ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS PUBLIC MEETING VOLUME I APRIL 10, 1995 APRIL 10, 11 & 12, 1995 ATTENDEES: Ruth R. Faden, Ph.D., M.P.H., Chair Kenneth R. Feinberg, J.D. Eli Glatstein, M.D. Jay Katz, M.D. Patricia A. King, J.D. Susan E. Lederer, Ph.D. Ruth Macklin, Ph.D. Lois L. Norris Nancy L. Oleinick, Ph.D. Henry D. Royal, M.D. Philip K. Russell, M.D. Mary Ann Stevenson, M.D., Ph.D. Duncan C. Thomas, Ph.D. Reed V. Tuckson, M.D. I N D E X PAGE Opening Remarks 5 Approval of Minutes from March meeting 10 Public Comment Dr. Gwendon Plair Concerned Relatives of Cancer Study Patients 12 Questions and Answers 20 Clifford Tidwell Cincinnati, Ohio 26 Questions and Answers 33 Mrs. Barbara Tatterson Cincinnati, Ohio 44 Questions and Answers 53 Mr. Joseph Peterson Carson City, Nevada 56 Questions and Answers Representatives from the Republic of the Marshall Islands: Banny DeBrum, Acting Ambassador Embassy of the Republic of the Marshall Islands 72 Howard Hills Rongelap Atoll 75 Almira Matayoshi, Marshall Islands 80 Questions and Answers Holly Barker, Chief Advisor International Economic and Public Affairs Questions and Answers 82 Rebecca Harrod Stringer (Statement read into record) 99 I N D E X PAGE Update on Research Proposal Review Project 105 Update on Subject Interview Study Jeremy Sugarman 173 Steve Goodman 179 Nancy Kass 183 Committee Discussion 220 Forward Looking Recommendations 297 P R O C E E D I N G S DR. FADEN: Good morning, everyone. We have Phil Caplan here from the White House to officially open this. Phil. MR. CAPLAN: Good morning. My name is Phillip Caplan and as the designated federal official for this meeting of the Advisory Committee, I hereby declare this meeting open. DR. FADEN: Thank you, Phillip. Good morning, everyone. Welcome. Thank you, Phil. Welcome everybody to what is the 13th meeting of the Advisory Committee. You realize we're having 14 meetings in 13 months. Is that right? 14 meetings in 13 months. 12 months. We'll probably have something like 18 meetings in 13 months. Okay. This is our 13th meeting. It's our next to the last meeting, and obviously a very critical one for us as a committee. I want to welcome members of the audience as well. I gather we're getting more people as the morning progresses. As I have done now with all of the other meetings, let me give you a two-minute overview about what's going to happen in this meeting. I will repeat it again as we proceed over the course of the next 2-1/2 days. We'll approve the Minutes, and we'll go to what is always one of the major functions of our meetings, which is to hear from members of the public. It's a continuing process for us. The Public Comment period is the first agenda item and we will proceed with that as quickly as possible. Basically, the rest of the meeting is given over to moving towards closure on some of the central issues that the Committee has had to work on. Basically, the meeting is divided into two parts. This afternoon we are going to focus on the work that we have been doing as a committee on the status of human subjects research today. So we are going to be hearing reports from the two major empirical projects, fact-finding projects, that the Committee has undertaken, assessing the current status of research. We are going to begin look -- yet again, we looked a little bit at this the last time, and we are going to look at it again, the recommendations that we would like to consider which speak to the future. Now, I want to put a big caution in here, and I can say this again when we begin that session this afternoon. We have only preliminary data from the contemporary projects. We will have the data fully analyzed, and the interpretation of the data in hand for the May meeting, not this meeting. So it's obviously premature and imprudent for us to be finalizing interpretations of what these data mean, particularly with respect to the subject interview survey but also with respect to the review project -- project review project -- proposal review project -- PRP; and what are the two Ps and the R. In any event, it's a caution not only to ourselves, of course, but to members of the audience that what we will be talking about with respect to the situation is preliminary, and we may find ourselves wanting to reverse certain positions, strengthen certain positions, as we fully come to understand what our data say between now and May. The discussion this afternoon, while terribly important, still has more of a preliminary cast to it, particularly when we come to talk about findings. I want to caution everybody about that. DR. KATZ: Ruth, can I ask a question about this, because in terms of the earlier game plan, I understand the necessity that, in a sense, we won't be able to come to final conclusions until the last meeting. How do you plan to orchestrate whatever we seem to come up with with what is going into the final -- DR. FADEN: You mean the actual language? DR. KATZ: The language and even the conclusions. DR. FADEN: Well, I'm hoping that between now -- and this is jumping ahead; we have an agenda item to deal with the special -- DR. KATZ: We'll talk about it. DR. FADEN: Yes. We have an agenda item set aside exactly for how to deal with this question of strategy. DR. KATZ: Okay, good. DR. FADEN: The goal is -- not goal -- one means that we anticipate using extensively is just extensive communications between meetings -- letters, memos, things like that flying back and forth so that people can continue the discussion between now and May, and then maybe we'll go through it again. We'll have a session. There is an agenda item set aside for that. Let me just check where it is. It's tomorrow afternoon. DR. KATZ: Oh, good. DR. FADEN: I know we're losing you on Wednesday, so I wanted to make sure we had that when we have most people. DR. KATZ: Okay. Thank you. DR. FADEN: All right. That's this afternoon. The rest of the time we're going to be focusing on, first, some specific chapters that speak largely to our inquiry into the past, then the findings -- tentative findings -- that we have been provided drafts of, which speak to the past, as well as our recommendations that speak to the past. Where I'm hoping that at least in some cases we can go beyond discussion to something closer to closure, maybe not on exact words, but on general sense, then we can work on the language in the findings and recommendations that speak to the past, refining the language and getting a consensus about the precise use of words, words that we feel comfortable with. I'm drawing the distinction between our recommendations that look to the future and our recommendations and findings that look to the past, and I think we're better positioned perhaps to reach toward closure on our inquiry into the past and the inquiry into the future, only because we don't have all of our data completely interpreted yet. So, having said that, that is kind of what's going to happen today. It's going to be very intensive for the next two and a half days. Very intensive, very hard work, and I hope they keep bringing us lots of coffee. The only other agenda item before we go to the public comment period is the approval of the Minutes of the March meeting. Are there any comments, criticisms, suggestions for change, errors that were discovered in the Minutes? [No response.] Would someone like to call for approval of the Minutes. MS. NORRIS: Approval. DR. FADEN: Is there a second? DR. OLEINICK: Second. DR. FADEN: Nancy. All in favor? (Hands raised.) DR. FADEN: Any opposed? [No response.] DR. FADEN: Thank you. The Minutes from March 15th through 17th meeting of the Advisory Committee have been approved as reviewed. With that, we go on to our Public Comment period. We have four people scheduled who have asked to speak and then the panel from the Marshall Islands. There are several speakers. I am going to encourage, as always, our speakers to be as brief as they can and give the Committee time to ask questions. It has been our experience that some of them have had fruitful exchanges between members of the Committee have occurred during this question and answer period. Our first speaker is Dr. Gwendon Plair. r. Plair, I saw you this morning. Good morning. I knew you were here because I saw you when I came in. PUBLIC COMMENT DR. GWENDON PLAIR CONCERNED RELATIVES OF CANCER STUDY PATIENTS CINCINNATI, OHIO DR. PLAIR: First of all, let me say good morning to everyone. As was stated earlier, I heard many people saying this is a very important session today. For me, as a son of a mother who was experimented on in Cincinnati University, Cincinnati, this is extremely important to me. Let me say to Madam Chairman, Dr. Faden, to members of the Advisory Committee, I appreciate this opportunity to testify before this committee, especially today. The discussions we are about to talk about will have a great impact on our lives, including yourselves. Let me say on behalf of the families of Cincinnati, particularly CROCSP; and also the survivors and victims around the country, we want to say thank you to the Advisory Committee for the exemplary work you have done in gathering and working on this information and the work you have done thus far. It has been amazing, I'm sure you would agree, we have all found out about recent experiments on human beings as well as environmental experiments. Thus, it becomes really important at this juncture in our growth and our situation, and also I hear the word winding down. It scares me, because there are so many things yet to be looked at. I come before you this morning with grave concern that there may be some issues not yet covered, some things not yet said, and information not yet gathered. To that end, I would like to read to you an excerpt from a letter that was sent forward to the White House from our Congressman Portman, that earlier, the first part of this month, I, as well as the Executive Director of the Task Force, Mr. Cooper Brown, went to my Congressman Rob Portman to ask him to sign a letter to the White House to continue to extend the charter of the Advisory Committee for at least three to four months so that you would have the opportunity to complete your task and not be rushed to complete your final report. It has such a major importance to us all. Let me just read a portion of this: "The Advisory Committee was chartered to write to the Human Radiation Interagency Working Group and advice and recommendations on ethical and scientific standards applicable to human radiation experiments carried out and sponsored by the United States Government from 1944 to May of 1974, with authorization to investigate more recent human radiation experiments, as well. "Among other things, the Advisory Committee was directed to consider whether there was clear medical and scientific purpose for the experiments to the appropriate medical follow up, if it was at all conducted, and the experiments designed, administration adequately met by ethical and scientific standards, including standards of informed consent, that prevailed at the time of the experiments and that exist today. "Clearly the magnitude of the task that was bestowed upon the Advisory Committee was something no one had anticipated. The Advisory Committee sometimes has something that no one anticipated, yet knowing what we know now, the extension of the Advisory Committee's turn is clearly the matter deserving special consideration by the White House. "The Advisory Committee has been charged with the enormous moral responsibility to sort out what happened to the Americans and see and make sure, if at all possible, that appropriate amendments and legislation is made or recommended." That's the brief letter from Rob Portman, Congressman from Ohio, Steve Chabot from Ohio, and also signed by Chris Smith of New Jersey. Since that time, we have received support from other congressmen and also talked to a number of senators who are willing and very seriously looking at what Rob Portman is looking at, and that is specifically to extend the charter so you have time to adequately finish your job. I brought a copy of that letter with me today, and it is a baton that I'm passing to you, in hopes that you will say to the White House, support the congressmen, as well as the senators and not pass the buck back to them, not back to the White House, but say you need the time to finish this report. The families are counting on you to do that. I have spent many hours with some of you and watched the hard work you've done. The litany of paperwork is astounding. The boxes from paperwork is astounding. The whole idea of extending this situation may feel wrong to some of you, and I must admit I've taken a few time offs behind it myself. But we cannot let down the many of hundreds of thousands of people who are counting, at this point, on you, quite frankly, to give a very solid presentation of what must be done regarding this issue. We are very concerned as families around the United States, particularly in Cincinnati, that this could happen again, not only to myself but also even to our children. As a father who recently had a son who married, I'm concerned about my grandchildren, that they may be like the children in Tennessee experimented upon, perhaps even in the womb. That's very scary to me. Unless there are policies and procedures that may possibly come out of this group here, it could happen again. A gentleman from Japan asked me to let you know that they are very concerned across the water what should be here today, too. They are watching also. I'm sure you may already know that. He shared with me that one of his grandparents was part of the Hiroshima/Nagasaki situation. And he's reporting about it. He was giving a report for me, information for me, and he started crying. He started sharing his story. It is important what you do here today, what you decide. Finally, there are three other issues that I would like for you to consider: That you will consider not only the extension of the Advisory Committee to get your final reports organized and ready, but also that you strongly consider something you talked about earlier; actually, the last part of '94 and that of going to the upper eastern states, particularly Rochester, and giving them an opportunity to have privy to the experiments that I had in Cincinnati when a panel was there. They really need it. There are many experiment victims and survivors up there that would like to speak to you about their experience. An added 60 to 90 days, maybe 4 months, would give you an opportunity to give them that chance to say what they need to say to you and, perhaps as you already found out, giving you more information about their experiences up there, that would help you find a report. I would also, while I applaud you, looking at the Atomic Veterans, I still feel that a lot more needs to be not only in the final report, but a lot more needs to be said about them. I think the way you have it now is a very good one, but still there are some things that can be done in the final report regarding that. Finally, there is some other new information that has come up that needs to be looked at as far as the experiments that have recently come to your attention. Those need to be looked at and included in the report. It becomes really important to me that we work together as a team. We may have different views on how we get to the finish line, and I think everybody agrees we're heading there, but let's not stop now, before we get there. I am concerned that some people may be packing up to leave and go home and not finish the work that we need to do here. There are a lot of families who are counting on you, including myself. I would like to not only give you the letter from Portman but assure you that I will continue to press congressmen, senators, and anyone who will listen, and I have sat in many people's offices to get the support to continue the Advisory Committee's work. I would also like to, because some families were not able to be here, give for the official report, some letters from families for your report today. There are a group of other reports that I was not able to bring with me because I came straight from work last night, here. I will make sure those get to the designated people so they have that in the part of their report. I want to thank you for this opportunity. Let's not stop until we cross the finish line. I'm handing the baton to you. Let's do the job. I thank you for your time. Thank you for your fine work. DR. FADEN: Thank you very much, Dr. Plair, and thank you for your expression of confidence in us. We obviously share the same goal in terms of doing right by the experience of the people who you represent. Let me open the floor. The floor is now open for questions and comments. Jay. QUESTIONS AND ANSWERS DR. KATZ: Dr. Plair, thank you for you eloquent statement. I agree with you, that the work of the Advisory Committee should be extended, but I may agree with you for different reasons and, therefore, a question. I do not think that there is much to be gained, but there is always something to be gained from further interviews in hearing your stories. We've heard enough stories, I think, to get a sense of what transpired during the Cold War period. We need more time, that was part of your argument to really make sure that our children and grandchildren will be better protected in the future, and that requires time to think through. But the question I have: What do you think would the benefits be of talking to people? Have you been heard enough? What more do you think is there to be heard, except giving people an opportunity to speak, and that is good in its own right by hearing more testimony. DR. PLAIR: There are three things I would like to respond. One is: You're correct, it is a healing process, but also the number, the large number of experiments, I'm sure you're aware, that happened in parts of the United States, is very essential to report, and I think they can very well add some information that you can utilize in final report. More importantly, from my standpoint, and we do disagree, one of the most important things that you can do by allowing and going to Rochester and a lot of people in that area and the whole eastern corner of the United States, to give testimony, is to reassure the American citizens that because you are seen as a government component, whether you want to agree or not with that, is you really are listening to them. They understand that, at this point, it may not be adding more information to the picture, but the fact that they're important enough for you to take that time to come up there and listen to them, where a great deal more of confidence to the American view, not only of the illustrious committee here, but also the government that they're listening to the people. The people really count. It isn't just the contract for Americans. It is not, as O'Leary said, an openness policy; you actually mean that. That's very important. The other is, I'm convinced, as time has transpired in this whole process that they're always seems to be some information that nobody knew about that comes up when you make these trips. I've been to a number of them, and I always find out something I didn't know before, and there may be some information that you need to know. DR. FADEN: Other questions or comment for Dr. Plair? DR. TUCKSON: Yes. DR. FADEN: Put your coffee cup down. DR. TUCKSON: For the record, it's tea. DR. FADEN: Tea. Sorry about that. We have to get this record accurate. DR. TUCKSON: Just a quick comment on that. First of all, I think you have to know how much we have appreciated your involvement with our work and your comments are extremely important, and obviously we'll be dealing with these issues. Just on that last point. It is not to disagree with you at all but just to note that for the advocacy community, it just seems to me it's going to be so important that you all are able to help us to create a climate from when this report is released, that we can't possibly solve or have it all contained in that report, and so, you're right, we could go from everyday for the next year, places, and continue to find things and it's extremely important. At some point, we are going to have to -- I think you appreciate that because you are clearly watching the process so carefully. At some point, we have to say, okay, we have to stop and take what we have and do the best we can with it but knowing that more work will have to go on. I just hope that you will, on that last point, be helpful with us and helping us to think about how we release the report, such that people don't believe that, all right, we have this problem solved, we go on. There is more work to be done, and we understand that and appreciate that. If we can't go to another place like you suggested, I hope it won't be interpreted that it wasn't because we didn't care enough, it's just simply a matter, at some point, you can always have a good place to do to. Your point is a good one. I don't want to disagree with you. I'm just looking, as we work together in the future, for your advice about how we are able to continue to get the work done. DR. FADEN: Comments or questions for Dr. Plair? [No response.] DR. FADEN: Thank you very much. DR. PLAIR: May I just add one other comment. DR. FADEN: Sure. DR. PLAIR: The other thing that I think is very important here. We say go to Rochester, one thing that has come up in Cincinnati, for example, is our City Council was considering, as far as the investigation, just dropping the personal investigation of situations until they heard that our congressman was looking into it more, and in fact he signed the letter. Also, the Advisory Committee was made a very strong opinion about what's happened in Cincinnati, and they decided to continue the investigation. To me, that also kind of adds a stamp to the fact that when you go, the Advisory Committee and the small committee going to a small place like that, what have you, it puts the politicians and those of the power that be on notice, and let the people down also. So you see again what I didn't know, you have a major impact on what happens even locally. DR. TUCKSON: That's exactly what I was just saying. DR. FADEN: That's a very good point. DR. TUCKSON: Yes, that's what we're trying to get to. If you could take a moment, and I know you've been busy on this, but if you could take a moment and jot those kind of things down and just give us that sort of input, because maybe that would not have come up in our mind. There's Rochester now, and I'm sure we can go and name several other entities that we won't be able to go to, but is there a way that we released the report, the way in which we set the groundwork, the meetings that happened, associated with the release of the report, in the body of the document; are there ways in which we can think of these unintended consequences, as it were, to be, in fact, very intended. It's a wonderful point you are making. DR. FADEN: That would be very helpful. Thank you very much, Dr. Plair. We'll take the letter. We can have copies made for all the committee and everyone can see it. DR. PLAIR: Thank you very much. DR. FADEN: We'll make sure that everybody on the committee gets a copy of Congressman Portman's letters so that we can see it for ourselves. Thank you, Dr. Plair. Our next presenter is Mr. Clifford Tidwell, and I understand that Mr. Tidwell's statement will be read by his nephew, Mr. James Tidwell. James Tidwell is coming to the table. Thank you very much, Mr. Tidwell, we appreciate your taking the time to present to us. MR. CLIFFORD TIDWELL CINCINNATI, OHIO MR. TIDWELL: I'm the president of Cincinnati Families and Radiation Victims Organization. My grandfather's name was James Tidwell, Patient 007. His statement is given on behalf of the Tidwell family by Mr. Clifford Tidwell, baby son of James Tidwell, Patient 007. Greetings to everyone. First of all, my name is Clifford Tidwell, and I am the baby son of Mr. James Tidwell Patient 007. I am here today to speak on his behalf and for the rest of the families of this radiation mess and all of the other families from the different parts of the state. As I stated before, in Cincinnati, Ohio, on October 21st, 1994, I am a person who doesn't get very emotional and show it. I was damn mad then and today I am damn furious because this is a big mess that we are all in. I am here today to speak my peace and let you know just how I feel about this situation and the behavior, and to be heard. I am also looking for some answers and someone is going to give me some, someone will tell me something, what exactly is going on. First of all, I don't see how our government could have allowed for this to happen and continually allow this mess to keep on going. That's the reason I want some answers, because we are talking about my father here, today. My father was a god-fearing, gifted man, with plenty of morals and values, for which he instilled in me and the rest of my family. I still can't see how the government could continually let this go on. You are talking about using human beings as guinea pigs, and it's just what they did to my father. They totally mutilated his body, and that's why I'm here today for some answers. My main question is why. Why did the government continually let this go on, knowing that the radiation experiments were doing weren't doing the patients any good. Anybody with common sense knows that what's done in the dark will come to the light, and what is in the wash will come out in the wringer. You can run along for a long time, but you sure can't hide from God. He sees everything you do and hears every lie you tell. I know that I only have a short time to speak, but I am going to leave you all with something to think about. When my father walked into Cincinnati General Hospital, he walked in just as straight as I am walking today. But while in there, he got paralyzed in his legs, and I want to know what happened to him in there that caused him to get paralyzed. There was nothing wrong with his legs. He didn't go in there for his legs. He went in complaining about a pain in his chest, and they found a spot on his lung. Immediately, they started giving him radiation. My father was a totally healthy man, weighing about 180 pounds, and when he died 32 days later he weighed 116 pounds. Every minute of the day he was in pain, vomiting constantly and having convulsions. No one in my family consented for them to give him any of that radiation. They used him because he was a black African-American man with no education. He couldn't read very well, and he sure couldn't write. He really couldn't understand what they were saying to him because they were using all kinds of big words, and by him not having any kind of education and learning all kinds of big words and by him not having any kind of education or learning, lying there in so much pain, whatever they said to him, he felt like they were going to help him and stop the pain he was in. He was in so much pain, he didn't know what radiation was, and that is why they went on and used him like a guinea pig. They probably thought that he had a family that didn't love or care for him. What little they knew, he not only had a family, he also had a family who loved him, loved and cared for him in return. They went so far as to give my father radiation to his brain, and there was nothing wrong with my father's brain. That is the reason why my family and I want to know why, when he went into the hospital complaining about pain in his chest, not in his brain, why would they give him radiation to the brain? On the 28th of October 1960, they gave him 4, 100 rads to his brain, and on November 10th, 11th, 12th and 13th, 100 rads a day. They also gave him 200 rads on November 18th and 19th. They also gave him 2, 300 rads to the brain on November the 20th and the 21st. They skipped November the 22nd and 23rd. They gave him 300 more rads on November the 25th; 300 more rads to the brain on November 26th. He died on November the 9th, 1960, and the final total radiation to the brain was 2600 rads. I want to know why they kept giving my father all that radiation to his brain, and the saw that it wasn't doing any good, but they kept on giving it to him anyway. In the beginning, there wasn't anything wrong with my father's brain. That is the main reason that I am here in Washington, D.C. today, because I am looking for some answers. They did not stop there. They kept my father's brain for experimental use. They started experimenting on his brain on January the 11th, 1961. Why did they keep his brain? No one from the family gave them the consent to take and keep any part of his body and experiment on it. It was also pointed out that they took his legs and arms, and that is why somebody is going to tell me something, and why. All of this is in his radiation report. In his radiation report, they did not have any names of the doctors or nurses who caused this mess. A whole lot of the report was blacked out. They were supposed to have had a chart with the doctors' and nurses' names on it, and what time of day or night they administered him all of the radiation and the reason. Somebody is going to tell me something before I leave Washington, D.C. Yes, I am mad and damnmad and dam furious, and I am going to be this way until I get some answers. They did not have to mutilate my father's body like they did. Oh, they were experimenting. They all knew that the radiation wasn't working, and they kept on using it anyway. It was a low down dirty shame the way they treated my father and the rest of the families that are represented here today. My heart goes out to them. I think it is a dirty shame that they kept this covered up for 34 years, and it finally surfaced. When my father died, I was 20 years of age. I was the baby boy. I can still remember it as if it just happened yesterday or today. That's the reason I am stopping here because how can someone do this to another human being. Thank you, each and everyone for your individual attention and cooperation. We have gone too far now to turn around. We are going to fight this to the bitter end. Thank you again, and God bless you all. DR. FADEN: Thank you very much, Mr. Tidwell. Thank you for your presentation. If you would stay with us, I am sure there are some comments or questions that people will have. Are there questions from members of the committee? QUESTIONS AND ANSWERS DR. MACKLIN: Thank you very much, Mr. Tidwell. It's a terrible story that you have just told us. I'm interested in the records that you were able to obtain. I understand from what you've said that you have the hospital records? MR. TIDWELL: Yes. DR. MACKLIN: And portions were blacked out? MR. TIDWELL: Yes. DR. MACKLIN: If you could perhaps tell us a little more. When did you get the records, who gave them to you and, to your knowledge, at what point was information blacked out of these records? MR. TIDWELL: Well, actually, my uncle had all the records. He gave most of the records to Dr. Plair at one time, to give to Mr. Tuckson for him to go over. At that point, I do not know. I have this autopsy, which they admitted -- well, he died on the 29th. They did the autopsy on the 30th -- 11-30 of '60. On the first of January the 11th of 1961, is when we found out about it. That's when the cuts started, the cutting of his brain. So, evidently, they had took his brain with the autopsy, and we didn't even know they did an autopsy on it. They took his brain and his body parts at that point. This is how we found out, through these records here, that I have here, that they took his brain, and they didn't start cutting on his brain until January of 1961. They did this without anyone's knowledge. We didn't give them permission. DR. MACKLIN: Then do I understand that the Committee has the information that is -- MR. TIDWELL: Well, they're supposed to have some of this information, from what I understand. DR. MACKLIN: I mean, you were able to get these records at the time the autopsy was done; is that correct? MR. TIDWELL: No, we just got these within the past year. We got these from the University of Cincinnati. DR. MACKLIN: What do we have? Have you received some? DR. PLAIR: Let me respond. Back in October -- DR. FADEN: Dr. Plair, could you just come to the mike, just for the record. Thank you. DR. PLAIR: I'm sorry. DR. FADEN: No, that's okay. We want to hear what you have to say and we need to have it on record. DR. PLAIR: Sorry. In October, when you were down for the meeting panel, there were some reports that I gave to you, actually to the committee, and it was one of the people that you were very interested in and you wanted to look at because of the particular situation, so I gave it -- DR. FADEN: Okay. So they do have it. Good. DR. PLAIR: Yes. DR. FADEN: Good. DR. TUCKSON: In that regard, first of all, thank you for your testimony. Thank you for coming and thank you for speaking from your heart. I know it's difficult for you to do. Have you had available to you any physician or health professional who has been able to sit with you and go over the records that you do have and the story that you have been able to piece together? Have you had anybody that really has been able to sit with you and kind of go through this and explain things, to the best that it's possible to explain it, at this point? One of the things that just comes to mind, and we'll wind up as a committee talking about it, but you know that we are going to have to look at a variety of recommendations that we have to make, and there are a variety of areas that we must make recommendations. One of the things that -- and I just wonder whether you see this as being important or not, and tell me whether it's important to you or not: it seems to me that while it is very clear -- and we haven't made our decisions, and I don't want to presume what we are going to find about the Cincinnati experiments, I want to be very cautious and not get ahead of the Committee; but let's say, in general, that it's possible that we, in fact, do document and tell you that in fact bad things happen. In some cases, some of the things you are concerned about maybe have been legitimate things that, if explained well and understood, would have been okay. Some things not, but some things maybe there isn't an explanation for. They wouldn't be terrible. It seems to me that what would be important is that somehow you had available to you expertise that you would have to pay for, who could sit with you and go over these details and explain them to you in a way that you and the rest of the family can understand, to take away pain that you don't have to have; not dealing with the pain you may legitimately have, but let's take away unnecessary pain. Would you consider it important that you had available, would you be interested in having available to you, a consultant, and expert, who could sit with you and go over line by line the case of your relative and help you to make sense of it? MR. TIDWELL: That would be nice. DR. TUCKSON: That would be interesting to you? MR. TIDWELL: Yes, it most certainly would be. It most certainly would be. DR. TUCKSON: I don't know. I haven't started to think it through yet, but -- DR. FADEN: Yes, I see where you're going, Reed. Yes. DR. TUCKSON: It's just so clear that it's -- you've just made such a powerful statement. MR. TIDWELL: What I was getting ready to say was the records that we have, I think you already have. In order for us, we need to have those records, in order for somebody to sit with us and read it to us and let us know what is really going on, to go over it with us. DR. TUCKSON: Yes. Because it just seems as if -- and I don't want to take too long with this; we have to move on with other questions -- but, first of all, the kind of person that would be available is important as well. The last thing you need is another bunch of gobbledygook -- MR. TIDWELL: Thank you. DR. TUCKSON: -- stuff and nobody can understand it, but to say it in terms so that we all can understand it -- all of our families can begin to understand and appreciate it. That's going to take time. The health insurance doesn't pay for that. It just seems that maybe we're going to have to find a way to make some of those services available on a consultant basis to people like you. I don't have any idea what the implications are economically, but some will be. Thank you. DR. PLAIR: Dr. Tuckson, let me add to that. That was something that was, I think recommended in one of our conversations with the task force, if you recall, something like that. Not only for Cincinnati but also other families around the country, so I support what you're saying, to remedy the whole situation. DR. FADEN: Lois. MS. NORRIS: I'm going to move on to the blacked out material and the records in general. Has anyone from the hospital tried to explain the reason that portions were blacked out or trying to review or had you approached the people from the hospital? MR. TIDWELL: My uncle, he had went over there and tried to talk to some of them, but they explained to him that the records were so old, that's the reason they were most, majority were sort of blacked out; you know, because they were old records But some of the records that we do have, you know, you can't read and that's about it. MS. NORRIS: I do know, as a member of the Committee, that we've seen a lot of material that's hard to read. DR. FADEN: It doesn't make it any more satisfying. It's really a problem. You finally think you've got something and then you can't read it. MR. TIDWELL: I would like to say this about Dr. Saenger, though. For a man to do something like this, who gives him the right to take a human being's life that way, to torture people, and for the Medical Board to let someone like him to practice medicine, it shouldn't be. I hope the Medical Board looks at this in a very serious way and never let nobody experiment on people like this here. This is something that's really tragic. DR. FADEN: We are really very grateful to both of you for travelling to D.C., and I know it's hard to communicate how important it is for the committee to keep hearing from families, but it does reinforce our sense of significance of what we're doing. DR. TUCKSON: I think as you close out on this, one of the things I just keep coming back to, you really are asking very specific questions here. MR. TIDWELL: Yes. DR. TUCKSON: I just want you to understand that, first of all, what will happen, again, is because we are focusing so much on Cincinnati and certainly the records we will go back again and make doubly sure that we again look at all the material you have given us. Even though we've looked at it and we'll go back and make sure and connect it to your comments today. I think, secondly, you've caused us to think seriously about a kind of a recommendation that we'll have to discuss, and I think, really, you've pushed us in a direction that I think is important. Number three: Some kind of way, we are going to be able to sit with you, and whether this is just retouching, but someone is going to sit with you when this is all over and your family. I hope there's somebody better than me -- MR. TIDWELL: I hope so. I really do. DR. TUCKSON: -- but we'll sit with you and do that. So, in other words, as you go home, your family is going to say, well, you went down there, you made a statement, and what did they say and what's the answers. Obviously, we can't -- I just don't want you to think this is going to go off into the space. MR. TIDWELL: I sure hope not. DR. TUCKSON: We're going to deal with that and you'll get those answers. MR. TIDWELL: Okay. Thank you. DR. FADEN: Thank you. DR. KATZ: Don't we have, within the records, documentation of radiation doses that are mentioned? DR. PLAIR: Yes. Yes, we do. We do have those. That's part of the report, and also you should have those. MR. TIDWELL: I have that report here with me, about the radiation, the days, how much that was done to him. I have those records here with me. DR. KATZ: We can get a copy of that. DR. TUCKSON: Why don't you see Gary to make sure we already have them. MR. TIDWELL: I think you already have some. DR. FADEN: Yes. We should be all right. Thank you, again, very much, and thank you for joining us again, Dr. Plair. I wish we could just answer all of your questions right now. DR. THOMAS: Can I respond to Jay? DR. FADEN: Jay, I think, Duncan wants to comment on your question. DR. THOMAS: The records which I have seen and provided in the briefing books maybe six months ago, is radiation doses in terms of the total body irradiation, and those numbers are up to about, I think, 300 rads max. Maybe there's a few in there with 400. I'm not sure. What we are hearing, this was news to me today, is localized radiation; in this case, to the brain, of I think the figure was 2600 rads. This is not something that I, for one, new anything about before or considered. I don't know whether we have comprehensive data on the entire series of patients, to any localized radiation they have in addition to that. I'd certainly like to know about it if we do. At one point, I tried to do some statistical analyses of survival outcomes in relation to radiation experiments, and all I had available to me at the time was the TBI doses, so they were clearly a totally a flawed analyses. DR. STEVENSON: There is definitely some, because I was at the Cincinnati meeting, some records available. There are definitely some records available about localized radiation that was given to the patients, in addition to the TBI. I was at the Cincinnati panel meeting, and I know at least one report summarizes many of the patients and where it was known. They gave radiation in addition to the TBI. DR. FADEN: I'll tell you, we will try to work on this. We just want to keep, as a matter of courtesy to the other members of the public who want to speak, let us go forward, but we will clearly pursue the subject that we've just discussed. Our next speaker is Ms. Tatterson. Is Ms. Tatterson in the audience? Thank you, Ms. Tatterson. Ms. Tatterson has also travelled from Cincinnati, and we appreciate your coming. Thank you for coming. It seem you've been joined by several people. Would you like to introduce them? MRS. BARBARA TATTERSON CINCINNATI, OHIO MS. TATTERSON: The families that are in the pictures here are James Tidwell, Patient No. 007: David Jungnickle, No. 027; Gertrude Newell, No. 020; Nina Kline, No. 075, and William Wright, No. 055. My name is Barbara Tatterson. I am here today on behalf of my 80-year-old aunt, Mrs. Bertha Jungnickel and my cousin, Donna Nance. David Jungnickel, Patient No. 027, was my aunt's son and Donna's big brother. He died at the age of 19 years old, at an age when life was just beginning. First of all, let me tell you a little about myself. I came to Cincinnati at the request of my maternal grandmother, for what was supposed to be the summer but lasted until after David died. I had a firsthand look at how things started and ended with David. At 30-plus years of bearing this horror, it now has come back for a repeat performance for us to see over and over again in our minds. We did not know that David received radiation treatments. In other words, the family was not notified of this kind of treatment, nor did they ask permission. We learned of David's involvement in this type of research by the Cincinnati Enquirer last year. When I arrived in Cincinnati, David was a muscular teenager who had many friends and enjoyed each and every one. He would go out with them often. Many of his friends would come to the house and he in turn would to go their houses. As his illness progressed, he was unable to visit friends, but they would continue with their visits to him. David's personality made a complete turnaround after treatments had started at Cincinnati General Hospital. I remember visiting David at the old General Hospital. Families would all get to visit on the porch that ran the length of General Hospital, during warm weather. All patients that were able would be brought down to visit with their loved ones and friends. Some would come in wheelchairs, others on beds, so that all the children could visit and more than two people could visit at a time. As time went on, it became harder and harder to visit. I don't remember when the burns and sores appeared on David, but when they did, I do remember that he vomited quite frequently and lost a great deal of weight, and when he ate, he ate very little, and what he did eat, most often he vomited back up shortly afterwards. He begged for pain medicine and most often was in tears because he did not receive it. My aunt would have to go and get a nurse to make sure that he did receive medicine upon her arrival. It became obvious after a short time that David would not be able to return home. He was then referred to Drake Hospital. Drake Hospital back then was not like it is today. The first time I went to see him there, it was the worst place I had ever been in. First of all, it was dreary, dark, and scary. You could have had a spookhouse there and would not have needed any decorations on Halloween. Some rooms had up to six patients in them, all crying for something and no one helping them. David would be crying to be taken off the bedpan, which he had been on sometimes up to a couple of hours, or his need again for pain medication. When we arrived, patients in David's room would ask my aunt to do different things for them, and she did. One patient even asked her to clean his dentures, and she of course did that. David's real relief came when his mother appeared on the scene. She would invariably have to chase after a nurse to get the needed pain medicine and to find out why he had been left on the bedpan for so long. When she couldn't find a nurse, a lot of times she would remove the bedpan herself, but still have to keep a lookout just in case a nurse appeared in order to get him some pain medicine. When they broke his leg, they did nothing. They didn't even try to set it or secure it so that it would be less painful when he was being moved. I remember David's crying to go home, which he knew he couldn't do and then crying to just let him die. This was all the more stressful because he always tried to put up a good front in spite of the pain. I remember the day before he died, knowing that he was dying, having to attend school and having to meet the challenge with a smile and, most of all, trying to do the schoolwork that was expected. I remember asking my teacher if we could say a special prayer for David because he was dying, and I thought if we said a prayer for him he would die peacefully. The next day they came to the classroom and asked us to go home, that we were needed there. I, however, knew that David had died. I found peace within myself knowing that now David would not have any more pain, and no one could do anything to hurt him again, and that he would at last find true happiness. The funeral was pretty much a blur. Some things I remember, other things I just kind of blocked out. One thing I do remember was my aunt telling visitors that what they did to him at those hospitals they should be punished for. No one should have to go through what he had gone through. However, she also remarked that she did not know what they had done, but did know different things that David had told her. At the time, she didn't understand. I also did not know for sure what had taken place until the Enquirer story appeared, and then I made several calls on behalf of the family to find out if David was among the casualties. At the funeral home when people would look in the coffin at David, most people didn't recognize him, and if they did they were shocked. He was down to skin and bones. He had no hair. But the worst things were the burns that they couldn't hide and the open sores they couldn't cover up. People would comment that he looked like a Holocaust victim. Last year, I attended the congressional hearings held in Cincinnati and was appalled at several remarks made by Dr. Eugene Saenger. One thing that he quoted was that "All a patient had to do was ask for pain medication and they were given pain medication." That was a lie. David begged for pain medication right after radiation treatments until he died, and he still was not given medication. When his mother arrived at the hospital and found out that he had not been given medication, she would have to go find a nurse and beg them to give something for his pain. It hurts me deeply to see my aunt and cousin go through this again. You see, David was a son, brother, grandson, nephew, cousin and most of all a friend. Even though he looked very much like a war victim from a concentration camp and I feel at times he lived in one, he was denied many things that our country is proud of, especially his freedom of speech. I sometimes wonder if he would not have been a juvenile if they would have listened to him. But I doubt it because of the fight that other family members had had to go through, trying to get justice done for their own family member. It's still very hard for us to understand how trusted doctors, nurses, and other medical professionals, and especially the U.S. Government, were involved in killing so many of their own people. As I read the newspaper each day, I see more and of these killing fields appearing before the public to read about for the first time. Most people do not understand unless they are somehow involved personally or otherwise. We are a free society in these United States, but what took place at Cincinnati General Hospital did not happen during any war, and most likely the other places that we have read about recently weren't either. They did a nice job of trying to cover it up so that no one would find out and, thank goodness, that people found it within themselves to speak up. I also believe that all people who are in charge were well aware of what was taking place, and knew what they were doing wrong but tried to hide it, hoping that it would never be discovered. One thing that I read about was that Senator Ted Kennedy tried to put a stop to it and Senator Taft told him that Cincinnati was his territory and he was not to interfere in anything in his territory. This was wrong. If a U.S. citizen, whether it be an elected official, or a person walking on the street, I feel it is their civic responsibility to report it. Senator Kennedy was wrong for backing down, and Senator Taft was wrong because he tried to play God with other people's lives, and it is our family members that lost. Dead or alive, someone needs to take that responsibility now, before another incident occurs. We need to concentrate on the up and coming generations so that nothing like this occurs again. Thousands of people have lost their lives, and for what? Didn't the wars take enough loved ones from us without doctors and public officials doing the same? I would like to know when the murdering of innocent people will stop. Who determines who the next victim will be? Will it be you or possibly a member of your family who will be guilty of this hideous crime and maybe even a victim. The time to stop is now before we have another Hitler in our midst. I do believe that all people involved in these crimes against humanity should be made to pay a price, whether it be jail time or something else. Money is nice, but it will not bring any of the family members, and that is a shame. Enough people have paid the price by dying, now that it's time to get on with living and loving and let all hate be left by the wayside. Let's clean up these United States, so that people can stand proud again and our future generations will not have to fight the fight we are fighting. Please stop the killing. DR. FADEN: Thank you very much, Ms. Tatterson. We appreciate your coming to Cincinnati and letting all of us hear that. This is clearly very difficult to hear about and clearly awful, I'm sure, to have lived through. Are there questions or comments for Ms. Tatterson? QUESTIONS AND ANSWERS MS. NORRIS: Ms. Tatterson, have you or other members of your family been able to obtain the medical records on your cousin? MS. TATTERSON: Not all of them. We have some that were sent to us, and the ones that were sent to us were like duplicates. It's like they ran the first part through the copier and then ran the second part through. Some of them that we have are blacked out. Other ones you can't read, and some of them the information makes no sense whatsoever. I did see on a couple of them where they removed tissue from David, for what purpose I don't know because they were not given the permission to do that. MS. NORRIS: Was that in autopsy or was that during treatment? MS. TATTERSON: No, no. That was during his treatment. DR. FADEN: Ruth. DR. MACKLIN: I have a couple of factual questions. The first is: I didn't quite get the chronology. You said that David was 19 when he died. How old was he when he entered the hospital? MS. TATTERSON: Sixteen. DR. MACKLIN: Sixteen. So this went on over a period of three years. Was he in Drake Hospital -- at what point was he transferred from Cincinnati Hospital? MS. TATTERSON: Right after they did radiation on him. DR. MACKLIN: I'm interested in knowing, because you mentioned in your statement that you wondered if he hadn't been a juvenile, whether he would have been treated differently. That's a very important question, and of course the family, when he was under 18, the family should have been asked for permission and informed about what was going on. But at some point he turned 18, which officially would make him no longer a minor but someone who would have to be told and explained or asked himself. MS. TATTERSON: I believe at the time that he turned 18, he was not aware of what was being done to him. For the first part of the treatment I know he was given chemotherapy. The radiation, I know, started later. It was like a year or two later -- more like two years later. DR. MACKLIN: So he might have been even 18 at that time? MS. TATTERSON: Yes. But I don't think at that time, even though he was 18, he was not aware of what was going on. He had pretty much given up. DR. MACKLIN: When you visited him, you mentioned that the family saw the burns and sores on his body. Did anyone ask the doctors or did the doctors tell you anything about that? MS. TATTERSON: That was sort of like the pain medication. You had to track someone down, and then they said that you had to wait for the doctors, and the doctors were never around when we went there. DR. MACKLIN: So you never had any explanation of what these sores or burns were? Is that right? MS. TATTERSON: No. DR. MACKLIN: Thank you. MS. TATTERSON: Thank you. DR. FADEN: Thank you very much. Thank you for bringing the photographs. They help to remind us about the people behind the pain. We move on, and our next person has also travelled some distance to be with us. Is Mr. Peterson here? Mr. Peterson is coming from Carson City, so he travelled a ways. Thank you for coming here. MR. PETERSON: I have extra copies -- 14 copies that I made, if you would like them now. DR. FADEN: Yes, that would be helpful. Thank you. That would be very helpful. MR. JOSEPH PATTERSON CARSON CITY, NEVADA MR. PETERSON: Madam Chairman, Dr. Faden, Members of the Committee, my name is Joseph E. Peterson. I am a professional pilot, age 48, born November 21st, 1946. I live in Reno, Nevada -- Carson City. I'm here on behalf of sister, Hilvey Ann Peterson, and myself, and our parents Jack W. and Vivian Virginia Perry Peterson. Both parents are deceased. In early 1945, our mother, Vivian Perry, was recruited into the United States Army to serve as a member of the Corps of Engineers, the Women's Army Corps. At the time of recruitment, she was an undergraduate journalism student, at Indiana University, Wilmington, Indiana. After basic training at, I believe, Des Moines, Iowa, she worked at Oak Ridge, Tennessee and Hanford Nuclear Reservation. While at Hanford, she met and married Jack W. Peterson, a naval seaman and air traffic controller at Pasco Naval Air Station, 10 miles away, downwind. They both mustered out of the service at the end of 1945. November 1963, my mother's suspicions were confirmed by her physician, Dr. Leonard Green, Valparaiso, Indiana, when she was diagnosed with acute leukemia. She died on February 7th, 1964, at the Mayo. She left behind an 8-year-old daughter, a 17- year-old son, myself, and our father, who died of heart disease in 1975, 11 years later. I would like to point out that all of our mother's and father's siblings are still alive in their '70s and '80s, with none of the same problems. My mother was 40 years old when she died; our father was 56. In 1986, I had a tumor, a folecular adenoma, removed from my thyroid by Dr. Merle Bruce, from Reno, Nevada. While undergoing diagnostic testing by ultrasound technicians at Washer Medical Center in Reno, the technicians remarked and queried me regarding had I ever, at any time, and to my knowledge, been exposed to very large doses of radiation. There are other buttons or nodules there that Dr. Bruce advises I should keep a careful eye on. Following these awareness, alarms went off in my head and I began to search for some relativity between my thyroid problems, and our parents' possible exposure to ionizing radiation in 1945. I was unable to get a response from inquiries to the VA or to departments of the military regarding our parents. I only tried once, but in the meanwhile I became acquainted with Dr. Wally Cummins in his efforts to collate information I wanted access to. Dr. Cummins is with the Hanford Veterans Cancer Mortality Study and, to the best of my knowledge, has not yet received the support that he has sought to do these studies. My sister and I both suffer from amplified allergen responses, leading me to suspect some sort of suppressed immune function or development. My sister's six-year-old daughter, Sarah Vivian, suffers from extreme depression following certain challenges. My sister is now 39 years old and suffers with the onset of thyroid problems as I speak. I was 39 years old when a tumor in my thyroid manifested itself. My mother was unable to breast feed either of us; suffered at least one miscarriage that I am aware of, and suffered from extreme postpartum depression following the birth of my sister in 1955. Earlier this year, I spoke with Dr. Tore Strammes, Lawrence Livermore Laboratories, regarding new advances in mapping radiation, induced chromosome damage in later offspring. In the course of our conversation, he apprised me of his doctoral thesis, which happened to be on ovocyte exposure in mice. The conversation confirmed the potential of my suspicions, and we hope to talk more in the not too distant future. By the way, we also discussed the Selafield studies and how they do not appear to address female exposure to ionizing radiation. I feel that problems in our family have been directly caused either by both of our parents' exposure, by either or both of our parents' exposure to ionizing radiation at Hanford, and/or Oak Ridge; Problems accelerated or amplified at genetic propensities; Tumors, nodules, or buttons on the thyroid; Leukemia, suppressed immune function were not part of our family history, or probably our family's future until our participation in the Manhattan project. I would like to add my mother was very proud of her work on the Manhattan project, and while she seldom spoke about her involvement, she was aware of the why and died with dignity and pride. She made a specific request that her grave marker was to be a VA flush marker instead of the more elaborate headstone on her parents' graves. The stone was to read: Vivian Peterson, Indiana Women's Corps, World War II. She felt strongly that her efforts helped thwart what would have been the deaths of hundreds of thousands of American fighting men and women if we had been forced to invade Japan. She often said if these weapons had to be, I guess it was a good thing that we got them first. My sister and I are especially proud of our parentage. Our mother was a grandniece of Samuel Houston and a Daughter of the American Revolution. Our father's great grandparents pushed a hand cart across the United States as Morman pioneers. I now fear for our offspring and the permanent genetic damage which may have occurred. I thank you for this opportunity to put this matter on record. DR. FADEN: Thank you very much, Mr. Peterson. Thank you very much for traveling this distance to provide us with this information. MR. PETERSON: Yes, ma'am. DR. FADEN: Stay a few minutes with us and see if there are questions or comments for Mr. Peterson. Do we have questions? DR. KATZ: Such a moving story. What lessons should we as a committee learn and ultimately communication to the public about the history of your family? MR. PETERSON: The exposure to these things -- of course, that was then, this is now, it's a different time. DR. KATZ: Yes. MR. PETERSON: Exposure to these things may cause permanent -- it does cause permanent genetic damage -- but we're talking about forever. We're talking about a thousand generations from now. Maybe I'll have offspring that will come out looking like a bottle full of grapes or two heads. Maybe the best thing we can do in this is full disclosure, exactly what the damage is, so that these crazy people in the world who are trying to acquire these weapons, to use them, or -- you know what I'm saying -- so they know of the heinous possibilities that are there. I think that's probably the most important thing. Thank you for your comment regarding, "a touching story." The stories I've heard before me, while they don't deal with permanent, genetic damage, are equally, if not more so, touching. DR. KATZ: A moving story. MR. PETERSON: Yes, sir. Thank you very much. DR. FADEN: We're not quite done. Reed. DR. TUCKSON: Just on that last point, which is important. It seems that, as I connect to you and really listen and hear you, that it must be very difficult to worry about the future and to worry about offspring, and permanent genetic damage. It sounds like a lot of what you are really saying is that's what your fear and concern is. Let's say that it turns out that, from the best of science and, God hoping, from the best of science that we could say in your case -- and I'm still talking theoretically -- but in the best of science, in your case, that we think more reputable people would say you don't have to worry any further, that this is not something that could go on and on and on through your bloodline forever. Do you think it's possible that, having said those things to you, and let's say they were scientifically valid, in your case, that that would relieve you of your anxiety, and do you think that you are owed that kind of conversation? MR. PETERSON: Well, the conversation is owed to every human being who has suffered potentially from this problem, yes, sir. As far as my worries and anxieties, I don't want to mislead you. I really don't have intense worries or anxieties because it's out of my control, and there's no reason losing sleep over something I can do nothing about. I am truly powerless in this matter, other than I can tell you I have to live a very stark life. I'm extremely sensitive, as my sister and others are, to things that most people would not be sensitive to, and that's more my concern, is taking care of business at hand, and I would leave it in the hands of the scientists to hopefully reverse any mark or damage on the chromosome thing in the future. I assume with the research that's going on that we'll be able to do that. I would hope so. Does that answer your question, sir? DR. TUCKSON: I think it does. I think that what I hear is -- and it's legitimate; I mean, in a sense, your anxiety and your concern is really about what's happening for your life, for your sister's life. MR. PETERSON: And our immediate offspring. DR. TUCKSON: And your immediate offspring. MR. PETERSON: Do you have children now? DR. TUCKSON: Yes, sir. I have a son in medical school at Indiana University. He might need it. DR. TUCKSON: I think just from what we have been hearing, I want to have a sense of realistic goals for the committee. One of the things that I try to understand better is, I try to imagine myself at night worried and thinking that whatever is going on could potentially go on through many other generations. MR. PETERSON: Yes, sir. DR. TUCKSON: I feel that if I were sitting at three in the morning concerned about that, and if that concern turned out to be not necessary, I would want that concern to go away. As a physician, I would want to be able to participate in helping that concern to go away. The question I guess I was trying to get to is, is it possible that information and facts, when justified, and given to families with clarity in ways that they can understand, is it possible that such facts and information could make such worries go away, or once this is being introduced in your mind, does it stay there forever? MR. PETERSON: I think there is an inherent disbelief in the totality of your statement because of the potential problems and because of what has already happened. It's sort of a mistrust -- it's not sort of; it is a mistrust of a personal survival nature. DR. TUCKSON: Thanks. MR. PETERSON: Okay. Thank you. By the way, I was only exposed as an egg, as an ovocyte; I was not a fetus. DR. MACKLIN: What year were you born, '46? MR. PETERSON: I was born in November of '46. Would have been conceived, what, February or March of '46. My mother and father left that area in the fall of '45. DR. FADEN: Thank you, Mr. Peterson. Oh, you may be here for a little while longer. Duncan. DR. THOMAS: Can you tell us anything about the specific duties that your mother, or for that matter your father, had at Oak Ridge and Hanford? Were either of them involved directly with the handling of radioactive materials? Were you ever able to find out any information about the occupational radiation exposures that they may have received? MR. PETERSON: No, sir, I have not been able to at this time. My mother had a rather pat answer for it when she was asked what she did there. She said, well, they chose dumb ones to be secretaries, but that I also did maid duty as well. I guess the secretaries also pulled maid duty. That's pretty the detail I can give you on it, that is, until I obtain the records. DR. THOMAS: So your presumption is that her radiation exposures would have been in the general environment of the plant not as part of her specific duties? Is that right? MR. PETERSON: I don't know that, sir. I don't know that. There's references made to B-1 accidents, a B-100 reactor, and I can't find out if she was there. DR. THOMAS: Can you tell me a little bit about your attempts to get that information? MR. PETERSON: Yes, sir. There were forms that the VA sent me to send to them to request; I never received any comments back from them. DR. THOMAS: So you filed this form that was sent to you by the VA, and that was the last of it? Is this what you're telling us? MR. PETERSON: Yes, sir. At the time, about seven years ago, I had a chance to talk to Dr. Cummins, whom I've never met; I just talked to him on the phone. And he said, this is exactly the information I'm trying to gather, and I'm having a problem because the VA is stonewalling, giving us the funds to do either dose -- I don't know if that was dose reconstruction studies or mortality studies, since the VA data gathers through the death certificates. DR. THOMAS: Thank you. DR. FADEN: Lois. MS. NORRIS: I didn't hear you respond to Duncan's question with respect to your mother, and I did not hear you respond with respect to your father's duties. MR. PETERSON: I believe he was an air traffic controller at Pasco Naval Air Station, 10 miles from Hanford, and was not at Oak Ridge. My mother was at Oak Ridge first and then at Hanford. MS. NORRIS: Thank you. MR. PETERSON: Yes, ma'am. DR. FADEN: Nancy. DR. OLEINICK: Thank you. The question of to what extent the prior exposure to radiation can lead to permanent genetic damage is, of course, a very important one, and there are a number of scientists that are continuously trying to understand to what extent this can happen in human populations. Of course, we're hampered by not have markers for every possible change that can occur. I'm sure you understand that. MR. PETERSON: Yes, ma'am. DR. OLEINICK: I'm just curious, in your conversation with Dr. Strammes, who did indicate, of course, the possibility of this type of damage, do you have any or did he provide any leads for you for actually making some determination? In other words, has anyone, for example, looked for chromosomal aberrations in you or your offspring? MR. PETERSON: No, ma'am. They have not. DR. OLEINICK: I just wondered if there was anything. This has been a supposition based on the evidence that you've accumulated, but there's no direct evidence in your case for some type of a chromosomal abnormality. MR. PETERSON: It's not confirmed, at this point, no, ma'am. I liken it to a cup of hot coffee being set on the table in front of you and you turn your head because somebody says, Hi, Joe, and you feel this burning sensation in your lap and you hear a clatter of silverware. The first thing you're going to suspect is your own cup of coffee has spilled in your lap. MR. PETERSON: Absolutely. MR. PETERSON: That's pretty much the way I look at it. DR. OLEINICK: I was just trying to understand what facts were available. That's all. MR. PETERSON: Yes, ma'am. DR. OLEINICK: It's a very difficult question. MR. PETERSON: Yes, ma'am, I understand. DR. OLEINICK: You understand that. MR. PETERSON: I suppose the term "experiment of opportunity" has been brought up to me a couple of times, and I applied it to my mother until about a week ago, when I thought I guess this applies more to me than anything else, at this point, my sister. DR. OLEINICK: Right. I understand the nebulousness of the work. MR. PETERSON: No, it's a very difficult question, and science is beginning to provide the tools to get to these questions, but it's probably going to be next to impossible to prove a case in any one particular case that there was genetic damage, with some rare exceptions, at least at the present time. Dr. Strom was very helpful in that. I asked him if there was any possibility of, for example, exhumation of my mother's esophagus and examination for that, and he said not yet, but it's not far away. DR. OLEINICK: Not yet. Right. MR. PETERSON: He said, however, since her brother is alive there's a possibility of that to compare with myself and my sister and father's family is all still alive, if that answers your question, it helps. DR. OLEINICK: Yes, it does. Very helpful. DR. FADEN: Can we let Mr. Peterson go? Okay. Thank you very much. MR. PETERSON: Thank you very much. DR. FADEN: Appreciate it. MR. PETERSON: Thank you. DR. FADEN: Okay. Our last segment of the public comment hearing we will have a panel from the Republic of the Marshall Islands. I believe that Ambassador deBrum and Mr. Hills are here. Ms. Barker, are you joining the group? All right. Thank you all very much for coming. We appreciate your taking the time to talk with us. REPRESENTATIVES FROM THE REPUBLIC OF THE MARSHALL ISLANDS MR. BANNY deBRUM ACTING AMBASSADOR AMB. deBRUM: I guess I will begin and then others will join me. Thank you, Madam Chairman. I will be very brief today as the Government of the Republic of the Marshall Islands as I appear before you. There is one main issues which I would like to underscore as the Advisory Committee is in the final stage of its work. The Marshall Islands is concerned about access to the information. We are at the mercy of the U.S. Government to decide what information it wants to give us. Unless we have access to all pertinent information, except information that violates national security, we will never under the full nature of the events that took place on our islands and the impact of the testing program on our people and environment. The Department of Energy has been cooperative and forthcoming and Hazel O'Leary's openness initiative is truly benefiting the Marshall Islands. In regard to DOE, however, I am concerned about its budget and personal constraints. There are hundreds of thousands of documents pertaining to the Marshall Islands at DOE, many too technical and scientific for our needs, but numerous documents would be of interest to us. DOE does not have the funding to copy the documents we need and has asked us to look for grant money and other sources of funding for copying costs. DOE also lacks the manpower to respond to our requests. After nearly 50 years of denied access, you can imagine that our requests for information in the present climate are justifiably large. The Department of Defense is another matter. A July 27, 1994 letter to Secretary Perry from the embassy remains unanswered. I used the Freedom of Information Act to request specific information from DoD pertaining to the Marshall Islands. Documents have been trickling in from some Defense offices such as the Defense Nuclear Agency and the Radiation Experiments Command Center. The International Security Affairs Office told the embassy, however, that it would take 5 years and $100,000 to fulfill my request. On Friday, I received our first document from the Air Force, along with a bill for $127 for the single document. An attached letter indicates that my request has been placed in a "commercial" category in which the Marshall Islands must pay for "all search, review and duplication costs." I do not believe that the citizens of the Marshall Islands should be forced to pay for any U.S. Government information about the weapons testing program on our islands. We have a right to know what took place on our land and what the medical teams and scientists were researching for 4 decades. This information is owed to us, it is the least the U.S. can do. The most important assistance that this committee can provide for the Marshall Islands is a mechanism for guaranteed access to information from both the U.S. Government and its contractors. If a long-term mechanism is set up, the work of the Committee will be a success in our minds. We intend to use the information to approach the Congress and request: (1) Health care for the entire exposed population, not simply the 4 northernmost atolls; (2) A broader definition and investigation of radiogenic illness such as women's reproductive health and second generation effects; and, (3) Recognition that information given to the Marshallese in the past about the effects of the tests on the people and land was based on erroneous data; and (4) Complete restoration of the environment. I hope the Committee will consider these points in its final recommendations. I thank you for your time. DR. FADEN: Thank you very much, Amb. DeBrum. Does Mr. Hills want to make a comment before we ask questions of the panel? HOWARD HILLS RONGELAP ATOLL MR. HILLS: I will just be very brief. I represent and am a registered agent of the Rongelap Local Government and represent them in their efforts to resettle their homeland and to take measures to mitigate risk as it still exists there as a result of contamination of those islands. I think the record before the Committee is pretty complete about what happened on March 1st, 1954, with the Bravo detonation. Just to reiterate it for the people in the room here who might not be familiar with it, they were approximately 100 miles downwind from a first hydrogen bomb test, which was approximately 1000 times more powerful than the bomb that was dropped on Hiroshima. The community received near lethal doses of radiation over a period of a couple of days. They were evacuated. Then in 1957 they were returned to their island, lived there until 1985, when they left, because of concerns about the health effects of remaining there in that environment. I think that the important thing for the Committee today is to have an opportunity to perhaps have some questions. Norio Kebenli is here. He was 11 years old on March 1st, 1954, and sustained a high level radiation exposure. Almira Matayoshi is also here. They both have travelled and just arrived here last night from the Marshall Islands for the dual purpose, really, of giving you an opportunity to ask them questions about their personal experience at that time and also for them to see what the Advisory Committee was doing so that they can report back to their community on what's going on here. I think just a couple of brief comments I would make and then I really will defer to them. One is that I want to provide to the Advisory Committee staff a letter which we have uncovered, actually through some work done out at Suitland Parkway; a letter from 1953. There's been a lot of focus with respect to the Marshall Islands on the fact that people who were managing the Bravo test received word before the test was conducted that the winds had shifted and there might be populations that would be exposed. I think that's a discussion that has to take place and we'll go on. A lot of other people have done a lot more research on it than I have. I think this letter from 1953, which was written by a political appointee of the Department of the Interior, who was the High Commissioner under United Nations trusteeship, the purpose of which was to help these folks move towards a decolonization and self-government. That trusteeship agreement with the United Nations also gave the United States the power to close the area for international security purposes. In other words, the United Nations knew that the United States was conducting nuclear tests and then they gave us responsibility to look out for the interests of the people and their land and whatnot. They also gave the United States permission to conduct a testing program. The point is that the High Commissioner who was appointed to carry out the United States' obligations under the United States treaty, wrote a letter to the Atomic Energy Commission and said, you know, we've removed the Bikineans from Bikini, and we have removed the Eniwetokese from Eniwetok. Those were the ground zero points for 66 atmospheric nuclear tests that were connected. But let's not move any of these other island populations, because it just becomes a political problem. We have to take care of them, we have to relocate them, we have Bikineans and Eniwetokese who are very unhappy. It's going to be a long-term problem. Let's not include any more islands within the security zone that's closed and evacuated. I think that letter, which I just talked to Ms. Barker earlier, may not be before the Committee, is a really relevant letter, and I will get it to the staff because it suggests that there some fairly cautious decisions made about not taking people out of harm's way. DR. FADEN: We would certainly like to see the letter. We're not sure if we have it or not. We don't think so, but we would certainly like to have it, so that would be great. I'm sorry. I didn't catch the names: Mr. Kebenli and Ms. Matayoshi? MR. HILLS: Kebenli and Ms. Matayoshi. Yes. DR. FADEN: Matayoshi. Would either of you care to make a statement, or would you simply like us to ask you questions? AMB. deBRUM: I think we will probably try to translate. DR. FADEN: That would be excellent. We are very appreciative of your travelling such a long distance, and we want to give you every opportunity what you would like us to hear. We are happy to have Ms. Barker's services as a translator. That would be much appreciated. AMB. deBRUM: I think they are ready for questions. DR. FADEN: We are happy to do it whatever way is best. MS. BARKER: They would just like to make a few statements about how they were effected. ALMIRA MATAYOSHI (TRANSLATED BY MS. BARKER) MS. MATAYOSHI: I think you need to hear a little bit about how we were damaged on Rongelap Atoll. At the time the bomb fell on Rongelap Atoll, this powder-like substance came and fell all over us on the island there, and I would just like to explain a little bit so you would understand exactly how we were damaged by all of this. All of the children, especially the older children, like me, remember when the radiation fell on our bodies, and it felt like hot needles, putting burning substances on us. There was nothing the children could really do about this. We just felt very vulnerable, and the adults, too, were affected by this. Some of them were throwing up and some of them were sick immediately. One of the children, LaDanjam became sick, and he got leukemia, and they took him off to Brookhaven. He was a teenager at the time. Her older brother, Hiroshi, was severely burned over his whole body. She wishes she had brought a photograph so you could all see it. But many people suffered very severe burns. And that boy died when he was a teenager. He died directly from that radiation. And when we got older, we were told to have medication, we were given medication so we wouldn't become ill, but when we don't have this medication, we feel like a chicken that goes side to side. Before the bombs, there were no mental children in Rongelap. Now there are eight children who are very mental. She said there's so much that I could explain, I don't really know what to bring up. She said this is just what I think is important. She said thyroid is always a problem there, and we're always getting our necks cut, constantly. She's talking about two cases in particular, where after their thyroid surgery they put some machine or mechanism in their throat that makes them like a robot, so that when they speak they sound like robots. She said that I came today to sit in front of your faces and request assistance from you, along with the lawyer in the embassy and explain to you the problems that we've confronted and the needs that we have. She's very appreciative. Thank you. DR. FADEN: We appreciate her comments. Thank you. Thank you, Ms. Matayoshi. Should we have questions, or would there be another statement? Should we go right to questions? MR. KEBENLI: I don't have any statement. DR. FADEN: Then we'll go right to questions. Jay, I saw you were waiting patiently. QUESTIONS AND ANSWERS DR. KATZ: Ms. Matayoshi has not yet returned to her home island yet. Am I correct? MS. MATAYOSHI: Yes, she has been resettled. DR. KATZ: She has been resettled? MS. MATAYOSHI: Yes. DR. KATZ: Is it safe there? Does she consider that the island is now safe for living? MR. HILLS: I just want to create context and maybe then you can focus your questions. DR. KATZ: Yes. MR. HILLS: The community left. They were returned in 1957 after the Atomic Energy Commission made a determination that it was safe. They lived there until 1985. They left in 1985 because there had been decades of people having their thyroids operated on and whatnot, and they were concerned about it. In 1982, the Department of Energy released a report that showed graphically there was still radiation there, and that created a lot of concerns, so they left. Since then, there has been independent scientific studies conducted that have been funded by the U.S. Congress and the Department of Energy and the National Academy of Sciences has basically accepted the recommendations that the people not return to Rongelap Island itself unless there's potassium treatment on the soil, unless there's food imported. So where we are right now is that they were returned from '57 to '85. They are not there now, and we're currently working on a plan for them, for those who want to go back, when the island can be brought within safety standards agreed to by our parties, which include the potassium treatment and importation of food. So the point is, they are not there now. I think her answer was that she had returned there and the community had returned there between '57 and '85. DR. KATZ: So safety, at this point, cannot yet be fully assured and further measurements need to be taken, if I understand you. MR. HILLS: All parties have accepted the recommendations of the independent scientific committee as to what steps and measures would need to be taken before it would be safe. To answer your question, it would not be safe for them to go back and eat the local diet and live there the way they were living under the agreed-upon safety standards. DR. KATZ: I have one more question. Maybe you can answer, because I haven't seen the documentation on this, if the documentation exists. When they first went back, I understand that the Marshallese also wanted to go back to these islands. Were they fairly informed of one of the dangers that they might still be facing if they returned to their islands; and, Two: If they were so informed, were they told what they must do with respect to what to eat, what not to eat, importation of food products, et cetera, in order to make their conditions reasonably safe for further living. MR. HILLS: I think the value of having them here is to ask them that question. I guess I will make one comment. That is, my impression, from what I know is, no, on all accounts. What they did receive is they did receive Department of Energy health services and medical treatment over a period of years for some of their conditions. I just want to get on the record one point to that I wanted to make today. That is, to this day, Department of Energy considers itself responsible for the actual exposed population, providing medical services, but they only provide medical services for those conditions that they determine to be radiation related. I guess I just want to make one comment. I'm not a doctor and I'm not a scientist or anything else, but when you see the photographs of what happened to these people and you see little kids with their skin all peeled off and all that, can you imagine that happening to one of your own kids; imagine saying to them at any point in their life, you come into the Department of Energy's doctor, and they're actually going to tell you that something is wrong with you, they're not going to deal with. I just think the population itself finds that totally unacceptable. They find it totally unacceptable that the Department of Energy does not have a clear commitment to deal with second generation issues, and there is also concern about women's reproductive health that they don't feel has been adequately addressed. I just wanted to get on the record: Imagine what it's like. If you had that happen to you, for the rest of your life you would feel that every health problem you had could be or probably is related to what happened to you, and the idea of having the Department of Energy doctor tell you go see somebody else about that condition, we don't accept responsibility, is one that I, intellectually, as well as in every other way, find very hard to deal with. I apologize. I just wanted to get that on the record. DR. KATZ: Did you ask her that question? MS. BARKER: Yes, I asked. She has a comment. MS. MATAYOSHI: She said that they explained not to go to the northern islands in Rongelap Atoll, to stay only in the southern area, and not to eat any foods from the northern area, and also not to eat crabs from the southern area where they were living. MS. BARKER: I'm going to have to get clarification. That was pretty long. She said she's met with DOE officials and she's met with congressional folks, both in the islands and in Hawaii, and when they explained to her and the members of the Atoll, that the U.S. recognizes exposed, what the level of radiation is there, they tell them and explain it, as she understands it, living in the community for two years, expect one or two deaths from radiation, not from other illness that would normally appear in the population; but that they should expect one to two radiation deaths in their community. She said in the years that they were in Rongelap, there were two to three deaths every single year, and she said that's what forced them off of Rongelap. They felt they weren't safe, and that needed to leave there and that there was no reason to be on that Atoll. Now she feels compelled to go back. She wants to go back because that's her home island and she feels a drawing need to go back to it. She doesn't care about her own health in all of this but she is concerned about her children and the next generation, and that's the point that she wants to make to you. DR. KATZ: One final question. At the time of the first resettlement, as I understand it, the Marshallese wanted to go back to the islands. Did the government officials warn at the time against the wisdom of returning and say that it was not yet safe enough and they strongly advised them against it, even though if they wanted to go back, they would facilitate it, but against medical advice? MS. MATAYOSHI: She said nobody explained that. DR. KATZ: In that fashion? MS. MATAYOSHI: No. DR. KATZ: Thank you. DR. FADEN: Reed and then Duncan, Nancy. I'm going to put myself on the list. Mary Ann. Reed. DR. TUCKSON: Yes, briefly, two questions. One: About how many people lived in her community of people? How many people are we talking about? MS. MATAYOSHI: At the time of resettlement? DR. TUCKSON: Yes. Or now. When you're talking about the two or three deaths a year, I just have no sense in what number of population we're talking about. AMB. deBRUM: Right now, we have three community, one on Ailuk, one on Nepi, and the other is on Majuro. There are about 2000 people right now. DR. TUCKSON: 2000, combined for all three? AMB. deBRUM: Yes. DR. FADEN: At the time that Ms. Matayoshi was talking about two or three deaths per year, how many people were living on Rongelap, at that time? MS. MATAYOSHI: About 80. She said about 80 or so because some went to Kwajeilin Atoll where the doctors were and didn't go back to Rongelap with them. DR. TUCKSON: I see. Thank you for that. The second question is for the Ambassador. One of the things I'm having a hard time with and I should know more about it and just don't, is the technical relationship that you have with the United States, with the government. As a citizen, as I read this, and your comment earlier about the notion that part of the Department of Energy would say no, or the Department of Defense could say, here's a bill for $127, and that you would get this kind of runaround from the different agencies. Is there no central place in the government that you have a relationship with? AMB. deBRUM: I think I'm going to ask Holly to respond to this. MS. BARKER: Yes. There's no central spot at all. We're completely dependent on what they want to give us. I think the point of Mr. deBrum's testimony is we can request documents; they'll give us what they want to, but we have to go through DOE in order to get to the contractors, like Brookhaven, to get the information. We still don't have the medical records, the medical files. DR. TUCKSON: So there is no -- and I think you answered, essentially -- no place in the United States Government that has an overall coordinating responsibility; there is no one point of contact between the United States Government officials and the Marshall Islands, such that there is this clear relationship. It's just you just go shopping, and there are lot of different grocery aisles. MS. BARKER: Formally, it's Department of Interior. They are an access point to the U.S. Government. When it comes to nuclear related issues, they don't have the time to go to depth that we need. They won't liaze to the extent that we need. DR. TUCKSON: So the Department of Interior, basically, is blowing it. I mean, is that what it comes down to? [Laughter] DR. FADEN: Do you want to rephrase that? DR. TUCKSON: I'm just saying, because this committee, when you say these things to us, we are going to have to decide somehow how do we handle this. I mean, she travels all this way, and you've got us all upset. The point being is, do we go in and run around in circles and holler and scream or do we call up somebody at the Department of the Interior and say, what the heck is going on here. Why are these people being charged $127, and why aren't they getting answers, and, by the way, you're the government person in charge of facilitating relationships with the Marshall Islands; do your job. Why isn't it as simple as that? MS. BARKER: I wish it were that simple, and if you would raise that kind of fuss it may help. DR. TUCKSON: All right. Thank you. DR. FADEN: Thank you, Reed. We're getting there. Duncan. DR. THOMAS: Just a comment first. I'm floored by the bill for $127, and I think I have to go on record as saying that's an insult. I thought it would be much higher. I'm ashamed on behalf of my country, and I would hope this would get resolved. I want to revisit the statements made by DOE to the effect you should expect 1 to 2 excess radiation-related deaths per year. I think that was the statement. I'm sorry, I may have missed the context in which that was said. Can you fill me in with a bit more background. When was this statement made, who made it. Was anything written down to that effect. Who was it made to. This is what you would expect if an entire population of size thus and such were to move back on a particular date to live there in perpetuity, it would relate to a particular time period because presumably the levels of contamination are changing over time. A lot of questions are raised by that statement, and I just would like to learn a great deal more because to me it's a profoundly important statement and something that I have not actually seen in any of the documents I have reviewed. It's a very, very clear statement, and I would like to really explore it to the fullest. So anything more you can tell us about that would be very, very helpful. MS. MATAYOSHI (being translated): She said they said it to her during a DOE meeting in Hawaii. She doesn't remember the year, but she was at that meeting with the senator from Rongelap, who's deceased. DR. THOMAS: Approximately when would this be? Would this have been back in the '50s or more recently? MS. MATAYOSHI: Sometime in the '80s. DR. THOMAS: Was he then referring to what would happen if they were to move back to the northern Atolls in the 1980s? Was he referring to present levels of contamination. MS. MATAYOSHI: She said that statement about one or two people dying, that was in another Atoll, called Lykia Atoll, which wasn't as acutely affected as Rongelap. She said they didn't make any predictions of how many people were dying on Rongelap or Bikini, but one or two could be expected to die in other areas that were less affected than Rongelap. DR. THOMAS: Do I understand that there as a DOE- convened conference in Hawaii sometime in the 1980s with environment representatives of marshallese? Is that? MS. BARKER: Yes, with the four atolls -- the four northern atolls, she's referring to. DR. THOMAS: It seems to me it shouldn't be that difficult to get a hold of the records of this meeting. DR. FADEN: We will pursue that. DR. THOMAS: There must be transcripts or something or other. DR. FADEN: We'll see what we can do. AMB. deBRUM: We'll see if we can get a hold of the record for the Committee. DR. FADEN: That would be helpful. DR. THOMAS: Prior to the 1980s, do you recall ever having been given a warning that was ever remotely as clear as that? I am now referring back to the period in the 1950s. Were you ever given warnings to that effect? MR. KEBENLI (Non-Translated): No, they didn't give out any warning (inaudible) back in 1957. DR. FADEN: Mary Ann. DR. STEVENSON: I have concerns similar to Duncan's. What was going on in that period of nearly 30 years in terms of monitoring the environment or monitoring possible radiation effects on the population in the islands that were resettled? Were there routine examinations that you're aware of? MR. KEBENLI (Non-Translated): Yes. They come every year. MS. MATAYOSHI (Through Interpreter): All the time they came to check us. DR. STEVENSON: Again, the feeling was strong enough 30 years after the fact to recommend re-evacuation, one has to assume that the exposure levels earlier in that 30 years were much more severe. I'm most interested in how many children were born at that period of time. MS. MATAYOSHI (Through Interpreter): She's talking about one of her own children that she gave birth to, her ninth one, and she said it was like grapes, it wasn't like a child at all. They were calling it a child, but in her mind it wasn't a child at all. It was more like substance or matter. DR. STEVENSON: Do you have a sense of how many total children were born to the population over that 30-year period? DR. FADEN: You mean from that community? DR. STEVENSON: From that community, that was resettled and subsequently evacuated. MS. MATAYOSHI: I don't think she knows the exact number. She's saying some, but many were mental. DR. STEVENSON: Lastly -- and Mr. Hills may know the answer to this question -- does DOE take responsibility for the populations that receive secondary exposure when they went back and resettled the island, or do they only take responsibility for those that were there at the time of the testing? AMB. deBRUM: Yes. Right. DR. STEVENSON: Thanks. DR. FADEN: We're running short of time but I did want to ask a question that the Committee has been focusing on with respect to the Marshallese. Ms. Matayoshi has said the people from Brookhaven came regularly to check you. When they came, what did you think was happening? Did you think it was medical care that you were getting? When you went to see the doctors who came, what was your understanding and your friends' understanding of what they were doing? MS. MATAYOSHI (Through Interpreter): She said we really didn't know how radiation affected the body so we didn't really understand what the purpose was at all. She said the only thing we knew is what we were observing and that the children that were born were like animals and they weren't children at all. And that's what we learned of our understanding of how radiation affects human beings, it wasn't from the U.S. people. DR. FADEN: When the doctors came and checked you, sometimes they must have taken blood or x-rays or things of that sort. Did you think that was medical care that you were getting, treatment that you were getting? MS. MATAYOSHI (Through Interpreter): Yes, she thinks it was something to help them; that they were looking at them and trying to help them. DR. FADEN: Nancy, one last question. DR. OLEINICK: Most of what I wanted to ask has already been asked, but just to follow up a little bit on the medical doctors. When some of the inhabitants were taken to Brookhaven and other hospitals in the United States, I'm just concerned with what the understanding of the people was as to why they were going, why they were being taken to the United States? Can you give me some insight there? MS. MATAYOSHI (Through Interpreter): She said we thought they were coming for thyroid surgery, and then if we didn't have it, we'd get cancer and we'd be worse off. MS. NORRIS: I'm so curious, and this should be very quick. Once people who were brought to the United States to Brookhaven, in fact, being treated or were some just being brought for study? MS. MATAYOSHI (Through Interpreter): She said it was for both study and medical treatment, that it was both at the same time. They did look at them because they were affected, and since they were sick already they did try to help them. DR. FADEN: Obviously, you have helped us a lot by coming here, and we appreciate very much the panel, your time, and the information you have provided us. Thank you very much. AMB. deBRUM: Thank you. MS. MATAYOSHI: Thank you. DR. FADEN: We're almost ready for a break. We have a statement that is going to be read by Steve. Is Steve here, or did we lose Steve? Ms. Rebecca Stringer has asked that her statement be read for her, and Steve was going to read it for her. Hi, Steve. Thank you. REBECCA HARROD STRINGER (STATEMENT READ) MR. KLAIDMAN: The letter is addressed to Dan Guttman. "Dear Mr. Guttman: I request that this letter be read into the record of the next commission meeting to be held. "My father, James Edward Harrod, AXC, US Navy, deceased, was a participant in the 1962 Atmospheric Nuclear Tests conducted in the Pacific Ocean. Specifically, he participated in Operation Dominic I. We have certificates of participation in our possession. "At the time of his participation in these tests he was on active duty with the United States Navy and was stationed with Fleet Air Wing 2 (FAW 2) Barber's Point, Hawaii. According to his certificates of participation, FAW 2 was part of Joint Task Force 8 for Operation Dominic I. "I understand the purpose of the hearings your commission are holding is to examine human and medical experimentation with radiation. I encourage your committee to declare that the atmospheric nuclear tests conducted by the United States Government were part of this human experimentation. "From the government's own documents, they claim that one purpose of Operation Dominic was an experimental testing to determine the effect of ionizing radiation on the equipment used by the military. "It is virtually impossible to separate the men and the equipment when you talk about ships and aircraft. "My father became ill in the middle of March 1966 and died April 24, 1966 of what Bethesda Naval Hospital said was probable bronchogenic carcinoma with widespread metastasis. However, besides my father's participation in Operation Dominic there were numerous incidents that caused me and my family to question the cause of that cancer. "One: The October prior to my father's death he took his routine flight physical, along with the routine chest x-ray. This x-ray was negative according to my father's medical records. However, when he was ill in 1966, Bethesda Naval Hospital requested Key West Naval Hospital to forward that x-ray. Amazingly, in 5 months time that x-ray had been lost. "Secondly: It has taken me almost 15 years to obtain copies of my father's military personnel and medical records. "About 15 years ago I wrote and requested these records and received a reply, stating all of these records had been destroyed in a fire at the Military Record Center in St. Louis, Missouri. "In January 1994, I once again decided to request these records after reading much material on the Nuclear Veterans. "I obtained the appropriate forms and requested a copy of all information contained in my father's file. "After three months, I received 24 pages of information that appeared to be summaries. This was supposed to be the entire record of a man who had served in the Navy for over 22 years and had been hospitalized for almost 6 weeks. I simply did not believe it. "I wrote a second letter, again requesting all information. Again, several months later, I received approximately 154 pages but still not as detailed as it should have been. It did not include all medical information, and it also did not include some information that I had copies of that should have been there. "Finally, I wrote a less than pleasant letter with copies to the White House and Chief of Naval Operations at the Pentagon. "After this letter, I received almost another 200 pages of information. The Records Center claims this is everything. "Somehow, I have a very hard time believing them after 9 months of trying to obtain only this information. "I have several brothers. However, only one was born after my father's participation in Operation Dominic. His date of birth is 12-20-1963. As a child he had what the doctors call a congenital hip deformity. This is a very minor problem. However, since congenital infers being born with this condition, it seems he is the only one in our immediate or extended family who has ever had this problem. "About 1 year prior to this brother's birth my mother suffered a miscarriage. "Most importantly, is the information, minimal as it is, that my father shared with my mother at the time. He rarely talked of anything connected with his job because of the highly classified nature of the work. He did, however, tell her one time that he had seen something that in his wildest dreams he could not have imagined and the only protection they had were goggles. "Any one of these incidents alone would probably create no questions. However, taken as a whole with my father's participation in these tests, they become more pieces to our puzzle. "Some of my research regarding Operation Dominic I has yielded the following pieces of information: "One: Most information regarding this operation is still classified; "Two: A report issued in 1989 by the National Research Council, entitled Film Badqe Dosimetry in Atmospheric Nuclear Tests, indicates that Operation Dominic I was a grave emergency. "It seems to me that if Operation Dominic I records are not declassified we may never know: "One: If, in fact, part of the military's role was experimental to determine the effect of ionizing radiation not only on equipment but also on personnel; "Two: And we may never know what harm was done to the military and civilian personnel involved. "It is imperative that these records be declassified and that your Commission be allowed to review them and determine if human experimentation was part of these tests. "The U.S. Government has stalled for years on releasing this information regarding their involvement and that of the military in experimental operations. They have used the reasoning of national security as a full explanation for keeping information classified. "Yes, my father voluntarily joined the Navy, but many of these veterans did not; "Yes, my father agreed to defend his country for the sake of his family and the country as a whole; "Yes, he agreed to follow orders without question; he was aware of the risks to his life in times of war or even in peace time from a shipboard or airplane accident. "No, he did not agree to be part of experimental nuclear tests; "No, he did not agree to give his life in a hospital suffering from latent effects of ionizing radiation. "What I would like to express to your Commission and members of the U.S. Government is that, while legally and morally, compensating victims may be the way you choose to go, it is not the main reason myself and many others are seeking full disclosure. "No amount of compensation will bring back the sense of loss we have felt over the last 28 years without my father's presence among us. "No amount of compensation will answer the ongoing questions we have regarding the circumstances surrounding my father's death. "No amount of compensation will tell his children or his grandchildren if there is a hereditary weakness toward certain types of cancer or was his cancer caused by ionizing radiation, and therefore poses no risk to us. "Only full disclosure of what exactly occurred during Operation Dominic I and all other Nuclear testing conducted by the U.S. Government and private firms and accurate amounts of exposure those involved received and what have been the effects will answer these questions. "I strongly urge your Commission to act without haste to fully investigate these tests and their relationship to the rest of the human experimentation program. "Sincerely, Rebecca Harrod Strinqer." DR. FADEN: Thank you, Steve, for reading Ms. Stringer's letter to us. Lois. MS. NORRIS: Do we know anything about Dominic I? MR. GUTTMAN: We know much more than we knew in November, yes. DR. FADEN: The question is -- DR. THOMAS: In what sense was it a grave emergency? MR. GUTTMAN: I don't know that we need to do this -- DR. FADEN: We can't do it right now. The issue is we should try to follow up on it. MR. GUTTMAN: If I were Mrs. Stringer, I'd be pleased to answer that question. DR. FADEN: That's enigmatic. We'll be doing it later. Maybe that will be a context. I think Lois' question generally is one that this letter is, and the rest of the Committee members need to understand what we do and don't know about Dominic I and how much Ms. Stringer's request that more information be made available is still a problem. Is it out there already or not out there. Maybe Ms. Stringer doesn't know what we have. MR. GUTTMAN: Right. The answer is that it is, at this point, quite astonishing, but there isn't a day in a week when we don't get new information from the Department of Defense on these things. DR. FADEN: Okay. We are going to take a break, believe it or not. We're about 15 minutes behind schedule. We're going to come back at 11:00 instead of 10:45, which is on the schedule. If you can come a little sooner, that would be better, and maybe we can push lunch off 15 minutes. We'll try to just eke it that way. [Recess] DR. FADEN: Would the Committee members please come back to the table. We're going to try to catch up on time. We are going to try to get one more important piece of business in before the lunch break. Committee members, if you could please come to the table. Okay, group. We are going to have to, unfortunately, do one of those really jarring head shifts that we have to do so frequently on this Committee and leave some very compelling testimony aside temporarily and now turn our attention to some of the contemporary work that the research has been conducting. The plan is to go through the status of the research proposal and review project before lunch and do the subject interview study after lunch, so that's what we're planning to do. We've got Sara, Gail and Shobita, you want to join us? We all have a draft in the slim packet that you got on Saturday morning. Anna and Dan and Jeff aren't here. I'm going to wait until they're here to say something about the extraordinary effort that went out Thursday and Friday to get this. Unbelievable. Okay. Sara, did you want to do a kind of overview for a few minutes or should we just launch right into questions? What would you like? MS. CHANDROS: It's sort of up to you. Given the short time that we have, if there are strong reactions already, I would welcome the Committee to just start talking, or I can just give an overview of the major -- DR. FADEN: Make it about five minutes that kind of orients people, and that will help us make that transition, listening to you start to talking about it. Then I'm sure the questions will flow. UPDATE ON RESEARCH PROPOSAL REVIEW PROJECT MS. CHANDROS: The most significant part of this chapter is the brand new section that gives tentative conclusions and the most recent findings with respect to the status of conduct of human subject research, based on your review of proposals. On page 16 of the chapter, there is a list of 8 major summary points that kind of summarize the major findings. The first of these is that our review seems to suggest that most research involving human subjects conducted or sponsored by the government appears to be ethically acceptable. However, the number of ethically troubling research projects is unacceptably high. The remaining points speak to elaborate on those two first points. At least one-third of the research proposals that have been reviewed involve no more than minimal risk. However, the greater than minimal risk studies seem to be where most of the problems are concentrated, that were identified by reviewers. These problems are apparent throughout all of the relevant agencies that we reviewed that conduct research. This is both in the intramural and extramural programs that the problems appear. We split the proposals into four biomedical categories: tracer by distribution, therapeutic, diagnostic, and epidemiological studies. The problems are also apparent throughout those categories. Perhaps more in some categories, such as therapeutic, than others, but they still appear in all four of those major categories. Another finding was that ethically-problematic studies were disproportionately represented in the cancer research that we reviewed, whether that's being a function of it being cancer research or high-risk research is something that we can discuss. Of the cancer studies, studies that are collaborative or group protocols, were disproportionately problematic, compared to the number of collaborative samples found in the sample overall. Then finally the last section discusses some of the common problems that were found in the ethically problematic studies with respect to the discussion of risks and benefits and some other major alternatives to participation and who is having these discussions, these sorts of issues. Is that a good overview? DR. FADEN: That's as good a place to start. I'm sure there will be plenty. I'll start making my list and checking it twice. I see Ruth. Ruth, why don't you start. DR. MACKLIN: Okay. I had a lot of very small points that I will give the draft, but I have one question about the way -- really, a question for Duncan, if anyone -- and that is, as a non-biostatistician, which is the naive reader, when I read something like this, I'm trying to say how it would look for a non-expert, and the percentages of responses are given, and the percentage is 50 percent but it's only 2 studies, and then the percentage is 25 percent, and it's only one study. I mean, I'm not asking a question about statistical significance, I'm just conveying it that way. When you convey something as 50; oh, my God, half the studies, we found this, and then you find out that there were only two. DR. FADEN: Which one was the 50 percent. DR. MACKLIN: Right. Or there were four and two were the 50 percent. I mean, how is this -- this is really a different kind of question from the second question I'm going raise, but let me just stop with this one; it looks odd is what I'm saying. DR. THOMAS: Just a general response. First of all, every time a percentage appears in parenthesis following it, it should be the numerator and denominator, and that would help. DR. MACKLIN: It does. DR. THOMAS: And it does in almost every circumstance I've seen. Although I would not put it forefront in what we do, formal statistical significance testing does have a role, in the sense that it will protect us from going out on a limb to make statements about the alarmingly high prevalence of blah-blah- blah, or the striking difference between this and that, which could be just due to small numbers. So I would encourage staff to actually do that testing behind the scenes, but I don't think we want to burden a qualitative report of this nature with a lot of significance testing. DR. MACKLIN: Let me get to my other point, which is jumping ahead, but I discussed it at length with Sara and Gail, and, Ruth, I know you have something to say about this, too. Let me call your attention to the place in the document. It starts on page 26. There's a lengthy discussion here about the responsibility for explaining risks, potential benefits and alternatives to potential subjects. I guess the discussion part appears at lines 4 and 5 on page 27. The Committee found evidence what investigators and IRBs do not expect consent forms to include -- it's referring to the descriptions about the quality of life and the alternatives, et cetera. Instead, they appear to expect the referring physician to provide potential subjects with detailed explanation of the choices available and how to compare the experimental protocol. Then there are some examples. This is one example, and there are examples throughout. Now, what the analysis says or questions, is whether or not the consent discussion -- in other words, what's the timing of the consent discussion and with whom will it take place. Who will be having these discussions? My understanding, and this may be a complex matter, and I think Eli and Mary Ann can maybe help out here; my understanding of your doctor, or your child's doctor, in these consent forms is that it refers not to the primary care physician, not to the internist who did the referring, but to the doctor who is conducting the research, who may also be treating the patient, but the specialist. So that when it says, "your doctor," this is a piece of paper. It's a consent form, and what it's referring to is the doctor who is conducting the research, who is at that point the patient's doctor -- see, they're shaking their heads yes and you're shaking your head no. DR. FADEN: Well, let's hear the difference. DR. MACKLIN: Yes. So it would make a very big difference if the person who referred to here is the referring physician, namely, the referring physician. Let's call it the patient's primary doctor just for the sake of it; the patient's, in general, internist, who isn't going to know beans about the research. He's not going to know the detail, he's not going to know the quality of life. So if there's a problem, the problem is more as Gail Geller mentioned, an old one that there familiar with, of the conflict of interest faced by a physician who is both the researcher and the patient's doctor, since the patient is eager to do the research but at the same time has to do what's best for the patient. That's an old potential conflict that could enter into. It would be an entirely different matter, and I think what this draft implies is that it's some other doctor, the doctor of the patient other than the physician who is now in charge of their care and who is conducting the research as well as treating them. I think this needs to be clarified very much in the draft because it's going to make a very big difference, both about the timing because, after all, if it's one and the same doctor, if there's only one doctor involved, namely, the researcher who is also the physician, then the questions here about timing on line 11, for example, on page 27: "Such text indicates that conversations between subjects and their doctors will occur after consent is given." Maybe that's just a poor use of verb tenses in the consent form, but I think it needs to be cleared up here who is the doctor, whether it's the referring doctor or the doctor who is the researcher before we decide what we want our recommendation to be. Is that clear? DR. FADEN: Yes, I think we all understand. Eli and Mary Ann, did you want to respond? The issue is very central. Let me suggest something. That is, these are a small number of proposals, all totalled. I think given what hangs in the balance, I don't know if people are going to have a panic attack; Sara probably more than anybody. Maybe we should go back and ask rather than speculate. DR. GLATSTEIN: I can't imagine that any investigator would depend on someone on the outside to do his explaining for him. DR. FADEN: I hope you're right. I hope you're right, Eli. DR. KATZ: It's not clear. DR. FADEN: It's not clear. DR. MACKLIN: I don't think of it as a primary care provider, but at least I know in our community there are a lot of private oncologists who refer. Often the discussion about what I can do with you, unless you go to NIH, is the following. And then you go to NIH or wherever, and you get the detailed description of what we can offer you on this clinical trial. But the alternatives and what I can do to you without you going to NIH or without you going to Hopkins or without you going to Sloan-Kettering is the following, and then you go to Sloan-Kettering to find out what Sloan-Kettering can do for you. DR. GLATSTEIN: I think that the biggest problem with respect to alternatives is generally going to be the issue of considering no treatment. That is an issue for a number of cancers. It is usually dumped by most physicians. It may be covered verbally, but it is usually not in the written part of the consent, although I must say, in reading some of the consent forms, sometimes it's covered and sometimes it should be covered and isn't. I can think of a couple, actually, that will surprise me where the state of the art is that no treatment is the standard of practice, that's not mentioned. I think that it is an issue. DR. FADEN: Let me see if I can. I threw out, and I didn't mean to. I think we could go back to the institutions and ask for a clarification of who the reference is in these particular cases. DR. GLATSTEIN: Most of the times it says your doctor. It's written by the investigator, meaning himself, and that is the way most is writing. DR. FADEN: It seems to me there are two issues. One is: that one; and then the other is -- three issues. One is: Let's find out who your doctor is. It might be that Ruth and Eli are correct, and that in all cases it's the equivalent of the principal investigator or the local investigator. Perhaps it's not. So we can establish that. The second is: In any event, there is no summary in writing of what it is that this doctor is saying. It says: Your doctor will give you the rest of the detail. That's the second order of problem, that the IRB doesn't have any written material which summarizes whatever it is that this person, whoever that person is, the PI or a referring collaborative oncologist who is sending her patients onto the tertiary care facility where the research is done, we can see that the IRB doesn't have a summary of the points that are covered. It may be covered that the IRB can vouchsafe that what is discussed is appropriate. Can we agree to that point? DR. MACKLIN: Yes. I didn't mention that, but I agree very strongly on that, that it's not supposed to be referring to some discussion that you had, even if the doctor is the researcher. DR. GLATSTEIN: One of the reasons why it's usually the investigator who is referring to himself as "the doctor" is most of us will take that written consent form, which is signed, and it will be considered documentation that we've tried to explain everything to the patient, should there ever arise a liability issue. DR. FADEN: Right. DR. GLATSTEIN: We're not trying to cover up for somebody else, we're trying to keep our own skirts as clean as possible, and we want documentation that we have tried to make the explanation clear. Any good attorney can show that a patient didn't literally understand all of the terminology. Some must do a better job than others, and some do a worse job than others in terms of putting this in simple language. The language is usually, no matter how we write it, there's enough jargon in there that almost any attorney would be able to show that the patent didn't understand the subtleties of what was being stated, but it's a document that demonstrates that an effort was made, and from that point of view, we consider it protection for ourselves. DR. MACKLIN: Could I just add a point here. I am not familiar with the scenario that you describe, namely, the oncologist in the community who then sends the patient to the center. The IRB on which I sit, and I'm only talking about that's my entire experience, the person who is bringing the study to the IRB is, at the same time, the patient's clinician, and the clinical investigator. DR. GLATSTEIN: There's precedent for that. DR. MACKLIN: Yes, I believe that is the case but then the phrase, "your doctor," will always be ambiguous, and sometimes it's going to be the one case and sometimes the other case, but there may also be a misleading -- I mean, we should consider whether we want to recommend the following; namely, referring not to a recommendation that these consent forms not refer to "your doctor," which makes the main emphasis on the treating role of the doctor rather than the person who is conducting this research. That is to say, it may be your doctor, but it may not be your doctor, but in any case, the person who has to be explaining these alternatives is the person who's conducting the research, which is another way of unambiguously reminding the patient, the subject, that the subject, at this point, is a research subject. DR. FADEN: It would be very helpful. I think it's an interesting suggestion. Your doctor, Dr. Smith, who is also the main researcher on this study, and it would be nice if the name was there; you'd have a blank and somebody could fill it in. DR. STEVENSON: They usually are required. DR. MACKLIN: At the beginning and the end. DR. STEVENSON: Right. But usually if you have any questions or problems, a name has to be put, it can't be anonymous. DR. FADEN: At the bottom. Right. But here is what we have seen are several forms, where there's a reference in the text to your doctor, or your child's doctor, will tell you, and it's completely ambiguous who that person is. DR. GLATSTEIN: The problem is that many of these studies are carried out by departments, and so the physician can be a number of different people who will be representing the investigator, that the physician will be -- DR. FADEN: Good point. DR. GLATSTEIN: -- they're all on the same wavelength but they are not all the investigator of record. Yes, you're right. There's more confusion here than I thought of. DR. STEVENSON: To some degree, I think the treating doctor, ultimately the one who decides or is responsible for explaining options to the patient, I think the word "treating doctor" is the right person because, as Eli said, many times in the departments the PI has designates in various places in the Center, who is informed and is authorized to carry out protocol procedures but is not necessarily PI. So it really has to be, whoever gets the consent is the treating physician. DR. MACKLIN: Wait a minute. Whoever gets consent? DR. GLATSTEIN: Whoever does the consenting; this is to say, which physician sits down with the patient and explains things to him, and that's not always the same guy -- not always the same person, excuse me. MS. GELLER: But I'm hearing Ruth Macklin argue that it must be the PI to do -- DR. MACKLIN: No, no. I didn't. I was making the distinction between the patient's private doc or personal M.D. and the researcher, but I don't mean the PI. I mean anyone on the research protocol. DR. GELLER: Right. But I'm hearing -- if I understand Mary Ann and Eli, they're saying the treating physician as distinct from the person leading the research, or it may not be. It may be a designate. DR. GLATSTEIN: We're not in the clinic every single day. If I'm here, I can't be there. DR. MACKLIN: The cover sheet of the IRB form will say something. It will have the name of the PI, and then it will say collaborators, where the list of collaborators are all of those. Any of those people are -- DR. FADEN: I think it gets even more muddled because you will have people who will be enrolling people in trial who aren't collaborators. DR. MACKLIN: That's a problem. That I think is a problem we need to flag. DR. FADEN: Isn't that how commonly it occurs? DR. GLATSTEIN: Yes. Yes. DR. FADEN: You'll have the Fellow or the senior resident. DR. MACKLIN: Yes, sometimes residents. DR. GLATSTEIN: In our own department, it's the staff's responsibility, it's not nursing and it's not a Fellow's responsibility. DR. FADEN: So it would be an attending. DR. GLATSTEIN: It belongs to the attending doctor and nobody else. DR. FADEN: But in your case, even there, though, it might be an attending who's a colleague of yours, recruiting somebody into your study, not his study or her study. DR. MACKLIN: Right. DR. GLATSTEIN: Yes. Yes. It depends on which study. DR. FADEN: Yes. It depends on what the patient's problem is, and then the patient looks like a candidate. DR. GLATSTEIN: If we've got a study with this disease, that I'm running, then he may put the patient on. He may have a study, or she may have a study. DR. FADEN: It gets all muddled. DR. GLATSTEIN: Yes. I might put someone on that one. DR. FADEN: Okay. DR. KATZ: I would just like to comment in continuation. I was struck on these protocols how rarely there was any indication as to who would obtain the informed consent, whether the investigator, whether it's delegated to others. I think in the protocol, it's explicitly asked for as to who would obtain informed consent. I rarely saw it in any of the 100 protocols. DR. GLATSTEIN: I think that's right, but I must say, it never even crossed my mind until I saw the questions being asked, because everywhere I've been it's always been the investigator's responsibility. That is to say, the staff physicians who are putting a patient on study, not residents and outside physicians. DR. KATZ: There are a few Elis in this world. DR. GLATSTEIN: No, I don't think that's right, but that's the way I was taught. DR. FADEN: Ruth, technically, still has the floor, and Nancy and Lois are waiting. DR. MACKLIN: I'll yield this floor right now and if I can come back if I need to. DR. FADEN: You can definitely come back. Nancy. DR. OLEINICK: I have a couple small points and then a larger one. One of the small points is having to do -- I don't know how small this is, but having to do with the question of all of these various numbers, as Ruth brought up, the percentages. One small point is, it would probably be simpler for the reader to have many of these numbers tabulated or graphed simply, because reading paragraphs full of numbers is very difficult to get a vision, whereas, a simple bar graph can transmit the information almost instantaneously. The danger of this is that it will tend to magnify the small differences, and again, these 50 percent where the population was 2 will tend to be blurred, so maybe with Duncan's guidance and some of us reading it, we can find some happy medium between that. I, too, was very concerned about the question of significance, and I think it's really important all the way through. You say it in a few places, but I think not enough, that these are very small populations in most cases. The population may increase somewhat because we haven't finished reading it -- DR. FADEN: That's right. DR. OLEINICK: -- so the numbers are going to be very small. The trend certainly may not be significant. Then going further on that question, we have in the summary on page 16, for example, Item G: One-third of the cancer studies that receive ratings of 4 or 5, and it should say on a scale of 1 to 5, at it should say on a scale of 1 to 5, at this point. It becomes clear later but not here. Under collaborative studies: However, collaborative studies represented only one-quarter of cancer research review in the total sample. We're making a statement as to whether we think one- third and one-quarter are different here. I'm not entirely convinced that that is a significant difference again, so I think we need some work on trying to show what we think might be significant, and then downplaying what we think is just trends, but we have no idea whether this would be -- DR. FADEN: Can I? I share that concern, but I have a kind of different reaction to it, which is, I don't think we should be playing on statistics at all here. I think we should go in the other direction and say let's look where the differences are. We care about them. I don't think the third one-quarter business is anything to go home about. I think it's not worth -- DR. OLEINICK: Then we shouldn't be making the statement. DR. FADEN: I agree. My inclination would, in that case, be to just pull that one out, but rather do we think that 10 out of 70 -- if we think that 10 studies are problematic, out of an n of 70, do we think that's a problem. I don't need a statistical test to tell me that. DR. OLEINICK: Yes. DR. FADEN: We either agree that 10 problematic studies out of 70 is something to worry about or it isn't. DR. OLEINICK: That's fine. DR. FADEN: There is no test. It's sort of at that level that I think we should be looking to these data. DR. OLEINICK: That's fine. DR. FADEN: Maybe that should be the signpost for how we present it rather than -- DR. OLEINICK: This is a qualitative study. We understand that. It's not clear in my head exactly where we should draw the line. Are there any quantitative data that are worthy of bringing out or should they all be? DR. FADEN: Here's one I would like to lay out, and I would love to turn to you and Duncan for how best to present it. That is, the issue that keeps reemerging about more than minimal risk and whether what's driving this whole thing is whether something is more than minimal risk or not, so you see when you analyze it by agency the data are presented to suggest, but HHS has more than minimal risk studies, so maybe that's why they got the grades that they got. Cancer has more and more higher risk studies, and so maybe that's why we find so many cancer ones in there. I don't quite know how to handle that one. If there's a theme running through that sort of cries out for some sort of statistical analysis, it's the role that risk rating is playing. DR. THOMAS: If you want to say that 10 percent of studies are ethically troubling, you don't need any statistics to make that statement. DR. FADEN: Right. DR. THOMAS: Presumably, the population value which would form your null hypothesis would be zero percent, then a single counter example is sufficient to disapprove that. Where you need statistical significance testing is when you're trying to make analytic statements, and by an analytic statement there is implied a comparison of some sort. I think what Nancy is reacting to is this proliferation of percentages throughout the report, which imply differences between groups, which may be nothing more than flukes. I support the notion that we should really only be reporting differences in percentages when they are sufficiently large to be of substantive interest and also reasonably likely to be not simply just due to chance. DR. FADEN: Let me turn it around. Maybe what we should do on this matter is send it out and seek those of us who have an interest and how best to present it to work on it. Another way in which presenters are used here, and I know because I worked hard with the staff to get this out, is to show that there are similarities not differences. For example, to make the claim that there are problematic studies throughout the federal government and both intramurally and extramurally, I don't really need statistics to be able to say, you know, if you have ten bad studies, it turns out that 8 of them aren't at one agency. They're kind of spread out across the federal government. It turns out they aren't all an intramural versus extramural, so how to present that data for that other purpose, we could really use guidance and feedback about that. That's an important point to make. DR. OLEINICK: It's a question of finding the right -- DR. FADEN: How best to present it. DR. OLEINICK: Right. DR. FADEN: Yes. Because you want to end up saying, look, they didn't all occur in one agency of the government or they didn't all occur just intramurally or just extramurally, but how many numbers to put out to be able to say that and how to package it is something that I'm sure we could all -- we could use some help. Nancy, you still have the floor. DR. OLEINICK: Yes. Let me bring up another point. It could be because this is definitely an incomplete document. I know the staff has been working very hard. I found there were a number of points that I didn't see addressed anywhere. It seems to me that one of the most egregious acts, should we find it, would be to find a study where we felt that it should never have been done in the first place. I don't see that addressed at all. Nothing that I reviewed into that category, and I don't know if there were any that came into that category, but that would be more egregious than almost anything. We don't even get to the issue of consent if we have a study that, because of scientific reasons, should never have been conceived of in the first place. I think that it at least ought to be addressed. Maybe we didn't find it. I didn't see it. DR. MACKLIN: Would our sample have turned those up? I mean, it may have been turned down by an IRB. DR. OLEINICK: The whole idea here is did one sneak by the IRB. DR. MACKLIN: Did one sneak by is not the whole issue. DR. FADEN: In other words, it's good news. DR. OLEINICK: Then we need to make the point. DR. MACKLIN: Then we need to make the point. Exactly. DR. FADEN: That's what I'm saying. DR. MACKLIN: If, fact, there are such things out there and they are turned out by IRBs, then that system is working reasonably well. DR. OLEINICK: Our whole point is what are the IRBs passing on. MS. GELLER: But doesn't that have something to do with whether the IRB considers scientific merit within its purview? I think that there's controversy about that, and they may not even think that it's up to them to review a study on those grounds. DR. KATZ: Exactly. DR. OLEINICK: First of all, what we're reviewing are studies that have been passed by an IRB. MS. GELLER: We don't know where. DR. OLEINICK: They have been funded through some mechanism by some branch of the federal government, so presumably there has been some form of peer review -- scientific peer review. Those are the studies that we're looking at. The question that I think should be addressed up front is, did any of them pass these levels of review; are there any of these types of what I would call most egregious sins. So far, I haven't seen any, and it may be that there are none, and that would be good news, that should be up front. We did not find any. I think that issue should be addressed. Also, the issue of inclusion and exclusion criteria, which were formed about, I don't know, 20 percent of all the questions that we had to address in the form, are not discussed at all. I think that should be, what do we know about how the investigators tell us who the populations are, what are the inclusion and exclusion criteria, and to what extent are those conveyed in the protocols and in the consent forms. We were asked those questions. The information is there. I think a little bit about the whole recruitment process certainly has been addressed in this question about who your doctor is, but what do we know about the recruitment process in terms of when. Actually, most of the protocols, at least that I saw, didn't spend much time discussing it, and I think it's certainly an issue, and we ought to address that. It seemed to me that one of the largest issues and one of the reasons that many of the protocols were downgraded was because of language on consent form. I didn't see any discussion of that in this chapter. It could be that this material just has not been dealt with yet, but it certainly should be in there. That is a big issue. DR. FADEN: Those are all very good points. Excellent. I'm taking notes. I'm sure everybody else is too. Lois. MS. NORRIS: A couple of factual questions and also a couple of comments. On page three, on the footnote, the only reference that I can recall with respect to the CIA, saying that the CIA maintains that it neither funded nor performed any human research involving ionizing radiation in fiscal year '93. Yet, with other agencies, we went back to '92, '91, '90, and with respect to NASA, I think we even went back to 1985. I wonder, and that stands out. MS. CHANDROS: Yes. This is something I don't have a complete answer to. I did ask, through other people on the staff, whether it covered the period '90-'93. I don't think we ever actually got a straight answer on that point. This was written before we made the decision to go back to FY '90, but we never got any additional information, including whether or not they do, so it is ambiguous. You're right. We either have to say that they didn't answer us or that it was not conducted. I'll get a more definitive answer on that. MS. NORRIS: The reason I asked that was because I had not seen many protocols myself in the last month. DR. FADEN: We'll send you one. [Laughter] MS. NORRIS: No, no. I've seen a lot of other paper. DR. KATZ: You asked for it. DR. FADEN: I don't want you to have a spare moment. MS. NORRIS: That's all right. I want that stricken from the record. DR. FADEN: Let me say that everybody on this Committee has overdeveloped super egos. We've laid out that we were well behind people, really. DR. KATZ: What happened to our egos. The super egos. DR. FADEN: I really don't know. Somewhere people have that hour from two to three in the morning and turn out yet another review for which we should all pat each other on the back. MS. NORRIS: The others were just following up on other things that have been said. I, too, noted what Ruth, Nancy, Duncan had noted with respect to small numbers, and therefore, sort of distortion in the percentages. I'm glad that you're dealing with that. DR. FADEN: We don't know how, but we will. MS. NORRIS: I trust you. The other thing was mentioned by Gail, and that is, the apparent inconsistency in terms of the IRB's perception of responsibility with respect to scientific merit considerations. I don't know how to address it. I don't know if we can address it, based upon materials, but I think it's noteworthy. The other thing I haven't seen in here, and it's possible, because I didn't read it carefully enough, and, if so, I apologize, but it seems to me that there is a consistent lack in consent forms of risk, benefit, cost, analysis comparisons. You see that more often in the protocol itself. I think the cost factor does become important, particularly costs in terms of quality of life and costs in terms of dollars and cents because of the reluctance of insurance companies to fund research. Unless that's made clear to a patient or a potential subject, that subject may not realize that there may be a significant amount of money involved in enrolling the research, and it becomes -- and Jay mentioned this last month with respect to one particular protocol -- it stood the -- there was a risk of it being very costly to the individual, providing few benefits, personally, and definitely impacting the quality of that individual's life. I think those things become very important, and I do not see that in a lot of the consent forms. DR. FADEN: Jay. DR. KATZ: I'll try to be brief and make three points. First of all, to compliment Sara and Shobita and Gail. I met with Sara in New Haven on Tuesday, and we spent the afternoon together. None of this was yet written. What they have done in a few days was absolutely astounding. I didn't start reading it until I awoke from sleep Saturday morning, did some other things Friday, because I thought I would be very disappointed and I was disappointed -- I'll get to that in a moment -- [Laughter] -- but this has nothing to do with Sara and Shobita and Gail, but there are other issues involved. One thing I was also struck by is the way, and forgot this morning to talk with Sara about it, the way this was discussed -- risky experiments. It is not really this so much that we are interested in because after all research, by the very nature of the beast, has to be risky. We have to find some new language for this. A more cumbersome way of expressing it might be that we are dealing with more complex studies, both with respect to risk and the informed consent process. It's really the two things that have to be brought together. Maybe we can think of a good phrase for it. But now Point No. 3: If this document is not changed in fundamental ways, I will have to write a separate comment. It focuses on two issues. They are as follows; On page 16, our review suggests that most of the research protocols currently conducted or sponsored by the federal government appear to be ethically acceptable. I would write this in the negative. It's not ethically acceptable, to me at least. On page 19, this is repeated explicitly, but it goes -- it pervades the document, in part, in the first full paragraph: The current systems for the protection of rights and interest of human subjects, the common rule, and the local institutional review boards on which the common rule relies for implementation has succeeded to a significant extent in achieving its goals. I don't believe it. I want to remind you, I'm not going to give you examples again unless you want me to. I gave them last time. In my review, now encompassing about 100 protocols, and at least for my purposes, I have no problem with taking also the whole sample, I found approximately of the 100 protocols 60 of them dealing with no risk, minimal risk, non-complex kind of issues, in which it was perfectly -- it was easy to state everything you needed informed consent for, to be quite forthcoming. Indeed, as I told you last time, I think some new mechanisms need to be devised to remove most of them from the view or from annual re-review, because it takes up too much time and it's really unnecessary in terms of protection of subjects of research. But of the remaining protocols, which raise more complex issues in terms of risks and the informed consent process, I found approximately 20 percent satisfactory, 30 percent what we call No. 3, more problematic; and about 50 percent 4 and 5s, very problematic. To me, that figure raises questions which does not permit us to make a summary statement with respect to as we did intend to, as was done tentatively, as expressed in Summary Statement 1. I appreciate, you know, we really are now under a pressure of time. I do not know how much more we can do about this and whether it's possible to come to a common understanding and how far we want to go in this, and there may be a need for some of us, one way or the other, depending on how it comes out, to express certain reservations. They will not be dissenting statements, they will be statements of emphasis. This is something we have to discuss either now or maybe tomorrow afternoon, when we talk about future strategies. Let me just make one more comment about my overall review, and that is that, in my review, I am very much impressed with the subtle or not so subtle engineering of consent that emerges from reading the informed consent form, not only with respect to expressing greater hope to the patients that seems warranted. I think also in the hope that few people and few patients will refuse participation, which will interfere with a satisfactory accrual of subjects to participate in research. Finally, I get the distinctive impression that's not only patients who are not satisfactorily informed, the IRBs are not satisfactorily informed either. The IRBs are not sufficiently informed because, after all, they are not as knowledgeable as the investigators, about the risk and benefits of the proposed intervention, particularly in those instances when standard treatments are available that may not be quite as good as the hopeful result from the experimental treatment. That seems to suggest that with standard treatment, patents might live with a better quality of life, at least for a period of years, and this is their choice to make. In one protocol, it was mentioned kind of complaining by the investigators, why don't doctors get these people to participate in the research protocols, and show that they have a fatalistic attitude about the advisability of treatment even though non-treatment for period of years, seem to be, at least in terms of the views of practicing physicians, a meaningful alternative. Thank you. DR. FADEN: Jay, you said there were two concerns. Did I miss the second one? The first one about the characterization of the current research. The two being, first, the statement that says most studies seem to be ethically acceptable, and the other that the current system has succeeded to some extent, or whatever the language is, I just wanted to make clear. DR. KATZ: Yes. DR. FADEN: We should clearly discuss this. Ruth. DR. MACKLIN: Yes. I want to go directly to this point. I think much of what Jay says, he's going to speak for himself after I do this brief interpretation, but most of what Jay says, as I heard his comments and agree with them -- I do agree with them -- emerges because of both this chapter's failure, as I believe it was Nancy pointed out or this document's failure, and our failure prior to that to distinguish very clearly between the rating or the evaluation of the consent issues and the risk issues. As I, in the reviews I did and I didn't do nearly as many as Jay did, when it came to the subjective evaluation and assigning the number at the end, it was especially difficult to do because almost all of the consent forms and discussions of the consent procedures stank. But some of the research was otherwise decent research, was not a bad risk benefit ratio. With my co-reviewer, when we decided to hold the study down a little bit from what otherwise might be a 1, maybe to a 2 or maybe to a 3, even, it was because the consent was so terrible. But what may have pulled some of them up, we didn't rate consent different. In other words, if we had done, if we were going to do it over again, which I am not suggesting we now go back -- [Laughter] -- if we were to do it over again, I would probably urge a separate rating for the consent portion and for the rest of it, that would then enable us clearly to distinguish what's wrong with this. DR. FADEN: In retrospect, that would have been very helpful. DR. MACKLIN: Now, what I hear Jay's comment, and I do agree with him, most of what Jay said, even though the complex research, it's partly because it's complex, it's partly because it's more than minimal risk, but the problems stemmed more from the failure to communicate, the problem with the consent, both to the IRB, the information conveyed to the IRB, and also to the subjects. Now, I want to know -- so this is an observation that I think it was Nancy or maybe Lois who said there isn't very much in here about how terrible the language was and the problems with the consent form, and that's easy to fix. The question then becomes how do the overall findings change if we make this distinction fairly sharply. I would suggest that we do make the distinction and separate what we thought was problematic; that is, we separate to the extent possible, the informed consent and information provided to the IRB, which in the majority of cases is less than adequate and in some cases is terrible. Then address separately the risk benefit ratios, which are discussed at some length in here, those where the benefits seem not to be justified, if any benefits, based on the risk; then if we can distinguish still further, I'm not sure we can, make the assessment of the IRB from what we can tell from the pieces of paper, the IRB process. So I would second Jay's concerns which I heard focusing mostly on the informed consent, both the process, what's said about it, and also information to the IRB, and see whether or not the conclusions don't come out slightly differently when we distinguish the overall subjective evaluations from the consent, the process, the consent forms, and the information given to the IRBs. DR. KATZ: Can I respond to that briefly. DR. FADEN: Sure. DR. KATZ: I do not know whether this is what you have in mind, and I have, of course, discussed this with Sara and give her also some of my forms, et cetera. I think we made this distinction in distinguishing between the 60 minimal risk, no risk, kind of studies, the other 40; indeed, in the 60 minimal, almost no risk experiments which, by and large, were, I thought fine, there were about 8 of them or 9 of them that raise some ethical concern, but I still put them in that category for my purposes. In the 40 that remain, they were both risky experiments and gradually increasing kind of risk, plus the informed consent process was faulty. Does that analysis, not that you should accept, or do you want more than that? DR. MACKLIN: No. No, no, no, no. I think that's fine. I'm going to put it another way, counterfactually going back to -- DR. FADEN: I was going to say, let me hear what you have to say, and then I think there is maybe a potential disconnect, but maybe I'm wrong. DR. MACKLIN: As Nancy pointed out, we did not find any studies that we -- DR. FADEN: Well, we don't know that yet. DR. MACKLIN: No, no. Well, we don't know that yet. Right. Right. MS. GELLER: I wanted to ask Jay if among the 40 that you consider problematic, were there any that Nancy would call egregiously sinful, that you don't think should have been done in -- DR. KATZ: Not egregiously, but there surely were a number of studies -- MS. GELLER: But shouldn't have been done in the first place. DR. KATZ: They probably shouldn't have been done that way in the first place, because like in one Phase 1, Phase 2 study, that was touted as a Phase 1 study, two of the reviewers, the documents there said, look, methodologically, this is not sound because they wanted to establish toxicity levels. The endpoints for toxicity levels for Phase 1 studies and the Phase 2 studies are different. I don't understand that too well. They said that should be rectified. It was never rectified. You know, it was said and left alone. There are a few similar incidences of that kind. DR. GLATSTEIN: I'm not going to try and defend it but let me just say sometimes people try to consolidate Phase I and Phase 2, and that's where you get into trouble with endpoints. Phase I is very clear. It is to determine what dose to use and that will be determined on the basis of toxicity. That's the endpoint. Benefit to the patient; hoped for but not anticipated, because most of the patients on the study won't be getting an optimal dose. You just don't know what numbers are optimal. It's only after the Phase I is done that you then apply and you know what dose to use, that you then apply that dose to a broader sea of patients to see if their tumor gets smaller. That's the endpoint for a Phase 2. In trying to consolidate, it usually does make for some chaos. DR. KATZ: Yes. DR. FADEN: Ruth, did you want to finish? DR. MACKLIN: Yes. I wanted to hear what you wanted to say about the disconnect. Jay's question that there was this congruence between the higher risk and the poor consent is something that we can address, but I think if we're looking at the risk benefit ratio as a separate issue, suppose the consent documents had been beautiful; how would you, then, in that class of protocols that raise this problem, how would you then have ranked or what would you have said about the problematic risk part if everything were adequately and appropriately conveyed to the subjects and to the IRB? DR. KATZ: Back to this point, if it was adequately conveyed, I gave it a 1. There were four studies that I pointed out to Sara, and she hasn't had a chance yet to completely review it. There was one consent form in particular -- not identified by the institution, I've tried to avoid that -- which was a complex kind of study and, to my mind, the informed consent form worked in a risky kind of study. It was just absolutely beautiful and an indication that it can be done. DR. FADEN: Here's what I'm struggling with. I'm trying to put this together. Obviously, foundationally, what's at stake here is how ultimately you're going to characterize as a committee, and this is why I think Jay is right to point to that ultimate end here; how well we think things are going or not. Therefore, the statement that Jay is taking exception to is very critical, and later on what we decide we want to say about this is absolutely critical and do think the language could be played with, but I think we do have to resolve, once and for all, how we're going to treat these less complex studies. My view is still very much they're part of the world, and if it turns out that the reason why it's not too problematic out there, is because there's a lot of simple research going on that's pretty straightforward and easy to communicate, and you would combine a softer language of saying that, but I think if you go immediately to a conclusion that things are 50 percent -- you know, it's a wrong way of conveying, I think, what's going on. Having said that, though, I have been struggling to do what Jay and Nancy and Ruth have just been talking about; getting at the core of what's going on here, and we start out with this notion, is it just the consent process, or is it something deeper than that? Then it occurs to me, after I'd been struggling with this for a while that that's a very stupid way to say it, is it just the consent process, and is it just the consent process. The reason is obvious on its face but, more than that, that you have different levels of consent problems, and this is what I wanted to show about the disconnect. Jay has his 60, and of the 60, maybe there were 8 that worry that you, of the ones that are less complex. By and large, you thought they were OK, from an ethics point of view. Ruth may have looked at that 60 and not liked 40 of the consent forms but not in a big deal way. Language was too technical; maybe the sentences ran on, but it wasn't -- so then there is, what is the problem? In almost all of them there's this thing that says the reading level is too sophisticated. Well, we won't be the first committee to point out that consent forms are written at too sophisticated a level. That's in the literature. We sort of know that, and why it continues, we don't know. That's a different order of consent problem from Jay's concern that some of these in these more complicated studies of disclosure statements are crafted in such a way as to literally manipulate people into agreeing. That's also just a consent problem, but it's a different kind of consent problem, and they should have sat there with the Frye test and simplified the reading level a little bit or a lot. Maybe something got a 2 because all the information was there, but it was at a college level and they were recruiting people who were not that well educated, versus you get a 4 because they suggest more of a benefit. They hold out more hope than the study would warrant. I think we have to get clear on how we value these different problems. This issue of, is there any study that should never have been done, immediately you say in the fashion that it was done, well, if you change it, you could have changed Tuskegee and it would have been acceptable. You could have asked permission; you could have given him a Penicillin, you could change to the counterfactual, and then it becomes OK. So at what point -- I've been struggling with that. There are a few studies in here that we have, that we haven't talked about, that involve people with questionable competence and studies that may not have held out any possibility of therapeutic benefit to them. There it becomes not an issue of the consent process but an issue of whether, in fact -- forget the science -- it's ethically permissible to do research on people who are incompetent where the risk is more than minimal, and there is no benefit to do that. It's an old issue, but it's clear that we -- it's suggested that we may have a few studies that fall into that category. DR. KATZ: Ruth, you just reminded me of something that was utterly unethical in the 60 studies. DR. FADEN: 60 minimal ones. DR. KATZ: Minimal ones. Namely, the description of the dangers of the venipuncture, which were talked about in the paragraph about all the things that can happen to you when they want to take some blood out of your veins. After that, after I needed a few in the last few weeks, I was utterly scared to have my blood taken. [Laughter] I read about all the complications that can occur from having a blood sample taken. DR. FADEN: I'm struggling. I think we have a lot of work to do. We need to look at the 10 or 12 -- what is it now, 12 that got 4s or 5s, because that's just a triage way into it and see if we can get a better diagnosis of what makes those studies ethically troubling, and there may be different reasons, different times. We also have to agree at the Committee level, though, about how to characterize the other end of the story; how much of it is a good news story, how much of it isn't, which is Jay's point. How do you slice this. We need to go back and look more carefully at the ones that got 1s and 2s and 3s and see how many -- I'm assuming if people gave a 1 to something, they really thought there was nothing much that needed to be changed about it. Maybe it was a mistake to lump the 1s and 2s. Again, we just need a rough way to cut it into it. I don't know. I'm looking for guidance. DR. MACKLIN: This is all wedded to how you look at these things, but rather than cast our conclusions in the form that looks at the overall rating, maybe we should cast our conclusions, in the concern with respect to the ethical concerns. It would be hard? DR. FADEN: It'll be very hard to do. We could start with that and end up with the other. Yes, we could. DR. MACKLIN: What page is the summary on? MS. GELLER: 16. DR. MACKLIN: Okay. "Our review suggests that most research involving human subjects currently conducted or sponsored by the federal government appears to be ethically acceptable." Jay didn't like that. DR. FADEN: Right. DR. MACKLIN: It may be on one interpretation -- the problem is, it's a statement without the interpretation, and without the -- DR. FADEN: The interpretation comes later. I know. Of course, it comes later. But I don't know how to go further with this. DR. OLEINICK: Jay is reading that as a sentence alone. He's not reading it in conjunction with B and C which do bring out the negative aspects that you are concerned about. DR. KATZ: I stopped reading after "A". DR. FADEN: Come on, Jay. You have to read it together. DR. KATZ: No. You might want to put it as I or Z statement, but that statement, it tells me something. DR. MACKLIN: See, I don't like the formulation of the statement because it doesn't specify. I mean, this is what I'm suggesting; that is, these statements be cast. Specify, essentially, the consent process or the element of consent with the risk benefit. Now, what is true is that most of the studies had an acceptable risk benefit ratio or had a low risk -- let's put it the other way -- a low risk. And although there were some problems with the consent, on the whole, they were ethically acceptable. DR. FADEN: That's what that's supposed to characterize. DR. MACKLIN: But it doesn't in that form, I think. DR. FADEN: We can certainly make it more meaningful by explaining that. DR. MACKLIN: I would be happy with a statement that said, although most of the research involving human subjects is ethically acceptable, most of the consent forms were problematic in one way or another. MS. GELLER: It could be as simple as changing the word "most". DR. KATZ: Too much jargon. DR. MACKLIN: Quite literally, 60 percent is most, but it implies sort of 90 or 95 percent, so maybe you could just define what you mean by most. DR. FADEN: This is another one of those things where probably, in retrospect, it's better to get more of the findings out before we draw the conclusions. We should probably work harder in the next couple of weeks. This is very helpful to get a more refined understanding of what we need to be looking for, get more characterizations out. If we can agree about the characterizations, we may not agree about the implication. If it turns out, as a Committee, we can all agree that the following correctly describes what we found, the Committee may or may not conclude that what we found supports the same conclusions. We can look at the same evidence. I guess what I'm saying is, let's see if we agree about the characterization of the evidence and we can see if we agree about what the evidence implies. Right now, we have to maybe step back a little bit and see if we can come to agreement about how to characterize what we have seen, and then we'll see if we agree about what that evidence suggests in terms of an interpretation of the overall, and get a better sense of, if there is disagreement on the committee, where it lies, at the level of characterizing what we found or at the level of drawing conclusions of what this needs from what we found. The consent forms are all written at too sophisticated a level is a real egregious awful thing, whereas for somebody else, there might be a minor detail and not worth indicting a whole system for. Let me just step back and try to characterize what we've got, which could be the task over the next couple of weeks, in more refined detail, and then come together in May with suggested alternative ways to interpret the implications of it. DR. KATZ: We may not want to respond to this right now. It goes to the question I raised at the beginning, this morning. What you may have possibly in mind I think must be presented to the Committee in the next couple of weeks by letter, and then get a response back to you because it will influence the shaping of the uses of the final document, which will be before us at the next meeting, and then we have to decide which side is going to make some statements about this, that, or the other thing. DR. FADEN: I agree. No, this is going to have to be going like every week. One of the things that the whole committee may not know -- I can't remember; it's in there -- but a subset of us have been looking at all the ones that got 4s and 5s, and everybody who wants to join us on this is welcome, because it's a huge pain. It's been Ruth, Jay, me; we've pulled in some of the people who were reviewers before -- Eli, Jonathan, Moreno, and staff. What we really need to do is get that dialogue very quickly and see if we can agree about what's going on in each one of these, maybe taking them one at a time, about what seems to be the problem, and then see if they're the same problem showing up and the same ones or not, and how awful are these problems. How do we want to characterize them. What we haven't done is paid the same amount of attention to the rest of the bunch. Mary Ann has been waiting patiently, and then Gail. DR. STEVENSON: I'm not sure this is a help or not, but in just doing the math on Jay's percentage breakdowns, in fact, it turns out that your numbers would support A; 60 percent of all the proposals you reviewed were okay. I think the problem is, you said 60 percent were minimal risk -- DR. KATZ: Yes, yes. DR. STEVENSON: -- and of the 40 percent remaining, 20 percent of those were okay, so that's another 8 percent of the total, so it sort of gets you to the majority. I think the problem is, from your point of view, and I think rightly so, perhaps what we really want to focus on is the more than minimal risk research. In that case, the majority were unacceptable. But because by pure numbers the minimal or no risk carries the day. It pushes the total numbers to look like most research is okay. I think the thing needs to be reworded, if it's agreeable to the Committee, to acknowledge that most research, because most research perhaps is minimal and no risk is being ethically conducted in an acceptable manner, but that's not really our emphasis. We're looking at high risk or more than minimal risk. DR. KATZ: Complex communication problems. DR. FADEN: Right. Of those, we are not at all happy. You're particularly not happy. I think I agree to start out the summary with "A", is technically correct but does not necessarily give the impression or the emphasis that we'd want, and so the wording needs to be broken, or the emphasis needs to be broken into no risk, minimal risk, versus more than or high risk, and then the numbers shift and the emphasis shift. DR. KATZ: You know the guy in the Middle Ages who put on the lamps in the streets and he was always singing, It's 10:00, all is right with the world. If you read No. 8, you know you feel like the lamp lighter. DR. FADEN: Right. [Laughter] DR. KATZ: You know all is right with the world. DR. FADEN: It's technically correct, but it's not what we necessarily want to convey. DR. MACKLIN: Right. The issue is striking a balance behind how to characterize it. There is also, right now, a numbered discrepancy between even within the higher risk, the proportion that Jay has rated as 4 and 5 and the proportion that the whole committee rated as 4 or 5, but I think in part it's because we didn't have exactly the same set of protocols. Is that right, Sara? MS. CHANDROS: We can count on that. The committee as a whole comes up with 30 percent being unacceptable, and Jay comes up with 32 percent, so again, we're not all that different. DR. KATZ: No, but actually, the figures, then you exclude, I exclude, then look at it from the perspective of the whole committee's results, and we are very, very close, indeed, the official review is a little bit even more severe than my review is. DR. MACKLIN: That's what I'm saying. So we're not that far off. DR. FADEN: It's a matter of how we look at it. DR. KATZ: Yes, how we look at it, yes. DR. FADEN: Which is critical. But also it's not sure that when you go back and look at this 1 and 2, even that is how we want to say it. This is very helpful. Gail was waiting, and then Nancy, and then we can stop. MS. GELLER: My point is actually a question. I feel like we need some guidance about whether there needs to be a second order of analysis, specifically on the flip side of what you're -- I have a concern that if we focus on only the greater than minimal risk studies, that we're overlooking some important statement about studies that may not have received 4s and 5s. I know that I reviewed a study that was given a 5, because it was considered low risk. I think it even got to a re- review by a third person. MS. PARTHASARATHY: It did. MS. GELLER: This is in my mind because it's troubled me. We gave it a 3, and it's really bothered me. We gave it a 3 because it wasn't a big deal study in terms of physical risk, but I know it was a molecular genetic study, and I know in my office, right now, which is the genetics office, it would not be acceptable at all. I wonder, from an analytic point of view, whether we might want to take the 3s, for example, or even some of the 1s and 2s; I don't know. DR. FADEN: Let's give ourselves a break. Let's put the 1s on one side and look for good examples there. I think we have to look hard at the 2s and 3s. MS. GELLER: Let's say the 3s, and we might be able to actually do a description analytically based on -- this gets at your point, Ruth -- specific questions, like the recruitment process, like who obtained consent. Those questions we can actually do counts within the 3s and may come up with very unacceptable numbers for consent issues and at least have something. I'm concerned about forgetting the 2s and 3s and saying that they're all fine, just because they're not physiologically risky. DR. MACKLIN: Right. Here's a kind of example in at least one case, with a co-reviewer, when the question was, do we assign it a 1 or 2, or maybe a 2 or a 3, more likely. I said to the co-reviewer, look, on the first part, where we did the research documents, it came out pretty well. On the consent form part, we checked every box unacceptable. DR. FADEN: Right. DR. MACKLIN: How could we give the entire project a 1 or even a 2 if every box is unacceptable? I mean, it says something, since we got these little boxes, we've checked, if you can see how many unacceptable there are. MS. GELLER: We can count them. It's quite simple. DR. FADEN: Nancy, did you want to comment on this, because we certainly do that. MS. GELLER: Am I hearing that we should do that, that the second order analysis is requested? DR. FADEN: Yes. We just have to find a 36 to 48 hours per day and that would be fine. DR. OLEINICK: To the extent possible, I don't know; I look at this as a decision tree. We take the project and it seems to me, and again, you know, coming from the science sense rather than the bioethics sense, it seems to me, question one, should the study even be done at all. Then the answer is a yes or a no. Most of them will turn out to be yes. Of those, has the subject population been chosen appropriately and so forth, and one develops a tree out of it. Now whether, in fact, we actually do this, it might actually be helpful to draw one of these trees and to fit in the numbers that we actually have coming down there, and it may help in formulating our analysis. DR. FADEN: You should know that, first one, we have a lot of proposals, Sara, and Shobita and Gail can maybe -- where the reviewer said they couldn't make a judgment, they didn't have that. MS. PARTHASARATHY: 33 percent. So that's about -- out of 90 studies, that's 30 studies where -- DR. OLEINICK: Didn't have the judgment to do what? MS. PARTHASARATHY: They said they couldn't evaluate with regards to scientific merit. DR. OLEINICK: Maybe somebody else ought to be looking at those proposals. DR. FADEN: That is a big problem, and it's a problem that IRBs have, generally, and it's the same issue. DR. OLEINICK: In fact, this comes up in the analysis, and I just want to make this one statement that I didn't make before. Again, Statement F in the summary; projects that were ethically problematic were disproportionately from the field of cancer research. I read and I thought about that. You were comparing cancer research to neuroscience, I think. DR. FADEN: This is the other one that shows up, to everything else basically. DR. OLEINICK: To everything else. DR. FADEN: Cardiology. DR. OLEINICK: Okay. The question that came to my mind was is part of the reason that we're coming to that conclusion is because, at least from the medical and science part, most of us have more knowledge of cancer research than we do of all the rest of it. I don't know if we can actually test that, but rather than just draw that conclusion and make it sound as though there is something more problematic about cancer research. There may not be. DR. GLATSTEIN: Well, there is something, and it's very straightforward. That is, that it's not system oriented, which most of the other medical sciences are. You go to a textbook of neurology, you start with the anatomy of the nervous system, and the pathology of the nervous system, and so forth. In cancer, there is no one basic system orientation. It's every system at risk. The science is fundamentally cell biology, molecular biology, biochemistry. It's so basic that it's a totally different game than virtually all the other clinical sciences. DR. FADEN: We need to close. Jay and Ruth, short. DR. KATZ: Very, very short. I'm just wondering, and it's for all of to consider and primarily, Ruth, for you to consider; I'm just wondering whether sometime tomorrow there will be a chance this afternoon and evening and in breaks for all of us to talk about this particular issue a bit, whether we are willing to begin to instruct staff and also it will effect the kind of input that Ruth Macklin and I as cochair of the committee will be able to make, to instruct the staff what ultimately this chapter will shape up. We'll be quite critical and concerned about existing regulations or reasonably pleased with existing regulations and they need this kind of cosmetic change. Whatever our views are, tentatively, and of course they could be changed, will very much affect the writing of this chapter, and can we sort of take a straw vote tomorrow, something like that, because it would be important for the staff to be able to proceed, think about it. DR. FADEN: Maybe we can actually even do it this afternoon, because we're talking about forward looking recommendations, it fits with the agenda. DR. KATZ: Yes. It'll come up again in that section too. DR. FADEN: It will come up, yes. So why don't we make that a discussion item for this afternoon. Ruth, last comment, and then we'll break for lunch. DR. MACKLIN: Yes. I can make this brief, but it's really a suggestion that the able staff here consult with Eli and Mary Ann here; it's about the document, and it's a different point. Starting on page 25 and 26, one of the troubling problems, that is, these common problems, are what the document refers to collaborative research, and I think it's probably the wrong term, because there's a lot of collaborative research that isn't this problem. These are the oncology group problems. DR. FADEN: Right. DR. MACKLIN: I think in order for this document to be accurate, it has to reflect what really goes on there and what the role of the cooperative groups are vis a vis the institutions. We know there's a lot of boiler plate and a lot of common language. Many cancer investigators hold the belief, and I really think we have to get at the bottom of whether this is a true or false belief, that they're not allowed to change the boiler plate that comes from SWAG or ECOG, for example. So on pages 25 and 26, where there's a discussion, it says individual IRBs who review such proposals sometimes require that modifications be made to the model forms, et cetera; that suggests that those IRBs are very strong and they do a good job, and the investigators say, okay, you said to do this, and we'll do it. Whereas, in other places, they may say, oh, I'm sorry we can't change this. That's what we hear all the time about drug company research. That is, when the drug company sponsors the research and the investigator says, I'm sorry, this is 15-page form we got from the drug company and we can't change it, and we can't do the research if you, the IRB, tells us to change it. I think at least with regard to the cooperative oncology groups, it ought to be clear, first of all, to see whether we can find out what people believe is the case and what really is the case about being able to modify those forms. DR. FADEN: Okay. Thank you very much, Sara, Shobita, and Gail, for the awful lot of hard work, but take comfort; there's at last as much hard work ahead of us. There is no break for the weary here. We are going to reconvene at 1:30. A F T E R N O O N S E S S I O N (1:40 p.m.) DR. FADEN: There is a slight change to the agenda, which will not affect Jeremy, Nancy, and Steve, because they're here, so we don't want to screw that up. We're going to continue with our discussion of what's going on in our contemporary projects. We are going to focus on the subject interview study. When we finish that discussion, however, rather than going into the looking forward part, recommendations, we are going to have a general time, which we've had once before, for people to just talk about where we are, what are we doing; do we still like each other at all. It's very clear they have given all of the intense work and effort that has happened, both staff but also the committee that each of us as individuals and collectively as a group need to take stock and see are we feeling okay with the pace at which this is going, and if not, why not; and what would we like to see changed, and so on. MS. KING: It would give you chance to vent too. You can tell us what you think of us as well. [Laughter] DR. FADEN: We serve wine. That's off the record. We would never serve wine or any other alcoholic beverage of any kind. Ever. That's what we are going to do. If people can have auctions with alcohol, we can have a candid discussion with coffee and cookies. So we're going to do that after Jeremy, Nancy, and Steve's presentation. I just wanted to say that now so that people can relax, know that there will be an opportunity to have these discussion, and we're not going to put it off until tomorrow, and so we can really concentrate for the next hour or so on the subject interview study. With that, the floor is the three of yours. UPDATE ON SUBJECT INTERVIEW STUDY DR. SUGARMAN: It's a pleasure to actually be at this stage of having some data to present and, in fact, we were able to get the data that we said we were going to go out and get. What we'd like to do is, I'm just going to give a brief overview, just a reminder of where we are with the data that we've presented to you and what directions we hope to move in over the next couple of weeks. Then Steve Goodman will briefly translate statistical language for those of you who want such translation, and then Nancy Kass will describe some of the direction for the in-depth portion of the qualitative portion of the subject interview study. Then we would like your feedback on the chapter draft that we circulated. Basically, I would like to reiterate what we mentioned in our memo to you, that these are very preliminary data; that these data that we are discussing do not represent all of the institutions that were involved in the subject interview study. The final data set will be delivered today to the Advisory Committee offices, and so the next analysis should be more complete. In addition, the analyses that are represented in the chapter draft that you have represents sort of first cut and sometimes second cut statistical looks at the data. We still have not looked at the open-ended responses in the survey instrument, which will help explain some of the confusing items the we have. We still have probably one of the most important components of the subject interview study coming up; namely, a look at a way to characterize the research projects that people are actually in. To that end, we have assembled a group of content area experts and then some non-experts in the content area to mimic an IRB. We are going to meet at the committee offices on April 21st and characterize all the research projects that we have consent forms for in terms of minimal risk or more than minimal risk, and then to clarify whether the studies are diagnostic, epidemiologic or therapeutic. Now, the other area in the data set which needs some explanation is that there was a good bit of discordance in the data. There was discordance of two types, at least on the first look. The first type of discordance that we uncovered was people who believed that they were research subjects but we could not find evidence of documenting their research participation. The second type of discordance was where a few people who responded that they did not think they were research participants, yet we uncovered some sort of evidence that suggested they were. Let me take the first type. The folks that believe their research participants but, in fact, we couldn't find evidence, could be for a variety of reasons. One: It could be that we just weren't good enough in our methods of finding out whether they're participants. The second could be: They could be enrolled in studies of some type that purposely don't include some kind of documentation which we would locate; something like Nancy Kass in her other non-advisory life conducts some studies with HIV- infected women; and purposely, there are no traces in the chart that would be identifiable. So there could be people in that sort of situation. We also polled some of the people who had been abstracting records for us and asked them what they said, and their opinion was that some of the respondents would say, everything here is research. Now, we will be able to get smarter about this by looking at the open-ended responses, and we hope to be able to provide some more explanation to that kind of discordance. The second kind of discordance, where we actually found documentation that people are research participants but that the respondents said that they were not, is also very preliminary. First of all, all of the data are not in from the abstraction so that proportion which you saw may go down. The second is we have not done an analysis yet, based on the level of evidence to make that claim. We have a series of procedures that were used in the field, that was very rigorous and went down; a medical record review, a research record review, speaking with research nurses. We don't know yet where that statement comes from. It could be all those people are in the hearsay category instead of the written documentation category. The third thing is that we don't know when the person was a participant at this cut. It could have been that that person was a participant any time there's some documentation in their medical record, so it could have been something long ago or it could be something ongoing. We don't know. Finally, some of the studies may be of minimal risk and some may be more than minimal risk. The purpose of the characterization of the research projects is to find out where that information, how accurate that information is, and to see what this is all about. Our thought is that a lot of this, as we get more information, the proportion of discordance should go down. What we are now in the plans of doing is to then verify each discordant case of this second type, by having either myself or Pat Perentesis, who is a nurse who has been doing a lot of the instruction, to go back and actually look and see what the documentation are; verify that it was real, and in the case that we do find someone that's in a more than minimal risk study, that doesn't know that they are a research participant, one of us will notify the principal investigator on site and have that matter taken care of. We felt that that was sort of our moral responsibility for uncovering this fact. Those are the plans we have to look further at the data and to try to answer some of the interesting questions that are posed by the initial round. With that, I am going to stop, and if we can just get all of our stuff on the table, then we can go from there. DR. FADEN: We'll let the three of you speak, then we'll open the floor. DR. SUGARMAN: Steve. DR. GOODMAN: Hello. I was charged with explaining some statistics. I protested mightily, on behalf of the Committee, I might say. I am not going to run through the results that were already in the report. I will just say a few things to perhaps help those of you who don't look at what are called multiple logistic regression models six hours out of your day or more. I just want to mention a couple things that we did that you need to be aware of when you even think of looking at things like this. Basically, the motivation for creating these models, as we call them, is to deal with the fact that there were many factors that wee obviously interrelated. Things like raised income, unemployment, education; these are all factors that are very closely related as you would know from other research and, in fact, we saw it in this research. We needed to separate out the effects of these factors, and models are a mighty and feeble attempt to do that and also to compress the morass of numbers you see in those tables to simple, or I should say single numbers. But what we did, in order to simplify things and, again, this is very much a first cut, even though these models may look a little bit fancy or sound fancy, is that we tended to group the answers in groups of two or three categories. For example, for most of the attitudinal questions where we had scales like very favorable, somewhat favorable, neither favorable nor unfavorable, somewhat unfavorable, et cetera, we divided those into three groups, into very favorable; we grouped somewhat favorable and neither favorable nor unfavorable, and then we grouped the unfavorable responses. For the moment, for all of the frequencies where they report, response: how often do you think medical research involving people helps to advance science, where there the possible responses were never, rarely, sometimes, usually, and always, we tended to group the usually and always, and put the sometimes rarely and never in another category. Now, much of the time, even though you might think that this is obscuring information, in fact, there's very little information, some of the categories, for example, that first question: How often do you think medical research involving people helps to advance science, there's only 2 percent who say rarely and a half percent that says never. So this grouping was done not just to make the models work but, in fact, there weren't enough responses in a lot of categories to make them meaningful. That's the first thing to know. Different groupings can produce slightly different pictures of the data. One of the things we're going to have to do over the next few weeks is go back and forth between the raw data and these models to make sure that they're providing a really perfect picture. The other thing I would say is we tried to use very general language and also keep a lot of numbers out of the text. You can express your preference for how the format should go. I would say, don't use the language that we used, when we'd say things like, twice as likely, too literally, for a variety of reasons. We are actually going to present the numbers in a way that might help you interpret them a little better, but that's really a very rough representation of how much more frequently one group attempted to answered something yes or no, than another group reflected in what are called the odds ratios from the logistic progression, but I really don't think you want me to explain them right now. At least it gives you a sense of roughly the order of magnitude effects, and none of the effects were huge, but those that we report here are the ones that we thought were not ignorable. I think I'll reserve any other further comments on this for any specific questions you might have after this discussion or after your own reading of the report. DR. SUGARMAN: With Steve's comments in mind, we would like you to consider what you would like in terms of the actual chapter that goes in the final report compared to the mass of this kind of stuff which will appear in the companion volume related to the subject interview study. It's not that these will be hidden, it's just how much of it would be in this chapter versus how much of it would be in a companion or more technical volume. Nancy. DR. KASS: I'm going to talk about the qualitative or in-depth component of the subject interview study. It seems like the theme of our presentation is telling you everything we have not yet done, so I will do that for our part. The format, the way that we presented the chapter that you have, that you got in advance, was talking about the primary domains of the subject interview study as a whole, and then saying what we found from the brief survey and saying what we found from the in-depth survey. The findings that you have there primarily are based on the reading of one person, Monica Shoch-Spana, one of the advisory committee's staff; her reading from start to finish, the first 25 of the 103 transcripts, as well as jots of impressions that the interviewers all had written down as they were going along. What we have yet to do is read the remaining 78 transcripts, from start to finish, and then also to read all of the outputs of the codes that everyone decided the last meeting were of interest, so we'll know that we'll have much more detailed findings to come in the future. Again, most of results that we have found so far are in here, and we have them on the general areas of things like blurred boundaries, what some of us might call sort of confusion between what is research and what is medical care; some findings about reasons. I think that many of these are I guess what I would call things that are aren't very surprising. There are things that people who are therapeutic research were usually doing it because they wanted to get better. People who are not therapeutic research often thought, well, it doesn't make much difference; I have that time, and if I can help someone. I think these are things that a lot of us would say, well, no big surprise. It's nice to have another study that does it, but no big surprise. I guess I would say in my own interpretation of what we have read so far that there really were two things that jumped out at me, and I'd like to share them with the committee, just sort of to highlight them. One: And this we found also in the brief survey but fortunately had the opportunity to have some elaboration on it, was this whole concept of language and terminology. Some of these words that many of us use interchangeably really take on different meanings for some of the respondents. The particular term that really stuck out was experiment or experimentation. Time and time again when we would talk to people about it, they said, ah-ha, yes, that's the one they're really sort of unproven, that's untested, that's riskier. There is a particular quote that we have in the report, first from someone who said you feel like a guinea pig. Medical experiment. That means you're a guinea pig. They don't know what it's going to do. This is completely new. You're going to decide what's going to happen to the rest of the people that they've decided to give this to, here you go. Then another person said even more explicitly, to me, experiment is like, you know, you go in the hospital and they're giving you different types of tests and medications and dye or something, asking you questions, keeping you there for a couple of days, taking samples, cutting you all up, and experimenting on you that way. That one happened to be an interview that I did, so I remember it very well. At various times through the interview, she kept talking about she was sort of too old to have an experiment done on her; she just really couldn't go in the hospital and have you cut you up for a few days. I think that language has implications for recommendations, and obviously one approach might be to try to change everyone's understanding of language, to fit more with what might be more ours, if I could use that term. Another interpretation might be to flip it around and say that if there is a project that is going to be offered that really is very risky and really is more unproven, that relative to other research, maybe we should consider stressing this is experimental; because that seems to be how other people understand that term. Another theme that I think jumped out to a few of us who were reading through some of the material so far, is the concept of trust. Sometimes it is trust in a particular doctor, who might have suggested the research; sometimes it's trust in a particular institution where someone is going for care and consequently ends up in a research project. Often, it's a broader, more generalized concept of the medical profession as a whole or the medical world as a whole, and I think that we heard that in different ways at different times. In an interview that I read on my way in this morning, I took note of one that I thought exemplified this, a respondent who said, I knew that it wasn't going to kill me. They wouldn't allow it to. I think that that whole theme of trust is something that I guess I would say we need to be humble about. I am not in any way saying that we should go around trying to say that it's inappropriate to have trust in most circumstances, certainly in a medical establishment. It is appropriately a very comforting thing for people with a serious condition, and I think that it is very appropriate. I just think that in cases where there is uncertainty, the uncertainty should be stressed and again remember that the trust is going to exist. DR. FADEN: Thank you. There is an awful lot to talk about. Anybody have a question, comment? Jay, Lois, Susan. DR. KATZ: Two comments at the moment. I was particularly struck with the finding, Jeremy, that 41 percent had been research subjects and didn't know that they had been. It would be important, and you make a good caveat, what is the time dimension of this, and I hope you can get some information on this. I was struck by this finding because in one of the first studies from the topic done by Brad Gray at an unknown university hospital close to where I live, found in his research where the wanted to find out and got permission from the investigators what their reactions can be to participation in the research project. I think his figure was 38 percent. I didn't have the book at home when I read this. There were 38 percent who found out for the first time that they had been participant in an experiment, and this figure is so close to his figures, so it would be nice to have some follow-up studies. If I make my second comment, I also was struck with the issue of trust that patient expressed, and of course you're quite right that one does not want to disabuse patients necessarily of their expectations of doctors, but what this communicates to me once again is the issue, not from the perspective of patients, from the perspective of doctors and doctor investigators; that, in a certain sense, they must disabuse patients from expectations that they have of physicians in general and say, look, we are not physicians, we are physician investigators. We are coming here, and of course we are also interested in you, but we are also committed to finding answers to research questions, and therefore we have dual loyalties in this kind of a situation. The trust you found puts obligations on physician investigators in how they must communicate with patients. I wondered, you know, whether instead of white coats they should wear green coats and green hats to make sure that patients -- DR. FADEN: Then they'll look like surgeons. DR. KATZ: -- that patients understand who the -- pardon? DR. FADEN: I was teasing you. They would all look like surgeons. DR. KATZ: I was thinking about men from Mars. [Laughter] DR. KATZ: Okay. That's it. DR. FADEN: Good point. Nancy, just to emphasize, sometime within the next couple of weeks we'll have the benefit of the entire 100 plus. It's likely that these impressions will only grow richer. There may be others, but I suppose it's possible that they maintain it against others that are marginal. We should tell everybody that Brad's work was done, what, 25 years ago. DR. KATZ: Brad's work about 25 years ago? DR. FADEN: Yes. DR. KATZ: Yes. It's a fascinating figure here. DR. SUGARMAN: You know, we do have the opportunity; we have it, and actually Brad Gray is one of our external reviewers on these data, so it will be interesting to actually maybe see what he has to say about that particular question and how we ended up addressing it. I reinforce that we are prepared to look at each one of these cases individually and are making plans to do so because we think it's important. DR. FADEN: By the way, which is really an amazing thing. In fact, I even figured out that that was the only responsible thing to do because so much hung on this, that Jeremy and Pat would have to look at each one of this discrepant cases to see if we could figure out what's going on here, which is just going to make your lives that much more fun. DR. SUGARMAN: If any of you are feeling left out of that process, we certainly can direct you in the right place. DR. FADEN: Lois and then Susan. MS. NORRIS: This is just another one of my quickie factual questions. In the "Not Employed" category, are you lumping people who are without jobs, along with retirees? It just seems to me that that's such a different, or likely to be such a different subject population. DR. KASS: I think you're absolutely right and, if you look at the age groups, there really probably were a fair number of people who were retired. Unfortunately, we can't go backwards. That's how the brief survey was written, but you're absolutely right. DR. FADEN: Some of these people are not employed, obviously, because they're ill and not because they would not otherwise be part of the workforce, so it's kind of a catchall. Not terribly insightful category. Susan. DR. LEDERER: I just wanted to say I think this was fascinating reading, and it's such important work. I give you the great compliment of wishing you had done this 50 years ago so it would be available for historians to use. I guess I was struck by your description of language and the importance of the distinctions that subjects were willing to make, and I wondered if you had any sense of what lead them to make those distinctions. What was informing their sense of the differences between experiment and study and clinical investigation, that you might not be able but in the in-depth interview, did you have a sense of what informed their understanding? MS. KASS: That's a good question. For the broad term, like experiment, I don't remember someone describing where it came from. It just seemed to be that's what their belief was. The only time I remember hearing people or reading that people were sort of thinking through how they got there was more with the clinical words we said, clinical trial or clinical investigation, when there were a certain number of participants who said, oh, clinical; that must have something to do with medicine. You're a clinic. There was some kind of thinking like that, but I'm not quite sure where that lead in terms of where they put it in the risk hierarchy. Study happened to be the term that people thought was the most innocuous and I think that's because they thought of it sometimes in its nonmedical, sort of common usage of study. You're learning about something, it's relatively innocuous. Otherwise, I don't remember an origin of experiment. Do you, Monica? DR. FADEN: Monica, I didn't realize you were here. Please join us. Anybody who can read 25 interviews in two days should definitely sit at the table. MS. SHOCH-SPANA: One of the hypotheses that we're going to test I think on the issue of language is what relationship there is between education level and terminology because, just from a very quick reading of only a quarter of the interviews, it seems that people who tend to use clinical trial and clinical investigation and are able to give the professional definition tend to have higher levels of education, and those terms are meaningful to those people. We'll be looking into that a little bit more. DR. SUGARMAN: In response, very early on in the subject interview study -- I guess this might count as history now; July, it seems like that -- when we spoke with a lot of physicians and investigators around the country about designing this, the terms experimentation and research were the two that really got people animated in their discussions. What the claim was that in the press when the press talks about research, it's medical researchers at blank university, discovered this, and it's the good. In contrast to a committee that might be formed to study human experimentation, is used in sort of a very different way. We haven't done a formal linguistic analysis of that, and I think that's what you're calling for. I don't know if we'll be able to provide those data of sources, but it seems to be that press attention, according to research is when it's good, experimentation is when it's sort of bad or evil. Some people said to us that experimentation was sort of the Frankenstein stuff and that it's been around for a long time compared to medical researchers. Those are the kinds of things we've been hearing and this is part of what's got us going on this. DR. FADEN: And I couldn't help, as I was reading these data, but think what would have happened if we had been called the Advisory Committee on Human Radiation Research rather than the Advisory Committee on Human Radiation Experiments, even something as simple as that changes -- DR. OLEINICK: Right. Can change the whole thing. DR. FADEN: -- the expectations and also the reactions. Clearly, there is power in that. Steve, do you want to respond? DR. GOODMAN: Yes, I had three real small points. One: with regard to the discordance, although we haven't gone back and looked at the reasons, there was, as you might remember, a very striking difference between the percentages of this discordance in medical oncology versus radiation oncology, versus cardiology, indicating that very much may be related to sort of the culture of those specialties, through very dramatic differences. I think we're going to end up having to make sort of discipline specific comments there. With regard to the comment about the education, that was actually borne out in the brief survey where the best and virtually only predictor of whether a subject thought that the two words were the same or were different was college education; and if you had college education you were more likely to see the subtle distinction between things like, or think that there was, a distinction between clinical trial, medical research and study. Finally, from the brief survey, we also do get a little bit of insight as far as why they might believe that the terms are different, because, as you may remember, we asked them where do you think a patient is more likely to get unproven treatments; where do you think they are likely to be better off, and where do they face largest risks. In addition to the qualitative questions, you might look at the spectrum of answers to that. Clearly, there, we see a profile of where they feel that experiments are riskier and less likely to be better off, although there were some interesting -- I don't know about discrepancies -- but there was -- I can't remember exactly which term; there were I think one or two terms where they felt they were both riskier and more likely to be better off. DR. FADEN: Ruth. DR. MACKLIN: I'm looking at the section entitled Consent, desperately brief on pages 18 and 19. I'm not criticizing it, I'm just noting that it's brief. It seems to me, from reading this section, that there where some interesting discrepancies between what we talked about this morning in the research proposal review project and what appears here from the findings of the subjects. For example, among respondents who did comment on the consent process, most descriptions were positive. Well, they were, as you read the next sentence, looking at something quite different from what we had available to us. It says: That is, respondents recounted that; staff explained research protocols, gave participants time to read over the consent forms and confer with family friends, and responded to questions the participants had. The other project gives us no insight into this. So if we think that things are really bad in the consent area, which I think there was a little bit of consensus or at least discussion this morning, this provides an interesting additional piece of information and one to me that is very encouraging. Namely, it's not just that researchers, that is, the investigators, don't view the consent form as the consent, that there is a process here, and that seems to me something that's if that's the explanation for why respondents' most descriptions were positive, I think that's a good sign and something that would never come out of the other project. That's my first observation. The problem areas, as Ruth pointed out this morning, everybody knows that that was what the librarian said. She understood the language; she worried that others with less formal education might have difficulty understanding the same form. She's a librarian. SHe's not a biomedical scientist, so that, too, if she understood it meant that, even though she's an educated person, it was not in language that was so highly technical that only with a Ph.D. in molecular biology could you understand the consent form. The next statement, too, that there's too much information or contained information that was too complicated, accords with the other project. I'm not sure what the next statement means. Maybe you can explain it here. Another respondent argued that it wasn't enough to, quote, "explain" a research project, researchers had to make clear to the subject what exactly the project was all about. Well, I would think that's what explaining it is, but maybe you can answer that question. [Laughter] But, now, the real problem comes with the next statement here. Another patient argued that researchers should be careful not to convey side effects in such a scary manner. She suggested that the consent form, like the research project itself, should help provide hope for participants. Well, now we have a problem. On the one hand, we're saying, you've really got to disclose this kind of thing; you've got to tell people that it will shrink your tumor in three weeks, for three weeks, doesn't mean it's going to cure you, because you're going to die anyway in two years or whatever. How we put this together, that is, what's in here, which is very interesting with the other project, and I'm now thinking both of our recommendations, not only how we read this, this is a different kind of study; but how we put those two projects together and what we say by way of recommendation I think requires a little bit of reflection for us. Then the dismaying part, of course, for some participants signing the form was a formality; indeed, many participants described that they had just signed the form, they hadn't read it at all. That would make a difference if it wasn't explained to them. If the trust that we talked about a moment ago was such that, oh, I'm not going to bother to read this, I trust my doctor, and they signed the form, that's very different from saying, well, the researcher explained it to me and told me all about it, and so when it came to the piece of paper, I didn't even have to read that because the researcher explained everything to me. Those are just a few little observations about this. DR. SUGARMAN: The issues about the length of attention posed to this, actually, you remember from a memo that we distributed a couple of weeks go about the domains we planned to examine, this is, in large part, Jay Katz requested that we look at issues related to the consent form and consent as one of the domains. In that huge category of things, if we were to redo the subject interview study, knowing what we know now, what question would you like to ask, in the brief survey we might have, would have, asked a lot of questions about consent forms or what consent forms meant to people. There are no items in the brief survey to provide quantitative, just whether they remember signing it. DR. MACKLIN: There is one item. MR. SUGARMAN: There are Items D2 and D3, which we were using these actually, to find the research project that the patient was referring to and was not designed. We may be able to glean some information, but these items, D2 and D3, were there so we could make sure, if we ever ran into a discordance problem, we'd be able to sort it out. So, one: D2 is, do you remember signing a consent form, agreeing to take part in whatever the respondent was calling the research project; and, The second is: Did you think you had enough about this project to make a good decision about whether to participate. As we went around the country to recruit institutions, their warnings were, I think, very important; That we were starting to get into the range of recall questions, and we had no idea what the actual process was. It might very well be confounded by the results. If you were talking to people that were happy, they were going to talk to you again, that we wouldn't know what to do with that information, and the study was not going to be well designed to answer that question. So this comes only from the in-depth, and not everyone was asked about consent forms in the in-depth interviews. These were people that volunteered this information. All that said, we got some interesting stuff. In terms of what to do with the data from the subject interview study and the research proposal review project, also I think meshes with the third contemporary project, namely, the agency oversight. Another way of looking at the trust question, for instance, is if people trust the system, is the system something that should be trusted. I think you need to look at all pieces. You've got the oversight, you've got the subject's perspective, and you have the investigator prospective. You don't have them linked. The nation wasn't ready to answer those kind of questions with linking the thing from start to finish. We don't have those for the same projects. I think in making interpretations on that data, to be fair, those are not necessarily fair generalizations, although someone might want to use them in that mind. The thing that came to my mind when I was reading this, a couple of the pieces from the transcript was, when I rent a car, I understand the process of the car. I've never really read that thing start to finish. I rent a car. I know that some of the things, whenever I start to read them, scare me. I know I don't understand them. I know there's collision damage waivers and all of these things on there that I sign away, and most of the time things go well, and I sign. But that was the analogy that came to mind when I read those. DR. FADEN: Go ahead. Steve and then Eli. Jay wanted to make a comment. DR. GOODMAN: This is just a footnote to that. All those caveats, granted the striking extremely high number who said that they had enough information, which is over 90 percent, and this is even in retrospect, which I think is the time when people are more likely to do some second-guessing, is interesting and an even much higher percentage saying they were not pressured into it, over 95 percent. I think there are problems with these questions. They are certainly incomplete, but those are among the highest percentages in the whole questionnaire. DR. GELLER: That's of the 60 percent that knew they were subjects? DR. GOODMAN: Yes. That's of the people who knew they were subjects. That's right. DR. SUGARMAN: No. Were people who reported they were subjects. DR. GOODMAN: Right. Who reported they were subjects; that's right. Who thought they were subjects. DR. SUGARMAN: We don't know whether they're subjects or not. DR. FADEN: The problem with this is always like the problem with student evaluation forms for the course. Did the course give you everything you need to know. Since you don't know the content, it's sometimes a little lingering question of what to do with the person's perception that they got everything they need to know if you didn't know it was out there to know. On the other hand, it's important because it gives them the feeling that they were treated respectfully, as clearly suggested here and that's very important. What is suggested here is that that they felt as if they were dealt with seriously and people were answering their questions, or that is suggested by that kind of response. DR. SUGARMAN: We also don't know, at this point, which kind of project this person was speaking from which we need to sort of sort through as well. DR. FADEN: Right. So all of that needs to be worked out. Jay and Eli. DR. KATZ: Yes. I think it's related to what Steve and Jeremy have been talking about. On pages 13 through 19, you talked briefly about altruism, now about consent. It would be nice, and where the two numbers, whether you're talking about one or two, about a great many. I don't know how an occasional comment or it came through all informants. I don't want us to get hung up on numbers again and percentages, but I didn't get a flavor, you know, again and again where this happened to be 1 informant, 10 informants, or something. DR. SUGARMAN: Those are good points, and that's divided into two parts, all data. The first part is in the brief data. We can provide a quantitative answer to that. Lord Calvin would be happy. We can express it in numbers, we can give that to you, and we will give that to you, and I think we've added those numbers into the text. In descriptions of the in-depth data, I will let Nancy talk about the problems related to that. DR. KASS: Yes. I appreciate your comment. I, myself, realize in rereading this, that we didn't do that adequately, although we will have read all of the transcripts. What we intend to do because I think this what we can do with qualitative data, is let you know if a theme seemed to come up a lot. Already we can tell, for example, what this interpretation of experiment or experimental, that that is something about that word meaning something different comes up a lot. We can convey that. What we also plan to convey is an occasional what I would call outlier response that we think is interesting and you ought to here. We will make a comment in producing each of those that says either we heard this a lot or we heard this occasionally, or, conceivably, about half the people seemed to think this way and about half the people seemed to think that way. Other than that, we won't get into numbers, but hopefully that will give you an idea. DR. KATZ: I know it is difficult, but there might be some internal review because I was particularly struck in the various comments under consent under 18, that in some instances you used the word, the informant describes, the informant recounted, and then the informants argued, and the informants argued, and I wonder whether there was some unconscious wisdom and whether you invested in argumentative descriptions or the counting description. DR. KASS: Probably urged not argued. This is the one who argued that researchers should be careful not to convey the side effects, it's just a scary matter. DR. FADEN: Eli. DR. GLATSTEIN: I just wanted to comment on a couple of things. With respect to the consent process, it is a process, it's not just what's written. When I was younger, I think I took advantage of the trust that patients would have, but over recent years, I urged them. First of all, I read the consent form to them, word by word, so they've heard it. I urge them not to sign it but take it home, have anybody else that they wanted look at it. Get the questions clear in their own mind, write them down on a piece of paper and then come back in a day or two, and if they have any additional questions, ask them at that time before they sign. In addition, if somebody signs and then decides that they changed their minds, they changed their mind, and we don't hold them to that. We've gone, I think, a lot further in trying to avoid the blind trust issue that I think at one time I think we did exploit. I think the other thing is that in the conflict, the dilemma between the doctor investigator and the doctor physician, I am sure it can happen as you get into a dilemma over that issue, but I was always taught that you write the protocol with the idea of, this is what you're going to do, and you outline the steps that you're going to take. Sometimes patients deviate from what you planned. There are always contingencies. When those contingencies development, you have to do the best you can with those contingencies to live up to the spirit of that protocol, but not necessarily the letter when something is complicating. In the end, you have to describe the deviance over the study as a whole in terms of patients that you intend to do this with, but for a variety of reasons you couldn't. Most of the patients, you're able to anticipate what is going to happen, and they do go according to the letter of the protocol, but if you're going to deal with 150 patients with one diagnosis, you're certainly going to have a couple of patients who deviate from what you had anticipated, and you have to do the best you can with that, in terms of trying to get them through the treatment. If they can't get through the treatment, then you've got to discontinue it. I mean, it's no more complicated than that. DR. FADEN: Nancy wanted to respond to Eli. DR. KASS: It's actually not directly on that point, but I guess two things that I'd like to see, just from a few of the comments. One is to describe again how we got the sample for the in-depth part of this. First of all, remember, and it is relevant, how quickly we needed to collect this sample. The reason why I say that is the subcontractor initially enrolled anyone who believed that they were a research participant, because we were so scared that we wouldn't get 100 people. It started to look like, actually, after we looked at the demographics of the first 50 or 60 people, that almost everyone was retired, white, and college educated, and we all of a sudden got very concerned about that. Consequently, for the 20 or so interviews that Advisory Committee staff did, we made a great effort to try to select people who didn't fit into those categories, and so we actually ended up with demographics -- DR. GLATSTEIN: Then you came to Parkland. DR. KASS: You're in Baltimore. Exactly. DR. GLATSTEIN: In Baltimore. Right. DR. KASS: So you can see that there are slight differences in the demographics of the in-depth sample from the sample of the subject interview study as a whole. Nonetheless, this probably does not represent America in general, and it's important to think of that when we're generalizing from some of the quotes. The only other thing, and always studies are a study in themselves, is just watching what happened when we gave respondents the consent form for our own study, and of course I only had the opportunity to do that for a few interviews because I only conducted a few interviews but, without exception, nobody read the consent form. I would like to think it's because I had explained it so thoroughly to them beforehand, but nonetheless, nobody read the consent form, and with one woman I almost got the feeling that she was trying to compliment me by saying, oh, no, no, no, I trust you; you know, I don't need to; no, I know this is fine; no, that's fine, and signing it, and it's always just a lesson in being on the other side of it. DR. FADEN: Ruth. DR. MACKLIN: Yes, just a small point. I noted in the general attitudes and beliefs towards biomedical research -- DR. GOODMAN: What page are you on? DR. MACKLIN: Page 19 in the paragraph A, under "A brief survey," the last sentence said: Controlling for multiple factors, the factors associated with more favorable general attitude towards research included being older and having reported, et cetera, and being a patient in cardiology rather than oncology. I'm just wondering whether there's any way to understand that, especially in light of the discussions that we had this morning, and particularly about the rankings of 4 and 5 that quite a few of the oncology protocols have. Again, I'm looking to see what, if anything, is link between the two studies, and so here, I mean I have no idea what the distinction is here. It may or may not relate to what we talked about this morning. Is there any? DR. GOODMAN: Well, looking at the model, first of all, I would always want to go back to the two-by-two table, to look at some of the raw data. I would say, I think, probably based on the model that's recorded, that actually that's probably a slight misstatement, that there is a slight, and I would emphasize slight, tendency for those, at least in the survey, who are in medical oncology and cardiology both, to have slightly better attitudes than those who are radiation oncology. That's actually the proper statement not cardiology versus oncology. So that's the sort of thing that we'd have to look a little more into to be able to see if there's anything much there, and these are somewhat marginal. You have to remember, in all of these models, what you are engaging in is a big fishing expedition, even though it's happening inside a computer, so some of these things that come out that are somewhat marginal, we really have to take with a grain of salt, and if that doesn't really hang together with a lot of other distinctions or lack there of, between the specialties, of which we saw relatively few, I would say that might not be something you would want to hang anything on. DR. MACKLIN: Was there anything that emerged in the in-depth interview that would draw any light on that? DR. KASS: No, I can't. DR. MACKLIN: Particularly, actually, what Steve just said is, in a way for us, perhaps oddly, more interesting than a distinction between cardiology and oncology. That is, if it's the cardiology and oncology on the one hand and then the radiation oncology, what can explain that difference? DR. GLATSTEIN: Well, I can give you a guess; that is, in cardiology, the kind of studies that are being done, I think, are going to have a higher degree of direct benefit translatable to the patient. Rather than percentages of success, they're going to have a more satisfying outcome, and they're not going to have the same degree of morbidity issues that virtually every form of radiation or chemotherapy are going to have for patients. I mean, in oncology, it's very much on the one hand, on the other hand, and the description of the side effects is scary. On the other hand, it's hard to get anyone to undertake that without enough description that they understand what they're getting into, which is almost automatically some degree of side effect. DR. FADEN: I think we should really take Steve's caution seriously here. You've got a potential here to 100,000 comparisons, of 100,000. We shouldn't invest anything, any one particular anything with great significance unless it makes sense and can be supported by an overall analytic strategy. DR. GOODMAN: Having brought up the question, we'll make sure that we look at that closely to see if there's anything there. DR. FADEN: Because of Ruth's point, that it would bear so significantly on the work of the Committee, we have to be very sure if there's anything there, it's just one of those. DR. GOODMAN: That's the sort of thing we're hoping to come out of today, points like that, so we could look at them, but there's about a million. DR. SUGARMAN: The other thing is that these general attitudinal data are on all respondents, so on the 1500 or so not just on the research participants, that we've generated. Now, we can also take that subset. We will also get smarter about what kind of actual projects people were on, whether they were diagnostic projects or therapeutic projects; is it cancer, not cancer; is it diagnostic, therapeutic; is it radiation, non-radiation. Those are sort of separate things which we're going to try to tease out, but we're going to try to do that in sort of an empirically based way. DR. FADEN: Eli. DR. GLATSTEIN: I just want to add there's a fundamental orientation in oncology which is considerably different from cardiac. A guy has a heart attack and comes in the hospital. If he walks out of the hospital, that's a success. In oncology, we don't really start talking about success until we've got several years of follow up, and we can argue about how much, but several years of follow up to feel comfortable that we've accomplished something positive. That degree of caution, it's a major difference in orientation in the fields, and I think it is conveyed to most patients, which is another reason why I think you're getting some difference in attitude, depending upon the specialty. DR. GOODMAN: It was precisely for those reasons that we broaden the inquiry beyond just cancer patients. We wanted initially to bring in cardiology to open up the possibility of more diagnostic studies, in addition to therapeutic, and also because we didn't want to just focus on one, for exactly those reasons. DR. GLATSTEIN: If you actually look at the five-year survival for patients who have congestive heart failure versus most forms of cancer, there is not a hell of a big difference, but the attitude about those diseases is very different. DR. GOODMAN: Right. DR. FADEN: That's a very interesting point. Sue, and then I think we really should -- DR. LEDERER: I was thinking about Jay's comment this morning and wondered if anyone mentioned fear of venipuncture based on their reading from the consent form. Disciplinary differences. [Laughter] DR. FADEN: "They should stop making the side effects so scary" comment speaks to that. Let me just say two things. Ruth has raised several times, and this is a challenge to all of us, the importance of trying to bring the two projects together. They're very different. Subject interview survey and the protocol review project are very different, but they are both intended to eliminate the same set of issues. We are trying to triangulize here, looking at the world from different perspectives to see what general conclusions we can draw, if we can draw any at all, and so I think you were very right Ruth, and it's very hard because we're still in the trees to get to the forest, but the goals should be to try to see the extent to which the two studies would point us in different directions, or the same directions, if we had had, for example, only benefit of, one, focuses of basing our impressions. Also, I think as a legacy to policymakers, we need to be thinking hard about we think these two different methodologies can accomplish by way of taking a pulse on the status of human subject research, so what do you learn from this kind of work, what do you learn from the protocol review project, what kinds of agendas or objectives are best met in terms of oversight with respect to our recommendations for the future, by one approach or the other approach, or some other approaches, which we in retrospect wish we could have taken but didn't have the time to take. So it's not only findings for the findings' sake, but also how useful a tool have these approaches been in our estimation; how much confidence do we have about what we have learned and what kind of things do we think we still are ignorant about. I think if we could ask the people who are directly involved, this panel and also the panel we had before us on the protocol review project, to be thinking about those sorts of issues, that would be terribly helpful, because that really has to be part of the report. Finally, I can't resist saying -- and I said this last time so I'll say it again -- that it really is amazing that these projects are actually done, that the protocol review one is not quite done, but Sara says it will be two more weeks, and we will be done. Done, I mean the, quote, "data" being collected. This project is finished in terms of data collection is really quite extraordinary. 1677 brief interviews completed and 103 or 104 in-depth interviews is really quite remarkable, and our responsibility now is to do right by these data and by the people who allowed us to ask them the questions to get us the data in the first place, because this is just, a word that happens in my house, awesome. [Laughter] This is awesome. It's not cool but it's awesome. So we should remember that. With that, thank you all very much, and we're not moving. If people need to take a break or whatever, get some coffee, we'll go on, but this is where the agenda is off calendar, or whatever the right term is, and we're doing to do the session that was scheduled for yesterday afternoon -- tomorrow afternoon. It's euphemistically titled Committee Strategies and Discussion. This is for taking stock, how are we doing, what's wrong with this picture, what needs to change, can we pull it off. The floor is completely open on that issue. Duncan. COMMITTEE DISCUSSION DR. THOMAS: I think we're in trouble, and we're in trouble for a number of different reasons, much of which will emerge tomorrow as we talk about some of the big chapters that still need a lot of work, and I will save those points for tomorrow. I do want to give staff credit for reacting so well to Henry's suggestion at the last meeting, that we establish a mechanism for interchanging our feedback on chapters amongst the Committee members. From my own perspective, that's worked extremely well. It has been very helpful to me to see what other committee members are saying about each other. I get this feedback directly through E-mail, and it's a mountain of stuff to digest. It's taking a great deal of time, but I think it's time well spent. I don't know how well those of the Committee that are not on E-mail how they perceive this, and I would be curious to hear their thoughts. DR. ROYAL: They're able to have a life. [Laughter] MR. GUTTMAN: Actually, we just recycle the same old messages. After a while nobody notices. DR. THOMAS: Suspicions confirmed. DR. MACKLIN: But you've got to read through the whole thing to see if it's identical or whether someone added one sentence. MR. GUTTMAN: It's called dose fractionation. DR. MACKLIN: Who says we haven't noticed, is all I want to know. DR. KATZ: Duncan, what is E-mail? [Laughter] DR. THOMAS: One broad area -- DR. FADEN: We really did need to do this. DR. MACKLIN: Yes. DR. THOMAS: One broad area that I have not seen addressed yet in any of the draft chapters, and it may be buried in chapters that we still have yet to see. It is this topic that we visited for a while last time about the benefits of radiation research. I anticipate that at least some of that will be included in the section on the chapter on isotopes. It may appear elsewhere, too. I just still haven't figured out where that's going to happen. This is why I'm particularly disturbed, because that chapter we will have only one opportunity to look at, it appears, unless something changes in the agenda for this week. As some of you know, I have made a pitch to try to get that chapter out, in whatever shape it was presently in, in time for us to look at for this meeting, and it didn't happen. MR. GUTTMAN: I should say, we've had a request out for some time among the agencies to give us what they think are their contributions. We got something from the VA, maybe from DoD. I know HHS has been working on it, but we haven't heard at all from DOE, so part of it is, anybody who wants to tell us that something has been overlooked, has been invited in writing to provide it. We haven't heard from some of the agencies. DR. FADEN: Duncan, could you just elaborate when you say we're in trouble? I think we need to hear what you mean beyond, and if you have a solution in mind or strategies, and other people as well. DR. THOMAS: The only solution I -- DR. FADEN: This is the only time we have. DR. THOMAS: The only solution I see is one that is so painful that I am reluctant to utter it, but that's to extend the work of the committee, because it would seem to me that, if we go on the course that we presently outlined, when we reconvene in May, our job will be to sign off in principle upon the chapter, leaving of course some details still to be resolved by staff, and for us then through correspondence to give our two cents worth and eventually, I assume, to sign off formally in writing. That presumes a degree of discussion that is going to happen at the next two meetings, that for me seems pretty implausible. It's hard for me to see how we can conclude the work in just two more meetings, so I've laid it on the table. VOICES IN UNISON: Two more? One more. DR. FADEN: One more. DR. THOMAS: Two more, including today. I was including the rest of this one. DR. FADEN: Next day and a half and the next one. DR. THOMAS: Right. DR. FADEN: Okay. DR. THOMAS: Rolled into that are, as I say, the chapters we haven't seen, which seem to me are isotopes, pregnant women, plus the one chapter that we have seen, and there appears to be a tremendous amount of discordancy amongst the reviews that I have read; namely, the biodegradabilities chapter, which is not on the table for discussion at this meeting. DR. FADEN: Right. Some of us like and some of us don't. DR. THOMAS: With that, I'll shut up. DR. FADEN: Okay. Nancy. I'm just looking, people should feel free. This is like a Quaker meeting. DR. OLEINICK: I would like to elaborate a bit on one of Duncan's concerns, which is this whole subject of the benefits of radiation. I've brought it up before. I don't see much, other than a sentence here and there. I don't see much that comes out. I think that this report is going to be misread and very out of balance if we don't have some section, whether it's a section of a chapter or an entire chapter devoted to the benefits of radiation and radioisotopes. I just started to list some, but I didn't finish my list. In addition to cancer therapy, which is a big number, diagnostic tests of many conditions; research at the level of say preclinical testing in animals where radioisotopes play a very big role. The use of radioisotopes for research that is not related to radiation or directly to treatment but just in basic biological research, the whole field of genetic engineering and so forth, would never have gotten off the ground without the use of radioisotopes, and I'm sure we could go on and on. I think we would be remiss if there wasn't something in this report that said, yes, there may have been problems, but out of this has come some extremely important information and tools for accruing additional science, and so I am arguing very strenuously that this report must have either a chapter or an important section of a chapter devoted to this topic. DR. FADEN: Mary Ann. Duncan and Nancy in particular voiced my concerns as well. I would actually like to formally propose that it is in a separate chapter. I think it's very hard to intersperse effectively in this specific chapter, to some degree, bringing out negative aspects of radiation. I just think it's very difficult for the writers and the readers to take it in in the same piece of writing; whereas, I think a separate freestanding chapter is there for the taking. I propose that maybe Chapter 10, Part 2, would be the place to do it. That's certainly open for discussion. DR. FADEN: I just want to make one comment. It occurs to me that this is particularly important. I told Jay earlier today that I had been very affected by his second piece that's in the briefing book today. Is it Jonas who you point out is suggesting that all research is not necessarily good in and of itself? At the same time, particularly in so far as we point out that there are difficulties in the contemporary context with human subject research, unless we provide the reader with a clear reason for wanting research to go forward at all. DR. MACKLIN: Right. DR. KATZ: Yes. DR. FADEN: There has to be a context that says, well, if there's a reason why you as a citizen would like the world of medical research to keep on going and here is why, and unless we provide that context, if we then launch into what is our responsibility with respect to the future and haven't yet provided that, then you're left with, well, you know, let's just stop with it. There's an answer. We can just stop medical research; who needs it. You can't control it. The system doesn't work, it costs money to fix it, forget it. Somewhere were have to explain to the reader why everybody should want to see the enterprise of biomedical research keep on going, maybe not in the way it's going today or maybe changed or whatever, but we clearly need to explain that if we failed in that, we do run a tremendous risk of being misread terribly. The real tension really is a balance that has to be struck and not merely a problem that can be solved by throwing half the equation out the window. We are all hearing that, but this is why we are having this now. So far I don't hear anybody arguing against that. Pat, Ruth, and now I see Ken and Jay, and people can just -- if you feel you're right on point, just yell. Pat. MS. KING: I'm going to deliberately try to do something and omit a lot of other things that are specifics. I always think that what I do best on committees like this is to try to keep the big picture in mind, because if it all doesn't sort of hang together, then the report becomes the weakest part. The weakest part destroys all the good that is done, unless you sort of keep some sense of the big piece. My second complication is -- and I've been trying to do this because this is important to me -- it's been difficult to do this because of the nature of the task the committee was given, so this is not about blame. This is the hardest working staff I have ever seen, and chair, I've ever seen in my life. So this is not about any of those things. This is about where we find ourselves, and I want to make that clear too. To the extent I've been able to read and to the extent I've been able to absorb, while there are difficulties in the biomedical research aspect of the reports, some of which we just heard, my own view is that part of the report that's in the most trouble is the part of the report that deals broadly with what I call openness, secrecy, the government side of the report. What I call the government side of the report. This is understandable to me because, despite all of the niceties and all of the things that we want to do in the biomedical research part, this committee is comprised of people who know a great deal about that field, but it is a field. We started with some general consensus, some general knowledge. We've started with a certain set of understandings, off of which we were able to work. Even in that, we're still going to have quibbles about how we do parts in these chapters. I don't think we started out with those same kind of assumptions on the secrecy, the intentional releases, the observational studies; all of this was new for a lot of us. My concern is that's the part that needs the most work and the most tightening up, which is what we're going to probably have to talk about tomorrow. I can only give you a couple of specific examples. This is why, also, by the way, I think we're having a lot of problems with the Remedies chapter, because remedies tend to flow smoothly once you have straightened out a lot of your preceding concerns. I have not read every chapter, and people knew I was in England this week, so I didn't even get the last bit of it. The part that I was trying to read is, I am still searching, for example, for what it means to make a national security argument, that this Committee has agreed on. For example, when you read several of the chapters, what you see is, the discussion was about fear, public liability; the discussion was anxiety, about public concerns. There was no national security argument made. I'm not quarreling with the statement, but what I'm looking for is, what is a national security argument; because until we have an agreed upon understanding about what is a national security argument, you can't argue that something wasn't. You know, we may think we have an understanding about what's a national security argument, but I'm not convinced, because I disagree personally with some of the statements made here, but I may be only one person in doing that. We make assumptions that I would like to concur with, to some extent, when we're talking about environment, as distinct from biomedical research, with respect to the use of public exposure and we make statements about public consent. Now, maybe I have missed something, but I've been still looking for the justifications for when you're talking about population work, conditions in which consent is required, how you obtain consent. You can't say the government failed, no matter how much we want to, without some understanding of what standards we are measuring against. Maybe I'm being too critical, and maybe I'm missing something. I will put all of this blame on myself, and you can point me to where to look. DR. FADEN: Let me do this, Pat. For the rest of the discussion, we need everybody to be as critical and mean as they want and absolve everyone of guilt and responsibility, all at the same time, so that we can have as frank a discussion as we need to have. [Laughter] DR. THOMAS: My cup runneth over. MS. KING: I feel some sense of responsibility because I think that I have not read as much as I should have read, but I must say, diligently searching for places where I thought it might appear and just try to get some description. I just read, for example, sitting here, a description of an internal debate about whether information should be released to the public, and it went all the way to the President. When I read a discussion of an internal dissent about whether things should be released or not and it goes all the way to the President and it's not released -- DR. FADEN: You've got to take it as national security. MS. KING: You've got to take -- that's exactly where I went. DR. FADEN: I did too on that one. MS. KING: So it said to me we need to have -- DR. FADEN: It's either national security or it's Watergate. MS. KING: I'm saying something, I'm not trying to foreclose anybody by saying I have my own ideas of national security. What I am trying to suggest is the Committee needs to have an idea of what national security means and what public disclosure means, et cetera. If we want to adopt in retrospect standards that exist today, then we should have a clear debate about the standards today and decide how to view it in retrospect. I could go on like this, but because I am concerned about the big picture and because I am concerned that the report must hang together; it must. If it's weak in one area, it will be shot to pieces. We have two audiences, it seems to me. One is the biomedical community, and they will work on the history as well. There is a broader public interest out there, one. Two: For those of you who have been reading the papers recently, it would be naive to assume, I think, that after the Japanese gas attack and after the current series running in Washington Post about what to do in response to nuclear threats, that we don't have a government that is, if it ever stopped being concerned, is it reconcerned about chemical and bacteriological warfare. These were not the only releases -- public releases. The radiation releases were not the only public releases. My concern is that when people who are interested in those subjects look at this document, they should come away with arguments that they can use with respect to how, what I presume will be work that will go over in the future, if not already, in some form or another, where people can point to if they want to make arguments of a certain type that were rejected in the past. You want solutions, you don't want just general suggestions. DR. FADEN: I would prefer if people have ideas about what -- MS. KING: So one of my ideas is that we should agree on a time certain by which we will have as much of the report as is possible to have. Two days. This is a lot. Look at Henry's book. Two days is a lot to have, to go start on page one and go all the way through. To have a period in which stop, give us the document all the way through -- DR. FADEN: From beginning to end. MS. KING: -- from beginning to end. Let us go through it. Give us a chance to go through it and identify areas that we think -- not small; you can send all the specific stuff you want to; let us identify if there are, in fact, big holes and what they are, and let us deliberate on them at the last meeting that we have. My second suggestion would be to see; this happened with the IOM research panel, as I was explaining to somebody this morning, where we operated with the view that we had to conclude by a certain time and, indeed, we did conclude by a certain time. But I, as a result of that experience, am less enamored about committee deliberations done by E-mail or fax because they're only good up to a certain point. Lots of misunderstandings crop up in these E-mail and fax communications, and after a while you don't know what you're responding to. All you have to do is be on the receiving end when you're trying to track one of these debates, and I try to track only one, to try to figure out what's going on. So, it seems to me that what we want to ask permission for -- and I know nobody wants to hear this, not even me -- what we want is to ask permission for one more meeting, not to be in June, but we want to have one more meeting three months from now -- three months from May -- that we could identify the big holes; let whoever is left to finish the behind the scene work on this, clean it up and let us have one last sort of go-round at it and put to bed. It will not be a Committee deliberation, it seems to me, without that. If we don't get permission, we don't get permission. I understand. This is the real world, I'm a big kid. I think we need a period of deliberation and then we need some other time when we're face to face. DR. FADEN: Let me hear your timing suggestion, and I want other people's reactions as well. The meeting in May is the meeting where we do have the whole document before us, a rough version of it, and we sit down in May, and then we have another, if we could do that? MS. KING: I anticipate that if we could this, the May document is going to look as follows: If you gave me page 1 through 2000, that you will have in the May document, when you would get to page 100, that will say this argument needs to be developed. That does not bother me because what I am trying to see is how it goes from beginning to end, and how they connect, and how you lead to a series of recommendations, and let us spend all that time in May working hard on what we identify as the big gaps or the big problems. DR. FADEN: When would you see this last meeting, if we could get it? MS. KING: August. And that's why I hesitated to put this out because August is my vacation month, too. DR. FADEN: Well, we could maybe do it July. Okay. I'm just wanting to hear people. Okay. This is it. This is what we have to get out. This is important. I've got Ruth Macklin, Ken, Jay, and anybody else who wants to join in, please do. Ruth. DR. MACKLIN: My comments are really rather trivial and small. Do you want to hear trivial and small things? DR. FADEN: If you're unhappy about them, then yes. DR. MACKLIN: It's not really unhappy. Actually, I should have said I have something on point in the other discussions. I want to go back to the benefits of radiation. I think I disagree with Mary Ann that there should be a separate chapter on it. The reason I disagree goes to how the benefits of radiation are to be described or recounted. I agree that the benefits of research on radiation ought to be in here somewhere, but we're not, in this committee, talking about every single experiment or research on radiation that was ever conducted on animals or on humans. We're looking at a specific set of, what we have here are 9 case studies that have to do with the charge to this committee. Now, to talk about the benefits of radiation research as a whole, like talking about the benefits of all research as a whole, is something that should be here. To say research and radiation experiments are not a bad thing, but what we're looking at and what we're charged to look at is some specific bad things that happened, or at least we have to determine whether there were bad things and say why they were bad things. So if we talk about the benefits, which I think should be in here somewhere, in some general statements, I don't think we need a whole chapter that talks about all of the benefits that ever came from radiation research. I think we can say that and give the kind of list or account that Nancy gave. I think it is incumbent on us to look at and say something about any benefits that may have come from these particular research, that is, what was learned here. I mean, one of the running recent E-mail blitzes had to whether or not there was any anticipated benefit, whether anything was going to be learned in some of the military research, the one on the soldiers and the sailors and stuff. Whether it was anticipated or whether in retrospect, and the way that chapter -- that chapter or is it in another chapter -- is presently constructed, at the end of the chapter there is a discussion of what the benefits were. No, I guess that's on the Intentional Releases. In any case, if we're going to talk about benefits and harms, they should be tied. You can talk about benefits generally, and I'm agreeing with that, but I think that we owe that kind of discussion to each one of these chapters if we're looking at particular studies and some of the bad things that were done; maybe there, we have to say something about whether or not they were expected to yield or did, in fact, yield beneficial results. DR. THOMAS: Either one of us. I think we're going to say the same thing. DR. OLEINICK: We're probably going to. Go ahead. DR. THOMAS: I would have a very hard time telling the story of the benefits of medical uses of external radiation in the context of a chapter which is structured around why the TBI experiments went wrong. That's why I think it's almost impossible to integrate what we have to say about the benefits of radiation within the present structure. DR. OLEINICK: Let me add to that. I think I would have a very hard time about talking about the benefits of the uses of, let's say, radioisotopes, which are many and not just involved giving radioisotopes to humans. I don't think we want to write a 100-page chapter on all of the wonders of modern science, but I think a short write up to indicate to the public that there have been many benefits from preclinical types of tests; and even from basic science, it isn't even directed towards the clinic, but eventually winds up and has the potential to wind up having a clinical benefit. I think there are many benefits that come out of all of this kind of work, and I think the public needs to be told about that. I would have, I think, a difficult time deciding what chapter to put that in. I think that would be very, very difficult. DR. FADEN: We have Ken and Jay waiting, and then we have -- MS. KING: It's on this point. DR. FADEN: Is this on this point? Okay. MS. KING: This is, again, I think the problem of segmenting. If we look at radiation as radiation, it has had benefits and it has had what may of us would call negative aspects. The negative aspects are going to turn up a great deal in weapons and with environmental releases of the kind of things that we think of as negative outcomes. We all wish the bomb had never gone off that Hiroshima and Nagasaki, and et cetera. I think that one way to avoid writing a chapter on anything, I think the committee wants us to examine a certain downside. I think that we ought to start off in our introduction somewhere -- and I mean this quite sincerely -- talking about radiation, its benefits. It's just like medical research. It's one of these things that's typical in our experience. That is, there's a scientific advance, out of which great good came and great ill was possible and, indeed, happened. That's sort of the setting for, it seems to me, our report because, in that sense, radiation is no better or no worse than a lot of things I can think of in terms of how you try to strike the balance between the good that can come and the evil and the bad things that one is worried about. I like it better that way because it makes it complex. It doesn't try to break it out in the biomedical context only. It tries to talk about this is what we have here, and this is what was profitable. DR. FADEN: Reed, are you on this point? DR. TUCKSON: Yes, I am. DR. FADEN: Sue, are you on this point, too; and Ken and Jay, you just have to hang in there. DR. TUCKSON: To not make it more complex, but I really do agree with both points. [Laughter] MR. FEINBERG: You've made it more complex. DR. TUCKSON: Thank you. First, is that the more I listen to public testimony and the more I talk to people outside of the meeting room, the more I am excited about our responsibility to be clear to multiple constituencies. While it may not be editorially wonderful and while it may make the task of writing this very complicated, the introduction had best be extremely clear in setting the stage for the rest of the report. We heard today from a very wonderful gentleman who made a very impassioned statement today, but it's real clear from listening to the import of many of the comments that he made, and he's a very legitimate American voice, an extremely legitimate American voice, that radiation, just having been exposed to it, is, in and of itself, a horrible thing. Those are the implications of the comments. I can understand how and why he got to that point, the point being that knowing how audiences will read a report, if we are not very careful in the very beginning to really kind of lay some of these issues out, we are going to have a lot of folks who will lose them from page 1(B), and everything we go down the road will be something wrong. Similarly, there ain't a whole lot of time in the introduction in the early parts to be able to devote to this, and so having some -- and we've talked about that before, in other contexts, about some short primer, as it were; but I think there used to be an index section somewhere, that really does kind of lay it out. Otherwise, again, if it's not self-contained in the body of the report, we're going to have a lot of folks who just aren't going to understand how we got to the wonderful lofty conclusions because we lost them from page one, because they didn't understand basic concepts, so I think we have to do both. DR. FADEN: Sue, and then Ken and Jay. DR. LEDERER: I guess I wanted to concur with both Ruth and with Pat about integrating benefits of radiation into the body of the text, and I think it should occur early. I see it belonging in the atomic century, and I guess I didn't know why it didn't occur there because it's context for understanding the point that we were created to explore. VOICES IN UNISON: That's a good point. DR. FADEN: Okay, that's good. DR. KATZ: I like that. DR. TUCKSON: Good thought. MS. NORRIS: May I do one more thing on point? DR. FADEN: Sure. MS. NORRIS: That is, in discussing the benefits of radiation, I think we must be very careful not to lead others to assume that we are saying is the ends justify the means. To the extent that the public was harmed and wronged for the benefits that we are now seeing, we should make it clear that we are not saying that what was done is justified because we've benefited from it, is what I'm trying to, in a stumbling way, get out. DR. FADEN: Yes. DR. MACKLIN: Part of it is, of course, all of these things are very difficult to get the balance. It's hard to get the balance right on all of these issues. MS. NORRIS: I just have the feeling that if the benefits are included in the chapters, that people are likely to read into it, that it's a justification. DR. MACKLIN: But we can always say it wasn't. We can always say it wasn't? This is a document in which we're saying things about ethics. We are not just merely describing. If we say: Something was learned but it was entirely unjustified to learn it that way by harming or wronging people, that's the kind of conclusion you can draw that won't let people make that mistake. DR. FADEN: Okay. Is it on this point, Henry? Now, we've got Ken, Jay, Henry. Ken. MR. FEINBERG: A few comments and two specific recommendations. I believe that it is a mistake to delay our work and seek an extension. I believe that, as I think Duncan or Pat mentioned, the work of the staff has been incredibly able and competent. I think the report is in much better shape than people around this table may seem to think it is, and relative to my experience on other committees similar to this, I believe that the report, whatever the criticisms, constructive criticisms directed at the report, this committee will be unanimous in supporting the report. There has been too much time and effort expended by everybody, and I witnessed the disagreements and the stylistic debate and even the gaps that are still found in the report. They are, relatively speaking, in my opinion, less weighty than the consensus that's developed over the last months, adds to the structure that the report is taking. I think a delay is a mistake. I think a delay will give rise to criticism, real and imagined criticism, that we are fishing for information, and until we find some smoking gun, we are looking to extend our life; That we are covering up, waiting until the summer months to issue a report in the dead of night, where no one will watch it, no one will see it, no one will read it; That we only have ourselves to blame with methodology that's run amuck, and we're going way beyond our charter, even though I do not believe we are. The criticism will be there; That the reason we didn't finish on time is that we went beyond the narrow confines of our mandate and are talking about uranium miners and Marshall Islanders and areas which were never intended that we get involved, even though I think we should be involved to the extent that we are; So that I think that, frankly, maybe there will be a criticism out there that the reason we delayed is to put in a plug for radiation, in terms of the benefits of radiation. Criticisms, real and imagined, tell me, based on experience, that it would be wise if we finished on time, issued our report, and let the chips fall where they may in meeting our calendar. Now, that leads to two recommendations, however, because I recognize what people are saying about the trouble, as Duncan says, in getting the thing done. I have two suggestions in that regard. First: It may be that even if we go out of business, on schedule, as our mandate requires us to go out of business on schedule, it may be that the report gets delayed 30 days or 60 days. I don't think that's such a terrible thing. If the ministerial function of getting the final report printed and finalized, requires a few extra weeks in order to get the job done, just in terms of scrivening, I think that's doable. I think we ought to coordinate with the administration, coordinate with the administration on the release date of the report; and if, in fact, we need a little extra time to put the report to bed, I don't have a problem with that. I don't think - - I mean, I don't know -- whether the administration will have a problem with that or not, and I'm not sure it's absolutely essential. I think it's wise to just touch base and find out when the report itself should be put on the desk, even if we've gone out of business weeks before the final report is actually released. I don't have a problem with that. That's suggestion No. 1, to bridge these concerns that have been expressed today. Suggestion No. 2 is a page out of the Catastrophic Nuclear Accident Commission that I was on. That is this -- it picks up a little bit on what Duncan and Pat have said before: On a date certain, let's say the final May Committee meeting, or whenever our final meeting is in May, either after that, if we have an extension in getting the final report disclosed or published, or even before that, if we don't have additional time after the May meeting or only a couple of days after that, one thing we can do is what we did with the Catastrophic Commission, and that is everyday, everyday, the staff finalizes the report. To the extent that -- and this is maybe a variation on what Pat suggested -- to the extent that members of the Committee are available to work with the staff on a 24-hour delayed basis or a daily basis, to put together the final report, fine. If we can be here, fine. If certain members can be here, fine. If other members can't be here on a given day, they can't be here. Either the pages will get circulated to them overnight mail, or will be faxed to them, or there will be conference calls. Basically, the last 30 days of our life, everybody is on notice that Chapter 1 on this day; Chapter 1A on this day, Chapter 2 on this day, Chapter 3 on this day. If you can be available, wonderful; come around the table. If you can't be available but you want to look at the report, we'll get you the pages. If you can't be available and you can't get the report in the mail, you have acquiesced in the final version. I think we're so far along in the presentation and construction of the report that I am comfortable, for one, that if, in fact, I cannot look at a particular chapter or a particular paragraph, it is not going to be the difference between my signing on to the report and not signing on to the report. If I can have some input in certain chapters, great. If I can't, I'm comfortable enough that others are looking after the drafting of the report with the staff so that the final version is basically completed and that there is no further need for the committee of the whole to meet beyond its deadline. Those are my two suggestions, and I offer them to the committee for consideration. DR. FADEN: Jay and Henry. Jay. DR. KATZ: Duncan wanted to say something. DR. THOMAS: If you're on this point. DR. KATZ: I will be on this topic, but go beyond it a bit. DR. THOMAS: I just want to say, I think that's a fine way to finish off the report. Once we've reached consensus on the big picture questions, and we haven't yet reached that consensus yet. I feel very uncomfortable that one Committee member could come in and rewrite a conclusion, or something or other, by that kind of a process. MR. FEINBERG: Duncan, you'll be the one person that will be -- no. [Laughter] DR. THOMAS: As long as it's myself. MR. FEINBERG: I think that there is time between now and May to get those big ticket items out of the way. I think the real problem that gnaws at some members of the Committee -- I may be wrong on this -- is just the problem of getting the physical document done. I don't think that should be a reason to hold up meeting our deadline. VOICES IN UNISON: No. DR. FADEN: Go ahead, and then Jay. MS. KING: May you're terrific for surfacing what is the issue. I think the issue is a different set of assumptions, and then the question is what you do with it. I think some of us feel that there has not been consensus yet on the big issues. That's my first point. And, if there is not, you don't have a unified commission. That's an invitation to not having a unified commission. There's a lot of room to debate, depending on whether the majority of the people here agree with you or agree with me about when we reach that agreement, how to try to clear it up. I think that is the big difference, although I want to be clear. I always tend to be the pessimist, and I'm not. I'm thoroughly an optimist. The reason I raise the point is, I think we're just about there. I don't have this view that we need six months to get there. I don't have that view at all. I was not contemplating that the Committee operate as a -- as far as I'm concerned, we could shut the doors on May 1 and say we will not receive another document, another piece of paper, another anything, and we're just putting it in final shape, and then taking a look at what it needs to put it into final shape. No more public hearings, no more anything, because I'm not contemplating that we continue as the way we've been operating. I'm trying to figure out a way to wrap it up, in ways that I think would be satisfactory to most people. But you may be right, because your way would be satisfactory to most people, in which case, that would be fine with me too. DR. FADEN: Okay. Jay. DR. KATZ: This is important stuff. I'm going to make two kinds of comments. One is: To respond to Ruth's original request, what still needs to be done very, very briefly; and then I want to talk about Alice in Wonderland. I assume that we pretty much have decided, at this point -- or not decided; it's been decided for us -- that we will finish next month. There have been some voices in the past that talk about extensions, but I think it's not close to 12:00. With respect to what still needs to be done, it seems to me that what we discussed this morning, the chapter and the protocol review, still raises many crucial issues that we need to explore. We will get to it eventually. I have lots of problems, at the moment, with the chapter, Looking Forward, and that's no mean task. Maybe all this in the other chapters, I do not know where. Ken got the impression that there is consensus amongst us. I think there is certain amount of consensus and certain basic issues amongst us, particularly as it affects the aspects of the Cold War period, but one always can get better consensus in light of the things done about the past. I do not think we have reached consensus about the implications of this for the present and for the future. We will not be able to arrive at a consensus. It seems to me, Ken has this in mind, but will come back to that. Once again, I'll try to be brief as possible. I have no problem with under the pressure of time, saying, Okay, we have to come to an end. Staff will finalize the chapter, and you can comment on the chapter. If you don't have the time or if you're unavailable, for whatever, and cannot comment on it, so be it. I do want a period of a week or two, at the end, to do the whole report and to have an opportunity to dissent from portions of it, and to have an opportunity to make additional report, to be included in the report. I would consider it an act of betrayal for all of us, if that opportunity wouldn't be provided for us; and provided to us in a way that we have time for reflection, that the opportunity must be provided, that it be sent to us, by camel, rhinoceros, or whatever, and maybe E-mail will help you. I don't know about E-mail, to send something to headquarters. DR. FADEN: Are you planning to go to Africa, Jay? DR. KATZ: No, no, no. For the course of this Committee's work, I'm staying put. DR. FADEN: We appreciate that. DR. KATZ: Two more points. Maybe Pat has something different in mind than I understand her to have in mind. I don't think we can hide a report that hangs together, really hangs together. I think that is impossible. It is impossible by the very nature of our assignment, of having been given an impossible kind of job to do in one year's time. Even though this impossible job has been done by staff, to an extent that I find extraordinary and have never seen accomplished before, but even with the extraordinary effort, there are too many complex issues that we have to address. If it can hang together, fine. But I am quite willing, even once the Board is finished, to put in production a statement; look, it hangs together in certain respects, it doesn't hang together in certain other respects because we didn't -- I know we come here from different philosophies and different wavelengths, and so be it, and I'm perfectly willing to admit that what I'm saying may be wrong. Finally, one other thing, and it goes back to the point I made before. We are coming here, a group of 14 people, with different perspective, different backgrounds. It's been a wonderful group, but we really haven't had a chance, because of the certain constraints upon us, to really get to know one another well. I don't feel I really know how some of you are thinking, and maybe many of you feel, because I've talked too much, that you know too well about what I am thinking about, and I apologize for that. The report may not be able to hang together, but we shouldn't hang ourselves together. What I mean here again is, if necessary, and we should all be very careful about this and reflect on it carefully, and surely I will reflect on it carefully on my part, that we must be prepared and be willing and be offered the opportunity to make some additional comments at the end of the report. I don't think there will be dissenting comments, but there will be comments of emphasis, and we must have the opportunity to do so if necessary, as limited about as we possibly can, but certain things are important, and then let the report meet the world. It cannot be written for all of the constituencies that we want to address. It's impossible task, I think, in the first place, and surely impossible for us to do. We must be aware of the limitations that we work under from the very beginning and some of us have commented upon it, that goes on in our proceedings. But, be that as it may, we have nothing to apologize for what we have accomplished in this year. It's been a wonderful accomplishment and we have to thank also Ruth for the leadership that she has provided us with. We couldn't do, and we would be foolish, to try to do the job that, in an ideal world and under ideal circumstances, we could have done that. It's just not in the nature of the beast. DR. FADEN: As maybe you noticed, I think we should just forget the break. If we have one, we'll have one later, but I think we need to get through this. I've got Henry, Reed, Ruth, and Duncan, and then maybe after a couple of more expressions we can see if we can get closure on at least this issue of whether we want another meeting beyond May, which is what seems to be at issue, among other things. Henry. DR. ROYAL: I'm just going to talk about several fundamental problems that I'm having. The first one has to do with the scope of the task. I am personally finding it very difficult to absorb, analyze all of the information that I'm provided with. Maybe I'm resonating with what Jay just said, and that is, maybe the number of person hours that's required for the scope that we're talking about is just too many, and so I would think that one of the things that the committee needs to think about is whether or not, in some circumstances, that the best decision might be to make no decision; to point out what the questions are, point out what the problems are but, for whatever reason -- lack of data, lack of time, lack of expertise, we were really unable to come up with a decision that we felt comfortable with. Let me give you an example. DR. FADEN: That would be helpful. DR. KATZ: You mean decisions or recommendations? DR. ROYAL: Whatever. I was struck when Pat said something about nuclear weapons, and maybe we would all be better off if they weren't dropped in Hiroshima and Nagasaki. A lot of figuring out whether or not the human radiation experiment was acceptable or not acceptable has to do with the risk benefit ratio. In terms of the military obligations, I certainly think that the risk benefit ratio is important and that risk benefit ratio is going to be very much determined by your world view about whether or not the world is better off or not better off with nuclear weapons. I personally don't have any expertise in trying to determine what benefits are or are not having nuclear weapons. I don't think that this committee is really composed of people who are in a position to make those sort of decisions. I certainly don't feel comfortable. One issue was this huge agenda and whether or not we should defer making comments in some areas because we lack the expertise time or information. The second thing that I'm troubled with that's a fundamental issue is, I don't really feel a lot of ownership of the chapters. I sort of feel like maybe they're okay, but I definitely feel, gee, this is not the way I would have told the story. I think it's very important that the Committee members feel that the report is a product of their deliberations and that they are not simply accepting what a very capable staff has given us. I am personally having a problem with ownership. I also have, and I have mentioned this several times before, a fundamental problem with how the story is being told. I have referred to the half-empty glass analogy, and I really think that that's the style in which everything is being written. The failures of people are highlighted, the achievements are often not noted. I have some problems with fundamental ethical issues, and maybe it exists somewhere in the final chapters and I just haven't gotten around to reading it. Just, for example, the concepts of informed consent; we're making judgments about whether consent was obtained or not obtained, at least we're purportedly making those judgments. But I really don't know, to this day, what the rules are what we really mean by informed consent. I personally have some difficulties with the concept that informed consent is what we are going to regard as being the cornerstone of ethical human research, not because I don't think that it's an important idea, but because, as we've heard from the contemporary studies, it just may not be doable. I personally would like to see other things emphasized besides informed consent. For example, educational programs to sensitize investigators to these ethical issues and whether or not that may be a more effective way of dealing with these issues. As I said, I agree with Duncan's first statement. I sort of feel that we're in trouble with some fundamental issues for the reasons that everyone else has stated around the table. I'm not crazy about time being extended, but I really don't see how we can reach closure on these issues. I think we're just sort of getting into it as opposed to being at the point where we're ready to have closure. DR. TUCKSON: We are at an extraordinarily important moment, aren't we? These last several comments are absolutely the most important moment this committee has faced. My first reaction to it, I guess we approach this in where we come -- I'm an internist, so I'm trained to live with uncertainty and to be able to move forward to reach the best conclusions and then act in reasonable periods of time. I do not agree with Ken's comments or concern, although I appreciate him raising it, about the pressure that we would be under if we were to extend that and how people would read in. My sense of it is more pressure will be if we don't extend it than if we do, from the constituencies that can raise the most hell. So I am less and not particularly intimidated by how anybody reads into it, and given that, if anybody wondered why we did if we did extend it, just hand them a transcript of this last hour, and I think we are immunized from any criticism. There's no Machiavellian in this that could be possibly involved in it. I think that we signed on to a task, and I think we signed onto that task as mature, grown up boys and girls, people that were experienced in the world. We agreed to accept an assignment. I don't think there is any conceivable way that we could justify ducking any issue and not coming up with a series of recommendations. That would be, to me, extraordinary; an absolutely extraordinary abrogation of an oath we took with the President of the United States. You just can't do that. That is to say, that the nation, having raised an issue of substance, and there is no question of the issue is substantive, to be able to say, after working on it, that you could not say anything as reasonable people to the nation about that, I think is a very frightening notion, and to me it's not even on the exam. None of the above. It's one of the none of the above. However, I also don't agree with Jay. I would be troubled. I respected Jay's points all the way through and I continue to learn from him every meeting, but the notion that each of us would write a separate, descending notion because we were unhappy with some part of it, then just gives us a ridiculous document, just a horrible document. There is no way that I am going to like everything in this piece. I knew that when I signed on. If I thought I was going to be happy with every word and own every word when I signed on, I would have been an absolutely irresponsible person, and there's no way I should have, in good conscience, signed onto the Committee. No way. You just can't do that. If Ruth has done anything well -- I'm sorry Jay doesn't agree with me on this; I don't know his disagreement -- but if Ruth has done anything well, it is to fault, perhaps, then overwhelmingly fair about process. We have all been given every single opportunity for due deliberation and comment on every piece of this along the way. To conclude my long-winded comment, First: What I am celebrating is we have a moral responsibility to bring this to close. Number two: I think we have an imperative to give good faith to the notion of collective, democratic holistic team conclusions. There is no ownership over all of it, but I must respect the process by which we get to a conclusion. Finally, it is that I think the next two days are going to tell you how much we are or are not. Right now, we are premature in trying to determine where the gaps are and where the differences are. I suspect that there will be some substantive work. The last thing that Henry said I thought was very, very important. We are just now getting to where the real meat is, and to be pushed around by an arbitrary deadline, after all of this daggone work, and now just finally getting our real hands around the monster, really understanding this thing, grappling and wrestling with it, to some arbitrary timeline, to be forced to give a report that we don't believe in, that Jay is going to write a dissent to, that Henry doesn't feel ownership over, that everybody is going to be upset about; to do that because of an arbitrary deadline, to me, that is irresponsible. It is irresponsible to the people that charged us to do the work. Nobody is smart enough to have created a timeline and a work plan that would allow you to get it down in exactly 365 days. Nobody is that smart. So we fail in that. We know there has to be limits or else we will go on for, good God forever. So I would suggest, and to me it just makes sense, that we be prepared to know that it will take us another three or four months. I don't like the implications any more than anybody else does, but we put that as the timeline there, and we get about the business of wrestling with the doggone tough issues, and let's see where we come out. I'm not prepared to set that three or four month timeline yet until after I hear the discussions tomorrow and the next day. I want to come back to respecting the sense that we are all in this thing together, and we've got to live and fight this thing out together, and we've got to come out with it together, or else it's all a waste. DR. FADEN: I've got Ruth, Duncan and Pat. DR. MACKLIN: My first comment is brief, and it's simple, and I want to agree with Reed, that we should try, if at all possible, not to have any addenda, additional comments, even if there are some small disagreements. I can think of several examples of reports that have out of commissions or committees in which there are addenda or dissenting views, and it takes away from the credibility of the whole report and, among others, I think of the one that we read right here on this committee, and that was the UCSF report, which I thought the comments at the end raise questions to me, both about the process, the commitment, the integrity, and the willingness to work together in consensus. I think it would be a mistake. I think we can hold our respective tongues if we're basically in agreement and try not to write any addenda. Now, my second comment is a reflection of what we have been hearing in the last hour, and I'm a little puzzled and confused about a couple of things. Let me start with saying a disagreement that I heard voiced. It doesn't matter, as they say, who said it; you know who you are. One view is we're almost there with this report. We need to do some polishing, we need to fill in some gaps, we need to get the structure right, but the substance is there, and it hangs together as well as it might or should, and it really needs a polishing; a little more deliberation, some more work by Committee and staff, but we're almost there. The other is a very different view. We are very far from there, not just in time but in two respects that I heard voiced, and then I am going to make a recommendation after I describe these. I want to use the words that two people used. Pat referred to the big picture. Well, I want to ask Pat. She doesn't have to say it all out loud here, but maybe she would like to, what is the big picture. If we get a picture of what the big picture is, then we may know how to fill it in or what needs to be painted in order to complete it. The second phrase was Henry's, and he said reach closure on issues, and the question: What issues. This is why I'm saying I'm reflecting and a little puzzled by what I have heard. I don't know what Pat means by the big picture, but once she explains it, it will give us some direction and some guidance. I'm not talking at all about the timeline of whether to extend or not, but simply about what we have to do. So I want to know what is the big picture and then we'll know what is missing or what we have to do to get the big picture. The second, Henry's point, reach closure on issues. I don't know whether that means: (A) There are things on which the members of this committee, in fact, disagree about and we haven't specified them and dealt with them, and we haven't yet bitten the bullet. That's one way to talk about reaching closure on issues. A second is: There are things we haven't discussed adequately. We haven't discussed fully, we haven't completely dealt with. They flurry of E-mail that you and I and Dan, Dan referred to as, questions raised -- MR. GUTTMAN: Too profound to ask. DR. MACKLIN: Right. Too profound to ask. Or questions that Henry and Ruth raised. It is true, as I became convinced in that and when Dan so capably summarized it, that there were some issues the Committee hadn't fully discussed, and therefore needed to discuss in order to reach closure on the issues. That is not to assume in advance that we might not disagree. That's just to say we hadn't discussed them officially. I think what we need to do -- maybe we can do this in the next day and a half, and I'll take careful notes and others might as well -- is identify issues on which the Committee members disagree, if they surface. Either push our fellow Committee members to see what the view is if there is this agreement; and, Number two: Identify issues on which we need to reach closure that we haven't yet fully developed or haven't fully yet discussed. Now, maybe if we do the later -- identify the issues on which we need to reach closure -- maybe that will satisfy Pat's big picture. I don't know; maybe not. No. Okay. So she's going to tell us what that is. But at least these two things in order to derive some benefit out of this conversation we've had for the last hour and a half, that might be a way to either allay some of these fears or at least become convinced that there are things about which we disagree or will never reach closure on. DR. FADEN: I have Duncan, Pat, and Jay, and then, if it's all right, I think we should just take a few minutes to figure out what we want to do with the rest of the meeting, the rest of the afternoon, the rest of our lives. I think we should think about this issue. I think we've got to get these three comments in and any immediate reactions to these three comments, and then I realize -- I agree completely with Reed's characterization -- I do think this is a very critical moment in the life of the committee. I do think it's the most critical moment we have had, and we have got to respond. We have to rise to the occasion and reach agreement about how to proceed, hopefully today. I think it's critical. Duncan, Pat, Jay. Dan has been very patient. I realize Dan has been very patient and other members of the staff, and it's an awkward moment, but I think if Dan would indulge us, I think the Committee needs to work this through for a little bit, and then we'll give you the microphone. MR. GUTTMAN: I'm not saying it was a smart comment, I just thought it was -- DR. FADEN: Duncan. DR. THOMAS: I can be brief because Reed and Ruth are far more eloquent than I could possibly be. I was going to speak to exactly the same issues. I, personally, feel very strongly that we should commit ourselves to trying to reach consensus and write a single report without dissenting views. That said, however, I respect that we are involved in a democratic process here and that nobody should feel committed to sign onto something which goes against their principles. It should prove that consensus at the end of the day is really not attainable and that person should have the right to express themselves. I hope it will happen. I, myself, am committed to working with my fellow Committee members to try to reach consensus on every issue. DR. FADEN: Pat. MS. KING: Well, a lot of what I wanted to say in addition and what I was about to say was said by Reed, so thank you, Reed, because I think I'd like you on my team. DR. FADEN: He's back there. MS. KING: I'd like you on my team any day. You bring us back, and I'll vote for you if you decide to run for office. DR. FADEN: It's funny that you said that, Pat, because that was exactly what I was thinking. I was thinking, where could we put Reed. MS. KING: First of all, as some of you know, I've probably served on more bioethics committees and committees like this than I care to remember. People ask me, why do you do it, and I don't know either, but maybe it's because it's important sometimes to say, but I have never served on a committee that didn't have a moment like this. That's the first thing. We are not unique. I have never been anywhere that we did not have a moment of crisis. The measure of any committee, it seems to me, is how you handle it. In that sense, if I sounded like I was trying to give lots of my qualifications, my daughter and my husband say that no matter how I do it, I always come out negative, but, honest to God, I am not really negative. I really mean that every committee has its moment of crisis, and the measure of the committee is how you deal with it. I would say two things, from listening carefully to some of the comments of the other people: Henry said something important; and that is, enough people on the Committee must feel ownership for it to work. That does not mean -- and I'm making a qualification -- that everybody on the committee has to feel ownership, but you certainly have to have the vast majority of the committee feeling ownership, and I don't mean by ownership agreement. You have to feel that you are proud of it, even if you can point to the places where you have profound disagreement with the Committee's conclusion. You, nonetheless, when backed into a corner, usually by the press, have to feel that your obligation is to come out swinging on behalf of your Committee, because, at that time, your particular views, no matter how profound, and even if you write a dissent, has to be that you think it's on balance and on the whole that the Committee's process and substantive conclusions were good ones and ones that you could be proud of. Because I think that what Henry said is correct and because I think there are a number of people here who do not yet feel ownership is the reason that I started where I started, which is the question about the big picture. The part, I think, not that there could not be a feeling of ownership but in some places there is not a feeling yet of ownership, is because it is hard when you get bombarded with the little pieces to see the big picture. You don't know whether you are in ownership or not. That's part of the problem. It is not that I think that there is not a not there, and since I have worked with Commissions like this before, where I expect the staff and the chair, thank God, to have done most of the work, usually what happens is this means a process of making clear what they have been doing, so that we either claim what we want and discard the rest or put in a substitution. That's the way the Committee, as a practical matter, functions. It may get to the point where they say, I like what the staff did. This is right. They made it hang together. Speaking for myself, what I haven't yet gotten is that I can feel that I figured out where they're going and what they're doing, and where I want to make a contribution. In part, that's because it comes scattered. Hence, my suggestion about I don't care if it's not perfect. Nothing is perfect. From page 1 to page X, I want 1 through X, one page after the other, and if you can't fill in page 40, put in big black letters, "I can't fill it in," so I can still see where I'm going. I think this is critical. When Ruth asked me what did I mean by the big picture, I always get how I feel about the big picture from reading the last chapters. For me, I have nothing grand in mind. I need to be able to look at what's being proposed in the last chapter, that connected up with something that comes before. I haven't been able to do that yet. Every time I try to do it, I have a problem. The first time it sort of went like Bingo and I was able to make a contribution, was when we were asked about the notification. Why was that so? because the connections were explicit in the piece. The justifications were there, the recommendation was there, the thought process was there. Didn't love all the thought process by any means, but I could -- yea, I can get my teeth into this, because I could see it. So, for me, big picture and hanging it together means when I can see something flow through, I rather suspect that -- this has been my suspicion -- that it is here. I am not a person who believes we are going to start from Day One and rewrite a lot of this stuff, but I rather suspect that as here, for me, it has not yet emerged. I think emergence is question of procedure. One last comment. I don't know if that helps, Ruth, with the big picture. If you read the proposals for that last chapter and you try to think it through, and you try to say does this work, does this not work and try to pull it back together and things, it becomes a very difficult process. I think, finally -- and, here, I have to be open because I have had this dispute on another committee in recent times -- I think that I would leave to each one of us our sense of personal responsibility about what you can buy into and what you can't buy into. I don't have a view and never have, that the public is served best in every case by a strong move to consensus. It is served by having a sense of ownership. The public can also be informed by some very principle dissents. That question and that dividing line is reached individually, after great internal thought for every person here. I am willing to respect -- I feel like Duncan -- I am willing to respect the fact that everybody is working very hard to have a good product, and I am willing to respect anybody who says, on Section A, or Chapter B, or whatever, these are the points that I want to make that I see that are different. I think that that is perfectly acceptable. I think that what Reed and Duncan said is it is the spirit with which we approach this task not necessarily where we come out at the end. The only way I know to claim ownership, to go back, to give us the chance of having some ownership, in addition to seeing it from start to finish, is some discussion of a process after that May meeting, that then pulls stuff together, finally. It's all of the things you need to do. Sometimes it takes months, sometimes it doesn't. I don't want a committee extension. Maybe a meeting is not the best idea. I happen to think that it is because some face to face is going to do a lot, that I can talk about later. But the important thing is for the Committee to decide, and perhaps it's best to decide it in the last part of Wednesday, exactly what -- after we've had a chance to discuss these next chapters, exactly what process we think would best serve us in helping us to achieve these goals. This does not have to be a perfect report. It undoubtedly will not be one. It does not have to be an exhaustive report. It undoubtedly will not be exhaustive. But it does have to be a report that says something that we can stand behind as a group, even if we only say four things or have four recommendations and not 25. It has got to be a report that says something that we feel comfortable with. DR. FADEN: I have Jay, and then I would like to just make an attempt -- MS. KING: I'm sorry I was so long. DR. FADEN: No, no. That's okay. Everybody's comments, I think, have been very important in this past how ever long, an hour and a half, I guess, that we have been doing this, and I think we should take a break. Let me see if we can -- Jay. DR. KATZ: While it is a pity that probably most of you, or maybe all of you, haven't had the opportunity which I had the good fortune to have, to read Jonathan Moreno's draft book on "Consensus on Bioethics". It's a wonderful book. It will appear, when? DR. MORENO: Friday, supposedly. DR. KATZ: Oh, on Friday. It's a wonderful book -- DR. THOMAS: Where could we buy it, Jon? DR. KATZ: -- about the pros and cons of consensus, dealing with various commissions; also some that you had been sitting on. He also quotes me, I do not know whether with approval or disapproval, which is good, that I've always argued against consensus reports, that I see a great deal of value is the reports of a group also reflect the opinions of others who could not quite go along with what has been written, and this for two reasons. My reason is not only that this enriches the report but it's also the reason that, for example, speaking for myself, I will not fight all of us tooth and nail on certain things in order to make it possible that all of us might agree with the whole body of the report, because if all of us were to do that, it would only weaken the ultimate thrust of the report. Reed misunderstood me when he thought, first of all, if I were to write something, an addendum, which is probably likely, but it depends. As I see it, it is inevitable. First of all, I don't think, at least at the moment, I see no reason to write anything in dissent. I see the reason only because I think there is in certain matters we are, in many matters we are, in agreement. As I hear it, we are not on agreement with respect to all the implications, or certain implications, of what we are in agreement about. We have little time, if we had much more time, I might try to convince you of my views, but even if I could do that, I probably would not be able to do that; there is just not enough time. Also, I don't mean by writing something, to write about anything and everything in the report. It must be on something that is crucial to me or to you, where you have to add something. I would hope, Duncan, if you were to omit, for example, say enough about the value of the radiation, and what it has done to people and society, that it would add a page or two to this as an additional kind of comment. It would only enrich the report and not diminish it and various other kinds of things. My hunch is, though I don't know yet, I've been surprised many times as to what has transpired here, that maybe I will not have to do so, but I want you to know that I may have to do so. Please, after you read Jonathan's book, even more so, that you won't hold it against me for doing so, because there's important underlying philosophical reasons why I think it is important, and it adds to the value of the book if we add a comment to it, because after all, life is only commentary. DR. GLATSTEIN: You're going to sell at least 14 copies. DR. FADEN: Let us do this. I personally need to take a break for 10 minutes now, to stand up among other things. Let's take a 10-minute short break. Come back and try to reach agreement. [Recess] DR. FADEN: Would the Committee please come back to the table. During the break, several of you came up and said some very kind words, referring about my mental health; quite a relevant consideration. I have to say that I'm very happy that we took the time to do what we did. I think it's critical. If Reed were around, I would say that he basically has expressed a large part of how I would have said it, in terms of I really do believe that the measure of who we are is how we respond to it. That's quite right. I haven't been on as many committees as Pat has been on, but I've been on enough of them to concur, at least in my experience, there is always such a moment. Committees either succeed or fail afterwards, depending on how we collectively address all of the issues that have been raised. Let me suggest. I know a couple of wanted to add a comment or two. Here are some things to consider. We have on the table, first of all, what to do with the rest of this meeting as well as what to do with the rest of the time for the committee review. Reed, you missed my expressing my attitude for your comments that I found uplifting. DR. TUCKSON: Thank you. DR. FADEN: All of the comments I think were terribly important, but you, at least, for me, helped me remain focused on the fact that what we're doing here is fundamentally a public service, and as a public service, we have to abrogate, in some respects, our own interests for the commitment that we've made. That is not an easy thing to do. Anyway, we have to decide what to do with the rest of this meeting and decide what we want to do with the rest of the life of this Committee. Let me say what I think has happened. I could not do justice to all of the eloquent comments and really the heartfelt comments that has been shared. First: I think I have not heard from anyone, not perhaps because no one thought that this was a good idea, but as an acknowledgment of the political reality, I did not hear anybody speak for a lengthy extension of the Committee's deliberations. You have not, because there aren't some of us who felt that that was a good idea, but because no one thinks that is realistic or possible. We have heard several people call for one more meeting, the timing of which is unclear. Pat has given a specific suggestion as to when that additional meeting should be, but it has been at least supported by several members of the Committee and their comments, a request that we not be stopped. If you feel we need one more meeting, we need one more meeting. I would like to suggest that we not decide that collectively right at this moment, but reserve the time that we set aside tomorrow afternoon, anyway, for Committee strategy and deliberations, for us all to think about; for us to do some work collectively as a committee tomorrow. We have that time set aside at 4:30, and the two major issues to decide, then, are how to proceed from now on in, including whether we wish to request one more meeting. If somebody at that point says they want a proposal for requesting two more meetings or whatever, we can entertain it. But it sounds as if the operative proposal is we have the meeting in May as the final meeting or we try somehow to squeeze in one more collective meeting, presumably sometime in the summer. I would prefer that we not decide that, or at least not as a group debate that now. Is that all right with everybody? (Nodding of heads.) DR. FADEN: That will give us the chance to think, relax, see how we do with some of the material that we're dealing with tomorrow. Ruth made two specific suggestions that have the potential to be implemented in the course of this meeting, and Duncan wrote me a note -- I think it was Duncan. Oh, good. If I can't recognize faces, at least Dan is helping me to decipher handwriting at this point. The note was unsigned -- that suggested that we take Ruth up on her proposal. Let me remind everybody what they are because they have implications for what we can do with the rest of the meeting. Ruth suggested that we have a discussion of what each of us thinks are the issues about which there are real differences and that we have a discussion about the issues, trying to flag them, where some of us think we don't know if we disagree or not yet, because there has been insufficient discussion, so those are separable. Basically, each of us take some time to think through where we think there is disagreement. Some people have expressed that there is -- DR. MACKLIN: Could I modify, since I made the suggestion? DR. FADEN: Absolutely. Absolutely. DR. MACKLIN: The first one I think is accurate; and that is, to identify points at which we disagree. DR. FADEN: Where we suspect that we disagree. DR. MACKLIN: Yes, we suspect. The second point didn't have as much to do with disagreement as issues on which there has yet been no closure, which doesn't mean disagreement, but the example that Pat gave about what a national security issue means. DR. FADEN: I meant to say that. I'm sorry. Thank you for the clarification. So one thing we could do is to have that as a homework assignment and come tomorrow morning prepared to take an hour or so and discuss it; see if our respective private intuitions are correct. I'm not saying we can resolve the areas where there is disagreement, but if we find out that there is, we at least know where the work lies. It's basically me getting up and saying, well, this is where I am on this issue, but I have this feeling that some of the rest of you, whether you want to name names or not, are not of the same mind on this question. You can try that and see where it goes. It would only work if people are willing to be pointed and specific; otherwise, it will be not a real good use of time. Duncan. DR. THOMAS: Although I suggested that as a homework assignment for tonight, of course, it will be more focused if we do it tomorrow night after we have had the discussion of major parts of the report. DR. FADEN: That would mean we would have it on Wednesday. The difficulty with that, I think we lose -- MS. KING: You only lose me, I think. DR. FADEN: I think we lose two committee members on Wednesday, which is one problem. You might remember that Wednesday was the add-on time, so when we extended we voluntarily imposed on ourselves an extra half day to this meeting, so we lose, I believe, two committee members -- Jay and Pat, if we defer it to Wednesday. DR. THOMAS: If we do it at the end of tomorrow, that might accomplish the same purpose. DR. FADEN: We only do it, and then also fold it in -- you could be thinking about it now and then see if more come up in the course of the discussion. DR. THOMAS: Right. DR. FADEN: Is that something worth trying? Is there an interest in trying to implement Ruth's suggestions, those two points? MR. GUTTMAN: Yes. DR. FADEN: Yes. Okay. Then looking at the agenda, what we perhaps could do is instead of leaving from four-thirty to five for committee strategy discussion, say maybe something like three-thirty to five, where we can have this discussion about where it looks like we're disagreeing and where it looks like we haven't had adequate discussion, and then have that lead into a decision about whether we wish to request a meeting, in addition to the meeting in May; try to fold all of that up by 5:00 tomorrow. That means that we have to make some decision about when we're going to discuss the looking forward findings, since they seem to be bumped from the agenda altogether. Shall I take it that the view is that we need to be discussing the chapters or the findings to get a sense about agreement or disagreement? There is a document that we have never debated previously, which is that list of how many findings, is it, Dan? MR. GUTTMAN: 31 or 32. DR. FADEN: 31 or 32 findings. They're expressed as findings and might be a more efficient way to identify where there is disagreement and agreement, than going through chapters where you tend to get hung up in style, and is it good to begin the chapter with this lead in or that lead in; not to diminish the debate of the chapters, but maybe we're trying to surface or flesh out areas of agreement or disagreement or underdevelopment. It might be better to go right to findings rather than the chapters? No? DR. MACKLIN: Well, the problem is that, in a way, the chapters lead into the findings. DR. FADEN: Well, they do, but we won't have the findings across all the chapters except the contemporary ones, and we can look at a few of them. DR. MACKLIN: Right. DR. FADEN: These four chapters that we were to debate on Tuesday morning are the basis for some of the findings but by no means all of the findings, since the findings cover everything except the contemporary situation, for which there are no findings yet, because we thought we would wait until we had finalized our interpretation of the two contemporary projects before we tried findings. DR. ROYAL: It would be useful, from my perspective, to discuss the chapters because I've had a chance to think about them in some depth. DR. FADEN: Okay. DR. ROYAL: I don't quite feel so good about the findings. The findings are detached from the evidence and I'm not sure that I understand what I agree with and what I don't agree with in terms of the findings. DR. FADEN: Eli. DR. GLATSTEIN: I agree with Henry, that I think that the chapters you've got on for tomorrow -- DR. FADEN: Are tough ones. DR. GLATSTEIN: -- is precisely the area where Pat alluded to; we don't have the big picture. I think we have the big picture in a portion of what we're doing, but I think that the stuff that you've got on for tomorrow is exactly where we need the discussion in order to define that big picture, and I think that's one of the things we're missing. DR. FADEN: Let's do this, then. We'll stick with the chapters, but could I encourage people to focus on the large issues in the chapter -- the findings, the interpretation, the conclusions and not the -- I think this paragraph should go before that paragraph kind of discussion, so that we maybe can have that discussion, maybe not the whole morning but sort of shave off. I'm trying to find time in the agenda. Let's stay with the chapters, but let's zero in on this chapter seems to be implying this and such, and I don't agree with that conclusion or that interpretation, or I'm not sure where that came from.. MR. GUTTMAN: I think that's what we really need to kick around, and maybe afterwards we will have a consensus, I hope. DR. FADEN: Let's do that and see if we can save an hour of time in the morning. If we don't, we don't, but I'm just trying to pick up little pieces. DR. MACKLIN: It's discussion, questions for the atomic -- DR. FADEN: So people should look at it tonight? DR. MACKLIN: Right. DR. FADEN: Presumably, they've already read it? DR. MACKLIN: Right. MR. GUTTMAN: They may not be accurate, but based on the various E-mails, that tried to synthesize some of what seemed to me to be the questions that are the ones that people are -- the base of questions. DR. FADEN: We just don't look at it now. MR. GUTTMAN: Yes. DR. FADEN: Pass it around but don't read it. They're going around but don't look at the questions yet because I still want to tell you how you're going to do it. I can't help it. I make teaching analogies as other people make clinical analogies because that's what I do in a good part of my other life, and so things often remind me of my other world. So, yes, you can distribute it but don't read it. Here's the reading list but I don't want you to look at it. So that's what we're going to do then. We do have homework, and the homework is to try, even in advance of the discussions tomorrow, to articulate for ourselves personally, where we suspect there are areas of disagreement and where we suspect there are areas of underdevelopment. Would that be a correct characterization for your second? Something like that, some shorthand like that. Maybe each of us coming in with a few notes would be helpful. In the morning, we are going to go right to the chapters and zero in on the substance of the chapters and not the style. Then we'll pick up with findings, but I want to pick up to save that hour because I want to, at three-thirty -- after the break in the afternoon turn to this wider question of Committee direction and this issue of do we have differences, where are the differences, and so on. Eli, did you want to make a comment that was hanging over from before the break? DR. GLATSTEIN: Well, just one other comment with respect to the biomedical research. John Harbert brought up a meeting or two ago over lunch the fact that a variety of papers being written, mostly in diagnostic radiology but also in radiation therapy on a variety of subjects, where new techniques, new technologies being employed, don't seem that they're going through IRBs. In fact, some communication has gone out to some of those authors, and the little bit that's come back, I gather, suggests that the authors of these various papers don't think it's research. At the very least, it's confirmatory research, even if it isn't original. In radiation therapy, I think the place where this is going on -- two places actually: One is so-called stereotactic radiation therapy, specifically gamma treatment, where large single doses of radiation are being used mostly for brain lesions. Obviously, the people who are using these doses have very limited experience with the consequences of those doses of radiation, and as far as I'm concerned that's research. The other area that I think is going on, is so-called high dose rate radiation therapy, dealing with brachytherapy insertions. Ordinarily, if you use isotope treatment directly in the tumor, you go at the rate of about roughly around a minute, and this radiation going on at the dose rate of maybe 200 or 300 rad a minute. Again, I don't think the consequences are particularly clear. In any event, these papers are being written and published and they're not being considered as research, and I think there is an area there that I think IRBs need to be made aware of. At the institutional level, I think there's a cleanup job that's needed. We haven't addressed that as a committee. DR. FADEN: No, we have not. I understand that we're going to get some sort of report tomorrow, if we have tomorrow, if not, Wednesday, on the status of this subproject, and then I think we can see where we want to go from there, that it is important, and we need to figure out whether we're making any progress and whether the strategy you adopted is addressing the concerns. DR. GLATSTEIN: One of the reasons why people don't want to call it research is because then they'd have a hard time charging for it. DR. FADEN: It's all wrapped up in one piece. DR. GLATSTEIN: Unfortunately, it is wrapped up in that same cloak. DR. FADEN: I think it would be very important if we could make a contribution to sort of disentangling this problem of the interrelationship; the different incentive structures for calling something research or not research, that have clouded the picture since the regulations were first implemented when the world, I think was a little simpler with respect to a university. DR. GLATSTEIN: It comes down to whether or not a paper is written and that defines it. DR. FADEN: Yes. DR. GLATSTEIN: I don't think most of us believe that. DR. FADEN: Yes. We're at a juncture here where we have 20 minutes, and there's a way which I feel like there isn't a whole lot we can do with the 20 minutes, but maybe we should take some look at the Forward Looking recommendations, because this may be all the time that we have. This is ridiculous. We have 20 minutes; we can get a sense of where we are. I know people have made plans, and so I feel an obligation to end at five, or I would say that we would go further. FORWARD LOOKING RECOMMENDATIONS Basically, what we had originally intended to spend the afternoon on was the section of this huge final chapter, as it's currently constructed, called Forward Looking Recommendations. Maybe the best we can do at this point is get general reactions to the 8 areas; I think it's 8 that we ended up with. It's the very end of this big fat thing. There are now 8. You see them on pages two and three; 8 areas where it's thought that we would be making recommendations. This is Forward Looking. Again, this is really premature because we haven't, as is clear from the discussion, from the two contemporary projects earlier today, we have by no means digested the findings or seeing the extensions and worry about the implications. This is the fat thing, final chapter, that had this Table of Contents to it; the very last part. They're marked by yellow pages, but the very last section of it, called Looking Forward, is an attempt -- if you recall in the March meeting, there was a long list of recommendations, but the committee came back with a clear response, which was, we want some sort of organization, we don't want anymore than 10, maybe, Forward Looking Recommendations. So this is an attempt to take scattered areas, divide it into 8 areas for consideration. In the next 10 or 15 minutes, we can discuss it. There are some things that need to get cleaned up. I went through it and saw this was a huge effort, as is everything, that you see here, to get things out in Friday's mail. If you notice hangovers to auditing and certification, that's a hangover. That was meant to go. We realized that the Committee dispensed with the issue of certification as such, so that was out. Those are errors. One thing we could do is say, this way of setting up, and there would be X number, small number, of areas where the Committee thinks things need to change in the form of grand recommendations, and then each of those recommendations would be explicated with perhaps some very specific sub-recommendations and the rationale behind that recommendation; a general category of class of recommendation is important. DR. KATZ: I have three very brief comments. DR. FADEN: Please. DR. KATZ: The latter recommendations I have less of a problem with, but just focusing on Recommendations 1, 2, and 3, I wonder about the order and how it appeals to medical schools and medical education and graduate medical education. That, I think, is, to my mind at least or my experience, is an exercise in futility in talking to the stars. It's been tried again and again and it's largely failing and it's still failing at my institution. DR. GLATSTEIN: Even as an elective, Jay? DR. KATZ: Well, as an elective, it works wonderfully, and that's what I am doing. But for a while Bob Levine and I did it as part of the retired curriculum. I was, for the first time, an utter failure as a teacher; otherwise, I'm only a partial failure as a teacher. Of the 100 students, it dwindled down very quickly to 20, but that was preaching to the converted, so it didn't work. You may want to recommend it but maybe later, down the road, whether we want to require and ask the federal regulations to be amended that, before you can become a researcher you have to have, like in the medical practice, as you have taken a course in surgery obstetrics, et cetera; not that it makes us obstetricians and surgeons, but at least you have to have fulfilled that requirement. That's possibly something to be considered. With respect to Recommendation 2, and how the IRB should -- certain things about the IRB process should be changed, the questions I have: To whom is it addressed, to the IRBs? And that will take me to Recommendation 3. The problem, though, besides that, to whom it's a request, many, many important issues that we found wanting from our review are not really mentioned here. Now, the question is, do we again have the time to flesh it out? DR. FADEN: Hopefully, yes. DR. KATZ: Yes. And really say all of the things that need to be said. Then with respect to Recommendation 3, which is something that I have recommended for a long time and I don't know how the committee feels about it, but if that is acceptable at all, and become Recommendation 1 in a certain sense. Or not necessarily Recommendation 1, but to almost Recommendation 1 and 2, something else may be 1. As I glean it now, I am not sure whether the majority of the committee is willing to endorse recommendations, so there are all kinds of things to be discussed here, and when can we do it? DR. FADEN: Well, I think we had just a short of amount of time. DR. KATZ: Yes. DR. FADEN: I think we can spend more time possibly on this one, as well as any other. Recommendation 3 is an important one, and it has been argued before and something like this for a long time. I think we have sufficient evidence in that context of this committee's experience to suggest that there is indeed a basis for such a recommendation. One of the things, there was Jay's article which represents one conception; sort of a standing, independent permanent body, and there was also the Federal Register's draft charter, or draft Executive Order, for a proposed ad hoc, shortlived commission. One of the issues -- there are several layers here -- one is: Does the Committee want to recommend that there be some kind of a body, and then within this you see, which way do you think it should go? Are we in favor of recommending a standing, independent, permanent committee of some sort as opposed to an ad hoc thing. I guess we want to just take the next few minutes, again not to finalize. We'll finalize these hopefully in May or if there is yet another meeting at that point, but to see what people's thinkings are and what you would want to know. Perhaps if you haven't reached a view, what you might want to know more about. DR. GLATSTEIN: I don't have a conceptual problem with the advisory group, although what I had honestly been thinking about myself was some sort of annual national meeting sponsored either by the NCI or by the American Cancer Society, but dedicated to ethical aspects of clinical investigation and the issues of the informed consent. There is a need. Before this screening of the protocols, I wouldn't have thought there was a need. But there is a need, and I agree with that. I think it needs to be at a fairly national type level. I also think that we can consider, at least in the cancer aspect, asking the Cancer Institute to insist that designated cancer centers, those that get that NCI designation, have a formal course in bioethics, not only for students but for those who are in fact carrying out studies, and they have to attend those lectures. I think there's a variety of ethical issues that somehow have slipped between the cracks. DR. FADEN: Ruth. DR. MACKLIN: I see a connection between Recommendation 3 and 2b; that is the oversight. That is noted on page 13 and 3a: How should this interpretive guidance be exercised and should it be relegated to a series, et cetera, et cetera. So the two are connected there. They have to be connected if we're trying to figure out what 2b, the oversight, how that's supposed to take place, and how the 3 is. So, for a moment, I am going to just discuss 2 together. The question on page 12, under 2b, how should this oversight responsibility be executed; should this oversight function be funding agencies specific OPRR for NIH, et cetera, or a common federal entity? Should it be bureaucratic function or a function of an independent body. Well, these are very important questions because if we conclude that the current system is not working well or not working optimally, and needs change, OPRR is not an adequate mechanism. If OPRR were doing what, in some sense or other, would make the current system good or optimal or workable, we wouldn't be asking these questions. The perception of OPRR, the perception of many people of OPRR, is that it is excessively bureaucratic. It looks at little issues rather than big issues, and on big issues it moves with glacial speed. That's just a comment about OPRR, which almost answers the question automatically, if people agree. DR. GLATSTEIN: Yes. DR. MACKLIN: Now, under Recommendation 3, I had the following reaction: On the one hand, I agree that there needs to be an establishment of mechanism to provide for continuing interpretation, application of ethics, rules and principles, et cetera. I think minimal risk is a good example. The problem is, it's almost impossible to do a responsible job of interpretation and application outside the context of an example. Outside the context of a research proposal, either looking retrospectively or prospectively. Minimal risk is defined in the current regulations for children. A definition is pretty precise. It doesn't answer all of the questions. Presumably, it would be the same for adults. The only reason it's defined for children is that there's a category that deals with the regulations, whereas they don't deal with it for adults. In fact, if they did what the National Commission's recommendations said they should do, they would have done it for institutionalized persons or the elderly, or any of these others. Now I look at the example that's here. Similarly, can therapeutic research with incompetent patients in an emergency room setting be considered minimal risk. Nobody can answer that question without looking at the protocol, without looking at what the intervention is. What struck me is that the answer to this question depends on the nature of the research and not on the capacity of the subjects to consent. Whether subjects can consent or not, one is the lack of capacity to consent; and, The second issue is whether or not the intervention is a minimal risk. DR. FADEN: That was poorly-crafted language. DR. GLATSTEIN: Yes. Yes. DR. FADEN: That was poorly-crafted language. DR. MACKLIN: Well, I don't want to blame the crafters. I'm only saying that even if you craft it well, you still have the problem. You can't talk about an incompetent intervention in emergency room. The fact that it happens in the emergency room, it may be minimal risk but with no time for consent. DR. FADEN: I think the issue is whether this standing body or this ad hoc body sees concrete particular protocols. That may be, but I would think the position here is more classes of protocols with illustrations. So the notion was, as problems percolate, various IRBs are struggling with the same issue. The radiation research example of pediatrics is a live woman; there's a commentary going back and forth now, and people are really struggling with the question. You've got the reg with minimal risk, minimal risk threshold, which has standing in the kids' regs, in the pediatric regs, and an issue keeps emerging and the IRBs are disagreeing about whether you can expose children, whether you can count it as minimal risk. If it's pediatric research, healthy children, because you want the normals, and they can't consent for themselves; can you count it as minimal risk. You can take some concrete examples. DR. MACKLIN: Right. But, now, I think this should go farther. DR. FADEN: Okay. DR. MACKLIN: The reason I think it should go farther is it buys into the current regulations and the distinctions there, and it shouldn't have to, in part because words like "minimal risk" have been found not only often not to be helpful but they have been found to have different meanings in different contexts and how one describes minimal risk as it has come up on my own IRB, for children who live in the South Bronx where the risks of everyday life are being shot with a bullet or being dropped down an airshaft by a cocaine-using boyfriend of their mother or something, becomes a question not of interpretation of the meaning but in the specific context. DR. KATZ: It would be best to add to this, if this comes up, you know, for example, with respect to -- and you mentioned it -- doing research in emergency room with patients who come in with acute head trauma and who are, of course, incapable of giving their consent, and then the question is not that a national body should review this consent form, but on the basis of the protocol begin to establish some policies for the nation as a whole, under what circumstance can this research be done. To avoid, you know, what happened in Wisconsin, that in order to comply with the regulations that they invented the oxymoron of the deferred consent, which in turn Beauchamp beautifully attacked in an article in IRB and made mincemeat out of the hunter. DR. MACKLIN: Right. All right. So now there are several problems here. The question, one -- the threshold question: Should there be national standards rather than leaving it to the IRBs. DR. KATZ: Yes. DR. MACKLIN: The second is: I don't think we should buy into what the current regs say. If there's a problem with minimal risk, we may want to recommend a look at the problematic features of current regs. So, for example, far more important than whether risk is minimal or a minor increase above minimal, which is what the regulations say, which strikes me as very silly as a way of trying to calibrate things; trying to take a harder look at the balance of benefits to risks and separating benefits to subjects from benefits to others, seems to me a way to try to advance the thinking and talking about it. DR. FADEN: The issue here, though, is, if I understand it in the context of this recommendation, is to craft a rationale that indicates that if we recommend there be the recreation of such a body, that it have a very broad mandate, that it not be simply to interpret the existing regs but to look at them. As classes of cases emerge that raise issues of interpretation to take the position, well, maybe it's not so much that the regs need to be interpreted, but it illustrates a problem with the current regulatory structure, but it's not set up well to handle that, though. DR. MACKLIN: Right, with the structure. But we need one more rationale here, it seems to me, for anything that would be national, since the current system, with the IRBs as it's described in here, the semi-autonomous or autonomous nature of IRBs assumes but does not argue for the claim that that's a good way to go. The argument that it may not be a good way to go is that, depending upon the expertise, the strength of certain members of IRBs, or the sophistication of the particular IRB, subjects in the United States, maybe citizens, may be put at greater or lesser risk, and there's a question of justice. DR. FADEN: Maybe we should get a clarification here that the proposal here is not for the recreation of a standing body that would review all of the protocols in the United States, in one centralized spot. DR. MACKLIN: Right. I know that. DR. FADEN: That would be, obviously, an impossibility. The notion is that it's a body that has -- whether it has both the oversight function and the interpretive function and the guidance-giving function, is the issue at the end, whether, essentially two or three -- DR. MACKLIN: Right. But it's giving guidance to IRBs, isn't it? In other words, whatever this central body would do -- DR. FADEN: Yes. DR. MACKLIN: -- if it talks about classes of protocol -- not that it's looking at -- DR. FADEN: Right, right. DR. MACKLIN: -- individual -- DR. FADEN: Correct. DR. MACKLIN: -- ones, looking at classes of one, then if it comes up in Biloxi, Mississippi or in Yale, New Haven, or in the Bronx, that class of protocols, there's an instruction to the IRB to look at this class of thing this way in the emergency room. DR. FADEN: Right. Right. Pat. MS. KING: Several concerns. This is one of those places where I worry about connection between evidence and the scope of the committee and recommendations we want to make. I know we can make recommendations about future conduct and research with human subjects, but some of these things go to issues that, to my mind, we did not examine. For example, I have my views about OPPR, NIH and how they operate, but that's not what we did. We didn't take testimony on how OPPR operates. We didn't talk about what mechanisms NIH has for responding to -- DR. FADEN: Yes, we did. MS. KING: We took testimony? DR. FADEN: We didn't take testimony but we did essentially an attempt to establish what the different oversight mechanisms are at the different federal agencies. MS. KING: But how they work rather than what they are? DR. FADEN: Yes. What they do. What they do. MS. KING: My question was how they worked. DR. FADEN: I'm not sure what the difference is. MS. KING: Because what statutory powers they have and what they actually do. Some of the comments here: too slow, too bureaucratic, and ways in which we would -- DR. FADEN: No. We have two bases. I understand where you're going, but just for clarification, we have two kinds of evidence generated by the committee that might bear on such a recommendation. One is a review that Wilhelmine is taking the lead on that we keep looking at periodically, which is the various agencies telling us how they handle their oversight responsibilities with respect to human subjects research, what they do. MS. KING: Okay. DR. FADEN: The other thing we have is whatever information we can glean from the research protocol review project generally about how things are going. If there are problems, we don't have them -- we can't say it's because of the IRBs or it's because of OPRR, it's because of the FDA, it's because of the Department of Defense. But what we do have coming out of that is the recognition, that data, for the first time that suggested, in so far as there are problems with human subjects research, it doesn't sit in only one federal agency. MS. KING: That, I understand. DR. FADEN: That we do have. So it's kind of piecing those things together. Then we have the historical evidence that suggests some of the problems seems that we have been investigating soon to have emerged because people were disagreeing about kind of the meaning of things. Maybe that's a problem still today, but that's the most speculative reach. MS. KING: What I'm concerned about is the link from what we have to where we're going and what we can support -- DR. FADEN: Right. MS. KING: -- opposed to some of my own feelings about what's wrong with the current structure, which I would not oppose. DR. FADEN: Right. MS. KING: It seems to me that asking for a review of the rules and regulations, it doesn't take a great deal of evidence to do that particular thing for it, because, if nothing else, you have time on your side. Those rules and regulations were proposed in 1974. This is 1995. Some of those proposed regulations that were proposed were never even adopted, so there are whole areas of research, and in those areas you don't need a strong evidentiary base to say good sense would suggest, like taking a look at affirmative actions -- DR. FADEN: Right. MS. KING: -- that you go back and you take a look at what the rules and regs are, which is one kind of recommendation. DR. FADEN: Yes. MS. KING: How to monitor, other than making a general recommendation, that monitoring needs to be looked at, is very hard for me because we haven't really debated decentralization versus centralization, because some of this is what that means. DR. FADEN: Yes. MS. KING: Part of the problems that we have alluded to, for example, like we don't understand minimal risk or minimal over those categories we crafted before, parts of those things are the problems that IRBs don't talk to each other and there's a central clearinghouse for what IRBs do, so the right hand never knows what the left hand is doing. We all know that from experience, that different IRBs interpret things differently. I don't know how we go beyond, even with specific justification, saying the monitoring process needs to be looked at, and almost leave it at that, and point only to the precise things that have turned up in our own studies, and leave it at that. DR. FADEN: I think that's an important caution. My own belief is that we have some ways of suggesting certain -- this is why I was saying earlier to the two staff panels we had on the two contemporary projects, that one of the key things we need to reach some sort of a conclusion, that is, whether these two projects that we undertook are actually useful ways to look at the status of human subjects research. One of the things that we have learned is, at the most, what the current review entails, oversight entails from the federal government, is either spotchecking to make sure that the paperwork is right and responding in cases for cause, where there is an allegation made, or somebody, as in the case of the FDA, goes out and actually audits and makes sure the paperwork looks right. But nobody has attempted what we might want to call performance or outcome based evaluation of the system, which is basically what we have tried in a very primitive way, to do. Instead of just looking whether the papers are all looking good and signed and in the right place, we've tried for the first time to get a feel on whether the outcome, the product is satisfactory. It's very primitive what we have done, but if we think that what we have done was useful and insightful, I think it would be our position to recommend that something like that be considered as a routine, regular way to look at the human subjects' problem, human subjects' experience, rather than to restrict oversight to making sure all the paperwork is in order. MS. KING: I'm not raising substantive, and I want to be clear about that. I am raising a procedural point about connecting what evidence you have to a recommendation. DR. FADEN: Correct. DR. KATZ: This is very, very important. MS. KING: And I am being very careful because I have an invested interest in the human research structure as well. DR. FADEN: I think this is terribly important, and I don't know how to do it except to be very clear about that rationale and try to separate. Obviously, keep convictions that people have from sources of information independent of the work that they did on the Committee, from reasons that we can put forward, based on the work of the committee for recommendations. MS. KING: Right. DR. KATZ: This is another important issue. You see, all these things are coming out now. This is another important intention. I think, even though Pat's point is very well taken, it is much, to my mind, just too gentle. I would go much further than that. Who knows who's right or who's wrong, but that's the problem. MS. KING: My problem, the only point where I am really going, Ruth, when the studies we have done come to conclusion, that the way it seems to handle this is to have agreement about what those studies show and what those studies show is a lever for making a recommendation. DR. FADEN: Correct. MS. KING: There may be other reasons for making recommendations other groups can think of, and I'm worried, because I know we're trying to do this before we have a clear understanding about what all of those studies show. DR. FADEN: That's what -- MS. KING: There are some things that we can do that we would not be out of line for. Review, for example, or something that's been in place for a long time and doesn't cover certain areas of research, does not take studies of investigations to show. DR. FADEN: I agree. Now, the issue is what the mechanism is for that, and we're back to whether it should be a bureaucratic function or it should be an independent commission, it should be a standing one, an ad hoc one, all that stuff. MS. KING: That goes to the first point about how much you can claim of what you show, but I would enter my caution now, and this is that on the list of all the things in the world, it's important to do it to set up a national body, if we go in the direction of a national body. Human subjects research may not be at the top of the list, and if we think it ought to be at the top of the list, then that requires a very strong justification, and I think that the - - to my mind -- and I think that if our approach is to extrapolate these recommendations from the studies that we have done, it's very hard to come down very hard on other than somebody taking a look at this or perhaps suggesting to suggest that. I think that's the dilemma we're in. I'm not saying it negates any recommendations -- DR. FADEN: I understand what you're saying. Ruth, you're going to have the last word. It's a little bit over five o'clock. DR. MACKLIN: It's really going to be a very small point on what Pat just said. That is, we do have some evidence - - I just passed a note to Sara -- from the Research Review -- the RPRP. That is, when you've looked at enough of these, you see differences in the performance of the IRBs and particularly on multicenter projects. Where it's exactly the same proposal, you see the way the different IRBs have responded to it, the difference in the consent forms, and the difference in all that. So if what you're looking for is some evidence for what we've done, we do have a little bit, and it's enabled some of us to look at these and say, what kind of IRB is this, and then look at others and say, this one really looks like a great one. I mean, it's not a whole study of IRBs, but it's enough to make some observations, particularly with exactly the same study and also with what IRBs require in the way of what their consent forms and their applications are like. DR. FADEN: I take it as a caution that we need to make sure that the evidentiary base for the recommendations that we make that draw on the work of the committee are made clear and that if we additionally have supportive argument that come from either common sense or the personal experience of committee members outside of your work on the committee, we can state that. MS. KING: You know, we're not the first to be engaged in this area. There are authoritative sources that have looked at some of the problems before. DR. FADEN: That's right. MS. KING: My only caution is hanging too much on what we have done without being clear about what our data supports and what we gain from other places. DR. FADEN: Correct. Correct. We are going to adjourn for now. We have homework, which is a kind of personal homework, which is to try to identify areas where we believe or suspect committee members may be divided as well as areas where we feel the committee has not had adequate session. We are going to start with the chapters and just work away. At 8:30, not 8:15, tomorrow morning. Thank you all very much. (Whereupon, the meeting was adjourned to resume at 8:30 a.m., on Tuesday, April 11, 1995.)