ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS - - - PUBLIC MEETING - - - Tuesday, November 15, 1994 - - - The meeting was held in the Grand Ballroom North, the Renaissance Techworld Hotel, 999 Ninth Street, N.W., Washington, D.C., at 9:00 a.m., Ruth Faden, Chairman, presiding. PRESENT: RUTH FADEN, Chairman KENNETH FEINBERG ELI GLATSTEIN JAY KATZ PATRICIA KING RUTH MACKLIN LOIS NORRIS NANCY OLEINICK PRESENT (Continued): HENRY ROYAL PHILIP RUSSELL MARY ANN STEVENSON DUNCAN THOMAS ALSO PRESENT: SARA CHANDROS PATRICK FITZGERALD MARK GOODMAN JOHN TILL GAIL GELLER PUBLIC COMMENTATORS PRESENT: GEORGE N. AHMAOGAK MAGGIE AHMAOGAK MARCIA HAGGARD DENNIS NELSON ROSSMAN E. PEETOK KATHY PLATONI C O N T E N T S PAGE Remedies, Ken Feinberg 5 Public Comment: Mrs. Marcia Haggard 69 Dr. Kathy Platoni 78 Dr. Dennis Nelson 89 Mayor George N. Ahmaogak and Rossman Peetok 105 Environmental Dosimetry, John Till 140 International Releases, Mark Goodman and Patrick Fitzgerald 174 Research Proposal Review Project, Ruth Macklin, Sara Chandros and Gail Geller 233 P R O C E E D I N G S (9:08 a.m.) CHAIRMAN FADEN: Would the Committee come to the table please? We're starting a few minutes late, and there's no reason for it other than my forgetting about it. Okay. Do we have a new agenda? Excuse me. Do we have a new agenda? We have a new agenda for this afternoon, 100 percent recycled paper. Please note some of the things that are moved around. We're going to see if we can get everything in. If you'll note, we're going to have a report from the Remedies Subcommittee, which is what we postponed from yesterday, which Ken will give and then other members of the subcommittee can help lead the discussion. It's scheduled for an hour. However, if we need more than an hour, the ten o'clock report will be moved into the afternoon. It will happen, but it will be moved. So we shouldn't feel absolutely constrained by the time frame. If the discussion needs to go until 10:30, it will. The one thing we cannot manipulate is the public comment session which is scheduled for 10:45, as we have guests from the public, and they've arranged their lives to come at the appointed time. So the only thing on the agenda that cannot be moved around is the 10:45 public comment session. So with that, Ken, can you lead us please? And we all received a memo from the Remedies Subcommittee which perhaps it might be helpful to pull out and look at. MR. FEINBERG: Thank you. This is sort of an interesting time to talk about this topic because we have been nibbling around the edges, both the subcommittee and the full committee, in recognizing that inevitably we're going to have to take on this subject of remedies. What I want to do this morning is to lay out some basic axioms about remedies, lay out some concerns that have been expressed both by the subcommittee in our deliberations, but also to lay out some personal concerns for the sole purpose of generating an initial discussion that will undoubtedly, as Ruth has said, take us into the next few months of meetings to hammer out this important section. So what I'm going to do in the next 20 or 30 minutes is basically provide some premises, some of which are reflected in the one-page memo that you have got, and then walk into the lion's den and prepare to incur the initial inquiry, criticism, wrath of my fellow members. So it's a task. Let me start off before we talk about the substance of the chapter and some ideas; let me start off by expressing some concerns about remedies that have been expressed both within the subcommittee, but also generally in the context of compensation programs for other similar wrongs: Agent Orange, Dalkon shield, atomic vets, uranium miners, et cetera, during the deliberations, the debates in Congress. But let me express a few concerns that must be kept at least in the back of our mind as we go forward with remedies. First concerns, four concerns. First, that we make sure that a remedies chapter is grounded in some sort of factual basis. This means that we must be aware at all times of the factual underpinnings of any remedies guidelines that we might propose. This raises problems, for example, of medical causation. Henry has talked about dosage levels, et cetera, trying to reconstruct dosage levels, the problem sin reconstructing dosage levels. The time that has passed that makes it very difficult factually to learn all that there is to know. We never know everything we need to know about these experiments. So any remedies program is going to have to presume certain facts or certain variables, and we cannot in the time that we have got develop a remedies chapter for every single isolated case. That's what the guidelines are for that we propose as a subcommittee. Time also plays havoc with other traditional variables in a compensation program. Many of the alleged victims are deceased. That has both procedural problems to it in terms of getting the facts. It also, frankly, has direct substantive problems in determining a remedy. For example, does the absence of consent in 1950 justify a remedy to an estate in 1994? I tend to doubt it, but it's worthy of discussion. If an alleged victim in 1950 was not given adequate consent, that victim has been dead for 30 years. Does the absent of consent inure to the benefit of an estate in 1994? I'm not sure. I tend to doubt it. But, again, this is all part of the first concern I have about accurate, factual underpinnings that justify our remedies guidelines. The second concern I have is one that some of you are aware of in other contexts, and that is the raising of false expectations. I think that at best we are misleading people, and at worst we are acting in a cruel fashion if we lay out the hope that people are going to get millions of dollars in remedies for what we are uncovering here. My experience in other compensation programs is that it is a dangerous game to raise the expectation level of people that we have the power, even if we wanted to, to award millions of dollars, a run on the bank in the federal Treasury, and I think we have to be very careful about that political problem. Third concern, in some areas involving mass releases, exposures, uranium miners, atomic vets, Downwinders, the Marshall Islanders, Congress has spoken, maybe not well, but Congress has spoken. It has spoken both in terms of legislation that is now on the books, and it has spoken in the form of various congressional investigations involving libraries of documents and reports in the House and the Senate. So I mean I think, again, we cannot reinvent the wheel. In many of these at least mass exposure areas, Congress has if not preempted the field, Congress has certainly had something to say, and I think that we as a Committee should keep that in mind, that we are not reinventing the wheel here in some of these areas. In others I think perhaps we are. And the fourth and final concern, which has been resolved by us as a Committee thanks to the work of the Subcommittee on Scope and Priorities, keep in mind that there is an ongoing debate about our mandate and exactly what we are authorized to do in the way of presenting recommendations. So those are just some; I want to sort of set the table by expressing my concern and, I think, the concern of the subcommittee that as we go forward we keep in mind these concerns as we try and fashion a remedies chapter. The subcommittee recommends to the full Committee that we basically follow a methodology on remedies that's reflected in this abbreviated, cryptic memo, namely, one, that our goal be to draft remedies guidelines that will guide not only policy-makers, but the public in terms of what variables we think are appropriate for other policy-makers to consider in picking up the mantle of the remedies chapter. As I understand our subcommittee work, we will not be recommending specific remedies. Instead we will be recommending what remedies are available if certain variables are determined by Congress and the executive branch to be worthy of a remedy. A blueprint is our goal in this chapter, a blueprint that would lay out a series of options. Those options would be available as policy-makers may pick and choose if they think the options are appropriate, and we would try and provide our policy- makers with some of the variables in the way of culpability, absence of medical causation, presence of medical causation, agency, victim deceased, victim alive, wrongdoer alive, wrongdoer deceased. We would lay out the variables that would lead policy- makers to agree -- in guideline form -- that would lead policy- makers to decide on their own ab initio whether they want to promote the remedy or not promote a remedy. Secondly, the subcommittee proposes that we do lay out a series of options that are available. I mean there are options available ranging all the way from compensation all the way to the other end of the spectrum, which is an apology or not even an apology is justified in certain cases, and there's a whole range of options in between, insurance, medical monitoring, that we should lay out as potential options here. Third, the subcommittee recognizes that any remedies chapter should distinguish between different types of experiments. There were experiments directed at individuals, individuals in a small group, a cohort or a control group, small, maybe not so small -- everything's relative -- but a group of discrete experiments involving individuals. There are then, and I love that phrase of Duncan's and others, experiments of opportunity involving mass exposures, involving atomic vets, uranian miners, and the Marshall Islanders, where after the fact there are experiments to determine impact, and maybe there are grey areas in between, Green Run, et cetera. I mean there are variations, but the subcommittee acknowledges that there are experiments directed at individuals and radiation experiments directed at A and B and C, and then there are experiments after the fact against thousands of people because the wind is blowing the wrong way. I'm not saying that any of those are more worthy or less worthy of a remedy. There are other factors that play when you talk about mass exposures as opposed to individual, discrete experiments, and I think the guidelines have to reflect that. The subcommittee also proposes sort of a rudimentary grid that would be mentioned in the guidelines. The availability of a remedy, if any, whatever that remedy might be, if any, would be driven by a grid which would reflect the degree of government culpability, the degree of government culpability, sort of the horizontal grid, with the interesting variation, degree of government culpability, (a) government officials performing the experiment, (b) agents of the government performing the experiment, an intermediate step. And a vertical grid which would talk about the degree of harm, either medical in terms of Experiment A causing Disease B or Injury C; absence of harm; and the interesting question of harm also being defined in terms of violation of individual integrity in not knowing, not giving informed consent. That's a harm, I suppose. So that all has to be considered. I mean the absence of informed consent may also violate the horizontal grid pertaining to culpability, as well as the vertical grid pertaining to harm. So that was basically how the subcommittee began its discussions in terms of trying to fashion some guidelines that would assist both the full Committee and the public in our final report. Now, that -- and Patricia has been enormously helpful in the subcommittee in pointing out that all that the subcommittee has done so far in presenting this cryptic memo that talks about a methodology for developing a remedies chapter is to beg the question of what substantive meat we give to the variables that determine government culpability and harm. I mean it's all well and good to say, "Look. We'll have a grid, and if the government is culpable, then that increases the likelihood of a remedy, and if the person was injured that increases the likelihood of some remedy," whatever that remedy might be, whatever that response might be by the federal government. But it begs the question a little bit as to how one defines government culpability, and that is where the compensation experts have to turn to the substantive ethics experts around the table to help us fashion what constitutes government culpability, if any, and nature of the harm, if any. Now, that raises a very interesting question, and now I'm branching off a little bit, and it's Feinberg on remedies instead of the subcommittee on remedies because basically the subcommittee stopped with the recognition that Pat had made to the subcommittee, that, well, we've got to flesh this out a little bit. But there are a couple of, based on past experience of mine in these compensation plans, there are a couple of thoughts that might guide the Committee, the full Committee, in deciding what life we breathe into this culpability-harm grid or guideline, so to speak, and it picks up on some of the things Ruth has said, some of the things Pat and Duncan have said, Henry, and others. First, I think that one should probably make a distinction between proposing remedies for past conduct that was viewed at the time as appropriate, but after the fact is now deemed to be inappropriate. In other words, in law at least it is very difficult to impose culpability on people who acted at the time in conformity with accepted standards and practices, even if in the light of 20, 15, ten years later we know better. I think that it is not necessarily accurate to say that if wrongs were committed in the light of history, but at the time the activity was reasonable, that does not necessarily mean that a remedy should not be available. The question is: what remedy should be available? Everything's relative, but it seems to me that although what I call retributive notions of justice say that perhaps some remedy should be available, I am troubled about -- I am personally, just to throw it open for discussion -- troubled about holding out the possibility of a remedy, of a recommended remedy, in cases where researchers and others related in one way or another to government action acted reasonably at the time. The culpability quotient is, it seems to me, far different than in a circumstance where the government agent acted unreasonably even under 1952 standards, and I think that's an important factor. I also think that -- and, again, you have a whole range of remedies. So it doesn't necessarily -- I'm not talking about everything or nothing. We're talking about degrees of remedy when at the time people acted in the culpability quotient, the horizontal grid; people acted reasonably. There is also the question which is obvious to everybody, whether one's looking at experiments back in the '50s or in 1994. In terms or remedy, one must discuss what, if any, harm took place. Now, this raises some very interesting issues, which have to be laid out. I think that the Committee will be on a fool's mission if it tries to reconstruct medical causation or tries to determine the harmful effects of radiation in specific experiments on the victims. I don't think we can get those answers. I think too much time has passed. I think that we do not have the resources, and I think that certain presumptions have to be made about the causal connection between the experiment and the impact of that experiment on individuals, and just keep that in mind because I think that if we try and even in our guidelines articulate what minimal medical relationship there has to be between exposure and disease or injury, we will hold ourselves out to a great, great deal of criticism. But there's another reason it becomes very important that we distinguish what the past wrong was, if any, in light of present knowledge, and that is that if we conclude -- let me just give you one example that is very problematic -- if we conclude that in 1952 there was no evidence of medical harm, either the alleged victim was dying or incapable of being further injured, let's say, but the wrong that was committed is determined to be absence of consent, a violation of personal integrity in that even if the person wasn't medically injured, the person was injured in the sense that certain experiments were performed without permission or without adequate permission, is that a wrong? I think that is a wrong. I think that's a serious wrong if we determine that variable, but when you translate that wrong from the general telling of the story, it shouldn't have happened; when you go beyond that and try and fashion a remedy for that person, one gets into very deep water. If that person is, as is I think likely, no longer alive, I think one runs into the problem, frankly, of fashioning a remedy other than perhaps an apology to the family from the United States. I think one runs into a serious question as to whether any other remedy is appropriate. Violation of personal integrity of a now deceased victim does not automatically to my way of thinking give rise to some sort of remedy that inures to the benefit of his or her estate. Whereas if, on the other hand, one demonstrates in our guidelines a variable that the person was medically injured, either died because of the experiment, was disabled as a result of the experiment, resulting in loss of consortium, lost wages, disability, that all the time compensation models factor variables like that into a remedy that injures to an estate for ten or 20 or 30 years later. But I want to make the distinction. I'm just trying to give an example of how delicate and sensitive this gets in terms of remedies. Injury to an individual because that individual's personal integrity was violated does not necessarily or even presumptively inure to the benefit of children 35 years later, but, again, I'm just raising some of these issues that I think we have to flesh out. Now, one has to distinguish, I think -- and here is where this Committee, I think, can perform an enormous public service, enormous -- it's one thing to examine the whole story and conclude that Remedy A or Remedy B is or isn't available for retributive purposes, to rectify a wrong done in the past in light of ten, 25 years later or whatever and propose something ranging all the way from an apology to compensation or what have you. There is a second, quite different remedy here that I think we've got to look at, and that is a purely prospective remedy. I think that probably -- and this is just a personal view -- but I think probably the best remedy that we can provide the citizens of the United States is a prospective remedy, not grounded in retributive notions of rectifying wrongs, but grounded in notions of old-fashioned deterrence, which is that from now on we propose the following guidelines, the following processes be followed prospectively, beginning in 1994 and into the future, to guide government researchers in how they go about performing prospective experiments. That section, it's a remedy. That section of prospective application of guidelines hopefully to prevent the type of wrongs that we are uncovering, I think, is a remedy for future violations. Those remedies may be extremely harsh. I mean I don't know enough about the profession, but one can see that if everybody is put on notice in 1994 as to the way that research activities should be conducted in the future, from now on -- this is the recommendation of the Committee as to how these experiments should be performed in the future -- I mean, the remedies can, you know, range all the way from civil compensation for violations to loss of licensing, to criminal violations proposed or suggested for policy-makers to consider. So I think that the question of prospective punishment for future violations of guidelines proposed by this Committee for the policy-makers to consider is a very, very important remedy that doesn't dwell on the past, but looks to the future. So those are just some initial thoughts. I think that I'm going to try and slip under the table here. It's very controversial, obviously, but I would hope that Patricia and Duncan would, you know, go first. They're on the subcommittee, and they've worked initially with me and with the staff, with Gary and others, in getting this far, but I think that sort of sets the stage for discussion. CHAIRMAN FADEN: Thank you very much, Ken. We appreciate it, and perhaps it would be helpful. Pat or Duncan, do you have anything to add or expand? DR. THOMAS: Just a couple of points. First of all, I think we would be remiss in our duties as a subcommittee if we didn't make some sort of recommendations about the distinctions between the different types of experiments and intentional releases in terms of how we come down on whether or not this particular experiment, Green Run, the plutonium injections and so on, is a candidate for special treatment under anything that we would recommend beyond what might already be out there. I say experiments as a class or as a set of classes to distinguish from any recommendations we might make about a procedure for how we would recommend the government go about adjudicating individual claims within the class. That, I think, is subsumed under what Ken has to say about the grid, and the grid will be our recommendations for how any individual case might be addressed. But to stop with just the grid I don't think provides enough guidance to the policy-makers as to whether or not we think that, for argument's sake, Green Run is something that has not yet been adequately addressed and we think is an important issue that merits, you know, special legislation or however we want to recommend Congress address the compensation needs, or whether we think it was so benign that we can just set it aside and turn our attention to the other classes of experiments that are more important. I think the subcommittee now turns to this difficult problem of trying to reach some judgments as to the perspective in which we lay each one of the individual classes of experiments. Now, we can't really do this until the Committee as a whole has reached moral judgment about each of the categories, but it's time we started thinking about doing that. So that was the essence of what was meant by the last sentence in the first paragraph of this memo where it says, "Such guidelines should be sure to focus on experiments at a class." That went through several iterations before it finally showed up here, and I'm not sure that the meaning of that sentence was necessarily clear to everyone. The second is I'm glad to see the final sentence of Paragraph 2 in there as well. Worth talking about creative alternatives, such as apologies and medical monitoring and so on, and then it concludes, "While recognizing the ethical implications that such responses may themselves engender," this is an issue which has been very briefly touched upon on several occasions so far, but has not yet had a full discussion, and it's time we did it. Yesterday the possibility of medical monitoring came up in the context of I believe it was the prisoners' discussion and didn't really have much of a discussion then either. I've said this a few times before. I'll repeat it. There are many conditions for which it's possible to detect the condition early and many such conditions for which there's really no scientific evidence that early detection does the subject any good. It may do nothing to prolong life. It may simply give the subject more years of living with the knowledge of his disease, more time for the insurance company to cancel insurance because of a pre- existing condition, and for a subject to lose his job, and all sorts of bad things can happen as a result of early detection, and nothing good may come of it. So there's an extensive literature that I don't particularly read -- I'm not an ethicist -- on this subject, and it's something that I think we owe ourselves to get a briefing on this subject. And then the final point was in response to something that's not in this memo, but Ken mentioned that Congress has already spoken in some cases, and we shouldn't be reinventing the wheel. I agree wholeheartedly with that. I just want to reemphasize something I said at the San Francisco meeting, namely, that Congress spoke in the form of the Radiation Exposure Compensation Act and included in there a requirement that the -- sorry -- not in that act; in the earlier act which established the requirement that NIH produce the radioepidemiologic tables for the purpose of compensation decisions and then included a clause there saying that we ought to be reexamining this periodically, and then when they went ahead and enacted the Radiation Exposure Compensation Act, I don't recall any such similar proposals in there saying that our compensation guidelines ought to be updated from time to time to keep them abreast with the evolving scientific knowledge. It seems to me sort of a foregone conclusion that there ought to be some provision for keeping our guidelines abreast of what's currently known. So that's all I wanted to say at this point. MS. KING: I don't have very much to add. I would say -- sort of reemphasize some of the things that Ken made in his personal comments that resonate with me. First of all, I think it's hard to talk about this area without having some kind of common understanding of what the ethical framework about redress is all about. So I'll just put it at that. I don't think we've started that work. I think that the question of culpability from an ethical point of view is very difficult to actually start to grapple with in the context in which we are operating. I take some of Ken's remarks to focus us not so much on what he calls retributive justice, what I call compensation theory, as to focus on deterrence and general and specific deterrence and what is appropriate for the future. I say that because what I have always been worried about is that the assumption is that the radiation experiments -- and they do constitute some special group; that's true, but there's been a lot of research that's been done on human subjects in the past in this United States, not all involving radiation where upon careful scrutiny I'm sure that we would -- I'm confident; because I'm a cynic, I've always been confident that we would find things that we didn't like. Not only am I reminded of that and have to keep these experiments in that context; I'm also reminded of the fact that currently research in the United States with human subject does not carry an established compensation framework other than what individual institutions are willing to provide out of the goodness of their hearts. That suggests to me that in talking about redress and remedies, that while it is important to focus on our task, we ought not lose sight of the fact that it exists within a broader framework. So Ken's last point about the future had real appeal to me because -- this is a personal comment of mine, not a subcommittee comment -- because it has been very personally distressing for me to know that for 20 years of work, after 20 years of work in human subjects research that we've never been able to mount a serious conversation about what we do with respect to those people who have suffered harms, as in fact some people have, who carry the ball for the rest of us because presumably they help provide information that's important to the society's well-being. And I don't want to lose sight of them any more than I want to lose sight of those who have already suffered. So I'm just saying that we have a tendency here to focus on the radiation part, which we should, which we must, which focuses us on the past, but there are two things to keep in mind. The past is larger than just radiation, and our current situation, at least from my mind, is somewhat less than desirable. That is why I think that the current ethics debate, an ethical framework debate is so critical to how this methodology actually is fleshed out. CHAIRMAN FADEN: I'm sorry. I forgot to plug -- I was apologizing to the microphone. DR. MACKLIN: I agree with, I guess, Ken's and Pat's comments that the notion of culpability is one -- the very concept is one that we have to explore. I mean there are simple and obvious cases of what's culpability and we don't have to worry about those. So, for example, one thing that I didn't hear in the presentations was the distinction between, if this can be made, the culpability of the government in some sense for what it ordered, planned and devised, and the culpability of individual investigators, researchers, the people who did the experiments. I mean all permutations and combinations are possible. Both may be culpable, whatever the criteria. Neither may be culpable. The government may and the investigator not, and so on. So I think we have to separate that out, and this is only a question or an observation. There may be a different notion of remedy or different concept of remedy for each of those. Second, and I think Ken alluded to this in his presentation, and he and I had a brief conversation before we got started, and the question here is whether even in the absence of culpability a remedy may be appropriate if the conduct was wrongful. That is to say yesterday I made the distinction -- Pat's frowning, but I'm going to explain -- I made the distinction yesterday between wrongful conduct and wrongful moral agency. I mean culpability of the moral agent. And so it's entirely possible that we may conclude that a person who acted carefully, a researcher who acted carefully with regard to the risks, not negligently, used the information then available about radiation, but simply failed to do what today would be required by way of informed consent, that that person could not be considered culpable, although we can legitimately say that the conduct was wrongful and that people were wronged because we have a notion of what it is to wrong people, and to use them for some purpose other than themselves. So by the very criteria that we would judge such an action today to be wrongful, so, too, would we judge it to have been wrongful then, but we would make a different judgment of the moral agent. So the question here is: if we were to determine that there is no culpability on the part of the agent, and yet the conduct was wrongful, how does that fit with a remedies scheme? And I guess my final point is, and I agree with Ken quite strongly that the difference between -- that there's a moral difference between compensating a person who is still alive and who was either harmed or wronged or both and the notion that one might have to fashion a remedy, and I agree with Ken that I don't see any ethical rationale for a remedy that would devolve to the estate when the person is no longer alive and it could not be demonstrated or there's not even any evidence that the experiment hastened the person's life, made them disabled, made them unable to work or caused some residual harm to the living members of the estate. But I really am very interested in the culpability part. CHAIRMAN FADEN: Ken, would you like to reply? MR. FEINBERG: I'd just like to reemphasize one point. When you make the distinction between culpability and wrong, and you said Pat's frowning, Pat had her back to me, and so I know some of Pat's frowns. I don't know some of her other frowns. Body language with Pat is important in what she's thinking. But just remember during this entire discussion, there are remedies and there are remedies, and if you have a scale of remedies all the way from, you know, pot of gold to no remedy, somewhere in between one can devise a guideline that takes into account both of your concerns, culpability versus wrong, government versus government agent, which I did make a brief allusion to. So I think that it's all part of the discussion. CHAIRMAN FADEN: I've got Henry and Phil for right now. Henry. DR. ROYAL: I like the sound of the grid. MR. FEINBERG: Uh-oh. DR. ROYAL: No, no. That's not an -- MR. FEINBERG: Henry's body language. DR. ROYAL: No, no, no. I like the sound of the grid. It sounds to me like the grid applies to all medical experimentation, not radiation experiments. Is that the intention? MR. FEINBERG: No, it wasn't. That was Pat raising that issue at least prospectively. DR. ROYAL: But if you looked at the names of the axes, culpability -- MR. FEINBERG: I think we may be able to. We may be able to -- CHAIRMAN FADEN: If I could just interject. MR. FEINBERG: It may be generic. CHAIRMAN FADEN: I mean we use the radiation context, but the grid itself if it's useful and represents right thinking clearly would have implications. There's nothing sui generis or one of the kind about radiation research. DR. ROYAL: And then the second question is fairness, singling out investigators that are doing a particular kind of research, singling out or identifying victims from a particular kind of research. Where does fairness fit into this? MR. FEINBERG: Well, I'm not sure Duncan and I agree on this. Duncan usually convinces me after two minutes, but one concern that I have is my first point, that the factual -- the story of what happened, the whole story, and the factual gaps in our knowledge both in terms of what's there if we stayed here and continued to deliberate for another five years, what else would we find, but also the resource problem that we don't have five years, and we're not going to get all of the information. I am very concerned exactly on this point, Henry. I personally am very concerned about distinguishing experiments, and here's why I'm concerned. I'm concerned because not from the perspective of a methodological report. In my experience, whatever we do and whatever we recommend runs a high risk that the public, especially allegedly injured victims and their families, will not take kindly to our saying that as to this experiment, this remedy; as to that experiment, this remedy; and even within experiments, A gets Recommendation A, B gets Recommendation B. The potential for divisiveness in fashioning remedies is the great danger in all of these compensation programs. The half a dozen that I've developed, one has to try and fashion remedies that walk the line between, you know, generic usefulness, helpfulness to our policy-makers and not making invidious distinctions among people and researchers and victims that will, you know, fan the flames of divisiveness among people unless it's absolutely clear and justified and can be determined, but I have doubts about that myself. CHAIRMAN FADEN: Pat and Duncan look like they both want to respond. MS. KING: Since we were in sort of the middle of this subcommittee, this is sort of, I guess, a subcommittee difference. Let me say that I think that it is inescapable that we have to work with the radiation experiment. That is, after all, the charge of the panel. But it is my hope -- and who knows how this will actually start to work out -- but it is my hope that -- and we need to discuss how the experiments will be used -- but one of the ways in which I see that they can be used, for example, is an experiment, depending upon the factual evidence, may be used to illustrate a particular aspect of grids or of culpability or the fine gradations that we start to make. Now, I take Ken's first concern, factual underpinnings, very seriously because when I've been listening to the case studies carefully for factual underpinnings dealing with this subcommittee, I don't know how Ken feels about this, but I don't think we're producing a lot for my needs, but it seems to me that one of the ways that we might bridge what I perceive as a gap between the other two members of the subcommittee is to think of ways in which to make connections because I think that the report requires us to make connections. I guess I'm also saying that I'm uncomfortable going all the way with classes of experiments and recommending particular forms of remedies for classes of experiments, but I don't rule that out because I can already see that something like medical monitoring may, in fact, be a recommendation that we would be all comfortable with, with the certain classes of some experiments. I think that some of the problems that Duncan raised about that can actually be handled. I don't think of them as insurmountable, and so I'm not completely ruling it out, but I think we have to think real carefully -- the medical monitoring is the only one that suggested itself to me so far -- that I can see directed to a group of people where we have identifiable subjects. We may decide that that's necessary in some instances. CHAIRMAN FADEN: Duncan, did you want to respond to Henry before we -- DR. THOMAS: Well, I gather the sense of Henry's question is why single out radiation workers for, you know, special culpability when they were perhaps doing nothing more than acting according to the standards of their time, and if they're guilty, so are many other types of investigators. Is that what the essence of what you were trying to get at with the question about fairness? DR. ROYAL: Yes. I think that if the ethical analysis that's done by this Committee is perceived to have focused in on a portion of the medical community which is no different than the rest of the medical community, then the fairness issue will come up, and the hard work that we've tried to do will come under unjust criticism or will come under criticism that it doesn't have to come under. DR. THOMAS: I would agree 100 percent with that statement. It seems to me, as Pat mentioned a moment ago, we are constrained to making recommendations really just within the narrow focus of radiation research, but we can make those recommendations in such a way as to say that to the extent that we are recommending guidelines for remedies for unethical research practices in this particular area, they ought to be equally applicable in any other area, as well. It comes back though in the larger context of this question of -- Ken put it more eloquently than I could -- if an individual is doing no more than following the accepted practice of his day, although we can judge his actions to be wrongful, it is not necessarily culpable, and we may end up recommending that -- not making any compensation recommendations in that situation. CHAIRMAN FADEN: Henry? DR. ROYAL: I'd like to just make one last comment, a slightly different subject, but it won't be long. When we make remedies, one of the things that I would encourage is that we give the recipient of those remedies choices. I think one of the bad things that we do is we think one size fits all. Medical monitoring, for example. To some people medical monitoring might be very reassuring to them. To other people it may be very anxiety provoking, and I would like - - when we recommend a remedy that a number of remedies of equal value that someone can choose from would be much better than us imposing a single remedy on them. CHAIRMAN FADEN: That's helpful. Thank you. Phil has got the floor next. DR. RUSSELL: I'd like to ask Ken. Does your recommendation regarding guidelines include recommendations for processes through which to execute the guidelines? In the previous systems, the process has gotten in the way of effectively executing the guidelines, and I think it is important that we have a credible process in place as to have a credible grid and guidelines for making judgments. MR. FEINBERG: That's an excellent point. The subcommittee I don't believe has addressed that. I know I don't recall the subcommittee having addressed it, but the issue of how to process the claims in light of the options, the guidelines, I think, is something that we should deal -- DR. RUSSELL: How and who and guidelines for process behavior type thing. MR. FEINBERG: That also raises, by the way, an interesting issue which I haven't thought of at all, and that is the process that should govern for prospective application of guidelines. That is, if the Committee picks up on the subcommittee's view that there is a value here in drafting guidelines for future application of experimentation, I have no idea where those guidelines go politically once we draft them. Does the National Science Foundation -- I mean I just don't know how that works, but it clearly seems to me that we should lay out some process for recommending at least that the guidelines that we promulgate for future experimentation activity be pervasive and get the type of treatment that we would hope that they get, but I defer to the others on that. CHAIRMAN FADEN: Duncan, did you want to? DR. THOMAS: Yeah, I just wanted to point out that the Remedies Subcommittee is planning a staff report at the next meeting, which is a review of the way the process has worked for preexisting compensation systems that are already in place, and that could be the starting point for recommendations that we would make about process for anything that we would come up with. CHAIRMAN FADEN: Jay. DR. KATZ: Well, I'll be as brief as possible. You know, this is -- in a page and a half issues are being raised that are very rich, need to be considered. I just want to make a few observations. Time is of the essence. I would suggest that the subcommittee by the next meeting give us their marching orders in a preliminary kind of way of what, after all, they've thought about it, and, Ken, you've thought about it the most and probably Pat also in her teaching. What are your recommendations, also including any disagreements between you, Pat, and Duncan, and what you might propose? Because only then I can really react and say this is what I like; this is what I don't like; this is what we need to debate and discuss, and we don't have much time left. With respect to such issues of you are awaiting the judgment of the Committee as to what is an ethical behavior, don't be constrained by that. Assume what you consider unethical behavior to be and what you would consider to be unethical for the moment, and therefore, X, Y, and Z follows. So I think we need that because this is a very tricky issue, a very tricky problem, and my hunch is on the issue of remedies and various aspects of remedies, there will be disagreements ultimately amongst members of the Committee, that we will not be able to reach a consensus on that, and we have to face up to that because things are here very problematic. They are very problematic with respect to the issue as to how much attention are we going to pay to legal definitions of culpabilities and be constrained by that or to what extent are we also going to say something about culpabilities in relation to remedies, and it's quite different to talk about general culpability and culpability in relation to remedies, and saying certain things that were done just shocks the conscience of our society and certain remedies have to be provided. It is a possibility, and I don't care about the fact that in tort law dignitary harm is not compensated unless there's actual physical injury. These are -- you might want to mention it in the footnote, but at least to my mind it shouldn't move us very far. Third, with respect to the issue of raising expectations, I know what you're concerned about and what all of us are concerned about, and we should be very careful to say that we are just a Committee that will make recommendations to the President, and the President may make recommendations to Congress or who knows what he will do come January. And we can make recommendations and tell the survivors and the families of the survivors, "Don't be blinded by our recommendations," because as Adlai Stevenson said, hell will freeze over before some of these recommendations are enacted. But we may want to make certain recommendations irrespective because we think that they are right and should be seriously considered. I mean within reason. I'm not talking about pie in the sky kinds of things. Even though we also know that there's very little chance that they will be enacted, but a small chance could become a slightly bigger chance, and we shouldn't be constrained by that in talking about some things that we are very much concerned about. And I've already talked longer than I wanted to. So I wouldn't be that much concerned about raising forth expectations as long as we carefully define that if we have certain expectations of the government, that the survivors involved and their families shouldn't think that they will cash in on them. And there was one final thing. Let me just say this. I think Pat said this or Duncan said this. We can make it quite clear that our recommendations, specific recommendations, have to be constrained by our assignment in the radiation experiments, but make it quite clear that some of these recommendations really apply to the whole universe of human experimentation, and these are not only problems faced in radiation research, but faced in research in general. Oh, yeah, and let's be -- I come, of course. I'm not a lawyer, and also I've had the fortune or misfortune to be a member of the faculty of a law school that's sort of considered a lawless law school, and I think we can consider fashioning certain remedies if you want to because they seem to be necessary to fashion these remedies, even though they are not at this point fully acceptable within the legal system. Okay. CHAIRMAN FADEN: Duncan. Let me just let Mary Ann know I saw her signaling. This is responses to Jay and the subcommittee, is fine. Duncan, Ruth. DR. THOMAS: I just wanted to clarify -- CHAIRMAN FADEN: Ken and everybody wants to respond to Jay. So that's fine. DR. THOMAS: -- what I thought Ken was referring to about raising expectations was not our view of the political reality of whatever Congress or the President may -- what actions they may take in response to our recommendations, but I think we were talking about raising expectations with regard to what we as a Committee might end up recommending. I think there are plenty of people out there that are expecting or hoping that we might recommend, you know, a broad base of compensation for chronic fatigue syndrome in all people around the Hanford plant and so forth and so on, and at some point these expectations are likely to be dashed, and that's what I think we were talking about. CHAIRMAN FADEN: Pat and Ken. MS. KING: There's something constraining about being a member of the subcommittee. So I'm not speaking as a member of the subcommittee. I'm speaking as a member of the Committee, commenting on the subcommittee on which I serve. First of all, I think that Jay's point is quite accurate in the sense that, one, we're way behind the eight ball in terms of time. Two, the Committee needs to think more broadly. I happen to think -- and this has got nothing to do with political concerns at all -- that conceptually this is a tough problem, that we ought not -- and we tend to do it; everybody is doing it when they're talking -- we move immediately to the practical, and we really have very much a legal model in our heads no matter what we say, and I think this is wrong. I really think that what we're talking about is a different kind of area. You may get to your legal model, but you're talking about a different kind of area. You are talking about people who were involved physically in research who face risks. Sometimes those risks come about in the past and in the future, and we should think expansively. So to my mind, the subcommittee needs to be reconstituted a little differently. Despite being called an ethicist in the world, I don't ever hold myself out as one, and I don't think I'm really qualified, although I do it all the time, as Ken knows, that I'm really qualified to do a kind of conceptual framework on what redress consists of and to think about it, but I think it's necessary in this area because I quite agree with Jay. So my plea is the committee can stay the way it is. That's all right, but we certainly need some staff ethical help that has expertise in ethics or a consultant. Ken will probably kill me. My body language, Ken? We can check out Ken's body language right now. (Laughter.) MS. KING: And I think that while I like Phil's point about process and I quite agree with his point about process. Process to me is the game putting the cart before the horse. My view of process is to a large degree affected by what I think I should be accomplishing and then what process gets me there, and what's really troubling me is I want to talk in redress terms in a broader fashion than my own legal training tends to focus me into, and I don't know how to say that any better because I'm as guilty as anybody. I find myself falling back into my legal framework. But I do revisit it because I think it is inappropriate for here. So that's my contribution as a Committee member to the subcommittee, that we need a different kind of input in the subcommittee, and I think we need it before next month. DR. KATZ: I have one question to ask you. CHAIRMAN FADEN: Okay. DR. KATZ: Of course, you also read The New York Times, and there are, I'm sure -- the Washington Post, too -- and from time to time Gina Kolata and others discuss ethical issues, and then they have five distinguished ethicists commenting on that, and each of these five ethicists consider certain conduct ethical or unethical. Now, in the light of that, is there some limited value, important value, but in a sense limited value also, to these ethicists' contribution? And you are not an ethicist -- to be an ethicist on the subcommittee. MS. KING: I accept all of the flattery, but my bottom line conclusion is the same: that the conceptual framework for this chapter, which should -- the rest of the work should not await the development of the conceptual framework. I'm not suggesting that, but I'm suggesting that we need to give real attention to the conceptual framework and not sort of make it as an aside because I, too, sort of feel the time constraints. CHAIRMAN FADEN: Ken wants to respond. Let me just interject one thing as the chair. This afternoon I want to make a proposal about reconstituting subcommittees that might address Pat's concerns. So we'll see how that goes. But Ken. MR. FEINBERG: Three quick responses to your comments. First, we are behind the eight ball. Frankly, the timing, although a problem, we can meet the schedule. One of the things the subcommittee as a group wanted today was to test the political waters of the Committee, but I think that we can move expeditiously. Secondly, I disagree with you when you at least suggest there's a presumption in your mind that the Committee will likely be divided on the subject of remedies. I hope very much that will not be the case. If, in fact, there is experimentation in the past that shocks the conscience, I would hope that the guidelines as drafted will provide unanimity. I believe that unanimity on the Committee is very, very important in this area. Third, when you talk about false expectations, I think Duncan is right in his response, but I also want to expand my concern about false expectations, and that is, as I think I mentioned, I'm concerned about the consumers, the groups out there, that have been following not only our deliberations, but have been tracking the problem for the last 20 years in Congress. And I want to just reemphasize my concern that we not act in a way that will raise false hopes among the groups out there as to what is justifiable among themselves inter se I think is a very important point. The only other point I'd say, Jay, is you say you're not a lawyer, but you teach at Yale Law School. Either you are a national resource or an unguided missile. I'm not sure. (Laughter.) MR. FEINBERG: Thank you. CHAIRMAN FADEN: We have Ruth and Mary Ann, and if there's a moment, I would like to raise a question or a comment or whatever. Ruth and then Mary Ann. DR. MACKLIN: This is a little more about culpability, but one element that seemed to me somewhat missing from everything that's been discussed so far, but it's been certainly discussed yesterday and in many ways by the Committee, is the for want of a better term, shorthand, Cold War purpose of the government in this research, and partly because that affects or promotes the need for secrecy, thereby limiting by its very nature what a researcher might otherwise have been able to disclose to people has to be viewed in some way as an element either of culpability or of constraint in some way. Now, I mean as I thought of that and heard Henry's remark, the question is: how -- I mean the fairness issue. Is this unfairly singling out radiation research? Well, I mean if wrongs were done by any researchers for any subjects, for medical experiments or any other, I would certainly concur that the framework or the grid ought to address all of them. But the fact is that it was people in the field of radiation who were doing this kind of research sponsored by the DOD and the DOE for a purpose other than, at least in some instances, other than contributions to medical science for the benefit of patients, and somehow that has to be in this grid, not as a general grid for deterrence in future things, although maybe also there, but because that was such a perhaps unique or not wholly unique, but such a central feature of this whole set of activities that we're talking about here. So I wonder if the Committee addressed or subcommittee addressed or has any comments on the particular aspect of government culpability when a researcher never would have done these kinds of things, some of these kinds of things, to patients were it not for the interests of the AEC or the DOD or whoever it was that was promoting this kind of research. MR. FEINBERG: Two answers. One, I don't think the Committee has addressed that, to my memory, and secondly, I'm not sure it's at all relevant. You raise the issue. Hegel would not be happy with you on that, but I mean are you suggesting that government culpability is somewhat perhaps diluted because activity aimed at a target or a victim, that there's a greater good or for the greater good of society? I mean I'm just not clear on how that variable somehow, if I'm correct, immunizes the government from - - the researcher from responsibility. DR. MACKLIN: It shows how unclear I was. I actually meant to suggest that perhaps culpability was enhanced. MR. FEINBERG: Enhanced? DR. MACKLIN: That is, things that otherwise would not have been done to people -- MR. FEINBERG: Oh, I see. DR. MACKLIN: -- and secrecy that otherwise would not have had to be -- MR. FEINBERG: Was hidden behind this justification. DR. MACKLIN: That's right. Hidden behind the justification -- MR. FEINBERG: I've got it. DR. MACKLIN: -- and also promoted a line of research or a type of research that, to use the example we looked at yesterday, the Cincinnati experiments, never would have been conducted as a piggyback. So I really meant to suggest whether there was some enhanced -- MR. FEINBERG: Maybe it -- CHAIRMAN FADEN: Let me just introduce one thing, and that is I think your point is well taken. We have to consider this, but we're dealing with a whole range of human radiation research conducted in this big period of time, some substantial portion of which will not have that connection. So we need to remember that, that some of this work clearly is related to Cold War kinds of concerns, but by no means all of the work that we are looking at has that connection. All right. Let me just get the process thing right, but it's a very important issue to raise. Mary Ann is next. I see Henry with -- right on that point. Okay. And then, Phil, did you have a comment on this point? So Mary Ann, can you -- all right. DR. ROYAL: Ruth, it's not clear to me that the distinction that you're making between an experiment that was sponsored by the DOD is an outlier in terms of what happens with medical, you know, and the term biological experimentation. For example, the plutonium injections. The concern there was, in my mind, for patients. The patients happened to be the people who were working at plutonium enrichment plants who were being exposed to plutonium, and doctors who were concerned about the health of the workers thought that this information was valuable to them in order to be able to protect their health. So the distinction that you're making is a very clear one isn't as clear to me. CHAIRMAN FADEN: Phil. DR. RUSSELL: The same lines. I think if you look at it wouldn't have happened if an agency hadn't promoted it probably pertains to all medical research done in the United States under government, whether it's NIH or anybody else. So the issue of the relationship between which federal agency funded it and ethics, I think, is a specious connection. I think the ethics have to stand on their own with regard to the fundamentals of the ethics of experimentation, informed consent, and so forth. I think the issue of which agency funded it and any presumption that it's ethical or nonethical is wrong. MS. KING: Well, I certainly didn't mean to suggest it was which agency funded it, but I'm talking about the nature of the research, which if it is secret, the purpose cannot be disclosed because to disclose the purpose was to disclose the fact that it was research designed to look at the effects of radiation on the body, but not it could be therapeutic for the individual patient. I mean again, it's not who funded it, but rather the kind of purpose that lay behind it that was not directed at the individual patient. DR. RUSSELL: I think there's a very large body of research that has nothing to do with patients at all. It has to do with human physiology, and it can be perfectly ethical. So I think you're drawing some conclusions here regarding the purpose of the research which are not directly related to the ethics. CHAIRMAN FADEN: Maybe there's a refinement here which is what we're trying to get at in the questions for the TBI case, and that is if it's determined that there were morally inappropriate dimensions to a line of research and that, to satisfy your concerns, Phil, occurs first, and then it's determined that in part or in whole those morally unacceptable dimensions of the research were because there was a government interest in advancing a line of work that -- I don't know how to express it -- related to a set of concerns that seemed to be in opposition to the welfare of the people who were being studied, then that adds a dimension that needs to be folded in, in some models adding to culpability, in other models perhaps not, depending on how one sets it up. But I think that the issue is not merely stipulative just because there was an interest in looking at the impact of plutonium on people or on whole body radiation, that it's necessarily wrong because it was related to a war effort or a plutonium production effort, but rather, if that were to add morally unacceptable dimensions to it, which is the first determination, and then if in part or in whole those morally unacceptable dimensions were related to another level of policy making -- MS. KING: Can I suggest -- CHAIRMAN FADEN: -- then it starts to -- MS. KING: Three levels, Ruth, and I don't want to lose the thought. This is an issue that cuts across several chapters of the report. We ought to assume that there will be research in the future where, again, there will be reasons that will say the purpose cannot be disclosed. What we have to do, I think, is to recommend ways of taking account of some of the problems realistically in the future. Some of this is very analogous to deception research where -- I say "analogous." I mean we know we've got issues. CHAIRMAN FADEN: Right. MS. KING: So actually this issue is not just a remedies issue. CHAIRMAN FADEN: Yes, definitely. MS. KING: It is a remedies issue. It is also an issue in two other parts of the report. CHAIRMAN FADEN: And I think there we're going to have a lot of Committee interest in that area. Let me do this. We are almost ready for our public comment period. Could we have Mary Ann and Nancy make their comments and unless there are specific questions to the subcommittee, not have subcommittee responses? (Laughter and simultaneous conversation.) CHAIRMAN FADEN: So that the public comment period can start more or less on time and we can get a quick break in in between so that we can give our public speakers full attention. Mary Ann. DR. STEVENSON: All right. I'll be quick. While this was going on I've had more questions come up. CHAIRMAN FADEN: No, that's all right. You've been waiting patiently. So go ahead. DR. STEVENSON: This is sort of in relation to things that Ruth just raised and the other comments. You know, this question of whether it is or is not which agency funded, I think there's a very important question as to the process whereby the funding was granted, and it was very clear that a lot of the experiments that went on that we're considering didn't really go through any kind of peer review scrutiny, and so of the example at the end of it is that once the Cincinnati experiments actually went out of the DOD funding into NIH peer review, they were stopped. I mean so that review process, I think, is very critical, although it certainly has its problems in keeping some level of ethical standards intact, or at least we hope it does, and so I think that's something that we can consider as a Committee in terms of promoting some sort of forward perspective guidelines to this topic in the future that Pat's raised. This may well come up again. So how do we safeguard against this kind of experimentation going on? And maybe a recommendation or requirement for some kind of peer review process by people outside of the field obviously, outside of the agency. But the question I was actually holding for this long was a comment on the grid, which I also find very appealing, and I think as much as we have a lot of work to do in establishing the framework for the government culpability axis, the harm- injury axis is also in dire straits particularly because -- and I fully agree with Ken -- we can't presume to make those determinations on dose. We don't have time resources, and even if we did, we'll never get the facts. So I guess I do have a question to address to the subcommittee as to how, and we'd better get going soon, we're going to establish that harm axis. I mean the model, the model that's standing is sort of the VA type model where one makes a list of presumptions. The person was there and they've acquired or developed this disease. Then they fall into that category. But we all know that there's been a lot of problems with that VA scheme and a lot of dissatisfaction that we've heard in our public comment sessions on the processing of those claims, and so I think we really need to give some strong thought to that and soon to establish that axis, that vertical axis of harm. CHAIRMAN FADEN: I know that there are people dying to respond, but in December we'll have a complete and total response to Mary Ann's question. Nancy, you'll have the last word and then we'll have our break. DR. OLEINICK: All right. Mary Ann asked one of the questions that I wanted to. I just want to make one other response to the comment that Ruth made concerning the special case of radiation, and I think this is not anything new. We've said it before, but at the same time period there were other experiments going on on chemical warfare, on biological agents that probably would undergo the same kind of scrutiny, and if the Committee were charged to do that -- and I think we're going to make a mistake by singling out radiation and saying that those who worked on radiation were especially culpable because of the radiation in any way. CHAIRMAN FADEN: I think there's agreement on that. With that, thank you very much. I had a feeling we'd take until 10:30, and we did. We're going to break now and resume promptly at 10:45 for our public comment period. (Whereupon, a short recess was taken.) CHAIRMAN FADEN: Committee members, I know you're out there somewhere. We can have public testimony, but there's no one here to hear it. Okay. We're getting there. We're getting there. All right. We need to begin the public comment session of our meeting which is in many respects the highlight and the most important part of our meetings. We can't conduct this part on our own. Let me just remind our public speakers before we begin about our format. We would appreciate it if you can keep your comments to five minutes, and that will leave us five minutes for Committee questions, and that will give you an opportunity to expand on your comments. We find that format is very helpful both to us and to the presenters, that we can get a chance to discuss together the issues that have been presented. We have a mechanical device here that's supposed to assist us with our process, and it basically will begin blinking when there is one minute left of your time for you to sum up. So it's set for that kind of an arrangement, and we hope that it's not too annoying and that it works to our advantage and not as a source of irritation. We have six speakers before us this morning, and I know that we're all eager to hear from all of you, and that's part of the reason why we would appreciate your all keeping within the time frame. Let me also remind all of our public speakers that our staff, as well as ourselves, are available to you at the lunch break and at any time that you want to provide us with additional documentation or more information. We're very eager to receive it, and most of the staff members are sitting on the side as opposed to in the audience. So anybody over on the side is someone who is connected with the Committee and would be more than happy to take additional information you or to arrange whatever would be convenient for you to provide additional information either in terms of discussion or if you have any documents or testimony in writing that you would like to provide to us. So please don't feel that the ten minutes you receive in public comment is all the attention you will be receiving from the Committee. With that by way of background, Duncan would like to introduce our first public speaker. DR. THOMAS: Mrs. Marcia Haggard wrote to me some time during the summer, and I called her a little bit later, and we had a rather long conversation about her experiences as one of the radium treatment patients. I think she has an interesting story to tell us, although not experimental in the sense that we have talked about. This was mentioned on several previous occasions, that there are some interesting parallels that we can learn about sort of what was in its day a standard but ill- advised medical treatment, and I'm looking forward to at last having the opportunity to meet Mrs. Haggard face to face and hear what she has to say. CHAIRMAN FADEN: Thank you for coming, Mrs. Haggard. We appreciate your time. MS. HAGGARD: Thank you very much. CHAIRMAN FADEN: Is your red light on, just so we -- on the mike. If you push the button, you'll get a red light. Now you're on. Okay. MS. HAGGARD: Distinguished Committee members, my name is Marcia Haggard, and I am a radiation survivor. I am very grateful to the Committee for the opportunity to speak here today, to share some of my radiation history and to comment on the need specifically of the radium exposed as I perceive them. Due to time constraints, I will only summarize my more complete statement that I have asked the staff to enter into today's record. Marie Curie died in 1934. That same year my parents were married, and four years later, in 1938, I was born two months premature with a small, benign birthmark on my lower lip. My concerned parents were referred to a physician specializing in the treatment of disfiguring birthmarks in infants. My own cavernous hemangioma was growing rapidly, and the doctor recommended immediate treatment with radium, a widely practiced therapy in that era. In October 1938, at the age of 11 weeks, when I weighed only seven pounds, I received a two-hour treatment from a crude applicator taped across my mouth and chin. The treatment was repeated seven weeks later. We don't know the dose I was given in the four-hour exposure. My doctors have estimated anywhere from 1,000 to 3,000 rads. The treatment was completely successful, and my parents often told me about the miracle of radium as I was growing up. At age 17 I suddenly developed large exostoses on my shoulder blades which were surgically removed. We now know that these bony growths are a common consequence in patients who ingest or are injected with radium as juveniles. We now suspect that I ingested some of the bone seeking radium in my infancy by sucking on the applicator. Major health problems did not appear until nearly 50 years after my exposure when I began to have healing complications following oral surgery. Eventually my doctors realized that I was suffering from radiation necrosis of my jaws. This condition, seen often in the radium dial painters, was called radium jaw in the 1920s, radium poisoning in the 1940s, and osteoradionecrosis of the jaw in the 1980s. Its hallmarks are poorly vascularized, demineralized necrotic bone with multiple sequestra; poor healing following surgical trauma; and constant, severe pain from radiation induced neuromas on the nerves themselves. We learned in 1988 from the research of Dr. Robert Marx that the risk of osteoradionecrosis increases linearly with time after exposure and can occur many years after radiation. I have had hyperbaric oxygen treatment, a recognized therapeutic modality in clinically confirmed cases of osteoradionecrosis; brain surgery to partially sever the main sensory nerve to my jaw and face to try and relieve my constant pain; and excision of most of my necrotic mandibular bone with cadaver bone grafting. There is no known cure for radiation necrosis. Medical treatment is aimed at preserving viable bone and coping with constant pain. I have never had cancer. Dr. Roger Macklis at Harvard is doing interesting research work on the puzzle of delayed onset of expected cancers in patients with internal radium burns. He suggests that the alpha emissions from the decay of radium in the bone into radon may stimulate production of a sort of super healthy bone marrow which may deter the onset of cancer. My radiation experience may be unique in that it spans a half century of time. It began in an area that Mr. Gil Whittemore described for us at the July meeting when radium was ingested, inhaled, injected, sold over the counter as a health tonic, cosmetically applied in the beauty parlor for excessive facial hair. When physicians and others who handled radioactive materials in their work were given some suggested dose exposure limits, but patients in the clinical setting, even infants, had no protection whatever. Remarkably we radium treated from those dark ages have not all died. I am only 56 years old and expect to suffer the pain of radium necrosis perhaps 30 more years. I'll abbreviate the rest of my statement. I contacted Dr. Eliezer Huberman at Argonne, who I learned was doing radium research. He was very interested in my case, but was not able to accept me into his treatment study protocol because of no funding, because he had a moratorium on human experimentation, et cetera. I also tried NIH and was told that the equipment there to measure internal radioactive body burdens can only be used for people who are injured in the laboratories or in their work at NIH. I urge the Committee to sponsor a follow-up of everyone who has been treated with radium and to allow for radiation necrosis to be an acceptable deleterious health effect. I am going to be having my second brain surgery at Johns Hopkins in a few weeks in an attempt to implant a thalamic stimulator which has in some cases relieved constant severe pain. I'm very grateful to this Committee. Dr. Thomas said many in the radium community have vilified the medical community, and I have no anger toward the doctor who treated me. I think he probably died a very painful death himself from handling radium daily in his work, and my present team of doctors has been as supportive and concerned as they can be. But we have no guidelines. We don't know what treatment to try. Thank you very much. CHAIRMAN FADEN: Thank you very much, Mrs. Haggard, and thank you very kindly for staying within the time limit. We appreciate it. If we could take questions or comments from the Committee members now. Duncan. DR. THOMAS: One of the things which you enclosed in the materials that have now been circulated to the Committee was a brief report of a Swedish cohort that's been established of patients who received similar treatments. In this country we've certainly learned a great deal from the misfortunes of the radium dial painters and other cohorts of radium injected patients in Germany, and so on. I'm not aware of any similar efforts for what I gather from what you said is really quite a substantial number of radium treatment patients in this country. Are you aware of any efforts to try to assemble such a cohort? Do you know of any investigators that are attempting to do something along those lines? MS. HAGGARD: I don't know of anyone presently. I know in some of my research at National Library of Medicine that there were journal reports in the 1950s, which included dial painters, but also had perhaps 30 people who had been medically treated with radium and were studied at that time, and indeed, it is their treatment that we base some of our work in my case now, but nothing recent. The Swedish hemangioma treatment at Radiumhemmet involved 20,012 infants between 1909 and 1959, all of whom were treated for hemangioma. They also did not have adequate funding and followed up only 129 females who were treated for hemangioma of the chest and simply measured breast size in adulthood, and although dependent upon dose, nearly no adult female who had been treated with radium for hemangioma of the chest grew a normal sized breast on the irradiated side. CHAIRMAN FADEN: Yes, Nancy. DR. OLEINICK: One of the concerns that's been raised by a number of individuals who have testified to us is the difficulty in obtaining their own medical records, and I wondered if it -- it looks like you certainly have some here, although I haven't had a chance to look through these yet. Did you at any time have trouble getting this information, your own records, at any point, contacting physicians? MS. HAGGARD: In terms of the original treatment in 1938, the doctor has long died, long ago died. My family physician from childhood is going to be 100 next year and has recently stopped practicing because he said he couldn't see quite as well. (Laughter.) MS. HAGGARD: I called and asked him if he, indeed, had been sent any of the records because I had seen him in my childhood, and he said, "You know, we didn't keep records then. We would have said Marcia Haggard or Marcia Schaefer, radium treatment." He said the applicators were huge, and there was no dosage, and I have included in the material I've submitted to the Committee pictures of the needles and the applicators and the estimated dosages, but it was a very crude arrangement. They weren't concerned with the dosage. They were just concerned with whether you had enough of an erythema dose to indicate that you had had success. In 1985, when I began having very serious health problems with necrosis, my very young and very wise dentist said, "Begin saving copies of all of your records because someday someone will be interested in this problem. We don't understand it," and since then I have maintained copies of every record in my own home. CHAIRMAN FADEN: We're glad you did. MS. HAGGARD: Thank you. CHAIRMAN FADEN: Are there other questions for Mrs. Haggard? (No response.) CHAIRMAN FADEN: Thank you very much, and thank you for all of the documentation you've provided the Committee. MS. HAGGARD: Thank you. DR. THOMAS: Thank you. CHAIRMAN FADEN: Our next speaker is Dr. Kathy Platoni. Thank you for joining us. Can you just make sure? Is your red button still punched? Don't unpunch it. Is it still on? DR. PLATONI: Yes. CHAIRMAN FADEN: Okay. Great. DR. PLATONI: Thank you. Distinguished Committee members, I'm very grateful for the opportunity to speak today. My name is Dr. Kathy Platoni. I am a licensed clinical psychologist and a major in the United States Army Reserve. I am speaking today on behalf of both my mother, Sydell Platoni, myself, and as the voice of my beloved father. I wish to express sincere thanks and gratitude to Mr. Bill Griffin, Iowa Coordinator for the National Association of Atomic Veterans; Ms. Jean Ralph and the National Association of Radiation Survivors for the long awaited opportunity to bring to light the truth about our relentless 12-year battle to uncover the facts regarding the death of my father, Eugene J. Platoni. My father's life was stolen away in his prime. Eugene J. Platoni died on February 28th, 1983, and after five months and $500,000 worth of the finest medical treatment available. The magnitude of the loss we have experienced has not diminished with time, nor can it be adequately explained or understood by four file cabinets filled with medical literature and the unclassified documents pertaining to his naval service during World War II. The cause of his death, angio-immunoblastic lymphoma, a condition so horrific and rare that it cannot be found in the medical literature to date, remains an enigma and a question mark that will not allow us to see closure in our lives. His autopsy listed 18 separate diagnoses as the cause of death: autoimmune hemolytic anemia, angio-immunoblastic lymphoma, serratia sepsis, transfusion hepatitis, upper gastrointestinal bleed, pneumonia, subphrenic abscess, fluid overload, disseminated intravascular coagulopathy, tachycardia, septic shock, anasarca, pleural effusion, ascites drainage of the pleural space secondary to trauma at thoracentesis site, anemia, Jacksonian seizures, clinical depression, and acute renal failure. The immediate cause of death was reported as cardiopulmonary arrest secondary to immunoblastic lymphoma. What is most bizarre about my father's disease process is that he maintained a state of perfect health until the onset of diffuse adenopathy, Coomb's positive hemolytic anemia, and cold agglutinins with drop in hematocrit. He was walking or running five to seven miles a day and living an extraordinarily zestful life style for a man of his age. During the course of his multiple illnesses, his blood type changed three times, from O to B and back to O. He underwent over 65 blood transfusions, daily plasmapheresis, hemodialysis, bone marrow biopsies, six full blood exchanges, a splenectomy, a cervical node biopsy, tracheostomy, endotracheal intubation and ventilation, thoracentesis and IV chemotherapy. He suffered brain death two weeks prior to death, which was indicated by Jacksonian seizures, which are violent convulsions that traveled down the left side of his body and up through the right side repetitively. By the time my father became comatose, he has suffered massive internal bleeding, development of a large cell lymphoma, and his immune system was ravaged by an immune deficiency process not unlike that of AIDS. The only early precursor of what was to devastate us for the rest of our lives was my father's diagnosis of chorioretinitis in 1965, a probably early symptom of radiation related systemic disease which involved partial and temporary blindness and that remitted spontaneously. Without reservation, I believe that my father's exposure to radiation during World War II is responsible for his untimely death as formidable disease, such as angio-immunoblastic lymphoma do not occur in a vacuum and without the strong likelihood of exposure to known or unknown carcinogens, such as atomic radiation. Were this not the case, lymphomas would not have been approved for inclusion for compensated radiation related illnesses under Public Law 100-32, which was passed in May of 1988. It is also highly unlikely that I would have been born with a thyroid gland trailing a tail behind it had my father not been exposed to radiation. I have undergone 22 surgical procedures within the last 11 years, beginning with the loss of 32 teeth simultaneously at the age of 23. I have had my skull reconstructed from anterior and posterior pelvic bone four times due to bone deterioration disease, in addition to implantation of a surgical steel Ramus frame in my mandible and transplantation of full thickness abdominal tissue grafts to rebuild the roof of my mouth. I have had my skull and throat muscles realigned and wired together from the orbits of my eyes out to my ears and down to my throat so tightly that a straw wouldn't fit in my mouth. I was diagnosed with polycystic ovarian disease in 1983 and after removal of a third ovary and a dermoid cyst, the latter of which consisted of hair, tooth and bone, I was diagnoses with trophoprivic hypothyroidism in 1984 after over 100 blood tests performed at Walter Reed Army Medical Center. I suffer from advanced osteoporosis so that my bones have deteriorated and disintegrated to the degree that they are indistinguishable from that of an 85 year old woman. I suffer from osteoarthritis in every joint in my body. There is no family history whatsoever on either maternal or paternal side of any of these diseases or conditions from which I suffer. This should not be a surprise as the contamination of one's genetic composition can readily result in such congenital defects and malformations if toxic exposure has occurred in one or both parents. There is more than sufficient evidence in the medical literature to support this statement, particularly among the offspring of radiation victims. We cannot remain in blissful ignorance any longer about the consequences of radiation exposure. Even fallout emitted during our government's atmospheric nuclear testing has exposed individuals to deadly radiation that remains actively harmful 50 years after the fact. There is no shortage of cancers among these individuals, their children and grandchildren, but they have gone unrecognized, and our government has remained free from responsibility for inflicting harm against millions of innocent individuals. Still the burden of proof remains a legacy that radiation victims and their survivors must bear, often an infinitely impossible task. To continue to accommodate this state of affairs is unconscionable. I will take my battle to discover the truth to my grave, but my own longevity remains a questionable entity. More than one atomic survivor has died under unexplained circumstances during the process of discovery. On several occasions during the last ten years, I have discovered listening devices on my personal telephone. Within the contents of my four file cabinets are documents and correspondence from the Defense Nuclear Agency, the Department of Veterans Affairs, and I'm afraid I'm going to have to stop. I've gone over my time. I've given my testimony so it's a matter of -- CHAIRMAN FADEN: Your statement is here. Perhaps we can cover some of it in questions. DR. PLATONI: That would be good. CHAIRMAN FADEN: Thank you. Are there questions for Dr. Platoni. DR. THOMAS: Maybe it was in the piece which you didn't get a chance to get to. What I didn't hear is could you tell us a little bit about the nature of your father's exposures to radiation? DR. PLATONI: That's what still remains a great mystery. All of his service records were altered, and under Freedom of Information Act I've only been able to obtain copies of what was easily accessible to anyone, and I do believe that many of his records are in some archives somewhere that are not accessible to me. His records were altered, crossed out in India ink, and as contradictory listings of his locations on ships he was on throughout his service records, and I believe you also have them. They've been entered into the record. DR. THOMAS: But your understanding is the exposure would have -- was he involved in Japan with the atomic bomb in Japan or where? DR. PLATONI: We do believe that he was off the coast of Nagasaki and/or Hiroshima because he told that story many times, but there's no documentation of that in his service records. At some point during his service he was exposed to radiation or used in radiation experiments. We cannot find anything. DR. THOMAS: I saw a letter here indicating that he had been at Eniwetok; is that right? DR. PLATONI: Yes, he was at Eniwetok, yes. DR. THOMAS: But that would have been after you were born, was it? DR. PLATONI: That was before I was born. I was born in 1952. DR. THOMAS: Thank you. CHAIRMAN FADEN: Are there other questions for Dr. Platoni? Ruth. DR. MACKLIN: Well, during the course of these illnesses that led to your father's death, was he aware of or did he have any information or suspicion about the suspected causes, that is, that it did have to do with exposure to radiation and that it might have had something to do with what happened during the war, and if so, did he discuss that with you and your mother? DR. PLATONI: During the course of his illness, he was in intensive care, and he was strongly sedated. So whether or not he did suspect I have no way of knowing. He probably didn't have the cognitive abilities with all of the medications he was on. The head of his medical team did, however, feel that radiation was strongly suspect in his case, but there was no documentation in the medical literature. All we have is my father's word that, yes, he was near the location where the atomic bombings had occurred at Nagasaki and Hiroshima. CHAIRMAN FADEN: Are there other questions for Dr. Platoni? (No response.) CHAIRMAN FADEN: Thank you very much, and thank you for providing us all of this information. We appreciate it. And we understand how difficult it is for people to keep their comments to five minutes, but we would appreciate it so that we do have more time for discussion and to get everyone in. I am not sure if Ms. Salisbury is here. She didn't check in. So we don't know if she came or not. Is Ms. Salisbury in the audience? (No response.) CHAIRMAN FADEN: Then I'll assume that she did not come. Our next public presenter is Dr. Dennis Nelson. Is Dr. Nelson in the audience? Thank you for joining us, Dr. Nelson. Please begin. I think the other way. Just put the red light on. Push it and if you see a red light, your mike's on. DR. NELSON: I would like to thank the members of the Advisory Committee for this opportunity to speak to you today. My name is Dr. Dennis Nelson. I am a research scientist and a retired naval officer. I have a Ph.D. degree in biophysical chemistry. I'm also a Downwinder of the Nevada test site. St. George, Utah was a town of 5,000 people in the 1950s, approximately 100 air miles from the Nevada test site. From the beginning the authorities assured the residents of St. George that radioactive fallout from the bomb tests represented no danger to the community, and for the most part they were believed. The residents did not know at the time that the site managers had already adopted a policy of directing the fallout clouds over St. George and away from the more populated areas in Las Vegas and California. In 1953, my youngest sister Margaret turned one. At the same time the pressure to develop the H bomb had greatly intensified the tempo of the test program and the decreased safety and violations of safety standards to accommodate these expanded test schedules. The inevitable happened in May 1953 when Shot Harry, a 32 kiloton thermonuclear device spread intense fallout over St. George. Spot readings of six and eight Roentgens per hour were recorded by the on site monitors. For comparison, after the Chernobyl accident, the City of Prybiat was evacuated when the radiation level reached five Roentgens per hour. Later an AEC scientist, Dr. Harold Knapp, testified that if it had rained in St. George on that day half of the population would have died of acute radiation exposure. In St. George, the residents were told by radio to remain inside for two hours while the fallout cloud passed by. Unfortunately the cloud had already deposited its radioactive load two hours earlier. No instructions were given to the citizens on how to minimize exposure. The on site monitors were told to take frequent showers, to discard their clothing, and to eat only canned or imported food. By contrast, the residents were not even told to wash their vegetables and fruits from their backyard gardens. They were not told to take showers, nor to avoid drying their clothing on an outdoor line. They were not told to turn off their evaporative coolers, which sucked the outside air into their houses. Instead they were assured that there was no danger. In secret, however, the government agents fretted quite considerably over this incident. When I was nine years old the AEC ordered all cars arriving from Las Vegas to be stopped and washed in St. George before proceeding north. I remember the wash water running into the city gutter system which supplied the irrigation water to our backyard gardens. I wondered if whatever was on the cars might end up in our food. I also wondered what the point was in staying indoors if the coolers brought all of the outside inside anyway. As children we often spent a great deal of time outdoors. In the summertime my brother and I slept under a mulberry tree in our backyard. My family believed the assurances, and after our initial curiosity over the tests was satisfied, we basically ignored the tests. I did, however, wonder what happened to my baby teeth, which I contributed to a can on the window sill of my fifth grade class. In September 1953, Howard Andrews, a biophysicist with the National Institutes of Health, wrote a supplement to the site reevaluation report entitled "Residual Radioactivity Associated with Testing of Nuclear Devices." In this report he warned, quote, "It seems necessary to adopt a rather conservative attitude towards the involuntary exposure of the general populations. An error on the radical side will not be immediately apparent, but the chickens will inevitably come home to roost at some later date." For my family at least, the first chicken came home to roost in 1966 and they have continued to return on a regular basis ever since. My mother was the first to be diagnosed with malignant brain tumor, and after surgery died at the age of 47. In 1969, my brother, age 19, was diagnosed with lymphoma, treated with a combination of surgery and chemotherapy, and survived. In 1977, at age 34, I was diagnosed with skin cancer which recurred in '82 and was successfully treated. In 1980, my father, a nonsmoker, was diagnosed with disseminated bronchiogenic adenocarcinoma of the lung and died after receiving chemotherapy and radiation, and in 1990, my youngest sister, Margaret, was diagnosed with cancer of the colon. CHAIRMAN FADEN: Take your time. We appreciate how difficult this is Dr. Nelson. DR. NELSON: And after her heroic battle including almost a year in the hospital and multiple surgeries, chemotherapy and radiation treatments, died in 1992 at age 40. At the time she was Assistant U.S. Attorney in Salt Lake City and in the prime of her life. The average age of death in my immediate family member is 49. Out-of-pocket expenses for medical care exceed $500,000. In 1990, Congress passed a compensation bill for the downwind victims. Only one of my family members is eligible for this compensation payment of $50,000 under the law. Livestock, as well as people, were affected by this radiation. The animals were the first indicators that something was seriously wrong. In the spring of 1953 a herd of sheet returning to Cedar City from their winter range near the Nevada test site began to die. Thousands of sheep died and many more lambs were dead or deformed. They were so deformed that they were destroyed. Initially government veterinarians from the Public Health Service, the Naval Radiological Defense Laboratory, and Los Alamos voiced a common opinion that radiation was at least a contributing factor in these deaths. Three years later when a sheep case came to trial, these same men would no longer testify to this effect. In the interim, the government attorneys and the AEC experts had launched a campaign to convince these men that their initial judgment was in error. By the trial date in 1956, the Los Alamos vet had changed his mind, and the NRDL and PHS vets had been persuaded not to testify. The government attorneys brought in two AEC experts who had conducted radiation experiments at Los Alamos and Hanford, and it was on the basis of their testimony that Judge Christensen ruled against the plaintiffs. The two AEC scientists clearly had a monopoly on the data. These two men have been named in other testimony before this Committee. They are Dr. Leo Bustad from Hanford that Ann Hopkins mentioned in her testimony in Cincinnati and Dr. Clarence Lushbaugh from Los Alamos. Twenty-five years later, as new information was discovered in conjunction with a different lawsuit filed by the downwind cancer victims, Judge Christensen determined that the government experts and lawyers had perpetrated a fraud upon his court and reversed his previous decision. Three Justice Department attorneys responsible for the fraud were John J. Finn, torts attorney; his boss, Bonnell Phillips, Chief of the Torts Section; and Warren Burger, head of the Civil Division and Deputy Attorney General of the United States. In 1983, the Tenth Circuit Court of Appeals in Denver overturned Judge Christensen's new finding and in 1986 the Supreme Court voted five to three not to hear the appeal, but by then Chief Justice Burger disqualified himself for unspecified reasons. The sheep owners remain to be compensated. Human losses followed. Karlene Hafen was the first childhood leukemia victim. She died in '56. The AEC and the PHS became increasingly concerned about the health aspects of the test program. In 1961, Ed Weiss, a biostatistician from the Division of Radiological Health, appeared in southern Utah where he began a retrospective study of leukemia and thyroid cancer deaths between 1950 and 1966. The attempt was to show that there was no effect of radiation on the downwind population. Weiss instead found that 28 leukemia deaths were present where 19 were expected on the basis of national average, and this was a further problem because of the fact that Utah had one of the lowest cancer rates in the country. The two Weiss reports were then forwarded to the AEC in 1965 for review and approval, along with a draft press release announcing a new clinical study of 2,000 school children for thyroid abnormalities, tooth, bone, and soft tissue abnormalities, segmental heterochromia of the iris, and ability to taste and smell a number of chemicals. Dr. Dunning of the AEC objected to the publication of the leukemia study on the grounds that it might, quote, generate serious issues from a legal viewpoint. Even the Science Advisor in Johnson's White House got involved with concerns that the federal government's liability for any clinical effects possibly due to radiation which might be discovered. After a high level meeting in the White House between HEW, AEC, and many lawyers and administrators, Dwight Ink, General Manager of the Atomic Energy Commission, reported back to the Commissioners that the problem with both Weiss reports were, quote, adverse public reaction, lawsuits, and jeopardizing the programs of the Nevada test site, unquote. The Commissioners directed that Surgeon General Terry receive a letter expressing their concerns, and the Weiss report disappeared from sight for 14 years. Only after Lynn Lyon at the University of U. published a similar study in 1979 did this report reappear. In the press reports about the clinical examinations of school children in St. George, a number of studies are mentioned, to include thyroid bone cancer and congenital abnormalities. I have been unable to locate any of the reports on bone cancer or congenital abnormalities or, in fact, any of the reports other than the thyroid and the leukemia studies. I'm still interested in what happened to my teeth. In Cincinnati, we learned that the AEC had a body snatching division, and now I believe that they also employed the Tooth Fairy. (Laughter.) DR. NELSON: In last Sunday's Post, Jessica Matthews wrote an article entitled "Expensive Secrets." It deals with the serious problems of our outmoded and expensive Cold War era document classification procedures. She maintains that, quote, overly indulgent secrecy protects the stupid, the incompetent, and the evil, as well as the merely wasteful. The absence of scrutiny by colleagues or independent experts lets bad decisions pass unchallenged and negligent management persist for decades. With some accountability, the several hundred billion dollar nuclear and chemical clean-up bill run up by the nuclear and defense establishments would never have grown so large. Secrecy breeds arrogance, and in the cost case contempt for the public. In the mid-1950s, the AEC, which knew different, promised those living downwind of its above ground nuclear test site that the fallout, quote, does not constitute a serious hazard to any living thing, unquote. I believe that those responsible for the human rights violations and environmental catastrophes of the Cold War era operated under a protective umbrella of secrecy and national security privilege. They must now be held accountable for their actions. Monetary compensation by itself is merely an insult and does little to heal the real wounds. The men who perpetrated this crime upon my family have been identified and must be punished or justice will not prevail, and I am not alone in this view. I would like to just read a brief position of the Task Force for Radiation and Human Rights, of which I'm a member. CHAIRMAN FADEN: Dr. Nelson, let me just point out if you do that there really won't be any time for questions. So that's your choice. DR. NELSON: Okay. CHAIRMAN FADEN: It's entirely up to you. DR. NELSON: Okay. That's fine. I think this is self- explanatory. This happened over 40 years in multiple iterations. So -- CHAIRMAN FADEN: Whichever you would prefer is fine with us. DR. NELSON: Okay. When we begin to talk about remedies, the task force is concerned that there has been no discussion of restoring the victims' rights. When many of these experiments took place, the victims had legal rights that over the course of the Cold War were methodically stripped from them. I'm talking about the court's gross expansion of the sovereign immunity defenses over the years which have robbed more than one radiation victim of their day in court. The Task Force on Radiation and Human Rights views the situation as follows. The challenge to this Committee is to make recommendations for nonexclusive remedies which protect the rights of the victims to their day in court. This right can only be restored to the victims by waiving the sovereign immunity defense of the federal government. Thank you. CHAIRMAN FADEN: Thank you very much, Dr. Nelson, and thank you for telling us what we appreciate is a very personally difficult story. Thank you. Our next two speakers have traveled a very long way to be with us. They are both from North Slope Borough, Alaska, and we appreciate very much their coming. We welcome the Mayor Ahmaogak, and please my apologies if the pronunciation isn't correct, and Mr. Peetok, if they would care to join us, and we understand that Maggie Ahmaogak will be joining us as well. Welcome. Is Mayor Ahmaogak the first speaker? Thank you. Thank you so much for coming. MAYOR AHMAOGAK: Good morning, Madame Chairman, members of the Committee. My name is George Ahmaogak. CHAIRMAN FADEN: Is your light checked? Please just press your mike and see if the red light is on. Okay. Thank you. MAYOR AHMAOGAK: My name is George Ahmaogak. I'm Mayor of the North Slope Borough. I'd like to first change our testimony. I'd like to present my testimony after the gentleman next to me presents his. Mr. Rossman Peetok comes from our municipal government from within our North Slope Borough. He's coming from one of villages, Wainwright, which is 90 miles west of Barrow. Mr. Rossman is one of the recipients of Iodine 131 and 125. He will give his testimony in Eskimo and my wife Maggie will be interpreting this testimony. He will also not only talk about his experiences with 125 and 131 Iodine. He will tell about the other recipients within his village that have gone through difficult process when they were administered this 125 and 131. After he gets done with his testimony, then I'll present mine also. Thank you very much. CHAIRMAN FADEN: Thank you. We welcome you, Mr. Peetok. MR. PEETOK: Good morning. (Speaking through interpreter) He wants to first say to you something that is very heavy for him to give to you. First of all he'd like to wish that he's sorry that for who came to Wainwright, that he didn't have a chance to see them. He'd like to talk about the five people that after taking that radioisotope that these people that were given the radioisotope had gotten sick. He'd like to talk about his grandmother, an elder in Wainwright. After 20 years of being given through this experiment, she no longer could talk because her thyroid was numb and kind of dead to her feelings, and as time went by she died from her heart attack. He's also mentioning his mother's father that had gone through the same symptoms and also died of heart attack. Another person that had been under these experiments also ended up with a hole in his thyroid and the windpipe was placed in the throat. Another one of the people that are under this -- undergone through this experiment also started having eye problems, couldn't see well anymore. For what he's gone through, that all of this past he has been one of them also and he has seen all of them gone through what he's just letting you hear. He also wants to mention some of the people that are from Point Hope, have the same concerns. From the list or the report that came out, there is missing names, only mention of five or six people that were undergone this experiment from Point Hope. They have not been isolated by name. At the time they went through these experiments, they were not told what they were being given, and they did not get their consent or let them understand that it was radiation that they were being given. All of the people that went through this experiment were never asked that they were being given what they took. He doesn't like the way it happened and the way they were treated. All of the people that are still alive from this experiment, those that are still alive from this experiment are still encountering problems. He would like for you to know and he's telling you now that he'd like for you to know that. And he thanks you for giving him this time and for listening. CHAIRMAN FADEN: Thank you very much, Mr. Peetok, and thank you also for your translation. We appreciate it. Now we understand we'll hear from the mayor as well, and perhaps we could hold our questions until the mayor's presentation. Please remain at the table if you would. Thank you. MAYOR AHMAOGAK: Good morning, Madame Chairman. I come before your Committee today to hear a deplorable story about human radiation experiments performed on dozens of Alaska natives from our villages in our North Slope Borough during the period of 1950s and 1960s, as well as radioisotope tests that occurred in the area dependent on for subsistence purposes by Eskimos of the Arctic for generations. As I will explain, the tests on Alaska native human subjects here were without consent or, as it turned out, merit. After providing limited information and doing little to overcome known language barriers, military researchers exposed our Inupiat people from the Arctic regions to radioactive isotopes in experiments designed to measure the ability of the United States soldiers from the Lower 48 States to survive in the Arctic climate. I also will discuss an intentional release of radiation in our region occurred during the early 1960s with the United States Atomic Energy Commission, performed experiments on the distribution of radioisotopes in Arctic soil and water, using contaminated radioactive soil from Nevada. These experiments occurred at Cape Thompson, at the Project Chariot site, in an area that has been used by generations of the Alaska natives for subsistence hunting and fishing. All of the experiences I am here to talk about today took place near my home, the North Slope Borough. The North Slope Borough is a political subdivision of the State of Alaska and encompasses approximately 89,000 square miles of the northern most region of our state. The vast majority of our borough's population are Inupiat Eskimos, whose ancestors have lived in the area for generations, surviving the harsh climate primarily through subsistence hunting. Until the 1970s when oil was first developed at Prudhoe Bay, our North Slope Borough was largely isolated. Many of the local inhabitants spoke only Inupiat, our dialect, our language. Most borough villages still at that time remained quite remote, and some of the inhabitants of these villages, particularly the elders and the Eskimo older elders, did not even speak English even today. In the summer of 1956 and continuing into 1957, the United States Army Aero-medical laboratory conducted a series of medical experiments on approximately 102 Eskimos and Indians from the State of Alaska and outlying areas, the iodine experiments. These experiments were designed to study whether Alaskan natives had physiological differences that enabled them to withstand the cold temperatures better than other people. The native trust was gained by impressing the elders with technology never before seen by remotely situated Alaskans. An X-ray picture of an Inupiat leader's head so impressed local leaders and other elders that the Army scientists were allowed to live among the Eskimos and observe their lives. Scientists were then able to perform cold weather experiments on our people. One experiment involved administering the radioactive Isotope 131 in pill form to test thyroid uptake. Many of the native participants have since reported that they were never fully advised as to what drugs were being used in experiments or what tests they were given and never informed as to the potential negative effects of exposure to radiation. This story was so shocking that CNN was prompted to produce a telecast exposing these experiments. Appropriate title: "Eskimo Guinea Pigs." In addition to thyroid experiments involving the use of Iodine 131, evidence has recently come to light that similar experiments were performed on Inupiat subjects by the United States Navy in 1967 and 1968 using another radioisotope, Iodine 125. Although records reveal that the village elders have been provided some information about these later tests, it is unlikely that any of the actual participants were informed about the procedures and the risks of the experiments. Not only did the federal government experiment with radiation on our Eskimo people. The United States Atomic Energy Commission also performed research and investigation involving radioisotope distribution uptake on the land and on which the local natives depend for subsistence purposes. Radiation was left on the Arctic lands for close to 30 years. Many of our local residents have contacted me to express their concerns that the radioactive isotopes left beneath the tundra may have made their way into the flesh of the caribou that graze in this area and upon which the local Alaska natives depend on for subsistence. My people are concerned about the potential health effects on their families in the result of the consumption of this caribou. When this situation was brought to the attention of the federal officials, a remediation effort was undertaken that was recently concluded with the publication of the Project Chariot site assessment and remedial action final report. Our people were deeply disappointed, however, in this report. After seeming to go great lengths to solicit public comment and recommendations, it is our belief that the Department of Energy failed to take these public comments seriously, and this has been sorely frustrating on our part. Therefore, in no way can our people believe that the final report is final. It fails to address most recommendations made by the borough, North Slope Borough Science Advisory Committee and submitted to the Department of Energy. A later released response document, which no one had an opportunity to review prior to Department of Energy officials presentation of the final report in a meeting last month in our native village of Point Hope did not satisfactorily address public comment. Such disregard for effective input from local experts undermines any determinations and conclusions the final report or this later document might reach. My people also have lingering questions as to whether all relevant information has been made available to us regarding Project Chariot. There exists a 1962 letter to Phil Holdsworth from the United States Atomic Energy Commission revealing an experiment design and location different from that described in the Department of Energy's final report. I want to thank Mr. Tom Gerusky of the Department of Energy for his prompt response to this letter, indicating his preliminary investigation led him to determine that those alternative experiments were never carried out. Neither I nor the North Slope Borough community, however, can rest assured that all possible instances of contamination have come to light until the department declassifies all documents relevant to Project Chariot. The continued classification by the Department of Energy seems to be in direct contradiction to the recent commitment of that department, as well as your Advisory Committee, to come clean about secret government experiments which may impact public health and engender mistrust of government. In your June 13th to 14th meeting, your Advisory Committee agreed to begin reviewing experiments involving human exposure to radiation that have been well publicized in order to meet with the public expectations. The North Slope Borough is confident that the Iodine 131 test and 125 will be a part of this review as they have been brought to the attention of the public by newspapers and television stories and are subject of the National Academy of Sciences' Polar Research Board follow-up health study prompted by congressional inquiry. We ask that your Committee give careful attention to the Iodine 131 and 125 tests independent of the Polar Research Board study, which will be released this coming fall. The borough will not be given an opportunity to review or comment on a draft of the Polar Research Board report and believes that the Advisory Committee examination will be broader in scope, encompassing ethical concerns and minority population issues. We also ask that this Committee give close attention to the Iodine 125 experiments. In addition, Project Chariot experiments are well known and were even the subject of a new book by the researcher Dan O'Neill entitled The Firecracker Boys, just published by St. Martin Press. With respect to the scope of the Committee's charter, it has been suggested that tests involving incidental exposures suffering in the course of routine medical procedures should not be included in the Committee's scope. While the use of Iodine 131 and other radioisotopes to examine the thyroid was and still is routine, the experiments conducted on the Inupiats in the 1950s and the '60s cannot be classified as common and routine medical practices. The Inupiat people used in the studies were not patients whose doctors were concerned about the functions of their thyroid glands. The Inupiats chosen for these experiments were healthy individuals who otherwise would not have been exposed to this type of radiation. Indeed, they clearly were not designed to offer medical assistance to the Inupiat subjects. The only purpose of the experiment was to gain knowledge to assist non-Alaskan natives in surviving Arctic climates. To that end, the proper dissemination of information to Inupiat participants was sacrificed, preventing any sort of informed consent on the part of these natives. To this end, the North Slope Borough all these years, ever since this experiment had started, has been put up with the problem of providing medical assistance to these people, travel, medical travel, funeral arrangements, and these are all coming from local sources. In its recently issued interim report of the Advisory Committee on Human Radiation Experiments, your Advisory Committee indicated that it would focus on the issues of whether in radiation experiments participants were properly informed of risks, give proper informed consent, or were deceived by those performing the tests rather than simply attempting to quantify physical harms incurred by radiation experiment victims. In addition, your Committee has chosen to examine whether particular populations were targeted as research subjects because of their lack of political or economic power. It is clear that this empowerment is a precise description of the Inupiat subjects in the Arctic region involved in the experiments I am discussing here today. I support your Committee's determination that these focuses are necessary due to the complexities of radiation dosages and the difficulties of establishing a link between present day negative health effects and an exposure to radiation decades before. On behalf of the North Slope Borough and the natives victimized by iodine experiments, I applaud this Committee's focus on ethical issues which transcend concrete physical harms and feel that such a focus is a key to granting the iodine experiments and Project Chariot the attention they deserve as instances of the abuse of trust between the United States government and the North Slope Borough residents. Perhaps the most important data we ask the Committee to consider in its review of iodine experiments, as well as Project Chariot, is the personal anxiety those tests have created for the vulnerable study participants. In a letter to me about the iodine experiments, a native named Winfred James, Sr., relates, and I quote. "There were five of us from the village of Gambell that spent the whole week at Ladd Field, only knowing that they were going through cold weather tests. If any other things were done, they never told us. I remember everything they did to us. We were given Iodine 131 and put in a small room lined with lead foil, naked and wired to all of our openings: ear, mouth, rectal, underarms, and so forth, until we shivered from temperatures dropping," and unquote. Similarly, in the interviews with CNN which aired in May of 1993, residents of another village within our North Slope Borough involved in iodine experiments told reporters that they were neither informed of the nature of the testing nor warned about the potential side effects of cancer causing drugs that were administered. In that documentary, borough residents, one of the eldest, Justus Mediana, said and I quote, "The scientists conducting the study never explained to me about what kind of testing I underwent. I didn't understand him anyway at that time. I couldn't speak English. I could only say, 'Yeah, yeah, yeah.' That's how I spoke English at that time," end of quote. Bob Ahgook, another resident of Anaktuvuk Pass, was asked by CNN if he understood the nature of the experiment. He said that he did not even realize the tests were to study the effects of cold weather and the thyroids of natives. He thought his diet was being observed. He told the CNN reporter, and I quote, "No, I don't remember the scientists telling me about anything. Maybe if I had known I could have received to take it," end of quote. These iodine tests on the Inupiat fit squarely with the intended purview of your Committee's jurisdiction. Limited information was provided to Inupiat participants. There were known language barriers, and there was an apparent presumption that the consent of village elders would suffice for that individual's participation. The borough, North Slope Borough, cannot countenance even the suggestion that a limited presentation about these experiments to village elders without further attempts to inform individuals participating in the experiments would qualify under any standard of informed consent. Even beyond the issues of informed consent, serious ethical questions exist concerning the targeting of this dis- empowered minority population for use as test subjects. Likewise the selection of the Cape Thompson area for Project Chariot experiments reflected a wholesale dismissal of the Eskimos of the Arctic who depended on the uncontaminated ecosystem for their subsistence survival. On behalf of the radiation experiment survivors and all the residents of the North Slope Borough, I appreciate the opportunity to share our stories with this Committee. I would be happy to answer any questions or provide any additional information that could assist the Human Radiation Advisory Committee in their review of this highly irresponsible and almost unforgivable government action. So we're ready to take any questions you have. Thank you very much. CHAIRMAN FADEN: Thank you, Mayor Ahmaogak. I'm sure that we have many questions. I'm not sure we can answer them all now. I know you're leaving us some documentation, and we will certainly pursue this further. Are there questions? MAYOR AHMAOGAK: I do have one statement. We have other people if the Committee has got time. There is one individual from one of our villages, Point Hope, that I would like to also testify on Project Chariot or Iodine 131. CHAIRMAN FADEN: Unfortunately, perhaps what we could do is take his testimony or her testimony, but not -- can we do it some other way? We'll figure out some way to do it. Let us take our questions at the moment. Ruth, did you have a question? DR. MACKLIN: Yes. Mayor, you mentioned in your written testimony and then spoke of the gaining of the native trust by impressing elders with technology and speaking to the leaders and the elders. To your knowledge, what did the Army scientists or the Navy personnel later -- what did they tell the elders or the leaders in your community of what they were doing? MAYOR AHMAOGAK: Well, at that time, like I stated, there was known language barriers, and none of them hardly spoke any English at all, and they didn't even try to explain to them through interpretation or anything what these experiments were involving. No one even asked them for their consent. They didn't even -- the natives that I travel all across the villages have told me the same story over and over. Nobody knew what they were being administered. DR. MACKLIN: What did the natives think? Was there any discussion among the natives and the people who lived there at the time or the leaders, any discussion about what they thought the purpose was of the Army or the Navy being there and living among them? MAYOR AHMAOGAK: I don't think that the purpose or anything was made understood by the United States Army. None whatsoever, as I understand it. DR. KATZ: But this is a slightly different question. If I understand Ruth correctly, suddenly these doctors appear, and they were there with you. What did you think they were doing there? Why this sudden interest? MAYOR AHMAOGAK: Well, the sudden interest is that they were starting to experience a lot of health problems with these individuals that are there. CHAIRMAN FADEN: No, I think the question goes to -- MAYOR AHMAOGAK: Maybe I'm not getting his question. CHAIRMAN FADEN: The question was at the time when the scientists first appeared -- MAYOR AHMAOGAK: At the time? CHAIRMAN FADEN: -- what did the people in the villages think about what was going on? We're trying to get to what misunderstandings or what misperceptions were intentionally or unintentionally created. MAYOR AHMAOGAK: The elder said at that time what you're referring to, they were never talked to, the villagers, none whatsoever. CHAIRMAN FADEN: No, we understand that. MAYOR AHMAOGAK: No discussion of -- CHAIRMAN FADEN: So your presumption was that this is the government, and if the government wants to do something, they want to do something. Was that -- was there no questioning? MR. PEETOK (speaking through an interpreter): They were told that they were just going through examinations. CHAIRMAN FADEN: That's important. That's very important. Let me take a list because I see many hands. Phil, did you have -- MRS. AHMAOGAK: And also related to that one, there were also people from Point (inaudible) that were also involved. CHAIRMAN FADEN: Thank you. That's very helpful. Phil and Ken and Duncan and Nancy. DR. RUSSELL: Were there any inducements to participate or payments involved in these studies? MAYOR AHMAOGAK: There was not to our knowledge. CHAIRMAN FADEN: Nothing, nothing. Ken. MR. FEINBERG: Mr. Mayor, what is the status of this inquiry of Congress? Is Senator Stevens or Senator Murkowski aware of this? Have they expressed any interest in this? What is the status of your efforts with the Congress of the United States? MAYOR AHMAOGAK: Our status so far insofar as we're concerned with Congress, we hear very little of the activity. One thing that we heard about is possible compensation, but never to this moment have we got any commitments of any sort, nor any type of assistance or provide any medical attention or assistance, for that matter, but we never had any kind of clear signal coming from -- but the only thing that I did hear was that there was some declassification of materials that was going to take place as a result of this. MR. FEINBERG: Have you raised this problem and this story and this experience with Senator Stevens or Senator Murkowski? Are they aware of this? MAYOR AHMAOGAK: They are aware of it. MR. FEINBERG: And no action has been taken? MAYOR AHMAOGAK: No action has been done thus far as I understand, but there's a lot of communications back and forth and a lot of attempt is being gathered to try to declassify a lot of information also, like what the gentleman said here also. There was five people that we're still trying to isolate from Point Hope that are recipients of this, and we have been going through this bungling experience of trying to get into the files since they're declassified at this time. But, yes, there has been, to answer your question, not to my knowledge any type of action has been given by our congressional delegation, but they are fully aware of it and they're doing everything they can to assist us to deal with this problem. CHAIRMAN FADEN: Duncan. DR. THOMAS: I was struck by your comments about the apparent belief that the consent of the village elders would suffice for that of the individual participants, and I'm trying to understand where such a presumption might have come from because it's not a presumption that we would make normally about people in the Lower 48. Is there anything you can tell me, anything in the Inupiat culture, any sort of a tradition by which village elders would have this sort of right to make decisions affecting individuals on behalf of the community? MAYOR AHMAOGAK: There is -- there was earlier days, elders' council and so forth, tribal councils that were there, but at this stage in the early part of the game when these tests were being administered, there was a communications gap to start off with, to begin with anyway, and most of the subjects didn't understand what they were being administered because they couldn't communicate, much less give their consent or whatever. I mean there was no English speaking Eskimos at that time. Only during the time that I went to school after that time I learned how to speak English. I mean most of the people are all up there. So there was a communications factor -- problem there. DR. THOMAS: So your presumption is it's because of the difficulty of the investigators communicating with the individuals that such a presumption might have arisen rather than that there is sort of any tradition of communal decision-making or anything like that? MAYOR AHMAOGAK: Well, as I understand it, going through from village to village and talking to all of the people, from what information that we had gathered even after Polar Research Board had been there, we went through from the North Slope; we were traveling and talking to these individuals, and their story remains the same. No consent; they didn't know anything, what they were getting involved with. Nobody made it - - explained it to them what they were going through. CHAIRMAN FADEN: I'm sorry. Mary Ann, you want to follow on this point, and then Nancy is waiting. DR. STEVENSON: Do you have a sense that the village elders who may or may not have given permission understood what the point of the experiments were, even if they weren't subjects of the experiments? Did anybody in the community truly understand or have an explanation of why these experiments were being done? MAYOR AHMAOGAK: Nobody in the community as far as they're concerned understood what this whole problem and this test was involved with. Nobody. DR. STEVENSON: And not the elders who -- MAYOR AHMAOGAK: Not even the elders. DR. STEVENSON: Okay. MAYOR AHMAOGAK: As I said, there was a communications problem, and they didn't know how to speak English one bit. MRS. PEETOK: Rossman just mentioned that he's one of the survivors of these experiments, and there was no permission ever asked of the elders. MAYOR AHMAOGAK: Anymore questions? CHAIRMAN FADEN: Yes. Nancy. Sorry. Just one more. DR. OLEINICK: Just one more. In spite of the language barrier, was there any way that any of the participants tried to express their desire to stop the experiment in the middle? Was there any way that it could have been stopped? It can be done sometimes by nonverbal cues, by just walk out of the room or something to that effect. I'm just concerned. I'm just wondering whether there was any way that the participants expressed the desire -- they didn't understand what was going on, but that they didn't want to continue or that they didn't want the next person to have to undergo what they were doing. Was there any way that that happened? MAYOR AHMAOGAK: I don't think there was a ways and means to express that because at that time the United States Army doing cold weather testing at that time is pretty powerful. DR. OLEINICK: Yeah. MAYOR AHMAOGAK: With these people coming into the community and doing tests. I mean it's the United States Army. What do you expect? DR. OLEINICK: Yeah. CHAIRMAN FADEN: Does Mr. Peetok have an answer? MRS. PEETOK: Yes. MR. PEETOK (speaking through an interpreter): At one point in time they had a mayor of the city council that had stepped in and asked why they were being -- why some of these people that were undergoing the experiments, why the clothes were being taken off, yes. He had told them to stop what they were doing to the people because of -- to stop taking their clothes off. That was the only instance he knows that the mayor had stopped the process that they were going through. CHAIRMAN FADEN: And did they stop at that point? MR. PEETOK: The mayor asked them to stop, and they stopped. CHAIRMAN FADEN: At that point. Could I ask you: were they uniformed personnel? Were they Army personnel in uniforms or were they scientists in white laboratory costumes or both? MR. PEETOK: They were in uniforms, military. CHAIRMAN FADEN: Military uniforms. Okay. Are there -- I'm sorry. Lois. MS. NORRIS: Do I understand that radioactive soil from Nevada was distributed throughout the tundra or on the tundra? Is that what I understood you to say? MAYOR AHMAOGAK: That's correct. MS. NORRIS: Was anyone informed that that was being done at the time? MAYOR AHMAOGAK: There was a person here from Point Hope that would like to testify if you have a few minutes. He'd like to tell historically that. CHAIRMAN FADEN: The awkwardness is that we -- what I want to identify is that Dan Guttman, the Executive Director of our staff -- MAYOR AHMAOGAK: Yes. CHAIRMAN FADEN: -- will be -- MAYOR AHMAOGAK: To answer your question, there was radioactive soil that was deposited from Nevada, which is several miles away from the village of Point Hope called Project Chariot, and the Point Hope people can tell the experience, what they went through. They're better off to answer that question. MS. NORRIS: You might be able to answer just one follow-up question. MAYOR AHMAOGAK: Yes, sure. MS. NORRIS: Do you know if there has been any testing on the plant and animal life to determine whether there was any uptake of that radioactive waste? MAYOR AHMAOGAK: There was at the last Department of Energy meeting that we had in Point Hope -- stated that they did take samples of ground squirrels, lichen, water samples, and radiological aerial surveys, and the bottom line report, what the DOE is convinced is that they didn't measure any contamination at all, but still I think the problems were that there was some health -- there was a lot of concerns like that 1962 letter that I spoke of earlier, saying that there was multiple plots. When Project Chariot remedial action took place, this cleaned up only one plot. To answer the basic question, the intended experiments was to do multiple plots, and the person that responded to us, Mr. Gerusky, only said that it was only done only once, but to date we're not satisfied from the government documents because they're classified. We can't get to see how many plots that they did actually clean up. CHAIRMAN FADEN: Mary Ann, can we make this the last question? We really want to hear -- DR. STEVENSON: Do you feel like you've received to your satisfaction information about the identification -- or you may do that yourself -- of the people involved in the exposures and the doses they received? Have you gotten that information to your satisfaction? MAYOR AHMAOGAK: Yes, we've gotten that information, and there again, going through bureaucracy and going through red tape and trying to get this information of how many people were involved, and we went through a tough process, but we did isolate the ones for Iodine 131. What we don't have is the five recipients that we have from Point Hope that we can't justify their names, but the next step that we took further for the Committee's information, for the people that are deceased, we're starting to dig into their files and their medical records and finding out what they died from. A lot of them are cancer. The ones that are living right now, we're doing further information with epidemiologists from Johns Hopkins University, trying to understanding to see where these sicknesses are coming from, but as the gentleman said, holes in their thyroid, all of that is very true. We have a complete disinformation gathering that we're doing. We're looking at Iodine 131, Iodine 125, Project Chariot, but there is a hellaceous cancer problem that we have on our hands, and we're trying to deal with this problem on our own with local sources and with no help from nobody. But we will find out. CHAIRMAN FADEN: Well, we thank you all -- MAYOR AHMAOGAK: Thank you very much. CHAIRMAN FADEN: -- very much, but did you want to make one more comment? MR. PEETOK: He'd like to talk about another thing that he forgot to mention. CHAIRMAN FADEN: Please. MR. PEETOK: After he took the Iodine 131, a woman, her thyroid gland swelled up pretty bad and couldn't eat anymore, and she started showing signs of getting skinny. She traveled from her home town. He's mentioning that this lady traveled from a camp, had to get away from the camp to the home in order to try and heal that swelling in the thyroid glands. She is still alive today. CHAIRMAN FADEN: Thank you. MRS. AHMAOGAK: That's what he wanted to add. CHAIRMAN FADEN: Thank you very much, all three of you, for traveling this great distance and for providing us with this information. Let me just point out -- Dan, you will be available? MR. GUTTMAN: Also, Faith Bulger and Barbara Berney is out there somewhere. Barbara, are you out there? Why don't you go over in the corner so that these folks -- CHAIRMAN FADEN: And, Faith, could you stand? MR. GUTTMAN: -- because you have been -- CHAIRMAN FADEN: If you would continue to meet with our staff members, we could get more information from you. We would appreciate that, and that's Faith and Barbara and Dan will be joining them as well if he can. MR. GUTTMAN: Yes. CHAIRMAN FADEN: That would be great. Thank you very much. We appreciate it. For Committee members, let me just tell you what the schedule is. We're going to go have lunch. We're going to have an hour lunch, assuming they can bring us lunch fast enough and begin at 1:15 rather than 1:30 and do the report on research proposal review projects first, I think. We'll try to figure that one out, but we need to come back at 1:15, not at 1:30, to try to make up for some of the time that we've lost. So please go eat. (Whereupon, at 12:12 p.m., the meeting was recessed for lunch, to reconvene at 1:15 p.m., the same day.) AFTERNOON SESSION (1:21 p.m.) CHAIRMAN FADEN: All right. If the Committee would please come to the table, we're going to being with Dr. Till's presentation. We're trying to pick up 15 minutes which we're rapidly losing. Now, our goal is to start now, pick up some time. Oh, good. I think as soon as we get one more Committee member we will begin and here comes our one more Committee member, two more Committee members. We're on. All right. Just as a comment, we're trying to pick up 15 minutes. Depending on how the timing goes, the current plan is we'll have Dr. Till's presentation. We will then discuss the intentional release case. We will then have Dan's briefing with respect to declassification which relates, in part but not in whole, to the Green Run issue. We will then hopefully have our break a little bit earlier and then begin the session after the break with a presentation from the Protocol Review Subcommittee, which should take up to a half hour, and then we will get to the Committee's strategy discussion. What are we going to do for the next month? Okay. We're back to our old temperature control problem. We seemed to be plagued with this every hotel that we go. People complained that it was cold in the morning. So they turned the air off. Do we turn the air back on? Okay. Would someone please request that the air be turned back on, and maybe at the break we'll turn it back off again or something, but it seems to be that in Washington they are incapable of creating a climate control that works. Let me begin. It's my pleasure to introduce John Till who is our guest at the end of the table, who is a graduate of the Naval Academy and served in the U.S. Navy nuclear submarine program and is currently a rear admiral in the U.S. Naval Reserve. I will, in the interest of saving time for his presentation, skip all of his eminent accomplishments and qualifications and go to the bottom line. He is the past Chairman of the Technical Steering Panel that is directing the Hanford environmental dose reconstruction project, and in that capacity he led an effort to actively involve the public in scientific research to determine the effects of early Hanford operations. Dr. Till is going to try in 15 or so minutes, and then we'll have time for discussion, to bring those of us who are technically and scientifically naive a little bit of understanding about environmental dose issues and environmental risk issues. We thank you very much, Dr. Till, for taking the time to try and educate those of us who need educating, which is some chunk of the Committee. DR. TILL: It's a pleasure to be here, and it's an almost impossible task to really give you a thorough understanding of environmental dosimetry, but I'm going to try in the few minutes that I have to describe to you through dose reconstruction work that I've been involved with for the past eight to ten years, how we reconstruct historical doses. But what I want to leave with you, I think, most important about that is how good or perhaps not so good, as you may perceive it, that we are in reconstructing historical doses. I want to stress that the work that I do as a scientist involves reconstruction of doses from environmental releases of radionuclides, and that's a very important distinction, as opposed to medical purposes or occupational exposures, but I've been involved in this work for about 25 years. I also would like through this presentation to share with you some of the lessons learned through the Hanford dose reconstruction project because I encountered in that project many of the problems that you're dealing with here, the same kinds of problems regarding access to information, interpretation of historical data, declassification of information. Let's see. If we could just click on the first slide, this is a rather simple slide, but I want to describe to you what dose reconstruction is all about. CHAIRMAN FADEN: Dr. Till, let me see if I can get something done about the lights. Is there anybody who can? Are there any light switches? DR. TILL: I'm going to keep talking so we don't lose time. CHAIRMAN FADEN: Keep talking. DR. TILL: But this is really just a very simple diagram, and it's to try to illustrate to people how we perceive dose reconstruction, and it's like a puzzle with many pieces, many more than is shown here, but thousands of pieces. The difficulty is that you really don't have a picture of this puzzle before you begin to put it together. There are many pieces that include bits of data, and I won't go over all of those in the puzzle, but information on the sources term, and that's what we call the quantification and characterization of the information of the material release to the environment, information on environmental monitoring data that may have been collected at the time, information on meteorological data. All of these are pieces to that puzzle. And that's what dose reconstruction is all about. The key to this -- and if you would go on to the next slide -- is really what's in these boxes, and if you've never been in the repository -- and I don't know if the Committee has ever made a visit to a repository -- I would urge you to do it because you will see the absolute and I have to call it chaos because that's what it is in most cases of how all of these historical records are stored, for those that you can find, and this is just an example of records stored at the Savannah River site. But, indeed, these records hold the key to dose reconstruction. We believe that if we can get to this information and get to the right pieces of paper, we think we can do a pretty good job of reconstructing the past. If we know, for example, what the meteorology was for a particular day or for a particular period of time, we can tell you pretty well today if that material went up a stack where it went, what direction, and how far. Okay. The next slide, and this is horrible. I know that. I made this in my office, but this is what we're looking for. These are original notes, and this piece of paper happens to come out of the Fernald site, and it deals with some log -- it's a log book, which is sort of the key source of data that we look for, but it's a log book that describes releases of uranium to surface water at the Fernald site. I just threw this up as an example for the kinds of records we're looking for, and what often you find in the historical records are summaries of data, summaries of releases that previous researchers have made, and that's not the kind of information we use. We believe in going to the most original source for the data. If we can find hourly logs, daily logs, monthly logs, then we come up with our own summation of characterization of the source term, for example. Okay. The next slide just describes to you two types of searches that we use in our work, and one's called a directed search, and really that's what I believe this Committee is doing in your work. You're sort of going to different locations looking for specific kinds of information. That's what was done at Hanford. We were dealing with about 48,000 boxes of records at Hanford. When the project started, we realized that we could not look through all of the boxes to find records, and therefore, we started to go to particular boxes where we thought the information was stored. There's a great weakness in a directed search of the records, and the great weakness, of course, is that you may not find everything. In some new work that we have been doing for the past two years, and this is a project that's been sponsored by the Centers for Disease Control, they've taken a new approach to looking through the records for a dose reconstruction project, and this approach is that we spend the first two years of work doing nothing but a systematic search of these records, that is, going through every box to see what's there to decide whether or not there are sufficient data to carry out a dose reconstruction in the first place, just making sure that you have everything; cataloging the records; and we have, and we've about finished this work, been through 38,000 boxes of historical records at the Savannah River site. It's extremely tedious. It's expensive. On the other hand, we have now for the first time ever in the history of that site catalogued all of the information in the historical records. Most of it, of course, is not useful to us, but other researchers now, for example, people who might be interested in medical exposures on site or occupational exposures on site, will know where to go to get that information. It's all in a massive database that we've assembled and is being turned over to the Centers for Disease Control. The next slide is just to make a point with you that we look through the boxes ourselves. I mean as researchers, I have a small research team. There are 17 of us. That is the point, that you can't send someone in who doesn't know what you're looking for to search for the information that you need in dose reconstruction. I would advise you in your work to be very careful. When you're sending out a message to do a search at a particular location, how you go about doing that. It's not a matter of trust, and that's my point. It's a matter of thoroughness, and it's also a matter of people out there not knowing exactly what it is that you need for your work. I've done this. We did it at Hanford where we sent people out to find particular records, and we didn't get back exactly what we needed. We had to go back and find it ourselves again later on. So the picture that I'm trying to give you right now is that in the first place we do have the capability of going back into these historical records, not always, but often finding bits and pieces of information that allow us to put together this puzzle of dose reconstruction as we call it. The next slide, of course, is the Hanford site. I'm going to shift a little bit to tell you that I got involved in a study to reconstruct the doses at Hanford back in 1988. It was an extremely enlightening study for me. I recognized immediately that this was a study brought about by public concern, and that as a scientist, we had to go about doing our work in a completely different way. We declared this study to be an open study; that anything we did, that anything we had could be viewed by members of the public at any time. But we had to deal with some very important issues at Hanford that I was extremely unaware of in going into the work. The next slide just lists a few of the things, which I'm not going to have time to go through all of, but in terms of the organization of the study, it was, of course, being paid for by the Department of Energy. We were working for Battelle Northwest, the very laboratory we were to be directing, and it took us about two years to get all of this sorted out and get the study transferred out of DOE and into the Centers for Disease Control. A great lesson in terms of how public studies should not be set up. Openness was a big issue at Hanford, and I'll talk just a little bit about that because I know you're dealing with some of these same problems. Access to and declassification of the historical records, and public involvement. I'm going to come back to openness and declassification very briefly. First of all, with openness on the next slide, I just list a few points that I think you need to remember. I know that this Committee itself has taken a very proactive stand toward being open and it's a necessity in the type of work that you're doing. We have to understand that in carrying out public studies and scientific public studies that they'll cost more if they're considered open, but I still stress that even in public studies, scientists have to have the right to have some degree of privacy in your work and to make your conclusions before you make them public. With regard to access and declassification, which is a major issue at Hanford, the next slide sort of lists our initial approach here, and that was that we had members on this panel who had appropriate clearances to look at classified information. The problem that we were confronted with was that of credibility. And so we took a very positive stand that any information we used in the study had to be declassified. Now, if you'll put yourselves in our place back in 1988 when we started this work, the first information we needed to create the sources terms at Hanford was information on plutonium production, and if you know that back in that time, of course, this was all classified. So we were immediately told that we could not have plutonium production information, and our position was that we had to have it, and therefore, through a discussion with the then Secretary of Energy, Admiral Watkins, we were able to get plutonium production declassified through 1961 and ultimately through 1972, which is what we needed. But my point to you about declassification, and we can talk about this a bit later, in the work that you do and the work that I do, everything as a scientist has to be peer reviewed. If it's classified, it cannot be peer reviewed, and therefore, as a scientist I cannot work with classified information, nor will I. I suspect that much of what you discover in your look through the historical records you're going to be confronted with the same problem. I want to make the point, and it's very important, that in dose reconstruction I've never come across a situation where information that we needed could not be declassified. It's hard for me to envision how anything that this Committee is doing cannot be declassified. Just what you need. Now, recognize that means you may have to get documents and documents with deletions, but there are ways to verify what the deletions were, and that's, of course, the approach that I would certainly recommend that you take. The next slide, and now what I'm going to do in the final few minutes that I have is just try to give you some appreciation for how we go about this science or some people like to call it an art. Maybe it is in terms of estimating doses to individuals from radioactive materials in the environment, and this slide just illustrates one study, and Duncan Thomas has already talked to you about this, I imagine, because Duncan was involved in this, as well. Two studies carried out, supported by the National Cancer Institute, carried out by the University of Utah, one a leukemia case control study; the other a thyroid cohort study. My point is that if you get the right information, one can do a rather decent job of estimating doses to large numbers of people. In the leukemia case control study, we had about 7,000 controls and about 1,100 cases. We had individual dose assignments for each control and each case, "individual" meaning that we knew the residence history of that person, and if you knew residence history, which we had special access to this information through the LDS Church, that was the key factor in assigning a dose to each person. So once we knew where they lived, we had an algorithm that we could use to assign the doses, and in the thyroid cohort study, a similar situation of 3,500 children that we'd been tracking for a number of years, where we assigned doses to each one of those individuals based on their diet, life style, and residence history during the period of atmospheric weapons testing. How good are we at doing this? We assign to each dose estimate, and these are best estimates of dose; they are not upper bound estimates. They're best estimates of dose, an uncertainty with each assignment. These uncertainties typically in the work we did at Utah range on the order of factors of two to four or five. Now, you may think, and someone mentioned the word -- used the word "accurate" here this morning for dose assignments. I would certainly never do that, but for the purposes of epidemiological studies, if you can estimate doses to a large number of people, you're estimating a best estimate of dose for every person individually and assigning an uncertainty. You can do a lot with that epidemiologically. How good that might be for the purposes of this Committee and special doses to special people, I'm not sure. The next study that I'll just mention briefly is work we're doing at the Fernald facility. Go ahead, Jeff, and this is just a photo of that site. This is just northwest of Cincinnati, Ohio, where enormous amounts of uranium are released to the environment particularly through the early 1950s and mid-1960s. The only thing I want to mention here is the process that we use in recreating the source term, as we call it. That's the amount of material that's actually released, and the approach that we take in every study is to try to come at the source term from as many independent angles as possible. Now, for example, around the Fernald facility there were measurements of uranium in soil taken over the years. They weren't all taken the same way. They weren't all taken in the same place. However, we can use that data, and we did use it to help us bound this source term between 160,000 kilograms to 900,000 kilograms. Now, you think that's horrendous, but that was our first cut at the source term. That's called our outside-in approach. What we did as well is to look at those historical records as I showed you earlier, all that we could find, and through almost 100 different release points estimated for each point for each period of time on a monthly basis how much uranium was released, and that number is on the order of about 350,000 kilograms with a fairly small uncertainty. So that's how we go about reconstructing the source terms for these facilities. Finally, what do we do with this information? We try to put these pieces together so that they give us some confidence that these aren't just wild guesses. The next slide just shows you some of the data -- I'm sorry. We need to move on one more -- some of the data, and this is our observed to predicted. This is a logarithmic scale. However, you'll see in the green what our predicted concentrations were, and this is at a location in the northwest direction from the Fernald facility, and you'll see the red line indicating what some measurements were that we found in these historical records. My point is here that we look at this and we say, "Hey, this is pretty good. We're at least in the ball park." It gives us confidence that our prediction of the source terms and our prediction of the calculated concentration of uranium around the Fernald site are pretty good. Okay. That's, I think, all for the slides, and I'm going to stop because I've gone very fast and just conclude by saying, first of all, this field of environmental dosimetry, of dose reconstruction is relatively new business, particularly the mathematical models that we use for predicting doses. These were not around in the older days. Even our appreciation for and understanding for pathway analysis, which of course in the case of iodine at Hanford was enormously important since the milk pathway was the key pathway we were concerned with; that information of that kind has evolved more in recent years rather than in early years. It doesn't mean that it wasn't known, but our ability to quantify material going through various pathways, to quantify the material ultimately getting back to human beings, and then converting that into dose is fairly new, within the last -- certainly within the last two decades. I've gone very fast. I apologize for that, but I hope I leave you with the impression that we do know something about this science and that we have some confidence in our ability to recreate historical doses. Thank you very much. CHAIRMAN FADEN: Thank you, Dr. Till, and the reason you're going quickly is our fault, not yours. It's the amount of time that we have to spend on so many different issues. Henry. We're obviously open. I saw Henry's hand. DR. ROYAL: John, one of the things that we heard about when we were in San Francisco was school children who were having what sounded possibly like thyroid uptake measurements made in school. Do you know anything about those? CHAIRMAN FADEN: Around the Hanford site. DR. ROYAL: Around the Hanford site. Sorry. DR. TILL: As far as the school children were concerned, I don't. Now, at the Hanford site there is a radioepidemiological study being carried out by the Fred Hutchinson Cancer Center. Is that what we're talking about? DR. ROYAL: No, I was talking about at the time that the releases were occurring, that someone testified before the committee saying that she had been brought out of her classroom and had been counted in some machine. So it sounded like there was actual organ uptake measurements that were being done in the general public at that time. DR. TILL: And I don't recall exactly when this was. I don't believe that this individual was talking about measurements that were made during the period when the highest releases occurred. DR. ROYAL: You're right. This was '52. DR. TILL: Right. It was after, and I think this is when, of course, more was recognized about the importance of doing some kind of surveying on the public. Unfortunately if we had had the foresight back in those days to make those kinds of measurements, it would give us the kind of validation that we need today. There were many measurements made of the thyroid burden of workers at Hanford, and that data are being used to help us with the validation, but it's extremely complicated, and it's not as useful as I would like. CHAIRMAN FADEN: Mary Ann. DR. STEVENSON: I don't know if you know this, but how well did the predicted dose estimates at the time that these releases were made, and we'll use Hanford as an example, correspond to the present day dose reconstruction? I'm just trying to get a sense of how well they guessed how much they were going to be putting out and how much they guessed they would expose people to really turned out to be accurate. DR. TILL: Are you talking about predicted dose estimates from the '40s? To my knowledge, there were none, and I've seen no estimates of dose that were made that are in the historical records. In fact, the first estimates of dose that I saw from Hanford, the first calculations of dose really were done in the middle 1980s. DR. STEVENSON: But when we read at least about the proving ground in Nevada, I mean, there were some sort of presumptions made as to given a certain size of a bomb how much release there would be and how much exposure there might be to Downwinders. There were some attempts, it seems like. Whether or not they were accurate I'm not sure. That's what I'm trying to get a sense of. DR. TILL: Actually I have not seen any calculations like the Downwinders. If that were in the historical records, I would like to see it, but I'm not sure that back in those days they were capable of making those kinds of calculations. CHAIRMAN FADEN: Nancy. DR. OLEINICK: I just wanted to follow up on what Henry was asking in terms of the questions about the measurements on the children. What you said was that in the very early releases, there were no measurements made, but that later on there was a realization that they needed to follow the population. Are you aware of data then on measurements on these children or even on adults later on in the '50s? DR. TILL: I really am not sure about that, Nancy. We had someone to testify about this. The point is that these measurements were suddenly being made, but they were really after a time period when we were most interested, and even suspected that you might be able to measure specific body burdens. So I really don't know the answer to that question. DR. OLEINICK: Okay. So you're not aware of it because I mean that would be of interest to us -- DR. TILL: Right. DR. OLEINICK: -- if the data were available. DR. TILL: Right, and in fact, if I were aware of it and had been sure that they existed, we would probably use it in the validation exercise. DR. ROYAL: John, just for clarification, could you tell us when the large releases of radioactive iodine occurred? It was from '44 to '48, '49? DR. TILL: Actually the largest releases occurred -- the releases began in December of 1944, and the largest releases occurred during 1947 and -- I'm sorry -- in 1945 the largest releases occurred, and by 1947 essentially they'd recognized that the problem existed with radioiodine releases. Filters were added. Cooling times were increased to reduce the releases very, very significantly by the end of 1947. The Green Run occurred in 1949. So the time period that we were most interested in in the study was '44 through '47. A total of about 780,000 curies were released during that time period. DR. ROYAL: And the Green Run, just to put that into perspective? DR. TILL: About 8,000 curies. CHAIRMAN FADEN: Other questions for Dr. Till? (No response.) CHAIRMAN FADEN: Well, we thank you very much. DR. TILL: My pleasure. CHAIRMAN FADEN: We appreciate your expertise and are humbled by your efforts relative to our time frames I think is what it comes down to. All right. I think that just following our agenda, we're going to proceed through and that's a good segue into our case study on intentional releases, which does focus on the Green Run at Hanford, and we've got Mark and Pat. Dan, do you want to come up to the table so that we can? DR. GOODMAN: Hi. Our presentation will address the -- CHAIRMAN FADEN: Oh, excuse me. Just let me interrupt. I'm sorry, everybody. It's Tab H. It's Tab H so we can find it. I'm sorry, Mark. Go ahead. DR. GOODMAN: Our presentation will address the facts of the Green Run as we know them and present some discussion points for an ethics analysis. One key question is whether the Green Run or something like it could occur today, and we, therefore, review current environmental regulations and their potential relevance to the Green Run case. I'll begin with a discussion of the facts and unknowns and including a review of the environmental regulations, and Patrick will follow with a discussion of the main points for the ethics analysis. First, the facts. The Green Run occurred in December of 1949. It was an intentional release of radioactive materials from the Hanford plutonium production facility. The purposes are at least partly known, partly unknown. What is known is that it was designed to test the ability to detect nuclear production, nuclear materials production in other countries and perhaps also nuclear weapons testing. It was to provide some historical -- well, there's also a suggestion of other purposes, but we don't have any documents that verify that there were any other purposes to the Green Run. They may be secret or they may just not exist. For some historical background, in the mid to late '40s, the Air Force began a program of atomic intelligence which included a variety of techniques for detecting nuclear weapons explosions and production at long ranges. In the previous year before the Green Run, there was a program of air sampling at Hanford and at Oak Ridge to test, again, radiation detection equipment. And then the Soviet Union exploded its first nuclear weapon in September of 1949. Within three months, the Green Run had occurred. Now, the source of information that we have are almost entirely -- well, the original documents are from the Health Instruments Division at Hanford. There are also some subsequent reports, but they rely on the same information. There are also some of the participants who are still alive, and we intend to interview some of them, but we have not yet done that. And the question of classification arises on these sources. We know that some sections of the reports from the Health Instruments Division are deleted in the declassified versions that we have. They may bear on some of the questions of interest, for example, who is responsible, what other purposes there might have been, what considerations were given to safety, but neither the Air Force nor the Department of Energy reports finding any planning documents or reports that address our questions in any more detail than what we already have. Now, the release itself -- let me step back and talk a little bit about how plutonium is produced. You put uranium fuel into a reactor. Uranium 238 is transformed by neutron activation into Plutonium 239, and then you take the fuel out, Step 2, allow it to cool for some period of time so that it becomes safe to handle, and then Step 3, you dissolve it and chemically separate the plutonium. In the process of dissolving it, you release radioactive gases, and among them particularly at the early times are Xenon 133 and Iodine 131, iodine being particularly biologically active. It has a half-life of about eight days. In 1945, the typical cooling period was 30 days. By 1949, it had been extended to 100 days typically, 90 to 100 days. The Green Run fuel was only allowed to cool for 16 days. Now, that's something like -- the difference between 16 and 100 days is something like ten half-lives or a factor of 1,000 in the activity of iodine. And as John Till had said, there were roughly 8,000 curies of iodine released at the time. There were extensive efforts at monitoring the environmental conditions, including meteorological conditions, the wind speed, temperature profiles, and they imposed -- they had imposed beforehand some meteorological constraints for, I believe, some combination of safety and the success of the experiment, these conditions that would make it possible to measure radiation. But as it turned out, the actual conditions were not favorable; at least were reported to be, quote, worst possible. The air was stagnant. The material was not dispersed at long distances, and then the cold front came through and essentially it all rained out very shortly there afterwards. There's extensive monitoring of air, water, induced radiation levels. What I found most interesting was the monitoring of radioactivity on vegetation, which over large areas exceeded by factors of 100 or more the current standards for intervention. That is, once the radioactivity reaches .013 microcuries per kilogram on vegetation, the state health department intervenes to protect the food supply. So we had levels that were over 100 times that. Now, because there was such extensive monitoring, as John Till has reported, we have a fairly good idea of how to reconstruct the doses, and it turns out because it occurred in December, many of the pathways for human uptake were greatly reduced. That is the food pathways, milk and also meat and eggs. So the primary pathway was through direct inhalation, and this accounts for the fact in spite of this extensive ground contamination, the individual doses were estimated to be relatively low. Now, we haven't reviewed this dose reconstruction, but Battelle has apparently done such reconstruction and estimates the maximum dose at about six millirem to the thyroid. That's something like 200 millirad to the thyroid. There's been no reconstruction of the total population dose, that is, added up over all the people, and for comparison, the Green Run was about one percent of all the radioactivity released during the period of 1944 to 1970, and in that period, the maximum individual doses have been estimated as high as 1,000 rad or so, which is roughly 30 rem to the thyroid. So a factor of something like 5,000 distinguishes those two. Let me move now to the environmental regulations as they exist now. I'm going to concentrate on the most clearly applicable provisions. We haven't done a thorough job of researching every environmental law. There are two basic types: the procedural constraints and the substantive ones. We're going, by the way, in a different order from what's in the briefing book. This would be, I think, 1(b). CHAIRMAN FADEN: Tab H. They're separated by yellow sheets. We don't have little sub-tabs. DR. GOODMAN: Anyway, there are two types of constraints in current law, the procedural and the substantive constraints. The procedural constraints tell you how the government should do things, and the substantive ones -- well, the government and private parties -- the substantive ones put limits on what the government or private parties can do. As far as procedural constraints, there are those that come under the National Environmental Policy Act and related legislation. These require government agencies to prepare environmental impact statements for, quote, major federal actions with significant impact on the human environment. These environmental impact statements should analyze alternatives for meeting objectives of the proposed program. The purpose of this is to require the agencies to inform themselves and also the public of the likely impact of their programs. Also under these and related regulations, EPA, Environmental Protection Agency, exercises oversight, that is, has an obligation to review and comment on proposed federal actions, including environmental impact statements, and if it finds actions unsatisfactory from the point of view of human and environmental protection, human health and environmental protection, it can refer them to the Council on Environmental Quality, which is in the Executive Office of the President. So they can buck it upstairs to the President roughly. And there are also provisions related to public comment and public notice for environmental impact statements. That is, the environmental impact statements, draft ones, should be made available to the public for comment, and those comments taken into account. But these procedural requirements do not enforce any particular outcome. The agency is still free to decide the most environmentally damaging approach if that is the best way to achieve its goals. There are substantive constraints primarily under the Atomic Energy Act and the Clean Air Act. At least these are the ones that would apply in the case of the Green Run. The Atomic Energy Act gives general authority to the federal government to regulate human exposures to radiation hazards. EPA and the Nuclear Regulatory Commission have general guidelines, but for the most part, the agencies are free to regulate their own conduct. That is, they develop, implement, and enforce their own guidelines, regulations under the Atomic Energy Act. The Clean Air Act, the authority under the Clean Air Act is with the Environmental Protection Agency, and there are quantitative limits on exposures to radionuclides released into the atmosphere. The quantitative limit is 10 millirem per year to the maximally exposed individual, which if this were repeated over a lifetime would correspond to some multiple, small multiple of one in 10,000 risk of induced fatal cancer. The goal was to reduce the risk to one in 10,000, but they didn't -- the actual numeric limit doesn't quite implement that. There are a number of other statutes that I won't go into, and then another question -- a basic question though is this is what happens under normal circumstances. Are there loopholes for exceptions for abnormal circumstances? And I've identified three types of loopholes: one, secrecy; two, national interest or national security; and, three, which I've touched on already, self-regulations. For secrecy, there are exceptions in the implementing regulations for the National Environmental Policy Act, NEPA, which say that environmental impact statement can be classified in whole or in part, and court decisions based on this have severely limited the ability of the public to find out what's been done in secret. So this is a real barrier to the public notice/public comment part. As far as national interest exceptions, the Clean Air Act has an exception that allows the President to exempt any proposed federal action from the requirements of the Clean Air Act. It requires the President to report by the end of the year to Congress on all such exemptions, but there's no prior notice required. Finally, the agencies are given authority to regulate themselves under the Atomic Energy Act, and one might think that there's an inherent conflict of interest in there, that agencies might not be as strict on themselves as if they were overseen by another agency. Some safeguards would remain. EPA oversight is there in any case: the authority to refer proposals to the Council on Environmental Quality and some reporting requirements, even if only to Congress. Now, this sort of leads to the question: could the Green Run have happened under today's regulatory environment? I don't think that's quite the right question because the circumstances of the Green Run would not be repeated. But the question really ought to be whether events that raise similar ethical concerns could happen today, and that's something that Patrick will talk about. DR. FITZGERALD: Thanks, Mark. What I'm going to do in my presentation is try to give the facts of Green Run and the environmental regulations an analytical framework. The object here is to highlight the areas where we might judge Green Run to question the adequacy of current regulations and to ask whether something analogous to Green Run can happen today. In the briefing book there are three memos which I'm going to be trying to summarize, and I'll summarize them at the same time. So you won't be able to follow the memos. The presentation won't specifically follow the memos. So what I'll try to do is to proceed by addressing five questions. First, did the Green Run create a favorable balance of harms and benefits and how well do current environmental regulations insure that future actions will have such a favorable balance? There are two primary concerns here. The first is that we adequately consider the harm to the total population. Intentional releases normally spread the likelihood of harm over a large population. For example, specific individuals might contract cancer from intentional releases even though that release may pose a small chance of harm to the individual in the exposed population. The Clean Air Act and the Atomic Energy Act, however, are designed to limit the likelihood that the maximally exposed individual will experience harm rather than likelihood of the harm to the total population. So these regulations don't address all of our concerns. Guidance within DOE, however, does regulate the collective dose and thus the harm to the total population. Any collective dose over 100 person-rem triggers a special reporting requirement that forces the facility to report to DOE headquarters with an explanation. This limit is close to the collective dose that Green Run would have produced from this perspective. The harm caused by Green Run would be significant, but not uncharacteristically high when compared with other releases. The second problem that we encounter in relation to the harms and benefits -- can people hear me over this? CHAIRMAN FADEN: I'm also waiting for these glass, crystal things to fall down at any moment. It's blowing so hard that they're clanging in case you're wondering about the chimes. So, Patrick, I wouldn't take it personally, but we may have to evacuate. I admit you're in a very vulnerable position. We're going to try to get -- if anybody's back there, could somebody get the blower turned down? Somebody should be checking into building safety regulations, in addition to environment. Try and proceed, Patrick, and we'll see if we can't do something about it. DR. FITZGERALD: Well, the first kind of problem under the harms and benefits was considering the harm to the total population. The second problem that we encountered is to try and balance harms and benefits from intentional releases and specifically from Green Run because they are so disparate. There are disparate social values. In addition to affecting public health, intentional releases can harm the environment and benefit both national security and the advancement of science. Regulations do consider some of these problems. NEPA, for example, directs agencies to independently consider environmental effects by requiring an environmental impact statement that conducts not only a cost- benefit analysis of economic values, but also a cost-benefit analysis of environmental values. Environmental regulations also address the conflict between national security and other social values. Each of the environmental regulations may be circumvented on grounds of paramount national interest. Threats to national security, therefore, can trump environmental regulations and the environmental values that they're designed to protect. Internal DOE guidance also attempts to weigh these disparate values. ALARA or "as low as reasonably achievable" standard is designed to consider unquantifiable values. More specifically, radiation doses should be as low as social, technical, economic, practical, and public policy considerations reasonably permit. If the emission is necessary for national security, a low collective dose might not be unreasonable because it's weighed against this other social value. At least one of the purposes of the Green Run was the development of a long-range monitoring system for plutonium production. Consequently, the Green Run is going to force us to weigh the value of national security against the value of public health. Adjudicating this conflict may be more difficult because of the sense of urgency and fear that Americans probably would have felt at the time during which the Green Run was conducted. The Green Run followed shortly after the first Soviet atomic weapons test. So developing a system to monitor Soviet plutonium production and thus to determine the extent of Soviet threat must have been considered paramount to national security at the time. The second question, did Green Run unjustly burden any individuals or groups in society, and do current regulations protect against unjust burdens? We might think that an intentional release distributed harms unjustly either because it distributed them disproportionately or because it distributed them in an egalitarian manner. Disproportionality in distribution results when individuals or groups that bear the harms are not the group that stands to benefit or when the entire society stands to benefit but only a subset of that society bears the harm. The harms may be distributed in an egalitarian manner if the individuals or groups who bear the harms are among the least advantaged members of society. Executive Order 12898, federal actions to address environmental justice in minority populations and low income populations, is designed to address some of these concerns. The executive order directs agencies to make achieving environmental justice part of their mission. Whether this executive order will be effective is yet to be seen because the proposed strategies for each agency will not be made public until February of 1995. Since the Green Run burdened a single community, we might consider it to be disproportionate, and since Hanford community is highly polluted, we might also say that the Green Run further burdened an already heavily burdened community. But the Green Run could have only occurred at the Hanford plant. In 1949, this was the only U.S. facility capable of reprocessing sufficient quantities of irradiated uranium for a full-scale test of long range detection of gases released in the plutonium production. So if a full-scale test was necessary, and this, of course, is an open question, no other site could have been chosen. The third question, did the government adequately consider the will of the affected populations during the Green Run and do current regulations insure that they will adequately consider them today? If the government acquired individual consent from everyone that was possibly affected by an intentional release, no intentional release would be possible. Invariable someone would refuse to consent. Thus, if intentional releases are ever permissible, we must rely on a less stringent standard for authorization than individual consent. The most likely standard will be some kind of consent of the governed obtained through democratic and fair procedures. Procedures for implementing policies, however, can be more or less democratic. When the burdens fall heavily on specific individuals or groups, some might argue that procedural requirements for democracy should be stricter than normal. For example, public officials could be required to consult with the affected public in an open setting. This raises several questions for intentional release in general. Does both the affected and the general public know about the release and its potential hazard so they can hold its representatives accountable? Is the group that is most affected by the release adequately represented? Is there a reliable means for considering public input? Is the public input considered seriously? Does the public have an effective method of challenging government decisions? None of the environmental regulations require individual consent. We might interpret some of the provisions, however, as requiring a kind of democratic consent. NEPA requires federal agencies to seek and respond to public comments on environmental effects, including the people living in the environment, and of all of their major actions. The government need not do this in any other public policy. In any other policy, it doesn't have to do it, for example, on economics, on questions of welfare policy, on foreign policy. The fact that the government does consult the public on questions of environmental impact makes environmental policy uniquely democratic. Despite this fact, we might question whether environmental policy is democratic enough. While NEPA requires agencies to consult with the public, it does not require that they follow or even be shaped by the public's wishes. There is no requirement that the public at large or the members of the public most affected by a federal action approve of that federal action. In addition, NEPA does not require public consultation when the federal action concerns classified material. One of the most difficult questions about weighing social values, how environmental values should be weighed against the value of national security, is done behind closed doors. In the case of the Green Run, we have no indication that anyone outside of the government was informed about the Green Run, much less that they consented to it. The public neither had an effective method of challenging the government decision, nor did they have a way to hold officials responsible for their actions. We can question, therefore, whether the government took adequate steps to obtain the consent of the governed. The fourth question now. How much of the Green Run was secret and do current regulations allow for similar occurrences today? Questions about secrecy are multifarious. Was the information kept secret? Were affected persons in the general public informed about the release? If they were, then what information were they given and was it effective? Were they informed about possible harms that might result from release? Were the members of the public consulted before the proposed release was finalized? What actions, if any, were recommended to the public to minimize potential harm? The Green Run was not made public until 1986, and some parts of it remain classified. As far as we know, the government did not provide any information to the exposed populations about the tests or about its risks. More importantly perhaps, we have no indication that the government warned the public of the release. This absence of warning prevented individuals from taking precautionary actions, such as leaving the area or simply staying indoors. If the current environmental laws were in place in 1949, it is unclear that they would have prevented Green Run. It would fall under NEPA, and thus, the Air Force would have to analyze alternatives. This analysis, however, would not have been made public since the Green Run was classified. Furthermore, no reviewing agency would likely have been in the position to refute or even authoritatively question any claims of national security made by the military or the AEC. Substantive regulations might not have been of much impact either. The Clean Air Act and the Atomic Energy Act regulations can be superseded in cases of paramount national interest. Given the perceived Soviet threat, this exemption might easily have been invoked. And now the fifth and final question. Was the Green Run reviewed prior to its execution and could similar projects avoid review under current regulations? Intentional releases raise several different questions about an adequate review, that an adequate review might have to answer. Can intentional releases achieve its proposed goal? Are there any alternatives that could limit unwarranted side effects? Do the side effects constitute an unacceptable cost? If there are attached studies, are they conducted in an ethical manner? Because these questions require several different kinds of expertise to adequately answer, they may require several different kinds of review. Do the current regulations require a proposed intentional release to be reviewed by disinterested third parties? NEPA requires that the EPA review major federal actions for their environmental impact, and NEPA also requires that any agencies with special expertise review proposed actions. In most cases, this would seem to guarantee a disinterested third party. It might be possible, however, to have the EPA or another agency that has a special expertise to have promotional interest in obtaining the data which the agency is trying to gather. In addition, even the reviewing agency does not have a promotional interest in the proposal, other government agencies may be more accommodating that individuals or groups outside the government. We have no indication that anyone in the government who did not promote Green Run reviewed its plans. It would be hard, therefore, to call those who did review the plans disinterested. We also have no indication that radiological safety considerations were taken into account, and plainly in the Green Run such documents may yet appear. An environmental impact statement under NEPA and EPA approval under the Clean Air Act would have been required for Hanford operations, which probably would have placed limited limits on the operational missions. A report to EPA would have been required on the atmospheric emissions and would likely have to have raised concerns since the six millirem for one day comes close to the ten millirem annual limit. But as stated earlier, the public would not have been given the opportunity to review the Green Run, and no agency that could have reviewed it would have been in the position to refute or authoritatively question the military or the AEC claims of national security. No current regulations would have required an executive branch to notify Congress before the Green Run, but if the President did invoke the paramount national interest exclusion to the Clean Air Act, he would have had to report to Congress at the end of the year. All in all, it seems that an effective third party review would have been unlikely. So in the Green Run it seems that we have the value of national security seems to have trumped our other ethical concerns. In addition, if today's environmental regulations were in place in 1949, they would have been circumvented by the executive branch. We can ask whether the Green Run should have happened, but perhaps more importantly, we should ask whether current regulations provide sufficient protection against analogous cases today and in the future. Should any public notice be required of classified projects? Should, for example, the public be notified of possible health risks that the classified project may pose even if they cannot be told about the details or about its nature? What kind of oversight should apply to classified projects? For example, should Congress review any executive action which invokes the paramount national interest exemption? If the Green Run did nothing else, it raises many interesting questions, and I hope you enjoy grappling with them. Thanks. CHAIRMAN FADEN: Thank you, Patrick. It was well done. Thank you both. We had a lot to read about the Green Run, and for some of us this is relatively new territory and very interesting reading. Let me ask one totally irrelevant question. It turns out that this is the low blower. Okay? So it either has to go off or we have to deal with the noise. Off? The noise is too loud? You'd rather keep it on? I shouldn't have asked. (Laughter.) CHAIRMAN FADEN: Do you want to move? PARTICIPANT: This is going to be one of the more difficult decisions. CHAIRMAN FADEN: Reed is not returning. Reed is not returning. So why don't you go ahead and move, and, Eli, are you very uncomfortable? DR. GLATSTEIN: No. CHAIRMAN FADEN: Okay. Then let's leave it on for the time being and see if it does inhibit discussion. You're still free to move because Reed is not returning. So it's okay, and if it gets so that we can't stand it, we'll turn it off, but I thought this was the high blower. It wasn't. Well, Patrick has left us with a series of very challenging questions, and the floor is now open, and we can either follow the discussion as Mark and Patrick have set it out or ask specific questions of the memos as well. There's a lot of fine material that we were provided. I see Henry and Lois and Ruth and Phil. Let's start there. Henry. DR. ROYAL: I find this to be a huge, complicated area, but there are a few points that I'd like to bring to the Committee's attention. The first is that environmental regulation is increasingly complex and controversial. I would recommend to Committee members a short book written by Clinton's recent appointee to the Supreme Court, Judge Breyer, entitled, I believe, Breaking the Vicious Cycle, and what Judge Breyer talks about is that if our goal as a society is to protect the public's health, that we need to take into account all of the benefits and all of the risks of various activities, and it's best that I just recommend the book to you. The reason that I brought that specific comment up was because of the discussion about whether or not it was appropriate that you expose 100,000 people to nine millirems. So the collective dose issue. In terms of the collective dose issue, again, what I would reiterate is that if we have limited resources to protect the public's health, that we have to take into account all of the risk and make sure that we are maximally protecting the public's health by spending what resources we have available to have the maximum health impact. That's the only point I want to make at this moment. CHAIRMAN FADEN: Thank you, Henry. Lois. MS. NORRIS: This should be fairly easy to answer and just for my information only. Does anyone actually know whether the Green Run achieved the hoped for results? I mean I'm just curious about that. CHAIRMAN FADEN: The question is whether it accomplished its mission? MS. NORRIS: Yeah. DR. GOODMAN: Unfortunately the reports we have talk about the monitoring activities of the Health Instruments Division, and they aren't from the Air Force talking about the success or failure of the program. Let me just read a bit from one of the reports here. "Under the worst possible meteorological conditions for such a test, the airborne instruments detected the radioactive gases at a distance of better than 100 miles from the stack. Under favorable conditions, it was estimated that with the same concentrations this distance could have been increased by up to a factor of ten." Now, I have no idea what objective criteria, if any, were placed on this test for success or failure, but that's relevant, I think, to the question. It's the most relevant information I've been able to find. MS. NORRIS: Thank you, and I had one more quick one. You mentioned that the Green Run exceeded by a factor of 100 or something the current standards for environmental releases. Today's standards? DR. GOODMAN: Right. MS. NORRIS: Were there standards in place at that time which have been changed since? DR. GOODMAN: Yes. One of the documents refers to a standard which is actually lower than the current interdiction standard for protection of vegetation, and it says the maximum I think they call it persistent concentration or permanent concentration on vegetation based on a rough estimate of the thyroid dose, I think, in animals, not in people. I'm not sure about that latter part though. The report cites it, however, with a great deal of skepticism, saying we believe the real limit is at least 12 and a half and possibly 50 times higher than that. CHAIRMAN FADEN: Right. DR. MACKLIN: I want to begin by commending Patrick and Mark for undertaking this valiant task, particularly the ethical analysis, and let me just say I would have probably done the same kind of thing looking at harms and benefits and trying to balance them and making this kind of analysis. But I'm coming to the view that it doesn't work. Now, I know that part of the motivation is to compare it with or use the methodology that is well entrenched and widely used and accepted in biomedical experiments, and I can only say there that I think in that well accepted realm the balancing of harms and benefits is often a kind of a fiction for all the reasons that you cite here, even when there is some -- I mean when you talk about the proportionality and the disproportionality and the balancing. Even when there is some way in advance, some reasonable way of quantifying or predicting what the harms are in biomedical research and there is some certainly imperfect, but some ability to predict what the likely or hoped for benefits are, even then, I submit that when IRBs are asked to do this kind of balancing it's largely a fiction, and the fictional part is in implying that the weighing is something like balancing an equation or using a pan balance scale where you can just look and see and then, you know, calibrate it. As difficult as it is there, but we sort of have to accept it, I think it's almost impossible either for intentional releases in general or as you've described this, what was known or could have been known about the harms or potential harms, on the one hand, and then as you quite rightly point out, the incommensurability of the benefits, harms to public health, benefits, presumed or hoped for benefits to national security. I mean at least in the biomedical realm when we're balancing harms and benefits, we're looking at physical harms or physical, psychological, or social harms to individuals, and then medical or physical benefits or at least even in normal healthy volunteers, contributions to knowledge about physiology. So the incommensurability is so great, that's one of the things that leads to my skepticism about the harm-benefit balancing. I have one comment which I think I conveyed earlier, and I'll share it with the whole Committee. The proportionality question as it's described on page 2 of Tab H, Part 1(a), this is the distribution question, and as stated here, it says, "Disproportionality in distribution results when the individual or groups that bear the harms or risks of harm are not the group that stands to benefit or when the entire society stands to benefit, but only a subset bears the risk of harm." Now, any research that involves normal healthy volunteers, that is, other than patients, has this feature of disproportionality. That is to say the people who stand to benefit are never the subjects in the normal healthy volunteers, and it is someone, and it's not even clear who, but someone eventually who may stand to benefit. So it's not as if -- and unlike clinical research where the patients are the ones who undergo the risks, but also may stand to undergo the benefits. So I think we should be careful. I'm just saying this. I'm not being critical of it, but only pointing out that if the same feature would be a feature of biomedical experiments in which normal healthy volunteers rather than patients are used, then that I think needs to be pointed out, the similarities and differences. So I guess in conclusion this is really an observation, not a question. I apologize for going on so long. I think what we may have to do is undertake an analysis of the appropriateness of the model. That is, as I said, this is a valiant attempt, and I would have tried to do it myself if I'd been asked to do it or forced to do it, whichever, but in concluding that it doesn't work -- CHAIRMAN FADEN: We spared you one thing. DR. MACKLIN: -- I wouldn't want to conclude that beforehand, a priori, but I think in spite of, you know, the meaningfulness of the words as they're put down here on the piece of paper, I don't know how anyone could reasonably go about that balancing, and especially if we're talking about public health versus national security with all of the unknowns that are in there, I think the answer to that balancing will come down to an individual's or group's predilection for placing public health as a very high value or placing national security as a higher value without any way of reasoned debate being able to resolve the disagreement. CHAIRMAN FADEN: Patrick, go ahead. DR. FITZGERALD: Yeah, let me talk about first the feature -- you claim that disproportionality is a feature which is common in biomedical experiments, too. I fully agree with you. I think the reason it takes on a unique aspect in intentional releases is that there is no individual consent involved. The problem of disproportionality, when you harm me to benefit somebody else, it's not so problematic if I agree to it. If I say, "Yes, I will give my kidney up," it's not a problem, but if you take my kidney without asking me, it becomes problematic. So that feature, the reason it's kind of unique here, I think, is because of the lack of individual consent. On the first question you were talking about whether this model of balancing could actually work. I'm not sure either. I think you're correct to say it does come down to predilection in the end, but I should point out that this is how agencies do it now. For example, the Clean Air Act. There's a general standard where you cannot expose an individual above a certain level, but if it's below that level, then the DOE guidance is as low as reasonably achievable, where "reasonably" is cashed out in terms of trying to weigh all of these disparate and seemingly incommensurable values. So if you think there should be another standard, I think that's the significant conclusion because you would be suggesting a new standard for the way DOE proceeds. DR. GOODMAN: I just wanted to add one point on that, and that is the question of the paramount national interest exception to the substantive environmental regulations. That would seem to allow one interest to completely trump another rather than being weighed in the balance in some way. So I think the question of balancing harms versus benefits is an important issue in determining whether these exceptions are adequate to protect -- maintain adequate safeguards for the environment and for public health. CHAIRMAN FADEN: I saw Dan wanted to say something, and, Pat, did you want to get on this point, too? All right. So we'll have Dan and Pat. DR. RUSSELL: It's very interesting because while I haven't read Judge Breyer's book, but particularly in the law, and Ken's not here, but Pat can correct me, when people don't have models, the balancing test is what comes in as sort of a catch-all, and you never know. Then the judge will say, "Well, I applied the balancing test," and that's the application, and then you argue to the next case. In the absence of a model, it's the so-called balancing test where everything gets put into the hopper. DR. MACKLIN: I think it's just as much of a fiction there. DR. RUSSELL: Legal fictions are a basic element of the law. (Laughter.) CHAIRMAN FADEN: Pat, you were on this point? Is your button on, Pat? MS. KING: I understand some of Ruth's qualms about the balancing test for some of the reasons she stated, but I would also say that -- I won't speak for ethics -- but public policy- makers and lawyers deal with this kind certainly all the time. I think that the real question here is for lack of a better model, and it just stretches my mind beyond belief to think that we'll come up with a better one. That's what I'm worried about because that's what you called for. It seems to me that the real issue then becomes what your last point was, and that is: who does the balancing and what do they take into account and what accountability can we expect from them? And we might want to focus on that. I was sitting here trying to think of some of the balances that have been struck that are pretty famous. I guess the one that's the most famous is the Delaney clause which talks about cancer, carcinogens, and the environment where Congress basically doesn't allow any, if I remember the Delaney clause well. But the balance was struck by Congress, and so it seems to me that one of the things that we're back to are the traditional accountability questions in a democracy, and that is nobody is going to be a perfect decider and nobody is going to weigh these things perfectly well. What we have to look at is to see what process determines who gets to make the decision and whether they're accountable in some more open way or at some time to a broader group. I don't see any other way out, and I think that may be critical here where you're talking about national security, where you have to be cleverer than usual in trying to think about ways of accountability. There are ways that we have. One of them, for example, is the -- I don't know how well they work -- briefings to designated outside officials. That is where some Congressmen come in -- Phil is shaking his head. I didn't say they work. I said Congress is where we're supposed to go for our democracy, Phil -- but it's that sort of out has been the way we have typically answered some of these risk balancing and benefit balancing issues. CHAIRMAN FADEN: As it happens, Phil is the next up so he gets to talk about democracy. DR. RUSSELL: The decision-making here was where the invoked the issue of paramount national interest. It's fundamentally a military type decision. It's a Commander-in- Chief's decision. The military is continuously faced with incredibly difficult decisions that trade off harm to a small minority against the national interest, and it's usually in the matter of the decisions come up as how many casualties do you expect to obtain this objective. How many body bags are balanced against the military objective? And I think the classical decision in history was Winston Churchill's facing the issue of the destruction of Coventry in order to protect the secret of the British capability with radar, and he sacrificed fundamentally, made the decision personally to sacrifice thousands of civilian casualties against what he perceived as the necessity to preserve that capability to win the war. I'm sure it was very difficult, and it was probably a decision that could only have been made by the Prime Minister personally. It was only appropriate that he make it. And so I think one of the things we have to concern ourselves with is how high up the scale is it necessary to go to affix the responsibility to make these kinds of decisions because these kinds of decisions can't be put off to a second or an independent party. This is a fundamental -- in this case they were trading off a measurable harm, a predictable harm to the civilian population for a military capability to understand the military capabilities of potential adversaries, the Soviet Union and China. We were very, very concerned about how much could they make and what kind of stuff they were making and what their potential was going to be. So I think we have to really understand that these issues are incredibly difficult. They are balanced. You balance a potential of national interest, even national survival, versus some harm, and then the question is who is qualified and under what circumstances to make such a decision and, of course, to be accountable for it afterward in some open fashion. One other comment I'd like to make is that the public comment process in the course of preparing an environmental impact statement has an immense impact on the agencies. Even though the ultimate decision is the agency's alone, they don't have to acquiesce to all of the public statements. It does, having been involved in more than one of these, I can assure you that it has an immense impact, and it changes both the content, the thinking and the outcome. So if it's possible to get public comment and so forth, that's very, very highly desirable, but some of these it apparently is going to be impossible. Then we have to really understand how to affix the responsibility, and I think one of the problems with Green Run is who made the decision and in what way was he or she accountable afterwards. CHAIRMAN FADEN: Thank you, Phil. Eli. DR. GLATSTEIN: Did I understand you right that you don't have the full story of Green Run, that some of it is still classified by the Air Force? DR. GOODMAN: Some portions of I think two of the relevant documents from that period remain classified. DR. GLATSTEIN: Why? DR. GOODMAN: We don't know what is in there. Dan can comment a little bit on that, but we don't have any indication that there's a complete set of information in documents that we haven't seen. There's just some excerpts from these documents, and people have said that if you saw what was in there, you'd understand why it needs to remain secret for national security reasons and maybe it's not particularly relevant to your work. I can't comment on that because I haven't seen it. CHAIRMAN FADEN: Dan, just as a point of order, shall we save the discussion until you do the whole thing on declassification or do you want? -- MR. GUTTMAN: I can just put out the facts. The facts may be relevant. CHAIRMAN FADEN: Sure. Jay, would you mind waiting until Dan responds on this question of classification? MR. GUTTMAN: There are two things at issue. One is the documents and the other is the information, and we've been told -- General Russell knows -- you can have documents that are secret or classified, and then you can have information that exists independently of it. So as Mark have said, the Department of Energy has said that all the Green Run information that they have has been declassified. The information that remains classified is within Department of Defense's purview. It appears to be a finite -- you know, everybody know what we're talking about. It's in this, you know, wherever it is, and -- (Laughter.) MR. GUTTMAN: -- the question, there are two questions. One is can that be made public, and we've been told at least tentatively not likely, but we're going to have to follow that through, and the second -- MR. GLATSTEIN: Even though it's 45 years old? MR. GUTTMAN: Well, Senator Glenn has just sent a letter to Secretary of Defense expressing that opinion, that he can't see anything in the 45 year old Green Run documents that should remain secret, but let me just make the parallel point. Mark was also suggesting that it's possible that we could all, I suppose, conceive of information that's 45 years old that maybe, you know, should be kept secret. I can't -- I'm not the physicist, but Mark conceives it. It may be that those documents have information not of interest to us, but information that might be weapons design secret, in which case it still might be that the information we're interested in -- General Russell's and Phil's question of who is responsible -- might be known today and can be obtained by interviews because some of the people who were involved with Green Run are still around. So there are two separate trails. One is the documents and whether they are accessible, and two, whether there's pertinent information and whether that is accessible even if not in the documents from people who are alive. CHAIRMAN FADEN: Yeah, I think the point Dan is making is a critical one. It was hard for me initially to understand the distinction between the two, but now I'm finally getting it. The document issue, just to underscore what Dan said, as best as we can figure it out here, we're not talking about tons of classified documents that somebody is sitting on and refusing to declassify. We're talking about blacked out sections in documents that we already have access to, and the blacked out sections are not a lot of text. Okay? But they are nevertheless blacked out. We don't know what's in them obviously because they're blacked out, but we don't want to give the impression that it's, you know, 20 pages of blacked out stuff. It's not like that, and so far as we can figure out, there aren't any other documents around that are wholly classified that we have not been provided, which leaves us with this big, open question: are there answers to the questions that we have in somebody's head if not on some piece of paper and can we try to ascertain that information through talking to people, even if we can't get that information from a documentary record because there doesn't seem to be one? Now, that still leaves open the question of what to do with these blacked out sentences, is really what it comes down to, in the document. Pat, is this on the declassification issue for the Green Run? MS. KING: I wanted to ask whether we have raised, and if so, what objection there is either in having somebody who has a clearance here or somebody who has a sufficiently high clearance outside of DOD who can review the material, somebody that DOD might trust and that we might trust -- CHAIRMAN FADEN: No, we -- let me just interrupt you. We can go look at it at any time, but we have been invited. Those of us who already have plans -- MS. KING: Then why have we not gone and looked at it? CHAIRMAN FADEN: That's the issue that we have been struggling with in line of the presentation that John Till made. The view was if we could get it declassified so everybody could look at it at one time, that would be best. It now looks like -- by the way was just turned off. MS. KING: Thank God because I was just about to leave. CHAIRMAN FADEN: We're trying to strike a balance. First it was hot. Then Nancy protested, and we offered her Reed's seat. As I saw that more people were getting cold, there were not enough seats to shift over. We turned it off, and we'll probably turn it on again because we'll get miserable in another half hour. So this is the subtext for all of our meetings. We'll do a guide to conference facilities. DR. RUSSELL: It's called the balancing test. CHAIRMAN FADEN: The balancing test, exactly right. MS. KING: But now is the time. Can we send somebody over? It may not be necessary to be declassified. CHAIRMAN FADEN: And we have been assured by people who have looked at it -- we don't have to take their assurances -- that were we to see the material, we would not find the answers that we're seeking in that classified material. We would learn something that maybe some of us don't want to know about that, but not the answers to the questions we're seeking. That's what we have been told by people who have looked at it. DR. GLATSTEIN: Yeah, but the point is this whole declassification/classification process is a means of anonymity that essentially blocks knowledge, blocks spread of knowledge, blocks a lot of things, protects people who make decisions, and then they're not subject to review. I mean this is -- if there really is a national security problem, it's understandable. On the other hand, it's very hard to conceive of this study, which is 45 years old, as representing a national security interest today. CHAIRMAN FADEN: Well, again, remember, just in fairness to the arguments we've gotten from the Defense Department, it's these several lines. It's not like it's the whole history of the Green Run that they've refused to declassify. I know nothing about this world, Eli. So I haven't a clue about what could be 45 years old and still worthy of classification. People who are experts -- DR. GLATSTEIN: It sounds like a bureaucrat's delight. DR. GOODMAN: Just to get a slightly more accurate description, it's something like a few pages in aggregate out of a 150-page report roughly, including over half of the first page. So maybe something about the purpose or some other background material is in there that is still classified and I don't know why. CHAIRMAN FADEN: I think the issue Pat's raising is we've been playing around with this issue now for months. Okay. We had been hoping that whoever it is who makes these determinations would reach the decision that these three pages could be declassified. There is now this letter from Senator Glenn that's been sent. If that works and the response to Senator Glenn's letter is, "We can now declassify these three pages," fine. If the answer is, "I'm sorry, Senator Glenn. As we told the Committee, we still believe that these three pages must remain classified for national security purposes," is it the will of this Committee that some subset go look at the three pages and come back and give some sort of report about what's in them? DR. GLATSTEIN: Yeah. CHAIRMAN FADEN: Yes. Fine. MS. KING: You may not be able to report, but I -- CHAIRMAN FADEN: Only report that -- MS. KING: -- but I do think that you need some independent determination that it is not of value to us that comes from this Committee. CHAIRMAN FADEN: It would seem to me that it would be with the understanding that some subset of Committee and staff went to look at this that we would be free to report on that point. It is or it is no relevant. If we report that it's relevant, okay, it puts those of us who go to see this in a terrible disadvantage, which was the dilemma that was raised earlier in the course of our deliberations. It would also, however, give more political leverage to the argument that it ought to be declassified, but that doesn't necessarily follow that we'd be successful with it, any more successful with a declassification request than previously, but we just have to all know the dilemma on which we are embarking if we go to look at those three pages. Henry. DR. ROYAL: I don't see what we have to gain by waiting to go see the document, wait another month or two to see what happens in response to Senator Glenn's letter. If Senator Glenn's letter is successful in declassifying the document, then fine. If it's not successful, then we're going to have to send someone two months from now, and I don't see any advantage of waiting two months as opposed to doing it now. CHAIRMAN FADEN: Phil, did you want to weigh in? DR. RUSSELL: Knowing that the original intent of the test was to develop intelligence capability, one can only assume that the remaining classified material relates to intelligence capability. I could also make the assumption that given the political liability that the Air Force is taking on by keeping that classified, they must have a pretty darn good reason to do so. CHAIRMAN FADEN: Yeah, I'm kind of persuaded by that at this point, too, the pressure. DR. RUSSELL: So I'm quite comfortable with the idea that we're not going to get any more information about those issues that this Committee cares about, and it may cause some difficult with communications if, for example, Ruth -- DR. GLATSTEIN: It's hard to imagine -- DR. RUSSELL: -- she has to state in public that she can't talk about it because it's -- DR. GLATSTEIN: Well, I appreciate that, but it's hard to believe that the technology over 45 years in that area has not changed so dramatically that what was learned and even the reasons it was ascertained in the first place are not irrelevant in 1994. DR. RUSSELL: Maybe. CHAIRMAN FADEN: One of the problems is I feel like such a rank amateur here. What do I know? I mean it's a very awkward situation to be in, and Phil is right. We're all in that awkward situation, where none of us -- you know, well positioned, but we're citizens. We've got to make a judgment here about how to proceed. It affects the dynamics of the Committee, and -- maybe it should be staff? DR. KATZ: The chair of the Committee or another member of the Committee who has clearance because you're in much too pivotal of a position. CHAIRMAN FADEN: I actually am glad somebody else raised that. I have a similar concern about my being the person to go see it. I think that it puts me in more of an awkward -- I appreciate your saying that. I hesitated to do that because I didn't want to suggest that somebody else be the person. DR. KATZ: Who has clearance on the Committee? CHAIRMAN FADEN: Does any other Committee member, Dan, have clearance yet? MR. GUTTMAN: Unless Phil has clearance, I don't know. You're the only one I know of. CHAIRMAN FADEN: We are trying to get people, and this has been whatever problem. There are several staff members who now have clearance. Mark has clearance. Patrick, do you have clearance. Mark has clearance. MR. GUTTMAN: Eight or nine staff members. CHAIRMAN FADEN: Eight or nine staff people, including Mark, who has obviously been following the stuff, has clearance, but we could either have this be a staff issue or we could push for someone else on the Committee. MR. GUTTMAN: Well, let me ask. Is what Phil was saying that we shouldn't? You weren't suggesting, Phil, that we shouldn't look at the document or were you? DR. RUSSELL: I would think it would be not advisable for Ruth to look at the documents. If the staff plus one other Committee member -- DR. GLATSTEIN: That would be fine. DR. RUSSELL: -- that would suffice. CHAIRMAN FADEN: Well, we can push on that matter. I think it's probably a good idea that Phil not be the one Committee member who looks at the material. DR. MACKLIN: I have a question, too, about this which is not to argue that we shouldn't look at it, but I think we have to at least be clear about what information or what kind of information, not obviously information, what kind of information we might find out that would bear on our work, number one. I mean, for example, is it going to enable us to do the balancing a little better because now we just have -- Phil's saying no, and I agree -- but I'm saying now we just have some general statement like national security versus general against public health, and I've been a little bit skeptical about this kind of weighing. Is it some information about, as Eli is suggesting, the people who made the decision, that is, where the responsibility lies? And if so, how is that relevant to what we're doing? In other words, I'm only asking if we can identify what we don't know that we would need to know to help our work, it would seem to me that would make it much clearer whether we ought to go do this or not. CHAIRMAN FADEN: We've got Nancy and Dan wanted to respond. DR. OLEINICK: Well, one of the concerns certainly is was there a discussion as to the impact on the population that was going to be potentially affected and should they be notified, and if the discussion led to a decision not to notify the public and to just let it happen, I think that might be rather -- you know, that would certainly go to the issue of would it impact our benefits and -- DR. MACKLIN: Well, we know that the public was not notified. DR. OLEINICK: We know that they were not notified. We don't know whether it was ever discussed. DR. MACKLIN: Yeah, wait a minute. We know that they weren't notified. So you've got two possibility. Either nobody even thought about discussing it, you know, which is pretty bad, or they discussed it and decided to hell with the public. I mean I don't see how in either case -- (Laughter.) DR. MACKLIN: -- it's going to -- you're right if we're fact gathering, but the question is: how does it bear on conclusions that we want to reach? Now, one of the central questions that -- I mean and the one that Patrick identified and the one that we're certainly concerned about -- is could this happen again. Now, if there's anything that we might find out by looking at these documents that would shed any light on that question, I think it would be significant and absolutely necessary to do it. But whether they discussed it or not or failed to discuss it, either way, I mean, there was a little bit of an omission there. CHAIRMAN FADEN: Dan, did you want to? MR. GUTTMAN: Well, just to comment on what Ruth -- to a lawyer, it's sort of the relationship between the formula, Ruth's question of, well, if we got more facts what would we know, which is the standard law school "what would you like to know" and you still can't figure out the answer, right? And the process, which is the notion of the deterrence factor in saying - - this is the part with Phil and what Pat was saying -- that decision-makers know that they will be obligated to tell people these things. Now, your point is, well, we can draw an adverse inference if they want to keep it secret. We'll assume the worst. That's sort of the balancing there. CHAIRMAN FADEN: Eli. DR. GLATSTEIN: It just seems to me, however, that when you talk about national -- I mean Mark used a great term. He used the term "trump," that national security trumped all other interests, and obviously there are times when that's perhaps true, but I hate the idea that anyone can just say "national security over any damned issue" and trump any other cause, any other basis for decision-making. DR. RUSSELL: You're speaking to the issue of the capacity of administration, the Commander-in-Chief, to govern and protect the national security. He has to have that leeway. CHAIRMAN FADEN: I think the issue is not that the Commander-in-Chief shouldn't have it. The issue is what are the procedural safeguards. Was this really a decision by the Commander-in-Chief? We don't know that. DR. RUSSELL: Well, I don't know, but I mean certain people putting words in the Commander-in-Chief's mouth. (Simultaneous conversation.) CHAIRMAN FADEN: I think where we're going as we go towards this is the Committee first has to conclude can we acknowledge or do we want to acknowledge that there might be instances in which intentional releases that have adverse effects or potentially adverse effects on civilian populations might be justified on national security grounds. If we want to acknowledge that there might be such a case, then we would move to the issue of what are the appropriate safeguards for assuring that it only occurs truly in an emergency or whatever the right national security language issue is, with the right safeguards for the national interest, and we can have Pat and Phil and whomever debate about whether Congress should have a role or not have a role. DR. GLATSTEIN: Yeah, I don't have any problem with the President saying this is national security. I have a problem with the general saying it. CHAIRMAN FADEN: So that's kind of what that issue is. We don't know authorized the Green Run. Okay? We don't have a clear fix on that, and that is a key issue. At least I don't think -- is that right, Patrick and Mark? We don't know who authorized the Green Run. DR. GOODMAN: I think that's correct. I think it's plausible -- we obviously don't know -- that that kind of information might be in there, and it might even lead to us asking the Air Force to look in a particular place, although that's speculation. CHAIRMAN FADEN: That's where I think it bears to your question, Ruth. Now, whether there's the answer to that question in this blacked out stuff, you know, we don't know, and if it turned out that the answer was there and we still couldn't get it declassified, we are in a funny situation at best, which is sort of my concern. So now we'll know there's the answer to that in there and the people who know can't talk about it. I mean we're sort of stuck. But my guess is that there's still going to be lots of stuff that we're not going to know even if we look at this material, and then we should still be pursuing the avenue you mentioned, Dan, which is trying to find out if it's possible to get any information from people's recollections of what happened and hopefully get that declassified, get people free to talk to us on the record about their recollections or their knowledge of what happened in Green Run, which is an avenue we have yet to actively pursue. Duncan. DR. THOMAS: Mark mentioned earlier on in his presentation the suggestion by someone or someones that there was some other purpose for the Green Run as well. I'd like to know if this is anything more than just a rumor. Is it based on anything? Are you free to tell us who makes these suggestions? DR. GOODMAN: Let's see. I talked with Bob Alvarez, who is now with the Department of Energy, and he hadn't looked at it for some time. He thought there might be something to do with radiological warfare. The General Accounting Office said they found no evidence of that. I was reading a book on environmental releases at Hanford suggesting that they were testing the option of shortening the cooling time as a routine matter so that they could increase plutonium production, but again, that's speculation. This is not a classified source. It's like quoting someone else and reading between the lines. DR. THOMAS: I guess my reason for raising this is I feel pretty strongly that we don't know the purpose, and whatever we've been told so far about it has something or other to do with intelligence gathering, long-range detection of Soviet activities, somehow doesn't seem to wash for me. It just doesn't make -- it doesn't make sense. It's hard for me to imagine what measurements we would have made around Hanford that would be of any real use in detecting that at very long range distances, anything really useful about what the Soviets were up to in terms of measurements made outside of Soviet air space that we couldn't have found out by some other means. So I feel pretty strongly that there's got to be a hidden purpose in here someplace or other. It may have to do with long-range detection, indeed, but if that's the case, we ought to be able to document that. I don't see any way we can find this out without actually looking at these documents. CHAIRMAN FADEN: Jay, did you want to say something? DR. KATZ: Yes. As Pat mentioned and Dan mentioned, balancing is the way of law, and balancing is problematic. It's problematic. The area in which I know the most about balancing is in family law and the best interest of the child, the doctrine which allows the judges to balance, but it doesn't only allow them to balance, but it gives them a tremendous amount of discretion and a tremendous amount of authority, and one can make and, you know, surely in the classroom one can begin to make some inroads in the analysis of the doctrine on what aspects of the balancing should be removed from judicial discretion, and judicial discretion ought to be curtailed. So I don't think we'll be able to get away from balancing in our work, but we don't really have necessarily to engage in reworking the Green Run and impose our own balancing on what transpired then, but what we might be able to do is two things. One is to discuss to some extent the problematics of balancing and the kind of balancing that generally has occurred, and also some of the things that Ruth Macklin referred to yesterday about what is being balanced, the kind of different things that are being thrown into the hopper, and we might be able to alert the reader that to the extent to which we have to live with the dangers of balancing, that balancing can be accomplished and done in a much more careful manner. But a related issue here is -- and I think we ought to do some more thinking and work on it -- is the whole problem of secrecy and national security because that's going to be the recurrent issue in the years to come. Can we begin to, again, let policy-makers and the public know about the problematics of invoking national security and investing it with secrecy? To what extent can it be limited, particularly in non-Cold War kind of situation? What kind of constraints and responsibilities can we impose on our Commander- in-Chief? There are some in the Environmental Protection Act, I mean, that he has to inform Congress about exceptions. Now, I do not know what that means and whether that's sort of a pro forma kind of statement, but can one think about these matters more carefully? After all, in the last 15, 20 years, we've tried to get away from the issue of secrecy. The Freedom of Information Act, including Secretary O'Leary's call to arms and the President's endorsement of it. So I think we should say something about it, not necessarily providing any solutions, but alerting people to the dangers and whatever bits and pieces of recommendations that we can make, so much the better. CHAIRMAN FADEN: Yeah, I think that unfortunately we've got a time problem. I think that where Jay ended is about where we need to end. Let me say a couple of things. There is a proposal I'm going to bring up when we go to do our strategy thing that would include -- and it follows a plan we had anyway -- a major discussion of secrecy and national security issues in December, in any event. So we will be revisiting the general themes about how this relates both to intentional releases and to biomedical experiments, actually visiting for the first time in a full-blown way. It would be helpful because we haven't had a chance to go through all of this, particularly with regard to the ethical framework for intentional releases, if we could get comments from Committee members about whether the framework that's proposed is more or less acceptable to run with as a structure for report writing and for further work, as well as the specific analysis, but that's being proposed as something for Committee endorsement. Maybe if we could just take a look at it at our leisure, which is Tab -- what tab is it? -- H(1)(1) and see if we're willing basically to endorse this as the structure or framework for looking at intentional releases, that would be a very helpful step. If everyone is all right, I'd like to declare our short break now and make it be very short, five or ten minutes at most. Then we will begin with the presentation from the subcommittee and hopefully still have an hour and a half or so for Committee discussion of strategy, blah, blah, blah. (Whereupon, a short recess was taken.) CHAIRMAN FADEN: Would the Committee members please come to the table? We're going to go hard and fast here. We have a lot of work to do. Come, guys. We're going to begin with the subcommittee report. So who's doing this? And we should have a document in front of us. Is that the document that was circulated yesterday? MS. CHANDROS: Yeah, there were two. CHAIRMAN FADEN: There were two documents. MS. CHANDROS: There should be something everyone got this morning, an update memo, four page. DR. MACKLIN: There are two documents. Let me identify what those are. The first one Anna is holding up that's dated November 8, 1994, update research proposal review project. Sara is going to talk about that and tell you both where we are on getting the proposals from the agencies and some additional points that we have to discuss about quota sampling, and after we do that discussion, we will then turn to a coding form that has been prepared and is undergoing constant revision even as we speak, and I'll say a few words about that. But first I think Sara knows so much more about what's happening on these points for discussion that I'm going to turn it over to her. MS. CHANDROS: Okay. Staff has been working on implementing the quota sampling scheme that the Advisory Committee adopted at the last meeting. the first thing was to get more materials on hand to get an idea of the universe going back from FY 1993 and put together the new table of what exactly that universe looks like. If you refer in your memo on page 3 under Roman numeral two, that's the updated matrix, what it looks like now, going approximately FY 1990 to FY 1993, and I'll be referring to that throughout the presentation. We determined the goal was to get between three and ten studies in each category, and these categories are divided extramural and intramural within the five agencies we're dealing with for this project and through four biomedical categories. It's diagnostic, therapeutic, tracer, and the epidemiological or experiments of opportunity. We found that going back to 1990 we were able to fill many more of the cells than we were previously, but there are still a few that are questionable, but I think we came much closer to achieving our goal. I should back up and say in obtaining these materials we went back to the agencies who for the most part were very cooperative. We still are waiting on DOD extramural materials. So the table is not yet fully complete, but we're close to it, and so that you can see on the table the denominator in each cell is the total number of studies available from FY '90 to FY '93. In cases where there were more than ten in a cell, we randomly sampled ten. In cases when there were less, that's indicated, like we have eight out of eight or three out of three, and I should also add we decided to anchor these studies in FY 1993 and then went back as far as necessary, and it seemed that going to 1990 was an adequate sample. We kept it within the most recent decade in which we're currently doing research. The next step, once we selected a maximum of ten studies in each category, was to go back and obtain additional materials on each study that we can use later for the evaluation. That involves going to the agency for certain materials and ultimately going to universities or other research institutions for certain materials. On the intramural side, we're going to get all of the materials from the agencies, and these include the original research proposal or grant application submitted by the investigator to the agency and then the protocol submitted to the IRB at the research institution, the consent form submitted to the IRB, the consent form as approved by the IRB, and then the IRB's final disposition letter. And the in addition, since we're going back to FY '90, we want to get any documentation that would indicate changes to the protocol over time. On the extramural side, we're going to only get the grant application submitted to the agency from the agency and all the additional materials, we're going to go to the universities for. We've actually begun to receive some of these materials on the intramural side, and we have them on hand to begin working on the evaluation, which will be discussed in a little while. The requests to the universities or the other research institutions cannot be processed until we have a complete set of materials, until this entire table is filled out. So we're still waiting on that one DOD piece before we can go ahead and synthesize our requests because those need to be very concise and organized. So that's the one limiting factor we're waiting for. There's a few issues that have come up in the meantime that I want to present, and we can talk about them now or they need to be addressed before we can continue. In the selection of a parallel sample of nonradiation studies, they're going to look something like -- they're going to reflect proportionally the amount of studies that we see here in Table 2, but to some smaller proportion. I'm sorry. I'm not explaining that clearly. For every two studies here, we want to have one or we want to have a one-to-three ratio. Previously we discussed one to three. It looks like one to two might be more reasonable given that we have a total of approximately 180 studies that we're dealing with. If you go on to page number 4, we presented a possible scenario for this for selection of a parallel sample. And then another question is: do we want the parallel sample to reflect the total population of radiation studies or only the ones that we sampled? I'm not sure how we should proceed to that. So we need to address that issue before we go on. I think that presents the overview of this side of it. DR. GELLER: Also, Sara, what about the issue of eliminating cells where there are fewer than three studies? MS. CHANDROS: Thank you. DR. GELLER: That's a decision that we need to make. MS. CHANDROS: Right. DR. GELLER: On Table 2, there are several cells where there are fewer than three, even going back as far as 1985 in the case of NASA, and whether we want to eliminate those cells. MS. CHANDROS: We might choose to review them in a nongeneralizable fashion just to keep them in the study, but know that they don't fit with the quota sampling scheme that we're talking about, but hold onto them to give us some indication of what some of the agencies are doing. That simply means that the agency doesn't do that much research, doesn't do any research in those categories or does very limited numbers, but we need to figure out how to take that into account. DR. MACKLIN: Yes, because it raises completely different issues. CHAIRMAN FADEN: The floor is open for discussion of the sampling, and then Ruth will present the evaluation issues and we'll talk about those separately. So this is comments or reactions to what Sara's got here. I've been meaning to say you've done a wonderful job, Gail and Sara, in pulling this together, and this is really exciting. DR. THOMAS: I guess we can talk details later. It's not -- so I don't want to dwell on these things. Just a few quick responses to a couple of the questions you raised. I would suggest that drawing the control sample you do it in relation to the sample that you have drawn rather than the population so that in some sense you can compare one sample to the other most directly. Again, it's not our purpose particularly to characterize the universe of all government research, nonradiation research. We're not particular interested in that. What we are interested in doing is making comparisons. With regard to the small sample sizes, it's really pretty academic what you do. I mean there's not a lot of effort being devoted to them anyway. I would advocate including them, and obviously any conclusions that one would draw about those cells would have to be very limited anyway. Regarding the VA, are these totals of seven that you've identified over the total 1990 and 1993? I can't tell which, whether that's because so far you've only looked in 1993. MS. CHANDROS: I'm sorry. Could you say it again? DR. THOMAS: For VA, VA intramural, both VA, that's all there is. MS. CHANDROS: Right. DR. THOMAS: There's only seven there. Is that all that they've done in radiation? CHAIRMAN FADEN: Does that go back to 1990? MS. CHANDROS: Yes, yes. I'm sorry. Yes. DR. THOMAS: Okay. Not much more you can do about that. MS. CHANDROS: Right. CHAIRMAN FADEN: We could go back and fund some investigators that were turned down. These are sample size. I don't think it would be, but I don't think that would be very legitimate. So short of that, we're sort of stuck. Are there other suggestions for -- MS. CHANDROS: Well, the one other question was if we're going to sample the parallel sample of nonradiation studies based on the sample of radiation studies, what proportion should we use there, one to two or one to three or something else. DR. THOMAS: The resources permitting I would be more comfortable with a larger sample just because as you start carving it up by agency you're going to end up with some pretty small numbers if you go one to three. CHAIRMAN FADEN: Could I make a suggestion? Given the -- are there other comments from other members of the Committee? (No response.) CHAIRMAN FADEN: I have this feeling, Duncan, that there's a tremendous confidence on the part of your colleagues in your advice to staff on these matters, and if it's all right in the interest of Committee time, if we could deputize Duncan to continue to work, to advise. (Laughter.) CHAIRMAN FADEN: I mean I don't hear anybody else jumping up and down with burning suggestions on this sampling matter for good reason, and so it seems as if the most efficient thing would be for the Committee to essentially rely on Duncan to work with staff. Whatever you all decide on these matters, I think the rest of us will be quite satisfied -- is the correct thing to do. Is that okay with everybody? (No response.) CHAIRMAN FADEN: So now we go on to the part of this project that involves everybody, and, Ruth, do you want to take it from there? DR. MACKLIN: Yes. This is the coding form entitled "Human Radiation Research Proposal Review Project Evaluation Coding Form" that we passed out yesterday just before we left. This is the third version. There will probably be more, and I requested that you please look at this if you could overnight for global comments, although specific comments will be welcome. Now, there are already proposed changes to what you're actually seeing. So it doesn't make very much sense to tinker with these items right now or to view this as the final version, but let me suggest the two main things we're interested in with regard to the specific items, numbers one through 29, and that is: do any of these questions seem irrelevant or unnecessary? That is we don't want to gather information -- remember this is a form that each of us will be using in reviewing the proposals. So we don't want to make this task more onerous than it already is, and we certainly don't want to be checking things off on boxes if the information is not going to be useful. So one thing when you look at these items, and we're not going to do this right now, but if you could do it as soon as possible and then convey the information to the staff, probably to Gail, but if she's not there to Sara or to me, and we can then eliminate with is eliminable. Also, if there's anything that's not on here that you think is a question that is pertinent and important and should be asked, we can help flesh out the As through Js or whatever, but if there's anything missing here, we want to know that also. Let's give one example because Ruth Faden had one or two suggestions for things that are on this form that are going to be omitted, deleted because they seem absolutely unnecessary. Does somebody have that, remember what those are? Number 9. Number 9 is on page 3, and it's about recruitment process, and it asks about the procedures involved. Ruth can give her reasons for saying why this isn't necessary, but this is an example of, yes, well, we thought of this as having ethical issues, but how is that going to bear on our judgment of the protocol, and the decision was it probably won't. There was one more example, I think. DR. GELLER: There were a couple of other examples that involved combining questions. The suggestion was that we combine Questions 2 and 3, thereby eliminating three in its current form. DR. MACKLIN: All right, but these are details, I mean, just to give you an idea of what will be changed, but the kind of thing we will seek your input as well. Yes, Jay. DR. KATZ: In light of what Ruth Faden said, to the extent possible, it's a long document. If some of the questions can be combined rather than going on for five, six pages, so much the better, and it seems to me, you know, with respect to the point raised by Ruth Faden about do we need anything about the recruitment process, if one wants to at the very end, one can sort of flag a number of things that may be omittable as questions and just say, "If you have any comments to make about the recruitment process, this, that, and the other thing," it sort of flags something for the evaluator, and it may lead to his or her making a comment, but if a number of these other items can be flagged in that kind of a fashion, it would make the forms less onerous. The only addition I would make is 29. Is there anything about the research -- oh, no, there are two things I wanted to mention. The first one is is there anything else about the research that raises ethical concerns. Maybe there should be another half blank page added to it. (Laughter.) DR. KATZ: You know, if there is anything, that's going to be part of the meat of the inquiry. And finally, with respect to Item 2, and it applies also to another, two in Item 2, it says now "yes," "no," "not applicable." That should be "yes," "maybe," "no," "not applicable," because it won't really be a yes or no at times because sometimes something is mentioned, but it's mentioned sort of very much in passing and hopefully it will be elaborated on with respect to 29, but I think you might want to consider having a "maybe" item for two and 20. CHAIRMAN FADEN: Well, the notion, I think, now in the proposal is to take 20 and 21 and sort of combined it in some way. DR. KATZ: Oh, okay. DR. MACKLIN: Yes. In fact, Jay, we tried actually in this version, I think, to account for any situation in which these three choices, yes, no, or not applicable, do not cover all of the options. So you might want to say "yes, but not adequately," or "only to a certain extent" or "poorly" and not just "yes," "no," or "not applicable." And for those questions, I think there should be for any question that admits of those additional options the comments in the line underneath that says "comments," allows one to say, for example, under three, "B and D are not adequately discussed." So that all the lettered items can be referred to under these comments. So we've tried to capture that. I think we'll try to take one more look to make sure that any time there's something other than yes, no, or not applicable, there's a comment line, and that's where that should go. DR. OLEINICK: I have a concern with the ability to capture information, as to whether the reviewer feels that the study was worth doing. You have certain questions here, for example, number 13 that asks how accurate is the background information and the rational. If it's an area that I know something about, I might be able to answer that quite directly. If it's in an area that I'm not familiar with, for example, if I'm asked to review a protocol in cardiology, I may not be in a position actually to address that question very well. And then the next question -- DR. OLEINICK: Could I just have a word on that one? DR. MACKLIN: Yeah. DR. OLEINICK: Would it help then to have an additional category "unable to assess"? DR. MACKLIN: I think that would be very important, but I think we have to go one step further, which is to ask how much do we want to be able to address the question from an ethical point of view. Do we want human subjects involved in this study, if the study isn't worth doing? Now, presumably in the original peer review there were reviewers who knew something about this subject and could address it, and I think we have to just decide whether we want to ignore that subject, figuring that it's unlikely that we're all going to be experts to be able to evaluate that in every aspect, or we need some more pointed questions to address it. I mean one way or the other. DR. OLEINICK: And you're really talking about scientific merit -- DR. MACKLIN: Scientific merit. DR. OLEINICK: -- as opposed to number 27, which was our attempt to get at -- DR. MACKLIN: Yes, I know. There were two questions here that asked -- well, okay. That's sort of coming at that question obliquely. There was also the question of did the investigator discuss the scope of the study. Okay. That's fine, and that comes in in the proposal and in the consent form, and again, it's all sort of dancing around the question, and we may not want to answer that question. We might want to say, "Look. We can't. There's no way we can judge that." CHAIRMAN FADEN: How about the following as a compromise? One suggestion would be 27 asks us to make a judgment if each of us as the reviewer believes that the risks are more than minimal. Admittedly, again, you're imposing your own sense of that. Do you think the benefits to the subjects outweigh the risks? That's something that presumably in most cases or in many cases we might feel we could do even if we were not expert in that area. We might also have another item that says only for projects that are more than minimal risk in the view of the reviewer, just for efficiency said, we might then ask the reviewer to make a judgment about scientific merits or how valuable -- if it's not your area of expertise, then the Committee could seek to have that protocol reviewed by somebody who is for that issue. How important or how good is this? I don't know what language, but something like that. So if it happens to be a radiation protocol that goes to one of our radiation scientists, they might be able to render a judgment on the scientific merit. If it goes to one of the rest of us or it happens to be one of the comparison projects and is in cardiology or orthopedics or what have you, we could seek outside consultation on that point, but only for studies where the reviewer makes a judgment that the risk to subject is more than minimal. Now, that's acknowledging that if it's worthless research, you shouldn't even bother a human being as an ethical matter, but as an efficiency sake, we sort of make a compromise and say we only seek that where the risk is more than minimal. I don't know. It's just a proposal. DR. MACKLIN: I have forgotten right now why we eliminated the basic risk-benefit assessment question. That is, the questions here only address the question of whether the risk is greater than minimal and then, if so, is the risk associated balanced against the potential benefit, but I thought on the earlier version we had the fundamental question, and since most protocols probably will be judged to be minimal risk -- they usually are on IRBs -- then Nancy's question, is it worth doing, is really in the IRB mode or in the way of evaluating research answered by looking at the risk-benefit ratio. CHAIRMAN FADEN: What are we going to do in those areas where we don't have -- I mean do we want to have that expertise sought somewhere else, particularly if it's nontherapeutic research? But even if it is -- DR. MACKLIN: Well, there are two questions, aren't there? One is do we need the fundamental risk-benefit question. Gail, do you remember what happened to that question and why we don't have it anymore? DR. GELLER: Well, are you talking about something other than 22 and 23? Twenty-two was definitely added after our last conversation. DR. MACKLIN: Yeah, but we're not asking for the risk. It belongs on the reviewer's subjective evaluation. That is, it really is in the last items where we're not asking descriptively what these documents say, but we're asking the reviewer to behave as if the reviewer were on an IRB and make a judgment about the relationship between benefits and risks. Now, there are two reasons why a study may not be worth doing, Nancy. One may be its scientific merit can be so poor you're not going to learn anything. So it's got an infinite benefit-risk ratio, in which case I mean it's really a scientific judgment about the sloppiness of the science or the methodology, but then the question is it worth doing is a different question. It's really the ethical risk-benefit ratio question, which perhaps we ought to put back in here. CHAIRMAN FADEN: Then we have to figure out some mechanism where if part of the benefit would turn on evaluation of the utility of the scientific information. Those of us who don't have the scientific expertise to render that judgment, and we know that it's not going to be at all on this Committee for some subset of the comparison proposals, would have to be addressed. We'd have to find some way to get that expertise in. That's why I was coming up with this compromise, but maybe the compromise is too much of a compromise because if you're right and most of these come out as less than minimal risk -- DR. MACKLIN: If they come out as minimal risk or less, then there's a whole dimension that's missing here. CHAIRMAN FADEN: That's right. If we do it that way, that's correct. How about if -- should we just struggle our way through this, try to figure out some way rather than in full Committee? DR. MACKLIN: Yes. Well, here was the proposal. What we were really hoping for were global comments, and these are helpful in a way as global comments. The subcommittee will be back to work on this endlessly until it's complete, and that should be soon because we should be receiving protocols reasonably soon, proposals for review. What we are going to ask is two things. The thing I already asked, which is that everyone please look again at this form and make any additions or suggestions for deletions and pass that on to us immediately, and the second is if you were willing to deputize, authorize the subcommittee to work out the final form so that we can begin this process. I mean members of the subcommittee, raise your hand so those who aren't on it can see to whom they're delegating this. (Show of hands.) CHAIRMAN FADEN: It's a live subcommittee. DR. MACKLIN: Yes, this is a large subcommittee. We meet by telephone. So if this Committee is willing to authorize the subcommittee to finish up the form, then we'll have your input following this meeting, and then we'll complete it. CHAIRMAN FADEN: Is that okay with everyone? Good. So what will happen is there will be a finalized form before the next meeting, and so if you're not on the subcommittee, you have two choices. I mean you have the request that Ruth has to send in your comments. If you want to join the subcommittee, you're welcome to do it, and we're going to get to that in just a minute. I mean if you really are very concerned about how this form ends up looking, please join the subcommittee because the decision will be made between now, and it will start to be used hopefully before the next Committee meeting so that we can get this done in a timely fashion. So it's sort of like "join us or don't complain" basically. That's what it comes down to, but it's a large group already. So it can be larger for anybody who wants to join us. DR. MACKLIN: Is that it? CHAIRMAN FADEN: Okay. Thank you all very much. And now we go on to an extension of this discussion of large versus small subcommittees. There are so many things that it would be good to do in the next hour and 15 minutes. Let me before I forget, Gail is going -- can you go ahead and circulate? One of the things we took off the agenda was a report from the Oral History Committee. In the interest of time, there's a written document. Please at your convenience, but quickly, critically review that document and get any comments back to Gail as quickly as possible at Advisory Committee offices. Again, anyone who after reading this decides that they would like to be very majorly involved in the oral history project is welcome to join that subcommittee. DR. KATZ: That's the oral? CHAIRMAN FADEN: The oral history project. DR. KATZ: It's coming out? CHAIRMAN FADEN: It's coming now. So I wanted to announce it rather than having another piece of paper. So please put this away with a note to yourself that this is something that needs comment and feedback back to the Committee, but we're not going to discuss it now. It's a report on where the oral history project is going and seeks Committee input. But if we could please not look at it now, I mean, I know it's a temptation, but put it away. Rather than go through a whole bunch of small points, just sort of working backwards through the issue of subcommittees, I wanted to propose a proposal for next month's meeting, which is something that I worked on with some of the staff after the meeting yesterday, as we were trying to figure out how to deal with this complex of issues, and the proposal is as follows. The proposal is that the December meeting be given over to these complex of large foundational framework guideline setting issues that we have only inadequately had an opportunity to address today, and to delay further working with particular case studies or hearing from project subcommittee reports until the next meeting. Let me tell you what the specific topics are to which the December meeting might be devoted. First, the issue of our deciding what criteria we want to use for retrospective moral judgment, essentially continuing the discussion that Ruth started us on today. Second, the issue of remedies, which we started with today, and ideally a discussion that linked the two would be what we would be struggling for, some way of sort of putting this all together. In addition, an interpretation of policies of the past, typified by the exchange between Jay and Ruth about what are we supposed to make out of the documents we have about consent provisions or policies during the historical period of interest, which will relate to issues of how we're going to understand the retrospective moral judgment question, as well as as much as we have available on practices during the historical period of time of interest. So insofar as the oral history project has any data to report, we would start to look at that and also what we can gain from secondary sources, as well as the issue of national security and secrecy, starting to take together then the questions of ethical criteria and retrospective moral judgment, question of a structure for remedies, putting that together with issues of national security and secrecy, and what we can -- how we are going to interpret the historical record with respect to policies, which of course bears on remedies and bears on retrospective moral judgment. How do we come to understand what these documents mean? And whatever we have available to us at this point on the subject of practices during the historical period, which again gets to issues both from the ethical framework point of view and the remedies point of view. Just what's our factual basis for concluding what was normative practice at the time? And then the question of how relevant is whatever we know about what the normative practices were for whatever position we want to take on remedies and questions of retrospective moral judgment. How to structure, how to package those five important topics during the two days is a real challenge. I'm not sure exactly how we're going to do it, but the proposal is that we somehow devote the entire meeting at this pivotal time in our deliberations to these big issues, trying to put them together with the goal at the end of coming up with a tentative working framework for both the question of moral judgment and ethical standards, the question of remedies, and the relationship to national security and secrecy. Now, we may decide to revise that framework as we start to apply it to cases, but at least we are at a position now, I hope, where we can try to come up with one, and if we cover that we do not have consensus on certain key points as yet, we'll work with that. Okay. We'll work with whatever we get. So that's the proposal on the table. How does that strike people as the agenda for December? Ken. MR. FEINBERG: I have no problem with the agenda, but I want to ask a question which picks up on a valuable point that Jay made this morning, which is on the one hand, the way you lay out the proposed agenda for December, you can't really talk about remedies because a portion of the remedies chapter requires a determination on the subject of things like retrospective moral judgment. CHAIRMAN FADEN: Well, we're going to try to put it together. MR. FEINBERG: Well, but when you say you're going to try and put it together, you mean you're going to try and circulate something in advance of the meeting? CHAIRMAN FADEN: Oh, yeah. MR. FEINBERG: All right. CHAIRMAN FADEN: Oh, yeah. MR. FEINBERG: Because you see, Jay is right. I think that -- and I guess I'm preaching to the choir, at least at the chair -- but I think it would be a mistake to defer a draft remedies guideline chapter until we debate retrospective -- I mean it's time to crystalize. CHAIRMAN FADEN: No, I think what needs to happen is that the work that's ongoing needs to be connected, the staff work. In other words, the remedies group, you keep doing what you were going to do. Come up with more concrete proposals. The people working on retrospective moral judgment papers for the Committee should continue to work on those. Ruth will continue hopefully to work with Allen Buchanan as some of the staff and I have been working. Then maybe the real challenge for the staff is to try to put those two together and say: look. Here's the relationship, okay, between this position with respect to retrospective moral judgment and this position with respect to remedies. See the links? That sort of thing. Try to get it out and then lay out for the Committee, you know, here are different packages or different approaches we could buy into and have a debate about those approaches. So it was not my intention to give the impression that the work stop until we have this discussion, but rather that the work continue so that the Committee can have as informed and concrete a debate of these issues as the Committee possibly can. Ruth. DR. MACKLIN: Following Ken's thought, I'm wondering if there's some way to put it together in advance. That is -- CHAIRMAN FADEN: Yeah. Oh, yeah. That's what I proposed. DR. MACKLIN: But in the following way. If the Remedies Subcommittee could think, as lawyers are wont to do, hypothetically, if this determination is made about retrospective moral judgment, what would then follow for remedies? So that all we'd have to do is fill in the antecedents and the Remedies Subcommittee could begin the work of thinking how it would fit, how the various remedies would fit against different options. MR. FEINBERG: I have no problem with that. It would be preferable, I think, if the various subcommittees working with staff in the interim were to develop their own recommendations and then the staff synthesizes -- CHAIRMAN FADEN: Let me propose the following. MR. FEINBERG: -- before we meet. CHAIRMAN FADEN: What I would like to propose is the creation of a uber subcommittee, a super subcommittee, which is to say take the people working on the legal stuff -- I shouldn't say "legal" -- on the remedies stuff because we don't want it to be fashioned that way, but the Remedies Subcommittee, and the people who have been working on the ethics issue. Make it one subcommittee with the different working groups. You should continue to do what you planned to do, and the people working on the retrospective moral judgment issues would continue to work on those questions. The staff would try to put it together, but then it would go back to this combined committee, subcommittee or whatever, in advance of the whole Committee so that we could see. Has the stuff put this together? You could critique it and revise it and we'd get it better. So that what comes to the full Committee reflects the combined efforts of these groups rather than keeping it separate, letting the staff be the conduit, and hoping that it works out okay. And I would also encourage other people who would like to join that effort to join it. DR. MACKLIN: Who's on the Remedies Subcommittee right now? CHAIRMAN FADEN: Duncan -- they happen to be sitting next to each other. I don't know if that was planned. DR. MACKLIN: But I mean I don't -- there were different ethics activities going on right now. There is no retrospective moral judgment subcommittee. So far that's -- CHAIRMAN FADEN: No, there was an Ethics Criteria Subcommittee under which this falls, which actually turns out to be you and me because nobody else volunteered for it. DR. MACKLIN: I was only going to say this is easily solved. CHAIRMAN FADEN: And Jay. Did Jay volunteer for that? Did you volunteer? Good. So it's Jay. Jay was not at the meeting at which it was formed. So it's Jay, you and me. So there's three of us. So there's three here. There's three there. I think it would be very helpful if one or two other people would like to join either to the these subparts or to the ethics subpart. Duncan had volunteered to be on the ethics subpart for the part that dealt with intentional releases, if memory serves me right. So he was sort of already crossing over. But right now it's three people focusing on remedies and three people focusing on ethical criteria within which retrospective moral judgment falls, who would bear the burden of trying to put together something for that part of it. I think it would be very good if maybe one or two other people could join that. Ken. MR. FEINBERG: On the ethical side of the super committee -- CHAIRMAN FADEN: Super subcommittee. MR. FEINBERG: The super subcommittee. Do we need additional people on the subject of prospective guidelines to guide future research as a remedy, which to me is a pivotal part of the remedies section which has pervasive influence beyond radiation That is a very important -- I don't know the first thing about it other than what I've picked up in this Committee, which is a lot actually, but I wouldn't venture to draft that. (Laughter.) CHAIRMAN FADEN: I think it would be helpful. MS. KING: Maybe it's because my mind at this point in the day only works in staging. MR. FEINBERG: Uh-oh. This is body language, too, I think. (Laughter.) MS. KING: I think he's a great lawyer because he understands body language. I think that that's a very important question that Ken just raised. Let me say I think that that won't be as hard as the retrospective part. So actually I think of this as in stages. I would like December to take account of the task that is the hardest for us, which is the looking backwards because the case studies and everything else depends upon it, and then the following month, Ken -- it's not that we shouldn't think about it. CHAIRMAN FADEN: That's okay. MS. KING: I'm only talking about how to stage it conceptually in my head. Only because as I'm listening to the proposal, which I think is wonderful because I'm very worried, as Ruth knows, about the Committee getting around to deliberating and making decisions rather than commissioning new projects and keep going to gather more and more information. So I'm very happy to see this shift. CHAIRMAN FADEN: Right. MS. KING: But if we are really to do that, then it means that December needs to be a time for fewer presentations. CHAIRMAN FADEN: That's right. MS. KING: And more time for deliberation, and I think if we get started on the hardest part we'll identify not only -- CHAIRMAN FADEN: My thinking was prompted from the beginning by Jay's comment at the very start of our session that we needed less reports and more time to talk, and that's quite right. So the notion would be the whole session next time basically would be for the Committee to be debating stuff, and with the goal of coming out with some decisions about how we're going to operate, and if we find we can't agree in certain pivotal areas, how we're going to proceed in the face of absence of consensus, hoping always that we will reach consensus around these issues. But that would be the goal. Your suggestion that we should do it in stages is okay. Remember that we only have three weeks to put this together. So realistically if we could hold off the part that is the general framework and the part that's backward looking, that would be a big thing between now and then. MS. KING: What I really think is that the sub- subcommittees and super committee could maybe identify, as Ken was starting to do, where we go right after December so we don't have to wait until December to say it. CHAIRMAN FADEN: That would be fine. MS. KING: That's what I mean by staging, and I just want to make that clear. MR. FEINBERG: What I was going to suggest along those lines is although December will not address prospective guidelines, it sure would be helpful if one or two people not for December but already were beginning to think about prospective guidelines. CHAIRMAN FADEN: We already have staff that are doing that. MR. FEINBERG: Fine. Okay. CHAIRMAN FADEN: And there is a staff project that's ongoing which is trying to prepare for the Committee what the current oversight, regulatory structure is and the effort with respect to intentional releases reported on today is in that spirit. It's trying to say, okay, what's in place now so that we can see whether we want to make recommendations. DR. MACKLIN: I understand Ken's motivation for putting this in the remedies category. I mean that is why this is something that's future looking, deterrent, but I think a crucial piece is missing that may be provided -- it may not be -- by the research proposal review project. That project is something that's going to give us the kind of information about what, if anything, needs fixing at least looking at those documents. Now, there may be other things that we're not even looking at that need fixing, but surely a critical piece of information and what might have to go into any such draft would be the results of the review of these proposals. So that's not an argument not to start thinking about it, but it's to say that a crucial ongoing project is, it seems to me, essential in being able to provide information for that. CHAIRMAN FADEN: What we're anticipating -- by the way, I called it a super subcommittee. It really isn't going to be any larger in number than the Protocol Review Subcommittee, which has eight people on it or something like that. So anybody -- so it's not like more people couldn't join it. It was just a structure for putting those two subcommittees in a working relationship for the purposes of producing something for the whole Committee to consider in December, where the interrelationships are already laid out, and the way to do it, I think, would be for the group that's already constituted as the remedies group to do what you were going to do anyway, but quickly, and the group that was constituted over here, which largely involves working with a manuscript from Allen Buchanan that we don't have yet, would do what it was going to do quickly, the staff producing a document that shows the connections between the two. I'm just repeating myself here, but so we're all clear. That staff document would go back to the members of these two subcommittees for critique, would be modified, and then all of the documents would be made available to the full Committee. Basically there would be an awful lot of reading for the full Committee to do, but it wouldn't be the documents type reading. It would be these analytical proposals, including the section on privacy and secrecy which Patrick has been working on. So there's a staff document that's being developed with Patrick and other assistance that will be out there to push us on those issues, that we could then all look at together, and we'd spend the whole time in debate. So would that work? I mean I don't know if it would work. Is it worth a try? DR. MACKLIN: I'm sorry. It's a dim memory at this time. Since we have all of these wonderful charts and have to use them to justify bringing them, could we see the five elements just even truncated, the five things on the board? CHAIRMAN FADEN: That would be covered in December? DR. MACKLIN: Yes, yes. I really had a comment about one of them, but we got off on other things, and that is the national security. I think you mentioned as one of the pieces national security, and I don't feel I know enough about that. I mean we haven't had -- CHAIRMAN FADEN: Whenever we get into a discussion these two come up. Is this working? I feel like Oprah. I'm going to start walking up and down the aisles here. Is it working now? Now that I'm all wired I want to sit down. The idea here is that we've got three big issues. They kind of relate to together. The ethics criteria, which includes this issue of moral judgment, retrospective moral judgment; the remedies. We've got to some up with some sort of structure for remedies. We know that -- and when we start talking about these issues, we butt off pretty quickly on this question of national security and secrecy. So we've got to start thinking anyway about how that infiltrates. And then as we look at the question of the backward looking remedies and also the question of retrospective moral judgment, we have this issue of our understanding of what the policies were during that period and our understanding of what the practices were in that period. We already know that we haven't sort of debated as a Committee whether we all understand the documents that have been put before us as meaning the same thing. So it seems as if we ought to have a discussion of that. The practices one is more primitive in terms of staff work. We don't have as much data available yet in an organized fashion about what the practices were. The oral history project may have some preliminary data. We can do some secondary source stuff, but we can at least start to introduce it into the debate. So these would be the topics. Jay. DR. KATZ: Well, we're moving now into -- CHAIRMAN FADEN: Is your mike on, Jay? DR. KATZ: Yeah. -- into a wonderful direction, and I feel Pat's feelings that the time has come for that, but you know, with respect, for example, it's more complicated that that. Take, for example, with respect to retrospective moral judgments. We also probably under that rubric have to consider, after we discuss the philosophical issues involved that Ruth Macklin was talking about and Buchanan I would assume will talk about; assuming we want to make some retrospective judgments in one form or another, what kind of gradations are we going to introduce? For example, it makes a difference going back to Auschwitz that human beings were just treated for research purposes in a sadistic, brutal kind of fashion never before or since recorded, theoretically in the annals of the history of human experimentation, and making moral judgments about the experiments themselves and a great many of them, in my view, are not very different from some of the experiments carried out in the civilized world both before Dachau and after Dachau and at the time of Dachau. So the point I'm trying to make: we have an awful lot to do here, and I would suggest that for December in this short time that we do not look for even completed kinds of draft documents. CHAIRMAN FADEN: Oh, no. DR. KATZ: That, for example, we only force whoever is writing what, as I suggested this morning after Ken was talking, to really take certain positions and to maybe write a few sentences or a paragraph here and there why and alternatives so that we get sort of a coherent proposal, but in stenographic and really outline kind of form because we can't do any more because it has to come to us maybe a week before the meeting so that we can really think about it. And there's a lot of thinking time involved here. So I would suggest that we do it in that kind of a fashion. If you want to write something more complete as a preliminary essay -- CHAIRMAN FADEN: I appreciate your comment, too, and I'm sure the staff does, as well, that we would all have to recognize that what would be coming wouldn't be a first draft of the chapters that are going to be in the report. We're looking at something that basically gets the discussion going and allows the debate to flow, and nobody should feel inhibited, that this is, you know, their best work or a nuance to refined treatise on the subject of either remedies or retrospective moral judgment. Duncan, did you want to get in on this. DR. THOMAS: If you'll forgive me, a slight change of subject. CHAIRMAN FADEN: Sure. DR. THOMAS: But it can be only temporary just because I need to leave shortly. I agree with everything that's been said that the time has come for us to take stock in this way and discuss some of the big topics. I presume that means that staff activity on the data gathering side of things that up till now we've been doing primarily by the case study method is not going to come to a grinding halt. CHAIRMAN FADEN: No. DR. THOMAS: That probably can go without stating. And furthermore, it probably makes no difference if we defer many of the case studies that we would otherwise be considering next time. If we do another medical experiment or another intentional release we're not going to learn anything fundamentally new. But I do want to look a little bit ahead because it defers until January the next opportunity to do a case study, and that's about the same time that we're going to start being inundated with data from the oral history project and the subject interviews and what's the third one? The protocol review, and we're going to have a lot to do those last four meetings. Count four, right? CHAIRMAN FADEN: Yes. DR. THOMAS: So the one thing which occurs to me that I think we should make a conscious decision that we're going to defer if that's what we decide. CHAIRMAN FADEN: That's right. DR. THOMAS: But the two kinds of case studies that we have not yet addressed that raise a whole lot of new issues. One of them is the institutional case studies, and the other are the intentional releases. Intentional releases are probably not such a big, new dimension. They're in a sense like the -- I said intentional releases. I meant experiments of opportunity. CHAIRMAN FADEN: Right. DR. THOMAS: Because they are similar to the experiments of opportunity, and we may not learn that much new from them, and we may decide that we don't want to pursue them in any great depth. On the other hand, they do raise some new kinds of issues, and we haven't yet made a decision about scope, how deeply we wish to pursue these things, and staff does need some guidance on how far to pursue that particular one. So I'd like to see just a little bit of discussion about whether or not we really want to defer those two until January. CHAIRMAN FADEN: Mary Ann? DR. STEVENSON: Can I add some similar concerns to Duncan, not because I'm opposed to that first proposal, but of the time constraints? I mean could we compromise and maybe have a day and a half for your proposal? You don't think there's enough time? CHAIRMAN FADEN: I just have this feeling that it's not going to work. I mean my sense is that we're going to need the whole time. One thought though would be a compromise, which would be to try to accomplish something on both of those areas by memo and through subcommittee in the interim. In other words, if the subcommittee in those two arenas could work towards proposals or towards something, get it to the whole Committee, some of that might be accomplished so that the discussion in January would be more specific. My other hope is that if we reach any resolution on these issues, these large framework, guidelines issues for the Committee in December, that that would affect from that point on forever, always how case studies would be written, in a way that would advance our work. I mean we would have identified the arenas that we consider to be the central ones for the work of this Committee, and that would help structure, hopefully help structure, the case studies as we get them from now on. So maybe if we have that compromise of trying to do some things by memo and fax and E-mail on these other issues, the two that have not -- I think you are right to point us to the fact that these are two types that we have not considered in collective debate at all -- and hope that the discussion would sharpen our ability to address those two in January. The discussion in December would sharpen our ability to grapple with those two and every other one after that. Would that be an acceptable sort of compromise? I'm looking at people who are concerned. MS. KING: This is on this point. Without going to whether it's an acceptable compromise or not, one other possibility, depending on how you actually plan the meeting in detail -- CHAIRMAN FADEN: It's two days. MS. KING: -- rather than how it's structured, is we're all reading. If we could read the case studies and set aside X minutes for us to -- and have people who write them, you know, here, but not present them, and we could just start to pull out of the case studies. I mean actually pull some things out of the case studies that are very useful to me in thinking about some of these questions. That's another way of not necessarily taking half a day, but at least it would accomplish, I think, some of the things that you and Duncan would like to accomplish. CHAIRMAN FADEN: Remember, too, that we -- DR. STEVENSON: I'm concerned that in hindsight we'll discuss these in January and they'll bring up issues that we should have been addressing in December. CHAIRMAN FADEN: We'll try to work out a compromise, but remember, too, no matter what, we have to set aside a good chunk of time for public comment. So when I talk about two full days, we must set aside time for public comment. So whatever else happens, it's not truly two full days for these topics. It's two full days minus the time that we must set aside for public comment. I should have made that clearer. That's part of my concern about adding other things, but maybe Pat's compromise of no presentations, some work in between, and try to get that issue out. DR. STEVENSON: Because I think one of the things that was slated for December was the discussion of the children. I mean that's sort of included in institutional studies, which are classically studies involving children, and I assume that those - - CHAIRMAN FADEN: My sense is though that, for example, the subcommittee can keep on working and the staff keep on working on those. That's not the issue. It's just that we won't have any discussion. Dan, did you want to come in? MR. GUTTMAN: What you certainly don't want is any backsliding on the part of staff. (Laughter.) MR. GUTTMAN: People sitting here saying they're going to take Christmas and Thanksgiving and just go somewhere. The mid-road, I think, may be what Anna and Ruth are saying, which is that the subcommittees can in essence function as the Committee would to make sure that -- for example, in our mind internally we've been thinking of December presentation on experiments of opportunity, children, California's case studies; that the relevant subcommittees can, in essence, impose a deadline so that the subcommittees -- is that what you're saying -- get that, and you'll know by December at the level of the subcommittee whether that's reasonable, doable, and then the next month can be spent changing it in relation to what -- CHAIRMAN FADEN: Whatever conceptual framework we come up with. MR. GUTTMAN: But it's not like we're in December and people just say, "I'm working on" -- DR. STEVENSON: Well, that wasn't my concern at all. I mean is there a sense that the information or the issues that might be raised from those particular studies would be important for out discussion in December? I mean critically important perhaps. That's why I think Pat's solution may be the best. The memos can be read. Some sort of summary can be read so that at least those things are included in the discussions in the December meeting. MR. GUTTMAN: That's possible. MS. KING: This is kind of a debate that's kind of crazy. Really it's a crazy debate because what we're really talking about in case studies is you're really talking about practices to some extent. I mean the way we got it there, the policies and practice, we're making this very tight definition of practices, but to some extent these case studies are telling us the same kind of information, which sort of feeds into those three. And I don't want to set anything into stone because I think it's very hard to put an agenda together, but I think that the sense is that there is some utility to case study -- at least I share this -- to those first three topics, and the question is how to work it in. It may be that the people on those subcommittees, if there's not time, interject at appropriate times in the discussion. I mean there are all kinds of ways to handle this. CHAIRMAN FADEN: Exactly. MS. KING: But the idea is to do it all in December. CHAIRMAN FADEN: What we can do is have reports on those three topics available to the full Committee in a form guided by the subcommittees. Everybody will read it. Okay? Whether we set aside time to discuss it or not or whatever, we would rely on each of us to bring it up where it's relevant as we're discussing remedies. Somebody would say, "You know, the UCSF case study pointed out that this issue of where to place culpability really needs to include the university president." Let's say it comes out that we would have to -- that's only -- DR. RUSSELL: That's a hypothetical? CHAIRMAN FADEN: That's hypothetical. (Laughter.) CHAIRMAN FADEN: That's purely hypothetical, but my point is we could pull on those. We should each consider ourselves as having the responsibility of pulling not only on the three that would have been presented in December, which will be new reading for nonsubcommittee members, but all of the other ones we've already had. I mean that should all be in our head. That's part of the reason for having waited until now to try this, is so that we would all have some understanding or appreciation of what kind of was going on at the time without necessarily having had a shared framework for imposing it. Now we've got this background. Let's see if we can come up with something like a shared framework, and as we're debating that framework, let's all of us pull out examples from the case studies that we've looked at already and the few that would be -- would that work? So it becomes each of our responsibilities to point out, but we would have documents on those three topics available, and we would all be expected to read it. DR. THOMAS: I feel pretty comfortable with this emerging consensus. The briefing book is a great discipline. You know, it focuses staff effort on getting a commitment to get something down on paper, and it forces us to read it, of course. It ought to force us to read it anyway. I also like the idea that we can draw upon all of that material in the general discussion, but I, for one, find that the general discussion of particularly these ethics criteria and some of these other more nebulous topics kind of hard to follow after a while. Maybe that's just because I'm not a philosopher. I would still like to see one short block of time where those people with sort of fundamental objections or major issues to raise with regard to each of the case studies or whatever -- CHAIRMAN FADEN: Okay. We can do that. DR. THOMAS: I'm quite happy to dispense with the formal presentation. I think we learn less from the formal presentation than from our discussion, but there needs to be a time where those points which somehow don't quite ever come up in the discussion of the other issues can get made. CHAIRMAN FADEN: We'll try to structure some time for that. We'll work out something. DR. KATZ: What kind of things do you have in mind? DR. THOMAS: Do you mean which case studies? DR. KATZ: No, I mean (inaudible) what you just referred to. Just the case studies or -- DR. THOMAS: At the moment we've only been talking about two case studies being in the next briefing book, but there may be maybe three if we include kids. I don't know whether that's ready for presentation or not. MS. KING: I would say that it was very useful this time and maybe we could do it more extensively next time if the Committee itself would be disciplined as well, and that is the focusing the discussion that was started this time I found very useful. I particularly liked the total body radiation. Maybe because it triggered my mind yesterday to think about some future directions for the report. But I sort of really liked it very much when you gave us a sheet and said, "Think these things." I, for one, wouldn't even mind if the staff got very adventuresome and said to us, "You know, we think ultimately you may want to make recommendations along the following lines. Have you thought about it?" I want anything that moves us to say, "Oh, that's a terrible idea. Throw it away," or, "that's a terrific idea. We'll start putting that one in our pocket." CHAIRMAN FADEN: I think that's in the same spirit of Jay's comment to the subcommittees directed to the staff, as well. We need to start having -- you know, it's provocative, but it's useful, and then people should not take it as this is the will or the word of the Committee. This is out there. Let's debate it and see where we are. You know, there should be no more classified research. Yes or no? You know, that kind of thing when we get to those sorts of issues. So I would concur just to get us moving so that we then have a focus for seeing where the Committee is, you know, the sense of the Committee is on some tough issues. I just got passed a note, and I brought it up last time, which was the issue of extending the length of the meetings. Duncan pointed out to us that we don't have too many more meetings left and an extraordinary amount of work to accomplish in the course of those next few meetings. The response was, "Well, let's go from three to five o'clock." So that was an extension. Then yesterday was the suggestion that on the second day we start at eight o'clock. So that was also an extension. The issue emerges whether do we want to continue to a half day on the next day. Now, we can either not do that. We can not do it next time. My own intuition is that we're going to end up having to do it for at least the last couple of meetings if we're going to get this. Not next time? December. All right, and it's also too close. We will plan for it, okay, for January, February, and March, and April. Before going another half day, we'll poll people and see how many people we would lose because I know people have made commitments. We will poll people and see how many people we would have. Half day on either side. How many people would we lose on going either way, and we'll try to come up with something. We won't do it for December, except in December the second day we'll start at eight and not at night and go to five. So that we won't tinker with December too much. We'll only start an hour earlier on the second day. And then we'll see what's happening. We'll immediately send out calendars looking to see how many people we would lose, you know, which days, with an understanding that clearly the closer we come to the end, the more important it is if you can find another day in that month, the more likely it is that we will be able to do the job that we would like to do, and we need the collective time for debate. Yes, Ruth. DR. MACKLIN: This is slightly off the topic, but it's related. I mean not only do we have to look at our calendars now for those months and hold those times if they're not already committed, because then they'll be gone. CHAIRMAN FADEN: Right. DR. MACKLIN: The other thing is, I mean, -- CHAIRMAN FADEN: Yeah, it's also a matter of the hotel. Can we get it, which is not trivial? DR. MACKLIN: But my other point is we're setting an agenda for December. Then we're saying what we'll roll over into January that we don't get to do in December. So now I look at this calendar and there's three more months. I mean I find it hard to think clearly about what to be doing in January without somehow working backwards, too. That is thinking of what we will have -- I mean if what you've proposed is the product of having worked backward, I mean, that's fine, but I mean it's as if we know what we're going to do up to here, but -- CHAIRMAN FADEN: Somewhere by fax was a sort of every month what we hoped to do. I don't know where it is. DR. MACKLIN: All right. CHAIRMAN FADEN: It went out, but it may be that it missed Ruth, and it was an attempt -- DR. MACKLIN: No, I'm sure it didn't miss me if it got there, but I guess I don't see it being folded into this discussion. CHAIRMAN FADEN: Well, it changes the character of December, bumping some stuff into January, and the issue is can we pick up the slack, and that's why I'm proposing some extra time, essentially to pick up some of the slack that the December is eating up, but I think this is an inevitable high priority. It may be that the compromise we've discussed about these other cases studies is sufficient so that we don't really have to bump them over to the next month, and enough progress is made on them. You know, it's not clear. It's not clear. We will try another one, but I think the bigger question -- not "the bigger" -- that's a big question, Ruth, and it relates to the question of the priorities for the next several months, and I'll just share a personal panic, and Dan is used to dealing with my panic attacks. We alternate, and that is how are we going to get this all done, major panic. And one concern is remember that when we decided originally to have all of these different experiment groups and the experiments of opportunity, the notion was some of these wouldn't pan out. We wouldn't have to be writing all of them up. None of them are not panning out, which is to say there's something to say about all of these. It's very hard to have a discussion about priorities. What do we say about what our priorities are? And rather than start that now, I was thinking that we might also be thinking about what we see to be the areas or the themes or the directions where this Committee can make particular contributions, and that might guide the allocation of resources. I mean we've had two issues emerge this time where I thought I heard the Committee saying, "We could really say something here," and one was this topic of what procedures or safeguards ought to be in place or how to address the question of classified, secret research and secret intentional releases, as a territory where this Committee might make some advances in the public policy arena where there's very little public debate. And another was this issue of multiple -- I've forgotten the term you used, Pat -- it was motives or purposes. MS. KING: Motivation. CHAIRMAN FADEN: Mixed or multiple, dual purpose or triple purpose type work which has more similarities to stuff that has been debated like the occupational physician or what have you or the institution that plays two roles, but that we might spend more time on this question than perhaps other committees which have debated questions of research ethics have in the past because of the particular character of our study. And we might think if there are any others and then say back to staff: push those lines of inquiry that feed into these themes where we can make a particular contribution more than other lines of inquiry that are on territory where other committees and commissions have already done work. Does that sound like a -- am I right in identifying those two, among others, but those two at least as to where this Committee could make a -- I hesitate to say "unique" -- but important contribution? Jay. DR. KATZ: Look. Everybody has been saying it now. Time is getting short, and I think what in my view I would suggest that we don't continue this kind of discussion we've just had in the last ten minutes today or next time; that between now and next time you, Anna, and Dan sit down and come up with a recommendation, your recommendations, then to be reviewed by the Committee of the whole. In the light of the time available, what do you think we can do, should do, must do? Which are possibly expendable? Which ones are definitely expendable? And then we will all react to it, but we'll start out with a document. And, secondly, that document should also include whatever we select, what can we and the staff finish in the period of time allotted to us, and that's becoming now a pressing matter, and it's becoming to me a doubly pressing matter because how are we going to negotiate the give and take of the draft document, of the final draft document, because my hunch is -- I haven't thought about it; I don't even want to think about it because it's nightmarish -- is because there has to be all kinds of back-and-forth between us both for purposes of clarifying the report, for purposes of figuring out what we as individuals can compromise on and cannot compromise on and how to handle this, that, and the other thing. When is the report due, May? CHAIRMAN FADEN: April 21st. DR. KATZ: April 21st. Midnight? (Laughter.) DR. KATZ: I hate to say it because I really would like for personal reasons to finish by April 21st, but you've got to look -- CHAIRMAN FADEN: Jay. DR. KATZ: -- at the problem square in the eye and say, "Can we really do it?" CHAIRMAN FADEN: Yes, and in the interim report we said we would do our very best to bring it home by April 21st. If it took a couple of months more to do it -- DR. KATZ: But we need to decide that now. CHAIRMAN FADEN: Well, I think we can take a hard look at that in December as well. (Simultaneous conversation.) CHAIRMAN FADEN: What we are committed to is bringing it home as close -- you know, within shooting range of April 21st. We in the interim report signaled, and I think we're obligated that we're not here seeking to be continued for another year or another six months or anything of that sort. We can discuss in December whether we think going another two months makes the difference between a mediocre report and a report we can all stand behind with greater, you know, pride or whatever. Those are the sorts of issues, but we must remember in the interim report we signaled that we would not be seeking any substantive -- MR. GUTTMAN: I think the word was "more than several." CHAIRMAN FADEN: More than several months, was that the -- MS. KING: At the risk of getting my head chewed off forever and for always, we cannot underestimate the impact of the past election. My view is that you have to think no extension because it's an uncertain shifting ground out there in terms of money, appropriations and willingness to allow any leeway. Now, I don't like making those statements in public, but it's done. CHAIRMAN FADEN: You don't have a choice in this Committee really. MS. KING: But it's done, and I think that each one of you may want to go search your understanding of what just took place and see if you think I'm making any sense or not. MR. GUTTMAN: Can I add something? CHAIRMAN FADEN: Go ahead, Dan. Is your mike off intentionally or unintentionally? (Laughter.) CHAIRMAN FADEN: I just want to know which that is. MR. GUTTMAN: The question, I'm not so much worried about the many roads staff is pursuing because a lot of them have some substance. There are two kinds of questions. One is that we have fragmentary information about all of these experiments. We know that. The more important question is this question of what themes are, what does each one of you think are the one or two or three things that are, after all the facts are looked at, the contributions that can be made because those are the things that -- we have more than anybody would want to read about human experimentation for any average, you know, school child. The question is: what are the themes you want to bring home through all of those items. And that part relates to Pat's point. What are the things that most resonate with the kinds of questions that the public is now interested in? The thing that strikes me as most interesting about what we've been looking at, two parts of the spectrum, when Ruth gave her interim press conference, those of you who saw the clips, the thing that made news was that there were thousands of human radiation experiments, and Ruth tried to artfully say, well, you know, that doesn't mean they're all unethical or anything like that. The numbers don't mean anything. But ironically what we're really looking at and we haven't really focused on is, you know, a major government program that started in the '40s, the funding of isotope research, and that is, in part, responsible for many of the medical benefits that we had been saying we had to include in the report dutifully. But those questions of, you know, the presence of big government, the immense contribution that was made, which were kind of obvious, you know, perhaps even cliched earlier are now much more interesting thematic questions, and the same point. The individual rights which informed consent -- you know, the balance of the individualism in relation to these things. In some respects it may be easier, I guess what I'm saying, to write a report that's meaningful now in today's world because the questions which might have been not asked, you know, four months ago are now much more interesting questions about the role of government and questions about, you know, why are we funding all of these people. So what I'm saying is that what might be most helpful from the staff's perspective is going back and looking at the themes. CHAIRMAN FADEN: I think Jay's proposal, and I think it's the only way to do it, is for us to come up with something, throw it out, and then the whole Committee can take it apart, and then if it turns out that we end up with the same document or one that's 180 degrees different, that we'll find out in the process, but I don't know how -- Jay and Ruth. DR. KATZ: Can you informally find out whether we can get an extension or is that impossible? Is that all in the cards? Is that possible? CHAIRMAN FADEN: My preference has always been to just work as fast as we can, as hard as we can, and only ask for an extension at the last minute. DR. KATZ: Yeah, but if Pat is correct that we may not get it, I mean -- CHAIRMAN FADEN: It doesn't quite work that way. I mean there's no single person you call up and say, "Can I have it?" DR. KATZ: Okay. It doesn't work that way. CHAIRMAN FADEN: I mean it's -- MR. GUTTMAN: How does it work at law school? DR. KATZ: We have a democratic process. We all decide, including the students. CHAIRMAN FADEN: Nobody is going to notice us for a while, we hope. We want to proceed on the assumption that there is broad spectrum interest in our doing our work well, and we will go ahead on that assumption, and we're just going to try to do as much as we can as quickly as we can. I don't know how to factor in Pat's comment. I think that for lots of reasons it would be good if we could finish on April 21st. If we can't, you know, if it some out three or four weeks later, I don't think anybody's going to shoot us. MS. KING: That's right. I don't think it should take a month or two. CHAIRMAN FADEN: Right. Nobody is going to say, "Okay. I'm sorry. Your report wasn't out by midnight April 21st. It can't come out April 30th or May 15th," or something like that. That's not what we're talking about here. I think we'd rather keep it in that spirit. We are going to work as fast as we can, as hard as we can to bring it home on time, and if we slip by a short period of time, we will slip by a short period of time, but it would not be because we haven't tried. I don't know what else to say on that issue. DR. KATZ: Staff thinks that's another problem? MR. GUTTMAN: Staff is working for nothing. (Laughter.) CHAIRMAN FADEN: Let us do a little bit more homework, and we can bring this back next time, as well. Before we conclude -- oh, Ruth, I'm sorry? DR. MACKLIN: No, just what I heard you say a moment ago was that you and the staff are going to bring to us proposals. I mean the most important things and the themes, et cetera, but my question is: how does that relate to what I thought we must do, which is respond to our charge? I mean is that within the charge -- CHAIRMAN FADEN: Oh, sure. DR. MACKLIN: -- of setting priorities? CHAIRMAN FADEN: Right. DR. MACKLIN: Is it going beyond the charge? I mean -- CHAIRMAN FADEN: No, it would be within the charge, but we've embarked on so many different avenues of exploring that charge. So the issue is what parts to bring up. It's a priority setting issue, sort of what parts to bring home with more detail or more refinement or with more attention by the Committee and the staff. It looks like we clearly -- I mean there are so many things that could be done under the context of this Committee's charge, and it's very clear we can't do them all. It would be consistent under the charge, for example, to render judgment about every single individual experiment if the Committee chose to do it as an illustration, but, yeah, your point, it has to be within the charge of the Committee. Anna is pointing out to me that there are reasons to try to want to combine some of the subcommittees. They have some of the same people on them. It would make it administratively much easier. Two in particular. We have two groups working on institutional case studies, UCSF and Oak Ridge. Can we make it one subcommittee on institutional case studies because you're going to be dealing with the same sort of thematic issues, are going to be the same, and you can learn back and forth. Hey, this worked with the UCSF one, but let's try it with the Oak Ridge, and so on. So is that all right with everyone? And the other is the biodistribution and radioisotope group, two groups. If they could be made one group for purposes of guiding staff work, that would be helpful because, again, there are overlapping issues and questions. And Anna has one more proposal. Why don't you go on mike so we can do it? MS. MASTROIANNI: The other one is the healthy adults group and also the external radiation with patients. Given that TBI is so far along and we had a presentation on that, the subcommittee could continue to do follow-up on TBI, but then they would really turn to finishing up some of the healthy adults, and also part of the healthy adults was done with prisoners. Is that okay? Great. DR. MACKLIN: So what's getting combined here? MS. MASTROLANNI: The institutional case studies -- DR. MACKLIN: No, no, no. Just the last ones. MS. MASTROLANNI: External radiation with patients and healthy adults. CHAIRMAN FADEN: In other words, the same subcommittee would be dealing with the issues having to do with patients and with well persons. It makes for fewer phone calls. It means that many of you were serving on multi -- you'll be doing the same amount of work, only it'll be in the context of fewer -- DR. MACKLIN: Just one other possible combining. We've been talking about remedies and ethics criteria. Now, the ethics criteria, as I see this, Lois is here. It says "info only," whatever that means. CHAIRMAN FADEN: She wanted to be notified of the proceedings. DR. MACKLIN: And Duncan, it says intentional releases. Now, does that mean he was only on this committee for the purpose -- CHAIRMAN FADEN: That was his request, that he was particularly interested in an ethical criteria with respect to the judgments about intentional releases, but he probably could be persuaded since it's now one committee anyway. DR. MACKLIN: That's now one committee. CHAIRMAN FADEN: Well, that and the remedies now are sort of one committee with two branches, one subcommittee with two branches. So basically de facto Duncan ends up on it anyway. There are two areas that don't have subcommittees, and we can decide either to fold them in or make them separate ones. One is the work that staff continues to do on national security and secrecy, and the other is the work that staff is doing on interpreting history, but the ethics policy history. In a way you could argue that just goes under the ethics criteria committee, arguably. I mean it's the reconstructing what the DOD -- one of the things we'll talk about in December, reconstructing what the DOD policies were and what the AEC policies were and what HHS' earlier policies were. It hasn't formally been stuck under anything, and obviously an awful lot of staff work under Jonathan's leadership has been going in that direction, and then there's the secrecy/national security stuff. So can I make a proposal that the policy part that Jonathan has been leading go under the ethics/remedies committee's purview? Is that okay because it's clearly relevant to both questions, ethics -- DR. KATZ: Could we keep the ethics in December? CHAIRMAN FADEN: Right. They're going to be connected. Imagine a bridge or however we put it together, however we imagine them connected. And then the issue is where do we want the national security/privacy work being done by the staff guided. It needs some committee anchor. I hesitate to create another subcommittee. DR. OLEINICK: Well, rather than form a whole new subcommittee, I was going to say it seems logical to put it with the intentional releases. It's been of interest to that committee, although not solely to that committee. CHAIRMAN FADEN: All right, and insofar as it spills over to biomedical experiments, you won't take that on as well. I just want to make sure that major staff projects have committee homes basically so that the committee staff know with whom they're working. Does that work, Anna? MS. KING: Can I suggest that you all go back and figure it out and line up the people and see if the committees are balanced adequately? In your opinion, if they're not, then you just call people up and say, "Can we shift you around?" CHAIRMAN FADEN: Is that agreeable with everyone? So you may be asked to serve and you will agree. MS. KING: You can't get blood out of a turnip, Ruth, but you can at least call. (Laughter.) CHAIRMAN FADEN: We're going to be very bled dry by the time this Committee is over. there's no question about it. The concern about putting it with intentional releases is that there are a whole set of issues having to do with classified biomedical research. I'm not sure the fit is that well. (Simultaneous conversation.) CHAIRMAN FADEN: You know what. Let me follow Pat's suggestion. We may want to take the secrecy thing and create some sort of a bridge again, you know, like a bridge one, kind of like the bridge between the remedies and ethics criteria we want. We may want to bridge the intentional releases with some other group and say that's the oversight for the secrecy/national security stuff. Is that okay? Because they raise issues about - - right, exactly. All right. I think we're falling apart here as a human matter. We have ten more minutes, so we're not officially disbanded until Phil comes here, just so you know. (Whereupon, at 4:46 p.m., the meeting in the above- entitled matter was adjourned.)