate chapter, not combined with prisoners and I would be in favor of deleting pregnant women, but I wouldn't oppose it strongly. DR. FADEN: Sue? By the way, we're getting -- if we can just all of us put the mikes, apparently the sound system is not good, so please put the mikes right in front of your face, as unpleasant as that is. Sue? DR. LEDERER: I guess my decision about whether or not to retain this chapter depends on how much staff resources we can devote to it because it is the weakest. So without having some idea of what can, what staff resources are available, it's hard to make the -- DR. FADEN: It's more a matter of relative priority, we can't sort of sit there splicing people out now. So the issue is relatively speaking, given the state that it's in, obviously it's going to take more time, high priority, focus on the kids and drop the pregnant women. DR. LEDERER: I guess I'd give it a high priority if it can be done well or reasonably well. I don't want to have it in there, if it's not going to be in good shape. I guess my other question that I'd like to raise, I mean and it's a problem that's arising is we did discuss potentially leaving out chunks like the prisoners, is does that mean we will not comment on what are among the most prominent of the radiation experiments that created this committee. Does that mean if we drop the children's chapter, we will have no comment on the Wrentham and Fernald school things? DR. FADEN: That was the argument. If you think about the implications, that's of course, one of the downsides in eliminating the prisoners. If you keep children, then Wrentham and Fernald remains. Vanderbilt goes out if pregnant women go out, so there are those implications in terms of the cases generating public comment. DR. LEDERER: And if I remember the charter, the testicular studies are explicitly mentioned, is that correct? The Washington-Oregon prisoner experiments? I don't remember. No, they're not. Okay. DR. FADEN: We can go on, but that's an important consideration. DR. LEDERER: Just one other comment about the prisoner experiment. I guess I would agree with Jay that in its current order, it doesn't seem to make sense, so if we're going to retain it, it should follow the children's chapter. DR. FADEN: I think that makes a lot of sense. Okay, we're now doing TBI quickly. We've got to keep going. This is, I think, incredibly helpful. TBI. I'm sorry, it goes this way, Sue? DR. LEDERER: I think this is a necessary chapter. I've already said my comments about length though. I think everything needs to be reduced. DR. FADEN: Henry? DR. ROYAL: It's a necessary chapter, but shorter. DR. FADEN: Nancy? DR. OLEINICK: Same thing. DR. FADEN: Jay, we're on TBI. DR. KATZ: I think on TBI, the only thing -- I thought it was a good transfer -- I think it needs a stronger conclusion. DR. FADEN: Okay, Phil? Go along with Jay. Eli? DR. GLATSTEIN: I agree it's a good chapter. It can be shortened a little bit, although I don't think it could be shortened a lot, it's too complex a subject and I think the conclusions need just a little bit more beefing up. DR. FADEN: Okay. Duncan? DR. THOMAS: I think this is a good chapter. If shortening is needed, I think the staff should do some soul search as to whether or not it's necessary for this chapter to try to cover the whole world of TBI or perhaps focus on one case study. It might help, but I don't feel strongly enough about it to push that. DR. FADEN: Lois? MS. NORRIS: I agree. DR. FADEN: Pat? MS. KING: It's a priority chapter. DR. FADEN: Ken? MR. FEINBERG: Pass. DR. FADEN: Ruth? DR. MACKLIN: No special comment. DR. FADEN: Mary Ann? DR. STEVENSON: Actually, one sort of technical problem I think needs to be addressed is there's constant reference to government-sponsored TBI and in fact, the government experiments were associated with existing TBI programs. I think that's actually a very important distinction that needs to be addressed and standardized in terms of the language of the chapter and I think the chapter spends a lot of time sort of wrangling about whether or not TBI was appropriate medical treatment and although I think that's clearly an important issue, to me, the more important message of this chapter is the ethics and responsibility of researchers doing dual purpose research and are there regulations in place now which to my knowledge I haven't got an answer back, I keep asking staff, are there regulations in place now governing the responsibility of researchers that are involved in dual purpose research. In other words, you get the good with the bad. You can't just sign off on the primary if your interest is the secondary experiment. I think that's too easy and we need to be very sure whether or not that loophole has been addressed so that researchers know they carry responsibility for the primary -- DR. FADEN: And also that the funders do as well. DR. STEVENSON: Right. DR. FADEN: It works both ways. DR. STEVENSON: So I think that really needs to be tightened up and addressed very strongly. To me, that is the ultimate purpose of this chapter, the most important purpose of this chapter and I think the conclusion should reflect that, the discussion of dual purpose research and spend less time wrangling about the medical indications of TBI at the time. DR. FADEN: I hope everybody is appreciating, as I am, just how useful this is going to be to staff, and also how much, especially when there's more consensus about where there are possibilities for moving things around when we started talking with one another. Is it all right if we skip prisoner research? There have been so many comments that it's clearly one where there's some argument for skipping it, some argument for keeping it. We're not going to resolve it, I think. Everybody is agreeing it's well-written and the issue becomes around everything else -- MS. KING: It's a possible compromise is to have, depending on what decisions are made by other parts, because I assume you all will make the decisions, a possible compromise is have a chapter on institutionalized populations so that we can retain some bit from prisoner, but really develop and put the priority on developing children. DR. FADEN: If we can have an understanding that institutionalized populations also includes hospitalized children. MS. KING: Absolutely, that's the value. I was trying to save time and I wasn't going to get into some of the pros of having that combination, but it's clearly one. DR. FADEN: If we understand that we are including institutions like Wrentham and Fernald and also children who are in hospital. DR. MACKLIN: I think that's a problem. I would say independently suggest exactly what Pat did about institutionalized populations. But I think the difficulty is this, adults may be institutionalized, hospitalized -- DR. FADEN: Well, adults can be institutionalized too. Long-term care facilities and also, I mean -- DR. MACKLIN: But we have to focus on what is the ethical concern. The ethical concern with children -- with prisoners in institutionalized settings is the so-called coercive that we know about. With children, it's that their parents are not there and present as an advocate which is probably not likely to be the case for children who are in the hospital who have parents visiting them, etc. DR. FADEN: What's interesting about that and this gets into the substance is arguably what we now better appreciate, is in the 40s and 50s that's what it was like for hospitalized children, so maybe this is in a sense, a problem solved, but from the oral histories, especially, the pediatricians, you have the message that in 1956 at Hopkins, for example, parents could visit once a week for two hours when they're children were in-patient or twice a week for two hours, so the modern understanding of what it's like to be a child and have the parent have a bed in the room is quite modern. DR. MACKLIN: That's certainly true. I guess the problem is the neatness of the categories or lack thereof. DR. FADEN: True. DR. MACKLIN: If we say hospitalized children count as institutionalized -- DR. FADEN: I understand. (Meeting interrupted by alarm ringing.) DR. FADEN: It's going to happen again. Anna passed me a note and I forgot to mention it. It's going to happen again. DR. GLATSTEIN: Thank you. DR. FADEN: Isn't that nice? Okay. Is it all right if we don't go all the around prisoners since so many people have commented on prisoners and we will just have to figure out what to do. Eli? DR. GLATSTEIN: I think when you talk about institutionalized populations, and then you ask the question how do things like the TBI experiments in Cincinnati occurred, this is exactly how it occurred. DR. FADEN: Because of the institution. DR. GLATSTEIN: Because when the patient is institutionalized -- (Meeting interrupted by alarm ringing.) DR. GLATSTEIN: Particularly, when these institutionalized in a county hospital setting, anybody who comes around two consecutive days in a row and shows some solicitous interest in the patient, is so different from the normal experience that that patient has, that the patient will go through a wall for that guy. And that is how these patients really get recruited. DR. FADEN: That's an important theme, I think, that we can be developing. All right, we don't know if this is going to happen every 30 seconds for the next two minutes or whether this is going to be interspersed through the day so I'm toying with calling for a break, but I said we won't have a break until we finish with all of these. Let's go ahead and try it. A-bomb tests. Henry? DR. ROYAL: As I'm looking at Nancy's list of the remaining chapters, A-bomb tests, observational studies and secrecy, if it were at all possible to combine those four chapters into a chapter, I think that I would be interested in that. DR. GLATSTEIN: That chapter will be three books. (Laughter.) DR. FADEN: Nancy? DR. OLEINICK: Not only would that chapter be three books, but I don't think -- although there certainly is some overlap, they do deal with different issues and so I think there is a rationale for keeping them separate. One of the other concerns is with all the -- (Meeting interrupted by alarm ringing.) DR. FADEN: Let's keep going. That was a little shorter. DR. OLEINICK: With all the work that staff has to do, it probably would lighten their load not to have to do major rewriting which would be involved in combining chapters, if we did not feel there was an overriding need to do so. So getting back to the question of the A- bomb tests, I would like to see this in here. I think it needs, again, a little more focus on exactly what the issues are that we want to get to, but other than that, I am in favor of this chapter. DR. FADEN: Jay? DR. KATZ: I'll talk about 6, 7 and 8 together, but leaving out 9. I think they are all right. I appreciate Pat's concern about the chapter 8 and Steve Klaidman and Duncan and Nancy and I, in particular, are sort of working on it over the next few weeks. I think it's an important chapter, Pat, for all kinds of reasons I don't want to go into right now. And maybe you can postpone a final judgment until you see what eventually will be produced, I'm sure, by the next meeting. I think it could turn out to be an important contribution, but only time will tell. MS. KING: Can I just ask a question? DR. FADEN: Sure. MS. KING: Is it more important to finish these chapters than to do something on contemporary research, devote some concerted time to contemporary research? Because if you tell me that it is -- DR. KATZ: If we're willing to set, we haven't confronted that. If we set these kinds of priorities, I have no question that contemporary research is much more important than the Marshall islanders and the uranium miners, but the uranium miners is a telling example of special obligations -- (Meeting interrupted by alarm ringing.) That investigators have toward subjects of research, past, present and future; and I wouldn't be concerned about leaving out the Marshall Islanders. We've heard from them frequently and they have told us stories that deserve our attention and our comments and I would -- (Meeting interrupted by alarm ringing.) Be sad if we left particularly that part of the chapter out, but also I feel and I may be wrong, if you put it in terms of absolute priorities, there's no question what my answer would be. I think that chapter can be reasonably well completed. (Meeting interrupted by alarm ringing.) You come up here against the issues of priorities and I just pass. DR. FADEN: We have been told that they weren't supposed to happen any more, but they keep happening. Phil? DR. RUSSELL: I have difficulty dealing with this because both of the bomb test chapter and the uranium miner chapter deal with the special problem of high risk, inherently high risk occupations, i.e., the occupation of being a soldier, the occupation of being a miner, and then dealing with additive problems on top of that and then trying to separate the two. I keep asking myself what does the bomb test chapter add to our understanding of the ethical issues and how do we put that into perspective with regard to the major message we're trying to convey. I tend to put it at a lower level in the priority list than the things like contemporary research management. DR. FADEN: Eli? DR. GLATSTEIN: I think 6, 7 and 8 are very essential chapters. I think these deal with issues that have not really come to the fore a great deal. They've sort of passed by in the case of the Marshall Islanders and the uranium miners, but I don't think the public has a good grasp of these issues at all and I think the government has done a very effective job over the years of sweeping it under the table. And I think it's about time this has to come up and be surfaced and I think that frankly, if we do not include these chapters, as separate entities, I think we do a real disservice to a lot of people who put a lot of time in to give us very appropriate testimony and I think that we owe them that and I think they deserve it and I think these chapters are really very essential. The one on secrecy, the last chapter, is a complicated one because certainly when there's a war going on and you can argue probably in the Cold War era as well, when you claim national security over something and you have some tangential basis for that claim, it sort of ends an argument. One of the things you learn when you work for the government, you can have a very nice discussion, you can have a real argument. Once they agree, the arguments over, the discussion is over and nothing necessarily happens, but there's no more discussion. I guess what I'm saying is these chapters need to be here, I believe, very strongly and although my personal interest is the research, I think we would do a major disservice if we omit any of them. DR. FADEN: Duncan? DR. THOMAS: I think 6, 7 and 8 are all essential chapters and I agree exactly for Eli's reasons why they need to be there. Of the three, I consider the bomb test chapter the weakest, in part, mainly because we are constrained by our charter to dealing with the experimental aspects of the atomic event story and that leads to all kinds of difficulties in telling the story. At the end of the day I find it really hard to see what the point of this chapter is. The weakest aspect of this chapter, to me, seems to be the ethical analysis, in that I think we have an opportunity here to talk about the concepts like the meaning of informed consent in a constrained military environment which is not mentioned or if it is mentioned, not done justice to. I've long had a lot of trouble with this chapter, but given the constraints under which we operate, I find it hard, without a clear concept of what the purpose of the chapter is, I'm hard pressed to know how to fix it. That said, I still think the chapter needs to be there and I won't belabor the reasons why. If we're in to discussing the three as a group, I'll go ahead and make my comments -- DR. FADEN: We can come back to it. DR. THOMAS: Intentional releases, I don't need to say anything about. It's obvious why it has to be here and the chapter is done well. So that one is without problem. Chapter 8, I think, it's premature to be discussing without seeing the whole thing. I think the uranium miner bits that we do have, tell a very compelling story that's absolutely essential to what we have to have here. In addition to the secrecy, legacy of distrust issues which have been touched on by a number of people, I think it also tells an important story about how research is used to avoid action. I think it tells an important story about the conflicts of interest when the same individuals are or the same agency is charged with a production mission and a protection mission. And about on the other hand that the trade off which happens when those two missions are separated and inadequate authority is given to the protection mission, it has an opportunity as well to talk about the tensions between the enforcement or worker protection mission and the research mission which is perhaps not adequately explored yet, but could be easily developed. The Marshall Islands part is more difficult. (Meeting is interrupted by alarm ringing.) The main message which I hope to see reflected in the part that's being developed now is the difficult ethical situations which arise when research and medical care are not adequately separated. That's just one of several messages we're trying to weave together and I think it's maybe premature to try to say what is the point of the Marshall Islands piece. I strongly believe it needs to be included and it would be a grave oversight to omit it. DR. FADEN: Can we do this? The rest of you who haven't commented, if you can speak about all three since so many people have, that will be efficient and I'll return to those of you on the other side who may have additional comments on 7 and 8. I would like to end this whole thing -- (Meeting interrupted by alarm ringing.) I would like to stop in no more than five minutes because we desperately need, I need a break. We all need a break. So if we can go through the others in 5 minutes quickly. We're up to Lois. I know we have secrecy. Some people have already commented on secrecy, so that's what we need, the secrecy chapter. Lois? MS. NORRIS: I have no significant comments with respect to intentional releases and observational studies to the extent that we have that chapter. I would not like to see the atomic chapter dropped, but I do think it needs a lot of work. I think it's confusing and the point kind of gets lost. The problems they're trying to sort out, the difference between biomedical experiments and field exercises and labeling them properly is difficult for me, so I think it needs work. DR. FADEN: Pat, do you want to comment further? MS. KING: I sure do. (Laughter.) MS. KING: Because the issue is not whether they are important issues. The issue is not whether something could be said about them that was important. The issue is not that there's not a great deal of public interest in this and public concern. All those things are true. I start there. I particularly care in contrast to what some of you may think about the Marshallese and the uranium miners examples. But it is precisely because I care that I am the most troubled. Exactly what Duncan pointed to that is missing in both cases, ethical analysis, which is the value of having these chapters here. These chapters raise critical issues, not really addressed before, I think, the question of researcher ethics and the context of these uranium miners, occupation, these are critical issues. When I read this chapter, that's what started my problem. We do a description, we haven't done any ethical analysis because the staff can't do ethical analysis. We would have to do it and we are in May 10th. And we're not going to do any critical ethical analysis in June or July and rather than take on a critical area where there's not a whole lot of work that a lot of us are familiar with, that's gone on before, I don't want to botch this. What I really think is critical here is that they do raise these issues and I'm not against any portion of the report talking about the issues that have not been addressed and how important they are. But in terms of priorities on May 15th, May 10th, I think that we have no choices. Intentional releases and the secrecy chapter are critical to our mission for different -- (Meeting interrupted by alarm ringing.) Those two chapters are critical to our mission and I see some things I won't comment on. We'll just keep working on those. The others deeply trouble me because we have not had the time to get around to doing with them what needs to be done. Duncan's comment that we can't really comment on this chapter is unfair because it's not all here was enough to tell me exactly what the problem was and so I -- those are my comments. DR. FADEN: We're going to march through and please, I apologize for all of these horrible interruptions, but if we can bear through and get this done, when we come back from break we can take on another issue and feel like something has been completed. MR. FEINBERG: Three quick points, first, it's too late in the day to consider dropping these chapters. I mean, Phil may be right six months ago or nine months ago. We've been hearing people in the public comment period and we have been opportuned and cornered by people who represent these various groups and have a legitimate argument to make. I agree with Eli that it's just -- I don't think it's realistic to think at the eleventh hour now we're going to drop these chapters in light of the constituencies that are interested in hearing what the story is. And they have every right to hear the story and there is information in these chapters that I find that Congress has not addressed, despite the fact that they've developed compensation statutes in this area. I just think it's too late in the day to talk about dropping the chapters, notwithstanding Pat's point. The second thing I want to say is to the extent that Pat is correct -- (Meeting interrupted by alarm ringing.) I think that the importance of these chapters lies in what we're still going to say in these chapters about ethical standards and ethical guidelines and the final point I want to make is we better say something about ethical standards and ethical guidelines because otherwise I do not see what these chapters are going to add to the overall report, other than telling the story because they sure as heck aren't going to give any solace to the constituency about remedies. So if you're not going to put in something that ties the story to the ethical issues that are posed in the rest of the report, then all we've done is -- and I'm not minimizing it, it might be very useful, we've told the story, but I agree with Pat and with Phil that right now you read these chapters, there's an interesting story and next chapter. I agree with Eli to the extent that Eli says it's important. I say it's too late in the day to say it's not important. DR. FADEN: So there you go. MR. FEINBERG: That's it. DR. FADEN: Ruth, then Mary Ann and then just anybody who wants to comment and then we'll break. We have secrecy and some people have not commented on and some people on this side of the table need to comment on this segment. Ruth and Mary Ann? DR. MACKLIN: In the spirit of agreement we've been hearing, I believe with Duncan, Eli and Ken that we need all these chapters and we can retain all these chapters. About Phil's point which I took the central point to be these, at least with these uranium miners and the military, these are high risk occupations and the studies were done in connection with them. That's certainly true and that point could be brought out, but there are additional points and as I think back on all the HumRRO stuff and particularly on the indoctrination part of it, studies that are accompanied by indoctrination -- (Meeting was interrupted by alarm ringing.) DR. FADEN: Apparently, this is coming from the fire department and the hotel has no control over it. For whatever that's worth. MR. FEINBERG: If it's strict liability, it doesn't matter where it's coming from. (Laughter.) And causation is irrelevant also. (Laughter.) It may be government immunity. (Laughter.) DR. MACKLIN: Anyway, I think that the points that are made that are critical of the chapters or the comments such as Phil's, need to be addressed in the chapter. I don't see that as a reason for not including the chapters. I agree that they need to be included. I disagree with Pat that the staff can't do ethical analysis. I think there are members of this staff -- I thought that's what I heard her say. MS. KING: We can't do the committee's ethical -- DR. MACKLIN: Right, fair enough, but that's our business to deal with. I think there are staff members who can do ethical analysis and as part of the staff's -- well, not problem, but -- (Meeting interrupted by alarm ringing.) -- to find those who can and take a crack at it and I volunteer to assist in shaping the ethical analysis. DR. FADEN: Thank you. Mary Ann. DR. MACKLIN: I'm talking about 6, 7 and 8 here, not 9. DR. STEVENSON: I don't have a problem necessarily with keeping atomic vets chapter in, but the purpose is not clear to me. There's a lot of narrative, there's a lot of telling of stories, but at the end of the day I don't know what the conclusion is so that's sort of -- if it can be cleaned up quickly and some purpose be made, fine. Otherwise, I think it should go out. The intentional releases is chartered, so I have no problem with that. And the observational experiments, to me the purpose or the reason for including them would be obviously, as everything else has said, for the ethical analysis because they have been dealt with scientifically and medically in other places and if we can do that well, I think we do a great service and there seems to be a division on the committee and maybe the staff whether we can do that and I'll defer that largely to the staff, but I think it would be very important if we could make an ethical analysis of those studies. DR. FADEN: Now, some people on this side only commented on one in the series. Is there anyone who wants to comment on something else of 6, 7 and 8. If not, I want a quick go around on secrecy. We've got to do this quickly. Is it all right? Let's go around and do secrecy. If you've already commented on secrecy, the secrecy chapter, fine. If not, this is it, last time. Then we'll have our break. This side this time, Mary Ann? The secrecy chapter. DR. STEVENSON: I think something like this needs to be in the report. I agree with keeping it in. DR. FADEN: Ruth? DR. MACKLIN: I absolutely agree it should be in. My brain is a little addled about the state of the secrecy part because I'm not sure about all those recent things that we got about the administrative embarrassment is in here or not because I forgot it, but I think it's in here, it's in this draft. But in any case I think we need it and it's a crucial point for the whole report because so much is said in the earlier chapters and the case studies about the reasons for cover up or the reasons for not disclosure or the reasons for follow-up studies. DR. FADEN: Ken? MR. FEINBERG: Certain remedies that are critically tied to secrecy and cover up, you have to have the chapter. DR. FADEN: Pat? MS. KING: I've already said it. DR. FADEN: Lois. Duncan? DR. THOMAS: This stuff is fascinating and I think it's an essential piece of it. It's not a case study like any of the other chapters and I wonder why it's not in part 1, but that's trivial. The only difficulty I have with it is we took some important material out of the experiments of opportunity and moved it into this chapter, namely the bits on fall out and I don't think it's been done justice to, but that's in the category of the detail which we'll fight about later. DR. FADEN: Eli? DR. GLATSTEIN: I have nothing to add. DR. FADEN: Phil? DR. RUSSELL: Very critical chapter. DR. FADEN: Jay? DR. KATZ: One thing that is missing in this draft is that the problem about secrecy and national security persists today including what's going on in the occupational health area. Luckily and I gave a copy to Dan, one of my students wrote a wonderful paper on employee test subjects under the occupational health statutes. There are some wonderful recent analyses in this paper and I ask that I could give it to the commission for it to make use of it and so I think some pages of it deserve to be included in the final report on secrecy because it's attention that persists in today's world. DR. OLEINICK: I certainly agree that the secrecy chapter has to stay. As a matter of fact, I actually like the placement of where it is, even though it's not a case study because it ties together themes that have run through the entire report up to that point. I'd like to go back. I've already spoken my piece, I think, on the observational studies. I think the releases is in and it's a good chapter and it's necessary. I'd like to go back and make another point about the chapter on the experiments in connection with the A- bomb testing. Another theme that comes through is again the protection of soldiers in research, in experiments and although the federal regs, as they are now, do deal with other populations, there are regulations on children even though not on institutionalized children, there are regulations on children even not on institutionalized children. There are regulations on prisoners. There really are none that I am aware of that specifically address the issue of soldiers. Now there was something that came through in the last meeting as kind of a rough memo or something on some suggestions. I didn't look very clearly, but I didn't see it in here and I think that's the kinds of things that we may want to be able to recommend, so in order to recommend, I think we have to have something in there that leads to it. DR. FADEN: Henry? DR. ROYAL: I would consider the possibility of moving secrecy to part 1 because it's not a huge study, but I think the chapter is in reasonable -- MR. GUTTMAN: The technical problem is the cross referencing then becomes impossible. It cross-references back to cases. That's the simple reality of it. DR. FADEN: Sue. DR. LEDERER: It's essential. I think it actually makes sense where it is. DR. FADEN: Thank you all. I appreciate everybody's endurance to sit here this long without a break. Let's see if we can have lunch a little bit later. That would be the one thing that makes sense and we'll break for 10 minutes, reconvene for maybe 45 and finish the project issues like how many more meetings we want, that kind of stuff, get that out of the way before lunch. (Off the record.) DR. FADEN: We're going to shoot for breaking at lunch at 12:30 and let me just make a point of planning here. At 12:30 just before lunch we are going to try to take a staff committee picture. There is a staffer coming over from the advisory committee offices that are not here. I don't know how many will come, but as you all know, we are losing a big chunk of our staff at the end of May so we are going to try for the staff that will not be with us after the end of May to create a staff committee picture. I have no idea how we're going to do this. Anna is figuring out where this is going to be and hopefully it will not take very long to do, but I think -- that will also give each of us an opportunity if we wish to see some staff members who are leaving and say a few words. Okay, here's what I would like to do between now and when we break for the picture and lunch. The other process issues, we need to returning some fashion to the question Jay raised about the status of the contemporary analysis of how to do what I would frame is the best job, and do right by it. We had some immediate issues -- at your place, I think these have bene distributed, is a tentative work plan for final report release. This is the document that is supposed to make everybody feel panic. Why don't you just give everybody the new one. Anna is going to give out the newer one. It looks better and we'll all be reading from the same page. Just throw out the one that has the bad xerox. Here's our work plan. Here are the things we have to determine. We have to determine how many meetings we want to have within this time frame. We have to determine what we're going to do about outside reviewers or seeking outside comments. We have to determine how we want to work with staff over the remaining intense couple of weeks and we need to talk, of course, about priorities and where people are willing to work. If we could take a minute to look at this, you will notice that in bold for Week 8 and Week 12, there is tentative meeting time set aside. And the issues, the calendars, Jeannie and Jerry circulated calendars and these were the dates that had the highest proportion of availability. (Meeting interrupted by alarm ringing.) Do you notice that didn't happen once while we were breaking? (Laughter.) Did anybody notice that? Okay, this reminds me, what meeting was it where we had no air conditioning? These are grand memories. Wonderful moments from this committee. (Laughter.) So add issue to debate and to resolve today is whether we should meet collectively as a unit once or twice. Twice would clearly be the absolute maximum. These are the dates that have been identified and they really can't be moved because they reflect a culling of people's availabilities and then if it's to be once which date is preferable,the June, the week of June 19th or the week of July 17th? Once we decide that we can move on to the other process issues, but it will have some effect of how we do business, knowing how many meetings we're going to have. Since this is responding to the committee's meeting last time, that it would like one more meeting and as I said, we don't have official approval, but we have been reassured that it is reasonable for us to be working within this time frame. All right, so the floor is open. Does anybody want to argue for one meeting or two meetings and if you argue for one meeting, if you already have a view about which one would be better, please say that as well. Okay, open for discussion. Ken? MR. FEINBERG: Who is going to be here in July? DR. KATZ: What did he say? MR. FEINBERG: Who is going to be here in July if we have a meeting in July. Will anybody be here? Is anybody available? DR. FADEN: Let's turn it around. This may make some difference. We don't have the list of who -- why don't we just ask people right now so we can see a show of hands. If there was a meeting on the June dates, who knows that they would miss the whole meeting. Let's start with that. If there was a meeting on the June dates, who would have to miss one day of the meeting? Just raise your hands so we can see what would happen. So we would have a meeting without four of our colleagues on one day, if we met in June. DR. MACKLIN: What are the dates again? DR. FADEN: It's week 8, June 21, 22, 23. This will help us. That's a very good point. Let's see who we would have around the table at one session or another. So if we met, I assume that the people who would miss one day could make the other two days or not? Yes, no. DR. KATZ: It depends if we meet -- if we meet -- if we have two days. If we meet on the 21st, rather than meet on the 22nd, I may have to lose a day and a half. If we meet on the 22nd, I may only have to -- I may be able to come those two days, but not be present for half a day. DR. FADEN: You know, it raises another issue which is whether these should be two or three day meetings which is also at question. We know we would lose part of four of us and what combination, we can't go into that in full detail. But we would lose parts of four of us if we have the meeting in June. If we have the meeting in July, how many people would miss the entire meeting? Okay. How many people would have to miss part of the meeting if it were to be held in July? Okay. All right, so that's -- okay, that's interesting. All right. (Laughter.) We don't know about Reed, good point. All right, group, let's continue. So now we know about the availability issue for those two days. Now maybe we should all take a minute to look at the weeks at issue and let me also say a little bit about what I hope will happen in the next meeting or meetings. My fantasy is that on the case studies and indeed for both Part 1 and Part 2, that we can resolve those chapters without committee discussion again, except where and if we identify real disagreements, people taking the position that they would dissent if a certain section of the report was there, or what have you. We'll talk about the method for that in a little bit. Ken had a suggestion that I thought was quite useful which some of us have discussed. My expectation is that we would spend the bulk of committee time interpreting and agreeing about the meeting of the contemporary projects and importantly, the recommendations which -- the core findings, the distillation of the seven, six, three things that we want to say and then the findings and then the recommendations, both retrospective and prospective. With any luck, the retrospective recommendations will be ironed out this afternoon. That also is my fantasy, so that the bulk of the remaining meeting time is devoted to our prospective recommendations, a large part of which, of course, has to do with the current human subject research situation. So that's my sense, my hope, not my sense, my hope of how collective time would be spent and that we would have to -- and this is the next thing we would be discussing, developing some process between now and the next meetings, working through the chapters that we had been working on so hard, all this time. So now with that in mind, here are the dates. We now have some sense of who will be available when and would anybody like to start the discussion about whether two meetings, one meeting, what would people prefer or argue for? Nobody wants to start out. How many people incline towards two meetings? Let's just see where we go. One, two, three, four, five, six, seven, eight people. How many people inclined towards one meeting? Only one more meeting versus two more meetings. The issue is do we want one more meeting, do we want to meet together one more meeting or do we want to be together two more meetings? How many people are inclined to one more meeting? Three. Okay, so now the issue is -- pardon? Can we hear from the people who want only one more meeting? DR. MACKLIN: A procedural question here. Doesn't it depend on the timing? I mean which of the -- DR. FADEN: We can do it either way. DR. MACKLIN: Depending on how much will be done by way of revision, my sense is that we needed two is based on the amount of committee discussion time needed to discuss remaining drafts and the state of those drafts at the time that we would be looking at them. So if we're going to pick a meeting time where we're presented with virtually completed drafts, for all the chapters, I mean with the whole thing, then maybe one meeting could do it. DR. FADEN: The problem is part 4, is it, part 3 and 4, parts 1 and 2, we have spent tons of work on and admittedly we've just gone through this painful process of picking apart parts 1 and 2 and all the work that has to be done, but parts 3 and 4 is frankly what we need to be doing right now so maybe I didn't make it plain enough, my own vision for how we spend collective time from now on is just disproportionately, as far as I'm concerned, got to be focused on parts 3 and 4. MS. KING: And the integration of the whole report which clearly poses a problem when you start to reach as far as we can go? There are problems with integration. There are problems where it's been treated so in isolation. DR. FADEN: I know, but hopefully that will, that can wait. What I'm concerned about is we need substantive committee discussion around concrete proposals for recommendations which we have not had. And that work has to happen and can only happen, I believe, effectively in committee, in contrast to this point working on the chapters where I think a lot of that can now be done in the ways in which we have been working between last month and this month, the memos, the E-mails and everything else, especially if we work out a proposal for doing that with staff and we'll talk about that later. Now if we had only one meeting, it's this group that decides whether it should be in June or July since we're the only people who care. So we all stipulate which one would be better or we can have both and each of us knows and I'm sure you all appreciate the tradeoff of the staff in having a meeting versus not having a meeting in terms of the time it takes to prepare a meeting against the guidance that the staff gets from collective committee discussion. Duncan, did you want to say something? DR. THOMAS: I'll go ahead and try, although my thoughts aren't well organized. My inclination in favor of one meeting rather than two is based on well a couple of questions to staff rather than anything else. The first is this trade off which you just mentioned. I'd like to hear from staff whether or not in their opinion the effort that goes into preparing for the meeting and the several days of sitting here listening to us talk versus that time spent just working on the writing process is more counterproductive or more helpful on balance. The second part of the tradeoff is whether or not they find the guidance they received from us in terms of the upshot of this attempt to build consensus in a public process versus what happens through the exchange of memos of getting us to talk to each other on a one to one basis or us against staff or whatever, the things that can happen, the thing that hasn't happened all along, between the meetings, which they find more helpful. MR. GUTTMAN: There are different kinds of problem, one, as painful as it is, it's very useful to listen to the committee. HHS sent us a comment of chapters saying that "the staff ought to be applauded, this is much improved, you've apparently listened to the committee." There are two separate issues I think Ruth is talking about. One is the Part 1 and 2 and the other is 3 and 4. 1 and 2, I think we're saying there are two things that you're telling us. One is that everything should be shorter, God knows that that is something that's going to be done, but we understand that that's the message. And the question is what's the principle for cutting is a separate issue. Then there are several chapters which we have pointed out require work where we desperately need committees, essentially for the reasons you all mentioned, if it requires a committee, what's the point? So one thing that would be very useful if committee members say I want to work on children or uranium miners and then we can then work and concentrate on those chapters. The other part, Anna is going to have the comments on the logistics and all that, but the other part is that I think it seems to the people up here that the third and the fourth, I can't comment, the fourth section really benefits from your thinking it through because the integration, it feeds back. We can't really do the ultimate refinements of the chapters until you flesh out all these sticky point questions. When Pat says I can talk about learning from the past, but saying it's wrong, so that affects the way in which you write everything. And all that kind of thing, those points that are painful, for a day's worth of discussion, they feed back into the way this thing gets constructed. DR. THOMAS: I came into this meeting with the hope that we could have with at the beginning a draft of Part 4 and basically a whole day to discuss it. That was the hope that we went into this meeting with. Had that happened I would have thought absolutely that we could finish with one more meeting. My major uncertainty hedging whether we need one or two more is the state of Part 4. DR. FADEN: Part 4 is in the most primitive state is what it comes down to. We have the situation stuff. I think we can hopefully -- we have to reach closure on what we want to do about that and we have a document which we didn't even present back this time because it hasn't really been changed sufficiently. Of the four, we're looking recommendations, a large part of that, of course, is rating the synthesis of the contemporary data which is now ongoing. So there is a way which it kind of is all of one piece. That's basically where we are. The findings one I was hoping we could have a discussion. That's why this sort of open-ended projected test, if you could write the end of the sentence, what would you write. It's a discussion I hope we can still have this afternoon because that will go a long way, I think, towards guiding the staff. Is there anybody else who was arguing for one more meeting, want to speak to it or should we just -- MS. MASTROIANNI: The concern is not with the actual meeting, Duncan, the preparation time for the meeting is, I think we have it down to a very fine system. The logistics problem that we encounter with respect to preparation for the meeting is what you need to see for the meeting. If you were to place, for example, a priority on the meeting of parts 3 and 4, then we would put our emphasis on preparing part 3 and part 4. The work would continue to go on with respect to part 1 and part 2, but we wouldn't have to push that huge document out the door and load you up with paper in preparation for the meeting. That's where the problem comes in as far as meeting preparation. If you want to see a whole draft report start to finish in the next four or five weeks, that is a tremendous amount of effort and we will devote our time to doing that. It's not the meeting itself. MR. GUTTMAN: If I may suggest, want you probably want is to see a redo of the two to three chapters that stuck out, the children, pregnant women, uranium, those things, but the other ones, let Sarah work on. MS. MASTROIANNI: It would just be how soon do you need to see the last rewrite. MS. KING: Anna was looking at me when she said if you need to see a start to finish draft, then that makes a difference, that leaves a different result. I too understand the pressures of time. This is what I think. I unlike other committee members do not believe that one can do a report piecemeal. It does not work that way. These chapters have been written in isolation by different people. You have to have a report that hangs together. But Anna makes a good point, but I think I would modify what you said, Anna, in one respect. Parts 3 and 4, I think, need a whole meeting. But what -- (Meeting interrupted by alarm ringing.) What we need and I don't think it will be a lot of trouble is part 1 is actually critical to having the rest of the report come together. It is where you start and 4 is going to be where you basically end up. Part 1 is also in very good shape. I mean, relatively speaking, as these things go. So what my ideal thing would be is to see 1 through 5, particularly 5, and 3 and 4 because those are the connections. There are two efforts, 3 and 4 need work, but in part, understanding the full extent of the work they need, needs to go to what we say we're going to do in the beginning and how we set ourselves out to how we end up. But I don't think it means a lot of work because we keep saying one -- DR. FADEN: I don't think Part 1 is going to change that much. MS. KING: That's exactly right. DR. FADEN: The point is, it's fine if it gets -- MS. KING: Five is the one. DR. FADEN: Five, potentially yes, but the other ones aren't going to change -- MS. KING: That's right. DR. FADEN: And the very first one might change because we have to set up the research stuff, but 2, 3 and 4 are not going to change that much. I mean they'll be shorter. Some people may be concerned that their favorite part got cut out and again, whoever said -- oh Lois, thank you. Staff is already very anxious. People talk about when I start cutting, what am I going to do with these phone calls I get. You cut out the part I loved the best in the chapters, so we're going to have to deal with that issue and hope that everybody will free themselves from that, whatever. (Meeting interrupted by alarm ringing.) MS. MASTROIANNI: I guess my question is immediately do we have to reissue to you Parts 1 and 2? Can't we just before, if we have a June and July meeting? MS. KING: I am saying to you I would like it that way, but I understand it can't be that way and I think 3 and 4 have to be the immediate priority, but what I also said was part 1 is in relatively good shape with the exception of work that we need in Chapter 5 because it came out basically not all new, but new in terms of the way we sought because when I look at 3 and 4 it does help to know how you have refined part 1. Now if you tell me it takes, that I am wrong, that it takes a lot of time to refine part 1, then I will drop it, but my understanding from what I heard around here is that most of part 1 is in pretty good shape and what I thought was, to try to bring it totally into shape would not be that difficult, with the possible exception of 5. DR. FADEN: That may be, but we can work, but the proposal is we can try to work towards that with particular focus on 5. If nothing else, 5 is revised, so if a notion that 5 is revised -- (Meeting interrupted by alarm ringing.) By the next meeting, and there is a part 3 and part 4 to look at and then the rest, if we have two meetings, the rest of that meeting, almost all of that meeting, and part 5 only if it needs to be debated or discussed is on parts 3 and 4. And then the last meeting, of course, by then there is a start to finish draft, there has to be by the July -- a clean, revised, everything redone and the meeting is going through it and finalizing 3 and 4 again. Because I would imagine that 3 and 4 will still leave at that meeting, there will be, we have to look at this, we have to look at that. That will be the proposal if we had two meetings, as to how it would go. (Meeting interrupted by alarm ringing.) Part of it is the staff resource issue. And the way I look at it, the people who are revising Part 2, in terms of dividing up the staff, some people revising Part 2, of the case studies, some of the people who could be revising Part 1 could also be helping with Part 3, so that's the tension. So if we need to take people, staff people and move them to get Part 3 going, that means that Part 1 has to lie fallow for a little bit, to push Part 3 around. So that's the dynamics. It's just thinking people, thinking whose skills and whose expertise are needed for what kinds of parts in the project. If we have only one meeting, arguably, it would be in July. To have it in July would not make a whole lot of sense, I guess, now that I think about it. Unless anybody -- the majority wanted two meetings. So the proposal is two meetings. Does anybody want to argue against it strongly? Did anybody change their mind? Nancy? DR. OLEINICK: No, I don't want to argue against it, but I'd like to say that if there is to be only one meeting for whatever reason, that I think it would be better to have that meeting in July rather than June, even though Ken might lose some vacation time and the reason is I don't think that this report is going to be ready for us to sign off on in one month. It's impossible. So I think we all agree on that. DR. FADEN: The proposal is we will have two meetings and in June the focus will be Part 3 and 4 and in July we will finalize Parts 3 and 4 because we won't get it all down and we will basically by the July meeting have a completely revised document and we will be dealing with essentially the details and the staff will have the rest of the period of time to make it pretty is basically the argument and hammer out any residual issues that hopefully will by that point be reasonably isolated issues. So is that -- that's the proposal. Okay. DR. KATZ: Are we meeting two or three days? DR. FADEN: That's the next issue. Do we meet two days or three days at either of thee meetings? DR. STEVENSON: Or two and a half which is the other proposal. I have an objection -- as a person, human being, two and a half is better for my mental health than 3. (Meeting interrupted by alarm ringing.) MS. KING: It's better for all of our mental health, but I prefer to do is schedule 3 and the incentive is to finish early and change your plane reservations. DR. FADEN: Do you know what? That's important to point out and also we should take a look at the schedules. We know we're missing four people for parts of that meeting, so maybe if we could wait and see what days were missing what people, that may affect too how we schedule. I mean if everybody is missing the same half day, we may just have a two and a half day meeting, but if it's scattered throughout and we need to have a three day meeting so we know we've got people for part of it. So let's just defer that until we take a hard look at the calendars of the people who can only make sections of it and let that -- is that all right Jay, and we'll resolve it that way. If it turns out that you all are missing the same half day, we'll just have a two and a half day meeting, otherwise we'll follow Pat's suggestion and this way it will maximize the time that any one can be a member. MS. KING: That's a big incentive. DR. FADEN: That is now the operative plan. The next issue to address is how we wish to proceed in the interim on the redrafting issue. some people have already, the issue has emerged and I'll just lay it on the table and tell you why I'm squashing it, that we reform again staff subcommittees to work, committee subcommittees to work staff on sections of chapters. It's not going to work all the time. It's too unwieldy. At the same time, there have been just natural expressions of particular interest or expertise on the part of committee members who have invested more time with staff on particular chapters and you all know who you are and some people have made some offers today. It would be especially helpful if people have chapters that they're especially interested in or sections of the report that they're especially interested in that they identify themselves. We can either do this around the table or just contact Anna would probably be better because staff is saying it's very helpful to them if they're trying something, if they can try it out on a committee member, so if you're particularly -- and it's sometime the residual of the old subcommittee that stood behind that chapter, but if you could give to Anna your name and the two chapters or the section of the report and in some cases it's already pretty obvious and well established, that you would be willing to put some extra effort in and see a rougher thing and give some feedback and guidance. That will help the staff so they'll know who they're going to the table with and can move things up a little faster and frankly, that's a big help to me because I don't have to be the one to do it for every one of them. So that would be a great help. So now there's the issue of -- do you just want to pass it around? Maybe that's easiest, just pass it around and people can sign up. If you only want to do one, do one. But at least staff will know they can hit you up on that particular chapter or chapters because you're available to them more than normally. Now the issue of how to move the parts 1 and 2 along, we'll reserve -- yes, I'm sorry, Pat? MS. KING: I'm speaking against my own interest. I am going to sign up for the chapter that I have the most interest in and sometimes that's counterproductive. We should all be warned for ourselves. I just told the person what I wanted to work on and I know what I'm doing. That's exactly what got us into trouble in some respects with the chapters. So there should be some way of controlling internally for that. We all have our biases. I mean I know what I'm doing. DR. FADEN: I hear what you say. It may not always be from the perspective of efficiency, helpful. MS. KING: Right. DR. FADEN: I understand what you're saying. MS. KING: But I know you need help. It's just that there needs to be some internal check on what we have decided because we'll go to the ones that we care about the most. DR. FADEN: That's okay. That means that -- let me lay it out there. It doesn't mean that because you're working closely in these last few weeks on one particular chapter, the chapter will end up sounding just the way you would write it. MS. KING: That is correct. DR. FADEN: You're a filter and a help to the staff but it still is going to go to the whole committee and you have no special voice at the end of the day, as it were. So that if it turns out you have a minority interpretation of how the chapter should go, even if -- thank you, Pat, that's very helpful. Even if you worked on the chapter more than other people in the last few weeks, it doesn't mean it's going to end up with the way you think it should end up if your colleagues, in general, think it ought to end up differently. So that's -- thank you, that's very helpful to state and get out front. You don't have a particular ownership on the chapter that you are assisting the staff member with because it goes to all of us and that will just work out. Thank you, I hadn't thought to say that. MS. KING: That's because I'm speaking against my interest. There's a chapter I would like to change around. Anyway, I'll sign up for it too. DR. FADEN: That's fine, thank you. I appreciate that. That's great. Now the next thing is is how to respond for all of the chapters -- (Meeting interrupted by alarm ringing.) Okay, do we have control over where we're having the next two meetings? (Laughter.) MS. MASTROIANNI: Very limited. DR. FADEN: Okay, all right. Ken floated the proposal and some of us have talked about it, the next -- as iterations keep getting passed you, of the chapters, clearly we want your feedback, your detailed reactions, your comments, whatever, but also an indication and it's a kind of variation of the phrase that Jay's left me with, nothing stands in the way notion, an indication that if there is anything in this draft that you cannot live with to the point where you would dissent; any phrase, sentence, clause, conclusion. If there's not, okay, then obviously there will be every effort made to accommodate your changes, suggestions, criticisms, what have you, but that's saying something to staff differently than if there is about your willingness to sign off if your other comments aren't in every respect taken, because the second proposal is that staff circulates it if they get diametrically opposed recommendations. Ruth says X and Susan says not X, that the staff member would then put Ruth and Susan in together and say look, you guys deal with this, would be the sort of next order, particularly when it's in that category of a dissent. That is the proposal. The obvious benefit to this proposal is it increases the likelihood we can pull this thing off. Duncan and then Pat. DR. THOMAS: And Henry. DR. FADEN: I'm sorry, I didn't see him. DR. THOMAS: Last time Henry floated a suggestion which was that staff react to each of our comments, I got that reaction on one of my sets of my comments and that's it and I don't begrudge the staff for that. Their time is better spent fixing the chapters than responding to our detailed points, but I would like to amend your second suggestion slightly that not just in the situation when there is disagreement, active disagreement between two or more committee members, but whenever there is anything other than a trivial wording change that the staff does not accept, that we be notified of that and put in touch with either the staff person or the other committee members whose disagreement was the reason why they don't accept that point. DR. FADEN: So in other words, if you send back detailed comments -- DR. THOMAS: I'm not going to argue about all the detailed comments, but if there are substantive points which they want to -- (Meeting interrupted by alarm ringing.) DR. THOMAS: I want to know about it. My frustration is that there are whole chapters that I've commented upon that come back without any of the comments addressed and I don't know whether it's because the staff hasn't yet gotten to my page of comments or whether they think I'm totally off the wall. DR. FADEN: Okay, so we're talking about three levels. If there's a section, if you get back a chapter and there's some aspect of that chapter that you object to so strongly that you would be compelled as a matter of conscience to dissent if it went out that way, that of course, is flagged by you. That's your responsibility. That's a big issue and that has to be dealt with. If there's nothing like that or even if there is and in addition you have substantive comments that you're raising, you want at lest the feedback back that they're not being taken. MR. GUTTMAN: Let me just say that as a practical matter -- DR. FADEN: Go ahead. MR. GUTTMAN: We have a book with everybody's comments going back to Day 1 and because the drafts have been going so quickly what I personally intend to do and with the other -- Steve or whoever it is that's been the hands-on person is in a week or two is to take the whole God damn book and see if I can get some commonsensical, not every comma, but it looks like Henry's been making his point that it isn't clear that we've been responding to it, to go through that whole thing systematically at one point. DR. FADEN: Pat? MS. KING: I recently had this experience where two committee members can disagree strongly, approaching -- (Meeting interrupted by alarm ringing.) I would not leave it to those two committee members to resolve. I would let the committee resolve it. DR. FADEN: Okay. MS. KING: And I would do that by having a memo of such comments that went to each committee to, in effect, vote on, or if they can offer modification, modification. With respect to the second comment, having again been in the position of having angry committee members, not all as gracious as Duncan has been, about their comments not being included, and understanding, actually the great deal of work that it takes to be responsive to a committee member. I would actually shift the weight, Duncan, because if it's troubling you, I think we should call back and say what did you do. It's not my dissent level, but I know I commented to you on this. I say that only because it's probably easier for us to follow what's important to us than it is for them to keep track of things that fall less into that category that we all may have a question about. The third point is what Dan offered to do is very important, so I'm making my second point, coupled with the assumption that Dan is going to try to make some overall effort to see some of these recurring issues and see what is happening. MR. GUTTMAN: We should include all the comments that we get from other people as well, the agencies, obviously, etc. etc. on factual matters. DR. FADEN: Henry and then I see Ken as well. DR. ROYAL: Two comments. First, on current system, I assume that the person writing the chapter reads the comments. DR. FADEN: I do too. DR. ROYAL: That I send in and everyone else sends in and at the time that they're reading that comment, they must have some reactions like this is something I want to implement. This is something that I don't want to implement or I'm undecided. I would be happy if instead of getting back from the staff which I occasionally do a long discussion about whether it is or isn't, a single letter indicating Y for yes, N for no and M for maybe, just so that I know what's likely to happen to that comment. The difficulty I've been having is that chapters change so much and so fast that it's very difficult to tell whether or not a comment that you made was or was not and Duncan mentioned yesterday,some very sensible comments that he had made that hadn't been changed simply because -- and you don't know whether it's an oversight, what the reason -- MR. GUTTMAN: As a practical matter, for efficiency purposes this may be best if I and Steve just go through our book of comments and look and see so we can give you a -- DR. ROYAL: I don't even want you to go back. I just want you to from now on when I send you a comment, whoever reads it, put down next to it Y, N or M. DR. FADEN: Let me just follow this, then you get a fax back to you and if you're unhappy, if there's a no next to something that you really care about, then you're going to go agitate. That's the proposal that's floated, so we understand it. DR. ROYAL: That gives you immediate feedback, you know you're in trouble if someone wrote down a no next to something that you thought was important. DR. FADEN: Ken and Jay. DR. ROYAL: Wait just a second. The second comment has to do with how you've defined a level of consent, of dissent. I understand that you only want to hear about major concerns that we hear about the report. What I'm afraid of though is if you make us go on record as saying that something is so objectionable to us that we're going to have to issue a dissent, that later down the line -- DR. FADEN: I see what you're saying, you're boxed into -- DR. ROYAL: To save face, I'm going to have to write a dissent, otherwise it's left to my conscience. MS. KING: No, we won't. They're the only people who have seen it. DR. MACKLIN: Not only that, reasonable people can always change their minds. DR. ROYAL: I think that we can understand the concept of major objections. I just don't want it to be so explicitly linked to an obligation to write a dissent. DR. FADEN: Ken and Jay. MR. FEINBERG: That's not my proposal. I don't -- I have two points to make. I don't really care how much back channeling discussion there is between individual committee members and the staff. The staff, to the extent that it has time, can respond with Y, N or M as long as it wants between now and June and July. My proposal is simply this, that full committee time should be reserved not for what we have been doing the last few months, not because it hasn't been constructive, but because there's a point of diminishing return, but full committee time should be limited to those policy issues that remain in the report that rise to the level of major problem and since I believe perhaps incorrectly that the number of issues that rise to that level among committee members will be de minimis and will perhaps be qualitatively vigorous discussion, but qualitatively won't pose time concerns, that's my proposal. To the extent that I read Pat to say that if Duncan has a disagreement with the staff on something, she wants to know about it and the full committee should -- MS. KING: That's not what I said. DR. ROYAL: That's what I didn't understand. MS. KING: I said your statement should not be resolved when there's a conflict between two people with major objections -- DR. FADEN: Two committee members. MS. KING: Two committee members. It is a committee judgment. I agree with what you just said. DR. FADEN: All right. DR. ROYAL: That's my concern. DR. FADEN: If I understand what we're saying, what we really want is kind of a -- it's an absolutely essential mechanism. We need it because otherwise we're going to drown. We need some sort of mechanism for flagging, hopefully, it's very few issues, that people feel so strongly about that we need to take committee time in June to address it or we try to do it by round robin before that, involving the entire committee. And the point is to use the language, whatever language, I appreciate your not wanting to feel, as a matter of integrity, backed into a corner if you lose, quote unquote, but that it ought to be reserved for only the most serious kind of objection. Now if you don't get satisfaction on some of your other things that you got a no next to and I'm always here and we can always decide together that this is not quite one of those things, but it needs to go to the whole committee. Or it's two committee members who both put in comments not at the level of this, but rather it turns out that Ruth wants this and Pat wants that and Jane wants this and I think Pat's suggestion is correct, that we might want to circulate this to the whole committee and some of us have participated in committees where there have been phone and fax and all kinds of messages, where different languages floated around and people get a chance to pick their favorites and we'll see where the will of the group goes. We'll use all those kinds of mechanisms from now on to get things moving, but I think we're getting a sense. Jay, you were on the list. DR. KATZ: A few small things. I think it might be useful from now on since we're nearing the end that if you send chapters out, that you identify it rather in your judgment, the staff's judgment. It is really a final draft or whether it's still a preliminary draft. A final draft can still be changed, it's not sacrosanct. DR. FADEN: Depending upon how far along it is. DR. KATZ: But if we know it's a more final draft, it would be helpful to me. The second thing is to what Henry says, you adopt, some of you have adopted some of my sayings. There's another saying I'm fond of, namely "subject to change without notice." That any statement we make and we feel strongly about, we say we are dissenting is always surrounded by the subject to change without notice so therefore, at least I, and maybe you too, if you adopt it, not lose any face if you change your mind eventually. Finally, with respect to the dissent issue, speaking for myself, I'm very concerned about it and I want to invoke it as minimally, if at all, but as minimally and constrainedly as possible. It really has to be something that goes to my integrity to be moved in that direction, but we may want to consider whether -- and again, this shouldn't be done lightly too, but some of the committees I've served on occasionally there was an issue that didn't really require a dissent, but deserved a footnote, where one or two of us would say it came up and it wasn't the artificial heart assessment panel and some of the committee members, the majority felt very strongly that irresponsible committees should decide who would get an artificial heart or not. I felt very strongly that it should be done by lottery because I have very little faith in these draft board kind mechanisms. And so we just wrote a brief comment in the text. It wasn't necessary to write a dissent. I do not know how the committee as a whole feels about it, but occasionally that may be a convenient method. DR. FADEN: Sure, that's fine. We can work that out. I'm concerned about time because it's 12:30. It sounds as if we are agreeing to this approach and that would be terribly helpful. We will follow this. We will write up something so you can all see what this means. The last and only issue I want to take up now and then we do our picture is, our photograph, we have had a running exchange about reviewing and there have been some people who have wanted a more formal approach to outside reviews and other committee members who have felt strongly that -- and you should all feel free to see if I've got this correctly that, on both sides, that under the circumstances, the most appropriate mechanism is if the individual committee members want to seek feedback or advice or counselor reaction from others, they certainly should feel free to do it and then bring it to the whole committee if they think it's worth going to the whole committee, but we're not in a position, both by the kind of committee we are and by the time constraints that we're under to solicit formal outside review. That's the issue that's on the table. I want to draw a sharp distinction between this question of getting other people to give us reactions to sections or parts of the chapter, personally or formally as a committee. I want to draw a sharp distinction between that and seeking technical assistance which we have done throughout and which we will continue to do and that's clearly the category in my mind where, for example, the risk assessment consultation that we're seeking falls. So when we have a need for technical assistance, we get it. That's different than what we're talking about here. Particularly, at this late date, I will put my own view on the table. I prefer that there be no formal committee mechanism. I don't think we can handle it. I don't think we can integrate it. I just don't think there's a way to do it. Certainly, all of us as individuals should feel free. These are public documents. Anybody can look at anything that we have, so that if you have a colleague or someone you're aware of whose reaction you would like to something, you're certainly free to do that. These are all public documents. And if you, if the feedback you get forms your own thinking and you wish to share that with your colleagues, of course, that would be appropriate, but my proposal is to follow the arguments put forward by Pat and Jay and at this point, not attempt to seek formal outside, solicit formal outside review. I just don't think -- we either can manage it or it's necessarily appropriate. Ruth and then Duncan. DR. MACKLIN: Although I was sympathetic to the view when it was first put forward that there be outside review, I thought Jay's and Pat's objections were so persuasive that I would make an even stronger claim that it's not necessarily appropriate, but that it might be inappropriate, particularly because the question of response to those or inclusion of those would not only delay the whole process, but obligate us to then begin to consider those, the comments of those who had been officially designated outside reviewers. So I don't see the point and I can't imagine what kind of people would be designated as outside reviewers and what expertise they might have that isn't already on this committee. DR. FADEN: Duncan? DR. THOMAS: I'm changing my vote too. I was totally persuaded by those arguments. DR. FADEN: We need belabor one point. I think our colleagues are pointing out the wisdom of this choice and so it's decided. At this point then, before we break for lunch, I remind you of the staff photograph, I just want to take a minute to acknowledge the fact that we are losing -- how many - - a lot, a lot of very wonderful staff members at the end of this month, so that for the committee as a whole, I personally want to have an opportunity to say good bye and thank you. The rest of the committee probably wants to say -- DR. MACKLIN: You have us the list, but for those who are in the room, could they stand up so we can give them a round of applause, those who are leaving at the end of this month? We know who they are from the list, but we would like to acknowledge them. (Applause.) For those who are not in the room, let them to listen to the applause on the tape. (Laughter.) DR. ROYAL: I particularly would like to applaud the ones who are staying behind. (Laughter.) DR. FADEN: With that, can you tell us where to go? MS. MASTROIANNI: Right outside. (Whereupon, at 12:43 p.m., the meeting was recessed, to reconvene at 2:00 p.m., Wednesday, May 10, 1995.) A F T E R N O O N S E S S I O N 2:09 A.M. DR. FADEN: We have only an hour and a half before we lose two people, two hours, if we go together. We're going to get anybody we can find to join the committee. If we could accomplish the following that would be a very useful step forward and bring ourselves to do the rest of the work we need to do. We have now revisited at least four different times, alternative formulations for addressing what we have come to call backward looking recommendations. We have a new iteration, replete with a cover memo with the iteration. Our euphemism for this which is situation. They somehow took on that terminology. Obviously, they won't be called situations in the final report, but for us, they have come to function that way. If we could pull that out and take a look. I have my cover memo but I can't find my situations, so I hope people are better organized. So basically, there are major -- Jeff, do you want to join us, join us for this? This is something that Jeff and Dan and I have worked the most on trying to get ready for this meeting. But what's proposed here is different than the last meeting. The cover meeting indicates the core differences. If you may recall, the committee was struggling and punted on the question of how to define adequate consent and it was left to a subset of people to try to figure this out and in part, in despair, trying to do that to the satisfaction of the committee and also because this reasoning seemed more generally defensible. We retreated to a different strategy. So rather than take on as the last iteration of the situations required, an explication of what would constitute adequate consent for purposes of different kinds of remedies, that issue has been sidestepped by taking a different tack. And also, the other big sticking point was the issue that Eli brought to our attention last time which we then had some considerable discussion of which is how to understand the complicated notion of net harm in the context of therapeutic research and so this is an attempt to directly confront that difficult problem by distinguishing between the two types of research enterprises, acknowledging that it is often difficult in a concrete case to claim that something is one or the other. There are lots of borderline cases, but the general principle would be so outlined. Could we just start with situation 1A, the context in which the remedy proposed is a public apology and where there is no physical harm as a consequence of participation and research and start with the proposal. Let me just say the rationale is a simple one. It says that a remedy is in order because the government failed to have effective policies in place to protect the rights and interests of human subjects. To recall the complicated discussion we heard yesterday and the day before, it doesn't say that the government should have had or should be blamed for not having. It simply declares the government did not have such and because it did not have such, it now is offering the following remedy. So that's how it's set out. It's now open for discussion. Ruth? DR. MACKLIN: I'm perfectly happy with the opening statement. I think we have to be careful what we say in the rationale for about failing to have a policy in place in light of the words that we have or might have in Part 1 that's going to say this counts as a policy or this was an articulated statement, etc. So the reason the first paragraph is fine is it says the government failed to have or effect, to have, implement or something. Maybe we should use the same wording here that whatever we're going to put into the first -- establish a policy, implement the policy or enforce the policy, something like that. So then when we get down below, when the sentence reads line 13, ought to hold the government responsible for failure to have a policy in place. Much of it is to say listen, they had much more in place than we thought. So this should accord strictly with the wording that we have there, but that doesn't affect what we have in line 2 to 6. DR. FADEN: That's very helpful. I'm looking for -- MS. KING: Ruth, I'm not going to make my point again, but in the interest of candor, this is something where I may have to write a separate opinion and I don't think I should debate it. So I'm not. But I'm just alerting you to the fact that fail to have does not satisfy me -- DR. FADEN: As a rationale for offering an apology? MS. KING: Right. DR. FADEN: What would? Let me turn it around. Is there something that would? MS. KING: I think all we have to say is we looked at these situations from the point of view of looking at them today, we feel that we would like -- it does not matter whether there was a failure to have a policy or not have a policy. These people deserve an apology because any of us looking at this situation today would say, gee, we hope that never happens again and we know you have suffered and we have documented some of that suffering and I have no problems with an apology. I have no other problem with the rest of the chapter. I just -- this is to say, government -- I just want to be fair to my fellow committee members and I want to spare you Monday. I'm just being fair to say something and that's the only reason I raised my hand. I don't intend to raise it. DR. MACKLIN: But then an apology is not the right word for what Pat is saying. An apology is an acknowledgement, we apologize to you because we did something wrong or we failed to do something right. You don't want to blame yourself for something, you say I'm going to express regret. So if you got an apology, you apologize for something. It's a backward looking, it's an act that's backward looking that ascribes some self-blame or wrong to what you did. Otherwise, you want to say the government can say well, we regret that these things happened to you. MS. KING: This is simple to me and Jay captured it best. There are things that I have done in the past that I thought were right at the time that I can see no other way to have done them at the time and thought they were okay at the time and when I look back on it I say to myself, I should not have done that to that person because now I can understand what happened to that person. I don't hold myself accountable at the time, but I am making what I think is growth, if you want to call it that, in terms of the way I now look back at things that I thought were in many instances the right thing to do at that moment and I feel badly and I do use the word apology. Now maybe Ruth -- I want to say technical -- maybe she is being more precise than I would have been, but I have never had any trouble going back when I've been able to identify such people and say, you know, I thought about this, I thought I was right at the time. I did the best I could at the time, but it was a terrible thing. I shouldn't have done it. I want to offer you an apology and it's a very weak thing to do at this stage in life, but I think it's important that you know this. DR. MACKLIN: But that's exactly what we're saying about the government. The government thought it was right at the time, but shouldn't have done it. MS. KING: No, we say we failed. I didn't say that. I said there were situations where I thought I was doing the right thing at the time which is a stronger statement. DR. FADEN: But the point is in retrospect you realize, you now think it's the wrong thing. At the time it was the right thing. You don't blame yourself, right, but now you think it's -- MS. KING: But Ruth, I don't want to debate, but what I want to be able to say is because I think it is the fair thing to do to committee members and you have asked for this, is to say that my silence here should not be taken as agreement, but I want to spare everybody what we just started going through. DR. FADEN: What I'm suggesting though is and we can perhaps try and work on this, let's hear how other people feel. If we can convey a sentiment we all can agree to, with a rationale that we can all accept, that would be preferable. So part of the struggle is to see if there's a language that is acceptable to Pat, as well as to the rest of us. But the first issue is is there anybody else that's uncomfortable with this formulation? Let's do that first. The rationale lines 2 to 6 on page 1. Phil? DR. RUSSELL: A simple statement that the government did not protect the rights of the persons is factual. It eliminates the issue of whether they should or should not have had a policy and whether they failed or not in that context. It justifies the remedy that they didn't, the government didn't protect the rights of the person who were used as subjects is sufficient justification for the apology. I would also like to deal with the issue of the phrase "recognized by the government." DR. FADEN: What line are you? DR. RUSSELL: Line 9. DR. FADEN: Okay. DR. RUSSELL: The principle of protecting research subjects was recognized by the government. The government is a huge and wonderful organization and doesn't perceive things with a single mind and it's quite true that the principle was widely recognized by many senior officials. That doesn't mean that the whole government doesn't recognize -- DR. FADEN: That's fine. DR. RUSSELL: We have to deal with that concept. DR. FADEN: Could I try the following language in response to what Phil suggested? I don't know how much the concern for, Pat, is the word "failure." If it simply was because the government did not have or did not implement or did not enforce policies to protect mechanisms, whatever, it's descriptive rather than saying the word "failure." I was trying to point out, would that be better? MS. KING: Much better. DR. FADEN: It gets to the same point, I think. MS. KING: Phil's point is factual, "It did not have." DR. FADEN: It did not have, because the government did not have the following things. We are now saying the government should apologize. You can draw whatever inference you want from that. MS. KING: Right and for some people it would definitely be different. DR. FADEN: Okay, that may move us a long way. Other comments? The kinds of things that Ruth and Phil are picking up about the language not being as precise as it should be or being overbroad is useful, but also we should also take great care to look at this because these are the words that are likely to be very heavily scrutinized as opposed to pages and pages and pages of stuff that we write that will get relatively little attention. We hope. We hope will get relatively little attention. Okay. I don't know about that, but -- if I don't hear anything I'm going to go on to situation 1B. Ruth? DR. MACKLIN: Just one small point, at line 15 and 16 where it says "government and government agents have no moral warrant," I mean, government agents isn't the right phrase there. I think you want something a little more precise. Those who are researchers are fine, contractors with the government, etc. etc., so it doesn't say CIA or FBI, whatever. DR. FADEN: Henry? DR. ROYAL: I thought the first sentence of implementation, on page 2, 13 and 14, was promising more than it can deliver because it says "it will be impossible to identify all of the subjects." And then it says perhaps even the great majority. DR. FADEN: It would be impossible to identify anybody. DR. ROYAL: Well, we're only going -- I think it should be stated we're only going to be able to identify a small number of the individuals. DR. FADEN: It goes forward and says we're not going to make any attempt to identify. If you read the whole thing -- DR. ROYAL: What it should say is only a small number of individuals have been identified. DR. FADEN: And they're going to get the individualized apologies. DR. ROYAL: Right. DR. FADEN: We can rewrite this. The point of it, the language is clearly not clear. DR. ROYAL: We shouldn't raise false expectations. DR. FADEN: Right. So the point wasn't clear. MR. GUTTMAN: I hate to address it, except this is what the committee is about. The technical reason that it's ambiguous is because it may well be that after the report comes out and all these experiments and the data base are listed, people may then identify themselves beyond our capacity and I don't want to be over -- that was the sort of -- for whatever it's worth. DR. ROYAL: But even if people come forward, realistically, only a minority of those people are going to have a piece of paper that says -- DR. FADEN: I think we're agreed, but that the language isn't working here. The English isn't right. The idea, the point that's being made, the statement, the meaning is supposed to be the committee is not recommending that the government undertake a massive effort to identify all these people who could have been because we think it's hopeless. Individualized -- we are recommending individualized apologies to people who are already known to be such subjects of their family members and if anybody else should come forward and indicate they are such, they too, will get an apology, but the clear distinction is we are not recommending that the government now go find a bunch of people so they can get a letter that says "we're sorry." We'll just work on that, the English. Duncan? DR. THOMAS: The two forms of apology that's proposed on page 3, there are two sentences here and I can't tell whether they're intended as alternative expressions or not. The first is an unconditional statement saying that we apologize for not taking adequate steps, blah, blah, blah. And the second is conditional statement which says since we can't tell whether or not you gave adequate consent, we apologize for not taking adequate steps. Same conclusion. DR. FADEN: I would vote that we delete from "since" until "we" on page 6. We have to fix the language in 1 and 2. DR. THOMAS: How about deleting the whole second sentence. DR. FADEN: Right. DR. THOMAS: Because the rest of the second sentence is the same thing as the first. DR. FADEN: Right yeah, we'll get rid of it and we'll also make the language conform with the rationale language so that it's the same. DR. KATZ: Where do you start deleting? DR. THOMAS: Page 3, DR. FADEN: Page 3, Jay. DR. KATZ: Yeah. DR. FADEN: "Such an apology may take the following form." We will change it to get rid of the "adequate for not taking steps" or whatever, to make sure it's the same as the language in the beginning. The government of the United States apologizes, blah, blah, blah, subject -- that's it, apologizes to you, to protect you, we'll come up with other language. This is redundant. We got the point. I see Susan and then Henry. DR. LEDERER: Given the change that Phil suggested, are we going to retain the language at page 1 at the bottom in the rationale? "The government is culpable for failing in its duty" -- DR. FADEN: We'll get it out. DR. LEDERER: And there's "failed" all the way through. DR. FADEN: In the interest of getting -- we can take it out. The problem is while we're agreeing to that, we can think about it as we march through, whether everybody wants to continue to take it out as we progress. DR. MACKLIN: You mean from this section or subsequent sections? DR. FADEN: I don't hear anybody insisting that we retain the language for failure, failed, culpable in situation 1A. In the interest of getting everyone to agree the descriptive approach that Phil has laid out, seems to be acceptable. I just want to reserve to see if that approach continues to work for 1B and 2A and 2B. Am I not being clear? DR. MACKLIN: The reason I'm hesitant, but I may give up my hesitancy in one second is this, the difference between what Phil suggests in the language of failure is one is descriptive and the second sounds blameworthy. DR. FADEN: Right. DR. MACKLIN: So to put the descriptive language in acknowledges that the government did not do government. DR. FADEN: That's correct. DR. MACKLIN: And I think it's not much more than a verbal difference to say they did not do X and they failed to -- but I'm happy with that. That still doesn't address the question of culpable, that is, sometimes people fail -- people don't do things and they're culpable for not doing them and at other times they don't do things and they're culpable for the omission. It is a culpable omission. So we can fudge that distinction in the statement for -- that we're making for the apology, but the rationale has to come to grips with this, whether we want to make a weak claim or the stronger claim. DR. FADEN: That's correct. And the issue is does anyone want to argue that the stronger claim that not only did the government not do it, but the government was wrong in not doing it, or blameworthy for not doing it. What I'm saying is, right now I don't hear anybody arguing that we need to retain a strong form in 1A. DR. MACKLIN: I'm going to put this down for the record, since I don't think the strong form is needed for 1A, I won't insist on it. But my view is the government was culpable for not doing what certain individuals, etc., as we discussed in the first chapter, but because that language is not needed, in order to come to the recommendation for the apology, I wouldn't insist that we need to use the language of culpability. DR. FADEN: For 1A. DR. MACKLIN: For 1A. DR. FADEN: Okay. Can we go on to 1B? DR. THOMAS: That leaves open the question is whether you want to make that recommendation elsewhere in the findings or someplace else. DR. MACKLIN: Leave it open. This is just -- I'm not, my decision is based on using only what we need at this point for this recommendation. DR. FADEN: I've got Henry. I'm sorry, Henry. DR. ROYAL: Two things, in the implementation section. DR. FADEN: Of 1A? DR. ROYAL: Of 1A, at our last meeting we talked about subjects were going to be identified and it wasn't - - that there were two possibilities. One is that they would just say I participated in a human radiation experiment and that was all the evidence that they needed in order to get this apology. The other version was there had to be some evidence. This sounds like it's the former, that someone only needs to say and I'm just making sure that everyone understands what this says. I don't have strong feelings one way or another. I just want to recognize that that's what it says. DR. FADEN: Yes, that's what it says and the point is you wouldn't have to do anything and say "I was" or "my mother was" in this and such experiment and you would get an apology. If people are comfortable with that. DR. ROYAL: The second thing of implementation is the second sentence from lines 15 through 17. I'm not sure that it's necessary. It really doesn't have anything to do with implementation and I'm concerned it might strike some people as paternalistic. So I would be in favor of deleting that. DR. FADEN: Fine, does anybody object? Now we're into situation 1B. It's the only one that bears a family resemblance to what it looked like the last time. This is the situation in which there was -- our shorthand word is "coverup." Withholding of information that people had a right to have, whatever longer terms one wants. Ken? MR. FEINBERG: Line 13 is a loaded couple of words. For example, is plutonium injections before it and total body irradiation after it. Are there any others and how many people are we talking about and don't we know their names. DR. FADEN: We do. MR. GUTTMAN: We know the names. We know the names of the plutonium injection people or their family members, obviously. MR. FEINBERG: Eighteen people or families. DR. FADEN: They're all dead. MR. GUTTMAN: Total body irradiation and we know that -- DR. FADEN: Let's be careful for the public, so people know these were the TBI experiments conducted during the war. MR. GUTTMAN: In Chicago. I don't know that we know the names. It was a handful of people, 5, 6, 3, 4. The reason there is a "for example" is that we have, as we know, incomplete evidence, that we know that there was a process of keeping these reports secret as they did in the case of plutonium and we know that other examples may well have existed, but we may not have them, when they were vetting the reports. We may not have a complete set. MR. FEINBERG: I think it's important that we spell out in this 1B section that the committee believes that we're talking about a very few people. This -- I mean it could change, I suppose, we can spell that out, but when you talk about compensation and you're writing up a section which develops the rationale why in the coverup there's going to be a recommendation for compensation, I think it is misleading to give people the impression that there may be thousands of people out there and we're really talking about a very, very finite group of people and it becomes very important as a practical matter, because to the extent that there was ever going to be compensation for these people, it would be in the form of basically a private bill from Congress or something to help these people. MR. GUTTMAN: Let me speak because this is so important and obviously a central question for the committee in secrecy and openness. There are three groups of people. One is the experiment specific of which we know the plutonium and these TBI people. There may be other experiments in that group, but the documentation is just not adequate and may develop. The second is in the case of that 1947, '48 period, there clearly was some impetus to cover up data in relation to the workers at Los Alamos. I don't know. We still don't know whether that was kept secret or not. That was open -- we don't know what the end of that trail was, okay. The third thing, just to be clear, because it goes -- as you all know, we are working through with the Defense Department and the VA, the question of this data keeping in relation to the atomic test and we don't know, that is a whole separate group, category of people. The documents say what they say. We've written about them. This isn't -- if that ended up as a cover up, that would be a specific significant different item than this one here, but that's something that also has a fact pattern that raises that kind of question. DR. KATZ: Are you saying then that it couldn't be a very large group of people? MR. GUTTMAN: Not in this one. DR. KATZ: I'm talking about in the 1B situation. MR. GUTTMAN: This one is directed at the 1947 AEC insurance department vetting. Public relations vetting. DR. KATZ: Here, it will be, as Ken points out, it will be a small group. But I got the impression that you were saying that it could mushroom. MR. GUTTMAN: Not this group. There may be one or two other reports out there. DR. FADEN: The language should be clear. I think we have to specify that the language indicates and that the committee believes that of the experiments it reviewed, only the following qualified. There may be experiments that emerge in the future, given that this is a cover up context. Who knows? Somebody could have covered up something we didn't uncover. That's the nature of a coverup, but in our investigation we have identified those two instances because I think Ken is right. This is a context for somebody is going to have to pass a piece of private legislation that's going to have to name people and we're basically saying these 18 family members, plus if anybody knows who the surviving family members or the three people who are in the TBI experiment done in the war in which the initials were crossed out and looks like the information was kept from these unfortunate people. They too -- but we don't know who they are. We do know who the plutonium families -- DR. KATZ: I don't understand something here, is the way it's being put now it almost sounds like a private bill again. If we are talking about general principles, aren't we also talking about the general principle here? And if we are talking about the general principle, if the next group comes out of the woodwork, shouldn't they fall under the rubric of our analysis? MR. FEINBERG: I'll accept -- DR. KATZ: I'm confused a little bit. MR. FEINBERG: I'll accept that and that's why I had suggested language that makes it very clear that it's only this small group as far as we know and if there are others that are discovered or whatever, that's a different ball game, but I just don't want to leave the impression right now in this 1B, we're recommending compensation for -- I want to be very clear about this. It's a very, very small group of people. DR. KATZ: Is that an issue that you want Congress to understand? Is that whom you're concerned about? They ought to know that -- MR. FEINBERG: Yes, Congress, but more importantly, it's the reader and the consumer of the report that I don't want to mislead. DR. KATZ: Okay. DR. FADEN: I see Pat, Ruth and Henry and then Duncan, too. I'm sorry. MS. KING: I actually think that Jay is on to something and the committee needs to decide. I understand the thrust of Ken's point. If we really accept Ken's point, then I would suggest this is not the way to do it, that it should flow from the shafters and the reason I say that is if I were a congressional staffer, I would look at this format and the way we have done it here and I would say if anybody who can show that they were a participant, never mind our language on government sponsored human radiation experiments, but if I was in a government-sponsored research experiment where I tried to get information and documentation about what happened to me, and I can show that there was a cover-up, I ought to be entitled to compensation. Now some will respond, but this says government-sponsored or funded human radiation studies and it does indeed do that, but it is set out here as though it is a general principle, so I think in attempting to do what Ken suggests which is to focus on our mandate, we have to make another kind of critical decision, I think. If we really want to do that, we would take away from what Ken wants to accomplish by his general formulation. If we really want to do what -- I would just do what Ken said, that we have evidence that in some of these experiments and this is what we should -- DR. FADEN: You're saying it would be much less ambiguous and more straight-forward. It still has to show up in this part of the report. MS. KING: Oh, absolutely. DR. FADEN: Whatever we call it. MS. KING: It looks like a general principle now and if it's a general principle, it will undo what Ken is suggesting. I don't have the -- I am not taking a position on which way we should go. I'm saying that it's very hard to do both. It's inconsistent to do both. DR. KATZ: Pat, are you also concerned if we do it the way Ken wants us to go, then in the eyes of some we will be considered rather crabby and rather unprincipled in a way by just singling out that small group of people, right? MS. KING: I agree with you, but I also think that in this area we were given a task to do and the better way to go in the case of conflict, my lodestar is to fulfill your task first. Even if it is narrowed to the way that Ken is recommending, people will, of course, be able to argue for a precedent for other kinds of cases, but that's very different than formulating a general principle which is sort of the way it reads here and then attempting to apply your general principle to a specific group of people. DR. KATZ: But then we can also specifically say we're fulfilling a task set to us by the President. MS. KING: That's exactly right. DR. FADEN: Ruth? DR. MACKLIN: I'm afraid I don't understand what is meant here by general principle. I just wanted to ask Ken a very simple question. MR. FEINBERG: The simpler it is the more thornier. DR. MACKLIN: No, it's really a very simple question. I understand what you objected to and the reasons you objected to and the key words that led to your objections were the "for example" because the question is what else might there be, what other examples and it could open up some floodgate. Now, my question is what would be lost if there were no mention of the plutonium injections or the total body irradiation? We might want to put that as no mention of any specific experiments in order then to leave open the door that whatever might come along, that is what Jay's talking about that might be discovered where there was a cover up would also fit this fairly narrow class. MR. FEINBERG: I think that would be terribly disingenuous, misleading. DR. MACKLIN: What if we were to say, add the statement that the committee was able to find only a small number. I'm just asking what would be lost, especially if we added a small number. DR. FADEN: There are the political realities that would make it very difficult to get such a piece of legislation. MR. GUTTMAN: It's the good, the enemy, the best, whatever the heck that is. DR. FADEN: It's a political reality. If we make a recommendation that requires congressional action and costs money. If it's not contained and circumscribed, it's going to be much more difficult to get that recommendation. MR. FEINBERG: It's not just Congress. I've heard over the last few months and going back many years in my practice, the constant criticism of consumers of these problems that they were misled, that they weren't told the truth, that they held out hope. I think just -- on 1B, you've got to be very specific and say compensation for 35 people. I mean that's what it is. That's what it is and to give people out there the idea that we can read this to include us and I mean it might be a lawyer's relief act, but that doesn't really help people who want some guidance as to what we're actually recommending. I'm prepared to say as I think Pat was suggesting, 1B to me is 35 people. Maybe. At the most. Let's say it. That's it. And let's move on to the next situation. That's really what we're talking about. DR. FADEN: Others are complicated enough, that we really do need the time for it. These are political reality type issues is what it comes down to, both in terms of trying to get something, the hope of getting a recommendation past, but also I think Ken's point is well taken. What we keep hearing is people's expectations, even of us, are very high and one of my deep worries all the way through this is we are likely, people expect us to be able to do lots of things and I keep saying we can only make recommendations, we can't do. What I don't want to do is contribute to that by making people feel as if a door has been opened and then it's slammed in their face again. MS. KING: I'm convinced. DR. FADEN: We've got Henry, Duncan and Lois. Henry? DR. ROYAL: I certainly agree that we should make it as clear as possible who this applies to and if we've agreed on doing that, then I don't have any comments. I think the words "to cover up or otherwise keep secret" is very vague and what one person described as a coverup -- DR. FADEN: We'll come up with better language. DR. ROYAL: Well, if we're talking about specific cases that we've identified, then we don't need to use this language at all. DR. FADEN: The rationale can still be provided of why we think these people, the wrong that was done here can be described, but the principle doesn't come out first. You say the context and then you say what was wrong with that particular context that these X people now ought to be offered some remedy. You can draw on a real example now because it's still -- DR. ROYAL: One of the things that's not clear to me is an experiment where there were national security reasons -- DR. FADEN: Either we open that whole thing up or we save these specific ones. If we can save these specific ones, let's go on and otherwise, we do need to get to issues like that if we were to have it be open and large. Another thing that's escaped by making it specific is that we've already drawn judgment about those experiments about plutonium and we can feel okay about it. Duncan and Lois? Duncan and then Lois. Obviously, they can't speak at the same time. DR. THOMAS: I'm a little disturbed by the wording on line 6 where it says "and or censure." It sounds like we're leaving it up to the government to decide whether or not it wants to dish out a little bit of compensation or punish itself. DR. FADEN: I vote we take that out. That's a hangover from something. I'm not sure where. DR. THOMAS: Are you proposing to take out the censure part or just the "or"? DR. FADEN: I would take out the censure part. We haven't developed what it means. I don't know what it would mean. DR. THOMAS: Okay, that was the second part of this comment that no justification is provided in a rationale for the censure part. Although you begin to -- I'd like to leave this open as a possibility. DR. FADEN: I think we can't leave anything open, Duncan, unless we absolutely -- DR. THOMAS: I mean open for committee discussion. If anybody else wants to push for censure? DR. FADEN: Does anybody else want to push for censure? Okay, then it's gone. We got to do this. If we could finish this,that would be such a gift. Just think of everything we've despaired about getting done. If we can get through this, this will be -- we've making a lot of substantive changes so it's not like we're just pushing this through. It's being changed as we go, but I'm trying to keep us on the main things. Lois -- DR. ROYAL: Two more really minor points, page 5, line 8. It's my understanding that in our two examples, everybody is already dead so within their lifetime is appropriate, but I don't think we want to close off the possibility that somebody is still alive, and could themselves be eligible. DR. FADEN: We'll figure it out. DR. ROYAL: And the final thing is line 17 makes no sense to me. It's just a wording problem. DR. FADEN: That should be repaired. Can we go on to situation 2A and 2B. Oh, I'm sorry, Lois? I apologize? MS. NORRIS: It's possible that lost track here during some of this exchange and if this has already been addressed, I apologize, but has anyone addressed their surviving family members in this part of the statement? Because you're talking about conceivably a lot of people. It's a rather vague category. DR. FADEN: That's a good point. I don't know how you work that out, but people who are -- MS. NORRIS: Direct descendants or something even, or something more specific than that because families can be very large. DR. FADEN: There must be some way I'm looking, that this is standardly handled. So thank you, Lois, that's a good point. We'll make sure. I have no idea how you do it, but there must be some way to do it. This is maybe the misplaced data trust. I just assume that our lawyer colleagues here on the committee and the staff know how to do stuff like that because I haven't a clue. But we'll figure it out. There must be some way to construct it. Nancy? It's a good point, Lois. DR. OLEINICK: Or do we want to make any recommendations about implementation or are we leaving this strictly to Congress? DR. FADEN: There's nothing we can do. DR. OLEINICK: Nothing we can do, just leave -- DR. FADEN: All we can do is make recommendations. Nobody else can do it. We can't do anything other than recommend that somebody who can do it, namely Congress, do it as we can't. MS. NORRIS: I have just one more point if I may make it and that's lines 20 on page 4 through line 1 on page 5. That's a very sweeping statement. Do we know of no exceptions to that statement? DR. FADEN: We're changing it. MS. NORRIS: I thought we saw some recent information that might impact that. DR. FADEN: A lot of this language will have to change. Now we're up to 2A and 2B. This is different. 2A, this is different than what we've seen before. 2A is the nontherapeutic context. 2B is the therapeutic context. We are now talking about where people have been harmed. We've got all the causation issues which we realize are complicated and we punt on it basically and the implementation section which we'll get to. What I'd like to do is see if 2A works as a general approach because I think 2B, both to 2B and the implementation stuff is the tough part. That's my own view. Ken? MR. FEINBERG: To use a precedent developed by Ruth, line 7 again, what are we talking about here? How many people? Does this have any meaning? And what is likely a very small proportion of it. What is it? DR. FADEN: Okay. If there's nobody, why are we doing this. If we can't tell why we're doing this and if there are seven people, I don't care really if there are seven people with some implementation changes that we'll get to, but my first question is the distinction, I read along this and then I saw the last paragraph on page 10 where we at the very end say, oh, by the way 2A and 2B have the same problem, what's nontherapeutic, what's harm? What is really harm? And as with the previous discussion, how many people are subject to this? DR. FADEN: I think that's certainly a reasonable question. We can give it to financiers. Henry? DR. ROYAL: The other problem is the analogy that's given with MKULTRA. We're talking about something that's very easy to have cause and effect relationship and I think that's a misleading analogy. DR. FADEN: We can break apart words. The notion was to communicate that it was nontherapeutic research and people were harmed. There's precedent for people getting money for that. Now what you're saying is the causal connection is a lot easier. DR. ROYAL: I'm saying that I'm afraid by including the MKULTRA example, that it's going to mislead the public into believing that causation is going to -- DR. FADEN: If you know the history, which I am only now relearning, the awards that were made in the Canadian cases, they had a lot of causal problems there to in the Cameron case. And the death one is reasonable straightforward although even there he was going to jump out the window anyway, so it's not as if the others were, were causally so simple either. I mean the harm to the -- there's always -- they didn't die from the injection and in the Cameron case the issue was the brainwashing, how much did that contribute to the psychiatric disease which the people already had anyway, so those were complicated cases. DR. ROYAL: But they weren't as complicated as the cases we're talking about in that 30 percent of the population is going -- I'm sorry, 22 percent of the population is going to die of cancer and 30 percent of the population is going to get cancer. DR. FADEN: Fine. DR. ROYAL: Twenty-two percent of the population does not jump out windows and 30 percent of the population don't jump out windows. DR. FADEN: That may be, but I just point out it's not that -- that's not critical. That's not as critical. MS. KING: Can we answer Ken's question? That is critical. Because if the answer is zero, we can go on. MR. FEINBERG: Line 14 talks about no potential direct personal benefit. DR. FADEN: From the experiment. Okay. Here's my take on it and we can get other people to answer. So far as I know, Dan, looking at staff, there is nobody yet, okay. The candidates that we know of, now see if this is right, where someone was in a nontherapeutic study and we know that -- we think that person was likely harmed as a consequence. There are totally nontherapeutic studies where there's no ambiguity. Take TBI. TBI there's ambiguity about whether it qualifies as therapeutic or not therapeutic and there's ambiguity, of course, on the harm one which will be true in every case. But TBI where the struggle is over, whether there was any therapeutic component to it or not, so that's a tough case. That's a tough case. These are the Cincinnati ones. There the ones that are in litigation and it's on-going and so there the problem is of course one of the disputes, the fact disputes is whether it was therapeutic or not. So they are, depending on how you slice it, one possibility, but that's a fact problem and a judgment issue about how you see it. Another would be if any of the prisoners, okay, in the irradiation studies were to develop testicular cancer, then there would be the dispute that Henry is pointing us to, the causal dispute, but that's a clearly nontherapeutic context and there is the possibility, however remote, I don't know how remote it is. I would turn to Mary Ann and Eli and others to comment on that, but they don't, so far as we know currently qualify because so far as we know none of them currently have the outcome that's of concern. But if there were such people today, they would fall under it. We're being candid, let's be straight on what's here and the other possibility would be if it turns out that any of the children in the tracer studies who are now adults can be -- can establish through whatever procedural mechanism, that whatever thyroid cancer, in this case, was resulted from their exposure prenatally and again, we have all the causal issues that Henry has alerted us to. Use our finite numbers of people and all of them are disputed. In some cases, as in the prisoners, so far as we know, no one has yet experienced the problem that might be attributed to their exposure. DR. STEVENSON: But on that, I think we have to be specific to what we consider the problem because they have complained of noncancer. DR. FADEN: That's a good point. DR. STEVENSON: But you've sort of opened up your pain, suffering, loss of income, disability. That's pretty vague. DR. FADEN: So we could narrow it if you wish, but the point is to get to Ken's answer, that's the basic ballpark and I don't think I've missed -- and if I've missed one, I may have -- Ken? MR. FEINBERG: I would then say this, I would take out the rationale and I would say just what you have said, that the committee finds that currently no one would satisfy this definition. DR. FADEN: We don't know that. MR. FEINBERG: You just said that currently -- DR. FADEN: No, we don't know it in the case of children. And we don't know it in the case of the TBI. These are candidates for consideration under this. Somebody would have to work it out. MR. FEINBERG: That's fine. Then what I would say is we currently do not, there are candidates, we are not prepared to say that anybody meets this criteria at the present time and if and when they do, they should petition Congress for relief. I don't think we should get into implementation. I don't think we should get into causation and the creation of a federal bureaucracy to process the claims. If and when people satisfy the criteria, the MKULTRA experimentation example of a private bill, they should go to Congress and ask for money. I don't think that we should lead with our chin here and call for the creation of a bureaucracy to process claims and determine causation, when there may not be any claims to process. I don't understand why we would do that. DR. FADEN: The complication is the following. The reason in difficulty in commenting and why the committee can't comment comfortably on the TBI case is that it requires an analysis case by case, medical record by medical record of every single one of those former patient subjects. The committee could not entertain that. We couldn't take that on. So what we're saying here is if a form is to be created or something recommended it's somebody else who actually is positioned to do fact determination on an individual patient case basis should do it. I'm just giving you the rationale, okay, from where this -- I see Duncan and anyone else. Duncan? DR. THOMAS: The problem I see with this recommendation is there's no restriction and nothing is said about the disclosure or consent so as it is presently read, you can be told that you're a subject in -- even today -- DR. FADEN: It's time bound. It will be time bound. You're right. DR. THOMAS: So this was conscious that there should be no such restriction, even if you were adequately told you were the subject of -- no potential benefits. DR. FADEN: It's time bound. DR. THOMAS: There is risk. DR. FADEN: And it's all because of the rationale that comes at the beginning. DR. THOMAS: Then where is the justice in it? DR. FADEN: The rationale is for the time period in which we have established that the government did not have effective policies, so it's basically working on the same rationale that starts out situation 1A. DR. THOMAS: So the absence of a government standard in those days meant that even if there was an investigator acted in the way he would have acted today, his -- DR. FADEN: The award is not from the investigator. The compensation does not come from the investigator, you see. So we're not presuming -- that's the way it's set up, okay. MR. FEINBERG: What I hear Duncan saying, I guess what I hear Duncan saying is that there's a rebuttal presumption that the person, it wasn't disclosed and the person didn't have notification and I guess what Duncan is implying is that it should be a rebuttable presumption if the government or the agency can demonstrate that the person got full disclosure, etc. and still wanted it done. No one is covered by this anyway, so I don't think it's going to matter. DR. FADEN: That's the issue. That question is -- MS. KING: It does matter. While we're having this debate we changed this to say that if you were in research, nontherapeutic research where you have given consent and there is disclosure and you get harmed, this is where our past and our present comes together and you get harmed, then you should get paid by this rationale, you should get compensation and if that is what we're interested in leaving, okay, but that is a big issue. I mean you'll be tackled, you're setting up a precedent. DR. FADEN: No, because the rationale is set up in that context that the government not having a system of regulation and policy to govern human subjects. It's bound by that. That's why there's a nonrebuttable presumption. It's set up. It does not apply at present. MS. KING: I didn't say it applies to the present. DR. FADEN: Or doesn't even set precedent for the present because the precedent, unless you were to claim that, and this is where it would, if you were to claim that the current system is ineffective which in the strongest sense, then it would be precedent. That's correct. Ken is quite right. This is a general structure set up for right now very limited number of potential situations, so far as the committee as made. It's in line with the committee's general finding with the exception of these very few contested contexts, we have not identified indications that people have been harmed. There are a few contested circumstances. We will say that. That's a core finding. It's on the list of findings that will be discussed. MS. KING: But once we say that, assuming that's what we're going to say, then what Ken says, two things, makes this consistent with the approaches in the other part of the remedies, so maybe somebody wants to go back and rethink that, but it makes it consistent and it doesn't raise hopes and it doesn't shut the door. What it says is, what Ken says is change the rationale. He isn't saying you couldn't basically make the suggestion. What he said is we couldn't find, there may be, if one of those things comes into account somewhere in the future, we think compensation may be called for. DR. FADEN: But the problem is there are two situations that are currently contested, so to whom are they supposed to prove, is the issue. We -- MR. FEINBERG: Are they in court? DR. FADEN: They are in court. MR. FEINBERG: Then when the court decides, let them go to Congress. It happens every day. MS. KING: We're only talking about what the commission, what this committee -- DR. FADEN: Let me see if I can unpack this for the rest of us, the notion here being is if it's established that our recommendation is, the principle is the following, as we lay it out. And our recommendation is if in some appropriate forum, presumably a judicial forum, this fact situation is established, the government ought to provide compensation even if the government wasn't one of the people, one of the entities sued in the original litigation. MR. FEINBERG: Well, the government ought to provide medical expenses associated with it. DR. FADEN: Stepping back here is basically saying this is the committee's position about how the government ought to behave, if this fact pattern is established in some forum. MR. FEINBERG: I suspect the government's position would be if that fact pattern is established, there's plenty of precedent for us paying. It may not pay well, but it will pay. MS. NORRIS: This one is easy, situations 1A and 1B is to specify that we're talking about human radiation experiments. This does not. And we're using an example, MKULTRA -- DR. FADEN: They were experiments, but you're right. MS. NORRIS: They were radiation -- DR. FADEN: They were experiments though. They were human experiments. They were not human radiation experiments. MS. NORRIS: I understand. DR. FADEN: I understand your point, Lois. Whatever it is. Let me make sure I've got everybody. Henry and Duncan. Duncan, go ahead. DR. THOMAS: Mine is along the same point. If there is to be a presumption that adequate consent and disclosure did not occur during this period, then that needs to be made specifically on line 16 where we talk about the dignitary harm as it wasn't evident what the evidence was for dignitary harm was. It wasn't required for the fact pattern. DR. LEDERER: Could I ask, does this situation apply to the Oregon and Washington experiments? DR. FADEN: That's what I meant by the prisoner experiments. DR. LEDERER: In which cases in which there were policies in effect because that was after 1966? DR. FADEN: That's a good point. DR. LEDERER: And there was consent, whether or not it was adequate. DR. FADEN: Good point, Susan. DR. LEDERER: And before -- DR. FADEN: When did they begin? They began in the 60s so they crossed over the period at issue. DR. LEDERER: But there were some that were done in the '70s. DR. FADEN: They cross over the period at issue so that's a very important problem for sort of thinking through. It may not be possible to construct it this way. DR. MACKLIN: I missed where the period is stated? DR. FADEN: It isn't stated. It should have been stated. It's in 1A. Henry? DR. ROYAL: The line 5 is confusing to me anyways, about what it is that we're thinking about in terms of the survivors. You pay medical expenses. I thought that would sort of be on-going medical expenses, is the idea that we think that they should be paid for expenses that were incurred during a person's illness? DR. FADEN: I think that's what was understood. I think we're now getting to the small points. The large point is what do we do with this? What do we do with this? So let me get clear -- can we get clear what the options are? One is we get rid of the whole thing. Two is we basically set it up this way and three is we set up the committee's view of what should happen, should anybody prove to the satisfaction of a court -- MR. FEINBERG: Or another forum if they go to Congress. DR. FADEN: Go to Congress and say look this advisory committee has waited and said people like me, or people like our family ought to be treated in a fine way according to this advisory committee. They agree this is how they ought to be treated. MR. FEINBERG: They better not say that, but if they say it they can say whatever they want. We're not saying that. DR. FADEN: What are we saying? MR. FEINBERG: We're saying that if an appropriate forum believes them. DR. FADEN: Congress. MR. FEINBERG: Or a court, then we'll recognize that they have a right to reimbursement for medical costs and other associated costs. But there aren't any -- they're in the pipeline now and they'll have to be resolved. DR. FADEN: I guess what I'm trying to get at is what's the force here. The force is we've been in an advisory committee and we've been asked to deal with questions of ethics, so we're delivering ourselves here and this is where I think this is potentially important, we're saying this is what we think ought to happen, if the following situation applies to anybody, so that's what I meant by saying that that person or family could then use that claim. MR. FEINBERG: Take this court finding, apply it to the general principle and please give us a check. DR. FADEN: It's more auditory than it is anything else, but it's there. MS. KING: It is auditory. It is not -- it is simply covering our bases and I think people should understand their clear option that, the third option clearly, and that is that we're saying is we can't put anybody there based on what we have done now and what we're further saying is that we don't want, we want to say however, if we have found somebody, this is what we would have recommended. MR. FEINBERG: And maybe, I don't know, I heard Pat earlier, it may have some important precedential value in terms of prospective application to principles, I don't know. DR. FADEN: It could. It sets a certain position, it establishes a certain view about how we understand government responsibility in the context of this sort of wrongdoing. MR. FEINBERG: One advantage it does have is that it eliminates most of the implementation section and basically says if and when you satisfy -- if and when a forum agrees with you and you can use our language for precedent, go to Congress and ask for a type of legislation, along the lines of the example we give in the rationale. DR. FADEN: Okay. MR. FEINBERG: That was easy. DR. OLEINICK: I don't think it was agreed to yet. DR. FADEN: I'm waiting to hear from other people. DR. OLEINICK: I guess I don't understand how the whole system works which you do. All right. MR. FEINBERG: Don't bet on it. DR. OLEINICK: Well, you seem to, you talk as though you do. (Laughter.) I certainly agree that we have no examples that fit this category, but it is not beyond the realm of possibility that there may arise one. Now let us say one arises. What is the likelihood that this individual will be able to take his case to Congress or the courts and without the input of a tremendous effort and a tremendous amount of money, investment in the whole process, will be able to get this remedy? MR. FEINBERG: Pretty good. DR. OLEINICK: Huh? MR. FEINBERG: Pretty good. MS. KING: I don't agree with him about it. MR. FEINBERG: Excuse me, if a court finds that a person was wronged like this, or if Congress concludes that a person was wronged, I don't know how much and I don't know what the terms will be and there's been a lot of criticism as to how these congressional compensation plans work. DR. OLEINICK: That's what we've been hearing. MR. FEINBERG: Nothing we are going to say is going to change that. We could say a person should get a zillion dollars and I don't think their chances are going to improve one iota. DR. FADEN: This actually goes further in what it recommends, if you look. What it's saying is this is really a very bad thing. If people were used in nontherapeutic research and they suffered a physical harm, that's a very bad thing, assuming the government was not properly regulating in the subject research at the time. That's the backdrop. And so what it's saying is there should be a sizeable award in such circumstance. MR. FEINBERG: We can give a pretty good example. DR. FADEN: Right. That's why they're in there, even though we can make sure we point to the distinctions that Henry wants to make, depending on the severity of the harm, the award, we're saying ought to be substantial. The problem is for some of us who are not comfortable with the legal system and how things work is we worry about this is likely not going to help anybody. MS. KING: That's right. DR. FADEN: And we need to confront that. DR. OLEINICK: I mean I'm looking across the table at two lawyers and one is saying that he thinks that the system would work,it's possible and the other is saying it's not likely, so -- MS. KING: Look at the MKULTRA experiments. They were experiments to use an old term from another commission that shocked the conscience. They were the kinds of things of which headlines on the front pages of papers - - private bills take effort to get through Congress. Going through courts take money, but I don't see that there's anything that we're going to do to say give people the money, help them with the private bills. The only thing we can do, possible to do now, is to try to design some system that you recommend that would allow these people to go someplace and then say to the government you want to help them, but that's not going to do any good either. That's my feeling. I think that some of these cases get through, but probably a small number of cases in terms of what you and I might consider as being justified, that would justify compensation. It's an uphill battle, because if there wasn't an uphill battle -- DR. OLEINICK: It would open the floodgates. DR. FADEN: It's not pleasant. I don't want there to be an misunderstandings on the part of the committee members about what this is. DR. KATZ: I still don't quite understand a number of things. One thing that I don't understand in all these situations, are we talking about just a small number of people? DR. FADEN: That's just what we went through. DR. KATZ: Is that correct? MS. KING: We're talking about a nonexistent number as far as we know, but there may be some -- DR. FADEN: I want to be careful with that language. There are people who believe that they qualify under this condition. We do not have the resources, nor were we properly constituted to know whether they did or not. Okay? So it's not that they don't exist. It's the candidates exist, but we're not in that position. It's a small number of people, but they do exist and they believe that they meet this description. We aren't in a position to do it. You'd have to do it case by case and we couldn't take each single patient, subjects case up and look at every doctor's record and every note. We just simply couldn't do it. Okay? So it's not correct to say that it's nonexistent. There are a small number of contested candidates is all I can -- DR. KATZ: Am I to understand there could be many, many more. That's not the question I am asking. I am asking from -- as we're sitting here this afternoon, as best as we know, are we talking about a small number of people? DR. FADEN: Yes. That's right. DR. KATZ: I wonder, you know, are there any implications to going through all this just for a small number of people? What will people say? What are you doing here, so far, maybe it will change. You aren't really offering very much. There's all this wonderful language here, but you are talking about a minuscule number of human beings. Does that make any sense? It makes some sense, but it escapes me a little bit. I'm not suggesting we should change anything, I'm just raising this as a question. MR. FEINBERG: I think you can't -- I'm willing to accept the proposition that if people can satisfy this criteria, what brought this all on was the language about there are likely a small -- I don't know what it meant. There are a small group of experiments where the verdict is out. If the verdict is out, then I think the idea I'm suggesting is -- if the verdict comes in, and they were wronged, they should go to Congress and get paid. And if the verdict comes in that they weren't wronged, then they shouldn't go to Congress and get paid. But we think that if it turns out that the record shows that they were wrong, we recommend that they get medical expenses, get reimbursement. DR. FADEN: Ruth and Mary Ann and then I think we should take a look before we lose everybody. Not that we have closure on 2A, but I have a feeling 2B is really going to -- DR. MACKLIN: In answer to my question about 1B, why do we have to name the experiments, specifically, I got out an answer that convinced me. Why don't we want to do the same here? DR. FADEN: These people are candidates and somebody's got to pursue it? DR. MACKLIN: Yeah, you gave us -- it helps to say why a small number if you -- MR. FEINBERG: I agree. DR. MACKLIN: So if you're going to do it in one case -- DR. FADEN: These are the subjects of these experiments, candidates of this, we couldn't track it down to the details. Somebody has got to do it and if it does, this is what we think. That would work. It goes a long way. DR. MACKLIN: I think it does two things. It says why it's only a small number because that's the only ones that fit this category, but it also is a little better because it alerts anybody who's in that category to the possible future, the fact that they may actually be in -- potential members in the category that they may be in the category. DR. FADEN: Okay. Mary Ann? DR. STEVENSON: I have a question on it because the discussion has centered around the decision point being whether or not someone, somewhere decides they're therapeutic or nontherapeutic. But there's another question, I think, and maybe we've already decided this, is the degree of the government's involvement or blameworthiness. I mean in the case of the TBI, right, wrong or otherwise, the government thought it was only sponsoring blood draws, urinalysis and psychological testing, not the clinical TBI, the quote therapeutic or nontherapeutic issue. We're just making a leap that the government had its hand in there, so the government is responsible and the same thing with the AEC and the isotopes. I mean in their own regulations at one point or another, they stated that really the local use committees had to decide whether or not the experiments were okay. they were the suppliers, so subsequently they went over to private industry, so I mean, maybe we already decided that the government has its hand in -- at any level, whether they say they were responsible for not, they are. I think we still have to raise that question. DR. FADEN: That's a very good point. It is basically saying any government hand is hand enough, whether it's a whole finger or a whole hand. DR. STEVENSON: That may again be something that ultimately is decided in court, rather than by us, so maybe it's a moot point and I don't want to spend a lot of time on it. DR. FADEN: Right, but that is -- you're correct. I think we should identify all of these leaps,inferences, presumptions, rebuttals, nonrebuttals, all that kind of stuff, so that's right. That's suppressed in here too, that you don't have to show big government involvement, any government involvement will do for purposes of the way this is set up. The proposal on the board is that we identify, flag the couple that we think are candidates for consideration, that we have not been able to -- with the resources available go down case by case, person by person. Now that's not the same as calling for Congress to write a bill because as opposed to 1B, we say these people qualify. We made that judgment. This is saying we haven't made that judgment. We think these are the only candidates in the category that we have so described. That's tentatively where we are. I'd like it if we could move on to 2B just before we lose everybody. 2B is a real mess. It's out there to complete the logical whatever. It's the residual category. It's experiments conducted in the period we're talking about. Susan is right. We have not been clear about what happens after '66, but at least for the period from '44 to '66, because of the, around the mid '60s between '62 and '68, all the agencies started to kick in with bigger-time requirements. So if the whole thing is premised on the government didn't do this, that and the other thing, they start to do this, that and the other thing i the mid-60s and the rationale here is a problem. But in any event, the whole category is a problem. The category is therapeutic research conducted at least from '44 to '66 and maybe further, depending on the rationale that's set up and it's this whole thorny question of net harm that Eli raised and that we all discussed last time. The proposal is out here that it's the same mechanism again, that it be treated like the 2A situation, only what you would get is less, whereas in 2A when it's nontherapeutic, you would get none of the cost of your medical care, but if you lost work and other kinds of things. 2B, you just got the medical care for the condition that, the harm that was created. There's a qualifier at the end that says look, this is potentially a sinkhole. This could go completely bananas and it's out here to round the circle out so we can -- and I would like to hear other members of the committee speak to it. Lois? MS. NORRIS: I simply have a question. How does this relate to our charge in the charter? DR. FADEN: No differently than any of these others. MS. NORRIS: I was thinking that therapeutic experiments were exempted from our -- DR. FADEN: No. Routine procedures, but not therapeutic research. DR. FADEN: Susan? DR. LEDERER: A question for clarification. The assumption here is that the consent was inadequate. DR. FADEN: The assumption is the government didn't have a system in place. The actual consent might have been terrific, you could have had a good guy ahead of time, because the compensation is from the government. The hidden whatever it is, the odds are, based on what we know about that period, that it wasn't so terrific and wonderful in most cases, because of everything we've talked about ad nauseam about the way in which clinical research was conducted, but there is no strong presumption that it necessarily was the case that an adequate informed consent was not obtained. What we're saying is we know the government didn't have a system in place. That's descriptive. We also know from our historical inquiry that it was quite common for such research to go on without the kind of informed consent we would like to see and therefore, and that's the same rationale for 2A. I see Ken and Duncan and Ruth. MR. FEINBERG: My position on 2B is this: I'm ready to give an apology, just the way it's written, an apology for the reasons we've talked about in 1A or whatever it was, 1B, 2C, 3X, whatever it was. If you want to reimburse medical costs, then I give my vote to Henry and Eli and ask them whether as a practical matter one can determine those cases where there's a net harm, whatever that means and if Eli and Henry tell me yeah, net harm, we can figure that out, then I'm ready to reimburse medical costs, but I'm very, very concerned about, as the black print points out, opening the flood gates and causing all sorts of chaos over what constitutes net harm and I'd like to hear what Henry and Eli have to say about that. There may be others, but I'd like to hear from Henry and Eli. DR. FADEN: I've got Duncan next on the list and then Eli wants to come in. So Duncan? DR. THOMAS: The principle of net harm is equitable and I support the principle. Its implementation seems to me to be completely impossible because it depends upon a counterfactual and what I mean by that is consider the case of a lung cancer who gets TBI and died two years down the road; that diagnosis or his expectation of life for argument's sake was one year, but it was a prognosis with considerable uncertainty so that 95 percent confirmation on that ranged from 3 months to 5 years, let's say. Well, he perhaps benefitted by the treatment because he lived two years instead of his expectation of one year, but on the other hand, you can't know what his expectation was in the absence of treatment. So are you to judge the extra year of life that he got as offsetting his benefit or not? I have no idea what you do with this situation. So I have no practical alternative to suggest here. I just think it's impossible to do. DR. FADEN: Eli? DR. GLATSTEIN: I agree with Duncan. I don't think you can implement this. Cancer comes in so many different sizes and shapes and forms and colors. There's a tremendous biological range. There are certain cancers that will kill you reliably within 90 days depending on what the treatment will be and there are others that really do not necessarily require any intervention whatsoever for a period of anywhere from three to ten years. This is after the diagnosis has been made. So that this is a real cesspool. And I would -- when we start talking about just the reimbursement for additional medical expenses, the complications of treatment, all right. Example, what do you do about the lady in Boston who recently had a demise because somebody gave her the wrong dose. I'm sure she signed the consent form. Somebody gave her the wrong dose. That's a clear instance of what undoubtedly will be established as a malpractice issue. DR. FADEN: I think that we want to distinguish the malpractice situation from this situation for sure. DR. GLATSTEIN: Yeah, but the point is you get in certain areas where you cannot do that. DR. FADEN: I agree. DR. GLATSTEIN: The fundamental problem in the transplant issue is you're talking about numbers, but you're fundamentally industrial as opposed to only what is usually called medical, because the idea is you don't care what it does to the bone marrow because they're going to replace it, although realistically, that just sets you up for complications in other organ systems, but that's a separate issue. DR. FADEN: I saw Ruth, did you want to get in? And then I want to -- DR. MACKLIN: First, as usual, I want to know what this applies to. If this is TBI -- DR. FADEN: Well, TBI, if it fails under the first one. See, the issue of TBI is whether it's therapeutic or nontherapeutic. DR. MACKLIN: Let me make my -- I wanted the categories, nasopharyngeal, I mean I wanted the categories because that always helps. DR. FADEN: Yes, nasopharyngeal, TBI depending, nasopharyngeal. DR. MACKLIN: What's missing somehow is the dual purpose notion. Now I agree we can't make these counterfactuals and this is a different counterfactual from the one Duncan mentioned and of course, Duncan elucidated a counterfactual in an attempt to give an account of what is net harm. In the dual purpose, which we found suspect, why do we find it suspect? Well, things can legitimately have two purposes in life, so the fact that things have two purposes doesn't automatically make them morally suspect. DR. FADEN: Right. DR. MACKLIN: What makes something morally suspect, if it's dual purpose, in these kinds of cases, is either some suspicion and let me just put it on the level of suspicion that (a) it might have not have been done for the therapeutic purpose, but not for the other purpose because it was necessary to enrollment of people in order to get the data in order to give the relevant government agency information. Or, what's suspect about the dual purpose is that subjects aren't told about that purpose and might possibly not, because they never would have been told that purpose. That, I think, we can reasonably infer. We're giving you this whole body radiation so we can give information to the government that's studying some things about - - etc. So what's missing here is, I mean, why were we concerned about piggybacking experiments? DR. FADEN: I want to propose a proposal. Ca you propose a proposal? I'm proposing something. We are struggling back and forth and increasingly it is becoming clear that the abstractions are the problem, that we have some concrete cases before us about which we would like to say something, okay. And in -- what happened in 2A transmuted into let's name a couple of experiments where we're worried, where people are potential candidates and where we think that the back situation where there's a form where we can look at this case by case or causally we can play all this stuff out. Well, what's troubling about the TBI thing can be characterized as a dual purpose, but when you go to the core of it that what's at issue is the quote therapeutic rationale is weak. At some point it starts to get weak on balance, the view that indeed this really is in the best interest of the patient in this context. So we might collapse the proposal and I'm not being particularly precise in my language, but the proposal is something like let's collapse 2A and 2B and have it be that the language that where we believe, either that it was either clearly not therapeutic or that the therapeutic rationale was weak or questionable and harm occurred in this period our position is the government ought to do the following should the fact pattern comes out. DR. GLATSTEIN: I think that's a judgment call. DR. FADEN: Of course. the whole thing is a judgment call. DR. GLATSTEIN: But the point is -- DR. FADEN: It's a judgment call whether it's -- DR. GLATSTEIN: The weakness of the therapeutic case has to be taken into account with the alternatives and where the alternatives suck -- DR. FADEN: I know, but that's what it means on balance. That's the point. that's exactly right. DR. GLATSTEIN: Where the alternatives suck, the basic point is the patient still wants some kind of intervention. DR. FADEN: I agree. I agree. DR. GLATSTEIN: In the vast majority of patients. DR. FADEN: I'm not disagreeing with that. Obviously that's the dilemma, but I'm trying to capture something about if you say it's for dual purpose that isn't going to do it, because dual purpose by itself -- you can have two purposes, both of which can be satisfied. DR. GLATSTEIN: The strongest case that we have for compensation is where we can document a cover up -- DR. FADEN: We already did that one. DR. GLATSTEIN: We did that with respect to the medical things, but there are some things we haven't covered yet. DR. FADEN: Right, we haven't gotten there yet. DR. GLATSTEIN: But still relate to cover up. DR. FADEN: I see what you mean, Eli. I'm sorry, I didn't mean to cut you off. So is it a proposal to just drop this? MR. FEINBERG: Let me ask Eli this question, would Eli be willing to go along or Duncan, both have spoken on this, would either of them be willing to accept a refined 2B that laid out the "suck alternatives" as you put it and would you be willing though after you lay it out so that the difficulty in the alternatives is made apparent to presume an apology, an apology? DR. GLATSTEIN: I have trouble with the apology, but I think when you start talking about compensation -- DR. FADEN: Nobody has trouble with the apology, I am sure. The point is is everybody comfortable with that as an answer? DR. GLATSTEIN: The point is the average physician is unwilling to tell a patient when the patient has no hope. DR. FADEN: I realize that. DR. KATZ: What's the relationship between money and apology? DR. FADEN: What's the relationship? MR. FEINBERG: Must be an academic? (Laughter.) DR. KATZ: It is something that intrigues me about that. MR. FEINBERG: It's easier to presume wrongdoing when the remedy is less compensable than the alternative. DR. KATZ: You can apologize for something and the apology is not accepted. DR. FADEN: Other than we are at 3:30, Duncan? DR. THOMAS: My problem with this one is more the implementation of the concept of net harm as the criterion than with the magnitude of the population that's potentially at risk. I accept the political realities which means that if we open the floodgates that our suggestion may go nowhere, but that's not really our problem. DR. FADEN: Well, I think you're responsible though, Duncan, as a matter of public policy. DR. THOMAS: It's not irresponsible if it's the morally the right thing to do. MR. FEINBERG: You don't think it is? DR. THOMAS: I'm going to try -- this is a round table way of trying to answer Ken's question. My problem with the net harm concept is that I just don't see anyway to breach these judgments and therefore, since I do believe that people who were harmed as a result of experiments for whom we have a reasonable presumption that they were not adequately informed of the risk before they went into it, deserve something, that perhaps we should back off and be more generous than be more restrictive. And so the argument would go during this period that we're talking about, we have a presumption that individuals were not adequately told about what the risks of these experiments that we were getting into and therefore we will offer compensation, along the lines as described here. These cover medical costs. Maybe not beyond medical costs, but at least medical costs for any harm which plausibly or probably -- there's a wiggleroom word there -- that is caused by the experiment, irrespective of whether they also got some benefit from -- DR. FADEN: Duncan, that would be thousands and thousands and thousands of people is what it would come down to. It would be more. It would be an overwhelming number of people potentially. Especially if -- DR. THOMAS: They were harmed as a result of their exposure? I don't think so. DR. GLATSTEIN: It depends on how you want to define harm. Believe me, there are a lot of side effects. DR. THOMAS: But those side effects would have all those substantial -- DR. GLATSTEIN: The problem is those side effects would be interpreted as compromising quality of life. I'm telling you, this is a problem that cannot easily be defined. DR. FADEN: Ruth? DR. MACKLIN: I understand what you're saying that's what this represents. That struggle -- DR. KATZ: Even patients that benefit will still have side effects. DR. FADEN: Ruth, you're up. DR. MACKLIN: What continues to gnaw at me here, given all these difficulties of the net harm and Eli's concerns and Ken's worries, is the question whether many of the people who fall under situation 2B would not have been given that treatment, that potentially therapeutic treatment, but for the government-sponsored projects. I don't know if we're ever going to get that, but that to me puts this into a category that warrants something possibly more than an apology. I mean we're saying, look, some guys did TBI and some people did these things. It was all an early time. There weren't any other alternatives, etc. etc. But I mean it would be surprising given everything that we've read and studied over this last year to find that well, these are people who might very well have been given this as an innovative treatment by their doctor, even if the government meant nothing to do it. So it's that piece. DR. FADEN: I'm not sure I understand which way you're taking it, because that to me counts against compensation as I understood it. DR. MACKLIN: I'm questioning whether they would have it. In other words -- DR. FADEN: But it might have benefitted them and the point is there are a couple of reasons why I have, beside the practical problems, I have some sort of moral problems about whether this is even right to do. First is that there's -- it seems to me that we have not examined nor could we the likelihood that but for the government's involvement in the sponsoring of research many people who fall into this class would have been made much worse off. Secondly, and secondly -- and that would have to play itself out. Secondly, what troubles me about this category is the possibility that some of these people may, in fact, have been better off, even if they didn't know that they were being randomized or whatever, then to receive that treatment or not receive it, an innovative treatment, in a research context, than if they got it in innovative regular practice and again, I keep going back to models like DES and whatever. So it's not clear to me that everybody was -- who was randomized without their knowledge into this trial in 1956 was actually wronged or harmed more than people who got that same innovative treatment. Again, likely without their knowledge or consent outside of an experiment. So it seems to me there's a fairness issue operating here and also I go too to the -- this is where I start to feel some mitigating historical stuff, operating. This was the therapeutic relationship, doctor/patient stuff at a time in which it's not even clear to me that subjects, patients would have objected, in some instances to their physicians deciding that they should be on a study without their expressed permission. And that, to me, or that they would have been upset that the government wasn't -- now that's where I'm coming in here, whereas I think in 1955, if I had been used as a patient without my knowledge in a nontherapeutic study, I would have been upset with the person for doing it and I would have been outraged at the government if they had given somebody the money to do it and not told me, not told that person they've got to ask me first. So I do get a little -- DR. GLATSTEIN: In 1955, that would have happened in almost every other country in the world. DR. FADEN: Which would have happened? DR. GLATSTEIN: That you would have been used without your knowledge. DR. FADEN: You think it would have happened here too? DR. GLATSTEIN: Possibly. But it would have definitely happened in every other country, including England. DR. FADEN: I don't -- that's fine. DR. GLATSTEIN: I guess what I'm saying is we are spending a lot of time on this and I think it's appropriate, but the same time I think the standards we're pushing here are actually at the forefront. They're way ahead of most of the world, in fact, all the rest of the world. DR. FADEN: I think that's probably correct as well. My point goes here, Eli, to the reasons why I think this whole category is problematic, not only as a practical matter and implementation, but I'm not even sure about the justification for it, for compensation in this context. It becomes more complicated, unless you do it on a case by case basis. And that's not -- DR. STEVENSON: Or you define what you mean by harm in a very restrictive -- DR. FADEN: It's some complex of things that I think are problematic. I am troubled though, and this is what leaves me feeling unsatisfied is where you have a very -- the covering up of stuff under this rationale, as therapeutic. That's what bothers me, the bothering then therefore, it's possible to stuff so much under that while it was some remote tangential rationalization that allows you to conclude that this is therapeutic research and therefore the 2A stuff doesn't cover it which is why I was pushing for some sort of softening of the language in 2A that would allow for -- MS. KING: I don't object to your language. I mean I think what Eli had to say was correct, that these will be questions of judgments, but questions of judgments, making those kind of judgments are much easier in the context of specific facts that you're taking a look at. If you don't have those facts, they're hard to do anything, but one of the clear implications here is that we will look, I'm sorry, that somebody will have to look carefully at the records, medical records and if the data would support that this was a questionable benefit or an intended benefit, not questionable benefit, but the intent to provide benefit was questionable here, somebody might be able to find those cases and if the goal is to leave that open, I'm perfectly willing to leave that open. I think the IRBs have to struggle with that issue now when they're dealing with research protocols. They have to make judgment calls. It's harder to make looking at the past with incomplete data, but in some cases maybe it will be made, and all we're doing is precisely what we did in the preceding recommendation. We're basically saying that somebody has to do the work to get themselves into that category. I'm not interested in foreclosing if they can get into it. DR. FADEN: I feel much more comfortable with that kind of a softening of 2A to allow for that kind of a judgment. Is that agreeable? 2A and 2B collapse. They basically say if it's clear that it was nontherapeutic, or if there's good reason for believing that the claim of therapeutic intent is suspect or whatever the language is and again it's a judgment call, then you would fall into it. It's to allow for whoever the decision maker is to say look, you can claim that you lay hands on a patient and it's therapeutic and of course, frankly, I think sometimes it is, but that's not what's intended here, that you -- I don't know, Pat, you said it better than I did, but that's -- MR. FEINBERG: What examples are there of your -- DR. FADEN: It's the TBI issue. It's exactly the TBI issue where what's at core is that is it clearly nontherapeutic or is it clearly therapeutic or is in that category where it's really questionable whether this claim about therapeutic intent is justified. MR. FEINBERG: Is that the only example? DR. FADEN: The only one I can think of. Okay? But it's a big one and it's one that means a lot to lots of people that have -- it's a big one, not in numbers. I think at least with children, it's harder to claim there was no therapeutic, the therapeutic intent argument -- I don't understand either of them terribly well, but on the children one I think it's hard to make that there wasn't a therapeutic intent on that study. How could you say that? I mean they really thought they were preventing -- DR. STEVENSON: No, I agree there was, but they still may result in a net loss. DR. FADEN: But they would be out. They're a clear example of 2B is what it comes to, as opposed to TBI which is -- MS. KING: Is in this questionable category. DR. FADEN: Right. Is in this questionable category. I don't know about the servicemen. I don't know about that as well. I think we're exhausted. Let me see if I can summarize. I'm exhausted. So people may differ in their stamina here. 1A, the apology category, we're all right. Okay? 1B, we are working on the language to change it so that it's specific to the instances with which we are familiar and laying out that if everybody else emerges, it fits the same situation, they too, should -- the rationale would apply to them. We're just not aware of it. 2A, is now turning into a combination 2A/2B where we're laying out what our view is of -- our position of how the government ought to respond if the following is the case. We're not putting in a large implementation thing because we're basically saying there has to be other forum or courts or otherwise if this comes up, if anybody wants to rely on or point to the judgment of this committee in support of a particular claim, here is our position. That's basically what's happening. MR. FEINBERG: I just want to know where we left Duncan's dangling point about a rebuttable presumption if there was full disclosure? DR. FADEN: For the 2A/2B thing? Well, we could. MR. FEINBERG: It's hard for me -- this is Duncan's point and Pat's point. I think if you can demonstrate, no one will be able to demonstrate it 30 or 40 years later, but if you can demonstrate that if the government can demonstrate compensation or reimbursement, here's all the records that show full disclosure. We told them everything and they said go, let's do it. It wasn't duress. DR. FADEN: Look, if you put the burden on the government to prove it, rather than on the patient not to prove it, then I think it's fine because given the documentary morass that we're getting here, because the way it's set up now, the patient/subject doesn't have to prove anything other than the harm part, right? And the therapy and the absence of therapeutic intent. So if you want to say if the government can prove that indeed adequate informed, that informed consent was obtained, then all right, we can work that in. It's unlikely, as you point out, given what we know about the records that that could be done, but we can put it in as a matter of whatever. DR. ROYAL: Not only that, it may be more expensive for the government to do the record search than it would be to just pay the claim. DR. FADEN: Okay, now Ruth? DR. MACKLIN: Can I say something about this group as a whole, this section as a whole? DR. FADEN: Sure. DR. MACKLIN: I'm looking at these situations and we mostly fleshed out the situations with either examples or with the universe of cases to which they would apply. DR. FADEN: Right. DR. MACKLIN: Now I'm looking at our case studies and asking whether our account is complete here, namely of everything in these other chapters where there's been no mention so far in these situations of circumstances in which we may be making some claims or giving some ethical analysis in these chapters. Are we leaving things out or are these not designed to cover everything. DR. FADEN: They're not designed to cover -- if we comment on that, we are not commenting I this context, so that's yet to come. We had hoped and I keep pressing for this, that we would have the language for the committee to consider for the intentional releases, the atomic vets, for those chapters that are not human radiation experiments. So if this doesn't fit anything we want to recommend for biomedical experiments, it's problematic. It's not problematic if the structure does not cover these other kinds -- MR. GUTTMAN: The point with the atomic vets, biomedical, the presumption is that they are already covered in terms of the -- they get equivalent of this -- I think we have to look at that, but that's the notion of it. It's not that they aren't conceptually entitled, it's that they're already covered for better or worse. DR. FADEN: But the language needs to be before the committee isn't the issue, the point is there will be language on each of those. DR. MACKLIN: These are situations and we change the language in the final report that apply to biomedical experiments. DR. FADEN: That's correct. DR. MACKLIN: I mean you can make the argument that the miners, the uranium miners were covered by existing statutes, but those were held by many people, we heard by many people that those were inadequate. MR. GUTTMAN: That's a separate question. DR. FADEN: We're going to set this up separately and we did have a discussion last time that said whatever we want to say by way of recommendations in these -- what we've been calling population exposures will be separate. We're not going to use the same structure. It may end up claiming that indeed some of the rationale is the same, but there will be different comments, not using this structure for whatever we want to deliver on population. We absolutely have to have that for the next meeting and we need to get that out. We can't keep saying we're going to do that next time, we're going to do that next time. We don't have any more next times. I think we have to stop. Does anybody want to say anything before we know where we are? If no one minds, I'd just as soon not wait for Phil Kaplan to close this. Dan, can you close this? MR. GUTTMAN: As the designated official, I hereby declare the meeting closed, if in fact, I'm a designated official. (Whereupon, at 3:51 p.m., the meeting was concluded.)