UNITED STATES OF AMERICA ) ADVISORY COMMITTEE ON HUMAN ) RADIATION EXPERIMENTS ) PUBLIC MEETING ) ) Blue Room Omni Shoreham Hotel 2400 Calvert Street, NW Washington, D.C. Thursday, February 16, 1995 9:10 a.m. Advisory 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. DUNCAN C. THOMAS, PH.D. REED V. TUCKSON, M.D. Staff Members: DAN GUTTMAN ANNA MASTROIANNI I N D E X PAGE OPENING REMARKS 168 Chairman Faden COMMITTEE DISCUSSION: 170 Intentional Releases COMMITTEE DISCUSSION: 231 Experiments of Opportunity LUNCH COMMITTEE DISCUSSION: 306 Human Experimentation in Connection with A-Bomb Tests COMMITTEE DISCUSSION: 368 Experiments on Children COMMITTEE DISCUSSION: 418 Plutonium Experiments ADJOURNMENT 434 P R O C E E D I N G S (9:10 A.M.) CHAIRMAN FADEN: Good morning, everyone. Thank you. We should start. I'd like to begin with the one piece of -- the one agenda item that we didn't finish yesterday, which is a quickie, hopefully a quickie, which is the approval of the minutes of the January 19th to 20th meeting. Are there any additions, corrections, deletions that anyone would like to make to the minutes of the 19th to 20th of January meeting? (No response.) VOICE: Move for approval. CHAIRMAN FADEN: Thank you. Is there a second for the approval? MS. NORRIS: Second. CHAIRMAN FADEN: Thank you, Lois. All in favor? (Chorus of ayes.) Any opposed? (No response.) The minutes of the January 19th to 20th meeting have been approved. Okay. See, that was good. That was fast. All right. We've got a furious agenda. The whole day is, with two exceptions for discussion, basically given over to our discussing chapter drafts. I was trying to think of what the right word was; critiquing, discussing. I'm trying to think of something that is encouraging of discussion but not to off-putting. We have one, two, four that we're dealing with today, or five today? Four. Four plus two times for Committee discussion, so we have four chapters: Intentional Releases; Experiments of Opportunity; Experimentation in connection with Atomic Bomb Tests; and Experiments on Children. Four very critical chapters. Of course, all the chapters are critical. We also have discussion time set aside before lunch for Committee members to take stock and raise any suggestions or concerns about course corrections or emphasis, given that we're coming down the wire. And then we have discussion time set aside at the end of the afternoon today for Eli, Duncan and Henry to educate the rest of us about an issue or issues emerging around the science of the plutonium experiments. So we've got a really busy day but hopefully a very challenging and intellectually engaging day, as well. We're going to go right now into International Releases. Mark Goodman and Patrick Fitzgerald are the staff members who've been working the hardest on that chapter and it's Part II, Chapter 8. Good morning. All right. Ruth had asked a good question, how we're going to proceed. We've sort of proceeded anyway and we can go page by page, but maybe we should start as we did yesterday with global reactions, questions, comments. So, we'll give everybody a minute to get to that chapter in their notes and then we can start. Anybody ready to launch into Intentional Releases? Committee Discussion: Intentional Releases DR. KATZ: I haven't had a chance to read it, so -- CHAIRMAN FADEN: It's hard to launch into it, then. DR. KATZ: -- so I have nothing to say at the moment. CHAIRMAN FADEN: What we were saying, Jay, yesterday, as it's obvious that the Committee staff will welcome marked up copies from all of us as individuals, so when you do get a chance to read it, certainly send your comments into the staff. And all of us will do that. This is the time to be used for sort of communal discussion about the structure of the chapter and its emphases, its direction and things of that sort. But I appreciate your honesty, Jay. I haven't read all of them all the way through either but I'm trying to stay on top of it. Are we ready to start or should we just go page by -- VOICE: No one's going to ask Pat King's question? CHAIRMAN FADEN: I was about to say I'm waiting, since Pat isn't here yet. Reed? DR. TUCKSON: The dumbest first question. How much -- can you just in a capsule way just capsulize the best of our knowledge of what we think the harm was to the folk at -- let's say at Hanford? I mean, do we have a real sense of understanding, the actual quantitative notion of damage, of injury? MR. GOODMAN: Not a very precise one, but a rough order of magnitude I would say. First of all, it's important to bear in mind that the Green Run is roughly 1 percent of the atmospheric releases at Hanford. There's major dose reconstruction underway, coming to a close, I think, for that exposure. The Green Run is 1 percent, roughly 8,000 curies of iodine out of a release that totals about 735,000. It's been broken down year by year so you can look at 1949 and there, Green Run was the main release, and you can look at the exposures. Exposure levels, I think I was told the maximum individual exposure was on the order of a half a rem, a half of a rad to the thyroid. The thyroid is relatively insensitive, so there's some conversion factor to rem. And the population in the nearest area was about 30,000, the Richland-Pasco-Kennewick tri-cities areas. So if you take an average exposure of something of a tenth of the maximum, you get something like a thousand person rad to the thyroid. And looking at a risk model, that's something on the order of less than a 1 percent chance of one induced cancer fatality within order of magnitudes of maybe a 10th of a percent or maybe a 10 percent chance, roughly. CHAIRMAN FADEN: Okay. Duncan? Did you want to follow that up, Reed? DR. TUCKSON: I think Duncan is. CHAIRMAN FADEN: Okay. Duncan and Lois. DR. THOMAS: Reed's question already cuts to the core of one of the central points that both this chapter and the chapter on the atomic bomb testing program, and perhaps other chapters raise, and it has to do with questions of scope. As Mark just explained, the emissions from Green Run constitute perhaps 1 percent of the total emissions from the Hanford Plant. There's no reason why the effects of Green Run should be qualitatively any different from the effects of routine emissions. Now, the power calculations on which the Hanford thyroid disease study are based, based on the estimated doses from the Header Project, suggest that there's sufficient doses overall from Hanford to have produced likely health effects. Likely enough that it's worth studying. So, our expectation is, absent the data yet which won't be available for several more years, that probably some harm was caused by Hanford emissions generally speaking. Of that, it's very unlikely that we would ever be able to ascribe any particular cancers to Green Run specifically. Our mandate really is limited to Green Run and not to the routine emissions from nuclear plants. And, of course, if we were to have chosen to expand our mandate beyond that, we would have to consider all nuclear plants generally speaking. So, how are we to behave when we get to the remedies chapter? That's the question which arises there. And it's the same question we're going to have to ask for the Atomic Veterans, inasmuch as that chapter has tended to be focused primarily on the subset of Atomic Veterans who are subjects of biomedical experimentation. So this is really something we're going to have to come to terms with. I don't frankly see how we're going to do it and it's certainly something the Committee needs to discuss. CHAIRMAN FADEN: Yes. Duncan and I and other people, we've been talking. It's a coherence problem. It's really hard to talk about the harm from the Green Run abstracted from everything else that was released. It's just very difficult. Lois. And Henry, is this right on this point? Lois, do you mind? Or was yours right on this point, too? DR. ROYAL: I take this opportunity to bring up something that I was going to bring up when we discussed areas that we would like to see emphasized in the report that are not yet currently emphasized. And I think what Reed is referring to is this whole concept of risk communication. I mean, how do you package radiation risk in such a way that it's understandable? And it's interesting to me that as I read these documents, despite the fact that I know what rems and rads and all this stuff mean in terms of what the units are, in terms of how to honestly communicate that to people is a very difficult problem. And specifically related to Hanford, I'm not sure where the responsibility of this Committee lies. On the one hand, as Duncan has said, it's possible that a statistically significant increase in thyroid cancer may be detectable with a careful epidemiologic study. On the other hand, as those of you who have been to public meetings know, we know that members of the public have been attributing all sorts of maladies to the releases at Green Run. And I think that part of our risk communication task should include not only what is likely from these releases but also what is unlikely. So if we've heard a lot of testimony about people suffering because they believe that their illnesses were due to releases at Hanford, do we have some obligation to try to put their mind at ease explaining whether or not that's very likely or not likely? So I'm sort of resonating with Reed's plea to what does this all mean. And I think what does it all mean needs to be discussed both in terms of what's possible and what's not very possible. CHAIRMAN FADEN: Can I let Lois in or is this -- MS. NORRIS: My questions have been pretty well addressed and in the process of being addressed, so -- CHAIRMAN FADEN: Is that all right? Okay. I'm sorry, Reed. I just -- DR. TUCKSON: No, no. I'm glad. I'm just struggling with everyone. I mean, Henry's point just really makes sense to me as well. To be honest with you, I guess because of having been a part of so many of those outreach meetings, this sense of people believing correctly or incorrectly that they were harmed -- and I've come to realize that even if they're incorrect, they still -- that the consequences of the belief are so damaging. I don't know. I've tried to imagine at 3:00 in the morning when the clock is ticking in the quiet of my home what it must be like to wonder about what's happening inside of you and to not know or to think about the picture on the mantle of your husband and just wonder that was there a reason that he went as soon as he did. I mean, that's just damaging in a way. On the other hand, -- and so it seems to me that Henry's point that if we do nothing else, trying to bring clarity to that, what worries me is what Duncan just said, that some of these things will take years before that can even occur. And so that means that -- that to me triggers a whole 'nother set of things that this Committee might need to recommend or do or at least make doggone well sure if we do nothing else that again, truth and reality is clearly presented and investigated and implemented. And that has to be very important. But just to bring my rambling discourse to a close, it's the sense that if I'm thinking about all the things in this chapter, at the end of it, what does it all -- I mean, yeah, bad things were done. And one thing's for sure. I mean, I think we have -- I think it's going to be productive for us to make thoughtful comment about the relationship between secrecy and public health. And the fact that it is -- it made me angry to think again that folk could have decided whether they were going to drink that milk that week or not or pick those vegetables that week or not. I mean, there were choices that people could or should have been able to make about their lives and their families. But even as I'm angry and I'm working that stuff out, as our colleague would say, at the end of the day -- he's ruined me with this phrase. I hate him for giving me this though. I can't stop. Every day now I think about that -- the end of the day. CHAIRMAN FADEN: Well, since Ken's not here, you can -- DR. TUCKSON: I get that. But at the end of the day, what does it all mean, other than the fact that there may have been some folks that made some decisions that I think were crummy, and maybe for good reasons or not. And I'm still thinking that through. What did it matter? Was it bad? And is the only badness not really physical badness but mental and psychological badness? And if it's mental and psychological torment to people over years because they've petitioned their government to find out, to get clarity, and they never could, which is another badness. But in the end of it, did they die? Were they suffering because of it? And for some reason -- and I hope somebody will tell me differently -- for some reason that seems to make a difference about how we read these chapters and deal with these issues. CHAIRMAN FADEN: I've got Ruth and Nancy. DR. MACKLIN: I'm going to respectfully differ from an ethical perspective because harm and benefit are only one of the criteria that we're looking at. And the fact that we're treating this as an experiment and looking, trying to use the criteria that we think are central in the biomedical sphere, as this chapter really strives to do and I think does pretty well, means that the question of people being subjects without their knowledge or consent, people being studied without their knowledge or consent is to me the central issue. So, even if people are not harmed, they were wronged, if we come to the conclusion that they were wronged. Since one could say exactly the same thing about biomedical experiments that produced minimal or no risk, why do we think it's wrong if doctors or medical scientists were to use people as subjects even if it's minimal risk if they got no consent at all and people were being used not for their own ends but for the ends of the doctor or medical science. So, to me, that is one of the central features of this chapter. CHAIRMAN FADEN: I'm sorry. He does this to me all the time. I can't even mumble in peace; right? I don't even have the right to mumble off the record. The issue that I was -- so I'm going to take advantage. Dan, let me interrupt here. The problem that I have with that analysis, Ruth, is that there is a very strong sense in which these people were not subjects of research. We have the language of human experimentation kind of imposed on us because of the mandate of the charter. And then we've got this anomaly that in the Green Run nobody studied the people. I mean, that's quite the irony of it. Maybe the people in Hanford would have liked to have been the subject of some follow-up epi investigation to see if they were harmed. In fact, that's a large part of their complaint. But it really wasn't a human experiment. The subject, -- it was an experiment, but it was an experiment, and I don't know what you call it. I don't know. It's a science study. It was a study to see how far -- you know, could you detect the spread of the plume or whatever. It was a military intelligence study. These people happen to be there, but it wasn't a biomedical study. So we have this awkwardness about how to set -- how to look at -- DR. MACKLIN: Well, I think we have to deal with that awkwardness in the text in these chapters and I would make the same point about the experiments of opportunity. I'll make it now when we get to that chapter, because I think it doesn't make a convincing case that those should be viewed as experiments. It has to be made a more convincing case. So there are two ways to go here, it seems to me. One way is to look at the Green Run simply because it's within the charter; set aside or make a disclaimer about the sense in which it is or is not an experiment involving human subjects. Just set aside that discussion and go ahead and do the analysis as it's pretty much conducted here with harms and benefits and secrecy or try to shoehorn it into the notion of an experiment, which I think would be a little intellectually dishonest. DR. KATZ: Can I ask you a question, Ruth? I think just for general clarification, truly mine. Do you feel at the moment that we are constrained to our charter with respect to these things? CHAIRMAN FADEN: Are you asking -- which Ruth? Me? DR. KATZ: Yes, you. Yes. CHAIRMAN FADEN: I was hoping you were asking Ruth Macklin. DR. KATZ: No. Do you feel we're under some constraint because of our charter on these experiments? CHAIRMAN FADEN: Well, the answer is yes, if you put it some constraint. I mean, if the answer is are we under some constraint by the function of our charter, yes. If we are completely constrained by our charter, the answer would be, in my view, no. So, -- DR. KATZ: I would go further, a little bit further than that. I think after all we have certain specific charges but also a general kind of charge. And if in the light of our deliberations we have for good reasons that we can justify laid out of the charter imposed upon us, I think we should do so and not introduce confusion by trying to say certain things that we have to say and put them -- and shoehorn them in the context of a charter that really makes the report in part incomprehensible. DR. GOODMAN: I'd like to respond to what the group and Ruth were discussing. The question of whether humans were subjects, whether it was an experiment and the like, I think it's -- I don't see the evidence that humans were ever subjects of experimentation in the events that I've studied, with a couple of exceptions, not to Green Run. But the other point that Ruth Macklin raised is that people were put in harm's way for the purpose of research. They were in a sense used, even if they were not the subjects. So the distinction is not as clearcut as you might think. DR. MACKLIN: Well, maybe the way to put it -- I mean, they would be used if they were studied. They were put in harm's way or potentially in harm's way, so here the question is was there insufficient regard for the human beings. That is, in the course of doing these intentional releases, was there were people there; living, breathing, eating, et cetera. I mean, that's a way of putting Mark's point. That they were put in harm's way but if they weren't studied in the way that the experiments of opportunity studied people, it would be hard to see them as experimental subjects. But we can use the same questions that we use or the same criteria for trying to evaluate biomedical experiments but we have to ask in a special way, as I think this chapter really tries to do. Whether or not, if there is secrecy surrounding something that's being done, I mean, in the whole nuclear field, was there any greater obligation to disclose to people or to inform people of what was going on and that they may be put in the way of some harm. CHAIRMAN FADEN: I've got -- let me just try this and see if this is -- this is always hard. I've got Nancy, Eli, Duncan and Jay waiting. But I see that -- and Phil and Reed waiting and then I see Henry has been added. I'm just going to leave it for you all to be assertive enough, if you want to jump in right on point. If not, I'm going to go down my list. So if you feel you're right on there, just speak up. Otherwise, I've got Nancy next. Nancy? DR. OLEINICK: Obviously this is related to the preceding discussion. I'm concerned that although it's been mentioned, we're not giving enough weight to the psychological harm that has been done to people partially because of just learning about exposure, the total exposure, and partially because at least in the charter and in much of the press, Green Run is called a human experiment. However we define it, it is still viewed out there as a human experiment. And I think we need to consider greatly the psychological harm to people, even if we cannot estimate the precise physical harm. And I think that is important as we go forward because we have to make recommendations and it's going to be very, very difficult if we constrain ourselves to thinking only of experimental releases. It's going to be very difficult to make recommendations as to how the public can be protected from further releases. It seems, as some of the discussion has gone, we have many concerns about biomedical experiments but basically there is a structure in place for regulating biomedical experiments. We may make some recommendations for the improvement of that structure but we have a structure for regulating the releases of radioactivity and mass exposures, which is at least unintelligible to me. At least it's unintelligible as to how well it works because so much of it is behind closed doors. And so I think there is this larger issue of how we deal with the perception which is the psychological harm, the perception by the public as to what they were exposed with -- exposed to, and where we go in adjusting regulations, if possible, or suggesting adjustments of regulations to prevent further releases whether or experimental or other kinds. CHAIRMAN FADEN: Eli and then -- DR. GLATSTEIN: I think that there are really two different problems here. One is the medical experimentation. The other is the population exposure. And let's just try to think for just a second. In the medical experimentation issue, the patient comes with a problem. The doctor, even Dr. Saenger, did not give his patients cancer. The patient comes in with a problem. The doctor communicates in some way to get their permission to use radiation in this instance for some purpose, with the idea that that purpose will probably help or hopefully will help. Maybe he's wrong. Maybe he's misguided. But they're going to use radiation for a specific purpose and the patient in some way gives an assent. The patient doesn't get injected without agreeing to be stuck. The patient doesn't walk into a lead-lined room without agreeing in some way that he's going to permit himself to be treated. When you get to the business of population exposures, in many instances we're arguing about. It becomes a statistic argument. How much radiation has the individual received? How does this compare? What sorts of long-term complications can we anticipate? Is it more than we expect in the background? Well, radiation in that sense without the individual's permission, without any knowledge that he's even being exposed -- because you can't smell it, you can't see it -- there's no way you can argue that that helps anybody, not even remotely. You can argue that you don't see any enhanced damage and that's as I say, a statistical issue. At some point when the dose reaches a certain level, it does become more than background. So-called threshold. Exactly where that point is is hard to tell. But the point I'm trying to emphasize is when the Atomic Veterans or the Marshallese or the Navajos or what have you, when they are exposed without understanding what's going on and without their permission, there's no good that comes out of that. And we should be thinking among the remedies about how to prevent these kinds of deliberate exposures from happening in the future. They should not be allowed. It is hard to conceive of why we need that kind of information frankly. The military may feel they need it, but we've got to have some check on the admirals and generals to keep them from exposing everybody ad infinitum. It doesn't make sense. MR. GOODMAN: Can I chime in on that point? I don't think there is any argument at the time of the benefit from exposing people. The release was, in a sense, a necessary -- DR. GLATSTEIN: I'm only pointing out the contrast between the two situations. We're responsible as a Committee for dealing with two separate problems and they don't have a lot in common. That's what I'm trying to emphasize. CHAIRMAN FADEN: For clarification though, Eli, I want to introduce that there is the kind of human experimentation that's done with a healthy subject and that is in some ways a bridge in some respects between the two. Because when you've got a health subject or for that matter an ill patient where there's no remote possibility that the experimental intervention could be to the patient's benefit, you're in a bridging kind of a way between the sorts of issues that the intentional releases raise and clinical investigation that's therapeutic research. So we've got kind of the spectrum in terms of the extent to which the argument that the subject herself could benefit comes in as a mitigating circumstance. But I think what you're wanting to highlight is the cold stark way in which the intentional releases illustrate the use of people for some other purpose. DR. GLATSTEIN: Yes. I'm trying to add on to what Ruth was saying earlier because I think she's right on the money. DR. GOODMAN: I think I would narrow the point to say there's no clear benefit to the people being exposed but people doing the release anticipate some benefit, some knowledge coming from it. DR. KATZ: Maybe they should expose themselves. CHAIRMAN FADEN: I think the message that's coming out is there's a huge moral burden that falls when you do this sort of thing because there's absolutely no way that the people who are going to bear the risk have a prospect of benefitting. And that -- I think that's the core of your argument, Eli. DR. GLATSTEIN: Yes. We've seen the concern at very high levels about the potential for liability and we were discussing last night the consent form in California came a lot earlier than other parts of the country because patients sued. I'm talking about medical consent for ordinary non-experimental radiation treatment or chemotherapy. Lawsuits are important in terms of forcing progress. They have done that. And the government itself has to recognize that. Individuals at high level have recognized it. We've seen that. CHAIRMAN FADEN: That's an interesting argument. I want to just remind people where they are in the line. And if they're not happy and they feel like they have to speak now, interrupt. The line is Duncan, Jay, Phil, Reed and Henry. If you can wait until it's your turn, fine. If not, yell out. I've got Duncan. Anybody want to yell out? It's fine. It's okay. I'm putting the burden on you rather than my trying to see who looks most distressed by the need to speak. MS. NORRIS: I'd like to see the transcript on that. (Laughter.) How do you spell that? DR. TUCKSON: I will not speak out, but I just want to know now, that she's back now and so I can't use at the end of the day and I'm very disappointed. CHAIRMAN FADEN: We were mocking you in your absence, Ken, just so you know. Duncan? DR. THOMAS: I've long since forgotten the reason why I raised my hand. We've gone around several cycles since then. Let me briefly revisit the point which Henry raised, which is an important one. There's this widespread perception that all kinds of health ailments are related to radiation exposures and I think we would be doing the public a disservice to confer the legitimacy and credibility of a Presidential Advisory Committee to those conditions for which there's really no evidence whatsoever. Somehow we have to make these distinctions. Where there is clear scientific basis to relieve that there could be a causal relationship. Such as with I-131 and thyroid cancer, we should say so emphatically. Where the arguments will come is all of the conditions for which there's basically no evidence one way or the other, what we recurringly hear from the public is gripes that their conditions aren't even being studied. Now, to some extent I think the public is uninformed as to the lack of evidence. There is more evidence from other settings. Perhaps not from their own population but from other settings there is indeed negative evidence, though by and large I think I would argue that negative evidence tends to be less convincing than positive evidence because of all of the limitations of epidemiologic research. So there is a difficulty that we're going to have to deal with. There are not that many conditions that we can say with absolute certainty that there is no possibility that there could be causal connection, although I think most of us scientists would argue that most of the things which are alleged are very unlikely to have a causal connection. And somehow it will be a delicate line that we need to address. I had another issue, but I think I want to give Henry a chance to respond to that point. DR. ROYAL: I'd like to have us consider the idea of having a primer on epidemiology and maybe as part of that chapter, also have something about public health tradeoffs. One of the things that the public I think needs to understand is the resources that we have available to maximize their health is limited. So, for example, one of the tradeoffs around Hanford might be are we going to spend $50 million on a dose reconstruction study and another $50 million on an epidemiology study which won't in fact change the health of anyone. It will increase our scientific knowledge but it won't change anyone's health. Or should we use that $50 million for any number of public health programs which clearly will benefit people. And one of the things -- one of the reasons why I think the public is disenchanted, and I think it's a very good reason, is that they actually never get anything. The scientists get something. They get money to do their research which they're very interested in. But the public actually doesn't get a thing. And when you go into a community like Hanford, I think one of the things that should be done is you should give them a choice. You can say we can do X, Y or Z. What would you like us to do? Would you like us to do a scientific study? Would you like us to implement the health program, et cetera? So in addition to something about the vagaries of epidemiology studies or a primer on epidemiology studies I think something about public health issues and giving the public choices would be important. CHAIRMAN FADEN: I'm sorry, Duncan. Go ahead. DR. THOMAS: I think you're a little bit hard on epidemiology when you say the public doesn't get anything out of it. (Laughter.) So, they do get some valuable data and that data is going to be the crucial thing when deciding whether or not anybody gets compensation. I think they would view that as something that's useful. Sure. One could decide whether or not to award compensation based on the present NIH radio-epidemiology tables, but I think they're going to be in a much stronger position to fight their battle after they have some data from their own population. DR. ROYAL: I would present the benefits and the advantages and disadvantages of doing the epidemiology study to them, making the arguments that you're making, and let them decide. DR. THOMAS: Fair enough. The other point I wanted to raise, if I can change gears at this point, is what is this chapter really all about? What distinguishes this chapter from the experiments of opportunity chapter is the intentional nature of the exposures by the investigators themselves. And I don't want to belabor that point. We're going to come back to that under the heading of Experiment of Opportunity shortly. But as a result of the decision by the investigators themselves to do this intentional releases, what ethical considerations does that raise? Unfortunately, this is a part of the chapter that has yet to be written so we only have some outline points to relate to. But one of these was -- I was pithily struck by -- is a quote by Richard Elliott on page 42 that's actually worth reading. This is the Information Director of the AEC Santa Fe Operations Office, and he argued: One -- here are the obligations. One. To inform concerned publics of the hazards created and of preventive action which may be undertaken. Two. To warn people in advance of potentially hazardous situations or of situations which may alarm them. Three. To report the fact not only with reassurances but also with details and interpretations. Four. And to the extent of the agency's responsibility, to reimburse the public for its losses. An incredibly visionary statement which was entirely honored in the breach, as far as I can tell. I mean, I cannot think of a single example in this chapter where any of these principles were ever implemented. It's such a fascinating statement, I would really like to know much more about it. In what context did this come about? Why was it ignored? What more can we develop? It seems to me -- it's almost as if this guy has written that chapter for us and I would really -- the reasons why these statements were so widely ignored is what I think is the real message of this chapter. CHAIRMAN FADEN: Dan wants to chime in. Looks like Mark does, too. DR. GOODMAN: By way of context, this was the Santa Fe Operations Office. It was in conjunction with the AEC Bomb Testing Program where the magnitude of the release and potential population exposure was much higher. And I think people thinking in terms of a risk model would have -- might have viewed some of the intentional releases that we're talking about as below the scale of concern. At least that is what retrospectively some of them are telling us, although there's contradictory evidence in some of the standards that were in place at the time that were exceeded. There wasn't a quite different context in terms of magnitude. MR. GUTTMAN: Actually, that's not -- it was, as Mark was saying, what that came from, those statements, Elliott was the Information Officer at Santa Fe -- at San Francisco, I think. CHAIRMAN FADEN: Can you give us a time? MR. GUTTMAN: '53, '54. Where that came up with was right after the Spring '53 test where they began to recognize that the beta burns allegedly and apparently after 20 years' retrospective analysis, caused sheep deaths and they realized that there might be some problems with off-site exposures. And that led to the AEC having a high level committee determine whether to continue with the testing in Nevada. And the internal conclusion was we had no alternatives because of national security to proceed, even if they're going to be potential damages. And that Elliott memo was apparently part of the internal discussions at that time about how do you begin to deal with the public outside the test site when you realize there may be some things that you didn't appreciate. CHAIRMAN FADEN: That's very helpful. I've got Jay, Phil, Reed and Henry. Jay? DR. KATZ: Yes. Just briefly. Eli, you made a very powerful point, an important point. But I think it sweeps too far. Namely, the distinction between medical experimentation and exposure I don't think can be sharply drawn. Of course, in medical experimentation, we not only try to benefit patients but we also try to benefit patients in the future and these patients in the future, if possible. And sometimes the experimental dimension for the sake of science takes somewhat some precedence over the benefits to individual patients. And this is the way it must be. And with respect to public exposure, I think one can also argue that yes, to be sure, these -- in a certain sense these individual patients -- individual persons didn't benefit who came in harm's way, but it was important to do it for national security, for the future of the nation, for their future and for their children's future. And I don't want to make too much of it, but that's really part of the problematics that we're confronted with. CHAIRMAN FADEN: Eli? DR. GLATSTEIN: I appreciate what you're saying and I don't disagree with the principle. But at the same time, once you invoke those words national security, all kinds of things can follow. And that is the part that I would like to see us address in the remedy section. To the best of our ability make a recommendation which would make it more difficult to do that. Not impossible, but more difficult. DR. KATZ: Exactly. But we have to face up to all these things. One final quick point. CHAIRMAN FADEN: Sure. DR. KATZ: Starting out with what Ruth and Duncan emphasized, is with respect to harm. There are the psychosomatic disorders that can be engendered by finding out that you had been put in harm's way. There are all kinds of questions about psychosomatic disorders, but they also exist. They are hard to evaluate.And other things are very hard to evaluate. And I'm sure I'm not saying anything new when I want to emphasize that here we have to be as careful as we can be about what we know and what we don't know; what we have to conjecture about for good reasons. Because, after all, the people involved by virtue of the way they've been treated, they don't trust the government. And they have all kinds of questions about the information -- all kinds of concerns and deep feelings about the way they were treated. We are a Presidential Commission. We are also responsible in a way to the Executive Branch. And some groups will feel that they're being -- in our final report they'll be deceived once more. That is a problem. We have to live with it. But we should be as careful as possible as we can be. What did we know; what are we conjecturing about; and why do we come to these kinds of conclusions and recommendations. It's going to be difficult and it will take time but I think that's also one of the tasks we have in this, with respect to intentional releases and other matters as well. CHAIRMAN FADEN: Phil is next. DR. RUSSELL: This is a fascinating debate. I agree with much of what has been said before. I'd like to point out that we need to clearly crystalize our thinking about this if we're going to have any credibility as a Committee. I think in the first place, there wasn't any human experimentation done. There was no medical experimentation done. In the second place, the harm issue, although you can't dismiss it, is going to be extremely difficult to assess. The separation of the Green Run release from the background where it's only 1 percent of the total and separating that from a lifetime risk of cancer of 22 to 30 percent, depending on whether it's fatal or overall, is virtually impossible, no matter how many epidemiologists you employ to try to sort that out. Furthermore, epidemiology, although an important science, seldom can prove causality. The psychologic harm issue is even much more difficult to sort out. Everybody worries about cancer. On the other hand, there are some issues that are very crystal clear. This is an environmental release issue and an environmental release that was done in secrecy and it put a population at some increase of risk, without attempting to quantify it. And it's also very clear that there's a failure of the public health responsibility with regard to that release. That is, I think, something that becomes very clear. That the population were not warned. They weren't given the opportunity to make personal decisions and the public health authorities in my view probably didn't do everything that they should have done. The remedies revolve around the environmental issues. We can't deal with the prevention of this in the future in terms of human experimentation and things like that. We have to look at are there current environmental regulations appropriate and sufficient to control the activities of the government bureaucracies in the future. And we haven't even addressed that issue as a Committee or Committee staff yet. We've concentrated on the regulatory aspects of human experimentation and I think what we need to say in the report is that this is an environmental issue and it has to be dealt with in terms of environmental contamination, public health responsibility and the secrecy issue. But I'm not sure we have the capacity on the staff or in the Committee to assess the adequacy of our current environmental laws and regulations. DR. THOMAS: It's not true that they're not addressed. The last 10 pages, starting with page 42, is all on that subject. The question is what do you want us to do differently. DR. RUSSELL: I see what you mean. Okay. CHAIRMAN FADEN: If I can introduce during a lull here, I think that one of my reactions to this chapter is that when you start the current regulatory framework, that's a different chapter in some respects. That will be the discussion. At least one way of saying it, obviously, is to say this chapter is the story of what happened and our analysis of what went wrong and then from 42 on we're talking the language of let's figure out what to do in the future with an eye towards whatever recommendations the Committee feels it can make. I think that's a sort of structural issue in the way in which the chapter is now set up to pull out that and develop them -- obviously you've set this first chapter up so that you can launch into the current situation. DR. MACKLIN: Just a footnote on that. I know it's jumping the gun but as long we're thinking this way, I had a much stronger reaction of the same sort in the next chapter, the Experiments of Opportunity, that all of a sudden there's OSHA and all these other things. I mean, we may want to pull all of that out and talk about current regulatory structures for these or other things. It doesn't flow naturally from the story and the ethics and especially -- I mean, I guess I picked up this point even more -- that there's a tendency when you see what the regulation are to forget about the ethics and look at the regs. And one has to step back and analyze both what happened in the past and the regs from some ethical vision. CHAIRMAN FADEN: I see Pat. Is this right on -- Reed and Henry are waiting. Is this right on this point? You'll wait? MS. KING: I'll wait. CHAIRMAN FADEN: Reed? DR. TUCKSON: I'm finding myself thinking a lot about, again, the testimonies that we've heard; how we've gotten -- who we've talked to and how we've gotten information. I think that one thing that's been said I think earlier this morning, and I don't know who said it, but I would say if we have any responsibility it certainly is to write at the very beginning at this chapter a very strong statement about -- that educates people about what is a legitimate concern versus what are not founded concerns. Doing that is going to be exceedingly difficult, obviously, to maintain credibility. I don't know how you do it and I think that one of the fears that we're going to have, one of the pressures we're going to have is to -- because those people that cried in those microphones all around America with their anxiety and their angst, you know, I certainly am feeling a tremendous pressure to respond to them in a way that they almost want to be responded to. That says -- I mean, that really does do that. That they will feel that we kept faith with them. Now, specifically about the Hanford people. But on the other hand, as a clinician I know that the absolute therapeutic responsibility to remove it to the best of our ability -- not to say that we can, but to remove unnecessary suffering and pain by saying it as well as we can say it, as clearly as we can say it. And I just think that this is going to be an immensely important task which at some point we're going to have to think about how we do it. I'm going to put a comma. Duncan looks like he's going to say something. Then I'll come back to it. DR. THOMAS: I've been holding off saying this because I still haven't figured out what I want to say. I'm shifting my view rapidly towards the view that these things that we're calling psychosomatic harms are indeed real harms and we should acknowledge that the mere fear of the unknown which are engendered in the populations downwind of these various intentional releases is in itself a very real harm that has maybe caused people to be sick. Not through any sort of pathological process. I mean, biological process. But that these endpoints are in many senses very real effects of the exposure itself. I think we should acknowledge that. On the other hand, I also am concerned that we could be doing harm ourselves by perpetuating unsubstantiated fears. And that's why it's so important that we really distinguish what is the really credible evidence from that which there is no scientific support so that we may actually do good by relieving concerns. DR. TUCKSON: That's exactly the point. DR. THOMAS: How we do it, though, without destroying our own credibility from those who will easily say -- read the first line of your proposed first line of our report and say, -- DR. TUCKSON: Just like all the rest. DR. THOMAS: Here's another government report so let's ignore the whole report. DR. TUCKSON: So I think that's a different -- so I think we need to at some point have conversation after we get through the conundrum we're doing now. At some point that's a tactical strategic issue for us. But the principle, first, to the latter point that he makes is the point that I started with. And the point you began with is where I want to get to. Something that Phil said I think that kind of helped me in a way is that Phil's absolutely right. That people do sit and worry about cancer but it's this notion of there's a different sort of worry when you finally find out that somebody did release some stuff in your air. And it's even a different kind of response when you kind of thought so and you asked some questions about it and then nobody answered you. And then you asked some more questions three years later and nobody answered you. And then you ask questions five years later and nobody answered you. And after a while you begin to wonder, wow, this really is getting to be a little scary. Why won't they tell me the truth. And there's a whole 'nother kind of harm. Whether we can assess it or put a -- how you deal with dollar figures on that -- I'm not even beginning to worry about now or if you do, but the notion that it is harm, I think, was real clear. In this regard, it seems to me that some statement I think needs to be made about our knowledge of -- so somehow I think the report has to -- I don't know how but to capture -- and maybe we can't do it in a credibly, intellectually credibly way, some sense of the pain and hurt of this psychological damage, even if it's no more than describing in very clear terms the public testimony and we've heard. Because we have to give honor to that testimony and I think this is one place and one way in which at least this Committee member is profoundly affected by that public testimony. And it says to me -- it has an impact. And so I think we have to speak to that public testimony in some sort of way. On a more quantitative scientific base without the precision that other disciplines may have, I think we have to speak to the epidemiology and I think that we have to deal with where is that. I'm still lost. And one of the things that we have to get to -- and I wanted to talk about it some tomorrow -- is I -- and we just haven't gotten time. Steve Klaidman and I and a few others have kind of started to look at how do we interview people like Christine Gebbie, the former Health Commissioner for the state of Oregon and for the state of Washington. And there are a series of four or five other people in those state health departments. I mean, we're not summarizing, that I can see, what we really do know about the real epi versus what folks think. And I think those sources have to be in this document to speak to that. And if that work is still ongoing and three years away, then we have to speak to the fact that that work is ongoing and three years away, but it has to be addressed. And that's a whole 'nother discussion. Let me bring -- and I've taken took long. The other thing I just wanted to get to is, having said all that, it's something that Eli says that helps me out. I come from an entirely different world than military people. I have never been around these people. I don't know how they think. And my biases are, to be frank, all in non-military ways. No question about it. Every part of my life is non-military and that worries me in this discussion of what Eli says about -- and I understand the limits in which he was saying. I'm not overreaching for Eli, but the sense of no good could come from this. I'm not sure that I know that we have talked to the most gruff, cigar-chomping military realist George Patton kind of person who absolutely can say to us and will say to us when this report is released, listen, you people, back in 1940 -- you don't realize this country was up against so-and-so and the ability to measure and know what was going on -- and it's very convenient for you people, public health Tuckson and others to make these pronouncements today, but do you really understand. And I want to be assured, absolutely assured that we have done all due diligence in having those absolute Attila the Hun mentalities presented and dealt with and unavoidably confronted before we wind up with a press conference with these people with all these stars on the shoulders screaming and hollering and saying well, they didn't even consider the most basic of issues that we would have presented. And have we really heard from them? Because I haven't seen those people yet. I've seen the people that I identify which, such as the public. And those are the people that have got my heartstrings pulled, but I haven't seen the other folks. Have you guys seen them? DR. KATZ: We have documentation to that effect in the transcript of the various Committee meetings of the '40s. DR. TUCKSON: But I mean, just like -- I mean, when I hear Henry or Eli, I mean, I've got people in front of me who keep reality checks on certain things. Who say, you know, this is the deal here. And I'm just wondering -- I want to go into a gymnasium with an opponent, as it were, and kind of make sure I understand where the left hook is coming from. And have I really planned for that? I mean, am I really -- because I'm saying my bias is not to consider that enough sometimes and I'm worried about that bias. CHAIRMAN FADEN: Dan, did you want to get in? MR. GUTTMAN: The answer is, of course, we're all -- you know, first of all, I'm not sure they allow cigar smoking in the Pentagon any more, but we are trying to. We've been interviewing, in the case of the military, the folks who were the leaders of the School of Aviation Medicine and so forth, and we're always -- when we get to the Atomic Vets, I'll tell you about the conversation we had with General Hagaman at the Defense Nuclear Agency. The essence was if we had another chance to fly through an atomic cloud today, I sure as heck would do it. I mean, so we know, because that's where you get the information from. And so we've been talking to some of those people. CHAIRMAN FADEN: Lois, did you want to get in on this? MS. NORRIS: I do. And that's simply to thank Reed for bringing this up because this has been something which has been burdening me. And I tend to see things in the same way Reed sees them and I tend to have the same concerns about my ability to judge this national security/national need question. I've never had to make decisions like that and thank goodness I wouldn't. I could not make a decision to send 5,000 men into battle. Those men being -- now, this has nothing to do specifically but this is the level of my concern. Those men being conscripts who really aren't in a position to say, oh, pardon me, general, I don't think I want to do that. And I've never had to make decisions like that. And frankly, I cannot understand people who have to make them and who can make them. You know, you send people into battle knowing that X percentage of them, X number of them are not going to come back for the purpose of gaining a hill, and for that reason I've had a great deal of difficulty particularly in considering the retrospective moral judgment chapters but it runs through the whole report. I don't know how to make those decisions as to what was necessary and what was right. I can say retrospectively there were a bunch of people who were harmed. There were a bunch of people who were wrong. There's no doubt about it. But how strong these mitigations are, the mitigation factors are, I can't deal with it. DR. GOODMAN: I'd like to respond, to the extent that I can, to the question of were these necessary; did they do any good. Patrick and I have gone to some lengths to try and find evidence that the Green Run did some good. Unfortunately, I can't say much about it because any documents that we might have seen are classified. VOICE: Oh, you can tell us. (Laughter.) DR. GOODMAN: But suffice to say we haven't found any documentary evidence of benefits of the Green Run, which isn't to say that there weren't any. The General Accounting Office did its investigation of this and conducted some interviews and the recollection of some of the participants was, yes, generally this was a useful thing to do. I don't know how specific that way. So, it's a very hard thing to get a handle on whether the Green Run did any good or not or was expected to do any good or not. Presumably, it was expected to do some good. I also want to get to the point that was raised a little earlier, the discussion of psychological harms. I think the focus here has been exclusively on the harm to individuals, but I don't think we should neglect the social and political harm. It's not just individuals who are afraid or angry, but it's society that loses trust for its government from events like this. CHAIRMAN FADEN: Phil, did you want to get in? We have people waiting but I could -- DR. RUSSELL: I'm prepared to accept the concept that studying the release of radioactive emissions from nuclear plants was an essential element of national security at the time because of the intense concern with what our potential opponents were doing and how could we find out about it. There were a lot of other efforts going on at the same time. The part that bothers me is that the harm that occurred was as much a result of mismanagement of the follow-on activities as it was of the actual release itself and that the harm from -- the actual harm from Green Run, pure radioactivity, I'm sure is going to disappear in the epidemiologic background. But the subsequent harm both to the individuals from a psychological point of view and to the society occurred because of mismanagement and the use of secrecy rather than rational public relations and good public health practice. I think that's one of the serious concerns we have here. I think a lot of the psychological issues and the community issues could have been mitigated by a more enlightened approach. CHAIRMAN FADEN: I've got Henry, Pat -- and Lois, did you have -- you have already? I couldn't tell where that had come. Okay. Good. Henry? DR. ROYAL: I just want to react to Phil's comment first and that is to say that I agree completely with him that much more harm was done by the management part of it, I think. The culture that developed was one that national security interests were above the law and that no one could question them. And when members of the public came to question them, they were very insensitive to any of their concerns. The main points that I had wanted to bring up is I'm still confused about the criteria that we're using to consider intentional releases. The Green Run is included because it was explicitly mentioned in our mandate and it seemed like it was not possible to avoid the Green Run. But I must say in my own mind I have difficulty distinguishing the release of radioactivity from Green Run from the release of radioactivity from atmospheric testing of nuclear weapons. It seems to me that in both cases the purpose of those experiments was not to measure effects on the population. In both cases the purpose of those experiments was to develop nuclear weapons and our nuclear capability. And I don't understand the distinction between the two. Duncan is shaking his head no, so why don't we listen to what Duncan has to say. DR. THOMAS: It just seems to me that the reason that Green Run is in there and the atomic bomb testing is not is that the Green Run had an avowedly experimental purpose for environmental monitoring purposes. Sure, environmental monitoring went on in relation to the atomic bomb testing as well, but that wasn't the purpose of the release in the first place. The sole purpose of the Green Run release was to see whether or not we could do long-range detection and that's why it's in the charter and the other is not. CHAIRMAN FADEN: I'm sorry. I missed the end part of your sentence. Was to see what? DR. THOMAS: That's why Green Run is in the charter because of its experimental long-range detection purpose and environmental purpose, admittedly, not a human purpose, but in the course of which humans were indeed exposed. Whereas, the bomb testing did not have such an experimental purpose. There was an experimental purposes in terms of testing whether or not a bomb works. That wasn't an environmental purpose. CHAIRMAN FADEN: Thank you. DR. ROYAL: But what I don't understand is why environmental testing is different than bomb testing. CHAIRMAN FADEN: I don't either. DR. THOMAS: I don't think there's a moral distinction between the two, but in the eyes of the White House there seems to be a distinction inasmuch as -- DR. ROYAL: That was what I was bringing up is whether or not we feel comfortable about that distinction and it obviously has practical significance. We have the downwinders who don't think that radio-iodine released from testing a nuclear bomb is any different than radio-iodine released from environmental tests. DR. THOMAS: Well, it's which has troubled us all along on this subcommittee, and hence, our decision to include things like the bomb test downwinders as part of our story. CHAIRMAN FADEN: We have -- Patrick wants to respond. DR. ROYAL: I just wanted to say one other -- address another topic. CHAIRMAN FADEN: Go ahead. And then Patrick and then Pat. And then I think we need to end for a break, unfortunately. Henry? DR. ROYAL: The other topic has to do with benefits. A number of statements were made that individuals who were exposed to the released radionuclides did not benefit from it. And to me that's a common problem in society where the people who derive benefits from certain activities are not necessarily the people who accept the risk. For example, we all like to have electricity in our homes but there are people who live next to coal burning electrical plants that accept risk so that all of us can have electricity. And I guess I view the fact that people living around these nuclear weapons complexes, that they accepted more risk as being similar to that kind of issue where everyone in society, whether they like it or not, ends up having risk imposed on them. And the real issue with imposed risk like that where you're not deriving any benefit yourself is the justice issue about whether or not poor disadvantaged people are being taken advantage of. And one thing that I think that we can at least say about the Green Run and atmospheric testing is that because the magnitude of the release was so indiscriminate, at least it didn't have this other unattractive feature of social justice questions, which to me, when I think of those, that tradeoff of benefit and risk and people that are getting the benefits are not necessarily the people taking the risk, that the social justice question is really the most important aspect of it. And fortunately in this case it's not part of the equation. At least as I see it. CHAIRMAN FADEN: Ruth, do you want to get in right on that? DR. MACKLIN: I just wanted to add -- because we've been talking almost exclusively about the Green Run. The point that Henry makes I think is critical if we're looking at people who were discounted. And here I'm thinking of the Bayo Canyon tests. When we were the small panel in Los Alamos, the releases in the Bayo Canyon; when we were in Santa Fe, the small panel, one of the Los Alamos scientists, in giving a brief presentation before the panel said these were all done in an unpopulated area. And I looked at the briefing book which had some documentation, and then I asked whether there were not communities of Native Americans and reservations and the Navajo reservations in that area. And they acknowledged as yes, there were. And, of course, there were very many Native Americans in the audience and people who testified. Well, when he revised his statement, he said a relatively unpopulated area. Now, I mean, the choice to do things in certain areas -- I mean, if there had been a -- and I'm just picking up now on Henry's point that a judgment that it's okay to do this here -- and this may not have been the case in Hanford but it may very well have been the case in New Mexico. The choice to do this here where nobody's living here and nobody includes the people who were somebody's is I think relevant and something that we -- because we talk about subject selection when we're talking about biomedical experiments. I think we also have to look at who's in the path or, in Mark's words, who's put into harm's way. DR. ROYAL: Yes. I actually think that might be a more important issue is whether or not some populations were overtly discriminated against or covertly discriminated against. CHAIRMAN FADEN: We've got Patrick responding and then Pat will have the last word, although I know there's much more discussion we could have. We really must go on to other chapters. So, Patrick, Pat and then Mark. MR. FITZGERALD: I just wanted to make a quick point. This is one of the things that I find myself angsting (sic) over also. One of the problems is that some of the nuclear tests were not primarily to test a designed weapon. And this is one of I think the population misconceptions about nuclear testing that there are several of the tests which are designed to test the effects of well-tested or previously tested weapons designs. And so Crossroads, for example, was not to test out new designs for nuclear weapons but to see the effect of weapons that had already been exploded. And at those tests I can see no distinction between an environmental release such as Green Run and a nuclear weapons test. In other cases, I think Duncan's point is correct. CHAIRMAN FADEN: Pat? MS. KING: Maybe this point was made before I came in. And if it was, you can feel free to stop me. The way I see the significance of the chapter, without debating what goes in it, is I think slightly different from what I've heard so far. I see keeping faith in a different way. One way to keep faith is to try to ensure that certain things never happen again or to try to put in, to make recommendations, that certain kinds of things don't happen or you make them unlikely to happen in the future. And so looking at it that way, and I should add I don't see and never had distinctions between above-ground testing and the releases and the environmental releases. I think what we should concentrate on are two things. One, we have an example in the '70s that would have involved releases that were potentially harmful, apparently, so far as we know -- and I haven't look at it recently -- they are not, when we were doing recombinant DNA experimentation. That wasn't secrecy but as we all know the scientific possibilities were known to a very small community of people who chose to make what they knew available to a broader audience so that in fact the public could have some say about what was going to be equivalent to environmental releases. So some of this is well documented so it's not discovering more information. I think it is important to contrast what happened in the '70s as a way of proceeding with respect to things that affect the environment with what happened earlier. And the reason I underscore that is some of these OSHA regulations and the regulations that are cited in this chapter were on the books then and the problem was that they did not necessarily precisely apply as a first way of dealing with public concerns and public fears. And the reason I stress that is because it seems to me that one would want to encourage, without using any kind of view from the military or otherwise, one would want to encourage people in and outside of all kinds of institutions to be aware of the possible dangers of releases of anything into the environment and to be willing to take as a matter of professional ethics, professional standards, a push for opening up the process. And, too, I think that the way it played out, while everybody would not agree with the assessment that it played out well, I think from a public point of view the public was not dissatisfied with the way -- some of the scientists were because it slowed down things considerably, but the public was not dissatisfied, I think, with the way things were ultimately resolved. And I suspect that if scientists were pushed, that damage to their work if the information had come out later and they had not released it, might have been more disadvantageous to them than the delayed process. So, one, I think that either here or in your second chapter, Ruth, we want to say something about thinking about how to do things appropriately. My second point is I think with respect to the secrecy and national security issues, this is heartfelt debate but I don't have too much trouble coming down on one side of it. And that is, I cannot believe the American people as a people are willing to see ourselves experimented upon in this way, even in the interest of national security. So I don't have the same problems as some other people have. I think that this is an area that needs to be returned to civilian control, which is indeed what our constitutional framework is. Now, does that mean I want to ignore national security? No. But I think that what this Committee needs to recommend is how to reassert civilian control over national security interests. And I think that there are procedural ways to recommend to do that. And part of it is to make a strong statement about what it means to release unknowns into the environment. That is not to say that it is never called for. It is to say that this is really different because of the potential for what kinds of harms follow. And, I would point out, and this is self-disclosures, since I've done some work on the downwinders problem when I was at Justice Department from a different perspective when the Allen Case first got started. The other side of this is in any debate to do releases of this sort into the environment in the future that we have to take account at the outset, I would think, of if there are unknown risks or risks that we can't evaluate, that we would build into what it is we intend to do a follow-up -- this gets back to Phil's point -- a follow-up for how we intend to ferret out those risks over time. I don't -- if we can't do that, that's what is concerning me. If we can't make any recommendations, this is not about money. This is about what kind of steps. It's a remedy of a different sort that I think that the Committee is well within its charter in terms of trying to propose. And it is a look to the future and it is to draw from the past. And I take the lesson from the past -- I take the lesson from the past is that the way this was handled, both in the decision to do it and in the follow-up as being unacceptable, and so where do you go from here. And I don't go in the direction necessarily of looking for all the people on whom the radiation fell so much, which is what I've heard so far. I'm coming at it slightly different and that is to see if we can keep it from happening again. CHAIRMAN FADEN: We'll let Phil have the last word. DR. RUSSELL: Ask Pat what she means by returning to civilian control, since the -- MS. KING: I knew he was going to get me on that. DR. RUSSELL: -- the Secretary of the Army, the Undersecretary of the Army, half a dozen Assistant Secretaries of the Army, the Secretary of the Navy, the Secretary of the Air Force, the Undersecretaries, the Assistant Secretaries, the Secretary of Defense, the Undersecretary of Defense -- MS. KING: Okay. All right, Phil. Okay, Phil. DR. RUSSELL: -- the Assistant Secretary of Defense for RD&E are all civilians. The Atomic Energy Commission is all civilian and the Environmental -- MS. KING: Can I put it this way? To try to give -- I'm using civilian control -- Nancy is helping me over here -- to mean a broader input of players. In other words, to add some teeth to what we mean by what we mean by civilian control. I do not necessarily take the fact that the Secretary of Defense is a civilian as a sufficient separation from the interests of the Department to satisfy my concerns. I don't want to be a military person, but what I am suggesting -- DR. RUSSELL: Well, what you're saying is take the responsibility away from the Department of Defense for national security and give it to somebody else. Is that what you're saying? DR. ROYAL: No. I thought the Department of Defense responded to the President, but -- and the Congress. But what I am saying is -- VOICE: Who are civilians by the way. DR. ROYAL: But the problem is a question of oversight, a question of being able to do meaningful oversight. And what I am proposing is, when I say civilian control, maybe I'll be more precise. I'm trying to think of ways to give teeth through setting requirements on our own officials that certain kinds of decisions have to be kicked up to certain kinds of levels. Part of the problem, if you've ever worked in a bureaucracy -- and you know this, Bill -- is that you have to figure out some way to make decisions like this rise to a sufficient level so that broader consequences can be taken account of, and that's what I'm trying to do. DR. RUSSELL: That's a different question, though, because -- VOICE: You don't need teeth. You need tongues. DR. RUSSELL: I would argue that the decisionmakers in almost all of these were civilians. CHAIRMAN FADEN: Ken, this is truly the last word. MR. FEINBERG: Do you want me to wait? CHAIRMAN FADEN: No. Go ahead. Do it. And then let's -- MR. FEINBERG: I agree with the last point that Pat made, which is it seems to me that the chapter will be much more constructive and beneficial if after telling the whole story the recommendations revolve around the question of accountability. I don't think that we're going to get very far talking about a weighing of harms and benefits, other than telling the whole story as to what happened. But I don't think epidemiology and calls for epidemiological improvement or change in these areas -- what I think would be the most constructive thing we could do is to provide a list of remedies that revolve around greater prospective accountability in the decisionmaking process. Now, that's a delicate thing. I for one am dubious about our ability to talk about such substantive items as the definition of what constitutes national security or reclassification of national security. That is a highly -- not only a highly difficult area, but one far removed from this -- this expertise of these Committee members, and one that's highly political and emotional charged. But I think that if we can come up -- and I think the chapter at the end in the 1-1/2 pages of recommendations moves in this directly, frankly, but I think it has to be fleshed out more. But if we can talk about ways within the existing power structure, for the reasons Phil says, I think the Secretary of Defense is a civilian and I think there's civilian control over a great deal of this. That's a political science issue. But I think that if we can come up with some recommendations as to how these types of releases in the future will be second-guessed up the chain or there'll be more accountability before it's done, I think that is within our charter and I think that is a subject that we should, and the staff, should be focusing on as maybe the solution. Because I agree with Duncan and others who talk about the -- ultimately the inability to come to closure on issues of epidemiology or harms and risks in this area of intentional releases. I don't think that we will be able to fashion a coherent consistent set of principles in that regard. Accountability, on the other hand, I think is something that we hopefully can develop that will send a signal that in the future this won't be done unless there's a great deal more oversight and second review. CHAIRMAN FADEN: This is obviously -- all right, Mark. This is like the mother who says to the child, "This is the last time you'll do this," right? And then 20 times later says, "This is the last time you'll do this." DR. GOODMAN: This is in closing. A final plea. I would appreciate written comments, and in particular, if you have responses to any of the discussion questions that are raised in either the cover memo, the discussion memo that was distributed later, particularly the latter one. I think it's more sharply defined questions. I would appreciate if you'd give some thought to those questions. CHAIRMAN FADEN: Hopefully, I think we've gotten to some of them, kind of, in the course of the discussions. DR. GOODMAN: Think about that. CHAIRMAN FADEN: We will, definitely. Okay. Let's do this. We are considerably behind schedule. If we could take more like a five minutes break and if the Los Alamos people could go without breaks until lunch, we could maybe do a short one here. See, a precedent has been set now to which all the rest of us can be held. (Whereupon, a recess was taken.) Committee Discussion: Experiments of Opportunity CHAIRMAN FADEN: We are now going to turn to Experiments of Opportunity. We've got Barbara, Gil and Faith, who are the primary drafters up at the table. It is Chapter 7, so we can all turn to that. We're going to focus in particular on the part of the chapter that has -- the overall structure of the chapter, obviously, and its purpose and meaning. And in particular, on the uranium miners and the Marshallese, which are the more developed parts of the chapter, if we can. Okay. I feel like I'm auctioning off something. I'm looking for hands. Ruth? DR. MACKLIN: I have a lot of what editors call local comments, but let me make my global ones first. I think there's a lot of very good material in the chapter, but I believe it needs restructuring, radial surgery, one might say, or restructuring. My major concern -- I mean, for example, I think the material that's at the end belongs earlier or embedded into each separate account rather than being collected at the end. Now, this is a general comment that I wrote, and I don't even remember what I'm talking about. I mean, I have a lot of comments on the pages that might be helpful. My main concern is the absence of a sufficient justification for calling these experiments. When this Committee first met, we talked about this for a very long time and I remember Duncan asking a lot of questions and we went back and forth about whether or not this can or should be called experiments. Now, we became convinced that that's an appropriate designation and we have a rationale for it. I think it has to be in the chapter, since the readers may not be as convinced. And as one -- I think one example of that was when Duncan referred to the narrow definition of experiments involving radiation effects that the Los Alamos people gave. They had a narrow definition. But beyond that, they simply rejected in their statement and their response to the Committee's request, they rejected the idea. They said it's a contradiction in terms to talk about an experiment of opportunity. So I think there may have to be some convincing out there that's not in the chapter. And that's not to be critical of what is in there, but it's to say that I think one needs to have a slightly more elaborate or a stronger justification that it is entirely appropriate to refer to experiments of opportunity as experiments. It's not just a term of art, but it's a word that we want to be able to justify its use as an experiment. CHAIRMAN FADEN: I'm looking for other hands. Duncan? DR. THOMAS: I, for one, have never really been very comfortable with the term experiments of opportunity because it is certainly not a conventional use of the terminology in my own field of epidemiology. This is epidemiology and we would use the word studies. And in my field, experiment is used to refer to things where the conditions are under the control of the investigator. So, an intervention trial, for example. A prevention trial would be an experiment. But one would specifically avoid using the word to refer to cohort or case control studies, which is basically what this chapter is all about. It may not be too late to change or terminology here and I would prefer not to use that word if we could avoid it. Some global comments to get at what is the purpose of this chapter. Now, one distinction which Ruth suggested, Ruth Macklin suggested at our last subcommittee meeting was that perhaps we should be refocusing this chapter on what might be a subgroup of things that we had been -- CHAIRMAN FADEN: I'm sorry? DR. THOMAS: A subset of things that we had been considering previously. Namely, those circumstances under which the exposure was continuing during the period of study so that the investigators had at least a potential opportunity to intervene to prevent further exposure. In that regard, certainly the uranium miners would constitute a very clear example of this situation. Less clear, whether the Marshall Islanders might fall in that category. These would be studies which went on for many years following the cessation of further exposures. So that's one distinction which I'd like to see some Committee discussion of. Now, what is this chapter really all about. What I see are several broad themes. One theme, the first theme which comes to mind is this problem of conflict of interest versus buck-passing and the way in which epidemiologic research is all too often used as a mechanism to avoid action. We see that theme certainly very well illustrated in the uranium miners' story. There has for many years been this debate as to whether the Atomic Energy Commission, later DOE, was in an untenable conflict of interest position. On the one hand, having the charge to promote the peaceful uses and otherwise of atomic energy, and on the other hand being charged with worker protection and public protection, for that matter. And yet when faced with a situation like the uranium miners where the worker protection by default became the responsibility of PHS and they were stuck with a position where they had no authority to act, so this is the buck-passing side of it. And it still isn't clear to me what recommendations the Committee might bring forth that would be appropriate to solve this sort of fundamental structural problem of government as to how you reconcile these conflicting demands. Another broad theme which the chapter illustrates to me are questions of consent, and more importantly, informed consent and what we do. And maybe I should say misinformed consent. Because of the secrecy that surrounds this whole area, the issues which I raised earlier this morning, that memo by -- I've forgotten his name again. VOICE: Elliott. DR. THOMAS: The Elliott memo -- applies as well in this chapter. That rather than openly tell people what the risks were, the risks were in general misrepresented or nothing at all was said. And that's probably enough to at least get us started. I have other points, but they can wait. CHAIRMAN FADEN: I think so. Jay? DR. KATZ: Just a brief comment with respect to Experiments of Opportunity. I can ultimately live with this term but we have to define it because, to begin with, it evokes different kinds of things in our minds. To me, experiments of opportunity takes me back to the notion of experiments in nature which Adolph Meir who was professor of psychiatry in Johns Hopkins invented and talked about around the turn of the century, when suddenly researchers were confronted by virtue of a patient with some other condition, with a situation that begged for experimental study. And so these were considered sort of problems presented by nature to researchers and therefore could lead to experimentation. Now, what do we mean by opportunity. Were the Navajos and Marshallese really experiments of opportunity or were they experiments -- and we may have to describe it -- that were being conducted in order to delay coming face to face with a situation that something needed to be done with respect to ventilation. And the research project was also instituted in order to give them time to mine uranium ores for as long as possible until data was assembled, even though you know, for example, that experiment, it was quite clear, that the real data wouldn't be -- it couldn't be accumulated for five, 10 years, because of the late affect of the appearance of lung cancers. These were experiments of collusion between the government in which also the medical professional participated because these were experiments that -- and let me see what else did I write down. These were in a sense manmade experiments, as I've already said, to delay taking action because the government has other interests in mind. And also the government and other agencies did not really come face to face with the fact that it had to resolve the conflicts between state health agencies, state mining regulations, federal regulations, et cetera. And the experiment, to some extent, was really fabricated and engineered in order to avoid confronting very difficult issues. CHAIRMAN FADEN: Phil? No? I'd like to comment on this issue of what we call these. And your term experiments of collusion is very powerful. I don't know that we'd want it as the chapter heading, but it's -- Jay, as I've come to expect from you, a wonderful use of language and very evocative. I share the same kind of traditional training bias as Duncan. I have trouble calling these experiments. I think of them, however, as research involving human subjects, as opposed to experiments involving human subjects. And the power of calling it experiments of opportunity is more rhetorical than it is sort of technically accurate in some strong sense. And I think we need to struggle with the justification why we believe it belongs, because we believe these were instances of research involving human subjects, if not experiments involving human subjects. And for that reason, as we had our discussion early on, we believe it falls under what we properly should be pursuing. I'm kind of indifferent as to how exactly we package this, but I think that it would be important to make it plain that we're not ignorant of the traditional distinction in some disciplinary perspectives between an experiment and other kinds of research that can be conducted with human subjects and how this is not in some strict sense an experiment, although terms like experiment of opportunity or experiment of collusion have powerful rhetorical power that we don't want to precisely lose. I think we can manage it and I think we can artfully explain this. But if there are strong feelings that we ought not to use the term experiments of opportunity as a title for the chapter, that should come out now. Phil, did you want -- DR. RUSSELL: I support Duncan on this. CHAIRMAN FADEN: I can't hear you, Phil. I'm sorry. I need you to talk in the mike. DR. RUSSELL: I support Duncan's view on this. I'm very uncomfortable with the term experiments of opportunity to describe what are occupational and safety and health issues. As badly as they were mismanaged, they didn't constitute experiments. CHAIRMAN FADEN: We've got -- Ruth -- I'm trying to decide who's hand. I feel like I'm judging a horse race, whether it was Ruth or Duncan whose hands came up. Ruth, he's conceded the floor. DR. MACKLIN: It doesn't matter. I don't think we're going to fight. I'm going to agree with this. And as I recall, one aspect of the very early discussion that we had -- and Pat was part of this, too -- was to ensure that we not use our terms so narrowly that it will push aside a lot of things that this Committee -- or exclude a lot of the things that the Committee should properly be looking at. So I think we bent over backwards both in coining the phrase and continuing to use it, experiments of opportunity, because the name of this Committee is the Advisory Committee on Human Radiation Experiments. But I think keeping -- I mean, we're concerned also about the credibility so that someone will know who are those guys. They're calling everything experiments. Just because that's the name of the Committee doesn't mean that we have to call everything we're studying an experiment. So I would agree with Duncan and Phil's second -- and I'm thirding it -- that we not use the term but we maybe put it in scare quotes, saying here's a way to think about this but more properly speaking this is research involving human subjects but it doesn't fit the narrower definition of experiment. Nevertheless, it's still part of what we are legitimately examining. CHAIRMAN FADEN: Is there anyone who wants to argue against that approach; if we use the term experiments of opportunity at least once, we introduce it with scare quotes and explain that it's an artful use of the term for literary purposes or whatever language we want and explain that we really see these as examples of research involving human subjects. Does anybody want to argue otherwise? Okay. Now the issue is -- before we go on to other questions about the chapter, what about the title of the chapter? This sounds like a minor point but it may affect how everything else gets structured for the whole volume. Are we uncomfortable about the title chapter being Experiments of Opportunity, even in quotes? Yes, Jay? DR. KATZ: I don't think we can decide this as yet. CHAIRMAN FADEN: Okay. DR. KATZ: With respect to all these chapters that I've -- most -- many of the chapters that I've either glanced at or read, I understand it had to be missing, but namely the concluding section which of course would be, I assume, a lengthy concluding section. And what I'd like to do is to just look through the chapter quickly, then read the concluding section and then go back and read carefully everything that comes before and try to figure out what is needed to support the conclusions and what can be eliminated. I think this chapter can be cut down significantly but at this point I don't know how to make any kind of recommendations. CHAIRMAN FADEN: That's fine. DR. KATZ: Because I don't have the concluding section. CHAIRMAN FADEN: I withdraw the discussion of the title. We can worry about that. The least of our problems is figuring out how to title it when it's all done and we're happy with it. So, I agree. We can wait on that one. But we now have an understanding that that term is not to be used throughout as if it means something outside the way in which we have created it to mean something for our own purposes. Duncan? DR. THOMAS: I want to revisit Jay's comment that these are not really experiments of opportunity, they're experiments of collusion. And I'm having some difficulty with that concept. The way I read the record of the uranium miners' story is that if this was -- perhaps substitute conspiracy for collusion. If this was a conspiracy by the government as a whole to avoid action by commissioning research, it was one of the most disorganized and hopelessly incompetent conspiracies in history. It wasn't an organized conspiracy between the PHS and the DOE. It was a war between those two departments in which the DOE dearly -- I mean, HHS would dearly have liked to have intervened but were powerless to do so. And to call that a collusion seems to me to misrepresent what actually happened. DR. KATZ: Okay. You know, that's a matter of interpretation and one can differ about it. I would still also consider the issue of collusion, but conspiracy? Well, it's surely not an organized conspiracy but a disorganized conspiracy perhaps because it was quite clear to the various actors what was really going on, I think. I mean delay, delay, delay. The Public Health Service was concerned about it, but ultimately caved in and went ahead with these studies, which they knew wouldn't produce data in a reasonable period of time in a situation where they also knew that these miners were exposed to the most excessive kind of radiation. Collusion may not be the right word. Conspiracy, which I didn't use as yet, may not be the right word. But some strong word needs to be found to distinguish these experiments from other kinds of experiments. DR. THOMAS: Well, you're certainly correct that the effect of the studies was indeed to delay action because of the negative results in the early years lent support to the possibility that -- well, maybe there wasn't much to worry about. But I'm still struggling with the idea as to in an ethical analysis of this, are we finding investigators at PHS at fault. What should they have done differently. And frankly, I don't know what they could have done differently. DR. KATZ: What they might have done differently and I've argued that with respect to Tuskegee. CHAIRMAN FADEN: Could you speak more into the microphone? DR. KATZ: I argued that with respect to Tuskegee, these very dedicated Public Health Service physicians who went in 1928, '29, '30 to the South to set up demonstration projects and to provide treatment for the syphilitic population. Then they're confronted with the fact that no money was available for continuing with these projects and providing treatment and they were about to pack their bags and go home. And suddenly they realized, my God, this is a golden opportunity to do research because nobody would treat these persons. And so we really have here a, quote/unquote, a great experiment in nature and we can begin to do some studies eventually with the intent of studying them through autopsy. And so this is what happened in Tuskegee and I think this is also what happened here with the uranium miners. Namely, that yes, this was also a golden opportunity to study these patients but it was done for the purpose of delay. CHAIRMAN FADEN: Could I get -- Phil has been waiting, and Ruth. DR. RUSSELL: I'm not sure I agree with you, Jay, on what the Public Health Service folks could and should have done. DR. KATZ: They should have gone home. DR. RUSSELL: Well, I don't think so. If you believe you have a responsibility to this population as a Public Health Service individual, then you're going to stay there and fight even though the bureaucrats are winning battle after battle. What I would like to hear from Duncan and the staff is what were the motivations of the bureaucrats that were continuing to deny the public health implications. Obviously, they needed the raw materials for the program. There were cost issues but there must have been something more than that to continue to deny the reality of the public health -- or the occupational health implications. VOICE: Cost issues. DR. RUSSELL: Nothing more than that? You can't find any motivation other than -- MS. BERNEY: I -- well, first of all, I think that we should acknowledge that at some level discussing their motivations is speculation. But I think there were other issues besides cost. I think they were -- they didn't want to acknowledge to the workforce that there were hazards for the usual reasons that employers don't want to acknowledge to the workforce that there are hazards. It makes the workforce less stable if people know that there are real hazards where they're working, they might go work somewhere else. So I think that was an issue. I also think that there were jurisdictional issues. I think the AEC did not want to take responsibility for health and safety in the mines at a jurisdictional level. Mine safety had always been a state responsibility. I don't think they wanted to mess with it. And the arguments on the other side that the states were not equipped to deal with this issue, we're just not powerful to them. I think it was basically a question of this is not our problem. We are not going to mess with it. And the human issues and the health and safety and public health issues were just not paramount to the AEC. The AEC is not a public health agency. They didn't think they had to act like one. And I think that the most -- and I do think that there was a big issue related to somehow public relations and labor force stability. The reason that I think that is because of the contrast of the way the AEC handled beryllium and the way that they handled radon exposure in the mines. Because beryllium was killing people rapidly in the plants where workers were exposed to it and it was also killing people in the community and it was getting press. And the AEC decided that that was not tolerable and they -- and we now have a lot of documentation on this. And they wrote contracts that basically said if you're going to supply products to us and in the production process of producing those products you're going to expose people to beryllium or you're going to use beryllium, you will maintain these standards. And they wrote the standards and they enforced them. And I don't see any explanation for that other than that in fact it was getting to be increasingly difficult to find a stable workforce for these beryllium plants and that there were articles appearing in the newspaper that say, well, people are dying in the community because of exposure to beryllium and that those plants where it's happening are contracting with the AEC, and they didn't like it. DR. MACKLIN: I think we should, if we can, focus a little on the chapters. I think what happened with the last chapter, we didn't focus on the chapters. And I'm a little worried about what's going to happen in the next iteration. Let me just pose this as a question both to the staff who wrote it and the Committee. The material on page 2, which is the Introduction, and again on page 21, poses these central questions or these questions that Duncan and Jay were just talking about. That is, the middle paragraph on page 2 asks specifically what is the responsibility of researchers engaged in experiments of opportunity, as we calling them. Do they have an independent obligation to communicate findings, et cetera. These questions are posed here and those are among the ethical questions. That is, you've got the researchers and then you have all the people, the miners and the -- I mean, mine owners, the employers, et cetera. Then these questions are reiterated again in a slightly different form on page 22 where it's crisply noted here these events raise questions about, one, the ethical obligations of researchers in situations when they have limited authority to intervene, et cetera; and two, the overall institutional responsibility. Now, I think what happens in the chapter is there's such a wealth of detail and so many stories that the questions tend to get lost or the analysis. It doesn't come back and revisit these questions. So this is not so much a criticism as a question. Should these themes somehow be carried through and should the analysis be imbedded or attached to the stories rather than thrown into the end. We've got these questions at the beginning and then the reader can get lost in a morass -- I mean, not a bad morass, an interesting morass and a welter details, only then at the very end to come back. So there needs to be some reminder of all along. And perhaps there might be a way to do it. I don't have a specific suggestion. As I said, I've a lot of local comments. As I mentioned when we discussed the last chapter, and I would say it again here, the material on OSHA and NIOSH and all of that at the end, I think doesn't really belong in the chapter. I mean, it's here almost as if -- well, there might be some solutions to these kinds of things. Let's look at the current regulations. But I don't think those regulations or even any modified regulations answer the questions that are posed, the ones I just referred to. So somehow, I think if we're going to talk about all the regulations and a need perhaps to see whether they apply as we did with the EPA regulations, that really is a separate analysis from looking at just what were the ethical obligations of the researchers and who did wrong here; who, if anyone, did wrong and what they might have done better. CHAIRMAN FADEN: I see Jay and Duncan. DR. KATZ: Two things to just quickly follow up on what Ruth Macklin just pointed out to us. I think there are too many questions here. First of all, in the introductory statement and then throughout the beginning part of the paper, what needs to be done -- and that takes unfortunately again considerable time -- is what are the major questions that we want to address in this chapter and what are subquestions. By the time I got through I was dizzy. Important questions, but too many of them, and I was dizzy. And then, in beginning to read the opening pages of the report, new questions. So all that I believe ultimately needs to be thought about and the major questions identified. I wanted to make one more comment I think in relation to what Duncan briefly introduced about the issue of culpability. You talked for a minute about culpability. I think we have to again consider for this chapter and other chapters, too, are we also trying to talk about -- are we to a considerable extent in these experiments talking about the terrible ways in which also various actors conducted themselves with respect to the uranium miners, with respect to the Marshallese and with respect to the others, and tell the story and also come to the conclusion that this was terrible, outrageous or whatever adjectives we want to use, or are we also trying to establish in this chapter whether specific individuals or specific organizations are more culpable than others, and maybe even should therefore be subjected to sanctions. If that is our task also in this chapter, it has to be worded differently than if our task is just to talk in general ways about impermissible, unethical, et cetera, et cetera, kind of conduct by all kinds of actors. DR. THOMAS: Well, I think we want to try to do both. We would be remiss in our responsibilities if we didn't discuss the question of culpability in more than just very vague generalities. CHAIRMAN FADEN: Can I -- Sorry. Go ahead, Duncan. DR. THOMAS: Can I return to Ruth's question? This chapter illustrates a problem that many of the chapters have in which we're telling multiple stories. We certainly sought very clearly in the intentional releases chapter and we'll see it again in the Atomic Veterans chapter and I suppose in many of the biomedical ones as well. It's been my view in guiding the staff in this writing exercise that we needed to have a fairly brief journalistic account of the facts as we knew them without a great deal of commentary interspersed, and then to revisit all of the narratives at the end to try to see what sort of synthesis we can make of them, what sort of general statements we can make about our ethical conclusions, drawing upon all of the facts at our disposal. It's not clear to me now having read what's been produced that that's in fact still a viable plan because so many of the narratives illustrate such different points that perhaps Ruth's model, which would be to sort of intersperse the ethical analysis as you go along might actually be more workable. It's a major topic which the Committee needs to address. We are somewhat hampered in having this discussion today in that neither of the two chapters we've discussed so far are yet finished. And where they're not finished is in the conclusions where all this synthesis was supposed to happen. CHAIRMAN FADEN: But let me point out that the reason is the conclusions come from this Committee. Okay? DR. THOMAS: Oh, I understand. CHAIRMAN FADEN: Now staff in some cases have ventured and rendered -- you know, everybody's an individual and have judgments and opinions -- have put forth their own views in some cases and some of the chapters are more developed in that way than others. But the two tasks that I've heard so far identified in this discussion are really tasks for this Committee. One, what are the major questions for this chapter, and there are too many questions or they're the wrong questions. What are the central questions we want focused on in this chapter. And secondly, what evaluation does this Committee have of the situation as it evolved with respect to the uranium miners, the Marshallese and anybody else who ends up in this chapter. We've heard different views and it isn't off the subject of the chapter. It is for the chapter, for is there Committee consensus on whether the Public Health Service should have done something differently or not or the extent to which the Public Health Service did wrong. Does the Committee want to say that as opposed to the AEC or as opposed to the mine owners, or as opposed to anybody else. That's part of what I'm hoping this discussion does. Certainly the discussion we had in the preceding chapter was along those lines and will give staff a lot more now to write about with respect to intentional releases so that the next iteration will be more -- will have a full draft and then we'll be able to take it apart and see if we agree in the spirit in which it's caught. So I'm hoping the discussion goes that way. And I see Ken and then Duncan again. MR. FEINBERG: I think probably the recommendation -- the type of recommendations that we say in intentional releases are the type of recommendations that will probably, in my view, guide this chapter as well. That is, recommendations pertaining to prospective improvement in accountability. It's a little bit more difficult in this chapter, at least for me, because I'm a little bit -- I don't want to say less troubled. Everything is relative. But you're talking about, at least with uranium miners, occupational hazards which to me is a little bit different than downwinders who are minding their own business. I'm not saying that at the end of the day -- CHAIRMAN FADEN: At the end of the day. MR. FEINBERG: -- it doesn't lead to similar recommendations, but I do think that if you take the last two pages of the intentional release chapter that talks about recommendations, I would like to see what the staff's view is -- and maybe the Committee as well at the early stages -- on how there are checks and balances in the future to make sure that there's a full consideration of the dangers associated with the hazardous occupation. The other thing is in this chapter, after all, Congress has spoken in some of these areas in terms of a recognition of wrongdoing and recommendations in the way of remedies. I mean, they've got statutory -- however -- whatever the deficiencies in the statutory remedy, Congress has recognized that there was some moral blame worthiness here and has reflected that in the statutory remedy. So, again, I conclude by saying where do we go in terms of providing checks and balances in the future to prevent some of the factual problems that arise in telling the story. CHAIRMAN FADEN: Duncan, and then Jay. DR. THOMAS: If Jay's on point, let him go ahead. CHAIRMAN FADEN: Jay, go ahead. DR. KATZ: Well, accountability is one thing but we also may want to and surely Duncan wants to -- maybe the whole Committee wants to -- say something about culpability. And about culpability, one can go in all kinds of ways. I think we're all agreed about general statements of culpability. But do we want sort of to identify also individual organizations and individual people and make stronger statement about that. If the Committee decides that, fine. There may be reservations by some of us. But then it gives staff the possibility to proceed at that point where we are now, and hopefully we'll be further along by the time this meeting is over. We are not really giving any kind of direction to staff. But again, you know, -- one final point. I'm not sure whether I ultimately do or do not disagree with Ken to make a statement, for example, of being less concerned about the downwinder persons than the Navajo Indians and others because they were, after all, involved in -- this is part of occupational hazards. I must say, Ken, it troubles me very, very much because this really had nothing to do or very little to do with respect to the risk of engaging in a particular kind of occupation. These people were exploited and deceived, mislead, et cetera, and in a sense almost treated worse than the statistical subjects. These were real people than the statistical subjects involved in the downwinder whatever you want to call the studies, experiments or enterprises. CHAIRMAN FADEN: I keep hearing for this if the Committee decides, the Committee decides. If the Committee wants to say -- we're the Committee. DR. KATZ: I know. CHAIRMAN FADEN: So if somebody wants to say this chapter should do the following, let somebody make a proposal and see if other colleagues agree should this Committee come out and say uranium miners were exploited, deceived and intentionally mislead. We want language that strong. Is that the guidance we want to staff. Is that the interpretation the Committee gives to this experience. Do we want to go further and say more than that. And we haven't yet talked about the Marshallese. But you're quite right. Staff needs guidance from this group about those difficult issues. If not, we can advert it and the staff will provide such language and then we can -- or other language, and then we can debate it. But at this point, language like that is not in this draft. I'm looking to hear anybody argue should it be there. DR. KATZ: I'd like to hear more from Duncan and others who are inclined, about what their thinking is at this point about the culpability issue and how that should be handled. Because -- with respect to these studies, because I'm still unclear on that. CHAIRMAN FADEN: Ruth? Duncan, could you wait one second and just let Ruth? She's been waiting and then you can respond. DR. MACKLIN: There's one way to bite the bullet here and we may want to do this. I mean, time may run out. The staff provided us in the overview for the chapter, the authors of this chapter, with a bunch of questions and these questions are repeated as questions in the draft. They're not answered. They repeated as questions. Why don't we just discuss these questions? I mean, these are the questions, the answers to which provide the conclusions. I mean, they were meant as questions to read -- CHAIRMAN FADEN: That would be ideal. DR. MACKLIN: Yes, of course. They were meant as questions to read -- to think about while you're reading the chapter and then they're repeated in the chapter. But they won't be repeated in the final draft. They have to be answered. DR. THOMAS: This was a planned meeting, though. DR. MACKLIN: Pardon? DR. THOMAS: This was a planned meeting this morning. DR. MACKLIN: So, I mean, I don't see why we don't discuss these questions backing them up or in light with the material and in light of the things that are in the chapter. That's the only way we're going to decide what the Committee is going to decide, by the Committee looking at these and seeing if we have answers. DR. THOMAS: Yes. I completely agree. That's the best way to proceed. What this chapter lacks is the synthesis at the end. CHAIRMAN FADEN: I'm sorry. The synthesis? DR. THOMAS: The synthesis. CHAIRMAN FADEN: Right. DR. THOMAS: That synthesis is what we need to sit down and write right now. And I think Ruth's suggestion that we follow the outline of points is a good way of going about it. Let me just make a few comments about structuring the chapter. At this point I am still persuaded -- I'm still of the view that the idea of some brief narratives followed by a synthetic analysis at the end is the way to go. And I want to make two suggestions in that regard. First of all, at 80 pages, this chapter is already by far the longest that we have and most of us, I think, were reeling by the time we got to it -- to the end, with just the massive detail that we're presented with. Now, this is an editorial problem that we will not discuss this morning, I hope, exactly how to shorten this. That's technical work which we will let staff worry about. What needs to go in these narratives are the essential facts to support the ethical analysis which has yet to be written. And it's of course difficult to know what to weed out until we know what are the points that we're trying to make and then it will logically follow from that. You know, what are the parts of the narrative that we need and what are the parts that can be relegated to appendices. Now, what do we need for the conclusions? We need, I think, three things at least. One, we need sort of a generic discussion of the ethical principles such as we have in several of the other chapters. And I think we all know what we mean by that. In addition to sort of ethical principles, sort of the -- I would include things such as the balance of harms and benefits and informed consent and so on. I would include some of these issues which I touched on earlier about conflicts of interest and buck-passing and so on. So that's one sort of generic, sort of philosophical section. We also, -- I believe strongly that we do need to have a section on culpability and we will debate now I guess what exactly should go in that section. Jay asked for my take on it, and let me just give you in one sentence what I think. I think people clearly did wrong in the case of the uranium miners, and I suspect in many of the other instances that we will look at. I don't think it's the PHS that's at fault for the reasons which I described earlier. And I'm prepared to support those at greater length, if people want me to, later. Finally, we need a section on sort of prospective remedies and there's good language at the end of the intentional releases chapter on this and many of those same points apply here as well. I'm not sure that there's anything really distinct about this chapter that I would want to add, but maybe if I thought about it some more I'd think of something. CHAIRMAN FADEN: How about if we go to a first question on the memo that staff prepared because that's really the big one. I think we're not now talking in the abstract. We're talking in the context of let's just take two cases, the two biggest cases in this chapter, the uranium miners and the Marshallese, and let's start. Anybody want to start? When the government controls -- the one bullet that begins that. There's two parts to it. Government responsibility. You can read government culpability if you want and responsibilities of the researchers. There are two critical pieces in looking at staff. But I assume that if we could get straight on this question, that would be a big deal. The rest of it might kind of fall into place. Phil? DR. RUSSELL: I think I can deal with that. The issue of the responsibility of the researchers is to keep on just as the Public Health Service did. They kept bringing the issue up time and time again and continuing to call attention to it. DR. THOMAS: I personally don't believe that research should be used as a device to avoid action. However, the difficulty which one faces is how much evidence is needed before you can make intelligent action. And this comes up over and over and over again. Clearly in the uranium miner case we were faced with a situation where some people felt that there was already more than enough information from the Czech Republic story to take strong action and there were others who would argue that that information was just not relevant or weren't persuaded by it for one reason or another and didn't know how to act on the basis of that information. Now, history has gone on to show that those people -- you said they had enough evidence to act right there -- were right. I think we could probably find plenty of other examples when the early warnings that some people said that they should take action right now, proved to be later flawed evidence and they were right to collect further information. So this is an ongoing tension. It's not just radiation. It's in any field. In the case of the uranium miners, I firmly believe that there was really no need for further study but the politics were such that those who would steadfastly oppose taking the necessary actions were not going to be persuaded by anything other than evidence from this population. And so faced with that, I think we were wrong to find the investigators at fault for trying to correct that information that would ultimately produce some action. CHAIRMAN FADEN: Jay? DR. KATZ: Well, Duncan, that's just a question and we could spend questions on why should the investigators have participated in this study when they really knew what was at stake and there human beings at stake in this study. They knew that the studies would be going on for years and even after years, would do, despite themselves, the kind of data, if data were needed to convince people to take action. Is there at times and isn't that what Nuremberg also was all about? And people have to stand up and take responsibility and say we will not participate in these kinds of activities. I agree with you that the Public Health Service officials were not the responsible agents but they were also responsible for what transpired. And again, to some extent, culpable by allowing this charade to go on. DR. THOMAS: I think the alternative of packing your bags and going home and saying I want no part of it is even worse. CHAIRMAN FADEN: I've got Henry waiting and then Phil. DR. ROYAL: I wanted to agree with Duncan's observation that this is a problem that comes up all the time about when you have enough scientific evidence to act on that scientific evidence. I must say that that is a crucial issue in terms of the uranium miners and that one of the reasons why it's hard for me to make a decision about it is I'm not comfortable enough with making that difficult complex decision because I'm not familiar enough with the data. I think the data would have to be looked at very closely and I'm not sure how the Committee is going to handle that problem. I mean, we can give some off-the-cuff answer. If I give an answer it would be an off-the-cuff answer just because I'm not familiar enough with the data. So one of the things I'm raising is whether or not we need to have some consultants who could look at the data and either agree or not agree that the data was convincing at the time that the studies group was going on. But the other part of it seems like the deception. I mean, the fact that people just weren't informed about what was going on. That's not a scientific issue. That seems pretty clear that that was wrong. CHAIRMAN FADEN: Phil and Ruth. DR. RUSSELL: I think the issue has to do with the way epidemiology evolves and the information that at first is questionable and then it gets more and more solid. And it may get to the point where it convinces the investigator himself but doesn't convince anybody else. Then you go on until finally you convince rational people but there are still irrational people in the world. Then the investigator is really stuck. The analogy of cigarette smoking causing cancer is a pretty good one here and I wouldn't have advised anybody to stop studying it just because they weren't being listened to by the industry or by the government. I think a cumulation of more and more data brings more people into believing in the right course and I think the investigator actually has a higher level of responsibility, even though the scientific productivity from a pure scientific point of view is less, the social benefits of acquiring more convincing data would appear to be greater. CHAIRMAN FADEN: Ruth? DR. MACKLIN: The phrase "when do you have enough information to act," is not going to help us here because the problem was that the researchers lacked the authority to act. So I think we have to separate -- I mean, what would their action be. They could pack up their bags and go home but would that solve anything? No. That's not action. We could raise questions about whether researchers have obligations beyond the research to blow whistles, call the press, do some other kinds of things. But I think it might help us in answering these questions if first of all we ask what are the researchers' obligations to the subjects. Unfortunately, our Chair, who did the right thing by pointing us to the first bullet, the first bullet is too global. I think we have to go down to the other bullets down below because those are more specific. And if we can answer all the more specific questions it may get us to the first questions. CHAIRMAN FADEN: Pick one. DR. MACKLIN: Yes. I was going to finish the point. I think we have to distinguish between the researchers' obligations to the subjects and the researchers' obligations to do something else, because -- I mean, I agree with Duncan. Packing up your bags and going home may be worse. And then you're out of the loop. Then you're just somewhere else and you're not even there in the process of collecting the data. So we have to answer the question what does it mean by having enough information to act when the people who have the authority and power to act are not the researchers. Unlike other situations where the researchers may say, now we're going to stop this study, like data and safety monitoring committees do when they say we have enough information to stop this study because now we know that this drug is beneficial or this drug is harmful. You don't have that situation here. So, the more specific questions here -- I think if we divide it up into what are the researchers' obligations to subjects, we have two basic ones here. And that is -- let's look at the third bullet. When and under what circumstances is a researcher obligated to inform study subjects of excess risks. And then it goes on to the obligation of the researchers to communicate certain things to these people whom they were studying. That's one set of questions. And then there's a prior question. The fourth bullet asks about entering as a researcher in the first place. Should researcher do a study. That is, these are the conditions. Should a researcher do a study when he or she must promise -- this is a kind of prior question. I mean, maybe we can get to it later. What were the conditions under which people agreed to be researchers. Now that, I think, gets close to the questions Jay is asking because it may be unethical to do certain kinds of research if the conditions imposed on the researchers in advance are such that they're unacceptable. But once the researcher is involved in the study, if there were no such conditions, then we have to ask what are the obligations to the subjects. I mean, I think that may get us to the first set of questions, the general ones, which says what are the responsibilities of researchers. Because if we can answer the specific questions, that goes part way to answering the general one. So, why don't we address the question of what the obligations of researchers are to communicate things to the subjects, the people that they're studying. DR. THOMAS: Well, this is certainly -- talk about prospective remedies, this is clearly an issue which is still very hotly debated today, particularly in the context of occupational and epidemiology. It's very common for an epidemiologist to, at the invitation of a company, to go into a company who is producing something nasty but about which there is relatively little known about health effects and mount some sort of an occupational morbidity study, let's say. Examine workers and let's suppose at this point that there is little or no prior knowledge so there's no risks yet to be communicated to the workers. In the course of doing the study, preliminary data is gathered. That preliminary data suggests that perhaps there is indeed a hazard but investigators still haven't finished all their analyses and they're not really sure whether or not they believe it. They may want to follow this cohort a few more years and collect some more data. At some point the data becomes reasonably convincing. If this is an industry-funded study, the first to find out about it is the people that commissioned the study; namely, the operators of the company. They now have a legal obligation to inform the government under TOSCA of the hazard and at that point that triggers further release of information to the workers themselves. So one aspect of the question is at what point does the worker community get informed of the hazards to which they're exposed. The other side of the coin which we also have to address is what about communicating the results to individuals. And it's not uncommon for this epidemiologic study to invoke some sort of new high tech procedure involving some lab test whose clinical significance is really not understood at all but it thought to be potentially an early marker for some condition which might be of some clinical significance down the road. And then there are all kinds of ethical debates about whether or not the results of abnormal values from this lab test should be communicated back to that individual or whether they should be communicated to his doctor or whether or not no information should be passed back. So these are -- both of these questions are hotly debated today and I'm not on top of this literature myself, but I suspect the staff could easily find relevant literature and expertise to talk to who would guide our considerations. CHAIRMAN FADEN: Ruth? DR. MACKLIN: The advantage of having the case studies is that we don't have to answer these general questions which I agree with you are debatable and hotly debated and debatable in the abstract because there are going to be different answer depending upon what's know, the level of risk, how much the study has gone. We have actual case studies. And if we apply these questions to the particular case studies such as the information that was known from Czechoslovakia and I mean into the Middle Ages or something about these dangers, it's not as if you're starting from scratch from the new substance that is believed to be nasty. So I think you may get different answers about what the responsibilities of researchers are, but I think if we applied these general questions to these specific case studies, it may be easier to come up with the answers. CHAIRMAN FADEN: We have about a few minutes before lunch. I'm wondering can we try at specific -- I mean, that's really the struggle here. I appreciate the context that Duncan has established and that may go towards prospective kinds of issues trying to generalize to the future, but right now does anybody want to argue that something was done rightly or wrongly at the beginning with the miners. Shouldn't anybody have said to the miners, -- I'm trying to get -- this sounds obvious, but let's see if we agree. Should somebody have said to the miners in the very beginning, look, there's a reason to think this is more than hazardous in a different way from regular mining based on stuff that has happened in Eastern Europe that's been known about for most of the century? So far as I can figure out from the little bit that I've looked at this, nobody said that. Now, should that have been said? And, if so, who were the various actors or agencies who should have said that to the miners working in the mine? DR. KATZ: Giving an answer to that question -- because even as a Committee by majority rule, I would personally say yes, they had the responsibility. CHAIRMAN FADEN: Somebody did. DR. KATZ: But Jay Katz, why should we listen to him? One has to play this out against also the issues should it be told. I don't think we can give even ultimately they may come up with some kind of answer, but we cannot give a yes or no answer because that question has to be evaluated, for example, against the perceived need by the Atomic Energy Commission -- CHAIRMAN FADEN: Of course. DR. KATZ: -- to get as much uranium ore as possible for national defense purposes. CHAIRMAN FADEN: Of course. Yes. DR. KATZ: So, the issue also is in what ways do we want to answer the question you've just raised. To me it's -- here what we can make is some Committee decisions. You know, how do we want to proceed with respect to giving what kind of answers. CHAIRMAN FADEN: I've got Henry and Ruth and Phil and Nancy. Henry? DR. ROYAL: The reason I have trouble answering this specific question about whether they should be told that uranium mining is worse, more risky, than regular mining, is again because of lack of knowledge on my part. Presumably different regular mines have different occupational risk rates. There are some high risk mines. There are some low risk mines. Because of other things. You know, what kind of safety compliance they have in their particular mine. And I guess I would be surprised if there wasn't an overlap between what the risk was in a relatively safe uranium mine -- when I say relatively safe, I mean where people are concerned about safety issues as opposed -- CHAIRMAN FADEN: But that was not the context here, Henry. I mean, nobody was ventilating. Nobody was anything. DR. ROYAL: No. But what I -- again, the lack of knowledge on my part is I don't know what increment of risk we're talking about from the radium versus the normal occupational risk of being a miner. If you told me that the number of miners that die every year is 200 from mine accidents and that the increment from the radon meant that 2.1 would die every year from working in a mine, I would be less concerned about it than if you told me that it was double the risk. And I just don't know those numbers. Maybe somebody does. Can you be more explicit on the risk? I am sure that that data is available and I think that that would help me anyway make a decision. CHAIRMAN FADEN: Should we go down the list and people can formulate an answer? I've got Ruth, Phil and Nancy, and then I think we're going to have to make a Committee decision about where to go. DR. MACKLIN: A brief point on this. I don't know. I mean, we're getting into the fine points of whether the disclosure to miners should have to have things in it like relative risk. I mean, that's actually not the kind of thing I'm thinking of when we talk about disclosing things to people. I mean, that's the kind of fine point we see on consent forms. You know, your risk of this procedure is better than the standard drug you're taking or whatever. I'm thinking of some very, very basic things. You can get lung cancer in 15 or 20 years. Now, even if nothing is going to be done about it -- I mean, people assume risks or take risks knowingly. I mean, I fly in airplanes. And when people tell me how much riskier it is to drive a car, that doesn't change whether I drive a car and decide to drive or take airplanes. But we're talking about the honesty of disclosure even if these miners, who probably didn't have many choices in their lives, would continue to be miners. Some might not be. Some might say, you know, I'm going to try to find another occupation because I don't want cancer. But probably a lot might have continued. That doesn't undercut the obligation to disclose even if people, because of their poverty, their geographic limitations or other constraints, would still stay there. So, saying what's known about a certain hazard may or may not lead to a behavior on the part of the individuals, but at least those individuals know that they've been informed and cannot later say, "How come they didn't tell us this stuff?" If they were going to make a choice between continuing to be a uranium miner and being a coal miner, then it might be important to give them this kind of information about relative risks. But telling them they're going to probably get lung cancer or that there's a high chance without any numbers attached to it that they'll get lung cancer in 15 to 20 years, is a pretty basic piece of information and I think they should have been told. CHAIRMAN FADEN: Phil and Nancy. DR. RUSSELL: Do we know that the miners were totally uninformed? Is that the presumption? VOICE: Yes. We know that. DR. RUSSELL: Okay. Mining has been traditionally a very, very high risk occupation and it's no accident that it's always been disadvantaged groups that have participated in the high risk, usually because of money. But Jay, I would reject the argument that it was a national security issue. They had plenty of other options for manning those mines, other than deluding a minority population. There were plenty of ways to get volunteer labor and to create labor forces and so on during those time periods. They're difficult, I admit, but they had other options. CHAIRMAN FADEN: Nancy? DR. OLEINICK: I'm not sure I can resolve all the issues here, but it seemed to me that someone should have taken the responsibility in some way to notify miners that there was at least reason to believe that their hazard, their risk of getting lung cancer within 15 or 20 years was very high. There were already data. Even if some people chose not to believe those data and wanted additional data, that someone should have taken the responsibility to inform them. I don't see how we can come away with any other kind of conclusion. Whether it was the investigators -- and if the investigators were the only ones who would have done it, then maybe they should have done it. And I don't think we're going to resolve all this issue. I would like to suggest that all of us on the Committee take a shot at answering some of these questions when we go home and in writing and circulating some of these answers. I think the questions are certainly right on point and answering them I think is our charge. I think that's one of the things that we should do and in writing and circulated among ourselves and see if by the next meeting we can come up with a document, even if it has some minority opinions in it, that will help us in our further discussions. CHAIRMAN FADEN: I see Pat and Duncan, I think, responding probably to Nancy's first point. And Faith. Okay. Pat? MS. KING: I have no objection to what Nancy proposed for those who want to engage in it, but I have a different kind of objection. One, I've been watching all the members of this Committee, including myself, avoid engaging with this chapter. And I have been sitting here, as I have been listening to everybody respond, trying to figure out -- I know my own reasons, but trying to see if I could figure out things about why some of the rest of you are avoiding engaging in the chapter. And I think with some exceptions of people who are willing to do so, that my observation is generally true. And it occurs to me that part of is that with respect to this chapter and with respect to many others, the people who know the material best are the people who have worked on the chapters. And we find ourselves in a dilemma, and the dilemma is as follows. When you're talking about trying to have a set of standards and you apply it to a case study, in order to do that effectively you have to understand the standards and you have to understand all the little factual details of the study. I, personally, in addition to what everybody else would like, I would like to see the staff take a crack at these answers and tell me why. That is not to preclude any Commission member from doing exactly the same thing. I don't see this as bifurcated operation and I don't have any problem tossing a Commission member's conclusion out the window just as I don't have a problem tossing a staff member's conclusion out the window. But I think it would be helpful for this study and all other studies -- and some of the studies have done it. Some of the things that we've read today are much further along in laying out reasoning for why staff has reached a conclusion. I would want to know that even if I reached an independent conclusion or a different conclusion because I assume that they know most intimately some of the information. And that is assuming I have been extraordinarily diligent, which I am not. But even if I were extraordinarily diligent, I would not know as much as they know. So my proposal is that -- I know why we want the Committee to deliberate, but I think the Committee deliberates better when it works off of something. CHAIRMAN FADEN: One of the problems, let me introduce, is that you're right. This chapter and also the chapter on intentional releases hasn't benefitted from as much Committee discussion, in fairness to staff, as some of the other topics that this Committee is dealing with has had. So we've had very little communal discussion of the experiments of opportunity. A very active subcommittee but not very much communal group time on this issue. So this hour and a half on experiments on opportunities is actually doing double duty. On some of these other areas we've had previous discussion that's enabled the staff, in addition to their own judgment and wisdom, to go further. So we're kind of -- I mean, I'm not entirely surprised that we're where we are with this chapter but that's okay. So what I'm hearing is a suggestion from Nancy for those Committee members who want to to take a crack at answering these questions, and also for staff to answer them. Actually, it's essentially in the context of rewriting the chapter to do it including that kind of interpretation and analysis. Let me just layer on that I would encourage us. There are lots of different substories in here. If we could do it for the uranium miners and the Marshallese, that would be good enough. I mean, if we can at least focus on the two central or the stories that are featured the most in this chapter, that would be very helpful. I've got Duncan and then I'm worried about stopping for lunch. I think we need to do that. Duncan? DR. THOMAS: Yes. I endorse both of those two suggestions. I was concerned by Ruth's comment at the very beginning of this discussion that the recommendations need to flow from the Committee and it's for that reason I think that this chapter and the intentional releases are behind the game just because we haven't heard staff recommendations. Nevertheless, I don't think that should take the rest of us off the hook and we should all of us, be very strongly encouraged to make our suggestions now in writing in terms of our answers to these questions and we shouldn't just want to see and respond to staff recommendations. There's a certain laziness in doing that. I find myself my own creativity is dampened by just intellectual laziness of responding to what other people did rather than have to come up with it de novo myself. CHAIRMAN FADEN: Faith, I'm sorry. Could you go quickly, because we really are going to have to stop. MS. WEISS: This is a very basic simple point but I'd just ask you as you look at the overview and the questions as you see the word researcher, think in your mind also, government researcher, and does that make a difference to you. I think in these stories, the government researchers, the government doctors are prominently figured in interacting with the people and I think that may make a difference to you as you answer the questions and think about recommendations because the perception of the person on the other side is a little different if it's a private researcher or a researcher they know their company brought in, as opposed to a government representative. CHAIRMAN FADEN: All right. DR. KATZ: Just one very quick comment is with respect to questions. And I'm not sure whether it will contribute anything. In the introduction to my book, "Experimentation with Human Beings," and it may or may not be applicable here. On the first few pages we set forth questions and ways of analyzing issues of human experimentation for purposes of the cases before us. Maybe staff and maybe some of the members could take a quick look at it and see whether anything in there -- we tried to be systematic -- could be useful for ordering these questions. It may not be, but it's worth taking a brief look at and it's only two or three pages. CHAIRMAN FADEN: Thank you. CHAIRMAN FADEN: Duncan? You have to? Okay. DR. THOMAS: The other point I wanted to make -- I couldn't let Henry's query go by unanswered. At the bottom of page 3, there's a very brief discussion, not particularly quantitative, of what was known beforehand, and I'm happy to provide you with the relevant material, more up-to-date material, about radon risks. But I'm particular struck by the last sentence. By 1951 the PHS noted that the attack rate of lung cancer, referring to the European mines, was 70-75 percent for the European mines and the very first surveys of radon levels indicated that radon levels in the Colorado mines were quite frequently as much as 10 times higher than in Europe. So there is every reason to believe that this is an extraordinarily high risk and the subsequent epidemiology studies have now borne that out. It's not trivial in comparison to the background risks of mining which are, of course, also big. CHAIRMAN FADEN: Okay. Thank you. That's helpful. All right. We're going to have to call it. Let me just suggest the following. I think we're kind of worn out, so I think we should have lunch now but only for an hour. Come back at 1:15 and then the time that was set aside for Committee members to discuss issues of where do we go next; are there emphases that we want to make sure get included -- do that for about a half hour. If we don't get it all done, we'll do some more of it tomorrow. And then go on to the other two chapters. So if the restaurant will cooperate, which is a big if, but if the restaurant will cooperate in getting us the food quickly enough, if we could reconvene promptly at 1:15, that would be really good so that we'd save as much time as possible. So those of you who are having subcommittee discussions during lunch, please remember we must get back at 1:15. (Whereupon, the luncheon recess was taken at 12:15 p.m.) AFTERNOON SESSION (1:30 P.M.) CHAIRMAN FADEN: I think we're just going to start the discussion because we have to start the discussion. We were supposed to start at 1:15, which de facto means 1:30. But we can't let it slide to 1:45. That just doesn't work. All right. Would everybody -- Dan, we're just going to start. We're going to start. Here's how the agenda is going to be revised. We are going to take from now until 2:00 o'clock, and if we need to go a little bit more we will, for an opportunity for Committee members to do some stock taking. We will have time again to do this on Friday if we need to, which is basically if anyone wants to raise issues that they would like to make sure don't fall between the cracks or if they think there are concerns that need to be addressed. Let's just try it now and then see how much time we need for discussion. So I'm going to give a half hour over to that now. At 2:00 o'clock we will do the chapter on Human Experimentation in Connection with the Atomic Bomb Tests. We will then take a break, rather than have the break at 4:00 o'clock, which doesn't make a whole lot of sense. We will take an earlier break and then we will have -- we will then work on the chapter on Experiments on Children and then we will have the discussion on the plutonium experiments. And we should have enough time to do everything. If we don't then we'll re-juggle tomorrow, but this ought to work. You also found a whole bunch of things on your seat when you came back, when we came back from lunch. This is always a high risk enterprise. You come back from lunch. You never know what you'll find. VOICE: Take your chair with you. CHAIRMAN FADEN: You take your chair with you. That's a good idea. The memo on radiation experiments involving children is for today's discussion, as is the discussion points on the purposes of the plutonium injections and the plutonium permissible body burden. So you can hold on to those because we're going to refer to those later in the afternoon. But the one that is marked "Update on the Research Proposal Review Project," that's for tomorrow morning's discussion. So if you would put that with whatever you want to look at tonight. And just to remind you, it's not long. There also was something distributed yesterday on the subject interview study. That's also for discussion tomorrow morning. So two pieces of paper for discussion for tomorrow morning. The other pieces of paper on your chair are for discussion this afternoon. Okay. With that, the floor is open for Committee members. It's kind of a free time for a half hour if anyone wants to bring up anything that they would like to share with colleagues about the course of the Committee progress, whatever. Henry? DR. ROYAL: Well, I want to thank Ruth for allowing me to do this. I talked to her a couple of days ago. I have to admit that my anxiety level from a few days ago has gone down a little bit from today. I don't know if it's seeing my colleagues and seeing that we're all in the same boat that has made me less anxious or not, but let me tell you about some of the things I'm anxious about. Number one, I'm concerned about the enormous scope of what we have undertaken and I don't know how the rest of the Committee members feel, but my capacity to be able to deal with all this information is being exceeded. And rather than just complain about that, I just want to bring up two things that might help in that regard. The first is the use of consultants. I've been a little bit -- it hasn't been clear to me who I can show documents to and who I can't show documents to. Given my current state of mind and given the amount of work that I perceive that I have to do, I guess I would like some acknowledgement of the fact that if I think I can show something to somebody who's going to help me get to a better conclusion, that that's acceptable and that there is no formal pathway that I need to go through in order to accomplish that. CHAIRMAN FADEN: Well, let me respond real quickly and then I'll look to Dan and Anna. These are documents, as in historical documents. They're in the public record for everybody, so that's no hesitation. If it's a chapter draft, that technically is to stay within the Committee. So I'm trying to think of what the procedure is. And certainly there should be a mechanism. There would need to be something that would happen. So let me distinguish between memos and all this sort of stuff which immediately goes into the public domain and chapter drafts which are in evolution, which take on a different status. Dan, what is your thinking? MR. GUTTMAN: The principal question here I think is one -- obviously we need to get people to read these things other than ourselves -- is one of fairness and a perception of conflicts and so forth, and if you're giving it to the plaintiff's law firm and the defendant's law firm. So I think this is really a common sensical question of clearing and making sure that anybody that you'd give this to is not someone that someone else says, well, you gave it to so-and-so. DR. ROYAL: Well, you understand that my problem is that because I'm -- my expertise is in the area of radiation and radiation biology. There are some groups that would say anyone who is knowledgeable in those areas, we're suspect. So, -- MR. GUTTMAN: The only one we've heard of is the American -- the ACR. DR. ROYAL: I guess that's particularly why I -- MR. GUTTMAN: Right. CHAIRMAN FADEN: I think what we should just do is simply this. If the principle is that it's not a chapter draft, whoever you want to consult is fine. DR. ROYAL: But it may be a chapter draft. CHAIRMAN FADEN: If it's a chapter draft, I think what should happen is you should call Dan and just have it be logged in. Dan's got a good head when it comes to issues of this sort. If he has any concerns, he'll discuss them with you. That puts a big burden on you, Dan, but at least that's the procedure for all of us. If Dan has an issue, he can raise it with me -- or a concern or a worry and we can talk about it. But in general, and this would not only be in the science areas. In any area if any of us has a colleague or an expert that we would like to consult and it's focusing on a chapter draft, we should use the mechanism of talking to Dan first. If it's other material or you just want to have a conversation with someone, of course that's -- DR. ROYAL: I think it relates to Reed's question -- to Reed's comment earlier about the generals. You know, I'm assuming that there's going to be some mechanism in place where this gets peer reviewed in some way, some of it being done formally and some of it being done informally. And that whole mechanism is not clear to me. But I think it's very important that it happens. MR. GUTTMAN: Well, there's two steps. One is the generals literally will have the opportunity to review it because if we have time we're going to have it being -- the fact reviewed by the agencies. Not don't say this; don't say that, but this is wrong. So the generals -- DR. ROYAL: Yes. But that has to start now. WE don't have much time. CHAIRMAN FADEN: Yes. It does have to start now. It is starting now. But that's for fact review only. That's not for anything else. DR. ROYAL: That's mainly what I'm interested in is fact review. CHAIRMAN FADEN: But that is starting now. But that's a very good point. So is that enough of a general principle for everybody? And it may be a personal matter. You know, I'd like to check out my intuition on this with a colleague and see if I'm right about that. And that is a very limited function and different from saying I would like so-and-so to be a formal reviewer of this whole document; viz, I think this person has a perspective or an area of expertise or a level of wisdom that we would benefit from. So I would also want to distinguish between those two uses. But if it involves a chapter draft, run it by Dan first. If it doesn't involve a chapter - it doesn't involve physically giving somebody a chapter draft -- DR. ROYAL: And it often to me means sending two or three pages of a chapter to somebody as opposed to -- CHAIRMAN FADEN: Yes. That's also different. Just run it by -- okay. Is there another point for Henry or other people? DR. ROYAL: Yes. Different issue. In terms of how the report is coming out and the work of the Committee, the thing that I'm still troubled by is I guess the standards to which we're going to hold individuals. We're holding them I think to a very high ideal. And one of the -- what I felt was an interesting example of a potential problem in terms of ethics that everyone is aware of that I wanted to bring up, because I don't quite understand the difference, is the -- Dr. Foster, the current nominee for Surgeon General, had done some hysterectomies on some institutionalized patients and everyone today acknowledges that that's not something that we would do today. But it's -- I'd sort of quote in the paper, for what that's worth, that Secretary Shalala had said, well, that was sort of mainstream medicine back then. And so as you know, I'm sensitive to the issue about radiation scientists and physicians somehow being held to a different standard and I think that I would certainly like to see the Committee address the issue of whether or not everyone should be held to the same standard. The third issue is just to alert -- DR. MACKLIN: I just want to clarify. I mean, using the example that you used, the question is whether today's -- we can retrospectively judge people to have done something unethical by what is now not accepted as ethically acceptable but was then. But in what you've followed that in saying is whether or not we're holding people who did radiation research to a different standard. Different from what? Others at the time? I mean, different from what? DR. MACKLIN: It's my sense that if I were to say that these researchers or physicians should not be criticized because they were doing what was mainstream medicine at the time they were doing whatever it was that they were doing, that that would not be accepted as a mitigating circumstance. DR. ROYAL: But then the question is not -- we would criticize anyone. I mean, all we have to do is have explanatory material that says the judgment that's being made is from today's vantagepoint, et cetera, and recognizing that everybody in that era -- people who did radiation experiments, people who did other experiments, doctors who treated patients and did not conscientiously or assiduously obtain the informed consent of patients were all doing the same thing. DR. ROYAL: Maybe that's really the point that I'm trying to make. And that is that the context in which these unacceptable things occurred is maybe not fleshed out enough for my liking. That I think that we should make it clear what medical research was like at that time. CHAIRMAN FADEN: Can we do this? If we could take this discussion, this particular point, and hold it until we do the chapter tomorrow on practices, because I think that's the chapter in which we're trying to flesh that context out. We'll see how comfortable people are with the treatment. There may be some disagreement, but that's where, right now anyway in the structure of the volume that context is supposed to be set. So if we could take that discussion and wait and see where we are on that, I would appreciate it on that point. DR. ROYAL: And the last thing is -- and I referred to it this morning about a primer on epidemiology, something about risk communication and something about public health tradeoffs, I think would be helpful. CHAIRMAN FADEN: And that's the suggestion that was made -- that you made I think earlier today? DR. ROYAL: Earlier. Yes. CHAIRMAN FADEN: Right. This is in the context of $50 million for a dose reconstruction study versus a Public Health Service program, or just the recognition that there's a limited pot, how much these things cost. DR. ROYAL: In terms of the limited pot, I suppose the other thing in terms of a limited pot -- and maybe other members of the Committee don't agree, but this whole issue of if you have a liberal criteria to compensate people, what it means is that every individual person gets less money versus having a stricter definition and having people that are truly -- or that it's more clear that the injury is related gets a bigger piece of the pot. CHAIRMAN FADEN: That's a very important point for the remedies discussion that we need to hold back a minute. We have to pull that out. I don't actually think that's in the remedies draft as it exists now, so we need to pull that out for tomorrow afternoon's discussion. DR. THOMAS: A question for Henry, again. I always want a little more elucidation. You gave two alternatives, a loose definition which gives a little bit to a lot of people. A strict definition that gives more only to those who were demonstrably harmed. Let's use that. Is there a third possibility? Are those the two that you had in mind and did I describe them correctly, or is there a third possibility which is a loose definition that would give a little bit to a lot of people and a more stringent criterion that would single out a few for more? DR. ROYAL: There is a third possibility, yes. DR. THOMAS: The theory of proportional recovery, which is what's in the draft that Ruth was alluding to. CHAIRMAN FADEN: We really will do this tomorrow. We really will. I promise we'll do it tomorrow afternoon. Whether we'll do it to everybody's satisfaction is somewhat more of a problem but we will talk about these issues tomorrow afternoon in the remedies discussion. Are there other comments that people would like to make? This is sort of a new -- I feel like a -- it's kind of a new time for us. Maybe we should do it once a meeting; free association or, you know, I've been worried about X kinds of issues. And don't feel compelled. It's okay if you don't want to say anything. But if anybody does, it's kind of like, you know, meeting. Duncan? DR. THOMAS: Two comments. One is to follow up on the discussion we had this morning about the public concerns and I want to bring up the suggestion, I think originally from Dan, although I don't remember that we ever discussed it in public meeting, that we might consider having a chapter perhaps early on in our report which simply is like an unvarnished account of the complaints that we're hearing from the public. That seemed to me at the time a compelling suggestion. But after the discussion this morning, I'm now coming to the view that it can't be an unvarnished account. It wouldn't hurt to have a lot of quotes from our public meeting in such a chapter, but then it needs to be followed up with some sort of commentary from the Committee as to what is our take on this. What do we believe; what do we think is implausible; what does the present scientific evidence tell us one way or another; and ultimately where we come down on this question that we talked about at some length this morning about psychosomatic harm. So that was one suggestion which I can pause to have discussion of or I can mention my other point. CHAIRMAN FADEN: You're waiting for people to react? DR. THOMAS: The other point is just a softball to Henry. I was really surprised that he didn't mention something that he and I had discussed by phone earlier, that the report, at least as I've seen it so far, really doesn't tell anything much about the -- sort of the success stories of medical radiation as such. And it isn't quite clear to me where that's going to fit in. For example, radiology, radio-therapy involving x-rays. Presently it would naturally fit into the TBI chapter, except the TBI chapter is structured in such a way as to focus on the dual purpose aspect of things and it would be almost out of place to introduce it there. Similar problems with some of the other things, the way the chapters are presently structured. CHAIRMAN FADEN: Yes. We know that. But do you have an answer? My response is that we know that, but -- MR. GUTTMAN: The immediate answer is we have, you know, like on your kitchen refrigerator door, a list of all the -- you know, where is this, where is this going. And that's obviously the most elemental one is what we tell the public about radiation in general, a most difficult one. Part of that clearly can go in the radioisotope chapter, but that's isotopes. The radio-therapy part of it, if you want to be -- it can go into the chapter that is contemplated right after the public testimony where we talk about the growth and something -- a work entitled from Roentgen to big government. We talk about, you know, radioactivity is discovered and it's got all these uses. I don't know how much time you want to spend on the particular detailed successes but, use in curing cancer. I mean, -- you know, in how much detail I don't know what you want to give, but you can put it right up front. DR. ROYAL: I don't know if it's occurred to you. It just occurred to me as you were saying it. This is the centennial year of the discovery of x-rays. MR. GUTTMAN: Not only has it occurred to us but Ron Neumann is booked to be in Berlin. He wants to -- while we're giving this report to the President or whoever, he wants to give the report in Berlin to the Roentgens. That was a facetious suggestion but yes, it has occurred to us. Yes. DR. ROYAL: Are we supposed to be discussing Duncan's other -- the unvarnished? CHAIRMAN FADEN: If you want. If you want, yes. Whatever anybody wants to do. This is unstructured time. It's like on talk radio. This is your hour. Call in with whatever you want. That's what this is. Call in with whatever you want. If there's nothing, no one wants to call, we'll go on to the next guest. DR. ROYAL: Well, since we're doing this, I think we should take the opportunity to commend the staff, even though that's not what we're supposed to be doing at this moment. They sit there at the end of the table and we criticize, criticize, criticize. But in fact -- and rarely praise. And I think they deserve praise for all the work and the hard work on these chapters. Having said that, and this is not a criticism but rather a plea, a plea for some coordination when we see the next draft. Many chapters have little bits and pieces in them about here's what ethics is, here's what research ethics is, here's the history of research ethics, here's when informed consent was born, here's when informed consent died, et cetera. And I mean, we have to think through the best way of introducing the ethics. I've always been -- I know we discussed this before. I've always found preferable to weave it in rather than set it off separately. So maybe people heard that and they're weaving it in, but it gets woven in and repeated in the same things. I mean, there needs to be some little coordination. And maybe this can better be handled with cross-references later on, but there's both repetition from chapter to chapter and also different styles and ways of doing it. I'm sure this is all going to get fixed. CHAIRMAN FADEN: Oh, yes, but it's not -- it's helpful to remind -- MR. GUTTMAN: That's the only problem? (Laughter.) DR. ROYAL: That's the one I'm mentioning in this pleasant forum. CHAIRMAN FADEN: If it's okay, we can go on and then we can have another open phones time tomorrow if people think they want one. In general, if anybody wants such time, let me know and I will call it this, as our euphemism, like for this kind of thing, and we'll do it. Okay? Committee Discussion: Human Experimentation in Connection with A-Bomb Tests CHAIRMAN FADEN: That said, we're going to go on to our -- this is our third chapter of the day, which is Human Experimentation in Connection with the A-Bomb Tests. Dan, is Patrick going to join you? MR. GUTTMAN: Yes. CHAIRMAN FADEN: You want to go down there or you want to stay up here? Whatever you want. This is Part II, Chapter 5, so bring out your big book. Chapter 5. Okay. We are open for discussion. MR. GUTTMAN: Can I -- I'd be happy to describe what I think are the difficulties of the chapter, what we need help on if that's of any value. CHAIRMAN FADEN: Let's see if anything comes out. We'll give people five minutes of awkward silence and if nobody has moved to speak, we'll let you take over. Duncan? DR. THOMAS: I touched on this morning what I see as the fundamental problem with this chapter, and that's one of scope. And the difficulty is there's a small number of Atomic Veterans who were involved in these various biomedical experiments that we're talking about. And then there's a large number of others who were doing the same thing, getting the same exposures, but were not part of what we can construe as a biomedical experiment. Certainly in a broad sense an experiment inasmuch as any bomb test was an experiment, but the bomb tests themselves weren't experiments as part of any sort of biomedical research. And that's addressed well in this cover memo. I want to give sort of Dan an opportunity to give his take on this question, but before I do, let me sort of try to give my perspectives. This issue really came to the fore, especially when we visited Los Alamos and had to address the draft response that we got from Dr. Kunkle, I guess it was, in response to the Committee's request for documents. And he was saying but all these things that you're asking for weren't experiments. We never did any experiments in connection with the bomb tests. None of this was experimentation. And I think I still continue to believe that the various categories that are outlined in this report here were indeed medical experiments, not all of them radiation experiments. The psychological studies, for example, at HUMRRO, were by no stretch of the imagination radiation experiments, although there was clearly experimentation involving human subjects in which people were incidentally exposed to radiation. The cloud fly-throughs are another notable example where experimentation was being done in order to try to learn something or other about the nature of the -- to learn something about how the bomb was working, what its decay products were and so forth, because that could tell you a lot about the yield of the bomb.And in the process, developed the most efficient way to get that information was to send humans into the cloud. And that raised then a concern about occupational safety. So we hung film badges on these people and for what could be broadly construed as just simply routine occupational monitoring exercise, no experimentation involved. Now there is a little footnote to that story which has to do with the swallowing of film badges which could be on the one hand argued as just another form, but untested, of occupational monitoring. But it's more probably actually construed as an experiment of some sort. Anyway, I think my fundamental difficulty with this chapter is that it doesn't really make clear the distinction between what is routine data gathering for occupational monitoring purposes and that which truly constitutes a biomedical experiment. And then secondly, that -- well, let me leave that thought for a moment. I'll develop it a little bit more back in my mind. MR. GUTTMAN: Can I respond? DR. THOMAS: Absolutely. MR. GUTTMAN: Actually, I'm surprised that I find myself in disagreement with Duncan. Obviously, because we have to write -- what we have been writing -- doing a good enough job. But I think it's clear to take the cloud fly-through case which Patrick did the work on, there we all acknowledge that mostly people were in the clouds to measure what was in the clouds, not to measure what was in people. And, of course, they wore badges as an occupational measure, but we were focusing on those few people who were there because they in essence wanted to use human beings as a measuring rod or yardstick to see what the measurement in the human beings would be, so that they would be feeling more comfortable sending people in subsequent trips. So that I think -- I guess -- MR. FITZGERALD: I want to qualify that a little bit. It's clear that the airplanes were in the clouds because they wanted to measure how much radiation was in the clouds. It's less clear that because they began especially with both sampling and penetration missions with drones, especially in the case of the penetration experiments, it's unclear that they chose to -- it's unclear why they chose to move to manned penetration, if it was not for the purpose of measuring the safety of humans flying through clouds. MR. GUTTMAN: What I'm saying is it's not that difficult for us to distinguish the occupational from the experiments. What is very interesting and ethically to me very questionable and problematic is that they set up things which technically were premeditated studying situations, and in retrospect, people, and in prospect, used the word experiment. But they didn't send them up in the biomedical chain with the exception of the flash blindness, which went through the biomedical chain, the cloud fly-through was an excellent example. Patrick points out that when they did it with mice, it was under the biomedical part of the test program. When they wanted to see the difference between the external and internal measurements of radiation with human beings, not the cloud sampling but to see the same thing that they saw with mice under the experiments, they didn't put it under a biomedical experiment. They treated it as occupational. I think what the chapter can do relatively easily is distinguish those. The questions you're asking, which is the one that's the most cosmically imponderable is is this all an irrelevancy since people were similarly situated as samplers getting the same risk and what's the difference if there was an experiment in one place and not in the other. DR. THOMAS: I guess I accept the distinction that if the purpose of the cloud fly-throughs was to collect data on the yield of the bomb, it could be done more efficiently by human manned flights than by drones, then that's not medical experimentation. But if the purpose was to establish whether or not fighters could successfully chase enemy airplanes into atomic clouds, that would be medical experimentation. And in the end, though, I still have this big trouble with the idea that the upshot of it is whether you call it experimentation or not, it's all the same thing in terms of its consequences for humans. And so I really wonder -- I haven't made up my own mind at this point how critical this distinction between biomedical versus not biomedical experimentation is for what we're going to write. MR. FITZGERALD: Well, I think when you go to the one extreme it's the penetration experiments, Red Wing Project 2.66, where it is explicitly referred to as an experiment, and as an experiment which involves humans for the first time, although they have done this with animals many times before. So, at that case I think it's quite clear that this is a biomedical experiment. And then from that kind of bedrock, you have less clear cases where there are biomedical components to projects which have other purposes and it's unclear to what extent or how analogous they are to weather biomedical experiments. MR. GUTTMAN: A way to think about it, maybe -- Ruth and I, we've discussed this internally and it may be completely fruitless, but I raise it. One of the questions you have about a bomb test like all of these multi-purpose -- well, Russell was not here. We used the word piggybacking -- is would the world have been any different if they didn't have the experiment. Were more or less people exposed to more or less risk. And so hypothetically you could say if they didn't have the experimental components of the cloud fly-throughs or the psychological testing, would all those people still have been going to Ground Zero or through the clouds in any event, and the bottom line, Henry's ultimate risk calculations, still have been the same. And that's where I don't know that we have the evidence. It really becomes very difficult. This is where Pat King says we'll never be able to figure this out. But what's really troubling that there is evidence that in fact the doctors -- this is the experiment of opportunity area -- in these conflicting roles where they were simultaneously saying let's teach people that this is relatively riskless and controllable and at the same time vouching for the safety levels. And that's where these boundaries and questions of things being experimental maybe just wasn't gratuitous. There was something that was materially useful in calling it. Nancy's nodding. That's just kind of ballpark of the kind of questions. CHAIRMAN FADEN: Duncan, did you want to say something? DR. THOMAS: Well, not in response to that. If people still want to pursue this question of sort of experimental definition we can, but I think I'd rather shift gears and talk about what is the real point of this chapter. And in my view, what these experiments -- what this chapter illustrates is primarily questions about the meaning of informed consent in a military situation and it really turns on two separate questions. The question of the informed part and the consent part. I think we all sort of recognize sort of the inherently course of military service, although we do pay lip service here and there about the obligation of inferior to reject the -- to refuse a morally unacceptable order. But by and large we heard testimony in San Francisco from one guy in particular that's haunted me every since to the effect that you don't really effectively have much choice to refuse an order to participate in these exercises. So that's the one side of it. The other side which continues to haunt us is this question about misinformation. And there are numerous examples in the documents that we've reviewed. Last time we talked a little bit about the HUMRRO experiments. I think it was last time. And the right answers to the questions on the psychological tests that were being administered and what our take today would be as to whether or not those right answers really were right. I'm also struck, for example, by one of the documents I reviewed, the experiences as Desert Rock Eight, which talked about an attempt to design a military exercise that would involve things like crawling through a contaminated field and crawling over barbed wire and various other things. And that they wanted this to be realistic so there in fact had to be some real contamination there, but they also didn't want to hurt anybody so they didn't want the contamination levels to be too high. And the document went on at some length talking about the inherent contradiction here between safety and realism. And it occurs to me that this must be just a universal problem in almost any military training operation. Phil has several times talked to us about an analogy with battleground training with live ammunition. That sort of thing. It's a shame we can't have Phil here to give us his perspective on this yet again. But those seem to me to be the major themes that I'd like to see this chapter address, rather than so much quibbling about the experimental nature. MR. GUTTMAN: It was about informed consent. The problem is that assumes we're in the experimental world. If we're not in the experimental world, then those aren't issues. And how do you -- DR. THOMAS: They may not be issues for us as our mandate to look at research, and yet they're still of very much real concern to the people involved. CHAIRMAN FADEN: I think one way to look at it, and I am also sorry that Phil isn't here. That was poor timing. He got called away this afternoon and we couldn't do -- I didn't think to shuffle things around. But when talking to Phil about this chapter, the first issue that you raised, Duncan, and I hope I'm getting Phil correctly. If not it's just me talking -- is the I think still unresolved question to some extent for the military, which is how to distinguish what you can order a soldier to do in the context of training and maneuvers and what constitutes the involvement of soldiers as subjects in research. So how you understand the difference between the two, which is clearly a big issue then. And as best as I can figure out, is not a resolved issue now, although that I would defer to Phil and others about whether that's correct. So that's one theme. And then when it's in the research side, does it make sense. Does it make sense to talk about getting consent from soldiers to be participants in research? There's clearly this tradition, this view in the military, that you do need the consent of soldiers for their involvement as experimental subjects. That seems to have been in there for a long time. So what does it mean? Is it something that is meaningful and what role does it fit and how much of a burden should we place on it in terms of protecting the interests and rights of soldiers and so on when the military wants to do what is understood to be research and the soldiers are to be the subjects. But you've got the first issue, which is how do you tell the difference then and I don't know the answer to now. But then it clearly seems confused at times what's one and what's the other. And then the next one at issue is okay, when you are in the research situation, there is this tradition that says you should get consent. You can't order a soldier to be a subject in research, so what does that mean, which is the next issue. So I don't think, Dan, it's like incompatible. They are like layers of problems, one within the next. I see Ruth and Nancy. Ruth? DR. MACKLIN: This is a poorly formed question but let me just start with a comment. We're never going to be able to find or discover a distinction between -- in the categories you're just talking, Ruth Faden was just talking about, between studies of occupational safety, let's call it that, or occupational hazards, and biomedical research. I mean, that's a stipulated difference. That's not something you discover. It's not as if if we look harder you'll be able to find it. It's one or the other, depending upon what someone wanted to call it because it's the same activity. You're looking, measuring and trying to find out what happens. You can call it one. You can call it the other, but it becomes important when we ask what rules ought to apply. So, I mean, I don't know if that's clearly stated, but I mean, in the sphere where there is no difference other than what someone stipulates that it is, I mean, we can look from now to infinity. We're never going to find some distinguishing mark between whether this was occupational safety studies or hazardous duty or whatever. Which then leads to my question, I mean, if that's correct. And I didn't read this carefully enough to see whether it's in here. Is there any evidence, given the fact as you of course do point out in the chapter that you had the Wilson memo and the Nuremberg Code and the rules that existed before then for volunteers, is there any evidence that there was a tendency to stipulate or define the activity as occupational safety or hazardous duty precisely because then you could legitimately circumvent what would otherwise be an obligation to get informed consent in accordance with biomedical research. MR. GUTTMAN: This is -- clearly what we're trying to say in the chapter is that it's extremely interesting that all these things which you could call experiments, the only one is the flash blindness that occurs in the biomedical chain, and that's the only one where they belatedly recognized, gee, this Nuremberg Code applies. Other ones they are clearly treating as occupational exposures. And your question is was that an artful effort. Another way of looking at it, what difference would it have made. And if they weren't paying attention to the Nuremberg Code in the first place, it wouldn't have made a difference if they had called it that. And that's why it's a very difficult question. It's the right question but the answer was yes, it was clearly a difference. It was occupational. It was artfully occupational. What difference it would have made, it's not clear. CHAIRMAN FADEN: Nancy? DR. OLEINICK: I'd like to suggest that perhaps the psychological testing conducted by HUMRRO, whether or not the military called it a biomedical experiment, was a biomedical experiment. If you read what we've seen that looked like protocols of sorts to us, I would have said without anybody telling me that that looked like an experiment. Now the exposure was not so much experimental but the psychological testing afterwards. And given that -- or at least I think it's an experiment unless somebody wants to tell me that it's not, where we come to ask the questions about selection of subjects and informed consent and so forth, what I recall reading in there is that there was little volunteering and that units were just selected to participate by their officers. That's at least -- which I didn't find discussed in here at all. DR. THOMAS: I don't think there's any question that the HUMRRO experiments were experiments, biomedical experiments even. The question is whether they are radiation experiments as defined by our charter. DR. OLEINICK: Oh. Well, yes. Okay. But they're still experiments. And we still have -- DR. THOMAS: We don't question that. MR. GUTTMAN: But Nancy, then the question -- Ruth, is this -- the question then to Nancy is well, let's say there was no informed consent and whatever stipulated meaning we have. Well, then, what do you say about the troops who went in and were equally exposed to risk but they, as Ruth said, didn't give the paper and pencil test to. CHAIRMAN FADEN: Arguably what you end up with, and this is why I think Duncan's initial comment and why the chapter begins the way it is, it's such a confusion. Arguably what you end up with is the military should have gotten informed consent from soldiers as to whether or not they wanted to complete the paper and pencil test. That's what you come out with here. Because they clearly thought that they were authorized and appropriate to order the people to be observers. It's a bizarre circumstance. That's one construction that you could lay on this. MR. GUTTMAN: Well, they didn't completely observe. I think what Ruth Macklin was suggesting is if we hypothesize that the rules were followed, would it have made a difference if they actually tried to use the Nuremberg Code and whatever the rules were on the HUMRRO tests. CHAIRMAN FADEN: So people would have said no, I don't want to volunteer. MR. GUTTMAN: That is the question. That all of a sudden maybe the world would have been different and they wouldn't have been able to expose the other 20,000. In other words, the question would have been if the system -- in other words, was it a complete epi phenomenon. CHAIRMAN FADEN: That's the counterfactual you can't engage, really. I mean, you can try it but it's a massive counterfactual. Right? You're stuck with this had the world been different. And then the problem is would the military still have wanted to do the troop maneuvers on the site of bomb tests. And then you get into the key issue, the harm that came from an Atomic Veteran, whether you were in a research -- technically a research subject or not. And that's -- MR. GUTTMAN: Well, there are elements, actually. But there are elements -- I don't want to take it too far but it's the case. There are suggestive elements of facts related to the counterfactual. The one that's the most suggestive is the officer volunteers they put very close to Ground Zero and actually did do something which you could call informed consent. They calibrated their measurements or whatever it be. It seems clear that one of the reasons they want to put him up there was to convince everybody else behind this is okay. So that is an instance where it doesn't seem as if the experimental cohort was gratuitous but it was necessary as part of a larger structure. And so then you begin to suggest -- wonder whether -- the question is were the experimental activities gratuitous or were they part of a larger structure. And the cloud fly-throughs, Patrick has found there was a claim we saved all these bucks by flying these people through clouds. We were able to show that it wasn't as risky as we thought. We saved more bucks. We didn't have to have decontamination procedures. So there's clearly, by having that as an experiment, there was an actual effect on the way the world worked. Then you can say something which we either reduced or increased risk depending on your perspective on it. MR. FITZGERALD: And they also seemed to play a similar role to the officer volunteers, to the effect that they had cloud samplers before then flying at later periods of time receiving less dosages and this -- one of the reports, the Office of Information Services says after the Red Wing and Teapot experiments that the morale of the Air Force was at an all time high, notably because they thought that -- okay, the risks of penetrating a mushroom cloud at such early times are not so extraordinary. MR. GUTTMAN: I guess what we're saying is it isn't -- in the legal, law school sense, it isn't obvious that the experimental subjects and the other folks exposed to the same risk were fungible. That there was something that was intended to be different in the way the system worked by having the experimental subjects out there. So you can't -- as strong as the temptation is to say they're all the same, it isn't clear that that wasn't the intent of the system. CHAIRMAN FADEN: Let's try some other observations or comments. Duncan? DR. THOMAS: Just to follow up from this last one, a simple informational point. I've always been curious about these officer volunteers who occupied close to Ground Zero positions and as part of their consent form, they were supposed to evaluate what their doses or their risks or something or other is. They did some sort of a calculation. I wouldn't know how to do that calculation myself. Maybe John Till would. But I can't think of too many people. But I'm perfectly capable of plugging numbers into a formula and getting a result out at the end and so I -- but I wouldn't critically be able to evaluate the validity of that formula that I was using or the data that was going into it. Do we know anything about the qualifications of these people? Were these sort of high level physicists who happened to be in uniform? DR. KATZ: We do know. They were very qualified and they knew what this was all about and had technical knowledge. And they were selected on that basis from the reports I've read. CHAIRMAN FADEN: Yes. MR. GUTTMAN: Well, the reports that we've gotten from the Defense Department, those people seem to be. Right. The other ones we don't know about, we don't know about. DR. KATZ: Dan, what is your thinking about the scientific merits of these psychological experiments that were conducted? MR. GUTTMAN: We actually interviewed -- it's a difficult one because it's easy -- because they were at the same time, they were doing at this several levels. The thing that we interviewed Dr. Crawford who was the supervisor, the first head of HUMRRO. He's a wonderful gentleman who came to the HUMRRO from Vanderbilt University where he was a dean. And he frankly says, hey, this was our first project. Everything happened quickly. I'm not sure how it used, sometimes the same point about it was so safe, how could you get realistic evaluations. So there was not an effort -- there is not an effort today to say these were very useful. What struck me as most remarkable, reading the HUMRRO reports -- I put it in the chapters. If you read the reports, you find that what they consider to be an effective indoctrination is getting people from 25 percent to 50 percent correct, which is pretty scary. And secondly, they conclude when you read through the lines, that the actual detonation experience doesn't improve but may decrease understanding. So that what seems to be the conclusion is you shouldn't put these people near the -- and if you literally read the reports -- so it's easy to be very critical. The question I have which goes to the doctor question, which is what were the doctors, the M.D.'s and the psychiatrists doing egging on this psychological testing after the first two Desert Rock-I and IV, if the results come in, there's not a great utility, and this joint panel on medical aspects of warfare says, well, quote, psychologists really aren't that useful but the benefits are so great. DR. KATZ: Dan, -- MR. GUTTMAN: That's disturbing. DR. KATZ: -- am I right in assuming that these psychological experiments were done under conditions where the harm was relatively minimum? Am I right about that? MR. GUTTMAN: Where the assumed, as Dr. Royal and Gladstein, et al., would say -- the immediate acute effects, or as Los Alamos said, there was no suspected immediate acute effects. The long-term effects are ones that statistically may be very small but we don't know. DR. KATZ: So they wanted to study panic? MR. GUTTMAN: Correct. DR. KATZ: And they did it under informed consent conditions; right? MR. GUTTMAN: No. Not informed consent; no. DR. KATZ: Not informed consent. MR. GUTTMAN: It was called indoctrination. DR. KATZ: Indoctrination. Okay. Telling them that their harm is minimal? MR. GUTTMAN: More or less. CHAIRMAN FADEN: Perfectly safe. DR. KATZ: Oh, perfectly safe. Taking all that for granted, whether right or wrong, how can they study panic under these circumstances? MR. GUTTMAN: Well, that was one of the questions. CHAIRMAN FADEN: Yes. There was a way which they proved too much. DR. KATZ: So to that extent if one wants to invoke the Nuremberg Code because it raises questions to what extent does it violate the principle they should only conduct experiments on human beings that will bring about some results fruitful to science. MR. GUTTMAN: That's what they're observing. It's an inherent contradiction, Duncan is pointing out. They continually fly and it's really not risky enough to get some good results. DR. OLEINICK: I think it's clear that the end result was supposed to be to find a better way to indoctrinate the troops so that they could send them into nuclear battle without having them undergo a panic situation or, on the other hand, a situation of great bravado where they took unnecessary risks. And that's what they were looking for. And then when they found out that they weren't quite getting the information that they expected to get, they continued and did it anyway, which seems to be another theme here. CHAIRMAN FADEN: I think it's important to emphasize, though, just so we get clear on the risk language, that they were only concerned -- the concern was acute effects. They worry was acute harm, acute effects, acute reactions. And when that didn't happen, then people weren't -- they didn't have a context for panicking because their fellow soldiers weren't falling down to the left or to the right of them and they were able to keep on doing what they were doing. It proved to be kind of a funny circumstance. But arguably -- I've thought about this a lot. I mean, once upon a time this sort of was my training. I have a feeling that some of the people who trained some of the people that did the HUMRRO may eventually have a connection in my life in some fashion. I don't know, but it's remotely possible. I thought about this because the person who ran this was at Yale and then the person who trained me was like four generations at Yale. So you start to obsess about things like this, given the nature of this Committee. The only thing I could think of was that they thought that as much as they told people it was absolutely safe, that when they saw the blast, that would be so disorienting that all of their assurances that it was absolutely safe would go out the window. So if there was a reasonable rationale for this sort of experiment in the first place, it is we're going to try to indoctrinate them by telling them how safe it is, and then they're going to be treated. They're going to see the blast go off and we'll see whether it holds, even in the face of seeing the blast go off. And if the blast goes off, if that causes -- seeing it go off causes the panic or not, given that we've given them all those reassurances, that's the only way I can construct it so that it's even remotely meaningful, is that they had some sort of suppressed hypothesis like that. Well, we'll assure them beyond belief and then we'll still see whether the reality of watching it freaks people out. Something like that. DR. THOMAS: We're reading a lot into trying to figure what might have been in their minds. CHAIRMAN FADEN: If they wanted to construct the best defense, they could have done something like that. They didn't. But I mean, that's the only thing I can think of. DR. MACKLIN: Doesn't that come through in the quotation that's here from Crawford where he's asked about the term indoctrination? This is on page 14. First, he, Crawford, reflects on the informed consent, and he uses the word. He's asked about informed consent and he replies by using the term indoctrination. And that's the word that was in all of these texts before. And then Crawford didn't know of the Secretary of Defense policy, but he says, because of the number of intensity of briefing, no soldier to our knowledge went into the test with no idea of what to expect. They were adequately informed. So he's using the language of informed consent. But then the next sentence is key, okay? What of the term indoctrination which today has a negative connotation? And his response seems to me -- I mean, this is of course not in the documents at the time. This is his interview. Exactly what Ruth said. Indoctrination had more to do with attitude, feeling and motivation. Education had more to do with factual or humanistic, the college curriculum. Well, forget the college curriculum. Informed consent, you're supposed to be presenting the information in a relatively unbiased way and not -- or as unbiased as you can, and not leading people to accept or expect certain kinds of outcomes. MR. GUTTMAN: We take issue with that because this is very interesting. I thought that was a wonderfully interesting answer on his part because today we would think indoctrination means like wrong facts, overstatement. And his reaction, answer, was quite wonderful. He actually said -- he referred Patrick and I to the unabridged dictionary for the term propaganda, which he pointed out was once the official doctrine of the Catholic Church, at least as the dictionary said. But the point is that he didn't need to say the facts were incorrect. He was using -- when you had today in the handout we have on the subject interview or one of the protocols, this Committee in its review is apparently distinguishing among three types of adequate consent. One is where the doctors just state it's 2 microcuries and the normal is 6 microcuries. One is which they say it's 2 microcuries and that's like brushing your teeth in the morning. And the preferable ones are the ones where they put it in the context where there's some affective understanding. And I think it was very interesting. And his response was he wasn't going to the factual component, the technical component, but the way in which citizens can be made to understand and appreciate and internalize. And in some respects it's more like what you're talking about. DR. MACKLIN: That's exactly what I meant. I don't think indoctrinate does not have to imply, does not nor need it imply incorrect information, but it means getting people to accept motivationally or affectively what they might otherwise just read. In other words, it's instilling something in them. Internalizing is one way to put it. CHAIRMAN FADEN: For what it's worth, in the field what happened, in the literature, the word indoctrination, it was replaced with social influence. At one point in the early '50s the psychological literature talked about indoctrination studies. Then they went to attitude change and social influence studies because the word indoctrination was too much connected in the public mind with propaganda. But if you look at the sort of intellectual history of that work, it started out being called indoctrination, then it became attitude change and social influence. The same research. Trying to get people to believe something was true. MR. GUTTMAN: Ruth, so what's the point? DR. MACKLIN: My point is to back up what Ruth Faden just said about what they were trying to do. Everyone says, well, we don't see that stuff in the documents. My point in focusing on the word indoctrination and Crawford's contemporary reconstruction of it is, it seems to me, supports what Ruth Faden said. Not only are they informing them. The fact of informing them doesn't count. They're actually trying to indoctrinate them into the view that you're not going to be harmed here. I mean, whatever techniques indoctrination incorporates in addition to giving information, you're trying to convince someone and get them fully to accept it effectively. So if they use that stronger method, not just informed consent but something that they thought was indoctrination rather than merely informing, I think that supports Ruth's hypothesis of what this was all about. Indoctrinate them and then send them in and have them look at the blast and see if they're frightened. I mean, it's a stronger thing than informing them and it presumably can test something psychologically. Right? If you indoctrinate people and then find that despite the indoctrination they get terribly frightened or they panicked, then the indoctrination didn't work and the thing that you're showing them is genuinely fearful. DR. LEDERER: You might alter your indoctrination techniques and test and retest the population for response. DR. MACKLIN: But you're certainly testing something legitimate if you're doing more than -- if you're doing more than -- I mean, if you're distinguishing between merely informing and indoctrinating -- MR. GUTTMAN: Well, you're not suggesting that the indoctrination was equivalent. CHAIRMAN FADEN: It has nothing to do with informed consent. It seems like it was pretty straightforward. The military had an interest in making sure that the troops would be comfortable in a nuclear battlefield, so they had to persuade the troops that it was safe to go out and be there. So they had an educational persuasion program they called indoctrination that they thought would work or they hoped would work. And then they wanted to test it, challenge it. Would it hold up in the face of being exposed on a mock nuclear battlefield, except it was a real test. But it wasn't combat. But nevertheless, when they see it go off, does the indoctrination hold or not or is this now the kind of experience that causes people to get scared again and will it hold up. And then, can we communicate it. If it holds up, then hopefully, this is where they failed. Hopefully the troops that were there will then go back and tell the other troops, boy, they were right. It really was nothing. See. Don't worry about it, guys. It's fine. And that part, apparently, didn't work. In part, because as you point out, they were also told not to talk to anybody. So, the whole thing was -- whatever. But I don't know if we should be spending so much time on the HUMRRO stuff. It's a little piece of it. It's important and it's very fascinating but there's so much going on in this chapter that I'm wondering whether we shouldn't move on to some of the other -- returning to some of the larger themes that you have in your document to follow Ruth's suggestion for the other thing. If you want us to go to that or if other members of the Committee want to bring up other issues. MR. GUTTMAN: Some big questions that have already been identified is what's the difference between experimental. Are we looking at the tail of the dog instead of the dog and does it make a difference. You know, are they all similarly situated and should they all be similarly evaluated. And that's one question. Another is the ethics of -- I think the long-term risk issue, however, small. If you were going to do this again today, would you have done it differently with acute concern for the longer-term as well as the short-term. That's one of the things that really we're struggling with. In other words, was there such a discount to zero of the long-term risk that they didn't do the kind of follow up and monitoring that may have resulted in less distressed -- and we had the discussion last night whether or not if you were to do it again today you would have done anything differently by way of monitoring and badging and following up and all that kind of stuff. CHAIRMAN FADEN: Duncan, did you want to get in on this? DR. THOMAS: Well, I have great difficulty in reaching judgments of moral culpability for their focus on the acute effects, given a general lack of knowledge about chronic effects at the time. Now, I need to temper that comment with the fact that we weren't completely without knowledge of long-term effects, but it would take some rather careful analysis to figure out what they ought to have known then about long-term effects. And I think it's pretty safe to say that in any event, based on -- although they would have been cognizant of the existence of long-term effects, today's risk estimates would place them considerably higher than the best available knowledge that they could have had then. That raises a -- there's a lot of discussion in this chapter -- unfortunately it's scattered across half a dozen different sections -- about the evolving radiation standards and the conditions under which various exemptions to the standards were authorized or by whom and all that sort of thing. That's really, I think, an important part of this chapter, which I don't mean to belittle. What I see missing, however, is any take on what our current view is. Not for the purpose of retrospective moral judgment, but simply to perhaps animate any discussion we might have about compensation policy about what is the long-term health effects of participation in either the experimental portion of it or just the Atomic Vets in general. It's hard for me to see how we can weasel out of this one, contentious though it is. But I think we need to say something or other about what is the purported dose distribution and the risks that would be expected based on conventional risk estimates, and probably also some commentary on what has been observed, despite their limitations, in the various epidemiologic studies that have been done. MR. GUTTMAN: The reason we had to weasel out of it, which I was suggesting, but my question as to whether it was possible to weasel out of it, by saying that today this is very controverted and mysterious and murky and the risks may be low but there's a lot of dispute. The question is should there have been at the time more done by the doctors and the radiation safety people to assure that whatever was done was done in a way where the data would be kept. And therefore, this dispute today would be something of a less consequential dispute. DR. THOMAS: I would agree with that completely. Clearly their recordkeeping was terrible. Their dosimetry program could have been done much better and we wouldn't be having these fights now about the adequacy of the epidemiologic data had there been better recordkeeping and better dosimetry at the time. In that regard, I think we can fault them because they certainly knew enough about long-term effects to know that they should have kept better records. CHAIRMAN FADEN: Ruth, did you want to -- no. I thought I saw -- Lois? MS. NORRIS: I do have a question, really. Do you have any sense that these records, exposure records, were intentionally not kept at all? Duncan is saying that they should have kept better exposure records. They should have known better because they had reason to believe that there would be long-term effects or could be long-term effects. And I just didn't now whether you feel that this is a conscious way of avoiding the long-term liability. We see evidence, I think, that there was this special VA recordkeeping operation going on and we can't find out what if anything was kept and what happened to it. But -- MR. GUTTMAN: Let me just give you the big picture. And Duncan knows much more about it than I do. First of all, lots and lots of dose badges were kept. Captain George, who probably is sitting out there, has Navy dose badges going back to 1947 for submariners and others. So lots -- part of what Duncan is saying is that even though they were kept, they were often kept sporadically or haphazardly. In some of the chapters at Desert Rock Four, the Surgeon General said we don't have enough people to do this. Let's give one badge per bus or platoon. So that is public and that's clearly known. And there's all kinds of reasons to question the efficiency with which a program that was put in effect was put in effect. The other question, the secret recordkeeping, what we know is we have documents which we've all looked at where there was a clear statement. Several documents saying in '47, because of Crossroads, let's keep records in anticipation of liability claims. The VA and others have looked into it and where those records are, what they are, we don't know. We know what we have in the documents. Also, there were plenty of other dose records and that is what the controversy today in part is about, is whether those badges, meters, were fairly representative of the groups that they were attached to and so forth and so on. So there are two levels. One is the adequacy of the large assemblage of data that we have, and the other is whether there was anything else. And your other question is the real intriguing one on whether there was some subliminal notion let's not look too closely, which you can see through these documents quite obviously. CHAIRMAN FADEN: I want to suggest that I mean at least for me I see a lot of parallels between this chapter, the intentional releases chapter and also the experiments of opportunity chapter, but especially the intentional releases chapter when we had the discussion earlier today about the two related issues. One, the issue of -- I think the term was used mismanagement, but that's perhaps not a powerful enough term that links up directly with questions of secrecy and obfuscation and wanting to avoid bad publicity and lawsuits. The whole -- that a lot of the harm that seems to have been done is harm that came from the way in which all the stuff was dealt with afterwards, quite apart from whether it was justified or not justified to have soldiers present in these various contexts in which they were exposed to radiation, which is the prior question. That is was done left open how it should have been handled afterwards and this gets into all the questions of the way the records were kept; whether follow-up studies were done; whether people were straight with the soldiers and their families afterwards and all of the sorts of issues that you see again that we talked about this morning with respect to Hanford. And it seems to me that if we have a theme that draws across these two, this is it. And it gets into the secrecy issues. I don't know exactly how we develop them, but it's the same kind of question and it relates also the argument that was made earlier about keeping faith with the testimonies and what we've heard from people that there was a dimension of anguish that was generated by these tests that was related to the way in which this was handled after the fact, quite apart from the issue of putting people in this context in the first place. So that if we have one theme which is how to tell the difference, the problems and the difficulties in telling the difference between when it's justified to call something an experiment and when it's justified to say it's okay in training and how you stipulate between the two and what the rules should be, that's one issue. Then, for when it's an experiment, there's the issue of -- okay, if it's an experiment, does it make sense to talk about consent duties meaningfully for people in the military and how does that play itself out. There has been a long tradition of it. What does it mean. And then, regardless of what the context was, there's the issue of what happened afterwards in terms of the issues that Lois has raised and what we have also identified with respect to the Green Run and the other intentional releases. And I don't know if these are ways to structure the chapter but that's how it comes through for me. Ruth? DR. MACKLIN: Again, maybe I missed it for not having read it carefully enough, but one ethical consideration that I didn't see addressed here -- and I made the same comment to Mark Goodman about the intentional release chapter -- is the question of acknowledgement of uncertainty about risks. That is, the questions that you pose and the way that the discussion goes is balancing known or believed risks against benefits, whatever those benefits might be. But the acknowledgement of uncertainty or of lack of sufficient information to be so confident that these were the risks is an ethical consideration. And so, for example, it goes both to the informed consent question but it also goes to what kind of risks researchers or military leaders or anyone -- you want to ask me a question? MR. GUTTMAN: I want to go beyond that. I'm really glad you're -- it more -- as you would say, in any situation of experimentation by definition there's uncertainty. You wouldn't be doing -- I think you'd -- am I right? You'd say -- DR. MACKLIN: I might say that. MR. GUTTMAN: But what I thought we'd try to -- but the thing that really is to me the most striking about this, and this is to me almost throughout the whole of what we're looking at, is you're in a situation where the doctors are simultaneously saying we don't know about radiation, Sure we know. We know more about it than we know about it than tuberculosis. We know more about -- you know. We don't know. A Shields Warren says in 1949 we have outlined the map of radiation like they've outlined the map of the poles in 1850. So internally, they're saying that. Externally they're saying we don't understand why the public doesn't get it. We know as much about this as we know about tuberculosis. And so, the thing that I think really has to be brought out in this chapter, it's not simply the normal -- the question is almost again, is radiation somehow different in that there is this political need to convey some sense of confidence that is above and beyond the normal situation or governmental need. DR. MACKLIN: But Dan, see, I think you have evidence in some of these texts. I mean, as you're saying, internally/externally. Maybe that's the dichotomy. But, for example, the quote from the December 1952 after DOD called for a study to be made to determine the minimum distance from Ground Zero, their report, 1952 report says there is no known tolerance for nuclear radiation. That is, there is no definite proof that even small doses of nuclear radiation may not in some way be harmful. On the other hand, there's no evidence that -- et cetera, et cetera. So this is one the one hand and the other. This seems to me an acknowledgement at least of uncertainty if not a certain amount of ignorance. Beyond that, they establish levels and then they go on and then say the things that you pointed to. So, part of the -- maybe it's being honest and forthcoming. Maybe it's simply acknowledging or an acknowledgement of uncertainty in a more forthright way. I think that somehow should be emphasized. MR. GUTTMAN: I think it's not -- what you quoted, of course, makes that point. But I was thinking more of where we quote the debates under NEPA. The psychologists get together with the nuclear airplane people and they discuss the greatest problem with radiation is the perception of risk. And this is a political problem because we're going to have more casualties from fear than we're going to have from radiation. And when you have doctors who are in the service of that idea, doesn't that -- then that's on top of the technical, you know, objective reality that you're describing. To me, that's the real ethical -- that's what makes this a distinct -- am I making -- that what makes it a real situation that's distinguished from others. It's not simply the normal there's unknown, we're taking risks. We have an obligation to take these risks. That's what the chapter really is. Should a doctor be in that situation or should the same doctor. You separate out people. You can have one doctor who's pressing the indoctrination and another one who's pressing the -- DR. MACKLIN: When you say, well, that's what the chapter is really about, I mean, this is something -- we're all so immersed in this that sometimes what is not said explicitly -- when people are saying what's the point of this chapter and what's this chapter all about, we can read into it. And then we have these discussions and it becomes crystal clear what the chapter is about. But maybe for the readers -- MR. GUTTMAN: No, no. I don't mean to defend the chapter. I'm saying that it's a very difficult thing because there's limited evidence and it's not clear how far to push it. That's one of the things I'd like to -- is that a sensible purpose of the chapter to look at, among other things, the question of whether the doctor is too close, so that they had a governmental incentive to go and take risks or suppress studies of long-term risk that otherwise might not have -- you know. If there were simply objective researchers out there studying something. DR. MACKLIN: No researcher is simply objective. Everyone is invested. MR. GUTTMAN: Okay. DR. MACKLIN: I mean, it's different if you have a quote/unquote double agent problem. That is, if someone both works for an organization that is trying to achieve a certain objective or goal and at the same time is trying to be an objective researcher. MR. GUTTMAN: The one quotation -- this goes back to the same point. Lois asked was there an intent not to collect. But the most telling quotation, Dr. Sells from the Air Force says in this NEPA debate, well, this may be an ethical question that's too deep for me to get involved in. But all the public is seeing us trying to get dollars for grants. And that raises anxiety, suggesting that we don't know things. And maybe we can be -- there's something such as being too scientifically scrupulous, which is his words. And so what comes to mind is the notion of these people thinking you have to balance your public expression of uncertainty in a way that you wouldn't normally do. I didn't mean to stop conversation. CHAIRMAN FADEN: Lois? MS. NORRIS: I think this question of too few people serving too many masters is very a important issue and I think it runs all across the whole report, really, the whole problem. And this is the doctors that who were serving on government committees and who have served in the military role in the Manhattan Engineering District who go back to their institutions and they're all driving research from an institutional and they're performing as researchers individually and they're sitting on government committees that are driving research, some of them civilian, some of them overlapping, joint committees and things like this. And I think it's a big problem. And at the same time they're answering the Hippocrates master and their own self-interest. And I find it hard to believe that these people don't have pretty significant self-interest and egos because they were at the center of the universe and it was a very small universe in the early days. And I think it's a genuine question. MR. GUTTMAN: How do you address it. That's the question. MS. NORRIS: I don't know. VOICE: You describe it. MS. NORRIS: You describe it. CHAIRMAN FADEN: Eli, you look like you want to say something, but I can't tell. DR. GLATSTEIN: I think that what Lois says is right on the money and I think that it's -- I'm willing to believe that at the time that these exposures took place that the military didn't really view them as experiments, but they should and they need to. They realized that it is more than just an assessment of unit function and that the deliberate exposure of these people -- of their own has a long-term consequence with it. And while their interest was short-term, you can't deny the long-term role, the long-term interests. You can neglect it, which is what they've done, but you can't deny it, and they can't deny it. This is all important, I think, in trying to come up with remedies and remedies that I think hopefully will make it difficult to repeat this same thing, even when someone invokes national security. DR. KATZ: Also, medical progress, invoking medical progress. DR. GLATSTEIN: Yes. If there's an exposure, that's a long-term consequence that results from it that people have to be aware of and take responsibility for. When you get to patient care and medical treatment, this is one of the issues that goes along with treatment of a malignant disease, the long-term follow up in terms of the consequences of the treatment itself, something which the HMO's are trying to deny these days. They would have it taken care of by primary care physicians who do not know the subject. And along that line, you know, when you get to this field of oncology and the treatment of neoplasms. Now, that field became a specialty precisely because primary care physicians did not wish to do it. Did not know anything about it and did not do it well. That's why it is a field unto itself and that's why the patients who do survive -- and there are some -- need to be followed in terms of second tumors that may or may not be related to the treatment itself. And that's especially important among the kiddies but it's important among those that are not kiddies. CHAIRMAN FADEN: Patrick? MR. FITZGERALD: Yes. I wanted to bring up one of the issues which I'd like to hear you talk about because I don't want to write it by myself. One of the issues is the interplay between monetary gain by government or the military or the taxpayers and national security. Whereas, in the gains for the penetration experiments were characterized beforehand in terms of national security and afterwards in terms of monetary gain, or the money that was saved by changes of decontamination practices and the like. And so what I wanted to get is some feedback on what you think about that aspect of the story, whether that is a problem, whether that isn't a problem, or what spin should be put on it. Spin's not the word. Sorry. DR. GLATSTEIN: Well, I would respond it certainly is a problem, and I think that it's one that the military has a right to look at and to investigate. If a plane crashes in Thule, it's the military's responsibility to deal with that crash and they have to respond. They have to respond in an appropriate way for the good of the surrounding environment, for the good of the people who live in that area and for the military itself or themselves. At the same time, the need to address that issue is part of the military profession and that is different than -- at least in my opinion, that is different than actually having to tell routine troops that they have to go and watch the atomic explosion and march in on Ground Zero right afterward. Those are two different things. The need to be able to deal with the problem of contamination and the need to investigate it is a real one. MR. FITZGERALD: The issue that I wanted or was hoping to get some feedback on is whether the value of national security in itself should be -- put that as somehow unique. Is it okay, for example, to change exposure over exposure limits for the purpose of national security? Is that somehow -- is that possibility to justify it in that way? But not, for example, in terms of -- DR. GLATSTEIN: We have limits. We have arbitrary exposure limits for the man on the street. We have a different set of limits for the guy who works in the nuclear industry. They're not the same. We have still another group of arbitrary numbers that we use when we deal with patients and they are logs apart. I mean, it's the matter of risk and benefit again. CHAIRMAN FADEN: Yes. I think it is related. And the question is, if the view is that these standards are not set in stone, I mean, they're like we said about the -- they're stipulated for a series of policy purposes and they reflect some sort of judgment about how much risk it's acceptable to take for what purpose. So the question is is it acceptable to take a more elevated risk for the purpose of figuring out how far you have to go to protect against contamination. DR. GLATSTEIN: Surely it has to be. But at the same time, the guy who decides he's going to be a member of that contamination team or decontamination team, he must have some idea of the exposure risks himself or at least that there is a finite risk that he's accepting above and beyond to make him want to do that kind of work. He needs to have enough information to make him willing to do it as the miner needs to know what his risks are, too, if he's going to go down in the mines. MR. FITZGERALD: It's a slightly different story. The story is that the military perceived that their decontamination procedures were too expensive. That they were being overcautious. So in order to test this hypothesis, they exposed particular individuals to greater risks and changed the exposure, in effect upped the safety limit to 25 to 50R instead of 3.9. Now, the question is is it -- does it make a difference that the value which they were trying to obtain by exposing them -- allowing individuals to be exposed to greater risk monetary rather than the issue of national security. DR. GLATSTEIN: I'm sorry. I can't hear you. MR. GUTTMAN: What Patrick did in his section, which is really quite elegant, it's really in the document. It turns out there was a contemporary -- it's clear that the most successful experiments were the ones where the discoveries you can save money by reducing the filters on the plane or the decontamination procedures. Now, in the abstract, that doesn't sound wrong. It turns out, it looks like Los Alamos, the AEC test manager said this is not good health and safety practice because I guess they're talking about the contemporary -- should be as low as reasonably practicable. It's not a money tradeoff. So, here we have a situation where we could say, gee, interesting. The experiment shows how to save money. Terrific. Or you could say isn't it a coincidence that the most useful experiment for national security purposes is not about the Russians. It's about how to save dollars. And Los Alamos is saying that is very problematic because that's not what we should be about, decreasing safety measures. And so that's a particular fact pattern that I guess we're troubled with and it's hard not to address it, because at the time there's a contemporaneous dispute between Los Alamos and DOD about is this what you should be doing with this data. DR. GLATSTEIN: But we've seen disputes between the military and its civilian advisors on a whole host of circumstances related to the radiation issue and in most of the instances the predictions, even though they were not based on a great database, the predictions of the medical advisors are really spot on the money most of the time. There's very little new information that was learned, which is why when Shields Warren ultimately says I don't see a need for human experimentation on these issues, you have to question why they decided to go against it. I mean, that's a repetitive theme. And I can only conclude that the reason is that because of national security concerns they wanted more information, even though it served, as far as I can tell, relatively limited purposes. CHAIRMAN FADEN: Ken and Ruth. MR. FEINBERG: But then, Eli, you say -- and I think correctly -- that the issue then becomes, assuming that there are certain justifications or benefits that go with a national security concern that's different from a man in the street average Joe, then the issue really does become, as I think we've been talking about earlier today in these other contexts, the process that you go through to provide the subjects with some information that will allow them to be aware of what it is that -- the risks that they run. It's sort of analogous somewhat to the litigation that we've been reading about for the last decade in Agent Orange or in asbestos, where in Agent Orange the issue is not so much that Vietnam Veterans were exposed to dioxin as a defoliant in Vietnam where there was certain benefits that were afforded them in this defoliant destroying vegetation where the enemy might hide. The issue was the culpability of the government in not disclosing up front to the service men what it was they were going through or disclosing to workers in World War II who were installing asbestos. DR. GLATSTEIN: The Marlboro man has the right to read the back of the pack. MR. FEINBERG: That's right. And it seems to me that -- I mentioned this this morning. Your intentional releases, experiments of opportunity, atom bomb testing -- where it really is going to come down with the report, I think, is not our second-guessing the military or the Defense establishment or the President or Wilson or whoever. The real issue comes down in these areas to what procedures were in place or what process there was ethically to make sure that subjects were aware or were put on notice or there was some accountability that if implemented would permit a recognition that this activity was justifiable, I think. At least that's where I'm coming from. DR. GLATSTEIN: Well, in the remedy section, I'm trying to figure out how we can come up with that notice on the back of the pack. MR. FEINBERG: That's right. I think the notice on the back of the pack for prospective research is the heart of the report, guiding people in the future so this won't happen again. DR. GLATSTEIN: Without knowledge. MR. FEINBERG: That's right. The process. The process. Not only the substantive standards, the ethical standards in 1995 but how those standards get implemented to make sure that people are held accountable. That is the great issue, it seems to me, that has to be, as Duncan says, synthesized out of telling the whole story, it seems to me. CHAIRMAN FADEN: Ruth? DR. MACKLIN: Patrick asked us a question. I want to try to go back to it. I don't think, unless I misunderstood your question -- I don't think these things are in answer to your question. Let's go back and let me see if I understand it. Given two different circumstances or situations in which a higher risk might be -- people might be put at a higher risk, namely, national security, an activity or a maneuver in the interest of national security -- that's A, and B, an activity that will save money, can one or the other better justify -- can either, and if so, can one or the other better justify placing people at higher risk. Is that your question? Something like that? MR. FITZGERALD: Exactly. DR. MACKLIN: Okay. Well, you have to I think in answering it start with some givens. It's relatively easy to make the -- I presume. I don't know about these things, but it's relatively easy to make the monetary calculation. Doing things this way costs this much money. If we eliminate this scrubbing or change this fixture or whatever, it's going to cost us less money. So, there's a better objective way of making the judgment of whether something does or does not cost money. I'm not sure you can make the same kind of objective calculations with situation A or B with regard to national security. It sounds like a much more complex, if not more subjective thing. So we would have to begin with something like a premise; that is, a hypothetical premise. If indeed it could be known or could be accurately or reasonably or plausibly maintained that the national security interest was what people said it was -- I mean, starting with that hypothetical, that's where you have to begin I think in questioning or comparing the saving money, placing people at a higher risk to save money versus the national security. Now, I want to make this argument tentatively to be sure, but I would argue that if indeed those premises, those conditions were fulfilled with regard to the national security, we knew this was indeed in the interest of national security. It wasn't just what someone said it was, that it serves as a better justification for placing people at higher risk since after all, the whole business of national security is about fighting wars. And as Lois earlier pointed out, sending people possibly to their death in battle. So, whether someone is ordered to go into the front lines where there's a shooting war or whether someone is ordered to do something that poses him at greater risk of radiation, it all seems to fit a picture of national security. Whereas, placing people at higher risk of radiation sickness or cancer later in order to save money -- I mean, given the same levels of lack of consent or lack of knowledge in order to save money, seems to be putting a monetary value on individual lives. Certain people are dispensable. Their sicknesses are dispensable in the interest of our saving a little money. And to me, that's outrageously unethical. So, if you're asking for a comparison with these conditions and premises in place it seems to be much harder to justify placing people at higher risk in the ways we're using now, the backdrop of the military and sending people in and lack of consent, in order to save the Department of Defense some money on materials or equipment or whatever than it would to send them in to do something in the interest of national security, which is the business at hand. CHAIRMAN FADEN: Jay, Duncan, Nancy and Henry. If somebody has been trying to get my attention and I missed them, -- if not, we're going to go with those four and then we must end this discussion, take a break, and move on to children. So, Jay? I'm sorry. Henry, are you ready? DR. ROYAL: I was going to directly talk about the cost effectiveness issue. The problem with safety and cost is that as you try to remove higher and higher percentage of the risk, it becomes exponentially more costly. You don't get the same amount of safety removing the last 10 percent of risk and so it costs you much more to remove the last 10 percent of the risk than it did the first 10 percent. So, drawing that line and deciding what's an appropriate amount of risk to remove and what's the appropriate amount of money to spend on it is a very complicated issue. I don't think it can be just dismissed as trading lives for money. DR. MACKLIN: I guess I would have to probably agree with that. In a very long discussion, I might come to that point at the end. But I was only addressing -- without going on that finer grid of how much and where you draw lines, I was simply trying to ask -- Patrick asked -- a comparative question about ethical acceptability of placing people at risk for purpose A versus purpose B. What you're saying is once you've decided that, then you still have all these other things. CHAIRMAN FADEN: What I think would follow is that Ruth's analysis still doesn't necessarily result in concluding that every time you don't implement a safety measure because it costs a lot of money is unethical. DR. MACKLIN: Right. CHAIRMAN FADEN: Right. So it still doesn't follow that simply because it would have been a better justification to do it for national security that it was necessarily unjustified to do it for this other purpose, but the presumption is tougher. MR. FITZGERALD: But it's a slightly different question. We want to discover whether we can place people at greater risk or not spend so much money on decontamination. So we're going to put particular individuals at even larger risk. So, I mean, it's slightly -- CHAIRMAN FADEN: But it's -- okay. We need to go on. You're right. The contras are difficult but we really do need to go on. I've got -- I lost my list. Oh, no. Duncan -- no, Jay. I'm sorry. Jay had it. DR. KATZ: Well, I very much agree with Henry on the cost effectiveness issue but I hope this is relevant, just briefly. And it doesn't go to national security but it goes to the other issue, namely, medical progress. Briefly, a true story. A few years ago the chief investigator of a multi-center research project called me and said he had an ethical issue to discuss with me. And the ethical issue was this. They were doing a very important study which was actually subsequently done under somewhat deceptive -- or maybe not so somewhat deceptive circumstances but the implications for medical progress in this instance were considerable. And they had -- it was a comparative study of two different treatments, which was to be randomized. And they told the patients about the randomization and that they would be chosen by lot. And too many patients refused participation in the research project. So, they had come up with the idea that they would still do the randomization by choosing people by lot but would tell them that they would be assigned to one arm or the other arm of the study after an evaluation of what was in their best medical interest. And he asked me whether that was ethical. My response to him was that I didn't know whether it was ethical or not but that he was lying to the patients. (Laughter.) And he became upset and said to me, look, Jay, you know this is an important study and it needs to be done and we tried, but it can't be done if we're completely straightforward. And I said to him, you know, you didn't listen to me. I didn't say -- I didn't answer the question whether it was ethical or not. I only commented on the lying. I might consider it quite ethical in certain circumstances, if one wishes to weigh the experiments against other considerations and come out with a conclusion that if this is an important study it wouldn't be my calculus, but I can appreciate it because ethicists differ about what is ethical or not to come to the conclusion that we have to entertain such subterfuges because there are competing values to be considered. So, with respect to the issue of exposing persons to greater risk, the first question I think that must be posed, or at least that I posed for myself, that goes to the process issue that Ken talked about, that the investigator and maybe the IRB have to consider is the issue important enough and the research question important enough that we want to expose persons to greater than minimal risk. And of course, also, will the research project be able to give some answers to whatever needed to be investigated. Once that issue has to be resolved then there is the second issue, how much must you tell the subjects about that. And if you can be completely forthcoming, then at least I don't see any reason why you cannot expose persons to greater risk. If you have to manipulate the disclosure process, then you may have to reconsider whether under these kinds of circumstances whether you can proceed with the experiment or not, but I think it's these kinds of things one has to consider. And all too often not only are subterfuges employed but all too often they are employed without a clear recognition of what one has been doing. And it's almost that the second is worse than the first. CHAIRMAN FADEN: We've got Duncan and then Nancy and then we have to stop. DR. THOMAS: I'll pass. CHAIRMAN FADEN: Thank you. MS. NORRIS: Pass. CHAIRMAN FADEN: We're taking a break. That's the exhaustion factor that has kicked in. It is 3:15. We'll come back at 3:25 and we'll do children. (Whereupon, a recess was taken.) Committee Discussion: Experiments on Children CHAIRMAN FADEN: We're now on to Part II, Chapter 3. All right, everybody. If we could get everyone to the table, please. Before we start, I want to point out something that Lois kindly reminded me of. Experiments on Children. I don't know how many of the Committee members have met Jeff Botkin and Greg Moskun who are consultants to the staff and have worked so hard on children's chapter with Cathy Taylor and Anna Mastroianni, as well as a subcommittee of those of us who've been working on the children's chapter. So, welcome, the two of you. We're really not that bad. Okay. The children's chapter, which is Part II, Chapter 4. And we did have at our places some discussion questions which we may or may not need, since we haven't been following them too closely, but it's dated February 16th. So with that, let's start to see if there are questions that the Committee wants to raise, Committee members want to raise for Jeff and Greg. Henry, you're on. DR. ROYAL: On line 52 is the rather specific statement that active medical follow-up is recommended specifically for individuals placed at risk of one excess case of thyroid cancer per thousand subjects. I thought that was a pretty clear statement. I was wondering what sort of things were considered in making that statement. MR. BOTKIN: Well, we thought it might be helpful to give the Committee something to really sink its teeth into. The risk level is indeed an arbitrary one chosen largely by myself as one that I thought would provide a reasonable yield if the Committee chose to pursue follow-up and compensation for individuals involved in this research. I think that what our analysis of the study shows so far -- and this constitutes largely the non-therapeutic research projects, is that the thyroid studies that were conducted in the late '40s and early '50s are really the ones that are potentially problematic for long-term consequences for the children. Some of those studies had estimated cancer, excess cancer cases of 1 to 3 cases per 100. Most of them were lower level risks than that. So I think the considerations were several-fold. First of all, is it worth following up people or not. I think the chapter tries to conclude that for cancer prevention, given the latency period of many of these secondary effects, that prevention may not be a realistic goal. If compensation, perhaps for medical consequences, is considered a reasonable goal, then had to draw some cutoff that would permit case finding and identification to go forward. And I think one in a thousand is more or less an arbitrary figure that seemed reasonable to me. DR. ROYAL: I'd like to pursue this a little bit more because it's a difficult issue. Did you take into consideration any harms of medical follow-up? MR. BOTKIN: Yes. DR. ROYAL: I guess the concept behind the medical follow-up is that somehow by detecting disease that's not clinically apparent, that that's going to end up with a better result for the patient. That's the hope. That by having a medical follow-up -- I'm assuming that by medical follow-up program you're talking about something other than the routine medical care that one would ordinarily get. MR. BOTKIN: Well, I guess what I was referring to specifically is case identification and again, given the latency period, many individuals who may have suffered harm from their involvement in this research will experience that harm already. So it was not my impression that cancer prevention was likely to be a realistic goal of follow-up. However, if the Committee would decide that individuals who developed thyroid carcinoma and had been placed at high risk due to their participation, that compensation for medical expenses associated with that illness should be considered. DR. ROYAL: That's very interesting because that's totally different than what I was thinking of. You're really doing it as case identification as opposed to expecting to alter outcome. MR. BOTKIN: Well, I guess I can't say -- and Greg definitely can speak to this better than I can. I think my impression is through my look at the literature is that the latency period is averaging somewhere around 10 to 20 years but that there may be secondary consequences that show up at any point in an individual's life, so that these experiments that were done in 1950 -- and it's now 45 years later so it's possible that prevention of future cancer may occur through case identification at this point, but I think unlikely. DR. ROYAL: Just in case it's not obvious to everyone what the concerns are about doing something special, thyroid nodules are very common, especially if you use a modality like ultrasound to look for them. You might have thyroid nodules in 10 or 20 percent of the population. So the danger if you're going to do follow-up for thyroid disease is that if you're going to follow up the thyroid and look for disease, one of the simple things to do is to do an ultrasound of the thyroid and you're going to find 10 to 20 percent of the population has nodules, which you would never have known unless you did the ultrasound. Then you're going to be stuck with the problem, gee, they have a nodule. We know they were exposed to radiation. How do I know whether or not it's a thyroid cancer? And the way you're going to figure that out is you're either going to try to do a needle biopsy which may or may not have some problems with it, or you're going to do surgery to take out the nodules. So the downside of doing anything other than saying hello to the patient is that you potentially will subject a lot of people to surgery who might not otherwise have had surgery. So follow-up a thyroid disease, it's not clear to me what the best thing is to do. But by the way, there's very good data from the Hanford epidemiologic study, plus just studies that were done for people walking through the door with ultrasound about the incidence of thyroid abnormalities. CHAIRMAN FADEN: Duncan and then Reed. DR. THOMAS: I, too, was struck by the sentence and underlined it, as well. So I was waiting for the rationale. The rationale comes on pages 25 and 26 and depicted in the long paragraph in 26. And it's quite clear from that paragraph that the rationale is as you describe, one of finding conditions for which the probability of causation is likely to be relatively high and has nothing to do with the risks or benefits of therapy. Now, I would contend that Henry's points should be the operative principles here in deciding whether or not to institute a medical monitoring program or project. It's not -- should not be to identify cases so that they can file for compensation but it should be to find out whether or not we can do some good. And the principles, many of which Henry has already touched on, are elaborated in the remedies chapter at pages 10 and 11 that I'm sure we'll get to tomorrow. So I don't particularly want to belabor this point but we've long recognized that there are harms in medical monitoring as well as potential goods. And the relevant calculation is whether or not medical monitoring is going to do more harm than good -- more good than harm. DR. ROYAL: And I would point out that the numbers that Duncan referred to on line 43, that those three to four cases occurring per thousand individuals is clinically apparent thyroid cancer. A real problem again with thyroid cancer is if you look at people's thyroids, there's a lot of people who have a occult thyroid cancer and the incidence is much higher than three to four per thousand. For occult it may be as high as 10 or 15 percent in elderly populations. CHAIRMAN FADEN: Can I -- DR. ROYAL: That is not clinically apparent. There are many cancers which if you look at the organ at the time of death in sufficient detail, that you'll find that it's present. So, for example, prostate cancer in men, very, very common. If you're 70 years old there's probably a 50 percent chance that you have microscopic evidence of prostate cancer. The same is true with the thyroid. Ten to 15 percent of elderly people will have microscopic evidence. So, when you go on this mission to find cancer, you're going to find it. You're going to subject people to treatment. But whether or not that treatment is actually curing anyone is left to discussion. CHAIRMAN FADEN: Reed? DR. TUCKSON: A terribly important conversation and I think we'll probably talk more about it tomorrow with the remedies. I think that Henry's concerns are legitimate. On the other hand, I think -- and I don't think I'm disagreeing, but the presumption is not that we're ordering people into some factory line that has only two or three branches of outcomes and that they're forced to have the outcome. Individual decisions are made for individuals. But I think that it would be also a little inappropriate if made our general conclusion that appropriate investigation ought not to be available to people because it's either too much, too cumbersome, whatever the reason is, and that we therefore fail to exercise individual responsibility or our responsibility to individuals. And so, I don't know. I just think it's -- those are important caveats but I'm not sure I know yet what they lead to. DR. ROYAL: If I could just respond to that. I think that you're absolutely right. The individual should be given the opportunity to decide whether or not they want to participate in a medical follow-up program or not. But they have to have realistic expectations of what that medical monitoring program may do, including the fact that they may end up having more surgery than they would have had if they don't participate in the medical monitoring program. I also think that it's somewhat coercive if the only compensation that you offer to a group of people is medical monitoring or nothing. DR. TUCKSON: Then you force people into that. Let me just say that I think that it really becomes further evidence of the necessity of writing introductory material, a background primer on this stuff for the American people that's understandable. And this is just yet another element of that discussion. And whether it is even possible to write such an addendum to this document, I think the editor that we choose for the report may have to have a second, a sub-editor. I mean, first of all, the editor may be that smart, that good at being able to do a technical document like this. I see you laughing. But it just seems that we might to give due diligence to hiring another kind of an editor just for this part of the project who really under -- I mean, somebody that really -- and by the way, that doesn't mean that who we have now doesn't. CHAIRMAN FADEN: No. Fine. Go ahead. DR. TUCKSON: I mean, no pejorativeness in this. But somebody who really has some experience in trying to explain complicated notions like this to the American people. That's just very important. CHAIRMAN FADEN: Let me just see if I've got everybody here. I've got Ruth Macklin. I've put myself on. Ken and Pat. Ruth Macklin has the floor and then Duncan again after Pat. DR. MACKLIN: I'm not on this point, so if anyone wants to continue -- CHAIRMAN FADEN: I'm on this point. Is anybody else on the remedies? Ken is. Who else is on remedies? Pat, are you on remedies? All right. Duncan, are you back to the monitoring? Are you still on monitoring? All right. So we're going to hold Ruth Macklin and the remedies. And then we can go back to the remedies discussion tomorrow, but I think I want to get clear on what's being -- the principle that's being debated back and forth here. If I understood what Jeff and Greg were proposing, you were proposing that the reason to do this is ostensibly by and large to find people who have already suffered a harm that is reasonable to attribute to their participation in research and offering them some sort of remedy for that. That was the principle justification you put forward? DR. BOTKIN: That's correct. CHAIRMAN FADEN: So these are people who don't know their research subjects, many of them, because this happened to them. They may know. They may not know. But they were children when this happened to them, so many of them may be totally unaware that they were ever experimentally exposed to radiation. And so the argue is they're due something because there's some subset of them that may have -- but then you also point out in the chapter that because the numbers are small, it's very likely there won't be a single case but there might be. I mean, we don't know. Now, the argument I'm hearing from Henry and Duncan is if we offer them -- that we're going to find people who don't have active cases of thyroid cancer and then they're going to want to know -- hey, now that you've told me I've been exposed, I guess I want to have a work-up to find out if I have cancer because now I have a reason to worry. So we have two kinds of people. The person out there who already has thyroid cancer or hypothyroidism. Is that also a possibility from this or just -- or both. Okay. Who have one or the other of these disorders, either thyroid cancer or hypothyroidism. And they will be relieved to find out that there's some remedy due them, whatever the remedy is, because we have adopted a view if we recommended that they're due something because they have this harm. It's reasonable to attribute that illness that they have to their having been involved as a research subject, assuming we decide that. The other argument is then there are all these people who don't have hypothyroidism or thyroid cancer who now are going to find out for the first time in many cases that they've had this exposure. We now give them something to worry about and we would offer them the opportunity at no expense to have a work-up. And it turns out that what I'm hearing is that some of them may have what would turn out to be unnecessary diagnostic work or maybe unnecessary surgery. But then again, you might pick up a case. It's unlikely because of time period. So that's sort of the -- I'm not coming down on one side or the other. I just wonder if I can understand what's at issue. So we've got different, very different structures going. DR. THOMAS: It's not just medical harm though. The other issues which are discussed in this middle paragraph on page 25. The stigmatization issues, the anger that they may feel towards their parents and so on. CHAIRMAN FADEN: When being told. Okay. DR. TUCKSON: And just one other part of your analysis or your summary is it's also the notion then of our responsibility to not be paternalistic to those folks and may yet be another group of Americans that make decisions for individuals without -- CHAIRMAN FADEN: The problem is we're going to make a recommendation, not a decision, one way or the other. DR. TUCKSON: Right. CHAIRMAN FADEN: I think it's inescapable. DR. TUCKSON: Right. But I'm saying that the point that at least I was trying to get to is that whatever the decision is, that ultimately I hope it deals with the individual person has an opportunity to have all of this understood so they can make their own individual decisions. CHAIRMAN FADEN: The only way that works though, Reed, is if we were to offer this case finding stuff. Because if the recommendation came out we're not going to contact anybody, we've made a choice for people. DR. TUCKSON: Right. Just like was made for them when they were children. CHAIRMAN FADEN: I'm just laying out that if you follow the logic of your position it goes in a certain direction. I've got Ken and Pat also wanting to comment on the remedies issue. Pat, Susan -- I'm sorry. Ken, Pat, Susan on the remedies. And we can continue tomorrow, but just while we're out here -- Ken? MR. FEINBERG: Putting aside the question of what the remedy ought to be, which is -- CHAIRMAN FADEN: Yes. Putting that away for the moment. MR. FEINBERG: -- I have a question for Henry on the science. And that is, is the draft accurate in the sense that there is a level of exposure where the risk is so substantially increased over the general body population or whatever, whatever the cohort may be, that it is fair to presume a connection. This is the issue that arose in the Presidential Commission on Catastrophic Nuclear Accidents. Is there a dose exposure level as discussed in the draft, given at great length, staff people talk about this on 25 and 26. I want to hear Henry on this. Putting the remedy issue aside, is there a group, however small it may be of people, where it is fair to conclude presumptively a connection between the wrong done, the exposure, and thyroid or any other cancer. Because if you don't get to that, if that issue isn't satisfactorily resolved, I don't even get to the remedy question because we're singling people out and we are presuming a connection. And I really want to hear -- we haven't had much discussion about this in the last few months and I'd like to hear, Henry, what you think about that before we get to whether or not the remedies are appropriate. DR. ROYAL: Unfortunately, it's a very difficult and controversial question. I didn't ask how the risk estimates were calculated, but I suspect that they were based on external radiation from x-rays. Is that where you got the risk coefficient from? DR. BOTKIN: Correct. DR. ROYAL: So, there is good epidemiologic data that radiation exposure from an external source causes thyroid cancer. The data for I-131 is more controversial. There are many -- there are literally tens of thousand of people who have been exposed to I-131 having had diagnostic studies and those people have been followed for maybe 20 years or so. There's a Swedish study that looked at that. And there's been no increase in thyroid cancer in that population which would have been given doses similar to or larger than some of these doses. CHAIRMAN FADEN: Can I just interrupt just to clarify on that? Were they children? DR. ROYAL: No, no. And that's what my next statement was going to be. And now we have the complicated problem of Chernobyl where thyroid cancers have now been attributed by some people to iodine release, but it's still -- exactly what the risk estimate is for I-131 for children is unclear, at least to me. I'm interested to hear what Duncan has to say. DR. THOMAS: I would add that I-131 does remain substantially controversial. In addition to the studies that you mentioned, we have also the Marshall Islanders. We have the Utah downwinders. And I suspect if I went back to my notes on that project, we would have cited other literature, as well. There is some evidence of an effect of I-131 on thyroid cancer. The magnitude of the risk coefficient is very uncertain at this point. But my take on your question is that there is -- though we may quibble about the excess in even the highest dose group here is more or less than twofold, in other words, more likely than not to have been caused by radiation, it's certainly in that ballpark. Where judgments that have been made, presumptive cancers and other situations, the thresholds which we've used there -- we're definitely in that ballpark. MR. FEINBERG: So really what you're saying, Duncan, is a threshold similar to that proposed in this draft does not leave the Committee open to the charge that we are including people -- whatever the remedy might be -- that we are inaccurately or unscientifically articulating a group that the causal connection is not scientifically or medically sound. And you're saying that we do not, based on precedent. We do not leave ourselves open to that charge with the type of minimal dosage requirement, exposure requirement, that we see in this draft. DR. THOMAS: We leave ourselves open to quibbles about the magnitude of the risk. And until I understand better what's the scientific basis for the many risk estimates which pepper this document, I would prefer not to commit myself as to whether or not staff's got the right numbers here. But I think the principle is that yes, it is quite plausible that some thyroid cancers may have been caused by these exposures. CHAIRMAN FADEN: So in ordinary language, the presumption that these were attributable to the exposure, the basis for that is similar to the basis in other context in which cancers have made it to a presumptive list. MR. FEINBERG: Otherwise, we're going to find somebody writing us a letter or saying in a hearing the trouble with all of this is that they made the wrong presumption on the basis of the medicine and the science. That is the critical question. CHAIRMAN FADEN: So the issue seems that the answer there is that's not so much the problem. We then move on to whether a remedy is in order. MR. FEINBERG: If Henry tells me and Duncan that that's not a problem and we're not leaving ourselves open to that charge of giving away a remedy for cases that would have occurred anyway, then we move on. Right. CHAIRMAN FADEN: Pat's still waiting to get in. DR. ROYAL: The problems I'm having with the case finding approach in attributing the cancer to the iodine exposure is I don't know how good the data is in terms of knowing what that person's dose is. I think, you know, probability of causation is a good structure to work in and I think that the probability of causation for thyroid cancer, unlike many other cancers, in fact, could be more likely than not to be due to radiation. Whether it is in any of these cases -- and plus how to figure it out for kids where kids are two or three or four times more sensitive to radiation exposure and how to do all of that isn't so clear. So the principle, I think, is good. Whether it's doable or not, I'm not sure yet. CHAIRMAN FADEN: Pat, can you bear with me for one second? Jeff, did you want to come in on just this point? And then Pat is waiting patiently. DR. BOTKIN: Yes. A quick comment. I think if the Committee decides that remedies are appropriate, then this kind of cutoff errs on the side of being over-inclusive. I think there will be people who potentially get remedies to which they don't desire, but that arguable is better than being under-inclusive. Again, if remedies are thought to be appropriate. CHAIRMAN FADEN: Pat? MS. KING: It's impossible to look at some of this and not immediately jump to remedies, but there are some things I'd like to remind people of. First of all, -- and Jeff will I'm sure correct me if I'm wrong. This data comes from published studies. DR. BOTKIN: That's correct. MS. KING: So this is a project that we presumably got these studies from presumably peer review journals. So some of our data here I would think is a little bit better than some of the data in the documents that we work with in terms of we're more likely to accept it. That would be the first point. And the second point is it's very important to note that the Executive Summary does not argue that there was culpability here. This recommendation for what they are talking about as follow-up is based on the risk posed being greater than was believed at the time. And that's also different, I think, from some of the other case studies that we have seen. So what we have here is, given the discussion between Duncan, Henry and Kenneth, if that's resolved satisfactorily for everybody, what we have basically -- and nothing else changes -- is an opportunity to do what lawyers would call strict liability or no-fault liability. And that's not exactly what we've seen before. And I think it's very important to think of it in those terms. That what we're talking about doing is we're not looking for ways to give money. I think about the discussion doing nothing versus follow-up. In this situation that may not so critical in the sense that we are not talking about culpability. What we're trying to do is we are trying to offer to some individuals a benefit defined by them as a benefit. I quite agree with Reed on this. Because we would see ourselves as acting responsibly. That the idea would be this is a justice issue not a compensation issue. Now, with that said, let me say that -- and I've shared this with Jeff. One of the difficulties in assessing this chapter is that this chapter is basically okay as far as I'm concerned as far as it goes, and it hasn't been able to go further, is what is the Committee going to do with respect to no-fault, which is the issue that comes up tomorrow. But in part we need before we can talk about a remedy, and I keep saying this, we need this chapter or whatever for our recommendation on prospective problems. What do we do with subjects injured in research protocols where we can detect no ethical or legal violation, which happens quite often, as those of you -- not often, but happens, for those of you familiar with the research. So the discussion here I think implicates a lot of very critical areas and actually medical monitoring follow-up is one, but it's not the biggest one. I think the biggest issue is that we have to keep our eye on the ball about what it means to be a subject in research who might suffer an injury. And this is complicated by the fact that here we only deal with non-therapeutic research. Jeff is yet to do his work on what we loosely frame therapeutic research, which presents even more complicated issues with respect to how you compensate. CHAIRMAN FADEN: Now, what I would like to do if it's all right is rather than have the whole rest of the afternoon go to this issue of no fault remedy, and that is something that will be debated tomorrow, we very much wanted to have the children's chapter before us so that we'd have case material to work with as a concrete illustration of what it would mean if we didn't do it or if we did do it. Susan wanted to make a comment and I would be very grateful to Ruth and Duncan for turning us to other parts of the chapter. And we'll return to the remedies issues for this particular case later. Susan? DR. LEDERER: This may be a question that can be deferred for the remedies discussion as well, but I guess I had a question about the issue of active notification. I mean, you present sort of an argument on the basis of interest of not informing people. Is there a right to know that you are a research subject? MR. BOTKIN: I think the conclusion that is drawn in the chapter is that for those who seek that information, for those who have some fears that they may have participated, they may have some health problem that's related to something that happened when they were a child, that there ought to be a mechanism to answer that question for that person. That, yes, indeed, you were, as far as we know, involved in a particular experiment. So, the chapter recommends that kind of information resource for people who would approach and ask that kind of question. I'm not convinced, for a lot of the reasons that have already been discussed earlier with respect to thyroid, that it's a benefit to anybody to actively seek people out who we think are at minimal or virtually no risk to inform them that they were participants in the study. I think that does risk lots of psychological reactions that would not ultimately benefit the individuals. So I was unable to find a right for people to be actively informed that they had been participants in this work. DR. ROYAL: I don't understand how this clearinghouse is going to work in terms of mechanism. I mean, there's going to be people that have been involved in all sorts of research that no one has any -- there's no centralized records. How -- I don't understand this concept that somebody's going to call up. They're going to say I was at such-and-such a hospital. I think I was in research. Was I? How does that work? CHAIRMAN FADEN: Dan? MR. GUTTMAN: That's presumably the notion. Remember our database? DR. ROYAL: Oh, but come on. Your database only contains a fraction of the research that's been done. MR. GUTTMAN: No. The radiation research. It contains more than a fraction of the radiation. This is radiation specifically. DR. ROYAL: It contains federally funded radiation research but there's many, many other kinds of research that's done. CHAIRMAN FADEN: I mean, as a practical matter, it would bear a lot of working out because it's a matter of knowing -- I was born at St. Catherine's Hospital in Philadelphia. My mother has this vague idea that I was given iodine when I was a newborn. I was born in 1949. Can you find out if there was a research project out of 1949. That's as far as maybe they could go. Then you'd have to go back to St. -- even if you could do that, who would go back to St. Catherine's to see. You could say, well, we don't have anything in our registry that says there was a study done at St. Catherine's in 1949. And is that what you're envisioning, Jeff? Something of that sort? DR. BOTKIN: Well, I don't think I've thought through the complexities of it. It would be enormously complex. But I think if we have a registry of the experiments that fall under the mandate of the Committee and some prospective work is done to find out as many individual names as we can and have those available as resource for people who then would call in, I guess I wouldn't see an active team available to go out and research each request, but simply a database that existed to the best of the information that could respond to people's inquiries. CHAIRMAN FADEN: So that's a kind of more constrained recommendation specific to some targeted studies that would be of concern. DR. ROYAL: But my concern about it is you've already heard the frustration that the public has when they try to get dosimetry from organizations that they think should have it, and they run into all these dead ends and they're unable to get the information that they want. To me, unless it's a reliable system that we set up it's just going to upset people more than it's going to help them. CHAIRMAN FADEN: We can also pick this up in the remedies discussion because this is a remedy. We're dumping everything in tomorrow. But I really want to see if we -- we can go back to it if we have nothing else to say about the chapter except this side of it, but I suspect there's some other issues. Ruth and Duncan I had noted for non-remedy related comments on the chapter. DR. MACKLIN: I have several, but I -- one of my comments which I was going to make first was actually ask Sue's question because this is something in between monitoring and remedies. Or not in between, but it's something other than monitoring and remedies. It's simple notification. And Jeff, with all due respect, I don't think you answered Susan's question. Susan asked, and quite appropriately -- I mean, appropriately because I asked the same question -- (Laughter.) -- do people have a right to know. Now, an answer in terms of the benefits of knowing or not knowing or the potential harms is not an answer to the rights question because people can indeed have a right to information that may harm them in some way, psychologically or otherwise. So since your response to Sue was also couched -- I mean, the paragraph is in the middle of 25 and it's an interesting defense. But if you want to make the claim that they don't have a right -- I mean, what you did answer was if they ask they may be told. But I suppose to argue that they have a right is to say someone has an obligation to give them that information whether they ask or not. So I think you may need a slightly stronger argument if you want to make it. I mean, I think using the word that Reed used before, it's a paternalistic argument that you make and it's based on surmise. Now, I don't have any suppositions to the contrary, but to say that people may experience negative reactions towards parents or guardians, they may not want to be reminded of their childhood, et cetera, is surmise. It's about what people want. We could equally well surmise that they want to be told what was done to them, if indeed this is information that they have a right to know. So I'm not really making an argument now except to point out that you can't answer the rights question by giving an answer in terms of the perceived harms or benefits. DR. BOTKIN: And I think that my response was more -- was certainly along that risk and benefit line. But based on the fact that I could not for myself at least define why there is a right to that information. DR. MACKLIN: Well, I don't think that's your task to have to do it here. We may have to grapple with that. I mean, with the Committee. Whether people have a right to know that they were experimental subjects. Let me go on to some of the other -- CHAIRMAN FADEN: Ken, were you right on the right to know? MR. FEINBERG: Just in response to that, Ruth, I like Henry's Machiavellian response to your question, which is even if you do have a right to know, the right relates to full knowledge. We can't mislead you. In the absence of information, historical information that will give you that knowledge, we don't want to be mischievous. That's really what Henry's saying. Henry's doing an end run on your question by saying we can't give you the information. It's lost. It's too difficult to reconstruct. And therefore, whatever right you have, we're not going to play a role in making things more confusing and giving you false hope. That's a pretty good answer, actually. DR. MACKLIN: Yes. But Ken, that seems to me an answer to the question if people call up and ask this kind of vague question. My mother said this, that or the other thing and maybe I was a subject. Am I? That's a perfect answer to that. But notification presumes that you have somewhere a list or a bunch of names such as they might have at the Fernald School or the Wrentham School. So notification is premised on positive identification of people who were members of studies. MR. FEINBERG: Well, that's right. There may be seven people like that. DR. MACKLIN: It would make things easier. DR. LEDERER: It doesn't change the question of whether they have a right to know, even if there are only seven. MR. FEINBERG: No. I'm saying -- all I'm saying -- I'm sort of picking up the mantle for Henry. I think Henry's on to something which is true. The right to know in the abstract might be fine. The question is can you give people, whether it be seven or 7,000 the type of information that makes the right to know meaningful and not mischievous. And I'm listening to Henry say watch out when you start going down that slope as to what you're going to tell people. The 1-800 number will start to ring and there'll be no satisfactory response to give to 95 percent of the people. You've got to take that into account. CHAIRMAN FADEN: We don't lack for discussions. That's never been a problem. Ruth, you had a couple of more points? DR. MACKLIN: Yes. I have a couple of things. And these are in the spirit of trying to improve the next draft. Structurally this chapter is very different from the others we've looked at and that's something to attend to in the future. But I mean organizationally and otherwise. But I really don't want to dwell on that. I have several fairly small comments but one that will either require recasting the argument or saying something a little different. On page 4 you refer to the Nuremberg Code. And of course, much will come before and after about Nuremberg. But I'm not sure the comment you have, while the Code did not speak directly to research with children, it is clear that consent for participation in research, per se, became the articulated standard. And then the next sentence says there's no reason to believe that research with children would be held to a less stringent standard. Well, I think there is -- and correct me. And Jay probably knows this -- some discussion about whether although the Nuremberg Code is silent on the question of children, the emphasis on the subject giving his or her voluntary consent being the sole condition under which research may be conducted may be understood to preclude third-party permission for those who lack capacity to speak for themselves, including children. Now either the Nuremberg Code is silent on it and doesn't mention it at all and so you can come to some inference, or else there's a debate about whether it meant to specify that only subjects capable of giving consent, which would at least preclude small children if not minors, whether it meant -- in fact, intended to preclude the possibility that anyone can ever consent for another for research. So, I mean, it seems to me that that has to be addressed directly. Jay, do you -- DR. KATZ: You're quite correct. All commentators who've spoken to that issue have said one of the reasons why the Nuremberg Code has been surrounded by controversy, because it excludes children, it excludes the mentally incompetent and all other people by definition who cannot themselves give voluntary consent. DR. MACKLIN: So it's something to attend to, at least. I mean, to address it, what's written here, in the light of what Jay just said and what I sort of thought, is inadequate, so you've got to say something else. Let me just go on so I don't spend too much time on any one point. MS. KING: Might I ask you and Jay a question in light of that consent issue? I know the reference in the document is to Nuremberg but is Nuremberg, the Nuremberg Code the gold standard in this area? Consent for children is very much part of family philosophy, whatever you want to call it -- family autonomy, parental autonomy. And the issues of consent with respect to children don't follow the same paths that we normally take with respect to adults at all. So, I would take it further, your question, and question whether Nuremberg, even if you could clarify it in the way that you're suggesting, is the word for purposes of consent at that time for either children or those who were incompetent with guardians. DR. KATZ: If I address a very brief comment. I do not know. I've only had a chance to glance at your chapter. And it may not be necessary for your purposes. There's a new literature emerging now on children research that talks about the important of assent by children after the age of 8. It's a very, very interesting literature and some people are now saying that, of course we cannot consent. But if a child after age 8 or so says I don't want to have this done, be it even a veni-puncture, it is ethically impermissible even with the parents' permission to enroll this child in a research project. If it's important for your purposes, I can send you a wonderful paper that's being written on the subject that I've just had an opportunity to read. It's very, very sensitive. CHAIRMAN FADEN: If I can introduce this. This is, of the many, many problems yet to be worked out in terms of the overall organization of the chapter, we have to get straight on where the hard work of establishing what the practices were for research involving children should go. Whether it goes in this chapter or it goes in the chapter that Jon Harkness is doing on the general overview of what the practices were for research generally and how they evolved and what the professional standards were. So we've got to figure that one out. We've got to figure out how much work should go in here versus how much work goes in Jon's chapter. But I really want to underscore Pat's point that there's another tradition or line of work and Jeff cited some of it when he cites -- the reference to Wentworth that underlies sort of public views about what doctors can do to kids that has a different path, to some extent, from what doctors can do to their adult patients. And you've got, I think, some of it in here, Jeff. And we've got to see what Jon wants to put in here. And then we'll sort of figure that all out. And that's one of about 100,000 problems of organization for the volume. No big deal; right? No problem. Ruth, I'm sorry. You want to continue? DR. MACKLIN: Yes. A couple of other small points. On page 5 you talk about the AEC literature which then becomes quite relevant to exactly what we're talking about here and you quite rightly question the vagueness of the term important and then say at a minimum you'd expect the proposed research to address a significant health care problem. Well, some might say is significant so much clearer than important? Now, I think you do go on to give criteria and maybe even later in the chapter, because you specify what you mean by significant. But I think you certainly have to protect -- we have to protect ourselves against someone saying, aha, can't say important but you can say significant. So maybe spell out criteria that would -- a little more fully there. Now I noticed something that I didn't see receive any discussion, and maybe I missed it, so I'm sorry if I did. But the point leaped out at me, and this is on page 10 in this. Yet another Boston University Law and Medicine Research Institute meeting. Now since I misunderstood yesterday's meeting, maybe I misunderstood this one, too. But we have SG, who I guess is Sidney Gellis, whom I don't know. When he was asked if they asked permission, he says, "No. We were afraid we would not get volunteers. We used ward patients only, thank God." Well, I think that's the kind of phrase that we need to -- that deserve a little attention in her, especially because of course you do go on to talk about Wrentham or about -- I'm sorry -- about Fernald, not Wrentham. I had another question about that. But it's just that it leaps out here and this says something. It's either the belief of one individual or it's the believe generally of this whole crowd, which is why we're trying to get to these old pediatricians. I don't know if you noticed that Henry Barnett's name is in this list of people who attended that conference. So, too, for everyone's enlightenment is Saul Krugman who did the Willow Brook studies on -- gave hepatitis to the mentally retarded children at Willow Brook. CHAIRMAN FADEN: It lends credence to the fact that these were not people who were ethically ahead of their time. DR. MACKLIN: Right. (Laughter.) Fair enough. Fair enough. So I just think that somehow to pick up on the phrase, it would be useful in pointing out the use of the children in these institutions. On page 21, which is a little bit more substantial here -- no. One other thing. And I'll be glad to maybe work with you, talk on the phone or something, about this on page 20. The paragraph in the middle is very important because you're asking here at line 729 whether it was wrong to use children in radiation experiments at all. And of course, you go on to justify children as subjects in research in this paragraph. And I'm not sure. I think you can make a stronger justification which is here in the chapter. But where is says as members of the human community children have a small but real obligation to contribute to the welfare of the community through participation and research -- well, in order to use that as the justification I think you'd have to get into a deeper discussion of how when people are yet minors or lack the capacity to act on their obligation, whether someone can put them in a position to fulfill that obligation. I mean, it's a complicated point. I think you can more easily make the point that's made elsewhere, which is the benefits that accrue. That is, you're talking here about minimal risk or low risk research and how as members everyone is a child at one point and today's children -- this was the argument that the National Commission made, I think. That children today benefitted from their predecessors, children in the past having been research subjects, and so, too, children of tomorrow will benefit if today's children -- I mean, some kind of generational reciprocity makes a slightly stronger or perhaps more persuasive argument about it than to impose the obligation on children where the children themselves are not in a position to exercise -- voluntarily exercise their obligation. So that's the point I have there. Now, on page 21 where you're making the -- concluding the argument about children as research subjects in radiation -- I mean, this is important, certainly key to the work of the Committee in drawing this conclusion -- you say the Committee does not conclude that radiation experiments using children, per se, were unethical. It's put in a slightly negative way. I mean, to say they do not conclude that it was unethical is firstly too many negatives that you have to read it a couple of times. But I mean it could be put more positively. But here you say -- the clincher is the cautious use of radiation in research with children was ethically sound when it was appropriately conducted to pursue legitimate medical concerns. But here I think you have to make it -- I mean, add the other points, which you do have elsewhere. That if you can only learn certain things that can benefit children by involving children in research, then it's the only way you can get certain information. And as long as you're not placing them at too great a risk, the benefit to all children or potentially to all children, serve as the justification. So, I mean, the legitimate medical concerns I think is a little too weak. I think you can make the point more strongly, so it would be something like this. That if research of a certain type using radiation could only be done in children in order then to provide benefits to children and if it's low risk, then it can be ethically justified. DR. KATZ: Discussion of this point, very briefly, is -- just two sentence. Again, I haven't read it, on page 20, that middle paragraph about as members of the human community, children have a small but real obligation to contribute, et cetera, et cetera. This may be perfectly sound ethical analysis. I know relatively little about ethical analysis. But I've just been teaching the medical issues from the perspective of law, and surely what you are writing here would go counter to common legal proscriptions and maybe that's the way it should be. Even parents don't have the right to volunteer their children for non-experimental procedures. It's a very murky kind of area of law, to be sure, but it raises all kinds of -- CHAIRMAN FADEN: Jay, there are a lot of us who are looking confused at what you're saying. DR. KATZ: Pardon? CHAIRMAN FADEN: A lot of us are looking puzzled at what you're saying. Could you -- DR. KATZ: On page 20 about as members of the human community, children have a small but real obligation. Who exercises that obligation? CHAIRMAN FADEN: Are you saying that legally it's impermissible for parents? DR. KATZ: It may be. For experimental purposes. CHAIRMAN FADEN: This is not my understanding. DR. KATZ: That's not your understanding? CHAIRMAN FADEN: No. MS. KING: I can't say whether it's mine or not. Tell me what you mean by legally it may be in doubt. DR. KATZ: For experimentation that is not in their interest. Bonham v. Morant, which is still -- MS. KING: But Bonham v. Morant says that a parent -- the interpretation is that the parent can consent. And the issue there was there didn't seem to be anybody's consent. DR. KATZ: Yes. And the parents can't consent either if it's not for his benefit, for the child's benefit. Well, anyway, let's pass it. I'll look into it. MS. KING: Please do because that would be very important. CHAIRMAN FADEN: We've got Duncan. Ruth, are you -- DR. MACKLIN: Just one last -- CHAIRMAN FADEN: And then Duncan. DR. MACKLIN: This is just a request for something. The only mention -- and again, if I read it too fast, I'm sorry. The only mention I find of the Fernald experiments is on page 22. I didn't find it earlier in this chapter and if it's not discussed -- I mean, it may of course be elsewhere in the report earlier but we weren't reading those chapters for this time. But if this is the first reference to it, it needs a little background here because you jump right in talking about Fernald. We know that is but the readers may need a little more about that. And since you mention also the Wrentham School, but that's not mentioned here. As long as you're talking about the background and the conditions in Fernald, maybe a little bit about Wrentham would be helpful, too, since these were the examples of the institutions from which the vulnerable subjects were drawn. I'm sorry to take so long. That's all I have. CHAIRMAN FADEN: That's helpful. I've got Duncan and then I've got Susan and then we probably should move on to the plutonium discussion but we have a few more minutes, I think. DR. THOMAS: Two hopefully fairly minor points. The first has to do with two statements, one of them on page 19; the other on page 22. The appropriateness of using mentally retarded or institutionalized patients as controls. I certainly don't dispute the ethical concerns which arise in those circumstances, although those ethical concerns I would think are rather similar to the ethical concerns which would arise for the cases as well as the controls, except for the possibility that there may be some additional benefit to the cases which would not accrue to the controls. What I don't see any recognition of is the potential that there might be a valid scientific purpose for use of controls drawn from the same population. If for argument's sake, I think one of the examples here is a study of Downs Syndrome and you're interested in trying to understand the etiology of Downs Syndrome. It would be a standard epidemiologic practice to match controls on various factors that might be independent risk factors for the disease that's not under study. And in that circumstances, it might be quite appropriate to draw your controls from the same institution from which you're getting your case. So that, I think, is more a scientific rather than an ethical quibble. The other point I didn't see discussed in here, and I wanted to know why, is the use of the children of the investigators. And one reason why it might not be in here is that perhaps we have only one instance of that, namely, the eight children of Los Alamos investigators, what Don Peterson called our youngest volunteers. Is it your impression that this is an isolated anecdote that isn't really -- does not provide any generalizable messages that we need to pursue and is thus of not particular interest to want to try to develop, or is it indeed the tip of the iceberg that's much more widespread. And if so, I think you really should develop a case study around that issue as well. What I see as fundamental issues are the untenable conflict of interest position that the parent finds himself in, who on the one hand he is as an investigator, interested in promoting the use of children for experimental purposes, and on the other hand he is supposed to exercise his parental responsibilities to look after the welfare of his children. And I don't see that any person can be expected to behave in a rational manner in that circumstances. And then the other aspect of that is that I don't see that it's ever been possible for anyone to verify that appropriate human subject controls have been exercise because there's simply no way to document that appropriate information was communicated and that appropriate consent of the parent was obtained. What I was going to comment about is the discussion about parent-child investigator is interesting in that one of the common things that potential child subjects' parents, will ask you is if this were your child would you allow them to participate. And the answer may be, well, no, I couldn't because I'd have a conflict of interest, would seem like a peculiar answer. (Laughter.) CHAIRMAN FADEN: Jeff, do you want to respond? DR. BOTKIN: Just a brief response. I've not seen the details from that experiment but we would certainly be pleased to include that. I guess the question then would be if that does seem to be an isolated event, does it deserve the expanded discussion in the chapter. DR. THOMAS: To your knowledge you haven't come across any other instances? DR. BOTKIN: Not to date, no. MS. KING: Historically, the problem has been no so much the children of researchers but the children who have investments in science because of their parents or because of their own prior histories. The National Commission used to discuss a lot that the children who were at risk of being included in research studies are the children of the lab workers, the children of the other people connected with the science establishment or children whose parents feel grateful to childrens' hospitals either because of early illnesses of siblings where the hospital had responded and is doing research or because of the child himself or herself. So there is an issue about close connections, but it tends to be a little bit broader than just parent-child. It tends to be these other kinds of problems that arise. And you may come across some of that. They never knew what to do with it. DR. THOMAS: I would personally expect that this is really a rather widespread situation and it's one which we're not likely to find out about as organized research projects. These are more -- you know, when one's trying to get pilot data you just want to get -- anybody will do. What's the easiest anybody you get? Well, you get your lab techs and you get your kids. And yourselves, of course. CHAIRMAN FADEN: If there isn't an objection, we'll have Susan's be the comment and any reaction to Susan, whatever you're raising. DR. LEDERER: I guess I just have two brief comments. They both refer to page 23. You have in the middle paragraph on that pages gives a breakdown of the race or ethnicity of the children, such as the information that you have. I don't understand the last sentence, but I guess what I would also like to see is some discussion about social class of the children, if you have any of that information. Particularly because I think that the reference that Ruth already pointed out to Sidney Gellis' comment about the use of ward patients may not be clear. And we may need some explicit discussion, you know, private patients versus ward patients. Is there a distinction? I guess I was also somewhat surprised that you didn't explicitly reference Bonham v. Morant in the text in the next paragraph because here you have sort of a legal decision from the '40s about the status of consent involving children in non-therapeutic research. I mean, that seemed a surprising omission to me. DR. BOTKIN: Well, two comments. The Bonham v. Morant is a case that I'd be more than happy to include. My reading of it suggests that there's still some debate about what it means. And so my lack of a clear understanding about what the case really was addressing led me to leave it out. CHAIRMAN FADEN: Clearly raised confusion. MS. KING: Feel free to just jump right in. DR. BOTKIN: The issue of social class, since we're dealing with largely published reports, the vast majority don't refer to that aspect of the patient population. Now some -- there's a few that do. The Vanderbilt study specifically is looking at kids as they say from white schools; one from an upper class, one from a lower socioeconomic class group. But the majority don't make reference to that. And I think in defense of that last sentence, I guess it's unclear without going into much greater detail with each of these studies what the nature of the population was that the subjects were drawn from, so it's very difficult to determine based on just the race of the subjects whether there was discrimination involved or not. DR. LEDERER: I guess I would just add to my comment, though, are there other instances in which children from schools for the mentally retarded are being used other than Fernald or Wrentham? DR. BOTKIN: We have leads on a couple of others, at least one other at this point that we're looking at. So there may well be other -- DR. LEDERER: I guess I would just like to amplify that section if at all possible to include these kinds of characteristics of children who may be vulnerable because of their social location. DR. BOTKIN: And I think the Law-Medicine Institute Study is very helpful in that respect. Not because it's going to give us the documentation but because it gives us a good reflection of the attitudes at that point, which I think will be of great help with this chapter. DR. KATZ: Have you included the Salk vaccine studies? DR. BOTKIN: No, we have not. DR. KATZ: Well, of course, he did his first experimental studies with mentally retarded. DR. BOTKIN: I think we're, of course, addressing the radiation studies and we're going to try to look at a couple of other key studies going on at the time as a reflection of standard practice. I think we haven't done that given the space constraints but I think it's a significant avenue to pursue to try to get a better understanding what people were doing back then. CHAIRMAN FADEN: Thank you very much, Jeff and Greg. We need your hard work -- everybody's hard work. So that's great. Committee members don't go anywhere. We have one more agenda item and then we're done for today. We can take a deep breath. And that is we have at our places some -- a memo from Duncan and one from staff on the plutonium injections and an issue that Eli and Duncan and Henry have been kicking around since Eli and Duncan came back from Los Alamos. Is that a correct chronology as to what's going on? So, I'm going to let however the three of you want to handle it, handle it. Just remember we end at 5:00. No matter what, we end at 5:00 o'clock. Committee Discussion: Plutonium Experiments DR. THOMAS: As Ruth said, this issue surfaced or maybe not surfaced is the right word but came to a head when Eli and I visited the Los Alamos National Labs two weeks ago and heard an extensive discussion about the plutonium injections and came away I think more confused than we started. Both of us -- all three of us, including Henry, have done extensive readings and discussions back and forth with the help of staff and I think all of us understand the issues much more clearly now than we did before. But they are rather technical and thought it would be necessary for -- it would be helpful for me to try to brief the Committee on what we now understand to be the scientific purpose and the ultimate utility of the plutonium injections. We are, of course, in our charge asked to do just that for all of this work. So, let me give a brief chronology, as I understand the story and then the others should feel free to jump in and correct me as we go along. There are still many things that we don't understand about this. From early in the century we had experience with radium, both the tragic experience of the radium dial painters as well as a number of series of medical patients who had been injected with radium for ostensibly therapeutic purposes. And the results in both cases gave us a lot of information about the risks of cancer as a result of radium exposure. The upshot of this as it appears to have been known in 1944 when plutonium production began was that a body burden of approximately 1 microgram was the lowest level at which adverse effects, namely oestrogenic sarcomas and head carcinomas had been discovered. And on that basis an interim standard for radium of 0.1 micrograms had been accepted and indeed is still pretty much the accepted standard today, I understand, for radium. Now, along came plutonium, a brand new element about which we knew nothing. Certainly nothing about its biologic effects and the recognition that this element was going to be produced in quite large quantities and substantial numbers of people were going to be occupationally exposed to it had an urgent need to try to develop some sort of standards for exposure to this element and not a clue as to how to go about it. Early indications were that plutonium was likely to be a bone seeker and therefore it made sense to try to compare its hazards to those of radium and use that as a basis for standard setting. Under the assumption that bone was indeed the target organ then one could do a rather simple calculation based on the ratio of their activities, plutonium having 15 times the half life and hence 1/15th the activity and the amount of energy that would be deposited per disintegration. Radium, after a somewhat more complicated calculation, depositing a total of approximately three times as much energy as plutonium. Then on this basis, on a gram for gram basis, plutonium should have roughly 1/45th or -- let's round it -- 1/50th of the effect of radium. So if the safe standard was 0.1 micrograms for radium, it followed then that an interim standard of 5 micrograms for plutonium might be a reasonable thing to assume and that was the first standard that we had in 1944, a very tentative one. Sooner after, based on the first samples that were made of the product that were made available for medical research, it became evident that the distribution of plutonium in the bone was quite non-uniform compared to radium. VOICE: In animals. DR. THOMAS: In animals. Yes. Thank you. And this raised concerns then that the non-uniform distribution in bone might produce different effects on bone cancer risks than radium would. So, pretty much out of the air a five-fold safety factor was added, reducing the 5 micrograms standard to 1 microgram early, I think around January of 1945. And incidentally, I should mention, one of these two documents which you have in front of you is a chronology of these events assembled by staff. Now, jumping ahead a little bit before talking about the plutonium injection experiments, I want to mention one other key event. In 1945 the first serious set of toxicology data really began to become available to be synthesized and on this basis the suggestion was that on a gram for gram basis plutonium was approximately three times more hazardous than radium, rather than the 1/15th, a fact that would -- I'm sorry. It was 15 times more hazardous rather than the one-third as hazardous that the previous estimate, based simply on energy deposition suggested. And this scared a lot of people. A conference, a tripartite conference involving the United States, Canada and Great Britain was held in Chalk River in 1949, leading to a new recommendation that the standard be lowered from 1 microgram to 0.1 micrograms. In other words, on this basis it appeared that on a gram for gram basis the plutonium and radium were of roughly equal hazard. Soon thereafter it was recognized that there were a few other factors that one needed to take into account; notably, high retention of plutonium than in radium and higher retention, when making the comparison with radium, a higher retention of the radium decay products in man than in mouse. That led to some adjustments which brought us back up to .5 micrograms, a standard that was adopted at the recommendation of Warren by the AEC of 1950. Now, that's kind of a long story which we will now try to write down in the draft chapter to explain, in a fashion which hopefully people can understand. And I apologize that you really don't have a text to go along with what I just said. And probably most of this went in one ear and out the other. But the end result is we had, for what it was worth, a standard for body burdens. Now, -- DR. ROYAL: If I could just make one point -- DR. THOMAS: Sure. DR. ROYAL: -- because it was really a source of great confusion. This standard was based on no human plutonium data. It was based purely on our knowledge of radium and the relative distribution of radium and plutonium in animals. DR. THOMAS: Right. So it's based on two things. It's based on knowledge of the radium risk in humans and it's based on the relative toxicology as well as the relative energy depositions of radium compared to plutonium in animals. But a this point, no human data has been used. CHAIRMAN FADEN: I'm just trying to listen. That's all. DR. THOMAS: Okay. Now we get to plutonium injections. So we knew that you pick a number, 5 micrograms, half a microgram, 1 microgram, depending on what area you were in. We have a standard for how much plutonium you can have in your body before it becomes sufficiently dangerous that we ought to remove you from further exposure. The question is how to enforce that since we had no adequate means for measuring how much an individual might have been exposed to. There's nothing like a dosimeter, a film badge, that would be effective in monitoring one in the situation where the primary exposures would have been accidental. Instead, the excretion of plutonium served as the primary indicator of how much you would have in your body. Now, from animal experiments we knew a lot about how the excretion decayed as a function of time since exposure and the very first standards, then, were based on an analogy with animal experiments which indicated that 0.1 percent of the body burden would have been excreted per day. So in 1945, based on rat and rabbit data, that was the very first means that they had for establishing occupational safety standards. A very legitimate question then came up. Well, is there any reason to believe that rats and rabbits excrete plutonium at the same rate that humans do. No way to answer that question by any other means except to expose humans to known quantities and found out how much they were excreting. We could understand the general pattern of decay by looking at the workers who had been inadvertently exposed so we could plot the time course of decay. But without knowing the accurate amount that was in their bodies, we couldn't actually measure the ingestion or inhalation or injection -- anyway, the exposure to excretion ratio. And that ratio was the key number that was needed for occupational standards. The upshot of these experiments was to establish that the biological half time of plutonium in the human was approximately 118 years, substantially higher than it was in animals, suggesting a lower rate of excretion in humans than in animals and probably the best summary of what was learned from this comes from the excerpt from Stannard that's quoted at the beginning of the staff memo. I think parts of this chapter may have been circulated to the Committee before. Maybe it was just those of us who were interested. But it makes interesting reading and perhaps for a future briefing book. If you don't have enough to read, we might circulate that chapter, together with a chapter that Henry recommended to us by Langham and Healy which goes through this whole history that I've just recounted for where the standards came from. That's rather hard going but we might provide an English translation to go with it. DR. ROYAL: I would recommend reading the first two paragraphs of the Langham and Healy chapter because it was written in 1971 and he's talking about how all of this is based on people's memories and trying to put together memos and all that stuff. And that his discussion of how the standards were actually set may be controversial because it required a synthesis of all this data and I thought you might find it amusing to think that in 1971 it was controversial. It's much easier to do now. DR. THOMAS: I don't think at this point there's any serious quarrel amongst the three of us that have been looking at this that it was I think necessary to learn what the relationship between intake and excretion was. And there's probably no other effective way to do it. Where we continue to have problems are in the appreciation of some of the limitations and the practical utility of these data. And I don't feel I've gone to the bottom of this yet. I'm just going to give you a hint as to what we see as some of the problems. But ultimately I think it will take some more staff digging through the various regulations and further commentaries on these experiments to really get an appreciation for their place in history and whether or not they -- well, how important they really were. I think one of the fundamental difficulties is that the route of exposure used here was by injection but the primary concern was about occupational exposures which would be primary through inhalation. Now, inhalation poses a number of problems inasmuch as the absorption of plutonium from the lung into the body depends on a variety of factors, including the chemical state of the plutonium, whether it's soluble or insoluble, its valence state, and so on. To make a long story short, soluble plutonium is eventually -- crosses into the blood and would ultimately be deposited in bone and thereafter the bone and to a certain extent certain other organs like the liver would be primary targets that one would be concerned about. And for those purposes, knowing the body burden as estimated by excretion might be a reasonable surrogate for what one's risk would be to those target organs. Doesn't tell you, however, very much about risk to the lung. The primary concern for the lung would be to insoluble plutonium, which is not absorbed into the blood, although it is ultimately removed from the lung by cilia reaction and excreted through the GI tract. Nevertheless, it can deliver a fairly hefty does to the lung, I understand, and the lung is one of the primary sources of -- primary targets for cancer. Organ dosimetry is not very well understood. I think it's probably safe to say even today for the lung, although there's quite a lot of work on that subject. Although we have been calling the plutonium injections -- we're including them in the chapter on bio-distribution studies, it's important to emphasize that the primary appropriate way to study the exposure to excretion route and that's all. Incidentally, some information was obtained through autopsies and some of the studies more systematically than in others about the deposition of plutonium in the different target organs. But in many cases that was certainly not one of the primary purposes of the study. So we're left with a bit of a puzzle. If we don't really know what the risk is as a function of body burden, then what good is it to know what's the relationship between body burden and excretion, and that's the puzzle that I think we're still struggling with. It certainly addressed a very key part of the puzzle, but if that part of the puzzle has other parts of the puzzle still missing, then I'm not quite sure where to put it in its ultimate perspective. CHAIRMAN FADEN: Can I ask a question that has nothing to do with the first part? The first part, I'm not sure I got completely, but was there a practical way to have subjects inhale -- I mean, be exposed through inhalation? Was that an alternative? DR. GLATSTEIN: They need to know how much goes in in order to assess reliably the -- extrapolate back. DR. ROYAL: The problem is that you had to know much not only was inhaled but how much actually stayed in the lung. When you inject in a vein -- CHAIRMAN FADEN: You know. DR. ROYAL: -- you know that it stays there. The trouble with breathing it in is not all of it stays in the lung. Some of it is coughed up and swallowed, so that -- and even what's in the lung isn't relevant because at the time they didn't have a way to detect the amount of activity. I mean, you wouldn't be able to measure that by urinary excretion anyway, so the inhalation part is very complicated. One of the things that we're trying to find out is how much of the total risk to the worker really was due to lung exposure and how much was due to bone and liver exposure. There are people around who know more about the solubility of plutonium than we do and we'll get a better idea of how much of the total risk problem was answered by urinary excretion and how much of a handicap it was, not only in the lung. But knowing something, seems to me, is better than knowing nothing. CHAIRMAN FADEN: I'm just trying to figure out was there some other way. Was there a way to get the question -- DR. ROYAL: Ultimately the lung dose was answered by developing detectors that were able to measure the amount of plutonium in the lungs. CHAIRMAN FADEN: But that didn't come until later? DR. ROYAL: But that came later. DR. THOMAS: Today we do Chamber studies. And the Chamber studies, one purpose of a Chamber study would be to study the relationship between exposure in an ambient environment and some biological endpoint which might be urinary excretion. That doesn't really quite help us. The Langham and Healy paper makes very clear the basis on which they tried to develop air standards and it was not that at all. It was from calculating back from body burdens to what the concentration in the lung would be, then working back from that to what the inhalation/exhalation parameters would be and from there you'd finally get to what an acceptable air concentration would be. It's a theoretical calculation. Now, the difficult is, although one would might conceivably have entertained the idea of doing a Chamber study, I don't know if they had the kinds of chambers that we have today to do these things. In those days it might not have been even technically feasible. But supposing that it was technically feasible to do it, it would enable you to establish a means of monitoring the air in the lab but it would be no use for protecting you in an accidental situation where possibly one person might be exposed to an extremely localized dose and knowing what the overall contamination level of the lab was, which is pretty close to zero, I gather, under normal operating circumstances, wouldn't do you a lot of good. DR. ROYAL: I hate to have our technical discussion again, but the reason that even if you knew how much activity was in the lung, it wasn't very interesting. And the reason it wasn't very interesting is no one knew what the risk coefficient was. So the inhalation problem, even if you did it by inhalation, it still wouldn't help you because you don't know the risk coefficient because there was no experience with plutonium in the lung so you don't know how dangerous it was, even if you know how much was there. You did know or at least you had some basis for knowing how risky plutonium in the bone and the liver might be because you could make an analogy to radium. There was no analogy for plutonium in the lung. DR. THOMAS: My bottom line here is that there is a back of the envelope calculation for which there was one key element that was missing that was easy to obtain and so they did it, while ignoring what was really the bigger concern that they had no way of dealing with. So you tackle the problem that you can solve and you ignore the problem, even the bigger more important problem that you have no idea how to solve. Maybe that's a little bit harsh but -- DR. ROYAL: It's a little harsh. CHAIRMAN FADEN: Okay. I for one an content to let the three of you continue to work this out. DR. ROYAL: We're having a good time doing it. (Laughter.) CHAIRMAN FADEN: But I understand the importance for the rest of us, which is ultimately when we come to reevaluate the plutonium experiments, we need this context. We need to understand what was behind their being performed in the first place and whether that rationale was coherent or defensible at the outset. So I gather that's why this is important for the rest of us, quite apart from the other ethical issues raised by the plutonium experiments, at least can we get clear on whether there was some scientific basis for proceeding, even if they proceeded otherwise inappropriately, and we're getting to that. On this very clear note, I guess we can end. The one question is we start at 8:00 o'clock tomorrow. To remind everybody, we have two quick memos from the Protocol Review Project, Subject Interview Study Project that were handed to you in the course of the meeting; two chapters on ethical practices and ethical standards and the remedies -- very important remedies memo which is in your blue packet. It was faxed to you and it's also in your blue packet. The remedies chapter, excuse me, chapter draft. Faxed to you and in your blue folder. (Whereupon, the proceedings were adjourned at 5:00 p.m., to be reconvened on Friday, February 17, 1995 at 8:00 a.m.)