ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS + + + + + MONDAY, MAY 8, 1995 The Advisory Committee met in the Terrace Ballroom at the Doubletree Hotel, 1515 Rhode Island Avenue, N.W., Washington, D.C., at 9:00 a.m., Ruth Faden, Chair, presiding. COMMITTEE MEMBERS: Ruth R. Faden, Ph.D., M.P.H., Chair Eli Glatstein, M.D. Jay Katz, M.D. Patricia King, J.D. Susan E. Lederer, 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 Thomas, Ph.D. STAFF: Jonathan Engel, Ph.D. Dan Guttman, L.L.B. John Harkness, Ph.D. Jeffrey Kahn, Ph.D., M.P.H. Lanny Keller Stephen Klaidman Anna Mastroianni, J.D. Jonathan Moreno, Ph.D. Ron Neumann, M.D. C O N T E N T S PAGE Welcome/Opening Remarks Ruth Faden 3 Public Comment Period Mrs. Barbara Tatterson 10 Mr. Clifford Tidwell 14 Mrs. Tidwell-Green 21 Mrs. Doris Baker on behalf of Zettie Smith 25 Mrs. Doris Baker 29 Ms. Pat Broudy 39 Doctor Gwendon Plair 62 Reaction to Overall Document Discussion 71 Lunch Break Open Discussion Bullet-by-bullet on Government Culpability 99 Medical Profession/Investigator Culpability 224 Meeting Adjourned P-R-O-C-E-E-D-I-N-G-S 9:10 a.m. DOCTOR FADEN: All right, if the committee would please come to order? Mr. Phil Caplan to open us up, would you please? MR. CAPLAN: Good morning. As the designated federal official of the Advisory Committee, I declare it open. DOCTOR FADEN: Okay, good morning, everyone. Okay, if we could start, please? Thank you. Good morning. I've lost count as to what meeting this is of the Advisory Committee, but whatever meeting it is, welcome. I am sure we're all aware that this is -- it is our 14th or 15th meeting. Does anybody know? 14th meeting. It also happens to be the 50th anniversary of VE-Day which has always been a sort of special day in my house. So, I thought it would be worth noting that we're meeting on this day. Okay, we have an extremely busy schedule. Let me just start by addressing an issue so that we can know where we stand. We discussed last time, the need for perhaps an additional meeting and some additional time to finish our charges responsibly as possible. Anna, could you get the door? Thank you. There we go, dead settled. Thank you. While we have not yet had any official response to our request that is in process, I've been given the understanding that the Administration is looking favorably on helping us have whatever we need within reason. So, while we don't have an official anything yet, we're operating on the assumption that it's likely that we will be able to have an additional meeting. So, let's just know that, because otherwise, we wouldn't be able to think through the rest of the day without panic attacks every minute around the possibility that this might be our last time together. It's unlikely that this will be our last time together officially, as a committee, although we have no official statement to that effect as yet. We are not expecting any difficulties with that request. Okay, that said, what are we going to try to do today? Well, given that we're likely to have additional time, the focus of this particular meeting is disproportionately on the structure of the report and on the chapters short of the chapters on recommendations. So, today and tomorrow, we will be focusing very intensively on the overall structure of the report initially. Then we'll march through section-by-section, the entire report. Last time, there was a request to get the report from beginning to end, no matter what shape some of the chapters are. So, a humongous effort was made and an obnoxious series of mailings sent to each of us, so that we could have this huge document now which includes everything we've got from beginning to end. I'll apologize in advance to all of us for the impossible amount of reading that this document suggests within the time frame that we got it. There just was no other way to do it. I really want to express on the part of the Committee, appreciation to staff, which was an extraordinary effort to get this all out within that time frame between the last meeting and this one. So, what we're going to do is march through the document, such as it is. We've identified for agenda discussion, particular chapters that really need Committee discussion, either because they've never really been discussed by the Committee as a whole, or because they've been radically changed, or because issues have emerged about how to structure, shape, or form the chapter. So, some of the chapters have been highlighted for Committee discussion. Then there is time on the agenda for the rest of the section, for any Committee discussion about chapters that were not specifically highlighted in that section before we go forward. So, that's kind of the structure. The third day, Wednesday, is set aside for findings, for retrospective recommendations, and forward-looking recommendations. We have not distributed any material, text for that yet. We hope to do so on Tuesday. We've tentatively already locked off -- you'll have seen the agenda shift -- forward recommendations on the grounds that we needed the time to digest what we wanted to say in the chapters first. The entire situation is fluid. If we feel that we need more time to march through the chapters, short of findings and retrospective recommendations, we will do that and then concentrate at the next meeting, almost entirely then, on the last section of the report which is basically where the Committee delivers itself of its overall position on what ought to be done with respect to the past, and what ought to be done with respect to the future. So, just note that the times are approximate. I'm going to try to keep this to the agenda, but if we need more time for any particular section of the report, we will take it. The only other agenda item we have for today -- well, there really are two more agenda items. We also have time set aside for processing. There are lots of issues to continue to resolve about how we want to work away at the report in these last final months, including in the issue of outside review and how to structure it. We've had a flurry of discussion about that between the two meetings. So, if your topic or a topic that you want to bring for a discussion to the whole Committee is not identified as such, that's intentional. We just had a slot called "Committee Discussion and Strategy" sprinkled twice, I believe, in the agenda and that's for us. We have a kind of list of things that Committee members have been raising in-between the two months. If there's something that you want to discuss that you haven't shared with me already, just feel free to bring it up at that time. So, that's why that's there. The other agenda item does not have to do with our bringing the report to closure in the literal sense, is our public comment period which, of course, bears directly on our thinking but isn't the issue of going through chapter-by-chapter-by-chapter. So, we do have a public comment this morning. We're going to start with our public comment period and then march right into the discussion of the whole report. Let me call for just one piece of business before we open the public comment period, and that is the approval of the April 10th through 12th meeting. Are there any changes or addenda that any of the Committee members would like to make in the minutes as they stand? Can I hear a call then for approval of the minutes? DOCTOR GLATSTEIN: So moved. DOCTOR FADEN: Thank you, Eli. Any second? All in favor? Any opposed? Thank you. Then the minutes of the April 10th through 12th meeting stand as recorded. With that, we're going right to our public comment period. We have five public comment presenters. We would very much appreciate that the presenters keep their comments brief. We're going to allot about ten minutes total for each person since we are so constrained with everything that we have to do in the course of this meeting with this large report staring us in the face. Again, let me just express our appreciation to all the members of the public who continue to take time out of their lives, and often at great expense and distance, to come to speak to us. Our first presenter is Mrs. Barbara Tatterson who is here from Cincinnati, Ohio. Mrs. Tatterson, good morning. MRS. TATTERSON: Good morning. My name is Barbara Tatterson. I am here today on behalf of my aunt, Mrs. Bertha Jungnickel. Her son, David Jungnickel, was Patient Number 027. These hearings have taken their toll on my aunt. I asked her to remain at home and I would prepare to represent her. Families need to bond together when difficulties arise because that is where they get their strength. Our group, Cincinnati Families of Radiation Victims Organization, have bonded together in order to get our message across to the Advisory Committee, the President of the United States, Congress, and all the other families of victims that have come forward since this tragedy has come to light. I know many of you have heard of Doctor Albert Schweitzer who received many prestigious awards, including the 1952 Nobel Peace Prize. He spent many hours informing himself on the technical details and health effects of nuclear radiation and writing pleas to end nuclear testing. His daughter was quoted in the Saturday Evening Post from November-December 1994 as saying that "he would be in despair if he saw the chaos in the world today." Not long before he died, he said "I ought to launch another appeal against nuclear testing, but I just don't have the strength anymore." He also believed that reverence for life and individual responsibility are the keys to a better world. He felt that these ideas must be planted in very young minds if they are to take root. It is a shame that this man died in 1965 at the age of 90 because I feel he could have contributed a lot more to our society today. It's also a shame that doctors today don't look at radiation the way he did. Maybe a lot of lives would have been saved and we would not be doing reruns of the past 30-plus years. You see, back then, there were questions from other people, but apparently no one would listen. It takes something of this magnitude to wake up everyone. Doctor Saenger's attorney stated that he felt an apology should be made to him. I, however, feel that he needs to apologize to all the families on behalf of their loved ones that he took from them. Doctor Saenger was presented a gold medal from the Radiological Society of North America, its highest award. Where are his victims' awards? They were given the radiation, not him. The sixth commandment is, "Thou Shalt Not Kill." However, Doctor Saenger and the U.S. Government killed many people because they considered them worthless members of society. Most were poor blacks and whites with little or no education, and some having terminal illnesses. It's a shame that in today's society, people are still judged by their skin color and their rank in society. This should not be an issue. We are all human beings and should be judged on what we do as human beings. God put us on this earth to get along, but as more and more time goes by, it seems to get worse. Our family members did not ask to be put on this earth. They were chosen by God. Does it take a two-by-four to wake everybody up? I hope not. We already have too many disoriented people wandering around. Since I was here last month, a number of articles have appeared again in our daily newspapers. One article from the Associated Press stated that the U.S. will be accepting nuclear fuel from European research reactors. This amounts to as much as 21 tons of used nuclear fuel to be brought into the U.S. over a 13- year period. My question is, why is the U.S. doing this? Don't we have enough problems without taking on more? I do not want to forget about my cousin, David Jungnickel, Patient Number 027. But you see, he has gone to a much better place and is no longer in pain. We can thank God for that. The same is said for all the family members that are involved in this mess. However, we need to think of the surviving family members. They have gotten a raw deal. They were cheated of time that they could have spent with their family members and have pushed their ordeal from years past to the back of their minds. Now, after all these years, their minds have been overwhelmed again by the tragedy of finding out what, exactly, their family went through. Time does not heal all wounds, as the old saying goes. Sometimes they fester and blister before they open, heal and disappear. I hope that you are listening. Many people have been hurt double-fold since the reopening of this mess. They want justice and an end to this, so that they can, again, get on with their life. I hope that you, the Advisory Panel, can see your way clear to expedite it for all the people involved. I want to take this time to thank you for listening to me, and hope that you find peace in your heart always. Thanks again. DOCTOR FADEN: Thank you, Mrs. Tatterson, and thank you for the kind comment. Are there questions or comments for Mrs. Tatterson? Thank you very much. MRS. TATTERSON: Thank you. DOCTOR FADEN: Our next presenters are two people, Mr. Clifford Tidwell and Mrs. Beatrice Tidwell, also traveling from Cincinnati. Good morning. MR. TIDWELL: Good morning. DOCTOR FADEN: I've been alerted that only the microphone in front of Mr. Tidwell -- are you, Mr. Tidwell? MR. TIDWELL: Yes, ma'am. DOCTOR FADEN: -- yes, is the operative microphone. So, when any of you speak, if you would use the one in front of Mr. Tidwell, that would be great. The others, apparently, are not being picked up. Please? MR. TIDWELL: Thank you. First of all, I would like to say greetings to everyone, once again. I'm here one more time on behalf of my father, Mr. James Tidwell, Patient 007, the Tidwell family, and also, on behalf of the Cincinnati Family of Radiation Victim Organization. I'm here today one more time, trying to get some answers on why they mutilated my father's body like they did. I was reading the Cincinnati Enquirer the other day, and they were talking about budget cuts. They said that the budget cuts have come up at a bad time. I'm here today to tell the government that they have already made their budget cut, and I mean a big budget cut, when they mutilated my father's body the way that they did, and kept it swept up under the rug for 34 years. Anyone with common sense knows that if there's nothing wrong with your brains, why go there? They gave my father 2,600 radiation rads to his brains and there wasn't anything wrong with my father's brains. Anyone with common sense knows that if there's nothing wrong with your legs and arms, why go there? They went there anyway, without any authorized signature from a family member. They took my father's brains and kept it for more experimental uses. My father walked into the Cincinnati General Hospital on October 6, 1960. He died November 29, 1960. He walked into the hospital like I am walking here today, as straight as he could. There was nothing wrong with his legs. He walked in. But while in there, he became paralyzed and I want to know why? Because his record shows that he became paralyzed after going into the hospital. I also want to know what caused him to get paralyzed. Excuse me. He sure wasn't paralyzed when he walked in. They also kept my father's brain and froze it without a family member's consent. Forty-three days later, January 11, 1961, they started the cutting. No one gave the consent to take any parts of my father's body and use them for satisfaction of experiments. We want to know why they did that. No one gave them the right to perform an autopsy anyway. They took that upon themselves and did it anyway. I have the proof to say that they did it. My family wants to know, why? That was a damn big budget cut, wouldn't you say so? You can't put a price on another human being's life. There is no amount of money that you all can try to compensate my family or any other family, victims, that's involved in this damn mess. They are talking about a budget cut. I think -- as a matter of fact, I know that this is a great, great big budget cut, or shall I say budget cutting on a human being's body and using their body parts for experimental reasons? I think that's what you call a budget cutting when they take a human being's body and cut it all up in pieces. No one in my family gave them the rights or authorized signature to do that heinous crime to my father like they did. Nobody gave them the right. We all want to know, why? If they can come up with an answer for why they did that to my father, without my family's consent, it would be the world's greatest answer to a scientist's method. They can't come up with an answer why, because they just did it on their own anyway. They can't lie and keep on lying by saying they didn't do it, because we have the proof in black and white saying that they did do this. As it was stated in my statement here in Washington, D.C., on April 10, 1995, we don't want to hear about "if we had only known." Well, you knew exactly what you were doing to my father because there wasn't anything wrong with my father's brains, legs or arms. We want to know why they went there? It's a long way to go from just a spot on the lungs for which they claim that they discovered. After this is all over -- for which it will never be over -- after all is said and done, they will have to stand in the judgment themselves. They're all going to have to answer to God Almighty. Like I stated in my last statement in April, you can run but you sure can't hide. He sees everything you do and hears every lie you tell. Before I close or shall I, say, speak my peace, they are going to have to give an account of their deeds that were done on my father's body. There is no way of getting around it. They would have to come in by the front door. One more thing before I close my speech or my mind. I would like to tell Doctor Saenger and his lawyer, Joseph Parker. I don't see how Mr. Parker could have made that smart remark in Cincinnati, Ohio on October 21, 1994, stating that all of this was nonsense. What I am here and my family is here to let you all know, that that makes a hell of a lot of sense. Anybody with common sense can see that it does make sense. We're talking about my father here today. The man who made it possible for me being in this world. The man -- I stress the word man -- he made it possible to be here today, speaking in his behalf because he can't speak for himself, because you killed him. You all know that you did. I'm here today, his baby son, speaking for him. I thank God Almighty that after 34 years of this mess being covered up, God saw fit for it to resurface and let the world know what's been going on and what is still going on. Mr. Parker said that his client didn't do anything wrong, or didn't bring any harm to his patients. I'm here today to tell them that they told a damn lie. Because of what they did to my father, the agony and the pain they inflicted upon my father, was nothing but harm. I have the proof. I want to know why. I want Doctor Saenger and his team to search their hearts and ask God where did they go wrong. I would like all of you to search your hearts and really take all of this under consideration. Make sure -- please make sure that you don't overlook the importance of this matter. Because like I said and will continue to say, we have gone too far now to turn around. We are going to fight this all the way to the bitter end because we are not going to let anyone sweep this up under the rug again for another 34 years. So, on behalf of the Tidwell family and the rest of the radiation families, we are going to leave this in the hands of God and let him be the judge. May God bless each and every one of us when we're absent one from another. Thank you again for your undivided attention. Mr. Clifford Tidwell. DOCTOR FADEN: Thank you, Mr. Tidwell. Thank you for your comments. We appreciate all that stands behind that. Either of you wanting to make a comment as well? We'll open the floor up for questions then. Are there questions for Mr. Tidwell or his family? Thank you very much. MR. TIDWELL: Thank you. DOCTOR FADEN: Mrs. Tidwell, can you -- MS. TIDWELL-GREEN: Good morning, ladies and gentlemen. Hello, my name is Beatrice Tidwell-Green. I'm the only daughter of James Tidwell, Patient Number 007. My father and I had a very special relationship and for me being his only daughter, I got extra attention from him. Therefore, we were very close and I was only 21 years of age when my father died. I was truly devastated when he died, for he died so quickly after entering Cincinnati General Hospital. He walked into the hospital, a healthy-looking man, but died looking like skin and bones. I couldn't believe it was my father. I just couldn't believe that a strong and healthy person could walk into the hospital weighing 180 pounds and within the first week, start dropping weight at two to three pounds a day. Does this sound normal to you? Well, it doesn't to me. My father would beg my mother not to let the doctors or nurses come near him because he kept saying, "they hurt me over and over again." I am finally glad that this has come to the light because it has been hushed far, far too long. I think it is about time that we knew exactly what happened to our loved ones to make them so violently ill. Doctor Saenger had no right to treat my father, or anyone else, like they weren't human. Who the hell does he think he is, God? Well, I'm here to tell you he's not. But God let it finally come to the light and let us know that he is still in the blessing business. I would like to know why and how Doctor Saenger and his associates could do something like this, and keep on doing it for years, even though it had no benefits to the patients. I believe that anyone with a heart and common sense could see that. Seeing my father suffer so much and die so quickly just broke my heart. It was really a double blow for my family because we had just lost a brother less than a year earlier, and were still trying to understand his senseless death. Then my father dies a senseless death. My family had to try and deal with that hurt, too. So, I say again, Doctor Saenger had no right, none whatsoever, to experiment on my father or anyone else. I am asking you today to search your hearts, minds and souls with compassion, and ask yourself does someone have the right to treat anyone as though they are less than human? In closing, I say thank you very much for listening because my father was very much loved by his family and friends. No one should have to suffer and die the way that he did ever again. Thank you again. DOCTOR FADEN: Thank you, Ms. Green. I appreciate your comments very much. I know we all do, and we know it's very hard to make these kinds of statements. We are glad that you did. It helps us. Are there comments or questions for Ms. Green? Thank you for coming up and talking to us. We appreciate it very much. MS. TIDWELL-GREEN: Thank you. DOCTOR FADEN: Okay, our next presenter is also from Cincinnati. Mrs. Baker, Mrs. Doris Baker here? Let's make sure that Mrs. Baker has got the right mic. Thank you very much. Thank you. Are they all working now? Oh, now we think they're all working. Good morning, Mrs. Baker. Thank you for coming. MRS. BAKER: Good morning. First, I would like to read Ms. Zettie Smith's statement about her mother, her statement first, which is Patient Number 55. "My mother, Lilly Wright, was admitted to Cincinnati General Hospital, August 23, 1965. She was sent there for a biopsy. She was confined to the hospital for one week. The summary of her illness revealed that her biopsy was performed on August 30, 1965 and a diagnosis was given of carcinoma of the breast. On September 18, 1965, she was given partial body radiation of 200 rad -- On October 8, 1965, local X-ray therapy began. In 53 days, she, Lilly Wright, had received 2,000 rads to her left and right chest. On December 1, 1965, X-ray therapy was started on the interminary chain, and to the anterior and posterior above the collarbone range supervascular. She received 4,000 rads in 40 days. Her white blood cell count fell to a low of 2,200 on December 3, 1965. These doses of radiation, in my opinion, were enough to destroy bone marrow and white blood cells and even the patient. We, the family of Lilly Wright, were not notified about these radiation treatments or any other procedures which may have taken place. We did not sign any papers to permit this experiment to be done on her. The doctor at the hospital gave her simple tubes of ointment to use on her breast, her back and abdomen. Her skin was burned on both breasts, her back and abdomen. There was raw flesh exposed where once there was skin. I had to apply this ointment to the exposed areas. When I applied this ointment to the raw areas, she was in such excruciating pain, I cried. She was given enough ointment for one week. She was also given morphine which lasted one or two weeks. DOCTOR FADEN: Mrs. Baker, would you like to take a minute or have someone else to read the statement? I know it's so hard to do. Take your time. MRS. BAKER: I have to finish this because she made me promise to finish it. DOCTOR FADEN: Well then, you take your time. Would you like some water or something? Would that help? MRS. BAKER: When I applied this ointment to the raw areas, she was in such excruciating pain, I cried. She was given enough ointment for one week. She was also given morphine which lasted one or two weeks. I do not recall the names on the three ointment tubes, but these products were given to her around December 1965. None of these medications helped her. When a person is real ill, I was under the impression that someone had to sign for medication such as morphine for a patient who is terminally ill. She was kept in the dark about the treatments that she was receiving. She never talked about it. It's not fair to treat another human being as a guinea pig just because they are poor and uneducated. Our parents didn't have the privileges we are blessed with today. I took my mother back to the hospital on February 12, 1966, about 10:30 or 11:00 p.m. My nephew and I stayed at the hospital until 3:00 a.m. I asked the receptionist if they were readmitting her, and she said yes, and that we should go home and get some rest. When I returned home, my husband called me from his job and told me my mother had died. The people at the hospital did not call me to inform me of her death. I'm her daughter. I should have been informed about her death before I left the hospital. I was at the hospital at 3:00 a.m., and the death certificate states she died at that time on February 13, 1966. I thought the nearest relative was to be informed first. How I feel about my mother participating in this experiment. I am very angry about this doctor taking it upon himself to use poor, uneducated human beings for his personal fame and gain. These human beings had the right to live the rest of their lives until God was ready for them to die. Not to die because man wanted to find out what effects it would have on soldiers in a war zone. My family was deprived of what days my mother would have lived. I know she wasn't educated, but she knew something was wrong. She didn't know what it was. I don't like it because she, Lilly Wright, was kept in the dark about this experiment. It's a disgrace to use high doses of radiation on anyone. Why didn't you experiment on your loved ones and not because they are special to you. Remember, some day, you will reap your just reward. Ms. Zettie Smith." Next, I will read to you my statement. Good morning to each and every one of you. My name is Doris Jean Baker, General Manager and Researcher for Cincinnati Families of Radiation Victims Organization, CFORVO. I come to you this morning as I have many times before. Most of you know me quite well by now. As you know, I have been in this mess for over a year now, and each time, the pain gets harder to deal with because my great-grandmother, Gertrude Newel, saved my life as a baby and I couldn't return the favor. So, I have to do the next best thing, fight the battle for her that she didn't know anything about. I am here for her and the other victims, as well as their families that were left behind. The 88 patients suffered and were in a great deal of pain 30-plus years ago. Now, some 30-plus years later, we, the families, are suffering and in great pain from our hearts, and are very angry about the story of what really happened to our loved ones. First, they gave them a damn number. Then they gave them a check-out call. Then they called them illiterate, poor, and went so far as to call some of them crazy. They charted them like they were meat in a packing house. Then they burnt them with their damn radiation. They radiated some of them so much that they were cooked like meat. My God, how could someone do something like that to human beings. They are the ones that are crazy and illiterate. They were more-or-less grave robbers. These doctors were mad scientists who should have been locked up in the nut house and the key thrown away. Or better still, they need to be radiated and burnt to a crisp. Now, why is it that everyone is saying these patients were Doctor Saenger's? Because my great-grandmother, Patient Number 20, Gertrude Newell, wasn't his patient. That was bold- faced lie. I am tired of hearing that mess. And my great- grandmother wasn't as sick as they said she was. She didn't beg for anyone to help her by putting radiation in her. She didn't know anything about that mess, nor did her family, meaning my mother who has since died. She was there with me. If my English is a little off, that's because I am very upset over what Doctor Saenger is saying in the papers and what I have been reading in all his reports about these deceased patients. When he said that my great-grandmother was in there for advanced cancer and that she couldn't get up and walk to the corner, he lied because she walked everywhere, even after they did her surgery in February of 1962. How in the hell could Doctor Saenger say that my great-grandmother and others in the experiments weren't important, especially when they didn't know about the radiation. He also stated, "if I'm dead, I'm no better off." Why not let this doctor try his mess on them, even if it's no good? Please, panel, give me a break. Don't you know if a doctor tells me I'm dying, "let me experiment on you. It won't help you anyway," and I let him anyway? I don't think so. Only a fool would do that, and these people weren't fools. They would never have agreed to that. Just like Doctor Saenger's lawyer, Mr. Parker, said that someone owes him an apology, who in the hell will apologize to my great-grandmother for her death? Who is going to apologize to my family and me for the pain that has come back on us? Why don't the press put my tears all over the paper? This is what my great-grandmother, Ms. Gertrude Newell, would say if she were here. "You see what short time we spent together has come full circle. Put what I am about to speak on in your hearts forever. My great-granddaughter is very smart. She is me and I am her. We are as one in body. She learned what I knew, but couldn't do anything about it. I learned the truth about her death. Doris will make it right for her and others. She will not stop what she has to do to accomplish the family's and her goal. God instills all this love and honor to mankind and mankind has gone and become stupid and destroyed the world. But in a little corner of the world, Doris and a lot of other women, and good smart men, will try and clean up what this government has messed up. She will fight a good fight to get these people their rights back, as well as getting my rights back." My great-grandmother is looking down on me and saying, "why did they have to lie to me and do this to me without my knowing it?" But I say to her that I am here now. You fought for me to live, and now I am fighting to repay you because among others, without you, I would be nothing. You are all that I am and all I have and will become. When is someone going to ask me if I am all right? Do you need help with your health? Are you hungry? No one has asked if they could pay for a counselor to help me get over this mess. Now, we have to love one another and to help one another. There is so much wrong in God's land that it makes me sense to my stomach. That's why I cling so to the CFORVO group that I am manager of. We care for one another and we fight for one another. To the Advisory Committee: I say that we from CFORVO would like to see the hearings reach a decision, in order for us to get on with our lives. You know the truth. You've heard it in statements and read it in documents that you have. So, stop us from being in anymore pain. We have laid the cards on the table and you have also done so. You need to be honest with us now. Give us new information, not old. You keep putting old information on the table -- we are not dumb. My job as general manager is handling many papers. When I was here in April, you had some of the same things on the table that I got in October of 1994. Please don't play stupid games with us. We are intelligent. We are not our mothers, fathers, sisters, brothers, aunts, uncles, and cousins. You took their rights, but don't take ours now. Doctor Saenger and his people killed my great- grandmother and all the other victims. You have read that as well as I. Here is the proof, her death certificate. It shows that she died from one of the side effects of the radiation, uremia. I told you that in October of 1994. You played me like I was a sucker, but that's okay. The family members that it happened to, came back and made you hear and see. I would like to take this time to thank the Advisory Committee. It was very nice getting to know all of you. I hope we will continue to work closely together to make this right. God bless you all. Before I close today, I want you to meet my family group, CFORVO, Cincinnati Families of Radiation Victims Organization. I want to first thank each and every one of you from the bottom of my heart, and God bless you all for the good work you have done for us. We will see the shining stars up above when this is all over. We will pain for a while, like years past. Only this time, we will understand it better and make it right for us all. Would the group stand as I call your names? Thank all of you again. James Tidwell, Barbara Tatterson, Este Tidwell, Beatrice Tidwell, Sandra Drew, Clifford Tidwell, Floyd Tidwell, Roy Tidwell. Once again, I thank you. And when I was saying about my grandmother's death certificate, I have a paper that was in Doctor Saenger's records saying that my grandmother died September 24, 1964. My grandmother died September the 29th 1964 in another state. How could he put on a paper that my grandmother was dead when she wasn't even dead yet? I did not appreciate that at all. DOCTOR FADEN: Thank you all very much for your comments and for your assistance. Jay? Mrs. Baker, if you could just wait a minute? You've got a question. DOCTOR KATZ: I want to ask you a question. I thought about it as the other speakers told their stories. My question pertains to everything that we've heard in the past and have heard today. You said at the end that you hope that we could relieve your pain, but of course that we can not do. The pain will always be with you. I am particularly appreciative of this today on the 50th anniversary of victory in Europe and the liberation of the concentration camps where a considerable number of my relatives died before and during the war. That pain can never be relieved. But what we can do, and I think what you want us to do, is to set certain matters straight. And the question I wanted to ask you is, have I heard it correctly from you and the others, and is there more in terms of what you would like us to do if we could do it? I noted three items. One is, you want us to tell the story and you want to learn why did all this happen. MS. BAKER: Yes. DOCTOR KATZ: And you hope that we will do so as completely as it is humanly possible. And you hope that will not obfuscate it in any way. The second thing I thought I heard you say that you want someone, and I would assume this involves a number of persons, governmental and maybe medical personnel too, to apologize for what transpired in the past. And I think I also heard you say that you want us to make some recommendation so that the perpetrators will be punished, whatever that might mean. I do not know, but we want to elaborate on this. Is there anything else that you and you group would like us to do if it were possible? MS. BAKER: We have been promised if we needed counseling, we haven't received that. No one has called. We had also been promised that someone would come and go over our medical records. That hasn't been done. I've heard that twice. The second time I heard it was last month. You know, no one has offered to see if we need anything because we pay out of our own pocket. We are poor, but these were our loved ones and we loved them very dearly. So, we would do whatever we have to, to get here, which we have been doing -- if it means spending bill money, food money, whatever. DOCTOR KATZ: So, reimbursement of expenses is also one of your requests? MS. BAKER: Yes, you know, it was like no one cares. DOCTOR KATZ: Anything else right now? If you think of other things, I would appreciate you letting us and me know, of course. MS. BAKER: Well, at the present, that's about all I can think of right now. DOCTOR KATZ: Thank you very much. MS. BAKER: Thank you. DOCTOR FADEN: Thank you, Mrs. Baker. Our next presenter is Mrs. Broudy. I saw her earlier this morning, so I know she's here. We have a packet from Mrs. Broudy, each of us do -- Good morning, Mrs. Broudy. We have a packet from Mrs. Broudy's association, each of us at our places, is that right? I'm just reminding the Committee about the material. MS. BROUDY: Yes, you did get a package from me, as usual. At least once a month, you get a package from me and then I have to narrow it down to five minutes. I think that's the hardest part. This is going to be a little longer than five minutes because I had to cram it all in. I know this is going to be my last opportunity. So, I will dispense with the greeting and just jump right into it. Destruction of film badges. The disposal of film badges in storage at Lexington Signal Depot became a problem in 1956. Filing of those badges in 201 files of personnel was considered ridiculous without controls. Suggestions were made that the badges be destroyed at the end of 90 days, although Congressional action was felt to be necessary before action was taken. Elimination of statistical records of radiological exposures of Army personnel. Army field services proposed eliminating the maintenance of statistical records of radiological exposures of army personnel to protect the government's interest in case of large numbers of lawsuits based on nuclear radiation exposure during war time. Fear existed that the Navy and Air Force might propose some more action. It was not intended that this would change the policy regarding health protection measures in use at isotope laboratories or atomic tests. The VA agreed that no details, statistical records are required. Question: Does the VA feel that all the armed services should continue to maintain detailed statistical records of radiological exposures under war time as well as peace time conditions? Plumbbob, off site and downwinder. Number one, a handwritten letter by C.H. Drake, July 23, 1957 to Headquarters -- I'm having a little problem of competition back here. DOCTOR FADEN: Right. No, we're listening. It's just maybe we could get the door closed. There we go. Thank you. It's more distracting for you than it is for me up here. MS. BROUDY: Plumbbob, off site and downwinder information. (1) A handwritten letter by C.H. Drake, July 23, 1957, to Headquarters, Off Site, Rad Safe, included population figures in San Bernadino County, California, together with figures for the 26 judicial districts which would be forwarded at a later time. Enclosed was a copy of the enrollment in the San Bernadino County schools which were "under supervision which are most schools" and "would be quite close for practical purposes." He had already sent the figures for the Barstow Union school district of California, broken down for each school. He also had the San Bernadino city figures. He enclosed a few film badges. (2) A letter from the Public Health Service to Oliver R. Placek, Public Health Service, Off Site, from J.D. Terrill, Chief Radiological Health Program, Division of Sanitary Engineering Services in which Terrill complains that he is having difficulty convincing various groups of the desirability of using film badges. There were many questions regarding research. (3) Doses to the thyroids of infants during Operation Plumbbob, Hardtack II, Dominic II, Storax, and Flintlock. Exposure at St. George, Utah during Harry of Upshot-Knothole estimated infant thyroid dose equivalent in rads, 84 rads to an infant thyroid. Doses St. George, Utah during Annie, Simon, Harry, of Upshot-Knothole, Tesla and Zucchini of Operation Teapot: total, 120 rad to infant thyroids. (4) PR, Public Relations by Placek, US Atomic Energy Commission thanking off site individual for wearing a film badge during the 1957 series. Placek compared this to "hundreds of others" permitting us to compare the radiation exposure actually received by you and your neighbors with the off site radiation readings which were published. Code 74, which has been a real sticking point with me. I've had many conversations with Dan Guttman and also Captain George, and was told that those documents had been destroyed. (1) Monthly dosimetry report from San Francisco Naval Shipyard including 128 names, rates, total hours exposed, total amount of gamma and beta received for the month of December, 1947. (2) Letter from A.R. Behnke to BUMED, Code 74, re: "Film Badge Holders" states that personnel working in the laboratory often are exposed to several types of radiation making it impractical to change badges during the progress of experiments. Personnel used beta and gamma emitting isotopes, concurrent with X- ray machines, with energies from 50 KVP to 1,000 KVP. He suggests a new type of film badge holder to accommodate all exposures. (3) Letter from R.A. Hinners. Remember him? He was the guy who volunteered to be in a trench 2,000 yards from Ground Zero. He is now the Director of the US Naval Radiological Defense Laboratory to Chief BUMED, Code 74, re: "Authorization for Experimental use of La(140) on Human Volunteers for Skin Decontamination Studies." The letter describes a field operation, land target studies, to be conducted at Camp Stoneman, California in which a radioactive stimulant will be used to contaminate various types of building and land surface areas with La(140) mixed with soil. "A project entitled the decontamination of Lanthanum 140 contaminated, in tact, human skin by the use of various decontaminating agents is desirable for measuring actual skin decontamination factors. The data to be derived from such an experiment is needed for practical use in a field operation where multi-curie amounts of La(140) contaminated soil will have to be decontaminated from the skin of operating personnel each day for a period between four and seven weeks, using the skin of volunteer human subjects, male members, civilian and military, of the staff of this laboratory." A literature search has indicated that animal skin for this type of information may yield data "which is fraught with inaccuracy." Captain Behnke gave his approval to proceed, subject to AEC and BUMED approval. Procurement of isotopes. Procurement and authority for the therapeutic and clinical investigative use of radioactive isotopes will be coordinated by BUMED Code 74. Installations desiring to use isotopes may obtain an initial supply of Atomic Energy Commission forms and other necessary information from BUMED, Code 74. Operation Paperclip. After World War II, German scientists were brought to the United States to work on their nuclear endeavors. I have furnished CIA biographies to this Committee of some of those, including the eminent physicist, Otto Hahn. He contemplated suicide when the atom bomb was announced in August of 1945 because he felt responsible for the lives of so many people in view of his discovery. He vehemently opposed the Paperclip Project and wrote a severe criticism entitled "Invitation to USA." The history of the Research Division, Bureau of Medicine and Surgery, US Department of the Navy states on page 99, "both the Army and the Navy set up programs and many distinguished scientists came to this country." Naval medical research got its fair share. I have listed the names that I received on the CIA biographies. Also, the last paragraph that I just read, I think there's about four or five that went to the naval medical research. Experiments Operation Plumbbob, contamination of personnel engaged in recovery operations, October 30, 1957. Personnel required to perform heavy work wearing several suits of protective clothing and full-faced masks recovered alpha contaminated sand from Area 11 and TS, Nevada test site, during a four hour work day. Face wipes, which were standard filter papers rubbed over the face, indicated contamination underneath the masks. The maximum noted was 34,000 disintegrations per minute. Evidence of contamination inside the mask after one hour was to be sufficient reason for halting the recovery operation. Positive contamination was found at one hour and recovery operations were suspended. Total time spent by personnel in Area 11C was approximately ten hours. Approximately six hours of this, total, were spent under conditions that contributed significantly to alpha exposure, despite the use of the best available equipment for respiratory protection. Urine samples were collected from the 11 men and sent to Los Alamos scientific laboratory for analysis. Results are indicated on attachment 7 of my original paper with attachments. While working in an atmosphere of extremely high alpha concentration could lead to significant contamination, the alpha air concentration was of the order of 10-7 -- I don't know how to say that. I think there's probably a scientific way of saying it -- disintegrations per minute, per cubic meter. Atomic Energy Commission DOD Weapons Effects Program for Operation Plumbbob, Anex A, Operation Training and Troop Participation Project. United States Army Program 50.1, combat team exercise will conduct pre and post shot maneuvers in the blast area of an atomic detonation. 50.2, approximately 3,000 Army personnel will attend shots of suitable yield from prepared positions in the blast zone. 51.2, VA squadron indoctrination, AFSWP, one VA squadron, Atlantic fleet will conduct airborne maneuvers in the vicinity of several shots during a period of about one month to accomplish indoctrination of pilots. United States Marine Corps, Program 52. Marine brigade exercise, 4th Marine Corps Provisional Atomic Exercise Brigade consisting of CPX staff of a division wing, regiment and air group, one BLT reinforced, one helicopter group, and one air group will conduct pre and post shot maneuvers in the blast area of an atomic detonation. My husband, Major Charles A. Broudy was one of those Marines. I could go into details of his last illness as our prior witnesses did. I haven't done that, and I don't intend to do it. But you can take your clue from what they said as to what my husband was exposed to and what he put up with before his death. History of the Research Division, Bureau of Medicine and Surgery, US Department of the Navy. Experimentation on personnel: (1) Experimental studies of a medical nature involving persons in a Naval establishment are forbidden except when the experimental design in each case has received the prior approval of the Secretary of the Navy. In the case of military personnel or their legal dependents, and that includes children, recommendations on requests received shall be made by the Bureau. (2) Participation by personnel of the Naval establishment, military and civilian, shall be on a voluntary basis only. Volunteers will not be required to execute a release from future liability for negligence attributable to the Navy. (3) For each instance, a statement shall be entered into the individual's health record, indicating the project number and the physical and psychological effect or lack of same resulting from the investigation. And that is not true, because of all of the men and widows that I have talked with about medical records, including you, Dan, and Captain George, those records have been destroyed. That's Code 74. So, consequently, we have no proof. Operation Dominic. This operation was fraught with errors from its inception, the worse being Bluegill Prime when a Thor rocket blew up on the pad with a 1.4 megaton warhead on it. Enclosed in my original long letter to the Committee this date, are four pages of radiation readings, ranging from 1.679 to 175.882 rem. That is not milirem. That is rem, and everything in-between. These are representative of the 39 pages with 67 numbers on each page, which equals 2,613 very high readings. Joint Task Force 7, Extract of Special Orders, Restricted Information. We've all heard that the atomic veterans were sworn to secrecy. One of our members sent me some material he had been hiding since his return to the States from a year on Eniwetok during which he witnessed three atomic bombs and nine hydrogen thermonuclear bombs. Operation Counsel. He included orders with the names, ranks, serial numbers, and MOS numbers of his outfit, which is also enclosed in that long letter. One of the paragraphs of a briefing letter to all officers and enlisted men states. "It may seem a bit melodramatic, but it is nevertheless true that your nation has placed a high trust in you. The security obligation placed upon you when you first came to duty at Eniwetok will remain with you for the rest of your life." This is why we could not get any attention before this Committee, and I thank this Committee very, very much for their attention and for being nice enough to listen to me all these many times. DOCTOR FADEN: Thank you. MS. BROUDY: I have just one little paragraph here that was given to me by another widow. She says, "Treason is defined as a breach of trust. Allow me to elaborate and state for myself and the widows I have worked with that the coverup and betrayal of trust on the part of our government constitutes moral treason." I've really loaded you guys down this time. This is a friendly fire thing from the Gulf War. I'm not even going to talk about it, but you've got a copy of it. In addition -- and this is my last thing -- I belong to the Task Force on Radiation and Human Rights. The Task Force on Radiation and Human Rights urges that this Committee, as part of its final report, recommend that Congress legislatively waive all sovereign immunity defenses in cases where US citizens are harmed by government-sponsored, unethical, human experimentation when informed consent has not been given. The Senate Veterans Affairs Committee recommendation, an excerpted copy of which is attached, is that the Feres Doctrine should not be allowed to stand as a sovereign immunity shield preventing suit against the military in such cases. The Task Force submits that the Senate Committee's recommendation should be endorsed by the Advisory Committee and expanded to include the waiver of all government sovereign immunity defenses where the charge is human experimentation in violation of the Nuremberg Code. If you were to make this recommendation and Congress were in turn to adopt it, not only is justice against past crimes made possible, but an effective deterrent for the future is, by this one act, put in place. Attached is a copy of the Committee on Veterans Affairs of the United States Senate recommending that Feres be done away with. Thank you very much for listening to me all these many, many months. And thank you again for convening this Committee. I just wish to say that I have listened to these testimonies and I've cried with them. I've cried with my widows and my few remaining veterans. We all have the same story, and we are all hurting. It's past time. This is the first time in 18 years that we've gotten any attention, even though I've been writing letters. As you know, I am a copious letter writer and researcher. Nobody has ever paid any attention to us before. I've testified in 15 Congressional hearings. I've gone through this issue with them. When the Markey Report came out in 1986, that was part of my testimony. It was totally ignored. This is the first time, and I hope to God that it's going to be effective. Please, make your very generous recommendations to the President. DOCTOR FADEN: Thank you very much. MS. BROUDY: Thank you all very, very much. DOCTOR FADEN: Thank you. Thank you for assisting us. We have a question. Just one second. DOCTOR THOMAS: Pat, I was struck by your comments about Operation Dominic and the Bluegill device which exploded. MS. BROUDY: The what? DOCTOR THOMAS: Bluegill, I think it was called. MS. BROUDY: The Bluegill crime, yes. DOCTOR THOMAS: Attachment 11, you provide several pages of a list which I find a little puzzling. I wonder if you could elaborate a little bit about what this list really consists of? MS. BROUDY: You mean those huge doses? DOCTOR THOMAS: Right. It's got names and identification numbers that are clearly blanked out for purposes we respect. MS. BROUDY: Well, it's been redacted. DOCTOR THOMAS: Does each line here represent -- MS. BROUDY: Pardon me? DOCTOR THOMAS: Does each line here represent one individual who was a participant in this operation? MS. BROUDY: Yes. And if you will note, if you go through those, some of the organization numbers are duplicated. So, there was probably more than one exposure to that individual. When I saw that, I could not believe the numbers. DOCTOR THOMAS: Well, are these gamma doses that are recorded here? MS. BROUDY: Probably. DOCTOR THOMAS: Because the text which follows says that there was substantial alpha contamination throughout -- MS. BROUDY: Substantial what? DOCTOR THOMAS: Alpha radiation. MS. BROUDY: I don't know whether it contains alpha. I'll tell you, I got that list from one of the victims of the Bluegill Prime Operation. He got that list from CIC archives in Las Vegas. And so, I don't know whether it includes alphas or if it's just gamma. But if it includes alphas, it's a real bummer. It's worse, much, much worse. DOCTOR THOMAS: Well, it's certainly puzzling because I've never seen any doses like this in any of the other groups of veterans we've talked about. MS. BROUDY: I had never seen anything like that either. DOCTOR THOMAS: It's totally mysterious. MS. BROUDY: Yes. There's a lot more pages. That's just four pages of it. In my long letter to you guys, I gave the name and address and telephone number of the gentleman who gave me that list. So, if you have that long, long letter that I wrote, together with its attachments, his name, I think, is the last paragraph of that letter. DOCTOR THOMAS: This is Jerry. MS. BROUDY: Jerry Stoddard, yes. DOCTOR THOMAS: Thank you very much. MS. BROUDY: You can contact him and he can give you the information. DOCTOR FADEN: Henry, did you also have a question? DOCTOR ROYAL: Yes. I just wanted to say that I'm also puzzled by those doses. If they were gamma doses, this would have been an extraordinary accident. MS. BROUDY: It was an extraordinary accident. DOCTOR ROYAL: So, we really should try to get to the bottom of what those doses really mean. MS. BROUDY: Exactly. There were a group of men on that island -- it was Johnston Island -- who were there when this Thor rocket blew. Actually, that was the third abort. There were several different groups of men that were there. Jerry was in a different group than, for instance, Michael Thomas. I mentioned Michael in there also. Michael was a pilot and he and his group, his crew, had to remain on the island. They could not be evacuated. They had to remain on the island because there was so much debris on the runway that they couldn't get their planes off. So, they were there for two or three days. The men that were evacuated, the men who were not in that particular situation, have no cancers. I bring that out in my long letter. There's a lot of stuff in there that I couldn't get to today. I want you to read that letter, if you would, very carefully because that letter is not exactly a culmination of all my efforts. I still have an awful lot of stuff I'm going to send you guys. I know you're getting awfully tired of getting this stuff from me, and I don't know whether it's going to do any good or not. I'm sure it will. But you'll be hearing from me until the end. DOCTOR FADEN: Lois? DOCTOR NORRIS: I just wanted to thank Pat for coming to see us so frequently, and also for sharing with us the results of your prodigious efforts. It has been very helpful to us and we appreciate it. MS. BROUDY: Thank you very much. DOCTOR FADEN: Thank you, Mrs. Broudy. We have one more public presenter and then we will take a break. Oh, Henry, did you have another question? I'm sorry. DOCTOR ROYAL: Could I just say one more thing about the radiation doses, so that we're all sort of on the same page? My unsophisticated understanding of nuclear weapons is that the material that's in a nuclear weapon really is not terribly radioactive. The radiation that comes from nuclear weapons comes from when it actually explodes and there's a lot of neutron radiation and a lot of fission products formed. So, the thing that's confusing about this list of doses is where did the radiation come from? Because to my knowledge, there has never been a nuclear weapon that has accidentally exploded in the sense that a nuclear reaction occurred. So, the confusing thing is, where did these "large doses" come from if the weapon did not explode? MS. BROUDY: I think I can answer that question. A thermonuclear bomb is comprised of several stages. The initial stage is a fission stage. The secondary is a fusion, and there sometimes are tertiary which are also fission. The secondary, which is composed mainly of depleted uranium is U(238). U(238) is a waste product. That's why they call it depleted uranium, and that does not explode. What happens is that when the primary stage explodes, fission, the secondary stage burns. It doesn't explode, it burns. Those fumes and that residual -- I think depleted uranium is considered to be 95 percent U(238) and then there's a little tiny bit of 235 in there. But it burns and of course, there are these fumes that are going all over this place. Even if it doesn't explode, we've got pieces of radioactive debris all over that island. The same thing happened with Crested Ice. It didn't explode, but pieces were -- they had to pick up the pieces. These guys are handling this radioactive material. They didn't necessarily get it from an explosion. They got it from being contaminated by proximity to the trash that was exuded from that bomb, those bombs. So, I can't answer your question as far as why the doses are so high. I can't answer your question as to whether or not that includes alphas. If it includes alphas, that's really, really tough stuff because alphas are twenty times as harmful as gamma, rad for rad. So, let's hope that it didn't include alphas. I think if you read that letter, 84 percent of the men that were exposed at Johnston Island to that detonation -- it wasn't a detonation -- to that abort, 84 percent of them have cancers or are dead. Their children are all affected. So, that's my answer as good as I can do, at not being a scientist. If there's any more questions, I'd be happy to answer. DOCTOR FADEN: We know where to find you, Mrs. Broudy. MS. BROUDY: Okay. DOCTOR FADEN: Thank you so much. MS. BROUDY: You're welcome. DOCTOR FADEN: We appreciate it. We have one more presenter, Doctor Gwendon Plair, who has also been with us before. Good morning, Doctor Plair. DOCTOR PLAIR: Good morning. Is this the one here? DOCTOR FADEN: I think they're all working now, but that one definitely is. DOCTOR PLAIR: Okay. First of all, let me again say good morning to Doctor Faden and the rest of the Committee members here. I want to say to you that probably all of the times that I have conversed with various members of the Committee on various radiation issues, particularly those relative to Cincinnati, Ohio, this is probably the most difficult testimony that I will probably give. I want to also leave at least 30 seconds to add a comment from the Task Force that I think is very important. I know we're a little bit over the time, so I will try to be as close as possible to getting all the information out. I hope you will hang in with me. This may be a tough go. Again, good morning, and thank you for this opportunity to testify before this Committee. Today is the most difficult day I've had in talking about this radiation issue. I'm here to speak on behalf of my family, as well as myself, as it relates to my mom, Beatrice Plair, or as most commonly known by Doctor Saenger, University of Cincinnati, then Cincinnati General Hospital in the DOD as Case Number 044. In March of 1965, my father came into my brothers and I room and told us that our mother had died in Cincinnati General Hospital. We did not know clearly what she had died from until March of 1994, nearly 30 years after she had passed. I should add that we found out through my brother, that my mother was an unwilling participant in the partial and total body radiation only weeks after I, myself, had been released from Georgetown Hospital for major surgery for streptococcus pneumonia of which I nearly died. I share this with you in order to give you some idea of how to hear my mother's horrible experience in Cincinnati General Hospital was difficult as it relates to myself. You see, I lived. The staff took excellent care of me, and they were honest and up front regarding my condition, including my primary doctor telling me I needed surgery or I would have less than a 25 percent chance of surviving what was going on inside my body. My mother did not have such an opportunity or experience. Like myself, she trusted the doctors. Like myself, she had come to the hospital where she believed she would get help. Instead, they abused, used, and threw her away like yesterday's paper. In retrospect, I recall my mother had a zeal for life, a savvy for getting things done, and a quality about herself that those who knew her really respected. She was the kind of person who had a strong reluctance to let go of anything that she felt was right. Her convictions were driven by her strong belief in Jehovah. I'm telling you so when I let you know that she was reduced to a crying, begging, defenseless in many ways individual, you can understand how my intense desire -- why I feel that this atrocity of justice can not go unanswered this time. I recall on one occasion, my mother sat for 45 minutes in the green halls and bowels of Cincinnati General Hospital after receiving total radiation, asking, begging and pleading for someone to please help her because the pain and the burning was so intense. There were fluids coming from various orifices of her body, and no one was there to hold her hand except for me. It was only after pleading with staff that she was finally given one tablet of Taulin. I was only 16 years old at the time. By the way, she had asked many times for help and she was told that she was not even hurting. I hurt for her and we hurt for one another. My mother was part, also, of a medication experiment too. Again, just like the TBI, she was not told -- as well as our family members was not told of her participation in this experiment either. Once I was told to sign for her admitting papers, and by those papers, they gave my mother another dose of radiation. This continued for 197 days. I recall a week before she passed, she told me she had previously -- she said, "I am feeling on fire. Why are they doing this to me? My God, Jehovah, why are you allowing them to hurt me so? I came here for help." On May 23rd of 1965, my mother died in her sleep from a collapsed trachea. Again, we did not know this until reviewing her records in 1994. She weighed 67 pounds, and previously, she had weighed anywhere between 130 to 160 pounds. Doctor Saenger, the University of Cincinnati, the city of Cincinnati, the DOD owes us an apology. They owe us a why. Why would our government who we trusted, why would workers in a hospital that we trusted, and a doctor with more accolades after his name and initials that run off of paper would do this to a person who fought so hard to cling to life? I just don't understand this. In closing, let me say to you, I'm particularly moved and upset by all the movement in Cincinnati to blame, it seems, the death of the family members and in my case, my mother, for causing their own death. From my understanding from her records, my mother may have had anywhere from five to ten years to live had she not received these exposures to radiation. No one wants to accept responsibility for their actions. No one wants to say that they're sorry, at the least. It particularly upsets me because, you see, Sunday is Mother's Day. There's an old Black spiritual that says, "sometimes I feel like a motherless child a long way from home." I may be a long way from home, but Doctor Saenger and associates, University of Cincinnati, Cincinnati General Hospital, the city of Cincinnati, and even the DOD can not take my mother away from my heart. At the most, I would say that he should ask us for an apology, but that's just a minimum. There's been too much harm and pain caused by what he did. Just like in Nazi Germany, families were split up and hurt because someone made a decision it was okay to do someone harm. I hope that this doesn't happen again. We can't afford for this to happen again. I want to thank this Advisory Committee for listening to me. As you can see, there may be two groups in Cincinnati, but we sure came here raising hell. We want results, and we're depending on you, as usual, to do the right thing. As a Vietnam Vet and an ex-POW, we don't want another Agent Orange situation here. We want results. We want our day in court, but we need your help to do that. That's the end of my presentation on that. I thank you for that. On the task force, we would like to -- and I will pass this around. Thank you very much -- I'll just read the highlights to expedite time. We addressed it to Doctor Faden, but it's to the rest of the Committee also. "In light of the extension of the Advisory Committee's charter, several task force member organizations have requested that the Advisory Committee hold the field hearings in the Boston or Rochester vicinity. Some of these requests have been made directly to the Advisory Committee. Others have written to the task force seeking our assistance in this matter." I'll skip the in-between part, but what I think is very important, moreover as the recent correspondence with Doctor Don McCloud, who testified at our Knoxville hearing, evidences -- a copy is attached in your copy that I'm passing around. The opportunity for field hearings provide, on a personal level, the very thing underlying Secretary O'Leary's openness initiative, faith restored in government. Ms. McCloud writes, "I, and their families, and the opportunity to testify will help the healing process that has been talked about earlier by other family members." The healing process is a chapter of our lives as well as to feel that finally, someone is listening. Secretary of Energy O'Leary's openness initiative in response to hearing of the Cold War era human radiation experiments has been repeatedly commented by the task force and its members. Somehow, we think that her initiative was intended for everyone in this country, not just for those who had money to travel to Washington, D.C., to be heard, nor for the Committee to be found most convenient to visit. We urge the Advisory Committee to hold the field hearings in the New England area, and that the Committee do so at its earliest possible opportunity. I would just add just a little two second piece of that. Also, it is brought about prosecution of those who have done harm. The task force has submitted to you the deduction of our remedies and principles regarding where necessary in -- violation is evident, that those people involved be prosecuted. I thank you again, Advisory Committee, for your time, for your effort, and for your fine work, but it's not over until it's over. God bless you. For the mothers on the Committee, have a Happy Mother's Day. DOCTOR FADEN: Thank you, Mr. Plair. Are there comments or questions? DOCTOR FADEN: Thank you very much. We're going to have a break now and reconvene about five of 11:00, a ten minute break. (Whereupon, off the record at 10:46 a.m., until 11:07 a.m.) DOCTOR FADEN: We're going to start. The time on the agenda from now until lunch has been set aside for us to discuss our reactions to the document, overall. We discussed whether this was something that should be done in the beginning or the end. We can do it both at the beginning and the end. That is to say, should we just march into the chapters and not begin by addressing our feelings about the overall structure? Or should we start with our feelings about the overall structure, the overall state of affairs, how it looks? The thinking was, we'd better start with the big picture, then go chapter-by-chapter, and then return to the big picture. But if there's not much big picture discussion, we will march right into the chapters. But the time now is set aside for a big picture discussion. So, the floor is open. Pat had asked, and others had asked to see the whole document from beginning to end. We almost made it. Hard core isn't there, but it's almost there from beginning to end, and we thank you. DOCTOR ROYAL: Well, it's hard to know where to begin. I'm still overwhelmed by the breadth of the report. So, it's still very difficult for me to get a handle on it. There's just so much to it. But let me tell you the things that bother me the most, and it was sort of crystallized by the article that was published in Scientific American. That was distributed to the Committee staff. But I wanted to read some things from this article because to me, this really emphasizes what some of my basic concerns are. For those of you who don't remember, the article with all the other materials that were given to read, let me just read a few things from it. This was published in the May 1995 Scientific American. Steve Klaidman sent press clippings and it was in my group of the press clippings. But the reason that I think this article is so important is, I think we need to read what this article says and decide whether or not this is the message that this Committee is trying to deliver. This seems to be the message that we're delivering. I think it's very important to decide whether or not this is what we want to be delivering. Personally, I have a different level of expectation from a scientific journal that's well respected like Scientific American than I might have from some other media. It troubles me greatly that this is Scientific American's view of what we're all about. The one-page article is titled "The Cold War's Dirty Secrets." The subtitle is "Radiation Experiments Ignores Ethics Guidelines." First paragraph: "Over the past years, a federal Advisory Committee has doggedly dragged into public view thousands of government funded studies in which people were deliberately exposed to radiation. The details to be released in a report next month are chilling. Some of these tests conducted between 1944 and 1974 exposed humans to levels of radioactivity now known to be dangerous. The numbers of subjects appears to be far greater than previously realized. It is also coming to light that many patients were not well informed about the possible dangers, or were deceived outright. Perhaps the most distressing of all, the Advisory Committee on Human Radiation Experiments has determined that informed consent was required but ignored." It goes on to say, "some of these horror stories" et cetera. So, when I read the report -- and this report has been in the public's light -- and then I see an article like this, what I'm reading in Scientific American is certainly not the summary statement that I would like the Committee to be delivering. And so, the issue that I am bringing up is whether or not my fellow Committee members feel comfortable with this message. Is this really what we want to be saying? If it's not really what we want to be saying, then what sort of responsibility do we have to make sure that we communicate more clearly what our feelings really are? DOCTOR FADEN: Jay? DOCTOR KATZ: Just very briefly to follow up on Henry's remarks, I'm really not yet sure from reading the report what the message is that we are trying to deliver, and in two ways. I'll be more specific about it as we get to individual chapters. It's also reflected already in some of the comments that I sent back to the Committee. I'm not clear as yet in what ways we want to evaluate the data that we have accumulated, particularly in light of the complexity of the data and the information we have and we do not have. Secondly, it's not at all clear yet, from most of the conclusions to most of the chapters not to speak of the final report, what the inferences are that we're trying to draw from all that we have learned. How far do we want to go in the conclusions that we want to draw from the work that we have done? How much will we -- and let me be a bit, what's the word -- To put it in terms of my own views, how much do we want to be confined by not having all the data available to us? How much do we want to really say something? Because even though we can't cross T's and we can't dot I's, the data to me suggests that certain inferences can be drawn, though not completely based on all the data. These things, we haven't really come to terms with yet. I think this afternoon and tomorrow, in looking at individual chapters, I, and I'm sure the rest of the Committee too, will have things to say about it. So, Henry, I'm not yet sure from your reading. Do you think that we have already come to certain conclusions, legal conclusions? I maybe don't find it except in there. DOCTOR ROYAL: I think that I share some of Jay's concerns about not understanding, really, what it is that we have concluded. I find it difficult reading these chapters, understanding what it is that we are supposed to conclude. One of the things that I've been thinking about as I've been reading the chapters, as Dan and I have had discussions in the past about, things not being black and white. As I'm reading the chapters now, I'm saying, "God, this is very complicated." But it's gotten so that you can't figure out what any of it means. At least, there's no summary statement. The fact that things were not done as well as we might hope that they would get done, it's very unclear whether or not the inference should be that even though they weren't done as well as we might hope, were they done in an acceptable way? Were they done in an unacceptable way? I can see people reading this report and saying that the Committee decided any number of things that are diametrically opposed, and being able to go to the report and justify their interpretation in the report. DOCTOR FADEN: I saw Pat wanting to comment. MS. KING: Well, first of all, I want to say I share a lot of Henry and Jay's unease. But I want to first say that I appreciate the efforts to get a front-to-back draft. I mean the beginning-to-end draft because it sends a real good message about what we've been able to do and in my view, how far we have yet to go. I divide my comments into some of the things that I find wrong with the draft that I think are staff problems, and what I think is wrong with the draft that I think are our problems. Both exist there and sometimes they get confused. I want to say this, that I do recognize that some of the clear lacks I see here are because the Committee has not done work that it needs to do. So, I guess we'll just have to do it. DOCTOR FADEN: Do it, right. MS. KING: But these are the general comments: I think that we don't have a message, but I think that's Committee work. I think it's just not there. I think that anybody who reads the transcripts and reads the draft can pull any message that they want to out of it because we have not been clear about lack of message. I have my candidate for a message, but I'm sure that we all have our candidates for messages. So, maybe that's one of the things that we need to talk about. I think that while staff drafts have to be over-broad rather than constrained because Committee members have to see everything, we are headed towards a report that's far too long. Maybe if we could have a message -- if we knew what we wanted to say -- we can not say everything. This requires a great deal of discipline. We can not say everything, and we certainly can't say everything well. I'm on the side of what we say, I'd rather say well and leave work for others in other parts of the report. So, I'm all in favor of cutting, a cut in chunks. Not because stuff is not interesting or good, it's just because it is impossible to develop it in a way that -- it doesn't have to be perfect, but that we at least don't want to run away from. So, I think it's too long. I think that some of the writing that's already gone is not qualified enough. I found it moralistic, judgmental. I keep going through and saying gratuitous comment, gratuitous comment. I think that that doesn't have to wait until our final drafts to start working on and getting clarified. The case studies, I think, need a systematic approach. To the extent that there's a systematic approach there, I have problems with it. And I think staff is having problems with it probably because of the lack of Committee guidance. You'll discover this -- I mean I'll talk about this when you talk about several chapters -- the best part of the case study chapters are the parts that are descriptive, that give what information we have and start to draw reasonable inferences -- or in some places, you could draw stronger inferences -- from some of the data we already have. Where a lot of the studies, not all, are weakest is in making the connections to an introductory framework. I started marking this up. I'd read the introduction and then I'd start looking for stuff in the chapter to support the statements in the introduction and they weren't there. The fact that we don't have any conclusions is not a staff responsibility. Many of those chapters don't have good conclusions because we haven't done the work on figuring out what kind of conclusions we want to have. DOCTOR FADEN: That's right. MS. KING: But I started to think in terms of an outline that I would like for each of the chapters to do. It wouldn't fit every chapter, but at least there would be some kind of system there. I even wrote a statement that says, "sometimes these facts are -- why are you muddying stuff up?" They're so strong. They speak for themselves and we didn't have to cloud it all up. We could lay out the facts and then draw inferences, and have some of the endpoint. So, I think that those are some of my general comments. I think that actually, the staff will be able to do a lot if we could reach some conclusions, because then they'd have an endpoint that they're targeting in their writing. I mean, what I see is, they're doing the best they can do not knowing where we want to go. When you have to write like that, boy, you just write all over the place. I mean, there's no other way to do it. A lot of that is in this report and I want to say clearly, I don't think it's your fault. I think it's ours. I think that you struggled mightily against things that are very difficult. DOCTOR FADEN: This is, I think, very important to be coming up now. I kept using the -- get hung up on language, but the last couple of days I kept using the image that the Committee needs to find its voice. MS. KING: That's it. That's it. DOCTOR FADEN: This is the meeting in which I'm hoping we will go a long way towards finding our voice on a number of critical issues. The findings question, I think, looms large. We have been playing around with findings. Then Dan and I had our fairly regular Sunday morning meeting when we stand and say, "okay, what's going on?" We had 33, 35 findings and I turned to Dan and said, "now, we want five findings, seven findings. What are the major messages that we want to deliver? We had a charge. What is our response to that charge?" And so, what we're going to do on Wednesday -- and maybe we'll do it in piecemeal as we go along -- is say, "okay, what are our major conclusions as a Committee on the five or seven areas that we were asked to address as a Committee? Those are our findings." Maybe if we can get clear on that, we can minimize the likelihood that reporters will find whatever it is they want to find in the morass of documents and interviews and so on that they have available to them. Because in fairness to the press -- and it's early. We haven't reached our conclusions, so we can't say, "here are our conclusions and you got it wrong because this is what we told you the Committee had concluded." That's the issue of finding our voice; what it is that we together agree we want to say. Hopefully do this not only chapter-by-chapter insofar as we can, but also overall. What's the cumulative take-home message that we have formed together? So, I think we're basically, lots of us, in the same place. Phil? DOCTOR RUSSELL: I'd just like to support what Pat said because I've been thinking about the two audiences, I think that are very, very important for this report. One is the scientific research community and the other is the government bureaucrats who have to administer R&D programs in the future. Both those communities need to be responsive if this is to be a successful endeavor. DOCTOR FADEN: Right. DOCTOR RUSSELL: They will not respond to hyperbole. They will not respond to moralistic and judgmental writing, as Pat said. They will respond to a factual report. They'll respond to a report that is as short as we can make it within the scope of our charge, which is obviously enormous. But nonetheless, they will respond better to a shorter report and they'll respond, I think, very badly to one that uses flowery language to attempt to make points rather than just clear statement of facts. The final editing of this ought to have a very tight concern, or very narrow concern, for keeping it factual and taking out the innuendos and the hyperbole. DOCTOR FADEN: Jay, yes? DOCTOR KATZ: I wish you would clarify this a bit for me, Phil. I very much agree with you that we shouldn't engage in innuendos. We shouldn't become another McCarthy Committee. That to the extent to which it is present, it should be carefully edited. But I appreciate that the scientific community might only want a factual report. That's something that they've been -- worked with facts throughout their professional lifetime. But are you suggesting, and to be so carefully worded, that we should not also make some moral judgments about what transpired during the Cold War and what the government and the scientific community allowed themselves to get involved in? Are you saying that that should all be eliminated? Or are you trying to convey something else to us? DOCTOR RUSSELL: No way do I think that should be eliminated. What I'm saying is that in the descriptive parts of the report, keep it factual. DOCTOR FADEN: Yes, that's the difference. DOCTOR KATZ: Okay. DOCTOR RUSSELL: And when the Committee makes a judgment, make it explicit that "the Committee's judgment on this point is." DOCTOR FADEN: That it is "for the following reasons." DOCTOR KATZ: Okay, I'm with you. DOCTOR RUSSELL: But separate the descriptive aspects from the judgmental aspects, and keep the descriptive aspects as factual, as straight as possible with a careful choice of adjectives. Make the judgments explicit and the recommendations explicit. Don't try and generate them or imply them, or otherwise indirectly influence -- descriptive -- DOCTOR FADEN: So, what you're saying is, you want a clear distinction. DOCTOR RUSSELL: We want a clear distinction between -- DOCTOR FADEN: Then when the Committee comes in with the Committee's voice and says -- DOCTOR RUSSELL: -- what we found and what the judgment is. DOCTOR FADEN: Okay. Okay. DOCTOR RUSSELL: Every editor that's ever reviewed anything I've read on this has accused me of being boring. DOCTOR KATZ: I -- objective. DOCTOR FADEN: All right. Lois? DOCTOR NORRIS: I just wanted to speak in support of what Phil and Pat have both said and qualified by what Jay said. That is, the report seems replete with "perhaps this is what they thought", or "perhaps this is what lead them to". Every time I see those words or words similar to that, it raises my consciousness level as to the fact that we're being lead to draw conclusions based on lack of evidence, as opposed to evidence. DOCTOR FADEN: That's a good point. So, it's this speculation, you said? Speculations is what I'm hearing are troubling. Mary Ann and then Henry? DOCTOR STEVENSON: Yes, I mean, again, on the same tone. I mean, one thing that I found very distracting -- and this is improved I have to say, particularly with the re-writes of the bio-distribution and radioisotopes chapters, and even the women and children's chapter. But this sort of inter-mixing of interrogatives and rhetorical questions in the midst of a so-called factual narrative is extremely distracting, to me irritating. I mean, the facts should be presented and crafted in such a way that the reader gets to those conclusions or concerns on their own steam, not by prodding or badgering. And sort of on the same line, I think in reading other people's comments, the word "dramatic" came up, or "over-dramatic". Sometimes I even found the writing to be almost sensationalistic. I mean, it works. It draws people in, but I think it does an injustice to everybody in the end. And so, I think we need to really leash that kind of thing in without turning it into a dull, dry, boring document. But any facts taken out of context or pinned up sort of in isolation can became horrifying or shocking, or whatever you want to make it. But it's not necessarily doing justice to anybody or anything. So, again, this is just reiterating, really, what the other people have already said because I think we do -- and in fact, I'm quite amazed and admiring of the ability of the staff to gather these facts and actually craft very careful histories and narratives of not just the case reports, but the ethics at the time. I think we've come a long way and the facts are there. We should be moving off those. We don't have to speculate as much as we might have before. DOCTOR FADEN: Henry? DOCTOR ROYAL: In terms of messages -- and maybe this isn't only for messages for the public, but this is even for myself -- I'd like to understand which of these experiments that we've talked about are the most troublesome? Why a particular experiment has been singled out as being most troublesome? Whether or not there's agreement among the Committee? I mean, as I've thought myself about the things that we've heard, it's not clear to me after 12 months that I can necessarily rank experiments in terms of how ethically troubling they were. I think that that's an important issue, whether or not we can agree or can't agree. Because if we can agree, then it adds credence to the fact that there is some systematic way in which you can look back on experiments and decide which ones are troubling and which ones are not. If we can't agree, then it's going to be difficult to say that the final judgment is based on the facts. It's obviously going to be based on something other than the facts if we can't agree. DOCTOR FADEN: Pat? MS. KING: What Henry just said was a part of what I said, that the case studies need some kind of systematic attack. You don't have to like all of this, but I want to add to what Henry said because I had a purpose in mind. I started with saying that we need to put in it why the case study was selected, consistently. That's not always in every one. Why we selected it. What we wanted it to do. So, it's in some and not in others. Then I would present what facts we have about this case study. Actually, I think that's our strength, as I said before. In some cases, we have to show methodology for selection, but not in every case. So, that varies. Then I'd like to see some weighing of the facts that we have on the case studies against the standards, but I'd like to do this sequentially -- DOCTOR FADEN: Against the standard? MS. KING: The existing standards that we have found to apply to that period and in that time. Then what we draw from that and what we want to say about those studies, if anything -- and another purpose, I think, for the studies is to illustrate problems that remain. Some people may want to add they illustrate problems that were later corrected that's in some of the case studies. And they illustrate problems that existed then, continue to exist, and then become the basis of our recommendation, I think, for a subsequent policy effort directed towards. Because I don't think we can do it. I don't think that we can make all the recommendations about what the future should be because we've had too broad a -- we can make some. I'm not saying that. I'm just saying we can't do it in the kind of detail simply because we have so much on our plates. The second thing that I think we have to keep in mind is -- and this is triggered by what Henry said -- we have, rightly I think, pat ourselves on the backs for uncovering a mother-lode of information. But in doing so, I think that we are becoming myopic. By that, I mean that the data that we have been able to uncover I see as the beginning of the process, not the end. I assume that future scholars are going to have a field day with some of the things that we leave in terms of making the data picture complete. But there's also a second data picture that's not complete and that is that we really do not, and should not I don't think, attempt to develop a cultural and social understanding of the times. There are a lot of statements in here that talk about individualism, privacy. Well, those things were not in place elsewhere in the society. I mean, if you take a look at this country from '45 to '74 and you look beyond what we did with human subjects, you will see a period of huge transition towards focusing on the consumer, for example, who would be a patient. You see a huge transition on what we mean by privacy. Don't forget, the Army-McCarthy hearings took place in this period. We ignore, I think, the broader picture -- and we have to -- but we have to be careful when we draw conclusions from our facts which are admittedly incomplete, in the absence of being able to undertake that broader inquiry. And I'm not saying don't call the conclusions, but that calls for very careful qualification and actually, a real recognition that there are going to be people who come after us who are going to do a whole lot of work that will help to flesh out that picture. We will have gotten them started on it, and I think that's a great accomplishment for us. I don't want to minimize that. I want us to keep it in perspective. DOCTOR FADEN: Jay? I'm sorry. DOCTOR KATZ: Yes, I just want to add something to Pat's comments because it illustrates something for me, illuminates something for me that I don't think all of you will agree with. It's the issue that we've uncovered lots of data, lots of materials, and we have become myopic. This is really my impression -- and I never put it in that kind of language or that kind of idea in mind -- about the way we've treated the Wilson Document and the Nuremberg Code that was covered early in our deliberations. We focused so much and have written our report so much in light of "look, the Department of Defense, et cetera, didn't follow these rules and regulations." Is it true, but to my extent in myopic vision, focusing too much on that document with all its problems? It leaves out of consideration, and we haven't given sufficient consideration -- and we can not probably do that though I think we can still do it a little bit better -- the whole context, scientific context and research context in which the Cold War experiments were conducted. That's the raw division, and I bring this to the Committee's attention. But I want to thank Pat for making clear for me because I've been struggling with that, if you agree with me. MS. KING: Well, actually, to a large extent, I do as I faxed the Committee, the first chapter was very enlightening for me. There's about a two sentence statement on how understanding of the Declaration of Independence, which caused some real soul- searching for me, for obvious reasons. Since every count that I can think of, I was omitted from the Declaration and I had to ask -- DOCTOR KATZ: In many ways. MS. KING: In many, many ways. I had to ask myself some very tough questions about if I were given the opportunity to go back and look at the drafting of that Declaration, and then what followed. What kind of judgments would I make? How would I like to characterize it? How would I like to take on that study? Those were tough questions for me. But I think that what it brought home to me was the need to exercise a great deal of care. That this was a period of transition, a very clear transition. We only have a small part of the picture. It has made me far more cautious than I started out, quite frankly, in thinking about where we are in this sort of larger picture of how much work there is to be done. DOCTOR FADEN: It's okay if we stop now? MS. KING: Yes. DOCTOR FADEN: I mean, it's all right. Over the year, I have learned to become comfortable with silence, which is very difficult. It runs against my nature. You may notice that we set aside extra time, and there was a memo that went to you, for something we've not done before, "reading time." I was teasing Anna that there is no way, of course, that we can bar you from using that time to get on the telephone, which I know is always a problem because we all have other professional as well as personal lives that need to be attended to during the break. But the discussion we've just had, I think highlights the importance of Part I, and in particular, Chapter 5 of Part I, which is what we will be discussing after lunch. Both those chapters, but especially part 5, came to you in its revised form very late. I think it was probably Saturday. So, in the first mailing, there was a Chapter 2 and a Chapter 5. Some of us waded in very quickly and very critically on that iteration of 2 and 5. So, 2 and 5 was rewritten -- both chapters were rewritten, especially 5 quite substantially. Then you all got the newest version this Saturday. So, let me ask you, if you haven't had a chance to look at Chapter 5 carefully, if you would take the reading time that you have at lunch today and read Chapter 5, or skim it as much as you can in the time period. Because Chapter 5 is really laying out, as it did in an earlier version -- but it's now in light of a newer, more advanced understanding of several hard more months of Committee deliberation and fact finding and analysis -- a proposal for the standards that the Committee should adopt. It's the first statement in the Committee's voice in the strongest sense. Here's a proposal for what standards the Committee wants to adopt for the following different circumstances. We should have a very thorough debate of what's in Chapter 5 and decide what it is that we like, and what it is that we don't like. So, if it's all right with the Committee, I'm inclined to say let's stop now, which is kind of what we had on schedule. We will return to these communal and total observation kind of check-in points throughout the next two-and-a-half days. The whole of Part I is the discussion item after lunch. But we're going to focus especially on Part V, as well as Part 2, but Chapter 5 is the pivotal one. What about lunch, Anna? This is a new hotel for us. Where do we go? MS. MASTROIANNI: Right. Lunch is at Chardonnay's which is out the door, take a right, and go up the stairs. It's an a la carte buffet. DOCTOR FADEN: We're scheduled, so there's some seating set aside? MS. MASTROIANNI: Plenty of seating. DOCTOR FADEN: We are scheduled to reconvene at 1:30. We'll reconvene at 1:30. If you want a quiet place to read, this room is open and you can come back to your place after you've had some lunch. If you want to read first and get lunch later -- Can you do that, or is the buffet open now? Do we know how long -- MS. MASTROIANNI: I don't know how long it's open. DOCTOR FADEN: I guess the safest bet would be to go get something to eat, and then use your reading time here. So, we'll go to it. We can start ripping things apart after lunch. (Whereupon, the meeting was recessed at 11:43 a.m., to reconvene later this same day.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 1:37 p.m. DOCTOR MORENO: And that makes -- reject or modify or accept wholeheartedly, that these chapter drafts are offered. Chapter 5, especially, takes a big bite. So, what I'd like to do is summarize in what I counted as, essentially, seven different headings, just talking about the second part of Chapter 5. DOCTOR FADEN: Which begins roughly on what page, would you guess? DOCTOR MORENO: Beginning roughly around page 34 or 35. DOCTOR FADEN: And just so everybody knows, this is the draft that's dated May 5th. If you were reading an earlier draft, you had the wrong draft. DOCTOR MORENO: And that makes a big difference. DOCTOR FADEN: It's a huge difference. Okay. DOCTOR MORENO: I'll just tell you what the headings that I'm going to speak to in the next five or ten minutes are, and then I'll go back to each one. The first heading will be "The Operative Standards for the Use of Human Subjects in Research" in general, between approximately 1944-1945 and 1974. The government standards at the time, what the Advisory Committee believes the government standards should have been at the time. On what basis any appropriate blame can be apportioned to government? Then moving to the medical profession, what the medical profession standards were at the time? Then what the Advisory Committee's views are about what the profession standards should have been at the time? Then finally, the basis for apportioning whatever appropriate blame could be apportioned to the medical profession. Let me begin then with the operative standards in general in the period of concern to the Advisory Committee. Those are listed on page 35. They're bulleted. I'll just sort of read them since they are relatively brief. "There was clear awareness from at least 1946" -- and again, this is what we gleaned from the historical record, from the various sources of documentary and human and otherwise that we've been working with. "There was clear awareness from at least 1946, if not earlier, that consent should be obtained from healthy subjects participating in biomedical research. Many established policies but not all of them dictated that this consent be documented in writing." And again, this is not referring specifically either to government or the profession. This is in general, all of those who were engaged in or authorized the use of human subjects in research. Secondly, "the need to obtain consent from sick patients for participating in research were discussed by high level government officials and sometimes required by government policies in the late 1940s. By 1953 at the latest, there was wide agreement that unusually hazardous experiments on sick patients required their consent. However, uniform standards for a patient/subject consent were not established until the mid-'60s, and not until the mid-'70s for minimal risk research." This refers to government regs. "Additionally, from 1946, what were seen as unusual risks associated with radiation experimentation mandate, prior group review of experimental applications be undertaken" and so forth. This, of course, was definitively stipulated in 1966 in the government. Now, the second heading is government standards, what the government standards were at the time. These we begin to discuss on page 36, and moving over to roughly around page 38. DOCTOR FADEN: Pat, do you want to stop for a minute? DOCTOR MORENO: Sorry? MS. KING: Yes, because I'm afraid if you keep going on, then I won't get to ask the questions, section-by-section, because it's hard to keep -- DOCTOR MORENO: Whatever the pleasure is of the Committee. MS. KING: One of the questions I have is, I honestly, from the words of this, don't understand the intent of the section. DOCTOR FADEN: Which section are we on? MS. KING: The one he just -- the Advisory Committee standards beginning at page 34. The page you started with, "Operative Standards within the Government During the Period of Concerned" -- DOCTOR FADEN: It is within the government. DOCTOR MORENO: It is within the government, yes, but I'm going to qualify it in one respect. The notion of consent should be obtained from healthy subjects was not only governmental, but we can go on and do that later. MS. KING: Okay. What I want to know is, what do you mean when you say "operative standards"? DOCTOR MORENO: These were the standards that, so far as we can tell, at the least that were required self-consciously within the government at the time. MS. KING: Well, this is the beginning of the confusion because as I read the factual record, we have documents that -- you all know in greater detail than I do -- that say that committees issued statements, for example, about consent, about risk. What is not clear to me is that that is an operative standard. Because trying to read Chapter 2, which I just got today, says we have all these little pieces of paper and we have all these things in the paper. But we also couldn't find any evidence of dissemination. We could not find any evidence of -- so when I say "these were operative statements", it's a very strong, flat statement that I take to mean "these are the standards I can show operated in government at all levels during the period at issue." That, I don't take is what the record supports. So, my first question is -- I'm not asking so much about the requirement of consent which is the first bullet, but some of the other bullets. I'm trying to understand what you intended to do in this section. DOCTOR MORENO: What we intended to say here was what minimally, a reasonable person would have said at the time in government about what was expected. MS. KING: Okay. That is what I have problems with because I don't read the record to support -- DOCTOR FADEN: Why don't we take it bullet-by-bullet. I think the problem may be "operative" because I'm not sure what -- DOCTOR MORENO: Yes, yes. MS. KING: But he just said that it is what a reasonable person would have understood at the time. MR. GUTTMAN: I think it's Reed Tuckson's point. I believe the way Reed put it was, if someone had the knowledge and reflected on it and was asked. DOCTOR FADEN: All right. MS. KING: That's a very narrow statement, "if you had the knowledge, if you reflected upon it and if you were asked." Because what I question, actually, is who had the knowledge? MR. GUTTMAN: The guys who made the statements. DOCTOR FADEN: Now, wait a minute. Let's step back. DOCTOR MORENO: Why don't we do it bullet-by-bullet? DOCTOR FADEN: Let's do it bullet-by-bullet, and let's see what we want to call what this was, okay? MS. KING: Okay. DOCTOR FADEN: The first one speaks to healthy subjects. Now, we have in Chapter 2 and rehearsed here under the section called "Simple Consent", evidence that several different government agencies at the same time, had documents that stipulated that some kind of consent should be obtained from healthy subjects. The CMR during the War, okay -- and it's clear they have statements about these should be volunteers. These people -- MS. KING: I agree with the statement you just made. DOCTOR FADEN: Okay. MS. KING: But that's different from what he -- DOCTOR FADEN: All right. So, how would you characterize that stage? MS. KING: Just exactly the way you said. DOCTOR KATZ: I don't think we can proceed this way because -- DOCTOR FADEN: How do you want to proceed, Jay? DOCTOR KATZ: What? DOCTOR FADEN: How would you like to proceed? DOCTOR KATZ: Because we've got to get our views out on this. Because I have similar and probably somewhat different problems in general about this chapter. And I almost wish we had started with Chapter 2 because in Chapter 2, all these problems are also foreshadowed the way people talk about consent and standards and things like that. But don't we have just to allow people to talk a bit, as briefly as we can, and give our views and then proceed to the specifics? DOCTOR FADEN: As long as we're clear about what we're giving our views about. I was hoping we could use the document to make sure we're all talking about the same thing. If you want to open it up, we can open it up. DOCTOR KATZ: I don't know whether we can begin to remedy things at this point. That comes, maybe, an hour down the road after Pat and others, you know, have voiced what they see as some of the problems. I don't know. This is just a suggestion. MS. KING: I'll withdraw my statements and be happy to do it anyway the Committee sees fit. I think the issue for us is, what standards do we feel comfortable in accepting as being how people should have governed their research at the time? DOCTOR FADEN: Well, wait a minute. I want to step back. That's too broad a statement for me. MS. KING: Okay, you can make another. I mean, I think that's the big issue here. DOCTOR FADEN: What we were trying to do in this section, what we're trying to do collectively -- now, to Jay's point about process and how we get there, I'm totally open to just -- this section is supposed to be the Committee's conclusions about what the government's standards were at what specified periods of time. It's not whether those are the standards we should use to judge them yet. I mean, we may conclude that that is or that isn't. Right now, this is really descriptive. This is our conclusion, our conclusions after combing all these documents about what the government's standards were. Now, the problem becomes, what do you call a standard, okay? That becomes the issue, okay. Is a piece of paper a standard? So, maybe we want to say something else than that. But we've got pieces of paper that say this and we've got pieces of paper that say that. We're going to have to label it something, reach some sort of conclusion. But these are conclusions, not normative conclusions against with what they should be judged. These are our conclusions about what the standards were in government, not among the profession, not for doctors. Just from the government's own documents, policies, regs, letters, practices, what seems to have been the government's standards over this period from '44 to '74? And if they shifted, when did they shift? All right? Now, how we want to proceed, that's the first task. Then the chapter marches on to the next task. This was an attempt to summarize that, nothing more, okay? But that stuff right from the beginning on what do we mean by a standard? MS. KING: Is Jay correct in that this was drawn from Chapter 2? DOCTOR FADEN: From Chapter 2 and 4 because it marches across time. MS. KING: Well, if that is so, then Jay has a point that part of the quarrel is to understand what Chapters 2 and 4 say, if that's the documentary record and if this is the conclusion we reach from those statements. DOCTOR FADEN: Well, we can proceed either way. I mean, what I had envisioned, but am happy to let go, is to say let's look at this first bullet. If we don't accept that this first bullet is a correct characterization, what are you objecting to? Which may take you immediately to Chapter 2, okay? But if you don't like the formulation in that first bullet, why not? Is it because you don't think it was a standard? Is it because you think the evidence doesn't support this conclusion? What is it? I don't care how we do it. I just want to make sure we do it. MS. KING: Okay. DOCTOR FADEN: Henry? DOCTOR ROYAL: I'd just like to say that I agree with Pat's concern that operative standards in government sounds like a very broad principle. It's clear that at the highest level of government, there was an awareness that consent was important. Whether or not that makes it an operative standard, I think is what the issue is. DOCTOR FADEN: If we get rid of operative -- MR. GUTTMAN: Would it make a difference if we took out "operative standards" and said this is a summary of what the Committee has found in Chapter 2, Jonathan? DOCTOR MORENO: Yes. I wouldn't -- operative standard. MS. KING: The other phrase, the other problem is "within government" because government is not monolithic. I think that these findings have to be tailored to the agencies. DOCTOR FADEN: So "within branches of government." DOCTOR MORENO: This is the most minimal description or account of what would have been the case, as far as we can tell, at any of the agencies at the time. Some of them were more specific and were more restrictive, shall I say, than others. But this is a statement of the floor at the time. MS. KING: So, we're saying here that all agencies of government that conducted research with human subjects, at the highest levels, there was an understanding that there should be consent -- DOCTOR MORENO: Yes. MS. KING: -- from healthy subjects participating in biomedical research? DOCTOR MORENO: Yes. DOCTOR FADEN: Notice it doesn't say informed consent. It just says consent. DOCTOR MORENO: Yes, just plain old consent. DOCTOR FADEN: And the evidence for that is summarized, actually, earlier in the chapter on pages, starting page 22, which is a summary, basically, of what's in Chapter 2 and then goes on to Chapter 4. Jay, would you rather go and have a more general discussion before we start picking apart the bullets? DOCTOR KATZ: I don't know. Whatever you suggest is fine. DOCTOR FADEN: However we do it, the bottom line is can we agree with the bullet? If we don't agree with the bullet, why don't we agree with the bullet as a description of what was found within branches of government during the period of consent to the Advisory Committee? DOCTOR KATZ: This probably is getting us off on a tangent, so stop me almost immediately. I still believe -- when we get back to it, when we discuss Chapter 2 because it's also contained there -- that I don't think, really, any standards existed. Yes, there was the Nuremberg Code and these memoranda, but they were written on sand. I'm not saying we should not take them to some extent seriously and make some judgments about it, but the medical profession in the '40s and '50s, complicated by the Cold War mentality was really completely unprepared to deal with these issues that we are discussing. Consent, informed consent, voluntary were words that they didn't understand, that had no meaning for them. They wandered like -- I don't know, like sheep or I don't know how to put it nicely. You know, the same problem really arises in this Chapter 5. I mentioned it in the comments that I distributed. When we begin to talk about simple consent -- and I gave the 11 definitions from Webster about what simple consent means. Even to this day, in the 1990s, do we know what simple consent means? I don't. DOCTOR FADEN: Well, do you know what informed consent is? DOCTOR KATZ: What? DOCTOR FADEN: Do you know what informed consent is? DOCTOR KATZ: Well, informed consent, at least I can talk about. I can say this is what the judges have said. This is what the federal regulations say that informed consent means, and then I can criticize it. DOCTOR FADEN: Okay. DOCTOR KATZ: At least I have some -- as you know, I have lots of problems with it, but I have something to grab on to. But in all these documents mentioned in Chapter 2, I have no idea what they mean by consent, what the agency means by consent -- DOCTOR FADEN: Volunteer. DOCTOR KATZ: -- by voluntariness, et cetera. And they didn't know either. DOCTOR FADEN: All right. I mean, I don't know how we can -- DOCTOR KATZ: Yes, but I do not know how to proceed. DOCTOR FADEN: Well, let me step back a minute. What you've articulated when you say there were no standards -- that's why the word "operative" I think is perhaps a key sticky point -- there were no operative standards? People didn't conduct themselves by anything like what we're describing. I'm not disagreeing with that characterization, Jay. The question is, how do you want to label the fact that there were policies, that there were statements, and the statements said that healthy subjects have to be volunteers. This was in the Defense Department, and at the AEC, and at the Clinical Center, NIH. All of those three branches of government had pieces of paper floating around -- whatever we want to call these pieces of paper -- that said they have to be volunteers. They have to sign release forms. You need their consent. The language varies from one to the other, but those pieces of papers exist, specific to healthy subjects for all three of those agencies. Now, what do we want to call that? Pat? MS. KING: I want to say that the documents uncovered by this Committee, plus whatever want to answer that, indicate that during the period of concern to the Advisory Committee, there was awareness at the highest levels of the AEC, DOD, NIH, from at least 1946, if not earlier, that consent -- they used the term, Jay, so I'm willing to go with that -- should be obtained from healthy subjects participating in biomedical research. That's a very different statement than here. That does not call it a standard. That says, to me, it is an accurate summary of what we have, which is that the documents that we have show us that at the highest levels of those three agencies -- and the NIH Clinical Center is not an agency, so -- DOCTOR FADEN: Branch. MS. KING: -- branch of an agency. Well, I said that consent should be obtained from healthy subjects participating in biomedical research. With respect to the second sentence, I can only remember the AEC having a requirement for written consent. And so, the second sentence to me is, it's a burden issue. DOCTOR FADEN: The NIH had it, too. MS. KING: NIH and the agency? DOCTOR MORENO: For healthy subjects. DOCTOR FADEN: For healthy subjects. MS. KING: Well, what I would do is to say the AEC and the NIH -- DOCTOR FADEN: And actually, Defense Department. They all did. They all had requirements of -- DOCTOR MORENO: And the Wilson Document. DOCTOR FADEN: -- written consent. It actually could be stated more. DOCTOR ROYAL: What does the word "established" mean in that? MS. KING: Yes, that was my next one. DOCTOR FADEN: Look, you had a statement. All right, this is what we're struggling for. How do we want to express it? What do we want to call these things? The NIH in '53 has a policy statement that says we're going to get written consent from healthy volunteers before they're admitted to the Clinical Center, okay? I'm paraphrasing roughly, Jonathan. Is that right? Something like that. We can go back and look in Chapter 2. The DOD has the Wilson Memo which says you're supposed to get it in writing, presuming that they meant the healthy subjects. The AEC has those two memos, right? The CMR also -- the Committee on Medical Research in the war sends back things saying, "get your volunteers to sign this piece of paper." So, it's the same question, really. We can just simply say that we've also uncovered documents from these three agencies requiring -- that's what the documents say -- that consent be in writing. You want to avoid calling it a policy. MS. KING: Well, "policy" has a certain implication, just as "operative standards" has a certain implication. MR. GUTTMAN: Except they weren't guidelines, because guidelines would have to be publicized. DOCTOR FADEN: Let me get to the core of the objection to calling it policy so we can understand why we're doing -- what is wrong with calling it policy? I'm not talking about whether the policy was effective, Jay, or whether anybody paid any attention to it, or whether it meant anything. I want to get clear on Pat's concern, and others who seem to be nodding with her, as to why we shouldn't call it policy if we've got written documents. I'm agnostic. I just want to make sure we understand why we're making the maneuver we're making. We can certainly step back and use different language. I see Mary Ann and Jay and Pat on this. DOCTOR STEVENSON: I guess when I think of policy, I think of something that was well described and distributed. DOCTOR FADEN: You mean a real policy? DOCTOR STEVENSON: Yes. It's never been clear to me that these things made it out of a file cabinet and that's why I hesitate. DOCTOR MORENO: I'm sorry? I didn't hear you. DOCTOR STEVENSON: Sorry. It's never been clear to me that a lot of these documents ever made it out of a file cabinet. I think of a policy being something that's widely distributed and known within a branch or an organization. MS. KING: I think we probably have a mish-mash. It sounds a little bit like the NIH's might actually constitute a policy, but I have to go back and check about that. I'm much more troubled by DOD's Wilson Memoranda, calling it a policy -- DOCTOR FADEN: And the AEC's memo -- MS. KING: -- and the AEC's statements in meetings and minutes calling it a policy, because I share Mary Ann's concern. I've been a government official. I've seen a lot of things die -- I mean, a lot of stuff get issued and die, and it would be hard to call it a policy. It is accurate to say policy where you could see it operating. Otherwise, you've got to stipulate what you mean by policy. If policy is a written document of an agency proceeding, like a Committee meeting -- that's what you have to call it because policy is a very ambiguous term. DOCTOR FADEN: And so, the argument is if we avoid calling it that, we avoid inflating or giving the impression that something was more than perhaps it may have been. Either that, or we have to refine things more carefully. MS. KING: Right. Or you have to define how you're using the term. DOCTOR FADEN: Jay? DOCTOR KATZ: It depends. You know, sometimes when I read here the word "policy," I get a sense, you know, that we're using it as really, here is something that was thought through, that was considered to some extent, and policies were established. I do not know, and I wish I could find on short notice the words to convey what my picture is what went on at the time. Let me put all these people from the Department of Defense, et cetera, on a boat. They were in stormy seas. They suddenly were aware that they were standing on the deck nakedly, that they had no policies with respect to conducting human research. Something was needed. DOCTOR MORENO: A fig leaf, perhaps. DOCTOR KATZ: What? DOCTOR MORENO: A fig leaf, perhaps. DOCTOR KATZ: Yes, thank you very much. They needed all kinds of fig leaves because there were already the boats coming that they feared public opinion. They would be embarrassed. The insurance company would be upset. The -- sharks or lawyers were about to attack with lawsuits, et cetera. They might be censored by Congress, et cetera, for having no policies. They were utterly upset, frightened, et cetera. Suddenly, somebody threw him a life raft. The life raft was the Nuremberg Code. They immediately adopted it. They didn't know whether the life raft was inflated or deflated, how far it would carry them, et cetera. Lo and behold, the problem was solved and they proceeded as they had done in the past. The waters, for a while, were a little bit calmer. That's the picture I have of what went on at that time. In a few hours, I can put it much better. What is the picture that we're starting out with? That's what I don't know. DOCTOR MORENO: Let me suggest the following alternative way of framing this. What we're looking for is what somebody in authority uttered in some fashion that the people who were responsible to that person, that person then expected those people to execute. DOCTOR STEVENSON: But we don't know that. MS. KING: In many cases, we don't have the last part, Jonathan. What we have are -- DOCTOR MORENO: I'm sorry, what's the last part? MS. KING: That they expected certain people to follow it. We have the statements. DOCTOR FADEN: We don't know what happened. MS. KING: We don't know what happened. Our record isn't clear. DOCTOR MORENO: No. I'm talking to the expectations or the intentions of responsible officials. DOCTOR FADEN: But do we know even that? MS. KING: But we don't know that either. DOCTOR MORENO: We have some of that. It's not true. We don't have all of that, but we have some of that. We have documentary evidence of the -- unless we think these people are liars or hypocrites, which is a far greater indictment than even the staff in these documents has even hinted at, we have statements of some minimal meaningfulness. Now, I take it that when the Secretary of Defense says something about written consent, that that is a statement of some minimal meaningfulness about his or her, in that case, intention. And the same is true of the general manager in the AEC and the other responsible authorities. MS. KING: I think that your choice of words in the memo is a more accurate statement than what you just said. You said "awareness" and I think that's accurate. What their intents were -- I'm one of those people who went through the draft and said you can not say they knew, they knew, they knew when we're going into our mental thought processes because we can't do that. DOCTOR FADEN: All right. What we can -- MS. KING: This says there was awareness. You know there was awareness because we have these documents signed by people at the heads of agencies that there was some awareness of this. What we can't figure out so easily, it seems to me -- we may be able to do it in some cases, but this is a summary statement -- that we can't figure out what their intent was. I mean, his intent may have been to sign this statement, stamp it "Secret" and put it in the bottom drawer. DOCTOR FADEN: Yes, I know exactly, but we've all been struggling, I think, with exactly the same problems. I got a little note from Jon here. I don't know how much we should fight out whether we call it a policy or not. If something comes from the Armed Forces Medical Policy Council, it sounds like a policy. If something that comes from the medical community from blah, blah, blah, it sounds like policy. If the Committee on Medical Research sends a letter that says you have to get signed something or other from your volunteers in your infectious disease research -- I'm thinking maybe this isn't a battle worth fighting, okay? We can simply say we found these documents. The documents say the following things on this issue. All three agencies had documents which indicated that consent was required from healthy subjects in research. Whether they were policies, effected policies, not effected policies, they had documents that said this is the way things were supposed to be. All right? Sometimes the policies look like one thing; sometimes they look like another thing. Can we say that? That's descriptive. It's true. Okay, we have these documents. It's accurate. Accurate is better than true. It's an accurate statement that we have documents from all three agencies indicating that consent was to be obtained from healthy subjects before they could be enrolled in research. MS. KING: I don't think anybody had any objection to that. DOCTOR FADEN: Can we change the bullet to words to that effect? We don't know what they meant by consent. The statement doesn't say anything about whether they ever effected these statements. It simply says there were such documents. DOCTOR KATZ: What does that mean? DOCTOR FADEN: Just that they had these documents. Well, it has moral relevance later because you certainly can't say they never considered or thought about how you could use a healthy subject in research. MS. KING: Look, we already said something because we found some documents, with the possible exception of the Wilson Memo, that nobody knew about before. That's one of the major things that we talk about in here. That our fact-gathering produced new and different data. So, one of the things that is easiest to say is a statement that says the documents that we have -- we don't even have to put the caveats in it. They used the word consent. Somebody else can come along later and try to figure it all out by what they meant by it, but it is accurate to say that they used consent. That's a new thing for us. DOCTOR FADEN: That's what I'm trying to get us to reach consensus, can we say that? Dan? MR. GUTTMAN: What Jay has just described may well be policy, you know, the fig leaf. That may be what policy can be in some cases. But each one of these documents was not an awareness, merely, in the sense that someone wrote a memo saying, "gee, I'm aware of this. It's nice to have it." They were all decisional documents. And, I think, in some significant sense, the AEC documents arose in '47 because Stafford Warren wanted to know what to do legally and financially about proceeding with the AEC's research program. The first Wilson letter followed the meeting with the lawyers and Stafford Warren, and was a directive. It was carefully stated as a passive directive, I think. Right, Jonathan? It said we understand you're going to do this, not that we're actually going to follow it. But the point is that, and also, I think the Defense Department which actually was then transmitted to the services, they're more than -- I just want to say, you're under-selling these. We all understand that they didn't seem to go very far, but they were more than awareness. They were awarenesses where people were required to focus by decisional momentum. It's a little bit more than an awareness. It's obviously whatever it is less than people feeling comfortable with an implemented policy. But it's more than just -- MS. KING: But we've been doing what Jonathan said we were doing, which is to making the minimal summary that one can make from the documentation. I assume that if the documentation supports more than the minimal assumptions -- MR. GUTTMAN: In some cases it does, yes. MS. KING: -- then at the appropriate places where we're discussing where more is supported, that that will be raised. MR. GUTTMAN: Yes. Yes, we do that. That is correct. DOCTOR FADEN: Mary Ann? DOCTOR STEVENSON: It can wait. DOCTOR FADEN: We'll reach for language. I mean, what I'm getting at in this discussion if we focus -- on the chapters, we're getting rid of the notion of operative standards because that denotes an effected policy which is not what anyone is saying actually happened here. But to say merely that some people in government, you know, wrote a casual letter saying, "gee, consent would be nice from healthy subjects," is also not an accurate description of the kinds of documents that we uncovered. So, we have to find the right language that captures what Dan was describing. This was not idle musings by, you know, someone who simply said "gee, maybe it would be nice if somebody thought about getting consent from healthy subjects." But it was something less than an operative, effected policy of the sort that we all recognize, in fact, didn't happen in all three of the agencies. Now, as a matter of contingent fact, I don't know what happened at the NIH in the Clinical Center. You know, we haven't checked the records that I know of. For all we know, they have signed informed consent forms for every "healthy volunteer" that was admitted to the Clinical Center from '53 forward. I really don't know. So, we have to be careful not to diminish what shouldn't be diminished, and not aggrandize what shouldn't be aggrandized. So, the art form will be finding the right language. DOCTOR KATZ: Can I ask a question? I hope it may clarify something, or it may confuse things more. I don't know. In reading this chapter, and after I was through and sat back, I didn't get a good sense of what the message was with the chapter. It started out in very strong language about ethics and morality and things like that, things about which I know. And philosophical and by ethical implications about all these things I know relatively little. I was confused, but it was really very strong language also, if not explicitly, implicitly condemning all kinds of practices. But then when I get to the end, to the final statements on governmental and culpability and medical culpability, I thought everything turned out to be rather weak. We indicted the government, but who is this government? I wonder who this government is who we found culpable? With respect to individual agents of the government, we said "no good would come of assessing blame to individuals unless what they did was patently evil or irresponsible to the degree that could be considered criminal" -- and that's sure about that that has to be criminal. It can be called reckless negligence or something -- "there is no evidence to support such a harsh judgment. Rather the record suggests a series of small errors." Now, I was struck by that, "small errors"? Is this what we said before? They were only small errors? I think they were big errors, not small errors. And then the same thing -- you've all heard it -- with respect to the medical profession. We finally indicted them only for non-therapeutic research. They shouldn't have conducted it the way they did, and not so much therapy as I read it "similar with respect to physicians. Unfortunately, the -- of the medical profession at the time was not sufficient basis for critique of the errors that lead to these wrongs." I didn't quite understand this sentence, but I think I know what it meant. It said that the ethics, of which in part I agree, that the ethics of the medical profession was, at best, still at the earliest stages of reformulation. Then it talked about non-therapeutic experimentation. But for that one, can't almost hold the medical profession really accountable in light of the Hippocratic tradition. Because in the Hippocratic tradition, there were no admonitions with respect to non-therapeutic experimentation. The Hippocratic Oath didn't address itself to these issues. DOCTOR MORENO: We point that out. I think that was -- DOCTOR KATZ: Yes, it's on one page pointed out -- DOCTOR MORENO: It comes under -- DOCTOR KATZ: -- and in other pages, it's the opposite, you know? But that can be reconciled rather readily. So, what the question really is, after all is said and done, what is the message of this chapter? I don't understand it. DOCTOR MORENO: I think the message of the chapter is that it is now wrong, and always has been wrong, to use people in medical experiments without their consent. That's the message. That's the strong line that the chapter takes. I think where things get to be more difficult is where we go from collectives like government and the medical profession, which are powerful entities in society from which we have very high expectations, which we as individuals are -- to use the expressed that came up before -- denuded before. We're very vulnerable with respect to those powerful entities. We have to hold them to a high standard. Now, we get mushier, admittedly, when we get to individuals, knowing how much blame to apportion to individuals when they were operating in a different cultural -- which is what you've been addressing yourself to. DOCTOR FADEN: Which is the whole challenge. DOCTOR KATZ: But the grandfather of research ethics, you didn't mention it, is Claude Bernard. DOCTOR MORENO: In other chapters we have. DOCTOR KATZ: No, no, he's mentioned in this chapter. He didn't mention consent at all. DOCTOR MORENO: Granted, yes. DOCTOR KATZ: You know, with respect to research. He said, "if it benefits them, do it." No mention of consent. It was something that was the part of medical thinking with respect to patients because the patients were supposed to be seen but not heard. DOCTOR FADEN: But we're all agreeing to that, Jay. DOCTOR KATZ: Yes, yes. DOCTOR FADEN: That's description. The question is, morally, what do you make out of it? We're all agreeing that that's what it was like. Now the question is, what is the moral significance of that description. That's what we're trying to argue about in this chapter. I want to try another group summary, but Pat wanted to come in with a comment. MS. KING: I think we're hopping and skipping around -- DOCTOR FADEN: Yes, I do too. MS. KING: -- so I want a process that we stick to. I got the message of the chapter and I didn't like it. So, I want to either have my mind changed, or have myself reaffirmed that I didn't like it. The only way, I think, that you can do that is where Jonathan started, which is that you have to first have a Committee understanding of what the evidence summarizes as. That's poorly stated, but you all got my message. Second, which is where Jonathan went, you have to have some understanding of the standards by which you are going to judge the evidence. And then third, you've got to judge it. I think that the only way we're going to get there is to be very disciplined about first, what does the evidence say to us as a Committee? I mean, how do we want to say it, which is where he started us, and then go to the next session -- it may take us all day -- DOCTOR FADEN: That's fine. This chapter is absolutely -- MS. KING: Don't let us stray from that. If nobody else will volunteer, when I get out of line, you can crack your whip. DOCTOR FADEN: If people agree with Pat, we're marching on forward. If it takes us all day, it takes it. This chapter has got to be understood by all of us. If we can't agree to something, then we've got to figure out what to do. That doesn't mean we have to agree with what's here, but we have to agree to something or discover where we disagree. Because all the judgments we want to make about the case studies' chapters hangs here. This is the framework we're putting out for making all the judgments we want to make from here on in. So, if we were talking earlier about the Committee finding a voice and deciding what it wants to include about prisoners, TBI, plutonium, whatever it is, we've got to figure out if this is where we all agree we're going to evaluate from, the framework we want to accept. So, is it all right? Can we just keep going? And then, Jay, we'll get to your objection to the whole thing as we get to it. Some people will think it's too harsh; some people will think it's too weenie, whatever. But why, okay? Why is it too harsh or why is it too lenient in its judgments? We've so far gotten past one bullet on page 35 with the understanding that we're now going to try to find some language that captures what these statements they were, statements we have found. They were from high government officials. They had some decisional authority, but we will not call them either operative standards or effected policies, or even policies. We will simply come up with some sort of language that describes it. The next bullet speaks to what we were able to find in the documents with respect to consent and patients, as opposed to consent and healthy subjects. Now, the case gets more mixed. The evidentiary base is more mixed. But I think the statement is accurate if we eliminated -- the statement that's bulleted is accurate if we take it without the preface of calling these "operative standards." Does anybody want to challenge those lines? MS. KING: I just want to ask a question about the wide agreement. DOCTOR FADEN: Sure. MS. KING: I know that there are documents from the AEC that talk about unusually hazardous experiments on sick patients. Does that surface with respect to other agencies other than AEC? DOCTOR FADEN: Only one, only one. DOCTOR MORENO: The Clinical Center. MS. KING: Well, what I would do here is not say that there was wide agreement. First of all, Ruth, I would specify the agencies we're talking about -- DOCTOR FADEN: Fine. DOCTOR MORENO: I've already got it written in. MS. KING: So, that's done. And when we say "wide agreement", what I would do is to say that the AEC and the Clinical Center agreed. We haven't been able to find anything. It doesn't mean that it wasn't there. DOCTOR MORENO: Right. Fine. MS. KING: It could be. We just don't have it yet, is what I would say. DOCTOR MORENO: I guess when doctors and lawyers agree on something, I take it as wide agreement. MS. KING: When what? DOCTOR MORENO: When doctors and lawyers agree on something, I take it as wide agreement, but I take your point. MS. KING: Look, the idea is that a lot of people may agree with you. But I think that the first stage is to say what the documents say, then let people argue about the -- DOCTOR MORENO: Right. We'll go descriptively at this stage. DOCTOR FADEN: Yes. And I don't think we have any DOD anything that speaks on research on sick patients at that point. So, that's fine. Other changes? Then you see the transmission in the mid-1960s. We all know what we're talking about here. This is where the guidance comes out, and then the yellow book, and then the rest of the world that we all know about. But it is in the mid-'60s, and all three of the agencies start kicking in with statements requiring consent from the mid-'60s onward. Again, Jay, what they did with it is a separate issue. We're now just describing what the statements were from the agencies. They start increasingly approaching formal policies, obviously, a published federal regulation -- if nothing is called a policy, that's got to be called a policy. We can get to that. All right. So, now, if we're done with that bullet, can we go to the next bullet, line 6 through 11 on page 36? All right, can we move on? MS. KING: Are you talking the third bullet or the second bullet? DOCTOR MORENO: Third bullet. DOCTOR FADEN: I'm sorry. It's the third bullet, lines 6 to 11. This is going to risk management, basically, the safety issues. DOCTOR STEVENSON: Was this, again, the AEC Isotopes Division-specific? So, it should be stated as such. DOCTOR FADEN: Good point. Henry? DOCTOR ROYAL: Yes, it's much too broad the way it's stated because one of the remarkable things is how little attention was paid to risk of the use of external forms of radiation. So, it's really isotopes that received special attention. DOCTOR FADEN: Good point. MS. KING: Well, that means we should eliminate the first sentence. Is that what the agreement is? DOCTOR MORENO: We eliminate or modify it to read -- DOCTOR STEVENSON: It should be "Radioisotope Experimentation." MS. KING: Lines 6 through 8 because are you going to say "additionally from 1946, what we're seeing is the unusual risk associated with" -- DOCTOR STEVENSON: It should be radioisotopes. DOCTOR FADEN: To the AEC and to radioisotopes. The Clinical Center's approach to higher risk studies would come in as a weaker form. DOCTOR ROYAL: The unusual risk part, is it unusual risk or is it that they were unusually -- DOCTOR MORENO: Concerned. DOCTOR ROYAL: -- conscientious or concerned? DOCTOR MORENO: I think that's right. I mean, that's why I tried to say "what were seen as." What they, themselves, saw as the uncertainties associated with -- MS. KING: Uncertainties is a better word. DOCTOR MORENO: Okay. DOCTOR ROYAL: It's a better word. DOCTOR MORENO: I'm trying to convey the fact that it came from them. They were the ones who were especially concerned about the kind of double-edged sword that they were dealing with, that they could be seen as dealing with. A great benefit, and yet, of uncertain dangers. DOCTOR ROYAL: There's a big difference in the nuance between saying -- DOCTOR MORENO: Yes, there is. DOCTOR ROYAL: -- "unusual risk" versus "unusual concerns." DOCTOR FADEN: This is what is awkward. Again, it's getting into the heads and this is hard. You know, why were they worried about radiation risks? Why did they decide that they needed to worry about it? I think, you know, we can speculate. Some of it seems to have been political. DOCTOR MORENO: Yes. DOCTOR FADEN: They were worried because this was not like typical medical research. If the public got upset about this, it could stop the whole bomb production problem. It was a funny difference, you know. So, there was a more political edge to it. DOCTOR ROYAL: Wasn't it also the first time that the government was really getting directly involved in medical research? DOCTOR MORENO: No. DOCTOR FADEN: Well, I mean, the CMR. There were a whole bunch of, you know, funding in research during the war, and then the NIH, and then National Science Foundation inherit the Committee on Medical Research's portfolio in large measure. Again, money is starting to be given out in large amounts. I mean, the interesting issue may be that it's the material that the government is distributing. Whereas, in the other programs, it's the money that the government is distributing. I don't know whether that matters. The fact that the government is licensing, distributing the agent as opposed to elsewhere where the government is giving you the money at your university and then you're doing it. Maybe that was part of it -- more ownership. MS. KING: What do the documents say? DOCTOR FADEN: Pardon? MS. KING: Are the documents silent on why they decided to do this? This is supposed to be a summary of what the documents say. So, the best thing to do is go back to see what they say. DOCTOR FADEN: We'll try to find language, but I think it's often not -- it's very obscure. MS. KING: Well, if it's not there -- DOCTOR FADEN: -- on why they decided to go ahead with it. DOCTOR MORENO: We've already reported, Pat, that there were public relations concerns. There were legal liability concerns. There were population specific concerns: pregnant women and children. There were multiple motives, apparently. DOCTOR ROYAL: But I think that that point that you just brought out, that one of the ways that this was different was that the government was actually distributing the agent and therefore, they felt more liable is a very important point. DOCTOR FADEN: We'll have to come up with something. All right, so we know that this isn't quite right. We know we've got to refine it to the AEC, make it clear that it's isotopes and not all forms of radiation. And then say whatever we can say about the Clinical Center's general program of looking at higher risk research which kicks in in '53, too. DOCTOR ROYAL: So, again, one of the things that makes it an unusual risk from the government's point of view. DOCTOR MORENO: Yes, in one sense of the risk, yes. It's the fact that they were giving stuff out. DOCTOR FADEN: Yes, they owned the stuff. You know, they're giving out the stuff as opposed to somewhere else where they're just giving out the money. That makes some difference, probably. So, we don't really know all the reasons. DOCTOR ROYAL: But in terms of communicating to everyone else, it's very important that we make clear what unusual risk means. Whether it means that it was unusually risky in a risk benefit point of view in terms of biomedical research, or if it was unusually risky in terms of the government because they might be unusually liable. DOCTOR FADEN: Yes, and we don't really -- so we need to be careful. Jay? DOCTOR KATZ: Just to go back for one moment to the second paragraph beginning at the bottom of 35, 36. I would suggest that we need to have a sentence here that suggests about what the nature and the quality of -- was to be. It was never explored in any of these documents. I think this is very important, and I have -- maybe get to Chapter 2, I even found evidence in some of the quoted announcement. I mean, they even said, "well, we need some kind of consent, you know?" DOCTOR FADEN: We need that qualifier for both bullets. DOCTOR KATZ: But we need that in here -- DOCTOR FADEN: Well, we need it for both. Both the first one from healthy subjects and from -- DOCTOR KATZ: We need it here. DOCTOR FADEN: -- there. I think we can somehow -- because for both of those, that statement is correct. In both cases, the statement about consent from healthy subjects and the statements from the government, various government agencies about consent in exceptionally hazardous experiments with people who are ill, there never is any of what you're describing, Jay. So, we should just make that clear that in both cases, that there is no elaboration of what is meant. Your point is well taken, but it also applies even to the first one, for the healthy subjects as well. All right. This is the easy part. No, really, because all we've done so far is agree how to characterize the documents that we have, which speak to -- MS. KING: There needs to be a section following this -- DOCTOR FADEN: Okay, what should that say? MS. KING: -- that does what Dan wanted done, but I think that the Committee needs to give guidance. And that is, the next section proceeds on an understanding that the preceding section was about standards, which we just took away. Dan's point was that in certain of the documents he believes are entitled are greater than this minimal weight in the context in which those documents were issued. So, for those documents, or for what he had in mind, that needs to be -- these are findings, if case you all happened to forget. DOCTOR FADEN: Oh, yes, yes. MS. KING: So, in order to support a second level of findings, that's what needs to be developed for that small area or large area, whatever, where you have something beyond minimal that you can draw inferences from, or you believe that you can draw inferences from. Maybe Dan can give us an example of what I have in mind because I can't give the example. MR. GUTTMAN: John Harkness was just muttering to me in the hall that he's Doctor Katz's right -- DOCTOR FADEN: Will you talk right into the microphone? MR. GUTTMAN: Oh. When the Armed Forces Medical Policy Council is asked to recommend a policy and it recommends a policy, there's something there that's more consequential than somebody just writing a memo. DOCTOR FADEN: Except that that something is the Wilson Memo that Jay believes isn't -- MR. GUTTMAN: With due deference to Doctor Katz -- DOCTOR KATZ: With deference to the armed forces, right? MR. GUTTMAN: No, no. Doctor Katz -- personal, not professionally. The fact of the matter is that Secretary Wilson's memo went out with the directive to the services and the Army did, indeed, implement that -- through its own memo, and to some extent, the 1975 Inspector General Report finds -- it was put into effect, obviously with flaws and -- but there was an instance of a policy. MS. KING: I think that's what we need here. I'm not sure I would disagree with you. I tend to agree a little bit with Jay about how much weight we give to it -- MR. GUTTMAN: That's a separate matter, yes. MS. KING: -- but I do believe that it is not of the same weight as some of the documents that we referred to when there was mention of consent. Because of the Secretary of Defense signing it for one thing -- I mean, that's the first thing that helps you with weight. I think that that's an example of what can be called out. But that's the next section that needs to follow. MR. GUTTMAN: Actually, the truth of the matter, hopefully, is that Jonathan has already done that in Chapter 2. Is that -- DOCTOR MORENO: Yes. I was going to say, I think we've covered a lot of that territory already. MS. KING: I did not get Chapter 2. I've been sitting here trying to read it so, I am -- ignorant of it. DOCTOR MORENO: Yes, all right. DOCTOR FADEN: But I think the point is well taken though in terms of structure. If we have this two-fold thing, okay, we first lay out these characterizations. Then the next section, which summarizes what is in Chapter 2 which is how far can we go in interpreting what these pieces of paper were? In some cases, we can say very little, and we're really only talking about three pieces of paper that. Well, maybe a little bit more from the Defense Department besides the Wilson Memo -- because there's some stuff that precedes it out of the CMR and then the AFEB and so on. So, there's a fair amount of evidence that this was around as something like policy, even if it didn't have the effect on practice that Jay is reminding us it likely did not have, okay. It's around as a piece of paper and it's around in lots of offices. The AEC one is the most ambiguous, and the Clinical Center is reasonably straightforward to establish what happened when they said healthy volunteers have to sign a piece of paper when they come into the Clinical Center from now on. Did they do it? We should be able to establish. It doesn't detail what the exchange was, how good the consent was, or whatever. But did they start getting healthy volunteers to sign consent forms in the '50s and forward when they were admitted to the Clinical Center. I don't know how much research on healthy subjects they even did at the Clinical Center, but we'll find that out. A little late in the game, but we'll find it out. Okay, so we'll try and do what Pat suggests and see -- it is, again, not new. It's summarizing what's in Chapter 2, but clipped. You know, getting right to the point and seeing if the Committee agrees with the characterization. MS. KING: Do you want us to look at Chapter 2 to see if it's there -- is it there in some summary form? DOCTOR FADEN: Except for the NIH Clinical Center, it's there. DOCTOR MORENO: I think it is, yes. Even the Clinical Center stuff is in Chapter 2. DOCTOR FADEN: No, I know, but we haven't checked independently to see what happened, other than that they had a policy that said, "we haven't traced to see" -- DOCTOR MORENO: Well, some of the interviews in oral histories support it. DOCTOR FADEN: That's true. They're on it. That's right. They do speak to it. They do say they did have healthy subject consent. DOCTOR MORENO: And that is quite -- DOCTOR FADEN: That's a good point. DOCTOR MORENO: -- uniform in the reports we got. DOCTOR FADEN: Well, do we want to do that work now, or do we want to march ahead? DOCTOR KATZ: What's simple consent, my old question? DOCTOR FADEN: That's my language. DOCTOR KATZ: Well, what is it? DOCTOR FADEN: Well, we were struggling. What did we have before simple consent? DOCTOR MORENO: Well, I think we had assent. DOCTOR FADEN: We were trying to distinguish between the -- actually, it was largely in part, in response to you, Jay, in you reminding us regularly about how we are to use the term "informed consent." As I went through my copy of the report, I kept marking report-wide issues, one of which is when we use the term "informed consent" and how we're going to use it. DOCTOR KATZ: Right. You mean voluntary submission, closer to voluntary submission? DOCTOR FADEN: I mean something like that. Basically, the notion that instead of dragging you off -- to contrast it with -- either passive or aggressive. So, if I make you a research subject without your knowing it because you were a patient in the hospital and I do things to you. You think it's my medical treatment and I let you think that it is your medical treatment. In the meantime, it isn't; it's research, okay? There is no even simple consent. The doctor didn't say, you know, "Mr. Katz, while you're here, we'd like to do a little research on you. Is that okay?" All right? DOCTOR KATZ: I'm leaving. DOCTOR FADEN: You don't even do that. Okay, he simply goes ahead and draws the blood from you and does whatever he wants. That was be in absence of simple consent, in contrast to, at minimum, saying, "Mr. Katz, you know, this is a research hospital and some of the stuff we do here is research. Is that all right with you?" And you say, "Doctor, it's okay. I'm sure you wouldn't do anything that hurts me." And he says, "you're right. I wouldn't" and that ends it. So, if something is distinguished from that, or alternatively taking a healthy person, dragging them off the street, holding them down by physical coercion and making them give blood, versus saying "we would like your permission to draw your blood for a research project. Is that okay?" And the person says "yes", okay. So, it's trying to distinguish between somehow recognizing some sort of respect for the person, minimally, as an agent whose body can not be used by another without some kind of authorization. It was to distinguish it from the full notion of informed consent where there's an adequate basis for the person to make an informed decision, and some provision for decisional independence and capacity, and a whole bunch of stuff. It's not a highly refined concept. DOCTOR KATZ: Yes. Something should be said about it except, you know, you're going to run into a problem here if I heard you correctly. That way of doing it, to my mind, is almost more disrespect than grabbing him and taking blood out of his veins because it is here that the deception of saying something that is utterly meaningless in a way, and that bring you up -- DOCTOR FADEN: Right. That's worth debating. I would disagree with you, so that's worth debating. DOCTOR KATZ: I know what you're after and one would have to find at least the first time it's being used, some kind of words to describe the dilemma that this word could -- DOCTOR FADEN: Right. You may be more comfortable, since you like to operate out of legal history, the distinction that is often made between consent and informed consent in terms of -- DOCTOR KATZ: Between what? DOCTOR FADEN: Consent and informed consent. If you want to take Salgo as the defining notion and saying, "okay, the cases before then talked about consent, but not informed consent." I think we don't have to take the whole Committee time on this one. DOCTOR KATZ: Yes, okay. DOCTOR FADEN: You and I, with others who are interested, could work this one out to find the right way to do it. Duncan? DOCTOR THOMAS: I was puzzled because in the previous draft, these notions of simple consent, the components of the simple consent follow non-coercion and understanding and were all clearly separated into three different sections. Now, they've all been kind of mushed together. What's left seems to address, primarily, the simple consent aspect of it. DOCTOR FADEN: We can pull that back in. DOCTOR THOMAS: Was this a conscious decision and if so, why? DOCTOR FADEN: I don't know anymore. DOCTOR THOMAS: What happened? DOCTOR FADEN: Jonathan, was it a conscious decision? DOCTOR MORENO: No. First, let me say that the idea of simple consent, I think, is analogous to that of permission giving. Perhaps that's better than consent, or perhaps that's one way of explicating consent. In other parts of the document, I think we still have those elements of consent. Here, we were trying to be a summary. And again, concerns were expressed this morning about the length of the final report. We've just added about six or seven pages in what we've done so far. DOCTOR FADEN: I'm concerned -- and I'm sorry for my own discouragement. I think we really need to get back on -- we're losing it and we still have so much more in this chapter to march through, if we can get back. It almost doesn't matter for the rest of what we need to do, how we hammer this one out. DOCTOR THOMAS: Right. DOCTOR FADEN: Pat? MS. KING: I had two thoughts. One, I think that this chapter with respect to language, you use the language of the time. We shouldn't change it to permission. We shouldn't try to stipulate our understanding. They used the term consent. When we get to a different part where we have some money we want to give to it, that's when you do it. So, I think when you're doing historical stuff, you stick with the historical terms. If history gives you any indication of how they were used -- and you talked about that too -- but changing it causes confusion. DOCTOR MORENO: But they used a family of terms, Pat. That's a good idea. MS. KING: Well, as long as we stick to the family of terms. I mean, my problem is, do we know what they meant by consent? It's more relevant to know what they meant by consent than it is to know what we think they meant by consent. DOCTOR LEDERER: But there's also the problem that when we use it in a document that's being read by people who haven't seen any of the documents, that they will take the meaning of consent that's being used today. So, I think that the language choices are important for the reader of this document. MS. KING: Well, I think that in the historical chapters -- I'm doing it too -- it is important though for us not to change the language from the documents. We quote extensively from the documents, and they used the word "consent." Now, what I think we should do is explain that what we've done. All it takes is a sentence or two until -- DOCTOR MORENO: We did that. MS. KING: -- we get to another point, and then we'll do our own -- DOCTOR MORENO: Not in this chapter. MS. KING: The second point is, I would like to ask Jonathan -- I think this is very important and I think he can't do it today. I think that if he could overnight -- give us tomorrow morning -- a statement with respect to the AEC -- it's just summarizing what he's done so we can focus on it -- and the Clinical Center and the DOD, about what he would call -- now that we've just said the first section was -- DOCTOR FADEN: You mean the section that's missing, basically? MS. KING: Right. What he would be prepared to call it and why. This is the policy because it was issued by the Secretary of Defense. It was disseminated. It was implemented by an agency. DOCTOR MORENO: We could give you some of that right now. MS. KING: I'm not talking about language, but I think we need to see it. So, if you have it in Chapter 2, tell me what page? I looked quickly through Chapter 2, and I haven't read 2. I was looking for a summary statement and I didn't find one. Just so that we could see that in the -- DOCTOR MORENO: Just so I'm clear, Pat, you mean a summary statement of what we take to be the levels of authority of the different statements that have been made? MS. KING: Right. But Ruth said there were only, basically, three. MR. GUTTMAN: Simple. Jonathan, we can do it. DOCTOR MORENO: We can do it right now. MS. KING: I'm not asking a big thing. DOCTOR FADEN: Right. But when you guys do it, do it for all three of the bullets, okay? MS. KING: Right. DOCTOR FADEN: If two of the agencies by the third bullet, drop out or one of them drops out, have them drop out. Make the strongest case that you can. DOCTOR MORENO: All right, but you don't want me to make it now? DOCTOR FADEN: Well, I don't know. MS. KING: I don't want it orally, and that's the problem. Because orally, we're not really focused on it. So, if we could actually look in front of us and see your reasons in this case. And I'm not talking here, polished language. I'm really talking about three or four sentences per agency. So, I don't think it's big. Just so we have something to focus on. DOCTOR MORENO: Okay. DOCTOR FADEN: Okay, and the goal is to see whether the Committee can agree on how to describe what these documents represented on a scale from usings through to an effected formal, widely recognized policy, something. You know, somewhere on this continuum from somebody scratching his head, or she saying "gee, you know, we ought to do something about this" through to an order that everybody follows. MS. KING: I take it that there is a consensus among the staff, for example, some of the documents really represent policies. I may agree with that. I'm just trying to see in a low bullet -- DOCTOR FADEN: Fine. All right. Absent that, it's a little hard to go forward, but we can go forward. Okay? Because the next task, Jonathan, was -- DOCTOR MORENO: Standards for judging government's culpability. DOCTOR FADEN: So now, we go here's the description of what was going on at the time that bears on research rules. I have, by the way, set aside problems calling these ethics policies. To me, they're just policies, rules governing the research involving human subjects. We can dignify them by calling them ethics policies, but I don't think of them that way. I just think of them as policies, or rules, or statements, or whatever. Unless somebody specifically evokes -- All right. So now, Jonathan, can you take us through the reasoning without -- DOCTOR MORENO: Well, I'm not sure I can, but I can tell you what our conclusions were. DOCTOR FADEN: What's the conclusion argued for here with respect to how to judge the conduct of the government and the culpability of the government? Two different kinds of judgments. DOCTOR MORENO: First of all, that any agency of the federal government that undertook experiments with human subjects but did not have a policy, a term which I'm now using carefully again, when the standards of the time would have required that they have such a policy would be morally culpable for any wrongs associated with human experiments. So that, if you were supposed to have a policy at the time and didn't, then you, the agency, would have been responsible, morally culpable, for any wrongs that happened to people as a result of not having such a policy. MS. KING: Can I stop you? DOCTOR FADEN: Yes. MS. KING: Now, I assume you had something in mind when you wrote that because who can object to such a straight statement? DOCTOR MORENO: Well, I'm sure that the members of the Committee will find a reason. MS. KING: The issue for me when I read this section and this goes to where am I going? I think if you make a statement like that, then you've got somebody to apply it to. DOCTOR MORENO: This came up, Pat, because as I think Henry and others have pointed out, oddly, the folks who tried to create a policy, even though they failed, perhaps, to implement it or get it all the way through, then get hoisted on their own petard.This is covering that kind of a situation. Those people who should have had a policy, but didn't, are not off the hook. MS. KING: I understand a little bit. I don't agree with Henry, by the way, because as I recited to Dan, the problem with Good Samaritan and law is precisely that problem that -- long time about do you go after those you've got records about, knowing that you're going to miss some who were smart enough not to put things in writing? That may be a grounds for mitigation. But who do you have in mind that we have facts that will support application of this statement? See, I don't have any problem with this abstract statement, but to me, it's not worth having here unless it's got a purpose. I assume that the purpose is even for future -- judges. Maybe that's the purpose, or that we actually have a situation that you think fits this. They should have had a policy, did not have a policy, and therefore, they are culpable for wrongs associated with the activities. DOCTOR MORENO: Well, I take it that the evolution of regulation of the use of human subjects from the late '40s to the early '60s is an implicit recognition that there ought to have been policies in place in the government. That's not true? MS. KING: I don't know why it follows that because we figured out today that we do things differently because it makes better sense to do it today, that I should draw from that the inference that they should have done it 20 years ago? DOCTOR MORENO: Well, it seems to me that the way that those policies came up, supports that. But we can argue that elsewhere. MS. KING: But that's what I want to hear because that's what I don't agree with. DOCTOR MORENO: I would be satisfied with the defense that this is something that the Advisory Committee ought. The Advisory Committee ought to say that, a Good Samaritan, to the contrary, problems of the contrary notwithstanding, you ought to go on record as having a policy if that's what is most likely to protect people to whom you're responsible. MS. KING: Well, I think when you take Henry's point -- because when you go after people who had policies who didn't deliver and you chastise them for doing that, you can not say that you realize that they at least tried, and now we're penalizing them. I mean, the kind of stuff we say about the Good Samaritan rules, but there are reasons for honing in here, you can't ignore it. They had a policy that they didn't implement. What I am worried about is this statement that said, "they should have had" -- this is a strong statement of a principle. It is more than taking care of Henry's point. That they should have had a policy. If they didn't have a policy or -- I want to know why should they have had policies? Your answer is, the fact that we know today that certain things are required is a justification for the should have -- they should have known it 20 years ago. I don't know how that accounts for evolution and transition and all those kinds of things. That's my question. DOCTOR FADEN: Can I try a variation? What I think is argued here is the conclusion which we have to decide whether as a Committee, we want to accept or not, on how to look at the government. There is a strong statement that says -- it's not in one clean place, but it basically says the federal government should have had clear and uniform policies concerning the use of human subjects in the research that it funded and supported. Okay, that's the judgment. Now, how do you get to that? That's the issue. The Committee will agree that the government should have had such policies in place, implicitly saying they didn't have them. They should have had them. Now, why should they have had them? Well, one, when you look at these statements, these documents, the language that we haven't decided exactly what to call all these things, it's clear that there was, at least, a recognition that you should get whatever they meant by consent, okay, from healthy subjects. We had these documents. Let's start with that, okay? We will decide, based on what we think of what Jonathan and Dan do tomorrow, how high up these documents went towards policy. In some cases, they may have gone fairly far. But we've already agreed that they didn't go to effective policy, that they were not implemented as they should have been implemented insofar as they began to approach something like policy. But the point was, first, that they were aware that consent should be obtained. Something they called consent should be obtained from healthy subjects, okay? But leaping ahead, when we do all the work in- between, we have evidence that they didn't do the job by that that they should have had. Then you say, "okay, well, what about when you go from the healthy subject to the ill patient?" Then there's language in here that basically claims that they should have recognized that there really was no moral difference, which is the hard part -- MS. KING: Yes, but I'm not understanding why they should have. DOCTOR FADEN: Well, that gets to the part where it starts to get shakier, okay? That's where it starts to get shakier. You can take it first with the healthy subject. You can not say that they were unaware at the time of the notion that people should be asked before they're used as human subjects. There was enough evidence around that the people in high authority in government knew that you shouldn't use somebody as a research subject without asking them first -- let's use that language -- or consent, whatever terms they called it. They seemed to have focused that notion primarily on healthy subjects. Now, what do you do with that piece of information in terms of making a judgment about the fact that they failed to go very far with that? That's an open question. The next leap is towards what we have called here, a non-therapeutic research with patients, okay? If high officials realized that you can't use people as a mere disease means only -- you've got to ask their permission before you can use them as research subjects -- were they justified in thinking that that protection applied only to healthy people? Why would ill people not be afforded that same protection? Should they not have seen that? MS. KING: I see no reason why they should have. DOCTOR FADEN: Okay. DOCTOR KATZ: Pat, do I understand you correctly? Why should the government have been concerned about these issues? Because they really could have felt that there was really nothing to worry about, about human experimentation with patients or by physicians. Because the medical profession is so dedicated to protect the welfare of human beings just wouldn't do anything that would be against the principle of primum non nocere -- do no harm. There was really no need for any regulation. MS. KING: And I actually think it was when we discovered that the medical profession wasn't doing it, that we started to say we had to extend the protections. Now, that's an equally viable interpretation. DOCTOR FADEN: No, I understand what you're saying. DOCTOR MORENO: But the documents don't support it, unfortunately. The documents show repeatedly that government officials attempted, in various ways, to intervene in physician activities and investigator activities. They show that from at least the mid-'40s on. They often shrank back from implementing it in various ways but they did not wait for the scandals that we're so familiar with, to break out to take an interest in the question. MS. KING: But what you're saying and what Ruth just said is they really didn't take a big interest in therapeutic research that they really -- The question I -- DOCTOR MORENO: I don't know what you mean by "big interest." They certainly took an interest. They did take an interest. That, we can show. MS. KING: Maybe when I read this whole report, I kept seeing a distinction between healthy volunteer and the -- for healthy volunteers, and then what happened when we got to sick patients. DOCTOR MORENO: Yes, yes. MS. KING: Now, I don't think that history changes overnight. That there is usually an evolution that is very hard to tag. DOCTOR MORENO: Yes. MS. KING: I mean, you'll have these darn markers. So, what I'm trying to figure out is, when I say 20 years ago, 40 years ago, they should have done this, the fact that they did something differently in another arena, and the fact that some people around at the time argued for doing something, does not, to me, translate into a should. I have not seen any -- MR. GUTTMAN: It's a little bit different because there are two kind of situations, based on the discussion that we were having at lunch. DOCTOR FADEN: Can I just say one thing? I keep getting little signs. Everybody speak in their mics, please? MS. KING: Oh, okay. DOCTOR FADEN: Pull them a little closer to you. MR. GUTTMAN: One possible setting was that as great debates in American history -- you know, abortion today -- there were vigorous proponents on both sides. After 100 years, one side wins out and then to say that the side that was the loser somehow should have been on the winning side, is a difficult question. What we're looking at here, and I think is what Jonathan is saying, it's not as if -- first of all, we're confusing two things. One is the notion of the autonomy of the medical profession, or the tradition which Henry pointed out and you pointed out that historically, everybody left it to the doctors and they're wonderful guys. That's one thing. That was clearly an historical reality. But in that context, in 1947 at the AEC when the lawyers and Stafford Warren sat down and the lawyers said there has to be consent, the doctors didn't say "that's contrary to the principles of the medical profession. That's amoral." They said, "okay, as long as we're the ones who get to put in writing." What Jonathan is really saying, to be quite focused and quite specific based on the evidence, is then when Stafford Warren goes over and forms the VA's medical research thing which gives out, according to the VA, enough isotopes for these thousands of experiments. Ruth and I are sitting there saying, "was it really thousands?" Anyway, some number of experiments -- there was no inhibition. It wasn't as if the VA researchers were saying it's amoral and unethical to require consent. The only issue, where it comes up in terms of a live, evidentiary debate, there's one place and it's very interesting. Jonathan may find more. Robert Stone, in 1948, when he gets into a dialogue which we only, unfortunately, have fragments about where the AEC, Gregg and Shields Warren are saying, "Stone, it looks like radio -- are unethical." His response is in terms of the AEC, the government shouldn't regulate the doctors. But from what we know, it's not about consent because Stone, of all people, as per the document we have in the briefing book, he's a vigorous proponent of the consent. So that, the should have is that there was no -- no, with sick patients. With sick patients and this document -- DOCTOR KATZ: But Dan, that's in part, the point, you know. We mentioned 1947. I was a second or third year medical student then. Let's assume I had been present at this meeting that you just mentioned. MR. GUTTMAN: Yes. DOCTOR KATZ: I might have wondered about, "well, what are they talking about consent?" And I didn't learn anything at all about consent in my medical school education except in an applied kind of sense. Namely, when you decide that you want to do something to the patient and for the patient, you'd better make sure that he will say yes, you know. Put it to him in such a way to say yes. DOCTOR FADEN: Wait. DOCTOR KATZ: And in the course of this, you know, you have to down -- this and the other thing -- because it was important, you know, that the patient accept doctor's orders. DOCTOR FADEN: All right, let's step back. What are we trying to do? We're trying to figure out whether the government did anything wrong in this period? What was it and why? Okay. And if they did anything wrong, how responsible are they for it? How blameworthy? Let's use that one. Should we blame the government for not having done something? We can all say they should have done something more, but do we blame them for it? What I'm hearing from Pat and from Jay and perhaps from others of you that are nodding is that the statement in the draft that says the government should have had policies to protect human subjects in the 1940s and '50s, is not a supportable position. MS. KING: Well, I didn't say that. I asked what was the support for it? DOCTOR FADEN: Right, okay. MS. KING: Which is different. And the answer I have gotten so far, Ruth, has not gone to that question, except for your statement. The answer from Dan and from Jonathan goes to the question of if the government had undertaken policies, they wouldn't have had any problem imposing them on the medical profession. I have no problem with that. I'm crystal clear about that. What I'm interested in is, why should they have promulgated policies? Why should they? What is it in the atmosphere, in the water, whatever, that should have made them understand that this is something they should have done? That's what I'm interested in. DOCTOR FADEN: Yes. Let's step back -- DOCTOR KATZ: Ruth, can I ask another question very quickly? It's in light of what you said. DOCTOR FADEN: Yes. DOCTOR KATZ: If we assume for a moment that we are now investigating what transpired during the Cold War and we learn that all this was done, what had been done. But the Department of Defense had not promulgated the Nuremberg Code, and they just continued on their merry way without the Nuremberg Code and any kind of regulations. How would we evaluate then what the government did? DOCTOR FADEN: Well, you know, I'm not sure. Counter- factuals are always difficult because you have to then stipulate what -- DOCTOR KATZ: Well, it's a thought experiment. DOCTOR FADEN: Well, I know that, but you have to also stipulate in your thought experiment, Jay, what would remain. Would you allow to remain, the evidence from the Committee on Medical Research during the war, before the Nuremberg Code, which required that participants in the infectious disease research be volunteers and give consent, that pre-dated the Nuremberg Code? So, presumably, you'd allow that to stand. DOCTOR KATZ: I would allow it to stand, to add to this, in the sense of that of course, they had raised the question but very, very quickly retreated from really thinking through to any, even superficial extent, the moral implications of what they were doing. That was just not part of their thinking. DOCTOR FADEN: How do we know that? DOCTOR KATZ: No, no, I'm assuming that for the moment. DOCTOR FADEN: Well, I know, but I don't know that. All I'm saying is that all I've got to go on is -- DOCTOR KATZ: Well, I'd read the document to be sure it's somewhat speculative. If we are saying that they really were concerned about these issues, that is speculation even from the documents. I said, you know, they were just spinning their wheels to some extent. DOCTOR FADEN: All I'm saying is not whether they gave it great concern or zero concern. There are documents that pre-date the Nuremberg Code that express statements from the federal government, in this case, the Department of the Army, saying -- Committee on Medical Research is the War Department? Who is it? DOCTOR RUSSELL: It's the Army as opposed to the Navy, right? DOCTOR FADEN: What is it, Jon? DOCTOR HARKNESS: The Committee on Medical Research was part of the Office of Scientific Research and Development. The head of that office, Vannevar Bush, who was sort of the science czar in the country, reported directly to FDR, and it was a major coup for the scientists of the country not to be under the thumb of the military. DOCTOR FADEN: So, it actually was -- spoken. So, it's a different -- DOCTOR HARKNESS: Yes. I mean, so when the CMR has a policy, it's pretty legitimate, in my opinion, to call it a government-wide policy during the war. MS. KING: We're not discussing that issue. We keep confusing issues. DOCTOR FADEN: But Jay raised the thought experiment, so I'm trying -- MS. KING: We're talking about in the -- oh. DOCTOR FADEN: I don't know how far to go with it because the point is with thought experiments, you have to decide where it stands and what remains. But if the point that you're going to, Jay, is the whole thing is because the Nuremberg Code existed, I think the answer is no. The answer is not it's merely a function of the fact that the Nuremberg Code came, although I don't think you can say that the experience of the Holocaust and the Nuremberg Code that came out of it is irrelevant either. It certainly is coloring some of the discussion that we see people having after the war, you know, they're worried about it. Let me step back, to go back to Pat's challenge. If we can not support -- and I'm willing to go back and try a better rationale, position, that the government should have had policies to protect the rights of interest of human subjects prior to the 1960s when they got these policies. What kinds of conclusions or judgments do we want to reach? DOCTOR MORENO: Well, the next possibility is that we hold the government responsible for the policies, if it had any. But it did have. MS. KING: Right. And I want to be clear that I'm not into that topic because then, I think you have to discuss documents. But this statement didn't say that. It says, "the standards of the time would have required it", is the operative phrase that triggered my -- DOCTOR MORENO: Gotcha'. DOCTOR FADEN: Phil? DOCTOR RUSSELL: Pat, I think you could make a case for an evolution of thought in those communities that were dealing with research and healthy volunteers from the turn of the century through the middle of the century. There was an evolution of thought in that community that made them very concerned about informed consent. The Walter Reed experiments -- remember, there was a death in that group and there was informed consent. This was known to the infectious disease community. A few years later, there was another set of experiments done at Walter Reed with typhoid vaccine. They had another death. Actually, they had three infections and one death from inadequately, again, volunteers with informed consent. There were continued experiments with volunteers through the early '20s. That infectious disease community was well aware of, one, the value of informed consent in terms of dealing with the emotional and political issues of high risk research. There was also, I think, a conviction on the part of that community that this was essential to -- and this was, of course, during World War II when there was a lot of work done with hepatitis. And again, more deaths and these were accepted as a part of doing business. Given that, the requirement for informed consent, however you want to define the term, was recognized. So, I think there was a fairly large community in the infectious disease, microbiology community. I suspect, but I don't have the documentation, that there was some similar evolution of thought in the people who were doing physiology experiments where they were really stressing people with heat and other kinds of environmental stressors to determine the limit. I'm less secure about that. So, I could make an argument that there was enough background experience with volunteer research, especially with very high risk volunteer research, that the biomedical research community was well aware of the value and the necessity of having a policy to regulate such. One of my problems is that I don't know how to interpret the term "agency." I don't know whether that means a medical research organization within one of the services, or whether it means the Department of Defense. Sometimes, the meaning and the implications are quite different. It seems that earlier in the historical record, that the policy may have been at a lower level. It may have been at the Army Medical School. It may have been at the Surgeon General's office rather than an army-wide recognition of it, and only later percolated up from the researchers who were doing the work and their immediate superiors, to higher levels of the organization. I don't think the very upper levels of the bureaucracy paid much attention to biomedical research prior to World War II. DOCTOR FADEN: All right. What I think I'm hearing -- I'm sorry, Pat, did you want to get in? MS. KING: I think that part of what Phil is trying to do is actually borne out. I mean, it's consistent with some of the documentary evidence, particularly about healthy volunteers. What I'm concerned about -- and I think I'm biased here -- I remember when I was in a recombinant DNA committee that people who were doing molecular biology -- and this is what we also have to use to balance this. People who were doing molecular biology never talked to the virologists. There were repeated statements. Even though there were statements, it never worked. That everything that we needed to know about how to take safeguards with respect to recombinant DNA experiments, if we went to talk to those people who dealt with pathogens, that we wouldn't have to sit in open meetings like this and debate it. But we couldn't get the two communities to talk to each other in any kind of meaningful way, except very disjointedly over a process of time. What I'm worried about when I say, "this should", rather than describing a transition where knowledge is gradually diffused -- and you can see signs of that. Should is for me a hard -- I mean, it's a tough word. I'd like to just be more careful about how I use it. I'm not saying I'm not willing to condemn where we have some evidence about policies -- DOCTOR FADEN: Well, I think what's happening is something like the following. My sense of it is that we can construct a case that the government had various degrees approaching policies approaching the level of something like a policy -- whatever we want to call these terms. I don't even care what we call it -- with respect to healthy subjects and that we can hold the government accountable if it didn't effect a policy protecting healthy subjects. There's a tradition; it's there; it's whatever. We'll come up with the right language, but that seems to me to be not the problem. It may have real important payoff, but it's not a problem. The problem is moving from the healthy subject to the patient, okay? And whether the research is non- therapeutic or therapeutic, what we want to say is what did the government did wrong, if anything, in the period from '44 to '66? If it did anything wrong, how blameworthy is the government without, for a moment, even beginning to get to the issues of what level of the government, agency, people, whatever. This is why I would kind of like to put this to Jay because you were apparently moving to criticize the chapter as it currently is, being too weak in saying, you know, "small errors," "government officials didn't do anything so bad." On the other hand, I hear you saying this was a time in which medicine was a totally different ethos, seemingly agreeing with Pat and others that this was the time at which it seems reasonable that the people in government just deferred to the issues. -- the big guys and they would take care of things. So, it would have never occurred to them to regulate because this was the province or the profession that had high esteem and seemed to be in control of itself. So, the question is which way do you want it? How do we set it up? DOCTOR KATZ: Okay, it's interesting. I was just thinking about it before you brought this up. Let me say a few words about that. It really takes us back to the beginning of our deliberations and maybe Susan Lederer will say something about this, too. Because it seemed to me in the presentation that she made and in the presentation that I made about the history of human experimentation, that there was an interesting tension there. That Susan seemed to be emphasizing more what a few people like Sir Henry Osler and Walter Cannon and others had said about the ethics of human experimentation. Susan seemed to emphasize more that there was sort of a moral sense about the way human experimentation should be conducted. I took the position that in a sense, there was not any kind of moral sensibility -- very little moral sensibilities at all, that human experimentation was, until the '60s and '70s, really by-and-large by the medical profession, subsumed under the rubric of therapeutic care to the maximal extent possible. No consciousness had emerged, isolated voices notwithstanding, about what should be the ethical standards with respect to human research. Therefore, I am taking the position, on the one hand that to really make a strong indictment on the basis of the existence of any kind of moral consensus -- make a strong indictment of the medical profession and the research profession, to me, makes little sense, though I would describe what they did. And I would also raise the question, and even then in a sense, be perfectly willing as an individual, to make some judgments. Though appreciative also of what I've just said, how could you doctors, how could you human beings behave the way you did? How could you treat human beings in this kind of fashion? How come you didn't realize that there are ways in which we ought not to treat other human beings, human beings under our care, et cetera, et cetera? But constantly being appreciative of the old Latin saying, "Hominem Lupers" -- what is it? "Man is wolf to the man." That's part of the human condition too. What's also part of this, but of the ethos of the search is, that these people were decent people in other ways. They really were interested in advancing the frontiers of knowledge for the benefit of mankind. But at the same time, they did also things that we have a somewhat greater appreciation about. But I think -- at least my review of contemporary research practices, suggests not sufficiently so -- and I'm already anticipating and wondering what our ultimate conclusion with respect to moral progress is going to be when we get to that chapter of our history. But be that as it may, this is the way I would put it, but surely I wouldn't say it, in one more sentence, that these were small errors. They were big errors. But even -- DOCTOR FADEN: But whose errors are you talking about? I'm trying to get a fix, Jay, on what you've just said as to whom it applies. It sounds to me like your comments and your analysis apply to the physician investigators. DOCTOR KATZ: Yes. DOCTOR FADEN: And what I'm trying to understand is how your analysis applies to the government officials who gave out the money, who set the rules, which is what this chapter is about? It's not about the doctors at UCSF who injected the plutonium. It's about the men in the AEC who gave them the money or gave them the plutonium. So, the issue is how do we analyze that level of responsibility? That's what we're trying to do in this part of the chapter. DOCTOR KATZ: Well, again, you know, this opens up a wound at least in the area of injury from a slightly different perspective. Namely, so far as I've thought about it, my thinking would be that I might hold these government officials responsible for not even thinking to raise the question, "is there anything to be worried about in any activities that you are going to engage in and are participating in with respect to research? Do you have any standards for this kind of conduct? Can we trust you?" That they didn't raise these questions, one can talk about -- DOCTOR MORENO: Jay, that's exactly what -- DOCTOR KATZ: What? DOCTOR MORENO: That's exactly the attack that this section takes is that they ought to have thought of it. But Pat objects that that's not a meaningful question. DOCTOR KATZ: I don't think so. MS. KING: I didn't say it wasn't a meaningful question. DOCTOR MORENO: I'm sorry. -- question that we couldn't give -- an answer. MS. KING: Yes. DOCTOR MORENO: How's that? DOCTOR KATZ: I think you would consider that a meaningful question, wouldn't you? MS. KING: Yes, but I wanted to know where it was going. DOCTOR MORENO: But if you didn't know what a meaningful question is, you can't give a meaningful answer to it. MS. KING: Right. I mean, it's a question -- DOCTOR MORENO: -- meaningful question, it really isn't -- language 101. MS. KING: It is a question you have to ask. And the question is, do you keep it when you figure out you can't give an answer to it, or that you can give an answer to it. DOCTOR MORENO: Right. With all due respect, I think we really need to move to the question of apportioning blame to the extent that there was any government failure to satisfy the three bulleted statements that we have been editing for the last hour, if that's appropriate. Otherwise, I'm afraid we'll never get to the even harder stuff. DOCTOR FADEN: Well, I want to get Phil and Susan and then we'll do what you say. DOCTOR MORENO: Right, right, right. DOCTOR RUSSELL: I think that one of the aspects of it that needs to be highlighted is what I perceive as a high level of tension between the government agencies who are attempting to carry out the policy imbedded in the Wilson memorandum. The example I use is that attempt through the Armed Forces Epidemiologic Board to implement a Surgeon General directive. It resulted in a strong set of arguments from their colleagues at Harvard, as a matter of fact, and I think members of the AFEB, who said the government has no business telling us how to conduct our medical affairs. That is, in my view, an important set of documents because it clearly outlines the tension and the difficulty that the mid-level of the government had in dealing with this issue. Even when the policy was in place, there was quite clearly a resistance out there to government involvement in their behavior. DOCTOR FADEN: Yes, which is not well enough spelled out. Sue, and then why don't we try marching forward? I'm not sure that we can. DOCTOR LEDERER: Yes. I guess I find myself in great sympathy with Pat, raising the hard question about why the government should have had policies. And our inability to come up with a convincing answer to that question, I think is problematic. I guess what I want to highlight is that any time that you're trying to chart the course of moral progress, flux, transition, these are the things that need to be emphasized and the tension that Phil has just pointed to. To go back to a point that Jay made, I guess my point in talking about Sir William Osler and Walter Reed and Walter Cannon, it's just to show that the idea that respect or protection of the rights of human subjects was not an undiscovered country in 1945. At the beginning of the century, there are a few sort of sentinel voices, if you will, or prophets, or voices in the wilderness who are identifying this as an appropriate area for concern. What we see, I think, in the '40s and the '50s is, you know, perhaps a critical mass approaching, you know, like "how are we going to resolve these issues?" I think rather than perhaps focusing on what the government should have done, it's for us to focus on what they did. I will use the word policy. DOCTOR FADEN: All right. Let me -- MS. KING: I agree with Susan, everything she said. DOCTOR FADEN: That's fine. I think that you've given great expression, Susan. But the reason why there is a struggle to raise the question of government culpability moves to the question of retrospective recommendations. So, there's an interplay here that goes back and forth between what judgments we want to reach about government conduct, and what recommendations we can make about how people ought to be treated who were treated, potentially wrongly. So, that's part of the tension here. If we can decide the government didn't do anything wrong just the way things are, ideas have to percolate -- MS. KING: But keep in mind that you can make remedies for people. You can come up with remedies; you can come up with recommendations without finding culpability as well. There are lots of reasons for doing it. DOCTOR FADEN: Right. The distinction that the chapter sometimes does not always make clear is between two different sorts of judgements, which is whether something should have happened, or something that happened was wrong. The judgment of the conduct, the policy, or the absence thereof, from blaming anybody for it, okay? So, you can have the statement that says it's wrong that the government didn't have policies to protect human subjects, once it got into the funding human subject business in a big way. I mean, you can argue that once you've got a situation where -- which is part of the argument that I didn't put forward -- this is the time at which the government, beginning with the CMR and then moving forward, is paying for all this human subject research, okay? This is not an activity being done by physicians in the private sector and the issue is, should government put its big foot in here and regulate it? Government is paying for this. We're talking about the research that it supports or conducts, not just medical care that's being provided and paid for out of people's pockets. This is even before the insurers are a big deal. This is research that is funded and supported by the federal government. There's a nexus for federal involvement. The government doesn't set out regulatory or other oversight mechanisms that adequately protect the rights and interests of the people who have become the subjects of this research that the government is either doing itself or paying for. So, it seems to me that you could take a position that says, "that was wrong. They should have had this because they were paying for it." Do we blame them at all? Do we blame them a little? Who would we blame? Then you start this whole complex evolving cultural blah, blah, blah stuff and say, "gee, you know, these were shifting times." There was a dominance in the medical profession. You get Beecher and colleagues at Harvard saying, "what do you mean you're telling us what to do? Don't tell us what to do," and back and forth. You begin to come up with a kind of understanding of why, perhaps, it didn't go the way it should have gone. But the question is, does the Committee even believe that the government should have had protections, even if it understands why and doesn't blame the government much for not having had such protections. This gets to the core, a core challenge. Do we believe the government should have had such protections? MS. KING: I can answer that easily. I haven't seen anything yet that would tell me they should have. That's not to say -- DOCTOR FADEN: So, the argument -- MS. KING: But Ruth, there's something else going on here. The should question is bigger than what the task -- in some ways, bigger than the task of this Committee. When you talk about should the government regulate because it issues money for human experimentation, that's in part, a human experimentation question that is in part, a regulatory question. We are talking about a period where, in comparison to today, there was relatively little government regulation about how to spend money. DOCTOR FADEN: That's correct. MS. KING: There's a whole social, economic, cultural context out there that we wouldn't dream of trying to take on. What I'm really asking, the should context question then, is there anything that has come within the purview of this Committee that we have taken a look at, that can help us with that should question? It doesn't mean that some other kind of examination won't make a strong argument for answering the should question in a different way. The problem that keeps recurring in this report is the problem I always have in my own writing, as the Chair knows only too well. I don't know where to draw these rigid guidelines and say, "I'd like to go beyond that, but I can't because we can't undertake that examination." We have that here. There's a tension in part of what Jonathan suggests where he's talking about what moral values were known at the time, at page 38. He talks to the moral value of privacy and bodily integrity that was broadly -- well, you know, you can't make a statement like that in a report like this until you're willing to take some kind of examination of that broad moral climate that talks about privacy and bodily integrity. Judges say, "I take judicial notice," but we're not permitted to do that, I don't think. I don't think we are. So, part of it is that I don't want to claim too much force, and I don't want to claim that we have been resolved or not resolved the big questions. Our focus is, what did we do from what we examined? What can we extract from that? That was the focus of my question. It doesn't answer the question -- DOCTOR MORENO: Well, look, there's a non-radiation example in the CIA for MKULTRA. I gather that there were no ethics standards in that agency -- it does say it's an agency in its title -- at the time, even though something like we've just gotten from the CIA indicates that they are still not prepared to assent to the proposition that they didn't get consent from Doctor Olson to take the LSD. If it is true that they did not get consent from Doctor Olson to be a research subject in that LSD experiment, and if it's true that the CIA did not have a policy governing human experimentation in the agency, sponsored and funded by the agency, conducted by the agency, then I'll put it on the table. Would we hold the CIA responsible, even more responsible? Not only for the harm to Doctor Olson, but also from the fact that he underwent that harm, death -- I take it to be a harm -- without a policy in place in the agency governing human experimentation? Or would we want to say, "gee, they didn't have a policy. In 1953, it was a different world. The CIA world was perhaps different from the DOD world where they did have a policy, whatever it was. Is that okay?" MS. KING: I'm prepared to say that until I see certain kinds of evidence, I don't see anything yet to bite the bullet. I understand why you're asking it. DOCTOR FADEN: Okay, what I don't understand is what counts as evidence? Because I don't think we're talking about documents here. MS. KING: No, we're asking why should? What is the criteria by which we're going to make a should statement? I have two criteria in mind. One, that we can show, we have evidence -- and I do mean evidence. Something to indicate that at the time, there were general standards that said that the agency should have a policy. It should have known. I understand that because that's what lawyers do. They use "should have known" -- you had an obligation. You may not have specifically known, but you have to come up with something about why you should have known at the time that there is either an existing set of standards -- it doesn't have to be written down -- broadly in the population, so you judge people by the standards of the time, or an institution by the standard of the time. Or you can judge an institution, it seems to me, in the absence of the standards of the time by an institution setting out a statement or a principle and acting inconsistently with it, or acting to ignore it. But I don't see that here. That's what I've been looking for. DOCTOR FADEN: All right. I'm going to do this. Dan, a last comment and then I'm suggesting a break. Then we can come back and maybe our minds will be clearer. MR. GUTTMAN: I don't think it's a fact problem. I think Jonathan and I can tell you quite -- you couldn't have a better case. Shields and Stafford Warren, who are the two principled doctors involved in the so-called AEC Wilson letters were both keen advisors to the VA in their isotope distribution program. Now, the question Pat's asking is should they have had a policy at the VA which is really the open agency. I could agree with Pat that there are all kinds of reasons they should have had a policy which Phil just articulated quite well, is because it would have been a big nightmare because all these doctors would be saying, "what are you doing?" and all this kind of stuff. That may have been a reason they didn't have a policy. But that's not the question, I think, that the Committee is really focusing on which is, was that a principle which was known to those that were in the middle of the process getting in the human experimentation business? It may be that the facts are there and the question maybe not be should they have a policy, but what do you do when you know that people who were in the center of these programs knew the right thing but for whatever reasons -- maybe because the practicality was, they couldn't have had an effective policy. MS. KING: Or it may have been that they were isolated. MR. GUTTMAN: Well, that's what I mean. That's right. So, what's the judgment then? What do you do then? DOCTOR FADEN: We don't have the fill-in-the-gaps part, okay? We have what we have, so we'll have to see what we can do. MS. KING: But part of what we can do has to take account of the fact that we know we don't have everything. DOCTOR FADEN: Right. All right. I think we should take a break. When we come back, maybe we should move off the government and on to investigators. I don't know that we can take the government thing -- DOCTOR MORENO: We'll do something less controversial like doctors? (Whereupon, off the record at 3:29 p.m., until 3:52 p.m.) DOCTOR FADEN: We have reached a point where I think we can do one of two things. We can continue to work on this issue of the government and how to understand the government. Maybe see where each of us is individually, but knowing that we're going to get back a document by tomorrow morning -- I'm sure Jonathan and Val and Dan are thrilled to do -- which try to articulate the level of formality, let's use that, that stands behind whatever we want to say existed in each of the agencies, relative to the three bullets that, as Jonathan pointed out, took an hour or so to edit about eight lines together. So, we can continue to work on the government thing and it might be useful to hear what you as an individual, each of us, think you need in order to go through this further. I would like, before the day is out, to move to the heart of the chapter that talks about understanding standards for judging the conduct of the medical profession and individual investigators to see how far away the draft is from being acceptable to the whole Committee there as well. So, want to make sure that we don't spend the whole afternoon only on the government side of things, especially since we're now going to have, in writing, more text from staff with which to sharpen our views. But not all of us have expressed our position or even your state of confusion about what you would take to decide for yourself what you want to do with the government section. So, it might be helpful if we did that for a few minutes and then left the government question and went on to the investigators. Is that comfortable with everybody? I think it will help staff when they go to work tonight to know what questions you have, to see if they can try and answer them. What would you need to know more to be able to make a judgment? MR. GUTTMAN: That was it. It's the -- for what more facts you need, if possible. DOCTOR FADEN: Well, not necessarily facts, but -- MS. KING: Is it a question of what we need to know more, or where we stand with what we know? DOCTOR FADEN: Both. MS. KING: So that the staff can have some guidance whether this broad agreement with a split view, so they can write it that way. DOCTOR FADEN: My concern is that I'm not sure that people have even formed views yet, but that's what we can see. So, if we could try it -- MS. KING: If you just don't have it at this meeting, you're not going to make it. DOCTOR FADEN: Right, I know. Well, we may not have it now. I'm thinking we may have it tomorrow, is what I'm saying, when we see this further document. But if people would just take a minute -- and I hate to sort of go around the room and point to everybody, but you know who you are. Please, just speak up. Duncan? DOCTOR THOMAS: I've been very loathe to wade into this argument because I confess, I've had a hard time following it. Let me take a stab at summarizing what I thought I heard this afternoon and maybe Pat can set me straight if I've got it wrong. Well, Sue really just clarified it, crystallized it for me with her remark to the extent that early in the century, there were a few, I think you called them sentinels, people who were really very forward-looking who were virtually crying in the wilderness. Then sometime around mid-1940s perhaps, there was this critical mass, I think you called it, of people who really began this dialogue in earnest. At that point, things began to move which eventually materializes in formal government policies. The sense I was hearing was that to the extent that this dialogue was going on in a responsible manner and eventually lead to policy, that that process was legitimate, and that we can't fault the government for not having seen right at the beginning what the final end product of that process ought to have been. That as long as the process was moving along in a sensible and timely manner, that it's unfair then to find the winner -- someone else was referring to the abortion debate, that the winner of that one was right all along and everybody sort of should have seen all along that they were right. So, what I'm hearing from Pat is the sense that she wants to know on what basis can we judge the government culpable for not having gotten to the right answer right at the very beginning of this process? I'm still a little bit unclear. At some point, you tried to explain what evidence you would like to see on which we could judge the government culpable for not having standards, and I was unclear as to what those criteria were. Maybe one more repetition of that, I would find helpful. MS. KING: I haven't, in all my reading, discovered anything yet where I'm prepared to -- DOCTOR FADEN: Pat, in the mic please because people in the audience have been complaining that they can't hear it. MS. KING: I haven't, from looking at our records, seen anything yet that would lead me to be willing to go on record as saying they should have had a policy. Now, this is distinct from the question of those agencies that started down the policy trail, which we have not talked about yet. What I was asking for is, does anybody have an argument that I might have missed, so that I could change my mind. But basically, I said it. I agree with Susan that I see this as a period of transition and flux and evolution. I liked in the first chapter, the analogy of the Declaration of Independence. I thought we were right on in the terms of how the understanding of that document has evolved over time and has expanded over time, and what we think it means as expanded. I would not be prepared to say they should have known during this period, enough to have set up a policy. What I also said was there are arguments from other fields that have yet to be examined or made that might shed light on this. From an examination of government regulation, from an examination of -- from an examination of everything. I'm just saying based on what we have, and what we have examined, I'm not prepared to say, and I won't say -- maybe I'll make it stronger -- that they should have had a policy. And Jonathan heard me right because that's when he challenged me. DOCTOR MORENO: Can I say something? It is unfortunate, I think, that we got off on that tangent of that counter-factual for so long that we do have documentary evidence to support the proposition that at least certain agencies by a certain time had policies. That, I think, would be a more important proposition to establish at this stage. DOCTOR FADEN: Which is part of the task between now and tomorrow. DOCTOR MORENO: Which is part of the task that we're undertaking. DOCTOR FADEN: Thank you, Duncan. We'd like to hear from Mary Ann, will you? DOCTOR STEVENSON: I'm not having so much trouble with the concept that there was precedent for policy or standards in dealing with healthy patients. I mean, Phil cited the infectious disease history and I don't need to go through that. But where I am having a problem is the sense of the government should have had standards for experimentation or work with sick patients. I think the evidence there is harder to come by. I think it's clearly sad, regrettable, and despicable, many of the things that went on. But is that period of time that elapsed from the '40s and '50s up to the '60s and '70s when regulation was mandated, the unfortunate learning curve? You know, it was a novel situation. The technology was new. The money, the whole development of the biomedical research field was sort of developing in front of everyone's eyes. I don't know how the government necessarily should have known that the agents, the doctors, the researchers, would need to have strict regulation to make sure their behavior was honorable or humane. It's sad, but I think it may be true that this was an unfortunate period of learning for the government for biomedical research, perhaps. I'm hard pressed to find the evidence that would have foreshadowed the need for that kind of regulation out the gate. I mean, especially when you look at all the debates that went on at Harvard between Beecher and real giants of the field, where they were very reticent to have any kind of legislation, based on the fact that the doctor or the researcher would be acting in a moral manner and that was sufficient. Clearly, it wasn't, but that was the thought at the time. DOCTOR FADEN: This is helpful. This is helping us get out. Is there anybody else that wants to contribute? Lois, not to put you on the spot but -- I'm putting you on the spot. MRS. NORRIS: No, because my concerns have really been addressed by a number of people. I share those concerns and I have the same feeling of unease with where it stands as I read it. But I've allowed others to speak for me. DOCTOR FADEN: Nancy, Eli, anybody else want to chime in? DOCTOR GLATSTEIN: Let me take a crack and see if I can get something out, understandable. The NIH has traditionally not been the regulatory agency. The FDA is, but not the NIH. In fact, the FDA regulates the NIH in many, many ways. Approximately 15 years ago when -- actually, it coincided with Reagan's election and the investigations of the NCI -- there was a demand made to have more regulation. They were not granted any positions for regulatory function, so they contracted that out -- the very expensive contract -- to try to have some point of regulation over extramural research. It's done reasonably well. But the point is that this is a function that's relatively new and there are no regulatory people within the NCI itself. This is all done contractually. The idea that the government sponsors the research and therefore is responsible for everything that takes place, that is not the tradition. That's something that may be evolving, and I don't think it has evolved as yet. As we were discussing during the break, the recent NSABP story about the guy in Canada who put patients on study inappropriately on the breast cancer studies lead to the NCI taking a very heretical point of view with respect to the NSABP director, Bernie Fischer, that ultimately cost Fischer his job. This was that even though the scientists had carried out the information, the government owned the data. The government bought the data. That is a very new concept that's only come about in the last few years. Maybe taking that point of view, you can probably argue that the government is responsible, but that's a decision made in the '90s. DOCTOR FADEN: We're moving in a certain direction and this is helpful. Nancy, Henry, anyone? I mean, not to -- people who haven't spoken -- DOCTOR OLEINICK: I don't know that I can solve the dilemma that we seem to be in, but it seems to me that some of the information that needs to go into the mix is the idea that the government did take some responsibility from regulation at that time. For example, in the distribution of radioisotopes, the AEC did mandate the formation of local committees for distribution. One of the factors that they were to consider was risk. There was no consideration of consent, but there was a consideration of risk. So, the government did take some responsibility in this case. Another question that we've been asking in terms of the observational studies and the uranium miners is, "well, the government did have regulations with regard to beryllium. Why didn't they with regard to the uranium mining?" So, on the one hand, the government does -- the government, we're dealing with "the government" as if it's a single unit. But "the government" did take the responsibility for some regulation of the processes, procedures that it was promulgating and funding, and on the other hand, doesn't. So, in asking for evidence that the government should have -- to go back to what Pat was saying -- "should have had policies", into the mix I would like to throw the idea that they did, as Susan said. Here's what they did; they did regulate to some extent. So, does that go to the point of if they went that far, should they have gone further? DOCTOR FADEN: That's very helpful. I was trying to say something like that myself, but you've said it better. DOCTOR OLEINICK: And I only asked the question. I'm sure I can't answer it. DOCTOR FADEN: Yes, that is the one line that has to be plumbed. Are there more comments? DOCTOR KATZ: I just have a question, Ruth. You know, again, at the beginning of the chapter on page 4, 5, 6 most specifically, and throughout the first 15 pages, there are all kinds of comments being made about moral judgments. On page 4, 5, 6, ten types of moral judgments are outlined. In the rest of the chapter, they are not specifically referred to either in the sense of applying these types to what the chapter is talking about, or saying which ones should we discuss in future chapters which may happen. And so, it's there and then it's left hanging. Shouldn't something be said about this at the end if we keep it in here? DOCTOR FADEN: Sure. DOCTOR MORENO: Yes. DOCTOR FADEN: Yes, I think that apparatus shouldn't be there unless it is used. It is used implicitly, so it has to be made explicit. That's a good point. That's a good point. That's a good point. DOCTOR MORENO: We have to make it explicit. I think that's right. DOCTOR FADEN: There's no point having fancy sort of analysis and then never referring to it again. It either serves a function or it shouldn't be there. It actually, I think, does serve a function, but we have to draw it out. I'm inclined to think that we should temporarily, until tomorrow morning, leave the government for the moment, go on to the profession and the investigators and then work our way back again. See where the issues fall there. DOCTOR MORENO: Well, in that case, we are moving first to page 44 which does use some of that apparatus. DOCTOR FADEN: Yes. DOCTOR MORENO: These are attempts, again, to articulate the standards of the medical profession during the period in question and even fairly early in the period in question. The first is, any experiment that are taken with healthy subjects required what we call "simple consent", whatever that is. Secondly, that an experiment that is intended to benefit the patient, or therapeutic research. Here, we conclude that it is a Hippocratic commandment to attempt to benefit the patient. It was neither conventional or thought morally necessary within the profession to obtain the patient's consent for therapeutically intended procedures or maneuvers. On the other hand, there was also, obviously, a corresponding obligation to base a deviation from standard procedure on well reasoned theory about the likelihood of patient benefit. Then finally, an experiment undertaken without any scientific or clinical basis for an expectation of benefit to the patient, a non-therapeutic experiment as it were. Here -- I think Jay and I were talking about this earlier -- the Hippocratic condition seems to have treated -- or if you could extend it which is, again, somewhat counter-factual. If you could extend it to the non-therapeutic situation, he would apparently treat this under the rubric of what we would now call a non-malefasance, making sure that one at least doesn't do any harm. If one is not intending to do good, at least one should not harm, which medical ethicists disagree about whether that was ever permitted or not under non- malefasance. That's about the best we can do with that category. DOCTOR FADEN: Duncan, did you want to say something -- have a question before you got out of the gate. DOCTOR THOMAS: I have a bit of a problem with the second of these two examples, specifically, the wording on line 20. DOCTOR MORENO: What page? DOCTOR THOMAS: Page 44, where you say that they should attempt to benefit the patient, "so long as all appropriate standard procedures have been tried and failed." I mean, it would sound like one could never do any sort of experimental randomized chemical trial, at least until the patient has already failed. Presumably, that means he's already dead. I'm not quite sure what you mean by that language. It seems far too strong. DOCTOR MORENO: So, that does need to be rephrased. You're right. DOCTOR FADEN: So far, these three are descriptions again, not the Committee's judgments. This is sort of capsulizing all of the scholarship that went into, primarily, the practice -- whatever number that is now, Chapter 3? All right, so this is basically reflecting the Committee's view of what the norms were within the medical profession with respect to research. These seem to have been the norms. Does anybody disagree with these descriptions of what the norms and practices were? Except for the kinds of editing changes that Duncan just suggested. Those are important, and obviously, everybody reserves the right to change a word, but the sense of them is accurate? It sounds as if everyone is comfortable with the sense of these three -- All right, so now we move on to, "all right, this was the way the world was, the ethos of the practice of medicine at the time." Now, what's the Committee's view about how to judge investigators in the context of particular experiments that would fall under these three headings? DOCTOR MORENO: Well, now, I think it is best to move to the differential treatment of sick patients as against healthy subjects. I gather that there is agreement that physicians in the period in question should not have experimented on healthy volunteers, healthy subjects without their consent. Then at the bottom of page 46, we go to the fact that there does seem to have differential treatment for sick patients. We take the position that there is no morally relevant difference with regard to medical ethics between doing research with people who are sick and doing research with people who are not. And that, in fact, there is at least as great an obligation to, for example, obtain consent or gain the permission of those who are sick to do experiments as those who are not. By the way, parenthetically familiar with all the arguments about the therapeutic exception, but I take it that we would not accept the therapeutic exception as a viable defense, the difference. DOCTOR FADEN: Pat, did you want to comment? DOCTOR MORENO: Can I just finish? MS. KING: Yes. DOCTOR FADEN: I'm sorry. DOCTOR MORENO: Let me just finish about that paragraph. This argument then takes Ruth Macklin's third fact pattern. This was a case of the profession having known principles, codes, standards and rules -- we can throw in statements and directives -- that were generally accepted in other spheres, namely with regard to healthy volunteers but not applied to the particular type of action or practice in question though they should have been. DOCTOR FADEN: You're talking now about research that provides no prospect of benefit to the patient? DOCTOR MORENO: Yes, right. MS. KING: Non-therapeutic. DOCTOR FADEN: Non-therapeutic research to patients, not all research with patients? DOCTOR MORENO: Not all research with patients. MS. KING: I don't think that this justifies making a should judgment. DOCTOR FADEN: No, it doesn't. MS. KING: Not what's here. The should judgment is as Jonathan stated it. That because we knew that you needed consent with healthy volunteers, you should have known that there's no morally relevant difference between healthy volunteers and patients in non-therapeutic research. So, because there's no morally relevant difference, you should have known that you should get consent from those patients as well. That's a leap that's too big for me to make. I'm not willing to say anything except to go back and describe again the evolution of how we go from healthy volunteers to consent requirements because this, again, is a retrospective judgment. I don't know what it means to say that because you know one thing, you should know something else. DOCTOR FADEN: Well, I, personally now would really disagree. I mean, the analysis has to go out further, so we have to work that one through. But let's get to the core of the crisp description of what's here. First, we all agree about what the norms were, so that went fine, okay? That went fine. That's better than we did with the government one. Then there's the issue of how do we want to view, if it was clear and normal at the time that you had to get consent from a healthy subject if you were doing research on a healthy subject, then it's obvious that if an investigator failed to get consent from a healthy subject, he did the wrong thing then as it would have been the wrong thing today. We can blame that person for it. Okay, that's an easy one, right? I'm trying to distinguish between judging the wrongness of the action and how much we blame the person for it. Now, we get to case 3, the therapeutic research, okay? Now we have an investigator who did therapeutic research on a patient without the patient's consent. Let's just make it no consent. He just does it without consent. MS. KING: But in those cases, am I not correct that where you're talking about therapeutic, to interact with the patient for purposes of therapy not for purposes of research -- DOCTOR FADEN: Right, right. MS. KING: -- there was a legal consent requirement. My understanding is about what there is a great deal of confusion is this borderline between I am treating the patient and I'm conducting research on the patient. As far as I could figure out, in the early '70s, that wasn't well understood. DOCTOR FADEN: No, I agree. I'm about to work that one through. That's fine. The tough one, I think, is the non-therapeutic research with patients, okay? The easiest case is whenever you have an instance in which an investigator used a person who was a healthy subject in research without that person's consent. We can all agree the person did the wrong thing then. It's the wrong thing now, and we blame that person for it. We say, "you did a wrong thing and you're blameworthy because of it." That's the easiest case because we can say that the standard even at the time was, you should have gotten consent before you did research on the healthy subject. The next easiest case -- let me see if we have consensus about it -- is the one that Pat was finishing the comment on. Now you've got the case where it's a physician who is doing research, has involved his patient in research, which the physician believes has a prospect of benefitting the patient. The thing that Duncan was straightening out. Maybe the physician hasn't exhausted all therapies, but it's a reasonable determination that the patient's interest could be served by being enrolled in this study. Now, the physician does this in 1954 without the patient's expressed consent, okay? We might want to say something like the following, "that was a wrong thing to do. But we don't in any way blame you for it. It's wrong not to get consent from people before you put them in research, but we don't blame you for it at all." I'll give you the other alternative, "that was the expectation at the time. It was also the expectation that patients had of you at the time. The view in that period was we perceived the physician with a great deal of authority. The physician has a lot of responsibility that goes with that authority, but it's you, the physician, who is supposed to decide what's in my best interest. As long as you're acting in my best interests, then I generally authorize you to do that. You can make these kinds of decisions without checking it out with me." MS. KING: Why do we use the term "wrong"? DOCTOR FADEN: Okay, because I want to. We can step back -- MS. KING: But let me ask you a question for clarification. What is it that leads you to conclude that it is wrong? That is what I need to understand. I understand you're trying to draw a distinction between wrong and blameworthy and culpable. DOCTOR FADEN: The conduct and the blameworthiness. MS. KING: And you're trying to draw a line. DOCTOR FADEN: Well, I was assuming, but I can break it out, that we would agree that today, it is wrong to do research, therapeutic research on a patient -- MS. KING: Right, and blameworthy. DOCTOR FADEN: -- without a patient's consent. MS. KING: And blameworthy. DOCTOR FADEN: Pardon? MS. KING: And blameworthy. DOCTOR FADEN: And was blameworthy. What I want to do is slice the difference now and say, for the same moral reasons that it is always wrong -- now, we'd go further and say it's wrong to do a whole range of medical interventions without a patient's consent. It's not just research. You don't decide whether I should have surgery or I should take a drug. You let me decide today. If I tell you back, "I don't want to decide. You decide for me," that's fine. So, it's all of the package of an understanding about where decisional authority ultimately sits. MS. KING: But if that package of understanding didn't exist at that time, which we've already said -- DOCTOR FADEN: All right. MS. KING: -- then how do we get to the leap of wrong? DOCTOR FADEN: All right. What you want to do there is distinguish between two variations, which I was just going to get to. We could lay this out in a tree diagram. One is, "it's wrong today; it wasn't wrong then," okay? Another is, "it was wrong today; it was wrong yesterday, but we don't blame you about it yesterday. We'd hold you accountable for it today." Now, we can start to unpack the choices between the two, but for purposes of right now, let's say it's one or the other, okay? In either of that, we can work that out, give you the arguments for both, and then the Committee can decide which formulation it likes better. But the bottom line is, we're not going to blame anybody partially for doing therapeutic research on a patient in 1956 without consent. Whether we're going to say it was wrong or not, we can debate further. Pat? MS. KING: Well, I think I understand it. I've read this and I think I understand because we've had many arguments and discussions about those retrospective judgments. The attempt to draw distinction between wrong and blameworthy, I think is a valid attempt. They do mean different things. But wrong, too, is a judgment, just like blameworthy is a judgment. DOCTOR FADEN: Of course. MS. KING: We may just have to have a split, you know, where it says that "all members of the Committee except one" is willing to say that this was wrong at that time because her reason for not being willing to call that wrong is because she does not have an absolutist view about principles through all time. DOCTOR FADEN: I understand. MS. KING: That there's an evolution there. DOCTOR FADEN: All I'm doing right now, Pat, and I hope you'll bear with me -- DOCTOR KATZ: Coming from a King, that is quite something. MS. KING: Coming from a what? DOCTOR KATZ: From a King. DOCTOR FADEN: That's marvelous. I want to see if we can agree about the blameworthy part. Then the Committee can see language that goes in both directions on the wrongness of the problem. I don't hear anybody saying we should blame physicians who did therapeutic research on patients in the '40s and '50s without the patients' expressed consent, okay? Henry? I'll go to the non-therapeutic in a minute. DOCTOR ROYAL: Yes, the main trouble I'm having is what I regard as very artificial dividing up of therapeutic and non- therapeutic patients versus healthy people. The implication is that somehow with therapeutic research, that there's a net benefit to patients? DOCTOR FADEN: No, the assumption is that there is an intent to benefit. That is to say, this is the part about -- I forget Jonathan's line here, but it's something about, based on reasonable clinical judgment that at the time, if you had made a reasoned judgment that was defensible as the patient's clinician, that it was in the patient's interests -- DOCTOR ROYAL: But the trouble I have with that construct is if it was valid to make the conclusion that this was going to be in the patient's interest, then it would be standard therapy? DOCTOR FADEN: I mean, the whole -- notion. We don't really know how to take care of you. You're not asking me, okay? I'm your doctor -- this is fun. I get to be Henry's doctor. I'm your doctor. It's 1956 and I am, you know, the world's whatever expert in whatever condition you have. Frankly, we don't have a clue what to do for you now, okay? So, we can fudgey around. The stuff we have we think is not terribly good, or we know that there is this new thing that's being tried and I decide well, you know, it's six of one and half-dozen of another. I've not had good success with what's around. Maybe I can do better by this patient by enrolling this patient in this study. That's the sort of scenario -- DOCTOR ROYAL: Okay. But what I would ask my doctor is -- DOCTOR FADEN: You wouldn't even know he's deciding this, is the point. We're just imagining a scenario in which the answer back is, "Mr. Royal, what you need to do at this point is take this pill. Just go home and take it and we'll see how you do." DOCTOR ROYAL: So, the division that I said that I didn't like was non-therapeutic and therapeutic research. But that's irrelevant because you're never going to ask me about consent. So then, the issue is the dividing line between research in medicine. You know, where it is that this thing that you're proposing for me to do and you're not going to ask my consent for, where the dividing line is between what's research and what's clinical -- DOCTOR FADEN: No, I think the understanding here is that those decisions, it didn't even much matter, basically. You're entrusting me to -- you are putting yourself in my care, okay? DOCTOR ROYAL: Yes. DOCTOR FADEN: I am going to take care of you as best as I can. Whether it's an experimental drug, an innovative drug, or its research, or standard therapy, I'm going to put all of that in a mix and I'm going to basically do what's best for you. DOCTOR ROYAL: See, the reason I'm having trouble working through this with you is because I think I believe what you believe. That is that patient consents should be obtained for research and for clinical. DOCTOR FADEN: Right. DOCTOR ROYAL: I'm having trouble with this artificial distinction. DOCTOR FADEN: It doesn't matter. Either way, it wouldn't matter. The point is that if you want to make an equivalent -- I don't know if this helps -- you would be no more blameworthy for enrolling your patient in research without the patient's consent than you would be for starting them on standard therapy without their consent. I mean, there just wasn't a consent mode then. This is what Jay keeps trying to impress upon us. This was a time in which physicians didn't go around asking patients' expressed, informed permission to do things. Now whether they do it any differently now is what we're going to debate tomorrow. The point is that the assumption then -- patients by-and-large comfortable with that, lies behind -- or at least were not objecting to it. There wasn't a social outcry against it in the '50s. That was the package. All that together said more elegantly than I can say it now lies behind what I'm assuming is the Committee's collective judgment that we will not blame any physician if the intent was therapeutic, as well as to gather generalizable knowledge. Quite apart from whether it was wrong or not wrong and how we want to slice that one, I really want to go to the non-therapeutic one because that's the tough one. But I saw Phil, Pat, and Sue. MS. KING: I was just going to try to explain it a different way because I can see that Henry was really puzzled. DOCTOR FADEN: Okay. MS. KING: That is, if you go back to the '50s, when you dealt with healthy volunteers, everybody knew you were going to give a benefit. You weren't going to do anything and so we thought about it. When we came to patients, we didn't have two ideas, were not clearly formed. One idea was, what is the difference between a therapy and research? Research, itself, the idea of what was research was not formed. We still have this debate about what is research in some circles today. So, that wasn't a known. What do you mean by research? The other thing that was unknown is that when you went to a patient and the patient was sick, this idea of benefit and belief of possible benefit was incredibly elastic. So that, it was everything from I've seen this work in other people, so I think it will benefit this patient. Some of it was outright quackery. There are legal cases where the deviation was so strong from standard therapy that we just called it negligence. And sometimes, if you really examined the belief that there would be a benefit closely, people would say, "that's nonsense. This patient can't possibly benefit from what we're about to do." But they didn't call it non-therapeutic experimentation on a patient. They just had this really elastic notion of I'm helping. What we do today is, we have chopped up the "I am helping" into discreet categories. Sometimes we know you're really bluffing when you say you have a reasonable hope of helping. That's nonsense. This is all non-therapeutic. You've got a sick patient here, you're doing something. It's not going to benefit this patient, but you may benefit some others who suffer from the same disease. Then there are other areas where we say if we do something, it's research but we don't have a reasonable basis of thinking that maybe you will directly benefit from it. Then we also have some cases that we throw out and we say, no reasonable person would have known from this evidence that there was any possibility of providing a benefit. So, I don't know if that helps. That's what Ruth was trying to say too about when you went to the doctor, he had it all smudged up. DOCTOR ROYAL: I think most of what we call therapeutic research is non-therapeutic research using those definitions. MS. KING: I agree with you. I agree with you. This is still an elastic benefit. DOCTOR FADEN: That's an important point to hold. MS. KING: And exactly right, yes. DOCTOR KATZ: Henry, that's quite a statement. DOCTOR FADEN: Yes, it's quite a statement. We need to revisit that. MS. KING: Quite accurate, too. DOCTOR FADEN: Phil and Sue. Then if we could go to the tough one which is what we're going to do soon. DOCTOR RUSSELL: In the judgment that non-therapeutic -- therapeutic research without consent is wrong even in retrospect, how far back would you go? In the evolution of medicine, at one time, the physician had practically nothing to offer except the authority and an assurance that they're going to make somebody well. The barbers had better results than the physicians in those days. So, at that point in time, it certainly wasn't wrong because that was the only thing they had to offer, just taking the total responsibility for the outcome in an emotional sense. As medicine moved into the scientific arena, the situation changed and you can say at the present time, yes, it would be wrong. But I'm not sure when that change took place. I'm not sure it had taken place by then. DOCTOR FADEN: I think you could probably strengthen it further. One of the arguments I used to play with myself as we go back and forth. And this comes out very clearly in a couple of the oral history tapes of the -- DOCTOR KATZ: Louder? DOCTOR FADEN: I was just saying one of the arguments when I go back and forth myself on this point that Pat and I are disagreeing, to show you that my mind is not fixed yet on that one. It's something we have heard powerfully in a few of the oral history tapes, oral history interviews, and that is the recognition that at the time -- and Phil and Jay can certainly speak to us -- people argue today that there's little of proven, established efficacy. But certainly, in that period, there was even less in the armamentaria that you could say was proven, established efficacy. So that, arguably -- and we've heard this from some of the people who were kind enough to let us interview them -- you could make the case that it was ethically preferable to put people in research where they had a chance to not get the newest thing down the line against something that maybe didn't help, but at least didn't hurt versus giving everybody the latest and the best, just quickly diffusing it through practice without any careful examination of whether this latest breakthrough really didn't, in fact, end up doing more harm than good. You can look at historical examples like DES as a case point. -- there's a quick rush to accept something that looks promising and instead of checking it out, diffusing it. So, where is the ethical boundary -- the ethical preference line, given that nobody's real permission is asked for anything, you know. So, I'm happy to sit on that. I do want to hear what we want to say individually and as a Committee on this non- therapeutic stuff. Sue, did you want to comment? DOCTOR LEDERER: I was just going to say that I would add that there is a tradition for surgical interventions of asking the patient's consent or permission. It's important, especially if we're going to use these arguments by analogy because that was the analogy that I think it was Irving Laimer used for establishing permission at NIH Clinical Center in 1953. So, it's a historically invoked analogy. DOCTOR FADEN: Yes. DOCTOR MORENO: It's even more, at present, than that. The lawyer, the Assistant General Counsel, I think it was, at NIH recommended to the medical board based on that analogy. DOCTOR FADEN: Okay. We are now into the third category which is the most morally contentious and which does reverberate to some of the cases that we will then be debating tomorrow. That is the situation where let's just stipulate, there's no intent on the part of the physician to attempt to benefit the patient by the research maneuver. That's acknowledged. There is no such intent. The physician nevertheless involves this patient in the research maneuver without consent, and this is 1951 or whatever. It's the period of the '40s and '50s. The position taken in the draft is that that was a wrong thing to have done, okay? And that even though it was commonly done, we suspect, based on our scholarship, the oral histories and the secondary sources, it was still nevertheless a wrong thing to have done. The people who did that should be blamed, at least in part, for having done that. That's what is set out. That's the position that's here. Now, the arguments have to do with the view that the use of a human being, to use the shorthand, as a mere means only to the ends of another, is a wrong that is not professional -- and this gets into the relative is an issue -- it is not an ethical norm that comes out of a particular sense of role responsibility or professional ethics. This is not a matter of medical ethics didn't speak to that question. So, it's not going to what the Hippocratic Oath said one way or the other. That by the same reasoning that -- and here, the analogy to a healthy subject -- you can't touch a healthy subject for research purposes without that person's permission, you have no more moral authority to do that with a patient than you do with a stranger. In fact, arguably, it's worse because you're exploiting a privileged, powerful, fiduciary relationship to your own end or the ends of society, generally, as opposed to the ends of the patient. That's the argument that's put forward. Now, you may want to say, "but what about the fact that it was commonly done? How much of a mitigating factor is that, even if you buy the analysis?" We can say well, it's a mitigating factor to some extent, but it's not as absolving of blame as in the context of research that had an intended benefit because it involved such a foundational understanding of common morality. It's not fully fleshed yet, but that's the position. Did I get it, Jonathan? DOCTOR MORENO: Beautifully, yes. DOCTOR FADEN: All right, Phil? Oh, I thought you were wanting to speak. Anybody? This is important because as we could all think ahead, there are chapters where if we make this distinction, it has implications for the judgments we will draw as a Committee. So, that's why it's so important to distinguish. DOCTOR KATZ: Ruth, a procedural question. As I listen to -- discussion -- DOCTOR FADEN: Jay, could you speak in the mic, please, for the record and for the rest of us? DOCTOR KATZ: Oh, as I listened to today's discussion, I think that Jonathan will turn out to be a magician -- DOCTOR MORENO: You said genius before. DOCTOR KATZ: -- a genius, yes. A magician and genius -- DOCTOR MORENO: Well, just a genius, you know, with magical powers. DOCTOR KATZ: -- if he will be able to put together a chapter, that on the next go-around, will not raise all kinds of questions. In fact, it becomes harder and harder to read draft after draft after draft. We have to stop sometime and say, "okay, Chapter 5. I've got some reservations about Chapter 5. I hope some of them can be taken care of. I'm perfectly willing to maybe not to either vote yes or no on the chapter, but to invoke another principle employed by the papal censors of books during the Middle Ages. Every book had to be submitted to the censors. They would say yes, it can be published. They would never say that it could -- no, they would say "this book can not be published because it is heretical." But they would never approve of a book. Instead, they would stamp on the first page, "nihil opstat", nothing stands in the way. I'm perfectly willing to vote on some of these chapters, "nihil opstat" and go on. Ultimately, you know, I may have to make some comments in the final reservation sections, some -- general kind of way, but so be it. I hope, speaking for myself, that I can keep it to a minimum. But we have to, as they say in Jewish, "mach schuss" -- to certain chapters. DOCTOR FADEN: I'm trying to -- DOCTOR KATZ: What kind of procedures do we want to establish for that? DOCTOR FADEN: Well, let me reveal what was obviously not too obscure. We picked out for the agenda items, the chapters where, at least in my view, is the most important that we -- the extent to which we agree or disagree to form. Where this, you know, I don't object to business probably is the least satisfactory. We all may have a different list of chapters about which we feel that way. But I was most concerned as Chair of the Committee that in this chapter, if at all possible, we can say something with one voice on at least some of these issues. If we can't, it makes it very difficult for a lot of the rest of the work of the Committee, namely the part two work, to have a chance -- the judgments with respect to the case studies -- of hanging together. You know, we could write this chapter without saying anything, but I would feel kind of badly about it. Plus, let me point out to you that I've been trying to get us to zero in on the specific charges that got us going in the first place. We were asked to come up with the relevant standards for judging these experiments, and the investigators, government officials and so on. So, this chapter is presumably our answer to that big charge. Now, if we can't do it, we can't do it. I have faith, of course, that we will because Jonathan is both a genius and a magician so it will be okay. But you know, this one is very critical because we were specifically asked. The Executive -- whatever that thing is called -- charter, but the other is the -- Executive order and in the charter, thank you. It says, "Committee, deliver yourself of a position on the standings by which to judge these experiments." So, that's what we're trying to do. Pat? MS. KING: First of all, I agree with you about how important the chapter is. I have standards by which I'm willing to judge the experiments. They do not include, however -- I will state my objections now -- reasoning back from present day standards. I'm going to be very clear about that because I have lots of reasons for reaching a judgment. I asked myself, what do I gain pragmatically by calling something wrong and not blameworthy, except to make myself feel better? My answer to that question was nothing, pragmatically. I can make a judgment about remedies without answering this question and labeling something wrong. I can make a judgment about some of the chapters without labeling something wrong. In addition to Ruth's reasons for how important this is, I would say this chapter constitutes a central aspect of our message. What I said before that I had my candidates for messages -- and I'm sure everybody else has their candidates for messages, too -- my candidate for a message is, I am less interested in labeling something wrong than I am interested in describing what happens to the fabric of trust between citizen and government, patient and physician, when you don't think through carefully the grounds on which you're operating, rather than labeling it. So, that is what I am worried most about in terms of what message we send. But I expect us to feel differently about what we think is the primary message to send. I want to put my marbles not on -- this is not Nuremberg. This is not the Holocaust to me, these things. I want to save my wrong and blameworthy for things that get my blood boiling. That is not to say that this does not get my blood boiling, but I'm trying to draw some distinctions here inelegantly. The second problem I have is, this is a report that is for public consumption, although it has special audiences that Phil described today. I think it is very difficult to understand the difference between wrong and blameworthy for citizens. I mean, I understand how we do it, because I followed your chapter and I listened to Ruth, and I've gone all through this. But when you deal with people's common understandings of how you make judgments, stipulating that we have established differences between when we use the term "wrong" and when we use the term "blameworthy," I don't think it's a stipulation that is going to be widely understood. That reinforces my view about how strongly I feel about the message I'm interested in and also, not having that confused. So, I am perfectly willing to be by myself. I said this before. I am also perfectly willing not to write a dissent. I am perfectly willing if anybody wants to say in here most of the members, all the members but one, we're prepared to do this and not belabor the point. But I think it is critical that everybody at the table today be required today, or no later than tomorrow, to have a preliminary view about this. Because staff can't write anything without some preliminary views. So, I'm going to ask everybody that they state their preliminary views. If you want to state them tomorrow morning, I'd be willing to let you state them tomorrow morning, but we need them. DOCTOR KATZ: Pat, could I ask you a question? If I hear you correctly, I agree with you maybe for what you think is important, maybe for a slightly different reason but that's unimportant. But in your view then, to satisfy you and to set this forth, would the chapter not really require a fundamental kind of overhaul, including -- let me be specific because I want to hear what you have in mind -- maybe eliminating almost the first 15 pages of the bi-ethical introduction because it deals so much with culpability of the past, et cetera? MS. KING: Actually -- DOCTOR KATZ: Or not? MS. KING: -- very well to see how well we use it. DOCTOR KATZ: I want to hear what the implications are of what you are telling us. MS. KING: With respect to the ethical discussion at the beginning of the chapter about retrospective judgments, I actually defer to what Ruth said because I think that's a critical question. You see how much of it plays out. One of the things I don't particularly like is the way it starts the chapter. It is inaccessible to most people, that part of the chapter. I'm worried that most people won't get through it. The way the Nash Commission handled this as an issue to the Belmont Report as sort of a separate statement, which was inaccessible in many ways, too, but it governed the Committee's deliberations in many ways, and I think Ruth sees the beginning of this retrospective chapter playing that role. I am in agreement that you've got to have something that plays a role like that. It's not clear to me yet how you leave it all in. But with respect to the rest of the chapter, I don't think it requires a major reworking because what I am really objecting to are all of those should's that go back from the current day. So, that's very easy -- DOCTOR KATZ: That's moral judgment. MS. KING: That's right. It's fairly easy to make that kind of judgment -- I mean, make that clear in the chapter without rewriting the chapter on my account. I don't know what other points people want to make about the chapter. DOCTOR FADEN: I'm thinking that it is now ten of 5:00 and we end at 5:00. I'm very mindful of what you just said, and I think this is right. We all, now, are on the spot and everybody has to sort of step up to the plate, whatever metaphor you like. We've got to know where everybody is on these issues. I want to respond to just one thing in defense of the position that's defended here that says that if somebody used a patient in non-therapeutic research, they did a wrong thing for which they are blameworthy. How blameworthy, is a separate issue. The reasoning behind it does not rest on reasoning back from present day standards. The position there is -- at least one defense is, "look, at the time, if that had come to light, that would have been viewed as wrong and here's the evidence." Where there were breakthroughs of indications that people were used as subjects, patients or otherwise, there was public outrage without consent. If you look at the cases that broke the controversies, if you look at the ones that Beecher identified, and then if you look at, for example, the Jewish Chronic Disease Case Hospital, and you look at Tuskeegee, what bothers people there in both of those experiments is that people were used as mere needs. It wouldn't have been the controversy if it had been "gee, there was a choice between injecting them with something that might cure their asthma or something else that might cure their asthma, and they didn't tell the people in the Chronic Disease Case Hospital. Therefore, they did an awfully terrible thing." There would have been no news story there. I think -- repressed and erupt, you would be able to construct an argument that at the time, there was no warrant in society to ceding to physicians. MS. KING: I've already said, if these were not in accord with the standards of the time, I don't have any problem. But making that statement in the face of practices to the contrary is a tough argument to make. I said that. That if you were talking about at the time, that's a different ball game. DOCTOR FADEN: Right. But what you'd be talking about is two different sets of standards, sort of the ethos within the medical profession and the ease with which they moved back and forth across these lines that didn't exist, and the general public's view of what it was the doctors were supposed to do and not do. That would be the part you would have to break out. It's ten of 5:00. Could we follow Pat's suggestion and see where people are on this -- tentatively where you are, and we'll return to it tomorrow on the specific case that we just described? Which does speak to some of the case studies that we're talking about later, this whatever bullet it is? We know which one we're talking about now. Henry? DOCTOR ROYAL: I had very little difficulty with this chapter before we started discussing it and I actually still have very little difficulty with it. I can't wait until we start talking about some chapters that I have problems with. The reason that I am not having much difficulty is because consent seems to me to be such an obvious important thing to obtain either from healthy people or patients. It is very difficult for me to put myself back 50 years, and to understand how I might have behaved 50 years ago even though today it's inconceivable that I would ever defend not having gotten consent. The things that I think we're going to have more difficulty with is what we mean by consent. But the principle that people have a right to decide what happens with their body seems to me to be such a self-evident principle that I'm actually surprised that anyone would want to say that not getting consent was right at any era. DOCTOR FADEN: That's helpful. This is what we need to hear from everybody. Who else wants to -- DOCTOR KATZ: Nancy? DOCTOR FADEN: Well, we can literally go around the table. DOCTOR OLEINICK: All right. Well, I, too, had little difficulty with this chapter until all this discussion. There were issues here that I thought somewhat had been resolved, but clearly have not. It seems to me that since the most controversial is the question of patients being involved in non-therapeutic research, I have a hard time not buying the argument that based on the consent practices of the time with healthy patients, that it is not such a huge leap to say that not only should the patient be given the same rights as the healthy person, but perhaps the patients should have been given even more rights by virtue of the fact that they were ill and probably in less of a position to argue. So, I really didn't have a whole lot of trouble with the way this came out. I had trouble with other ones, but not this one. DOCTOR FADEN: I can't wait for the rest of this. Jay? DOCTOR KATZ: Well, ultimately, I'm quite willing to join the papal censors and say "nihil opstat," nothing stands in the way, and live with this chapter. But with one reservation, because as I was reading this chapter, I briefly alluded to it before, I wondered what our final judgment will be about contemporary research practices? In the light of this chapter and the way this is written, and particularly the first 15 pages, what will we have to say and what kind of judgments will we have to make about what's going on in the -- So, depending on what the Committee decides, and that's still hidden behind the veil of ignorance, that I may have to eventually come back to Chapter 5. But I may not, and it really depends on the outcome of the group's view when we turn to the protocol Review chapter. DOCTOR FADEN: Tomorrow. Phil? DOCTOR RUSSELL: I'd like to refer back to Jay's comment about the chapter and Jonathan's genius. I sincerely hope that the chapter does raise more questions than it attempts to answer because I think that that's part of our charge, to look at the questions in several perspectives and only answer those that we are very confident that we have the information with which to answer them. Dealing with the issue of non-therapeutic research, specifically, it may be helpful to put it in the context of whether it's within or without the bounds of the doctor/patient relationship. The physicians that did volunteer research on normal individuals clearly knew that they were outside the bounds of the doctor/patient relationship and behaved that way. Then the question is, where there are physicians doing research ont heir patients that are non-therapeutic, they are also outside the bounds of the doctor/patient relationship. The question is whether they recognized it or not and how they dealt with it? I don't have a lot of difficulty dealing with the concept that they should have known and that they are blameworthy when they didn't deal with it in manners that their colleagues dealt with the parallel. Now, I don't have the wisdom to know whether something was, in retrospect, blameworthy, right or wrong. I have difficulty -- the simple military mind can't deal with that one. DOCTOR FADEN: This is very helpful. Thank you, Pat, for encouraging us to do this. I think this is helpful for all of us to hear where everybody else is. Eli? DOCTOR GLATSTEIN: Well, I have some problems with this chapter, unlike some of the others, but they're not major. I think that, again, I want to come back to the theme that we really have several different issues that we're trying to resolve. One has to do with biomedical research and another has to do with population exposures. I think they're drastically different. There have been abuses at the biomedical research level. You put the numerator, the number of examples of that, over the total denominator and I think it's a relatively small problem numerically. But it's not one that we should whitewash. I think when we reviewed some of the protocols, I was personally surprised at the number of instances where I felt the informed consent did not reveal enough, and I think there are some problems. But I think in today's world, there's no question that an informed consent is necessary. I think everybody understands that. We can argue about exactly when and where that was supposed to be the standard of practice, but it sure as hell is the standard of practice today. I think that the chapter needs to communicate that the vast majority of the experimentation that we have seen in biomedical research has been okay. There are some question marks and we have chapters devoted to them and we go into the details why. I don't think those instances should be whitewashed, but at the same time, I don't think we should obscure the fact that the bulk of the biomedical research has been ethical. There is room for improvement and we should focus on that. DOCTOR FADEN: Thank you. Duncan, did you want to add? DOCTOR THOMAS: Well, like Henry, I didn't have great difficulty with this chapter until we started talking about it. I guess by-and-large, I still like the chapter. The only part of the chapter that I am having difficulty with at this point is the bit that we discussed a great length before the break. DOCTOR FADEN: The government part. DOCTOR THOMAS: One government bit. I think I want to reserve judgment, at least sleep on that, before I commit myself. DOCTOR FADEN: On this particular -- DOCTOR THOMAS: On the specific question of whether they should have had standards. Other than that, I think by-and- large, I support the conclusions, certainly within the medical part. I don't have any difficulty with the conclusion about non- therapeutic research. I support Eli's point about the population exposures. That's dismissed in one line. Well, not dismissed, but deferred to Part 2 in one line on the grounds that the issues are so fundamentally difficult that we can't talk about it in this chapter. Now, that, I appreciate, but the philosophical nature of the points that we're trying to make in phase one about what are the standards, it does seem to me belong in Part 1. It's difficult to develop them in Part 2 which is supposed to be our narratives. I still would recommend that we perhaps work it into one of the existing chapters, or even have a mini-chapter of its own on that subject. DOCTOR FADEN: Lois? DOCTOR NORRIS: I don't have the same level of concern about the physician part, the medical part of it as I did about government. I do, like Duncan, prefer to reserve judgment until I see the response to some of the questions that were raised today before I am ready to buy off on that. DOCTOR FADEN: Pat? MS. KING: I don't mind being skipped. DOCTOR FADEN: Okay. We'll just skip me, too. We've got Mary Ann and Susan. DOCTOR STEVENSON: I've already voiced my concerns about coming to a conclusion yet about whether the government should have known that a policy was needed for regulating therapeutic research, or at least protecting patients as opposed to healthy subjects. Even though, like Henry, my own personal experience in training would lead me to sort of find it inconceivable that you wouldn't get consent from a patient for therapeutic or non- therapeutic or clinical procedures, I'm still really troubled when I read, I guess, Chapter 3, the professional standards chapter. Here, you have people like Lasagna and Beecher even admitting that they did things that they had less than pride in, in retrospect. I have no personal experience with having grappled with that, and I really need more information to understand how these people who we think of as not being horrible people, being, actually, quite moral people, could have done these things, things that in retrospect they say are now wrong. I mean, I still don't have a handle of what the thinking was then because by self admission, they did do things that were less than honorable in terms of non-therapeutic research. So, it's hard for me to come to the conclusion that it was wrong unless I have a better understanding of how these people, who I don't consider as horrible, did these things. So, I guess I feel like I need more information. That troubles me. If they were just rotten people, I could say "forget it. They're rotten people. They do rotten things." But they weren't. What was the environment? DOCTOR KATZ: May I respond to this? DOCTOR FADEN: Could you do it briefly? I want to get to Susan since we haven't yet heard from Susan. Jay, do you want to wait and let Susan respond? DOCTOR KATZ: Oh, sure. Of course, of course. DOCTOR FADEN: Then Jay can respond and we can close. Go ahead. DOCTOR LEDERER: Well, I think I'm going to agree with what Mary Ann has said, in that, knowing that what counts as a morally relevant difference or distinction is, itself, historically conditioned. The fact that I disagree somewhat with Ruth's characterization about the public support, or actually the public criticism of experiments like Tuskeegee and the Jewish Chronic Disease Hospital because I think it wasn't only that people were being used as means by investigators, but that they were being harmed. That there was the potential for great harm to them. That seems to me to be a missing component of the characterization in one of these bullets. Namely, the responsibility of the investigator is not to harm, so that you would be culpable if you did something, without consent or with consent, but you harmed the patient. Then you would be culpable at the time. So, I think that given that, I can't sign on to finding physicians, as a profession, morally culpable or having culpable moral blindness just based on the argument that they could have and should have seen that there was no morally relevant difference between patient subjects and healthy subjects. DOCTOR FADEN: Okay. This is, I think, terribly important that we've got this out. We can see what to do. Jay, did you want to respond to Mary Ann? Then I think we should just close for the day. DOCTOR KATZ: Yes, I wanted to respond to Mary Ann very briefly. I just want to say that, with respect to the -- before responding, with respect to the Jewish Chronic Disease Hospital case, Southman, the principle investigator, really only got a slap on the wrist by the committee. Two years later, he became president of the American Association of Clinical Investigators. So, that's the aftermath of Jewish Chronic Disease Hospital case. But one example, personal example, in light of your question and I'll be very brief. Some of you know it. In 1954, two of my colleagues and I did research on hypnotic dreams. We used for these purposes, normal subjects. They were usually graduate students or the spouses of graduate students. It was funded by NIH and we were concerned that some of our subjects might develop an acute psychotic reaction because of the nature of the research. We wondered what to do about it. We went to the chairman of the Department of Psychiatry at the time and asked him, "if this should happen, would you make three beds available to us in the hospital?" He said, "of course." And so, we went back to one of the offices, talked, believed we had fulfilled our ethical responsibilities. The question is, should we discuss it with them? Should we explore these concerns with them? It never even occurred to us. And now, I'm an over-sensitive individual. I think I was sensitive then, but it was not part of my thinking. And a footnote to this, a year later, something made me uneasy about this kind of experimentation and I decided to drop out. One of my colleagues, still a good friend, looked at me in utter amazement. He said, "Jay, for these reasons you are dropping out, that you feel that maybe you are doing something wrong? You're doing these people a service. You're benefitting them. Because if they develop this kind of a reaction, then surely they will for the first time, come face-to-face with their neurotic conflicts and they will do something about it. Without that, they will be condemned for the rest of their lives of living with their unconscious problems." So, this was, at least in my small world, the ethos of the time. So, now you can look at me in new kinds of ways. DOCTOR STEVENSON: No, but I think the point illustrated, once again. DOCTOR FADEN: At least Jay is doing that, showing you how exactly -- DOCTOR STEVENSON: Right, exactly. But I mean, there was a process. I mean, one year you didn't think of those things. The next year or two years later, you did. DOCTOR KATZ: Well, just in a very minor kind of way. Just a general unease, you know. But I hadn't formulated it all in my mind what my unease was all about, I just didn't like it. It was years later when I started really thinking about it. There's an interesting story about that too, but I'll tell it to you another time. DOCTOR STEVENSON: But that doesn't still doesn't make me feel any better about condemning these people for what they did. DOCTOR FADEN: I think it's not supposed to, actually. DOCTOR STEVENSON: Right. That is the point, exactly. DOCTOR FADEN: That is your point. I think what we'll try to do is see if we can put together -- we have some better sense with what to do with this section. I saw Eli and Phil, maybe? Eli, did you want to make a comment? DOCTOR GLATSTEIN: Yes, just in response to Jay. I think this is a very critical issue. He's making the point that it wasn't in his frame of reference. DOCTOR KATZ: I'm sorry? DOCTOR GLATSTEIN: He's making the point that he had no frame of reference for some of the these issues when he was doing the work. I think this is very critical from the standpoint of training of young clinical investigators. They need to have the appropriate role models who do think of these issues, who can train them not in how to think, but at least what issues to be concerned over. I think it's very easy for someone to go through medical school and residency and have these issues simply neglected, much more easy than most of us wish to admit. This is where, I think, we need to also address some attention in terms of recommendations, because I believe there are some that need to be made. DOCTOR FADEN: I think the connection you're making is very important, Eli. I don't know whether it speaks to what you were saying earlier, Jay, about reserving judgment until you see the whole package? I would hope, especially as we attempt to give an explanation for why things happen the way they happened, apart from what judgments we make about the rightness or wrongness or blameworthiness of people, that we think always about the extent to which those same conditions may be occurring, continuing today. MS. KING: I think about it all the time. DOCTOR FADEN: Yes, that's really the -- MS. KING: That's what makes me cautious. DOCTOR FADEN: Right, exactly. Okay, well, here we can understand why Jay did what he did. Is there any reason to think that we can be saying when no one would ever have that same absence of a frame today, which is not so clear. Okay. Obvious implication, the agenda has shifted a little bit, in case anybody has noticed. I think that we should probably pick up, if we can, if Jonathan and Valerie and Dan have material for us. We'll either pick right up with the government part tomorrow morning, or go on to some of the chapters and come back and read at lunch. I'll check and see what the timing is like. We're going to try to hit all the chapters that are identified. We may not get through that, but we'd like to hit all the chapters that are identified if we possibly can. So, this one being so critical, we'll give it some more time, and then we're going to try to move on forward. Please, try to stay up with the agenda, although we know we're slipping. The Tuesday afternoon discussion on the contemporary world, I believe has to be Tuesday afternoon because Jeremy is only coming in for that and will only be there. So, even though we may have only marched two chapters into the agenda, we are going to switch to the contemporary situation. So, if you haven't done your reading of those two chapters and you're thinking we're not going to get to them tomorrow because we're so far behind, we will get to them tomorrow because we've got a scheduling constraint where Jeremy will only be with us. So, tomorrow afternoon, please look at those chapters because they will be on the agenda. The project review chapter came to you late, so that's another one that came to you on Saturday, together with Chapter 5, that we would encourage you to look at. Especially since, because of a family emergency, Sara is not going to be with us. I think I know it well enough that I, with Shobita and Jack, sort of answer almost as many questions as Sarah could answer. But it would be really helpful if you read that chapter because she won't be around to give us the sort of orientation to it. Okay? That's it? 9:00 tomorrow morning, and 8:30 on Wednesday morning. So, it's 9:00 tomorrow morning and 8:30 Wednesday. (Whereupon, the meeting was concluded at 5:15 p.m.)