ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS - - - PUBLIC MEETING - - - WEDNESDAY JUNE 21, 1995 - - - The Advisory Committee met in the Executive Chambers at the Madison Hotel, 15th and M Streets, N.W., Washington, D.C., at 9:00 a.m., Ruth Faden, Chair, presiding. COMMITTEE MEMBERS PRESENT: RUTH FADEN, Ph.D., MPH, Chair KENNETH FEINBERG, J.D. ELI GLATSTEIN, M.D. JAY KATZ, M.D. PATRICIA A. KING, J.D. RUTH MACKLIN, Ph.D. LOIS NORRIS NANCY OLEINICK, Ph.D. HENRY ROYAL, M.D. PHILIP RUSSELL, M.D. MARY ANN STEVENSON, M.D., Ph.D. DUNCAN C. THOMAS, Ph.D. STAFF PRESENT: DAN GUTTMAN, L.L.B. ANNA MASTROIANNI, J.D. STEVE KLAIDMAN JONATHAN MORENO, Ph.D. VALERIE HURT LANNY KELLER I-N-D-E-X Page Opening Remarks, Ruth Faden, Chair 3 Public Comment Martin Freeman 9 Anthony Roisman 15 Geoffrey Sea 29 Philip Harrison 39 Rachel and Zina Greene 48 Julie Boddy 63 Committee Discussion: Findings(1944-74) 69 [Part IV, Chapter 18] Committee Discussion: Recommendations for Remedies for Former Subjects [Part IV, Chapter 19] 102 P-R-O-C-E-E-D-I-N-G-S 9:10 a.m. CHAIRPERSON FADEN: Good morning. This is the fifteenth -- Welcome to the fifteenth full meeting of the Committee -- Advisory Committee on Human Radiation Experiments. Mr. Caplan is here from the White House to open us officially. MR. CAPLAN: Good morning. Almost there. As the designated Federal official for the Advisory Committee on Human Radiation Experiments, I'd like to declare this meeting open. CHAIRPERSON FADEN: Thank you. Well, here we are again. I want to start by, first of all, thanking everyone for hanging with us through this summer. I know that for all of us these last two meetings that were not scheduled, I agree, have caused havoc with personal schedules and personal lives. So I want to extend to everyone here -- and I think we will have everyone shortly. Everyone is coming in, so far as we know, except for Reed who will not. Reed will not be here until the third day. Other than that, Jay is coming in at 1:30. Other than that, we expect mary Ann and Lois, Sue, Ken -- Lois is here -- Ken, whoever; but anyway, we expect everybody but Jay this afternoon, and Reed the last day to be walking in momentarily, and again some of the problems here, the fact that some people were supposed to be on vacation now or otherwise doing traveling and have just changed their lives to be here, and we are all very grateful. We have a very full day, a very full three days, and let me just run through real quickly what we're going to try to - - what we will have to accomplish. We really have no choice anymore but to bring closure to a series of things. With the exception of our all important public comment meeting session which we are about to enter in just a moment, the whole of the next three days is devoted essentially to our discussion of the contemporary period and our work with respect to the contemporary period and findings and recommendations. Today after the public comment period, the agenda is dedicated to a review and, hopefully, approval or modification of the findings of this Committee with respect to the historical period 1944-74, and a review and, hopefully, approval in some modified form of the recommendations that bear on that historical period. So the whole day today is given over to the period 1944 to 1974, our historical work, both findings and recommendations. The whole day tomorrow is given over to the contemporary period. We will review the latest drafts reporting on the results of the Committee's two empirical projects, the subject interview study and the research proposal review project. We will spend a fair amount on the research proposal review project, because there's an awful lot that we have to sort through and decide about, including additional work by Professor Katz as well as the work of the whole committee. We will then work through the recommendations that bear -- the forward looking recommendations that bear on the current system for the protection of human subjects. So it's all of a package tomorrow. We deal with our empirical work on the contemporary period. We then look at our findings with respect to the contemporary period: Are we comfortable with the findings as they've been drafted for us. Then we look at the recommendations, the draft recommendations that are before the Committee for consideration with respect to the contemporary period. In the afternoon tomorrow we have set aside time for a discussion of Committee process, how we want to proceed over these last couple of weeks, and also the organization of the report and a discussion of personal statements by Committee members. Finally, on Friday we will continue with our deliberations with respect to recommendations for the current system for human subject protection, if we have not yet wrapped it up. Then we will move from there to the two other areas of recommendation, areas for consideration for recommendations before the committee: First, recommendations with respect, forward looking now, to intentional releases and national security considerations, and human subjects research and national security considerations, so that we have a set of recommendations that look at -- draft recommendations that look at that arena. Then, finally, we have a series of recommendations forward looking that address the question of openness, the issues of openness. So that's what we'll be doing on Friday. So we're packed, and we'll be deliberating and, hopefully, deciding all the next three days. This is when you can't hide anymore. I'm looking for the right metaphor. We can no longer say, well, next month could we have this in another form or next week, you know, if we could revise this and rework it perhaps in three months time, we can get clear on what we want to do. This is literally -- what is it? -- the end of the road. MR. GUTTMAN: We're not even going to joke about this. CHAIRPERSON FADEN: Right. okay. So that's it. What we decide is what we decide. Let me call for an approval of the minutes for the May 8-10 meeting. Are there any corrections, changes, addenda, modifications that anyone would like to propose to the minutes? We never saw them? Well, we're going to take that off the agenda. DR. THOMAS: Ruth, before you move on, can I just clarify an item about the agenda. Is it during this period on the discussion of former subjects you intend to include the discussion about population exposures and all that? CHAIRPERSON FADEN: Yes, backward looking. Yes, the issues on notification, population exposures would go there. Again, the agenda is laid out this way, but it's also fluid. I mean, if we need to take more time, we will move things around. There are a few constraints, but we can basically go with what we need to go, realizing that we have to get through all of this somehow by Friday at three o'clock. I apologize about the minutes. So we will take that off the agenda, see if we can't get them to you, and then put it on the agenda for Friday. Is that something we can do? Okay. Let me move on. Then we're ready for our public comment period, and we have seven presenters from the public. Two, I believe, are on one panel. Let me just start by pleading with the members of the public. As important as it is for us to hear from you, we have a great need to be able to hear from each of you in an adequate amount of time. So if you could limit your comments to about five minutes, that would be great. That gives the committee a chance to ask you some questions, which often turns out to be the most useful for both the member of the public and for the committee. So let me start then and see if our first public commenter, Mr. Martin Freeman, is here in the audience and can join us. Good morning, Mr. Freeman. Thank you for taking the time to speak to us. MR. FREEMAN: Good morning. Madam Chair, ladies and gentlemen, thank you very much for affording myself and the others an opportunity to speak with you this morning. I am an attorney. I am lead counsel in the litigation that was instituted this past Monday in Rochester on behalf of six families of those who were injected with plutonium. I am one of four firms and two public interest lawyers that have joined together to represent people who have been exposed to radiation without their knowledge or consent, including not only families in Rochester but those many people in Boston, Chicago, California. We've been asked also to look at cases at the Fernauld School as well as prisoners' cases in Washington, Oregon, and we've also been asked to look at cases in Alaska and elsewhere as well. We read with interest your draft recommendations, and I would like to simply begin by commenting on what I believe to be perhaps the single most important entry in those recommendations. It is at once not in the text but relegated to a footnote, but at the same time it is at the very beginning. It is in a footnote to the title that is Footnote 1. It says that the Advisory Committee only addressed the question of whether the government owes remedies to former subjects or their surviving family members, and that the remedies identified below should not be construed as excluding remedies that subjects may be otherwise entitled to from non-Federal institutions or individuals. From our perspective, representing the United States citizens who have claims to make, this is an extremely important entry in your recommendations, and perhaps should be taken from the footnote status and put into the text. In fact, rather than approaching it as a negative statement, that we are not going to exclude remedies, perhaps the better wording would be to say that you are intending to preserve those remedies. This is not just a semantic difference. The reason it is so critical is because at once, while you are here acting as an investigatory arm for the Executive branch of the United States government, it is quite probable, and we ask that you may wish to inquire of the appropriate sources, that another branch of the Executive Department of the United States government is planning to fund the defense by the private sector of the very same claims that fall into your recommendation 2, as well as the other claims, and to choose the lawyers. This seems to be a clear contradiction perhaps where one arm does not know what the other arm is doing. An inquiry should be made to be certain that your recommendations are not being made without full knowledge by you and by the Executive branch of the government that other sectors of that same branch are making plans to fund the defense by the private sector of these claims. In connection with Footnote 1 as well, I would also ask that you take a careful look at the last three words of the footnote where it says don't exclude remedies that subjects may be otherwise entitled to from non-Federal institutions or individuals. The word non-Federal does not appear before individuals, but it could be construed to be that. The reason that you want to be certain that you don't wish to exclude remedies against individuals who might be Federal individuals but not the government itself is that there is an entire class of action that the United States Supreme Court has developed and sanctioned, and that is what is common called the Bivens action. You want to be certain that anything that you recommend does not exclude a Bivens action brought against those persons connected with the Federal government who worked in concert with the private sector. You also have one further consideration with respect to Footnote 1 which we would request that you consider. That is that you want to be certain that nothing that you do jumps into the state laws around our country that have abolished joint and several liability, so that in the event that Congress should decide to award compensation to individuals who were exposed without their knowledge and consent and with a cover-up of what was done don't have their cause of action against the private sector inordinately reduced by a comparative negligence allocation because of the fact that the government is accepting responsibility. If the government decides that the compensation is full, fair and just and gives a full award, that would not be a problem; but if a statutory scheme is developed which compensates persons by the government at a low end, leaving open to the private sector to lay the majority of the blame on the government where it should not lay and, therefore, demolish or largely destroy the claim against the private sector, then what was not done in a sweeping way will be done in a piecemeal way. That's a little bit technical, and I appreciate in five minutes that I can't cover it all. I would certainly be happy to answer questions regarding that. In any event, we finally -- The final comment I have to make is with regard to recommendations 2 and 3. I only suggest to you that the recommendation you make to establish machinery to permit claims under recommendations 2 and 3 for compensation must be one where the satisfaction of criteria for falling under recommendation 2 or 3 -- the machinery to do that must be clearly delineated. Perhaps now, it is only recommendation 2 that requires any kind of new machinery. Perhaps now, those claims to be brought under recommendation 3 already have the available machinery in our court system. I'll be happy to answer any questions. CHAIRPERSON FADEN: Thank you very much, Mr. Freeman. Thank you for reading our draft recommendations. Let me just institute for the record that they are draft recommendations. MR. FREEMAN: It says that on the top of every page. CHAIRPERSON FADEN: Just so we all know that how they end up, hopefully, bears a family resemblance and perhaps more, but these are draft recommendations. Are there questions or comments for Mr. Freeman? We appreciate your careful reading of Footnote 1, and we will pay some attention to it. MR. FREEMAN: Thank you very much. CHAIRPERSON FADEN: Thank you very much. Our next presenter is Mr. Anthony Roisman. I should be practicing pronunciation before I do this. I apologize. Mr. Roisman. MR. ROISMAN: I, too, am pleased that you have provided us this opportunity to address the Committee. While I do have some critical things to say, I'd like to begin with some positive things. One, I think that the effort, particularly by the Secretary of the Department of Energy, Secretary O'Leary, and her staff, to get the facts out, at least those that are under their direct control, is commendable and probably unique in government annals. I just would like to say on behalf of all of us who have been concerned with this issue that the work of the Department of Energy, particularly of Ellyn Weiss and her office, have been extraordinary, and your Committee's decision to take a substantial portion of that information and put it in detailed form, at least in the drafts of the portions of your report that we've seen, so that it's readily readable by people who are not going to be able to do what you and your staff have done, is also extremely important. This is a very important story to be told, and there are some terrible things that happened, and they need to be known, and the lessons need to be learned from them. Your report and the disclosure of information is critical to that happening. Secondly, I think the Committee's willingness to talk to the public, to travel around the country, to hold meetings that are open like this, and to involve the public in this process is also extremely commendable. The worst thing that could happen would be to take any of this, no matter how distasteful, no matter how embarrassing, no matter how much it may impact even on work of determined and dedicated scientists today, and to bring it out into the open and to let the public see it and take actions based upon it is also commendable, and I hope that as you near the conclusion of your efforts that nothing will cause you to back away from that. Having said those two things, I am already fearful that the Committee is beginning to back away. I want to talk about something that I think is highly sensitive and extremely important. There is, it seems to me, as expressed in the remedies draft, a reluctance on the part of the Committee to do something that, I think, must be done, and that is to acknowledge that to provide appropriate remedies will necessarily have a chilling effect on medically relevant research. What the Committee has not been willing to come to grips with is the fundamental difference between right and wrong. This not a hair splitting, Thomistic scholarship. This is an easy question. It's not complicated. Every single human being has an absolute, unequivocal, nondelegable right to the integrity and dignity of their own body. No one, not the most distinguished doctor in the world, has a right to invade that body, even for the most incredibly humanitarian purposes, without the full, informed consent of that person. That didn't start with the Nuremberg principles, but it certainly is enunciated there, and it didn't begin to be violated by doctors who operated under Nazi Germany, but it certainly happened there; and it hasn't stopped in 1995, although it has probably gone down. The people whose families were part of these experiments and studies are all part of your scrutiny, because that one unequivocal principle was violated. The remedies section of this report, as now drafted, does not openly acknowledge that, for every single person, a remedy is required. If the consequence of that remedy is that a doctor sitting at NIH today will hold back on an experiment because he or she is unwilling to tell the potential patient all of the ramifications and risks of the procedure and, therefore, some important research will be stopped, then so be it. It is the price of living in a free society. We will no more tolerate a beneficent medical dictator than we would a political dictator. Neither are entitled to exist in this society. Now your Committee has on it members who make their living and have made their living in the radiation experiment field, who work in the radiation area. I spent 20 years of my legal career dealing with the radiation community, and I can tell you, it is a club. If you do not as a Committee recognize the unavoidable personal interests that some of your members have in seeing that the activities of their colleagues and even of themselves are not labeled wrong, and their attempts to persuade you that when a person was very, very sick, it was okay to invade their body without their complete consent because just maybe they might get better -- If you don't realize that that's just as wrong as taking somebody and injecting their body with plutonium and then trying later to cover it up without ever telling them that they were injected, then you've missed the point of this inquiry, and these remedies don't recognize that. They hair split. They hair split on the issue of harm. Your idea of harm is physical injury, but when we talk about human rights, the remedies go much broader than that. If you look at the litigation history of Section 1983 of the Civil Rights Act, you will see that the United States Supreme Court as recently as 1978 recognized that emotional distress and humiliation are just as much harms for which money recovery is appropriate. How much money? It depends upon how much harm. Don't fall into the trap of thinking that, unless someone's radiation dose was at a level that was physically dangerous, nothing went wrong. To do that is to send a message to the researchers from now on that, if they honestly believe they're not doing any harm, and if they honestly think they're trying to help somebody, it's okay to not get their full informed consent and fully explain to them what they are doing before they do it. The streets of hell are paved with good intentions, and the history of these radiation experiments are proof of that. Lastly, I want to mention the question of the apology. With all due respect to whichever staff members or members of the Committee drafted this apology, I must say it reads like it was written by a computer. This is not an apology. An apology is to invite every single person whose family member or themselves were the subject of these experiments to a face to face meeting with the President of the United States and appropriate other government officials, and to have them told to their face the government's regret that this happened and the government's assurance that it will not happen again and the government's gratitude to them and their family members for having unwittingly given up something for the alleged benefit of society. That's what an apology is. It's not some sort of newspaper notice, like you do in a class action case, that if you send in a slip you can get $20 because you were sold stock inappropriately. The human side of the remedies is missing. Thank you. CHAIRPERSON FADEN: Thank you, Mr. Roisman. Are there questions or comments from the committee? DR. MACKLIN: I actually have two questions. One: I think the Committee has throughout the document endorsed the principle that you enunciated so forcefully, and I concur with that. That is the inviolability of a person's body and the integrity of the self and the dignity. That doesn't permit the invasion of that body without the person's consent. Seems to me that that's stated and articulated throughout. When you in your presentation just now focused on the remedies section, it seemed to me you were adding something to that principle, and I'd like to know what it is. That is, is your claim that violation of that principle -- that is, the voluntary informed consent of individuals is absolutely necessary -- are you adding to that claim something specific and concrete in the form of a remedy or a type of remedy that is owed to people when that precept or principle is violated. Since what you first said was the wrong, no one here is quarreling with, and I think is in this document what you added is a specific form of remedy for violating that ethical and moral and legal principle which, if I'm understanding correctly, you're saying that built into that principle is that a remedy is owed in the form of monetary compensation. Is that correct? MR. ROISMAN: Absolutely, Doctor. I think that is correct. Our legal system has abandoned some of the other remedies. The Bible talks about an eye for an eye. I would suggest those are inhuman remedies, and like the death penalty, I would not be supportive of them. So we translate human suffering into the currency of our modern time, which is dollars. For that reason, it is essential that these remedies, not by trying to specify how much dollars should be given -- you all have appropriately not tried to do that, and I think that's right. I don't think this is the place to do that. In fact, I'm inclined to think the courts are the place to do that, and juries are the place to do that; but that's a debate, really, that will take place if and when Congress decides to take up the matter; but, yes, in our legal system it has to be something in compensation and, I think, the apology. Both are critical parts of that. DR. MACKLIN: I just wanted to be clear what was the principle and what was the remedy for violating the principle, since they are conceptually distinct. My second question -- and I think this goes much more to contemporary research today. I'd just like to know your views on this and the way you stated it. There are some people who are not fully capable of giving consent to a research maneuver, and the way it's put both in Federal regulations and in practice is that the patient's guardian or legally authorized representative may give consent for that maneuver. Does your -- The assertion of the principle as you stated it -- would it preclude consent being given on behalf of next of kin. I should say permission being given on behalf -- by next of kin on behalf of a patient who is not able himself or herself to give fully informed consent? MR. ROISMAN: No, absolutely not, but to the extent that that patient, for instance, signed a right to die provision during their lifetime, that would take precedence. So a person who was dying -- DR. MACKLIN: Absent any other conditions that would preclude it, you would -- So that, in other words, there are circumstances under which the next of kin, parents in the case of children, perhaps an adult son or daughter on behalf of an elderly person, might give permission for a research maneuver. MR. ROISMAN: If that person were legally authorized, I don't have a problem with that conceptually. No. CHAIRPERSON FADEN: I just wanted to make one comment on your concern about the message that's being sent to the contemporary community of biomedical investigators. Another draft recommendation which the Committee will debate tomorrow speaks specifically to the question of what the public policy ought to be from here on and forward, if a subject is used without consent in a biomedical experiment. There, the draft recommendation calls for compensation. What we're struggling with, of course, is the difficult problem of how to sort out what's appropriate, both looking backward and looking forward, but the Committee is clearly concerned that the message to the biomedical community be just as Ruth articulated, that it be understood that it is unacceptable to involve human subjects -- to involve persons as subjects in research without their appropriate consent or without appropriate authorization from a designated authority whose charge it is to look out for that person's interest if that person is incompetent. So that's clearly a message the Committee wants to give. Whether it gives it in the form of this draft recommendation I just described or otherwise is yet for the Committee to debate, but there is no question that that's a commitment. I think I'm speaking for all of my colleagues here on that issue. So how we go about giving the message is, of course, what's at issue, but that there's agreement with the point that you make, I think, is clear -- on the general principle, on the importance of that principle. MR. ROISMAN: But I think there's a problem that I have with the Committee's perception that you alluded to a moment ago, and that is that the past conduct is somehow or another judged differently. I don't think these rules -- that is, our sense of right and wrong has not changed from 1940 to 1995, and the fact that maybe a very large number of members of the medical community were engaged in similar practices should be cause for greater alarm, not greater comfort. I think it's wrong if the Committee allows the fact, if it is a fact, that in the medical research community in the 1940s, the 1950s, giving these inadequate or nonconsensual experiments and studies was the practice, to make that an excuse. The law, if we were talking about common law principles, would not excuse a practice. The law excuses what's called the state of the art. If it was not possible because of technological problems to give adequate consent, that was one thing; but when it was possible and when people knew the difference and chose not to do it, even if an entire industry chose not to do it, that's not an excuse. That should be cause for greater alarm, that they could do it together as sort of a mob violation of rights rather than an individual. Don't be frightened away by the magnitude of the number of people who were in some way or another mesmerized by government funding, by the Cold War, by the promise of nuclear medicine. It's precisely those kinds of temptations that we have to worry about. The way to make sure that tomorrow's scientist doesn't give in to that temptation is to let him know that yesterday's scientist didn't get off the hook when he had those temptations. That, you can do in the remedies. CHAIRPERSON FADEN: Thank you for your presentation. You're a very articulate spokesperson. I'm sorry. Dr. Glatstein. DR. GLATSTEIN: I don't think you identified which cases you're representing. MR. ROISMAN: Mr. Freeman and I -- I'm sorry -- are together in that same group of lawyers, but my particular focus at the moment happens to be on the Massachusetts General Hospital and Dr. Sweet. Thank you. CHAIRPERSON FADEN: Thank you. Our next presenter is Mr. Geoffrey Sea. Mr. Sea, nice to see you again. MR. SEA: Good morning. There are two parts of my testimony this morning, and I'll try to demarcate them. First, I am here representing the Task Force on Radiation and Human Rights which, I believe, you're all familiar with, and International Radiation Injury Survivors. On behalf of the Task Force and IRIS, I'd like to make the Committee aware of United States treaty obligations under the International Covenant on Civil and Political Rights and other international human rights charters. The International Covenant on Civil and Political Rights was concluded in 1966. It entered into force in 1976, and was ratified by the United States in 1992, one of the very first international human rights conventions joined by the United States, along with the Genocide Convention and the Convention against Torture and other cruel, inhuman or degrading treatment or punishment. The Covenant, as it's come to be known, has a number of sections that are explicitly relevant to human radiation experiments. Specifically, Article 7 states, "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation." In addition, the Covenant lays out specific requirements of signators to provide remedies when provisions of the charter are violated. The remedy section is also quite explicit. Section 3 of the Covenant states, "Each state party to the present covenant undertakes (a) to ensure that any person whose rights or freedoms as herein recognized are violated shall have an effective remedy, notwithstanding that the violation has bee committed by persons acting in an official capacity; "(b) to ensure that any person claiming such remedy shall have his right thereto determined by competent judicial, administrative or legislative authorities or by any other competent authority provided for by the legal system of the state, and to develop the possibilities of judicial remedy; "(c) to ensure that the competent authorities shall enforce such remedies, when granted." Now the United States has taken its obligations under the covenant quite seriously, and last year in 1994 provided a comprehensive report, again under the provisions of the Covenant, on the human rights conditions in the United States, the first time the United States has provided such a report to an international body. They specifically make mention of the radiation experiments as being a potential violation of the charter. That is currently under investigation. There is reference to the work of the Advisory Committee, and there is what we consider to be an admission in that State Department report that human experimentation without informed consent is specifically illegal in the United States. The report says, "Nonconsensual experimentation is illegal in the United States. Specifically, it would violate the Fourth Amendment proscription against unreasonable searches and seizures, including seizing a person's body; the Fifth Amendment's proscription against depriving one of life, liberty or property without due process; and the Eighth Amendment's prohibition against the infliction of cruel or unusual punishment." Now it is the intention of the Task Force on Radiation and Human Rights to ensure full compliance by the current administration with the Covenant. The treaty talks in terms of meaningful remedies and access to justice and is very specific about the access to justice being a judicial remedy. We are concerned about the remedies section of the draft report, and we don't see in your recommendations an explicit and full compliance with what the Covenant calls for, and that is to make sure that there is access to a judicial remedy. Specifically, the body of the Committee's report, and I think the weight of the Committee's deliberations over all these months, clearly shows the great complexity of the human radiation experiment issue. There were many, many individual experiments. Each comes with their own set of facts and circumstances. The interest of justice in determining the facts of each particular case and ascribing the appropriate remedies cannot be served by any simple or affordable administrative or legislative system. I think most of you would agree with me about that. The only effective remedy, therefore, is full access to the courts, as Tony Roisman has already spoken about. We are looking for the Committee explicitly in its recommendations to say that any administrative or legislative system must be nonexclusive and must not require from participants any abrogation of their right to seek judicial remedy. Now the Covenant also includes provisions -- includes mechanisms for ensuring compliance, and the Task Force intends to make use of those mechanisms. They include the filing of a complaint with the Human Rights Committee of the United Nations, which is in charge of ensuring compliance with the Covenant. This provision of the Covenant has not been used before in the United States. There are no complaints on file as of yet. It may well be that ours is the first complaint by victims of the human radiation experiments. We are not yet determined to take this course. We are hoping that the Committee ensures that there is compliance with this and other international human rights charters, and we urge you to make sure that that's the case. We will submit copies of the Covenant and of the U.S. report and other relevant documents. Now I'm going to move on to the second part of my testimony, and if I had two hats here, I would physically change hats. I also, as many of you know, work for Lieff, Cabraser & Heimann which is a law firm involved in both the Vanderbilt and Cincinnati litigation, and I'd like to make some specific comments on behalf of our firm and our clients in regard to those two cases. In the Vanderbilt case, we're concerned about the fact that the chapter that dealt with Vanderbilt has been radically changed and is in the process of being altered. It's difficult to make specific comments without having a working draft to comment upon, but we are concerned that there has been a continuing lack of clarity about the role of epidemiology. Epidemiology is the only sound basis for making determinations about whether harm has occurred in any particular experiment. In the Vanderbilt case, we have the study by Hagstrom and others from 1969 which is so far the only peer reviewed epidemiological study of any population involved in the human radiation experiments. The Hagstrom study clearly showed that there were four cancers in the control group of some 600 women who were studied among their children, and that there were no excess cancers in -- there were no cancers at all in the control group. CHAIRPERSON FADEN: Mr. Sea, could I just ask you to sum up. MR. SEA: Sure. Basically, our position is this, that there was confusion in the chapter in Vanderbilt, and I think there is continuing confusion about recent attempts to dismiss the Hagstrom results, because of various new attempts to show that the doses were too low to have produced those results. You cannot challenge epidemiology with dosimetry. This is the only study that's been done on the effects of these kinds of doses of this isotope on in utero -- on fetuses exposed in utero. If the results of the epidemiology show that previous assumptions about dose response effects on fetuses are incorrect, then it is the epidemiology that takes precedence. That being the case, we think that there is also confusion about the dosimetric studies. The one solid dosimetric study which is the Dyer and Brill study led to a conclusion that there was a question about whether the cancers were the result of radiation damage, and we feel that that has been misinterpreted in the Committee's discussions about Vanderbilt as not being a question, but rather it's been misinterpreted as suggesting that they were not caused by the radiation when, in fact, Dyer and Brill concluded only that there was a question about them. One comment about the Cincinnati chapter, and that is that it is the general conclusion of the chapter and of the Committee's deliberations that the Saenger experiments were not done for therapeutic reasons, but were primarily motivated by military purposes. That being the case, there is still a continuing reference in the chapter to the experiments as being dual use experiments, and we feel that the use of this term is misleading. It's contradictory within the points raised in the chapter. The experimenters claimed that they were dual use. The chapter concludes that they were not dual use but continues to use the term. So we would simply urge the Committee to replace that term with either so called dual use or alleged dual use or something to that effect, but not misleading. Thank you. CHAIRPERSON FADEN: Thank you, Mr. Sea. We are a little pressed for time, but if there are Committee members who have questions, we should get them now. Are there questions or comments? Thank you very much. Our next presenter is Mr. Philip Harrison. Is Mr. Harrison with us? Good morning, Mr. Harrison. Thanks for coming. MR. HARRISON: Members of the Committee, thank you for inviting me again to speak with you on the issues of Navajo uranium radiation. My name is Bill Harrison from Shiprock, New Mexico. I notice that the program lists me as Albuquerque, New Mexico. CHAIRPERSON FADEN: We'll correct it. MR. HARRISON: I don't mind, but it lists that. So I usually go down once or twice a month to visit. I chair an organization called Uranium Radiation Victims Committee. I have been working with this committee and my people for almost 15 years. I have previously testified before the Committee in January of this year in Santa Fe, based on my input and commitment working with the impacted people. I have endured so much of the many untold stories and hardships the Navajo people are going through. This is the reason why I wanted to come and speak with you again before you. Thousands of Navajo uranium miners have mined and milled uranium from the 1940s through the 1970s. These workers and their families were highly exposed to radiation hazards without their knowledge. Today hundreds of them have died from their radiation exposures. These exposures occurred primarily before the enactment of the Federal health and safety regulations in the late 1960s. The Atomic Energy Commission had failed to warn the workers and failed to enforce proper equipment to adequately ventilate the mines. The working conditions were sometimes unbearable when numerous workers were dragged out of the mines unconscious, being overcome by dust, smoke and radon gas. The government knew all along what the outcome would be and secretly initiated studies on these miners. I remember my father being examined annually every so often and told that was the company policy in order for him to continue working. These studies were done without their knowledge and consent, and I feel their rights were violated. Today, these studies are still being carried out. It was not until about 1978 the Federal Mine Safety and Health Act had finally assured the miners of a safe working environment and enforced safety measures. Today I have drawn the conclusion that the Federal government had intentionally sent workers to these mines and mills to study the effects of radiation exposures. In the process of all of this, the miners and millers and their families are all contaminated. The Navajo uranium workers have willfully worked very hard in defense of their country. Some of these miners were veterans of World War II, but yet they were victims of their own government. In October of 1990, legislation was signed and an apology was made to these victims. After three years the compensation program is not being fair in making compassionate payments. Every day I have Navajo families in my office asking why they are not being compensated. The majority of these people don't read and write, but yet they feel they were mistreated. The radiation compensation - - Radiation Exposure Compensation Act does not provide adequate compensation. I think Department of Justice should start compensating the claims and that Public Law 426 be amended. The Navajo uranium millers, which were left out, should be included. Overall, the criteria should be flexible, fair and equally considered. I have one final comment I'd like to make, and I've been reading this book here, "Bad Blood," about the Tuskegee syphilis experiment, and have to say that I can't see any difference between what the syphilis experiment and what was done to my people in the mines. As I understand Tuskegee, bout 400 black men with syphilis were studied for almost 40 years by the Public Health Service and never treated, even though by 1946 they could have been treated with penicillin. In other words, the government knew of the danger to these men and could have done something to save lives, but chose instead to study the long term health effects and lied to the men in order to do these studies. The same can be said about uranium miners. It appears that by 1951 or 1952 at least, the Federal government knew that working in unventilated mines was going to cause lung cancers and kill miners. The government had the authority and could have done something to save lives, but it chose instead to conduct the long term health studies, and lied to the men in order to accomplish the studies while keeping them in the mines. If anything, it seems to me that what was done to my people was worse, because the government created the health hazards, in the first place, and you cannot say that with RECA. There is justice for this wrong. Who was put in greatest danger in the mines? The smokers. They were effectively handed the death certificates when they entered the mines. Yet RECA makes it impossible for the families of these men to now get compensated. You could say that by denying compensation to these men, it creates greater risks. RECA has stood justice on its head. Thank you. CHAIRPERSON FADEN: Thank you very much, Mr. Harrison. Your presentation is very timely, given what we will be deliberating today. Are there questions or comments for Mr. Harrison? Yes, Duncan. DR. THOMAS: Thank you, Mr. Harrison. You mentioned that you would like to see RECA amended to make it more equitable. I heard you make two specific recommendations to that end, one of which was that the uranium millers be included, and the other that some change be made to the requirements for smokers. Are there other things which you would like to see changed about RECA as well, that you would like to see this Committee consider this afternoon? MR. HARRISON: First of all, I mentioned that about every day -- I have an office at Shiprock, and I have families that come in. I've seen a lot of deficiency letters and denial letters of people that don't qualify because of the criteria. For example, they might have a compensable disease, but yet they don't have enough working level months, and that seems to be one of the biggest problems. About the smokers thing, same thing with that. They might have a compensable disease, but yet they don't have 500 working level months. DR. THOMAS: Could I clarify then whether -- It sounds to me like your primary problem with RECA is with the criteria themselves and not with the documentation standards that are required. Is that right? MR. HARRISON: Yes. DR. THOMAS: Because I've heard other testimony, particularly at that meeting we had in Santa Fe, to the effect that the requirements placed on the miners to provide documentation was often just impossible to meet. Is that -- Do you see that as a major barrier to compensation? MR. HARRISON: That is -- It seems like it takes really a whole lot and a time consuming thing to get the documents to meet the criteria, because a lot of these original records and things are not available, and people are just -- The miners are just turned off by submitting claims. I know I have seen families to where that they don't want to submit a claim because of the -- a lot of people are turned down for claims. DR. THOMAS: Are there any specific documentation requirements that you feel are unfairly discriminatory against the Navajos relative to, let's say, one of the white miners who would be making the same claim? MR. HARRISON: One of the things that I have observed or have seen was the medical records part. For example, the chest X-rays are being read in Albuquerque by NIOSH approved doctors are not being accepted here, even though they come into D.C. with positive readings and then they're sent out here, and then they're being read negative. Due to that, a lot of these are being turned down. DR. THOMAS: Is there any reason why that would be different for a Navajo miner than for a non-Navajo? MR. HARRISON: Again, I have been hearing things. There's -- I have a lot of friends that have worked with a lot of Navajo people, their own people, and they also have worked with the white people on the outside, and they have been told they didn't have any problems with these kind of medical records things. The other question was how the RECA should be amended is I think the millers that have been dying lately, the Navajo uranium millers -- I've seen a lot of illnesses in that, and I would like to see them included, and also I have come across some death certificates of the spouses of these miners. I've seen two or three of them. They had died from pulmonary fibrosis, and these families had lived for so many years within the mining camps. I grew up in the mining camps, and I know the scenario of how we used to live. My father mined over 20 years, and my mother has got all sorts of health problems right now, and I would like to see something being done with the millers and the spouses and also the amendment to it. In my work, it's not a paid position. I've been there for my people. The last month or so, like I said, I've seen so many of these complaints or concerns from people, and then there has been -- An interest has been stirred up now to where that they want to go back to court. I don't know how we're going to be doing this, but it's been talked about of taking this thing back to court. I believe there's about almost 200 people that were denied claims. CHAIRPERSON FADEN: Thank you very much, Mr. Harrison. As I said, your testimony is quite timely. Lois, did you have a question? I'm sorry. All right. Thank you so much. We have two people who will be presenting next, Ms. Rachel Greene and Ms. Zina Greene. Good morning. Thank you for coming. Will you both be speaking? MS. RACHEL GREENE: I'm deleting from what I had prepared. So I may not be that eloquent. What I want to address is stated right here. It's the question about the difference -- how to define the difference between ordinary practice and experimental procedure when it comes to medical radiation. In 1964 at Stanford University when I was 18 months old, I had radiation treatment for cancer. It was on the first lineal accelerator in the country. My parents signed a form releasing liability. The first sign of -- Well, anyway, I had a very good prognosis, and the cancer did not reappear. The first sign of any secondary effects from my radiation treatment came when I was 12 years old. I had curvature of the spine which was caused by the radiation, stopping the growth in some of the bones where it had been. Okay. That was almost to be expected, and we took that in stride, you know. We knew there were going to be some ramifications to the treatment. What happened -- Okay. In my mind, it is reasonable that a medical procedure such as radiation would have some side effects, particularly when treating patients who are still in their developmental stages. What happened 14 years later, however, was tragic and should not have had to happen, because it was preventable. I have with me a paper that I'm going to be referring to. The title is "Radiation Induced Chronic Arterial Injury." It was published in 1987 by two doctors, Himmel and Hassett. I will be able to give copies of it to you, if you would like to have those later. What happened to me in 1989 was that I was walking around with a time bomb inside of me. I had arterial damage from the radiation inside my aorta which I didn't know about, and there had been no way that anyone followed up with me to let me know that that might have been a concern. So on the morning of October 4th I lost the sight in my left eye, and I had had a stroke. What happened after that was that I was misdiagnosed many times, because the doctors were treating me and looking at me, and they didn't understand that my previous radiation history had an impact on what was going on, and they looked at me and thought I was an unlikely candidate for a stroke. I finally found a doctor who diagnosed me properly, and what happened was they were basically trying to treat me with one hand tied behind their backs. It wasn't until a family friend with a medical database located this paper on chronic arterial injury caused by radiation that my doctors were able to give me a diagnosis. The damage that I have now is easily treatable. I am on anti-coagulant therapy, and it has virtually no side effects. So it doesn't make sense, you know, not to go back and screen those people who've had radiation and look at this hidden arterial damage that might be happening. My doctors are first rate professionals at Georgetown University, but they were treating me as if with one hand tied behind their backs. The fact is there has been documentation for some 50 years now of radiation induced arterial injury, but its recognition has not been widespread. What still shocks me is that, had we known to suspect arterial damage, we could have found it long ago and taken preventive measures. Until today, I have been invisible to doctors, to fellow radiation patients, and to the people regulating the ethics of radiation exposure. In this paper -- I just want to take one quote from here -- he says, "Very little work has been done to define the risks that patients incur for major arterial complications following therapeutic doses of radiation." I consider that statement to be sort of an indication about how the radiation treatment has been experimental in that whoever is administering it is not carefully following up on some of the information that is available. One of the statements that one of my doctors made when I was in the hospital was "Nobody lives 25 years after radiation." I would just like to implore the Committee here to set stricter standards for long term follow-up care, especially for children, even if that simply means a handout outlining possible conditions to test for down the road. A small amount of knowledge can make the difference between life and death. MS. ZINA GREENE: Hello. I'm Zina Greene. I'm Rachel's mother, and I'm here in support of Rachel. I'll just be very brief. When her doctor said that in the hospital, he said they don't expect the children to live. Of course, I went through the whole process with her, both of them. The fact that radiation at the time -- the lineal accelerator was brand new. We had -- Stanford had the first and third, which is where we were. Mayo had the second at that time. We were never followed up. No one ever cared what happened to Rachel. So -- but I didn't -- I guess at that time it didn't hit me until she had the stroke, and I took the occasion, especially after the doctor challenged it by saying, well, they didn't expect the children to live 25 years. So I picked up the phone, and I called Stanford, and I called Mayo, and I called Boston, and I called Philadelphia. I don't have my notes anymore. I easily called 10-15 major clinics, major radiation places. Of course, I started with Stanford, and the amazing thing was that they all returned my call, the heads of the radiation departments, and the second most amazing thing is that nobody had the least bit of information. No one kept any longitudinal studies. No one knew what happened to their patients after that gave this radiation. Obviously, it was experimental, because you signed away your life. I mean, I signed away that anything could happen. I mean, I go in for surgery; I don't sign away that anything in the world can happen and the doctor is harmless; but when you go in for radiation, you sign away your life. Anything can happen, and they're not responsible. So, obviously, they knew it was somewhat experimental, and yet they kept no studies whatsoever. I think that that needs to be looked at. I don't think you should be given radiation, especially to children, without following up on long term studies as to the effects, whether or not it saves their life. There are children that live, and we should know what to expect. The basic question that I had is, all right, she's already had curvature of the spine. She's already had a stroke. What should I expect -- What else should we expect? No one had any idea. No one even really cared. Thank you. CHAIRPERSON FADEN: Thank you both. I appreciate that it was very hard. Are there questions or comments for Ms. Greene or her mother? Eli? DR. GLATSTEIN: Having spent time out at Stanford, I'm surprised to hear that. They have a large follow-up clinic for adults and children both. They have someone who is dedicated to pediatric work and have had for the last roughly 20 years or so, following up on children. I think the point that you raise is a good one. I'm not sure that most of the major institutions don't try to do that, but I think that it's coming to a change these days because of managed care where there's a strong movement to have the children and the adults followed by primary care physicians who are not experienced with radiation at all. What happened to you at the completion of treatment? You were just discharged? MS. ZINA GREENE: Just discharged. MS. RACHEL GREENE: Actually, technically, I was followed for 27 months. MS. ZINA GREENE: At Stanford? MS. RACHEL GREENE: I read that in my medical records. DR. GLATSTEIN: And then what happened after 27 months? MS. RACHEL GREENE: That was it. MS. ZINA GREENE: She was considered cured, no reoccurrence of cancer. DR. GLATSTEIN: Well, 27 months is certainly not long enough -- MS. ZINA GREENE: Well, for an 18 months old child, they considered that. Because of the high metabolism, they considered that to be cured. DR. GLATSTEIN: Well, there was an old saw that children who lived -- an infant who has cancer presumably had it develop during the development as a fetus, and if the child lived the age plus nine months that that was cure, but I think that was disproved a long, long time ago. I don't know whether it was true in the mid-Sixties. I would have to chase down the papers, because it was a long time ago. I think that was proved to be just an old saw, but -- Well, as I say, I'm -- They've had a program dedicated to follow-up not only of the children but the adults as well, and they've got a specific person who is responsible for the pediatric cases. I know her very well. She's advocated extensively the business of follow-up on the kiddies for just the point that you're making, and that is that, as people live longer, we do see more problems. There's no argument about that. Once you undergo radiation, it can't be taken away, and that is an issue. However, that is -- As we're using the term, that is not experimentation. That is treatment. The consent which you signed didn't sign away legal responsibility, but it did state what you were being treated for, that you were going to receive radiation. It probably outlined the short term complications that you would expect during and shortly after treatment and the major long term problems which were known at that time. The paper which you quoted, I think you said, was '87. There is reference to isolated cases before that and, of course, when you treat enough patients, almost anything can happen, but arteriosclerotic disease in major arteries is certainly unusual. It is not a common event. It may be more common in people who are irradiated in infancy, because the tissues are still developing. That's quite possible. I don't know good information on that, but I would emphasize that what you received was thought to be at the time the best approach to a problem which presumably couldn't be resected at the time. MS. RACHEL GREENE: My question to that is why, once there was more knowledge available, wasn't I contacted? DR. GLATSTEIN: Well, that's a legitimate question, but presumably by that time -- Were you still living in California MS. ZINA GREENE: We lived in California for five years, about four and a half years afterward; but we're followable. I mean, people -- They do longevity studies in anything. I mean, we don't disappear. We're people who would choose -- If someone said to me, this was important that we follow you, I would have kept in touch, because I'm responsible. DR. GLATSTEIN: Well, I think that the HMOs need to hear that, because that whole process is being changed now so that -- to keep costs down. The HMO is predicated on the assumption that the specialist is the one who costs all the money. CHAIRPERSON FADEN: We have two more people who want to ask questions. We want to get them in. DR. THOMAS: Eli, I think these women have identified what is, in fact, a real gap in the research system. Those people who were treated with radiation, or indeed any form of clinical treatments for childhood cancer, if they were involved in an organized trial, were followed for a few years, usually at most. What I'd like to -- There is one piece of good news, however. This problem which you've identified has now indeed been recognized, and there is now a national childhood cancer survivor study that's just getting under way, and I'm aware that Stanford is one of the centers that's participating in this. I'm not exactly certain what all of the inclusion criteria are, what years one had to be treated in order to be a member of the study, but I would strongly suspect that you may indeed find yourself being contacted shortly by the organizers of this nationwide study. So that it is -- and something of the order of about 25,000 people who received radiotherapy of children will be enrolled in the study, and the focus is not just on mortality. It is a very broadbased study, looking at all the conceivable problems that people who may have undergone treatment for cancer as children may now be experiencing. CHAIRPERSON FADEN: May I interrupt? We could get the name of the study and the organizers. Yes, we will get that for you. Thank you. Then you don't have to go hunting and calling 800 numbers of whatever. We can at least do that. We can at least get that information to you. Ruth? DR. MACKLIN: This is a very simple question. You mentioned that you've had access to those medical records, that you may even have in your possession. Do you have the form, that piece of paper that you signed? You said a number of things about it. It would be very instructive and illuminating to take a look at whether it was a release, a consent form, a complete waiver of whatever. You don't have a copy of that, do you? MS. RACHEL GREENE: We don't, and we could probably get it from the hospital. MS. ZINA GREENE: No. I only remember leukemia looming large. They said that it increased her chances of getting leukemia. DR. MACKLIN: In particular, the question whether the form that you signed acknowledged that this was an experimental form of treatment or an innovative form of treatment is one item that goes to the gap or the possible gray area between therapy and experimental or innovative treatments. The other was what was there by way of what you were waiving, since even a treatment consent form or a consent form for research does not usually have all those "sign your life away" provisions that you described. So it would really be interesting to see that, if you could. MS. ZINA GREENE: As you know, you're kind of catatonic at that moment as a parent, and they present these several pages. Yes, you read them, and you sign them, because the doctor says you should do this, but I think, as you say, if they're just now starting that longitudinal study on children, it had to have been experimental, because they had no idea what happened to children as a result of radiation therapy. DR. GLATSTEIN: I don't think that's entirely true. There were certainly good ideas, if patients survived. The problem is that so many of them don't or didn't at that time, at least, that they weren't a lot of 25 year survivors at that time. However, the guy who says that they didn't expect you to live -- If they didn't expect you to live, quite frankly, they wouldn't have wasted your time or theirs. MS. ZINA GREENE: No. Actually, most of the people there, the few mothers I did get to know, their children went on to die within six months to a year. DR. GLATSTEIN: That's true, but at the time they treated it wasn't thought that they were hopeless. CHAIRPERSON FADEN: We thank you very much for taking the time. There's something -- a piece of information. You put some very important issues before us. Thank you. Our last presenter is Ms. Julie Boddy, if she is waiting. Thank you for being so patient, Ms. Boddy. Thank you for waiting. MS. BODDY: I feel very grateful to be present before this group. My initial experience with radiation toxicity occurred in 1942 when I was a three-year-old recovering from third degree burns on the back of my legs in Berkeley, California. Before I left the hospital, right before I left the hospital -- my only source of information is the recollection at that time. From the vantage point of middle age, X-ray treatments were administered to the back of my legs. My mother told me they were supposed to thin the very thick scars back there. Ten years later I had thyroid cancer. Its removal was followed by radiation of remaining lymph tissue and the surrounding area. None of that experience by itself brings me here, but rather the silence, evasion and deception surrounding that experience that I have encountered over the years and the possibility now of making some change for the better. I have ben very moved by reading earlier testimony before this group, particularly by the strength of witnesses' desires to know what happened. I feel that way, too. I want most to tell you of quite recent experience with the Public Health Service. About 10 years ago an official in Alameda County, California -- He told me that with reluctance -- telephoned my home in Takoma Park. Alameda County is the place where I grew up and had my radiation treatments. The Public Health official told me he had called to determine whether or not I was still alive, whether I had any living children, whether any of them had any significant health problems. Although I was uneasy at his refusal to give me his name or the name of the study he was working on, I liked the attention and was happy to help out, if I could, after he promised to send me written information about the study. I felt proud in a defiant sort of way, and also grateful for being alive and for having three children, three healthy children. Someone's interest in this part of my life countered a lot of shame I felt about my experience with the edge of life, and also some guilt at being able to find ways of coping. So I really felt the fool when I realized that I never heard from him again, that his office didn't send me anything or contact me again in any way, never let me know a thing. I've been very familiar with silence of this kind. When my parents were living, it was too painful to talk with them about the burns, the X-rays, then the nausea, big water blisters, inflamed lymph nodes, and the still thick scars on the back of my legs. I knew my medical bills had cost them a lot of hardship, and for many reasons it seemed best for me to ignore what had caused the hardship and concentrate on living as if nothing had happened. The strain in my family seemed to be echoed in the atmosphere of secrecy and denial that I felt everywhere in those Cold War years. It has seemed to me that a kind of guardedness could have a kind of limited helpfulness as a defense when I think about my experience with cancer. I didn't find out I had thyroid cancer until nearly 10 years after it had been diagnosed. Nobody told me, and I didn't ask. My thyroid gland had a growth, I knew, and the whole thing had been removed, and we wouldn't want any of it to grow back. That's all, and the knowledge that I had cancer, that very scary word, didn't seem especially helpful when I got it. I had recovered, and my children had been born already. I don't think I'll ever know what my parents knew about my medical treatment, but even so, I'd like to know who irradiated the back of my legs and what they had in mind when they did it, if it's not too late and long ago, and maybe it's not. The public health study I contributed my data to was done in the 1980s. I'm also familiar with the torment of secrecy, and I'd like to use the opportunities I get in my life to be done with it and to help people with similar problems as I have been helped and, if I'm lucky, to forestall more people from having to undergo such a thing. For instance, the agency that sponsored the Alameda County study needs to bother to tell me about it, at long last. I have grandchildren now, and they and their parents also deserve to know. I think that, for once, the people who did the study and who have used the study need to tell the truth to the people they have used for the study, and I think the public should be able to know about the work like this that they have paid for in many ways. I just wanted to add that, until I heard Rachel speak, I wasn't aware of the arteriosclerotic condition, and I think that affected one of my children at one point in his life. Thank you very much. CHAIRPERSON FADEN: Thank you, Ms. Boddy. Thank you for taking the time. Are there questions or comments? Thank you very much. We appreciate your coming. That concludes the public comment period of our meeting, and probably the best thing for a head shift as we move into the rest is to take a very brief break, about five minutes, and then get back together. (WHEREUPON, the Committee recessed briefly at 10:33 a.m. and reconvened at 10:50 a.m.) CHAIRPERSON FADEN: I was thinking at the break that this committee experience has given new meaning to the term burnout, at least in my experience, but the challenge is to continue with the same level of enthusiasm and hard work through these next few weeks. So if we can hold this together for the next few weeks, we're home. I do want to express collectively to every member of the Committee just how much I appreciate all the work that everybody has been doing in between the two meetings. The extraordinary work on the part of the staff really should also not go without comment. It's been a remarkable period of time, and people have just continued to pour stuff out, and that's why we're able to do what we're able to do today. Plowing in here, the first agenda item for Committee consideration is the draft set of findings for the period 1944- 74. Now this time the findings were actually sent out something like 10 days before the meeting, some fair period of time in advance, and we did get reactions from several of the Committee members who were able to review them and send back comments. These comments are very helpful. What is particularly heartwarming to see is that, in contrast to some of the other areas for agenda discussion today, most of the comments that we did get back from Committee members, by and large, were supportive of the findings and with some detailed sort of comments about this word, change that, this needs to be edited, this phrase is infelicitous, this area is unclear. What we had specifically asked for was an indication from any Committee member if there was a finding that you could not live with in its current form. From the three -- I guess it was four Committee members who responded, no one said that of the findings in their current form. What I would like to do is identify for purposes of having the most efficient discussion possible those findings, if any, where there is sort of debate or indecision about whether the findings should be endorsed in the form that it's in. I want to distinguish that from editing, an even higher level editing kinds of concerns which several of you were very kind and careful to send back. My suspicion is that there are other areas for our consideration in the course of the next three days where there will be some considerable need for debate and discussion. So I'm going to -- I would like to preserve as much time as we can, plow through those parts of the agenda where there is agreement, and preserve time for a sufficient discussion where there is likely to be more unclarity or disagreement. So if it's all right with everybody, what I'd like to do is just call for -- if I go down the findings, just call for where if anyone would like to indicate that they would like to have a full discussion of that finding, and see which findings there are that fall into that category. Is that agreeable to everyone? Then we'll go back and spend the time on the others, and you, obviously, can decide to change your mind before the discussion is over and say, oh, I would like to reopen finding 5(a) for consideration, but is that a process we can begin with? Okay, good. We'll see where that takes us. Everybody should be reading off the same page. It would be helpful. I see Nancy is looking. DR. OLEINICK: That's all right. This is my own disorder. CHAIRPERSON FADEN: I finally decided. I spent an hour last night just putting all of these into different folders so I could find them, because I was realizing that I would be -- whatever. Do you need a copy? DR. OLEINICK: No, I have a copy of that. CHAIRPERSON FADEN: So we all have -- Yes? DR. ROYAL: Could I just clarify what we're doing? I assume you're going to read each of the findings and, if we say that we don't have any major objections to that finding, are we going to also go back to those findings to make some minor comments about those findings or are we not going to revisit those findings at this meeting? CHAIRPERSON FADEN: No, I would like to go back and see if there are minor comments that people want to make that are above editorial comments. The first issue is major concerns. I really want to have a lot of discussion of this finding, and let's see if there are zero findings that fall into that category or 10 findings that fall into that category. Then we'll go back and look at the other ones and see if there are lower level concerns that people want to raise. I would just ask that, if your comments are editing type comments, to just send them in writing, if you haven't already done that, so that we don't take Committee time to say that that's an infelicitous phrase and I would prefer some other phrase, unless you think that the infelicities were significant implications and it's more than just infelicitous, that it might give a wrong message and you want to make sure that we're all in agreement about what we're trying to communicate. So with Henry's qualification then, this first call around -- I'm not going to read them. I hadn't planned to read them. I just had planned to call them out, give you a minute to look at them, and say is this one -- All it takes is one of us to say I want to have a substantive discussion, and that will get on the list. So is that agreeable? Okay. Finding 1? Finding 2? I'll give you a chance to look. Finding 3? Now I should probably break this one up by each part, if you want, and see if they're all the same: 3(a)? MS. KING: My problem is with the finding, the statement of the finding. CHAIRPERSON FADEN: The initial statement? Okay. Not with the substance. MS. KING: The one that's bolded. CHAIRPERSON FADEN: Got it. Okay. Are there -- Let me just break it down and see if people want to then discuss the text. It may be that it needs to in order to address your concerns with the bolded statement, but let's just see. 3(a)? 3(b)? Finding 4? MS. KING: This is very hard. It's much harder to do than you think, because you don't know when there's editorial comment. I, for example, have a little problem with Finding 4, which I find elsewhere, that we use broad phrases which is editorial issue, like government agencies, rather than a more careful specification of exactly what -- CHAIRPERSON FADEN: All right. Why don't we put that in for right now, because I think that is -- and it may take us one minute to resolve or it may take us a half-hour. So I'll put that Finding 4 in as an example. Finding 5? If it's the same issue that we can handle in 4, then we just handle it one time and then resolve it. Finding 6? Okay. Not six? No. Seven? I'll save it for the minor list when we go back. Pat, do you want 7 on the list? MS. KING: Yes. Seven raises for me a question of what constitutes a finding. CHAIRMAN FADEN: Okay. Finding 8? Henry, okay. DR. ROYAL: Actually, you can put that down in the minor category. CHAIRPERSON FADEN: Okay. That's a minor one. This is only by way of budgeting time. That's all I'm trying to do is make sure that we save the time for the areas where we need it most. Finding 9(a)? MS. KING: I have a problem with all of 9, but you don't have to discuss it for me. DR. ROYAL: I agree with that. MS. KING: I don't know if it's worth discussion, because I'm not sure that my objections are trying to make it better or go to the core of the finding, and I don't want to waste your time doing it for me; but if there are other members who want to discuss it, that's fine. CHAIRPERSON FADEN: Okay. Well, we'll put 9 up there. I'm not sure if I'm hearing Henry saying, and Mary Ann as well, that there are -- Okay. Rather than -- I guess we should just look at 9(a), (b) and (c) as a passage. Finding 10? 10(a)? Let's do 10(a) first. Pat? DR. THOMAS: Minor point. CHAIRPERSON FADEN: Minor point? Pat, do you want it on the minor list or the major list? I know this is rough. MS. KING: I think it may be minor. CHAIRPERSON FADEN: Minor? Okay. That's 10(a). It's hard to predict. 10(b)? DR. THOMAS: Again, a minor point. MS. KING: I have a major problem with that. CHAIRPERSON FADEN: 10(b) moves over. All right, Finding 11? Finding 12? DR. ROYAL: I have some problems with 12. CHAIRPERSON FADEN: Okay. Finding 13? Finding 14? All right. That takes us to -- Then the next of findings are for tomorrow. They're contemporary period. MS. KING: Fourteen is very minor. I have a very minor question. CHAIRPERSON FADEN: Let's just plow right into it. Finding 1. Let's just go in order. Let me just say that 1, 3, 4, 7, 9, 10(b), 12 and 14 -- we could get through a good chunk of those. We have both this morning until noon, an hour now, and then we have another hour and 15 minutes after lunch. So if we would be mindful that, even if we can't save any time, it would be good if we could get through the findings discussion on the historical period by 2:15 this afternoon. So let's just start. Finding 1. I'm sorry. I should have noted who asked for the finding to be on the table, but I'm gathering by the movement of the microphone that it was you for Finding 1. Okay, Henry, please. DR. ROYAL: The problem that I have with Finding 1 is the use of the term "several thousand human radiation experiments." From our review of -- From our contemporary work, we've learned that different words have different connotations, and experiment, for example, is looked upon more negatively than other words. I had actually thought that we had had this discussion before, and I had thought that we had reached some agreement that in the report that we were going to try to differentiate human radiation experiments where the purpose of the experiment was to determine the effects of radiation experiments in which radiation was used as a tool to study some biological process. My concern and the reason I have a major objection to the way this is stated -- I might not have this major objection if what I read in the media was consistent with what I think that we're trying to say in the report, but for example, I have this article that I read last time from the Scientific American that says details of the report are chilling, some of the tests conducted between 1944 exposed humans to levels of radioactivity now known to be dangerous, and the number of subjects appears to be far greater than previously realized. What my concern is with this first bullet or this first finding is it doesn't make it clear enough that, when we say that there were several thousand human radiation experiments, that this does not mean that there were several thousand experiments in which the effects of radiation were tested on unwitting human subjects. Because I think that's such a critical issue and because to me it's been very misinterpreted in the things that I've read in the media, I think it's very important to make it very clear in this first finding what it is we're talking about when we talk about several thousand human radiation experiments. CHAIRPERSON FADEN: So, I take it, your proposal is to add a sentence that clarifies that -- clarifies -- I'm trying to get the right word --that most of these experiments were likely not conducted to study the effects of radiation on human beings, but did involve the exposure of human beings to radiation for however we want to describe it or something that distinguishes that. DR. ROYAL: It's going to be very important up front in the findings, because it's such an important point to distinguish experiments that would do to measure effects versus experiments that used radiation as a tool. There is a finding later on, and that's another thing that I don't quite understand is the order of the findings, but presumably they can be reordered. CHAIRPERSON FADEN: Yes. Let me put that on the agenda. That's important. DR. ROYAL: That sort of refers to this issue. CHAIRPERSON FADEN: Can I take it -- MR. GUTTMAN: The intent of 10 is the thought that you're talking about, what is in 10? DR. ROYAL: Yes, but I understand why it comes as 10. MR. GUTTMAN: No, but that's the thought, that sort of distinction. CHAIRPERSON FADEN: How about - DR. ROYAL: I think that 10 should be incorporated into 1. CHAIRPERSON FADEN: Well, or at least -- I'm not sure that it should. It depends on whether we want a harm finding separate from a characterization of what they were, because the scary point isn't only that it was harmful but that it was, you know, this sort of nefarious inflicting of radiation on unconsenting people for these dark purposes. You're worried that this first finding would suggest that there were thousands of that kind of experiment. DR. ROYAL: Exactly. CHAIRPERSON FADEN: That's quite apart from the issue of harm, although it's all wrapped up. So what I'm understanding is that there is a proposal to clarify what we know about the characteristics of these 1,000 experiments. That would be adding a sentence. I don't want to craft the sentence in committee time. There may be some cases where we have to craft the words together, but if it's all right with -- If no one objects to a sentence of the sort that Henry has laid out, we will then come up with a sentence and circulate it to everybody and come up with something that is satisfactory. Is this still on this point? DR. RUSSELL: Well, it's related in the sense that the order of these findings is a -- The rationale behind the order is a little obscure to me. I wonder if we could help out some of these things by putting together the ones that have a logical flow. For example, human radiation experiments -- Then there is a great medical benefit that was obtained. Then there was harm. If you put those three in a row, I think you could handle some of Henry's views and make it flow a little better. CHAIRPERSON FADEN: That would be fine. So the proposal is we deal with human radiation experiments, and then we do intentional -- Somewhere we do ethics, and then we do intentional releases, but that we take those three findings that characterize human radiation experiments and present them in a series. Is that proposal agreeable? Then we can see if we need that second sentence. We may still want that additional sentence. We will do both. DR. MACKLIN: Just to clarify, what would these include? In other words, what are the -- what would be the grouping here? CHAIRPERSON FADEN: Finding 1, Finding 11 and Finding 10. So it would be Finding 1, 10, and 11, in what order, how many there were, the risks associated, then the benefits that came. So those two proposals are acceptable to the Committee? Done. There are other problems with order. I'm not sure that we're done with the order problems, but that's very good. DR. ROYAL: If I could just plead with the authors of the report to keep in mind the confusion that there has been with human radiation experiments being these dark, nefarious experiments -- I like that expression -- versus -- MR. GUTTMAN: You want that up front? DR. ROYAL: Yes. Maybe that could somehow fit into the title of the report. -- that we should be careful about using the word human radiation experiments if we don't intend it to mean this dark, nefarious experiment. CHAIRPERSON FADEN: The problem is that some of them were a bit; many were not, and they're all lumped together is your concern. DR. ROYAL: Exactly. I would have thought that an important issue for an ethics committee is to try to distinguish those which were dark and nefarious from those which were not dark and nefarious, and to my mind they have not been distinguished very well. CHAIRPERSON FADEN: Can we go on to 3, please. Pat? MS. KING: I would follow up with what Henry said, and that's in a different way. That is, there will be many people who will not read a report, who will only read findings and recommendations. CHAIRPERSON FADEN: So it's very critical. MS. KING: Therefore, we need someplace here -- I don't know how you want to craft it. We need the definition of human radiation experiments, because if it's not here, people are not going to look for it. It's got to be in the paragraph, because you have to assume from findings and recommendations that everything has to be crystal clear, because in many cases that's the only thing that will be read. CHAIRPERSON FADEN: Right. And there will also be an Executive Summary which will be largely findings and recommendations. MS. KING: That's the same problem. CHAIRPERSON FADEN: Same problem. Exactly. All right, let's more on to 3. Again, I'm sorry I didn't note -- Oh, Pat was that -- You raised 3, I believe, the bolded statement. MS. KING: Yes. I don't understand in 3 why we make a statement in the positive and then make a statement the third sentence in the negative, and then have a long set of deliberations that don't address that. I'm one of these people who don't like to draw strong inferences from negative things. This is a statement that says there is no policy on research involving human subjects, but it's not further explained, and it sort of sticks out like a sore thumb. What are we doing with that last sentence? CHAIRPERSON FADEN: Which one, the one -- MS. KING: "During the period 1944-74 no government policy on research involving human subjects contained a provision permitting a waiver of consent requirements, for national security reasons." The sentence that came before, the sentence that states what is, in the sense of what we have found, what seems to be the second sentence is an implication to be drawn from what was not found. I'm not quarreling with how we want to deal with the absence of this or that we want to point it out, but I think it stands out like a sore thumb, and it's not further referenced, that I could find in the deliberations. CHAIRPERSON FADEN: It isn't. You're right, and it was tacked on. Perhaps it ought to be a separate finding. Lines 21 and 22, and Pat is quite right. There is no mention ever again to this in the text under the 3(a), 3(b), 3(c) -- or 3(a), 3(b) don't return to that. We could make it a stand-alone finding. It is a finding, and it's a finding that's important, because some people expected that there would be such an exception and that perhaps that would have explained some of the events that we were charged to investigate. MS. KING: I agree with the second point. The problem is that we say in the first sentence that there is no -- that we did not have comprehensive policies. So that means that there are holes and there are omissions in policy. When you get to then make a statement about what we didn't find standing alone, there definitely has -- My view is why have we picked this versus all the other things that are also omitted. I assume we do so because of the reasons that you just stated. CHAIRPERSON FADEN: That's right. MS. KING: It's a funny kind of finding, though. DR. ROYAL: Wouldn't it be better to have that statement in the security, secrecy, openness thing? I mean, that's what the surprise is. CHAIRPERSON FADEN: All right. What we need to do, it seems to me, are several things. First, we need to take it out of this finding. The agreement is there. Then either it should be a separate finding. Where it belongs, it's not clear, in grouping. I mean whether it should go where there is discussion about national security sorts of things or here with human subjects. It also needs explication, as all of the findings have, and it was not provided, and that's the context. Why are we commenting on this hole as opposed to all the other holes? In there, we have to acknowledge that, since they didn't have comprehensive policies, the fact that they didn't have a specific exception is less of an excitement. Right? If you don't have comprehensive policies, then it's hard to have a formal exception to it. That's part of the inconsistency that you're seeing there, which is quite right. Okay, that's fine. So if everybody -- I'm sorry. Mary Ann? DR. STEVENSON: This is a minor point, but it's going to come up again. I would just like the word "some" to go in front of government on 3 and also on 4 as a qualifier. CHAIRPERSON FADEN: Some government agencies. Quite correct. We will make sure that's throughout. Then because the explicated text then indicates -- That provides the information by agency as to which ones had what kind of requirements by what date. So we will make sure that in the summary statements we introduce "some" both in 3 and 4. We are now on to 4. DR. STEVENSON: Same point. CHAIRPERSON FADEN: Same point. So from at least "some" government agencies. It's quite correct. Lois? MS. NORRIS: I do have just a factual question on 4 when you get to it. CHAIRPERSON FADEN: Sure. We're on 4. So if we're on it -- If we're doing a finding anyway, if you had a minor point that was above an editorial comment that needs discussion, let's just go ahead and do it. MS. NORRIS: There is a statement beginning on line 19 of page 4 saying that private and Federally sponsored investigators seeking to conduct experiments using radioisotopes supplied by the government were required to have risks and potential benefits to subjects reviewed by a committee at each research institution and, in some cases...et cetera. Then on page 5 beginning on line 1, by 1949 this policy applied to all investigators. I don't understand who the other investigators are, if you're talking about private and Federally sponsored. It's not clear to me. CHAIRPERSON FADEN: I think the ambiguity is what we mean by sponsored. I think sponsored meant you got money from. Is that correct? I'm looking at Valerie, Jonathan or someone. Is that the sense of what we meant there that distinguishes 46 from 49? It's a good point, Lois. What's the difference? You have to come to the mike. I'm sorry. DR. MORENO: This has been going on for the last eight months. There's an ambiguity about who counts as an AEC contractor, whether the labs, the traditional half-dozen big labs count as contractors or not, and it's an ambiguity that finds its way into the language of the finding. We haven't quite sorted that one out, based on the records that we have. CHAIRPERSON FADEN: Well, we need some way -- Lois is quite right -- of distinguishing the difference between what was going on in '46 and what seemed to happen in '49. What was the change? If we say it's not clear to us what it was, then we can say that, that in '46 they had it applied to what looks like this group; in '49 it seemed to have been expanded, but it's not clear exactly who was out in '46. It's not a huge problem, but I think Lois has pointed out that the text is confusing. DR. MORENO: Granted. DR. ROYAL: Is it necessary to have as much expletive material in Finding 4? Do we have such a detailed explanation? (Laughter) Explanatory, yes. I'm still in dark, nefarious experiments. I just think that -- It seemed to me that the explanation was unnecessarily verbose, that the finding itself was fairly clear. CHAIRPERSON FADEN: This is a general issue about how much explication we want for any of these findings. On the one hand, it should be a crisp document. On the other hand, Pat is reminding us that some people will read this and only this. DR. ROYAL: But there are some findings like 5 that have very little explanation. CHAIRPERSON FADEN: I think, yes, the issue is there's nothing to say there. DR. ROYAL: My suggestion is that the finding itself is clear on 4 and that I would cut down on explanation. CHAIRPERSON FADEN: I think we could ask staff to see if they could tighten it a little bit. I have a feeling you need most of this here to explain what that means, on the assumption that nobody, in fact, is going to go back and read the radioisotope chapter except a few devotees of the Committee. DR. MACKLIN: One way to do it, even though it doesn't give the full details but they are given elsewhere, is not to break it down by agency in this way. In other words, the thing that makes it seem long is that it is broken down by agency, and do you think it would be misleading -- CHAIRPERSON FADEN: I think it's a mistake. I think that the agencies are very -- have very different characteristics and histories, and they came at it differently, and that's part of the force behind saying some government agencies, that that correction is appropriate, requires, I think, that we then indicate how the agencies differed in their histories. We can probably do it a little more crisply than is done here, but I'm afraid that otherwise we're going to have a lot of uninformed people who will just presume certain things, like it must have been HHS or it must have been the AEC or it must -- whatever, depending on their particular biases. DR. ROYAL: If that's one of the important points of this finding, shouldn't that be in the boldface. Shouldn't we say that the -- Maybe add another sentence saying that the AEC had policies since such and such a date, and NIH had such and such, and DoD had such and such? CHAIRPERSON FADEN: You mean, put it in the finding? DR. ROYAL: Put it in the finding itself, if that's important. MS. KING: I think it makes the findings very long. I originally had specified here myself -- "specify agencies," but I think "some" does it, because you can't answer your question then unless you read the deliberation -- I mean, unless you read the text, and I do think it is very important to criticize by agency, not the government as an entity. CHAIRPERSON FADEN: So the charge, I think - the message is try to make it shorter, but not cut it out, if that's okay. The one you pointed, the one that's brief is brief because there's literally nothing to say. Maybe we can say a little bit more. Seven is the next one on my list for big discussion. MS. KING: Well, one of the problems I have with 7 is in other findings we gave years, and we gave dates in the finding and this is a finding, to me, that seems to call for dates. CHAIRPERSON FADEN: Finding 7? MS. KING: Six. CHAIRPERSON FADEN: Oh, I'm sorry, on 6. So you want the dates inserted? MS. KING: I think so, because it makes it say that, you know, if you don't have any dates in the finding, it sounds like the government never consistently effectuated their requirements and policies. I'm not sure that's what we wanted to say. CHAIRPERSON FADEN: We can certainly introduce dates on Finding 6. Mary Ann? DR. STEVENSON: I just found the wording in this confusing. I think I know what whoever scripted this is trying to say, but it says policies on consent to human radiation research. I think they're trying to say external being -- from external sources, because by contrast there's more consistent implementation of policies on risk and radioisotope research. It doesn't necessarily make sense just to say human radiation research, because isotope research is human radiation research. CHAIRPERSON FADEN: I don't think that was what the intent was. The intent was to contrast consent to any kind of research involving human subjects to which, in this case ionizing radiation -- DR. STEVENSON: Oh, so it's consent versus risk policies. CHAIRPERSON FADEN: Right, whereas by contrast the risk policy -- and the risk policy only indicates the radioisotopes. So it clearly needs to be made clearer. We can put in dates, and we have to make it clearer. DR. ROYAL: So this finding has nothing to do with nonradiation human research? CHAIRPERSON FADEN: Correct, because we didn't do that level of -- DR. STEVENSON: So that the actual title of the finding needs to be changed, because I found that confusing as well. It's a general statement, and then it goes down and is very specific to radiation. CHAIRPERSON FADEN: So it's either got to be changed in the title -- DR. STEVENSON: Human radiation or research involving human subjects and -- MR. GUTTMAN: Well, it's general on consent, and it's radiation specific on risk, for practical purposes. DR. STEVENSON: Well, no, because you say human radiation experiments. CHAIRPERSON FADEN: No, it really isn't. I mean, the point is we've got -- It's a very good point. It's got to be one or the other, and it's got to be clear. DR. ROYAL: I thought maybe the finding was trying to say that the implementation of policies with radioisotope research were more advanced and more consistent than the rest of biomedical research, but now I'm confused about what the finding is. DR. STEVENSON: I thought it was being more specific and thought we were referring to other radiation research. MS. KING: This is also a problem with Finding 4, as I look back. The title says government policies on risk for research with human subjects, but the finding deals with human radiation research. CHAIRPERSON FADEN: Well, but then the explication then goes on more generally. So we need to get -- This is going to be a constant tension throughout. MS. KING: There are two operative assumptions, and that is that some people only read the findings, and you also have to understand that some people will only read the bold parts. CHAIRPERSON FADEN: Quite right. MS. KING: I mean, they will only read -- This is like legislative history, and they will only go to that if there is something in the finding that says I should read further. CHAIRPERSON FADEN: Quite right. Pat? I'm sorry, Ruth. DR. MACKLIN: I think there is -- Part of this difficulty might possibly be cleared up by not lumping the consent and risk together, and a second thing is, when you look at 4 and you look at 6, one is government policies on risk and the other is government implementation of policies. Those two blur together in a certain way. So the fact that other findings have an (a) and a (b), maybe what might make sense is to talk about the policy and the implementation and limit it to risk. Then we can talk about radiation risks. Then you eliminate the disparity between the consent policies and the risks applying only to radiation, because there's a kind of look of redundancy here, and the reader has to go back: Wait a minute, I thought we just looked at government policies on risk, when you get to the implementation. So that might be a way to clear it up. CHAIRPERSON FADEN: We could actually do the same, consent policy and then implementation. DR. MACKLIN: And implementation, and then do it separately for risk. CHAIRPERSON FADEN: And always make clear whether we're commenting here on all of human subject research or only human radiation research. DR. MACKLIN: And the consent will be -- Well, it won't always be, though, as we know, but the risk -- all we looked at is the radiation. CHAIRPERSON FADEN: Except that we did look at the NIH policy with respect to the clinical center for review of risk, which did not single out radiation research but, presumably, would have applied to any radiation research conducted at the clinical center. So it's in there, and speaks to the general body of work being done at the clinical center beginning in '53. So we have to work -- It's very clear what needs to be - how the revision needs to go. This is helpful in the extreme, and doable. This is the sort of stuff that's doable and doable quickly. Are we on 7 now or Finding 7, status of human subject protections. MS. KING: I raised this problem, because it raised to me what we mean when we use the term finding. Sometimes findings are conclusions based on what facts you have, and this is a finding that looks more like a conclusion. Lawyers would think of this as having a piece of direct evidence, and then you draw implications from it, and then you make a finding that's based on circumstantial evidence is the implication. That was my first thought, and I thought that that was confusing for the reader, since you had so many factual findings before. Two, I thought it was redundant, because I think that what we want people to do is draw this inference, but I don't think they have any trouble drawing the inference from what went before. So the confusion for me was not worth the restatement, is really what I'm saying. DR. ROYAL: One thing in Finding 7 that wasn't so clearly stated in 3 through 6 is it talks about concerning all research involving human subjects. So Finding 7 was a statement about all of biomedical research. It was unclear how much of 3 through 6 was radiation versus the rest of biomedical research. CHAIRPERSON FADEN: Which is something that we're now going to go back and fix. DR. ROYAL: That's right. So if you go back and fix it -- CHAIRPERSON FADEN: But we will be commenting intermittently on both, because in some cases we looked -- Our examination of policies with respect to radiation research taught us about policies for human research generally, because they were not segregated. In some cases, they were segregated. So we have findings that bear on both. The rationale behind this -- and let's see if we decide the rationale no longer -- is not a good one, based on what Pat presents -- is that it is the core of what we rely on in the retrospective remedies. We basically say this is the conclusion and, you're quite right, it is a finding of that second sort. This is a judgment that the Committee has reached based on the factual -- the descriptive findings that -- the 3 through 6, and it's based on this conclusion that the Committee has drawn that it now makes the following recommendations with respect to what is owed former subjects. So it's a summary. It's in here, because it's the set piece, but then pulled out for that other section; but perhaps it's not necessary. DR. MACKLIN: It seems to me, it will do that work if you just use this sentence at the beginning of the recommendations and refer back to the findings. CHAIRPERSON FADEN: Okay. DR. MACKLIN: That is, it can still do the same work without having to state it here, if it's a summary of several of the findings. CHAIRPERSON FADEN: So the preferred approach would be to use this formulation in setting up the recommendations with some footnote that references that this conclusion is based on Findings 3 through 6. That would be fine, and take it out here. MS. KING: Actually, I don't think you need to reference it that way, because I think it's clear; but I don't have any objection, because if you do it in one place, you have to do it every place. That is the basis of my statement. I think it's easy to do here because of the way this was set up and says Findings 3-6. In other parts of the recommendation it won't be so easy to directly link a finding to a recommendation. So I think you run into difficulty, because it will set yourself up for doing that. CHAIRPERSON FADEN: So then the proposal is amended to still take it out of here as an explicit summary finding, but use this language. MS KING: But it works as a statement without referring to the finding. CHAIRPERSON FADEN: Okay. Follow your suggestion of moving it to the recommendation. I don't have strong feelings about it. Either way is fine. Okay. Finding 9. MS. KING: Finding 8 does not have any deliberations underneath it. It stands out like a sore thumb, and it's a very controversial issue. CHAIRPERSON FADEN: So we need to -- MS. KING: I would think so. CHAIRPERSON FADEN: All right. MS. KING: You're condemning the whole profession. CHAIRPERSON FADEN: So we need to put in text. DR. ROYAL: This is important information. I'm curious what the other Committee members think. The statement that it was conventional -- I guess the thing that confuses me about it is it may have been conventional, but it wasn't conventional because of concerns about ethical issues. It was because of concerns about access. The reason that you had to ask healthy people to participate in research was because that was the only way you could get access to healthy people. The way it's written, it makes it sound like it's based on some kind of moral principles, and I don't think it was based on moral principles. I think it was based on practicality. CHAIRPERSON FADEN: I think that we really can't say. It would be very difficult. By conventional, that was meant to be descriptive, that that was what people did, without conveying any implication about what motivated people to do it. I think to say that -- When you -- I mean, I also agree that, to some extent, it was clearly animated by the fact that it's very hard to drag people off the street and submit them to experimentation, but in part legal concerns -- I think in part concerns about ethics for some investigators, if you look at the historical work that's been done, but it wasn't meant to convey any of those things. This was meant to simply say that's what was done, not why, but just that. Okay? DR. ROYAL: Maybe if we had in an explanatory paragraph -- CHAIRPERSON FADEN: I think we could say that, you know, why people did this is complicated and could have been in part because of concerns of ethics but also in part because of just conventions of society. You can't -- and in part because of legal concerns. It's straightforward battery if you grab somebody off the street and inoculated them or cut them open or whatever. So that's something could be addressed in the one or two paragraphs that we can easily add. That's a good point. We can make sure that that's covered. So we need text on 8, and that will be one point that is clarified. We're now on 9, which is in three parts. DR. STEVENSON: I guess I had a problem or at least I could use some discussion about the last sentence in 9(b). It's a very strong statement. I'd just like to hear more discussion before we come down quite that hard. CHAIRPERSON FADEN: Yes, I think it's meant to be. Sue? DR. LEDERER: I have a question, too, about what was meant by the biomedical profession. Does that mean physicians? Does that mean -- CHAIRPERSON FADEN: You know what it was. It struggled. I think at one point it was plural, biomedical professions. It was the notion of what do we do with the Ph.D. folks who do do research involving human subjects who are not physicians. So the notion was, I think it was meant to be plural and that may be a typo. Biomedical professions was some sort of a shorthand for people who do research involving human subjects who are often physicians but also sometimes Ph.D.s. DR. LEDERER: do you think that will be understood? CHAIRPERSON FADEN: Probably not. So maybe we need to make that clear. The finding -- To go to Mary Ann's point -- Did you want to go to that, Ruth, right away -- Mary Ann's question? DR. MACKLIN: Yes. The statement is strong, but the paragraph that follows on page 9 is supposed to justify it. That is -- I mean, either you object to the strength of the statement because you don't think that that statement should be as strong as it's worded or you think the statement is okay but you think that there's not adequate justification provided for it. Now the only -- I sent in some brief comments on this one to suggest a way of trying to strengthen the justification. The operative line here, the one that presumably provides the justification, is the one that starts on line 3 at the end of that line: "Even at the time, it should have been recognized that, despite the significant decision making authority ceded to the physician within the doctor/patient relationship, this authority did not extend to procedures conducted solely to advance science without a prospect of benefit to the person." Now why didn't it? What was there -- What is there in the doctor/patient relationship? I suggested something, and I didn't provide any wording -- I apologize -- that would cite the Hippocratic tradition in medicine. That is, the doctor/patient relationship is one that cede authority to doctors to do something for the benefit of the patient. It's not ceding authority to doctors to do whatever they want with patients, but the presumption underlying the Hippocratic tradition is that the doctors' maneuvers will benefit the patient. So without any -- and this finding addresses specifically this type of research, namely, that offered no prospect of medical benefit to participants. That's solely what this finding is about. Right? 9(b)? CHAIRPERSON FADEN: Correct. DR. MACKLIN: Okay. Therefore, I think the citing the Hippocratic tradition or some words that indicate that what the doctor/patient relationship is is a relationship that authorizes doctors to do things for the benefit of the patient, but that no authority is ceded to the doctor by the traditions that the doctor should be helping the patient. If that -- If something like that were added, then the question is does that justify -- is that adequate to justify that even at the time both the government and the -- I would say the medical profession here, because if we're talking about the doctor/patient relationship and the justification, we're not talking about biochemists or molecular biologists. CHAIRPERSON FADEN: Well, and in fact most of the Ph.D.s would fall under the 9(a) category, in effect -- not 9(a), excuse me; in the category of research with healthy subjects, by and large, not exclusively but most Ph.D.s. DR. MACKLIN: Well, pretty much, but I mean, I think in any case, it's not a profession -- CHAIRPERSON FADEN: So we can work that out. DR. MACKLIN: Yes, but then the question is whether some strengthening of both that wording about what the doctor/patient relationship authorizes by tradition, by longstanding thousand-year-old tradition, would be sufficient to justify the strength of the statement that Mary Ann questioned. CHAIRPERSON FADEN: We should be clear about what's going on here. 9(a) doesn't have any text that follows it, because it seems to be one of those self-evident things that, if you broke the rules of the day, then you could be held responsible for breaking the rules of the day. DR. ROYAL: Although it doesn't explain what "held responsible" means. MS. KING: I want to make a statement, because I'm not going to participate in the discussion, and the reason I'm not going to participate in the discussion is because I don't think it's fair to the committee for me to tamper with writing, if you have hopes that I won't dissent from this finding, because I plan to do exactly that, and I don't want to compromise dissenting from the finding with efforts to try to make it better, because I don't think it can be made better from my perspective. CHAIRPERSON FADEN: Okay. So you -- MS. KING: I mean, I will be happy to say something, but the reason I'm not talking is because I don't want to be misleading. I have had that happen to me where people participated in a discussion to try to make it better, and then end up saying, well, I still don't like it. So now that I have weakened your finding by participating, I'm now going to dissent. So I don't want to get myself into that spot. CHAIRPERSON FADEN: I'm wondering. We're going to have a discussion about dissents tomorrow afternoon, about how to proceed with them, dissents, personal statements, whatever. I'm wondering if there isn't a way, though, to inform the rest of us about the character of what you want to say so we can all know. MS. KING: I don't want to say anything. That's why I don't think that this is going to work. CHAIRPERSON FADEN: You don't want to comment on this. MS. KING: I don't want to make a retrospective judgment. CHAIRPERSON FADEN: Okay, fine. MS. KING: And so, therefore, it's not a question of making it -- I could look at it and try to be objective and say, for those of you who want to make a retrospective finding, it might be strengthening if you did X, Y or Z. CHAIRPERSON FADEN: But you don't want to make -- MS. KING: Since I don't want to do that, I don't want to get myself in the position of -- or be misleading, because if you want to make a strong statement, it shouldn't be weakened to try to accommodate what I'm interested in. CHAIRPERSON FADEN: So we can all understand, and we will come up with process issues tomorrow, your position will be that you don't want to comment -- you don't want to make judgments on the past, and you are not supporting Finding 9 for that reason. But Finding 9(a) even, because that one, I thought -- MS. KING: I think that I'm going to -- I haven't decided as yet. I don't have any substantive disagreement with 9(a), but I think I would rather put 9(a) in the context of how I would like to explain my views on this entire matter. So I'm still thinking about that. CHAIRPERSON FADEN: Okay. I'll talk to you about it. Henry. DR. ROYAL: One of the problems I'm having with the wording in 9(b) is that 9(b) on line 17 -- It says no prospect of medical benefits to the participants. In 8 it talks about healthy subjects of biomedical research, and then at some points we talk about patient subjects. I don't know whether or not these different terms were used very specifically or whether or not they're being used interchangeably. So, for example, with 9(b) if this meant healthy subjects, that would mean something different to me than if it meant patient subjects. CHAIRPERSON FADEN: Well, I think what it should have is protected the rights and interests of -- on line 17 -- all human subjects in research that offered no prospect of... -- So the notion here is -- The force of 9(a) -- 9(b), excuse me, is that the government agencies did not have effectuated policies to protect the interests and rights of people who were used as subjects in research that offered no prospect of medical benefit to them, and they went some of the way with healthy subjects but ignored altogether people who were patients who were still, nevertheless, the subjects of research that offered no benefit. So it should have had an "all" in there, and then the parenthetical "(and not only healthy subjects)" makes sense. DR. ROYAL: So then this is making the distinction between therapeutic and nontherapeutic research. CHAIRPERSON FADEN: Right. The force of the difference between 9(b) and 9(c) is that in both cases we say -- In 9(a) -- and Phil has raised the use of the word therapeutic research, because he was concerned about research in prevention like vaccine trials and things of that sort that could be thought of as offering a prospect of benefit in some cases, obviously not in all cases. So we'll need to have somewhere a box or whatever that says by that term we mean offers some sort of a medical benefit, that you don't have to be sick and get well but just basically that you could be benefitted medically by this research as opposed to no medical benefit. DR. ROYAL: I feel very uncomfortable about the distinction between medical and -- I'm sorry, between therapeutic and nontherapeutic research. The reason I feel so uncomfortable about it is it's holding nontherapeutic research to a higher standard. CHAIRPERSON FADEN: Only for the past. DR. ROYAL: For the past. The reason I feel uncomfortable about that is in some respects patients who were enrolled for therapeutic research are much more vulnerable, and people are willing to take much greater risk with those individuals because they're sick. So the net risk to people with therapeutic research may, in fact, be much greater than nontherapeutic research. So I feel uncomfortable about singling out -- holding nontherapeutic research to a different standard when, in fact, those people might have been exposed to considerably less net risk than people with therapeutic research. CHAIRPERSON FADEN: The rationale here -- I'm sorry. Go ahead. DR. MACKLIN: I wanted to make a slightly different point about this same section. Should I? Well, I mean, one of it is -- One point is whether or not the use of the term therapeutic and nontherapeutic is felicitous, partly on the ground that it has been much criticized before this committee got started, and Phil's point is very well taken. So even though it's a little more of a cumbersome phrase, we might want to say offering direct benefit to patients or subjects -- well, but I mean, if they're healthy subjects there is no -- CHAIRPERSON FADEN: No, but you could have a healthy person, and the benefit is they are going to be inoculated against -- DR. MACKLIN: That's right. Exactly. Yes, the inoculations. So providing direct benefit -- those are words that we talk about at other points. Those are words that have to do with consent process and the consent form. It just may be a better way to go than continuing to use the distinction therapeutic and nontherapeutic, because it glosses over these problems. I only want to make a plea for recasting that entire convoluted sentence, the one in 9(b). It's a very long sentence from 15 to 19. It goes on and on, and then it has that little clause at the end "and not only healthy subjects." So I found it confusing and convoluting, and you can make the point that clarifies this much better by not tacking on the "and not only healthy subjects." Maybe that's all I'll say for the moment. CHAIRPERSON FADEN: To return to Henry's point, I think we should be clear about what is going on here. This is looking backward, and basically first saying in both cases whether the research offered a prospective medical benefit to subjects or it did not. It is the Committee's judgment, and the language is identical, the first two lines of 9(a) and the first two lines of 9(c) -- It is alleged here that it is the Committee's judgment that the government did not have an effectuated policy that adequately protected the rights and interests of human subjects, whether it was research that offered medical benefit or didn't offer medical benefit. The next line -- The next part of it, though, splits off and says, all right, what are we to make of this in terms of judging the past? Here's where the distinction is introduced, and this is what everybody who wants to sign on here -- or if we're going to have this, we could change it. It goes directly to your discomfort. The argument here is that there was no -- that the context and the culture of the times did not provide anything that would mitigate against the judgment that the people who were responsible did something inappropriate, because as Ruth has put out, the rationale up there says, when it comes to research that doesn't offer a prospect of medical benefit, that there was no context for saying this is the way it should be that is powerful enough that would allow us to say, well, today we would think it was wrong, but we have to make concessions to the practices and values and contexts of the time. The point that you make about patients being the most vulnerable, often the most vulnerable, and being put sometimes at far greater risks than other subjects of research because of views about the desperateness of their condition and the likelihood of what have they got to lose, certainly bears directly on the contemporary situation and even would be true historically of the past; but the argument that's put forward behind 9(c) suggests that, because at the time doctors -- Here, the focus is on the government. We get to the professionals at the moment. At the time doctors were ceded so much authority to make decisions about treatments generally without needing to get express consent from their patients that was meaningful that it would seem odd now to say that there was something -- that the government ought to be blamed for not buying into that deferral to physician authority and regulate more the decisions that physicians made to enroll their subjects in what was an experimental protocol. It's a rationale that, basically, says you have to look to what was going on at the time. We're talking now about government officials and saying the government should have not made a distinction between healthy subjects and other persons when it came to research that offered no prospect of benefit, because as Ruth has articulated, the medical profession had no moral warrant at the time in the context of the social values for making decisions about who could be used among their patients for research from which they could not benefit, but because the culture of the time ceded to physicians so much authority to decide what kinds of treatments patients should get and when and didn't conventionally expect physicians to ask their patients' express consent for all kinds of decisions, including therapeutic decisions, including the kind of testimony that we heard this morning, that we have heard all the time, that fine line between -- You know, in that same decade, the same intervention was given to lots of patients, just off protocol, as a treatment decision by the physician, put them at great risk, but it was not a research project. At the same time, different patients are given that treatment in some sort of organized or quasi-organized research project, and in neither case was express consent obtained. Now it was conventional. So -- DR. GLATSTEIN: In one case the consent wasn't taken. The lady thinks she signed away all her rights. CHAIRPERSON FADEN: That's, you know, the way in which things are presented, and that's also going later. That was in the Sixties. We're talking about the Forties and Fifties. So the view is that there is something uncomfortable, if not unjust, about saying, look, where you got this treatment and it was in the context of a research project, the government should have stepped in and made sure you got your consent, but where you got exactly the same treatment, which was equally unproven, from your physician at the same time, and it was off protocol, and you still didn't get your -- and no consent was obtained, somehow the government -- That's the kind of context that we're dealing with. DR. ROYAL: Let me tell about the specific concern that I have, and maybe you can tell me the implications of this finding. Let's talk about thyroid uptake test. You're going to give someone I-131, and to figure out what the thyroid uptake is. When any new test is introduced, it's necessary to do that new test in people who are sick and in people who are not sick. The concept that somehow in the context of this one experiment where you have both people who are going to directly benefit and people who are going to indirectly -- who are not going to benefit because they are your controls -- I don't -- In the context of the same experiment, the investigator is held blameworthy in one group of patients in its experiment and not blameworthy in the other. CHAIRPERSON FADEN: Now let me stand back. The way this is structured -- DR. ROYAL: That's confusing to me. CHAIRPERSON FADEN: It is confusing. The way this is structured does not speak to what the Committee's views are about what current practices ought to be. It's not saying that now we believe that this distinction has the same moral force. It's only that we're looking at it in terms of trying to do the kind of difficult work that we've been struggling with all along in terms of retrospective moral judgments about the past. Today you would need the consent, arguably, of all patients. DR. ROYAL: Absolutely. CHAIRPERSON FADEN: Right. All subjects, regardless of whether they would benefit or not, plus you would be more careful on informed consent from your patient for a therapeutic maneuver that was off protocol. So the context now is different. So looking back at the past, yes, there would be -- DR. ROYAL: We're making people who did diagnostic tests who had to do those diagnostic tests on normal people in order to figure out what the -- CHAIRPERSON FADEN: Yes, but we're saying -- DR. ROYAL: Then we're saying that they are more blameworthy than people who did therapy. CHAIRPERSON FADEN: Right. DR. ROYAL: But yet you couldn't have gotten any benefit -- No one could have benefitted from that diagnostic test if normal people -- CHAIRPERSON FADEN: Correct, but those normal people did not stand to benefit themselves, short term, from their exposure to radiation, however small, in that development of that new diagnostic therapy. So they were being used, arguably, towards a means that was not their own. DR. THOMAS: I wouldn't find fault with them just for - - only if they didn't do it with proper disclosure. CHAIRPERSON FADEN: Right. Because the argument that Ruth is putting forth -- There's nothing about being a doctor that allows you to use people to develop a new test for which -- using maneuvers from which they could not benefit, because you have this noble purpose of wanting to advance science, which is -- or advance medicine, which is very good and we applaud it, but you don't have any -- You didn't even then have any authority to do that. DR. ROYAL: My difficulty comes in. We've already admitted that the environment back then under 9(c) was that physicians often did not get consent in this medical therapeutic environment, and I'm saying that if that were true in the medical therapeutic side that it was also true in the medical diagnostic side, but yet we don't seem to be making the same accommodation on a medical diagnostic side that we're making on the medical therapeutic side. CHAIRPERSON FADEN: But it's not an accommodation based solely on what was practiced. It's also on the moral arguments that underlie why that practice was defensible at the time or not. So we're not simply saying we're reaching these judgments solely because we looked, and we're going by what the practices were. If the practices were X, then it was okay. We're saying the practices were X, and it was wrong in the case of people who could not benefit -- wrong at the time. Okay? DR. MACKLIN: Look, all you have to do to accept this, Henry, is to recognize that the same type of action can be ethically permissible in some circumstances or conditions and ethically unacceptable under certain circumstances and conditions. Surely, you can accept that principle. That is, what you're saying is, here, they're doing exactly the same thing to two classes of people, and how can you say they're wrong -- that they have to be held responsible in the one case and not in the other, and the responsibility is for the failure to get consent. Well, I mean, that's one of the things about making moral judgments. The circumstances, the constraints and the conditions can make the same action or type of action right in some circumstances and wrong in other circumstances. Here, the relevant circumstance is whether you were a patient or a person who might stand to benefit from a maneuver, whether it's a vaccination, a diagnostic maneuver or a therapeutic intervention. In those cases, the standards of the time and the conventions of the time were such that it was a doctor/patient relationship. The doctor saw himself or herself as helping the patient, and the precepts of the doctor/patient relationship could allow that, did allow it then, even though we don't accept it now without consent; but as soon as you have someone on whom exactly these same maneuvers are being done and it will not be for the direct benefit of that person, either prospectively, either therapeutically or diagnostically, then you don't have the features of the doctor/patient relationship. So that's the basis for saying the physician can be held responsible for the one set and not for the other, even though it's exactly the same type of action. DR. ROYAL: It seems to me that the issue is whether consent is obtained or not. If consent wasn't obtained, that should be a problem, and you're willing to mitigate the problem in one circumstance and not willing to mitigate it in another circumstance. CHAIRPERSON FADEN: In that historical context. DR. ROYAL: Yes. In the -- The mitigating fact is, in my mind, number one, the risks were very small, and number two, the benefit to patients would not have been possible without obtaining some normal values. DR. LEDERER: I think both those rationales were offered at the time. That would have been a way to construe using patients, say, in diagnostic tests, not for their benefit but consonant with the Hippocratic tradition, because you weren't harming them. You were concerned about their benefit in some global sense, but you knew that administering this minute level of isotope was not going to harm them, and it was going to provide useful information. I think that rationale would have been in place at the time. CHAIRPERSON FADEN: And from that, you conclude what, Sue? DR. LEDERER: Conclude that -- I guess I would conclude that I'd like Ruth to sort of refine her invoking the Hippocratic tradition language, because in that sense I think that rationale doesn't go -- The rationale that you offered to strengthen this, I think, doesn't go to making this argument as good as it could be. DR. MACKLIN: Well, I certainly didn't use the expression "do no harm," which I find extremely unuseful in every context. So when I referred to the Hippocratic tradition, i was speaking more broadly, and you can -- Jay is not here, could supply the right words for that. Now if you say "do no harm," and the physician truly believes, has good evidence that this little bit of stuff that he's putting into the patient would do no harm, it might fit that part of the Hippocratic tradition, but how about the other part, the fact that it's going to provide benefit to others? It's not part of the Hippocratic tradition. The benefit, if it's benefit, to medical science and other patients or other future people, other suffers, whatever, is not part of the Hippocratic tradition in which what the doctor does in invading the body of the patient is do something to help that person. Now we need -- If we need to find words from Hippocrates or some other words, that's what I have in mind, and I wouldn't use the "do no harm," because it puts too much emphasis on, well, we're only doing this little thing. You know, that's a little weasel worded. I'm not saying you are, because you can always justify doing some teeny little thing that's not going to do some harm, but with absolutely no prospect of benefit for that individual. DR. LEDERER; I think it depends on whether we're under -- what our understanding is of this Hippocratic tradition and what their construction of the Hippocratic tradition was in the 1950s. I think -- It had many of the problems that you just pointed to, that they believed it was not going to harm. The evidentiary base was often poor, if not wholly erroneous, but it allowed them to operate in ways that they thought, they believed that they were operating ethically and within a broadly defined Hippocratic tradition. DR. MACKLIN: would that go for the plutonium experiments? I mean, Henry is giving us this nice set of examples in which there's very little prospect of harm, and the benefit to others which could be demonstrable for plutonium. The argument you just gave could be used to justify the plutonium injections. DR. LEDERER: Well, but that's not the argument I understand that they offered for it, that they were invoking therapeutic benefit as a -- No? No? CHAIRPERSON FADEN: Never. DR. MACKLIN: But they did say they didn't think it would be any harm, and they were looking for occupational health and safety benefit in a global sense. CHAIRPERSON FADEN: Here's the structure. The structure is this. The way the recommendation is set out, it says today we would think it was wrong to have any of these research projects proceed without consent, therapy, no therapy. It doesn't matter. Today we're in agreement, it was wrong that the government didn't have a structure in place that would have monitored and made unlikely that these events occurred. So we're all agreed to that. What we're struggling with is whether we want to say that anybody in the past -- This is the old chestnut -- whether anybody in the past, in this case government officials and biomedical professionals, should be held in any way blameworthy for the fact that the way it was then isn't the way we would like it to be today or the way today we believe it should be. This is an attempt to make a distinction between the extent to which we are -- we believe that the people of the past ought to be blamed for the way it turned out. We're saying where there was an intent to benefit the person who was the subject of the research, we blame people less. Where there was no intent to benefit the people who were the subjects, we blame them more for not doing today we think is the right thing. It's that simple. Now the stating of it is simple. Whether that's, in fact, the position you want to endorse is more complicated; but that's basically the structure here. In general, we're saying by today's standards it's wrong that they didn't have effective policy, that it's wrong that people did research without consent, on anybody. DR. ROYAL: One of the concerns that Ruth mentioned was about minimum harm, that that's a very easy thing to say or no harm or whatever, but it's also a very easy thing to say that there was the possibility of benefit. This distinction that we're making between whether there was a little bit of benefit or no benefit -- It seems very arbitrary and mush. I would either rather have us blame everyone or make -- admit that the culture of the time was that you needed to get normal values when you did this test, and just as it was the culture of the time that you did what was best for the patient. I guess I just don't understand why we're willing to forgive not getting consent in one instance and not in another. CHAIRPERSON FADEN: I think what you said has bothered me a lot, too, which is the line is not always clear, and there's an awful lot, in fact, in the oral histories. We hear an awful lot of the language of rationalization. We rationalized this, said, well, gee, you know, just touching somebody can sometimes have an effect that's positive, the Hawthorne effect or whatever. It's gotten very powerful in that particular area. So we told ourselves that even though we sort of knew it couldn't possibly benefit the patient, it would be uncomfortable and so on and we wanted to do this, you know -- this work, we thought, well, you know, they will feel attended to and cared for and blah-blah-blah. So we know that this is a problematic distinction. We know it's a problematic distinction today. It's possible that -- You know, another formulation that I've played with is one that says that, to the extent that the intent of the research was to benefit the person who was the subject as well as to advance science, there is -- we would blame the people less. To the extent that that motivation and that intent was not present, we blame them more. DR. ROYAL: As opposed to making it a black and white issue. CHAIRPERSON FADEN: Right, as opposed to making it black and white, another way to set it up. Now that has problems from the perspective of government, the way you set up the claim for judging what the government ought to have done. You say, where it's clearer that there was no prospect of benefit, the government should have had more effective -- you know, clearer policies, we blame them for not having the policies. Where it was at the other extreme, we blame them less for not having the policies, but the view -- In fitting with this general rationale which was that at the time -- and people will criticize us if we go with this view. I mean, we heard this morning testimony that says it doesn't matter, we shouldn't -- Even if that was the value of the time, we should cede nothing to the fact that it was wrong to do research on patients, even if the intent really was to benefit that patient, without the patient's consent, even if -- For that to be coherent, I think you would also have to say, and it was wrong when patients were treated without their consent during that same time with the same intervention off protocol. One formulation would be to make it more of a sliding scale. To the extent that there was no intent to benefit the person, we blame people more. To the extent that there was a forceful intent, as I think intent is important here, intent to help the person by involving them in the research, we blame them less for not getting consent. Ruth? DR. MACKLIN: It would probably make it too complicated to introduce in these findings, but all along, and certainly in the discussion on retrospective judgments, we distinguished between judging actions to be wrong and blaming the agents who performed them. This seems to be exactly what we're talking about here. That is, the actions of using people without their knowledge and consent for things that could not benefit them, and even might only put a little bit of harm. It's using people as a means to an end, and that kind of action is wrong. Doctors were relying on their power more than on their ceded authority, moral authority to do that. Whether we want to blame people for doing those things -- and that was the distinction -- We have made distinctions all along between the action and the agent and the government and the doctors. We have to see what these paragraphs are saying. I mean, the government in 9(c) did not have an effectuated policy that adequately protected the rights and interests, et cetera. Maybe we want to make in 9(c) -- I'm asking this as a question to try to deal with this -- a distinction. Here it says government officials -- This is line 15 and 16. The committee finds that the values of the time -- it should be militate against or mitigate the claim -- that government officials and biomedical professionals are blameworthy for not having had protections and practices. So maybe we want to distinguish between the government officials or the government and the actions of the biomedical professionals. I mean, it just might be a way of saying that we're not going to hold responsible individuals because they were so steeped in the culture of the time they couldn't see otherwise or couldn't do otherwise. DR. STEVENSON: But the government was responsible. Is that what you're saying? DR. MACKLIN: Yes, because the actions were wrong. If the actions were wrong, they were wrong by today's standards, and I guess the question is, if we say should have had -- CHAIRPERSON FADEN: We mean that they were wrong at the time as well. That's what this says. DR. STEVENSON: But I don't see how one -- If the medical profession was blinded by whatever -- for whatever reason, then why would individuals in the government be more enlightened? It's not clear to me the logic -- CHAIRPERSON FADEN: Well, I agree with you, actually, and I think when you listen to the oral histories -- and I guess maybe Sue and I are taking a different take there, and even a little bit that Sue and others have educated us about sort of popular response. Also I am very much affected by how the AEC responded to the plutonium experiments. I think there was a view that, if it was widely known out there that we were doing stuff to people with no intent to benefit them, that would not be well received by the wider community. As a consequence, there was this sort of "phumphing" around it. There was a lot of rationalizing and hemming and hawing. By contrast, I think that there was this view that, if you were doing it to benefit the patient, if your intervention was really intended to benefit the patient, nobody was going to get upset with you in 1947 that you didn't do an informed consent process and lay out the options and the benefits. You went to the doctor, and the doctor said you need this treatment, and that was the way it was done, and no patients would have been offended and the public wasn't to have been offended by the discovery that that was how medicine was practiced. Whereas, if it had come out that people were being catheterized -- dying patients were being catheterized to advance medical science with no prospect of benefitting them without asking their permission, it's likely that the reaction from the public and the general community would have been different. What do you mean, you're doing this, much as there was the concern that if it gets out that we did these plutonium -- that we injected these people with plutonium, we're going to have a public relations problem. Why? Because the public generally wouldn't have found this within the range of acceptable behavior by physicians. DR. ROYAL: One of the reasons why I'm troubled with this distinction is it perpetuates the myth that most biomedical research -- that the intent of it is to directly benefit patients. I think that that's a myth that we need to put to rest. The main reason why subjects should agree to participate in biomedical research is not because they expect to benefit from biomedical research. I read Jay's statement, and I thought one of the most meaningful paragraphs to me in that statement was the fact that we don't acknowledge to people who are participating in biomedical research what a wonderful gift that they are making to society. So this whole thing about that there's this class of research that benefits -- directly benefits people, and there's this other class that doesn't is -- I don't like that distinction at all. CHAIRPERSON FADEN: I think what we should do -- I mean, that's a very important point that you make, and it's very powerful, and we have to think about the implications of how we want to look back at this. DR. ROYAL: The other thing that bothers me is, if we make this moral distinction based on benefit, it just encourages people to promise benefits that don't really exist. DR. STEVENSON: Which is a major problem in our contemporary -- CHAIRPERSON FADEN: Well, that is, but that's why -- Whatever we say, we have -- If we make any concessions -- Let me interrupt myself. If we make any concessions grounded in the historical context, the value structure of the historical context, we have to be very plain about saying that our concessions are in that historical context and are not intended or meant to transfer into the present and the future. So this is risky territory, because unless we make it very, very, very plain, we do open ourselves to misinterpretation and to sending exactly the message we don't want to send to the research community and to the public generally. I think we should do this. I think we should take a break for lunch. This is the toughest -- I'm sorry, Pat. MS. KING: I guess I can't keep quiet, my husband would say. CHAIRPERSON FADEN: This is a valuable. MS. KING: He would say that that is indeed my problem, because I always have to inject my views, but it has struck me sitting listening to the discussion about this finding to at least raise the following question and to put it on the table. One is whether -- why does this have to be the subject of a finding as opposed to a carefully explicated chapter, which is what we have, and we'll do better, and what does it have to set up? The reason I raise this question is I don't think there's disagreement or this same kind of disagreement about recommendations. I think that the disagreement is how you get to recommendations, and putting it in a finding is to make the disagreement explicit. In my case, it requires a dissent; whereas, if you have it discussed in a chapter, which is what other commissions have done in the past -- Nothing rides on -- If you can't make a strong case for having the supported recommendation, why can't you do the explanation and explication that we have been -- I have been listening to in the context of that chapter, but I don't know how it will set up. I don't know what you have riding on this finding that you think is critical that you have to set up a finding. One of the problems, it seems to me, in a structured report where you have findings is that you run into this problem that where people are in agreement on recommendations, they aren't necessarily in agreement on findings once you depart from descriptions. CHAIRPERSON FADEN: Well, this is an interesting suggestion. I have to sit back and look at the recommendations and do my homework during lunch. Ruth? DR. MACKLIN: That seems to me -- If it's the marginal cases that we're concerned about, and some of the examples that Henry is giving, that's a good rationale for taking it out of the findings; but I think it weakens the prospect of saying that those who did the plutonium injections were culpable, and I wouldn't want to take it out of a finding that would not make that explicit. That is, to withdraw it is then to remove almost entirely the notion that blame can be assigned for actions at that time, because it's putting in a chapter and it's describing it. So I'm going to argue for keeping it in here, because -- CHAIRPERSON FADEN: In some form. DR. MACKLIN; Yes, in some form, precisely because I think we have the paradigms of cases in which the government and the individuals who carried out those actions were culpable. If we have gray areas, that's what -- I mean, you can't make these sharp lines without having to address the problem of drawing a line somewhere or other, but if you wipe out the retrospective judgment on the grounds that there are some gray areas, then I think you weaken and eviscerate the contention that some things that were done were wrong, and people can be blamed for them. MS. KING: But to return to an earlier point that Ruth made about ethical acts -- an act can be ethical in some circumstances and unethical in others. It seems to me that if we want to make a statement and be sure we cover plutonium experiment type incidents, the better route to go where one would not get disagreement is to describe why you would make a retroactive judgment about plutonium experiments, not a broad, general finding could cover an entire period, for the reasons I stated before. I understand what you are saying. It's sort of like you have to be either/or, and you can't be a little bit pregnant. Either you make a retrospective judgment and you pick up everybody or you don't make one and some people that we would agree should be blamed get -- that there will be total agreement that they should be blamed would get off. I think that the way is not to go in either direction, but to pull out those instances where there's agreement that there ought to be blameworthiness, and describe why. CHAIRPERSON FADEN: The awkwardness is that in pulling out one experiment that we reviewed, and we have to then go through all the others, I think, or otherwise it's kind of conspicuous. MS. KING: It's fairness. CHAIRPERSON FADEN: Yes. It's kind of a conspicuous problem. We would then have to -- MS. KING: That's the only one that we keep repeating. CHAIRPERSON FADEN: We had to either, by implication, say that in these other cases we see the actors as less blameworthy or whatever. I'm just worried about it. Maybe we don't, but I would be concerned that there would then be, well, you've come in on this one; that's one of your seven or eight case studies; what's the committee's judgment about blameworthiness in the other seven or eight? That would be reasonable. In some cases, we also reached judgment in there as well. I think we need to break for lunch. This is hard work, and we need to be restored. We are supposed to return at 1:15. I think, if we could keep to that, that would be very helpful, because we have so much to do. Hopefully, the restaurant will cooperate. Ask them for stuff that comes quickly, regardless of what you like to eat. (Whereupon, the Committee recessed for lunch at 12:15 p.m.) A F T E R N O O N S E S S I O N (1:32 P.M.) CHAIRPERSON FADEN: I want to share my panic with everybody. I need to have it diffused for the entire Committee. We are now all of about 15 minutes behind schedule, which in and of itself is not a problem, except that according to the schedule, we really only have about another 45 minutes to finish findings for the historical period. I did say earlier that we can move things around and so on, but the concern that I am having is that I think everything on the agenda is going to take more time than has been allotted, and everything on the agenda has to be addressed in the course of this meeting. We have no slippage. So I don't know how to do this except to have people please do some triaging with respect to their comments and make sure that you definitely bring up the issues that you think are really disturbing or important or critical and use a little restraint when it comes to comments that you think could be handled by E-mail, faxes and things of that sort. So it's got to be restricted now to comments that -- I have forgotten the various formulations -- rise to the level of a big deal. Okay? So we're into rising to a level of a big deal. Now where we are is that over lunch I, in talking a little bit with Henry and a little bit with Ruth, sat with Jonathan and Val and tried to come up with a reformulation of the finding that we were having so much discussion of, which is finding 9. Val is somewhere trying to magically make new language appear. I would like us to address it while it is still fresh in our mind, but let's put it away until we see this in language which is trying to take account of some of the issues that emerged. There were, however, in addition to finding 9, three other findings that when I went around the room, people indicated they wanted to have discussion of them. Minor comment ones may not make it. We can save them for the end of the meeting or if you want to change your mind. But those are findings 10(b), 12, and 14. So if we could move to finding 10(b) again. I apologize for not recording who it was that indicated that they wished to speak to finding 10(b), but Pat. MS. KING: I was one of those people who raised a comment about 10. That I think we should not mix biomedical experiments with these observational studies in one recommendation. CHAIRPERSON FADEN: Okay. MS. KING: That they should be separated out. CHAIRPERSON FADEN: So the proposal is that 10(b) be a separate independent finding. MS. KING: Right. CHAIRPERSON FADEN: That's fine with me. MS. KING: But it goes again to the definition of human radiation experiments. CHAIRPERSON FADEN: Yes. Yes. That is correct. Henry, on this point or on this finding? DR. ROYAL: It's on this finding. CHAIRPERSON FADEN: Okay. Can I just see, is anyone objecting to Pat's suggestion? DR. ROYAL: I think it is a good suggestion. CHAIRPERSON FADEN: Fine. So that will happen. This will be made a separate -- 10(b) will be made its own finding with its own heading. Henry. DR. ROYAL: On 10(a) it says that on lines 13 and 14 it says that we're talking about human radiation experiments in which doses in the range causing acute radiation effects. Then in line 18 it talks about gallium. The thing that is confusing to me is I thought the death in the gallium injection was due to the chemical toxicity as opposed to the radiation effects. I wanted to seek some clarification. CHAIRPERSON FADEN: I do not know the answer. DR. ROYAL: So if that is true, I mean, the finding sort of says that there are several experiments causing acute radiation effects. CHAIRPERSON FADEN: I am not sure that is the best phrase, either. I mean what we are trying to communicate is that we found several experiments in which the doses were what, high enough to -- DR. ROYAL: I think that those words are okay. CHAIRPERSON FADEN: Okay. DR. ROYAL: Ruth, on that point there's a gray area between those where the doses are high enough to cause acute radiation effects, and those where there is potential to cause long term harm which we should also acknowledge. CHAIRPERSON FADEN: Okay. So is it correct to say that the Committee did identify however several human radiation experiments in which doses were in the range capable of causing acute radiation effects or the possibility of long-term? Okay, that's fine. Dan. DR. THOMAS: To be precise, it should be something rather like a substantial increase in long-term risk. CHAIRPERSON FADEN: Substantial -- DR. THOMAS: Because we have already recognized in the previous sentence. Even the tracer experiments have the potential to cause long-term harm, but the potential is negligible. DR. STEVENSON: Sorry for butting in, but significant risk, since we're using that later on our recommendations. CHAIRPERSON FADEN: We want to communicate that some were on a level where the likelihood of there being long-term consequence was higher, significant, whatever. DR. STEVENSON: So significant was for perhaps acute and long-term side effects. DR. ROYAL: I'm having trouble with the adjectives because the adjectives mean so many different things to so many different people. CHAIRPERSON FADEN: All right. Can I do this? We will come up with a phrase. DR. ROYAL: I like the concept of using, including long-term risk, but whether it is appropriate that the adjective should be significant. CHAIRPERSON FADEN: Fine. DR. THOMAS: Significant sounds like statistically significant. CHAIRPERSON FADEN: All right. We will work on the language circulated. The intent is to add a clause that indicates that these experiments, the doses were in a range that the prospect of long-term risk was something. Okay. I'm going to push along. I wanted to get, if we can closure on Henry's point. Is yours on Henry's point or is it a different one? This was the gallium issue and whether the toxicity. DR. THOMAS: Mine is back to 10(b). CHAIRPERSON FADEN: Before we get to 10(b), on 10(a), now that they are going to be separate findings, let's wrap up 10(a) and then go to 10(b). Is that all right, Duncan? DR. THOMAS: That's fine. CHAIRPERSON FADEN: Dan, while you were out of the room, Henry raised the issue of whether the deaths in the gallium experiments were not as a result of chemical toxicity, technically not the radiation itself, in which case it is a little incoherent. MR. GUTTMAN: That's a good question. We'll show Henry the materials and take a look at it. CHAIRPERSON FADEN: We will work on the text to make sure that it fits. All right, if that's all right, 10(a) will be revised. We have now 10(b) on the table. Duncan. DR. THOMAS: The only point about 10(b) was page 11, lines 3 and 4. The issue is not that the uranium miners remained at significant risk, but that they continued to be exposed at high levels. CHAIRPERSON FADEN: Okay. DR. THOMAS: The atomic bomb survivors were at continued risk after the bombing, but that's not the issue. CHAIRPERSON FADEN: All right. The miners continued to be exposed at high levels instead of remained at significant risk. You're right. That is what it is we need to draw attention to. Yes, Henry. DR. ROYAL: I think there's an important word missing from the finding. It is also missing from the chapter on the Marshallese. That's the word accidently. There's a big difference between the uranium miners and the Marshall Islanders in terms of their radiation. One was a deliberate exposure and the other one was an accidental exposure. CHAIRPERSON FADEN: We will make sure that that difference is reflected in the finding. DR. OLEINICK: And also in that same finding, the most severe exposures we're saying are not in the biomedical experiments. I think we're talking in the range of the TBI experiments, aren't we? So I'm not sure. I think that maybe needs, with the exception of the TBI or something to that effect. CHAIRPERSON FADEN: Okay. DR. ROYAL: The TBIs are the only ones that I can think of off hand that had acute radiation effects. MR. GUTTMAN: But that's with people who were not patients. CHAIRPERSON FADEN: That's the clause in here. Notice it says the most severe exposures to people who were not patients. That is what that is supposed to take account of. Thank you, Dan. I forgot that's -- on line 1 of page 11, that you really need to read the whole first line of 10(b), the first line of 10(b). That's why it is there, so that it's differentiated from. Thank you, Dan, I forget we did that. All right. If that's it for 10(b), can we go to finding 12. Jay, let me explain what is happening. Earlier today when we went through the findings, I just called off one after the other and asked people to identify those that they wished to have substantive discussion on. So what I am doing is just following that list. So that's 10(b). So now we're up to 12. Yes, Ruth. DR. MACKLIN: I'm sorry. I just have to go back because the mention in 10(a), the only types of experiments that are mentioned refers to the great majority, were radioisotopes in trace doses. The point about the Cincinnati experiments, that it's excluded by the language of line one on page 11, raises the question where is it mentioned. CHAIRPERSON FADEN: It is mentioned in the next line. It's 13 and 14 and then in the text. The Advisory Committee did identify, however, several human radiation experiments in which doses were in the range capable of causing -- and then the text refers specifically to total body radiation experiments, as an example of those that were in the range capable. DR. ROYAL: Are there any other examples? If not, shouldn't that sentence say however, total body experiments. MR. GUTTMAN: The problem with that is we presume there were other external -- you know, cancer therapy experiments. We didn't study them in depth. That is the difficulty with that. I would assume that it would be high doses from what you have all told me. DR. ROYAL: It might be worth -- I'd like to see an example of what you have in mind. I think what you say is true, the more I think about it. MR. GUTTMAN: It seems intuitively obvious. We've gotten into that. CHAIRPERSON FADEN: It's just that we don't know, but we guess that there must have been some other cancer therapy studies in which obviously therapeutic doses of radiation were administered in a research context other than TBI. We just didn't have them in our study. DR. MACKLIN: But that doesn't preclude mentioning the TBI. CHAIRPERSON FADEN: No, that's why it's there in the text that follows. No, you're right. It doesn't. But that's the only one we studied, but we're presuming there were other ones. DR. THOMAS: It just occurs to me that to flush out the finding about long-term risk, it might be worth having one more example. The example which comes to mind I guess would be one of the children's experiments involving high thyroid cancer risk, relatively high, less than one in 100. CHAIRPERSON FADEN: We'll consider adding a children example, but we'll circulate that around and see if it works, to illustrate the long-term risk. Whereas TBI is intended to illustrate the acute. Okay. If we can then go on to 12. Again, I don't know who asked that 12 be -- DR. ROYAL: One of the things that I didn't care for about 12 was it doesn't communicate risk very well. MR. GUTTMAN: Thirteen is the risk one. DR. ROYAL: Risk, okay. Well, that's why 12 doesn't do it then. DR. GLATSTEIN: If that's the worst thing that happens, it's a good day. DR. MACKLIN: I have a question. I mean the way this finding reads, everything is in bold as the finding. Nothing is in the explanation. Why doesn't the finding end on the top of page 12 with controlled? I mean that's the finding. Everything that follows looks like the stuff that is in the paragraphs following the finding. CHAIRPERSON FADEN: Quite correct. I think that's right. Easily done. The reason, by the way, was that we were trying to speak to the entire historical period of 1944-74, and the laws kept changing. DR. MACKLIN: But it begins to look less like a finding and like the entire history. CHAIRPERSON FADEN: Got it. That's fine. Okay. If there is no more on 12, then the other one that was suggested for discussion was 14, for substantial discussion. Ruth, please. DR. MACKLIN: Let me just state, this is a global comment which I sent in. That is, it's too long and too diverse. I think it should be split into more than one finding. Beyond that, not every item under 14, I mean, they are subheadings under the public trust, or they are related to the public trust, but not every one is. I mean some focus on -- some of the items and the things discussed focus on trust, some on secrecy and openness, which is of course related to trust but can be viewed as separate from. Others have to do with hazards and failure to disclose them. It's a very mixed bag. It seems to me it loses the notion of a finding there and either there should be specific findings in those areas or a number of different headings to incorporate what is under there. I'm sorry I'm not being very helpful specifically, but this was my sense in reading on and on. It is the longest and the most diverse. CHAIRPERSON FADEN: And the one you are going to stop reading because it -- yes. Pat. MS. KING: I agree with Ruth. I think this goes again to the question I asked before, what is a finding. I don't think that this is a finding in the way that the others are findings. I think this is our punchline, our major bottom line that pulls together all the recommendations and all of that kind of stuff. I think it should not be a finding. I think that it should infuse the whole report. This is the way the executive summary should be starting, about what we come up with. Big news is that the public trust has been put at issue. I have problems dealing with it. But I also agree with Ruth that there are apples and oranges here. That in itself, if you must have a finding, we need to clarify these apples and oranges, and we need to be clear about why we are putting them in. CHAIRPERSON FADEN: All right. So I am hearing two related suggestions. One is -- I'm sorry, Ruth, did you want to follow up on that? DR. MACKLIN: I just wanted to add in light of what Pat says, it becomes clear. One of them is certainly secrecy. I mean secrecy followed by or perhaps secrecy with the gloss, secrecy for public relations purposes. That's a finding. CHAIRPERSON FADEN: There should be a finding about secrecy. MS. KING: And that should be with the openness. Aren't we doing different kinds of findings for openness? CHAIRPERSON FADEN: No. We're doing different recommendations. But these are our findings for the historical period 1944-74. So what we do is have one finding about what we found out about what was kept secret. That is a descriptive finding. Pat has raised the issue of whether this punch line, this conclusion -- MS. KING: I take it back what I said before. If there is not another section where you have divided this up which goes to secrecy, if you are going to have a whole chapter on secrecy and recommendations on secrecy, you certainly need some findings on secrecy and openness. DR. MACKLIN: But the trust is the conclusion. CHAIRPERSON FADEN: So Ruth, I'm hearing Ruth and Pat agree that the bolded statement does not have to be a bolded statement here. It's much the same sort of argument as the conclusion about human subject research, the status and the protections. But what we need are findings under perhaps one or two headings. One on secrecy, one on openness, or maybe they can be combined and not this many. Not this long a list. DR. MACKLIN: Destruction of records is another category. I think it's about destruction of records. DR. LEDERER: I think there should be something about records, particularly because we have so many -- CHAIRPERSON FADEN: I'm sorry, Sue, I missed the first point. DR. LEDERER: We should have something about records as a separate finding because we have a number of recommendations that go to record keeping and record access. CHAIRPERSON FADEN: So we have findings about the state of records. DR. LEDERER: Yes. CHAIRPERSON FADEN: Okay. That's great. MR. GUTTMAN: That's the question. The two obvious categories is one, the records, and the secrecy. Is there something that is like an affirmative obligation to discuss with the public. Part of what comes out is that people had a sense that the public didn't understand. What are the big categories besides secrecy and recordkeeping that are in the trust ballpark? MS. KING: The other category, but I assume you'd put it in the secrecy and didn't want to pull it out, are what we call the national security concerns, which is what we mentioned this morning. About the policies not having a caveat. We put that off for another place. CHAIRPERSON FADEN: It's going to be a separate finding. MS. KING: This is where it is appropriate, because it is secrecy/national security records. CHAIRPERSON FADEN: Right. So there's findings about secrecy, openness and national security. Findings about the state of the Government's records. But I don't know that there's -- you are talking about a finding that would speak to what? MR. GUTTMAN: I guess my question is very simple. If you look at the whatever number of things are lumped together here, what are the operative categories that they fall under? CHAIRPERSON FADEN: Well, we have come up with two. DR. MACKLIN: One is secrecy. One is records. MR. GUTTMAN: That's my question. Is there any other? DR. MACKLIN: Well, there's a third. I mean, failure to disclose and inform need not be secrecy because secrecy is hiding and lying. I mean for example, the one that's on page 14 between line 11 an 16, they denied to the press and citizens. I mean that's lying. That's hiding things. CHAIRPERSON FADEN: That's secrecy. DR. MACKLIN: That's secrecy and hiding things. MR. GUTTMAN: Deception. DR. MACKLIN: Yes. Those are all good terms. But that is under the secrecy one. Then the failure to disclose or to inform in the case of the uranium miners, that's one example. I'm just looking at the top of 15, the potential hazards for collective benefit. CHAIRPERSON FADEN: There are several of these bullets that speak to the government didn't keep the kind of records that people wanted them to keep, which is different -- didn't even create the records, I'm sorry. They didn't create, collect data about exposures, which is separate from the issue of collecting the data, creating the records and then losing them or destroying them. It's the issue of they never bothered to collect the information in the first place. There they kind of stand out as something different from the issue of failure to disclose. It is neither secrecy nor is it the state of the records. It's they didn't do the follow-up. DR. MACKLIN: The top of page 14, I guess. The intentional releases. I mean the initial Green Run falls under one category. But the second example, 250 intentional releases near the land of the Pueblo Indians, the Pueblo do not appear to have been informed of the full scope of the program until 1994. Now that is failure to inform and disclose, which is not the same as what is in the next paragraph, denied to the press and citizens. CHAIRPERSON FADEN: Okay. So we want to break those apart. What I am hearing is we want to break these apart into something like now three categories. Secrecy and national security, the state of the nation's records and findings with respect to disclosure. MS. KING: The last one is very tough because if you are asking people -- it is factually accurate that they failed to disclose. So that's no problem with a finding. But what the finding is doing is a problem because if the idea is that the findings are supporting something else. Then it seems to go to something that we're going to say in the recommendations. Otherwise, we would say a lot of this in the chapters out of which all this was derived. I am not aware that we have yet had a full committee sort of exploration of what we think of as an obligation to disclose, to affirmatively disclose, as opposed to deny. CHAIRPERSON FADEN: Okay. Why don't we see the future of that when we go to the recommendations, and see if in fact, to use the point that you keep raising, we need to be commenting on this as a finding. MS. KING: I'm not sure I'm comfortable with affirmative obligations to disclose, without a careful explication of what we mean. It's hard to keep up with all the paper, but I haven't seen one yet. DR. THOMAS: Pat, I propose to bring this up tomorrow afternoon when we do our -- and there's a document which we'll be circulating later in the afternoon. CHAIRPERSON FADEN: Here's where we are, again. We have commented on all the ones that were in our go-around were identified as requiring major comment. With the public trust one, it's clear this is going to be reworked. We will not have this reworked in time for committee deliberation. It will have to be done by fax and E-mail and so on. But we'll get the core of it down. I don't know what to do with this last issue of whether the findings that bear on failure to disclose remain in or remain out. But certainly as descriptive findings can be presented, they are accounts that we now believe to be correct about the state of affairs. We have the language to go back to finding 9. If we can try to see whether we can reach some sort of agreement, if this helps at all. This is what got hammered out at lunch time. Why don't we take a minute to read it. This didn't get quite right. Can I just introduce what's missing? It's just a little bit. In the second paragraph and in the third paragraph, it says by contrast to the extent that research was intended to offer a prospect of direct benefit to subjects, this militates against the claim. Then language picks up from the original draft, the government officials and biomedical professionals are blame-worthy for not having had such protections and practices. So basically what belongs in there, against the claim does not complete the sentence, is line 15 and 16 of page 9. If you can find, we are on finding 9, Jay. DR. KATZ: I see it. CHAIRPERSON FADEN: 9(b). This is a proposal that came out of discussion before lunch. That 9(b) and 9(c) be combined. This is just the recommendation itself, without the supportive argument. And replaced with this language. But what is missing is that on the second and third paragraph that ends in the word claim, it ought to continue with the rest of the sentence on lines 15 and 16 of page 9 of the original text. DR. KATZ: What is it the text should read, the word effect? CHAIRPERSON FADEN: Carried out. MR. GUTTMAN: Put into effect. CHAIRPERSON FADEN: Put into effect. Thank you. MR. GUTTMAN: Ruth Macklin suggested why use three words when you can use one? DR. KATZ: Does it mean promulgate or does it mean more than promulgate? CHAIRPERSON FADEN: It's more than merely promulgate. DR. MACKLIN: Encourages. DR. KATZ: Promulgate is not encouraging. Promulgate is sort of, I use it as sort of the official, like the federal regulations are promulgations. If it means that, it's different from overseeing. CHAIRPERSON FADEN: It includes that, but not only that. DR. MACKLIN: It's implemented, disseminating and implementing and enforcing. CHAIRPERSON FADEN: Promulgating, disseminating and implementing and enforcing. It is all of those things. DR. KATZ: Then I have some problems with that statement, because I don't think by today's standards if it encompasses all that, that I feel that these are only today's standards, but that -- CHAIRPERSON FADEN: The issue is, Jay, if that's the case today, it's wrong today. In other words, if today we don't have an effectuated policy, that's wrong today too. DR. KATZ: Oh. Okay. That's all right. CHAIRPERSON FADEN: If that's the case today, today we conclude that the government still doesn't have an effectuated policy that does all of these things, that it is wrong today. I mean, our standard is that the government should have this. Okay? That's our standard today. Whether they do or they don't is a disputable empirical issue, which we'll come to tomorrow. Right? But today, the issue, we think that the Government should have such an effectuated policy and we are saying that by today's standards, if that is the standard, looking back they did not have it then. Tomorrow, we will discuss whether they have it now. Henry. DR. ROYAL: I'm just a little bit confused about 15 and 16. You said that 15 and 16 were going to be added in at the end of the second paragraph? CHAIRPERSON FADEN: And the third one. In other words, just with the word claim, shouldn't end there. It's just to fill out the thought. DR. ROYAL: So both of them will have it, 15 and 16. CHAIRPERSON FADEN: They are parallel. They are as parallel as we could get them. It's just we didn't finish out the thought. MS. KING: I take it that the verb tenses in paragraph 2 are deliberately constructed. CHAIRPERSON FADEN: I have to be careful there, Pat. MS. KING: I mean, I would take that as referring to the past. CHAIRPERSON FADEN: Yes. MS. KING: Thank you. That's all I need to know. CHAIRPERSON FADEN: Yes. This is referring to the past. Ruth. DR. MACKLIN: I take it you are asking for our endorsement of the -- CHAIRPERSON FADEN: Is this better than the last one, and is it okay? DR. MACKLIN: Well, it introduces new ideas. It's got a scale of blameworthiness -- CHAIRPERSON FADEN: As opposed to a yes or no. DR. MACKLIN: A scale higher and lower or lesser or greater. I go along with that. I think that's okay. I think we need to work on the wording. For example, in the second paragraph that says Government officials and investigators should be held more blameworthy for not having had such protections. Then there's a period. So one always is more blameworthy than not. Then in the next sentence, we know it's going by contrast. Then it says this militates against the claim. But what you need is the contrast. More blameable or more blameworthy, less blameworthy. Were blameworthy where there's no prospect for -- less where there is. We can, I think, take the wording from the former one and put it into -- CHAIRPERSON FADEN: Well, that's okay. That we can do. I appreciate that the language is not as -- that's the intent. The language is not as good as it can be. But this introduces two notions. It introduces the notion that there's a scale of blameworthiness rather than we blame these guys and we don't blame those guys. Then it introduces the notion that the riskiness of the research also could militate against a claim, a judgement of blameworthiness. DR. MACKLIN: I am concerned though about the language of minimal risk here. That is today's language from today's regulations. People still don't know what it is. CHAIRPERSON FADEN: What would you like? DR. MACKLIN: I don't know what words I want to use, but there's another element that hasn't been addressed here. That is, unknown risks. The unknown risks, when you are dealing with something that is new or brand new or hasn't been done before, I think can not be captured by minimal risk or believed to be minimal risk. That is, protecting subjects' interests doesn't only mean assessing I think this is minimal. But rather, taking, using due diligence to distinguish between what is known and what is unknown, and recognizing that there may be long-term risks. That is, the whole notion that you can be too arrogant in thinking about what are risks on the basis of what little is known. So somehow, this assumes, the way the language is written, has a presumption that these are known or believed to be minimal risks, when in fact, it may not have even been recognized or addressed. CHAIRPERSON FADEN: You want language something like there was good grounds, reasonable grounds for believing that the research posed no or little risk. Something like that? DR. MACKLIN: Right. Something like that. Yes. CHAIRPERSON FADEN: Good grounds. Adequate grounds, something like that, for believing that -- DR. MACKLIN: That's right. CHAIRPERSON FADEN: And that gets into the sort of ignorance issue. If they couldn't possibly have known. DR. MACKLIN: But adequate grounds or -- because if you couldn't possibly have known but you dismiss it or discount it, there's higher culpability there than having good grounds and being able to say we have good grounds or evidence. CHAIRPERSON FADEN: Right. Good grounds for believing that the research posed no or little risk. Is that all right? DR. KATZ: It doesn't get us out of the dilemma, but it probably the best we can do. It goes to the whole problem of how to handle the issue of unknown risk in research is very, very complex. It goes to the question if the researcher doesn't believe for example, that there are, I mean in good faith, that there are some possibility of known risk, yet there are some intimation from the literature that there might be, others have talked about. You know, it comes up with the uranium miners much more closely, et cetera, et cetera. But I think that's about -- CHAIRPERSON FADEN: As good as we can get right now. DR. KATZ: Probably we can do without getting into the whole thing. CHAIRPERSON FADEN: What we don't want to do is judge these people against things they couldn't possibly have known. That's their sort of non-culpable ignorance. But we want to hold them for what would be culpably. We want to distinguish between the two. So it's good grounds for believing that no or little risk. DR. ROYAL: One of the things I had hoped to learn on this committee is how to take into account uncertainty. I must say that I can't do it today. I'm not sure what it means to say that researchers 50 years ago should have done it. CHAIRPERSON FADEN: I think what it says is that if they were really uncertain -- DR. ROYAL: I don't object to the language, I'm just making an observation. CHAIRPERSON FADEN: I think all this says is that if they were uncertain about the risks, then we blame them more for not getting consent. DR. ROYAL: But you are always uncertain. CHAIRPERSON FADEN: Well, the higher -- you know, you are less certain or more certain. I mean, no? Yes? You don't think uncertain -- never mind. DR. KATZ: If you learned how to deal with uncertainty, then you would be God. CHAIRPERSON FADEN: And that we can't learn to do on this committee. MR. FEINBERG: Is that a finding? DR. KATZ: One hundred seventy. CHAIRPERSON FADEN: Ruth says it's militate against the claim. We'll look it up. DR. MACKLIN: Mitigate means lessen. It's often, I have to with apologies to the people who drafted it, mitigate means lessen. So you may mitigate the severity of something. CHAIRPERSON FADEN: But you militate against a claim. DR. MACKLIN: You mitigate the force. But if you are talking about blank against something, the word is militate. It's just a confusion in language that many people have had for a long time. CHAIRPERSON FADEN: And until WordPerfect fixes it, I'm probably going to keep on making it. DR. MACKLIN: WordPerfect doesn't go with the meanings of words, only with the spellings. CHAIRPERSON FADEN: It's a real problem. DR. MACKLIN: It's militate. CHAIRPERSON FADEN: All right. Yes, Duncan. I'm sorry. DR. THOMAS: There is one thought that seems to have gotten dropped from this draft. The last two lines of page 8. The Advisory Committee further finds that even at the time both the Government and the biomedical profession should have had such protections and practices in place. Did we decide that this morning? CHAIRPERSON FADEN: No. We didn't. DR. THOMAS: Or was this an accident? CHAIRPERSON FADEN: No, no, no. That was what was in contention. So what happens here instead is the view that we blame them more for not having them in place in these circumstances unless in those circumstances. So the two paragraphs are taken to kind of replace that rather than a blanket for non-therapeutic and no blame for therapeutic, which is how this was written. In other words, those two sentences applied, were only found in the finding 9(b), but not at all in finding 9(c). So this is an attempt to even it out a little bit. Instead of saying we slam you in the non-therapeutic context and we don't slam you in the therapeutic, we have moved to a sliding scale that says, how wrong we think you were in failing to have these protections. We almost have a two by two table. Forget it. You don't want to do that. Is this on the road? DR. STEVENSON: Sort of a practical issue. How is this, which it clearly will affect our recommendations? Because now we are not black and white, we are gray. CHAIRPERSON FADEN: I don't think it will matter much, but let's see. DR. STEVENSON: I think it is going to matter a lot. CHAIRPERSON FADEN: Moving to this? DR. MACKLIN: I think it will matter a lot. Duncan and I had a little debate on E-mail that some of you noticed and commented on. I think this goes right to that. CHAIRPERSON FADEN: Let's see. I mean we are going to right now go to recommendations for the past. This is all supposed to come together. I may be wrong, Mary Ann. Then we'll see how it whosey whatsy. With that, with apologies to people who had comments on 6, 8 and 10(a), if it's okay, I would like to go to -- well, let me just step back. I think we covered them. But 6 we already did discuss. Eight we discussed, 10(a). I think we have covered them. We have in fact covered them, because we did discuss 10(a), 6 and 8. So with that, we're going to go now to the recommendations for the same historical period. I would keep stocking it out though, because as Mary Ann points out, they are supposed to go together. Let's get the other thing. We're talking about the recommendations that appear, this is chapter 19, they are those that appear on page 1 through -- let's see, where does the retrospective part end. Through 12. Also we had some that came recently. So you need to be looking for loose pieces of paper, which is also frustrating. They would be with respect to intentional releases, Marshallese, and uranium miners. Did the text get out on notification as well? It did? I didn't get that. It's also in the blue folder. So it's going to be a little problematic because we may not all be reading from the same page. We'll have to make sure, particularly when we get to those where there have been a flurry of activity, that we all have the same version in front of us before we begin the discussion. If it's all right with everybody, I'd like to go down the list again and just call for where people would like some standard discussion. We're just starting with recommendation one, page one of chapter 19, which begins with the public apology. Just go down the list and we'll see what needs attending to. Recommendation one? MS. KING: Yes. CHAIRPERSON FADEN: Recommendation two? MS. KING: Yes. CHAIRPERSON FADEN: Three? DR. THOMAS: Yes. DR. KATZ: Yes. CHAIRPERSON FADEN: Four? We have to make sure which four we're dealing with. I have a feeling that all of these are going to end up on that list, but I'm going through the exercise in the vain hope that one will slip through here. Five? MS. KING: Five is attached to a June 13th memo. CHAIRPERSON FADEN: Replaces what is in the text? MS. KING: I'm sorry, supplements. DR. MACKLIN: So there's A, B, C, and D. CHAIRPERSON FADEN: All right. Who wants to talk about five? A and B showed up in what we got. Then D and C came later. Marshall Islands is 6. June 19. Anyone want to talk about that one? Briefly. All right. Uranium miners is seven. I think we're going to have to do it. That's it. We're just going to have to walk through it. It's hopeless, guys. We're going to have to do the whole thing. With that in mind, how much time do we have? We have the whole rest of the afternoon. We should be able to do that. Let's just go serially, if that's all right. Just march through them. Public apology, recommendation one. Pat. MS. KING: My problem is, is this is like an appeal to God and country. If you are going to apologize, and so some people would say is innocuous. I don't think that it is innocuous, because in my view, undercuts the credibility of the committee's work. If you are going to apologize to all subjects of human radiation experiments, you should be apologizing to everybody who participated in the research that was government sponsored in this period, because one of the things that we keep saying is that the practices that we abhor were generally available. If we're going to apologize to everybody, particularly if we're talking about individual lives where feasible, I just sort of think that's ridiculous. That is my gut reaction. Why -- the government has done lots of things wrong. The government has done a lot of things it shouldn't have done, perhaps. What warrants an apology? Our assumption seems to be that apology is easy. I think of apology as a very important thing when a government does it. Witness the struggle with the Japanese government to try to deal with 50 years ago. There are discussions about different kinds of words that are appropriate to use. I do not think a government apology is a light thing. So I think when you make it generalized like this, you lose it. So I don't like this recommendation. DR. MACKLIN: When you say generalized, what would be more specific? MS. KING: I think that you have a particular reason of justification of egregiousness which our findings have not warranted for me yet, to do a public apology that goes across the board. That does not mean you can't apologize to individuals, where you pull out individuals or individual experiments where there should be apology. But this is like apologizing to everybody who participated because there was not a government policy in place. This is also an event where the committee has not -- this is an apology in the context in which the committee has not named anybody as being blameworthy other than government for not effectuating policies in some circumstances. This is a case where the committee has not found -- I tried to get a piece of paper -- serious harms of a physical nature as opposed to dignitary harms to individuals. What we have come up with does not meet my criteria for a generalized apology. CHAIRPERSON FADEN: I've got Henry. I don't know who else wants to comment. Ruth. Duncan. Okay. Henry. DR. ROYAL: I'd like to ask Pat to clarify whether or not her concern, whether her concern was individualized apologies versus a government acknowledging that during this period of time what was done was wrong. Do you object to both of those recommendations? MS. KING: My basic objection is to making a generalized public apology because how I'd like to see government public apologies addressed in general. Having the government, where feasible, look for individualized persons only makes it more difficult to me. I would rather see -- I need justifications to say why should the Government issue an apology to all participants in this period as opposed to other areas of human endeavor where there might even have been harm, that we know there have been no Government apologies for it. To me, this is sort of lessening the force of what it means when a Government apologies to its people. I do not take apologies lightly. I am willing to apologize in the context of a specific experiment if we give reasons, or in the context of specific factual circumstances that we identify. But to all who were in human radiation experiments, which I can not distinguish from all experiments, I have difficulty with. CHAIRPERSON FADEN: Ruth. DR. MACKLIN: I think first of all, there's something between physical harm and dignitary harm that Pat pulled out, physical harm as opposed to dignitary harm. This morning we heard testimony from somebody who talked and poignantly, about the emotional harm and psychological harm that affected people or the families of people who were subjects of experiments, even if they didn't undergo physical harm. Furthermore, there are other kinds of reasons besides harm, physical or emotional, for the apology. That is, the secrecy, the cover-ups. MS. KING: We have separate recommendations for those, for cover-ups, about which I'm not upset. It's this generalized one that just to everybody that I am having -- DR. MACKLIN: Well, let me just -- you gave two different rationales. We'd have to grapple with each of them separately. One was the seriousness of the harm, that you said where people weren't physically harmed. The other was why have an apology for this when there are all these other things to apologize for, or for research generally. Now I think this possibly goes to the reasons for the creation of this committee and its charge. How could we ask the government to apologize for things that we didn't study and that we didn't look at or draw any conclusions about, even though it would be warranted for the Government to issue such an apology if we had or if someone else does. That is, we can only make recommendations in the arena where we have some findings and some discussion, even though there's good suspicion. I mean, radiation was not alone. Everybody knows that. MS. KING: But the general report does discuss experimentation and research in a broader context than human radiation. In fact, we constantly refer to and contrast practices with respect to human radiation experiments and other experiments. So I do not mean to belittle or to try to try to give weights in a way you describe to dignitary harms versus physical harms. What I was trying to say was we need, it seems to me, strong justifications if you start with my starting point, that a public apology is a significant event from Government, that you need strong justifications, in my view, for separating out human subjects research, because that's the way I see it, human subjects research from other areas of Government endeavor so that the apology has meaning. I don't see that in our report. Others may disagree with me. I point to the things that would have been factors in helping me get there. It was no single thing. It is the totality of what we have uncovered. Where I weight this in my own head, in terms of human endeavors and how right or how wrong or how bad or how egregious it was, in individualized circumstances I am more than willing to apologize. I think we obviated the problem when we said apologize to everybody. When you can identify individuals, find them and identify them individually. I think you find individuals and you apologize to individuals and you know what you are apologizing for, rather than issue a general statement. CHAIRPERSON FADEN: Duncan and Jay. DR. THOMAS: I am mindful of the comment by Anthony Roisman this morning, that this apology sounds like it was written by a computer. I share many of Pat's concerns. I feel like trying to write a generalized apology of this nature sort of demeans the whole thing. I suspect that our difficulty comes from this apology trying to do double duty, both for a general recognition of Government failures in the past, as well as an acknowledgement of specific crimes to specific people. So what I think I'd like to propose is that we separate this into two separate recommendations or at least a two-part recommendation. The first is that as a policy statement the Government recognize that its policies in the past were inadequate and apologizes globally to the American public for its failures that are documented in our report. In a sense, it accepts the recommendations of our report, at least in this area. CHAIRPERSON FADEN: You mean its findings. DR. THOMAS: The findings. Sorry. The findings in this report. And then that it issue individualized apologies to specific individuals where warranted. I feel uncomfortable with the idea that the only apology that happens is that somebody identifies themselves by calling a hotline or writing a letter to the Government, and then gets a computer generated letter back which is a form letter, the same that anybody can get, basically. I think we need to make many of these distinctions that Pat has talked about, between those that on the one hand were physically harmed, those that had serious dignitary harms, those that suffered psychological harm and so on, and that that's going to demand different kinds of apologies in different circumstances. CHAIRPERSON FADEN: All right. So if I understand what you are proposing, Duncan, it's an acknowledgement. I don't know whether it's an apology exactly. You recommended that Government acknowledge that they didn't have such an effectuated policy and they regret. DR. THOMAS: I mean it's one thing for us to criticize the Government and making a strong finding for the inadequacy of our policies in the past. It's something else for the President to stand up on national T.V. and say yes, you were right. CHAIRPERSON FADEN: And then the second part of that is we would then move the generalized apology and we would labor on some of these other recommendations where we have identifiable or classes of experiments identified, those people would get apologies. DR. THOMAS: There are people who we will be recommending get no money. But nevertheless, we recognize that they were wronged. Those deserve at least an apology. The apology needs to be tailored to the specific experiments. CHAIRPERSON FADEN: What it sounds like is that the public apology, whether it remains a public apology, the proposal is that it now be from the American Government to the American people, and not the American Government to former subjects. DR. MACKLIN: I think acknowledgement is a good term that can capture that difference. I mean, unless, I want to hear Pat's reply, is there is much worry about a government acknowledging -- I'm sorry, did I go out of turn? CHAIRPERSON FADEN: No, it's okay. Why don't you finish your thought. Jay was waiting. Finish your thought. DR. MACKLIN: Duncan used the word acknowledgement, which is a way of the government admitting past wrongs. I heard Pat's concern to be apology, which is a more serious -- not more serious, a different sort of act. So what I just want to hear from Pat is whether or not you think a government acknowledgement of past wrongs and harms produces the same worry for you as the apology. MS. KING: I'm reminded of the debate in the Japanese Diet about words, is what I am worried about. I in my own mind, I understand what Duncan is saying. No, I don't see a difference. The second thing I would say is when we speak of the Government, one of the things that we have not clarified, this is an additional complication, is who are we making this recommendation to? Is this a recommendation to Congress and the President? Are they the Government? CHAIRPERSON FADEN: Yes. MS. KING: Then we should say that, because when we keep talking about the Government, as though it is some overarching force out there, the Government is people. So if you don't address it to people, nobody will -- but no. It doesn't help me, Ruth. Because I think that is quibbling about words, just like they are doing. DR. MACKLIN: No. Not about -- well let me step back. MS. KING: Acknowledgement versus apology. CHAIRPERSON FADEN: Is from your point of view, quibbling about words. But I want to get Jay in, well Jay why don't you get in. DR. KATZ: I want to ask this of Pat, in particular, and of course everybody, and also Duncan because I was taken with his concerns. I think she is quite correct. But I heard something in what Duncan said. Is it that we want to recommend an apology? This kind of apology I don't think we shouldn't, but should we recommend that the President and Congress draft resolution, a pulpit resolution to condemn what went on during the 1940s, 50s, and 60s, an official resolution of saying this behavior at the time was really or certain aspects of the behavior was really inexcusable. MS. KING: It's the same with quibbling about words. DR. KATZ: Is it quibbling over words? It's not words. It may mean we want to do that. Why is it quibbling over words? MS. KING: Even to condemn what you did in a period as a matter of public, as an official government agency. DR. KATZ: As an official government, congressional. MS. KING: We're talking about the scale of the words you use to say to the American people this was wrong. Ruth and I don't have to debate. That is my objection to recommendation one because I am aware of time. I seem to be the only person who is upset about public apologies. CHAIRPERSON FADEN: I think that's not correct. Okay? But I think that others are looking for wanting to say something to -- MS. KING: I would omit the recommendation. Mine is easy. CHAIRPERSON FADEN: Pat wants to have it go. I'm hearing two other alternative proposals. Duncan's to replace it with a general acknowledgement or apology to the American public that the Government acknowledges it didn't have in place a system for adequately protecting the rights and interests of human subjects, and regrets that it did not have such in place. Jay's, I take, is further, which is a resolution that says that there were wrongs that occurred at this time and we condemn it as a government. DR. KATZ: I'm not sure about it. CHAIRPERSON FADEN: But you are laying it out as an idea. DR. KATZ: I thought that Duncan was moving in that direction, but I'm not sure. CHAIRPERSON FADEN: Henry and then I think we do have to come to some thought, and maybe come back to this one as we march ahead. If we sort of hammer one down, we'll never get to the others. So I'll stop. DR. ROYAL: I share Pat's concerns about this generic apology. We actually talked about this once before, about you know, the Xerox machine just sort of cranking them out. Recognize that we were going to devalue the apology depending on how freely we gave it out. The thing that I don't know is I would have thought in 1974 when the new regulations came in, that there was at that time an acknowledgement that things had not been done the way they should have been in the past. Jay is shaking his head no. DR. KATZ: The government, then HEW, has never apologized for conducting the Tuskegee syphilis study, even though some of us have been urging various people for the government to do so. CHAIRPERSON FADEN: It's a big deal. MS. KING: An apology is a very big deal. That's what I've identified. CHAIRPERSON FADEN: But I want to respond to just one thing that you said, Pat. I feel this awkward position. I can think of other things that have occurred in the history of the United States that are very, very wrong for which apologies have not been given. I don't want to feel like we can't have that addressed here because that hasn't happened. It's sort of one of those problems that it isn't to say that if this deserves a public apology, quite apart from the issue of whether it is to individual people or to the American public generally, that does not mean that because it's the only one that is ever made, that other areas where apologies also should have been made, that that was okay. That should not be the inference in your mind that says. MS. KING: I understand your argument, Ruth, but another trend, strain of what I said, which is I take it to be the major part, that I do think because apologies are a big deal that they require a huge justification. I have tried to explain. It's not generally accepted, why I don't think that what has happened in human subjects research in terms of what is in the committee's report rises to that level. That doesn't mean you can't call it wrong. You can't call it a lot of things you want. The question here is, does it rise to the level of requiring a public apology. In my mind, it doesn't. I am trying to give reasons for that, all of which others would reject, some of which others would reject. CHAIRPERSON FADEN: Let's do this. I want to get a sense of the group about the recommendation as it stands, which is to particular subjects of human radiation experiments. I heard other people supporting Pat, that they had reservations about that kind of a recommendation. Is there anybody who wants to argue forcefully for the recommendation as it stands? Ruth. DR. MACKLIN: I certainly want to argue for retaining it in some form. Enough concerns have been raised for me to question as it stands. But if nobody raises his or her hand in answer to your question, it looks like no one wants to argue for retaining it in some form. I want an argument for retaining it in some form similar to, but no identical with the way it now stands. CHAIRPERSON FADEN: By the "it" I should take you to mean apologies to subjects of human radiation experiments as opposed to a generalized. DR. MACKLIN: Yes. Apologies or acknowledgement, as Duncan worded, which may be a better word, of the acknowledgement of the Government's role in those activities. CHAIRPERSON FADEN: So I think that we will have to return to this, because clearly, we'll have to see. All right, recommendation two. This is -- well, I'm not going to summarize it. MS. KING: I raised a question about this. It's because I think this is a general problem with the recommendations. I'll raise it here. That the Advisory Committee recommends that the Government deliver a public and individual apology, whatever, it kept secrets. I think that throughout, the recommendations should be directed, the reason, to specifics. To an agency, to the President, to the Congress, to both. That is because the Government is made up of people. When people take a look at your recommendations, they are not in it if you're not there. Also, if we focus on who we are asking to do what, I think often as we go through the recommendations it will have import for what it is that we are asking people to do. In some areas what we would like to see done as a question of implementation, is a lot more difficult than I think we suggest. It's helpful to figure out who we are going to give responsibility for it to. That problem begins with me here, which is where I focus. So that's why I said problem two. CHAIRPERSON FADEN: Your problem is not with the substance, but with the who is supposed to deliver it. MS. KING: The second problem, this is a general statement about the recommendations. I think we should -- these implementation in some areas will raise hackles, I think. Congress knows it is empowered to pass legislation. I would be very careful about when you are talking to Congress as opposed to making recommendations to the agencies, about how you frame implementation and our suggestions. The reason I would be careful is because you don't want it to become, if it ever gets to the floor of Congress, this subject of -- discussion on the floor to Congress, you don't want that to obscure what is going on. It makes a difference. CHAIRPERSON FADEN: I'm sorry? MS. KING: The tone in which you speak. CHAIRPERSON FADEN: So the question is change the tone? MS. KING: And in this case when it's Congress, I would be very careful about specifying implementation at all, other than making a recommendation that Congress consider it. People are very jealous of their prerogatives. CHAIRPERSON FADEN: Okay. So we can work on it. MS. KING: Or we should have a strong reason, when I say strong reason, for pointing out something quite specific in a case because we think that difference from other areas. CHAIRPERSON FADEN: Can I go back? DR. KATZ: Are we talking about medical experiments only here in this section? CHAIRPERSON FADEN: Yes. Recommendation two. DR. KATZ: Maybe you should put medical. It comes clearly from one, two, three when you mention it. But I was sort of confused. CHAIRPERSON FADEN: Yes. These are specific to biomedical experiments. MS. NORRIS: There is that question in my written comments, because human radiation experiments are defined to include intentional releases. CHAIRPERSON FADEN: Yes. We're back to that same problem. I have got Duncan and Henry. Ruth. DR. THOMAS: I feel uncomfortable having the designation of the three specific cases that we found as part of the recommendation itself. That to me seems to be implementation or supporting text anyway. To me it somewhat detracts from force of the general statement that the first two sentences provide. CHAIRPERSON FADEN: So you would take those to then become the first part of the explicating, that whatever we're calling these things. DR. THOMAS: Yes. I like the flow to go directly into the continuation of general philosophy under deliberate attempts, and would suggest moving it into a part of implementation. CHAIRPERSON FADEN: This was introduced, I think in part, because of a discussion we had last time about raising expectations and having dashed hopes. So Ken had been arguing for writing the recommendation in such a way that it was specific. DR. THOMAS: I agree it deserves to be part of this block of text, but I don't like to see it bolded. CHAIRPERSON FADEN: So it would be to move it into somewhere. The concern is not to give the message that this recommendation, based on the committee's findings, now applies to tons of people. That's the concern, so that we don't have a lot of people who once again have their expectations raised and then are disappointed. Henry and then Lois. DR. ROYAL: I agree with the recommendation. That is, that there should be an apology and financial compensation when efforts were made to keep the thing secret to individuals who were subjects of the research. What is unclear to me is whether or not the examples meet that qualification. For example, with the total body irradiation study, what we know is that in the research report, that their initials were crossed out of names and that subjects were not identified. But what information do we have about consent or lack of consent in that case? Or is what this recommendation is saying is that we're just going to assume that no valid consent was gotten from anyone during this period of time. I think that is an important distinction, whether or not we're specifically saying that we have evidence that no consent was obtained in these three cases. CHAIRPERSON FADEN: No. It's more than no consent. The claim here is more than no consent. DR. ROYAL: I understand that. CHAIRPERSON FADEN: The burden is worse than that. The burden is worse than that. DR. ROYAL: Yes. But you understand that the initials could be crossed off of a research report because the research was secret. But that does not necessarily mean -- CHAIRPERSON FADEN: That the people didn't know. DR. ROYAL: That the individual people didn't know that they had participated in the research. CHAIRPERSON FADEN: That is a good point. MR. GUTTMAN: That's true. Ruth and I have talked about it. Are technically neutral as to what in fact happened between the doctor and the patient. The evidence is that the government said we will not permit this to be published because we're afraid of a lawsuit. In that particular case, someone said well if I cross off the names of the patients, they will never know. CHAIRPERSON FADEN: There is a text that suggests that the reason they were crossed out was to keep people from knowing that they were subjects. That the Government wanted it out there because they did not want to get sued by these people. MR. GUTTMAN: This is where Robert Stone -- DR. ROYAL: I remember the case of the University of Chicago. CHAIRPERSON FADEN: Right. So the argument here is that if it were merely that they were crossed out, we wouldn't know why they were crossed it. It might have been to protect their identities. I mean, we wouldn't know why. But the documents, the language suggests that the reason that it was crossed out was so that these people would not know they were subjects of research, and therefore would not sue. We should go back and look at that and see if in fact that interpretation is correct. MR. GUTTMAN: I think to respond to Henry's question, I think the intent of this -- CHAIRPERSON FADEN: I don't think that's right, Dan. MR. GUTTMAN: No? CHAIRPERSON FADEN: This says were to keep secret from these individuals that they were subjects of research. That is what it says. If these people knew they were subjects of research, they couldn't possibly fall under the recommendation. These are for people who, if they found out despite the efforts of the Government, then of course that would be all right. But the point is, the argument here is there were attempts made to keep people from knowing that they were subjects of research. That's what makes it so egregious. DR. ROYAL: But the evidence is not clear, at least it's not clear to me whether -- CHAIRPERSON FADEN: So the issue is whether in that case. DR. ROYAL: Was to keep other people from knowing or to keep the actual individuals who were the research subjects from knowing. MR. GUTTMAN: I guess part of Henry's question is it's old story. We just don't know what the reality underlying that particular experiment was. We don't know what Dr. Stone told the patients. CHAIRPERSON FADEN: Then it would have to go out. MR. GUTTMAN: The question is how you read that evidence. CHAIRPERSON FADEN: That's correct. So I think what we need to do is rather than do this, we have got a proposal that says let's take this out. This is a good a reason as any for taking it out. Then we will have to look at each one of these three and see. DR. ROYAL: And provide the evidence. CHAIRPERSON FADEN: Yes. DR. ROYAL: That they either meet or don't meet this recommendation. It's still in terms of the evidence that the committee is looking for, as I understand it, we're assuming that no consent was obtained, so that they automatically meet that first criteria. CHAIRPERSON FADEN: We are assuming only that the Government didn't have policies and practices in place that were effectuated, that would have made it unlikely that consent was obtained. MR. GUTTMAN: Actually, there's more than that. Is that the evidence we now have that's in the document update, is that in 1947, the question was what research reports should we make public. The Medical Board review said you don't make research report public unless it meets the following criteria, informed consent. CHAIRPERSON FADEN: That's not -- MR. GUTTMAN: But it goes to the question of why something would have been kept secret. CHAIRPERSON FADEN: But he was talking about the generalized presumption for the whole thing, not particularly to this one. I don't think we can have the documentation for each of these three cases. But I think it has to go through the committee. The committee members have to agree that these three qualify. If they don't, if one goes out, it goes out. I became persuaded that all three of these fit that description, but if other people do not, we can take one out or we can have a footnote or separate them, and probably, or most or perhaps this one. But I don't think we can rehearse the evidence for each of these in this recommendation. That would be too burdensome. We have got chapters elsewhere. This is supposed to be the Committee's conclusion. So if we don't all agree that the plutonium injection experiments, the CAL-Z subject, and this third one can be considered to be people who would fall under this recommendation, then we need to change the language and say whatever turns out to be accurate of the view of this group. Is this right on this point, Ruth? DR. MACKLIN: It's right. CHAIRPERSON FADEN: If it's right on this point, otherwise I have Lois and Nancy waiting. DR. MACKLIN: It's right on this point because you gave the rationale -- now Ken is back and he can defend it -- for why we wanted to specify something here. Namely, not to raise expectations, not to raise hopes, et cetera. CHAIRPERSON FADEN: And we're on recommendation two. DR. MACKLIN: And make it clear that this is a very small number of people. Now I'm not sure whether we want in saying we found three cases to which it applies, is that to presume that these are the only cases to which it might apply? CHAIRPERSON FADEN: They are the only ones we found. DR. MACKLIN: The only ones we found. But now someone is disputing these three cases. So what I would like to know is whether this recommendation can be stated without specifying these three. Perhaps the clearest one, the for example, the 18 subjects of plutonium experiments and CAL-Z, as a for example, and make the claim that based on the Committee's inquiry, very few others would meet this condition. MR. FEINBERG: Why are you so hesitant? DR. MACKLIN: To specify? MR. FEINBERG: Yes. I mean are there others that we know of? DR. MACKLIN: There was just the debate right here about the third category. Several subjects of total body irradiation experiments. In other words, if that is taken out because of uncertainty or we don't have the evidence, then it's two. MR. FEINBERG: Then it's two. CHAIRPERSON FADEN: I think the implication would be that then you would say the Committee has found two cases about which they are confident and one that is a maybe. If there are more out there, we haven't found any, but there could be. Maybe we should just say it straight out like that. I am not ready to concede three yet. MR. FEINBERG: The whole idea was to deflate expectation that this is going to be a wide open recommendation that thousands of people can meet. That was the idea. I think it was a valid point. MS. OLEINICK: The next step -- CHAIRPERSON FADEN: I'm sorry. You're actually, we'll -- MS. OLEINICK: I guess I'm behind but it really is related to this. The next step beyond what we're talking about is if we have two cases that are for sure, well one would think are sure, and one that's a maybe, then there really aren't any more, then there's no problem. But you know, the wording in here says, there's others that are not known, should their identities come to light, they and their families should also be compensated and so forth. So that is leaving it open that there may be others. CHAIRPERSON FADEN: You have to. MS. OLEINICK: I guess my question is I don't know who these people are or how they are going to identify themselves. But should they, by some mechanism, to whom do they demonstrate this evidence? What is the evidence? If we say there's a possibility of more, I think we have to be a little more clear as to what happens next. CHAIRPERSON FADEN: I don't think what we're saying is there's a possibility of more. What we are saying is that we could not possibly have looked at everything. In fact, because this stuff is kept secret, there could be something there that we didn't bump up against. MS. OLEINICK: Yes. But there is this little window that's open here. CHAIRPERSON FADEN: Right. Absolutely. MS. OLEINICK: I am concerned that somebody 10 years from now will find oh gee, I found this in an old letter in my grandfather's trunk or something. Then what do they do with it? CHAIRPERSON FADEN: They go to their Congressperson. They go to their member of Congress and say look, I was used this way, and there's this report, and can you get some kind of response, can you write a personal bill, can you have hearings, can you do whatever, because it looks like I was in one of these that that advisory committee 10 years ago didn't know about. I mean, what else could you do? MS. OLEINICK: Well, I don't know. I wouldn't know what to do. MR. FEINBERG: Is it only during World War II? CHAIRPERSON FADEN: The TBI one is -- the ones where this occurred was only World War II. Not TBI. TBI experiments obviously occurred afterwards. But this purposeful effort to not let people know they were subjects of research. What's at issue in the Cincinnati experiment is whether they were told what the purpose was and what the risks were and that there was Defense funding, but these people knew they were subjects of something. Whereas the claim here is there's an effort to -- well, it's different from this. I didn't express myself as carefully as I should have, but it wasn't intended to deal with ambiguities. With deliberate efforts to cover up, hide from people that they were subjects of research. Henry, if we could just let Lois get in. That would be good. Is that all right or is it right on this? DR. ROYAL: No. CHAIRPERSON FADEN: Okay. Lois. MS. NORRIS: This goes to raising false expectations and also to Pat's comment about the fact that you have to expect that people will not read beyond the findings, get down into the text below it. Again, I raise this because compensation is involved. We're talking about awarding to surviving family members. That is a very broad term to me. Maybe it means something more specific to the legal community. But it could mean second cousins and stuff. I notice the text refers to next generation. CHAIRPERSON FADEN: What do we want to say? That's a good point, Lois. What do we want to say? MR. GUTTMAN: I don't think the intent is that everybody who is related gets money. Ken and Pat, please elaborate. Whatever sum of money shall not be extinguished because person is dead. MR. FEINBERG: You're talking about spouses and children. MS. NORRIS: Is that what surviving family members means? CHAIRPERSON FADEN: Isn't it surviving spouses, children or parents? DR. ROYAL: Why don't you just say to the estate? MS. KING: They won't be alive, but that's what you usually cover, because some people don't have spouses or children. Everybody has got parents. CHAIRPERSON FADEN: But they are not going to be alive. So it's a sort of non-issue. MS. KING: That's all right. But you don't know if the children will classify. CHAIRPERSON FADEN: You don't want to say to the estate of? This is not my world. MS. NORRIS: It's not mine either. That's why I sort of raised it. CHAIRPERSON FADEN: I don't know. So to award -- MS. KING: The intent here is to get to the immediate family. Ken would agree with me that immediate family usually means those people. MS. NORRIS: So then why don't we say immediate family? Isn't that -- CHAIRPERSON FADEN: To surviving spouses, children or parents. DR. ROYAL: Or immediate family. CHAIRPERSON FADEN: Or immediate family. MS. NORRIS: That means more to me than surviving family members. CHAIRPERSON FADEN: To surviving immediate family members. Fine. We got it. Ruth, you were actually on before I added Henry. Are you off? All right, Henry. DR. ROYAL: Two additional comments. One is the reason that Ken had wanted to list the individual experiments is not to raise people's expectations. What about the fact that financial compensation is left very open ended. CHAIRPERSON FADEN: About how much? DR. ROYAL: Is that going to raise people's expectations? MR. GUTTMAN: No. Not in today's world. MR. FEINBERG: Not if they read the Congressional Record, it's not. CHAIRPERSON FADEN: Anyway, we can't do anything about it. MR. FEINBERG: That's up to Congress. CHAIRPERSON FADEN: We couldn't make a recommendation about how much or what or all that kind of stuff. DR. ROYAL: And the second thing, and I hate to keep bringing these up. But with the 18 plutonium injections, let's not forget that CAL-1, I believe it was CAL-1, is a signed -- CHAIRPERSON FADEN: It's CAL-3. DR. ROYAL: CAL-3. In the chart that says two physicians and one nurse say that this was explained to the patient. So where does CAL-3 fit in this recommendation? CHAIRPERSON FADEN: I've actually struggled with that a lot, because well there's that documentation and there's other documentation that applies to CAL-3 after the fact for the follow-up studies that looks as if efforts were made to mislead him and his wife about the purpose of the follow-up studies. So it seems to be a mess. To my own view is one of fold them in. But you are quite right. That there is kind of conflicting evidence about exactly this situation that Mr. Allen and his wife were in at that time. My inclination, my preference would be to fold it in. If you want a footnote that indicates that it was ambivalent or something -- MR. GUTTMAN: But this illustrates the point in some respects. This goes to the Government. The Committee seems to be concerned because of the Government's conduct in trying to cover up. For all the Government knew, maybe these people did get consented, but the Government by the document seems to have intended to cover things up. DR. ROYAL: Maybe the recommendation or the explanation needs to be clearer. I actually like what you said, Ruth, about the fact that things were covered up until 1974. It is clear that people were, even if they were told by the investigators at the time -- CHAIRPERSON FADEN: They were mislead later. DR. ROYAL: They certainly were mislead later. We have very good evidence of that. So maybe to distinguish the immediate consent process versus what went on later would be helpful. CHAIRPERSON FADEN: We can do that in the text in a sentence I think, indicate that the bulk of evidence with respect to the plutonium was sort of -- or even in a footnote, rests on the evidence with respect to Government actions to mislead. It doesn't rest on what happened between investigators and subjects, since we really do not know what happened between investigators and subjects. That would be fine. We don't have documents that bear on that the way we have documents that bear on the other stuff. Can I take it that on this recommendation, with the exception of moving the three examples into the text, which is what people want rather than into the bolded, and with an open issue of whether the third one stays or doesn't, the three people, that this is basically okay. We have not addressed Pat's question about -- Ken, you were out of the room when this happened. Pat would like the term the Government in line 5, replaced with somebody, the President, Congress, the Inter-agency working group. MS. KING: I don't think the President can do it. I think it has to be the Congress. CHAIRPERSON FADEN: Congress, okay. Well, the public apology can come from anybody. So who are we going to put? I mean the issue is that's why it says the Government, because I'm not real comfortable about parceling out. MS. KING: I think Congress is who this ought to be addressed to, myself. You know, you don't want people saying that is that person's job over there if you ever want to come back. It's Congress. CHAIRPERSON FADEN: Is there any objection to having this directed at Congress? I need some politically astute people to tell me if there are any problems with that. Or is it all right to say the Advisory Committee recommends that the Congress. DR. ROYAL: I am not a politician, but it strikes me as not being very good politics to have a presidential advisory committee telling Congress to apologize for these experiments. MR. FEINBERG: I wouldn't get into this, because also I can see Congress passing a resolution of apology. But I can also see the Secretary of Defense or the Secretary of Energy or somebody writing an individual letter to some individual on an individual apology. I can see that. MS. KING: Nobody is precluded from doing a gratuitous act that we don't recommend, or an extra act. If anybody wants to do that, that's fine. But I think we're talking to somebody or some office, Ken. MR. FEINBERG: If you want the Congress, I don't really care one way or the other. MS. OLEINICK: All of the agencies that sponsored this research we are finding fault with, were agencies of the executive branch. We are asking the legislative branch to apologize. It seems a little strange to me. CHAIRPERSON FADEN: Well, we'll work on this. We will work on it, Pat has raised. I think it is an important issue. We have got to resolve it one way or the other. We have to decide either there are good reasons or there are not good reasons for it, for naming it. But basically, recommendation two survives some whatever. Now I see what Ruth meant about the implications of what we did before for what we are doing now, although I'm not sure that it necessarily sort of changes things a lot. But it is certainly worth considering. We are now onto recommendation three. This emerged, the distinction here between research that offered a prospective benefit and not, emerges in here because of a long discussion we had last time that Eli raised, about how difficult it is to deal with the concept of -- DR. GLATSTEIN: Yes, and I have trouble with the idea of deciding that the therapeutic rationale is unpersuasive. I'm not sure who decides or when it is done. Sometimes experiments go right for the wrong reasons. Sometimes they go wrong for the right reasons. CHAIRPERSON FADEN: True enough. DR. GLATSTEIN: I don't think we can put any teeth in that. CHAIRPERSON FADEN: How about if we bracket that clause on line 6 for a minute, and see whether the general structure is one that people are still interested in endorsing. The clause that I am saying to bracket is, or in which the therapeutic rationale for the experiment was unpersuasive. Let's bracket that for a moment and read it without that clause in there and see how we do. So there's no prospective benefit anticipated at the time, the person suffers an injury. We're saying that that person should get -- DR. GLATSTEIN: I don't think I have a problem with that, if they give him injury. DR. THOMAS: I have no problem with this recommendation either. But at some point this afternoon, I want to put on the table a revisiting of the discussion we had the last time about whatever it is we are going to recommend for people injured in therapeutic research. CHAIRPERSON FADEN: That's the next one. I mean it's in there. DR. THOMAS: It's not. CHAIRPERSON FADEN: It should be done now because this has the rationale for why. DR. THOMAS: That's the point. The rationale here contains some discussion for why we're not making the specific recommendation. But there's not in the recommendation itself any mention, in this recommendation or any other recommendation, until we get to the prospective recommendations, 13. In 13, there is no rationale given for why this argument should be made only prospectively and not retrospectively as well. So there's I think a justice question that needs to be addressed. CHAIRPERSON FADEN: That's what this was intended. I think we should do it now, because that's what this rationale was intended to do. It is intended to say why we're not offering money in the "therapeutic" context and not in the non- therapeutic. The presumption here was everybody was getting an apology, which now is up for grabs. Ruth. DR. MACKLIN: Now we have to go back to what we did earlier because that's what the implication that I saw for the grid or the sliding scale of culpability. That is, the sliding scale of culpability did not distinguish between -- in other words, enabled blame to be laid at the door of those who did therapeutic experiments that were high risk and/or believed or known to be high risk and for which no consent was obtained. So the nice schema that we outlined for blameworthiness along those dimensions, it seems to me, comes right back here. If there's blameworthiness, what do we say about the blameworthy? Why are the people who are the victims of those who may be accorded high blame for what they did not commensurately compensated in the appropriate categories? So in other words, do you just blame with no consequences to the people who are the victims of the blame? And that's what has to be addressed here, I think. CHAIRPERSON FADEN: Okay, I've got Pat, and then we can start with the discussion. I think it has that -- the reason is we should have it now. We should get it out now and see if that's what this whole recommendation is about. MS. KING: I think this recommendation is not going to culpability. I read this as a recommendation that, in my lawyer's term, would be strict liability, which is -- yes, that if you were harmed and you were participating in research that did not involve the -- CHAIRPERSON FADEN: The prospect of benefit. MS. KING: -- so it does not conflict with what went on in the findings. But Ruth is right that there is nothing here to be equivalent to the findings. I read this as quite different as a matter of fact. It's just -- the key point here is -- and whether you were in the category of what we loosely call non-therapeutic or research with no direct medical benefit. Because it takes in everybody, whether there was blameworthiness or not. CHAIRPERSON FADEN: It doesn't say no consent. MS. KING: Right. It just says if you were harmed. CHAIRPERSON FADEN: Yes. This one doesn't say anything about consent or the absence of consent being obtained. What it's presuming is that the government didn't do a good job about policing human subject research at the time. It doesn't say -- you could have actually been very carefully informed and given a very meaningful consent in 1956 -- MS. KING: Right. CHAIRPERSON FADEN: -- to a physiology experiment that went wrong or whatever if it involved human radiation exposure. And if you got -- something happened to you, you would get money here. MS. KING: Right. CHAIRPERSON FADEN: Duncan and then Henry? DR. THOMAS: I'm not sure that consent shouldn't be part of the formula for the following reason. It's precisely the members, the participants, in the therapeutic research that are most likely to have experienced some harm because by and large, the non-therapeutic research is minimal risk research anyway. So there are very few people that will fall under this category that will be eligible for compensation. Now we made -- we had a long discussion last time about the concept of net harm, and we recognized that patients in therapeutic research were making a gamble, that they were going into it presumably with open eyes, understanding that they were at increased risk. But they hoped to get some benefit. And it was the difficulty of implementing this concept of net harm that led us to dismiss compensation across the board in this case. The point that I was trying to make in this exchange of E-mail with Ruth was that if a subject actually goes into therapeutic trial with open eyes fully informed about what the risks and benefits are, then it's their decision. And if they lose, that's tough. But if, on the other hand, they were not properly informed about what the risks were, then they might have made a different decision and they might not have consented to participate. And in that circumstance, then it seems to me they deserve some kind of compensation. So I really think that, at least on the therapeutic side, it's difficult to resolve this question about net harm unless we fall back on some sort of rebuttal presumption that during the period that we're talking about, subjects were probably not adequately informed about the risks. If ever this should surface that indeed, they were properly told, somebody produces a consent form, well then they're out the door, but -- CHAIRPERSON FADEN: What do you do, Duncan, with the fact that it's likely to have been the case that also during that period patients were not informed of the risks of therapy when it was offered to them in a non-research context? DR. THOMAS: Well, that was a new element which I recognized in the supporting text here that I haven't actually come to grips with yet. I appreciate the point that it seems inequitable to offer compensation to research subjects that are harmed without adequate consent, but not to regular therapy patients. But the latter really goes beyond our mandate. I mean, it's specifically excluded. DR. GLATSTEIN: Duncan, we heard this morning form this woman, 30 years after treatment, an infant who is a long-term survivor and who is having unusual complication of treatment. It has given her some kind of vascular obstruction. If this was part of a study, it happens that this was an individual patient, this probably wasn't the right forum for them to present, but they had some other points to make, but this patient has been harmed, and I don't argue that. But she's also really had some tremendous benefit. Had she died within a year or so, no one would be complaining about complications of treatment. I mean, would you have this patient have compensation for this complication of treatment? I mean, that's the dilemma. DR. THOMAS: Well, I accept the difficulty. CHAIRPERSON FADEN: Arguably, to defend Duncan, it would be hard to say that that person had had a net harm. I mean, that would be -- DR. THOMAS: This is why I think -- CHAIRPERSON FADEN: That would be rough on that one. DR. THOMAS: The discussion we had originally was more of a harm, but the patient really isn't in a good position to judge it, and I'm not sure who honestly is. CHAIRPERSON FADEN: We've got Henry and Jay. I mean, it's tough, and Ken. I mean, this is a very tough nut to crack. Did I say Henry? DR. GLATSTEIN: And they did talk about the complications of radiation of the spine. They did talk about leukemia. They didn't talk about the particular complications this lady has had. DR. THOMAS: Yes, but those were not known in those days. DR. GLATSTEIN: Exactly. DR. THOMAS: That would be, it would seem to me, good reason why if one might well exclude compensation in this case. We don't expect investigators to disclose unknown harms, unknown risks I mean. DR. GLATSTEIN: It is awfully hard to draw the line on some of these points. DR. THOMAS: Of course it will be hard to draw the line. But I mean, this is exactly the point that Mary Ann made the last time. If you're really concerned about dishing out too much money in this type -- including the therapeutic ones, what you do is you put strong conditions. DR. GLATSTEIN: But the way it's handled today, this would wind up as a liability case, you know, if they really felt strongly about the injury. And I don't have a particular problem with that. I think that's as appropriate way to judge it as any. DR. THOMAS: Well perhaps then our appropriate response is simply to say that the civil justice system is the appropriate way of dealing with this. We can't be silent on it. That's my point. DR. GLATSTEIN: Maybe the attorney was right with that self-serving statement about emphasizing that option. I hadn't thought so, but maybe he is. CHAIRPERSON FADEN: That's interesting. We've got Henry, Jay and Ken at least. Henry? DR. ROYAL: The statement about injury resulted, it's not really clarified anywhere about what we mean by that. CHAIRPERSON FADEN: It comes under implementation. We had this whole sort of discussion about how causation is so tough and somebody's got to figure out how to draw the line and that it's a values question, and blah, blah, blah, blah, blah, rather than our saying here's the rule we think should be used. DR. ROYAL: So that this recommendation -- well, it's not clear to me what the recommendation is. The recommendation is that some other group is going to decide whether or not injury resulted -- CHAIRPERSON FADEN: Right. We have an approach. It's on page eight, line three. DR. ROYAL: Yes, I just turned to where it is. CHAIRPERSON FADEN: Yes. We're not going to do it, okay? DR. ROYAL: Should this recommendation include the language that Duncan said? And that is, that for the -- again, so that we're not raising false expectations, something along the lines that for most non-therapeutic research, the risks were small. And it's unlikely that many people will fall into this category. So my question to the committee is whether or not we're concerned about raising expectations by this recommendation and whether or not we should use some language like Duncan used? CHAIRPERSON FADEN: Yes, we could certainly do that. We could certainly do that, indicate. And that probably would be appropriate and easy to do relative to this other. I mean, easy to resolve. Jay and Ken? DR. KATZ: I only have an observation question, and I do not know whether it makes any sense. But by the way to introduce it, I thought when I read recommendation one and two, there was this broad apology covering everybody, and then recommendation two singling out a handful of people that we give some money to to begin with. There was something in Congress about ordering. But that was really what I wanted to refer to. And sometimes ordering can help, but would it be better -- why are we starting out with medical recommendations? If it's only a small number of people, why not start out with the intentional -- and all the other ones that encompass much wider groups of people. And if we make this recommendation, and then give our justifications, will be easier then to put the medical situation in context? I don't know if it will work. CHAIRPERSON FADEN: Maybe. I think, maybe. DR. KATZ: And here, for example, you know, that there are certain things missing like no -- ethics clauses, recommended for government -- CHAIRPERSON FADEN: No, that's it. That's forward looking. DR. KATZ: No, I'm just saying -- I'm just saying the medical is taking over perhaps a little bit too much -- CHAIRPERSON FADEN: Right, okay. DR. KATZ: -- in all this. We really need to have primary ethics clauses for all government regulators and other kinds of officials as we want to have for -- investigators. CHAIRPERSON FADEN: Save that for when we get to the forward looking ones. DR. KATZ: Yes. CHAIRPERSON FADEN: But I think your point is certainly worth -- we should keep in mind that it may be better to lead with something other than 18 people. That may be very, very important. I've got Ken and Pat. MR. FEINBERG: Sometimes broader language is better than narrower, detailed language. Listening to this debate, I like more and more the way the recommendation was drafted. I may agree with Eli that the language that would put in brackets that the rationale was unpersuasive might be changed to something along the lines of where the therapeutic rationale has been rebutted or has been -- CHAIRPERSON FADEN: Or was questioned at the time. MR. FEINBERG: -- found wanting or something like that. CHAIRPERSON FADEN: At the time. It has to be at the time. MR. FEINBERG: At the time, yes. But I hear what Duncan says and what some others have said, and I read this to mean that the therapeutic rationale at the time, if another forum: a court, the Congress, if somebody concludes that it was a sham or it was rebutted or the presumption has been overcome, and Henry's point, if there's causation, and we should put in the annotated part explanation -- CHAIRPERSON FADEN: It's there. MR. FEINBERG: -- the likelihood that there won't be many cases, if any. CHAIRPERSON FADEN: Right, right. MR. FEINBERG: Then I think that's the way to deal with this problem. I think we could stay here all night and come up with all sorts of examples debating the net value of the therapeutic research, etc. It seems to me another forum ought to do that. And what we ought to be saying is something along these lines; that when it comes to the therapeutic rationale, we'll pay medical -- we'll recommend medical costs if that therapeutic rationale just -- the Eli test that Eli would say -- even Eli would say it's bogus. DR. GLATSTEIN: Let me respond to that. I think what I could be very content with I think is if you could identify patients who were on studies who are damaged, who were not fully informed of the alternatives. CHAIRPERSON FADEN: It's going to be a lot of people. DR. GLATSTEIN: Well, I find that much more acceptable than the rest. CHAIRPERSON FADEN: Yes. DR. GLATSTEIN: If people haven't been honest with what the options are, I find that a good deal more acceptable than just taking patients who have agreed to studies, presumably where they have been informed, and then suffered an injury. CHAIRPERSON FADEN: All right, and this has, I think, come up now twice, the notion that the recommendation be altered to reintroduce evidence about consent as bearing on whether compensation is received or not, or provided or not is the right term. The way -- it's -- to emphasize what's on the table now. The way the recommendation is written now, the person who wants to recover would not have to show that they had not been adequately informed. And it wouldn't matter if the investigator could pull out a consent form from 1957 that had a whole bunch of information in it. It would only matter about the therapeutic rationale and whether there is an injury that can be attributed by whatever criteria of causation to the research experience. Now this is a recommendation to the government. We have that footnote that the people this morning emphasized they were so happy to see, which is it doesn't say anything about people being able to recover from other sources in the government, through litigation or what have you. Nothing is barred, nothing is given away. And it was presumably in that context that people would find out the consent questions. So that if somebody wants to sue Dr. So-and-so and Hospital So-and-so, then arguably, they would -- the issue of consent would emerge in that kind of litigation. We're trying to structure something that says from the government, because the government didn't have policies in place that effectively monitored research. We're going to let you -- we're going to give you this as a way of a remedy to the fact that the government wasn't doing things properly. If you reintroduce the notion of consent, okay, it's going to make it much more -- then you're going to get into this apparatus of consent by what standards. Do you mean by today's standards that they didn't give an adequate and full information, Eli? So it's 1954, and we're going to say if in 1954 they didn't provide people with the detailed description of all the risks and benefits and alternatives, then they should be able to recover. I mean, that's okay. I just want to point out that you have to come -- DR. GLATSTEIN: Let me try to clarify that. The thing I'm most concerned about is trying to make sure that patients who suffered injury from radiation are not handled any differently than patients who suffered injury from surgery or chemotherapy or a variety of other approaches. Right now, we're making radiation medicine's bad boy, and I want to be careful we don't do that. I don't think that's particularly right. MS. KING: Do we have any cases that fall arguably within this recommendation? CHAIRPERSON FADEN: If you look, let's see, on implementation, lines 12 to 23, there are several cases put forward where the fact situation needs to be resolved on a patient-by-patient, or a subject-by-subject basis. And we haven't been able to do that because if you're a candidate for this, depending on how this would go, there are four, I believe it is, candidates of experiments that might well fall -- this is page seven, lines 12 through 19. MS. KING: Well, it occurs to me that we're spending a great deal of time dealing with something in the abstract in the sense that when one does perspective stuff like this, you usually have a fact situation in mind that you could extrapolate from to make a more general principle. And the difficulty that we are getting into is that we'd be going on a circular motion. If we have cases that we're trouble about that we have not been able to resolve. And if they're resolved in a certain way, we think that we would recommend to the Congress that there be compensation. You know, that's what we should say because this question of specifying the category without having a factual date is what's getting us into trouble because we're trying to anticipate all of the infinite arguments that could be raised. We'll never craft a recommendation that way. CHAIRPERSON FADEN: You know, I've thought about that a lot, Pat. And I'm not sure that's what's at issue here. What's at issue here, at least for some people: Ruth and Duncan in their E-mail and others, is whether these four experiments, where we couldn't get down to the fine points of the fact determination. But if they break a certain way, they would be covered by this reg. And they could become the focus. And we could say if somebody can look at this case by case, you know patient, whatever, don't address the question of -- that's Duncan's put on the table, which is whether people who are in a situation where they might have benefitted, but were harmed, ought to be, at our recommendation, also candidates for compensation. MS. KING: Well, I would make the same point about Duncan's concern. And that is that our dilemma keeps coming from trying to be speculative. And my view is -- maybe I'm too practical, but I believe in the art of the possible. If we have things that concern us, and these are the cases that concern us, these cases have attributes -- CHAIRPERSON FADEN: Right. MS. KING: -- that's what we should deal with. Because we are wasting, in my view wasting, but all would agree we're spending, a lot of time. CHAIRPERSON FADEN: I agree. MS. KING: And the recommendation, that when I listen to the conversation carefully, goes to the what ifs. We will be here all day. I -- and not make any progress. I would prefer not characterizing it so much. It's one of our big recommendations. I would have an area where the committee is concerned, troubled, whatever you want -- CHAIRPERSON FADEN: The following -- MS. KING: -- and say what we think. And if you want to call that a recommendation, fine. But I would do it that way rather than trying to construct the category, which is very hard to do, and then say if you come along and fit into these categories, because now we're trying to anticipate all the variety of things that might come up, then action follows. CHAIRPERSON FADEN: Well, it's easier. It's easier to do. There's no question about it. It's easier to do. And it basically would take the rationale -- the first paragraph on page five, lines -- the first full paragraph, lines ten to 20, is the rationale that underlies why those four experiments trouble us. I mean, if the fact break a certain way, we are worried about them because they fit something like this description. I mean, they could come afterwards. You could retain a lot of it. MS. KING: You could retain a lot of it, but you wouldn't spend all your time worrying about the wording and -- DR. GLATSTEIN: I would argue that the -- it comes down to the individual circumstances, and that that's best assessed not by a committee decision, but by a court of law. CHAIRPERSON FADEN: Well, we don't -- if you look at what it says on implementation, we would then pull that out to follow Pat's new suggestion, and say look, here are the four that trouble us because they may have these attributes, and they trouble us in different -- for different reasons. So we get the TBI one, the Vanderbilt one, the I-131. Is it three or four? Pardon? MS. KING: And prisoners. CHAIRPERSON FADEN: And prisoners. So there's four. And these are the four, and they trouble us for the following reasons. And you know, if it -- in the case of the prisoners, it's if anybody in fact has been harmed, which is still an open issue. So if down the road, somebody gets testicular cancer, we think there should be -- and it's determined by whomever that the testicular cancer is attributable to their radiation exposure. So that would be a way to go. Now we don't have to get into a whole defense of why we're not dealing with the therapeutic context, because we have not had a therapeutic study. But the implication would be though, because the way the TBI is set up, that what's at issue is the therapeutic argument was found unpersuasive at the time, that essentially it would be -- MS. KING: That's fine. You know, there's language unpersuasive. It's fine. It's just not an admissible recommendation, Ruth. If you're describing -- CHAIRPERSON FADEN: Right, okay. MS. KING: -- if it's a term used in context. CHAIRPERSON FADEN: All right. So that is a proposal. Let's see, to replace recommendation -- MS. KING: And to the extent that we -- in the remedies section for subjects, I would have, and you can do it any way, an area where the committee is struggling, we can't resolve cases final. And I would describe what our problems are. I would describe that they need fact-finding and I would say something that the facts indicate that we believe should follow. And without trying to do the -- set it as a principle and then trying to fit it into it, I don't know if that makes sense. CHAIRPERSON FADEN: I haven't heard from my colleague, Attorney Feinberg, over there who is -- DR. GLATSTEIN: He couldn't take it. MR. FEINBERG: Fine. CHAIRPERSON FADEN: Fine? Yes, I think we need -- MR. FEINBERG: Going from the general to the specific, a cardinal principle of American jurisprudence. MS. KING: Thank you. CHAIRPERSON FADEN: It would take some work. It's not going to be so easy to do, but this -- is it the will of the committee, and I don't think we can pull it off between now and maybe by the third day at the meeting, I don't know, to try rewriting it, something along the lines Pat has said and see what happens? MR. FEINBERG: Fine. DR. MACKLIN: Could I just understand this? CHAIRPERSON FADEN: Ruth, was -- do you have? DR. MACKLIN: Rewriting it along those lines means starting with a specific -- CHAIRPERSON FADEN: No, I think -- I'm not sure what you would start with. DR. MACKLIN: I don't understand. CHAIRPERSON FADEN: I would think -- I would still lead with the notion that what's in the context -- what's being said in that paragraph on page five is what's at issue here. The committee -- lines ten through 20, okay? And we have -- DR. MACKLIN: But this category was not arrived at out of thin air, or out of the vapors of philosophy. We come to the category as an inductive method from the cases. CHAIRPERSON FADEN: From similar cases, that's correct. That is correct. That's -- DR. MACKLIN: From the cases, and you've heard the testimony and the allegations. CHAIRPERSON FADEN: -- right. That is correct. DR. MACKLIN: So -- MS. KING: But the problem is we can't -- we don't have enough. It we had enough data on the four cases, we would not be having this argument. That is what the problem is. But if the cases are suggestive for us of an area that needs to be resolved, we can't resolve it. And not being able to resolve it, we can't give contexts to unpersuasive, and we can't give context, it seems to me, to some of those terms. That's what's troubling people. CHAIRPERSON FADEN: No, I think that's not -- again, I don't think that's right. What's troubling people is the therapeutic research one. It's like do we have any -- do we want to say anything? And here, I think where your analysis or your strategy is important, Pat, is to point out to this committee that we haven't struggled with any cases. We haven't spent our time looking at cases that were unquestionably therapeutic research that had bad outcomes. We haven't focused on that. So we could simply have a rationale that says we're not commenting on whether compensation is appropriate there because we didn't focus on those. We focused on these kinds of studies for the reasons that are indicated in that paragraph, because they can really be very offensive. The notion that people would be used merely as means by the government to some other purpose is, you know, part of why we were set up. So we spent a lot of time of those kinds of cases, and so we have a recommendation about how those sorts of cases ought to be handled. MS. KING: I would do anything -- if that would end the discussion, I'd be happy with that too. CHAIRPERSON FADEN: Is that okay, and then simply say we're not talking about the therapeutic because we didn't focus on that? MS. KING: I didn't understand -- I was trying to comment on Duncan's problem. CHAIRPERSON FADEN: Right. We didn't agonize over that issue. It's a very complicated issue. It's like trying to resolve it in five minutes when it's taken how many different people who have looked at compensation in the context of medical research forever to figure out so we could have something that says the reason we're not commenting on it is because we haven't focused on that problem. We have focused instead on the kind of research in which people have been used for purposes other than their own benefit, because that's the problem that set us up in the first place. MS. KING: That's fine. DR. THOMAS: Well, I understand that. Let me be clear as to what it is we finally end up recommending. It sounds to me like we're saying that even in the case of the non-therapeutic research, there are all these uncertainties like whether the therapeutic intent was persuasive and whether there is a colossal connection with the harm and all of these other things which we can't resolve in any specific instance. And we're going to have to leave that up to the courts anyway. And we're saying the same thing basically in a therapeutic context. CHAIRPERSON FADEN: Right. DR. THOMAS: That people still have their right to their day in court. CHAIRPERSON FADEN: No, I think the difference is this. I would take it, and maybe we need to frame this more plainly, that let's say there's a suit against an institution. And in that suit, the facts are determined in a certain fashion and the recovery is from that private institution. Our recommendation is to the government. DR. THOMAS: Right. CHAIRPERSON FADEN: The government ought to then also do something to those people -- DR. THOMAS: Right. CHAIRPERSON FADEN: -- for those people. We are not saying that analogously for those in the therapeutic context. We're not commenting on the government's responsibility in the therapeutic context because we haven't focused on that arena, we haven't investigated any of those cases, we haven't deliberated hard about them, okay? There are other reasons, but they don't have to get into where the committee disagrees about how to look at therapeutic research and how it valued it or not, but simply to say we couldn't do the refined fact-finding subject by subject. But in an arena in which that's done concludes the following way, then the government should, of its own initiative -- DR. THOMAS: So you're arguing that -- CHAIRPERSON FADEN: -- even if the government isn't sued. DR. THOMAS: -- that in this case, they ought to be able to recover? CHAIRPERSON FADEN: Right. DR. THOMAS: We're saying that they should not be barred from suing the government. CHAIRPERSON FADEN: Well, the government should take the -- well, I mean my view is if -- let's say there's litigation and it comes out and it falls out in a certain way involving any one of these. Then it should be quite appropriate for somebody in Congress to propose that there ought to be some kind of compensation bill or an apology given to these people. DR. THOMAS: All right. Now would you -- in the hypothetical situation that someone brought a therapeutic case to the courts -- CHAIRPERSON FADEN: Right, we're not commenting. DR. THOMAS: -- and won -- CHAIRPERSON FADEN: We're not commenting on how the government -- DR. THOMAS: -- in the course of that litigation, we were able to establish that this bad outcome happened as a result of government funding without adequate safeguards, you would not preclude, in that situation -- CHAIRPERSON FADEN: No, but -- DR. THOMAS: -- the government taking the same action, would you? CHAIRPERSON FADEN: No, but we're not recommending that they do. We're just not saying. That would be the force of the difference. DR. KATZ: Can I ask Pat a question? CHAIRPERSON FADEN: Okay. DR. KATZ: Because what you said -- am I to understand that what you were saying more generally is that we should state more clearly what our concerns are and speak also about many of these things in terms of our concerns and about what troubles us about the other thing, and state it, not in terms of necessarily having established all the facts because we can do that. But these are the major issues. And if they -- these are the major problems that concern us. And if that is what took place, then we have the gravest reservations about what happened? Is this what you're saying or not? MS. KING: That was what I was initially proposing because I'm concerned about the abstract nature of this. On the other hand, I'm much more interested in moving this along. CHAIRPERSON FADEN: Yes, I am too. MS. KING: And if the recommendation now reads as follows, because I don't know -- make sure we agree to it, "The Advisory Committee recommends that a human radiation experiments at the time did not involve prospect of direct medical benefit to the subjects and in injury resulted" -- you see, I think if you leave -- CHAIRPERSON FADEN: Right. MS. KING: -- "that the government should deliver a public and private, etc., etc." I'm willing to go with that because that's nice and clear. But yes, you understood me correctly the first time around, but the people like this better and I'm perfectly comfortable with this in leaving therapeutic aside. CHAIRPERSON FADEN: All right. I think what will happen is the following. Let's put it this way, this is what will happen, okay? (Laughter) CHAIRPERSON FADEN: We are going to have to leave this recommendation. We are going to get out of the rationale that it tries to make this big distinction between therapeutic and non- therapeutic, and ground our commentary in what we've studied, and therefore, why we have an opinion and have some sort of footnote, rather than fight with others on the committee about why I think it should be this way and why he thinks -- since it's much ado about nothing in many respects, which is to put it in a practical sense, not in a philosophical sense. We will redo it. We are keeping the gist of the recommendation, and we're going to highlight these four cases and bring them up forward. And I think that will do it, but of course, everybody will have a chance to look at the final language as we put it together and see. We need to go on to the population-wide recommendations, which we're going to do now. We're scheduled to go until five o'clock. That's an hour and a half. I mean, obviously if we need to take some time tomorrow, we will. But it would be nice at least to make a big dent. We probably -- I hesitate to say we should take a break because our breaks tend to take about 15 minutes. So if people would get up and get a cup of coffee if they want and come right back, we're going to just launch right into it. But we're not going to have a break if that's all right. Intentional releases is the next one -- does it matter? Is there a logic to the order in which we ought to take these out? I don't know that there is, but Duncan, do you want to -- does anyone have a view about the order in which we should take up intentional releases, A-bomb experiments and -- releasing uranium mines? DR. THOMAS: My gut sense is the two most controversial ones will be the atomic vets and uranium miners. I'm not sure in which order. CHAIRPERSON FADEN: All right, how -- DR. THOMAS: Maybe we should do them first. CHAIRPERSON FADEN: All right. We should do them first in that case. Now the atomic vets recommendation, experiments in connection with A-bomb tests come in two ways. There is text beginning on page nine of the chapter, and then we all received a fax that was dated June 13th with 5(c) and 5(d). Maybe it came in a package. I'm sorry, not in a fax. It came in a subsequent mailing. So there are four parts to the recommendation for experiments in connection with A-bomb testing: 5(a), 5(b), 5(c) and 5(d). Does everybody have them? If not, we'll get copies. There are four parts. Two came with the -- actually, if you can look at your neighbor's, that would probably work just as well, if the person next to you has it, while Anna gets more copies made. All right, why don't we just start the discussion because we don't have any time to have it? All right. There are -- there's both the four recommendations and then there's all this additional text with these points and observations. All right, the floor is open for discussion of the recommendations with respect to experiments in connection with A- bomb testing. MS. KING: What are we reading now, Ruth? CHAIRPERSON FADEN: We're starting with 5(a) which is a new chapter. MS. KING: Oh, 5(a), okay. CHAIRPERSON FADEN: Yes, 5(a) is in our chapter and then there's 5(b) and -- 5(a) and 5(b) are in the chapter and then 5-whatever it is, (c) and (d) are what Anna is getting copies of for those of us who couldn't find the extra mailing. Okay, so that's where we are. So the floor is open for taking apart (a) and (b) or maybe (c) and (d). Is everybody happy with this recommendation? Eli? DR. GLATSTEIN: I'd like to recommend that we recommend that the Act delete the necessity to prove -- to reproduce the dosimetry. That seems to be virtually impossible. We don't know all the factors, and I think it's been a basis for rejecting claims that I think very likely are justified. CHAIRPERSON FADEN: Okay, so that's a change. You can do an addition to or replacing the recommendation. DR. GLATSTEIN: I'd just say the need to reproduce the dosimetry is irrelevant if they can document that they were exposed, you know, in terms of the actual explosion. CHAIRPERSON FADEN: Okay, so that's on the table. Does everybody -- I'm still waiting on people who don't have (c) and (d) DR. MACKLIN: That's 5(a)? We're just looking at 5(a) now? CHAIRPERSON FADEN: No. I think ElI's proposal is to add something. It's a new one so it would be in (e) or 5(a). So it's basically saying the statute should be changed; (a) says the statute should be updated -- should be updated to make sure that the epidemiological tables take account of new information. And this would be to say that the statute should be amended so that people wouldn't have to have -- DR. GLATSTEIN: Wouldn't have to reproduce the dosimetry. CHAIRPERSON FADEN: -- wouldn't have to reproduce the dosimetry. DR. THOMAS: Actually, the epidemiological tables per se do not -- CHAIRPERSON FADEN: Require? DR. THOMAS: Where is this? Are unequivocally covered by statutes. They just provide some scientific basis on which the Act is based. CHAIRPERSON FADEN: Okay. So that's the -- DR. THOMAS: So anything that we're going to say about the Act such as changing the list of presumptive cancers, really needs to be done separately. CHAIRPERSON FADEN: Okay. DR. THOMAS: This is a scientific statement that the tables ought to be updated. CHAIRPERSON FADEN: Okay, so that's separate. So this is finally a 5(d)(e), I guess. DR. THOMAS: Yes. Well, I think Eli -- DR. GLATSTEIN: In conflict with 5(c). CHAIRPERSON FADEN: Okay. Yes, the 5(c) is milder as I recall. DR. GLATSTEIN: Much milder. In fact, it's going the opposite direction. DR. THOMAS: I'd like to keep 5(c) quite separate. CHAIRPERSON FADEN: Well, wait a second. Not all of us have the 5(c) here, so -- my 5(c) just went to get xeroxed. DR. THOMAS: 5(a) says, "Based on the world literature", not on follow-up of atomic veterans. There are these tables about probability of causation. Those ought to be brought up to date. 5(c) is quite separate and it says, "Furthermore, there ought to be further epidemiologic studies using better dosimetry methods." CHAIRPERSON FADEN: So it's not in conflict. It's just different. DR. THOMAS: Yes. And I think the point that Eli and I are making is there ought to be a 5(a') in here someplace which says, "In addition, RECA ought to be updated." And that would entail a) reconsideration of less, compensatable diseases; and b) elimination of the requirement for dosimetry construction. But it's essentially a distinction between the so- called -- what's it called -- presumptive cancers and the others. CHAIRPERSON FADEN: Okay, I've got Ken. MR. FEINBERG: I sent a memo around to the committee members raising a question of Henry and others and Eli, asking whether or not recommendations pertaining to review of dosimetry methods, dosage levels, etc., made any sense as a matter of public policy? Was it going to likely result in any improved statistical fact gathering that would make the Act more credible and more valid in its compensation decisions? And before I would agree to certainly 5(a) and certainly 5(c) and (d), I would like to have a little bit of discussion on whether these recommendations are meaningful as a practical matter, or whether or not we are just falling into a black hole here where once again we're placing too much reliance on epidemiology and science, and the results aren't going to be any different. They're going to be ignored by the Congress, and we're just spinning -- we're just repeating -- deja vu all over again. And I'd like to hear what -- I had sent this memo around just asking this question. If the scientists on this committee think something good is going to come out of this, I'm perfectly willing to go along with it. I am dubious, and that is why I was intrigued by ElI's point, which basically as I heard it was, forget all of this talk about dosimetry and dosage. Were you exposed? If you were exposed, then you are eligible. And that's a recommendation. That's fine. But I'm concerned about the methodology in the recommendation. DR. GLATSTEIN: All those methodologies make some basic assumptions. And basically, it comes down to a best-case scenario and a worst-case scenario, a range of doses. And I don't think anything positive really would come out of it. CHAIRPERSON FADEN: We've got Henry and Duncan and I don't know who else. Henry, on Ken's point or any of it, as long as it's on -- DR. ROYAL: In terms of 5(a), I don't have any objections to 5(a). 5(a) is to update the epidemiologic tables. And I think that basing compensation on probability of causation is the only equitable way of attempting to give compensation. Maybe I have the wrong concept of compensation, but it seems to me there's going to be a pool of money that's going to be available to the atomic vets. And the advantages and disadvantages of having a liberal criteria versus a strict criteria is that if you have a liberal criteria, people who should be getting the money because their cancers really were caused by radiation end up getting less money. If you have a liberal criteria -- I'm sorry, if you have a strict criteria, it's possible that some people who should have been compensated won't be compensated. And I mean, if we had unlimited -- an unlimited amount of money to give everyone money because they were sick, that would be fine. But if we have a limited amount of money, then it does seem to me this whole issue of what areas do you want to make is an important issue. And if I heard Eli right, he believes -- I think I heard that he believes that any veteran that develops a cancer which is potentially radiogenic should be compensated. DR. GLATSTEIN: I think that if -- DR. ROYAL: What is to be exposed -- DR. GLATSTEIN: If they were there. I think that if you can -- I think that trying to reproduce the dosimetry is an obstacle course, and I think that the means by which the dosimetry is reproduced has so many assumptions in it. Now I don't think the numbers mean a damn thing. DR. ROYAL: Yes. I think there have been a few communications from the staff that have implied that there were many flaws in the dosimetry. And it's very interesting if you actually read the IOM report, what the flaws are. The flaws, by and large, in the dosimetry is that the reason that the dosimetry was collected in the first place was because they needed some documentation to show that the occupational radiation exposure limits had not been superseded. So when you're badging people for that reason, the people who you're going to badge are the people who are going to be in the most hazardous areas. And those people who are in the most hazardous areas, if you can show that they did not exceed the expected radiation dose, then you can be competent that people in less hazardous -- so one of the things the IOM report says is that the dosimetry is not very good for epidemiologic studies because there's a systematic over-estimation of the dosimetry. And one of the things that you were sent around is despite the systematic over-estimation of dosimetry, there's a histogram that you've been sent around that shows that the median dose to the atomic veterans who were there on the battlefield was 600 milirems. And I'm having difficulty with the justice issue of compensating people who have been exposed to 600 milirems because they developed cancer, given that we're all exposed to 300 milirems a year. If you live in Denver, you get an extra 100 milirems per year. There has been -- it's such a small dose. And this is actually one of the things I dislike about this -- about the report, is again, we don't distinguish one radiation experiment from another radiation experiment, one radiation exposure from another radiation exposure. It's just that the atomic veterans were really exposed to quite a small dose. And the problem with the dosimetry in general has been that's it's been over-estimated. As a mater of fact, again the IOM report says that when a veteran puts in a claim, that usually the benefit of the doubt is given to his individual dosimetry. So if there's a choice between a high number and a low number, he gets the high number, which is great in terms of being conservative and making sure that that is probably -- the causation has not be underestimated, but is lousy if you're trying to do an epidemiology study. So I think that if we spent millions of dollars doing dosimetry and epidemiology, what we'll find out is that the risk is smaller than we thought, and I just don't see where that's going to get us anywhere. CHAIRPERSON FADEN: Well, let me just see if I can understand. I've got Duncan and Ken waiting, but if I can unpack this so I'm sure I understand what's happening? On the table are several different things. One is the proposal that there be an updating of the epidemiological tables, which -- DR. ROYAL: Not a problem. CHAIRPERSON FADEN: Okay, big deal. No one seems to be -- there there is on the table a proposal that isn't reflected in the text here that the dosimetry requirements be dropped from -- the Act said that all you had to do was show you were there. And then Henry has just given us an argument why that may not be an appropriate response. DR. ROYAL: Yes, but why aren't we doing that for any of the other radiation experiments? Why do -- what the recommendations say is that you have to show that harm was done, and here we're saying that you don't have to show that harm was done. We're just going to assume that if you develop cancer, that it was related to your exposure as a veteran. CHAIRPERSON FADEN: And then there is, just so I get clear on it, then embedded in here are proposals that there be more epidemiologic studies or other kinds of studies, which is not -- MR. FEINBERG: A point of information, not a question. CHAIRPERSON FADEN: Okay. MR. FEINBERG: A question for Henry. If you're going to argue that mere exposure in this context is not sufficient, as Henry has just articulated, as opposed to Eli saying let's do away with dosimetry mere exposure is sufficient, I'm asking Henry just a question which is, what is the alternative? What is his approach? Is his approach buck it to the very Congress that enacted the law in the first place? Is his approach -- I have to know, I'd like to know whether we go all the way from Eli saying a presumption: if you were exposed, you're eligible -- CHAIRPERSON FADEN: If you got a radiation -- MR. FEINBERG: -- all the way to the other end of the spectrum. Duncan is saying, let's get state of the art dosimetry and dosage and really look at this from a scientific point of view that's credible. And Henry is saying I don't like either. So I'd like to know from Henry what is his solution? DR. STEVENSON: Can I just ask one clarifying question? CHAIRPERSON FADEN: Sure, Mary Ann. DR. STEVENSON: What is the threshold now? Duncan will know. I mean, as it stands now, what does the Act require? Or does anybody know? It doesn't have to be Duncan. DR. ROYAL: Fifty. It's supposed to be -- the probability of causation is supposed to be 50 percent. In reality, my understanding is that because the benefit of the doubt in the dosimetry goes to the veteran, that the probability of causation is probably considerably less than that in order to get compensation. CHAIRPERSON FADEN: Well, there are two ways to do this. This is the presumptive measure. DR. ROYAL: Yes, I think you're wrong about that. DR. STEVENSON: Right, because isn't there a presumptive list that doesn't require a dosimetry? DR. ROYAL: Yes, the presumptive list requires no dose. DR. STEVENSON: That's what I thought. DR. ROYAL: And the non-presumptive one, there is a minimum dose which we're just -- MR. GUTTMAN: Anytime you talk about this -- needless to say, this is not our direct mandate, but I have been told that it's five or four, but it's in that range. DR. STEVENSON: Okay. So the issue really is that -- MR. GUTTMAN: I wouldn't want anything I said -- DR. STEVENSON: This is always right. MR. GUTTMAN: Right. DR. STEVENSON: So really there's a group of cancers that do not require any sort of dosimetry? CHAIRPERSON FADEN: Already. DR. STEVENSON: Already. The question is whether you want to open that window a little bit more -- CHAIRPERSON FADEN: That's right. DR. STEVENSON: -- and how much more. I presume some of the ones that are knocked off the list would be things like lung and colo-rectal cancer, which have a high natural instance - - CHAIRPERSON FADEN: That's right. DR. STEVENSON: -- depending on your environmental exposures. MR. GUTTMAN: Parenthetically, this is a conversation Pat Broudy and I had, we all know Pat Broudy, last week. And the basic trade-off is between, you know, a system that some of the vets see as a complete bureaucratic boon-doggle with contractors doing all these, you know -- and versus look, we were there. Let's get it. And the question is how you can -- CHAIRPERSON FADEN: One of the things you can do is you could have a modification between these two. And I don't mean to presume -- Henry's got to answer a key question. DR. STEVENSON: But I think you have to sort of address practical issues. I mean, no matter how many times you did the dosimetry, lung cancer is still going to be compounded by the fact that there's a huge smoking influence. So it seems like a complete and utter waste of effort to -- CHAIRPERSON FADEN: One issue -- I suppose people have thought about adjusting the level of compensation downward -- DR. STEVENSON: Right. I mean, it's more for greater or fewer for -- less for more or more for less. CHAIRPERSON FADEN: So for the more common cancers, if you got rid of a dosimetry requirement and you forgot -- and you didn't worry about whether they were smokers or anything else, the award would be less. Whereas, if it's from one of the ones where it's a less common cancer, the award would be more, and they could all be on a presumptive list. The problem is how far we can get into this. I mean, what we're doing is -- DR. STEVENSON: I mean, just in terms of dollars and cents, the amount of money that's going to be spent on redoing dosimetry -- CHAIRPERSON FADEN: Well, that's the issue. I mean, you get into this, and I think that's what we're hearing is there's more money spent on studying it. In the meantime, you see people who are dying. And that's a real-time problem. If we're concerned that something is not -- you know, I hear two things from taking away, and the reason we're in this in the first place is that we can't separate the vets that were in radiation experiments in conjunction with A-bomb testing from everybody else. It's sort of all a smush. And that's part of how we got into this in the first place. We've heard complaints, both that it take so long for these claims to be processed -- that's a different kind of problem. MR. FEINBERG: We'll get to that in a second. CHAIRPERSON FADEN: Right. MR. FEINBERG: I mean, I think the record is absolutely -- have we heard from the VA on this or have we heard from some vets? DR. STEVENSON: And again, there is the problem with the cancers that are not on the list -- MR. FEINBERG: Well, what are we -- DR. STEVENSON: -- or the cancers that you need to prove your case, that the -- CHAIRPERSON FADEN: Here's the mildest position we could take. We could say we have heard, okay, from numerous witnesses that there are problems of the following sort. We are concerned about these problems and we recommend that the Administration promptly address these problems, fix them if they're there, okay? That's, you know, not very profound. But it bases -- as we've been listening here, the kinds of problems we've been hearing -- MS. KING: But it is based on -- I am going to point out that it is based on the evidence that we have. And this is one of the things that troubles me in some of these areas. The evidence that we have is witness testimony, and we have to be very careful about this. MR. GUTTMAN: Oh, right. It takes a long time, yes. CHAIRPERSON FADEN: I mean, the VA has acknowledged to us that it takes a long time for a plant to process them. They have not denied this. They said it takes 20 to 24 months, I believe, is what they told -- DR. STEVENSON: Did they tell us why? DR. THOMAS: Technically that's -- DR. STEVENSON: Did they tell us why? DR. THOMAS: Yes, because they don't have any people. CHAIRPERSON FADEN: They don't have enough people for the process. MS. KING: But this presumably is for the cases that must be proven. They're not the probable causation -- MR. GUTTMAN: Just to be clear so that the VA doesn't jump down our throats, the 24 months referred to the appeal. I don't know that the reality of the underlying District Court action is. DR. ROYAL: One other factor you might want to know about the process is, is according to the IOM report, then a veteran puts in a claim, instead of having his group dosimetry, they had an individual dosimetry done for him. And that costs $3,000. And there are 250,000 atomic veterans. So if multiply $3,000 by 250,000 -- DR. THOMAS: But that's just the wrong calculation entirely because that's not what the IOM is recommending for use for epidemiologic purposes anyway. DR. ROYAL: I was referring to the reason that it takes the VA 24 months. That's a considerable amount of record- searching that has to be done in order to do these. Rather than answer Ken's question, which was to provide a solution, I just want to make sure that everyone understands the problem. The problem is that you have these 250,000 -- this group of 250,000 people, of which 25 percent of them are going to die from cancer. And of that -- so 25 percent is, what, 60,000 people, something like that? In that population of 60,000, there may be, if you did calculations based on what we believe the risk estimates are, may be 50 or 60 people who will die of a cancer that's related to the radiation exposure. So the problem is that we have 60,000 people who are going to be dying of cancer. And in that population, there's going to be a certain small number that truly have been harmed. But there's no way to identify those few people. So the dilemma that you're faced with is what is a fair thing to do given that you have a large -- CHAIRPERSON FADEN: And you throw in the other reasons why these people might be candidates for compensation like the fact that even though only a subset, and we can dispute from -- whether it's 60 or 1,000 or whatever, but some subset of those people's cancers will have -- of those that will die of cancer will have been caused by their exposure. But then all of these people who have been agonize, I mean anguished and made heart-sick by worrying about it and their families disrupted and the deep grief and distress, all that kind of stuff factors in as well. So when you talk about which way you want to go through the trade-off, there's a way in which all of them have suffered in ways that we can feel deep regret about, or at least all that worry -- some significant number have suffered, although only a small number, in fact, will have a cancer that results from their exposure. Now, I don't know how you factor that in, but I think that's what's animating behind, you know, some of our concern about this is that we're not only feeling regret about those whose cancers resulted from their tour of duty on a nuclear battlefield, but also because they've been made anguished and worried all these years about what's happened to them because of that experience. And we feel bad about that. And that's why there's a national apology that's already been made to the vets. MR. GUTTMAN: Not to the vets, no. CHAIRPERSON FADEN: No? Not to the vets? MR. GUTTMAN: It's in the Act. CHAIRPERSON FADEN: But it's not to the vets? MR. GUTTMAN: The vets got put in after the -- CHAIRPERSON FADEN: Okay, so it's technically not, so we can think about it. But any event, if you take that away, there's a factor there that underlies, I think, some of what we heard too and what makes it persuasive, maybe gets Eli to say what he wants to say, I don't know. But I'm concerned because we're again spending a lot of time on something that we -- what sounds before us is not what we want. The (a), (b), (c) and (d) is not doing it. That is clear. DR. ROYAL: Let Duncan go first. CHAIRPERSON FADEN: Maybe (a) is okay, but (b), (c) and (d) doesn't seem to be making anybody happy. So I don't know what to do at this point because this is like the fish and cut bait time. I've got Duncan. I'd like to hear from some other people who perhaps have not spoken, Pat, Duncan? DR. THOMAS: I want to come back to Ken's memo to the committee. Why do we want to do all of this stuff and try to answer all of those questions. First of all, with regard to why bother updating RECA -- I'm sorry, why bother updating the radiation -- radioactive epidemiologic tables? I think the first thing that needs to be said was that the Act was never particularly well-based on science in the first place. This, in part, represents the historical accident for the time in which they were writing the Act, and who happened to get certain Congressmen's ears at the time. And although the radio-epidemiologic tables were ostensibly commissioned for that purpose, I tried to show you in my briefing last summer that there is only a poor correlation between the sites that are recommended in -- that are high probability sites in the tables and those that are listed for compensation in RECA. So if nothing else, even if one didn't update these radio-epidemiologic tables, you could still have done a better job of writing the Act in the first place. But if you're going to rewrite the Act, you might as well do it on the basis of the latest available science. So I see no reason not to want to update the tables based on latest data, and then make a more informed judgement as to whether or not you wish to change the list of presumptive cases making them either more or less restrictive. And one could make arguments in both directions for different cancers. Now how do you use the tables? You have two options in front of you. For any given cancer site, you could use if as Henry suggested, to say that we decide at some probability of causation, we will compensate, or we're going to set up some kind of sliding scale. And we'll use the tables in a formal, mathematical way to decide whether or not or if so, how much compensation you get. And it will be a different formula for each site. The alternative is to say we don't have much confidence in the dosimetry constructions anyway, the point that Eli has been making. And so even if on average our formula was fair, it's going to be quite unfair for some individuals whose dose reconstructions are too high or too low. And therefore, what we will use the tables for is a guide for telling us which are the more or less radio-sensitive sites, and use that simply to identify the sites and then proceed presumptively, simply requiring whether you were there at the time. In my view, the latter is probably more defensible given that Congress has already gone down that road for some sites. And I leave open the question of what one ought to do for the moderately radio-sensitive sites, particularly moderately sensitive and very common sites, for which you may decide that you're really not prepared to compensate everybody with that. In any event, we're not the committee to make those specific judgements. So then I want to turn to the other half of Ken's memo which was, okay, if it's worth updating the tables, why do we want to spend all this money to redo the atomic vets cohort study? I accept all of the points that Henry has been making over the last few months about why you might not expect to get a great deal of scientific evidence from that. But I would argue that probably the best case I could make for doing this is that we have really very little scientific evidence about the risks from fall-out. Since all of our evidence is based upon other types of exposures, medical exposures and the atomic bomb survivors, who were not exposed to fall-out. And it our hedge that the atomic vets may have been exposed in ways that are unique to that population that we would otherwise not find out about. And so, should the cohort study demonstrate that that particular cancer is, indeed, convincingly associated with their radiation exposure, then that might serve to add a site to the our list of presumptive causes. DR. ROYAL: If I could just interrupt there. I don't understand what you're saying about fall-out. The IOM report said that the dose from internal radiation exposure was negligible. So what do you mean by fall-out? DR. THOMAS: I remain unconvinced by the argument that -- I just would like to leave that question open. It's -- CHAIRPERSON FADEN: My concern is that we're not all working at this with the same basic knowledge or expertise, and that's true for other recommendations as well. It's painfully clear with respect to this recommendation. I'm searching for some procedure that will allow us to speak as a committee. I'm not sure exactly how to do this, Duncan. I'm sorry, I didn't mean to interrupt. Are you finished? DR. THOMAS: I'm about basically finished. CHAIRPERSON FADEN: I've got Ken, Pat. Mary Ann, were you on the list? Ken, Pat, Eli -- now Ken, Pat, you've got it, and then Eli. MS. KING: We can't leave anything open because the barn door is about to shut, thank God. (Laughter) MS. KING: My suggestion is that we draft a recommendation directed to the VA which deals with veterans which calls your attention everything that has come to the committee's knowledge by subject area and ask that the VA consider making recommendations to the Congress to amend the 1984 Act. That is what I would do because we are not in the position to do anything specific as a committee. And the only thing that we want to do is to say that we take what has come to our attention seriously enough to put it in a recommendation form. And that is what the recommendation should be, not (a), (b), (c), (d) and (e). (A), (b), (c), (d) and (e) should be folded, I think, into a discussion of why we got to a recommendation that the VA has to review this with a view in mind to recommending changes n the Act, recommending to the Congress changes in the Act because that's the way it would go in the government. And that is what I would do. Or if you wanted an Executive Branch recommendation so you asked the President to direct the VA, that actually gets a greater clout on it. That's fine too. But that's the weight, that's the thrust this recommendation should have I think. CHAIRPERSON FADEN: That was basically what I was suggesting earlier, but you say it with more force. And we would illustrate the areas that are of greatest concern to the committee that need prompt attention. Please do something. Now Eli was waiting and now Ken. Eli? DR. GLATSTEIN: Yes, briefly. I would push to reopen the IOM study, but making sure that they have a list of the people who were there. Apparently, one of the problems with that previous study was they included people who weren't there and excluded people who were. And the numbers don't add up properly. And I would make the following point: I don't trust the epidemiological correlations for the very simple reason that there's an inherent bias in the mathematics. It's based on person and years of follow up. And they take the number of people and they multiply by the number of years. Inherent in that logic is the assumption that 50 patients followed from one year equals one patient followed for 50 years. Believe me, that ain't true. Now here you have a population of -- the reason I'd redo the IOM study is because here you have a population of patients with 40 years of follow-up. It's a circumscribed population. I believe the data to be generated from information about low dose radiation exposure, single, low dose radiation. It would be better than anything we'd ever seen. And if we the names of those people and chase them down, including those that are already under ground, we could find out whether there really is a cancer risk or not from the low dose exposure. And I don't believe that answer is clear at all. Do you disagree, Duncan? CHAIRPERSON FADEN: I'm trying to figure out whether you're agreeing with Duncan or disagreeing with Duncan. DR. THOMAS: I think we have a number of points of technical difference which we can talk about later. But we're both of us supporting the notion that there should be a continuation of the study. CHAIRPERSON FADEN: For a reason that I think is quite different than is of interest to the atomic vets, you're saying that this would be a source of potentially important information. DR. GLATSTEIN: Terrific information, in my opinion. CHAIRPERSON FADEN: All right. That's a different reason for recommending the study then, to think that it's in some way going to advantage the position of people who deserve compensation. DR. GLATSTEIN: I think we could put the issue to rest if we had the data. CHAIRPERSON FADEN: But the point is, you've got these people who are not -- DR. GLATSTEIN: Yes, for the time being, I want to give them the benefit of the doubt. CHAIRPERSON FADEN: All right, and that's the issue. DR. GLATSTEIN: Yes, yes. CHAIRPERSON FADEN: All right. So we want to lay the thing out and the issue -- let me hear from Ken. Let us all hear from Ken and then see if we can go back and get closure on Pat's thing. MR. FEINBERG: I very much endorse Pat's solution to this problem. I think it's the most realistic pragmatic solution. I would only suggest in the interest of pragmatism that the recommendation not go just to the VA where there's a lot of criticism as to what happens if it goes to the VA. I'm not saying it's valid or not. It's just criticism. And it ought to go to the Administration and to the Congress as well and let them decide to what extent these allegations are worthy of follow-up. MS. KING: I would say the drafting though -- that the guideline to the drafting should be -- we have to be clear about what we sort of think in some loose sense in terms of our impressions. And a distinction between the greater expertise some people on this committee have in this ares than the others, this is a committee statement. So it really needs to be quite specific in terms of what has come to the committee's attention. And it can come from us. I mean, it can come from individuals, from other committee members. CHAIRPERSON FADEN: Sure, of course. MS. KING: What has come to our attention and try not to be -- I haven't read the IOM study. I haven't -- couldn't follow it if I could read it. But I want to be careful about making statements about the study and about its assumptions unless the committee is willing to make a statement about the study and its assumptions. I want to avoid this kind of -- you know, that in the description. CHAIRPERSON FADEN: Okay, this is fine, Right. What I'm hearing then is we will redraft this recommendation directed to all three of the agencies identified by Ken with specific examples of the sorts of issues that are of great concern to the committee based on what has come to its attention. What I'm also hearing is at least two members of the committee suggesting that we -- recommend this follow-up study. But it's for a different purpose, is what it sounds like. It sounds like it's for the purpose of learning more about the actual effects of one time, low dose exposure. That really is not -- would not, in my view, be folded into under the atomic bomb testing things because it's not directed at advancing their interest or resolving an injustice with regard to that population. It's saying that there may be something useful that comes from such research and the committee would be interested in seeing that done. MS. KING: But you might want to put that here, Ruth, because if you're going to make a recommendation like that and you think it's a serious recommendation, it takes a lot of time developing and discussing and talking about it. And I don't think we have that time. So I would, in fact, say that two committee members in the discussion of this issue suggested that we think this is a suggestion worth thinking through more clearly in terms of the broader impact that it might have. Because if you think about elevating it to a committee recommendation, that creates another problem. CHAIRPERSON FADEN: In terms of educating the rest of us? MS. KING: Right. CHAIRPERSON FADEN: Well, we'll figure out how to package that, either independently with the work that that would require, or within the general recommendation to the Administration and Congress. This is not going to be as easy as it sounds, but at least it gets us off the particulars of whether we're going to recommend (a) or (b). We're going to say here are the problems and here's -- and they need immediate attention, so please do it. Okay, that takes -- what was the other one, Duncan? DR. THOMAS: Uranium miners. CHAIRPERSON FADEN: All right. Uranium miners is also in that hand-out, which is where? DR. THOMAS: There should be two pieces to this one, which I'm told have been distributed. There's a one-paged one that was faxed I believe in a package together with numbers four and six. And then there's another one I'm told went out the same day, I didn't get a copy for myself, dated June 17th. CHAIRPERSON FADEN: Well, we want the June 19th. We don't have Steve here. He was in charge of putting that together. Jeff, is Steve outside? Could you ask him to come inside? DR. THOMAS: Steve said -- I just checked with Steve at lunch and he said it went out just before this one did. CHAIRPERSON FADEN: What does it look like? Can you hold it up? DR. THOMAS: It says "Suggested recommendations for compensation for uranium miners." Have you guys seen this or not? CHAIRPERSON FADEN: It's our understanding that this does not supersede this. DR. THOMAS: No. This is to provide the rationale, the background, for the recommendation. CHAIRPERSON FADEN: It draws on -- this is your analysis that -- DR. THOMAS: Right. This is the source document on which the recommendation was based. CHAIRPERSON FADEN: Let's start with the recommendation and see -- DR. ROYAL: This is number seven? CHAIRPERSON FADEN: Yes, we're on the recommendation of uranium miners. Right. It is uranium miners, start with that, and it's the June 19th -- yes, and it explains -- does everyone have the thing that Anna distributed so we all have it? What Duncan is referring to, if I'm remembering correctly because I worked with Steve on this at the last minute, is the reference, for example, to the radon and lung cancer risk study. That context is provided by Duncan, among other things, in this thing we're trying to track down that should have been sent to you, but we don't know what happened. I thought it went together. MS. MASTROIANNI: We were informed that it was sent to the full committee, but I'll make copies of it right now. It's kind of long though, so I don't know if you want to postpone it or -- CHAIRPERSON FADEN: I don't think we can postpone it. I think we should go ahead and try -- DR. THOMAS: Well, we could -- we, I suppose, could to the other two. It's not going to take more than -- CHAIRPERSON FADEN: Well, if people haven't read it, they're not going to be able to read it in the context of this discussion. DR. THOMAS: Oh, that's true. CHAIRPERSON FADEN: So there's no way. I think we should just plunge right into it. And I'm afraid, Duncan, you're going to have to explain. DR. THOMAS: I can do that, but I want them to have it anyway. CHAIRPERSON FADEN: Oh yes, that we'll do. All right, let's start with the recommendation itself, okay? And then we also had -- and see what's at issue here. DR. THOMAS: The recommendation makes two rather apple pie kinds of comments, which I think actually need to be stronger. But I don't have any problem with them in as far as they go. The first recommendation is that the criteria ought to be reviewed to see whether or not they're consistent with the latest scientific knowledge. And the second is that the documentation standards ought to be liberalized. MR. FEINBERG: No, that's not what it says. DR. THOMAS: The second part. MR. FEINBERG: The second part doesn't say the documentation standards ought to be liberalized. It says to determine whether fairness demands that they liberalized. DR. THOMAS: Yes, yes. Thank you. MR. FEINBERG: Big difference. DR. THOMAS: That's right. CHAIRPERSON FADEN: Now again, it came to what we -- DR. THOMAS: Now I didn't write this recommendation I'll have you know. CHAIRPERSON FADEN: All right. In line with what you just had -- the discussion we just had with respect to experimentation in conjunction with atomic bomb tests, presumably what's missing here is to whom is this recommendation directed? It would be the same thing again. Right, it would be just like the one we just talked about, that the President -- in this case, it would not be VA. It would be the President and Congress or whomever. DR. KATZ: But how did you feel it should be liberalized? DR. THOMAS: Well, I feel it should be -- I'm not going to speak specifically to the documentation standards. We had a little bit of discussion about it this morning. And I think the committee is well aware of what are some of the difficulties that people have in meeting the documentation standards, and that speaks for itself. CHAIRPERSON FADEN: We could handle this exactly the same way as was being proposed for the atomic vets. Here are the issues that have come to our attention about which we have very serious concerns. We think they need to be handled immediately. DR. THOMAS: Well, the point I'd like to make is that the first sentence I would like -- I would argue for making stronger. It's not simply that someone ought to review the criteria to see whether or not they are in line with the latest scientific evidence. I'd like to see a stronger statement to the effect that indeed, they are not -- they are too restrictive. We are not the ones who proposed the specific alternative standard. But the point of my four-page note here is to outline a number of strategies which we might endorse for recommending compensation criteria. And why don't I just outline what I see s the four possible strategies? The first strategy is a let's base it on the probability of causation principle. But in view of all of the various uncertainties that are involved, which are discussed in the first couple of pages of my note, let's not require a 50 percent causation, which is approximately what the law presently asks, but set a much lower threshold. Ten percent, 20 percent, five percent, you pick a number. We leave that decision up to Congress of course. The second one is to say well, let's not follow the probability of causation specifically, but let's review what are all the possible levels at which one might conceivably, well not conceivably, might realistically attain a 50 percent probability of causation. In some miner groups, that might be 500 wlms. In other miner groups, it might be 10, 50 wlm. Decide what that lower limit is that would unlikely to be unfair to anybody, and set your compensation criteria at that level. The third strategy -- MS. KING: I want to ask a question. I have a real problem, and that is the recommendation, the way it's developed, I like because it's neutral. It calls for a review. It doesn't direct, as some of your comments are doing, the direction in which the review should go. So I have a dilemma. And the dilemma is if we sit and discuss what you're proposing as a direction in which the review should go, I'm not going to be in any better position say yes, I'm ready to go with that, than I am now. And so what I want to ask before we go through that is I know you think it should be stronger, but stronger means going in a direction. And what I want to know is what is the justification for going in a direction? You're telling us how we can do it. I don't -- why should the committee go -- DR. THOMAS: Well, this is very frustrating for me to try to lead this discussion with, you know, a very carefully thought-out document which makes the case very forcefully. Yet, the current standards are far too restrictive, without anybody having had the opportunity to see them. CHAIRPERSON FADEN: Well, a couple of us read it, I guess, but not everybody got it. DR. THOMAS: So, it's difficult for me to respond to that point. I agree with you that our purpose is not to specify the mechanism by which Congress decides to liberalize it. Although, I, for one, actually think it would be helpful to at least have a brief discussion of the different approaches they could take. And I would like to have the opportunity just to finish out the other two options. We can decide it's not worth -- DR. ROYAL: -- uranium miners, right? DR. THOMAS: Just uranium miners at this point. Can I finish? So let me suggest the other two possibilities, are to adopt individualized compensation criteria using rather detailed tables or formulae is not one that I find particularly attractive, but it's perhaps the one that's scientifically the most defensible. And the fourth strategy, which is the one which I, myself, endorse, is to say compensate all uranium miners. And the rationale for that is that the majority of uranium miners who got lung cancer -- I'm sorry, compensate all uranium miners who got lung cancer. CHAIRPERSON FADEN: Who got lung cancer, correct. DR. THOMAS: We have two studies in Colorado and New Mexico, whites and Navajos, respectively, which showed the majority of lung cancers in those two populations are attributable to radon. CHAIRPERSON FADEN: Even among people who were smokers? DR. THOMAS: Even among smokers. And hence, although some of those lung cancers will be attributable to smoking or other factors, at most, you're going to compensate twice as many people as you otherwise ought to. And then you're sure that you're not denying compensation to anybody who deserves it. So those are the four strategies that I laid out. And I can go on and tell you what I think is the evidence for why, but it would be better that you actually read the document. CHAIRPERSON FADEN: We've got Henry and Ruth. I don't know who's -- and Jay. So Jay, Ruth, Henry? Is that okay? No, Jay was last. I'm sorry, Henry, Ruth, Jay. I got it backwards. Henry, Ruth, Jay was the order in which I saw the hands. DR. ROYAL: I generally agree with Duncan's last recommendation, and that is that uranium miners should be compensated if they get lung cancer. And I think that one of the things that's -- and again, I'm absolutely disturbed at -- is the fact that it's not clear that the uranium miners are very different from the atomic veterans. CHAIRPERSON FADEN: But they are. DR. ROYAL: The uranium miners we're talking about clear evidence for -- CHAIRPERSON FADEN: High doses. DR. ROYAL: Yes. So there's a huge difference between these two groups, and I just hope everyone recognizes it. My only reservation has to do with a lack of knowledge on my part. Duncan says that the probability of causation was 59 percent in Colorado and 66 percent in New Mexico. What I've done now -- and maybe you know off of the top of your head, Duncan, is whether or not those probabilities of causation are generally applicable to all the uranium miners at all of the mines or whether or not New Mexico and Colorado, that the probability of causation was significantly higher there because the radon doses were significantly higher there? DR. THOMAS: Those are not provenance of causation. Those are proportions of cases that are attributable on average. Part of the difference between those two numbers will be due to differences in radon levels; part of it will be due to differences in background exposures. And because nobody has any data on the subjects who were not included in the study I can't really answer the question as to whether or not they're representative of all miners. DR. FADEN: We've got Ruth and Jay. DR. MACKLIN: I want to address Duncan's recommendation, but by way of Pat's concern. And by way of Pat's concern, we have to agree as a committee whether we want to go in a direction to recommend something first and ask what is the premise on which Duncan's recommendations rest. Well this Recommendation 7 here, consider that and review this is a piece of wishy washy nothing that goes nowhere and probably doesn't do anything for the uranium miners. If we believe, as I think there's ample evidence, partly from what Duncan said about the rates of lung cancer which would be attributable, and on the basis of what we heard, what we have in our report and what we heard from all of the people who testified before us is that it's very difficult to go through the process; try to use the existing acts to get anything. And Duncan, unless you want to tell me otherwise, some of those same difficulties might also result from your 1, 2 and 3. DR. THOMAS: Absolutely. DR. MACKLIN: And therefore, if the problem has been delay, stonewalling, rejection, we don't pay attention to you, come back, return, give us this -- I mean some of those same things are going to happen with your first three. DR. THOMAS: If anything Number 3 makes it worse. DR. MACKLIN: Makes it worse, because you've got to go review it in the end. DR. THOMAS: It does something which is scientifically state-of-the-art and would take forever to implement. DR. MACKLIN: So if we are talking about people who are still alive or they're family where they have been wronged by everything that happened including failure to ventilate those mines when it was known that being in those mines was hazardous and there could have been ventilation, it seems to me we have a very strong premise for being able to state that our recommendation about the uranium miners should go in the direction of compensation or presumption and not more study, more evidence and more neutrality, and therefore more stonewalling and failure to be able to make the claims. DR. FADEN: Okay. I've got Jay and now Ken. DR. KATZ: Very briefly. I very much agree with Duncan, who just said that the evidence from reading the chapter, Steve Klaidman's chapter is very powerful. The evidence of what they did to the uranium miners is almost incontrovertible, and here is one instance where we can move in the direction which Duncan wants to move I think, and I'm in support of that. DR. FADEN: Now let's hear Ken. When you say Duncan wants to move, it's the latter, the recommendation that all uranium miners who contract lung cancer be compensated? DR. KATZ: Without red tape, yes. DR. FADEN: And that's based in part on the moral analysis in the chapter and on the evidence from the recent scientific literature that indeed the proportion of cases attributable to radon exposure in the mines, in fact over 50 percent. And this is where you're drawing this analogy to other contexts? DR. KATZ: Right. DR. FADEN: Okay. Ken. MR. FEINBERG: I'm still am sympathetic to Pat's point. For what it's worth Congress just enacted a statute five years ago that lays out the ground rules for compensating uranium miners. Now Duncan's recommendation endorsed by Ruth and endorsed by Jay basically as I hear Duncan, Duncan says, notwithstanding what Congress just did and the evidence it took and the conclusions it made, we are not going to suggest that Congress revisit this issue based on our findings. We should not recommend a wishy washy approach, but we have concluded that Congress erred and that anybody with lung cancer who was a uranium miner should be compensated. I'm not prepared to go along with that. I think that whatever we have learned, whatever we're factoring into a recommendation is something that we ought to send to Congress and say Congress, in light of this report shouldn't you reconsider a five year old statute. Well, Jay, you go, no. DR. KATZ: Why do you feel that way? MR. FEINBERG: Because, I'll tell you why. Because I don't share the view of Ruth and Duncan that we know it all; that we've got -- Your point. It's the opposite of your point. I'm not prepared to say that the record that we've developed, giving the Veterans' Administration -- or not the Veterans' Administration, but congressional committee or whatever -- giving them an opportunity to explain why Congress did what it did just five years ago. I'm not prepared to say that that record justifies our recommending that Congress amend the statute. It may be Congress should amend the statute. I'm not saying it shouldn't. I'm making a process point which Ruth considers to be wishy washy. It is wishy washy. Just like the recommendation on the atomic vets for the same reason is somewhat wishy washy. And that is, I'm not prepared in this area to trump Congress and say to Congress, even though that's statute five years old we're recommending everybody with lung cancer that worked in the uranium mines might be paid. I think process wise that's the wrong way and it's impolitic, and I don't think it's the right way to go. DR. KATZ: Have you read the chapter, and the latest versions, which is very much in line with to -- so if that's not enough evidence for you. DR. FADEN: Wait a second. What I want to get clearance. MR. FEINBERG: It's not that it's not enough evidence for me. That's really not the point. The point that is implicit at least in what Pat is raising which I share is, Congress probably has 15 green volumes in the committee where it looked at this whole problem, and for this committee to simply say, we have a different view, a better view, we recommend this, I think in this area is impolitic and not justified. DR. FADEN: I've got Ruth, Pat and Duncan. DR. MACKLIN: I have a question for Ken. I'll state the question but then I want to make a small point. If Congress had not looked at this and we were just starting with what we have and what we know and have gathered and all the evidence would you make the same argument? MR. FEINBERG: I probably wouldn't. DR. MACKLIN: Okay. MR. FEINBERG: I probably wouldn't. DR. MACKLIN: Now we have started or at least have tried to adhere to some moral premises in trying to make this argument. I mean at least they're in there. At least there are some premises that are there that we did not use as a primary basis in drawing that -- formulating that moral premise, and as I listen to Duncan, we don't use as the premise what the schemes are have been, but what we think is just under the circumstances and on the evidence. Now, it's not in a vacuum; it's with a lot of evidence and a lot of scientific evidence and testimony. What you're saying is someone else did something like this; an important body to be sure, and for reasons that I hear you saying that we couldn't possibly have either a) done it better, but in any case it's impolitic to presume that we've done it better when the Congress has spoken. Now I'm just not convinced by those -- MR. FEINBERG: It's not just impolitic. I mean it's all well and good for you to suggest and for Duncan to suggest that the moral premise here is overwhelmingly in favor of compensation for the uranium miners. Unlike most of the other areas of our report this is an area where Congress has not only spoke, but Congress has spoken very recently after taking, I would assume, substantial amounts of information and consideration that we haven't either focused upon. DR. MACKLIN: Including the evidence of the difficulty that the miners have had in making the claims? DR. FADEN: Well they couldn't have done that because -- DR. MACKLIN: Well that's a rhetorical question, but that's part of our data that's different form their data. MR. FEINBERG: I don't know. I haven't even heard their data. I'd be very interested to know what -- I mean I imagine if the Justice Department testified on this question they may have a different view; I don't know. DR. FADEN: They couldn't have, because of the timely act -- MR. FEINBERG: Well I'm saying since 1990; since the statute. DR. FADEN: Because in 1990 they couldn't have known how it was going to work out because they didn't know. But that's a little whatever. We have two views here. And I just want to get Pat in. And Ken I'm sure you'll have the chance to come back. MS. KING: I actually end up where Ken is. I would say a few other things in the process that influenced me. One, whenever I look at these recommendations I think about the credibility of the entire report, because I have things in here I care about too. And I've been long enough to know that if you leave yourself wide open your whole house of cards starts to fall down. I do care about that, so I assess carefully questions of both process, how much evidence I have, how politic it is to do something as well as the substantive merits of the issue. I have not been persuaded by the Uranium Chapter and I particularly haven't been because the question of affirmative obligations to warn troubles me, in the context of this particular one. So a lot of the moral arguments that people have made in this context, I am not as clear and as sure about rightness and wrongness; that's where I thought. Two. It's not part of our mandate. I have some parts of the mandate that I care a lot about that I want the recommendations to say. I think what we're asking Congress to do is go back to the beginning. We don't need to ask them anymore because they're not going to do it anyway unless they want to. And one other thing that I think that we need to keep in mind is -- and this is a process point -- if we think that we have done a better job of doing it and that is what we tell them, their view is, "And who are you?" We are the elective representatives to all of this balancing and weighing; you are not. And finally, my last point is this. It's real hard as an individual for each one of us to make a judgment about what we would like to be able to do to make ourselves feel better. There's a lot of stuff I'd like to do to make myself feel better. And what is realistic to do if you're trying to accomplish certain goals. And part of this is I think that this is a luxury that we cannot afford. That's my bottom line. DR. FADEN: Duncan, you want to wait. I'm going to try to see if I can summarize where we are and decide how we want to proceed. DR. THOMAS: Although nothing would make me happier than to have a forceful recommendation from this committee to the effect that all lung cancers in uranium miners ought to be compensated for; I'm not exactly holding out for that. The point I was trying to make -- and I'm cognizant of Ken's points about what is politic and that we shouldn't presume to tell Congress its business or perhaps even presume to tell Congress that they got it wrong. What I am arguing for however is a much more forceful statement than we have on the table at the moment; not just a wishy washy statement that Congress ought to reconsider, but rather strong guidance that the cold hard scientific evidence comes out strongly in favor of the view that the present requirements are too restrictive. In reaching that conclusion I'm not basing it on any moral argument based on the chapter; it's just what the scientific data says. So it's a statement about risk and that's all. It's nothing to do with the history. MS. KING: Well that's easily accomplished with the recommendation as it stands; that the reason for making the recommendation is the statement that we have new scientific evidence. And that's just why we're asking you to -- DR. THOMAS: But I want to say the direction which that scientific evidence is. DR. FADEN: And the new scientific evidence says or suggests, or whatever language you want. But the point is if the new scientific evidence said, in fact only 10 percent of lung cancer patients were attributable to radon we wouldn't be making the recommendation, so it's sort of implicit that the evidence and -- MS. KING: This is a new statement. But it is one thing to state what the new scientific evidence is and the conclusions that were drawn on the studies. It is an additional thing to say, based on this scientific evidence this is the direction that we suggest you move in. So we have to tell me what you want to do. DR. FADEN: All right. Let me step back. We have at lest two and maybe three things on the table. One, is a proposal that there be a recommendation that says the committee recommends that the act be changed. This is the strong one; that all uranium miners ought to be compensated from now on if they get lung cancer. The other recommendation is to take what is here and to beef it up and we make a recommendation to Congress and to the Administration that the 1990 Act be reexamined in the light of new evidence -- and then we get this departure point -- which suggests that the proportion of cases attributable to lung cancer or attributable to radon exposure is higher than was thought at the time that the act was promulgated and therefore it's a matter of fairness. The act may need to be revised. Is that kind of what you had in mind? Some language to that effect? DR. THOMAS: Yes. DR. FADEN: So in 1990 you didn't have this evidence; now we have this evidence. We can then add, in addition that the committee has heard testimony if you are having difficulty getting their plans processed, and this too should be investigated. And Congress hopefully looks at whatever it is; takes another look at the act. It's time to take a look at the act in light to two things. Most importantly the scientific evidence that has been recently released, and secondarily the testimony that we have heard that people are having difficult recovering under the act, both of which is information Congress you couldn't possibly have had in 1990 because it's only information that's become available since the act was promulgated. Is that okay? DR. THOMAS: You only mentioned two. DR. FADEN: I think it's only two. Basically the two reasons why the Congress has to look at the act again is the new scientific evidence that says probably more people got more people from being in the mines than you thought in 1990 when you passed the law. And two, we have heard testimony that people are having difficulty getting their claims processed, and this needs to be looked at as well. So, go back and look at. You have the right idea in thinking that uranium miners should be compensated but maybe the new facts suggests that the ability to get compensation should be increased. Is that okay? DR. THOMAS: Yes. I support that. I just want to make minor points. There are two issues which we're not addressing and I think we should make a conscious decision not to address them. DR. FADEN: Okay, and there are? DR. THOMAS: One of them is the -- DR. FADEN: Millers? DR. THOMAS: Millers. DR. FADEN: Yes, I wanted to ask you about that. DR. THOMAS: And the second is non-malignant respiratory disease. In both cases we really don't have very much evidence to go on and I'm kind of at a lost to know what to recommend. DR. FADEN: And they are not covered? DR. THOMAS: Well, they are covered. Well millers are not covered; non-malignant respiratory disease is covered but there are formidable difficulties containing under that one. DR. FADEN: Can't we just plead that they look at these two issues again; that Congress look at those two issues again? DR. THOMAS: I'd be content with that. DR. KATZ: I'm much more moving still with the first position. DR. FADEN: The recommendation that Congress should just change the act. DR. KATZ: I mean it may have to be worded as best one can in the politic/non-politic kind of way, but at the moment I just want to say that I am with Duncan Number 1, not Duncan Number 2. DR. FADEN: We will write up both ways of doing it, and we may end up with some subset of the committee wanting to go further or something. We'll figure it out. And if members of the committee would like -- Jay, if you would like to try your hand at that recommendation that would be helpful; the stronger point just so it's out there and people can see what it is. Maybe Duncan and I can work on the other one with other people. DR. KATZ: I'd rather work with him. DR. FADEN: Work with that. Then we'll get it out and we'll see where we are, and we may end up with something. We will end up with something; I don't know what the something is, but it sounds like the recommendation that Congress look at it is at least -- there's no one who said they can't do that either. And the reasons for why they should do that, and if some members of the committee want to go further we'll figure out a way to accommodate that in the context of the recommendations. I don't know exactly how. I haven't heard from everybody. I'm assuming that is correct; that everyone is comfortable with at least the version of the recommendation that says to Congress, you have to look at this again because new evidence has emerged which suggests that the act may be now unjust. And I'd like to get some sort of ethics language in there that may be based on new evidence, not a fair policy for redressing the remedy. DR. KATZ: With a question we probably will get back to tomorrow. Maybe you should consider it tomorrow or maybe just take two minutes -- to have two recommendations, because as you notice I indicated in that short memo I sent out, when we move too much towards compromise then our voices get muffled. DR. FADEN: I think that's an important point. Let's see how many people go with -- If it's a split -- We just have to see how this goes. I don't know how it's going to fall out yet. And it sounds like there is enough fluidity here in this committee in terms of where people are going that we may end up with I don't know what yet, so maybe -- I don't know; we'll see. And since one is sort of a stronger version of the other there might be a way -- a subset of the committee -- I don't know what. MS. KING: A lot of reports are written that way. DR. FADEN: Yes, that's exactly right. The committee recommends. Let see how if falls out. DR. MACKLIN: Is Jay's point if you start with a weaker recommendation it's going to be weakened further when it finally gets to be implemented? Is that basically what's behind it? DR. KATZ: No, no. Our own voice gets muffled in the process. DR. MACKLIN: I don't know what you mean by muffled. I mean I know what you mean if you say, if we have two choices, a strong recommendation and a weak one and we choose the weak one the likelihood is that whoever is going to implement this is going to weaken it further. DR. KATZ: That's could be another consequence. But just that we -- None of us are really saying what we believe and half of us make it weaker to accommodate the stronger -- DR. MACKLIN: I said what Duncan believed. DR. FADEN: And I think Ken is saying what he believes, and Pat is saying what she -- I mean I think people are saying what they believe. MS. KING: I think he's talking of what we talked about this morning, that when we make the effort to more towards consensus what we do is we change wording to gather more people there but in the process you have a less strong recommendation, and at some point you shouldn't do that is what he's saying. And I agree with him. DR. FADEN: And the issue is where are the points, which is why I'm saying let's wait and see how this breaks out; we'll have to see how it goes, as to whether there's an honestly achieved consensus that gets you where you want or not, in which case we'd go otherwise. We'll just see how it's falling. I just wanted to make sure that there was no one on the committee who was comfortable with the likelihood that they could go with one or the other or both before I ended the discussion. And since I hadn't heard from everybody that was the key concern. So I take it that everyone will find a home with one or the other or both. And now we have to get the language out and see how people shake out. We have two more to do. If we were to complete our agenda for the afternoon we would have to do both the Marshallese and the intentional releases. I don't know which is more likely. Ratification clearly is not going to get done today, so that's got to get shifted over into a time tomorrow. Yes, Ken? MR. FEINBERG: Let me just suggest this. I read with interest the Marshallese recommendation -- DR. FADEN: This is the new one, right? MR. FEINBERG: Right. And the intentional releases, and although I am perfectly willing to engage in a discussion as we should of both I do want to point out along the lines of how we have treated atomic vets and I think with some nuance how we have treated uranium miners. I read the Marshallese recommendation and the intentional release recommendation as recommendations in which we ask the Congress in both situations to review the record and decide whether or not its treatment of intentional releases and the Marshallese should be changed. If one accepts the view expressed around this table in the last hour that these approaches to the Marshallese and intentional releases makes sense methodology, process-wise, which I do. I mean this is sort of a variation on again what Pat has said earlier. Then we rather rapidly resolve these issues. I like this approach. Again, the Marshallese you'll notice we say maybe Congress ought to expand the program if it is demonstrated that the inhabitants received exposures comparable to those on these two islands. And intentional releases says, Congress you might want to change the law if -- So just in light of the time I'm just suggesting that I basically would do with these two recommendations what Pat suggested we do with atomic vets and what we are moving in the direction of doing with uranium miners. DR. FADEN: So if I tell you what you're saying, Ken, it's basically saying, instead of the Advisory Committee recommends an apology it's the Advisory Committee recommends that Congress consider -- MR. FEINBERG: Oh, I don't care about an apology. An apology for the reasons Pat said this morning -- I'll apologize if they want an apology. DR. FADEN: This is a big deal apology. This is akin to the apology when you're crossing nations and things like that. This is a bigger deal apology. I think it's appropriate, and it's not happened in quite this way. MR. FEINBERG: I mean I like Ruth's point about the moral high ground on apologies. I mean I think it does mean something; I'm not poo pooing it. DR. FADEN: So you're going to the second part, which is, the Advisory Committee recommends that Congress looks at the whatever to make sure they're -- In both cases the plea is for justice. MR. FEINBERG: Yes. The real issue is that we satisfy bucking the issue to Congress with this recommendation. DR. FADEN: Let me just say one thing that is troubling me, and see if other members of the committee are clear on this. Either way we're bucking the Congress. We don't have the power to do any of these things, so either we're recommending that Congress think about whether they should do it or recommending that Congress do it, but either way we can't do it, right? And either way we're bucking into another body who has the authority to actually do these things; we can't do them. So what's at issue is the way in which it's presented to the Congress and the forcefulness behind it. Either way we can't issue the apology and we can't change the laws. We can only recommend that either Congress think about that there may be a problem here or that we recommend directly that Congress do it. That's what's hanging out there. Somehow I get the feeling that sometimes we have this discussion it's as if we could just make it happen. So I just want to make it clear that everybody understands that no matter what we can't make it happen either way. It's in fact a recommendation to Congress; the question is how we're phrasing it. MS. KING: Refresh my memory. Is this statement about the apology to the Marshallese, which I agree with you is big time apology questions -- Was their reason for limiting it, for not making clear that there was a research component? DR. FADEN: That was our mandate; I mean that was the context in which we are -- MS. KING: Oh, but we've been departing from our mandate on many questions. DR. FADEN: Our focus was on the issue of apologizing for having the bomb dropped and accidently -- going the wrong way is so far from where we were but the part that we were attempting, we saw ourselves as being in appropriate territory, was looking at how the research that followed that event was conducted. And so the apology that we can recommend arguably is directed at that part of that episode of history. MS. KING: The reason I say this; this statement is a very interesting statement. It says, we're going to recommend an apology for not making clear that there was a research component to a medical follow-up. Now I would assume that a medical follow-up is a good thing. Well, I don't know, but the idea is we would have wanted them to do a medical follow-up I assume. DR. FADEN: Correct. MS. KING: And what we're now asking for an apology for is for not making clear that there is a research component to it. And in light of all my conversation before -- I'm not recommending this -- This struck me because if there is an apology of the kind of level in which we discussed, governmental apologies before, this is not what it's for. It's for -- it's conducting above ground testing in the Pacific in a way that so many people were exposed to radiation that would require a research component. So this is one of the areas where I -- But what struck me was, either we don't ask for the apology, or if we have to, we're going to ask for an apology you've got to go big time because it didn't make much sense to me this way. DR. FADEN: Here's where, if you followed Ken's formulation of your formulation we could move in that direction. We could say that Congress consider -- Let me make sure. Has there been no apology to the Marshallese? I thought there was. DR. ROYAL: There's a $150 million trust fund. DR. FADEN: I think there is one. Let's take the apology one out, because when you widen it, I'm not sure -- Actually I have this memory -- I have to go back and look at the compact, but I think there is something -- Well beyond the financial, but I think there may even be language like that already out there, so let's just check on that. DR. KATZ: By the way, in light of this language irrespective of apology or no apology, there was a research component to the medical follow-up, almost sounds a little bit funny. I think -- Isn't what he had in mind is, when the choice was between providing treatment and doing research that the treatment was not in some ways not the prime of the consideration? DR. FADEN: It's problematic that Steve isn't here, but my understanding as we've been sifting through this is, here you get a really mucky empirical record and you've got people contesting whether and to what extent what was done was for research purposes and what was done for not research purposes and what the Marshallese were told and what the Marshallese were not told. It's a very bad record to try to draw conclusions from. It really hasn't been very easy to figure out what happened, and people's recollections and people's claims are conflicting, and people's experiences seem to have been different. And so this language -- I worked with Steve on this and he was trying to find language that was as true to the record as we knew it, as we could, and still say something. Maybe it really shouldn't even be here because if it doesn't say -- So let's hold the apology out for two reasons. One, we have to figure out what the context is of a larger apology. I believe perhaps that's already happened. And then, if this is too vague because the facts are too poor, then maybe it's not going to help any to even say it. Can we get to Ken's point, which is whether we want to state it this way or state it in the form that Congress consider whether -- If you go starting with the second part of line 3, "The Advisory Committee supports the government's current commitment", that's fine. And recommends that the same commitment be considered. Well recommends that Congress consider whether the same commitment should not be extended to. It's a because of the following reasons that it looks like from their examination they were exposed to the same levels. Is that agreeable? DR. MACKLIN: And the justification here for mentioning Congress explicitly whereas earlier the question of do you say to the present, is that when we were quibbling over whom we're directing these recommendations to, the justification here is that Congress has already acted on this point? DR. FADEN: I'm not sure it's Congress either. This we've got to be careful about. This is not Congress; this is an executive branch thing. DR. MACKLIN: Well this is an international. DR. FADEN: Yes, I think it's different. There was a deal that was struck and it went to the Interior Department or whoever, so we have to direct that -- that whoever it is who's administering this consider, and it would not probably be Congress in this case. I don't know, so we're poor on the facts here. MS. KING: If this is a treaty then it goes back to Congress anyway. DR. FADEN: All right. So we have to look and see though -- That doesn't get to your question; I just stopped you when you said it. DR. MACKLIN: Well, no, no. My question was more on the general one of the distinction between making a recommendation that something take place, and then Pat's concern before was if you throw this recommendation into the air nobody act. On the other hand we heard an argument -- I guess it was from Ken, hard to remember now -- that well if you start saying this guy should do this and this guy should do this you're telling people what to do. So I in my naivete and the complete ignorance of this field or this area don't know which is the better part of wisdom and I want to hear from the people who've made this comment before whether they think the recommendation should be thrown to the air or directed to the appropriate agency. MS. KING: I think it should be directed to whoever has ultimate responsibilities, so we should find that out. DR. FADEN: And it's going to be different in different cases. I mean again she's saying about the same act that it be different morally, and the same act be different politically depending on what the context is. So we may want to take these recommendation by recommendation. DR. MACKLIN: I mean, again, I can say these things because I know nothing about it. If you think that making a recommendation to X, whoever X may be, is going to fall on deaf ears or not get acted upon because of the knowledge that one has of that agency or organization that seems to me -- I wish Ken were here -- a good practical reason for not making the recommendation to that agency. Agencies have track records; they have interests; they've got many other things that they do. So that would be my suggestion. If we have any evidence that making a recommendation to some particular body or agency is going to let it die there then that's a reason not to do it. DR. FADEN: Right. And it may be a reason to send the recommendation to somewhere else. I'm sorry, Mary Ann. DR. STEVENSON: I was just saying, in the case of the VA Ken suggest you send it to the VA and Congress and the Administration. MS. KING: One of the thoughts that occurs to me about the drafting of the section as we go in this direction with a group of recommendations, if in fact turns out that a Marshallese, one that's directed to Congress too. It seems to me that there is a value in having some place where they are discussed together. Congress has enacted several separate and discrete pieces of legislation. That is probably appropriate because it covered different kinds of problems. But there are other ways that we keep identifying in which there are similarities as well as differences that would have required specific pieces of legislation. So there's a value in asking Congress to say that you have acted in these area, there's a time to do a comprehensive -- not comprehensive legislation, but a look again, so that we don't get the act for vets addressed, but don't get uranium miners addressed. Am I being clear? That there's a certain kind of thing about that saying, Congress, this is a big area where people have exposed, and it needs fine tuning. You may fine tune in the context of the specific act, but as a group there's something compelling as well. We've taken act after act. There's something to be gain from the sum as well as -- So it takes like a little introductory part to try to say -- DR. FADEN: Yes, I think we can do that; that's a good point. MS. KING: It makes it more compelling. There's something wrong with every one of these we think that we are saying take a look at again. DR. FADEN: Okay. So we're going to somehow come up with some way of -- Because we have interestingly enough thought about them that way for a reason, and now there is yet another reason for thinking of them collectively, not only because they were population exposures, but in part because they were population exposures they have each been addressed in one way or the other by the government, and we have concerns about the adequacy of the way in which those things are playing out. MS. KING: That's the thrust of the earlier recommendation when we were having the science discussion that I didn't understand about the symmetry and some of the scientific evidence. When you said it was greater than atomic vets, one of the things that gets lost is when you address a specific problem you lose sight of underlying issues that might go to all of them. That's really what I'm trying to figure out a way to just address. And that might be an appropriate place to mention at that point. DR. FADEN: What it is sounding like -- I'm sorry, Jay, and I'll get to you in just one second. With the exception of the uranium miners which remain unresolved as to exactly how the committee will address it one way, two ways, or whatever. For the experiments in connection with the atomic bomb testing, intentional releases and Marshallese, our recommendations will be directed to whatever the appropriate government agency body is, or are, if it's more than one, that we have serious concerns for the following reasons and think you need to take a look at it because updating is in order. And we will try to come up with both science and ethics reasons like similar cases like similar cases should be treated similarly and in the case of the Marshallese it looks like the people on this island were exposed at least as much as the people on that island. Please take a look at this because if so, as a matter of fairness they should be covered as well. The intentional release is the same sort of argument. Okay, so that's the structure. There would be some text that would put them together but the format would be the same in each. I see Jay and Sue. DR. KATZ: It goes back to something that Pat said earlier about -- but then she went back on it -- that we voice things in terms of our overall concerns. And with respect to our present discussion what concerns me that we're not only writing this report for Congress, we are writing this report to the American public, to other decision makers, and that in light of some of our concerns, like of appending Congress for example, that we begin to lose our moral voice at times, our strong voice, and that maybe, except as specifically indicated, where we need to address the VA about a specific point of paying attention to this and that and the other thing. Even though I like what Pat earlier said, it would be nice to address it through somebody, that at times we can avoid addressing it to a specific group including Congress, and speak to certain issues and what we would like to see done about them, because to us they seem the right way go. DR. FADEN: Sue. DR. LEDERER: It's just a question. Some of the explication of this recommendation on the Marshallese speaks to American servicemen who did not receive medical follow-up. Are they being handled somewhere else or is there a recommendation as to their medical follow-up? DR. FADEN: There is a fact that we're waiting to fill in which is whether that's been corrected since 1980. The recommendation as it's set up right now says that, if in fact that's the case, that nobody's paid any attention to these people, we would then put in the recommendation to Congress would be to take a look at this as well. DR. LEDERER: But it ends on a very strong note; unacceptable. DR. FADEN: It doesn't seem at all right. What we've been able to establish is that at least until 1980 except for some very initial follow-up nothing seems to have been done, and now the last sort of final fact checking to establish in recent times whether anybody has paid attention to it. Thank you for reminding me that that's in there though. MS. NORRIS: Excuse me. But I had a question earlier on that. Shouldn't you change the caption then if you're going to include servicemen on this? DR. FADEN: We will. The reason it's on here is because it's at least possible that the gap has been filled from 1980, particularly in light of all the recent stuff. We haven't checked that out, but thank you, Lois, you're right. If we fold again then it has to be changed. Henry? DR. ROYAL: It's important to make the distinction between medical follow-up that's being done in order to gain scientific information or medical follow-up that's being done in order to benefit patients. And the way medical follow-up is written about in here makes it sound like the committee believes that medical follow-up should have been done to benefit patients. DR. FADEN: Soldiers in this case. DR. ROYAL: Soldiers in this case. And I don't understand how the committee arrived at that conclusion. For example, presumably the medical follow-up is for the early detection of cancer. Does the committee has some particular test in mind that these service men should have been having along the way? When you read Mary Ann's thing about how we made decisions about children it seems to me that this is contradictory. MR. GUTTMAN: Actually, I think the notion -- I think is what Dr. Cronkite, who's the commander, that his assertion was, this was a comparability. They were comparably situated to the Marshallese who were intensely -- DR. ROYAL: Yes, but again, I think Dr. Cronkite's statement refers to the fact that it was unacceptable not to follow them because of the scientific information that we could have gained and not because he believes that they would have benefitted in some way; that they would have benefitted in some way personally. MR. GUTTMAN: We can ask him. My recollection of reading the transcript was a moral judgment not this would have been good data judgment. DR. ROYAL: Well, many physicians believe that going to the doctor is a good thing, and that the more people go to the doctor the better off they are. MR. GUTTMAN: Or going to the epidemiologist. DR. ROYAL: But the scientific evidence that people actually benefit from going to the doctor for preventative reasons is very weak. And again, when you say medical follow-up, to me what it means is that we're recommending another observational study, and we need to make that clear what it is we mean. And if we believe that there's good scientific evidence that medical follow-up would benefit patients, that's and extremely important thing to say, because it has tremendous implications. But I don't know that there's any good scientific evidence. DR. FADEN: Your point's well taken. I think part of it is a general sense that you have a very special case here, of an accident in which there was very high exposure that was unintended; quite dramatic. And so the one argument that might be put out is that although ordinarily when you think about medical follow-up of this sort that we're trying to do that we'll talk about but we obviously can't do today with respect to notification of subjects of experiments, that the context here is quite different; that even if the expectation was not great that there would be any direct medical benefit; that these people were owed special attention and special handling. And that kind of attention does not necessarily result in better medical outcomes as much as a feeling that these people would be -- it's those sort of worried problem. And the general sense that these people had a very extraordinary experience that was most unfortunate. It's a small number of them and they were kind of forgotten, and what they must be feeling. DR. ROYAL: But the thing that I don't like about the statement is it doesn't have full disclosure. You just said it might not benefit them; it might mainly put them at ease. And people should be told up front what the purpose of the medical follow-up is and they ought to be able to decide for themselves whether or not it will help them to go to the doctor every year or every six months or every day, or whether or not that's just going to make them worried well. And they deserve to be able to make that decision themselves. They shouldn't be told medical follow-up is good for you; you should do it. DR. FADEN: What we need to do is two things. We need to find out whether there is a basis for thinking in the technical medical outcome sense; that there's a reason to look at these people again. And insofar as the answer there is no or unclear we need to flush out the reasons why. DR. ROYAL: And I'll tell you that I don't know of any evidence that medical follow-up -- DR. FADEN: If this were moved especially; well especially to start now. DR. ROYAL: -- even at any time will affect patient outcome. DR. THOMAS: I think I would agree with that judgment. I just want to clarify that what was in Cronkite's mind according to the transcript is medical benefit to the patient. DR. ROYAL: I don't have any doubt that he may be a person who believes that, but that was very common in medicine and it's still very common in medicine, but it doesn't make it true. DR. FADEN: It's sort of like you have a bad outcome in surgery and even though it's not going to do the patient any good the surgeon should come and see the person more often when the outcome is bad. It's kind of a thing that's somewhat operating here. DR. ROYAL: As long as there's full disclosure and the patient knows there's a bad outcome -- if you would feel better or if your doctor comes by -- DR. FADEN: I'm sorry. DR. ROYAL: Just as long as the patient knows that that's what the whole point of the exercise is, and he's misled into believing that he somehow is going to benefit from it. That to me what the issue is. DR. FADEN: We certainly don't want the army to order medical -- DR. ROYAL: Exactly. DR. FADEN: All right. We've got that. Ken, you're going to have the last word. MR. FEINBERG: I just have three very quick logistical questions. One is, where do we go from here on revised recommendations? Will those be our hands this week? DR. FADEN: You mean before the meeting is over? MR. FEINBERG: That's my first question. DR. FADEN: I think we can try it on one or two of them; I don't know. That's going to be something we're going to have to caucus about right now. MR. FEINBERG: Because we did that -- I saw that we made some findings. DR. FADEN: We did it then and it would be nice if we could do it again. MR. FEINBERG: I'm just asking that. Secondly, is the schedule for tomorrow morning at 9:00 a.m. consisted with what's been printed? Are we still on? DR. FADEN: Yes, we have to be because one of the people on the SIS can only be here and then has to go back clinic. So what I'm going to do is, we're going to start with the agenda as it is written. We will need to carve out a time, and it will either be tomorrow afternoon or it will be on Friday for an hour's discussion of notification and follow-up. Where that falls I don't know yet. That's the only thing we didn't touch on at all of today's agenda, so that's not too bad. MR. FEINBERG: And my last question is when do you plan to put on the schedule a discussion of Jay's point about personal views and the rules of the game? DR. FADEN: Tomorrow at 4:00. Is that correct? At that will stay. All right? We did good. (Whereupon, at 5:09 p.m., the proceedings went off the record.)