ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS * * * * * PUBLIC MEETING * * * * * MONDAY JUNE 13, 1994 * * * * * The Committee met in Washington Hall, Ramada Plaza Hotel, 10 Thomas Circle, N.W., Washington, D.C., at 9:30 a.m., Ruth Faden, Chair, presiding. PRESENT: RUTH R. FADEN, PHD, MPH, CHAIRPERSON KENNETH R. FEINBERG, JD JAY KATZ, MD SUSAN E. LEDERER, PHD LOIS L. NORRIS NANCY L. OLEINICK, PHD HENRY D. ROYAL, MD MARY ANN STEVENSON, MD, PHD DUNCAN THOMAS, PHD PHILIP K. RUSSEL, MDSTAFF PRESENT: FAITH BULGER, JD JAMES DAVID DAN GUTTMAN, LLB DENISE HOLMES JEFFREY KAHN, PHD, MPH STEPHEN KLAIDMAN JONATHAN MORENO, MD ANNA MASTROIANNI, JD ALSO PRESENT: PHILIP CAPLAN PAT BROUDY TOD ENSIGN TOM SMITH GORDON SOPER C-O-N-T-E-N-T-S CALL TO ORDER - PHILIP CAPLAN 4 INTRODUCTORY REMARKS - RUTH R. FADEN, CHAIRPERSON 4 INTRODUCTION OF NEW STAFF - JEFFREY KAHN 10 DISCUSSION OF APPROVAL OF MINUTES - RUTH R. FADEN, CHAIRMAN 12 INTRODUCTION TO REMEDIES - KENNETH R. FEINBERG 14 RISK COMMUNICATION - STEPHEN KLAIDMAN 50 OVERVIEW OF STAFF - DAN GUTTMAN 66 EFFORTS OF STAFF TO DATE WITH RESPECT TO GETTING INFORMATION ABOUT ETHICAL GUIDELINES, STANDARDS, AND CODES - JONATHAN MORENO 98 DOD REPORT - DAN GUTTMAN 121 COORDINATING REPORT - DON WEIGHTMAN 150 VA REPORT - DENISE HOLMES 170 DOE REPORT - DAN GUTTMAN 186 DHHS REPORT - FAITH BULGER 194 DECLASSIFICATION LETTERS - DAN GUTTMAN 209 PUBLIC COMMENT PERIOD 224 LETTER FROM JOHN J. McCARTHY 225 LETTER FROM CHERIE ANDERSON 228 THOMAS SMITH 238 PAT BROUDY 242 TODD ENSIGN 248 P-R-O-C-E-E-D-I-N-G-S 9:35 a.m. MR. CAPLAN: Good morning. My name is Philip Caplan, Special Assistant to the President for Cabinet Affairs. As the designated federal official for this meeting of the Advisory Committee, I declare it open. CHAIRPERSON FADEN: Thank you, Phil. The reference is we may have another designated federal official in the future. (Laughter.) Thank you very much, and you'll come back to close us, I trust. We apologize for the absence of air conditioning. I assume somebody's working on it. I wouldn't -- I don't know; famous last words. I want you to know that last time we were freezing. So this time I specifically wore a jacket, and probably everybody else has adjusted accordingly. It's a pleasure to welcome everybody to our third meeting. We have both good news and bad news with respect -- I'm looking for my table of contents, which is -- where is our agenda? What tab is that? No, in here, do you know? There we go. Thanks. We have both good news and bad news in terms of attendance at our Committee. The good news is that Phil Russell, who has been with us from the beginning but, unfortunately, was out of the country the first two meetings, is here. He has been in touch with staff. So he, hopefully, has some sense of where we've been going, and we've benefitted from his advice, but it's wonderful to have him come and join the dynamic. That's the good news. The bad news is we knew from the beginning that Eli and Ruth Macklin would not be able to make this meeting. We know when we've been scheduling these that there are always people who we couldn't accommodate, and they had pre-established traveling plans. So we thought we were going to be holding a meeting two Committee members down; that is to say, without Eli and without Ruth. Unfortunately, we have in the interim lost a few more Committee members. There was a death in Pat King's family over the weekend and she will not be with us today or Monday. The funeral is today and out of town. So she's very distressed, obviously, about other things, but very distressed about missing the meeting, and particularly wanted me to communicate to staff that, for those of you who are waiting to hear back from Pat on one thing or the other, that you should know why it is that you haven't heard back from her. She will be -- I will be talking with her by phone on Thursday and will bring her up to date. Also, Mary Ann's, who was to be with us both days, baby is ill, not seriously but too ill to come with. So Mary Ann is coming tomorrow, we hope -- later today or tomorrow. So that was unexpected. And Nancy had trouble getting out last night for some reason that we don't know, some transportation problems. So she is joining us late. I don't even know if we're legal. How many do we -- I guess we have enough people to be -- we're fine. We have enough people to be legal, but it's really unfortunate that we're down a few. Hopefully, Mary Ann will join -- I mean, Mary Ann will join us and Nancy will be here shortly. So Nancy is still expected today; is that correct? She will still be here today. So goes life. We could not control these events. So we'll have to go forward. Our objectives for this meeting are beginning to be almost routinized as we're into a pattern here. We've had two whole meetings. This is our third. Our first objective is to continue with the continuing education effort which we have imposed on ourselves that we're trying to teach each other from our own perspectives and background, so we can have kind of common language. We've had some wonderful such presentations in other areas. Today we're going to be treated to presentations by Ken Feinberg and Steve Klaidman, and they will take up a good chunk of our morning. You should know that these educational sessions are being videotaped. So they will be available to Committee members who are not here and also to staff who are not here. Let me just say that we had to make some sort of decision about who from the staff could come to the Committee meetings. We have a wonderful staff and they're so wonderful that if they were all here, they couldn't be working. So we're going to try to rotate the staff through and give Committee members an opportunity to meet as many staff members as possible, and staff members as much opportunity to be involved in the proceedings that the Committee as possible, but we made a decision that somebody needed to be working while we were deliberating. So not everyone will be here all the time, and staff also will be able to see videotapes of the Committee sessions, in particular, the education sessions. The bulk of our time today will be spent getting updates from staff as to what staff has been doing in relation to direction from the Committee, so that we can continue with the process that has worked pretty well so far of the staff giving guidance to the Committee as to what to do in the next three weeks. This is very critical. As I mentioned last time, the staff can only be as productive as the direction from the Committee is good and specific. So we're hoping to continue with the dynamic of the staff presenting to us and then our giving the staff feedback as to what needs to happen next. Dan's going to give us a general overview later this morning, and then we'll hear from the specific working groups of the staff. We also are going to give over some time tomorrow for reports from the subcommittees. We, as we all know, broke ourselves down into subcommittees at the last meeting. The subcommittees actually have been working away, and there will be reports from the subcommittees, and then at the end of the meeting we will break down tomorrow afternoon into subcommittees, so that that work can continue to happen, take advantage of the fact that we're all assembled and can easily have subcommittee meetings in there. Finally, as in all of our meetings, we have time set aside for public comment. This is a critical part of the process for the Committee where we can hear from members of the public who wish to influence or assist the direction of our work, and that will be this afternoon. If no one has melted away by then, we will have time for public comment. We are hoping to get the air conditioning fixed. With that, we have some new staff members. I don't know if we can continue always to announce this, but Jeff is going to do an overview of who's been added to the staff, so that we can know. DR. KAHN: For full descriptions of individuals, you can look at the biographical sketches in the briefing book. Just to proceed through that list alphabetically in terms of who we've added since last meeting, hopefully, if folks are here, you can raise your hand or stand up, so individuals can see who you are. Sara Chandros has recently joined us. Sara is back there. There she is. Sara is a doctor of science candidate at Johns Hopkins University School of Hygiene and Public Health. Her undergraduate training is in biology, specifically in molecular genetics. Gwen Davis -- Gwen is presently a candidate in the MPA program at the Lyndon Johnson School of Public Affairs at the University of Texas. She is joining us as a summer intern. Patrick Fitzgerald, there's Pat. Pat has recently joined Louisiana State University as an Assistant Professor of Philosophy. He's finishing up his Ph.D. in philosophy at the University of Arizona, and he has agreed to join us for the duration of our work. Mark Goodman, is he here? There's Mark. Mark has a doctoral degree in theoretical physics and has recently done some work at the Office of Technology Assessment, where he's worked on space and weapons policy. Gary Stern, here's Gary. Gary is an attorney and has recently come to us from the ACLU, where he was Legislative Counsel in its Center for National Security Studies. Kathy Taylor -- Kathy is trained as an attorney and is in the process of finishing up a Ph.D. in philosophy at Georgetown University, specifically, the Kennedy Institute of Ethics. Departing from our usual approach, let me just introduce one consultant who's with us today. That would be Ted Webster, sitting over here, who is visiting us from Harvard University, where he has expertise and is an expert in radiation dosimetry. He'll be with us as needed and we asked him to come down to meet you folks and to lend his expertise, if you need it today. CHAIRPERSON FADEN: Thank you, Jeff. This is totally and utterly humbling if you read the staff bios. We have assembled this remarkable staff with incredible talent, and we just better do good here, folks, because we cannot blame the staff, as it were, I don't think. MR. GUTTMAN: You can blame the Staff Director. CHAIRPERSON FADEN: We can blame the Staff Directors, though, because they're up here and they can be blamed easily, and we can't blame the staff. Good. That's what we like, a person who takes responsibility. That's good, Dan. (Laughter.) All right, we have a formal agenda item, which is the approval of the minutes. We're going to, from now on, try to routinize it, so we can get the minutes to you in time, so that I can just call for an approval of the minutes as part of the agenda for the subsequent meeting. We didn't get the minutes to you in time enough to do that here. So rather than ask for a formal approval of the minutes at this meeting, I'm just going to alert you to the fact that you've received the minutes. Please take a look at them. If you have any suggestions for comments or changes, please let Anna or Dan know. What I would like is authorization from the Committee for me to approve the minutes on behalf of the Committee and to make judgments about whether any changes that are suggested can be made without bringing it to the full Committee. Is that acceptable to everyone as a procedure for -- great. So, for this time only, I will exercise judgment and introduce any changes that come from Committee members, and if I think it's a big change, I'll fax it to everybody. Otherwise, I'll take it that I am deputized or authorized to approve the Committee minutes on behalf of the whole Committee. Next time we'll try to get them to you enough advance, so that we can go through the more conventional process. Okay, with that, we go to our first educational session. Ken Feinberg is going to give us an introduction to remedies. There was a wonderful packet of readings. I hope you had a chance to go through them. Ken, how do you do under heat pressure? MR. FEINBERG: Fine. CHAIRPERSON FADEN: Good. Okay. Then we're all right. (Laughter.) MR. FEINBERG: Ruth mentions, how do I do under heat? Since the subject of remedies elicits a good deal of heat, there's a certain symmetry in my presentation and a certain symbol significance in the fact that there's no air conditioning on yet at this time. Let me say at the outset that for the next 20 minutes or so this is an introductory primer on the subject of remedies. There are people in this audience who are national resources on the subject and have heard all of this before. Pat Glynn is here. He knows everything there is to know about what I'm going to say. Jonathan Russo is here. He knows everything that I'm going to say. Hopefully, they won't be too bored by the subject, and they may have something to add afterward during the Q-and-A session. Now let me start off by telling everybody that this subject of what remedial action should be taken by the Committee, if any, what the remedies should be that we would recommend in our Committee report is provocative because for the last 10 years in this country the subject of remedies has been tied to the growing interest in the subject of mass tort litigation -- of mass tort, mass exposures. It began with Agent Orange in 1984, the recent phenomenon, and grew with a list of the very visible public litigations that have occupied publicity: Agent Orange, Dalkon Shields, asbestos, DES, Pfizer-Shiley heart valves, now silicon breast implants. All of these tort cases in the courtroom involving exposures of thousands, millions of people, leading to the question: in the judicial system, in the tort system, what should the remedy be in the way of compensation or in the way of other remedies? Now not just those cases; you've got the Nevada downwinders; you've got the Marshall Island people; you've got all sorts of cases not quantitatively great, but qualitatively very important, involving what do we do with people mass exposed to a harmful product or a harmful activity. You must distinguish those people, those types of cases from the traditional one-on- one case that we all know about and learned about in law school -- an individual victim harmed by individual culpability by an individual private defendant. Keep that difference in mind during the next 20 or 30 minutes as we talk about the subject of remedies. Why? Because how you fashion a remedy -- how you fashion a remedy depends in large part in 1994 on whether you're trying to fashion a remedy for an individual who was harmed directly where there is no dispute about the cause-and-effect relationship of the wrong conduct to that individual versus a whole group of people harmed, allegedly harmed, by culpability involving mass exposures. And I would point out that when you get into the mass exposure area, you often, not always, have a dispute involving the role of the United States Government in allegedly causing that harm; Agent Orange, for example. So keep that gap between individualized causation cause and effect and mass exposure cause and effect in mind as we go forward in the next few minutes. Why? Well, let's talk about peculiarized remedies. Particularized remedies come up when you're trying to fashion a remedy for an individual who was harmed by wrongdoing. Traditional notions of culpability, traditional notions of causation, causing a particularized injury -- Joe is mowing with the lawn mower. The lawn mower safety guard doesn't work. A rock goes up and hits Joe in the face and Joe is harmed. That's the traditional garden variety tort. Joe has been injured by a faulty, state-of-the-art-designed lawn mower where Joe -- there's no question Joe was injured by the lawn mower, and the question becomes: what remedy does Joe have against the lawn mower manufacturer for that individual injury caused by the defective mower? Dalkon Shield is not very different. A. H. Robbins manufactures the Dalkon Shield, a defective contraceptive device. That contraceptive device does injury to individual women using the shield. What is their remedy? An individual woman's remedy for use of that Shield causing an alleged injury. The Pfizer-Shiley heart valve cases, although there are 55,000 victims allegedly, it's a particularized tort. What should we pay or what should the remedy be when an individual heart valve user is injured by a defective device, heart valve device? What should Shiley pay that heart valve user for that defective device, even if there are 55,000 users? Take that and apply it to experimentation or radiation experimentation. In particularized cases involving finite known individuals, the issue of remedy, as provocative as it may be, is relatively less provocative than if you're talking about mass exposure cases or experiments. Do we know that an individual was harmed by an experiment particularized to that individual or small group of individuals where the facts demonstrate that an individual was harmed, that there was some degree of culpability or wrongdoing, and the causal connection between that wrongdoing and the individual harm is finite, real, and null. In those cases, as provocative as they may be, we don't run into the same type of problematic degree of causation as we do in the mass exposure cases. My name is Joe Jones. I was the victim of a specific experiment directed at me by X or Y. As a result, I suffered a certain injury and the subject then becomes: what is the appropriate remedy? Now that's one type of case that the Committee's looking at, examples where individuals are the subject of known experiments where the facts are clear; the wrongdoing may or may not be clear. That's what we're looking at. And the issue becomes: what do we do? What remedy is afforded, if any, that individual with a particularized injury? The injury in such cases may be physical. It may be mental, anguish, anxiety, et cetera. It may be neither. It may be risk. It may be that regardless of physical injury or mental injury, there is an assumption made in the law that that person, even though he or she may not have any physical injury, has an increased risk of subsequently securing some injury. And should that be the subject of a remedy, physical, mental, risk creation or increased risk creation? Those are some of the injuries, alleged injuries, that one gets involved when one starts to evaluate and analyze exposures, radiation exposures, or any type of exposure in the context of what we're doing to individual targets of an experiment. Now change and let's look at the second type of injury, much more problematic -- much more problematic: the mass exposure experiments. What do you do if the issue is not, did Joe get injured by this experiment with the facts showing this degree of causation between the experiment and the injury? What if, instead, the problem involves mass exposures? Two hundred and fifty thousand Vietnam veterans are exposed to the Agent Orange defoliant. Nevada ranchers are in the universe where an atomic bomb is detonated, resulting in downwinder allegations of harm. The Marshall Islands, that Jonathan knows so much about, what do you do? What do you do in those cases where you cannot demonstrate particularized injury, you cannot prove that Joe's injury was caused by exposure to that radiation? Ladies and gentlemen, that issue bedevils the courts today and it bedevils the Congress. No one knows for sure what to do. Why? Because using traditional notions of tort law, the traditional notions of tort law are found to be wanting. They don't help. Why? Because no one of those -- allegedly, no one of those individuals who were the subject of that exposure can demonstrate under traditional tort notions that their subsequent injury was caused by that exposure. Some have an increased -- some may come forward and say, "I have leukemia. I tell you, Judge, my leukemia was caused when I was on that ranch and the wind shifted and I received dosages of radiation." Under traditional notions of tort law cited by the court in the Allen case in the materials, that person will be thrown out of court. That person will likely have an impossible burden of trying to demonstrate that his or her particular cancer was caused by that exposure. He or she may believe it. There may be anecdotal evidence that demonstrates it. There may be epidemiological evidence that shows that that group of ranchers has a greater incidence of leukemia than the general body population. Under traditional remedy rules, that person is going to be nonsuited -- nonsuited -- because that person will not be able to overcome his or her burden in the law of demonstrating that despite the fact that he or she smokes four packs a day, that their lung cancer or their injury was caused by that exposure. There are also factual problems that arise. In Agent Orange, Mr. Vietnam Veteran, how are you going to demonstrate in the courtroom that you were, in fact, exposed to Agent Orange in Vietnam? Can you demonstrate that you were at the site at a particular location in Vietnam when the herbicide was dropped? Mr. Rancher, demonstrate to us that on that specific day you were right at the ranch when the wind shifted and you received abnormal amounts of dosage of radiation. Can you demonstrate that? Maybe in an isolated case you can; maybe you can't. More likely than not, you cannot. So that leads to a much different remedial discussion, creative devices set up by the law, by the courts, by the Congress to try and deal with mass exposure cases like Agent Orange and like the downwinders in Nevada. That's the dilemma. Now how do we -- let me say one other thing that's important. When you talk about the mass exposure cases as opposed to the particularized cases, the individual cases, you also, history demonstrates over the last decade, are much more likely to get into a major discussion over government culpability -- government culpability, like Agent Orange, like the downwinders. In these cases not only do you have problems of causation, trying to demonstrate that your particular leukemia was caused by the exposure, you also likely get into a discussion of the government's role in that exposure. Was it intentional? Was it willful? Was it negligent? Once you get into that discussion -- forget causation and science for a minute -- you get into some major obstacles to remedy because, as some of you know, once you allege wrongdoing by the United States, you get involved in some major legal discussions over government immunity, over government immunity from suit and over government immunity from remedy. The government, as most of you know, has successfully -- successfully -- in the courts opposed breaching this immunity in cases like Agent Orange and in cases like asbestos. In those examples, the government claims immunity and the courts have uniformly -- uniformly -- upheld the right of the government to be immune from any culpability or any not culpability, but any wrongdoing, any remedy. In one case at least a lower court found that the government was not immune from suit when it came to the downwinders in the Nevada test site cases. An appellate court reversed the district court in the materials, the Allen case, and said, no, the government, for sound policy reasons, is immune from such suit. And that may be a problem with particularized causation as well, but the bottom line here for everybody to understand as sort of a first-year primer -- primer -- is that when you start discussing remedies for individualized lawsuits or individualized remedy, and even more when you talk about mass exposure cases like the Marshall Islands, you get into not only problems of medicine and science, but you get into serious legal issues involving government immunity. Everybody has to understand that when you talk about fashioning remedies. All right, having said all of this, what are the creative solutions to the subject of remedy that are out there right now as precedent for everybody to look at? Well, when you talk about fashioning a particularized remedy, what should we pay Joe once we've found that Joe was, in fact, harmed by a particular experiment which caused the injury? That's a traditional tort remedy. That happens all the time assuming you get around the problem of the following: One, very important in all of these cases, what are the facts? What are the facts? It's all well and good to allege that Joe specifically was injured by this experiment. Was he, in fact, injured by this experiment? What do the facts demonstrate about the experiment, about the culpability of the government or its agents? Were they, in fact, agents? Did the experiment, in fact, cause Joe's injury? These are issues which require, as the staff and others are looking at now, a real basic investigation, so that we learn what happened. One cannot begin to fashion a remedy to compensate or solve Joe's dilemma until we know, in fact, exactly what happened and know whether Joe, in fact, was injured by the experiment. That is why, I suggest to everybody, there is such an interest in this Committee in getting at the facts, because until we know exactly what happened, it's very difficult to prejudge and presume a particular type of remedy. Once you have the facts, you can then establish criteria and develop a remedy. Now if you look at what the Congress has done in recent years, that's exactly what they've done. Take analogous situations in the materials like Japanese internment, the victims of internment in World War II. That is a situation where the United States Government, the Congress, enacted legislation, once it had all the facts before it, that said, nothing to do with medicine and science, but it said we know these people were injured, taken from their land or from their property, whatever, and placed in internment camps or what have you. We want to rectify that wrong. Years later, we want to provide some remedy. That's what happens in these individual cases. There are other examples -- we all know of them -- where the government has decided or the courts on their own have decided for 200 years, frankly, that once you know there was a harm done and there's a wrongdoer where it can be demonstrated that the wrongdoer caused that harm, you fashion, using criteria that are acceptable, known criteria. Based on what's been discovered, you fashion a remedy for that person or that group of people, using a grid, some sort of grid if there's more than one person. The vertical grid, the degree of wrongdoing by the culpable actor; the horizontal grid, the nature of the injury, how serious. Some injuries are more serious than others. That's how the grid looks in these particularized cases. Fashioning a remedy for mass exposure cases is much more difficult, even if you have all the facts. Why? I've already mentioned why. First, the government's role may be subject to all sorts of legal protections, legal obstacles to government obligation to provide a remedy. Those obligations are well- grounded in the law and deserving of some respect as public policy matters, deserving of some respect. But aside from the culpability question, the vertical grid, when you get into mass exposure cases like Agent Orange, like the downwinders, you get into very problematic issues involving causation, science, and medicine. Did No. 134 in the Marshall Islanders, did No. 623 of the Vietnam veterans, did they get exposed (a)? How much exposure, Henry's subject, (b)? And even if they were exposed at a level that Henry and others would say was very harmful, is their specific illness caused by that exposure? When you get into that subject, that is why you have such a provocative discussion going on today about fashioning remedies in mass exposure cases. Let me give you one example, Agent Orange. I've got about 10 minutes here. One example. In Agent Orange, the United States District Court, one of the most distinguished judges in the country concluded, based on all the available data, that no individual Agent Orange-exposed veteran could demonstrate under the law that his or her exposure caused the alleged disease; couldn't do it. Either they couldn't prove that they were exposed, they couldn't prove that they were exposed in enough heavier dosage of the herbicide, the dioxin, or there were multiple intervening causes, four packs a day; the Agent Orange veteran went home and worked in a different plant where he could have just as easily been exposed to harmful toxic substances causing that injury. Couldn't show it. Compounding the problem in all of these mass exposure cases is the subject of latency -- latency. The disease may not manifest itself 20 or 30 years after the exposure. During that 30-year interim there is no manifestation of disease, no manifestation of injury. Are we to wait 30 years before that person develops that illness, that injury? So the District Court in Agent Orange basically said this: I cannot justify compensating individual Vietnam veterans for illnesses A, B, C, and D, but not illnesses E, F, G, and H. Indeed, even as to illnesses A, B, C, and D, I see no legal cause-and-effect relationship at this time between the exposure and the illnesses. Nevertheless -- nevertheless -- the chemical industry certainly wants to settle the litigation. They're concerned that if they don't settle the litigation over the next year or two or three, such a relationship may occur and they may be held in the courtroom and may be found liable. I, therefore, agree that if they want to settle, I'll settle the case. Now how do we distribute the funds in Agent Orange? The court said as a remedy, I will not split the Vietnam veteran class by compensating A, B, C, and D and not compensating E, F, G, and H; can't do it. It can't be justified as a matter of science and medicine. What I will do is say, let's look not the etiology of disease; let's not look to the alleged claim disease; let's look to the degree of disability, whatever the disease. If a person is 100 percent disabled, a Vietnam veteran, who can show he was exposed to Agent Orange, however the dosage, he'll get a share of the settlement proceeds. If he can't, he won't. That's it. That's it -- a workmen's compensation model, not a tort model, not a science model, a disability model, like Social Security. Look to the degree of disability. That was the creative solution in Agent Orange. How does Congress develop creative solutions? Take a look at the Radiation Exposure Act. Take a look at any number of the handful of legislative enactments designed to deal with remedy involving mass-exposed populations. What does the Congress say? Does the Congress try and develop a particularized tort model? You have to show that your individual disease was caused by downwind radiation? Of course not. The Congress immediately throws up its hands and says we can't possibly do that; science and medicine won't let us do that; we can't justify it. So, instead, when Congress does act, Congress creates presumptions, that's all. Like the court did in Agent Orange. Downwinders, if you live in this area geographically on the date when there was downwind radiation, you get paid. You get paid. Now there may be variations of where you lived and how much, but basically in the black lung program involving West Virginia miners, if you have this disease, you get paid. We're not going to get into individual factual investigations of whether in mass exposure cases did John get enough exposure, did Bill, did Alice, did Mary? No, when Congress acts, Congress says, if you can satisfy the presumption, you don't have to show causation; we'll presume it. We'll presume it and you'll get paid. Theoretically, if the Marshall Islanders live in a certain area, if the downwinders live in a certain area, if the Vietnam veterans occupied by a certain area, theoretically, pay them. It's presumed. Maybe there can be a rebuttal presumption. This is how Congress deals with the problem. Now the courts in Agent Orange, when they talked about degree of disability, dealt with it that way. It's a presumption. If you're 100 percent disabled, we presume it was caused by Agent Orange exposure. That's all. You'll get your check. It is a very provocative subject, and very often the scientists and the doctors come into the courtroom and throw their hands up and say, Judge, Congress, why are you telling us to come here? We can't help you. If you're looking for a magic bullet from us that says, Doc, Scientists, come in here and say that Agent Orange causes soft tissue sarcomas, can't do it. Yeah, in mice, we've got some animal studies. We can't say with the degree of assuredness that you would like that that illness was caused by that exposure. You expect too much from doctors and scientists in that regard. There's too much ify-ness about conflicting cause and absence of facts concerning the degree of dosage level. We can't do it. We can only give you some guidance, some anecdotal help, some empirical studies involving animals or mass dosages, but beyond that, we can't give you the answers you want to develop the criteria that justifies the remedy that is often sought. There are too many unknowns and too many variables. Now a couple of concluding points: take a look at what is probably the best radiation discussion of remedy, and that is the report two years ago of the Presidential Commission on Catastrophic Nuclear Accidents. That is a report readily available. My supply of it is virtually inexhaustible. (Laughter.) And there are some excerpts in the materials for today for the Committee. That report deals with the mass exposure radiation cases, not the individual experiments, but what do we do with Jonathan's people, the Marshall Island people, or the Agent Orange people, or the downwinder people? What do we do with them? And there you'll see the Presidential Commission on Catastrophic Nuclear Accidents talking about epidemiological criteria, that this body population, this cohort, this group of targeted victims has a greater degree of injury than the general body population. They should get some sort of proportionate recovery based on the increased incidence of cancers among that body population. And there's some very good discussion in the report, picking up on where Henry was last week or a couple of weeks ago, talking about the need to first decide what minimal dosage levels are necessary to trigger any type of remedy based on epidemiological evidence of cause and effect. That Commission report is pretty interesting, it seems to me, in that area. Final point -- two final points: first, let's assume we get over the methodological barriers that are talked about: getting the facts, fashioning criteria, minimal dosage levels, epidemiological evidence for mass exposure cases, real hard evidence of cause and effect with individual experiments. What are the remedies? At the end of the day, what remedy is recommended? Well, there the limit on remedy is limited only by one's creativity and imagination. Remedies range all the way from hard compensation. Let's pay X dollars for Y injury. That's one remedy. That's the standard 200-year tort remedy, but that's not the only remedy. One can say let's provide some sort of medical monitoring of the cohort, of the population allegedly harmed, especially in cases involving latent diseases that may not manifest themselves for years and years, like asbestos. Let's provide not compensation; let's provide medical monitoring free of charge, which is a form of compensation, of course. Let's provide periodic checkups, periodic health reviews to give the alleged victim some comfort that they are well or give them -- lessen their anxiety by providing them with some sort of medical monitoring. Let's provide some sort of insurance program. Joe, John, Mary, Alice, you're not sick yet. You were exposed. You have a life insurance policy. You have a cancer policy. If and when you manifest an injury, we will pay you X. Until and unless that happens, we won't. There are other creative remedies that have to be at least examined. Final point: the Committee, of course, has to look at its mandate. I mean I end with a subject that really can perhaps be mentioned at the outset. When one looks at the Committee's mandate, this Committee has to decide what is its mandate when it comes to remedy. I mean, how far does the Committee go not only in investigating the facts, not only in fashioning some guidelines that may govern remedy, but is it the Committee's prerogative, as part of its mandate, to get into this subject in anything more than a passing glance? What are the guidelines for remedies that the Committee will recommend? How creative should the Committee be in looking at this problem, in fashioning some options? It is very problematic, it seems to me, as to who far the Committee goes in this area. In the areas where there have been remedies that have been fashioned, those remedies have been fashioned either by the Congress, the Executive Branch, or the Judiciary acting in cases like Allen and Agent Orange, the downwinders in Agent Orange. So I think we've got to take a look at that in some depth. We've got to make a policy decision as to how far this Committee wants to get into this very provocative area, but I think that in some way to some degree the Committee can't avoid the subject of some passing reference at least, and maybe something a good deal more than that, in terms of a discussion of remedy. That's basically sort of a 30-minute primer of the problems, very provocative problems, that confront the Committee. And questions? CHAIRPERSON FADEN: Thank you very much, Ken. I'm sure I have questions, but I'm going to -- Duncan? Duncan's got one, and then Nancy. I'll just look first, alert eyes and hands, okay, that we've got everybody. DR. THOMAS: Ken, you raised the issue of possibilities of offering compensation for increased future risk of disease that hasn't yet happened. I notice in the material that you've provided from the President's Commission on Catastrophic Nuclear Accidents that that possibility was considered and it was said that this was not a possibility that they found, on balance, appealing. I wonder if I could get you to expand a little bit on that, both in the particularized and in the mass exposure case? I have heard it said that in most cases in the particularized situation there is no provision for any such compensation, except in a particular setting, and I'm unclear as to what that setting might be. I'd just like to hear you expand on this concept a little bit further. MR. FEINBERG: Should increased risk of a disease be compensable is the question. In the mass exposure cases, which is all that the Nuclear Catastrophe Commission was looking at, they concluded that it would be ill-advised, and that's because by definition they were looking at the possibility, however remote or however likely, of a mass nuclear catastrophe in a populated area with radiation spreading throughout hundreds of miles involving millions of people. The Commission concluded that everybody would allege an increased risk or an increased likelihood of disease and that the scientists and the doctors would be unable, would simply be unable, to factually conclude as to whether there was an increased risk for just a small group, a larger group, a huge group, and the Commission concluded that it would be extremely divisive and problematic and just a bad idea. In the particularized cases, increased incidence has only been accepted in certain jurisdictions alleging increase incidence risk of cancer. Here there are a handful of states that have made compensable such increased risks, but, again, it is so problematic as a scientific and methodological point that the courts are reluctant to wade in and get into that hornets' nest of whether or not in point of fact that increased risk is real or can be corroborated, and the courts have just stayed away from it. CHAIRPERSON FADEN: Nancy? DR. OLEINICK: Yes, Ken, I wonder if you would just speak for a moment to the possible remedies for early death and the possible remedies to the heirs of those who do not demonstrate the A, B, C, D, E, F, G, but I don't remember whether death is on that list or not, but the individual, of course, could not be compensated in any way at that point. MR. FEINBERG: There is no question that on particularized cases the law has long recognized that even, if the victim is deceased, the estate can receive compensation. Even in the Agent Orange case, the court recognized that if a Vietnam veteran has died from -- was exposed to Agent Orange and died from some illness, whatever that illness might be, then the estate, the immediate family would be entitled to compensation. So I think the law is clear that if there is a deceased, then offspring of the estate can receive compensation. DR. OLEINICK: That in the case where the decision has been made for some kind of monetary compensation, but where the compensation or the remedy is to be medical monitoring or insurance or that sort of thing, it just ends, I assume? MR. FEINBERG: I know of no remedy there. Now, of course, you have some cases where the offspring allege second- generation, third-generation injury. Then, again, there would be a remedy for that person, but not as a result of the death of the father or the mother. CHAIRPERSON FADEN: Henry? DR. ROYAL: When deciding about remedies, do you take into account any of the benefits of the activity? Presumably, Agent Orange, for example, did not only expose the veterans to risk. Presumably, it was being used because it was going to save the lives of soldiers who were fighting. How does that fit in? How do the benefits fit in? MR. FEINBERG: Well, that's an interesting question. When we held hearings on the Agent Orange settlement all over the United States, we heard from Vietnam veterans who came in to the hearing and stated that even though they suffered injury or might have suffered injury or could suffer injury as a result of the exposure, more than one veteran commented, "Thank goodness for Agent Orange," because it was an herbicide, a very effective herbicide, apparently, that prevented Viet Cong and others, the enemy, from hiding in the underbrush. You raise an interesting question, Henry. In all of the examples that I'm aware of, there really has not been any reference made to the benefit except insofar, I suppose, on the vertical grid, when you talk about government wrongdoing or private party culpability, the argument would be that the remedy should be "less" because whatever degree of culpability one may conclude was wrong, there is a balance in terms of the benefits that the alleged wrongdoing afforded the victim, and I suppose even implicitly there is some recognition of that in fashioning the remedy. So that's an interesting question as to how that would play in here. CHAIRPERSON FADEN: Lois? MS. NORRIS: Do statutes of limitation have any bearing on this subject and, if so, how do they deal with the case of latent effects? MR. FEINBERG: Very -- you must be a lawyer. Statute of limitations are very important here in two respects. First, as a narrow law, if an individual claimant wants to assert injury in a lawsuit, the statute of limitations may bar that suit. That's a legal question. The individual claimant says, well, Your Honor, a five-year statute of limitations doesn't apply to me because I didn't even manifest an injury, a latent injury, until 10 years later. So really the statute of limitations should begin to run when I first learned of the injury, not when I was exposed. The courts are bedeviled by that argument, and, as a practical matter, the courts have gone both ways on that. I would say generally the courts say that the statute of limitation should not bar the claim, but there are courts with so-called statutes of repose where they would say, well, we don't care if you were exposed and everybody knew the product was harmful that was eating up the vegetation in Vietnam, your claim began when you were exposed and has since been extinguished. Now the reason that doesn't loom as serious an obstacle to recovery as it might is because when you fashion settlements of these cases, whether in the courtroom or the Congress, the statute of limitations is ignored, invariably. That's what guides -- that's one factor that guides the settlement. We will ignore statutes of limitation, statutes of repose, and presume that the claim is timely brought. So in fashioning a remedy -- and none of these cases end up getting litigated, remember. None of these cases get litigated. They all get settled sooner or later, usually sooner. The statute of limitations is avoided as an obstacle in fashioning one of these settlements. That's a point I really should make. You look at Agent Orange, Dalkon Shield, asbestos, DES, Pfizer-Shiley heart valves, breast implants. It is rare that these cases get tried. Some do, and you can always find asbestos litigation. It's been going on for 20 years now. But the great massive number of cases get resolved and settled out with some sort of remedial program like those I've talked about this morning. Other questions? CHAIRPERSON FADEN: Duncan and then I'll stick in my question. DR. THOMAS: I understood you to say that in the particularized situation the standard rules of evidence would preclude epidemiologic evidence of a group increase of risk such that the probability of causation would be greater than 50 percent. Did I misunderstand something? MR. FEINBERG: Yes. DR. THOMAS: Because I understand that -- MR. FEINBERG: Yes. DR. THOMAS: -- many of the individualized asbestos cases have been resolved on that basis. MR. FEINBERG: I'm not suggesting that with particularized individual cases you can't offer epidemiological evidence. I'm suggesting that usually there's a lot more than that. Usually, in the particularized cases, if the facts so justify, you can show injury and cause and effect. In the mass exposure cases, like Agent Orange, epidemiological evidence may be on the only real evidence that's available to show an increased incidence of injury to that group as opposed to the general body population, but I didn't want to leave you with the impression that in a particularized case epidemiological evidence is barred. It's just usually not as -- have as much strength as other evidence that may exist. CHAIRPERSON FADEN: Henry, did you want to ask another question? DR. ROYAL: Yes. CHAIRPERSON FADEN: Last question, and we'll have yours be the last. DR. ROYAL: No, go ahead. CHAIRPERSON FADEN: No, that's okay. I'll hit Kenneth later. DR. ROYAL: Ken, is there any concern that paying people for anxiety may be adding insult to injury, that it may be counterproductive? I mean, you're basically saying to victims, if you are very anxious, we're going to pay you money; if you're not very anxious, we're not going to pay you money. So you're basically saying be anxious if you want money. MR. FEINBERG: Basically, we're saying anybody who's been exposed and satisfies the criteria should get some minimal payment for anxiety; you're absolutely right. In the Pfizer- Shiley heart valve litigation, settled last year, every one of the 55,000 "targeted victims" of the valve received anywhere from $3,000 to $6,000 per case simply by filing a claim on the theory that everybody walking around with a potentially defective valve is anxious, and everybody got paid. They didn't get paid, relatively speaking, they didn't get paid that much compared to somebody who was the victim of a fracture of that valve, but you're right, anxiety payments basically are across-the-board payments paid to every member of the cohort or the class who satisfy the definition. You're absolutely right. CHAIRPERSON FADEN: Ken, thank you very much. That was terrific, and I know we'll be turning to you over and over again as our work proceeds. We are taking an unscheduled air conditioning break. There's a remedy in store. They're going to try to open up the partition and, apparently, there's air conditioning next door. I'm not sure whether they're moving us or whether they're hoping the air flow will come in. I'm not sure, but how about if we take a five-minute unscheduled rehydration break, basically, and we'll resume. (Off the record.) CHAIRPERSON FADEN: If we could start, please, our unscheduled air conditioning break has cost us a little bit of time. So we're going to try to catch up. We just got word that Reed cannot join us until tomorrow. He apparently had -- there was some attempt to notify the office, but it got missed. So he will be here tomorrow. I was not saying anything about Reed because I wasn't sure exactly what the status was, but he will be coming in tonight for some reason. Okay, so we're going to pick up where we left off and see if we can shave a little time maybe out of the next break. We're going to have Steve Klaidman give us presentation on risk communication. Steve? MR. KLAIDMAN: When I walked in here this morning, it was warmer in the room than it was outside. I was reminded of a piece of New York Times lore, a place where I first worked in the newspaper business. It was in the early days of the UN, and Ralph Bunche was holding a news conference in a room that turned out to be not air conditioned and he invited the journalists in the room to take off their coats and introduce themselves, and they went around the room doing that. The young New York Times reporter covering this meeting was A. M. Rosenthal, ultimately, to become executive editor of the paper, and he was wearing the best shirt he had that day, which was torn, and so when they got to him, he pulled his coat around him tightly and said, "I am A. M. Rosenthal and The New York Times never removes its coat. (Laughter.) At the dawn of the Pleistocene epoch, about a million years or so ago, a squat, hairy hunter emitted a noise that was somewhere between a squeal and a grunt when he saw his nearby companion being attacked from behind. This, I believe, was the world's first instance of risk communication. In the 1970s, more or less, someone coined that term. In a sense, this parallels the development of bioethics from the relatively primitive Hippocratic corpus of ancient Greece to the coining of that term in the second half of the 20th century. Bioethics, of course, has earned academic respectability. It is a serious discipline of considerable breadth and depth. Risk communication, on the other hand, is both narrower and shallower. It is, nonetheless, critically important because without effective risk communication between journalists and audience, between physician and patient, between researcher and subject, people will have a harder time avoiding hazards generally and, more to the point for this Committee, there can be no genuine informed consent. The reason risk communication has evolved into an academic discipline is that a noise between a squeal and a grunt is not a sufficiently nuanced message in all situations. Moreover, formidable cognitive and emotional obstacles stand in the way of delivering it. Many of these obstacles are, of course, related to the same fears that led physicians from Hippocrates to Percival and beyond to treat the idea of informed consent as inimical to good medical practice. But in the world in which we now live, autonomy usually trumps beneficence. Therefore, in the absence of informed consent, medical practice and research may well be judged immoral, which almost brings us to the subject of risk communication, the means by which a consent is adequately informed. Risk communication has an analytical component concerned with identifying and classifying the ways in which messages about health risks and benefits are perceived and applied component concerned with delivering these messages in diverse settings, such as doctors' offices, hospital wards, chemical plants, or people's homes -- the last mainly through a spectrum of mass media that includes The New York Times, USA Today, CBS Evening News, the Sally Jesse-Raphael Show. Now the reason for the almost is that before talking about risk communication I need to say a few words about risk to answer the question, "Risk of what?" and risk assessment, the infant science of estimating the outcomes of exposures to hazards. Even among professionals, the word "risk" means different things to different people. It might mean, for example, probability of premature death or loss of life expectancy. For purposes of this discussion, however, I'll stipulate that risk means the probability of any nontrivial negative outcome occurring as a result of a treatment or of an experiment. Risk assessments transmute uncertainties about the likelihood or frequency of any particular outcome into probabilities. Risk analysts, therefore, are, in effect, bookmakers who handicap hazards rather than horses. Unlike bookmaking, however, which takes place in a relatively transparent environment with two clearly-defined constituencies, each of whose goal is the same, risk assessment takes place in a politically-charged, value-laden, culturally-influenced environment crowded with interested parties, each of which is determined to put its particular spin on the final product. As a single example of the kind of underlying bias that is built into the process, here in a highly compressed form is how the federal government estimates the risk of potential carcinogens. Typically, bioassays are used in which the more sensitive sex of the most sensitive species of an animal is given the maximum tolerable dose of a substance to see if it produces a tumor. Linear extrapolation from animals to humans is done by one of two methods: skin surface or body weight. These produce results that vary by a factor of 10. No one seems to be sure which is the better method. Then a safety factor of 100 is plugged in to arrive at the final risk estimate. If the estimated risk is greater than 1 in a million, federal policy in most areas is don't take the risk. An ordinary scientifically-illiterate person is perfectly capable of understanding that risk assessments like this are at best crude estimates based on worst-case scenarios further distorted by artificial safety factors. This, however, is not the problem. The problem is that people who confront health risks are afraid and they abhor uncertainty and they are uninterested in probabilities. They want to be assured that everything will be okay or to be told that a particular drug is safe or unsafe. They do not really want to be told that if they take Tamoxifen, their chances of getting of getting breast cancer will decrease by 20 percent, but that their chances of getting uterine cancer will increase by 10 percent. The challenge, then, is to devise a way to inform patients and subjects of experiments of the probability that certain positive or negative outcomes will occur as a result of specific treatment choices, including nontreatment, or of agreeing to become a subject of an experiment. To meet this challenge, the risk communication researcher must try to understand the full range of perceptual and other problems that influence the way people process and understand complex technical information. We don't need decision theorists to tell us that most people have no systematic way of deciding what to do when faced with complicated choices, especially when powerful emotions such as fear and love are also involved. These decisions are even tougher when they involve uncertainty, probability, and scientific complexity, which is often the case with health risk decisions. There is rarely an opportunity for trial and error, the average person's favorite decisionmaking tool. If the question is something like, "Do I dye my hair and risk cancer 20 years from now," the answer is you either do it or you don't. The same goes for taking Tamoxifen. Another problem faced by anyone needing to communicate health risk information is that the public already has a skewed perspective on the comparative riskiness of various hazards. For example, the public consistently overestimates the following causes of death: accidents, pregnancy, child birth and abortion, tornadoes and floods, botulism, cancer, fire, and murder. And it regularly underestimates diabetes, lightning, stroke, tuberculosis, asthma, emphysema. The social psychologist Fischhoff, a long time student of such questions, noted that the movie "Jaws" greatly increased people's awareness of risks on the beach. Perhaps, he observed, Stephen Spielberg should make a film about lung cancer. Fischhoff also speculates, by the way, that the reason for the public's misconceptions about the frequencies of these hazards is related to how often and how saliently these causes of death are encountered in people's lives and in the news media. Here are some of the other factors that influence risk perception in no particular order: whether the risk is imposed, as in the case of a hazardous waste dump being sited in your back yard, or voluntary, as in the case of smoking or skiing; whether it is natural, such as aflatoxin, or manmade, such as DDT; whether it has an immediate effect, as in a car accident, or a delayed effect, as in AIDS; whether it is potentially catastrophic in impact, like a nuclear disaster, or involves an exotic technology, like gene splicing, and whether the consequences are reversible or irreversible. When people are afraid, they may go into denial, and when they are scientifically illiterate, they may not understand what they read or are told. There is a tendency to mistrust positive technological assessments, in part because accidents and lies tend to be more vividly recalled than on-time-arrivals and true statements. And, according to the sociologist Alan Mazur in what may be a related phenomenon, even positive media coverage of new technology often generates a negative public response. Until now, I've referred to something called the public, but, as you all know, for most purposes there are multiple publics. To deliver understandable information about health risks requires tailoring messages to specific populations. For example, a message whose basic purpose is to limit the spread of HIV infection among drug addicts in Washington's poorest neighborhoods will need to be dramatically different from a message whose goal is the same, but whose target audience is Georgetown University students. Unless the message is crafted to emphasize its relevance to the group that is being addressed, there is a substantial likelihood that it will be either ignored or rejected. Similarly, if you expect to reach a target audience, it helps to select the right channel or channels of communication. These range from one or more on the mass media spectrum to direct contact between physicians and patients or researchers and subjects. To return to the AIDS drug user analogy for a moment, you do not reach this community through The New York Times. Rap radio may be worth a try, but, basically, the risk communication job falls to people who can go out onto the street and talk the talk. Mass media can make information available quickly and to a large audience, but because of technical and institutional constraints, such as lack of time or space, they regularly truncate and oversimplify complex stories. They also have less ability to alter attitudes or motivate behavioral change than face-to-face conversations. These examples illustrate a clear link between perceptions of risk and culture, but the full story remains to be told. Anthropologists like Mary Douglas have hypothesized that risk perceptions are to a large extent culturally determined and that attitudes about riskiness are often surrogates for attitudes about, for example, social institutions, nature, moral behavior. Attitudes about nuclear power generation may reflect people's feelings about nuclear weapons as much as they reflect fear of catastrophic events or of radiation itself. And people's concerns about pesticides in the food chain may have as much to do with disturbing the natural order of nature as they do with fear of cancer. Cultural factors of this kind can be a formidable barrier to effective risk communication. I should say at this point that most groups or individuals with health risk messages to communicate also have a political point of view related to cultural context, political party affiliation, regional considerations, career goals, so on. As a result, like most political messages, health risk messages almost inevitably have a spin put there by industry, by government, by so-called independent researchers or interest groups. This, of course makes it very difficult for ordinary people to choose among the multitudes of conflicting messages. A common response to this confusion is to make a decision that reflects other forms of preference such as taste, for example, and to ignore the risk message until such time as the data become overwhelmingly clear. Now let's leave the real world of politics and return to the theoretical question of how to construct messages that promote informed choices about health risks. Because people's beliefs and opinions are easily manipulated, messages must be framed in a way that does not encourage one interpretation over another unless clearly warranted by the evidence. Consider this example provided by the risk communications researcher Vince Covello: a group of study subjects were asked to imagine that they had lung cancer and had to choose between two therapies: surgery or radiation. The therapies were described in detail. One group of subjects was then given information about the probability of surviving after the therapy; the other group was given information about the probability of dying. Presenting the data in terms of dying rather than surviving resulted in a sharp drop in the number of patients choosing radiation over surgery. It was 44 percent to 18 percent. And it is worth noting that when the experiment was repeated with the subject population of physicians rather than laypersons, the results were virtually identical. The risk communication experts offer no elegant solution to this kind of problem. The current working hypothesis is simply that target audiences should be exposed to both perspectives. Without belaboring such obvious points as risk communication intended for general audiences should be jargon- free and all information material to good decisionmaking should be included, I would like to conclude with a few words about risk comparisons, which can be an effective way to convey health risk information when properly used. A well-thought-out comparison should help people assess the seriousness of an unfamiliar risk by reference to a familiar one. Here are some guidelines, also provided by Covello, that, if followed, should result in a risk comparison achieving its goals: Be specific about the intent of the comparison and caution against unwarranted conclusions. Make clear what the assumptions and uncertainties are in the risk estimate. Target the comparison to a specific audience, taking account of their needs, concerns, and their knowledge. Compare similar or related risks; for example, two modes of electricity generation or two forms of treatment for the same condition. Formulate the comparison to address quantitative dimensions of risk, such as estimates of immediate or delayed deaths, short-term or chronic illnesses, loss of life expectancy, transgenerational effects, and so on. Target the comparison on qualitatively similar or related risks. Qualitative characteristics of risk include catastrophic potential, reversibility, immediacy of consequences, impact on future generations, uncertainty, dread, controllability, and so on. Risk comparisons are tricky and there's no guarantee that they will succeed in conveying the desired information in a form that encourages informed decisionmaking, and often too little space or time is devoted to delivering them, which I'm sure comes as no surprise to anyone. This brief presentation, for example, fills more time than 20 average-length news stories, television news stories, that is. Similarly, busy physicians often spend too little time with patients to explain risks and benefits carefully. Nevertheless, there has been progress. Public service messages are sometimes well designed. Journalists are attending seminars on risk communication, and more and more physicians and researchers are aware that it takes some subtlety and sophistication to effectively deliver information about health risks. Thank you. Any questions? CHAIRPERSON FADEN: Thank you, Steve. Are there questions? Jay? DR. KATZ: Steve, wonderful and complex presentation, but there's another dimension that you had to leave out, and I wonder whether there is some information available about it. It's not only, as you started out, that, of course, patients do not want to know that tamoxifen is helpful with respect to this, that, and maybe that detrimental with respect to the other issues, even though that does not preclude that patients shouldn't be given this kind of information. But there is the problem which has been -- which has hardly been studied, namely, that physicians and investigators have a devil of a time to inform patients and research subjects about these issues because it creates anxieties in them, particularly when they want to invite them to participate in experiments, and then if they were to fully disclose all the things that possibly might go wrong and that the subject ought to consider, that is not an easy thing to do. Do you have some data on that aspect of the problem? MR. KLAIDMAN: Yes, it's clearly an important question, and as much a question about whether to communicate as how to communicate. And I'm not aware -- let me put it this way: I would not be at all surprised if there are specific studies dealing with just that question. I don't know what they are, Jay, but I'd be happy to look into it for you. CHAIRPERSON FADEN: Are there other questions? (No response.) Thank you, Steve. Then we're on to our break. We have a choice. We could skip break, since we've sort of already had one. Is everybody able to skip the break? Then if we skip the break, we'll see how it goes with lunch. But we'll go then to Danny giving us an overview of the staff and then we'll do a staff report, two staff reports before lunch, if we can get them in. Dan? MR. GUTTMAN: Thank you. There has not been a day that we've been at work that many of us have not been told that our task is daunting, impossible, or similar words, and it remains that way. It is an impossible task. My sense is that with the staff and the Committee that we see here, we are now in the zone where there is some positive as opposed to zero chance that we will make, probably already have made in some areas, some contribution. And the question is how to best focus the terrific resources you have, and I just want to give the overview, and I hope in the next two days we can begin to get into the details, so we all can be productively used and not doing things of little value. The search that was directed by the President through the Cabinet Secretary, Ms. Varney, is, with some exceptions, some agencies, almost completely completing the phase 1. And, again, with some exceptions -- this is a generalization, so I know there are agencies out there that are saying they're not in that category, but with some exception, that search was directed at identifying places in the organizations today and predecessor organizations that conducted or sponsored experiments and identifying, listing, providing basic information on the experiments, just numbering them, capsule descriptions, as opposed to, for example, you know, bringing us all the documents relating to those or, more generally, looking at the headquarters organizations or other related organizations that might have coordinated, set policy for, or utilized organizations. I would say that the search was directed at the feet rather than the head, but in my experience it's not clear which is the feet and which is the head of our government. (Laughter.) The net result, if you look at it, is extraordinary in the sense both of its extraordinariness and its uncertainty of implications. The Defense Department, to take an example, which is still in the completion of phase 1, the Navy -- I see Captain George and his group out there -- has identified about 700-plus potential human studies, and I use that term loosely, not in any technical sense, because we haven't looked to see what that all means. You'd have to go into the literature. The Air Force, probably a couple of hundred; the Army reports about 2,000; DOE, through its abstracts of periodicals, many, many hundreds -- just to give an example, we're talking about lots of studies. Now many, many, many of them are post-1974, without giving any qualitative judgment as to what that date means, and many, many of them may be innocuous, without meaning to attribute any qualitative sense to what innocuous means. But the point is we've got a lot of studies. What we're trying to do, what I'm trying to do to get some set of collective arms around this is to create a big picture, a framework from which we all can begin to work a common framework and begin to fill in pieces and figure out where we want to go and where not. For lack of a better metaphor, I use the term "mapping," and I'm trying to create maps that go in three basic dimensions simultaneously. The first mapping is what I would call institutional mapping, which is where were the places, going back to 1944, that were connected to these experiments, connected either as an actual conductor, a sponsor, a funder, a coordinator, a policy setup, or connected in the sense that we would meaningfully seek to know why and how and what the experiments were about. We're looking not only within agencies, but we're looking across agencies, and we're looking within and across agencies into the private sector and back. I think the institutional mapping is something that is relatively far along. It's amazing how little today we know about what was our government 30 or 40 years ago. It is really like we might as well be looking for, you know, who was there at the table at the signing of the Magna Carta in some instances; it's probably much easier to do that. But the kinds of things that we're finding, for example, that we are filling interesting gaps within agencies. In the Defense Department, which we'll talk about -- Dr. Soper and his crew is out there -- did not initially look at the Office of the Secretary of Defense. We're talking about getting into it, but we now know one of the most important, interesting things we're looking at is this 1953 Secretary of Defense issuance of what we are referring to as the Nuremberg Code. That came out of a recommendation from a medical policy council. And if you look at the 1952 Defense Department organization chart, sure enough, there right up there in the Office of the Secretary of Defense is the Medical Policy Council. So now we're going back with Dr. Soper and his folks and looking to see what kinds of things we can find about why that was issued, what experiments it stimulated, and what came out of it. Just a couple of days ago, Colonel Bailey and Dr. Soper faxed over a declassified last week, former top secret until last week, document which was the recommendation going to the Secretary. That is at this point just beginning to show the kinds of interesting chipping away both at these higher-level documents, but also things that have been kept secret, for whatever reasons, until very recently. So one is institutional mapping within agencies to find all the components that are relevant. Every time we meet with an agency we find interesting discoveries. We were meeting with the Defense Nuclear Agency the other day and we were talking about, how does anybody know whether anything is useful? And they said, well, you mean the QRRs, and I assume General Russell knows what QRR -- or I hope he does. Anyway, we said, "What's a QRR?" And, as it was described to us, this was kind of a shopping list that each service puts out every year about kinds of research they need. And I don't know if that is a valid description or not, but our immediate instinct was, gee, can we get those QRRs, so we'll get some sense of why people needed this kind of research? But, anyway, this is a bit-by-bit working through with the agencies, sitting down and getting comfortable, so we can talk about the way in which we can find things out. The second is, of course, mapping agency-private sector. Those -- you've had a chance to look at the January 1947 AEC Advisory Committee minutes. That is in the package we gave you. It's quite an elegant little organization chart -- if you have a magnifying glass, you may be able to read it -- of what the AEC was proposing back there in 1947, with many branches and every one of your alma maters were probably all included there, somewhere in the chain. We see not only the Emories and the Rochesters and the Cals, but we see the NIH and the PHS and the National Cancer Institute. So back at the dawn, in fact, we now have been told that the World War II Committee on Medical Research, which was the center of our War Department medical research, "transited or transisted", or whatever the active verb is, into -- its contracts were transisted into the predecessor of today's HHS. For those of you who used to read Spy magazine, it's kind like a separated-at-birth kind of thing. Our government at one point probably was almost like one government, and it's hard to recover that, that information we're trying to recover. The third, and the most interesting, equally interesting, kind of mapping is the way in which we see connections across agencies. Today they're kind of -- it's like the continents after the continents were divided, but back then South America was connected to Africa, something like that. We see, for example -- Denise Holmes will talk later in the day about 1947, how General Groves and the Manhattan Project and the folks in the military and the AEC went over to the VA and set up this Atomic Medical Division, which we'll hear more about -- a connection immediately, again, sort of at birth, if I can use that metaphor -- I don't know if it's a good one -- a connection of these two agencies. Then what happened we don't know. We'll try to find out. We find -- you were just given, the folks from the Army just gave us last week the Secretary of the Army's June 1953 implementation of the Nuremberg Code, and on the last page of it, it says, anybody got any questions about how we should go about implementing this document, which includes Secretary approval of every experiment? The people to check with include not only the Surgeon Generals of the Army, Navy, or the Air Force, but also the Public Health Service. So, again, back there in '52 all of a sudden we find that HHS's predecessors were kind of clued in. Now why or how or when or what, these are questions. We're beginning to create that map. The second aspect or dimension of the map is ethics, and I guess it's more of a timeline than a map, but it's a map in part. This is area where we've, obviously, gotten the richest discoveries. Susan Lederer last week talked about Walter Reed, and General Russell has told me at some greater length about Walter Reed. So I guess it's obvious that the Army was a leader in the notion of, you know, serious concern. Back almost 100 years ago, Captain George just dug up in a naval history, 1932, something that looks like some kind of protocol. I don't want to use the word in any technical sense because Ruth will say I've misused it, but something of interest back in 1932. In 1942, the Committee on Medical Research, again, Jon Harkness, an historian, dug up documentation that they took informed consent seriously. Now, of course, we have the 1953 series of documents which are, obviously, setting a much richer framework. Where that framework goes, what it means, I will not begin to hint at because Ruth will say I'm beyond my area of expertise, which, of course, I am, but that's why it's an interesting story. The third and the more difficult one -- so we've got the institutional mapping, which is kind of interesting and under way, and the ethical mapping, which is a surprise and a delight because it sets a framework for making decisions about particular experiments that we hadn't thought might exist. Then the more difficult one, the one that I hope we can begin to get a bigger grasp on, a better grasp on, is this experimental map. We've got like thousands of experiments. So what do we do? How do we group them together? An obvious a priori way of sorting them out is we can look at two kinds of ways of looking at them. One is governmental purposes defined broadly. For example, the plutonium injection experiments were done, clearly, in part to find out how to protect workers who were working with plutonium. Obviously, in part, Dr. Saenger was looking at what happens to people on the battlefield after irradiation, combat effectiveness. The problem with government purpose, it's not easy to identify government purpose because what we have, for example, from Captain George is a list of 800 sort of capsule descriptions, iodine 131 in the thyroid, and that doesn't tell you much. In fact, folks from the Navy say there may not have been a clear governmental purpose for a lot of this. It may have been basic research. It may have been scientists doing things. So the government purpose is a very difficult thing to tease out. Last meeting we referred to this notion of piggybacking. You know, which comes first, chicken or egg? And our hope is by getting into the headquarters policy documents we may be able to sort of group things by governmental purposes that are not presently obvious. Some kinds of experiments, the purpose is obvious; others not. But getting into the policy documents of the program offices, you may find memos saying the following uses of gallium X, Y, and Z are because we've got this problem down there in Alaska. We don't know. That's why this is serendipitous. The other is a scientific categorization or medical categorization. We've struggled; we've had discussions. I know Duncan is extremely interested and Mary. The Cold War Committee has tried to figure out how to group these couple of thousands. NASA at our meeting on Friday said they'd be interested in helping us with the taxonomy. My working thought, having talked to everybody, is to sort of, instead of trying to sit down with the thousand, as Nancy sort of tried to do, and say, gee, I can't make head nor tails of half of these abstracts -- if we pulled these thousand articles, we'd have to get a thousand people to read them -- is to sort of start from the direction of categories that seem to make sense and that are studyable and that take us in interesting areas. So, for example, we looked at Dr. Saenger. It turns out Dr. Saenger, whole body radiation, is part of what are probably three or four dozens of whole body radiation experiments. How do we know that? We know that because in the 60's Oak Ridge was hired by NASA and the AEC to do a retrospective, and you look at that and there's a grouping of information, and NASA says a lot of the documentation is destroyed. But it also raises innumerable interesting questions because the institutions performing them were not only Dr. Saenger's, but VA hospitals. There were places with no seeming kind of connection to any government entity. So, in other words, that's one kind of group. Another kind of group is if you just take the plutonium injection and expend it out, Gil Whittemore points out that it's sort like -- and Gregg Herken, our historian, said what was going on -- I'm going to finish shortly -- is a march through the higher reaches of the periodic table. They discovered all these exciting -- well, they discovered plutonium and they became more intimately involved with these other, uranium, et cetera, and they decided, gee, let's find out what happens when you inject it, when you this, when you that, and you so forth. That's kind of a whole kind of school. What its borders are and boundaries are is not clear. Dr. Stannard has probably written much more than we will ever know in his book about a lot of that kind of stuff. So it's not -- the issue is not to reinvent the wheel, but just to see from among the experiments we already have whether that's kind of a group. And Gil is looking with the Stannard book to see if that can provide some kind of template. Intentional releases, this is just my final kind of thought. One of the things that's interesting is we have in our charter these 11 intentional releases which to me sound like mysterious intelligence-gathering experiments, but when you look at the documents, including the Markey experiments, what was happening back in the forties and fifties, they had these new substances and, whatever kind of curiosity, they were sprinkling them in the water, putting them in the air for fallout. The Markey report talks about fallout being tested with the cows, and then what happens when the people drink the milk? Well, literally described, that's an intentional release. Now I don't know whether it's nocuous or innocuous, but in terms of conceptualization, that may be a whole other category. A final kind of category, which Gregg Herken is as much of an expert as anybody who hasn't had security clearance recently can be, is radiation warfare. That's a whole category where there's probably more classification than these other categories, but it's one where people are curious about it. So, anyway, the basic point is that we're trying to get a grasp by this big picture, and filling in the big picture increasingly by sort of the iterative process. So somebody is looking at the Department of Energy and they see something that's connected to the VA. So all of a sudden, we now know that the VA actually is connected. It's not just sitting out there. And then one kind of experimental conceptualization will lead to, well, what are we leaving out? Well, obviously, tracers is a monstrous category. I don't begin to know what that means, but, you know, just begin to include more and more categories. This is where the scientists, obviously, are essential. But basic staffing problems and issues that we're working through now are, one, grouping the experiments in meaningful ways, so we're not just reading an experiment and saying, well, here's another experiment; what's it mean? Right? What's the way to go about this to tell a story? Two is keeping the documents flowing from the agency and reviewing them. DOE has provided us with about 10,000 to 15,000 documents which we're going through. DOD has provided us with several boxes. By and large, we have not yet gotten documents from the other agencies, and this is not a suggestion of dereliction. They've given us groups. It's a question of waiting for direction, and this is why we're here discussing these particular agency reviews. The third big picture item is classification, which I'll conclude with, and we're hoping to begin to chip away bit by bit. We have been told repeatedly that insofar as we're talking about biomedical research, whatever that means, that, if ever classified, should be readily declassifiable today. So that the issue in terms of a lot of the things that are central to our interest is sort of locating where it is and making sure that as quickly as possible, to the extent it's got some cobwebs of classification around it, those are whisked off. Then looking at the kinds of things where, clearly, there may be more difficult classification issues. Maybe radiological warfare is one today and maybe it hasn't been looked at in 20 years; the Green Run may well be. But, in other words, sort of focusing. Ruth, as we will talk about, sent a letter and we've gotten assurances from the agencies we'll get as rapid a turnaround as possible. We use the term three weeks on the classification. So, basically, the big picture, we all want to see how we can fit into it, and the problem is, how do you do this so that everybody doesn't have to know everything, but everybody knows enough of everything, so that when they're looking at something, they can say, I don't understand it, but I should talk to so and so. The key to me at this point conceptually, where we really need your help, is this experimental grouping. And, again, this is not down at the end of the line where we're judging a Dr. X or Dr. Y. This is just so that we can go tell the story, and then we see there are 30 or 40 of this kind of experiment, and if you want to then say, let's pick out two or three and go all the way to the bottom on them -- and this is what the agencies are telling us; they'll go to the ends of the earth to go to the bottom of those two or three, and then you can make judgments or not, and the two or three could be based on the population served, or whatever. But we're just trying to get the big picture and sort of corral things in the right direction. Thanks. CHAIRPERSON FADEN: Questions? Comments? GENERAL RUSSELL: Dan, how much data are you getting on the sources of funding for the research and tracking that back to the organizations that provided the funding? MR. GUTTMAN: Well, that's the question we presently put out to the agency, DOD in particular, because that was not what had been the object of the initial search. We went and we said, for example -- DNA, the Defense Nuclear Agency, has just told us after we went and talked with them a week ago that they can give us the budget proposals going back to whenever they can find them on research. And with the Army, for example, we've talked about either R&D review boards, or whatever the name was, to see where at the headquarters level -- that's exactly the kind of thing we want to get. We haven't gotten it because that just wasn't what the focus. GENERAL RUSSELL: For individual projects -- MR. GUTTMAN: Yes. GENERAL RUSSELL: -- how will they even get a clue, some clue as to who generated it and why, if you knew the source of funding. For example, if it's Navy, 6.1 funded money, it's investigator-initiated basic research and that's quite different than the work from the point of view of why it was done than work done with other kinds of funds that are directed by a staff organization. MR. GUTTMAN: Let me just say (a) I didn't know that; (b) that's why you're on the Committee; (c) Robert Joy, who General Russell has referred us to, who's I guess the preeminent military medical historian, has been of immense help. Every time we go to an agency, he -- NASA said that when they got started in '58 they turned to him and so we've got -- the point I want to make is I think what you're illustrating is the way in which this seemingly unrelated archaic, bureaucratic budget data could help narrow our inquiry into these hundreds of other -- you know, figure out what is individual inquiry; you get a sense of what is not government purpose. MS. NORRIS: Forgive me if this is clear to everyone except me, but we have been provided with some materials, including the Manhattan Project history and some AEC interim Medical Committee reports, which contain contemporary risk assumptions, and I'm wondering, do you anticipate that this will be used as part of the process of determining the ethical standards in a chronological -- MR. GUTTMAN: Let me just say that in the morning Lois came over -- I hope I'm not embarrassing you -- saying you were just a citizen; you didn't know what you were contributing. My response is the statement that is an incredible point and I wanted to make -- this is a critical point. One of the things we're finding, the basic question is: looking back at the world then, we have to know what the standards were then. How you judge risk today may or may not be relevant. We all are very acutely aware of looking for the ethical standards. We've got people, you know, out there beating the bush for ethical standards. What about the scientific standards? And I had this conversation with Mary Ann several occasions, and she will talk for herself, but one of the things that leaps out in some of these old Manhattan Project documents -- and I'm looking forward to what General Russell and Henry and Nancy say -- is it looks like they may be giving us a scientific baseline at the beginning of the period. So instead of running around saying, well, who knows how to judge these, we'll have something that actually was contemporaneous that gives us a clue. Now the question I'm being asked -- two important conceptual points: Gil Whittemore literally has written the book on the history of -- it's coming out in Harvard University Press -- on the history of radiation standards, the federally- accepted standards and the quasi-public committee that sort of set them. So we can really make a terrific contribution in linking in the way in which these standards get set, because when we go to these agencies, we're always asking, well, how did you know, when you started building the nuclear submarine or the atomic-powered airplane, how did you know that the guy, the men and the women would be safe? And they said, well, we took the data from some place else. Everybody's sort of like this (indicating); right? So the ultimate question is, well, where did this data come from? So Point No. 1 is we got to pinpoint what was the contemporaneous baseline, but Point 2, I think -- I'm not sure if it's too deep and difficult a question -- one of the elemental contributions the Committee could make is all this data that this entire edifice of research and understanding rests on, where does it all come from? We don't know. Obviously, Hiroshima and Nagasaki is one point of essential reference, but the question is: where underlying this was animal research; where was human research; where was just rule-of-thumb assumptions? That's something that we're going to be able to maybe get into. DR. KATZ: Dan, a number of points, but I'll only mention one because it will come up during the rest of the day and tomorrow, but you raised the question with them: how did you know that it would be safe for humans? Did you also ask them the question, or shouldn't we also ask the question: to what extent did you worry about how safe it is for human beings? In my work, and even in these documents and other documents that I have, I am so greatly impressed how little people even worried and discussed the question: what are we doing to human beings in these situations? Have you raised that question? MR. GUTTMAN: Well, I don't want to give away any secrets with Dr. Soper and others in the audience, but having gone to the law school where you teach, the way we ask that question is we say we assume the Defense Department was extremely concerned about human beings, to which the answer is absolutely. Then the question is: well, where is the evidence that shows that you did studies and where were those studies. Is that correct, Doctor? Is that we proceed? Yes. We can ask this question or you can ask the other question: how come you didn't care about it? We can ask that question, too, but -- DR. KATZ: You can, but did you discuss it? Were you concerned about it? MR. GUTTMAN: Yes. That's exactly what we're trying to get into in the policy stuff, is when these things, when these programs got developed, where did the research piece get filled in? CHAIRPERSON FADEN: For example, with respect to the Green Run as an illustration, it's essentially, did anybody worry about the implications for human beings going forward with Green Run? We're trying to get to the documentation that would give us at least a hint. I'm trying to think about what to do. Dan's overview was to give you a sense of sort of how we're thinking, the staff is structuring, but maybe now is not the best time to have a discussion about how -- MR. GUTTMAN: Well, I think the subcommittees will get in -- CHAIRPERSON FADEN: Well, when we get into this, when we have subcommittee reports and then the discussion, that's the substance in which we can start to give the direction to the staff, unless there's a view that this mapping orientation is not useful, which if we find that out early, we will -- MR. GUTTMAN: If anybody has any better ideas, please, yes. CHAIRPERSON FADEN: It's -- DR. KATZ: Let me only raise one issue -- CHAIRPERSON FADEN: Sure. DR. KATZ: -- very briefly because it will come up. Should we soon begin to map not only for 1954 forward, but we move backward and have some people begin to map for 1994 backward? MR. GUTTMAN: Yes, well, let me just make clear, the mapping, while it sounded like Cold War presentation, in practice it goes up to the present. For example, when I say that the Army provided 2,000 experiments, many of them were up to the present, 1993, 1990s. So this is all-inclusive. I didn't focus on the present period because it's an easier one to get information on, but it's all-inclusive. It includes your period -- CHAIRPERSON FADEN: So the map -- MR. GUTTMAN: Yes. CHAIRPERSON FADEN: But it may be that we need different ways of thinking through how to get the information and that we should start that process -- MR. GUTTMAN: Right. CHAIRPERSON FADEN: -- sooner rather than later. I think that's right. Henry, last comment and then we'll go on. DR. ROYAL: My comment is somewhat related to Jay's. There were many different charges of the Committee. One is to tell as much of the Cold War story as we can. Can you give us any idea of how much of the Committee's resources are going to that activity versus other activities? From my perspective, it seems like most of the Committee's resources is going to telling the Cold War story, and I guess the followup to that would be, how do we decide how much of the Committee's resources go to which activities? MR. GUTTMAN: Briefly, Ruth, obviously, is the governing principle here with you all, but we are right now sort of front mowing, trying to get the information flow from the agencies, so we'll have something to work with. That is, I think -- the information, as I said, covers the entire period up to '94. Two, I think what Ruth will discuss for you tomorrow might, for lack of -- be sort of how we're covering the more contemporary period. Is that -- CHAIRPERSON FADEN: Well, in part. MR. GUTTMAN: In part, right. In part. In other words, we're going to -- my hope is that the staff will operate in an efficient way, so that what it learns at the dawn of this period will then be able to carry over as the work changes into whatever you people want to go in the more modern period. CHAIRPERSON FADEN: I think your question's important, Henry, because I ask about it all the time -- and look at all the people, and we have such a talented staff -- as to what is everybody doing. And my guess is, although I haven't kind of Pert charted it, my intuition is that, yes, more than half of the time of staff at the moment could be described as being involved in activities that relate to the Cold War story. I would guess that's probably right; maybe somewhat more than that. The issue is for how long it will go that way and at what point do we shift things over. I mean, getting the early history straight is important and somehow seems to have driven the initial sets of inquiries, but I think we have to be ever mindful, because one of the things I worry about -- we've discussed this at length -- is that as this work progresses, there are an infinite number of wonderful threads that could develop lives of their own and could become projects in their own right, and we have constantly, I think, the task of trying to make sure that the threads that are pursued, with staff being the precious resource that we have, are the ones that we really need more, that we want to pursue, because it is amazing how you spend a day. I would hope that by the time the crisis is over that all of us would have time to spend in the Committee offices. There isn't a day that doesn't go by where somebody doesn't come in with, gee, guess what? And the "guess what" is quite interesting. Then there's this judgment of, okay, how interesting a "guess what" is it? Is it enough of a "guess what" that we should now take three people off to be pursuing it or is it a "guess what," gee, that's nice; let's put it away and make sure we don't lose it and see that we're going to develop it. But it's a real problem. MR. GUTTMAN: I want to make a point. This can cut into my time on the Defense Department. They're doing a great job. CHAIRPERSON FADEN: Okay. MR. GUTTMAN: But the conceptual question I have is the extent to which what we're looking at is two different stories or two stories that, if we really are good at analyzing it, are mutually reinforcing in terms of comprehension. So the two areas -- for example, I had thought that in the Cold War, the early period, we were looking at a period where there were no standards and all these people doing research, and today we've got a lot of rules; you know, it's not the best of all possible worlds, but you've got a lot of rules. We now find out that there were standards, at least from reading the Secretary of Defense's memo and the things that follow after it. So that looking at that Cold War period in light of what we're looking at in the modern period, it's a much more interesting relationship. In other words, it wasn't like we went from no rules to rules. It's we had rules; then why did they not percolate? Or maybe they did percolate. In other words, the kinds of questions can inform each other. The second critical area where they have to inform is in the so-called experimental grouping, because I think you're going to have the same kind of problems getting your hands around the modern experiments. You've got to deal with that problem in some efficient way for once and for all. CHAIRPERSON FADEN: We haven't resolved it. Would you mind if we went on? I'm just worried because we -- also, I'm hoping for a miracle, that at lunch they will fix the air conditioning. I don't know if that's possible. They're bringing in fans? That's cute. That's very cute. (Laughter.) Okay, so we'll see. So I'm thinking if we can get through what we need to get through, take a break at lunch, and hope that we will have a more pleasant environment when we return from lunch. I'm a little bit concerned about that as well. Jonathan, could you go on with the next item? Jonathan Moreno is going to give us -- now we'll start getting into the substance of what Dan was making reference, and Jonathan will give us an update on the efforts of the staff to date with respect to getting information about ethical guidelines, standards, codes. DR. MORENO: Thank you. One of the pleasures of this project so far has been to observe close-hand the education of Dan Guttman as a professor of the history of research ethics. Unfortunately, his presentations seem to come before mine, and since he manages to stay one lecture ahead of the class, I find myself usually at a disadvantage. But let me just call attention perhaps, the Committee's attention, to one or two items by way of giving you a sense of where the ethics data collection is going from here. As Dan mentioned, we are getting declassified material now at a fairly rapid clip in the staff office. The difficulty this presents for us organizationally is that over the weekend, for example, I found myself writing a cover memo so that I could hand out something that only became apparent to us Friday afternoon that was perhaps useful for you to see. The attachments in your book, one and two, and the piece that I handed out during the break are all documents that we received last week. One bit of information that may be of interest to you was of interest to me. I assumed that the date, June 7, that appears on Attachments 1 and 2 was the date of declassification. This shows why it's so important to have a multidisciplinary group. My colleague, Jon Harkness, informs me that the date, June 7, is the date that the National Archives Xeroxed the material, not the date that it was declassified. So it's not, I gather -- perhaps it's neither here nor there, but I just don't want the Committee to assume that that was the date of declassification. Perhaps I'll just without rehearsing some of the things that Dan said, again, perhaps I'll just call your particular attention to Attachment 2, which was correspondence prior to the Wilson memorandum of February 26, 1953 and the attachment I handed out during the break, Attachment 3. Attachment 2 gives us a piece of the story prior to the Secretary of Defense's February 26, '53 memorandum. It was in that memorandum, as you recall, that language was used from Nuremberg Code with some changes that indicated that that was to be the Department of Defense's standard concerning the use of human subjects in atomic, biological, and chemical experiments. The material prior to it indicates that this is a discussion that had been going on for some time, and the material, Attachment 3, after it from the Secretary of the Army gives a sense -- that June '53 memorandum gives a sense of how Secretary Stevens and perhaps other officials in the Department of Defense envisioned implementing the Defense Secretary's February memorandum. A question, an historical question that is raised is: why there was this flurry of activity in the Department, what appeared -- I'm inferring that there was some activity in the Department perhaps during the fall of '52, the winter of '52-53, about this question. This shows how important it is to put the pieces of the story together, as Dan was saying. That 1975 Inspector General of the Army report that we described to you briefly last time, and I redescribe under the Department of Defense on page 1 of our follow-up ethics memorandum this time, that '75 IG of the Army report suggests that there are at least two reasons for the interest in 1953, '52-53, in the Department in this question of the ethics of the use of human subjects. One was the Nuremberg Code, the results of the trial that specifically mentioned the Army IG report as an explanation for this interest. The second was that in 1950 there was something called the Reorganization of the Army Act. Now I have yet to find an historian -- perhaps General Russell can tell us, somebody can tell us what the Army Reorganization Act was. GENERAL RUSSELL: I'm not that old. (Laughter.) DR. MORENO: I thought perhaps they taught it in elementary school. (Laughter.) But that, at least, is another lead that we need to follow. There's also some -- perhaps one could draw the rational inference from the second attachment that there was a perceived greater need in '52 and '53 to move from animal models to human subjects; that there is some suggestion that as much as could be learned of relevant questions concerning atomic, biological, and chemical substances had been learned from animals and that now in order to answer further questions, there was a need to turn to human subjects. Those are at least three possible explanations, and perhaps there are others as well, for what I think is an emerging mini-story here about the specific interest of the Department of Defense in '52 and '53. What that means is then that the staff is going to have to go back and do some more work in the period prior to early 1953. For example, the Armed Forces Medical Policy Council seems, given what we have learned from these attachments, seems to have been the venue for much of this discussion in 1952, I presume, and so now what we're going to do is try to find, with the help of the people that we're talking to in the Army, the minutes from the Armed Forces Medical Policy Council which are referenced in the 1975 Army IG report. Perhaps they will tell us some more of this emerging mini-story that I think is quite interesting. The only other thing I'll have to say by way of preparation for the Committee for your consideration of this material is that we are asking, staff is asking for some more information from various departments and agencies, including NASA and the Central Intelligence Agency, and I presume that we'll have some more information for you to report next time. Other than that, I'll leave it open for comments. CHAIRPERSON FADEN: And your memo is in Tab H now. DR. MORENO: Tab H. CHAIRPERSON FADEN: Everybody has Tab H. DR. MORENO: And that Attachment 3 should be joined in some physical fashion to that page. CHAIRPERSON FADEN: Only it doesn't have holes in it; right? DR. MORENO: It does not have holes in it. I'll be glad to punch holes in it for you during lunch. (Laughter.) CHAIRPERSON FADEN: Before we get to questions for Jonathan, we have to make a collective decision. I could make it. Is the fan noise so irritating that we don't want the fans? Or should we try it with the fans for a while? This is values clarification. We have a higher priority for relief of heat than we do for hearing one another. So the fans stay. Okay. Again, we'll either have an air conditioned space after lunch or we'll meet in the swimming pool. I'm not sure what we'll do. MS. NORRIS: You're all invited to my hotel room. It's plenty cold up there. CHAIRPERSON FADEN: There must be some place in the hotel where the air conditioning reaches. Are there questions for Jonathan either on his comments or the memo that was in your briefing book? DR. MORENO: Perhaps I'll just add, my practice, when I give a lecture, is to say that I'm finished now, and then before somebody can make a comment, I have a tendency to add something that I thought of after I said, "I'm finished now." The thirties is going to be an interesting period for us to reconstruct. As Dan pointed out, there is this history that suggests that as early as 1932 the Navy Bureau of Medicine and Surgery, or the Research Division of the Navy Bureau of Medicine and Surgery, had a policy, using the word "policy" perhaps with a small "p" at the very least, that required that only "informed volunteers" be used. It's worth perhaps adding to that that we have anecdotal information from people who were old enough to talk to people who were old enough to remember that as early as the late thirties, when the National Cancer Institute was started, the first institute of the National Institutes of Health, there were, according to these anecdotes, discussions in the course of reviewing protocols, research protocols, there were discussions about ethical issues. Although there was no prior ethical review per se at NCI in the late thirties, so far as we know, ethical questions did arise in the late thirties. As we go along -- and Dr. Faden will tell you more about our plans to collect information, perhaps through oral history as another fashion -- as we go along, it will be interesting to see how much of that story we can piece together and do the kind of mapping that Dan described in the thirties, for example, from the NCI to the Department of the Navy, just to take a particular example. CHAIRPERSON FADEN: Yes, Phil? GENERAL RUSSELL: I think we need to be careful about assuming that the medical department, whether Army or Navy, policies were the service policies. I think we also need to be careful in distinguishing between the research that was done at the -- under the management of other parts of the armed services, even though it's biomedical research. Most of the research that we're talking about in the Army was done under the auspices of either the Corps of Engineers or the Chemical Corps. This 1953 memorandum puts the Surgeon General in a position of -- in the Army -- a position of commenting on the proposals, but you have to look at the implementing regulations to understand what policies were actually being carried out and how rigorously they were being enforced. DR. MORENO: That's very well taken. As a matter of fact, the IG, Army IG, '75 report indicates that, even by the Army's own standards concerning the voluntariness of the so- called volunteers with regard to the perhaps inappropriate incentives being given to them, that the Army did not follow its own rules, even though the Army IG concluded probably nobody was hurt in those chemical experiments. So you're quite right; the issue of implementation is a separate matter. Moreover, it might be worth pointing out that, so far as we can tell -- let me rephrase that. We cannot tell in what fashion, for example, the standard articulated in the Wilson memorandum apply to extramural contractors and when it applied. We know that the rules apply now when DOD has an extramural contract for research; ethics rules apply. We need to fill in -- part of the post-'53 story is to fill in when those rules, in what fashion those rules applied. GENERAL RUSSELL: I think you'll find as we dig into it -- we'll probably have to get it from interviews, and so forth -- DR. MORENO: Yes. GENERAL RUSSELL: -- that there was an implicit assumption among the contractors in the Department of Defense and the Atomic Energy Commission that the civilian medical community that was conducting the research had a set of standards that was far above what the government was going to impose on them, and that they didn't early on perceive a need for close oversight of biomedical research conducted in the big universities, which were supposedly setting the standards. It took us until 1974 to figure it out, that we needed to watch. DR. MORENO: Yes. Well, we did, I think it is fair to say, have the sense from that material, that contract letter from 1947 to UCLA from the AEC, we did have this guide we also handed out in the briefing book; we did have the sense that discretion concerning a satisfactory level of consent was going to be left to the investigator. So that suggests -- that's consistent with your hypothesis -- probably more than hypothesis, there's probably good evidence to confirm this hypothesis that the assumption was in the government and among the investigators that their standards, the latter standards, were at least as high as those of the government on this issue. That, I think, is not a conclusion that is, as you say, one that we can necessarily embrace at this point. GENERAL RUSSELL: I think we can look at what the staff capability was of those agencies doing the contracting. My guess is that they had very, very little staff capability to make those kinds of judgments, either ethical, legal, or biomedical. CHAIRPERSON FADEN: So you're suggesting that we could learn a lot just by looking at the staffing pattern: who was where doing what? GENERAL RUSSELL: What kind of expertise did they have on the staffs of the agencies that were doing the -- CHAIRPERSON FADEN: The contracting. DR. MORENO: We need to see if they had a philosopher, I guess, on the staff. CHAIRPERSON FADEN: Bioethics experts were -- I doubt it. Are there other questions for Jonathan? Gordon, we're sort of kind of -- DR. SOPER: I was going to ask, are you going to take questions now from the audience? I can wait. It's your call. CHAIRPERSON FADEN: Would you mind if we wait? We have to get a policy on what to do about that. But is it directly on point? Is it -- DR. SOPER: It's just a matter of clarification. CHAIRPERSON FADEN: Why don't you go ahead and clarify? DR. SOPER: Well, I heard the word "1930." CHAIRPERSON FADEN: Come to a mike, though, or we'll lose it, Gordon. MR. GUTTMAN: This is Dr. Soper from the Defense Department. DR. SOPER: Gordon Soper from the Defense Department. I heard the date 1930, and, obviously, we are prepared to do anything that's the wish of the Committee. The issue that we've been looking at was fairly formed as far as dates are concerned, and I'm now seeing that there's perhaps a need to go back earlier. It only makes our job harder, I think, when we go and look for records based upon some time period and then we get other direction from the Committee to look earlier. If you can give us a sense as early as possible how early you want us to -- what are the dates to look for, I think that would be helpful. DR. MORENO: That's well taken. May I only explain why we got into the thirties? It's true, of course, that radiation work started in, insofar as we can tell, '44 or '45, but when we're looking at ethics standards, we're looking at standards that were devised for other substances, for chemicals and for biological substances. So we can't adequately understand what the ethical standards were for the radiation work that started in '44 without it raising questions about what the historic standards were. But I'm very -- I think we are very sympathetic to the search problem that we have posed for the Department of Defense and for the other departments and agencies. And, frankly, had it not been for the fact that the Navy came forward with this reference to this '32 standard, we wouldn't even have put it here. CHAIRPERSON FADEN: What you don't know is what's going on behind your back; somebody in the Navy is getting a nasty look. DR. MORENO: Yes. (Laughter.) DR. KATZ: Jonathan, the '32 standard, is that the one that only says that research should be conducted -- DR. MORENO: Informed volunteers. DR. KATZ: Is this based on a voluntary basis only? Perhaps they're meaning the same; it doesn't mean anything. It doesn't mean voluntary in -- DR. MORENO: In the full, red-blooded sense of the word "voluntary." DR. KATZ: It means they can't be tied up and sent into the experimental chamber. DR. MORENO: Well, in fact -- I mean, I didn't want to -- as a staff member, I did not want to be conclusionary about the significance of that expression, but it's perhaps worth pointing out that other Department of Defense statements subsequently, the forties and the fifties and the sixties, I think expressed reservations of the Department about the adequacy of voluntariness that had been required historically, and the '75 Army IG document, which I think is a wonderful document, says it very clearly. They, themselves, see the shortcomings in the standard of voluntariness -- the understanding of the concept of voluntariness that was applied. DR. LEDERER: I would just make two points. First, there is human radiation experimentation before '44. DR. MORENO: Yes. DR. LEDERER: There's certainly a whole body -- you know, they were x-raying for experimental purposes before then. DR. MORENO: Yes. DR. LEDERER: So those experiments and the standards by which they were conducted would be important for us to consider. The second thing, there are Army regulations from the twenties dealing with volunteers. So, I mean, you know, we can go back -- DR. MORENO: Yes, I did not mean to exclude the history of the x-ray. I meant only to reference the stuff that we're supposed to be looking at, but that is, of course, quite true. We're going to have to talk about the twenties Army regulations. CHAIRPERSON FADEN: Yes, Duncan? DR. THOMAS: At Tab F, we were provided with a whole bunch of documents that were released as part of the Symposium on Openness, I gather. One of these is fascinating reading. It was the last one in the stack. It's called "Radiological Experiments in Human Test Subjects." In particular, the last page of this is a blank application form, "Application for Approval - Radiological Experiments on Human Test Subjects." What I find so interesting about it is it doesn't ask anything. I mean, it asks about the investigators' credentials. It asks about the scientific procedures, about the background literature, and so on. I can't find any place in here where it asks anything about informed consent or any of the other things we might want to know about. I mean, it raises the question for me: could we learn something by getting more of these interesting documents? CHAIRPERSON FADEN: Yes, it's a point well taken. DR. THOMAS: I can't figure out from this document where it comes from. CHAIRPERSON FADEN: It's a point well taken. DR. THOMAS: It says something or other about a concern about possible criminal codes of the State of Washington being violated. So this may have something to do with the Washington prisoners; I don't know. But, you know, I would like to get more of these things and see what we can learn about. CHAIRPERSON FADEN: Yes, that's a point well taken. I actually had the same reaction. On my copy I've marked that, too. It's clearly a Hanford-related document because it says -- not Hanford, but we need to pursue it further, yes. It's certainly not what the form an IRB would send out would look like today, for whatever that is worth. All the key questions that we would now expect to see filled out are not here asked, which is interesting, yes. Yes, I'm sorry, Henry? DR. ROYAL: Because the data-gathering task is endless -- CHAIRPERSON FADEN: Yes. DR. ROYAL: -- should we ask the staff to explicitly identify the threads that they're following and explain why they think that that particular thread is worth following? CHAIRPERSON FADEN: Yes, yes. DR. ROYAL: So that we would have maybe a single sheet of paper maybe from the ethics group saying here are the threads that we're following and why we're following these threads. So that we can have a better idea of exactly what it is that they're doing. CHAIRPERSON FADEN: Absolutely. Jonathan, do you want to comment? It's a procedure that we just adopted, but that's all right. DR. MORENO: Sure. You'll hear more about our proposal to do precisely that and to put some boundaries on this territory, this endless territory, tomorrow and perhaps later. But may I say that, as Dan said, we're completing phase 1 with some of the departments and agencies, and I can already see the emerging line of research for DOD, one of which I've described just now, and perhaps for HHS. It's not clear to me that we're there yet with a couple of the other departments or agencies. So you'll just have to bear with us. I think we will get to that point. CHAIRPERSON FADEN: Yes. DR. MORENO: We won't get to that point at the same time perhaps, but I think that within the next few meetings we will. CHAIRPERSON FADEN: To follow up on Henry's suggestion, maybe what we should do is incorporate a procedure whereby for each of the areas of work that the staff is undergoing at committee, we need to report not only to look forward and saying, this is what we're planning to do over the next three weeks and here are the reasons why we're pursuing these threads. We have at the staff level organized a group that has responsibility for the work of the Committee overall, and I've asked for three-week projections of work with milestones, which was a good suggestion that came from staff in part. So what we could do is maybe find a vehicle to make that available as a way of standardizing feedback to the Committee and for the Committee to be able to react and say, "Well, why this," "Why not that," and allow our collective judgment to bear more directly on how staff is allocating its time. Would that be of interest? Okay, then we can try and do that. Henry? DR. ROYAL: The other comment is that it surprises me that -- and maybe I'm worrying about this, but it surprises me that the way this search is being conducted is to go back and try to find primary documents, and it seems like whether we uncover a primary document is sort of hit and miss. I guess the thing I'm surprised at is I would have thought that, you know, the history of bioethics would have been reviewed many times before and that there would be some source material that you could ask your questions there, and then once you've asked your questions, have a focused search for documents, as opposed to people running into the office saying, "Look what I've got today." CHAIRPERSON FADEN: I wish the world were better ready for us. (Laughter.) It's as if we would be turning to you, Henry, and saying, "How come you all haven't figured out whether the extrapolation stuff is right or not?" It's just the field is really not that well developed with respect to historical examination, and the department where there has been the most extensive scholarship is DHHS. So with respect to DHHS, there is -- and DHEW prior to DHHS -- it's by no means definitive, but there has been much more scholarship on the evolution of guidelines and policies with respect to human subjects research for DHEW and the DHHS, relatively little with respect to the other departments that we're looking at. So that's part of the problem. But you know what the problem is, that nobody sat there and said, "We're going to have this Committee next year. Let's get some work done for it." So it's a problem, but at some point we will have to say there's only so much energy we can put into constructing the history; we know as much as we need to know to go forward. Are we done? I think we should stop and try to still get the DOD report in. Thank you very much, Jonathan. And Jim David is now joining us from the staff. MR. GUTTMAN: As a preface, again, the part to emphasize is you're not sitting in the meetings -- first of all, Dr. Soper, Captain George, and the Navy people are in the audience. I don't know if Colonel Merrick or anybody else, but if you want -- the Navy people are relatively easy to identify. Dr. Soper, you've already met. Anybody else from DOD here? I'll be short. It's impossible to really explain how difficult this search thing is unless you're there. I'd just make clear for everybody, to the extent there are source documents, we sure as heck are looking at them. The Stannard is a good example. After World War II, the Manhattan Project did a series of very detailed reviews of its research, and we've got those. They list about 4 million animal studies, for example, and anybody can look at those. The basic context, as I mentioned earlier, but it's a particular context for DOD, is when DOD went out to do its search in January of 1994, it initially in its phase 1 asked DOD-wide offices: look for the agencies or organizations that sponsored or conducted experiments, the documentation that would be related to that, and the specific capsule identification of experiments. So what we are getting from DOD, have gotten in many cases, and still being completed in others, is the identity of the primary likely suspect entities. I didn't know the Corps of Engineers, until General Russell mentioned it -- I'm not sure if the Army identified it, the places where experiments would have been conducted or sponsored, the places where documents related to those experiments might be, and capsuled descriptions. So, by way of primary source, one of the things that Captain George and the other services did, they went to the computer databases they have and to the noncomputer previous databases -- for example, the Defense Technical Information Center -- and looked for ways of culling capsuled descriptions of literature that might be of the kind of thing we're looking about. We still end up with quite a few, many hundreds, thousands, of items. So that you've got a need, then, to say, is there a way to get some understanding of what this all means. Instead of looking at 800 capsuled descriptions of Navy experiments, is there a place in the Navy where you can go to say, well, anyone that is coming out of this office is likely individual investigator, maybe not government purpose, or likely this kind of program or likely this. And so what we're kind of trying to do with the agencies -- and DOD in particular -- is work to try to mesh this initial identification of experiments with some kind of way of getting documentation, and it doesn't have to be some new, fancy classified document. It can well be something that's been around for 30 years in the public literature, but nobody has connected. We're eager to do things simple rather than complex, connected, and put this in context. The Defense Department, briefly, we met with the Defense Department as a whole search group, our staff, on May 20 and have since then had many phone conversations, conducted follow-up, service-specific meetings with the Defense Nuclear Agency and with the Army, and I should note, as we are doing with all the agencies, the material you got we sent through the Defense Department for review. This time we had two drafts. Obviously, it doesn't mean they approve or endorse what we say; it's simply that we're all trying to do our best to make sure that what we're presenting you with is as fair and accurate as possible. As I said, the Defense Department's phase 1 search was to identify places conducting experiments, documentation, and the specifics of the experiments. They are now completing phase 1. They look for guidance on phase 2. The Defense Department -- and this is, again, not a way of limitation, but a way of what was done and what was not done -- did not do, with some exception, headquarters-type searches. So, for example, the Office of the Secretary of Defense and relevant Office of Secretary of Defense offices, such as the Medical Policy Council, were not looked at. So we're going to have to go back and look at that. A second kind of thing that was not done was, with the exception, I know, of Captain George, was actually mucking around in record centers and archives in St. Louis or San Bruno, and I think Colonel Merrick also from the Air Force didn't begin to look into the archives, where we know that lots of the documentation exists. So, for example, the historian of the Secretary of Defense, Dr. Goldberg, says, if you want to know about the Medical Policy Council -- Jim David can tell us as well -- go to boxes such and such and such and such of the archives. In fact, last meeting, you may remember, we had presented some 1950 HHS PHS documents which were obtained from the Office of Secretary of Defense files, when they were from, Jim informs us, the Medical Policy Council files in the archives. So a big question with DOD and all these other agencies is both identifying relevant high-level archive and records center documents and figuring out what is the most efficient way. We're acutely aware that you don't want to waste time looking at 1930 if it's more important, more likely to be of use to look at 1960. We're going to work with the agencies on that. A third point about DOD, it turns out that even though the central January 31 memo specifically called on DOD entities to look for intentional release-type experiments, it turns out the Defense Nuclear Agency, which is clearly an entity that was responsible for some of them, did not so look -- and I gather the Army, because the Chemical Corps didn't, either. So they're go, Dr. Soper assures us, they're going to go back and look for that. Now where we are in terms of our understanding in light of the institutional ethical and experimental mapping, I can just illustrate by way of taking the Navy, which, again, I'm picking on Captain George because he's doing a terrific job and he's been out there looking in the 1930s. One is at the Navy, for example, we know from Captain George that there were three primary likely research institutions: the Bureau of Medicine and Surgery, the Navy Radiological Laboratory -- well, the Bureau of Surgery, which has had a longstanding existence and has many, many subentities, as discussed in the report, all kinds of medical hospitals and laboratories; the Navy Radiological Laboratory, which was created in about '46 or '47 in light of the Pacific tests to look at what happens to ships and sailors after an atomic test, and was disestablished in about '69; and the Office of Naval Research, which has historically been a contract research organization. It turns out, we discovered from the documents, that after -- when the Manhattan Project -- before the AEC got rolling, the Office of Naval Research administered AEC Manhattan Project contracts. So maybe there's a place to find that kind of documentation. So we know that there were three general places to look. What Captain George has told us -- and, again, I stand corrected if he gets up and corrects me, but I hope we conveyed accurately what he said -- in the case of the Naval Radiological Defense Laboratory, for example, they, the Navy says, kept pretty good technical reports. So if we could get access to their hundreds of technical reports, we could skim them and look at them and see what it is that's of interest. The problem is that when that laboratory was disestablished in '69, the library of jurisdiction was dispersed and it's not clear where those reports are. Similarly, the Bureau of Medicine and Surgery, again, there was a central part in that Bureau which was sort of an overhead funding, coordinating part. Captain George has told me last week that they're looking for those files; they didn't appear to be in, I think, the Suitland archives, where it had been suspected they would be. They may have found them now, but there is a discrete set of files we're looking for. The third part, the experimental mapping -- and this gets, again, in part to Henry's question, "How do you narrow it down?" Well, the Navy has given us 800 descriptors of experiments and a lot of them are from journal articles, and a lot of them may be innocuous and some may not be. This is where we're desperately in search of what kind of guidance to narrow and begin to tell that story. Now just by way of illustration of how things get put together, Captain George in his search tracked the ethics code, whatever we call that thing, back to 1932. In addition, he found that when he looked at the St. Albans Hospital files, which is the Navy Cancer Research Institute Hospital, now closed, in 1949, in one of the study documents he found that there was evidence of protocol pre-existing the first formal, what he had found as the first formal Navy reg. So he's already backtracking. Because he's curious, he was looking further to see what was that study about. It was something having to do with radiation sickness, and I'm sure he'll tell anybody who wants to get into details what he's finding, but one of the things he found is that study, which is of interest because of the protocol thing in '49, apparently, was done jointly with the VA. So just by looking at that particular thing, we get some connection with our friends at the VA back in '49. So these things are both grand and piece by piece. In summary, what we're trying to do, by way of proceeding -- I'll get into the specific options we identified, but the general thrust is -- one is to see if we can focus the service entities accessing headquarters, meaningful headquarters documents as efficiently as possible. Many of them are archived in Washington. That will require decisions about staffing and efficiency, obviously, and about which particular files to go first. We're going to get into details. The second, one way of accessing that, we hope most easily, is to quickly get the histories of the programs that we're looking at, not only the medical, but that would mean, obviously, the histories of the medical divisions, but also if you're looking at radiation, the Chemical Corps histories for radiation warfare. So we're asking, as we meet with each of the services and DNA and Army, can you give us quickly sort of an index to your histories and give us immediately the ones that are declassified? We're told that the medical-specific histories should be quickly declassifiable to the extent that they're not completely classified, with maybe some exceptions. Then the other ones, the kind of Rad warfare or the intent-to-release-type things, we'll kind of work our way through. So we're focusing on the easiest, highest-level documents and kind of moving down the food chain. Then at the same time, we're going to try to, as we have lists of these hundreds of experiments, begin to make some sense of which ones shall we kind of group together and ask for the further information or further documentation on. Obviously, we're not going to look at 800 Navy experiments. The question is: which of that set and how? The hypothesis is, the more we know about the overhead policy structure of the Navy and related entities, the more we can say we'd like to focus on X groups or X classes, working with the Navy on that. The final point, of course, is classification. As I said, we hope to chip away at that by focused, targeted efforts, so that we are at least gradually accumulating a fair body of things that are no longer secrets. Going to the option part -- CHAIRPERSON FADEN: Page 16. MR. GUTTMAN: -- page 16 -- CHAIRPERSON FADEN: Tab J. MR. GUTTMAN: Yes, and this is sort of a more particularized discussion, more particularized recommendation of things that I hope and trust we're in sync with with the Defense Department, so these are not surprises. They may be, but I hope not. One is, basically -- CHAIRPERSON FADEN: Dan, if I could interrupt, in the interest of time, I'm wondering whether -- I don't know how carefully people have had a chance to read the report. It's a very detailed report on the Department of Defense. I'm wondering if we could take a minute -- MR. GUTTMAN: Sure. CHAIRPERSON FADEN: -- to just read through the options collectively and see if there's any we might be able to endorse them en masse or have a conversation only about the ones that people are concerned about or can't understand them from the context, in the interest of getting them endorsed or amended, so staff could continue with its work. Then Jim or Dan could respond. So let's just take a minute. MR. GUTTMAN: While you're reading, I should say that we're already kind of working ahead with the DNA and the Army and engaged in specific meetings and requests. CHAIRPERSON FADEN: Let them read. MR. GUTTMAN: Yes, you can read. CHAIRPERSON FADEN: Remember, these are not mentioning mutually-exclusive. Every option here is one that staff would like endorsed. So they're not asking us to choose. These are all things that staff has reached judgment they would like to do. So unless you have objection or you think that this is more than staff should be doing or you don't understand, we could endorse it, and go have lunch. DR. KATZ: The problem here with respect to endorsing or not endorsing this, for me to endorse it or not endorse it, and also in the light of what Henry said, namely, how much time is available for pursuing all these leads and how should they be prioritized? The next step is -- and, hopefully, perhaps by the next meeting staff can give us some indication of what the priority, what their priorities are, so that we can then look at it and say, well, No. 7 should really be No. 1, and No. 1 should be -- et cetera. CHAIRPERSON FADEN: How about if we -- this is in line with the proposal that's come out of Henry. DR. KATZ: Yes, exactly. CHAIRPERSON FADEN: For the next meeting, the recommendations from staff come in a different format which align with indications for branch points, where one would take us, where the other would take us, and rough estimates of the time and staff commitments that would be involved to pursue those. I don't think we were ready to do maybe much before the next session. DR. KATZ: Exactly. CHAIRPERSON FADEN: So we can try. We can try. That's the working objective. And if we can't, we can maybe do it partially, but the Committee could start to make some more refined judgments. These are really requests for the Committee to basically say pursue a range of different strategies with the Department of Defense, still in a quasi -- in a more targeted, but still in an exploratory -- MR. GUTTMAN: Well, the generality of it is pretty simple. We've looked at the lists of experiments. We have not that many documents. We're trying to get a sense, a survey, of the headquarter policy program documentation from the top documents, the history document, books of history that are written, policy documents, and so forth. That's not a cut that anybody has taken yet and it's going to be, we think, extraordinarily useful, hopefully, in forming where you look, where you focus your particular experimental stories. CHAIRPERSON FADEN: Nancy? DR. OLEINICK: I have a concern I guess which is overlapping the concerns of the others on this Committee, but having had some experience now with looking at what documentation we've received from the Department of Energy, supposedly we had a book of several hundred experiments. These were not completely experiments. They were just a variety of documents that DOE has somehow found in their records. Many of them are published reviews or reports to the DOE. From experiments that I knew should be in there that are not in there, I'm really quite concerned that we're missing a lot, that what we have is going to be a lot of a wild goose chase into areas that we don't want to go into. So this is something that we can talk about more in terms of the subcommittee report, but I bring it up here because I'm concerned with this retrieval of -- retrieved documents identified by contractor organizations. I mean, it seems so completely open-ended; I don't know where it's going to go. CHAIRPERSON FADEN: That's absolutely right. DR. LEDERER: That was a concern that I had on this list of options, and maybe you could tell us a little bit more about what is involved in retrieving documents identified by contractor organizations. MR. GUTTMAN: Let me say, the break on this -- and this is something that I guess I took more for granted than I should -- the break on all this is the resources which are extremely finite, not so much of staff, but of the agencies. So there is nothing that's going to get done without Dr. Soper and Captain George and others saying this is reasonable; we can do it. This is not -- we just are not in the business -- we can't be for a billion reasons -- of saying, "Go get stuff." So the basic point I want to make is that what Nancy is saying, and what I think you're all saying, is we have to get a grip on the experimental universe in order to know where to focus. Where I think this particular set of options is going is there is a value in any instance in looking at the headquarters policy documents. We don't know -- we're not going to be able to get a billion documents. We don't have any now, and it's that value. This other question is the essential one: how you group -- how you get a handle over what experiments -- CHAIRPERSON FADEN: But I think the question is much bigger than that, Dan. It's not just how we get a handle on the experiments. It's how we decide how we're going to allocate our time and resources generally -- MR. GUTTMAN: Okay. CHAIRPERSON FADEN: -- and whether -- and how much time is spent getting our arms around the experiments, and sort of what would the purpose be, and towards what end? So I think what we're hearing from the Committee is that we need to find a way to present to the Committee very measurable alternative objectives: for the next three weeks we would like to do this, or we could do that; if we do this, this might follow; we might learn this; if we do not this, something else might follow, and how much staff time we think it would take. I think we could assume from the options listed here that they aren't meant to be as totally without bounds as they, at least some of them, suggest. Clearly, no requests or avenues are going to be pursued unless there's the thought on the part of staff that there's a yield there and that yield is likely to be reasonable. But I appreciate what people are saying about this is not as helpful as it could have been. I should have thought about that when I reviewed it. DR. LEDERER: Well, I guess my question arises because I wonder if the Ethics Subcommittee is also planning a request to contractor organizations, by which I mean universities. CHAIRPERSON FADEN: Right, we are. DR. LEDERER: And is there some way to coordinate these -- CHAIRPERSON FADEN: Yes. DR. LEDERER: -- so they're not receiving all these separate requests for information? CHAIRPERSON FADEN: What we should do and we can do is, first of all, Don will be giving a presentation later today, a brief one -- It is today, isn't it, Don Weightman from staff? -- which will give you some picture of how these are being coordinated. So we are trying to -- and Dan's trying to lead an effort that will make sure that we don't have a staff in which the right hand doesn't know what the left hand is doing. So that we are trying to coordinate all of this, so if there is an interest on the part of the ethics group in finding out something from the Department of Defense or from the University of Chicago, that this is being coordinated and coming from one voice from the Committee. MR. GUTTMAN: There's some confusion. Let me make a clarifying point. The retrieved documents from contractors is not the Committee going out to universities or contractors. This is, as I understand it, DOD, like DOE, told its contractors to identify documents. So this is a question of getting a hold on things through the DOE. Obviously, it's not all -- it's just to begin the process. They are out there. If we ever want to make use of them, we have to begin to think about how to do it. This is not the case of former contractors, for example, where you have to go out and survey or we go out directly. This is within the chain of DOD search. CHAIRPERSON FADEN: But, Sue, your question is an important one. Staff's recognized it. They're working toward a structure that would make sure that all these requests or these avenues are coordinated and we're approaching the multiple questions in a combined and efficient strategy. There are going to be slipups, but pretty much that's what's being tried to happen. Yes, Henry? DR. ROYAL: One of the reasons why I think it's hard to decide how the Committee's resources should be utilized is because there's no clearly-defined list of deliverables. I'm not sure what it is that this Committee is going to be producing. Because I don't know what it's going to be producing, I don't know what it needs in order to produce whatever it is that it's going to be producing. It seems to me that we ought to have a list of what it is that we're producing and then we'll know what we need to gather to produce those things. CHAIRPERSON FADEN: That's also in the plans for the next few weeks. We need an outline for a report, among other things. Yes? MR. GUTTMAN: My thinking -- and this is why I talked about the mapping -- is that in the immediate future, at present in fact, you should be getting the beginnings. Yes, institutional maps are doable immediately. So you'll get some sense of where things are coming from. Ethics timelines you're getting already. Then the question -- again, I'd just go back to it again and again; it's your question. Are we talking about 500, 1,000, or 10 experiments? That's where we need your input because then the question is -- or you may be directing -- you may have an institutional map which shows terrifically interesting kind of programs, but if the experiments attached to it turn out to be innocuous or completely irrelevant, then you're spending time just looking at something that's not there. That's why we need your input most critically on what are the kinds of scientific efforts that -- I mean, we can suggest some, but that's where -- CHAIRPERSON FADEN: Let me guess, Henry, that you're going to something that's a little more broad than that? DR. ROYAL: No, I was specifically going to address the Committee's input into what the endpoints were going to be. I think we should start doing that now. I don't see any reason why the Committee members couldn't write down on a piece of paper what it is that they think the Committee should come up with that they would then feel that the Committee has done whatever it's supposed to do. CHAIRPERSON FADEN: That would be an excellent exercise. That would be very helpful. Jay? DR. KATZ: Well, I think I'm only echoing Henry's point and I've been thinking about it. Maybe we could possibly do it at the last meeting in July. We do have our charge, but that's really not good enough in a way, though it lays the ground work. What is the vision of this Advisory Committee? What is it ultimately that we want to accomplish? I think that the only way -- and I think the time will soon come where we have to talk and agree on the vision -- CHAIRPERSON FADEN: Yes, I agree. DR. KATZ: -- of our work -- CHAIRPERSON FADEN: I agree. DR. KATZ: -- and I would also recommend that, if we do it at the end of July, someone a week or two before then should sort of think about it and present that vision in an informal document, so that we can all think about it and then maybe spend the morning or an afternoon discussing about it, because I think the time has come to do so. Then it will be a little bit easier also to figure out what we want to pursue and what we don't want to pursue. CHAIRPERSON FADEN: Are there reactions to Jay's proposal? Henry and Duncan? DR. THOMAS: Yes, I think that person needs some input from the rest of the Committee. So Henry's suggestion that, first, each of us be asked to write our own vision, outline of the report, whatever, and pass it to that person to summarize for us -- CHAIRPERSON FADEN: That's me. Yes, Henry? DR. ROYAL: But I'm not sure that it should be one person that should take all of the different visions and compile them into one vision. I would like to not only write my own vision, but I'd like to see other people's vision. Maybe they can be lists of items that people can prioritize. CHAIRPERSON FADEN: How about homework for the Committee members as well as the staff, and we can share? Everyone can read everybody else's, and then we could have a discussion about it and then designate one person or two people or three people to try to pull something together based on that, with a goal of by the July meeting reaching closure. We can begin the process as early as the next meeting, which is the first July meeting and then try to reach closure by the second July meeting, because we don't have a meeting in August. I think my experience with committees is that we're about at the point where committees start to ask about what is our vision, what is our purpose, where are we going, what will our report look like as a concrete reflection of our vision and commitment? So this is exactly, I think, where we need to be at this juncture. Is everybody amenable to -- DR. KATZ: How do you see it now? CHAIRPERSON FADEN: Well, what I think -- what I'm suggesting is something like the following, and I just got a very helpful note from Anna, which is that we take 15 or 30 minutes later today to talk about this a little bit more. DR. KATZ: Good. That would be a good idea. CHAIRPERSON FADEN: We're close to lunch and I'm melting. I don't know about anybody else, but my ability to concentrate is directly proportional to my ability to stay awake. DR. KATZ: Good idea. CHAIRPERSON FADEN: But the general idea of what I'm hearing is that we will ask each of us to write down our thoughts about the vision and purpose of the Committee, based on a following conversation we will have later today or tomorrow that will allow us to get a more concrete sense of that. We will each take the time to write something down which may include a rough outline of the report or that may be too ambitious, but, basically, what we'd like the Committee to accomplish and the vision and focus we would like for the Committee. We will distribute everybody to everybody else, so that at the first July meeting we will set aside good time to have a discussion about what people's sense is of where this Committee is and what it should accomplish. Then after that discussion, we may conclude that there is, indeed, so much consensus that it becomes a "Ruth, write it up" or it may be there's really some competing visions here; we need to have two or three people try to write down alternative things. In any event, at the second July meeting we will then finalize or come close to endorsing a shared set of visions. These are loose words: vision, commitment, objectives. DR. KATZ: Maybe we can talk a little bit about it more in the afternoon. CHAIRPERSON FADEN: We will talk about it more in an air-conditioned environment in the afternoon. With that, can we break? Can I just take it that in the interim we will give staff general approval to use their judgment to pursue issues with the Department of Defense? Is that all right? And we will also ask the staff not only for this report, but for all reports to take on a different character with respect to subsequent Committee meetings. We're going to break for lunch. Hopefully, lunch is some place where it's cool. The same place as last time, which is the back of the restaurant. It's on this floor. Follow the crowd. They have set aside a last part of the restaurant for the Committee. (Whereupon, at 12:36 p.m., the proceedings recessed for lunch to reconvene at 2:09 p.m. the same day.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2:09 p.m. CHAIRPERSON FADEN: Okay, we're going to get started. We're going to start and we're going to take things a little bit out of order. Hello, group. Dan? Thank you. If we could just start. All right, the bad news is that there's nothing that can be done about the air conditioning. This is it all through the public area of the hotel. So there's no place to be moved to; is that right? You shut off the air conditioning elsewhere, so more is coming in here? Okay, well, thank you. So it looks like we may get something at some point. This is really upsetting me because I no longer have license to complain since there's nothing that can be done. It's unfortunate. So the challenge will be to stay attuned and not to become irascible as the heat becomes unpleasant, but maybe it will get better. Also, we are changing the order of the items on the agenda a bit. Don Weightman, who was on the at the end of the afternoon, I've asked if he would mind moving up and being the first person on the agenda. I'm doing this -- and he kindly agreed -- and I'm doing this because I wanted to make sure that all Committee members had benefit of and an understanding of how the staff is, indeed, functioning and is coordinating activities. So if we could start -- MR. WEIGHTMAN: Hi. My name is Don Weightman. I've been with the staff officially since June 1, although I'll say that at times it seems as if it's been a bit longer than that. I'm here basically to function right now as a kind of traffic cop. There's an enormous information flow, both in terms of information that the Committee and the staff have asked for or are in the process of asking for from the various federal agencies, and, in turn, production of documents and other information from the agencies to the staff and, ultimately, to the Committee. What I'm basically trying to do at this point is to manage that flow so that the flow doesn't become unmanageable in either direction and people start getting overwhelmed. Obviously, this is an immense task, and the task of the Committee is immense. As a matter of fact, I spent about 10 minutes on Sunday afternoon paging through my thesaurus under large quantity looking for the right adjective to describe what we have in front of us, and, frankly, words weren't adequate. But we are breaking it down into manageable pieces and beginning to work on the pieces. Let me talk about some of them. We're into some very good dialog with five of the six agencies that have been asked to turn information over to us. We're farthest along perhaps with the Department of Energy, which is very obviously, as a result of the Secretary's initiative, deeply, seriously, and thoroughly committed to doing whatever has to be done to make the information that we need available to us in a timely fashion. We're very far along, too, but in different ways, with the Department of Defense. Part of the problem with the Department of Defense is that it's one department but it has many heads; it has many uniformed services and other agencies. Since many of those have a role to play in the stories that we're trying to tell, identifying them and talking to their people about what they can make available to us and when is not a one- stop-shopping task; it's a multiple task. The various uniformed service -- Army, Navy, and Air Force -- are part of it. The Defense Nuclear Agency is part of it. The Office of the Secretary of Defense is part of it, and so while we're working very hard, it isn't a straightforward, up-or- down, yes-or-no single meeting kind of effort. HHS also is a decentralized agency, and so it's not merely asking a question about what it may have known at various times about human experimentation, but working with it to understand how its organizational components evolved and where information might be found about each of those components. I think it's safe to say that we're forming efficient and effective working relationships with the various agencies, but without meaning to engage in any criticism, that's got to be qualified just a little bit. One big issue that the Committee needs to know about is the matter of archival material, which is being turned up or identified as part of the process of our research and as part of the process of the agency's response to the questions about human experimentation, and there's just flat out a matter of who's going to look at it and when they're looking at it and how it's going to be prioritized. I understand that that question has now been engaged with DOE. I think it's still open with the other agencies. Dan summarized the results of the search so far. He's correct in saying that we're pretty far along on the first phase. What that means is that we've got a fairly good handle on the item-by-item biomedical experiments involving radiation and involving people. That means that we can give you order of magnitude estimates of how many of them there are out there. Where we are now is trying to get the most efficient way we can to get the background, the context, the historical and organizational matrix in which these things were done, and getting information about that in the most efficient way possible. So we're in dialog with the agencies about programs, policies, and coordination, and their review of our requests is now underway. In terms of what we've got, we've got perhaps 11,000 documents, more or less, from the Department of Energy. I understand that we've begun to get documents from the Department of Defense, and the other agencies are in the process of responding to the document requests that we've identified as our highest priority. We're working really hard, and I don't think this point can be emphasized enough, to avoid gridlock. Part of it is just asking the questions that the Committee members identified, of the sort the Committee members identified this morning, asking each agency for agency histories as they relate to the human experimentation program, both on the programmatic level, and if you had a medical or a medical research division, well, what can you tell us about how that operated? How quickly can you get us a history, organization charts, program documents? So that we can try to pinpoint our future requests in the areas that are most likely to be productive, rather than asking for the whole universe and then drowning in data. In terms of a particular question that was asked this morning, we are, in fact, asking the agencies for their documentation relating to experiments that were extramural and were funded by the agencies. Let me give you an idea of how that works, again, to try to give you some confidence that what we're doing is trying to pinpoint rather than to ask for the flood. When an agency is funding outside contractors to do research for it, information related to that process is basically going to occur on three levels. At the very highest level you're going to get line items in budget at the departmental or agency level year by year, or however their fiscal cycle works. With luck, you'll get a line item that says we have contracts out with the following entities relating to the following experimental programs in more or less detail, sometimes with sums of money identified. You may, on the other hand, get only a single line, if that, with no further data at all. It's going to vary a lot. The second place to look is in the program areas. If the Department of the Army is, through its Chemical Corps, just to take an example, funding certain kinds of experimentation, then, presumably, information related to that process is going to exist at the level of the Chemical Corps and the senior staff of the Chemical Corps, and you can look there during the relevant time periods to see what it was that they thought they were funding. On the ground floor level, what you're going to get is procurement documents and the files, to the extent that they're still in existence, of the contract officer. Basically, this is going to be a lot of back and forth of, "Well, have you met your milestones," "Please send us a check," that kind of stuff. We're not planning to look at all of that, although it's responsive to the agency's charge. What we're doing is working with the agencies to identify areas where that could be sampled in a meaningful way to see whether the evolution of controls over external contracts that involve human radiation experiments can be looked at and summarized in a fashion that doesn't lead us to an endless quest. Some of the checks that were in place to see that we don't embark on an endless quest is that it turns out the General Accounting Office in 1968 did a survey -- we haven't been able to see it yet, but we've certainly asked for it -- of how the Atomic Energy Commission performed its biomedical experimentation contracting. Obviously, that's a place to start. If the GAO has backup data still in existence for that, we'll get it. We'll look at it. We'll compare that with the procurement process as the different agencies have identified it for us, and then try to figure out whether pursuing this line is going to be fruitful or whether we're in danger of spending a year chasing stuff that, if found, would be incredibly useful, but is not likely to pay off meaningfully in comparison with the other priorities that the Committee has identified. That's only an example. There is going to be a concern that relates to the kind of logistical maneuvers that I'm describing that's going to have a lot of impact on what we're able to do and how quickly we can do it, and that's the issue of classification. We talked a bit about it over lunch. Dan is going to explain a little bit more about what the Department of Energy told us about how the declassification process works. I want to flag, though, one point for your consideration just in terms of thinking about managing what we do going forward, which is subject to the usual qualifications, caveats, and concerns. By and large and for the most part, it's probably safe to say that most of the data relating to biomedical research, individual experiments, if it's not declassified already, it can probably be declassified in time for us to look at it, sample that universe in a relatively meaningful way. An order of difficulty more is the radiological warfare, precisely because it becomes more closely intertwined with national security and similar concerns that prevent either declassification at all or speedy declassification of the sort that we need to do our work. Somewhere in that universe in terms of difficulty is the issue of intentional releases. It seems to have been that nobody has -- excuse me -- that certain components of the Department of Defense have not yet really seriously begun to look for intentional releases, although they've committed themselves to doing that now, but that's an area where there's a concern that not only will we not be able to get stuff declassified, but the veil and culture of secrecy may be sufficiently well developed that we'll have trouble trying to figure out where to ask the questions about where the data is that we might want to see. I don't want to say that I know this is going to be a problem, but I'm in business to try to give you a heads-up about stuff that I think you're going to be needing to worry about as the process develops, and that's certainly one area. Let me tell you a little bit about how the staff process for this kind of coordination is evolving. On a real crude, but working document level, right now there is a log for each of the six agencies that relates to stuff they've told us they've given us or will give us, stuff that we've asked for, the correspondence back and forth, notes of meetings. The idea there is that if the coordinator for that agency is out of the office or I'm out of the office and somebody needs to know, geez, have we asked for this already, there's one place to go look; there is one place where a record is being kept. A second benefit of that process is that that let's us see just how heavily we're burdening any given agency with what they're asking them for, and it enables us to survey that to see where it makes sense to prioritize. If, for example, DOE has a great big shipment that's ready to go, we can then compare that with other agencies, where things are with the rest of our staff resources, and say, yeah, get it down here by tomorrow morning, if that's what you can do, or don't worry, next week is fine in terms of the other things that we're doing, the other places that we're concentrating our efforts. There's a similar record to be kept of each and every time somebody, speaking broadly in terms of the ethics group and the Cold War group, identifies a further question that they'd like to ask the agencies. Again, just keep a record so that we can prioritize our requests, coordinate them in a meaningful way, ask them at a meaningful time, and at the same time if there turns out to be something that we've got to know right away in order to answer some both very important and very time-sensitive question, that that particular request gets pushed to the head of the line and asked right away and identified in that fashion for the agency, without at the same time crossing up other ongoing efforts that we're depending on over the longer run just as much. The third area where -- oh, I will add that as we get a little further along on the computerization process, that we've going to have all this up on various kinds of databases, so that any staff person can consult that information not by walking into my office and looking at a notebook, but just by hitting the database and looking. The third area where we're working on this is that there's something called the coordinating group which we hope is doing precisely that, meets once a week in which we review this process, review what each area of effort expects or hopes to accomplish in the week, two weeks, three weeks going forward, and talks about that in terms of longer-range milestones. I think it's safe to say that very much a part of that discussion, the weekly coordinators' dialog, is what kinds of resources do you need right away; what kinds of resources do you need, but not right away; what kinds of resources will you need two weeks, two months, six months down the road as you pursue your project and as you identify certain new groups of tasks that need to be done? Another question that Dr. Royal brought up and that I had planned to ask you to start thinking about is the notion of sort of a single sheet or a one-or-two-page management report for your consideration as you're making decisions about what to prioritize, what to put to one side, what to say, well, much later if at all, what to do right away, and what the costs will be in terms of resources used, tradeoffs in terms of other projects. I have some things that I've flagged that I think that you might want to know about, but I had much rather ask you, get your concerns, the information that you think you need to do your job, and hear about it that way than guess and turn out to be wrong. Here are the things that I'm thinking that we need to report on: what's going on with each agency in terms of what the focus is with that agency? How much they have been able to identify in terms of volumes of potentially-responsive documents? How much they have been able actually to turn over? How much they've identified that might be helpful, but involves some kind of classification issue? When they expect to either turn things over or get a little further either in terms of reporting on declassification or reporting on when they'll be able to turn things over? And, finally, some sense of what questions are still open in terms of things that we haven't specifically identified yet, but are areas of concern that relate to a given agency. But that's only a start. Again, the tradeoff is going to be between not flooding you with information that you don't need while making sure that all of this stuff is consolidated in a useful way. I'm not asking that the Committee members here respond to that inquiry now. My suggestion would be write it down; talk to me about it; let's have some dialog about what would help all of you to sort of deliberate in a useful way as we start prioritizing and identifying some tasks as higher priority than others. Two other, three other areas where this sort of coordination goes on sometimes literally in the sense of sticking my head into the next office, but also as part of the coordinators' group meeting and the other sort of monitoring processes that I've been describing: one is that we're developing a list of potential witnesses and people who might be interviewed for several purposes. One of them is that we've been informed by several of the agencies, especially where these witnesses might have been principal investigators or other contractors with the agencies, that if we can give them that kind of data, it will facilitate their search for responsive documents. The second purpose is, depending on how it plays out in terms of what we can and can't do as an advisory committee in terms of interviews and formal data-gathering of that sort, identifying who we want to talk to and when we want to talk to them, coordinating that process with the effort involved in identifying and contacting universities, so that we're not hitting them up in a bunch of different ways at a bunch of different times that makes them use up resources unnecessarily, and, also, just to focus our efforts a little bit in terms of gathering background data on those witnesses, so that when we do interview them, that it's as high a payoff period of time as possible; that we go in with enough of what's publicly known about that person so that we don't have to spend a lot of time asking background questions, and enough in terms of information that the witnesses or that the person is likely to have, so that it's as productive and as focused a process as possible. This is very much driven by the -- there are worlds of things to do here, so let's concentrate on making what we can do within the year as efficient as possible. The second area of coordination going forward is with the outreach program. The groups to which we're reaching out are, some of them, very much interested in what they can tell us. Some of them have fairly considerable and sophisticated document collections. Some of them may have access to either individuals or groups of people that we can talk to that will tell us more. So I'm working very closely with the staff involved in the outreach program to get their data as it becomes available and sort of feed that into the here's what we're going to do next in terms of making the best of our staff and Committee resources. The third area is just the general ongoing effort to identify not only prior histories and prior secondary source published data, but other public sources that we can look at. Again, it's a matter of there's a world of information out there. We don't want to drown in it, and at the same time, wherever possible, we want to go after any given bit of it in the most efficient way possible. Dialog with you is real important because I can give you information about what the staff is doing, and the staff can report until you're just drowning in information on what the staff is doing. So some sense from you over the next few weeks and the next couple of meetings about what data you need in order to decide what you want to be doing would be very, very much appreciated. Thank you. CHAIRPERSON FADEN: Thank you, Don. You may not be entirely clear. Perhaps I should explain Don's coordinating role overall to the Committee staff. It's very helpful to have his level of management introduced, but what I realize now is probably missing is an overall understanding for the Committee of how the staff is organized because, indeed, it's organized. It may not be the right organization, but it's organized. So what we thought we would do is get a document to you by tomorrow which we have anyway, but we'll make it prettier. Anna will have it made prettier, and it will be a prettier document which describes how the staff is organized. We'll give Jeff a few minutes in the agenda tomorrow to maybe go over that document, if that's all right. So you can all have benefit of how this is fit together and Don's role in it, which is basically to make sure that as we extend into more elaborate data-gathering efforts with the agencies principally, but in new directions as well, that Don and then with David -- and we can talk about David's role a little bit tomorrow -- together can make sure that the information is being coordinated and that these requests are going in and out in as efficient a way as possible. I think that what Don has already shared with us gives us some idea that it's possible, that it can be done. Are there questions for Don or can we go ahead? This was more really for our information than for anything else. Again, if Committee members have suggestions to Don about how you would like to see information fed to you about data-gathering efforts, Don's going to take it; right? And then Jeff will take a few minutes tomorrow and we'll kind of go over the whole staff. Then if we could pick up -- what we're going to try to get in this afternoon, then, are reports on the VA, or a report on the VA, and updates on DHHS and DOE, before we go to our public comment period. It would be really great if we could get this all in, so that tomorrow we can spend essentially the entire day on where are we and where are we going next, and prepare ourselves for this memo that we're all going to write to each other, things of that sort, in which we can embed the subcommittee reports, where most of the Committee work as opposed to staff work has taken place thus far. So if we could start, Denise -- is Denise going to give a report? Okay, Denise Holmes, who has been coordinating the effort at the VA, will give us -- will walk us through the memo which is Tab what, Denise? MS. HOLMES: Tab I. CHAIRPERSON FADEN: Tab I. So if we can turn to Tab I -- MS. HOLMES: I'd also like to let the Committee know that Dr. Susan Mather and Dr. Neal Otchin of VA are here and might be available for any related questions that I might not be able to answer. CHAIRPERSON FADEN: Can you just move the mike in a little closer? MS. HOLMES: Sure. CHAIRPERSON FADEN: Thank you. MS. HOLMES: All right, I'd like to talk a little bit, first of all, about how the agency has approached the project so far, then a little bit about the results of their search. Within that, there is a story to be told, an historical story to be told about the creation of an Atomic Medicine Division within VA. And, finally, to turn to staff observations about the search thus far and some specific recommendations for the Committee to consider. In January, Secretary Jesse Brown of VA asked all of the VA Medical Centers to locate all records regarding radiation- related research. It has been primarily a field effort. There are 172 different Medical Centers around the country. Staff notes that from the beginning the Secretary has been very committed to this effort, has been very curious about the creation of the Atomic Medicine Division, and has constantly been reminding the staff within the agency about the need to revitalize the effort. One of the attachments, Attachment D, is a memo dated June 1 to the Acting Under Secretary for Health simply reiterating the Secretary's interest in and commitment to this project. A series of directives has gone out to the facilities to search for various kinds of record. As recently as last week, there was a directive instructing how to handle questions that have come up through either the DOE hotline that have been referred to VA or to VA's own hotline itself. In January, the Secretary appointed an internal coordinating committee, which is chaired by the General Counsel, and they have been meeting regularly since the start of the year. There's also -- within Dr. Mather's office there's coordination of the effort that's being performed in the field. What has happened thus far, the results of the search thus far? First, I will note that there are, as of this point -- Committee staff and VA staff are both unaware of the existence of any classified documents connected to our charter. The agency does not have classification authority. It does sometimes receive classified materials from other agencies, but as of right now they're unaware of the existence of any human radiation-related classified documents. Within the central office, there's been no discovery of records of specific research projects. They have reviewed some annual reports and other materials, and we have received from them portions of some policy manuals. The Medical Centers received two different surveys, and copies of those surveys are Attachment E, behind the staff memorandum at Tab I. As to the issue of contractors, there's a little bit of lack of clarity about the extent to which contractors might have been used early on. In response to these surveys that have gone out to the field, each Medical Center that responded said there are no contractors connected with this at all, but there's an annual report in 1965, fiscal year 1965 annual report, which says that early on there was some extramural research conducted. However, the staff has told us that they believe that in the early years of radioisotope work with VA that that was purely intramural research and that there were no contractors involved. The second section of the staff memo talks about the history of the agency, and within that there is a story to be told about the creation of this Atomic Medicine Division. Secretary Brown spoke about this in his testimony before the House Committee on Veterans' Affairs February 8 and spoke with this Committee about it at its first meeting. There are three attachments related to this. Attachments A, B, and C are the three historical documents in Committee staff's possession regarding the early work in radioisotope research and specifically this Atomic Medicine Division. In the fall of 1946, Major General Paul Hawley, who was the Director of Medical Programs for VA, became concerned about the problems that atomic energy might create for VA and that later turned out to be specifically service-related disability claims that veterans might raise. General Hawley began to discuss these issues with representatives of the Manhattan Project, including General Groves. And there's a footnote in the memorandum that discusses some of the people that were at an initial meeting with General Hawley. And by way of context for you, staff notes that all of this was occurring shortly after Operation Crossroads, and I know that Dan wants to talk about that in a little bit to give you a little bit of the linkage there. But in Operation Crossroads some of the principal actors in the VA story, specifically, Stafford Warren and George Lyon, they were involved in Operation Crossroads and then later involved in setting up the program at VA. VA created a central advisory committee on radioisotopes in the fall of 1947, and there were five members of that committee: Drs. Stafford Warren, Shields Warren, Perrin Long, Hugh Morgan, and Hymer Friedel. Dr. Friedel and Dr. Stafford Warren and Shields Warren also served as advisors or special consultants to the individual VA Medical Centers around the country that were engaged in radioisotope work in the early years. The committee, this central advisory committee, was to report to General Hawley, and at its first meeting on September 5, 1947, they made five recommendations. The first recommendation was to create an Atomic Medicine Division within VA; secondly, to create a radioisotope section within that Division to administer the radioisotope program; and, third, to classify the existence of the Atomic Medicine Division as confidential and instead to devote or direct public attention to the radioisotope program specifically. Those recommendations were adopted by General Hawley, and the Division was created. There were three objectives of the radioisotope program: specifically, to use radioisotopes in medical research, to use them in clinical diagnosis, and to use them in medical treatment. The first lab was begun or was up and running in early 1948, and then that number expanded to 14 fairly quickly, and grew throughout the 1950s. There's also another historical note that I'd like to add, and this is discussed in that section as well. In 1960, there was a nuclear reactor installed at the VA Medical Center in Omaha, Nebraska. One of the first three documents -- I believe it's Attachment B by A. Graham Moseley -- says that this was the first such reactor, and that, of course, suggests that there may well have been a second and a third and possibly more than that. So one of the curiosities for us is, what was this reactor doing; why was it installed; and what others might have been utilized? On page 10 of the staff memorandum are several key staff observations, and I'd just like to highlight several of those for you. First of all, other than the three reports that I mentioned that are attached as Attachments A, B, and C, the VA has not identified any other historical documentation about the creation of this Atomic Medicine Division. Secondly, thus far, VA has identified very few records within the Research Service, which seems to be the key central office division that we would be concerned with. Third, VA has not searched in-depth for general policy records either at the central office or at National Archives or Federal Records Center locations. Fourth, the agency has not begun to work with other agencies to identify coordination and cooperation of the various agencies' efforts in the late 1940s and early 1950s. I'd like to turn to the staff recommendations which are on pages 11 and 12, and we listed eight options. We presented eight options for Committee action. The first five are Committee advice and direction to VA, and the remaining ones are direction to Committee staff. Option No. 1 is that VA should proceed, as Secretary Brown had instructed, to trace the story of the Atomic Medicine Division, its creation, its work, and so on. Secondly, VA should expand its search effort to incorporate and to focus on high-level policy documents. Third, VA should work with other agencies to trace the coordination of their efforts in the late 1940s or late 1950s. Fourth, VA should conduct formal interviews with key personnel, retired researchers, and other people that might be able to offer some of the early history. Alternatively, at the Committee's direction, Committee staff could conduct any or all of those interviews as well. No. 5, VA should trace the history of the Omaha nuclear reactor, as well as that of any other reactor or reactors that it may have had. Committee direction to staff, Option No. 6, at the bottom of page 11, is: staff recommends that the Committee direct it to continue communication with VA on the matters discussed in the memorandum and at this meeting. Option 7, that the Committee direct its staff to facilitate the exchange of information between VA and the other agencies. And the last option relates to three possible avenues that the Committee might want to pursue. The staff would engage in fact-finding to enable the Committee to determine whether and, if so, when and how to proceed with that, to follow specific VA researchers over time; secondly, to trace VA links to research performed by affiliated medical schools; and, third, to track the use of VA patients by other medical school researchers. CHAIRPERSON FADEN: Thank you, Denise. The floor is open for questions to Denise. Phil? GENERAL RUSSELL: Is there any history of transfer of funds from the Atomic Energy Commission or the Department of Defense or any other agency into the VA during those periods? MS. HOLMES: I am not aware of the transfer of funds from any of the documentation that I have seen. GENERAL RUSSELL: Is there any record of centrally- directed research within that structure or is it all, as I suspect, all investigator-driven academic-type research? MS. HOLMES: Well, we're trying to figure that out. What we know right now is different researchers in different places were doing projects, but there was review by a central research committee, and the fact that there was this central advisory committee on radioisotopes suggests that there must have been some sort of coordination, but I haven't -- GENERAL RUSSELL: Well, there's always been central review of the projects for prioritization and funding purposes and scientific review, but that's a lot different than a top- down-driven research program. MS. HOLMES: Uh-hum. GENERAL RUSSELL: Knowing the way the VA operates, I would be very surprised if they undertook any centrally-directed program. Now the other question is, however, were there a lot -- were there programs or projects carried out within the VA and the associated Medical Centers that were funded by the Atomic Energy Commission or the Department of Defense or somebody else? MS. HOLMES: And that's an avenue that we're going to explore. GENERAL RUSSELL: An awful lot of the funding for VA- associated scientists comes from outside. A lot of it comes from NIH. CHAIRPERSON FADEN: That's part of the last set of options for consideration. GENERAL RUSSELL: Where did the money come from for that reactor? MS. HOLMES: That would be something I'd like to know, too. CHAIRPERSON FADEN: Other questions? Jay? DR. KATZ: Denise, have you received protocols from the VA -- CHAIRPERSON FADEN: Jay, could you speak into the mike? We just have this problem. DR. KATZ: Oh, yes. Have you already received protocols of research conducted at the VA? MS. HOLMES: We have some material from Boston of projects that Dr. Belton Burrows was involved in. There are some logs. There are some -- I believe that most of that is material after the project was underway, though, not here's my proposal for what I'm intending to do. DR. KATZ: But the obtaining of these data is still in its early phases in terms of actual research projects? There's, of course -- MS. HOLMES: In the early stages of the collection from VA? DR. KATZ: From the VA, yes. MS. HOLMES: Yes, yes. CHAIRPERSON FADEN: Nancy? DR. OLEINICK: Yes. Do you have any indication yet, and following -- I guess one of your options here was to follow the individuals, the researchers. Some of them may have had funding from other agencies, but not be officially located in the VA hospitals, but be using VA patients, and so forth. So do you have any indication yet of individuals who would be named within as being involved with the VA protocols, but would not necessarily be VA staff? Do you understand what I'm saying, that they -- MS. HOLMES: Yes. DR. OLEINICK: -- might be involved with other agencies? MS. HOLMES: I think the only document that I've seen along those lines is something from the AEC which listed four VA hospitals, but it's not clear to me that that was directly, that the funding was directly to VA or the researchers were VA researchers or if they were some place else and that was just their hook, if VA was just the hook. I'm not certain of that. DR. OLEINICK: I think it will be very helpful when you actually have some of this material in the database because here's an opportunity where you have -- I think the universe as defined by VA ma be easier -- well, I think it would be easier to define here than in some of the other agencies. When we have some of the names, I think that's going to be one line to follow that will be very useful, and it might be easier to start in some place where it's more circumscribed than in some of the other agencies. CHAIRPERSON FADEN: Yes. So that's essentially an endorsement to continue with that strategy? DR. OLEINICK: Right. Right, uh-hum. CHAIRPERSON FADEN: So everyone remembers, this is, for the Department of Defense this morning and VA today, these are -- this is the first report from staff on these departments. So this is where the experience is the newest. It's also where we're giving the largest amount of agenda time, too. Are there other questions for Denise about the VA experience so far? Can I take it in the context of the discussion we had earlier this morning about the need to find a procedure for fixing priorities and direction for the Committee, can we, with that as a backdrop, as the plan to be accomplished by the end of July, can we endorse the options that staff has proposed for the VA activity? That last option has three options in it. I don't know, Denise, if you're asking for direction as to which to pursue over which or whether you want to, you and the other staff working on this want to spend a little bit more time to see what you get out of these different approaches. MS. HOLMES: I think that all of these might be helpful paths to pursue. As of right now, we can't identify these would be good researchers to track over time, but it seems that that is a good -- CHAIRPERSON FADEN: So we can start -- MS. HOLMES: -- line to track. CHAIRPERSON FADEN: So if the Committee endorses Nancy's endorsement, we can give Denise and her colleagues direction to pursue that path. So is it all right to take it as a general understanding of the Committee that the staff should continue along the lines lined out in these eight options, with the proviso that as we get onto our big agenda of priority- setting for the Committee at large, certain things could be retracted or emphasized? But for right now, go ahead. Thank you very much, Denise. It's great. Okay, if we can proceed then, we're now going to updates of two departments on which we heard reports at our last meeting. Those are Energy and HHS. Should we do Energy first? That would have Jim David come back to table, Jim, if you wouldn't mind. Is Jim giving the update? Let's just get people to the right tab. What tab is it? MR. GUTTMAN: Tab K. CHAIRPERSON FADEN: Tab K. So if everyone would please turn to Tab K. MR. GUTTMAN: In essence, for those that recall what was recommended last time, we're following along pretty identically the options that were recommended. To put this in the context that I think the Committee is interested in, DOE is through with its phase 1 sweep of the field offices primarily, but also to some degree the headquarters, and they've now sort of dragneted out there and are in the process of seeing how many boxes they've located where there are human experimental-type data. What they are now doing is coming to us and asking the question that we're all asking ourselves. They'd like to, then, in their phase 2 pursue a finite number of what you could call groups of experiments or you could call stories, and the questions are: which ones? And that's the same question we've been discussing this morning, so that we can guide them. We've begun with DOE to look at the high-level documents. They've located a good proportion of the Division of Biology and Medicine files which are central files, in many cases extremely rich information, you know, research institution by research institution, experimental protocol almost by protocol. Classified documents, last time we talked about the Division of Intelligence, where there was some question about getting access, and Glenn Podonsky and his group are now working in individual intelligence, we understanding, trying to find out what kind of classified materials exist, and that may be -- it may be like Geraldo's Al Capone safe, but it may be very interesting. Also, we're getting a box of classified advisory committee minutes. On the radioisotope licensing information, DOE has come up with a dry haul in terms of the information that Oak Ridge had on the shipping distribution lists. That, apparently, had been destroyed in the normal course of affairs many years ago, but they'll still look for AEC licensing data. The other study we've got in the declassified draft, the 1974 document collection underlying the Inspector General plutonium report. DOE's search team, Glenn Podonsky, is going to be looking in the Inspector General's Office for that information. The database, we've been using that, and I think maybe Steve Klaidman has talked to you about using that, in particular, to help figure out where to do outreach hearings to identify groups of people that are clustered. And the archives, as Don has suggested, a big issue is how we're going to go at the archives documents that DOE and other agencies have. The other item that I want to call your attention to, I think, is in the last meeting we talked about the data in the university files that were the plutonium experiment subjects, and I understand Ellyn Weiss, who I think is here, is in the process -- there she is -- the process of drafting a letter from DOE to basically say, we'd like to sit down and meet and discuss the least burdensome, most appropriate way to get access to this kind of information. Jim, I think that -- so, basically, the staff, as Don said, is now in a mode of very intense working with the Department. Jim is working, in particular, talking about how to figure out which archive materials to go through. Don is sort of coordinating the requests of the various groups. The ethics groups want such and such, and we're all trying to figure out how we're begin. We haven't really gotten -- we've got the initial 11,000 pages of documents, which has got a lot of interesting stuff, but how much more and how we want it is the kind of thing that we're in the intimate process of determining. The DOE question about which stories to pursue is the one that they'll need your direction from. Jim, is there any -- MR. DAVID: No, I don't have anything to add. CHAIRPERSON FADEN: Are there questions, then, about the update on DOE? DR. THOMAS: Just a trivial point: this AEC memo from -- AEC report from 1958 is one of the useful things. I'd like to see the other half of it, if you could get it for us. MR. GUTTMAN: Yes, that's the kind -- what I meant. That's a good point. We've got a terrific amount of materials. In other words, the Division of Biology Medicine files are just research agenda by research agenda, institution by institution, and, you know, the University of Rochester's room and phone numbers in 1948 and that kind of stuff, a lot of stuff, yes. CHAIRPERSON FADEN: Lois? MS. NORRIS: You seem to have gotten not all the pages of that report. Pages 2, 4, 6, 8, is that -- MR. GUTTMAN: I got that. I just wanted to point out, we've got the odd-numbered pages. We have the odd-numbered pages. We have the whole thing. MS. NORRIS: Okay. That would be useful. CHAIRPERSON FADEN: It sounds like it was a screwup, is what it is. There's no mystical classification problem here. It was just a clerical screwup. It's not that every other page was not classified. (Laughter.) We will get you that. MR. GUTTMAN: We can't say it's only Duncan's copy, can we? No. CHAIRPERSON FADEN: No. But it looks like that; I apologize. We apologize. Are there other questions or comments on the DOE? We have two options for Committee action. Three and four, they're pretty straightforward. They basically say keep going. The substantive part of the option one under Roman II is endorsing see if we can track, get the picture with respect to bodies of research, if that's a reasonable way to get a more coherent approach. So take the whole body approach, for example; what can we learn about how DOE went about supporting whole body radiation studies? And maybe we can come up with a few others like that. Again, the idea here is to try to come up with some ways of summarizing or controlling, which we will spend more time talking about tomorrow, of trying to give some coherence as we put together the early part of this story. Other questions or comments for DOE? (No response.) Okay, before we go into DHHS, I was asked to make an announcement. We are at the end of the day going to have our public, time for public comment period. We would like to request the people who -- there is one person who has already asked for some time during the public comment period and two people who have sent us letters who would like to have those letters read into the record. We will take care of the latter, but with the person -- hopefully, that person is here who has expressed an interest in advance in talking during the public comment period. If that person would find Kris during the break -- wait. I'm sorry, Kris is out. So it's Gwen. Gwen, could you stand up? Thank you, Gwen. Find Gwen during the break and let her know exactly your name and title, and so on, so we can get that correct as a matter of public record. Also, if there is anyone else in the audience who would like to speak during the public comment period, would you also please identify yourselves to Gwen, not now, but to Gwen, please, at the break? And the break will be shortly. So we can get your names correct and also get an order for your presentations. 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