ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS PUBLIC MEETING VOLUME II APRIL 11, 1995 APRIL 10, 11 & 12, 1995 ATTENDEES: Ruth R. Faden, Ph.D., M.P.H., Chair Kenneth R. Feinberg, J.D. Eli Glatstein, M.D. Jay Katz, M.D. Patricia A. King, J.D. Susan E. Lederer, Ph.D. Ruth Macklin, Ph.D. Lois L. Norris Nancy L. Oleinick, Ph.D. Henry D. Royal, M.D. Philip K. Russell, M.D. Mary Ann Stevenson, M.D., Ph.D. Duncan C. Thomas, Ph.D. Reed V. Tuckson, M.D. I N D E X Committee Discussion Intentional Releases Human Experimentation in Connection with Atomic Bomb Tests Observational Studies Professional Standards and Practices Findings P R O C E E D I N G S [8:32 a.m.] DR. FADEN: Good morning. We have a tremendous amount to do today. We should just I think start; we're going to try to get through four chapters, and ideally do it more quickly than by lunch, so that we have time to do everything else we need to do. Mark, you were here at the end of the discussion yesterday so you know that what we're going to is try to focus on not stylistic questions on the chapters as much as, are we agreeing about what we want to say in this chapter; conclusions, findings, interpretation? More than it would be -- if we don't have a good lead- in into the chapter, the readers won't be engaged; this is the wrong style for a general audience, stuff like that. Only because we are trying to use the chapters as much as anything else as a vehicle to flesh out the extent to which the committee is of a mind, a like mind about foundational issues, as anything else. So if the discussion seems to go away from your chapter, it's okay. It would deal with intentional releases, but it might go away from, might not be on paragraph 3, page 18. Although it may well be. So we're starting with intentional releases, which everybody should find. Here it is. Okay, the floor is now open for comments about -- Nancy, you got it. DR. OLEINICK: First of all, as I said to Mark before the meeting, I have apologized for not having reread this entire chapter the second time around, because I just didn't get there; there weren't enough hours before. However, I did look over certain things that I had seen before and I have seen the previous. One of the questions that came up, I know for Duncan and for me, and so probably he intended to ask this, but I'm just getting there first is who was Elliot? And what was the context in which his statement was made; because that's -- the reason is that the statement which is now found on the bottom of page 48 seems to crystallize a lot of the big issues that are in this chapter. Here was somebody back in 1953 who made these statements about informing the public and warning of hazard and so forth. Where was this statement made? We don't have any real context for that, and I guess it didn't come out as one of the things that you probably didn't have an opportunity to do between the last iteration and now; but I think it's so important that we really would like to have some more information in there. DR. GOODMAN: Well, Dan can probably say a little more than I can about this. MR. GUTTMAN: We picked up on Elliot; it was a footnote in Bart Hacker's book that came out; it's a very good history of radiation safety until more documents come out. And he apparently was a public information officer in relation to the Nevada Test, and so this was made in connection with the beginnings of the question of well, we're getting fallout and so forth, and how do we deal with the situation. It's quite long. Mark, it's about a 15 or 16 page memo, just the section it was excerpted from which of course we'll give you. So the context, generally he wasn't talking about intentional releases; he was talking about the Nevada Tests and what to do, and there was controversy about whether they could go on with the Nevada tests. In 1954, the AEC had an in-house review, which was a remarkable document -- I'm pretty sure we gave you what we had at the time. As I recall, the most interesting statement was by Dr. Stakeman, who was chairman of the Advisory Committee on Biology and Medicine, who said, you know, this is risky business but the Russians are here, so we've got to move ahead. Anyway, it was in that context, the Elliot statement. DR. THOMAS: This was a review of Elliot's statement? MR. GUTTMAN: No, no. Elliot was making that in the context of these discussions where fallout is all of a sudden something that is beyond an internal -- we can take care of it, we don't have to tell anybody. There becomes a question of, how do we deal with this? Because people in Nevada and people in Utah are raising questions. DR. OLEINICK: So it was not made in the context of intentional releases? MR. GUTTMAN: No. That's right, no. I think we -- that's right. Well, unless of course you consider the bomb an intentional release, obviously. DR. OLEINICK: Well, in one sense it was, but --. But you have a separate chapter on the bomb, and this doesn't appear in there. MR. GUTTMAN: Well, the chapter on the bomb is about the exposure to soldiers, not necessarily the community. DR. THOMAS: I agree it belongs in this -- it's appropriately placed in this chapter. But what we're not given is any reason to know -- DR. OLEINICK: Where does it go? DR. THOMAS: -- whether anybody should ever have paid attention to him. Was he just some low life that nobody had any reason to listen to anyway, or was he a person of considerable authority? What reaction did this comment provoke? Was it widely discussed at the time, and so on. Was a conscious decision made to ignore it, I guess is the question. MR. GUTTMAN: That gets into this question of the bomb and the way in which that was handled. DR. OLEINICK: And maybe so comment on it belongs in the chapter on secrecy. I'm not quite sure because frankly, you could have definitely sent the stuff on this. You could have. We're not saying you didn't but it's hopeless to find it now. MR. GUTTMAN: Right, and the reason it was there is it an articulation of a principle. DR. OLEINICK: Exactly. And it's a principle around which a lot of this chapter hangs. Which is why I'm bringing it up. And here's somebody who actually said it back in '53. MR. GUTTMAN: Right. That's right. Although as Pat liked to point out, having articulated the principle, it still doesn't tell you where to draw the line; you tell people everything; right? DR. OLEINICK: Right. MR. GUTTMAN: So while it articulates it, we'll get you the document. I don't know that it resolves the --. DR. FADEN: Henry, I'm putting myself on the line. Henry, Pat -- and then I'm putting me on the list. I'm sorry, Nancy, were you done? DR. OLEINICK: No, no, no. That's okay. I've asked that question. DR. FADEN: Hopefully you'll have more than one. And remember, the idea, too, is to sort of really surface what we all think we're trying to say in this chapter. What are the four points we want to make, or the five points we want to make about intentional releases? Around which all the material can be presented. Henry? DR. ROYAL: This is one of the chapters that certainly convinced me that it's going to take a long time before we can reach a consensus on it. I think that the risk of the intentional releases are systematically overestimated and I think that the benefits are systematically underestimated, and it's going to take some work to work that out. A particular thing that troubles me in this chapter and other chapters is the way in which we attempt to communicate risk. I find it ironic that an ethics committee which is looking at consent forms and looking at how well investigators communicate risk to patients would be satisfied with the way risks are communicated in these chapters. Let me give you a specific example: For the Green Run, the way the risks are communicated is that the number of millicuries per milligram of I-131 on vegetation is given, and what's given is the range, and then the example which is cited in an attempt to communicate risk is the ratio of the maximum value that was measured to the permanent permissible levels in vegetation. And that ratio, if I remember correctly, was 80. That does not at all help understand what the risk was from this iodine release, and the reason it doesn't help is because you have no idea whether or not this maximum value was on one leaf, was on many leaves, whether or not these leaves were in an area where they could be ingested. As a matter of fact, I think they were on site. You don't know how long those levels persisted in the environment. It is impossible to get any idea of risk from the data which is given. The only rationale for citing the maximum value that was measured is to get the maximum scare factor, and I think that anyone who knows anything about risk communication who would read these chapters on how risk is communicated would find them objectionable. DR. FADEN: How would you structure it? DR. ROYAL: I think that what is important to people is not what happens to vegetation in terms of how many microcuries of iodine there were per kilogram of vegetation. What's important to people is to understand how it affected their lives. So if I were writing about the risk of I-131 in the Green Run release, I would indicate how many excess thyroid cancers one might expect from the Green Run; I would compare that to the number of thyroid cancers that we would normally observe in the population that was exposed; and I'm going to give you some numbers that I'm remembering from a document I might have read a year ago, but these numbers are available. For preparation for the Hanford Thyroid Study, epidemiologists made calculations about how many extra thyroid cancers might occur in the population based on reasonable dose estimates and risk coefficients for thyroid cancer. My recollection is that the number was in the 30s or 40s, I don't know, maybe Duncan remembers that number or not. Does that sound about right to you? DR. THOMAS: I don't remember the number, but it's in that order of magnitude. DR. FADEN: Sorry, could you just -- 30 or 40 excess deaths, cancer deaths? DR. ROYAL: I'm not sure that's fatalities. It may just be excess thyroid cancers. And fatalities would be one- tenth of that. DR. FADEN: Okay? DR. ROYAL: Now that's for the entire release at Hanford. This is one percent, the Green Run is one percent of the Hanford releases. So my guesstimate, without going back to the original sources, would be that the Green Run might result in 1/100th of the 30 excess thyroid cancers, which was postulated on the entire iodine release from Hanford, or less than one thyroid cancer. I don't know if other members of the committee agree with me, but it seems like that's what's pertinent to people, in that we have an obligation to try to make the risk as clear as possible, and I don't think the risks, the way they're being communicated, is at all clear in these chapters. DR. FADEN: I think this is a big point, because it goes to like "Let's see if we agree or not" about how to characterize this. So Pat, if you wouldn't mind, I've got Duncan wanting to respond to this, Ruth to respond to this, and Reed, did you want to respond on this point? So let's just stay on the issue of how do we want to characterize the risk from Green Run, and Mark has something he wants to say, too. Duncan. DR. THOMAS: I'm sorry, I left my annotated copy upstairs and replaced it with the new version, so I'm having difficulty finding this part that Henry's objecting to. Feel free to interrupt at any point when you find it. DR. FADEN: So we're leafing through to find the page number. DR. THOMAS: It does seem to me exactly the kind of risk calculation that Henry is calling for is in here, and I'm finding it on page 53, the bit in the text where it begins by saying: The Green Run represents only 1 percent of all the radioiodine releases from Hanford - and then goes on. The details of the calculation are provided in Footnote 140. But it comes to the conclusion that about .01 excess thyroid cancers would have been caused by Green Run. It seems to me exactly the calculation that Henry was calling for. DR. ROYAL: Well, part of the chapter that I was referring to, and I'm not sure the reader is going to reach page 51 -- DR. FADEN: 53 line 9, is where Duncan is. DR. ROYAL: Is on page 9 where they cite the highest vegetation level is 28 microcuries per kilogram on the site. And nearby communities had one at 4.3 and thought that they had actually calculated the ratio; it might have been -- VOICE: Henry, page 9 which draft are you reading from? VOICE: You're referring to --? DR. ROYAL: It's the 3/21 draft, not the most recent one. DR. FADEN: No, April 7 is the more recent draft. DR. GOODMAN: One of the things that has happened since then is a lot of the quantitative discussion of risk has been taken out of there, where it didn't really provide useful information to the reader, and incorporated into the discussion of risk at the end. The purpose of having something in that section in the first place is to indicate that it should have rung bells with the safety people at Hanford. I think that's the main point that needs to be raised in the historical narrative, that this really was an extraordinary event at the time. DR. FADEN: I want to make sure we're all working from the same text. I know this is confusing for people because the mailing was late on Saturday morning, and I know that Eli didn't get his mailing -- DR. GLATSTEIN: I got it. DR. FADEN: He got two mailings. That means Henry didn't get his mailing, so let's make sure --. DR. ROYAL: I do have the -- DR. FADEN: Oh, you do. DR. ROYAL: -- I have not had a chance to go through that particular chapter. But this theme of citing maximum dose rates is to cite things in a way which is not meaningful in terms of figuring out what the risk might be, is a theme that persists through many of the chapters. I've pointed them out. In some of my memos, I'll be happy to point them out again. What I'm hearing is that there is a consensus that going to excess cancers and comparing them with the naturally-occurring cancer rates is a more appropriate way to express -- VOICE: I agree with that principle. DR. FADEN: Does everybody -- DR. GOODMAN: And that's what I've attempted to do. DR. FADEN: Right. In this draft there are apparently changes in the direction that you -- MR. GUTTMAN: Parenthetically, what happened, Henry, is that it seems confusing when you're telling the historical story and people don't understand the risk concepts. So we grouped them all at the end -- but it's a question of how do you best present it. DR. ROYAL: I think it's -- I don't understand, and again maybe it's not in the current version. I don't understand how you can tell readers that the concentration was such and such without attempting to give them some idea of what that means in terms of their risk at the time that you're giving these numbers. MR. GUTTMAN: Then it should be -- DR. ROYAL: If you give them these numbers and you don't give them any explanation, they're just going to start ignoring all of the numbers in the text, because they don't mean anything to them; and they're not going to get a clear understanding of what the risk is all about. DR. THOMAS: There's a fundamental difficulty with the whole category of intentional releases, communicating this; in that what primarily is often easily quantifiable is the magnitude of the release into the environment, which does not immediately translate without a great deal of very complicated pathway analysis into human exposure. And the human exposures in any event will be extremely variable, and an important dimension is the population -- the integrated population of adults; and that itself, that's even harder to come up with a number for. So that what Henry is calling for, though it is clearly a good way to communicate risks, it's often something that cannot be done, with at least the data that's available to the committee; because we're not about to go out and do dose reconstruction. DR. ROYAL: But dose reconstruction exists for Hanford, and it should be used -- DR. THOMAS: And is in this. DR. GOODMAN: And it is. I also want to point out that at the same point where I now have fewer numbers, just a couple numbers for comparison, there's also a statement: Fortunately, the public health effects were mitigated by the fact that it occurred during the winter, and the environmental path was suppressed. DR. ROYAL: I don't understand the use of that word, either; "fortunately" as if it were some act of fate that had happened during the winter as opposed to -- that was one of the factors that was taken into consideration. DR. GOODMAN: I don't think there's any evidence of that; it happened right after the first bomb test, first Russian bomb test. Everything I have read suggested that was the reason for doing it so soon. DR. ROYAL: But how do you know that one of the reasons why they weren't willing to do it in the middle of the wintertime is they realized that people weren't going to be growing crops at that time? DR. GOODMAN: I don't know anything about that; there's absolutely no evidence of discussion of risk. No documentation and no recollection of the participants. DR. ROYAL: Well, that's sort of another theme I think that runs through many of the chapters, that when there's an absence of evidence, that rather than saying that there's an absence of evidence, we make assumptions. I'm not sure that those assumptions are correct. So the assumption that's being made is what time of year it was when the Green Run occurred was not taken into consideration. The reason they were assuming that is because we don't have a document that says it was taken into consideration. DR. GOODMAN: Well, the other point about that is that people, as I discussed in the section on risk and lack of knowledge about risk, weren't really aware of the environmental pathway, aside from inhalation. So they wouldn't have known at that point that winter was a better time to do it. DR. FADEN: That's the stronger argument for interpretation. It's just we're thinking about that pathway at that time, according to what's in other parts of the chapter. Rather than that they would have been indifferent to it had they known about it. In that sense, it is fortunate that -- since it wasn't yet on the sort of radar screen of scientists at the time to worry about that pathway, it is good luck that it came out in the winter. Can I ask one question on this risk point, and then we've got Ruth, Reed and -- Mark has already talked. In that same paragraph that Duncan brought to our attention, where the fatal thyroid cancers by .01, this is a simple risk communication point. I don't think people know what .01 is; in fact, I know I've done work, people don't know -- people don't understanding percentages, let alone .01. You've got to say it in English, okay? "The expected number of fatal thyroid cancers by .01" isn't going to help most readers. That's a tiny point. The next thing, though, and say it in words. The next line, though, I didn't understand. That is, "there is roughly one chance in 100 that the Green Run killed anyone." What does that mean? DR. GOODMAN: Killed -- DR. FADEN: Killed even one person. DR. GOODMAN: Even one person. DR. FADEN: What does that mean? DR. GOODMAN: The number is .01, then that's a hundredth of a cancer, so that means one time in 100, there's a cancer. DR. FADEN: Is that right? DR. THOMAS: We're assuming that the incidence follows a Poisson distribution with a parameter of .01. That would be the technical definition. What that means is one of two things: The expected number of excess cancers is .01 or equivalently, the probability of observing one cancer or more; it is one that is due to this event, is .0001, or less than .01 percent. DR. FADEN: So can you do this in English? DR. GOODMAN: It's one percent. DR. FADEN: This is just to illustrate the difficulty that Henry is raising with respect to risk communication. I read that paragraph and I thought -- MR. GUTTMAN: I had pointed it out to Mark, too, but he said it was right; so I figured he was an expert. DR. FADEN: Boy, one in a hundred sounds like a lot. Now, I actually think -- DR. THOMAS: 100th of a case. DR. FADEN: That doesn't -- that English to me doesn't mean one hundredth in a case, though. I didn't know what we were trying to say here. It was like cutting against each other, and this is the sort of core issue. What are we trying to communicate? It sounds to me like what we're trying to communicate is that it's very unlikely that the Green Run killed anybody, okay? Now that doesn't mean that it wasn't a bad thing; that doesn't mean that other things weren't wrong with it. DR. ROYAL: We've heard from many people who are concerned about their health, intentional releases. And I think that it is very important that this committee to try to, as clearly as we can, communicate the risk. I think that we owe that to the people that we heard. And I don't think that the risks are being communicated very well. DR. FADEN: Could you try it, Duncan, in English? What is it with the one hundredth of a case? This is page 53, line 10. DR. THOMAS: I will do a better job if I can sit in peace and quiet and think about it for a little while. DR. FADEN: Then let's -- DR. THOMAS: Let me take a stab at it, though. I think I would use the expected incidence wording rather than probability wording, because I think that's a little bit clearer. But it would be essentially: The committee estimates that the additional -- well, now that I think about it, I'm not sure which of the two is clearer. Let me offer both options to the committee, and maybe the committee can guide us as to which they think -- Option No. 1 is that the committee thinks it's extremely unlikely that any excess cancers were caused by the Green Run; and more precisely that the probability of even one excess cancer is approximately one percent. That would be Option No. 1. Option No. 2 is, the committee considers that few, if any excess cancers were caused by the Green Run, the most likely value being 1/100th of a case. Actually, now that I think about it, the first seems to be -- as I try to say it, the first really does seem to be much clearer. The concept of a fractional case, I think will be difficult for most people to understand. DR. ROYAL: What's a 1/100th of a person getting cancer? DR. KATZ: Did you say the incidence is one percent in your first formulation? DR. THOMAS: No, I said that it was a one percent probability that as much as one case -- that one case or more was crossed. DR. KATZ: One percent. Maybe that can be -- DR. THOMAS: If one says one percent incidence, that applies one percent per person. DR. KATZ: Yes. DR. GOODMAN: I tried to put that across with even one person, but it clearly needs a little more explanation. DR. FADEN: For the roughly one chance on 100 that the Green Run killed even one person was what stopped me. But this gets to the core of it; I mean, this is not a disagreement about the interpretation -- it's just "how do we say this in English" which is so difficult. Ruth and Reed obviously have been waiting patiently to get on this risk communications. DR. MACKLIN: I have another question; maybe I'll defer that until later. I have one just on -- DR. FADEN: Just on this. You're on the list for your other point. This is just on the risk issue. DR. MACKLIN: I wanted to ask Henry if some other statements here, not in the quantitative terms, just to see the extent to which there may or may not be agreement on these other formulations. On page 2, these are general statements about the level of risk to people. Page 2, lines 15 to 17, says: The amounts released were small enough that it is probably impossible to separate the possible long term effects on people from other sources of disease, although the Green Run did exceed the safety standards of the day. That's one place. Should I wait before each one? I only have two or three. DR. FADEN: Yes, I think that would be fine. DR. MACKLIN: Because if we're trying to -- your point about risk communication is going to apply to some people and not others depending on how they deal with the numbers, and Mark says "Well, he took those particular things out." So I just want to look at this, sentence by sentence. DR. ROYAL: Let me tell you why I don't think that's a fair comparison. When Mark says that it exceeds the safety standards of the day, those safety standards were based on a permanent level of iodine. You could have a safer situation in which those safety levels were transiently exceeded if they went down below what the constant maximum value was. So to say that they exceeded the safety level implies that the risk was higher than if they had been kept constant at the safety level, and that's not necessarily true. DR. MACKLIN: So in other words you're disagreeing with this formulation, as well. DR. ROYAL: I'm saying that what we're doing is we're comparing a transient concentration -- DR. MACKLIN: I understand. But the question is how to understand --now the point is, how to understand or interpret the safety standards of the day in this context. So let's go to page 16, lines 1 and 2. DR. FADEN: Before we do that, I just want to make sure I get closure on this. DR. MACKLIN: It's the same clause. DR. FADEN: Before the clause, although the Green Run did exceed the safety standards, and I'm presuming before the clause that sentence is unobjectionable. I'm trying to -- DR. MACKLIN: Right. DR. FADEN: Before the clause it is, the amounts released were small enough that it is probably impossible to separate the possible long term effects on people from other sources of diseases. Is that a general characteristic? DR. ROYAL: That's a true statement. DR. MACKLIN: Actually that was the part I wanted to concentrate on, but now we have this other problem with the other cost. DR. FADEN: Now, continue -- DR. MACKLIN: So now let's deal with the clause. Page 16, lines 1 and 2 are a little more precise with regard to talking about the safety standards at Hanford. "The Green Run clearly did not conform with the safety standards in place at Hanford at the time." How about that? DR. ROYAL: Again, the safety standards, I believe they're referring to, of the permanent -- DR. GOODMAN: In that case, I'm talking about safe operating practices. DR. ROYAL: I actually don't know what that statement means, because when Hanford was first opened it released a lot of iodine in its normal operation; and I don't know what -- it's such a broad statement, I don't know what concentration of what was exceeded where -- it doesn't have any meaning. DR. GOODMAN: That statement is not based on any concentration of radioiodine on anything. It's based on the change in operating practices that took place between 1945 and 1949. So that by that point a typical release was more like 1 curie of radioiodine per day, and they were trying to reduce that still further, where the Green Run released something like seven or eight thousand. So the point being just that it exceeded all of their practice. It was an exception to all their practices that were designed to --. DR. ROYAL: What were the releases in the years '44 to '47; do you know those numbers offhand? DR. GOODMAN: About 700,000 curies of radioiodine. DR. ROYAL: I was trying to figure out a daily release, so we'd have to divide by 900 or 1000; so it would be about 70,000 -- 700? MR. GUTTMAN: 700,000. DR. FADEN: Total for that period. The operative issue here is that they lowered their standards. DR. ROYAL: When Hanford first started operating, during the first three years, it reached 700,000 curies of iodine. DR. FADEN: In a couple of years. DR. THOMAS: Say over two years, because it's easier to do the arithmetic, that translates to 1000 curies a day. DR. ROYAL: And the Green Run was 7000 a day. DR. FADEN: It sounds like there's no way this statement isn't factually accurate. DR. OLEINICK: Maybe the problem is that we're talking about DR. ROYAL: I think what it should say is what it means, and what Mark now says he means is that at the time that this release occurred, Hanford was releasing one curie a day, and this release was 7000 curies. DR. FADEN: So it exceeded it. DR. ROYAL: Yes, but why not say explicitly what it is that you're talking about? DR. FADEN: That's fine. DR. ROYAL: I honestly, until Mark explained what it was he was referring to, I had no idea what that sentence meant. DR. THOMAS: There's a subtlety here, and maybe we should deal with it right now. DR. FADEN: Yes, let's not leave anything -- no stone unturned here. DR. THOMAS: If this little calculation is right, and we figure that's 1000 curies a day, they certainly weren't doing that on a uniform basis. It would be, I presume, quite intermittent whenever they -- DR. ROYAL: Those numbers are available from the HEDR report. The HEDR has a day by day release of iodine. DR. THOMAS: Ah, very good. But the implication is that days when they were doing the processing, there would probably have been 10,000, and in between there would be nothing. DR. ROYAL: But those numbers all exist. And somewhere in the older version of the chapter, it said that it was more than any iodine had ever been released in one day or something, if I remember correctly. And I don't know that it was. DR. THOMAS: We should establish that. DR. FADEN: Ruth, thank you for pointing out all of these places. DR. MACKLIN: I have one more place. DR. FADEN: Please, go ahead. DR. MACKLIN: This place goes to the benefits as well, because Henry, when we started talking about this, you talked about the risks and benefits, so let's look at this one. And this is the bottom of 17 and the top of 18, where it starts by saying on line 19 on 17 it's not easy to balance the harms and benefits, given their vastly different character and the uncertainties of the historic amount. How does one compare, and now it's a statement here, of the benefits or what the alleged benefits were, the benefits of potentially improved knowledge of Soviet nuclear activities with the potential harm to residents living near Hanford. And the judgment, the only one that applies to the benefits here, or what could be learned is under the magnitude of the release. Hindsight leads to skepticism about the need for a release of the magnitude of the Green Run. Presuming, I take it, that the benefits as described, the benefits of potentially improved knowledge of Soviet nuclear activities were what one could learn from that. So my question is, Do you agree or disagree with this characterization of what are the potential harms and benefits? You said benefits before, and I wasn't clear in your statement -- DR. GLATSTEIN: I was going to ask you about that. DR. MACKLIN: Yes, what you meant by the benefits. DR. GLATSTEIN: What benefits are we really talking about? DR. ROYAL: Well -- VOICE: What page? DR. MACKLIN: Bottom of 17, top of 18 in discussing the balance of harms and benefits. DR. ROYAL: I have no particular expertise about what the purpose of the Green Run was, what the state of knowledge was, and how much it contributed to our state of knowledge. Now, apparently, it took a long time for us to recognize what the purpose was, and the purpose was that the United States knew that the Russians were making weapons and they wanted to get some idea about what rate at which they were making it, and they thought -- at least this is what I understand -- that by monitoring how much iodine was coming out that they might be able to get some idea of what the plutonium production was in the Soviet Union. So that was the benefit, in words, theoretically, whether or not the Green Run allowed them to do that, I don't know. DR. GOODMAN: Actually, if you think about it, you'll realize that monitoring iodine emissions from a plant will not tell you how much plutonium -- DR. ROYAL: I said iodine, but presumably they were probably looking for other radionuclides. DR. GOODMAN: The principal ones that are released in an early dissolving activity would not be the ones that would tell you how much the Russians were producing. DR. FADEN: Pat wanted to get in on this. DR. ROYAL: I'm confused, Mark. Why did they do this experiment? DR. GOODMAN: You might learn something about where the facility was. DR. ROYAL: So you're saying if not the rate of production, it was where it was. DR. GOODMAN: Right. DR. FADEN: Pat, did you want to get in on this one? PROFESSOR KING: I have these pages all marked up because I can do nothing about the risk stuff, because I'm not good at that. But the reason that this exact point is marked up on mine is because of a problem I have had in certain parts of the chapter of drawing too much from the evidence that is available. That is a question of what you do with what you have. What inferences reasonably stand up. And I would have been happier with this segment about some of the judgments if it had been clearer that we were not saying what they should have done at the time; because I actually think that's quite hard to do. I would have been happier if it had said: We think there are some lessons that we might draw in hindsight from. And the language really gets mixed up here. At some point we say, the implication is, they should have done it differently. I think if you're trying to draw an implication of, "they should have done it differently" you have to have a certain level of proof to be able to do that. An implication that says "In hindsight with what we know today, what can we learn from what evidence we have that would be useful for us to draw on?" When can you, in my mind, have a lower level of evidence? Because you're using your evidence for different points. I kept marking up this page saying "hindsight, hindsight." I've got it written all over the page: hindsight judgments rather than trying to do what I think is a more objective way of describing what we have, is I guess a little bit in what Henry is trying to get and I am, too: I am not often disagreeing with what we want to do so much as I have had some disagreements with how we do it. And I think that these judgments, in terms of lessons to draw, is exactly what the committee wants to think about. Rather than saying: You should have done it differently, guys, at the time - - am I being real clear about that? DR. FADEN: Yes, you're being very clear about what you want to say. Now the issue is, how many people agree with that. Reed has been waiting very patiently. Is your point lost, or is it on here? DR. TUCKSON: On here. DR. FADEN: Okay, and Ruth, I'm not sure if you're done. DR. ROYAL: I'd like to comment. DR. FADEN: Okay, so I've got a growing list, of: Reed, Eli, Mary Ann. DR. MACKLIN: I'm finished with that point. DR. FADEN: So your point is on something else. Reed, you've got it, and then Henry. DR. TUCKSON: I like the last statement that Pat just made. I think all of us are struggling to make sure that we state things clearly and not overreach, and I think this conversation is very important, to make sure we don't overreach. The one issue that, as this discussion unfolds, I would like to have people comment on as they continue to make their points is this: is that if I pull out a gun and start shooting in this room and only, thank God, hit one arm, the outcome that -- well, my experiment only did result in one arm being shot. Therefore, we will make some conclusions. But the fact that I sprayed the room with bullets is also in and of itself important. So that while I think it is important, very important, particularly for the reason that Henry made of the witnesses that have come to see us and the concern, the anxiety out there, it is important that we also let people understand what was first possible to the best of our ability. And if we can't make a good statement on it, we need to say "This is the best that we can say about what was possible." We don't know. Number 2, I think we need to say to people that people thought about that possibility at the level of knowledge at that time, and chose rightly or wrongly, justifiably or not, chose to do something in excess of what they normally would have done. They made a decision to do that. Cold-blooded. Then get to these issues of, the actual results of all of this were that, this many people probably got cancer. And then there are other consequences of the secrecy and so forth which we'll get to later. So they were the biological and then the non-biological consequences. So I just think that I'm -- I guess to bring it to a close is that, we need to be very precise about each of those points, not overreach; but you have to I think put all the points out there. DR. FADEN: Thank you. Eli? DR. GLATSTEIN: I wanted to get back to this issue of benefits from these exposures. It's not really clear to me what those benefits really are. It may have been some information that made people feel better, but I'm not sure that individuals really benefitted from that exposure. And I think that's the heart of the problem here, that people are making decisions about who gets exposed or not exposing themselves. It's much different than the medical exposures where the desire and the intention is to benefit the patient. This is a totally different issue. Along the lines of risk analysis, I have some problems with all the quantification that goes on in these risk analyses. I can't do any better, but most of them if not all of them really depend upon number of people exposed and number of years they have been exposed, and they come up with a person-year exposure. Inherent in that kind of logic is the idea that 50 patients exposed for one year equals one patient for 50 years, and that's not logical. The knowledge that you get from these probabilities clearly increases with time; and realistically, you know, it's 50 years ago, following the atomic bomb explosions that the U.S. set up the U.S.-Japanese health program to follow the patients, the individuals exposed in Hiroshima, Nagasaki. That's still going on today because we haven't got good answers. I'm all for trying to make that risk business as clear as possible, but I think when we go through these protocols we're talking about acknowledge of ignorance? I think there's a hell of a lot of ignorance about what we do, even on these issues. Now you may quantify it as best you can, but that doesn't mean that it's actually meaningful. It's just the best job we can do. DR. FADEN: That's actually a very critical point here, to see whether there is agreement on -- Eli has characterized this as well, and I pull back from that for just a second; and if Mary Ann and Henry will indulge me. On the one hand, there seems to be -- I'm looking for people who have relevant technical expertise. Henry and Duncan at least have spoken, agreeing that -- Nancy seems to be shaking her head, in the characterization with respect to likely excess cancer deaths. At the same time it sounds as if you -- and that we could use whatever -- when we finally work out the language, some way of saying this. DR. GLATSTEIN: There are a lot of assumptions that go into those calculations. DR. FADEN: At the same time what I'm hearing Eli say is that you would want some sort of qualifier that says "Well, we can't be certain that this is the end of the story, because this is all based on whatever." Now, that kind of qualifier would undercut whatever kind of message you're trying to communicate about the likelihood that this didn't do any -- DR. GLATSTEIN: The point about a medical exposure is it has a potential -- there is an intention of trying to give benefit for very specific reason; it could be a diagnostic reason, it could be a therapeutic reason, so forth. The point about these intentional releases is there is no benefit that's intended. DR. FADEN: For the people who are exposed. DR. GLATSTEIN: For the people who are exposed. DR. FADEN: But that's why you get a fundamental justice issue here. The point is there is a benefit, at least the people who do this think is worth the exposure. And that's - - DR. GLATSTEIN: That's hard for me to accept. I know that there's information to be generated; and that information may be used, but I'm not sure that that information is critical as people -- you have to put this in the context of the paranoia about the cold war. DR. FADEN: Correct. But the issue is, this is why Ruth took us to this line. I mean, the line itself is a question. DR. GLATSTEIN: I'd have more ease of acceptance of that if we were talking about a hot war, not a cold one. DR. FADEN: Granted, but the line -- DR. ROYAL: You're a little bit late, then, developing nuclear weapons if you wait for the war to begin. DR. GLATSTEIN: Yes. DR. FADEN: Minor problem. The line that Ruth drew to our attention is a question; how does one compare the benefits to potentially improve knowledge? You could put potential benefits to make it more symmetrical, which probably ought to be there. Potential benefits and potentially improved knowledge of semi-nuclear activities with potential harm to residents living near Hanford. And they are both conditional. Benefits might happen and the harms might happen, and as Reed points out, the people back then we think made a tradeoff. Mark's point is we don't have any documents that bear on their reasoning process, right? DR. GOODMAN: Right. DR. FADEN: So we don't know what they did, so we have to just simply say "We don't know how they reasoned through this." Because we have no documents available. All we know is that they did it. We presume they did it because they thought the benefits outweighed the harms, but we don't know that. DR. ROYAL: We do know that they knew that they had released 700,000 curies of I-131 during the other period. DR. GOODMAN: They probably didn't know it that precisely, but they did know that they had released a lot. DR. ROYAL: They knew they released a lot of radioactive iodine. DR. FADEN: Ruth, do you want to get in on this? DR. MACKLIN: Yes. I want to say something specific. It goes to Eli's point, but I think we have to be careful how we characterize -- that is the nature of the benefits is what issued here. Not potentiality, but the nature of the benefits. Because we have to be careful with Eli's point, since Eli, your presumption there is that when the radiation was used in biomedical cases, it's for diagnostic, therapeutic or other purposes. Now, that may benefit the subject. But of course that's not always true. There are patients or subjects healthy, or patients for whom, where research is done where the contributions to knowledge are the benefits and not -- there are no direct benefits, or anticipated diagnostic, therapeutic or prophylactic benefits to the people. So we have to be careful not to lump all the biomedical ones as if the research will benefit those individuals. Nevertheless, in the biomedical context, the plutonium examples and the stuff in the atomic vets chapter, all of those benefits are, or hoped-for benefits are health-related. That is, the contribution now of whether it has to do with troops or civilian populations or whatever, the knowledge to be gained in terms of the information when you're weighing the risks and benefits are health-related, and that's what I mean by the nature of the benefits. The benefits here of potentially improved knowledge of Soviet nuclear activities, and I guess what Mark said is, it can tell you where, basically; it might be able to tell you where, but not much else. It has nothing to do with health benefits. DR. KATZ: It's also health related, to future generations. How the next generation may be affected. Yet children may benefit. DR. MACKLIN: National security -- I mean, I don't want to lump everything into health benefits. If people are going to die because somebody drops a bomb, that's a war thing. DR. FADEN: The issue is, to characterize it as different, are you doing anything more than saying it's a different kind of benefit, a different arena of social values? DR. MACKLIN: It's a different kind of benefit, and therefore as hard as it is to weigh health-related benefits to others, to the potential for harm, the risks of harm to the individuals in the biomedical context, it's much harder, as I think this tries to convey here, to weigh something that's not related to health but is related presumably to detecting what's going on 6,000 miles away in the tundra, to the particular harms to the people in the city of Washington. I'm just saying weighing risks and benefits -- Ruth, you used the expression before, we don't know what they did; maybe they were weighing this. I think they probably didn't weigh it, we don't know. DR. FADEN: I can't imagine that they did -- PROFESSOR KING: Can I add something to Ruth's point? We have to be careful about understanding what is perceived as a threat to the community's security versus a threat to individual health. I follow Ruth's argument, and I have no problem making her argument, but an additional consideration of that argument is that we actually in theory have set up a way to do the latter better than the former. Medical research, to a large extent, made by private persons, not elected, not delegated to make lots of judgments. We are biased to think that somehow that tends to be better. Actually, when we look at it, we have a constitutional structure that in theory, and I'm going to keep emphasizing in theory, is set up to and agreed to by us in some form of common consent, to make precisely the kind of judgment that we're criticizing, in terms of how it was actually made. So we actually have to be careful, I think, in how we lay out what the issues are. I realize this is hard, because we all have strong feelings about some of the evidence that we have seen. But when we're making these kinds of things -- you have to, with care, lay out what the issue is and so Ruth is correct, but there's this flip side to it as well. DR. FADEN: I think that's exactly right. Mary Ann has been waiting. DR. STEVENSON: I had the same reaction to the section that Pat was describing. My inclination is to just move it entirely out of that section of the document and put it back -- DR. FADEN: Where are you? DR. STEVENSON: Page 17, 18, the retrospective assessment of Green Run. And I would put it back in, the later pages where actually the risk analysis shows up, or somewhere toward the end of the report where it's very clear that what it is is a retrospective assessment/ judgment of this Green Run based on present day standards, rather than inserting it here where it looks as though you could remake history. DR. FADEN: The reality of that -- check me out on this -- we don't know how the decision was made, we don't know who authorized it, we don't know how high up that authorization came from. So we really aren't in a position to criticize it from that point of view because we don't know. For all we know, the President authorized the Green Run, or some guy in an Air Force base authorized the Green Run. Is that right, Mark? We really don't know where the authorization came from? Or is that an overstatement. DR. GOODMAN: We don't know, but we do know that the Air Force was given the mission of long range detection of nuclear tests, test explosions, and it appears that this was a natural extension from their point of view of that mission. DR. FADEN: But we don't know who authorized it, and we can't simply -- DR. GOODMAN: It was an Air Force mission. DR. FADEN: Right, but we don't know whether it was an Air Force commander who made the decision without checking upward -- and this goes to Pat's point; we don't know at what level this decision was made, to trade off some public health risk against some perceived national interest in defense. Somebody made that decision, or maybe they didn't even think about the health side, down side, we don't know. But somebody made that decision. We don't know who, the level of authority was of the person who made that decision. So it's very difficult to criticize the Green Run procedurally. We don't know if the procedures were right or not right. We don't know now. But you can, in Pat's language say "But look this is how it should be done, in the future. This is what this committee thinks ought to happen if somebody ever wants to do something else like this again." We don't know how it was done at the time of the Green Run, but it ought to be done in the following way. We know a little bit more about the fact that -- we note they didn't tell anybody, and they didn't tell anybody for a long time, and we haven't gotten to the secrecy stuff part of it, but we can certainly comment on that. But that's I kind of think the sort of thing we need to make clear in the chapter; is that what I'm hearing? If we knew more about how the Green Run, who had decided to do this and what their reasoning was, we might be in a position to criticize it. So it's not as if we're taking the position that one can never criticize the past, to go back to our retrospective moral judgment issues; it's simply, in this case, we don't know whose idea ultimately -- who signed off on this and who ordered it and who decided to go forward even when the weather conditions weren't that good -- all that detail is kind of --. PROFESSOR KING: I must also say we're not even in the position, unless we have something in the documents. We're not a committee that can assess "Well, what if any benefits actually resulted." I do think we are a committee that can say there were costs. There were costs to the secrecy that, whatever the benefits were and how others who might assess the -- we are in a position to point out what costs there were. And the costs have to do with what information we actually have about exposure, risks, and what risks came about. Those are the things we can point to. There were costs in terms of trust in government, which are the things that we make, that we talk about here. Those are important costs that, even with the costs, some future group might decide that the benefits are still great; but our job is to show what we lost, I think. If we believe that we lost something. I do. DR. FADEN: I've got Henry and then I saw Sue, and then Nancy. DR. ROYAL: Just to make things more complicated, another thing that troubles me about the risk-benefit analysis that we're attempting to do is, we're usually comparing the risk of a certain decision to nothing; as if the alternative has no risk associated with it and ideally what we want to know is the net risk, the difference in the risk of one action versus another. So for example with Green Run, the risk of doing it was that you were going to cause thyroid cancer. There presumably were some risks of not doing it. The risk of not doing it being that you wouldn't be able to detect the Soviet weapons development program. DR. FADEN: Or maybe you wouldn't be able to do it as quickly, or something. They thought that. DR. ROYAL: Yes. So that's just something that we haven't talked about in terms of risk-benefit. The second thing is, Eli was mentioning the uncertainty about the risk. I think that there's much greater uncertainty about the benefits. It really depends very much on your world view. So when we start trying to do a risk-benefit ratio, which I think is the important thing to do when you're trying to decide -- DR. FADEN: Well I thought that what I was hearing is that the committee is saying it can't do a risk-benefit assessment of that. DR. ROYAL: I understand that, but then it's impossible to make any judgments about whether the decision is right or wrong, without doing a risk-benefit ratio. DR. FADEN: I think that's what the committee is concluding in this case. Should we get clear on that? Which is not the same thing as saying that bad things didn't flow from it, and that we have thought about how it should be done in the future. We're simply saying that in this particular instance, we're not constituted, nor do we have the evidence available us, to be able to say that was a wrong thing to do at the time. Unlike some of the other things where we are perhaps prepared to say that. And we're not saying it was a right thing to do at the time. We're saying we don't know if it was a right or a wrong thing to do at the time, in the case of this chapter. DR. KATZ: So what can we say? DR. FADEN: Well, that's what I'm trying to get clear on. Can we say it was a wrong thing to do at the time? Are you prepared to say that? DR. ROYAL: The question I have is if we can't -- DR. GLATSTEIN: I think so. DR. FADEN: Okay, tell us why. DR. KATZ: I don't know what we can say. DR. FADEN: I think that's what we have to get out. If somebody wants to argue that the committee should conclude that it was a wrong thing to do it at the time we need to hear the arguments now. So Duncan, let's hear them. DR. THOMAS: I'd like to organize my thoughts first. I sense that -- I'm moved to emasculate this chapter, which I find very disturbing. DR. FADEN: I think let's -- PROFESSOR KING: I don't think any of us wants to emasculate the chapter. I want to be clear about this. I think that I couldn't find anything here; maybe it's not here, maybe it's buried in additional documents, but I couldn't find anything here that could lead me to make a judgment. So I'm willing to be convinced differently. I don't run away from the judgment, I don't find it. That's my problem about evidence. So if there's evidence that could make me feel differently, I really want to be convinced. DR. FADEN: I think committee is prepared -- let me see about this -- Let's put it this way: I have trouble with the decision at the time. I have no trouble making a judgment that keeping this stuff secret for all those years afterwards was wrong. Now, is everybody on the committee willing to sign on that there was wrong about some point in the history, there should have been a disclosure to the people at Hanford about what had gone wrong, and it didn't have to take 30, 40 years of FOIA requests and everything else to get it out. That's clearly wrong. DR. GLATSTEIN: Was Green Run the first intentional release that anyone knows about? DR. FADEN: Intentional release of -- DR. OLEINICK: Of radioactivity? DR. GLATSTEIN: Radiation into the environment, intentional. With potential population exposure? DR. OLEINICK: What about the one at Oak Ridge that preceded this? MR. GUTTMAN: The Rala started in 1944, right? DR. GOODMAN: Yes. DR. ROYAL: And there was atmospheric testing. DR. GOODMAN: Depends on what you count as an intentional release. DR. GLATSTEIN: Well, a deliberate exposure to the population. DR. ROYAL: No. It was not the first. DR. GOODMAN: Well, there were deliberate events that resulted in population exposures. The bomb tests, operation of Hanford. What distinguishes something like the Green Run is that it was an environment experiment; the environment was a critical part of the experiment. DR. FADEN: As opposed to the routine releases, which were a part of the operation of the plant; but nevertheless, dumped stuff in the environment. DR. GOODMAN: Right. DR. FADEN: And put the community at risk. DR. GOODMAN: Right. DR. FADEN: One of the things that has already troubled me is this issue, if you really want to get to it, the question is the dumping of all the stuff in the community of which Green Run is this drop in the bucket. That's really what has already bothered me about this, is that we had more constrained folks on the Green Run; but in fact the larger issue is what happened at Hanford overall. DR. OLEINICK: Of course. DR. FADEN: Ruth? DR. MACKLIN: I want to try to look at your question, or suggest a way of looking at it -- I can give you my answer; on your last question which was, was it wrong at the time. DR. FADEN: Right. DR. MACKLIN: I think the only basis we might have, given the inability to balance, to know the benefits, given the inability to balance the risks and the benefits, and given the world view issue that Henry raises; the only grounds remaining, then, for trying to answer the question occurs on the paragraph or is embodied in the material on page 18 between lines 9 and 13. Ignorance and uncertainty about risks. How ought people to act when they are responsible people making judgments when there is ignorance or uncertainty about risks and they know that there is ignorance and they know that there's uncertainty. Now this is only five lines here, but when it says: They knew their knowledge was uncertain, they had been wrong by a large margin earlier, when the discovery of the vegetation pathway -- and as it turned out, they were wrong here because they didn't understand the milk pathway. Now of course retrospectively we can say that, but the point I'm looking at here is when people know that there's uncertainty, when they've been wrong in the past, what is their obligation to act based on their uncertainty and the knowledge that they had been wronged? A little humility, it seems to me, when you're dealing with lots of people, might suggest that you act on the knowledge that you have ignorance, or the knowledge that you are uncertain; and so that would be the basis, I would suggest, for arguing that it was -- if we want to argue that way, that's the basis for argument. DR. KATZ: Ruth, can I ask just a clarifying question; it's related to this and mainly addressed to Duncan and Henry. I admit it's naive. Am I to understand that -- and it indeed goes to the question that was raised here about, why did they keep it secret for so long -- that they might have kept it secret because they felt that maybe more danger occurred to the population than in fact did occur. And they were just ignorant of the consequences of all the Green Run releases was really by and large inconsequential in terms of their medical implications, or human implications. But they were ignorant about this, and therefore were embarrassed to share the knowledge with the population. Or is that not so? DR. THOMAS: You're suggesting a cover up. DR. KATZ: No, we know it's a cover up, but could they have said to the people: Okay, "Father, I have sinned." But really, there's nothing to worry about, you know. Here it is. There are really decremental implications. Is that a stupid question? DR. OLEINICK: I don't think they do that. No. The other thing is, the Green Run document itself suggests that the operation was essentially bungled; the idea was they were to have perfect weather and they didn't have perfect weather, and it did interfere with the experiment. So the experiment was in essence, at least a partial if not a complete failure. And somewhere in there it says they didn't want to do it again. DR. GOODMAN: Yes, and another element of it -- DR. FADEN: We don't know why. DR. OLEINICK: We don't know why. DR. FADEN: We're saying they're not going to do it again, if somebody says: I recommend against doing it again. DR. GOODMAN: There's a little more context. That actually was because the experiment had gone awry and did not go as predicted, so the risks -- there was a recognition that they didn't understand enough about the risks. DR. KATZ: They did not. DR. GOODMAN: Right. DR. OLEINICK: So hindsight told them that maybe this was something that either shouldn't have been done, or should have been done better. Again, we don't know exactly all the -- DR. FADEN: We can describe all that, and it's in there, it's in the chapter. We can describe all that. PROFESSOR KING: This is also relevant to the continued need for secrecy. It's really why it has to be described. DR. FADEN: Because they bungled it. PROFESSOR KING: Right. It's relevant because of danger of this at the time. DR. GOODMAN: I don't think that had anything to do with it. I think it was habitually secret at Hanford, and it never came up to release information until much later. DR. FADEN: Can I try to -- and this is exactly what we need to be doing, which is great. We're going to the substance of the chapter, we're going to what does the committee want to say about this important historical event. I don't know if we have consensus or not, but I wanted to pick up on Ruth's suggestion that Duncan is still working on, and I don't know if Nancy wants to contribute to, what argument could be put forward to judge it as wrong to do at the time as opposed to the way it was done. Somebody made a decision to go even though the weather was the wrong way, and that is a different kind of wrong decision. They shouldn't have tried to go to the moon that day; it was a mistake. Not the idea that it's a mistake to go to the moon. So that's a different order kind of question. The first question is, you know, the issue of whether it was wrong to do something like the Green Run is the one that the committee is having difficulty saying it can make a judgment about, because of all of the factors that ruth summarized. But then Ruth put out that there is this issue of, they knew they didn't know a whole lot. My response to that is that maybe something the committee -- I'm trying to get something the whole committee could agree to, is to say that given they didn't know a whole lot and they recognized they didn't know a whole lot about what the risks might be, that there was a tremendous burden on them, whoever it was to decide this, to make sure that a lot was at stake on the other side, and not doing it. We don't know that that's the case, but we can at least I think make a judgment that says "This was the kind of situation that whoever it is that decided this had the real burden to be making the arguments that the need on the other side, the cold war side, was really great" because they didn't understand the risks really well, and there was the chance that they could do harm to this community. As it happened, it doesn't look like they did that much harm from this particular release; but at the time, they weren't well armed with --. DR. ROYAL: I'm not sure that I buy this uncertainty risk, uncertainty argument. And the reason I don't buy this uncertainty argument is again that they had already released 700,000 curies of radioactive iodide into the environment; so if you're certain about the 7,000 curies, you're uncertain about the 700,000 curies. Somewhere along the line, somehow, a decision had been made to do atmospheric testing of nuclear weapons, which was releasing enormously more. So if you're going to do the uncertainty argument -- I don't see where uncertainty comes into it, because if you're uncertain about the 7,000 curies, what about the mega-curies that -- DR. FADEN: But again, it's against what benefit? Presumably there was a judgment, the benefits are different. Again, we're in a position to know that -- DR. ROYAL: Regardless of what the uncertainty is, clearly, releasing 7000 curies into the atmosphere has to be less harmful than -- DR. FADEN: Than 700,000. DR. ROYAL: Or, even the 700,000 is a small amount compared to the amount of radioactive iodine that was released in the environment from atmospheric testing. So at a time when you're releasing these enormous amounts of radioactive material into the environment, 7,000 curies must have seemed like not a big deal. PROFESSOR KING: But Henry, I go about to thinking about my venipuncture examples for biomedical research. We think they're not risky; we have a lot of evidence that they're not risky. I think it is wrong to expose a human being to harm even for a venipuncture, even though they may be minuscule, for trivial reasons. So the fact that there was atmospheric testing going on and a lot of radiation being released into the atmosphere does not to my mind -- it's not your point, it's a different point -- does not justify the release in any other instance where you might expose more people to harm, unless you have asked yourself very hard questions about what potential benefit that you intend to receive. DR. ROYAL: I agree the risk-benefit ratio is important. PROFESSOR KING: So I think what we want to say is, whatever evidence we now have that we are clear about, what were uncertainties then, in drawing our lessons, we say that they did not notice at the time; but now that we know these things, what we draw from this is, that when people make these kinds of decisions, they operate from the principle that it's never justified to expose more people to risk without having examined with care, or however you want to make this language, about the benefits of this particular, just once reported that experiment, after all. That without looking hard, very hard, at what you hope to get from this amount of exposure. I think that's a better way. DR. FADEN: I think that's -- PROFESSOR KING: That's what we want to say, the fact that there's atmospheric testing going on cannot justify exposure of additional people to risk other than those exposed by the testing for other reasons. DR. FADEN: Right. Here's what we're going to do, and this is awful because we have to decide whether we want to stay forever with this chapter or go on to the other ones. I don't know, but I see Reed, and I saw Sue, and Mark. And then we have to make a decision about whether we want to take this chapter to the end or we want to go on to the next chapter and see where we are. Or go on to the next one. PROFESSOR KING: I have some different points, other than the risk. DR. FADEN: So maybe we should take ten minutes to do the other ones and then go on. Can we wrap up on the risk one? I think what I'm hearing is something like, that we are not in position to say that the release itself was wrong. Not that it was right, either; it's simply that we're not in a position to do it, but that we -- the secrecy issue is a separate matter which so far I haven't heard anybody wanting to defend the secrecy for all those years. DR. GOODMAN: I'd like to butt in here because I don't want to bring up this point at the very end as you go on to --. I want to report on a conversation I had with a retired CIA official from the joint Atomic Energy Intelligence Committee; and he was not aware at the time with the Green Run, but it was known within the atomic energy intelligence community. I asked him about the magnitude of the release; and his -- it wasn't necessary. His response was, "Well, in -- it was just plain silly. That it was so enormously out of proportion that it's hard to justify." At the same time, however -- DR. KATZ: I don't understand. What was silly? DR. GOODMAN: The magnitude of the release. DR. FADEN: He's saying that now. DR. GOODMAN: He's saying that now. And then I asked him, well, would you then say that people should have known better? And he wouldn't go to that length. DR. FADEN: That's the difference. That's what we're struggling about. DR. GOODMAN: I think the magnitude is an important question in addition to the ignorance. We should say something to the effect that we now know that nothing like that was necessary. And I think in fact if they had thought for a few -- if they'd thought for a little bit about what they were monitoring routinely at Hanford, they would have realized that the magnitude was not necessary. DR. ROYAL: What Mark is saying to me goes to the point about the report should be the voice of committee members; and if Mark says that the magnitude was greater than it should be I would want some member of this committee to feel comfortable and to be held accountable for making that comment. DR. FADEN: I think we have to do it stronger than that, Henry; the entire committee or the bulk of the committee has to agree that it's a statement it wants to say. Not in any one committee. I'm going further than --. DR. ROYAL: Because this again is sort of a common theme that runs through many of the chapters, where we talk to people 50 years later. It's not clear in some instances how many of their mental faculties they still have left. They say something and then we use that hearsay evidence as some kind of evidence for whether or not the magnitude was appropriate or not. I just think that that's a very sloppy way to make decisions. DR. TUCKSON: Well -- DR. FADEN: Mark obviously disagrees, but -- DR. GOODMAN: I disagree. It's very difficult to discuss it in an open setting. DR. FADEN: Well, the point is, Mark, everything has to be in an open setting and everything we write has to be in an open setting, and every piece of evidence that we have has to be in an open setting, so we have no choice. That's the constraint of this committee. Now what we need is a view that the bulk of the committee can sign off on; ideally the whole committee. That's the discussion yesterday, on as much of this as we possibly can; and that's what we're struggling to achieve. The only way that you or anyone else can sort of assist with that is to put out the evidence that would cause the committee to have that view. That's really what it comes down to. It's not that you're powerless, it's just that you have to marshall evidence to show that that's the interpretation the committee ought to take. And what the committee is saying, I think is, that so far on this draft, it isn't there. Now if it exists somewhere that can be publicly shared, that's the committee's mission, and we want to get it out. That's sort of what we're stuck with. Reed and Sue. DR. TUCKSON: I think the last point you made is very important. Not to go long on it, but I think that one of the areas that is tantalizing on this point is on page 15, lines 1- 10, where you have this very important but brief comment that the health physicists and some other folk did set up a review board that did say, in fact, that the degree of risk justified in wartime is no longer appropriate here. You've got people already at that time saying "Ho, wait one minute here." They got overruled by somebody else. And I think it is -- DR. FADEN: Guys, this won't work. We can't do this right now. So if you want to leave, but it's too distracting to the committee. DR. TUCKSON: But actually, I'm talking -- I need him, actually. DR. FADEN: We need Mark and Dan to attend to Reed's comments or it's not going to work. DR. TUCKSON: But anyway, just on this point, and we don't have to debate it now, but just for later, I think one of the areas of data that is required is to explain more fully what this whistle-blowing was in lines 1-10 on page 15. And if we could understand, is there some substance here, that really does -- what is it that led them to say that the level of risk does not -- the level of benefit/risk is out of whack here, and we shouldn't go forward. What is that we should -- because what's implied here is that when they were overruled for some reason; either they were wrong or there were some other exigencies that were at play, and I think that -- unless you can tell us that there is just no way to understand this any better, this is important. DR. GOODMAN: But this was about routine operations. This paragraph is about routine operations at Hanford, and it's not directly related -- it's background material for describing how the operation could be changed to reduce risk levels. I'm trying to figure out how to compare the Green Run, which was a large release, in context of 1949, set it apart in some way from the wartime releases which actually, in fact, took place in a different context. DR. TUCKSON: The reason I raised that is exactly the point, because of Henry's important point, which again is that in the scheme of things at that time, this release, he's saying, isn't that big a deal when you are having this overall release. And he's asking us to think about what we compare things to. Well, here, it's already true, and it's just that it's important for us to understand we're going to make this statement: If it's already true that the baseline of their normal operations is already under concern, then the notion that you're going to go well beyond that has another level of importance. DR. FADEN: Okay, you're sort of supporting the mindset even at the time it shifted. We have Sue, Henry, and then we have to take a few minutes on other points in the chapter. We've got to do it quickly, because we are never going to get to the other chapters. Although this is as important as going through the findings; it really does it much better and we're just fleshing out where the committee stands. Sue, Henry, and then we'll open the floor for discussions about some other part of the chapter. Like ten minutes, and then we'll have to stop. DR. LEDERER: I'll be brief. This is echoing something that I took Pat to be saying, that we want to be clear about knowing what we can, and communicating that as clearly as possible; and if we want to make judgments about what should have been done differently in the past, I think that this draft doesn't get us there. I do think there is a way in which we could use some of the material that's in the draft maybe to enable us to make that judgment if that's a judgment the committee wants to make; and I think that we could make more of the comparison with the release of biological agents into -- intentional releases of biological agents. It's in here in a note, for example, on page 49, and you make the observation that the committee found no evidence that there was deliberate release of radioactive material into populous areas, suggesting that somehow the decision making calculus for the release of radioactivity is different; and that's going on by the Chemical Corps in the release of biological agents. Can you give us more information about that? If in fact the committee wants to evaluate the decision making calculus at the time and reach some judgment about what should have been done -- now may that's not an area we want to pursue. DR. FADEN: My own personal view is we'd be happy to pursue it if we had a good enough evidentiary base for making the judgment. That may be one avenue to try to plumb, to see if we can get to it. I don't want to shirk that responsibility; I think it would be -- it's incumbent on us to make it, if we can make it. But right now I'm not seeing -- again, I want to parcel out the secrecy stuff, I think that's separate, where I think the committee is positioned to say something; but that's an interesting avenue to pursue. Are you suggesting that there's reason to think that more care was taken here than in the biological element --? DR. LEDERER: Well, I'm asking -- DR. GOODMAN: The footnote. it's Dan's footnote, but my understanding of the program is that in the biological warfare program, there were at least simulated biological agents that were thought to be practically harmless but were in fact not harmless. DR. LEDERER: The note says hazardous substances are disbursed in the air in Minneapolis and St. Paul. DR. GOODMAN: Right. And as it turned out, they were not entirely harmless. So the wording is unfortunate there. They were thought to be practically harmless and they were not. DR. LEDERER: My question is, though, is there some sort of decision-making protocol that these people enter into that should have been incumbent upon the people who were releasing radioactivity into the environment for experimental reasons? That's what I -- that's going to -- DR. GOODMAN: I don't think there's any more structured decision-making for the biological and chemical warfare programs than for -- DR. LEDERER: Do we know that? DR. GOODMAN: We could; we haven't looked into it. I think if we looked at Leonard Cole's book, we would have a strong basis for saying something about it. DR. FADEN: We will pursue it, Sue. We'll see if we can mine anything there without too much effort, but we need to go on. Henry, can you bring this point, and then let's go on to other issues on the chapter, or the general issue of risk. DR. ROYAL: Two quick points; one is that the social justice issue about who takes the risk. One of the things that I think is an important consideration is, these people's families were living in Hanford, that people who knew that the releases were going on, were also the people who lived in that community, their families lived in that community. DR. FADEN: Is that true? DR. ROYAL: If you've been there, there's no place else. DR. FADEN: No, I mean for the people who made the decision. DR. ROYAL: Well, if you're asking the general -- DR. FADEN: We don't know who made the decision. That's what I'm saying; and the people who were there didn't have any choice. DR. ROYAL: -- but the people who carried out the monitoring -- DR. FADEN: If there was an order, they wouldn't have had a choice, is what I'm saying. We really don't -- again, it's a case of the evidence. If the decision was made by somebody in D.C. DR. GOODMAN: Clearly it was. DR. ROYAL: That wasn't what I was implying. DR. FADEN: But then the people who carry it out aren't positioned to say "we're not going to do it." It's an order; it's like the atomic vets people; what are they going to say? "I'm sorry, we're not going to march?" Now they could have evacuated their families and we don't know if they didn't. We don't know if they didn't send their kids to Aunt Marsha in Los Angeles when the release took place. So here's a case where, I think that's an instance where we just -- it would be pulling beyond what we know. DR. ROYAL: The second point that I wanted to bring up is, we were talking about forward looking recommendations, and I'm impressed with our difficulty to come up with risk-benefit ratios; and I hope that our forward-looking recommendations struggled with that issue, because I don't see how we can expect other people to do a risk-benefit analysis if we can't even provide any guidelines to do it, never mind do it ourselves. DR. FADEN: I don't think that's -- DR. ROYAL: You think that we can't provide guidelines? DR. FADEN: No. I think that here I want to go back to Pat's point and your point that you raised earlier, which is where -- on this particular issue, we are not constituted to make tradeoffs between national defense and public health. Somebody is, hopefully, but it's not us. Those kinds of payoffs have to made, and they are never ultimately made based on careful decision analysis that's quantitative. In the end, these are decisions that people in positions of authority do. They've got to do it, and sometimes they're assisted by quantitative analyses and sometimes they're not. But in the end, you know, somebody's got to make that call. That we can't make that call doesn't mean that somebody out there doesn't have to, and will. So I'm not sure where you're going with that. DR. ROYAL: Well, if what you said was true, then you've basically delegated the authority to make this decision about a release to someone else and haven't provided any guidelines under which circumstances that decision can be made. DR. FADEN: No, I don't think that's right, either. I think you can make all kinds of suggestions about procedures and who ought to be making these sorts of decisions -- this goes back to the Eli's issue that I'm not sure that we're ready to endorse, that only the President can make this sort of a call. Those are judgments that citizens and this committee -- DR. ROYAL: So you want to describe the process as opposed to -- DR. FADEN: Sure. You have to. What would be a just, fair, appropriate procedure? What are the sorts of considerations -- this should only be made by elected officials; who should make these kinds of calls and what kind of considerations or what's the burden on them, how should they be accountable to the public and whether there should have to be public notification, and wonder what conditions can they go under the table and all that kind of stuff. Is something we can comment on, looking forward; rather than if the ratio is X:X, can you move forward. I think we're worn out on one chapter and we haven't even gotten to the other three. A few minutes on other issues in the chapter, and we'll take a break? How will that be. Let me just get a list of hands of people who have comments they want to make about other dimensions of the chapter, and let's try not to -- sort of get your comments out and go on. So I see Pat, Ruth, Reed, and that's good. Also, some of you have written comments, the staff wants them. PROFESSOR KING: One point that came up in discussion, I think -- I won't repeat all my mea culpas, but if we have to make a point, it seems to me, that the committee could only make decisions based on documents available to all, because not all of us were cleared and when we made that decision, the result of that decision, for good for ill is to do it a certain way. So in the introduction we've got to be very careful about this. The second thing then, I wanted to go back to is, maybe this is somewhere, but nobody has told me for 24 hours. We have got to even get to Ruth's second point where we might want to take a position on disclosure, and we cannot do that until we talk about what we have in mind when we say something is a national security decision. We have a lot in here about what is not a national security decision. You can't make judgments about when a public disclosure is warranted; you can't make -- they're the kind of judgments that I think many of us are desirous of getting into. I think that we can probably get into without taking on that issue. DR. FADEN: It carries in to the other chapters. PROFESSOR KING: It does carry into the other chapters, and this is what the big issue is. I think that's the big issue with this chapter, myself, for me to help, to do what I think that the chapter committee --. DR. FADEN: We will return to that question in the context of all the chapters to raise the national security issues is this sort of tradeoff; which is all sequenced except for the practices chapter does, so it's okay. DR. ROYAL: Before we leave this chapter, could I suggest a process issue? DR. FADEN: Can we get Ruth and Reed's -- is it a process issue that's just to this chapter, or for all the chapters. DR. ROYAL: For all the chapters. DR. FADEN: So how about, can we do that before lunch; or do yo want to do it before the next discussion. I just think we need a break, is my intuition. So if we get Ruth and Reed's comments then on this chapter, take a break, and you can raise your process issue, and then we can go on to the other chapters. I think that would work best. Maybe I'm wrong in pushing for a break this early -- it's actually not the early, is it. Only one chapter, that's what makes me feel like it's early. Ruth. DR. MACKLIN: This is a small point and it's uncontroversial. [Laughter] DR. TUCKSON: I disagree with that. DR. MACKLIN: This is a plea for clarity and consistency. On page 2, which is right in the beginning, lines 14 and 15 you say: There's no evidence in any of these cases that radioactive material was released for the purpose of studying its effects on surrounding human communities. On page 46, lines 6 and 7 it says: A few cases involve the deliberate exposure of human subjects to trace quantities of radioisotopes. DR. GOODMAN: Where is this again? DR. MACKLIN: Page 46, lines 6 and 7. A few cases involved the deliberate exposure of human subjects to trace quantities of radioisotopes in the environment. Now, these appear to be inconsistent because the first says no; but if you can render them consistent, fine. DR. GOODMAN: They're not inconsistent, because in one case it is volunteers in an enclosed area. In another case, I'm referring to the community at large. DR. MACKLIN: Okay, so just clarify what appears to be an inconsistency and make it disappear. On page 49, this is just -- merely terminological, but if in fact it is true, as you're now telling us, that these cases did not involve radioactive material for the purpose of studying its effects on human subjects, you're sticking by the first statement on page 2, right? DR. GOODMAN: Sorry, where are you on --? DR. MACKLIN: No, I'm sorry, my next point on page 49. This is related to the same thing. Page 49, line 15 and 16 says: The intentional releases involved a fairly clear principle for the selection of the subject populations. Well, I don't think you can talk about subject populations if you're saying that what we are doing here is not studying surrounding human communities. So you could simply say those who stand to be affected, but it becomes unclear -- exposed or whatever, but subject population implies quite strongly that they're subjects of an experiment. So I'm just talking here about their existence. That's all. DR. FADEN: Reed? DR. TUCKSON: I don't -- we can get into it later, but the issue of how we dealt with the surrounding populations and the public testimony, I thought we might do a little bit better job on. As I read it, we didn't get introduced to these folk; I mean the plane travel, because of the rough terrain, they have to calculate which way they want the wind to blow so that the plane didn't have -- what we had no sense of is, who is living there. And I think we need to bring -- those folks were there and we don't hear about them until the very end. DR. FADEN: Yes, actually my notes reflect the same thing. I think, and I've said before, that I think this chapter can be made very alive by pointing out the fact that, the fact of you know, consequences being minimal and notwithstanding, we know this caused real anguish to people. And that's where the secrecy issue comes up, and that will take us to the national security stuff. For me, from the beginning the real tragedy has been how people have been made to feel about where they live and about their government, and that has -- it's a whole other order of consideration and concern, and we don't speak to it here except in sort of very dry language. DR. TUCKSON: And just to associate -- we won't work it through now, but again, it's also how we use the public testimony of people that lived -- so first's it's the description of the communities that were at risk, because they weren't just the scientists; they were a whole lot of folks that got dragged along with this without anybody much acknowledging it. I think what's real clear is at least we need to -- because a lot of people will read this and make a supposition that because these areas were isolated -- and therefore the people that were living there were people that we disenfranchised people. So it's important to understand the context one way or the other of who those folks were that lived in those environments. Then secondly we need to understand how they viewed all of this, and that public testimony I think -- we struggled with this last meeting, was how do you integrate? I don't think we quite did it here, and we can talk later about how to better do it. DR. FADEN: Right. DR. MACKLIN: Could I just add to that the part that I thought wasn't sufficiently fleshed out from the last draft, was the part about the soil in Alaska. We heard from several people living in Alaska, and I didn't get a sense from reading this draft in comparison to the previous one whether the soil -- whether there is now a real danger from that soil and was the risk higher? There's a lot of emphasis on the Green Run, -- it wasn't clear to me, especially because we did hear from the people from Alaska. DR. FADEN: Mark, thank you very much for your work on this chapter. We have stuff to do; but this is tough material. We're going to take a ten minute break, no more, come back, go right on to the next chapter. [Recess] DR. FADEN: Would the committee members please come to the table? All right, what's the next one on the list. Okay, we're going to do atomic vets. There are discussion questions which we can use. Could the committee members please sit at the table. We're doing atomic vets. The chapter is called the bomb test chapter, human experimentation in conjunction with atomic bomb testing, is how it's called; human radiation experiments in bomb tests. Dan did provide us with a memo yesterday for discussing -- it's actually, and I think very helpful, but we're obviously not in a reticent group here. It's I think a pretty apt characterization of at least the memos and E-mails that I've seen flying back and forth. Patrick has joined us. So here we go. The memo itself raises at least the tough questions as I see them. We're off. Duncan? DR. THOMAS: Some of my comments may be based on the previous draft, since I haven't had time to transcribe all of those comments over onto this latest one. The memo raises a number of issues, some of which have been hotly debated in a sequence of E-mail back and forth. I'd like to begin the discussion by focusing on question 4 in the memo. Is the concept of voluntary consent in the military adequately treated? If not, how should it be? When I reviewed the previous draft, I had a number of quibbles but felt that by and large the chapter was not in bad shape, with this one exception; because I felt it didn't squarely confront the question of how to obtain informed consent for experimental purposes, when informed consent for everything else in the military is not required. In my quick read through of this revised chapter, it does seem that some material had been added to address that point, in the context of the fly-throughs, and I was delighted to see it there. Perhaps I missed it in other places, but that's the only place where I -- I had seen this issue squarely confronted. I liked the material I saw, but I still think we need to elaborate upon this question in the other context. No discussion of informed consent for the HumRRO, for example, or the decontamination stuff and so on. So that's I think my own fundamental problem that I'd like to raise with this. DR. FADEN: Dan, what is the status on the consent -- MR. GUTTMAN: This is the question, this is one of those too-profound-to-discuss questions. What we know is what General Pinson told Patrick about the fly-through; we don't know much about the ground problem, although it says 'use the word volunteers'; the decontamination we can presume they --the HumRRO we know quite clearly, because we interviewed the person who is a wonderful guy who led the HumRRO. And he said what he said and what we quoted him as; it gets to the question of what you make of. Nobody said that there was a Nuremburg code adherence where they gave disclosure, and asked people: Do you agree; this is something you can choose not to do. The question there is what you think of; what the committee wants to say about the reasonability of informed consent in that situation. In the HumRRO situation, I think it's quite clear, they didn't follow what you would call informed consent in the Nuremburg code sense. The question is would anything like that have been any more meaningful. Because as Dr. Crawford said, "Well, you know, this was the military in 1953." DR. FADEN: Ruth? DR. MACKLIN: All we have about that question in the chapter was the Crawford interview. MR. GUTTMAN: Correct. DR. MACKLIN: The only other piece of testimony we heard on that point, and admittedly it was one person saying something, was Israel Torres, wasn't that correct, in his statement to the committee, he made some comment -- not the one that's included in here about his experience, but about voluntary. MR. GUTTMAN: Unfortunately it's apples and oranges, and this is the hypertechnicality, perhaps. He was not, to our knowledge, a subject of one of these so-called experiments. He was someone who was generally in the training part of it. Now, I don't have any reason to believe -- Pat wouldn't have any reason to believe that he was treated any differently than the people in the experiment. I guess that's the point I would make. DR. MACKLIN: Then just remind me, the quotation by him in here of what he experienced in the witnessing of the bomb, that was in the context of general troops? MR. GUTTMAN: Yes. At each one of these tests, there would be 200 psychological, physiological testees and 800 people. And he was, as far as we know, just one of the many. DR. FADEN: There's not a whole lot. DR. MACKLIN: In other words, we have nothing except Crawford's comments -- MR. GUTTMAN: Well, he's a pretty percipient witness because he was in charge. DR. FADEN: He was the boss. MR. GUTTMAN: He was the boss, but also it's not hearsay, not direct recollection -- this is a case that couldn't be clearer; there was a "indoctrination." And I think they -- in the positive sense of the term. So the committee can make some comment about whether that -- you know. DR. MACKLIN: No, no, no. We have to distinguish the indoctrination, which was designed to give a certain view to the people who were going to participate with the separate question of the voluntariness of their participation. They're related, but they're distinct. DR. FADEN: But the question is whether participation in what? And the only issue would have been their agreeing or not agreeing to fill out paper and pencil tests, because their participation at being present at the bomb testing was not ever presented as an option. So the nuance here is that the most that should have happened, according to the way the world worked then, was that their consent should have been obtained for filling out these paper and pencil tests, but not for being present --. MR. GUTTMAN: Actually not so simple, because it was a physiological test component. DR. FADEN: All right, so for that part, too. MR. GUTTERMAN: And that required the presence of the bomb. DR. FADEN: I know, but everybody else who was in the bomb was ordered -- the point is the context is one in which the only thing you'd be agreeing to was the measurement stuff; whether it was physiologic or whatever. It doesn't follow that your presence at the bomb was one that would have required consent, the way they set it up at the time. Nancy, I'm sorry -- DR. OLEINICK: Well, it seems to me, the limited information we have is, it's clear that there's certainly nothing in the order that we would call an informed consent. Because the little bit that we have I think is basically from the report, and it's Crawford's report, which is so-and-so's unit was ordered to go and do this, and fill out the paper and pencil test, and that was the end of it. So there's really not a whole lot, and that doesn't sound much like informed consent to me. DR. FADEN: Okay. I think that part is --. DR. OLEINICK: Yes, right. MR. GUTTMAN: There are a lot of difficult metaphysical questions, but I don't think informed consent is one of them. The meaningfulness of that is a question. DR. FADEN: Duncan, does that get to your concern? DR. THOMAS: Yes, I'm sure it does. The other aspect of it is, this chapter has got to lay the groundwork for any recommendations that may flow from it in our discussion tomorrow. And I'm having great difficulty there. It isn't clear to me why the atomic veterans, who were subjects of HumRRO or any of the other experiments should be entitled to any special consideration in terms of remedies; but perhaps that's a point that's be deferred until tomorrow. DR. FADEN: Dan. MR. GUTTMAN: Let me just lay out -- this is a very, we all know, difficult complex set of steps we've gone through here. The bottom line is, we've had a lot of these conversations; Duncan and I have talked about it. All the veterans who were at the atmospheric tests are covered by legislation. There's an obvious question as to the adequacy of that legislation, which we've heard from a lot of witnesses about, but I don't think that that would differentially affect experimental and non-experimental subjects. If there had been no legislation, you'd be sitting here saying "Gee, should we give these experimental people a benefit and not the non-experimental." What you've got to sit here and say is, are we in the business of talking generally about this legislation? So looking prospectively, that's A, in terms of the particular remedies. In terms of the policy issue, what the chapter tries to do, and maybe not successfully -- and this is where we ask for questions is suggest that maybe if experimental protocol had been adhered to, precisely the kind of thought process that we're all talking about, not that they were wrong in the past, but what does that tell us about how to do it in the future? That that process might have focused on taking more care to at least take dose measures and to do monitoring and follow-ups that 20 years later, looking backward, you wouldn't say "Gee, what was the exposure level?" And so the hypothesis of that is chapter is that the story might be a kind of "what if" to tell us about how the world works. Then the question is going to the remedies. We spent a lot of time, some of you have been involved and Ruth has been directly involved talking with the military today, how would that work today? In other words, how would a situation like this work if it took place today; and that's where we're focusing the recommendation. The policy thrust is, if you're going to do another thing like an atomic bomb test, it wouldn't be an atomic bomb; might be a laser or something like that. How would you assure where the boundary was between experimentation and occupational exposure, and how would you assure that whatever side of the line some troop was, they'd be protected at least from the risk by an independent risk assessment. DR. FADEN: I can tell you what's happening with this, but I'd like to go back to the chapter. I sat down with some members of staff, Wilhelmina, Jeff -- I can't remember who else was there; -- MR. GUTTMAN: The army came over. DR. FADEN: The whole army didn't -- MR. GUTTMAN: Seemed like it at the time. DR. FADEN: It was very useful because I started with a base like of zero knowledge, and we tried to put them with the counter-factual; what would happen today, what are the protections, and they came armed with a stack this high of regulations that of course didn't exist at that time that exist now. It was so overwhelming to me that the process we are going through is, Wilhelmina has written a draft. You don't see it here yet because we don't know if it's even roughly right, trying to characterize what they were explaining to us that's gone out to the Army and then to the other services, or we'll be going out to fact check, have we got it right as to what the current regulatory context is in the services that bears on something like the atomic vet situation; it's very difficult because it's sort of hard to imagine directly analogous events occurring in forward in the future, but it's possible. So we're sort of trying to unpack that. In addition to the recommendations that were floated last time with respect to research involving soldiers that bear on this question of consent and non -- they're in the findings, the forward looking recommendations. So we're struggling with that. We were handicapped, I thought handicapped in that discussion because Phil is out of the country and it would have helped a lot to be able to turn to Phil and say, "Could you explain this to me in English?" and it was sort of "What did he just say?" So we were disadvantaged by that, but we figured we can wait for Phil to come back, so I kind of forged ahead on my own, so we're learning a lot. The short answer is two things. And this bears on this issue of how to understand the time. There are a whole host of regulatory protections that are in place now that were not in place then. Whether we're positioned to evaluate how good or how adequate those protections are is a separate matter. But at least we'll be able to describe it to the committee. And the other is, that at least from the perspective of the people in the services with which we have spoken, the differences between the services today, the all-volunteer services and the military of 40 years ago when enlisted people were by and large draftees, in terms of issues like consent, is from their point of view very different; which is not to say that all the consent issues have gone away, or the questions about voluntariness in the context of military service have gone away. But the view seems to be that you're dealing with the language that -- a different kind of soldier, because of the different kind of context. Now, I don't know what to do with that, either, but we'll have to play with that later. All of this is taking us away from the chapter. Lois? MRS. NORRIS: Just a question: do you have a sense as to whether all of these regulations and provisions for risk assessment, etcetera, now, which are designed to protect service personnel could be trumped for national security reasons? DR. FADEN: That's what we kept asking. We kept asking, could they be trumped, and who has the trumping authority? So we were again, to go to the point I was discussing with Henry, going to procedure. Who decides if they can be trumped, at what level? And frankly some of the representatives who came were not certain on that point, and checking. I really am not even going to try to do it, because I'm going to do it wrong; but there were all these different -- MR. GUTTMAN: But it's okay, because there's only one other person in country who knows what the rules mean, and we were talking to him. DR. FADEN: Lois, that's exactly what we kept pushing. Let's say, okay there are these protections, there are those protections, but whose position -- to stay in this instance again the national security issue is such, the military need to know is such, that we're going to trump all these things and we're going to expose these soldiers or sailors or what have you, even though otherwise that would not be permissible under 40-68-22 or whatever the regulation is. DR. KATZ: Is Desert Storm, to some extent it's slightly different, but to some example an example in point? Of certain things. It's not quite opposite, but it is also opposite. DR. FADEN: Obviously it bears on it, but it would not have fallen under any of the -- apparently there's a whole regulatory structure for the development of new systems, or new anything, under which obviously nuclear weapons would fall. But any new anything that's outside of the medical arena, which would be the focus here. But I'm sorry, it takes away from the chapter and we have so little time. Henry. On the chapter, right? DR. ROYAL: Yes. I don't know where to begin; Why don't we begin on page 2, about measure of these effects. To me, that statement is confusing. Maybe it's the background that I come from that makes this confusing, but you remember that the people at Los Alamos didn't regard these as human radiation experiments because they were not really meant to test the effects of radiation. And to me, when you talk about effects, the picture that comes up in my mind is what's called a dose-effect curve where the way you figure out causality is by saying that the effect that you're looking for increases in frequency as the dose goes up. So when I think of effects, I think of this dose effects group. Then the thing that ends up being confusing is when you actually read what the "effects" are. The effects either have nothing to do with radiation dose or they're actually not intended to measure effects; they're actually intended to measure dose. So to someone who is used to thinking about dose effects curves, calling this effects is very confusing. DR. FADEN: Can we change the language, though? That does not sound like a huge one to me. PROFESSOR KING: Can't we just say that in some cases we gather data from the human beings that were there? It seems to me that's all the same. MR. GUTTMAN: Yes, Henry's point is a critical point, because once you're into this he's absolutely right. I learned he's absolutely right. What Los Alamos is saying is, if we want to measure effects, the exposures would have been a lot higher. DR. ROYAL: Correct. MR. GUTTMAN: But the reason I -- when Henry and I E- mailed discussion, and it was clear to me immediately he was right but at the same time, because he read this more carefully than we have read it, there is at page 20 of the draft a description, which Henry had pointed out to me which I hadn't focused on, of what the researchers thought they were doing; and it pretty clearly was kind of the HumRRO psychological tests, and the italicized language says these plans to expose, should include studies on the effect of atomic weapons detonations. So that I think what we have here is a situation where the contemporaneous definition technically may have been weapons effects, although as is clearly the case, that's a very confusing term. DR. FADEN: But who cares? MR. GUTTMAN: Well, it's -- DR. FADEN: Let's find other language. DR. THOMAS: It's crucial because it affects this question of scope. Are these releases for the purposes of testing human health effects, right? And they're clearly not. PROFESSOR KING: Not the sentence; but I still don't understand why the sentence is doing all the -- whatever else you may say may be correct, but this sentence is a lead-in to all these bullets that follow and I'm just -- and it doesn't describe the bullets that follow. MR. GUTTMAN: So you're saying to gather data or something like that. PROFESSOR KING: There may be another issue here. MR. GUTTMAN: Something like to gather data would be a better -- DR. FADEN: What I'm missing is; I mean, you're not disputing that some of these are research involving human subjects; they may not be looking at dose -- what was the term that you -- DR. ROYAL: Dose effects curve. DR. FADEN: Dose effects curve, in one kind of research question you could ask. So it doesn't, it doesn't knock it out of charter merely because they're not looking at dose effects curves; maybe they have some other kind of research question that involves human subjects; it's just not a dose effects curve. DR. ROYAL: One of the issues that was on the question sheet that Dan passed around is whether -- these qualify as human radiation experiments. Some of them I don't. I would need to hear the rationalization for qualifying them as human radiation experiments, like the flash blindness test. DR. OLEINICK: Yes, that's not a radiation experiment. That's a human experiment, but not a human radiation experiment. DR. FADEN: So if we can say that. DR. OLEINICK: It's strictly looking at the extreme quantity of light. Of course, that light is a form of radiation. MR. GUTTMAN: But not ionizing. DR. FADEN: All right, but we can simply say that it's a research -- it's research involving human subjects. DR. OLEINICK: Exactly. DR. FADEN: Was that in the context of atomic bomb testing where the thing being studied wasn't radiation but -- DR. OLEINICK: Yes. DR. FADEN: Okay, so we can characterize. But do we want to go down that? We can go down these and see which ones we can characterize as what. DR. OLEINICK: Yes, and the first one measure of dose. MR. GUTTMAN: Well the first one, the way I guess, Ruth Macklin and I were talking -- yes, it's not an effects study, but it's what do these guys pick up with they're crawling around on the ground study. DR. FADEN: Maybe I am missing, maybe because it's not my area, I don't care so much, and I want to make sure that the language is not misleading for people who do use these terms more technically than I would understand them. The issue is just, is this research involving human subjects? The HumRRO thing is obviously not a dose effects curve, but it's research involving human subjects. It's psychological research. DR. ROYAL: But it's not a radiation experiment. MR. GUTTMAN: Well, a way to ask that: Would you have done the same thing with the detonation of TNT? DR. FADEN: Well, you might. MR. GUTTMAN: Not to measure the psychological reaction to the -- DR. FADEN: You might do it to anything, but it's akin to the flash blindness study; it's done to illuminate something in relation to atomic testing. DR. OLEINICK: It's not a radiation study -- the rationale for that study was that soldiers had a psychological problem in facing to fitting on a battlefield where there were atomic weapons. They did not have the same psychological barrier to other kinds of battles; and so that was the background rationale. So in that sense, it's a radiation experiment, although they were not looking at effects of radiation per se, they were looking at the effects of a weapon that incidentally produced radiation and produced fear. DR. THOMAS: Well, not incidentally produced radiation. DR. OLEINICK: No. DR. THOMAS: The question was, dealing with -- DR. OLEINICK: It produced radiation, and that's why the fear. DR. OLEINICK: -- the soldier's fear of radiation. DR. MACKLIN: Were there ever or at that time or at some time before similar experiments of non-radiation war --TNT-- I mean, anything that would be looking at these same kinds of things with non-atomic weapons. I mean, the reason for asking that is it might get to the question of how essential the ionizing radiation component was here as something that deserved special study in all these different experiments. MR. GUTTMAN: The thrust of it; you know, we're talking about the history of the army psychological research program, and I'm sure, you know, the staff with the authoritarian personality and all that kind of stuff in World War II -- Ruth knows better than I do there was this kind of research -- but I think the basic thrust is that clearly there was a thinking at the high levels of expertise and officialdom that there was a very particular concern about a substance that you couldn't see, you couldn't smell, you couldn't touch, and whatever else somebody thought about anybody else, they wanted to know about this. You know, whatever you want to make of it, you can make of it, but that's clearly what seems to be -- DR. MACKLIN: I think if you make that point here, -- DR. FADEN: All we have to do is say that. MR. GUTTMAN: Yes. DR. MACKLIN: It's the unstated things that make this less clear, not what's stated. MR. GUTTMAN: I thought it was stated. DR. OLEINICK: Well, it may not have been stated on page 2; I think it's stated later on. You were just giving a summation of the kinds of experiments. MR. GUTTMAN: Yes. DR. FADEN: Maybe what you want, I don't know if this is satisfactory, is some sort of an explanation that makes it plain, that some of this research was intended to look at the impact or a fact of radiation in some fashion. In others it looked at psychological performance human factors issues raised by concern about people's emotional reactions. But they're not in some narrow sense all human radiation experiments. MR. GUTTMAN: Following the conversation earlier, if it can be worded correctly this really should be, is that it should be pointed out that nobody, with the exception of the army which was told not to do it, was saying "let's put people out there to see that they're injured by radiation." And they may have not had a sufficient understanding or concern about the long term effects, but that these experiments were things that were not attempts to measure like they did with monkeys or rats, acute effects, that there was a very conscious risk decision not to put people in that kind of situation. DR. FADEN: Henry, did you want to go down the list? We could certainly do that. DR. ROYAL: I didn't particularly want to go down the list as much as bring out the issue that the effects that are prescribed are not related to the dose of radiation. And it's not clear that they're related to measured effects. Some of them are related to measuring doses of radiation. DR. FADEN: So we can get that language. I don't mean to dismiss the question; it's just that I think it's a matter here not of dividing the committee -- I'm looking for points where there's controversy. I don't think this is a point that's -- here's the point of let's get it right, and I don't think anybody wants to disagree with Henry about what this characterization is, so let's just get the characterization correct. DR. ROYAL: Correct. DR. FADEN: Fine. So I'm struggling in the next half hour, and I do want to make sure we get -- oh, we forgot Henry's procedural point, I'm sorry, about what, you had an issue of how you should proceed from here? DR. ROYAL: Yes. I do think that it's very important that the committee feel ownership of these chapters. The procedural question that I have is, we're now sending in comments on the chapter, but it's very unclear what then happens to those comments, who is making decisions about when to incorporate them, when not to incorporate them; and what I was going to suggest as a procedural issue to handle these comments was to give the committee ownership of these chapters, is to appoint the committee member for each chapter who is the one who these decisions about whether to do anything about the comment or not do anything about the comment will be discussed with that committee member? And then if I think a comment should have been accepted and wasn't, I should discuss that with that committee member? Or if I think that a comment was accepted and shouldn't have been accepted, I should discuss it with that committee person. So what I'm trying to do is -- DR. FADEN: Right, I understand what you're saying. DR. ROYAL: -- get the committee itself more involved with making these decisions. DR. FADEN: Pat? PROFESSOR KING: Can I make a counterproposal, because actually, my experience is that leads to continued fragmentation of the committee rather than the committee as a whole claiming ownership. But it is a tough program. I would be the first to agree with that. My suggestion is that, and I did this and I was amazed that I guess I'm the only person who did it; I asked for an annotated copy of the chapter. So I have a highlighted change made in every chapter. So they did it for me; it must be possible to do it for everybody else, so you don't even have to search for what happened. I asked specifically for -- if you want to see what I'm talking about -- my copy of the chapter looks like this [showing], and the reason I asked for it is, I always wanted to find out when I made a comment or a change what would happen to it; and then two, that I could focus on it so I could see -- DR. FADEN: Did I like it better before? PROFESSOR KING: -- if I liked it better before; if I thought this made sense, and that this would make a list for me. I really didn't want to discuss it with another committee member; this was going to be my list to raise when we got to deal with these tough questions; because the only people that can resolve the hard ones, I thought, would be the whole committee. So my suggestion, to try to get at the same goal that you're getting, trying to get to, is that we all received these annotated -- they're not annotated; they're blocked out. DR. FADEN: We raised it at the last meeting. I can't remember who said they didn't -- somebody ruled against it, I don't remember who it was. PROFESSOR KING: And I was the only one who asked for it. DR. FADEN: So we didn't do it. DR. ROYAL: That's addressing a different issue; that's documenting what changes are made. It's not helping with the process of how does one decide what changes to make in the first place? PROFESSOR KING: But what I am suggesting is that having a committee member do that is only layering; that the committee needs to claim ownership, not one committee member. And I think that what we need is a process that makes it easy for you to tag issues to bring to us as a group. I'm not enamored of -- DR. FADEN: Deputizing people. PROFESSOR KING: -- deputizing people on different chapters to resolve my conflict. If I deputize anyplace, let them make the initial judgment call in the committee; the chair and the staff. I just want to be able to find it, so that if I think they did a poor job, then I can raise that. DR. ROYAL: I'm trying to make sure that 'they' is clearly identified so that -- DR. FADEN: So Pat is saying staff. PROFESSOR KING: I see no advantage to an additional layer, is what I'm saying. DR. ROYAL: That's vague to me, who staff is. MR. GUTTMAN: Well, staff could use all the help, and welcomes all the help that -- anybody that wants to do this -- DR. FADEN: There are designed people for every chapter. The names are on the chapter; it's not vague. If it changes, if it becomes a different person, then it becomes a different person. But it's not the one person for every chapter, but it's Dan on a lot of chapters. MR. GUTTMAN: Anybody else who wants to do this is welcome. DR. FADEN: But the issue, and there are two different proposals, and let's hear what other people say. I understand what Henry is saying. I think both are doable. Both are doable, and it's which people would prefer to do. Nancy? DR. OLEINICK: I was going to suggest a somewhat modified version of what Henry said, which was that each chapter be assigned a committee person to serve as a clearinghouse, but not to be the sole person who reads and comments on that chapter, but to serve as a clearinghouse for all the comments. It just might make the communication with staff better; I don't know, it may add another layer of bureaucracy to it. DR. FADEN: Duncan? DR. THOMAS: I would hate to feel that I have to persuade Henry of my views in order to get my comment into a particular chapter; and I suspect he would probably feel the same way about me. I'd like to suggest, as an alternative, that we have a system of subcommittees that have taken ownership of respective committees, and that would sort of diffuse this responsibility. DR. FADEN: Right. Just remember how little time we have, folks. I mean, a subcommittee -- my only reaction to that, Duncan, is why I said that proposal is doable because it's one person. Subcommittees, and the orchestration of subcommittees at this point and getting conference calls together and all that kind of stuff is, given the week that we're in, I just frankly reject. It would be nice, but I think now we don't have the time to do it. What Henry proposes I think is doable, as a practical matter. We can discuss whether it's what everybody wants or so people want or whatever, but it's doable at least because it's one human being. The staff person that is doing the chapter only has to confer with one committee member rather than trying to pull a subcommittee together. PROFESSOR KING: Let me be more specific, because I understand why Henry is interested in this process, because this is where the rubber hits the road. I do understand, because I have been in a position, and I'm sure Ruth is not welcoming a position either, staff, of having to resolve nuances that come in from five different committee members at one time. This is a considerable problem, so I don't want to underestimate it. But it doesn't become less of a problem by having one person handle it. What I think happens is, this is the process that Reed was talking about yesterday. This is when each individual committee member has to decide what is so critical to them in developing a report that they make an issue of it and bring it to the committee for resolution because it's that important, or you swallow hard and say "this is not where I'm putting my marbles." Now that's a crass description of what coming to some committee ownership and resolution means. But I think that only each individual committee member can do that, knowing that we all get an opportunity to try to persuade us all. I think having me resolve the point that you make, and when it comes in from four other people, it's not going to make you any happier. Because after all, it's just me, and if I resolve it in a way you still don't like you want to bring it to the committee and I don't blame you. Because the fact that I'm committee and not staff doesn't say beans. I may still be all confused in my thinking, from your point of view. So all we've done is add a layer of -- well, people that you have to go through, I think on such a short period of time. If we had more time, I could think of a lot of different ways to work this through. We don't have much time, and that's why I suggest that way, a way to you for keeping track of what are the critical, critical, critical or the less critical, in your own ordering for yourself about how you want to deal with issues, and where you want to come to the committee and where you are willing to not come to the committee. DR. FADEN: Ruth? DR. MACKLIN: I want to speak also against one committee member being designated, because that committee member is going to be torn between his or her own views on a point where there may not be agreement with what the person who is requesting the assistance -- I think that this can be handled by a modification of the procedures we've now been using. Many people have been responding by E-mail; not everyone, and we have to make sure we get to those who have not; but many people have been responding by E-mail, and if the person who would like to see a certain change incorporated were to append to the E-mail message "I want to see this change in the draft and would like to see other committee member's views on this" -- DR. FADEN: That's an interesting thought. DR. MACKLIN: As many people who are reading all that E-mail stuff will respond, and maybe the header should say "Below are things that need responses, and anybody who is not on E-mail can get that by a fax the next day." DR. FADEN: It sounds as if you're -- and I of course want to hear how Henry thinks -- what you've suggested, following up on Pat, seems to be a very reasonable way to go; namely, each of us identifies the areas of greatest concern to us. Not only these -- you don't simply send in as comments to staff on that chapter; but it goes to all the committee members, saying "I think this is a big issue in this chapter, and I would like it done in the following way. What do people think?" And then it's out there for the whole committee, even if the whole committee isn't meeting face-to-face to react to this position that Jay feels real strongly about, and then Jay -- your issue, always, Jay, if you don't know where your colleagues are, you're not really certain if people are agreeing with you, you just lay it out there and people are obligated to respond to you: "Jay, I think you're off the wall" or "Jay, I support you 100 percent" or "Jay, I'll go with it if you are willing to back down on this point." And then it becomes -- if you're worried about it going through staff, this is sort of directly to each other. But you obviously aren't going to do it on every comment, like change 'that' to 'it.' PROFESSOR KING: But that's most important, because I've got to have some way of knowing, since we all have other full time jobs, that this is something I should pay attention to, this is not just somebody sending in a list of comments. So I would be very happy, that when I make detailed comments on a chapter, that the rest of the committee does not have to get what I -- DR. FADEN: Unless they want to. PROFESSOR KING: -- make those detailed comments unless they are going to ask for it. I would like for the rest of the committee to get anything that I designate as being important. I mean, there's got to be some way -- DR. FADEN: So each of us would pull out -- all right, here are the two things that I'm really going to -- you know, I'm invested, I think this is wrong or I think this is really problematic and I'm not going to be happy unless these two things are addressed or my colleagues persuade me that I'm wrong. Whereas on these other things, you take them,fine, you don't take them, fine. PROFESSOR KING: You want to see how they got incorporated, too, Henry; because something that was unimportant to you at the time may become important depending on how it is included. DR. FADEN: Now is this amenable as an alternative to you? DR. ROYAL: Yes. DR. FADEN: Okay. That's great. So what I'm hearing is, we each have to take responsibility. We can't ask staff to figure out which ones of our comments are the important ones. Okay? So if you send back detailed comments and you don't flag any, then if it's on E-mail, those who like to read everything will read everything, but those who can be faxed or not faxed depending on each committee member's preference. But those things you indicate you wish shared with your colleagues will be sent to your colleagues, whichever way they like to get it, and will be noted as "Here are Sue's major concerns about this chapter, to which she would like responses from the rest of us." Like: "Sue's right." "Sue's wrong." "Sue's only half right," whatever the deal is. And that's how we will do it for every chapter, and I think that will work. Also, I like getting stuff the way Pat got it, with strikeouts and redlines. Some people don't like it, and I don't remember who it was last time said they don't want it. You don't like it? DR. MACKLIN: No, I don't want it. DR. FADEN: So we will just poll people; people who want strikeout and redline can get strikeout and redline, people who don't want strikeout and redline don't have to get strikeout and redline. Because that's obviously a personal issue. This is very helpful. So now, instead of wondering what we're each thinking on the stuff that matters to us, we will know where we are each thinking. DR. MACKLIN: Should each of us -- this is just a trivial point, I'm sorry to have to ask it; but should each of us be responsible for setting up our E-mail distribution so that we do the distributing, because -- DR. FADEN: No. I think that's -- DR. MACKLIN: -- you can't send it back to Worldcom, wherever that is. In the sky. Because Worldcom bounces it back. MS. MASTROIANNI: I actually -- DR. MACKLIN: Everything that I have written to staff has always been intended for everybody on the committee, but there's apparently some uncertainty about that, and I haven't developed, from my software, sending my message to everyone. I send it to staff and assume it's all going to be distributed. MR. GUTTMAN: Why don't we check with our technical staff as to what -- DR. KATZ: What happens to me? MS. MASTROIANNI: Maybe the best thing to do, honestly, is if it's easy to get to me, I think the best thing to do is to send it by E-mail to me, or fax to me. I work very closely with Tracy. She knows what to do, and she will make sure it's very easy for us to just turn around and forward it to, and all we have to type in is "committee members" and it gets out. DR. MACKLIN: So for example if we want to communicate with the staff responsible for any draft about the nitpicking stuff, we write it to the staff. If, however, we have a response that's for distribution to everybody on the committee, the things we're flagging, then we send it to Anna. Is that correct? DR. FADEN: Here, yes. DR. KATZ: What happens to non E-mail people? DR. FADEN: You get faxed. PROFESSOR KING: It usually comes the next day. DR. FADEN: Everybody I think is available either by E- mail or fax; it will come to you in one fashion or the other. If people want to see your colleagues' detailed comments, you're welcome to see that, too. So that's up to -- Anna. MS. MASTROIANNI: I think really the easiest thing to do is for me to be the central clearinghouse of all the comments; I'll make sure they're distributed to the appropriate staff people. As I said, I have a person that I work with very closely, and we can get these things turned around very quickly DR. FADEN: So you want all the comments to you. MS. MASTROIANNI: So why don't you direct them to me; I'll make sure that they're -- you can discuss them directly with the point people that are listed on the chapters if you want to call them. That would be great, but I can act as the central coordinating person for the distribution of written comments. DR. FADEN: And we can poll each of you to find out if you want to get your colleague's detailed comments or only the ones that your colleagues have flagged for discussion. MS. MASTROIANNI: We already have matrices, so we'll just do up another one. DR. FADEN: The issue that -- I hate to sound this way about it, but I don't want to people to feel compelled to identify issues that they want to bring to their colleagues. If you have them, you should bring them. If your view of the chapter is there's nothing you care that much about in that chapter, you're basically happy with it or whatever, then don't feel like you have to find something or you've not done your job as a committee member. So I don't want an instruction that says "you must" after you've read each chapter, have identified the two things you're going to take your stand on or you haven't done your duty. But if you've got those issues, as many of us do have in many of the chapters, now we have a wonderful mechanism. I think it will work, or making sure that everybody else knows what matters to you. And that means we should be able to get a lot more -- we should come to the main meeting a lot better informed about where each of us is thinking, which is a great advantage, too. Can we go back to the atomic vets chapter for a little bit? We wanted to do one more -- I don't know if we're going to get all these chapters done before lunch. Back to atomic vets, in connection to the bomb testing. Henry. DR. ROYAL: I'm not sure that I understand the recommendation about how things could have been done better. There's the measuring the dose better part, there's maintaining the records better, and then there's this follow-up issue. In terms of measuring the dose better, I'm not sure what the basis is of that recommendation. I know that the National Academy of Sciences did some study and said that they could have been done better from a scientific point of view, but it's not clear to me that the rigor that's necessary for doing it for a scientific point of view or for an epidemiologic study is necessarily what was necessary from a more practical point of view. In other words, when we do something for scientific purposes, we often do it much more rigorously. So it's unclear to me what the statement develop dose better means. In terms of the record keeping, the record keeping seems to me to be a generic problem that our government has. All of its records seem to be very difficult to retrieve, and I don't know that the dosimetry data are any different than that. In terms of follow-up, follow-up I particularly don't understand. If the doses were in the range that I understand them to be, that is by and large less than 10 rems for most people and in most cases less than 3 or 4 rems, from an epidemiologist's point of view it would be of little scientific value doing a follow-up study in that patient. If one had unlimited resources -- if follow-up means epidemiologic study. I'm not sure if that's what's meant by it, but if follow-up does mean an epidemiologic study, if you had unlimited resources, you can argue in favor of science for almost anything; but the reality is that today, in 1995, we're cutting back on the budget of the RERF, which is following up the atomic bomb survivors; and so here we have an epidemiologic study that's providing great -- well, it's providing the best scientific information we have about the effects of radiation, and the concept that we don't have enough money to do that study which has proven scientific value, and we're going to propose doing another study, this other follow-up study, I don't understand that concept. One of the things that I do think that we owe the people who have been exposed to radiation is to provide the best scientific knowledge that we can. And we do that by doing the studies that are most likely going to give us the scientific information that we desire; and I am very unconvinced that the follow-up study would provide the scientific information that we would want about radiation effects. DR. THOMAS: Well, I have absolutely no quarrel with Henry about the relative scientific value of the atomic bomb survivors versus the atomic veterans study. But I don't think epidemiology has always done for the purpose of contributing scientific knowledge about magnitudes of radiation risk, or the like. A lot of epidemiology is done for the purpose of shedding light on social problems and, confronted with a situation where, on the one hand there is grave skepticism about the official dose estimates and on the other hand allegations from all quarters about all kinds of different health effects, for which there is really no scientific evidence one way or the other, the failure of the government to be in a position to provide any evidence to support its claims of reassurance that, "you guys, you don't have anything worry about and we don't owe you any compensation" I think is a situation that could have been rectified had better dosimetry been done at the time and had better records been kept, so that it would be possible to do an epidemiologic study which would have some reasonable power, not for proving the null hypothesis; one can't prove the null hypothesis, but are at least for establishing whether or not the fact there did appear to be any increase in specific cancers within this group. So I actually think that it would have been a reasonable thing to do. Some ten years or so ago I was involved with a GAO report on the feasibility of doing an atomic veterans study, and we came to the conclusion that it was worded almost exactly the way Henry just said, that on scientific grounds based on what we think we know about ghost distributions. Such a strategy will have no power for detecting any effects of magnitude for particular interest to us; and we went one step further and tried to figure out how big the systematic or random errors would have to be in order to justify such a study. And then came to the conclusion, and I don't have these numbers at my disposal but I can probably look it up again, that had doses been systematically underestimated by X percent then indeed the study would have power to detect that effect. Now that to me would seem to be an outcome that would be of some interest. So I guess I differ with Henry in a sense that I don't think the atomic veterans study is -- a properly designed atomic veterans study would have been an inappropriate thing to recommend. I do agree with him that it's unlikely that if what we think is true is indeed true, that it would shed new scientific light on effects that we otherwise don't know about. MR. GUTTMAN: Just a clarification; I don't think the chapter -- Duncan may recommend it -- but the chapter is not saying "let's propose an epidemiologic study." The chapter is trying to say at least at looking forward to the next time they do these things, set it up so that if somebody wanted to do an epidemiologic study, then there's a separate question of whether today. DR. FADEN: Nancy and then Henry. DR. OLEINICK: I just want to question Duncan on something you said. You said something about epidemiological studies have some value for shedding light on social problems. I'm not quite sure what it is that you're getting at with that statement in that if you don't have the dosimetry and didn't have the data early on, what social problems are you going to identify by recommending such an epidemiological study? It's just not clear to me what it is that you meant. DR. THOMAS: Just take the example of dump site epidemiology. These are the sorts of things that are done all the time. You have a population that's living around some toxic waste disposal site, and they are all up in arms because they've got excesses of this, that and the other ill-defined conditions. And they want expenditure of massive public funds in order to clean up this dump site. This is something for which other people have some skepticism, as to whether this is public funds that are well spent, because they claim, there is no scientific evidence that any of these allegations of the public have any plausibility at all. You know, we've made some measurements in the environment and we don't find any toxic chemicals in people's back yards. So we don't think you've got anything to worry about. So we're at an impasse. One thing that can be done in this circumstance is to actually collect some systematic data. There are deep problems in designing a rigorous epidemiological study which would establish whether or not the fact that there is any excess morbidity around this dump site; but assuming that one can solve these what I'll call technical problems and do a credible epidemiological study, even though your prior knowledge would say "I don't expect to find anything here" I still think it's worth doing to demonstrate a negative. And indeed, because I would also admit the possibility that maybe the community is right, and maybe there is some pathway that we were previously unaware of, that it's worth doing the study just to detect that possibility. DR. OLEINICK: So are you recommending such for the atomic veterans? DR. THOMAS: No. I would want to think about that question a little bit more, but in this situation our options are compromised by the failure of the government to keep good records and do dosimetry in the past. And therefore it becomes very difficult to do good epidemiology today. DR. FADEN: So the argument in the chapter is, as Dan articulated it, is that it was a failure not to have --. That's the argument; it was a failure not to do careful dosimetry at the time and not to keep accurate records. DR. THOMAS: And we can find the -- DR. FADEN: So the issue is, is that position acceptable to the committee or do people want to argue against that. DR. THOMAS: Let's just make clear; there are two recommendations here. There is the first recommendation; and if we were ever to do this again, we should keep proper records. And then this other thing is that the government is culpable for not having done things properly in the past. Some of which we may or may not wish to make some sort of recommendations. DR. FADEN: So shall we take the backward or the forward one first? DR. MACKLIN: Take the backward one first, because it's more germane to the chapter. DR. FADEN: Did the government do something wrong -- MR. GUTTMAN: The technical intermediate hypothesis that had some procedures that we would call experimental procedures been followed, there would be a greater likelihood -- DR. FADEN: Dan, that's a separate issue. And actually, you know and I don't necessarily agree about that. MR. GUTTMAN: Go ahead. Fine. Enough. DR. FADEN: And the whole committee talk about that. The issue is, quite apart from whether, had there been more adhering to research procedures it would have filtered down to all of the atomic vets or not, the question on the table right now is, should the government have done the proper dosimetry and kept better records at the time, so that today or ten years ago when the GAO looked at this problem they could have done a decent epi study it if was determined that it should have been done, for the reasons you describe. PROFESSOR KING: What is the argument for culpability? DR. FADEN: What's what I'm trying to get at. Why should they have done it at the time? DR. THOMAS: Because they should have recognized that there was a potential health effect, a potential long term effect which went beyond their sort of immediate judgments; and that they should be in a position to address that their risk estimates at the time, which was that these risks were minimal, were in fact correct. That to me is the reason why they should have worried about -- they should have worried that their knowledge was uncertain. DR. FADEN: Okay, can we try to get back to this -- is anybody following this or -- PROFESSOR KING: I honestly didn't follow that. So I think what I need is a breakdown that says -- I hate to be so basic and reveal so much ignorance. But why should they have known is, why should they have known a long term uncertain risk is the key to trying to make -- according to Duncan's statements, is the key to making a culpability judgment. It is -- DR. FADEN: Should they have known at the time that it was worth worrying about long term downside effects. PROFESSOR KING: And what are we saying suggests that they should have known at the time is really what I'm asking, because that provides the key to the culpability issue. DR. FADEN: Henry, you were on the list. DR. ROYAL: I mean, the thing that I don't understand is that if the doses were what we think they were based on the measurements that they did make, that we think that an epidemiologic study would not have shown any risk. So we've not shown any excess cancers, so we're suggesting -- the thing that I have trouble with is, how much money are you going to be spending to do the dosimetry, do the maintenance of those records, and how much good will you produce by having done that money. I assume this is a health benefit issue or a science issue; either one, whatever the benefit is it's either scientist or health. I think that we have an obligation to make sure that we get the most health benefit or the most scientific value out of money that's spent, and I'm not convinced that this is the way to do it. DR. FADEN: I think I'm a little confused. I think we're un-confused now. Stepping back, we're talking about these soldiers, it's 1953 or these sailors, it's whatever year it is, right? The issue is, they're marched out onto the nuclear battlefield and they're exposed to radiation in the line of duty. Now I tend to think this; we are going off the human experimentation thing here which is a bit of a problem. DR. ROYAL: Yes. DR. FADEN: I tend to think of this as in the category of how you think about occupational exposures. Is this the sort of thing that you keep records on employees to see what they're exposed to, you keep that up so that you can know whether you're putting them -- DR. ROYAL: Right. DR. FADEN: It seems to me that's sort of the mindset that I would tend to look at this. This is a public health/occupational monitoring issue. DR. ROYAL: Right. DR. FADEN: And from that point of view, you know, if you want to get to whether they did a wrong thing at the time, were they keeping records of the workers at Hanford, were they keeping records of other people who were exposed occupationally to radiation at the time, was that already normative? And if it was already normative, why was this thought to be different; because it was one shot? DR. ROYAL: Correct. DR. FADEN: And is that an adequate argument. I don't know how else to think about it. DR. ROYAL: I think it was made very clear, either in this chapter or in some accompanying material, that that was the reason, was that this was supposed to be an infrequent exposure and that's why they didn't issue everyone a badge. DR. FADEN: Dan and Mary Ann. MR. GUTTMAN: First of all, in light of the Green Run discussion, this is what I think the evidence is not: We're not talking national security. We're not saying should they have put the troops there. Maybe the second or third time you could ask the question. The question is deciding to put them there, what kind of precautions. Then we're talking about, was there any reason to think, not that they would be at immediate risk, but maybe, some time down the road, or looking backward, well they were sure there would be no problem. And what the chapter shows, and this is why it's a public open discussion because this is controversial stuff; is one, as Eli mentioned earlier to me, it was after the atomic bombing we started studying this, because this was kind of unknown. Second, after Crossroads, putting that aside, to me the most important evidence is that the very people we're talking about, Stafford Warren, the medical military radiation expert said it's a very serious problem of long term latent effect. Maybe it's a little, maybe it's a lot, but we are writing memos saying we've got to worry about this. And three, when they made the decision to put the people out at the test site, yes; they characterized it, they said it's going to be okay, it's not going to be acute, it's much lower than an acute effect. They said the literal wordings of the memo are, we do not know a safe level. We are hopeful, we expect, we believe, we pray there's not going to be any long term effect. There are other documents. Lois pointed out one of the transcripts we handed out where someone said "Look, there's a statistical risk." I was shocked when I read it. He didn't say there was no risk, but 20 years from now someone is going to get cancer. But that's down the road; we've got a cold war. So the question here is not whether they should have done it, but having done it with what they knew should they have said "The least we owe these folks, if it's not a national security issue and it's not that we don't know about risk, is something that we'll make sure 20 years from now we can at least look back and say we did our best." PROFESSOR KING: Dan, I don't understand the question. The key word here is culpability. MR. GUTTMAN: Right. PROFESSOR KING: And the issue is, and I don't have a foregone conclusion I'm waiting for somebody to list for me -- and Ruth actually started doing it -- what is it that we look to that says at the time that they put them out there -- I'm not talking about national security -- what are we saying supports a view that they should have put in place a long term monitoring program? This would be a hard argument today to make to people about what you should do in evidentiary terms; not in the broad statement of "you should do something." DR. FADEN: There is also a difference between a long term monitoring program, which is expensive, and just keeping the records. PROFESSOR KING: That's right. DR. FADEN: So all we're talking about now is badging people and keeping their records, and keeping them accurate and making them available. A monitoring thing is the next level of decision. That's expensive, and it's -- PROFESSOR KING: And Ruth offered one avenue of dealing with this, and that is similarity with what was going on in other places. So you have to explore if there was indeed similarity so that there were some standards known at that time. That's all I'm asking -- I'm just asking for those listed. DR. FADEN: I think what Dan was just saying is not irrelevant on that point; he's establishing that the people at the time characterized this as an unknown situation with potential for long term. So one piece is there; it's not as if at the time people were ignorant and thought there was no way in the world that anybody could be harmed, or there was any possibility of latent cancer, so we'd be crazy to expect them to do that. PROFESSOR KING: What I would ask is a question to that, because this is what confuses me in this. We do selective quoting sometimes, and what I want to know is whether there was a debate at the time about whether there was long term risk or that there was a consensus that there was long term risk, because these things make a difference when you're trying to make judgments in hindsight. DR. FADEN: Let me get everybody's hands up; and we do want to do national security. and we do have at least one more chapter. Let me just see hands. I've got Dan, Henry, Ruth, Nancy, Eli and Mary Ann. We may eat lunch around 3. MR. GUTTMAN: Two points; in mix match fashion, the question Pat then asked first: I don't think culpability is the issue, it's a matter of, was there something that went wrong that could be identified the next time around. PROFESSOR KING: That's not what Duncan said; that I'm responding to. So would you clarify that? MR. GUTTMAN: What the chapter tries to show is that with the knowledge at the time, if they had independent people sitting around and thinking about these things in some fashion they could have identified steps to be taken which may or may not have cost a lot of money, but they would have been looked at whether it cost a lot of money. DR. FADEN: You want to fall short of saying "and it was wrong that they didn't do it?" MR. GUTTMAN: That's a separate question; but I don't want to throw out baby with the bath water of what it was that the story looks like. Two, is Pat's question is what all lawyers get asked is, well, you're obviously presenting -- what's a surprise to me; and there's tons of information we have, is it may be -- Henry and I E-mailed on this again -- that the notion that long term risk was really likely going to be low is more of an historical notion that we have today and we say well these guys were right, because when you looked at the documents at the time, people weren't saying "Well, it's a threshold." Those are the documents we seem to have. We may be not reading the right documents, but people were saying "We don't know. We hope it's low, it looks low, it's not an acute effect" but nobody was saying "we're certain." It wasn't that kind of -- DR. FADEN: Mary Ann wants to -- DR. STEVENSON: The information to make those judgments was just simply not available; and that information came from studying A-bomb population, to a small degree, therapeutic radiation patients. And you just couldn't get that information at that point in time. But clearly there was a recognition that radiation could cause cancer. That was known and certainly well known by them. What the dose was was not clear, and that isn't still entirely clear at low dose levels; but there certainly was a recognition that there was a risk; and I think that has to be addressed. That's the point, not necessarily that a long term epidemiological study had to be done at that point, but record keeping on these people, I think it was not an unreasonable thing to request. And proper dosimetry, at least in the representative populations could be extrapolated to the population as a whole, was not an unreasonable thing to request. Clearly, there was enough interest to have instituted a study in surveillance operation in Japan by that point in time. Clearly that was a much larger dose. But I mean those kinds of things were already in place, and I don't think it was unreasonable for our own population to ask for the same. DR. FADEN: Henry, Ruth, Nancy, Eli. Unless you want to say something -- that was your point, Mary Ann, or that was your backup list? DR. STEVENSON: No, that was my --. DR. FADEN: Henry. DR. ROYAL: Two issues; we've referred to whether or not proper dosimetry should have been kept, and I guess I don't understand what that definition means. Because you've said that not every individual needed to be badged. DR. FADEN: Maybe. That's a technical issue. I don't know, I would defer to -- DR. ROYAL: So I'm a little bit confused about what proper dosimetry was or was not obtained, because I don't know what the definition is of proper dosimetry. The second issue that I wanted to bring up is, don't forget that the atomic veterans are not the only individuals who were being exposed to radiation during this period of time. People who were occupationally exposed, who were nuclear workers, were being exposed to cumulative doses, which were significantly more than what the atomic vets were being exposed to. So all of this uncertainty about what the effects of reaction would be most relevant to the people who are receiving the highest doses, not the people who on one or two occasions received or were exposed to radiation. So it's not -- I think the concern about uncertainty and what you do about uncertainty is a real one, but that you would be driven not to focus on the atomic vets; you'd be driven to focus on people who were being exposed continuously into larger cumulative doses. DR. STEVENSON: I would say as well as, not necessary the exclusion of. Because again, no one knew what the dose threshold was. DR. ROYAL: If you're doing an epidemiological study -- DR. STEVENSON: You're just keeping records, at this point, in my mind. DR. FADEN: We haven't gotten to the point of saying that they should have done an epi study. That's the next level up. Or monitoring. DR. ROYAL: So the real issue is, how do we define proper dosimetry when we're not planning to do an epidemiologic study yet? DR. STEVENSON: You don't know if you are yet, but if you don't keep the records, you never can. DR. ROYAL: So we're saying that when we collect records against exposure to any hazards, we should collect them with enough rigor that we would be able to do an epidemiologic study if we decided to do it at some time in the future? DR. FADEN: Can I put something on the table; my understanding is that when we talk about the lost division at the Veterans Administration and so on, that there was an awareness that this might lead to liability claims against the government. DR. ROYAL: Yes. DR. FADEN: They were worried that a case, which is the best evidence that they thought somebody might be harmed, was that they thought that somebody might sue them. That a veteran might sue them later. DR. GLATSTEIN: And they had a secret division. DR. FADEN: It's all of a piece, isn't it? One issue for keeping records, and so people are occupationally exposed are they now under workmen's comp when a claim that their injury is related to their occupational exposure, whether it's to a chemical or to ionizing radiation so that there's some evidence of the degree of their exposure. DR. STEVENSON: Right. It's as important for the negative answer as for the positive. PROFESSOR KING: One of things we have to be careful about in modern day, people who are afraid of liability do all sorts of things because they're afraid of liability. It means nothing except that they're afraid of liability. It does not necessarily mean that they think that what they're doing is wrong. DR. OLEINICK: I didn't say that. PROFESSOR KING: But part of problem is we draw assumptions from the fear of liability that I'm asking, can we really draw from; because people properly are afraid of liability in many instances, in my view. It does not mean that those people did something wrong. Sometimes they may think they're doing something wrong. DR. FADEN: Oh, no, I agree with you; but the point is they thought that somebody might think that their cancer or so problem they might have might come -- DR. ROYAL: But they had good justification for that; they knew about the radium dial painters -- DR. FADEN: Right, exactly. That's what I mean. DR. GLATSTEIN: Yes. DR. TUCKSON: It turned out to be true. DR. FADEN: I'm sorry, Reed, maybe I'm not saying well. DR. TUCKSON: No, I think you are. As I hear the discussion, it is that there was an awareness on the part of the officials that they were marching people into an area where they would be exposed to something that could harm them. They knew it, there wasn't any question that they were doing it, there was a question about whether or not they would keep information or not, for a variety of reasons. Either it cost money or because they were worried about liability or whatever the reasons are. It turns out, for whatever reasons, they didn't do a good job of it. And now it has come back to haunt them and us, because there are people who are saying "I do think I was harmed by that." "You did march me into that area, I was exposed, I think I am harmed." The fact that you decided to not keep information ought not be -- what I hear them now saying to us: "That's not my problem. That's your problem. You made that choice. You marched me in there." Now whether or not you do anything else -- I don't see any way, and I'd like Pat's pulling me the other direction; that's helpful, but I don't see any way you can avoid it. PROFESSOR KING: Your statement, Reed, is only significant in terms of what is the demonstrated proof. There's not anything inaccurate in what you said. If I am to draw from that that the people who marched me in were culpable, that's one thing. If I am to draw from that that people are now entitled to a remedy because they are harmed, that does not go to culpability, that's another thing. So the point that I keep going back to is -- DR. FADEN: What are we concluding? PROFESSOR KING: -- what are we concluding here? Because I think we're learning a lesson about how to try to think about these things in the future; there may not be any quarrels here. Duncan started this discussion by saying culpability. For me, culpability means, as I said yesterday, depending on your conclusion, what you need to demonstrate to support your conclusion changes, depending on what kind of conclusions you're trying to draw. DR. FADEN: So if everybody buys Reed's characterization, then the issue is what implications, if any, do we want to draw from his characterization. DR. TUCKSON: I at least want to then -- DR. FADEN: I'm sorry about Ruth and Nancy. DR. TUCKSON: -- Pat, I won't get us to where you want me to go, I think, but I will say as a result of that, there are consequences. Now I want to just get past the point, Ruth, that you're saying and see whether or not anybody disagrees with me. I want to get past the point at least where is, if any. There's a whole series of things that come from that. But I think the simple fact that you marched me in there, did not check on -- I can't find out about what happened to me well enough to know. Whatever that is, there are consequences. Something has to happen as a result of that. As a human being, I'm entitled to that. Now what that is is something else. DR. FADEN: We've got Ruth, Nancy and Eli. And I'm not sure how we're going to do everything we're going to do today. DR. GLATSTEIN: Well, that's your problem. [Laughter] DR. TUCKSON: And you're culpable. DR. FADEN: Great. Ruth. DR. MACKLIN: I'm not sure what to say at this point. We're talking about the issues, and when we talk about the issues we've come away from the chapter. Dan is always pointing out to us that it's in here, and of course he's right. Everything that this discussion was just drawing on is in this chapter, and I think the problem -- it starts pretty much on page 50, there's a little bit before, but it starts pretty much on page 50 and there's a section called the bomb tests and long term risks and all the comments that people have made in drawing on their recesses of their memory, here, the committee read this, and I had to re-look at this again to take it out of the recesses of my memory. It's all in here. Now we're having this discussion -- the part about liability, the part about the secrecy of the records, the part about the recognition of long term risks and the debate about what to do about it, and this nice comment here by this participant in the 1950 committee on medical sciences was stated: But when you start thinking militarily of this, nice adverb -- DR. FADEN: What page are you on? DR. MACKLIN: This is page 54, line 5. When you start thinking militarily of this, if men are going to go out on these missions anyway, a high percentage is not coming back. "The fact that you may get cancer twenty years later is just of no significance to us." Now, I think the problem that we have when we start discussing these things without reference to the text that's here is that it's first of all easy to forget what's in here when we have the discussion. If we tie our discussion to these comments or these pages, between pages 50 and whatever they are here, 59 or something, we see that we can make the points that we're debating about by reference to what is here in the text. So my question about all this is, and that's why I said I didn't exactly know what to say, is this a problem that readers are going to have the same problem that this accomplished committee is having? The chapter starts off in the intriguing way many of these chapters do, sucking us in by writing about these events, but without giving us a road map or a picture saying what it's about. Whenever anybody asks, and then Dan says in about four or five sentences what the chapter's about all of a sudden, "of course that's what the chapter is about." MR. GUTTMAN: I thought we did it there. Henry saw what it was about. DR. MACKLIN: We saw what it was about, but you have to step back. If we're asking the kind of questions we're now asking, having read this more than once and discussed it many times, there's something about the way the chapter unfolds that somehow fails to make clear -- DR. FADEN: There's two things; how the chapter unfolds and what the chapter is concluding. We are having a huge controversy and we don't know what we're talking about. DR. GLATSTEIN: That's because we haven't figured out what we want to do about it. DR. FADEN: Well, it's more than that; we don't even know what we want to decide we want to talk about and decide about. The point is we don't know whether we're talking about culpability, whether it's only a hindsight judgment and it's a -- for now, from now on. It's really not clear what it is. DR. MACKLIN: Well, but look. When it says here on page 50: The government and its experts believed from 1946 on that the bomb test might cause disability claims; although before that there's a claim about the long term risk. There was frank acknowledgement that the long term effects of lower level exposure were uncertain. So there's discussion and acknowledgement about that. So that settles one of the things; what did they know and what did they think about and what did they discuss. Then there's claim about undertaking in secret to collect data needed to evaluate liability claims, and I think we have to separate the question of evaluating liability claims and their concerns about that from the question of keeping the data for other purposes. But I mean, it's just a question of keeping the data. And then the sentence says: Notwithstanding their early concern, the tests that were undertaken did not devote scrupulous attention to the maintenance of the records and follow-up needed to evaluate risk in retrospect. The question is how to strengthen -- one question is how to strengthen that statement, and say they were remiss. DR. FADEN: Well, that's the issue. What are we concluding? That's just a description. Nobody is going to disagree with that description; it's accurate. DR. MACKLIN: So all we're now debating is what conclusion to draw about that. DR. FADEN: That's exactly right. The conclusions aren't drawn yet. What are we concluding? What that a bad thing? It was an unfortunate thing, but was it a wrong thing? You know, it's all that sort of stuff. DR. MACKLIN: But then the question was, what was the nature of the wrong? What was the nature of the wrong failure to keep these records, because, using this quote again on page 54: The fact you may get cancer 20 years later is just of no significance to us. Then we would have to claim, well, it wasn't of significance to them but it ought to have been. DR. STEVENSON: Or they were trumping it with military concerns over -- DR. FADEN: That goes to marching them -- that was Dan's point. That goes to marching them on the fields, not to keeping the records afterwards. DR. STEVENSON: No, but the fact that they justified not being -- they acknowledged cancer was a risk,e core of what we're supposed to be talking about. Dan? MR. GUTTMAN: I think -- Look, Ruth is right; everybody knows there has been legislation. What we're looking at is a focus on this that has -- this has been a very public story in many obvious respects; congressional legislation. We really are the first people to focus on the role of the experts who knew about what might have been the case relating to the radiation effects, and what that inside discussion was, and what kind of action should be taken. So from my own parochial perspective, this is a story telling and a lesson learning. Not, who should be blamed or who shouldn't be blamed; it's what was the system at that time that should have taken care of, and what in retrospect should have been some precautions. And how did that expert system work. The experimental part is in the heart of that expert system, because that's where the doctors were actually saying "Let's use this to keep data, but let's also put them out for training purposes. To me, it's a story putting right in the heart of our charter the picture that other people have pointed the -- you know, the big picture, too. DR. OLEINICK: Well, focusing it back on the experiments again, one of the issues that is discussed earlier in the chapter but isn't in this last section is that within the context of the HumRRO experiments, there were at least two places that I remember where the indoctrination for the troops said very explicitly that this experience was going to be absolutely safe. Now in the context of understanding that there probably wasn't absolutely safe, again within the experiments, do we want to make any comment on that? This focuses on the experiments, rather than just marching atomic vets into a battlefield. MR. GUTTMAN: That's right. That's it. Where the people should have been most acutely aware of risk was in the experimental setting. DR. OLEINICK: Right. MR. GUTTMAN: And that's the way I put this chapter. You know, maybe if it was just generals marching troops, then you could say they don't know about radiation risks. But when you get to the experimental setting, then you have people who-- DR. OLEINICK: Who knew something, knew that there were risks, and yet were telling the troops -- DR. FADEN: Wait. This is a little bit of the confusion; because --the military consulted with medical advisors. They knew that radiation could cause health effects, and to say if it was just the generals marching in the troops, is ridiculous. Because they clearly understood that they had to figure out from their medical experts whether -- now, the advice they got is a separate order of problem. But they went to their medical experts both inside and outside of the military, and they were told, "It's okay, go ahead and do this." Rightly or wrongly, with whatever discounting of long term risks or whatever. And the human experimentation side of things didn't enhance or detract or anything from that analysis; that was going to happen anyway. The HumRRO people were psychologists who were no more privileged than the generals with respect to radiation risks, and I'm sure got their script from somebody else, as to the indoctrination. Basically we're told -- it's wrong, but it was basically the same message they were giving to all the troops: "Go out there, it's safe, don't worry about it, do your duty, we wouldn't let you out there" kind of a thing. So I'm not sure what you tag onto the psychological effect; that's what I don't understand. DR. KATZ: Ruth, can I ask you a question here? Isn't this a crazy experiment altogether? DR. FADEN: That's a separate course, yes. DR. KATZ: If we wanted to study panic and tell the soldiers that it's absolutely safe, either they wanted to test who believes that the government is telling the truth, or who believes that the government is lying. But to learn something about panic and fear, et cetera, from that crazy experiment, I am dumbfounded. DR. FADEN: I've gone through this before. My sense of it is that they were trying to see whether --they should have had a comparison group of people who didn't get the indoctrination who went out there without the indoctrination; then you'd see the difference between those who got the indoctrination and those who didn't; they didn't do that. But that's neither here nor there. So they showed that with indoctrination and given the kind of test that it was, nothing happened. Yes. But in the whole chain of being of what happened in this context, like trivial. That particular one, the HumRRO stuff. We can make out of it what we want, but it's not -- MR. GUTTMAN: Phil Russell is not here, but when things go wrong there are multiple checkpoints; and the HumRRO is not the psychologists, it was the Joint Panel on the Medical Aspects of Atomic Warfare, which was the doctors who were saying "it may be very little benefit, because psychological research is trivial, but we have to take every opportunity to put" -- in other words, it's the people who might have been able to check it who were actually -- DR. FADEN: They were also positioned to check whole thing. They didn't need HumRRO as an excuse to check it; that's my point. You're going to say but for HumRRO, they wouldn't have had an opportunity to comment. They certainly had an opportunity to comment on whether this was something that ought to have been done to the troops. And HumRRO didn't give them a better context or worse context for doing it; that's what I don't understand. If the psychological experiments weren't there, would we absolve the Joint Panel of having to have commented on whether this was an appropriate thing from a medical point of view to march people on to a nuclear battlefield or not? I wouldn't think so. So what cash value is there other than to look at the experiment and say it didn't follow the Nuremberg code; it should have. But big deal; it's the tail wagging the dog. There are other ones in here that are more, whatever. Some physiological measures and some paper and pencil tests. Maybe I'm wrong. DR. TUCKSON: As we try to get somewhere with this, then let's go back, as we think it through logically then, to maybe Pat's -- I think what Pat was trying to get us to. Ruth, the statement you made before this one, which is you've said that already the Congress has ruled that these people were owed an apology. DR. FADEN: That's right. DR. TUCKSON: So we don't have to fight that war, you said. DR. FADEN: There are other wars, but not that one. DR. TUCKSON: So now the next stage -- and I'm asking, I think -- the next stage then is to determine whether something else more than apology is owed to these people. Is that the issue that's really on the table here, or is it the issue of trying to go back and look at -- are we trying to basically get to agreement on this conceptual principle? DR. FADEN: The remedies part of this is another discussion. And we have remedies proposed to be debated for this context. Now the point is that this chapter is supposed to connect with the remedies, and sort of make the point why we think the remedies that we're going to suggest are appropriate. But what we're floundering with is what we want to do with this chapter, in and of itself -- we can have this be entirely descriptive. As Ruth was pointing out, there's a lot in here that's very engaging and important just to get out there as history. The issue is, do we go any further than that in this chapter and draw any normative conclusions about the past versus looking it and saying "Well, from now on, if we have the lessons learned, people do this again, they should keep records or they should do this or they should do that." And that's what we're struggling with. DR. TUCKSON: And I think that part of that answer again comes back to depending on the answer to the remedies issue. Let's say for example if we conclude that -- Let's say this -- and I don't know, I'm not there yet -- but if we decide that in fact people did not keep records in part because they wanted to immunize themselves from eventual suit, Pat's caution keeps me from saying it absolutely because she's saying you can't make that direct inference yet, because we don't have the information. But that becomes important for what this chapter says or doesn't say. Let's say that that you actually do have information that says that they didn't keep records because they were worried about suit. Therefore, because they didn't keep it, now that people are coming forward saying "We feel wronged and we can't get the information to determine one way or the other" and we decide, well therefore you then can't get -- we can't prove the case beyond a shadow of a doubt, and so we refused to rule on that issue. So in other words, the people who did a bad thing got away with it. So I think -- So what I'm getting to is is that, although I understand we want to have a tidy discussion, some of the conclusions that we may reach are going to determine what has to be in the chapter. DR. FADEN: I think maybe what needs to happen, and I don't know if we can do it now, but I think we've probably gone as far as this chapter as we can. It's not as satisfying in some respects, at least to me, as the discussion we had on the previous chapter. It's more all over the place, if you ask me. The other chapter, I have some sense of what position is tentatively, ought to be developed. I'm not sure I was happy here, but it does seem to me to be clear that this chapter needs to be read in conjunction, very closely with what the current remedies are for atomic veterans, and what suggestions we are making. PROFESSOR KING: I was going to ask, it might help the discussion -- the one chapter I read careful always is the remedies chapter, and for the life of me I can't remember what's in there about atomic vets. So if we could just have somebody tell us what's in there about the atomic vets, then we would at least know what this chapter was intended to do. MR. GUTTMAN: To me, the chapter is a story and it's a lesson learned. Whether it's culpability or not you can say. The remedies are very difficult for two reasons; One is that Congress has acted, and the experimental and the non-experimental are in the same boat. You may have a problem with Congress's action; a lot of people do, but that's a policy problem with relation to a piece of legislation that is not unique to experimentation. The second question is how would you prevent what we're looking at happening again in terms of the way the system worked. And there the chapter tells us a story, but Ruth was saying earlier it may be the system has been -- DR. FADEN: The system is definitely different. Whether it's different enough is the issue; but it's definitely not the same situation as existed then. MR. GUTTMAN: Yes. DR. FADEN: So the major lesson is we wouldn't like this to go on again, and the issue is whether the current situation has sufficiently changed so that it minimizes likelihood that it could happen again. PROFESSOR KING: I'm not suggesting that we do it now, because I tend to agree the chair that there comes a point where discussion is no longer useful; but one of the things that does occur to me to think about in the future, is verification. One of the ways to think about this chapter is to think about what we would want to have done differently; and we actually need to have that before we have the new regulations. Or a description of what they would look like. Because the only way to have some sense of how to, for us to test the adequacy of what has been done is to have an idea of what we think should have been done based on what is described here. Which I actually think is a wonderful role for a chapter. I never had any problem with that as the remedies connect, dumped stuff in the environment. DR. GOODMAN: Right. DR. FADEN: And put the community at risk. DR. GOODMAN: Right. DR. FADEN: One of the things that has already troubled me is this issue, if you really want to get to it, the question is the dumping of all the stuff in the community of which Green Run is this drop in the bucket. That's really what has already bothered me about this, is that we had more constrained folks on the Green Run; but in fact the larger issue is what happened at Hanford overall. DR. OLEINICK: Of course. DR. FADEN: Ruth? DR. MACKLIN: I want to try to look at your question, or suggest a way of looking at it -- I can give you my answer; on your last question which was, was it wrong at the time. DR. FADEN: Right. DR. MACKLIN: I think the only basis we might have, given the inability to balance, to know the benefits, given the inability to balance the risks and the benefits, and given the world view issue that Henry raises; the only grounds remaining, then, for trying to answer the question occurs on the paragraph or is embodied in the material on page 18 between lines 9 and 13. Ignorance and uncertainty about risks. How ought people to act when they are responsible people making judgments when there is ignorance or uncertainty about risks and they know that there is ignorance and they know that there's uncertainty. Now this is only five lines here, but when it says: They knew their knowledge was uncertain, they had been wrong by a large margin earlier, when the discovery of the vegetation pathway -- and as it turned out, they were wrong here because they didn't understand the milk pathway. Now of course retrospectively we can say that, but the point I'm looking at here is when people know that there's uncertainty, when they've been wrong in the past, what is their obligation to act based on their uncertainty and the knowledge that they had been wronged? A little humility, it seems to me, when you're dealing with lots of people, might suggest that you act on the knowledge that you have ignorance, or the knowledge that you are uncertain; and so that would be the basis, I would suggest, for arguing that it was -- if we want to argue that way, that's the basis for argument. DR. KATZ: Ruth, can I ask just a clarifying question; it's related to this and mainly addressed to Duncan and Henry. I admit it's naive. Am I to understand that -- and it indeed goes to the question that was raised here about, why did they keep it secret for so long -- that they might have kept it secret because they felt that maybe more danger occurred to the population than in fact did occur. And they were just ignorant of the consequences of all the Green Run releases was really by and large inconsequential in terms of their medical implications, or human implications. But they were ignorant about this, and therefore were embarrassed to share the knowledge with the population. Or is that not so? DR. THOMAS: You're suggesting a cover up. DR. KATZ: No, we know it's a cover up, but could they have said to the people: Okay, "Father, I have sinned." But really, there's nothing to worry about, you know. Here it is. There are really decremental implications. Is that a stupid question? DR. OLEINICK: I don't think they do that. No. The other thing is, the Green Run document itself suggests that the operation was essentially bungled; the idea was they were to have perfect weather and they didn't have perfect weather, and it did interfere with the experiment. So the experiment was in essence, at least a partial if not a complete failure. And somewhere in there it says they didn't want to do it again. DR. GOODMAN: Yes, and another element of it -- DR. FADEN: We don't know wion. It always give me pause. And it seems to me if this chapter, which has this borderline between experiment and non- experiment, which you point to, that perhaps one of the things that we might think about is in the military, that drawing a line between what is experimental and what is not experimental is often a question of what somebody calls it. It is not magical; it is what people call it. There's this thing about which we think we know research when we see it. Research is often what we call it, from the perspective that we have adopted here of the people that were harmed it really didn't -- what we're saying is, it didn't make any difference whether I was in an experiment or in a non-experiment; I was harmed. DR. FADEN: With two exceptions, you're right. DR. KATZ: How is that different from medicine? That's also the way you call it. PROFESSOR KING: Oh, I wouldn't say it is, but I won't get into that argument. But I'm saying that that may be a very important statement to make in a military context because if that is indeed true and especially true in a context that I would say is more coercive than prisons, and I have been through the prison debates, I would draw from that that the safeguards that you need have to be directed, not necessarily at consent, although it's always -- you should have it and it's desirable, all of your proposal have to be risk protection, and they have to be stronger than the risk protections that you might encounter in other areas, because what you're trying to do is to compensate for the fact that you can't even count on consent, or voluntary consent or informed consent in this arena. And I think that's very worth doing. I don't know how we can spell it out, but I'd be happy to try to work on it. I think that is an important thing for this committee to do. My last comment would be, in the doing of it, we should not draw the lessons just for radiation. The next time this stuff happens, it's not going to come labeled "radiation"; we don't want to fight the last battle, we want to try to avoid the future battles. So part of it should be in the form of general guidelines about what kind of procedures you take; not to do dosimetry studies or -- I don't want to get into the technical jargon. I think the message you want to leave is, that because of this context, because of the risk, because we can't think about the future in terms of exactly what we will test next time or be interested in or what the risk will be, what kinds of precautions you want people to put into place. Without any stuff about -- I don't want to make the normative judgments now. I want to draw a lessons so that we prevent the future ones. So maybe we would argue if we were trying not to make the normative judgments. And that's what you're trying to do here, as I understand it. MR. GUTTMAN: To me it's a story. It's a story, and what do we learn from the story? Others may have a different view. DR. FADEN: Pat's just given you three articulated things we've learned. MR. GUTTMAN: That's right, yes. DR. FADEN: And in fact they're there, and they're certainly the strategy -- they're in the strategy for where we were going with respect to the future. But the first is from the perspective of people who were there. It really didn't matter much whether you were an experimental subject or you weren't, technically; what difference does it make? You can't rely on consent for much, even if they hadn't had consent, and it would have protected them -- they would have be able to refuse the psychological test and they wouldn't have to give a urine sample; big deal. You know in most of these, maybe the flash blindness and the ground zero stuff is something else; we have to make sure we're not using overgeneralizations, and the big issue is are the risk protections adequate? I mean, you want the consent thing there because it is -- principle, and you want to maintain that in fact, if there are areas where servicemen can-- servicemen and women can refuse, they ought to be allowed to do that. You want protections for that, but recognizing the context, which may be the same in medicine, but at least is clearly the case here; you want to make sure the risk protections are good enough; which if the three major lessons learned, and that's exactly what we're working on with the military now, to find out are there risk protections, how good are these risk protection procedures today? And who has the authority to override them, blah, blah, blah, because it wasn't so great then. PROFESSOR KING: There is no reason, even on the grounds of secrecy, not to take risk protection. DR. FADEN: No, of course not. PROFESSOR KING: There may be on grounds of secrecy -- this is why I separate out consent. There may be on grounds of secrecy that a disclosure of information gets you to a problem. But there's no reason, even if it's done secretly, that you cannot put into place a risk protection system that is not dependent upon -- DR. FADEN: Public disclosure. PROFESSOR KING: Or disclosure to the person affected, right. DR. FADEN: Ruth, you had a comment? DR. MACKLIN: I only wanted to try to make sure before we leave the chapter that we've adequately addressed the six items that we are supposed to be discussing, because if there's going to be a revision of this chapter, and if the discussion of these is needed, we have to be able to provide that. So I don't have a view of it; I just want to put it on the table to make sure that we don't forget them and then have the problem of having to deal with them when the committee is not assembled. PROFESSOR KING: If in question 6, the "could have taken" reveals the thrust of the chapter. I would say that's not what we want our focus to be. I don't want to try to second -- "could have taken" suggests we will try to second guess them at the time. If that reveals your framework of thinking. I am thinking about -- I read that data, I'm not going to spend a lot of time worrying about -- if people want to worry about it they can worry about it, but what they should have done or could have done at the time, I'm much more interested in -- I learned from this that because they didn't do X,Y,Z for whatever reason, we got into trouble. In order to avoid ever getting into trouble in the future, I want to make certain kinds of proposals. MR. GUTTMAN: The "could", Pat, means that it was within their capability, not that we're blaming -- in other words, it's not something that we're telling people to do something in the future that is just going to be impossible because they're not going to know what it is that they're supposed to do. The "could" is a -- you can't say that they should have done it if they couldn't ever conceivably have done it. DR. FADEN: Pat doesn't want to say should have done it; Pat wants to say they should do it in the future. MR. GUTTMAN: But you have to be able to say they could have, factually and logically in the past, in order to say -- PROFESSOR KING: Why. DR. FADEN: It may be that we may want to go further than Pat wants to go, as a committee as a whole. I'm just trying to articulate her position for right now, where the whole committee was going. MR. GUTTMAN: What's critical here in all this, is what you have is an assumption about risk awareness, I think. Because if you don't even know that there's a risk then you can't tell people in the future that, you know, do this next time if the next time they don't know there's a risk. We're sort of saying, "If you think there's a risk, you should do such and such." DR. FADEN: That's okay. PROFESSOR KING: It's just a way of saying it. DR. FADEN: Are there other comments on 126? Thank you, Ruth, for drawing us to that. The risk stuff I think we don't want to revisit right now. Just as a matter of energy conservation. We still haven't done national security and we have two more chapters to go. We may never do findings -- we may never have any. [Laughter] But that's a separate problem. Are we ready to take a break? I have this feeling that we are in need. DR. TUCKSON: I think we are, but I just am worried -- look, this is the fun stuff. This is what all yesterday was about. This is the wrassling with the real stuff. And while I just hope that -- you seem a little frustrated, and -- DR. FADEN: Me? DR. TUCKSON: Ruth, as the leader, and you've got the timelines and we've got the agenda laid out, this is what we're supposed to be doing. DR. FADEN: I know. DR. TUCKSON: And I don't think we should feel badly, because we're working hard. DR. FADEN: That's for sure. DR. KATZ: Ruth, how are you going to end the afternoon? DR. FADEN: I don't know. DR. KATZ: I'd like to know, what are you going to do before I leave? DR. FADEN: We did say we would revisit this afternoon, at about 3:30 or 4:00 this issue of, do we want to have another meeting or not. DR. KATZ: And define the final process. DR. FADEN: And the final process for how to get this done. And we must decide that, because if we are or we're not, that changes, that obviously has dramatic implications for how things get done. So if I remember correctly, we said we would leave time at the end of the day; we wanted to see how today went; everybody wanted to sleep on it and all that good stuff. And so we're going to come back; wherever we are we're going to stop probably after the coffee break in the afternoon. DR. KATZ: And we can remind you that it's 3:30? DR. FADEN: Yes. DR. MACKLIN: Do we have to start that early? I mean, that discussion will take as long or as short as the time allotted; and since it took us so long to deal with these chapters, I mean it seems to me that we need to spend valuable time looking at the actual -- DR. FADEN: I don't think it -- it's not clear to me that we need an hour and a half to decide if we want another meeting or not. DR. MACKLIN: It'll take it if we allot it but it won't take it if you a lot less. DR. FADEN: But the issue is, we're deciding not only whether we want to have one more meeting or not but also what the process is for -- we've kind of done that with the discussion Henry introduced and Pat's comment and then Ruth's suggestion would be implemented. So I think you're right, I don't think we need to stop at 3:30. DR. TUCKSON: So when we come back after lunch. DR. FADEN: We'll go into more chapters -- DR. TUCKSON: We're going to go right to the next chapter. DR. FADEN: I think we have to. DR. TUCKSON: All right. [Whereupon, at 12:10 p.m., the meeting recessed for lunch.] A F T E R N O O N S E S S I O N (1:30 p.m.) DR. FADEN: What was distributed, so people know, are the letters that have gone out. Kris has distributed the Cortland letter that was referred to yesterday, that people asked for, plus two others, with respect to extensions. Did everyone get something from Mr. Brown? VOICES: Yes. DR. FADEN: Okay. So that's something from Mr. Brown, and there's some news stories. That's just there for reading, for people to take a look at. DR. THOMAS: He showed it to me before. DR. FADEN: We have some material that's left for our reading that we should put away for right now because we need to do more work. I hope everybody had a very restorative lunch, as the pace continues. I gather, from Barbara sitting here, that we are moving on to, what is the latest title of this chapter? Observational studies. If Barbara would bear with us, she could see how much committee discussion is going on. Barbara is available to answer questions, so if we have questions about the chapter or we want reactions, for that matter, but what we are really try to do is see to what extent, using the chapters, to advance the chapters, there also is a vehicle to see the extent to which the committee members agree or disagree about key issues in the chapter or even agree with what the key issues are, so we should be commenting on, that would be good, too. The floor is now open. Duncan. DR. THOMAS: What we have is part of the chapter here, and so there are issues which we could discuss that are in the chapter, and then there's issues about what ought to go, or ought not to go, in the chapter. Let me just sort of mention the two basic sections without one or two address at the moment, that have been kicked around, have been in and out and in and out of the chapter, and, at the moment and in the interest of time, in order to get something that could be presentable for committee discussion, we focused on the two that were best developed, namely the miners and the Marshall Islanders. The two pieces which, as I say, have been in and out of this chapter, are the discussion of fallout, which in its last incarnation was focused primarily on Operation Sunshine, and an executive decision was made by some of us. The questions that were raised by Operation Sunshine related really more to questions of secrecy than to epidemiologic research. So we made the decision to move some of that stuff over into the secrecy chapter. That chapter has not been recirculated to us. DR. FADEN: But you're not proposing that that be revisited? DR. THOMAS: Not at this point. DR. FADEN: Okay. Some of us have been arguing, however, that there was some epidemiologic research carried out in relation to fallout and if we are going to have a section of this report on observational research, it is kind of puzzling that none of that material ever gets mentioned in the report. That is, I would say, in the category that Ruth raised yesterday that we have not reached closure on, we have not adequately discussed, that would be one of them. The other section, which is not representative of the chapter as it stands at the moment is worker studies -- nuclear workers. Some material had been written in the previous draft relating to that, which was really quite ill- developed, and so we again decided if we were going to do anything about this at all, it, too, needed to be fleshed out some more before it was ready for Committee discussion. I should point out one final issue that somewhere in this report, it seems to me, it would be ironic if we wrote an entire report on the history of human radiation experimentation without ever once mentioning the atomic bomb survivors. Without wanting to go to press the argument that this is a human experiment, nevertheless, since we have chapters here on epidemiologic research, it seems to me kind of ironic that that is not mentioned and could even be considered almost an insult to some people that we don't address that. I certainly have had E-mail correspondence with some of my friends at RERF who have taken that view. DR. FADEN: That's the acronym for the? DR. THOMAS: Radiation Effects Research Foundation, Hiroshima. With those preliminaries, let me focus on what I see as a quick tour of some of the outstanding issues that have been raised in the correspondence that I have been hearing from. I would say, regarding the uranium miners, the major outstanding issue remains the use of long-term studies as a mechanism of avoiding action and, faced with this situation, what was the appropriate response of the Public Health Service physicians. Jay maintains, still, that they should have refused to do the study, and I feel somewhat differently about that. That is, I would say, one major category of what I would call situations with real disagreement. DR. FADEN: Okay. So we're flagging. This is a very helpful way to do it. DR. THOMAS: I'm just trying to make a catalog at this point. DR. FADEN: Okay. DR. THOMAS: The second item, and I credit Henry with raising this concern: Are we so sure that adequate knowledge was already available in the mid- to late 1940s of the hazards of radon from the previous Czechoslovakian miner experience, that the government had enough information to take action at that time. It's my opinion that they did, but I don't think that chapter documents that, and I have been encouraging staff to continue to provide the documentation as part of this chapter. Henry has some counterevidence, which I am sure he will be happy to tell you about. DR. FADEN: Here is a disagreement of a different order, which was the data either was sufficiently compelling or was not sufficiently compelling, based on the European experience. As it was known in the early 1950s, Duncan one side, Henry the other. DR. THOMAS: Correct. DR. FADEN: The earlier one was what the Public Health Service ought to refuse to do the study; the Public Health Service, it was appropriate for them to do the study. DR. THOMAS: Correct. I would say the third issue, and it is somewhat related to the first, is: Should the PHS or, these days, anybody ever undertake a study, whose one of the conditions of doing the study is not to warn the miners of the hazards. DR. FADEN: People being studied; that's an easy one for me. DR. THOMAS: For me it's an easy one, but this breaks down into actually two component pieces, which I have only recently appreciated. The first is, whether or not at the time of undertaking the study, they should disclose to the studied population what the purpose of the study is and why they're worried. The second, which is even more troubling, is whether or not they should undertake it with commitments that they will not inform the workers of the results, which I find extremely troubling. Documentation in this revision now establishes that that appears to have been the case. DR. FADEN: Okay. DR. THOMAS: Perhaps I should shut up and let some other people talk at this point. There are other issues that are raised by the Marshall Islanders as well, but maybe the best way to work is, I don't know, focus on each of those. DR. FADEN: Let me just get clear on what you just said. This last issue is not looking at this, but this is an issue for today. DR. THOMAS: Yes. DR. FADEN: Okay. A question of how epidemiological research ought to be conducted with respect to subjects who are thought to be potentially at risk with exposure to potential hazard. DR. THOMAS: Correct. In any study that we ever undertake, there is always this question of, at what point should the results be released and at what point are we sufficiently confident of our knowledge that we are prepared to talk about. DR. FADEN: That's not an issue you're talking about, I don't think. DR. THOMAS: I think it does bear on the second aspect of this one, because as I read the documents now, it is saying that PHS undertook it with an understanding that it would not release the results. DR. FADEN: There are two issues here: One is: How you decide, essentially, that they be safe in monitoring for analogy, when the data is compelling enough that you declare something a hazard and something ought to be done about it. The second issue is: If it's in the minds of the people doing the work or the hazard of sufficient magnitude, can you, then, which seems to have been the case, here at some point in the minds of the PHS researchers, ought we to withhold it even at that point, is sort of two different questions, the latter being a somewhat simpler answer, I think, than the first, but maybe I'm not being clear. The evidence is there. By whatever criteria, the evidence exists, that this is a hazard of some magnitude of which protective action should be taken, what is your duty versus how do you draw the threshold; what do you define as an acceptable risk versus unacceptable hazard. It is the more difficult question, which I don't think the committee can begin to approach, except perhaps some suggestions procedurally about how such decisions might be made. The issue of, it it's by whatever criteria established to be a sufficient "hazard," quote/unquote, for which protective action can be taken, exists and could be taken, what is the duty then? I have names going, so I've got Ruth, Nancy, Jay. DR. MACKLIN: Yes. This is just a question of clarification, and since Jay is going to talk next, he's going to clarify it. The circumstances under which there is this disagreement; that is, on the question of whether the study should have been undertaken at all, should anyone agree to it, to the extent that Jay is disagreeing, and that is what you are now talking about here, is a disagreement, is that under the conditions under which this study was done, or is it not even mentioning those conditions, so your first point and the third point are related. DR. THOMAS: That's what I said, I thought they were related, and now, as you pose the question, they are intimately related. Yes. I don't think anybody is saying that one should never have studied the miners, period, but the way in which they were studied, without either taking action or without issue of warnings, is what is ethically unacceptable. DR. FADEN: With agreeing not to warn, no matter what. Is that the core of your objection, Jay? DR. KATZ: Yes, and I feel very strongly about that, and it is also influenced by my views on the Tuskegee syphilis study, but another group of public health service officials did what I think they could not have done and should have walked away. Who knows how the committee ultimately will feel about this. If it feels that it should not have and should have undertaken the study, as Duncan might still feel, the only thing I would like to ask for is the privilege of having a footnote, just a footnote, at the appropriate place, and very briefly, in two sentences, my reasons why I feel very, very strongly the other way, or Duncan may have to write the footnote, depending on how we come out. DR. FADEN: In the interest of maybe getting a little more progress than we did in the previous chapter, can we stay on this point for a minute and see where the committee is on this issue, how many people are comfortable about having an opinion, how many people don't have an opinion yet, and what they need to hear more of. As to the issue that is on the table now, should the Public Health Service have agreed to conduct the study under the condition that they gave the mine operators, namely, that they would not warn the miners directly, no matter what, which was the deal. PROFESSOR KING: Can I ask a clarifying question about what Jay said about what you just said. DR. FADEN: Okay. PROFESSOR KING: Is our primary focus what the Public Health Service should have done as an institution or what the researchers should have done as individuals? That was never clear to me. Sometimes we talk as though we're talking about the researchers, and someplace we sound like we're talking about the institution. I think that's a critical difference. DR. FADEN: Do we know who entered into this agreement on behalf of the Public Health Service? Was it the Surgeon General? DR. THOMAS: Actually, I tried to get as clear as possible, as best as we understand, to litigate the case, there is no piece of paper that the judge in the decision refers to the Surgeon General, but the authority was the Surgeon General. Whether there was a piece of paper, who actually negotiated it, isn't clear. Is that correct? MS. BERNEY: The pieces of paper that we have are not the agreement. The pieces of paper that we have make reference to an agreement that was made. DR. KATZ: Pat, I can maybe throw some darkness of that issue. [Laughter] DR. KATZ: Also informed by Tuskegee, because Public Health Service seems to be such a loosely organized organization, that when these people get involved and there were higher echelon people involved from the Public Health Service in Tuskegee as it seems to be through here, but I get the impression from the uranium miner studies and surely from Tuskegee, that it never was discussed at the highest level of the United States Public Health Service. They had a lot of discussion, freedom so that these people, fairly senior officials of the Public Health Service decided to do this study, but it was never officially reviewed. PROFESSOR KING: I'll try to be more specific because I'm only -- the analysis. That is, the people who work in -- an institution is always represented by its employees. So I really read very carefully the one that preceded this one because I had this one. That draft, it was not always clear that we were talking about individuals as agents of, therefore representing institutions. So we're talking about the institutions, or as individuals. I just wanted to know why we're talking about it. DR. FADEN: Let's start with agents because I think later on there is this issue if you want to get into it, whether these individual investigators ought to have gone any further than they did, since then they're functioning with these people. But we start with people in their capacity as an agents of the Public Health Service. So the issue that's on the table - - and Nancy is being very patient; I want to hear from you -- is how the individual committee members feel on this question. Duncan and Jay have presented themselves. The choices that presumably, without entering into this agreement, counterfactual, we don't know what would happen. The claim, the position, the mine operators took is, we're not letting you in; this is private property. We're not letting you in unless you agree to this. As Barbara has pointed out in the draft, there were AEC -- MS. BERNEY: We don't know that, Ruth. DR. FADEN: Oh, we don't know that? MS. BERNEY: No. We don't know that the mine operators said, you can't come in here unless you agree to this. DR. FADEN: So we don't know why this clause is there? MS. BERNEY: That is also implied. DR. FADEN: So it's a guess that it's there, but we don't know. MS. BERNEY: It's implied. We don't have any direct statements or anything like that. DR. MACKLIN: But it says something more explicit than that in the draft. MR. GUTTMAN: There's two aspects. One is, Duncan Holaday, as I understand in the Gay court case said, whatever is quoted in there, to the effect that this is what we agreed to, the judge's decision which purports to be the undisputed facts, although, as the lawyers know, that doesn't mean necessarily that's the case. Good. Read the quotation from the Judge's decision, saying, of course, on behalf of the Surgeon General, this has to be done with the agreement to miners. I think there may be some other documents which allude to that, so it's one of those situations where the people who would be in the position to contradict that statement seem to be the ones that are asserting it. We don't have independent -- DR. FADEN: So we don't know for certain whether we have Public Health Service held firm the mine owners would neglect them in any way. We don't know that. We wouldn't have known it even if they threatened it because you never know what happens when you call somebody's bluff, right? So it's one of those situations. That's the issue on the table, should the Public Health Service have agreed to this arrangement. There is also the background that I wanted to get to, just as an aside, but there were some mines that the AEC had authority over that they could have studied where they were not private, where they had the authority to go in. Right? MR. GUTTMAN: Yes. The Judge's decision, again, points out by '59, the AEC was looking at its own properties, and the judge is opposing some of them, so there is a dual track, and it's a little bit complex. DR. FADEN: Let me just stop now and let other people talk. MR. GUTTMAN: Yes. DR. FADEN: Nancy. DR. OLEINICK: I have my own jaundiced view of the world, I guess, but for me the undertaking of an experiment begins with knowing whether that experiment scientifically has any merit, and that depends upon what was known at the time. It is still not clear to me how much of that information, which presumably derived from the European mines, was known and accepted by the people in positions to make these decisions. It is not clear to me. We discussed this on the teleconference on this subject, and presumably there was information that was going to come to us, and I guess in all the other paper, it may have come. I don't know. How could I know. But, to me, that question is an important one, which needs to be addressed. Should any reasonable scientist at that time have said, look, we know that there is such and such a risk, and therefore we should follow along this path. On the other hand, you know, a lot of epidemiological data come out with very big error bars, and maybe it was really not clear. I would like to know if Henry has other information, or anyone, what were the data; how were they interpreted by those at the time. That will certainly color my decisions as on this issue. DR. FADEN: Let me see if I can articulate it. You mean, if there was evidence already available, suggestive that this was, quote, a hazard -- I'm going to use that within the sense of the word -- then you would judge more harshly the Public Health Service's willingness to enter this agreement. DR. KATZ: Can I comment on that, please, just very briefly. DR. FADEN: Jay. DR. KATZ: As far as I'm concerned, the evidence is overwhelming from the German studies reported in the literature. You can make the argument if you want to be a scientific purist, because the point was raised that the German and Czech miners work under slightly different kind of conditions, and therefore it's not comparable to what was going on in the uranium mines. Secondly: When the first readings were taken, the radon levels were so excessive that the people were frightened. Well, you don't have the scientific evidence and you can study this to death as it was done for ten years; but speaking for myself, I'm convinced, on the basis of the data, that the evidence was -- at least to the extent that I would not have allowed Eli to mine uranium. Some other people, yes, but not you. DR. GLATSTEIN: Bless you. DR. FADEN: Henry and Duncan. DR. ROYAL: I'm not an expert on the history of scientific knowledge about radon, but one of the things I think is helpful is to imagine the complexity of the problem. I tell you what I think people understood in the mid- 1940s. I think what they understood was that there was a high incidence of lung cancer in European miners. Then the next issue is what is causing that extraordinarily high incidence of lung cancer. I have always been amazed that someone was able to figure it out, because if you think about what the problem is, you've got uranium dust, you've got moles, you've got cigarettes. [Laughter] DR. KATZ: Cigarettes, always. DR. ROYAL: You have fumes from the mining equipment. So to sort out why it was that these miners were getting such a high incidence of lung cancer was very difficult, although it was clear that they had a very high incidence of lung cancer. What I think the subsequent study showed was a clear -- DR. FADEN: Which ones are you referring to now? DR. ROYAL: The PHS. DR. FADEN: The Public Health Service ones. DR. ROYAL: Showed a clear dose response relationship, which made it very convincing evidence that it was related to radon. As I said, other people may have a different interpretation of what our level of knowledge was, but that is my understanding of at this moment. DR. FADEN: Duncan. DR. THOMAS: Yes. Mine is not all that different. The two pieces of information that I would say were reasonably well accepted at the time -- DR. FADEN: The time being now, 1950? DR. THOMAS: Let's pick 1945 as a reference date. Was that there was an extremely high level of lung cancer in the Czech mines, and that the levels of radon in the U.S. mines were as high, if not substantially -- in many cases, very much higher -- than in the Czech mines. The things that were not known, in a way that I would say would be universally accepted, particularly by those who have some reason not to want to accept it, is the causality of the connection. Secondarily, the actual magnitude of the dose response, which one would need to have if one wanted to establish some sort of safety standard. That's an important point. One can say that based on this alarmingly high incidence that we have, then we know that we need to take -- if one has accepted the causality argument -- that based on the ratios of the doses in the U.S. to the dose in Czechoslovakia, we know that we have to take action to lower ours. One might not know how much one wanted to lower them in order to reach a, quote, acceptable risk. For that, one would need dose response information that I doubt was actually available in the mid-1940s. DR. FADEN: All right. It sounds like what you started out saying was a disagreement between you and Henry is not a disagreement, because the characterization sounds very similar to what Henry just gave. DR. THOMAS: I think there is a difference of opinion, and let me try to crystallize where the difference is. DR. FADEN: Okay. DR. THOMAS: The question is whether or not there was a reasonable presumption of causality which would have justified taking action. Henry is not persuaded, and he raises -- and, indeed, in his written comments he has quoted before on the history. Maybe it be worth actually reading that into the record what they have said about it. DR. FADEN: Can I just leap ahead here for just a minute so I can understand the relevance of the disagreement. We are not here -- we may later, but we are not here -- debating whether the government should have allowed the mining to continue, to start, or wherever. We are debating whether the Public Health Service should have agreed to do a study under the condition that it not warrant the workers, if it found something that was troubling. DR. THOMAS: I thought we were debating two questions simultaneously, but I appreciate your desire to try to separate them. DR. FADEN: I am trying to do that one first. DR. THOMAS: All right. But I want to tie them together a little bit more closely. You said, whether the PHS should have undertaken the study -- should have done the study under the condition, and then you enumerated one of what I think are two conditions. DR. FADEN: I just want to go with what the actual conditions were, what was the actual condition. I don't want to make them up. I don't want a hypothetical. What was the condition they agreed to? MS. BERNEY: Not to alarm the miners. DR. FADEN: Does that mean not to tell them? MS. BERNEY: The language is "not to alarm the miners." Duncan Holaday actually says later that they would not tell them information about their particular mines, what the conditions were in the mine in which they worked, and they would not alarm them. Duncan Holaday pushes it further, and he says that they wouldn't warn them of the hazard. DR. THOMAS: Ruth, you're absolutely right, that this question of causality and dose response doesn't bear directly on this issue. DR. FADEN: Well, it bears but not in the same force. DR. THOMAS: Not in the same force. I agree. DR. FADEN: To go back to the issue of threshold, the point is, from my mind, there is sufficient evidence that it varied to bear on the public health question, the Public Health Service, as opposed to the one about whether the government should never have allowed this mining to take place at all. DR. THOMAS: I want to broaden the question slightly. I am happy to focus the discussion for the time being on whether PHS should have undertaken the study, but I want to argue there were two conditions involved. Condition No. 1 is that they not alarm the miners. Condition No. 2 is implicitly that therefore no action should be taken until we have convincing evidence. DR. ROYAL: The ventilation. DR. FADEN: Right. DR. THOMAS: All right? To organize this discussion you want to set that second question aside for the time being, that's fine. DR. FADEN: I do. DR. THOMAS: We can come back to it. DR. FADEN: I want to come back to it. That wasn't -- DR. THOMAS: That is somewhat different from whether the government should have undertaken mining. DR. FADEN: It's also different because it's different entities. The Public Health Service was not in the position to ventilate the mines. DR. THOMAS: That is why I want to separate the Public Health Service, had the authority to go forward with the study or not go forward with the study. The decision whether or not to ventilate the mines or to require the mines to be ventilated was never, as I understand it, the Public Health Service's authority to do anything about it, indirectly but not directly. You're talking about the AEC, or you're talking about the mining offices of the states, as to requiring ventilation. Would the Public Health Service have required the mines be ventilated if they hadn't -- DR. THOMAS: It was not their authority. DR. FADEN: Okay. That's what I thought. That's why I want to separate the two, so the issue right now is the Public Health Service, and then we can go on to the other entities of government. DR. THOMAS: In that case, I propose to defer the entire discussion about what was the scientific state of knowledge at that time until we get to this other question. PROFESSOR KING: I agree with Nancy that in order to make a judgment about whether the Public Health Service should have undertaken the study, people like me need to know what we thought we knew with this confidence and what we thought we needed to know with reference to the people in the mines, not raising the question of whether we should continue the mining, but you can't even approach this question about should the study have been undertaken, irrespective of any conditions until we get clear about the need for a study or the non-need for a study. Does that make sense? DR. THOMAS: The need for the study is unequivocal, in my opinion. We had clear evidence that there was a high risk of lung cancer in uranium mines. So the question, then, turns on is it causal and, if it's causal, how big is that risk? So that's adequate justification for doing a study. I don't think anybody questions that. PROFESSOR KING: There is still time, because when I read this chapter, part of it is, if it is true that where you need -- this is a long assumption -- if it is true that where you need to go get answers to important questions, is the only place you can get to is this mine, that you can't get into without permission, then the question of whether you say shuck the whole thing or agree to that condition, in part, is related to the importance of the question being answered. So I don't know how this works back on itself, but when I read the chapter, my initial reaction was Nancy's, which said, one way of thinking about this is weren't we better off having some of this information that came out of the study or would we have been better off foregoing all of the information altogether. DR. FADEN: There's a missing link, because he wouldn't necessarily had to foregone all the information. MS. BERNEY: I there's one piece of information that would be quite helpful, and that is, there was an industrial tolerance for radon that applied to industrial facilities, prewar. PROFESSOR KING: How does that relate to --? MS. BERNEY: There was a limit -- an exposure limit -- DR. FADEN: In another occupational setting. MS. BERNEY: -- for all other occupational settings that was being used by the AEC. DR. THOMAS: What industry was that? MS. BERNEY: Well, it applied to people who were painting luminous dials. It applied to medical and laboratory facilities, and I would assume that it would have applied to other AEC plants, where they were handling radon-producing materials in the '79 hearings. This is not in the chapter yet, but I think it's the '79 hearings, somebody testifies, specifically, that that was never meant -- I think the quote is pretty close to: "That was never meant to apply to mines, that was intended to apply to enclosed spaces." DR. THOMAS: Do you know what the numerical value of that limit was in relation to the mines? MS. BERNEY: It's my understanding that it was 10 picocuries per week, but I'm not positive of that, but I can get it. DR. FADEN: Whatever it is, we'll get it. We'll get it. We have so many other issues to discuss, I don't know how much further -- maybe we can't go any further right now. We sort of know the kind of arguments that have to be laid out and maybe the best thing is to -- MS. BERNEY: And I will provide those documents to you by the end of today. DR. MACKLIN: The other thing that disturbs me -- DR. FADEN: Let me stop you. Don't give it to people at the end of the day today. DR. MACKLIN: Okay. DR. FADEN: Give it to them Wednesday in the packet with all the papers; otherwise, it's going to get lost. This is a little tiny point. Thank you. I'm sorry, Ruth. DR. FADEN: Yes. The other thing that disturbs me about this dichotomy, the importance of the research so it had to be done versus don't agree to do it at all under these conditions, is our uncertainty just exactly what those conditions were and who imposed them. For example, the other words in here, in addition to, "don't tell the miners," the individual workers, this is Holaday's recollection, "there would be no overt publicity." Overt publicity. What else is there? Is there covert publicity? I think we have to think of what other possibilities there might have been so that if public health researchers who truly had a conscience and decided, following Duncan's line of reasoning, it's important for this to be done. Moreover, I'm doing it under these conditions, so I am going to agree to these conditions. There are creative ways that people can, and particularly if it's a conscientious stance that they have to take at some later time, whether it's a leak to a newspaper, a covert rather than overt publicity. What I am objecting to is the dichotomous choice that we are faced with because we have lack of sufficient information about just what these conditions were, who imposed them, and what might have been done to circumvent them. DR. FADEN: Jay and Duncan. DR. KATZ: Then I'll shut up on this point, and I will be perfectly content with my footnote, if necessary. I'm sorry to say that, but occasionally I must say, and I apologize for putting it that way, look, all of us; look at the situation. Here are these poor Navajos, these poor white miners. We had sufficient knowledge; we had knowledge as to what transpired in the Erzebirge, and elsewhere, and even the Germans passed the law that no German citizen could work in these mines. We do about these tremendously high radon levels in these mines, to be sure we didn't have, at that time, real good scientific evidence and, to be sure, it would be nice that the studies should be done, but for the sake of humanity and for the sake of what has been going on in part in the world of human experimentation, it seems to me so clear that we must say something in the name of science to conduct this kind of experiment. It was also clearly in the service not only of gathering data but also in the service of delaying, doing anything about it. That seems to be reasonably clear. Give us another 6, 7 years, and let's not spend the money, which supposedly was not in fact a large amount of money. That we have to condemn this kind of experimentation, it seems to me so obvious. In fact, I appreciate all of the objections that you are raising, and they are significant. I really have no problem. DR. FADEN: Okay. Ruth and Duncan and Eli. DR. MACKLIN: Jay, I can't accept your argument -- DR. KATZ: I know. DR. MACKLIN: No, no, let me say why. What is required in the name of humanitarian concerns. Refusing to do the study is not going to bring about the action; that is, these miners are in the mines anyway, and the Public Health Service, we are presuming, did not have the authority to act in some way that would either ventilate the mines or whatever. DR. KATZ: People might have become aware that there is something terrible going on. DR. MACKLIN: Yes, but wait a minute. They may have become aware, and the Public Health Service people might have said, look, publicly, that is, overt publicity, we are not going to do this study because; but the naysayers, or the people who said we didn't have enough evidence, or maybe it's due to genetic factors or whatever else people were saying, would then squash the thing and say, all right, they made this publicity, but who cares, and what's the result. The question that I would have for your argument is if the aim is to get these miners, individually or as a group, warned about the danger that they were facing, is not doing the study the most effective way to do that. Now, I can think of ethically questionable ways to achieve this goal; namely, make a lying promise that you are not going to tell the miners, and then blow the cover off it once you start getting the data or the results. Now, that is unethical in one reading because, of course, you are making a lying promise, but it will accomplish the goal, or more likely accomplish the goal, because it will both have the data, which then might be -- DR. KATZ: Seven years down the line? DR. MACKLIN: Well, we don't know that it would have taken -- DR. KATZ: We know that it would have taken considerable. DR. MACKLIN: The question still remains: Would revealing this in some public way before have had the effect that I think is presumed by your approach, which is that everyone would have listened to what was then obviously uncertain or questionable evidence, because there was obviously a great interest and great political power in not listening to that. DR. FADEN: Duncan, Eli, and then I propose that we are going to have to move onto other issues in this chapter. DR. THOMAS: I think Ruth just said it more eloquently than I could. I'll let Eli -- yield to Eli. DR. FADEN: Eli. DR. GLATSTEIN: I think if you let this go by, I think it's a terrible precedent for scientific investigation. I don't think that you are supposed to be making deals in order to develop your studies. I think that if you think you have something to study, you should try to study it. If there is obstruction, you should identify that obstruction and try to work as much as you can, call attention to it. Put public pressure on. I think it's a terrible precedent to make some under the table deal to get the information that you want and then, in this instance, have to wait another decade to show enough dead bodies at the end of it to justify the action which should have taken place in the first place. This is a terribly moral and ethical issue, I believe, and I think to let this go by is a very bad precedent for science in general. I think it ought to be clear, unequivocal, that you just don't make these kind of deals. If you are thwarted by vested interest, all you can do in that setting, I believe, is call attention to it as much as you can in the media. Put pressure on the SOBs. PROFESSOR KING: This is why we have a question of both institutional, and I think we ought not lose sight of this. A lot of statements I have heard made so far do not go to the Public Health Service they go to how individuals in the Public Health Service should have reacted. That's a different set of analyses. I won't say different set of ethics, but it's a different set of analyses. I disagree with it. That is not the same as Public Health Service. PROFESSOR KING: Illustrate what you mean. Do you think Eli's point goes to the Public Health Service or not? DR. FADEN: I think that Eli would have to develop his point for the Public Health Service, which is one agent in government and the context in which we are talking about, we are talking multiple agencies of government, where people are not free players -- where the institutions are not free players. That does not mean you cannot have whistle blowers in the government, so the thing -- DR. FADEN: I think you could take Eli's position and apply it to Public Health Service. DR. GLATSTEIN: Well, it's not clear who made the deal. DR. FADEN: Public Health Service's obligations are to protect the public's health, blah-blah-blah-blah-blah, are ordered to do it by the secretary, somebody, whatever, is another order. That's why I'm confused about how you separate that out. This was a deal between the Public Health Service and the private mine owners. PROFESSOR KING: What I can't get any information about is -- DR. GLATSTEIN: Was it the PHS or individuals in the PHS? DR. FADEN: We know it's got to be somebody. I'm sorry, Pat. PROFESSOR KING: I guess what is troubling me is, I guess, what always troubles me, is if I knew more about the underlying deal between Public Health Service and the mine owners, I could perhaps make a lot more statements; that's one thing. If I knew a lot more about interaction between Public Health Services and other agencies that were concerned about these issues, that would help me a great deal more. I think that one of the things that we keep running into is how bureaucracies ought to act, and that is what we are in the midst of -- bureaucratic behavior. Some of the statements that are made are more appropriate to individual behaviors and there are not enough people who are acting realistically of bureaucracies to me. DR. OLEINICK: Another thing that colors everything here is we are judging it again by today, and I think it's appropriate to some extent to do that, but those were the McCarthy years when lots of people were afraid to make statements, that even though they knew it would be correct to act in one way they were afraid to do it. That, again, is all part of the bureaucracy and how one arm of the bureaucracy could sort of control everything else, but I would say that tempers my criticism. DR. FADEN: I think, at this point, maybe the only thing we can do is, try to lay out all of the problems in making out the argument. DR. KATZ: This was after Nuremberg, let's remember that also. Keep that in mind. DR. FADEN: Yes. Lay out all the arguments and all the issues and see how this falls out. One of the changes, including the distinctions introduced between judging the government -- judging the Public Health Service versus judging individuals and the ambiguities, as Ruth pointed out, in terms of what we don't know about the details of the actual arrangement or what the alternatives were. It is also unclear. There are so many counterfactuals here; that's what makes it difficult. Let's imagine that Public Health Service said no way; we're only going to do the study if we can warn the miners if, at some point, we think the data support that. It still might have taken four or five years before the data would have supported that, maybe 6 or 7, what would have been gained. So if your background view is they should have introduced the ventilation right away in the first place, and that, just because if you're going to err and you don't know which way to go, you ought to err on -- which goes to your other issue, Duncan -- so the whole rest of it does kind of fall away. It doesn't much matter. If you are waiting for the data, you're waiting for the data. Eli's point is sort of generalizable to the future, that investigators ought not to make Faustian bargains with people in order to investigate even important questions. DR. KATZ: But if you get it, then you can't get wonderful scientific data. DR. FADEN: That's the tradeoff. DR. KATZ: That's the problem. DR. GLATSTEIN: Yes. But it also gets to the issue of the end justifying the means, which is an argument that lots of us dislike. DR. FADEN: Pardon? DR. GLATSTEIN: It also gets at the issue of does the end justify the means. A lot of us don't like that argument. DR. FADEN: That's the core of the Faustian bargain problem. DR. GLATSTEIN: Yes. DR. FADEN: I think we need to lay this out, and if we don't have time to argue this down to the ground, they have the issues, and there will be condemnatory footnote. Here is a prediction. I don't think the Committee is going to come -- either we're going to reach some sort of agreement about how to interpret this or we're going to agree that we can't figure it out, and we're going to lay out the story as best as we can tell it, and there will be some footnotes. DR. KATZ: I want a footnote. DR. FADEN: Yes, that may be how it ends up. We'll see how it goes, but we've got to lay all this out. There are four issues. We have to go sometime on the Marshallese section of the chapter, plus there are the three issues you raised about fallout, the worker studies and the atomic bomb survivors and how we want to treat those three issues, in a report, whether in this chapter or somewhere else. Can we spend a few minutes on the Marshallese section of the chapter, if that's all right? I know we haven't exhausted this part of it, but in the interest of getting to other chapters, I don't know what all else to do, except use the other mechanism proposed for after the fact exchanges. DR. THOMAS: That's fine. I'm prepared to move on. I just want to point out that you have closed off discussion not only of the issue of warning the miners and undertaking the study in that case, but also the secondary question, which is the state of scientific knowledge. I think we can pursue some more, but I don't think we need to do it now. DR. FADEN: The concern I have is if we do that, we won't -- we've identified these debates, and this issue of things people care about. If committee member A wants to make out the best possible case that they knew enough, write it out and write it out, we can even import the language. If somebody else wants to make out the case that they didn't know and here is what the state was, and let's send it around and let people see what's going on here, we've got to move this. We can't argue it to the ground today in this room. I would propose that we use the mechanism that we agreed this morning and flag this as an issue. I would also encourage committee members to write draft text, that we could import and look at and say, okay, here's the language. This is how I think we should say this, and then other people can say, are you kidding? You know, there is no way in the world I would want it say that way, other than always putting staff in the middle of disputes of this order. If you care enough, step up to the plate or whatever -- this is baseball season now, again, right? We want to get the right images; and produce something. We'll spend some time on the Marshallese Chapter. Questions, comments? DR. THOMAS: I see two issues, and there may be others that people want to raise. The two issues are the separation of medical care and research; and the second issue is issues relating to the resettlement. There is language in this draft which I support, regarding the resettlement question, that the committee has not seen any compelling evidence that the purpose of the resettlement was experimental in nature. Based on my reading of the documents, I think is my own personal conclusion, but it's not well supported by the documents which we indeed have seen, and I think the various claims that have been brought forward to us, the views of the Marshallese are not dealt with adequately in the present draft, so I think we need to come to terms with some of the little snippets of quotes from different documents which would suggest an experimental purpose, and I think we owe it to them to comment upon those. DR. FADEN: Okay. DR. THOMAS: I also accept the position of staff that we don't have the resources to get to the bottom of this question nor do we have the time, but I think we ought to say something. DR. FADEN: Are you saying, then, Duncan, that because we don't have the time to get to the bottom of it rather than have a categorical statement, the evidence suggests this, and there is also evidence that somebody else has to get to the bottom of it? DR. THOMAS: I would support something like that. DR. FADEN: Okay. DR. THOMAS: That's in the previous draft where we pussyfooted around there by having a little footnote; that, to me, is completely unacceptable. The alternative of ignoring the following is an option which the committee might discuss. I would not support that. DR. FADEN: Okay. Jay. DR. KATZ: I just want to mention, I talked at yesterday's open forum session where -- who was the official of the Marshallese -- DR. FADEN: The acting ambassador? DR. KATZ: The acting ambassador, and also with a lawyer, and he said he can get to the Committee some documentation in the next few days. Who knows whether they will be able to do so, but my point will follow up about the lack of warnings that the Marshallese received when they were resettled. It was not really made clear to them what they exposed themselves to -- DR. FADEN: In returning. DR. KATZ: -- in returning, and if we can document that, that would be I think something useful to include. DR. FADEN: Did you have other issues, other questions about this part of the chapter? DR. OLEINICK: Duncan, how are you interpreting the statement in the Brookhaven report, indicating that 200 people who had not been in the vicinity of the Atoll at the time were resettled and used -- let's see, the word is, a satisfactory comparison population, implying that they were to be a control. How do you interpret that by saying that the resettlement itself was not part of an experiment, or is that -- I'm not quite sure how to interpret it, but it sounds like you've come down on that side. DR. THOMAS: I'm saying that in recognizing that, for reasons other than experiment, a decision has been made that these people want to go home and they should be allowed to because it may not be all that dangerous to their health. Recognizing that there remains some contamination and may be a health hazard, it would be unethical not to try to find out whether or not there was a hazard. It's an experiment of opportunity. It's not driven by -- I mean, we didn't relocate people there so that they can be guinea pigs. DR. OLEINICK: So that they can do an experiment. Okay. DR. THOMAS: Nevertheless, it's important to study them. DR. FADEN: This is more an experiment of opportunity than any other of the ones that we have ever labeled as such, because here's an opportunity, let's add a comparison group, and let's turn it into a quasiexperiment, would be one way of interpreting what you just said. DR. THOMAS: Sure. DR. OLEINICK: We're resettling these folks anyway. DR. FADEN: Right, so let's take advantage of that. DR. OLEINICK: Okay. DR. THOMAS: The existence of control groups, to me, doesn't really make something an experiment. DR. OLEINICK: No. But it sort of indicates that somebody might have been thinking about it. I didn't say it made it an experiment, it indicates that somebody might have been thinking about it in terms of an experiment. DR. FADEN: Pat. PROFESSOR KING: This is not related to that point, so it's next on the list. DR. FADEN: There isn't a list yet. PROFESSOR KING: I found there are parts of this chapter, when I was talking about making things hang together yesterday, and the whole report; there are some questions raised here that actually go to what we are doing today. Page 26, it says we are currently researching the question whether any physician or officials in the 1950s supported the notion that there was an ethical obligation to provide basic medical care, if feasible to research subjects. It is very close to making a recommendation to follow up prisoners for what happens to them as a result of radiation, and then not saying anything else about their medical care. It is the same potential confusion from the perspective of the recipient of your trying to do something in part. I'm not being clear. Part of what's discussed here, the difficulties of the researcher/provider care role in trying to convey to the Marshallese what the services provided were going to be, part of it was some behavior that we can make separate statements about, about the care providers or researchers themselves. What strikes me as interesting here is that for people who participated in research, that we might recommend monitoring of or medical follow up for, we are recommending -- DR. FADEN: Only for the radiation. PROFESSOR KING: -- only for the radiation; that is very much akin to some of the issues that we are touching upon here. I am not suggesting we go one way or the other. I am just suggesting we be clear about how we may overlap. The other place where this issue has arisen is actually with respect to the whole discussion, not in this committee but in prison research, because that was the issue of prison research as well; that we know that many prisoners agreed to participate in research because they got some health care in research connected to their research but did not get general medical care. So these issues which we are raising for ourselves, I am only offering a caution that we not slip into, and say something here that we understand that we may be on the verge elsewhere of doing something quite similar. DR. FADEN: Or alternatively, quite differently. PROFESSOR KING: Or quite differently. DR. FADEN: I must say, I didn't think about analogy, now that you've stretched it or that other issue. When I puzzled over this -- and I'm looking at Ruth because she is doing so much work on research in countries with less adequate medical care than in our country, this of course is a very live issue today, for people who do research in communities where there is literally no medical care or very poor medical care or whether if you're going in there to do research, involving a population while you're there, and your medical team includes physicians, you ought not provide basic primary medical care in addition to whatever the technical services are that are coordinate with the research. This remains a big issue today. In the context of the Marshallese then, given what we have heard on the difficulty and even communicating the difference between research and treatment, if anybody cared to make it, it's even more acute, but that's certainly true at other parts of the world, currently, that it's difficult for people to distinguish between a medical person who is doing research and a medical person who is providing primary care and how you set that out, given that they're in this context, no alternative or reasonably good alternatives for medical care for the community. So that's one of the issues you lift from this. This hasn't gone away. This remains a problem. PROFESSOR KING: This is not a cost. What strikes me - - and I'm always the one who's talking about evidence and what you draw from the evidence; but it seems to me that it is not out of line to make some statements about not being accidental, that which I don't attempt to do it in the context of the uranium miners or only the Marshallese, but that it is no accident that where we run into these really tough questions, that we can't resolve with historical record, necessarily, that we are talking about the most vulnerable. I see that as the major thing that emerges from this. We are struggling with this case by case by case by case, but what leaps out at me is Indians, Marshallese, poor people, and what also leaps out at me is the question of environmental racism, as it is phrased today, is very much precisely this kind of question, where do you go and do what you think you need answers to, or where you go to take care of a problem. That doesn't require worrying about how to resolve factual questions, to draw some of those kinds of statements from here, which I think we need to draw. DR. KATZ: Pat, what do you make if Hume, who once said that morality cannot be judged and can only be felt? [Laughter] PROFESSOR KING: Well, I would say in response to you, Jay, when I heard your statements a few minutes ago, all the lawyer in me bristled and the human part of me said, God, if I was ever in a tight situation where I had to make an argument about how to protect people, I want Jay in the room. DR. KATZ: Thank you, thank you. That's good to know. [Laughter] DR. FADEN: Okay. Lois? MS. NORRIS: I just wanted to back Pat up in her cautions, because those are things which have been very much, or which I have been very much aware too, and I don't know if you remember, but I've alluded to them either in question or caution form and comments on various perspective or potential recommendations, and I think it's important to bear that in mind, that we don't come out as recommending something which has been shown to be less than satisfactory. DR. FADEN: I don't know if the committee is ready to make statements. As the draft is constructed now, there are at least three issues flagged, there are many more. One is this question of whether general medical care should have been provided as well as the medical monitoring and the radiation related care. Another is this potential for inflicting harm, which was interesting to me, the notion that infectious diseases could have been brought to the Marshalls as a result of the monitoring and then the failure to immunize children, a particular singular kind of question. Then there is the issue about the virtual impossibility for the record, as it's been presented to us, whether or to what extent the Marshallese were subjected to interventions that offered them no prospect of benefit, that were solely done in order to consider the effects of radiation, everything from venipunctures to stands to whatever. In addition, it has never left me and I don't know where the clipping is, but somewhere I saw a documentary in which there is footage, a Marshallese person who was brought, I believe, to Brookhaven, for examination, and somebody does this film and talks to see what we can learn from this thing. It's done in the most disrespectful and offensive fashion than I have ever seen captured on film, short of some of the footage from the Holocaust, and I think that's missing too. Now, that needs to be in there somewhere and we can't actually show the film clip but we can show the attitude that emerged at the time, which is important to bring out in this part of the cultural context here. This issue of whether they should have gotten consent from the Marshallese is, in my view -- and I'll just come out with -- sort of beside the point. We know, and we'll get to the chapter on Practices, that people weren't in the business of getting consent in clinical research with any regularity. I'm not saying it was right or wrong, but there were so many larger questions being loomed here that it could be put in that context, of whether they got people's consent for research is, while important, not the first, second, or third one on my list, although it needs to be discussed and put up front as an issue. We weren't getting consent as a routine matter in many contexts here. Again, that doesn't make it right, but it's less the question than some of the other issues here that I think is even more foundational. I don't know about the 200 people who were resettled, who were in this comparison population, for example. They were followed. Presumably, you could argue they were put at now risk, so maybe it's to their benefit to be monitored, but it's all sort smooshed together. We have to just acknowledge that it's all smooshed and put together and that you can't tease it apart in this context, and the whole thing has a flavor. DR. STEVENSON: Yesterday, though, when I asked the question about whether or not children were born during that resettlement were followed, I was given the answer no. DR. FADEN: Right. There are the issues that the young man who is the anthropologist -- it was odd to have an anthropologist talking about the study of reproductive risks but, nevertheless, that is what's interesting. We certainly need to follow up on the issue of whether, in fact, they did not look at reproductive outcomes in the immediate studies in the Marshallese. I just don't know. There's a lot to write about here. DR. GLATSTEIN: This is a protectorate of the U.S., is it not? DR. FADEN: It was at the time. DR. GLATSTEIN: It was at the time? We accept some responsibility for population, do we not? DR. FADEN: Yes, we did. DR. GLATSTEIN: We exploited this population, did we not, as a government? DR. FADEN: You might say that. DR. GLATSTEIN: Surely, there's a minimum standard of health care that we should be delivering to them. DR. FADEN: At the time. DR. GLATSTEIN: Now. DR. OLEINICK: I don't want to argue anything against I've heard in the last few minutes, but the Marshallese, this population was chosen for bomb tests, not experiments, biomedical experiments on people. They were chosen. Supposedly it was sparsely populated, part of the world and so forth. In that respect, this was a vulnerable population, but in terms of the experiment itself -- DR. FADEN: The research. DR. OLEINICK: -- the research part of it, they weren't chosen I think because of their being a vulnerable population. Am I making myself clear? First, they were chosen for the exposure. Once they were exposed, they were chosen for the experiment because they were exposed, and it's only indirectly because they were vulnerable, so it gets a little muddied again. DR. FADEN: It definitely does. PROFESSOR KING: One way to answer your question is, if, in fact, you were put in a position of great jeopardy for reasons that had nothing to do with research, which made you a prime research target. Then the question becomes you are providing information for society not for yourself, necessarily, and the question then becomes what, if anything, society owes to you because it is now obtaining information from you, that you really were in no position to have any control over, whether you became the carrier of the information. That's what the question is. In light of page 33, I just have some other cautions. I think a health researcher's primary responsibility ought to be not to sponsor research nor to the subject's employer. This pertains to confidentiality as well as clinical research. One of the things I think that we have to be very clear about is that when we tell people these things, people believe it. This is not the real world here. There is in both the provision of medical care and research a real problem about conflicts of interests that we don't explicate between being both employed and being a researcher. So to resolve it by saying what ought to be is to ignore actually the very real world, where these kind of conflicts are really acute, and where there has been, at least I know on the provision of medical care side, some real work that goes to how you chase out those conflicts. What we need to be saying is, I think, we need to make people aware of the conflict not what ought to be, because I'm not sure what that "ought to be" means anymore. In other words, I am saying that we have not gone -- I looked at the entire draft for the conflict question and a discussion of them, and I didn't find them, and I think that we need to include that in the chapter. DR. OLEINICK: Does that mean we should be silent on "oughts" because people disagree or have questions about that conflict? PROFESSOR KING: No, I'm not saying that we should be silent on "oughts" but to say what the "ought" is without a real exposition of the real world may be very far from that "ought". It can't be misleading on its own. DR. OLEINICK: That's right. PROFESSOR KING: I don't have any problem with the "ought" statement. My point is, the "ought" statement, by itself, without reference to conditions in which people also operate is, in its own way, misleading. If I were to rely on the "ought" state only, I would be in a terrible predicament, because that is not the way people actually -- I am not objecting to what you want to do, Ruth, I'm just trying to flesh it out and say that we need an exposition of the conflicts. DR. FADEN: Actually, I think the statement here is problematic. It's not clear to me that it's even right as an "ought" statement, but we have to look at that. If we talk about the conflict, for example, in biomedical research, additional biomedical research between your role as a scientist and your role as a clinician, there are times when you want to say this patient really should drop out of that trial, but you don't say that, or you don't know whether to say it or not, because it's all that stuff that goes around. DR. MACKLIN: Yes. But, Ruth, that's not what this statement; this is talking about the sponsor of the research, so do I have to do everything that the drug company says I have to do? DR. FADEN: I wasn't willing not to; I was taking it that the health researcher's primary responsibility ought to be to his or her subject, and some people would argue that it ought to be a science. DR. MACKLIN: But the contrast here is not -- I mean, I understand what you're saying. DR. FADEN: Relative. DR. MACKLIN: That would be a different statement. DR. FADEN: Okay. DR. MACKLIN: Here, the contrast is you have a choice. Is your primary responsibility to your subject or, alternatively, to the sponsor, or the employer and, given that choice, I think that statement -- DR. FADEN: Statement stands. DR. MACKLIN: Yes. I think it stands because you would have to identify the principles that are in conflict here, and the principle that the real world operates by, that I think Pat is referring to is, he who pays the piper calls the tune. That's not a moral principle. PROFESSOR KING: I will repeat once more: I am not making a -- statement, except to the extent that I said that complete statements about ought in the absence of providing people some of the realities is, in my judgment, to do harm. That is not to say that I'm against the "ought" statement, it's just to say that the "ought" statement also needs to be there, along with the fact that in most instances, subjects need to know that he who pays the piper, whatever the saying is, or the squeaky wheel gets the grease or any of those other kinds of things is likely to be what actually prevails. So we're not disagreeing, Ruth. I'm just saying that sometimes an appeal to a moral norm, while fine in and of itself, can, if not done properly and done well, end up, I think, harming, because it leads people to have expectations, based on that. DR. FADEN: I need some sense -- PROFESSOR KING: But, anyway, this needs to be - DR. FADEN: -- sense of the group. We -- I think -- We have the three issues of where -- we're going to deal with the three -- whatever -- categories that aren't in this chapter or at least not in this chapter in any detail. Do we want them in the chapter? Do we want them out? We also have to decide when we're going to deal with the national security question that Pat raised, whether we want to go to the chapter on practices or not, and that time is eluding us. It's now a quarter of three. We were supposed to break at 3:15. I think -- Do we want to have real quick reactions to the question of whether fallout research worker studies and atomic bomb survivors, how we would like to see them handled or do we want to start that as a discussion topic right now or do we want to move on to something else and try to handle that issue in some other fashion? DR. MACKLIN: As a procedural point, I think we should first determine what the next step will be in developing this chapter and what the needs are. That is, it's not what we want to -- I mean, I appreciate your asking us this in this way, but more important than what we think is a priority for discussion is how we move the chapter along, and I don't see how we can do that if we abandon the discussion right now of what else were to be in here. So to do it briefly, I think that seems to be our -- DR. FADEN: Let's do what else ought to be in here. Do we want to say something in this chapter and at the time this chapter -- do we want to say something anywhere else in the report about, one, fallout studies? The proposal is to have that discussed primarily in secrecy, in a secrecy chapter -- although you have the fallout -- studies, but, nevertheless, fallout studies, the atomic bomb survivor studies and worker studies, all of which are observational in character. They're observational - - type studies. We could -- just note it, say we can't cover the world. They also raise issues, but we can't do everything. Do you want to pull one of these into this chapter? What do we want to do? Anybody want to make any -- DR. GLATSTEIN: I guess I'm for keeping the chapter short and sweet the way we -- that is to say focused. The more stuff you add into this chapter, I think the more diffuse it becomes -- two things together -- we're having together trouble getting away with it. I would advise not to add any more to this particular chapter. DR. FADEN: But if we're going to add the atomic bomb survivors -- DR. MACKLIN: Well, the question is do you want to just acknowledge that there are a range of epi-studies, you know, some large, some small that we could have considered? These two came to our attention because we had people come and give us testimony about these two and it was brought before us in a way that the committee could -- DR. FADEN: The rationale for focusing on these two, really, turns on the public's turning to us for commentary on this experience -- these two experiences. Now, that's -- We also have workers come to us, but not in the numbers or with -- whatever -- that we have these two issues. DR. MACKLIN: Since this is in a section of the report that's called "case studies" and there had to be some principle of selection for the case studies, there's no grounds for saying it has to be inclusive. So following what Eli just said and the obvious point that we can make somewhere that there was some principle of selection, these are the case studies that raise the richest set of issues and the conflict on the question of what are the obligations of researchers in these so-called experiments -- studies of opportunity, whatever we're calling them. So as a case study, I think we can choose what we want and justify this inclusion and say a word about the fact that others were not included and these were included because, and leave it at that. DR. FADEN: That would be my intuition. DR. GLATSTEIN: One word. One word. (Laughter.) DR. FADEN: Now, that's my intuition, too. I think it's because I'm so overwhelmed by everything else that we have to do, but it seems to me that's the only relevant -- DR. THOMAS: I'm sympathetic to that, too. I never intended that we should do any kind of an investigation of the -- survivors study. I think we simply should recognize that it's probably the greatest experimental opportunity of our time and that could be said -- in a sentence or two at the beginning of this chapter or, indeed, in one of the chapters at the very beginning of the report. I just want to acknowledge -- In regard to fallout, there is a major story relating to the failure to disclose this to the down-wind population, but the epidemiology does not, in my view, raise substantial ethical concerns and is largely occurring in an era long after the fallout was finished. So it is not a major theme that I wish to develop in this chapter. If we can address the failure to warn questions in -- by reference to the materials that were in last month's briefing book about that whole discussion that went on regarding the first underground -- in one of the other chapters, either -- chapter or the secrecy chapter, I will be content -- And I'm still groping to see what are the ethical issues relating to the observational studies. So I'm not -- I don't know what I want to say about it. It's not to me a big topic. DR. FADEN: So why don't we -- What I'm hearing is the consensus that this chapter is going to focus on these two case studies, and we will give the reasons why we landed on these case studies. We will make sure that these other epidemiological studies are mentioned in an appropriate context, recognizing that there are other things we could have written about -- examined and written about. We chose these two, and these two are the two that are developed here. Is that all right? NANCY OLEINICK: -- spend a lot of time making arguments back and forth on this, but we're sort of out of time. DR. FADEN: Yes, we're sort of out of time and we either have to say we're going to add this one or we're not going to add this one. We can't have it on the table any longer. DR. GLATSTEIN: If Henry's book gets any bigger, he's going to have a hernia. DR. FADEN: I have a book of books that -- you know, the ones that I'm reading tonight, which is the ones that I'm reading -- I can't lift. (Laughter.) I mean, I literally can't lift the major one. Okay. So that -- I mean, we could go on, obviously, with this chapter indefinitely, but we can't. We can't. All right. So thank you very much, Barbara. I know this must make -- feel awful, because God knows what to do next, but we'll figure it out. Okay? We'll figure out something. Now, the issue is as a committee we have yet to do the chapter on practices, professional standards and practices. Totally different kind of chapter. If we're going to talk about national security issues, we ought to do it now, because when we go to -- if we go to professional practices, then our heads are going to go to a totally different kind of set of concerns. So while we're talking population exposures -- So I think although we've lost Pat temporarily, hopefully she'll come back since it was her issue that we need to address. Let me just -- go take a look -- Oh, thank you, Patrick. Somebody take a look and see if Pat's around so we can proceed to it. Here's what I would like to propose: We talk about this national security issue and see if -- what the various members of the committee are thinking about this. We then take a break. Okay? We come back. We had a disagreement -- committee disagreements earlier about how much time to give over to this issue of committee strategies and whatever time, all that kind of issue. We're arguing that we don't need all that much time and Jay wanted to make sure we had enough time if we need it. So I would like to propose that we come back from the break and we spend from 3:30 to 4:00 on this question of committee strategies discussion, with the understanding that we're stopping at 4:00 and going to something else yet to be determined, either the practices chapter or -- just to finish out the chapters. And only if you cannot -- I'm going to act as if four o'clock is -- you know -- absolutely a fixed whosie-whatsie -- only if the committee is absolutely persuaded that it needs more time to resolve this question will we go past 3:30 to 4:00. So that's a way of compromising between the two views that it shouldn't take that long and Jay's view that what if it does. If we start at 4:30, then we would lose people. So is that all right for an agenda? And we still don't have Pat, but I think we should proceed, if we're going to proceed, on this national security question. I'm not entirely certain what Pat had in mind, but I guess the large issue is are we all in agreement about how we're using the term "national security concern" and "national security interest." Dan. MR. GUTTMAN: If I can just -- There are two ways I can see of framing the question that comes, sort of bubbles up. You know, we all hear "national security" and then all of sudden you're into the facts and you're -- and you're saying, "What is 'national security.'" Two ways it comes up that we have to deal with. One is we found a number of documents where people say -- this is almost Nixonesque -- this would be wrong, you know -- that, "This is not something that is a national security secret. However, there may be public relations implications. Therefore, I'm going to keep it secret." So one kind of question is is it just the luck of the way the world used to be that you could find a document like that, nobody in their right mind would ever actually say that again -- (laughter) -- you know, or does it happen that decision makers are sitting around in the Nixonesque thing saying, "This is not national security. It's public relations, but don't quote me on that," you know. So that in the real world, as the decision makers operate respectively how does that look? Does it make sense to say the self evident: You shouldn't substitute public relations for national security? Or, as Ruth as been pointing out, obviously, the lines blur, is anything that justifies a program -- You know, one of the big -- The next point is the -- where it becomes the difficult question is what people are often saying is that this program is in the national interest. DR. FADEN: Not only the national interest, is needed as a - - MR. GUTTMAN: Yes. Right. Yes. Right. Right. So that anything -- DR. FADEN: Everything's in the national interest -- MR. GUTTMAN: -- anything that justifies -- Then you have several levels of -- as Ruth Macklin was saying -- suppressed and hidden premises. The key hidden premise is that this program may be questioned, not by the Russians, but by the American public, and why would the American public question it? Because they don't understand what the program's about. So it's the laying out of all these levels and can you say - - We're not idiots. We realize they are complex, but there are - - there's some kind of rough one side or another. That's one issue of national security is it's the secrecy and the spectrum from national security justification to out and out public relations and the other things. As people have noted ad nauseam, as a lawyer, it's obvious, just because you say I'm afraid of a lawsuit doesn't mean you're afraid of a valid lawsuit. Right? It means that anybody can sue anybody for anything, and that's a legitimate fear. The second national security question is the one that we thought we'd be dealing with at the heart of the whole effort but has come up only indirectly, which is what happens -- Can any of the things looked at be justified on national security grounds? And my reading of the evidence is what we've found is, to my surprise, nobody got up and said, "Well, this seems kind of repulsive, but we're justifying it on grounds of national security." What more likely happened is nobody got up, for example, in the case of plutonium experiments and said, "Well, we did this during the war, but you have to understand, there was a national security reason, so, American Public, this is why we did it." So that you don't find kind of a direct conflict, which you would hope would be a nice way to focus the discussion. And the question that I think Pat is talking about is if we're not finding a direct conflict, there's clearly a national security interest in all the things -- a lot of the things we're studying. Where is it and what is it? In the bomb-test example, for example, it's kind of lurking in the background when people say, "We should fly through the clouds and collect data of the dosage in the human beings, because we could save money on the decontamination." Now, you read that as a national security, because money is -- you know -- related to the ability to fight the Russians. So that there are two kinds of basic questions. One is the secrecy spectrum and the other is where in all the history we've looked at is there a confrontation between the sacrifice of the individual and the assertion of national security premise, and if it's not a direct sacrifice, then the educational lesson to take home is how does that work in practice. People won't say directly, "I'm going to do it." But by some mechanism, the system sort of does that in any event. That's, I think, that's the laying out. Is that -- DR. FADEN: Yes, that's actually very good to do it in those two dimensions. MR. GUTTMAN: Yes. DR. KATZ: But from my -- I haven't gotten the final papers yet. I may have something to send you in order to -- a little bit. In some of the papers, they are writing national security issues -- My impression so far is in talking with them -- DR. FADEN: Who's the "them"? I'm sorry, Jay. DR. KATZ: Some of my law students. And "national security," that means a very ill-defined concept, an issue like, you know, one might say patriotism is the last refuge of the scoundrel and so is invocation of national security. You can invoke it so readily, and then what do you ultimately do with it? Procedurally, what seems to have happened -- and this holds even true in today's regulations. There's always an ill-defined national security exception built in without -- pushing it procedurally saying, "Well, the President is the final authority to decide whether -- " MR. GUTTMAN: Well, let me suggest there are two -- You're thinking like a lawyer. You should think more like a human -- an analyst of human behavior. DR. KATZ: Thank you. MR. GUTTMAN: Right. As your law student, let me tell you -- DR. KATZ: Yes. (Laughter.) MR. GUTTMAN: The question is -- That's right. If we're looking at it as the law professor is, where do you draw the line, the answer is, well, you know, who knows? Right? They'd have to see more evidence. "Give me the case. Give me the facts." But what we have here, which is not unprecedented -- extraordinary, is a body of evidence where we see the various tensions at issue and we see arguments that are adduced in both directions, and so that what you can do at least is tell the story of the way this presents itself. Someone will come in and say such and such. That's public relations, and how should you talk about or think about the invocation of public relations or how should you accept or use the idea that this is going to protect this program. Is that automatically -- You know, if somebody says -- Somebody in the Defense Department says, "If we tell the public, they may misunderstand and our program will be in jeopardy." Is that automatic? In other words, what I think you can talk about is not so much, but where is the line and it's murky, but from looking at all of the stories we've seen the way in which this gets argued out and how it looks like -- Because the public only sees the end result. They don't get told anything, and 10 years later, they learn something happened or -- DR. KATZ: How does it help -- MR. GUTTMAN: Well, because it helps you understand how the system works, that it's more complex and how these lines get drawn and that -- If you can't draw a line easily, you can explain how it is that the lines sometimes get drawn in ways people -- DR. FADEN: Ruth's been waiting to get -- MR. GUTTMAN: I'm sorry. Okay. DR. MACKLIN: Well, no -- I'm only going to follow this. I'm not going to say anything else. From what -- I mean, now, I agree that was an excellent summary of what the issues are. Now, I think what we need to do is look at each illustration and see whether it would count as a national security justification. This is not a question of whether we can justify the action on that basis, but what counts in each of the array of different kinds of circumstances where we say, "They didn't invoke national security. They invoked public relations or fear of liability." So I want to for the moment just set this saving money business aside. I never know where to put that. I mean, you can lump that under any category you like. Let's come back to that one. Keeping secrets from the enemy or the -- well, let's say the enemy. Clearly, that's a -- one would argue if anything's a national security concern, if there is an enemy and we have secrets that we think could help them and harm us, keeping secrets from the enemy. That's one example under the secrecy. Finding out things that would help us detect what the enemy is up to is another something that has to do with the outside, you know, the enemy, in a sense. I mean, I'm looking at things like -- et cetera -- that purpose, with a national security purpose. Then -- things that have to do with soldiers in battle, protecting or -- either protecting soldiers in battle from harm or trying to discover what would impair their ability to reenter if they're flying through clouds or if they're looking at blinding flashes, et cetera. So those are national security -- You're going to fight a war and you got soldiers who then aren't going to be able to do these things because they're irradiated or they're whatever. They're frightened or whatever. DR. FADEN: If I understand what you're saying, there's a clear national security interest that's reasonably invoked if you're saying we want to figure out how well -- how to make our troops fight well. DR. MACKLIN: That's right. Yes. Right. That's -- In a war, where you're considering -- Right. So any of the things. I mean, that's different from the secrets from the enemy or finding out about the enemy. That's things that have to do with the soldiers -- DR. FADEN: Right. DR. MACKLIN: -- which is a national security interest. And then there are workers in war industries or in war- related things, whether they're uranium miners or millers or whatever, who are working in the industries that manufacture things or do things or get the weapons or whatever it is that one could argue that if they all fled -- I mean -- that if they all fled these industries, then you wouldn't have any war machinery or production, et cetera, et cetera. So that's something else that could be, again, "national security." Now, those seem to be relatively -- relatively -- uncontroversial. I mean, how you use them and how you apply them is a separate question, but -- DR. FADEN: How much it justifies all that kind of stuff. DR. MACKLIN: Right. Right. That's a separate question, but these seem to be the legitimate ones. Then we get to the murkier ones which are informing the citizens in this country and putting that under the heading of national security, I mean, things that could produce a panic among the people. Now, I -- I mean, it's a little more than public relations, because it's not, "Oh, people aren't going to trust us or like us," but it's what might there be that you could tell your own citizens, that is, that you are keeping from your own citizens which if you told them could damage the national security. Now, I don't know what to do with this category, but I'm saying this may be a more controversial one, and maybe we have some examples to flesh that out. And then at the bottom -- This is all I can think of at the moment -- but then at the bottom of this list is the money, you know, saving money for national security; and, here again, I mean, you'd have to give the specific examples in order to make the argument that it's not just saving money, which people try to do in every case at all circumstances, et cetera, but that failure to save the money in this circumstance would in some way be damaging to the national security. DR. KATZ: What about producing grain? DR. MACKLIN: Do what? DR. KATZ: Producing grain. Farming. Is that part of the national security? DR. MACKLIN: Well, it's part of the national interest, but not national security. I mean, not everything that is in the national interest should be subsumed under the category of "national security." MR. GUTTMAN: One of the things that seems obvious -- is that there is an element of the national security issue that, if you people literally, it's not a national security issue. It's a risk-communication issue. It's people saying, "The public won't understand." DR. MACKLIN: Yes, but then the question is, "So what?" What will the damage be? I mean -- in order to link this to what is a legitimate withholding or failure to disclose. Right? MR. GUTTMAN: Yes. DR. MACKLIN: I mean, it may be risk communications -- The question is what is the envisaged outcome or result of the failure to keep -- MR. GUTTMAN: I guess what I'm saying, though, is that it seems to me that's obviously questioned. One of the things that's striking is the sense that, really, the experts and the officials have the sense that the people that they were -- it's like the doctor-patient relationship -- didn't understand and that somehow that was really an inhibition, that if they had some sense that the public could understand, that was really -- I don't know if -- to take it as literally as it comes across on the paper, that if there was -- It's like what we have today in our own ability to express these difficult concepts. If somehow people had a greater comfort, if the decision makers had a greater comfort in the public that some of this withholding would dissipate -- I'm just asking that as a question. It's not whether it's right or wrong, but as a lesson that you look backward and you say, "Well, if people had a better way of addressing subjects like radiation or whatever, would the public -- then that area of murkiness might shrink." That's the question. DR. FADEN: Eli. DR. GLATSTEIN: Well, I read this chapter -- secrecy of national security. That's fascinating reading. On the other hand, I think what needs a bit more emphasis in this chapter is the linkage of these secrecy issues -- however you want to define them -- the direct correlation between secrecy and distrust of the government, which is one of the themes that we've been wrestling with. It's mostly related, I think, to this issue of public relations, as you're using the term, and then using that as an excuse for claiming national security. But, in any event, I think we need to beef this chapter up with respect to how the impact of this classification system does relate. I believe it correlates directly with this sense of distrust that occurs once the secret comes out, which in peacetime it virtually always does at some point. I think the business of what happens in a war is complicated, and the Cold War situation was even more complicated because it was neither fish nor fowl. And I think we have to be very careful about -- I think we have to be very careful about using a national security argument when we are in a cold war. In a shooting war, I think, you know, everybody closes ranks, as they should, but the cold-war situation is one of fear and intimidation and ultimately paranoia, and those are things we really have to be very careful about, that despite those very real phenomena we don't compromise the openness of the society that we're used to dealing with. And I think this chapter needs some beefing up as far as the relationship of its classification system about secrecy, how it directly affects the public at large. Public distrusts any time -- I shouldn't say "any time." The public is very distrustful of this argument, now. We don't trust our leaders, because they've taken abuse of this privilege. DR. FADEN: Um-hum. And we have illustrations. I'm trying to think how to link Ruth's comments with your comment. You know, I'm having -- I'm not sure that I can, but I think that -- Ruth, did you want to respond? DR. MACKLIN: No, no. I just want to -- I said that my comments really were -- came out of what Dan read and are an attempt to try to get a handle on the dimensions of national security. Eli's talking about the chapter, and I think -- MR. GUTTMAN: Yes. DR. MACKLIN: -- that deserves a separate discussion. I mean, I wasn't discussing that. So I'm not trying to make this link. DR. FADEN: Right. Okay. I'm trying to figure out what role national security issues play in the whole report, okay? What's its function? What's it doing for us? How far does this committee have to grapple with it? We have it in the secrecy chapter, at least indirectly, and then you have to watch through the kinds of -- the kinds of things Ruth was pointing out, saying, you know, it got murkier and murkier. If Dan's analysis was correct -- and I think -- it is, from my own reading of the documents -- we don't have classic case, you know, where somebody said, "We ought to obtain consent from these people, but we are not going to get consent because of national security reasons. Instead, we're going to make them human guinea pigs without their knowing it." Now, why did we not have such a case? In part, it's because people weren't that into getting consent -- I mean, the structure was such that at the time, despite what we have learned about the AEC and the Wilson memo and all of that, the sense of commitment to the inviolability of potentially human subjects, which you ought not to do research without consent, was not so rigidly a part of the structure anyway that people weren't sort of framing these things quite so starkly as we would have to if we were to do it today. And if you think about the MK Ultra Experiments -- but they did shock the conscience at the time when they came out. Now, presumably, there you had an instance there -- It's not ours, but there you had an instance where somebody made a judgment that, "We're going to do this to people without their knowledge for some national security interest. We're worried about brain washing. We're worried about mind control on the part of the enemy." Okay? "And so we're going to abrogate the rights of citizens in the interests of this national security thing and of research context." And I think the issue is -- to take us to where Pat was this morning, although it's outside of the immediate radiation issue - - in the modern context, now, somebody who wanted to do that would really have to confront the regulatory structure, if not the moral fabric -- You're supposed to get consent from people before you do research, and if somebody today said, "We've got a pressing national security interest, mind control, too." How could we do it and what's the committee's legacy, if we're going to have any -- maybe we won't -- on the conditions under which it's okay to suspend? Is it ever okay to suspend consent commitments in the interests of national security and are we going to deal with these issues or are we not, since the past doesn't necessarily force us to? I tried to provoke something and I guess I did. I've got Ruth -- Ruth and Dan. DR. MACKLIN: Well, let's hear Dan first. MR. GUTTMAN: I think there's something very real here, and, obviously, that's because I've been reading too many documents -- not the right ones, but -- (laughter) -- and that is -- and this is probably Pollyannaish. We really haven't gotten the real secret documents, either. Just the little bit of surface secret documents. I don't know. But, you know, you say what is there as the things and the interesting cases are the instances where these guys are keeping secrets and you're saying, "My God, that looks really -- It's not a national security secret. Why was that?" And the one that Ruth and I always discuss is in the baby- bone sampling. They're going around the world taking baby bones, and they're telling people they're taking the baby bones. They're just not telling them that they're doing it for -- You know, I mean, if you're telling people you're taking baby bones, why don't you just tell them what you're doing it for? So it's that kind of -- And it's the same thing with the plutonium injection -- said, "Let's make this thing public." The doctors said, "Let's make this thing public." And somebody in the Public Relations Department, with the approval of the then Shields Warren, says, "Are you crazy?" So the cases that are the most interesting are the ones where we're not in a pitched battle about should the American public know our plans to invade Russia, but why are these things somehow -- It's not that they didn't think about the issues at the time. It's how does it end up that things get kept in without -- You know, when you look backward, you say, "Why did they do it?" Because it's that kind of thing where you can look at those cases and say, "Well, is it just that they didn't think about it? Is it just they didn't know or it never happening again, because today we know the difference between public relations -- " I mean -- saying there seems to be tensions in the way the world worked that are continuing and today will say, "Yes, it's not a national secret, but it can affect the program, if -- " DR. GLATSTEIN: This is also very much related to something Pat's brought up several times and that is the behavior of a bureaucracy. MR. GUTTMAN: Yes, that's my point. It's an aspect of bureaucratic behavior. That's right. And it's an aspect of professional behavior, and it goes into -- You know, and it gets into that -- with the way in which national security is -- you know -- mixed or glommed together with these other things, and -- it and separating it out. DR. GLATSTEIN: Well, whenever there's controversy, it's very safe to declare it a national security, because that ends the discussion, you know, there's no more controversy to be discussed, because we'll just call it "national security." I mean, it's an argument ender. DR. FADEN: You know, it wasn't -- I keep thinking about MKULTRAr, not because it's a -- it obviously isn't, but it's contemporaneous and it bears on these issues. And when I came out and said, "No, that is not a satisfactory -- " The MKULTRA. The CIA, DoD -- PROFESSOR KING: But didn't MKULTRA come out many years after -- DR. FADEN: It came out in the '70s. PROFESSOR KING: And if I remember correctly, wasn't it undertaken during the Korean War? DR. FADEN: Um-hum. PROFESSOR KING: So the real interesting thing is -- when it happened -- during the Korean War -- DR. FADEN: This is right. PROFESSOR KING: -- because a part of -- I wanted this discussion not because I had fixed reasons, it's because, honestly, I was really confused, but it seems to me that when we are talking national security, at the time people are classifying as opposed to when we can declassify it, because I think that those are two separate questions. MR. GUTTMAN: Well, could I answer part of that- DR. FADEN: Yes, and then I think we need to end it. MR. GUTTMAN: Just to address part -- Where that comes out is in the atomic vets chapter. What you really have that's really fascinating is this crazy -- picture where at the time you've got these soldiers who are the psychological experimentees being told, "This is top secret. Don't tell anybody." Meanwhile, they're on the front of Life Magazine. So that it's the way that -- When you look backward, you see a very refined pattern where national security is not simply asserted and everything on one side is black. It's that the public gets this -- you know -- DR. GLATSTEIN: Peepholes. MR. GUTTMAN: They get peepholes and pictures and then there's public relations. I mean, that's what I'm saying is it may be, Pat, there's a story that will help people understand how the world works. It's not a recommendation of, well, the line should be here or there, you know. It's -- DR. MACKLIN: I see that -- DR. FADEN: I'm going to let Ruth have the last word. We're going to have our break, come back at 3:30, do our strategies discussion at four o'clock. We're picking up on the practices chapter and the discussion. Unless, of course, it turns out at four o'clock we have the rest of the afternoon for strategies. Hopefully- DR. MACKLIN: I think it was Pat who raised the question of national security as something that we have not reached closure on, and then we all got worried about it. And, now -- DR. FADEN: So, now -- DR. MACKLIN: Wait a minute. Now, the question is are we still worried, and, if so, what to do about it, since we didn't find a bona fide example -- or paradigm, a pure example, except retroactively when people say, about the early plutonium injections during the war, when they say, "Of course, they could never have told them. Forget about informed consent. They could never have told them because there wasn't even a name. They didn't even have this." They called it "product" or whatever. So, I mean, that's -- but that was retroactive. I think the way that -- We don't mean for our purposes to do either of two things. I don't think we need to make a -- give a global account of national security, what it is and what it means and how we understand it in this document. I don't see that that's needed. The second thing I think -- and I say this a little less hesitant -- uncertainty, but I believe this is true also -- we don't need to ask the counter-factual question, namely, if it had been national security that was invoked, rather than the liability or the public relations, then would it have justified the secrecy? I don't see why we have to address that because national security was not in those cases invoked. It was these other things. In other words, that counter-factual, we don't have to put into the report, because nothing hangs on our being able to answer it. What I think we -- my suggestion of what we do need to do is find every instance in search mechanism or whatever in which the words "national security" appear in these various chapters and see what needs to be said about it in light of this little discussion that we've just been having. DR. KATZ: Pat, before you respond, maybe you want to respond to a question of mine, too. It is the issue of national security was also invoked with respect to the internment of the Japanese at the beginning -- after Pearl Harbor, and then a whole legal literature developed on that question, could it really be justified, the internment, on the basis of national security? And what is the implication of all that with what we are -- with - the question of what is the meaning of national security? PROFESSOR KING: Well, my original question about this committee had a discussion -- had discussed what its understanding -- it was because of the way we used "national security," specifically -- in the intentional releases chapter, where I could go through and outline the places where we made a conclusory statement that says, "National security doesn't do it here." I cited one yesterday. I said -- in one place, we go all the way to the President and we're telling that national security is not working. What triggered me is our need -- not the kind of discussion that came out of the internment -- our need to understand what we mean when we resort to a dismissal of national security concerns, because in places we do do that to reach a different point. DR. FADEN: -- was not a national security issue. PROFESSOR KING: That's right, and -- DR. FADEN: So what do we mean by that when we say that? PROFESSOR KING: That's right. DR. MACKLIN: Did someone else say it was a national security issue? PROFESSOR KING: No. It's just reading the chapters where we actually said that national security was not at stake here. DR. FADEN: So what's our evidence for that claim -- PROFESSOR KING: Well, the evidence for that claim and what did we mean by that was what originally got me into this. The second reason that originally got me into this -- and it perhaps does go to Jay's point -- and that is that I don't think there's any way realistically out of this national security bind. I think, however -- for us. I think, however, that what we want to do throughout the report is to keep driving home the costs of having kept information -- and that does get to what Jay's point is that when people understand the costs, we raise the level of discussion about openness and secrecy in society. I don't think we can do more than that, but I think in order to do that well, it means that we're going to have to be more precise in how we are using the terms that to me seem to have been thrown -- I mean, that's not the only chapter, but that's where I started -- it started leaping out at me, and I kept -- reacting to it in that way. DR. FADEN: I think that's very helpful, and combined with Ruth's caution at the end, it's practical. That is to say, we can go through the document, see how we use it, and then -- DR. MACKLIN: But then I think once we see how we use it, we only need a little more justification to say why it wasn't national security, rather than make the conclusory statement -- DR. KATZ: That's not what Pat means. PROFESSOR KING: We, also, in most of those places, that was what I noted. We have no -- unless it's something in the documents that hasn't made its way into the chapters yet, which is sometimes the case, I'm sure. No, we didn't seem to have any basis on concluding that something was not national security either. So there were -- MR. GUTTMAN: The instance she was thinking of -- they didn't simultaneously say, "This is not national security." So, you're right, there are two separate -- DR. FADEN: The conclusion drawn in the chapters -- let's put out the evidence -- MR. GUTTMAN: Yes. Yes. DR. MACKLIN: But what counts as the evidence? I mean, do we need to make an argument or do we need to provide evidence? In other words, it would be -- hard for us to marshal evidence that something was not a national security concern. However, if we can, by the process of elimination, go down something like enumerate the list and say, "Well, it didn't have to do with secrecy for the enemy and it didn't have to do with getting soldiers into battle and it didn't have to do," et cetera, et cetera, I mean, to specify the elements of what might have been national security, so what else would count as national security? DR. FADEN: That's exactly -- in some cases, I think you're going to find that you can't make the claim -- the intentional release is what is the best -- to that chapter. Listen, I think that's very helpful, between what Ruth's done, Pat's done. And the fact the conversation's completely fallen apart, I know you need a break. So we're going to take a break, but it's going to be like a five-minute break. We're going to come back at 3:30, no matter what. (Brief recess.) DR. FADEN: Okay. We can start. We are going to try to do this in less than a half hour. We're only going to take more time if we have to. Okay, group. Okay. Here is where we are. All right. We said we were going to revisit this question of how we wanted to be perceived. Today, we're moving it up to 3:30 so that in case we need more time to do anything, we'll have more time to do that. Originally, we were talking both the issue of whether we wanted another meeting or not, which is what Pat raised, as well as the process question of how we're going to do things next. I hope I'm not overreaching, but I think the discussion we had this morning in which we settled on this notion that we're now going to be communicating with each other central concerns or issues and we all have an obligation to identify those and we all have an obligation to respond to our colleague's request for reactions is a major process decision made. So that maybe -- so that we can get on to other business, we can just look at this question of whether we need another meeting in order to do our work responsibly. And we held off on concluding on that last time just because everybody was all worked up and so we said let's have a day to think about it and see how it goes and see how we feel about it. The floor is open for discussion. Maybe we can end it quickly. Maybe it needs to be a longer discussion. The issue is does the committee feel that it needs additional meetings besides the May meeting or an additional meeting besides the May meeting in order to bring this home responsively. Anybody want to -- Pat. PROFESSOR KING: Well, I feel even stronger than I did yesterday that there is -- to sort of tighten it up -- tighten up the report, that we need an additional meeting, a day meeting. If I were to say accurately how I felt, I would say we need more meetings. I'm trying to be realistic. I don't think more meetings are probably in the offing, but I think that the difference in allowing a time frame between May and not a June meeting, but -- DR. FADEN: A July one or something. PROFESSOR KING: Something like that would make this an immeasurably better report. Not a perfect report. Won't cover everything or anything like that, but one that we feel like we can stand behind, and that's my -- and stand behind it. So I'm still -- I feel even more strongly than I did yesterday that that's a minimal level to achieve a minimal report, quite frankly. DR. FADEN: Okay. Other comments? DR. KATZ: Second. DR. FADEN: Second. DR. TUCKSON: Third, fourth. DR. FADEN: Third, fourth. Is there anybody who wants to argue about the fact that we need one more meeting? Then we can discuss whether -- is there more that we need. DR. GLATSTEIN: I think the only issue is can we get it. DR. TUCKSON: The only thing I would say is that, Pat, I think -- one more meeting, I think that it may very well require two. I'm trying to debate that on the notion of how much we've gotten done today, how much time it took and how many issues are still outstanding, and I think that if we could try to make a quick conjecture of how much we'll accomplish tomorrow and then coming back, all the stuff that gets rewritten between now and the next meeting, getting that squared away, and then our sense of what the final meeting is supposed to -- you know -- has to accomplish. The only thing I would ask the chair is a sense of -- I mean, there must be some finite -- the fact that we're all tired and all that, but all that notwithstanding, and the fact that, you know, we all got things to do with our lives, and the fact that -- all those considerations, what are the finite rules that absolutely will govern, like the money or -- DR. FADEN: Well, I mean, the finite -- Yes, I mean, this will require money, another meeting. We're not budgeted for a meeting past May. It will require money. We have issues right now, you know, real practical issues about budgeting for staff, and also the beginning of June, we go into a reduced staff mode, and they're spending for a reduced staff from June through the end of August for tentative funding. This is all very tentative. So that's kind of where we stand. I think a funding stream past August 31st is very problematic. I'm just sort of laying that out there. Everything is contingent. I -- Clearly, I had a real quick conversation earlier this afternoon and the response that I got -- "We want you to do a quality product. Tell us what you need within reason," you know, "Tell us something reasonable which you need and we'll do our best to do it." So I think we're fortunate in that we have -- you know -- sympathetic people that we're dealing with who understand that we're trying to do a responsible job, that we take our work seriously and we don't want to -- you know -- we don't want to come out before we feel like, as Pat puts it, we can stand behind it in a way that makes us all feel like we can say something with integrity. But, again, it's not an infinite -- you know, "You want it forever, you can have it forever." So that was the message I got. "Come back. Tell us what you need, within some reasonable time constraint, and we'll work with you. We'll see what we can do." That was basically -- I'm sorry. Ruth and then -- DR. MACKLIN: Yes. On the question, you said "reduced staff mode." What does that mean in practical terms? I mean, we have to think -- I mean, we can all assemble here, just come back, right? So what does the "reduced staff mode" mean practically speaking for what is required by way of work for the remainder of the -- DR. FADEN: I think -- We'll need to identify the work and then we'll know, but I think that it's probably okay. I mean, we have to go back and sit and look and see what we really expect to get done at each point along the way. The rationale from the beginning was that we were -- you remember we would come out with companion volumes, so the notion was we needed staff to close out and to do the companion volumes, and this is a sort of rethinking that says, "Well, the final report's going to come out with companion volumes now," is sort of how this is going -- looking at it that way. I'm not in a position to sit there and go exactly how many people it's been negotiated down to, but I think the better sense is if we could figure out a tentative sense of how we want to do things, then the staff can go figure out how many people are necessary to get it done within that time frame and then go back and say, "Well, here's -- You asked us what we need -- what do we need to get this done in a reasonable fashion. Here is what we need to get it done in a reasonable fashion," trying to be mindful of the fact that we're now only going to ask for what we really need for -- where we need to go. PROFESSOR KING: Do you want to hear from us what my strategic thinking was in terms of how this played out from -- how other people might see it playing out so that you could draw from all of us whatever you need to try to persuade whatever the powers that be -- DR. TUCKSON: Could I just ask you -- on that point -- but just quickly on that point, even though we are rushed for time, got a lot to talk about, I for one think it is very important that some of that conversation get on the record, because one of the things that is very, very important is that the reason why we feel we need to do it and the issues that must be discussed must come from this committee, because the last thing I want to see happen is the chairperson of this committee to be by herself trying to go forward. This committee must stand beside Ruth, and we gotta be very clear about why we're doing it, because we don't want to do this either -- (laughter) -- that we cannot leave the chairperson out there, leave -- out there in the -- these transcripts gets the sense that Ruth Faden didn't -- you know -- didn't do what she was supposed to or whatever it is, that's a bunch of crap, and so I want to make sure that nobody gets that impression. DR. FADEN: Thank you, Reed. PROFESSOR KING: You want him -- (laughter.) DR. GLATSTEIN: -- bodyguard. DR. FADEN: Thank you. Now -- so let's have a discussion. Jay, you wanted to comment, but, yes, it would be helpful -- DR. KATZ: I wanted to make a pattern -- respond to you because I want to suggest one possible scenario and it's on the suggestion. But let me start out, I'm not sure whether at this point, my -- notwithstanding, that I'm very much in favor of the extension, but if the majority want that, now feels we should have an extension, I surely would join it. But it would seem to me -- and I thought about it a little bit -- is we have the next meeting the middle of May. I would assume possibly -- and these dates may have to be adjusted -- that some time, maybe by the 10th of June, we can all get what looks like the penultimate copy of the final report in toto -- DR. FADEN: You mean after the May meeting, right? DR. KATZ: Yes -- the 10th of June. Then I would think that maybe that if we were then to meet some time the middle of July, and we can also have some correspondence, and really meet for two days and look it over, and probably there will be a number of disagreements emerging that possibly can be straightened out, and I would suggest in the light of -- I think -- something similar in mind, that we then have a real final get-together meeting the first week or so in August or some time around then, and that's the final meeting. And, of course, that's when -- if some of us have some principal objections that we can then, in private, add our own personal statements and maybe circulate them to the group, because others may want to join in on whatever one or the other of us has to write, and so that, essentially, as you suggested, by the end of August the report can be submitted. I mean, this is -- I'm not wedded to the dates, but I think it's possible the framework to consider. DR. THOMAS: I'd like to move the schedule up a little bit. We've heard repeatedly over the last couple of days statements to the effect that it's difficult to judge this particular piece, because I don't see where it fits in the whole. So Pat made a suggestion yesterday, if I recall correctly, that for the next meeting we provide a full copy of the report, possibly with holes in it. We really don't want to see the whole thing. I don't see how we can make a decision as to whether or not we're close to consensus if we don't have it all together. DR. FADEN: So the idea is before the May meeting, there is a from page 1 to page 800 with holes in it, say, and then there's another complete draft with a meeting that's now being contemplated after May that's a revision. Okay. And then -- DR. KATZ: Is that what you have in mind? DR. FADEN: Yes. That's what Duncan has in mind. DR. THOMAS: Yes, and the thrust of the next meeting, the main meeting, be to, like we've done today, try to explore those parts of fundamental controversy so that we can, hopefully, go away through May feeling that we have reached consensus -- DR. FADEN: On something. DR. THOMAS: -- on all the -- Well, hopefully, on everything, but that's a pipedream. DR. FADEN: Okay. DR. THOMAS: But let's make that our goal to try to get consensus on all the major points, so that what remains for the following two months is tidying up and the kinds of discussions that we can effectively do by E-Mail and phone and so on. DR. KATZ: Duncan, one question. Just one question. My hunch is we won't get that complete document by two weeks, I mean, at the earliest. DR. FADEN: April 28th. DR. KATZ: What? DR. FADEN: April 28th -- ANNA: April 28th to 29th is probably the earliest -- DR. KATZ: April 29th, and the meeting is -- DR. FADEN: May 10th. ANNA: 9th and 10th, so it's about 10 days. DR. KATZ: Is it possible for -- I mean, I think -- I find - - I will be unable -- I mean, I will do it in -- that I can do it is no problem, but it's final exams and the final week of tests. I would be able to do it, right? But if everybody else can do it, that's -- DR. FADEN: I know it's happening right now, because I'm doing it myself. I'm going out of the country. I've got exams. It's my daughter's wedding. I mean, we're all doing this. So let me just spare everybody by saying this is going to be a mess. Okay? If we do this, we just know -- all right? -- everybody's got plans already made. Everybody's got commitments already made, and there really isn't any way around it. That goes for staff as well as for committee members. We've all -- arranged our lives around something. We're now saying that we need -- we think we need to do some things a little bit differently, and it's going to play -- with lots of people's private lives. And we can sort of put that on the record, too, because -- nobody wants to do this. This is not because we -- as much as we like each other, it's not because we can't stand -- together again that this is coming up. Do we -- It sounds like we have a tentative sense of the time -- Reed, do you want to get on this issue of why are we doing this? DR. TUCKSON: No, no, no. I think we're getting there now. Let me just -- Duncan -- and just see where he and Pat are. What Duncan says is we get the whole -- Tomorrow, we talk about some of the remedies and we argue back and forth and so forth. Then, we're going to leave with a bunch of stuff in hand. We got -- Each chapter -- We left every discussion of every chapter with, "Okay. Well, we got a sense of it, but we don't have it nailed down." So all the balls are in the air. We come back. We get the whole book, the whole thing gets dropped on us in May -- We come in in May and we then somehow are going to go through a conversation where we believe that -- All right. Excuse me. We get the -- We get the book. We have this intense conversation back and forth over planks that we're all concerned about. We try to ratchet those down as best possible. We have a discussion in May that deals with the conclusions of internal arguments among each other, trying to ratchet things down. Those get presented to the group and the group has to buy into the compromises that warring factions have made. We have new warring factions presented because we finally read it all for the first time and we thought, "Oh, my God, this doesn't fit." Somehow those get presented in an orderly way. (Laughter.) DR. GLATSTEIN: -- optimist. DR. TUCKSON: Then we -- Now, the meeting is over. Now, work goes on for some period of time to fix the stuff that's been discussed, and then we didn't say we'd meet again unless -- We meet again to bring all the last balls in order, bless it as best we can and make -- DR. KATZ: But, me, I can't do it between -- in the end of April and the -- Maybe some of you can do it, but I can't, but that's only one person. DR. FADEN: Okay. And we're going to do it -- We're talking about cycling it through twice. DR. TUCKSON: So basically what I think I'm left with is two meetings. DR. FADEN: Well, what I've heard is two things. May was another meeting or Jay had three. Somehow getting three in between now and August 31st, May and two others. Now, that may have the advantage of -- because of dates, we may get some people at some and some people at the other, which just may be a practical reality. DR. TUCKSON: But I think August, everything has to be -- I mean, because there's nobody in the office left to even change the comma in August, right? DR. FADEN: Well, after August 31st. DR. TUCKSON: I mean, the doors are locked. DR. FADEN: As it is right now, as it stands right now. DR. TUCKSON: Well, I think it's good to have that reality. DR. FADEN: Yes, as it stands right now, that would -- that's the structure. Now, I saw lots of hands. I saw Ruth and I saw Pat and I saw -- Ruth. DR. MACKLIN: I'm just looking through the chapters. There are at least two that we've not seen at all. ANNA: It's three. DR. MACKLIN: Is that right? Three? Three? That we've not seen at all. Now, what we were discussing today were all chapters that we have seen before -- at this meeting. Well, one to come that we - - DR. FADEN: One to come we had not seen. DR. MACKLIN: Yes, but everything we've discussed that took more time than we thought we would, we have seen before. So, I mean, I was listening carefully to what Reed just said, and it seems to me we're going to have to give over a substantial portion of the May meeting to looking at, and in depth and in detail chapters or discussing chapters that we will only be receiving at the end of this meeting and looking at for the first time. So I'm just trying to fit into the time table that Reed just gave us what is realistic about -- DR. FADEN: I'm sorry. We were just checking on the number of chapters. It's two. ANNA: It's three. DR. FADEN: Oh, that's right. You're right. It's three. DR. MACKLIN: Chapter 4, Ethics, policies and practices, the bridge, we haven't seen, and 5, Conclusions, ethics, practice and policies. DR. FADEN: We have that. We have seen that. We've worked on that. Chapter 2 -- They just have different titles, so it's hard to keep track of them. DR. MACKLIN: Children and pregnant -- DR. FADEN: -- and children -- Right. Those are the ones -- we have not had committee discussions. DR. THOMAS: And biodistribution, we have not ever reviewed as a chapter. We've seen it, but we haven't discussed it. DR. FADEN: Right. So, you're right. So the point is we can layer this. It gets worse and worse. DR. MACKLIN: Well, I mean, I see the tasks for May not at the reading Jay's worried about of having to read the whole thing as the penultimate draft, but reading at least three chapters for the first time and the -- distribution and discussing as -- for the first time. So, I mean, I think realistically in what Duncan -- DR. FADEN: You're saying that Duncan's -- trying to get the thing from beginning to end is really probably not -- it's hopeless for May. Well, we saw -- the recommendations and the findings there which we could profitably do in May if people would -- No matter how we do this, we're squeezing two more meetings. We're squeezing -- The reality is that we -- as hard as everybody has been working, we're going to now have to really use this mechanism of sending in criticisms and comments and circulating it around so when we get together everybody's -- you know -- will really -- I can bring to you, with the help of staff, a more focus. What I -- you know -- once we cull that in these exchanges back and forth the following three points here. People are really having disagreements about the next -- To the extent that we can do that, we will make progress faster and have a hope of pulling this off. To the extent that we don't, we don't. But what Ruth is saying is maybe should give up on the idea of beginning to end -- by May. PROFESSOR KING: We cannot give up on the idea of doing it beginning to end. DR. FADEN: Do you do it by May or do you do it by the next meeting? PROFESSOR KING: It must be done by May. You gotta work backwards, and what -- This is like watching the sausage being made. It's not going to be a pretty picture. If you back up from what the constraints are and you take a look at what the constraints are, you gotta fit what we can do in constraints, not try to expand the parameters because they're only expandable a little bit, and we are assuming that we get them August 31st -- Even if you get that, optimally, you always need three cracks at a whole draft when you're dealing with a committee of this size. Anybody who has a different number, I'll take it, but my experience is you need three times full draft. I start on the assumption we will not get three times face- to-face full draft, and I will say why, and -- I said what I thought to get to a minimally acceptable report, and that is because we're dealing with finite resources. We have to save face-to-face meetings for only the most critical issues because it takes staff time to prepare us for these meetings. You know, you gotta consider the whole thing. And so it will take staff time to do a May meeting. It will take staff time to do an additional meeting. The only way that most of the report can be ironed out is actually going to be in between meetings. That's the realistic idea. DR. FADEN: Yes, that's what I was trying to say. PROFESSOR KING: It will not be a final report. Even if we could get a July meeting, what will have to happen is after that somebody's going to have to draft something, and we're going to end up signing off by E-Mail or Fax machine. DR. FADEN: Unless we squeeze a third meeting in. PROFESSOR KING: And to squeeze a third meeting in requires a cost-benefit assessment is really what I'm saying. DR. FADEN: Of the staff time that it takes -- PROFESSOR KING: Of the staff time that it takes to try to pull us all together. My view is we go for a -- we delay this moment of truth. We have to go front to back, even if you got to have three pages marked "haven't done yet." We gotta have a package that comes front to back. I don't think it's going to be a perfect package. That's why we need another meeting. We can't have a final report where you know that the last time you saw it as a group there were pages not written, that were explicitly not written, since these are the holes. One of the things we may have to contemplate is chopping off whole chapters. This is serious. I mean, if you don't have time to review the chapter -- the chapter's got to go -- serious enough to be put in a -- Think terrible times. Think about what you'd be minimally willing to stand up and defend, and that's the way I think about this. And I think that -- I can't figure out a way -- trying to figure out a way to get three face-to-face meetings on a front-to-back. I can't figure out a way to do it. Two is the best I can come up with. But I'm willing to be second guessed. I mean, I don't think this is -- DR. FADEN: This is part of what I think needs to be communicated, that nobody is even happy with what's being -- articulation of need is minimal, is what I'm hearing from the committee, not to do this in a luxurious and relaxed and reflective mode, but rather to barely get it done. Is that what I'm -- DR. TUCKSON: Yes. DR. FADEN: Yes. So the notion is to just barely get it done. That's what it's going to take. DR. MACKLIN: Let me just get it clear. The May meeting which you already scheduled and two -- DR. FADEN: One or two more. It depends -- and that's where the tradeoff goes and that's really up in the air. Now, I'm looking at Anna. And I really know, I appreciate it, want to acknowledge for staff as well as for the committee, the personal calculus or whatever -- calculi -- that are going on here like, "What is this going to do?" See the report's going to -- "What I did with my summer vacation." All right. Does that end the discussion? Do we have the reasons articulated well enough from the discussion yesterday? I think so, but -- come back to the transcript. DR. MACKLIN: How are we going to -- a mechanism -- DR. FADEN: A mechanism for -- DR. MACKLIN: -- a mechanism for determining the dates. I mean, that's -- I mean, you know, I'm particularly troubled by this -- DR. FADEN: You're going to be out of the country. Everybody is -- DR. MACKLIN: Everybody's going to -- I mean -- So, I mean, but here's the part of the tradeoff -- If there's only one more meeting left for May -- DR. FADEN: Right. DR. MACKLIN: -- then that's it. Whoever can't come, can't come. If, as you said, well, you're not going to be able to get everyone at the final two meetings, given commitments already made, but if there are two meetings, then at least everyone -- there's more of a likelihood that everyone can be at one or the other than -- for obvious reasons -- than there is if there's only one more meeting. So I don't know if that should fit into the -- DR. FADEN: I don't know if we can do it in the abstract, and, obviously -- Can we circulate calendars tomorrow? Circulate calendars tomorrow. We're obviously asking people to be as flexible as they possibly can, given the awfulness of the circumstances. So this is -- you know -- everybody's got to reach in and make their own private -- about what they're willing to give up against what they had already planned to do or how much of a hardship it would be to show up on that date. I really don't know how else to do it. And then we'll see. Pat's quite right to point out that there's a staff cost associated with each one of these meetings, so that if you have to have two meetings so that you get everybody to one or the other, that's a problematic issue, and I don't think you can -- the tradeoff until you look and see how many people you're going to lose, and if there's no date on which you can get more than six people, that helps you decide what we're going to have to do. But we're dealing with -- You know, everybody's -- are already fixed for the period of time that we're talking about and I know you all are all people who are making commitments for 1998 at this point. So, you know, we realize this is not easy. Jay. DR. KATZ: I think at this point, I don't care whether we have one more meetings, two more meetings or three more meetings or no more meetings. The only thing, though, I'm also realizing we have to have a meeting. The only thing that I would like personally, and I hope that I and maybe others would join me and that we can be -- that I can be indulged to that extent, mainly that when I get the final -- ultimately, the final copy of the report that I have three weeks before I have to sign off. DR. FADEN: Well, I don't think anybody can have three weeks. I don't know. We'll have to work on -- DR. KATZ: I'm just talking about -- Well, what do you think we can have? DR. FADEN: I don't know. We're going to have to sit there and figure it out, but three weeks is an incredibly long time in the world in which we're working with. DR. KATZ: Before it has to be submitted -- DR. FADEN: You've got a production issue, too. It's got to be printed. I don't know, Jay. I understand your request and I know why you want it, but I can't tell you now. We're going to have to sit down and chart this out at this point day by day. I really don't know. DR. KATZ: Well, then before too long, you will let us know what -- approximately what the time is? Because we need some time. DR. FADEN: Oh, without question. PROFESSOR KING: But one of the things, Jay, is if you know areas where you already feel strongly about, then one of the things you can set as a priority for yourself is to follow the development of those areas -- DR. KATZ: Yes, but, you see -- You're quite right about that, of course, but the way it's been going -- and that's actually a good process -- major things will develop as -- even to the very last minute, and that make, then, a big difference and you have to give it, then, some thought as to -- PROFESSOR KING: But then you do care how many meetings there are, because -- the smaller the amount of time at the end to do what you want to do. These are these tricky kind of tradeoffs that keep going back and -- DR. KATZ: But my hunch is there's going to be significant changes between the last meeting we have and the final draft. That's what concerns me. DR. FADEN: Given how little time we have, if we -- we've reached probably as far as we can go. I would like to go do some -- Let's do the chapters, and there's one last chapter to do -- DR. TUCKSON: Just some sense of -- I hope somehow to squeeze in a couple of minutes of a little conversation either today or tomorrow on how we set the priorities for the next meeting. So, in other words, how do we get a sense of how the discussion is going to flow? And we don't have to do that right now -- DR. FADEN: I think we should do that tomorrow- DR. TUCKSON: And that way we'll kind of -- And, also, I think a sense of -- sort of highlight those issues that folks are going to be focusing on that have already come up as we kind of adjourn and kind of -- So just so we can -- you know. That's something just to -- for efficiency's sake. DR. FADEN: I think we should do that, and we'll do it tomorrow. Although, I apologize to the people who can't be here, because I think if we do that now, we won't do it -- DR. TUCKSON: Good. DR. FADEN: -- as well as we can. So for those of you who aren't going to be here tomorrow, you want to leave thoughts or call in and -- your personal priorities, if you know them already, for what you want to make sure gets in next time that would be helpful. Okay. I think I've got it. Another chapter. We're going to do a chapter. Do the fourth chapter that we were supposed to do today. We finally -- It was scheduled for 11:15 this morning, just to let you know where we are on the schedule, and that is the chapter, "Professional Standards and Practices." We've got Jon Harkness here and Dan should be around someplace, and Gail Javitt contributed to the chapter and I've read a couple of iterations of it. So thank you for being patient, Jon, in case you notice it isn't 11:15 in the morning anymore, but -- Okay. Now, you've probably been hearing, if you've been here, that what we're trying to do is see how much committee agreement -- consensus there are about the points that are being made in this chapter. This is a radically different chapter from the other three. This is not a case study. It's in what we have been calling the "Ethics Series" in Part 1. So the floor is open for discussion. Have to find my copy. Are we too tired? No, we're never too tired. Thank you. Ruth's going to start us off. DR. MACKLIN: I think this chapter is in excellent shape, and I don't see anything really controversial here. (Laughter.) DR. FADEN: Having said that -- DR. MACKLIN: There are a series of small points, some of which -- DR. FADEN: Yes. If they're small points, I think we can go on to something else -- DR. MACKLIN: There are a couple of things also that I'd like to just get some further clarification on. A great deal -- and see if there's agreement or if more has to be said. A great deal -- I mean, a lot of this is historical, and, you know, reporting of what happened historically. A great deal of emphasis and weight is placed on the AMA, and I know that. I mean, not just Ivy and his connection with it, and I know that there's a figure here that cites how many physicians were members of the AMA, and then there's something in a footnote. I'm sorry if I don't have -- There's something in a footnote saying, yes, the AMA at that time had more influence or adhered to it, et cetera. But what I don't get the sense of is how the lives of everyday physicians or whether that figure of membership in the AMA -- because as I think I mentioned at a previous meeting and others concurred, I know that what was important to doctors in the '40s and '50s and in those years was being a member of your county medical association -- DR. HARKNESS: Right. DR. MACKLIN: -- or whatever that entity was, so that you could admit patients to hospitals, and that you paid your dues to the county membership, you automatically were in the AMA as a result of that. So if you could just say a little more about that to convince us, more or less, that membership in the AMA and that the role of the AMA was as significant as it seems to be in the way the chapter's written. DR. HARKNESS: Well, you're absolutely right about the AMA. I mean, in my -- according to my historical understanding. I think it was 1903, the AMA came up with this -- what historians have seen as sort of the brilliant technique of expanding the membership of the AMA. The county and the state membership in the medical society it's meant by definition that you're a member of the American Medical Association. It was a terrific sort of breakthrough for the AMA as an organization. Perhaps what I should be doing here is sort of backing off in acknowledging that the AMA -- membership in the AMA was not necessarily a defining characteristic of being a physician, that it was -- for a lot of physicians, I think, a pro forma part of their life, and, yet, the AMA was recognized by the legal community and I think by the general public as the formal embodiment, professional embodiment of the medical profession. DR. MACKLIN: So, I mean, the acknowledgement would help there. I'm just going -- A couple of actually very small points, small points, but it's areas where I may even have some minimal expertise. One of -- (Laughter.) No, this is another question, actually, and that is about the publication in JAMA -- Yes, page 8. Page 8. It's a little bit confusing what goes on here. Maybe it was clear to other people. Ivy writes his rules and -- DR. HARKNESS: Right. DR. MACKLIN: -- and they're given on page 6 and discussed. Then they are presented to the Judicial Council -- DR. HARKNESS: Right. DR. MACKLIN: -- and they distill it down to those three. DR. HARKNESS: Right. DR. MACKLIN: And my question -- and then there's a cite on page 8 to the editorial -- of Nazi physicians and then another cite to the supplementary report of the Judicial Council, which - - DR. HARKNESS: Right. DR. MACKLIN: -- apparently reports on things. My question about all this is what actually was published in -- Was it these three statements -- longer set of principles ever published? There's a much later footnote that kind of repeats things. I mean, it goes much later and explains a little more. I don't remember where it is, but later on. So could you just clarify what got published and since there are two -- they're citations to two different issues -- JAMA and to the longer and shorter version of Ivy's thing. I mean, that just -- DR. HARKNESS: Okay. I can answer you now or I can answer you in print or both. DR. FADEN: Why don't you do a two-second answer now. DR. HARKNESS: Okay. DR. MACKLIN: I mean, maybe I'm only requesting clarifying you to the draft. I mean, I don't even care about the -- but I mean, what I'm saying is this -- DR. FADEN: It's not a big-deal point, so we can get it covered in the draft. DR. HARKNESS: Yes. DR. FADEN: Okay. DR. MACKLIN: Okay. One other point, and I am -- This is not an area of my expertise, and I apologize, but I have been so very soundly criticized by historians, and this is your field, so on page 39 and possibly earlier, but this is the first time I started noting it and commenting it, there are several references -- No, I'm sorry -- very sorry. There are several references, page 25, to Nazi doctors and what Nazi doctors did. DR. HARKNESS: Right. DR. MACKLIN: And it has been pointed out to me by historians -- the Holocaust -- that not all the German doctors were Nazis, that German doctors did these things, and though it was during the Nazi era, it's a factual error to refer to all of the doctors who did these things as "Nazi doctors." So that is not something that my expertise -- DR. FADEN: So we just want to make sure -- DR. MACKLIN: In a very recent conversation with some historians, when I use these phrases, "Nazi doctors," they yelled at me and they said, "Philosophers shouldn't talk about history." (Laughter.) So I just -- Well, that's what they said. Can I just -- a couple more little ones here? DR. FADEN: This is relaxing. (Laughter.) DR. HARKNESS: I'm waiting for Jay Katz. DR. MACKLIN: They're small points, but in a couple of cases -- Here, this is one that is -- I feel more confident than I do talking about German or Nazi doctors. On page 15, you cite "Primum non nocere," "First, do no harm," and you refer here to that principle as saying -- you refer to it as "beneficence based." Now, I guess my point here is that if we're going to start talking about using the words -- the terms that are used to describe ethical principles, we probably have to use the ones that are standard in bio-ethics, not -- although you might make some comment that it -- I mean, fit it into beneficence is usually thought of as non-maleficence, okay? Not beneficence. And -- I mean, this is why it's important for experimentation, because it could be argued that non- -- it could be argued that -- it could be argued in different ways, but it could be argued that non-therapeutic research on patients -- that is where there's no direct benefit to them is ruled out by non-maleficence. DR. HARKNESS: Right. Right. DR. MACKLIN: However, beneficence can surely justify research on people with no direct benefit to them, so long as you can make the argument overall that the overall benefits, that you're maximizing benefits by doing research that will help future patients or other people, and the only people that are harmed -- You see, you've got the small people who are -- the small group, the experimental group, who are being experimental subjects on whom the harm might -- some harm might befall, but then you have this presumably very large number of people who will be benefited by the research. So beneficence can justify non-therapeutic research. Whereas, it would be harder using the principle of non-maleficence to do so. So all I'm suggesting here is first of all we use the right principle and then hook up that principle with the -- DR. HARKNESS: So you're saying that beneficence can be used to justify non-therapeutic research that benefits the community. DR. MACKLIN: Exactly. DR. MACKLIN: Yes. Yes. I mean, the Belmont Report, which spells out beneficence, that becomes one of the principles, and they don't say -- The Belmont Report doesn't say -- the commentators that you're -- doing that. So that's just about terminology. And I think my last point -- I'll give you the page on which I've made little remarks. My last point is the use of the phrase "proxy consent," on page 39. People -- where it means permission for the patient to be -- permission given by somebody else, sometimes called "third-party permission," but "proxy consent" is generally not a preferred term today, since it's been argued -- and it's been argued for a long time, actually -- that only the person on whom the research is done or only the patient can give consent, and so I think the preferred terms are "third-party permission" or "authorization given by a surrogate -- an appropriate surrogate." DR. HARKNESS: This is what happens when I spend more time reading documents that are 30 years old than 3 months old. DR. MACKLIN: Well, it was actually -- I mean, Alex Caper made the argument. We -- the book -- it was a number of years ago -- on children and who speaks for the child -- the Hastings Center, and Alex Caper made the point at the time that we shouldn't really be talking about "proxy consent," and he was drawing on that from a legal notion and in other context of especially things like spousal authorization in other countries where husbands have to give consent for permission for their wives. It's absolutely -- so as not to give the impression that one person can legitimately give consent, but is -- that person is authorized to give permission. So that's -- for the moment, those are my comments. DR. FADEN: Okay. DR. HARKNESS: Thank you. DR. FADEN: I like this chapter, too. DR. KATZ: I should make some comments. (Laughter.) But I will make them brief and it will be -- DR. HARKNESS: -- brief. I've heard that -- (laughter.) DR. KATZ: I'll give you my notes and -- DR. GLATSTEIN: -- it's the Judy Garland story. (Laughter.) DR. KATZ: I'm tired and I will be more incoherent than I usually am, and so I want to be brief. There are problems with this chapter, as I see it, and the problems are the remediable and I'll be glad next week to sit down and talk with you about -- in terms of my perspective, and lots of the pieces are there. You've done a wonderful job by putting the pieces, but what emerges to me from what you put down is that the Nuremberg code has many, many faces. It has a face - - DR. HARKNESS: "Phase" or a "face"? DR. KATZ: Faces. Faces. F-A-C-E-S. See, I'm -- (laughter.) It first of all has the face of the Allied Military Tribunal that said that they were only putting down ethical principles that had already been accepted by the medical community, and, in my view, that is a wrong assumption, that this is not so, and unless they wanted to fall back, which they didn't want to do, on the two codes of ethics promulgated by Germany and by Prussia in the beginning of the 20th Century, which are even more stringent -- strange as it may sound -- than the Nuremburg Code. Then, the Nuremburg Code is an aspirational code and, as I've observed, it speaks to the stars, and without interpretation and constant construction, it is a document not for earthlings, but for the heavens. I can't conceive it as a code that has practical implications as apparently Secretary Wilson thought it might, and that's -- one can argue about it, it's questionable -- questionable assumption, and it is a code that except for General Wilson was never really accepted. When the first code was promulgated, the Helsinki Code, it made -- it was quite different from the -- in some ways the same, but in many important ways different from the Nuremberg Code, and what are the implications of that with respect to the Nuremberg Code itself? And there are a few other things and I don't want to go into them now. And somehow, you need to -- it's all there, but you need to bring this crazy quilt together in some kind of a way, not for us, you know, because, after all, it's our committee and our document. And what really ultimately -- something needs to be said about it maybe in the conclusion, maybe it can be defined a little bit better. Oh, yes, one other thing is very important -- the Nuremberg Code as a code only for normal volunteers, and the Nuremberg Code as a code that can guide the medical profession in medical practice -- to that also. I think all this needs to be separated -- and it takes some work. I don't think a great deal of work. You've done an excellent job. But I don't know whether -- You might want to respond -- briefly. DR. HARKNESS: Yes. I'd like to respond briefly, and then I'd be interested to hear, perhaps, if any of the other committee members have any thoughts. I have to admit I'm a bit baffled. The last time we discussed this at a committee meeting, what I took away from Jay Katz' comments at that meeting is that I was being too single minded about -- in my interpretation of Nuremberg and a Nuremberg Code. Again, I think I thought at that time that, yes, Jay Katz is right. I should be looking at this from a lot of different perspectives, and what I set out to do in the second half of the chapter that I -- had not written last we spoke about this, was to pay attention to the variety of ways in which I believe historical actors did take Nuremberg and the Nuremberg Code, and my purpose here -- and this is -- my purpose. May not be the committee's purpose, and this is for you to decide. My purpose here was to try to represent in a coherent way some of the confusion that existed about what the Nuremberg Code meant, what the Nuremberg Trial meant, and I think to try to give Nuremberg one face, to use your word, would be historically irresponsible. DR. KATZ: Let me interrupt you again. I didn't make myself clear. No, I like the many faces. I don't think that you've articulated -- that is really your purpose -- to do. That it has these many faces is actually the excellent contribution of this chapter, but I think it doesn't -- that this is your thesis and ultimately our thesis doesn't really come through clearly enough -- DR. FADEN: That, I think we can work out. I think -- There's a lot that is in this chapter that is important and different from -- not currently in the literature, and I think that this is really a process that has emerged out of the committee's deliberations, and I have to admit, I'm very excited about this chapter. It's not -- magnitude of other kinds of things or contributions that this committee will make, but this is a real clarification of an understanding that has largely, I think, not previously been put forward, and so I think it's important to get it right. It's not primarily or exclusively -- certainly not exclusively and I don't know if primarily a chapter about the Nuremberg Code. The Nuremberg Code is a vehicle for trying to think about what was going on then, and I think it's done a superb job. You may remember, I don't know if everybody does, but I'm addressing this to all of us, that this notion that where did the Nuremberg come from -- come from this idea that the Nuremberg Code reflected actual practice. This notion that it might have had something to do with normal volunteers and not patients was an idea that dawned on several of us in the context of this committee's deliberations as we heard exchanges, for example, between Phil Russell and Jay Katz trying to figure out why their worlds didn't seem to reconcile, and Phil is drawing on his experiences -- position dealing with healthy subjects in the military and remembering what went on in the war, and Jay is talking about his medical school training at Harvard in which he -- the patients in the '50s. And all of a sudden it occurred to me and several other people as we were working through this, maybe there's a way to figure out what's going on here. And what has been exciting is the fact that when we've gone back -- Now, Jon had done some very fine work originally, and then we had -- we went back and looked even more carefully -- Don and others -- at what was really going on, and -- reading the transcript of the Nuremberg Trial carefully to see exactly what kinds of examples were evoked and what sorts of examples were not evoked to try to get -- for the judges to have reached the conclusions that they had reached, it starts to fall to pieces. The Oral History Project, which is extraordinary and -- maybe we've had sort of a down day, so I want to point out where things are wonderful. The Oral History Project has added immeasurably to being able to document many people's impressions, Jay's and others, of what life was like then. Now, we have a -- base and an evocative way of making -- and it all sort of fits and hangs together and -- you know, we should be sure, we should all be comfortable that this thing is right -- right, that it's a different kind of chapter from -- you know -- virtually anything else in the book, and it's kind of critical for understanding whatever we want to say about what was going on at the time. It basically is a way of saying that, Jay, you were right in feeling you were right, and here's what was going on. And, you know, my only great fear is that there's something seductive about an explanatory hypothesis, you know, something that's reconciles contradictory views. It's seductive, and you want to make sure that it fits. "Gee, this is cool. Can we make it work?" So my only concern is that we pushed it too far and if we found -- you know -- a hammer or a nail or whatever the right metaphor is, we've gone too far with it in the interests of trying to make all the -- you know -- all the -- now tidy. So that would be my caution as we review this chapter, and I'm certainly eager other people's reactions, but, generally, I think this is -- you know -- an important committee effort that we should feel good about. PROFESSOR KING: I didn't read this version. I read the prior version -- much better. I have no comment on the -- part of the chapter. I mean, everybody else is very expertise. What I would do if I were to read the chapter from start to finish now would be to say if there's anything in this chapter in our explanatory -- that undermines or should cause us to rethink or reflect on the way we use the Nuremberg Code for different purposes in other chapters, that is not to say that there is anything wrong with this at all. That is the only thing I'm suggesting, and that is -- And maybe Jon is one of the first people -- some of the best people to focus on this question in relationship to what we -- what our views here do to some of the views elsewhere to make sure, because this is a perfect place to poke holes, if they exist, to make sure that we use it consistently. You don't have to respond to that -- just need a -- if people are satisfied with this and this is basically the thrust we're going to go with, then you just have to read some of it, especially the classic, the Wilson memo, how it's used, those parts of the report in which we have those kinds of discussions and statements. DR. FADEN: This is again where reading the thing from beginning to end -- PROFESSOR KING: End will help, but -- and you might think about that -- DR. FADEN: -- and see how this chapter fits in the ethics series. PROFESSOR KING: Right. DR. FADEN: And as it reverberates through the whole book. PROFESSOR KING: That, I see, as the only -- I mean, that's where your explanatory -- the questions you put by explanatory -- topics as being pushed too far. In answer to that, that's where it is likely to emerge, if it emerges at all. DR. HARKNESS: I think one piece of the puzzle with regard to Nuremberg that doesn't end up getting a lot of discussion in this chapter as it exists now, but as we're thinking about -- and I may be -- my own chapter here. Not mine, but -- PROFESSOR KING: That's the best way to be able to do it. DR. HARKNESS: -- is that people like Wilson and those within the Defense Department who were really paying close attention to the Nuremberg Code and saw it as a legitimate and useful statement were themselves not physicians, and I think that is something that comes out in the DoD chapter that -- sort of spearheaded, but -- maybe I can figure out something -- DR. FADEN: Are there other comments or questions on the chapter? And, again -- detailed stuff, you know, Jay's and others comments about rewriting, that's -- we need to get that. It sounds as if this is the chapter in which we don't have deep disagreements or deep divides, which is a huge relief. We'll have to see what Jay's written comments are, but at least for right now for the rest of the committee, nobody's saying, "I disagree," or, "I take exception or whatever. And, again, that's understandable in some respects -- it's so different than the case studies and that's a different kind of challenge to the committee. PROFESSOR KING: We draw no conclusions in this chapter -- DR. FADEN: Well -- PROFESSOR KING: -- in a real sense like we do in the case studies -- DR. FADEN: I think you draw lots of conclusions -- DR. KATZ: You know, Pat's comment is very well taken -- what Jon has done -- and I expressed myself correctly -- is it's just the weaving together -- that you're trying to paint a tapestry that you haven't, I think, just clearly stated -- that if that is the path you've set for yourself, which I think you did and you agree with it, it just needs to become clearer. But then the problem is if that is -- if that was the cast of this chapter, it'll become a little bit more difficult when we talk about the Nuremberg Code, which piece -- which strand of -- are we identifying, and that's going to be the big problem, but what Jon has done is leaving something that -- in bits and pieces I've argued for for a long, long time. But -- DR. HARKNESS: Yes, I can toss around ideas from the staff about this. Sometimes, I've used this very simple-minded analogy with this chapter. In the first part, I talk about the speed limits. In the second part, I talk about the driving speed, and what do you use to judge whether a person's a responsible driver. Does he drive the same speed as everybody else or whether they adhere to the speed limits. And that is the sort of question that isn't answered in this chapter. It's laid out -- DR. FADEN: That's an interesting analogy -- goes back to our other discussion. May I do this? For what it's worth, I don't know whether we want to have it today, because we're tired, hearing no other comments about this chapter, aren't you relieved? DR. HARKNESS: Yes -- DR. FADEN: It's analogous to being the last protocol that the -- reviews -- (laughter.) As we think about the agenda for the next meeting, we should be flagging chapters like this that don't need to come to committee discussion. That doesn't mean that individual members don't have strong suggestions for how things could be changed or modified, but, clearly, we didn't need -- it's nice to have, but we didn't need to have a committee discussion about this chapter. That's my retrospective judgment. If there's any way to predict which ones of the chapters don't need this next time, that's the -- it's obviously the game that was played in deciding what would get on the agenda today, but the goal would be, insofar as possible, to do refining with an eye towards the agenda in May in this very limited time frame that we're on. The chapters that most need committee discussion are chapters that we can resolve how it should be finalized without taking up a half hour, even a half hour, of committee time. So that's part of why I think people are really going to need to be sending back messages like, "I like this chapter. I've got some issues I want to change on it, but I don't -- you know -- nothing here that I think I want to bring to committee discussions," and when you're flagging your whatever kind of things, we need to be hearing about that. We have -- Thank you very much, Jon. DR. HARKNESS: Thank you. DR. FADEN: We have another half hour. Okay? And we have three choices. Okay? We can quit a half hour earlier. That seems crazy, given how we're talking about how we don't have minutes. Okay? We can try to do what -- suggested which is try to think about what we think should go into the discussion to the -- although maybe that is better done on Wednesday -- or we could just launch in to one or two options. We have the future- oriented recommendations we barely touched -- right now or we have -- we can pick up right with the agenda item where we would have gone and which is right to Findings and just start with Findings. PROFESSOR KING: I vote for Findings because the Findings -- some of those chapters -- DR. FADEN: So let's just start with Findings and march through as far as we can get. If we don't get past Finding 1, we don't get past Finding 1. Okay? That's all we can do. Is that agreeable to everybody? Okay. There are 31 Findings. Only 31 doesn't exist -- For right now, let's -- you know -- we can have discussions, but I don't think -- Now, is not the time to talk about how this should be organized, should there be subheadings with -- you know -- Findings under one heading and Findings under another heading. Nobody wants to read 30 consecutive Findings like this, so they have to be better organized. That's -- you know -- that's acknowledged. So let's just look at the context Finding by Finding. Finding 1, page 1. Comments -- It's okay. It's terrible. Who wants to say this? It's obvious. It's great. Anything? PROFESSOR KING: Yes. But I'm doing what you said not to do, and I -- but I'm sitting here trying to -- and saying to myself, can I get -- can I try to conform to the chair's desire? DR. FADEN: Don't even try. PROFESSOR KING: One of the problems I have here is that the Finding needs to be three sentences where the wording is careful and it is -- part of what disturbed me here was -- DR. FADEN: So much text. PROFESSOR KING: -- so much text, and the explanation. It was not in the nature of a finding, and that suggests to me two things. Maybe we don't really want findings, and I'm really open to that. I mean, I'm open to that -- or that we really do want findings and we have something in our heads that said this is what we want to be cited for, you know -- And it kind of got to the point where I thought that this was an exercise for helping us organize our thinking about some of the prior chapters, and then when we're really -- we're more structured -- the recommendations. That's sort of how I read it. Now, I'll put that out to you. I'm perfectly willing to work on this as what I think the finding is and maybe "finding" was a wrong word and we had something else we wanted to do here. DR. FADEN: Well, one other thing that's lying behind the surface -- and -- can speak to this more than anybody, since he works -- labored so hard to get this out -- is we also have to produce an Executive Summary. PROFESSOR KING: Okay. DR. FADEN: All right? Executive Summary -- will be whatever -- what are we talking about? PROFESSOR KING: -- recommendations. DR. FADEN: They can't just be recommendations. The Executive Summary can't just be our recommendations. We've got to give some context to the recommendations. So it's for the large number of people who aren't going to read the whole report, who only will read the Executive Summary, which is -- it's going to be 50 pages, 60 pages -- 50, 60 pages, the Executive Summary. So I guess another hidden sort of agenda here is if we can get through this, agree basically that this is what we want to say on each of these points, this then becomes the text from which the Executive Summary is fashioned. Okay? So that probably should have been shared, but I don't think it emerged until after it was written that it could serve that function. MR. GUTTMAN: Obviously, depending upon how much time the committee has, the more you have a clear idea of what's important and what's not, then instead of like a page, you can convey the one sentence. What this is an effort to do is if you had a press briefing today what would the questions be? Question No. 1: "Dr. Faden, how many experiments you find?" "Billions, but we don't know much -- " Right? Question No. 2: "What about intentional releases?" And it's that nature to see if we captured the basic kind of questions without all the nuanced -- you know -- ethical analysis, et cetera, et cetera. So that's what this is. That's -- Yes. DR. FADEN: Ruth. DR. MACKLIN: Yes, I had the same reaction that Pat did. This is -- Finding 1 is "Finding 1:," and then there's a title, rather than a finding. So I had exactly the same response. I would like to see them cast into findings. DR. FADEN: But one sentence. DR. MACKLIN: Yes, one sentence. Now, if it turns out that the effort to cast four paragraphs into a one-sentence or two-sentence finding is going to raise a great deal of controversy among this committee, then I think we should look at this the other way, because I don't think we should labor over how the word or whether -- what constitutes a finding if the purpose of this section is really or could also be or mainly be the Executive Summary. So I think we ought to take a crack -- take a crack -- at what might be in -- for each of those or however many we get through -- a one-sentence finding and see if the attempt to put this -- these paragraphs into a finding -- Suppose everybody agrees on the paragraphs but disagrees on what the sentence would be for a finding, then I think it's not worth it to go through the exercise of trying to recast these in terms of findings. MR. GUTTMAN: Well, let me just -- the other thing I wanted -- What I tried to do is convey some of what I suspect, as best I can discern, are what we would refer to as the "nuanced points," that we found lots of experiments, but that we didn't find a lot of information about many of them. I mean, things that are the second -- you know -- the next question -- to see if when you're looking at this it's sort of this check list of -- you know -- obviously a section risk which is blank is -- you're going to say, "Well, the public wants to know are these risks." Right? And then you get to your risk-communication questions. So this is more of sort of an internal exercise in are you covering all the bases, right? DR. FADEN: Right. But I think -- either for the Executive Summary and or if we decide we want a findings chapter, what I'm hearing is we would like to try it with one sense and then the elaborating -- Is that a -- elaborating text -- elaborative -- whatever form of the whatever, the text that -- the explicating text or whatever the right -- could follow after this. Okay? Reed. DR. TUCKSON: I think just the other part of that -- you just sort of -- the end of your last -- which is I think equally important is the ability to make the statement in one sentence, but you also -- as I read this is to make sure that the things that we've chosen to comment on -- if you add up the equation of the things we've commented on also that equals all things of major substance, the major issues. So if you've got an issue that isn't in a finding -- DR. FADEN: It's a problem. DR. TUCKSON: -- we've got to go back and say, "Why didn't that issue get in? And there's an issue that's in here that isn't a big enough of a deal. Why the heck did we put it in -- " DR. FADEN: So that's -- and that's really what we're trying to accomplish here, and it would then be just lifted right into the Executive Summary -- the Executive Summary of our findings, Executive Summary of our recommendations and into the -- and also it might just find -- this might become a chapter of the book for somebody who wants a quickie tour, then, presumably, each one of these findings should be somewhere in the chapter, right? So then -- it's backward. If we found this is a finding, there better be some chapter or chapters where this finding is available in more detail. Do we want to look at Finding 1 or do we still want to have -- I think you're right, Pat, I think it's good to have this -- So we're now -- PROFESSOR KING: With that context -- DR. FADEN: That context. MR. GUTTMAN: Now, I'm not sure if you want to read it, but -- DR. FADEN: Right. So that -- is Finding 1. Okay? Or does anyone have trouble with Finding 1? We haven't come up with the one sentence yet, but that's obviously -- that'll be around the next iteration. Okay. So then we're into Finding 2. DR. MACKLIN: Are we supposed to be answering these questions that come at the end of each one -- on page 2 -- DR. FADEN: Yes, I mean, that's it. I mean, I -- MR. GUTTMAN: The question there was -- the gist of that question is do you want to say more than that -- these zillions of experiments or do you want to leave that for -- I mean, this is presentational. PROFESSOR KING: The gist is less. DR. OLEINICK: I want to add one word, though -- the word, "biomedical" here, just to -- distinguish it from what's coming next. It's one word -- DR. FADEN: I had that in intentional releases DR. OLEINICK: Is there any reason to say something about -- I don't even know if we know -- but, basically, there were so many more people exposed to the potential release of this than in the biomedical experiments, and just to contrast that. I don't think we can get any -- numbers, but talking about -- MR. GUTTMAN: Yes, actually, I -- DR. OLEINICK: -- orders of magnitude, different numbers. And do you want that in here or not? MR. GUTTMAN: That's a great point -- more controversial ones later on -- risk -- DR. OLEINICK: Well, it does lead into risk. This is just a statement of that. Lots more people were exposed to releases than to radiation from the biomedical experiments. MR. GUTTMAN: Actually, I'm not sure that's correct, but that's -- DR. OLEINICK: Well -- MR. GUTTMAN: I just think it's very simple. If we have 4,000 experiments in the data base, an average experiment is -- I don't know -- five or ten people, right? Pick a number, right? DR. OLEINICK: Pick a number, but I think whatever number you pick -- DR. FADEN: Let's not do this again, okay? You try it and see whether it makes sense and if you feel comfortable about doing it. It's a contrast we shouldn't make unless we feel real good about what would stand behind the contrast. Really just pulling numbers out of the air, we shouldn't even attempt it. So let's see what we can do with that. Right? No? MR. GUTTMAN: I agree. I mean, your principle -- was exposed -- DR. FADEN: Yes, I mean -- MR. GUTTMAN: Where do you draw the line? DR. FADEN: Yes -- (Laughter) -- fallout, everybody. Finding 3. If it's small language points, we can take it as small language points, like I'm thinking about this comment about -- cases and all. If you want to fix it and get language like that, we can do just from getting responses, but bigger question issues now. So you've got small changes on the text just give us -- you know -- give Dan the text, but if you've got larger objections or concerns about the way the finding is cast, that's what we should be discussing. (Several speakers at once.) DR. TUCKSON: So this finding -- I mean, is the point of this one to say that there were rules? MR. GUTTMAN: Principles. DR. FADEN: Principles. MR. GUTTMAN: Principles. The difference is it's slightly less than policies. It's a principle. DR. TUCKSON: Okay -- principles, that's what we're saying. MR. GUTTMAN: As -- put it, when someone asked the question, someone was thoughtful of the answer. DR. MACKLIN: Okay. So then it shouldn't be -- the word "standard" should not appear in the finding. It should be "articulated principles." MR. GUTTMAN: Well, no, Ruth, to be -- about it, this is a small but very important point. In the -- DR. FADEN: This is a huge point. MR. GUTTMAN: It's a large but very small point. DR. FADEN: This is a huge point. MR. GUTTMAN: Oh, no, no, no, that's a different point -- many different points. Two points. We're mixing apples and oranges. As to the informed consent, we used the word "principle" because somebody said something. It was a statement of principle, whether it was a policy or -- you know -- a rule is problematic. It's a principle. What the standard part of that -- this is actually written carefully, because I thought Ruth Macklin might read it -- is we have in our charter an obligation not only to address the ethical norms -- I don't know what the word is -- but also the scientific, and the assertion here is that when we looked at the history, the scientific standard wasn't best expressed as like ".02 microcuries," but that the AEC had a human-use review process, so that the way that the AEC contrived to control the risk element, the technical, the scientific element was to put a process into effect, and that was not simply a principle, they actually did. That was a rule. It was a standard, and it went into effect. DR. MACKLIN: I'm sorry. I looked at it too quickly. MR. GUTTMAN: Right. So that was the way. "Principle" was used in one context and "scientific standard." Now, if you don't want to say it's a scientific standard, that's another matter, but that's the explanation. But the standard was a process. There were some standard standards as well, but -- PROFESSOR KING: That is -- the confusion. A "standard" is not necessarily a process. What you just described was putting into place a process that says nothing about what the process was supposed to refer to. Maybe it would be better if one would break this out, the three different principles, and talk about each principle separately -- MR. GUTTMAN: Yes. Yes. Okay. PROFESSOR KING: -- rather than combine it in -- one. I didn't have any problem with the informed consent, because I thought I knew what you were referring to. It was the one about -- and I think what -- there's too much said here. This says, "These are the principles today," and it says, "These principles were understood and known and the standards were understood and known -- " MR. GUTTMAN: Right. PROFESSOR KING: " -- in this period '24 to '74." MR. GUTTMAN: Right. PROFESSOR KING: So my recommendation is -- I don't think there'll be any question about informed consent, but I still am not clear about -- when you say, "in important respects" -- MR. GUTTMAN: No, I know what I meant. Let me -- I did -- I did -- We did -- We don't know -- Let me -- This is actually -- This is thoughtful, as opposed to other things -- this is thoughtful. The question we asked the scientists, there are absolute standards, you know. .2 is the most you can put in somebody's body, and then there's a process. We don't know what the number is. It requires the judgment on a case-by-case basis. Therefore, we have a review committee. So that is -- how you would judge the scientific component of whether things were conducted ethically, you could be looking at a number or you could be looking at a process. Okay? So that what were asserted is that they were quite advanced and quite concerned, and they put -- a process, a risk -- central part of the story. You want to talk about benefits without being prompted by the public or by Congress, they said, "We're going to use this stuff. It's dangerous. We have to have a review process." The reason it's qualified, in effect, is -- this is what Gil is working on in the isotope chapter -- is to what extent was that process focused on the risk element to the then exclusion, but without as direct a consciousness of the benefit element? In other words, were they primarily concerned about, "Is this going to be too deadly?" or were they also assessing the relationship? And that is partially a question of historical fact and it's partially a question of the regulations, and you people are the experts. I didn't want to say it was the same as a risk-benefit process. It was clearly a risk process, and, in that sense, it was an important process. That was the -- PROFESSOR KING: Let me give you another statement -- In line 20. MR. GUTTMAN: Okay. PROFESSOR KING: "The agency's requirement for -- established in essence a scientific standard." MR. GUTTMAN: Yes, you're right. PROFESSOR KING: That is -- DR. FADEN: Not right. MR. GUTTMAN: You're right. PROFESSOR KING: -- not right. MR. GUTTMAN: Right. A process. Assigned to a review process which could be deemed a process by which -- You take the Cincinnati experiments, for example, as Ron Neumann has pointed out, that a difference between what happened in the external radiation setting and the isotope is there wasn't a review process. So if you want to say, "How do you judge those two experiences?" You can say, "Well, in one setting, there was a review process that the scientists looked at the risk in a process of expert review." DR. MACKLIN: Well, would it be correct to say that this established a process by which a scientific standard was set? MR. GUTTMAN: Well, I don't think it's -- By which particular cases were judged. If you want to know -- DR. FADEN: The problem is how to use the word "standard." MR. GUTTMAN: Yes. DR. FADEN: Since it was done case by case -- MR. GUTTMAN: Right. DR. FADEN: -- as opposed to saying, "Here's the permissible body, whatever standard." MR. GUTTMAN: Yes. DR. FADEN: It was done case by case. They looked at each one of those and they said, "This is okay. This one is not okay." Okay? Kind of like -- MR. GUTTMAN: Today. DR. FADEN: Today. Okay? So I don't know how we use the language -- use of language -- Let me point out another larger problem with this finding. I don't know if it's larger, but different, which is -- I have my marked up copy at home. '44 to '74 cannot be one period without a whole lot of text, because you've got a lot of things happening in the '60s that are not reflected here, including the Yellow Book in '66, which comes in and revolutionizes -- having said what are the federal ethics standards. This one is talking about the early stuff, and, basically, we have to figure out is this the findings that draw from what's now Chapter 5, the Ethics Policies and Practices Conclusions Chapter, and also the radioisotopes chapter, that isn't -- that most of us have not seen, but we can't cover the period from '44 to '74 in one thing. You got -- you know -- 40-75 and a whole bunch of things happening later in the period which shows just how complicated this is going to be. We're going to have to sort of -- all that out, because the ethics principles and standards changed. I don't know -- and we need to -- I am a benefit person. When I read this, I was just hung up on the word "principles and standards." I'm not sure that it's right to use the words "principles" here either. When you look at -- And I'm kind of confused. So I think that maybe we all should look at that one very carefully and figure out what it is we're trying to say based on what we're referring to. So it's -- PROFESSOR KING: Well, part -- I would think that maybe -- I think to a lay reader there may be less confusion than there is to us. When we see the term, "There are several standards that are central to the ethics of human experimentation today," we would not describe full consent as the principle. DR. FADEN: Right. PROFESSOR KING: We would describe the principle variously as respect for persons, you know -- which conditions -- requirements for full consent are derived. I'm not sure, however, that that special way in which ethicists would use the term would make this inappropriate for a broader audience, and this is a question for the ethicist because you're trying to ask whether you're going to be comfortable with what you're saying, but the vast number of people, I don't think that's going to stop people. But I don't care, was also what I'm saying, Ruth, if you can find another -- or both Ruths -- principles, that's okay with me, too. What is, I think, a more critical concern, because it applies today, is -- not the confusion. IRBs are both a process to which they do, in fact, have standards. DR. FADEN: They do. That's the difference. PROFESSOR KING: They have standards, and what this is is there was a process, and it's not clear to me that they also had standards that they used in the course of that process and procedure. If they did, Dan, then what we should be saying is what the standards were and then say they had a process in applying the standards or -- MR. GUTTMAN: That's right. DR. FADEN: So this is as far as we can take it. Finding 3. 1 and 2, basically -- DR. KATZ: Could I ask one question? DR. FADEN: Yes. DR. KATZ: On page 4 -- what do you mean that -- was not directed to all experimentation? On line 12. MR. GUTTMAN: The Nuremberg Code. DR. FADEN: Yes, the Nuremberg Code. MR. GUTTMAN: The Nuremberg Code. It was atomic, biological and chemical warfare. DR. KATZ: Hum? DR. FADEN: Says atomic, biological and chemical warfare. DR. KATZ: Oh. DR. FADEN: In the Wilson memo. It's clear -- atomic, biological and chemical warfare, and so it's not that. It's not that -- say that because this is too -- It manages to say that, don't you think? PROFESSOR KING: It says it in a preceding paragraph, so maybe the sentence -- DR. FADEN: Is unnecessary. PROFESSOR KING: -- is unnecessary and you should use top secret in the preceding paragraph -- DR. FADEN: Okay. So this one has to be broken apart or expanded or whatever, but you've got to recognize that it floats over that 20-year period, so much happens that we can't -- PROFESSOR KING: And we also have to say that -- are we going to be clear that the third one about the burdens and benefits of science, if we can't say anything about it -- You see, the way you structured this is that there are -- that if there's nothing in the history that we can point to with respect to the third, we'd have to say that -- You just sort of dropped it out of sight. MR. GUTTMAN: Oh, yes -- Right. Well, actually -- we handled that is in the next -- downwards in the practice section -- actually, this is in the -- I don't think we want to cover what really -- the details here but -- PROFESSOR KING: Well, this is a critical detail. MR. GUTTMAN: Right. I thought we had here -- PROFESSOR KING: What? Your list? MR. GUTTMAN: No, no, somewhere -- Basically, the point here is that in 1949, as Jonathan has written about, the AEC Isotope Division had -- you know -- about children and pregnant women, and that is -- DR. FADEN: That wasn't a justice issue -- MR. GUTTMAN: It was indirect, a backhanded way -- put that under risk. PROFESSOR KING: Either you have to rewrite this -- MR. GUTTMAN: Okay. PROFESSOR KING: -- or if you stick with the lead in that you have here -- DR. FADEN: You got to go through each -- PROFESSOR KING: -- you've got to go through each one -- MR. GUTTMAN: Yes. PROFESSOR KING: -- and make sure, as far as I read everything, there's no justice issue here. I didn't see what I call a justice issue -- MR. GUTTMAN: Is it the case that the only way that justice came up was this backhand, back-door way by the risk -- DR. FADEN: Why is it even a justice issue? It was not a justice issue. MR. GUTTMAN: Well, then -- PROFESSOR KING: I think there's probably no evidence. MR. GUTTMAN: Okay. Well, that's -- PROFESSOR KING: Then you gotta say that. MR. GUTTMAN: That's fine. Okay. DR. FADEN: There was no -- I mean, there was almost nothing. There was nothing. They didn't worry about it. MR. GUTTMAN: Okay. DR. FADEN: They didn't think about it. MR. GUTTMAN: Okay. DR. MACKLIN: But I don't think that has to be mentioned in this section. I mean, when you say, "Today, several principles are central," you could mention only the two that are relevant to this section here, "among these are," without bringing in some third thing that's going to confuse the reader and doesn't belong here. MR. GUTTMAN: If we write the rest of the report, we could probably -- DR. FADEN: Okay. It's five o'clock -- DR. TUCKSON: What are we focusing on tomorrow? DR. FADEN: Well, one choice is to march through the findings, the others, to recommendations. I'm inclined to think that we should do -- retrospective recommendations -- situations. Yes, I think we should go right to the old Situation 1 and 2 that are now Situations 1a, 1, 2a, 2, then get to notification, see what we can do with that. What we really need are people's detailed reactions to these comments; if you've written in the margins, if you've got questions, if you've got criticisms, that would be very helpful, so that -- If we go through all the remedy stuff, what we used to call "remedies," looking backward recommendations, and we have time, we can go back to findings. Is that agreeable? Okay. DR. MACKLIN: We're not going to be looking forward? DR. FADEN: No. One of the things about looking forward is in a way it makes sense to wait, because we don't have all of our interpretation of the contemporary data straight yet. So once we get that straight, we'll be better positioned to do that. Oh, we should take comments from everybody on anything. Anybody who's written up or has marked up or has reactions or wants to tell somebody something that we were going to discuss today but we ran out of time on it, we should get. [Whereupon, at 5 p.m., the meeting adjourned, to reconvene at 8:30 a.m. the following day. - o 0 o -