ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS - - - FRIDAY DECEMBER 16, 1994 - - - WASHINGTON, D.C. - - - The Advisory Committee met in the Empire Room of the Omni Shoreham Hotel, 2500 Calvert Street, N.W., at 8:00 A.M., Ruth Faden, Chair, presiding. - - - PRESENT: RUTH FADEN, Chair KENNETH FEINBERG, Member ELI GLATSTEIN, Member JAY KATZ, Member PATRICIA KING, Member SUSAN LEDERER, Member RUTH MACKLIN, Member LOIS NORRIS, Member NANCY OLEINICK, Member HENRY ROYAL, Member PHILIP RUSSELL, Member MARY ANN STEVENSON, Member DUNCAN THOMAS, Member REED TUCKSON, Member ALSO PRESENT: ALLEN BUCHANAN, Staff GIL WHITTEMORE, Staff JONATHAN MORENO, Staff GARY STERN, Staff VALERIE HURT, Staff DENISE HOLMES, Staff DAN GUTTMAN, Staff DORIS J. BAKER VINA COLLEY GREGORY PLAIR DIANA SALISBURY LENORE FENN PETER LEWIS ROBERT PROCTOR WILLIAM T. JACKLING FRED BOYCE SANDRA MARLOWE PAT BROUDY I-N-D-E-X Page Opening Remarks, Ruth Faden 4 Public Comment Period 5 Committee Discussion: Integration of 105 Retrospective Moral Judgment, Remedies, and Historical Ethics Policies (continued) (Tab H) Committee Strategy and Direction 176 Report on Spokane Small Panel Meeting (Tab E) Reed Tuckson Final Report & Appendices, Ruth Faden P-R-O-C-E-E-D-I-N-G-S Time: 8:13 A.M. CHAIRMAN FADEN: Could the committee please come to the table so we can begin the meeting. Good morning. Welcome to the second day. We're going to begin our morning meeting with a session of public testimony. We have lost about 15 minutes, but we'll try to -- We'll give the full period over to public testimony and readjust the agenda accordingly. We'd like to begin with just a brief reminder of how we work our public testimony. We would like to ask the presenters, if at all possible, to keep their comments to about five minutes and let the committee ask you questions for a remaining five minutes, so that each person can get about ten minutes. Obviously, we'll do our best to stay on schedule, but we will adjust accordingly. We have a timer which is supposed to help us. Sometimes it's off-putting, and we hope everyone understands its function is to keep the session rolling, but we do have a timer, and it will do the typical yellow blinking light, and then red light when the time has concluded. We have nine people who have asked to provide us with testimony this morning. Our first person is Ms. Doris Baker, and she's going to be introduced by Mr. Plair. Could Mr. Plair and Ms. Baker -- Are you here? Good morning, Mr. Plair. MR. PLAIR: Good morning. CHAIRMAN FADEN: Good morning, Ms. Baker. MR. PLAIR: First of all, let me say good morning to the Advisory Committee on behalf of the CROCSP in Cincinnati, Ohio. I'm going to take just 30 seconds to say, on behalf of -- I'm the Chairman, Gregory Plair. On behalf of myself, the officers and family members of CROCSP, of which we have two officers here today, Mr. James Tiswell who is assistant to myself, and also Ms. Doris Baker who is General Manager of CROCSP, we wanted to personally direct our thank yous to the Advisory Committee for their coming to Cincinnati, Ohio, in October. We wanted to thank you personally for that. It was very important to us, and we wanted to acknowledge the panel that came, headed by Dr. Tuckson, was very attentive. They not only listened, but they heard what we were saying. We encourage the Advisory Committee to continue listening to the victims and the survivors of the situation, not only in Cincinnati but around the country. So at this time I would just like to thank you again and wish you happy holidays on behalf of the CROCSP family members in Cincinnati, Ohio. At this time I would like to introduce our General Manager and CROCSP family member, Doris Baker. Thank you very much. CHAIRMAN FADEN: Thank you. MS. BAKER: Greetings to each of you this morning. My name is Doris J. Baker. Forgive me if I sound bad, but I will make it. I presented testimony on October 21, 1994 in Cincinnati, Ohio. Once again I stand before you to testify. I want to tell you a small part of my story about my great-grandmother, Gertrude Newell, study patient Number 20. In 1962 the government and Cincinnati General Hospital and Dr. Saenger put my great-grandmother in a study that she didn't even know she was in. They put 200 rads of whole-body radiation in her head, buttocks, pelvis, and other parts of her body. They also gave her Cobalt-60 2200. I wonder why, I asked myself. She originally went into the hospital for rectal surgery to remove a tumor, but they put a bag on her stomach. They said she had colon cancer. She died from the side effects of that radiation that they put in her. Why won't President Clinton come to one of the world's most awful tragedies in his homeland, especially when he was voted into office. This has touched the black, white, rich and especially the poor. This isn't about color or creed. This is about God's children from the past to the future. They kill my babies, our babies and, of course, your babies, too. I hurt very much for the children of this world, as you should also, because the government has not only killed a lot of human beings in the past, present, and soon many more will die in the future. They may live a little longer in the future if they are lucky, but some won't make it, like little kids and young adults. This is what I think is very sad. I watched a little girl, four or five-years-old, die on a video tape. She lived one day after the tape was made. She was a beautiful child that will never reach your age or mine. I also found out that people have lost their jobs over this mess. The wrong people were fired. Don't you think the good always get punished, and the bad get awards and handshakes? What about my great-grandmother and all the victims from my hometown? I keep hearing that these victims were Dr. Saenger's patients. He stole their body and on some he even stole their body parts without their knowing. Last but not least, who is going to make it right for the victims and their families? Will you, the Advisory Committee, please hurry and feel the pain with us and not for the defendants? Thank you, and God bless you all. CHAIRMAN FADEN: Thank you, Ms. Baker. MS. BAKER: Can I please hold up the pictures? CHAIRMAN FADEN: Of course. MS. BAKER: These are some faces of some of the deceased victims, and this is all of the victims from my hometown who are diseased that Dr. Saenger and the government radiated. I'm finished. CHAIRMAN FADEN: Thank you. Please stay for a minute. There might be a question or two. Are there questions for Ms. Baker? Thank you for taking the time to speak with us again. We appreciate it very much. Thank you. MS. BAKER: Thank you once again. CHAIRMAN FADEN: Is Ms. Vina Colley in the room? MS. COLLEY: Good morning. CHAIRMAN FADEN: Good morning. MS. COLLEY: My name is Vina Colley, and I am President of a group called Portsmouth/Piketon Residents for Environmental Safety and Security, PRESS. PRESS is also a member of the Military Production Network, which represents more than 40 grassroots, national and local organizations representing communities living in the U.S. Department of Energy nuclear facilities. We are also a member of the Human Radiation Task Force. I went to work in 1980 for Goodyear Atomic, which is now Martin Marietta. I was hired as a second class electrician, as a healthy, energetic, and hard working employee. I felt lucky to land a good paying job that I felt also served my country. You see, patriotism runs as deep as poverty and unemployment in the rural Appalachian community surrounding the Portsmouth Gaseous Diffusion plant in Piketon, Ohio. It was the most money I had ever made. I also thought it was a very safe job because of the attention given to wearing hard hats and safety glasses. I realize now I was wrong. The entire time of my employment at the government- owned facility, myself and fellow co-workers were exposed to radiation and chemicals without being informed about the effects of the dangers involved. In a memorandum dated September 24, 1947 to Colonel James Cooney and Mr. Edward Huddleson from Mr. Green, it was admitted that the people hired by the contractors were not, because of security, told of the hazards involved in their job. This policy of secrecy continues to this day. As a result of my exposure to radiation, my health has been severely affected. Some of my problems include: Chronic bronchitis, shortness of breath, rashes, arthritis, depression, stomach problems, and I have Uranium 235 in my lungs, and urinalyses have revealed the presence of fluorides. Finally, in 1987 I was diagnosed with multiple leiomyomata. I have also had a total abdominal hysterectomy caused from my exposure to hazardous chemicals. Some of the tissue removed during my hysterectomy was taken from the hospital without my knowledge or my consent. This is confirmed by a letter from Scioto Memorial Hospital submitted with my testimony, which states: "The specimen as received weighs 164 grams, total. The weight of the specimen would have been 190 grams. The specimen has been opened previously, and there is evidence that some tissue has been removed." I have tried to locate my tissue, but I have been informed by the hospital they do not know what happened to it. Recently, I have learned about the experience and various programs involving the collection of human tissue, etcetera, which our government actively participates in, programs such as the Comprehensive Epidemiologic Data Resource which started in 1964 with a feasibility study of the Hanford workers in Washington. I have also learned the extent of the U.S. Transuranium and Uranium Registries, established by the Department of Energy, which holds close to 20,000 tissue samples. I believe that my tissue was removed from the hospital and taken to some transuranic registry. Workers at Piketon and other DOE sites are continuously exposed to hazardous chemicals such as Uranium Hexafluoride, Technetium, Thorium, Plutonium, and many other similar contaminants. Yet under the justification of national defense, DOE has intentionally sought to cover up the health effects of its workers from these exposures. People like Dr. Eugene Saenger are involved in this cover-up. As early as 1943, the harmful effects of radiation have been known. In fact, in a 1961 statement to the Committee of the Women's Strike for Peace, Leo Goodman, Secretary, Atomic Energy Technical Committee of the Industrial Union Department, AFL-CIO, identified some of the known effects of radiation exposure, including: Epilepsy, congenital malformations, neuromuscular defects, blood and skin defects, defects in vision and hearing and skeletal defects, mental defects and defects in the gastrointestinal and urinary tracts. Proof of wrongful exposure to radiation and harmful effects of such exposure exist in the form of lists of radiation injury settlements, and include the names and place of accidents, settlement and dates. These settlements are paid to workers who were exposed while working in the AEC. I have a list here of workers in the United States who were paid by our government for radiation exposures. If such wide hazards of radiation have been known, could you please tell me Dr. Saenger was permitted to experiment on these individuals to find out the effects of radiation on the human body? These experiments were conducted without the knowledge or the permission of the victims. By allowing this activity to occur, the AEC and its followers engaged in activities similar to those under the Nazi regime of World War II. The practice continues today. To learn the full injustice committed by Dr. Saenger and other so unethical government employees, a full investigation into the falsification of all records must be conducted. Also, a complete declassification of all records pertaining to the Portsmouth Uranium Enrichment facility and all facilities controlled by DOE and DoD and contractors must occur. Experiments on workers at the DOE sites are not limited to the past, but continue to this day. It is time our government be accountable and settle up with workers like myself. As stated at the Whistleblowers Conference in Bethesda, Maryland, November of 1993, we cannot go forward until we take care of the past wrongs. Evidence of past wrongs can easily be demonstrated in a discussion of the occurrence at the Piketon plant. The "E Area" of Piketon Plant is a section of the uranium recovery operation. As workers explained, the uranium operation consists of three stages. First, the uranium comes in the form of shavings, chips, broken rods had to be powdered in a rod mill. "It was the worst thing, temperamental. It kept you on your toes, trying to run the thing. All at once you would see dust all over the place. The lid had come off of your rod mill, and uranium dust would be all over the place." Then if the material had to come in the form of uranyl nitrate hexahydrate, it would be fed into a calciner that would be entered into the top of a conversion tower. Fluorine would be pumped into the bottom of the tower and would react with the oxide to form uranium hexafluoride, which could then be entered into the cascade. The fluorination would create tremendous heat, which the operators had to keep controlled. The temperature would go wild. You would try to cool it, and then, all of a sudden, you have cooled it too much. At that point the UF6 within the tower might crystallize, and the operators would to enter the tower to prevent it from building up and going critical. The tool they used was a sledgehammer. You'd have to get in there and beat on it. You'd bat on it so much, it would blow out on you. Every shift and every day, you would bat on it. All E area equipment was open to the atmosphere. No glove boxes were used. Operators would wear coveralls, rubber gloves, and an assault Army mask. Since the masks were not self- contained, they were almost 97 percent ineffective anyway and, when they were removed, the inside of the mask became contaminated. All the material handling was done by hand. Some workers would try to keep the area clean, but the air was laden with dust. The dust was so thick that some workers could write their names in it. Some of the dust was washed down the drain in an attempt to keep the area clean. The dust that filled the room and settled was insoluble uranium oxide. Workers in E-Area also ran tests in which Plutonium was used. Between around 1957 and 1965, the chemical operators working in E-Area were being massively contaminated and were essentially unmonitored, since the company only checked the urine. In groups of four, Portsmouth workers began to make a three-day trip to Y-12 weapons plant in Oak Ridge, Tennessee. Elbert Bowman, age 38, died of lung and kidney problems. William Murphy died of a heart attack, but he also had cancer. Before Bill's death, he had a child born dead. Bob Elkins' hair turned white, and he began showing signs of leukemia. William C. Bird, cancer; G.E. McClellan died. One of the men had prostate cancer, and one other had a massive heart attack. Tom Salisbury told me ten years after he left the plant, he developed colon cancer, and he felt, out of all the workers that worked at the plant, E-Area workers should have been monitored. He relayed this to me, because he felt someone should know. Documents that are available show that the Portsmouth plant has larger than normal inventory losses of Special Nuclear Material from the period of October 1, 1980 through March 31, 1983. In a memorandum to Secretary of Energy Admiral Watkins wrote to Honorable John D. Dingell that "Due to the large uncertainty, our 1983 conclusion that the Piketon plant loss could have ben greater than 100 kilograms of uranium 235." The records for the releases of the oxide conversion area of X705 and the feed plant have not been released to the public. The feed plant operated between 1958 and 1962, the oxide conversion area of building X705 which operated from 1961 to 1978. Both of these plants emitted insoluble uranium, which will significantly affect the workers and the off-site community. The X705 recovery was found to have a large Transuranium problems. In July 1978 a test was run on the air filter traps, which disclosed a number of unexplained airborne samples. This disclosed a problem of, no matter what training and equipment was available, there would always be a risk of unexplained equipment failures and resulting employee exposures. On March 7, 1978 when 28,000 pounds -- Could I have your attention, please? I've come a long way, and it's cost me a lot of money. I've slept on floors. I've researched this stuff for nine years, and it's hard for me to have people not paying attention. On March 7, 1978 when 28,000 pounds of uranium hexafluoride was released over a few days, the comparison between this accident and the accidents one year later at Three Mile Island indicated that the dose to the bone surface (endosteal tissue) from Piketon was greater than the similar dose from Three Mile Island. I have attached estimates of air emissions releases of radioactive material and fluorides from the Portsmouth plant, Diffusion Plant, between 1950 and 1984. This document was prepared by Arjun Makhijani, a Ph.D., and Bernard Franke and Milton Hoenig, Ph.D. Radioactive waste was burned at the Portsmouth plant from the mid-1950s until 1986, around 50,000 pounds annually. From 1955 until 1992 some 23,122 pounds of uranium was released into the air, while 17,213 pounds of uranium was released into the water. An estimated 11,308 pounds of uranium was also hauled away to landfills and incinerators. July 17, 1975, 250,000 gallons of sterilizing chemical was discharged from the decontamination building to the drainage ditch which enters into the Scioto River which enters into the Ohio River. Approximately 18 million gallons of water per day is used at the plant to keep the system cooled. Portsmouth recirculating water currently is being discharged into the Scioto River. There is a 2 1/2 inch pipe from the plant that goes straight to the Scioto River, which runs into the Ohio River. Spent reactor fuel from West Valley, New York, was sent to the Portsmouth plant. All of this spent fuel was contaminated fission product, technetium and plutonium, which gummed up the works. It is also important to note that no uranium from a commercial reprocessing plant has been successfully reclaimed. There are three enrichment plants in the United States: Oak Ridge, Tennessee, Paducah, Kentucky, and Portsmouth, Ohio. All of these facilities are owned by the government and contracted out to Martin Marietta. The Portsmouth and Paducah plants passed into the hands of a government entity called the U.S. Enrichment Corporation. The Portsmouth, Ohio, story serves as a fitting introduction to the complexities and frustrations which characterize occupational health and safety in the industries producing nuclear materials for national security purposes. Incident rates for injury and illness are high, and exposure to toxic substances are reaching a crisis proportion for both workers and communities living around these government-owned facilities. Ionizing radiation is deeply connected to the defense sector. The Portsmouth plant, which enriches uranium for use in nuclear power plants and bomb production, has been operated unsafely. Employees have frequently witnessed large uncontrolled atmospheric releases of highly radioactive uranium gas. The community has never been informed of such releases or otherwise been given the opportunity to seek safety outside of the community. In 1979 the Oil Chemical and Atomic Workers Union stormed Senator John Glenn's office over health and safety issues. This was the first time that an entire workforce has risen in protest against the nuclear industry. Furthermore, the union has joined forces with environmental and anti-nuclear activists. The younger workers that come into this plant, like myself, never graduated from high school. Moreover, the plant pays the highest and the best wages in our part of the state. New workers are often required to perform dangerous operations without receiving proper instruction. These workers suffer severe damage to their health before they even know what's going on. I have spent nine years of my life reading everything I can get my hands on, and still I do not know what I have been exposed to. It seems that it is easier to get rid of the workers than to fix the problem. I have listened to this panel for the last and have become very troubled by your discussion. It is evident to me that the members of the Committee do not understand the plight of the workers and other victims of radiation experiments which you are researching. Accordingly, I feel that you must add to your panel a representative of the victims of these experiments, for only they can lend this Committee the perspective that is needed for you to make your decision. This is a child that was born in Pike County. This is his leg, and this is a tumor. The boy has an inoperable brain tumor. He's around 15 years old now. You cannot count the brian tumors and the leukemia and the cancers in this community. This mother was told, don't worry about this child, you have two healthy children, but the other two children wind up having a lot of problems, too. So I'd like to pass this around for the Committee to see. I'd also like for the Committee -- and they're making copies -- for you to see the workers and the causation of cancers from radiation. By the year of 1900 there were 170 recorded cases in which X-ray had produced biological damage to individuals, and it seems hard for me to understand why Dr. Saenger has been permitted all this time to do these experiments, when we already knew the causation. To me, what he has done is injustice. We want accountability. We want someone to stand trial for what they've done to the American citizens and, unless you do this, it will never change. I have the exposure records of the workers that traveled to Oak Ridge, Tennessee. CHAIRMAN FADEN: Thank you, Ms. Colley. Can we also have a copy of your testimony? MS. COLLEY: Yes. CHAIRMAN FADEN: That would be helpful, since you provided us with a lot of information. We can make copies for all the Committee members. Thank you very much. MS. COLLEY: I'd like to suggest that some of these workers from Oak Ridge, I'm hoping, will come out to testify when you come down there. I'd also like for the Committee to get a copy of Leo Goodman's statements. Matter of fact, he published a book, and I have a copy of all the incidents, partial incidents of accidents that's happened in the United States. So I've included his statement here. I've also included workers at the Piketon facility that have died of cancer or heart problems, and there's a big list of their names. DR. TUCKSON: I know time is short. Let me just ask you a quick question. In your community, as you described the difficulties, you said you can't count all of the brain tumors and so forth and so on. Have you been at all in touch with the Health Department of your state and county? Have they -- particularly, the epidemiologists there. Have there been any dialogues back and forth? MS. COLLEY: You see, the cancer in our county go to -- We live in small, a rural Appalachian area, and we have to -- 100 miles. We go to Cincinnati. We go to Columbus. We go to Cleveland. So our cancers aren't counted in our county. If you die of a heart attack, then your death certificate doesn't say you died of cancer, which was the underlying problem. I read an article in the paper in Cincinnati two years ago that in Scioto County we had a higher rate of cancer, and it was being noticed in Cincinnati, Ohio, 100 miles away from our community. DR. TUCKSON: I see. So in other words, it's that because of the location, people travel to other states, surrounding states. Is it all in one state or do people wind up going to other states -- hospitals in other states? MS. COLLEY: They go different places, because -- Well, we just now got a cancer thing set up in Scioto County, but before there was no one to treat. Also, I'd like to note that there's a list of hospitals who have been tied up in some of the experimentation. DR. TUCKSON: Well, we'll talk further. Obviously, you've been in close touch with the Outreach Committee and so forth, but it would just seem to me that one of the things that, in addition to speaking with us and to the DOE and so forth, is that -- It seems to me that perhaps there ought to be an opportunity to try to get at least those commissioners of health for the affected states, and to see if we couldn't find a way to better understand some of the disease incidences that you have noted. MS. COLLEY: The community ourselves -- We have went door to door. We've knocked on doors, and we've dated our cancer ourselves. You know, it's kind of hard for someone to come into a community like mine, because people usually don't move away. We stay around the area, and we know everybody. I'm worried now, because I think that the people who run ATSDR and CDC and Health and Human Services and all these people are whiting-out your names so you won't know if you've been a victim. So the longer we stall on this, someday we'll never know that we're victims. DR. TUCKSON: I understand. Well, thank you, and again, just realize, though, that since you have been doing that hard work, there are people employed in these state health departments who are expert at being able to capture and collect data. I just think that maybe they ought to have the opportunity to hear from you so that they might think of this as an area that might capture their attention, and also might be a legitimate part of their responsibility, so that you don't have to do all of this yourself. That's all I'm saying. MS. COLLEY: Well, that would be okay, but they're too scared to come forward, because there's no other jobs in these communities, and the health departments and them won't come forward. We went through the vital statistics in Ohio. The state of Ohio has risen in 65 percent cancer deaths since these facilities have started production. DR. TUCKSON: Well, if you don't ask them, then you cannot, I think, legitimately -- MS. COLLEY: I've worked with all the agencies, and I know how they give you the run-around. They're too scared, because there's no other jobs in these communities, you know. The agencies are hiding. DR. TUCKSON: If you don't ask them -- MS. COLLEY: I have asked them. I have asked everybody. My phone bills have been $400 a month. Who else do I have to ask? DR. TUCKSON: Okay. We'll follow up on it. Thank you. CHAIRMAN FADEN: Our next presenter is Ms. Diana Salisbury. MS. SALISBURY: good morning. CHAIRMAN FADEN: Good morning. MS. SALISBURY: I would just like to say before I begin from my printed text, I know this is very difficult for the Committee to understand, because the Committee approaches this from the role of authority figures, judging other authority figures; but we are perceived in community groups as very emotional and easily dismissed. I want to explain just a tiny facet of our perspective. These are not risk assessment excess deaths to us. These are our families. These are our neighbors. These are people we have known. These are real people with names and faces. So sometimes we do tend to get just a little bit emotional, which I truly believe should be part of the Committee's discussion. With that, I'll begin. My name is Diana Salisbury. I am here today as a member of local environmental groups, including Serpent Mount/Ohio Brush Creek Alliance and Portsmouth/Piketon Residents for Environmental Safety and Security, and as a citizen directly affected by the past actions of the agencies and institutions in pursuing nuclear technology and in pursuing knowledge of its effects. I would like to thank the Committee for giving me the opportunity to testify here today. I would also like to extend my appreciation to the Panel on Human Radiation Experiments for the consideration and attention that they showed to the witnesses in Cincinnati, Ohio. The magnitude and the scope of the experiments already revealed through the committee's efforts are staggering. The extent of governmental agencies and their agents' experimentation on the citizens of this country represent a dark and sinister chapter in this nation's history. Under the cloak of secrecy and in the national interest, more citizens were placed in jeopardy from their own government than they ever were from any foreign power during the Cold War, and I wonder about now. The location and function of the three Federal facilities located in Oak Ridge, Tennessee, Paducah, Kentucky, and Portsmouth, Ohio, are critical to the Committee's task. These facilities were designed to enrich uranium for military weapons and were located in rural regions of the Appalachian mountains. That is where these facilities were placed. They were put away from people. Unfortunately, we didn't get the word. We consider that we're people. The Appalachian population represents one group selected to bear the risks and burdens for the greater societal good. The Portsmouth Uranium Enrichment Plant is actually in Piketon, Ohio, in the foothills of the Appalachians. Goodyear Atomic initially operated the plant from 1955 until 1986 when Martin Marietta Systems became the contractor. The Portsmouth facility is unique in both size and function. Portsmouth's mission is to convert solid uranium gas to between two and five percent for commercial reactors and to more than 93 percent for nuclear weapons programs. The plant is among the largest industrial facilities in the world, covering more than 10 million square feet of building space on 3800 acres. The cascade system forces uranium through fluoride gas to accomplish this 93 percent level of enrichment. The facility is now over 40 years old and was designed to operate with atmospheric releases or what they call purges. The GAO report estimates that environmental releases affect the human and natural environment in a 50 mile radius from the plant, and that GAO report is from 1985. A representative of Martin Marietta Systems, Inc., testified that two intentional releases occurred at Paducah, Kentucky. Until 1985 the Paducah plant, like its two sisters, were operated by Goodyear Atomic. Intentional releases have also been reported at Oak Ridge. No intentional releases have been documented at Portsmouth to date. This is a quote, again from the GAO report. "According to its own reports and a consultant's study, Portsmouth has not demonstrated to Ohio EPA that all sources of hazardous air emissions are included in the hazardous air emissions permits nor have permits been issued covering all known releases." The Portsmouth plant is presently a party in a law suit centering on airborne releases of uranium hexafluoride. The actual amount of uranium hexafluoride is subject to dispute, and here's where it gets tricky. The current estimates are under dispute by the oversight agencies, because all the documents have not been included in the data used to compute the releases. The documents required for more adequate data on releases would be available from the same agencies that claim the estimates are inaccurate. You see where it gets sort of cyclic here? The agencies who have the data criticize the data, because it's not complete, but they won't release the data so that it can be complete. It's kind of holding it with both hands and not letting go. The agencies most interested in providing documents are the sources where we must go to get the documents, not only at Portsmouth but also in this whole burden of proof on the victims to show what happened. Now I know the Committee is providing documentation and documentation, but it is ultimately up to the victims to show that the authority figures acted inappropriately. The presumption is authority figures have to be shown to be inappropriate in behavior. Their actions are assumed correct. The burden of proof is always on the victim. Workers have raised concerns that they were unwitting participants in experiments at the Portsmouth site. They, the union workers, told us that Portsmouth workers and occupational health injuries are understated and that employees are merely part of an experiment to prove that radiation is safe. That's a quote. These individuals did not, however, provide documentation to support these allegations. Now that statement comes again from a 1985 report. The GAO also found similar allegations in 1982 and similar allegations again in 1980, and none of these reports have ever been investigated, not a one. The workers did express concern that urine sampling was taken at the beginning of the week rather than at the end of the week as proper procedure stipulates, due to the insoluble nature of uranium and its short retention time in the human kidneys. So by taking urine samples at the beginning of the week, there would have been from Friday through the Monday morning for the uranium to be out of the system before they were tested. So what would the test prove? Very little. There are two important issues raised in the 1985 GAO report. Workers raised questions concerning being unintentional participants in experiments without the investigation of these complaints. In order to prove the allegations, workers would have been required to obtain documents from the agencies they were accusing of conducting experiments on them. The burden of proof should not rest solely with the victims or alleged victims. The data made available clearly does show that releases at the Portsmouth plant violated standards in place at that time. The releases would not have been allowed either in Oak Ridge, Tennessee, or Paducah, Kentucky. When documents and data are made available to the public, they are often confusing and use units and conversions not easily understood by the general public. The amount of uranium hexafluoride released accidentally in March of 1978 is easily understood in tons or pounds, tons 10.5, pounds, 21,125, and I see a typo on my paper. The units provided by the Department of Energy use kilograms for some material and curies for others. They divide the uranium up into U-234, U-235, U-238, and it is listed in three columns, some in kilograms and some in curies. Now it can be converted. There is a conversion chart. It's like 6.48 times 103 will convert curies to grams, and then you convert to kilograms. It can be done, and it's not inaccurate, but it's not something the general public can easily interpret. How much is a curie released into the environment? It doesn't come trippingly off the tongue. In testimony before the panel in Cincinnati, Owen Thompson, a former worker at the Portsmouth plant, stated that he was treated by Dr. Saenger of the University of Cincinnati and that his records were not returned to him. His worker's compensation claim for injury from radiation exposure was denied by Dr. Saenger on the basis that Mr. Thompson could not provide proof that his brain cancer or other injuries were caused by his exposure to radiation during his employment at the Portsmouth plant. Mr. Thompson's cancer did not appear until after the two-year period had lapsed for him to file his claim. Now it doesn't take an expert in cancer research to know that exposure and appearance of cancer is not in a two-year time frame or less, and I'm sure, as a world renowned expert, Dr. Saenger must have been aware of that fact. I do have the letter written by the attorney regarding Mr. Thompson's case, and it's most illuminating. Owen Thompson was a member of a special squad and handled problems at the plant and participated in high risk, high exposure activities during his employment. He is presently now in his early Forties, and is terminally ill. He has undergone surgery for brain tumors and has tumors on both knees, had an incredible amount of health problems, some of them cancer, some of them other than cancer. During his testimony in Cincinnati, he indicated that he was at the initial stages of his employment -- and I wish you could have heard him say it -- "big and strong, and not afraid of anything." I wish he could have been here to say that for you, and I wish he could have been here to tell you about the next incident that I'm going to tell you about. "I did my country wrong." Owen Thompson said that after his health problems, after what's happened to him. He said, "I did my country wrong," and listen why. The Inco Nickel Plant was dismantled, because it was contaminated with uranium, asbestos, and nickel carbonyl. The factory was so contaminated with uranium, asbestos, and nickel carbonyl that it had to be removed from the city of Huntington, West Virginia. One contractor died immediately during the dismantling, and another died within a few days, indicating a pretty high dose. The full account given by Owen Thompson of this incident is not even in the public record. The documents on this project indicate that the scrap metal from the Inco plant was to be transported by truck from West Virginia to the Portsmouth site in November of 1978 through March of 1979. Now I'm seeing stop. Okay. Now what is crucial about this incident is there was nothing done to mitigate any exposure to any of the communities where this material was being transported, and this was hauled in at night and buried at night on the plant site while machine gun guards stood over Owen Thompson. Now the reports don't say that. My point in all this is, the reports don't always tell what really happened. What's in the report sometimes is not anything like the full discussion. Now I also have a letter to include from Ms. Sherry Brabant who was originally told that her mother was not a radiation experimentation victim at the University of Cincinnati. Ms. Brabant's mother was, in fact, a radiation victim, and Ms. Brabant testified to that effect in Cincinnati. The documentation we get is fragmentary. It is not often released to us. When it is released, we sometimes can't understand it, and what is in the documents sometimes is a pretty much refined version of what happened, in the first place. I think I've gone well past my time, but I will submit the rest of this in the public record. CHAIRMAN FADEN: I was about to ask you. That would be very helpful. The problem, of course, is the tension between the time for testimony and the time for questions, which makes it difficult for all of us. Is there anyone who has an immediate question for Ms. Salisbury? Eli? DR. GLATSTEIN: Can you furnish the references that you've listed here? MS. SALISBURY: Absolutely. DR. GLATSTEIN: You've listed them, but they're not in association with -- MR. SALISBURY: And I will furnish you copies of those here. DR. GLATSTEIN: Thank you. CHAIRMAN FADEN: Thank you very much. We appreciate your time. Again, if we could just ask people -- I know it's extremely difficult, but in order to give us the time to hear and listen to everyone, if we can keep the written comments -- reading from the written comments to a confined period of time, and give us a chance to ask questions, that's sometimes preferable. On the other hand, if you want to take your whole time to present, the choice is clearly yours. If we could -- Is Ms. Fenn in the audience? Could you please come to the table. There is an attachment -- Good morning. There is an attachment. Ms. Fenn's statement is attached to the list of presenters. MS. FENN: Do you all have a fact sheet about Boston Project which was meant to come with my testimony? It grounds what I want to tell you. CHAIRMAN FADEN: Yes, we do. MS. FENN: Good. Great. CHAIRMAN FADEN: It would be at our places, and it's a document that begins "Project Name, Boston Project." The date is 10/53. MS. FENN: I'm only going to read the first part of my testimony, because I understand you have it all and can read it at your leisure, and that should be a little more than five minutes; but if you don't have any questions, I'll read more of my testimony. CHAIRMAN FADEN: Why don't we stop and see. Thank you. That's very kind of you. MS. FENN: I would like you to know about two episodes when I was involved with human radiation experiments without informed consent. In addition, I would like to describe a climate of disrespect and even brutality toward researchers, patients and laboratory animals that inevitably permitted and even invited such experimentation. So The Boston Project: In the summer of 1955, I was 17. I had a summer job at Massachusetts General Hospital I was secretary-technician for the Hypertension Lab, working for William Chapman, M.D. A curious, enthusiastic doctor's daughter, I roamed the hospital in off-hours, watching operations, asking questions, learning about alcoholic cats, the buffer system in the blood, everything I could. Researchers, glad to find a willing listener, invited me into their labs to share their excitement and their quests. A medical student who worked in Nuclear Medicine invited me to "help" with procedures conducted by William Sweet, M.D., on Jacob Lefton, a semi-comatose patient with a brain tumor. Dr. Sweet was President Eisenhower's delegate to the Atoms For Peace conference in Geneva. I believed in medicine, and was grateful for the opportunity to learn about the cutting edge of progress. I should put "progress" in quotes there. You can do that. The circumstances were unusual. We gathered in a remote part of the hospital after 10:00 P.M. Jacob Lefton, sedated and restrained, was on an operating table. A large rectangular bone flap was lifted from his cranium. Dr. Sweet placed probes connected to scanners in his brain tumor tissue, his normal brain tissue, his chest, thigh, leg, etcetera. He was then administered a radioactive isotope, and as multiple scanners started to whiz, records were kept to indicate the relative concentration of radioactivity in various body parts. Brain and brain tumor tissue spilled on the floor. Meanwhile, Jacob Lefton wept, struggled, prayed and cried out for help. When I expressed concern for his suffering, I was told that he would "not remember the pain as pain." Being solicitous, I took him a perfectly ripe nectarine a few days later, but he seemed to be sleeping. So we didn't talk. Two weeks later -- and I have this information in my calendar of 1955, if it's any kind of evidence for anything. Two weeks later, we gathered again at night, and Jacob Lefton was treated with a different isotope. I learned that the point of the process was to discover which of several radioactive isotopes concentrated most intensely in Jacob's tumor tissue. I assumed that the concentrated radioactivity was healing Jacob's tumor. Everything went as before. Dr. Sweet was utterly absorbed in Jacob's brain and the scanner's numbers. There was a German doctor who went, although it is hard to imagine, right up to his elbows in Jacob's brian. Even more brain tissue and tumor tissue spilled onto the floor. Jacob wept, struggled, prayed and cried as before. A few days later I, deeply penitent by now, took him a perfectly ripe peach. This time, his wife and adult son were visiting, weeping softly in the darkened room. I explained myself and the peach. Ms. Lefton was kindly. She said he was too sick to eat the fruit, but that because he was being treated by Dr. Sweet, they had hopes he would recover. Indeed, she remarked, after each "treatment," he did seem a little better, but it didn't last, at least so far. At Jacob's third "treatment," I repeated Ms. Lefton's comments about his temporary improvement, and asked what the future held for Jacob. Someone explained that Jacob's increased responsiveness after each procedure was, in fact, due to the spillage of his brain and tumor tissue, which temporarily lessened the pressure on his brain. Jacob was not receiving "treatment." There was no treatment. This experiment was not for the benefit of the patient. As another and different radioactive isotope was administered, and the scanners whizzed, I talked about this new information with the anesthesiologist, who turned out to be only a medical student. We had both believed, as Jacob's family believed, that Jacob was receiving treatment. The next day, as we had agreed, the medical student reported what we had witnessed to the head of the hospital. The procedures stopped. I continued to visit Mr. Lefton, who died in December. In fact, I sculpted Mr. Lefton for an art course. The dignity of his strong and sinewy body and of his continuing belief that he could be, should be, and would be rescued stirred me deeply. So I still have a green light, but I'm on page 2 of 5. So I can stop and take questions, if that's what you would like. CHAIRMAN FADEN: Questions for Ms. Fenn? Ms. Fenn, if I could ask a question, you were then working in the hospital as a young person at that time. Did the physician, Dr. Sweet, ever acknowledge what was going on to you, either with pride about -- MS. FENN: Dr. Sweet didn't talk to -- CHAIRMAN FADEN: I saw that coming. I understand the phenomenon. I've seen it myself. MS. FENN: There were doctors who did, but he didn't. I don't know what he told whoever he was getting the isotopes from. Certainly, though I'm not a professional, this doesn't sound like what I was told they were doing. They were comparing and contrasting different isotopes. CHAIRMAN FADEN: Were you aware of any other patients on whom these procedures were performed? MS. FENN: No, I was not. CHAIRMAN FADEN: Do you know if Mr. Lefton's wife or son ever came to understand what happened to him? MS. FENN: No, I don't, and I had a hard time wondering about whether to share that information with them. CHAIRMAN FADEN: I'm sure you did. Duncan? DR. THOMAS: At the end of your testimony, you attached this fact sheet. Was Mr. Lefton one of the 12 patients that's reported in this? MS. FENN: That's my understanding. DR. THOMAS: What's puzzling me a little bit is the description seems to differ from your description of the procedures. It says that 12 tumor patients were intravenously injected, and you described the administration of the radionuclides directly into the brain, as I understand it. MS. FENN: I said it was administered, and to tell you the truth, I don't remember where. DR. THOMAS: So the procedures which you witnessed could have been part of the biopsy that's described in the following sentence? It wouldn't seem to me like a normal procedure for doing a biopsy to have brain spilling onto the floor and so on. MS. FENN: No, I don't -- It wasn't delicately done, no. DR. THOMAS: It's puzzling. Where does this page come from? MS. FENN: It comes from a collection at the Center for Atomic Radiation. The Center for Atomic Radiation is run by Dan Burnstein and other people. I was trying a few years ago to get the information, because I thought it would make an interesting article for The Boston Globe about how the so called safe permissible dose of radiation has declined precipitously over the decades; because I thought, if people saw that, they might be a little suspicious of the so called current safe permissible dose. In my quest for information, I ran into the Center for Atomic Radiation Studies and, in fact, they sent me along with information to share with your committee. So I'd like somebody to connect with me afterwards and pick it up. DR. THOMAS: The three references at the bottom of this page would describe publications that resulted from the 12? MS. FENN: Yes. I have not -- I just got this last Monday, and I have not looked up the citings, but I have talked with doctors who have read the citings. In fact, when I was trying to figure out how to approach Ms. Lefton, I called a medical ethicist to guide me on how to phrase the question, and he had read one of these and knew that there was one semi- comatose patient. That was Jacob. DR. THOMAS: It would be useful to take a look at these papers. MS. FENN: For me or you? DR. THOMAS: Well, certainly, for us. I'm sure you would find it interesting as well. MS. FENN: I'll agree with that. CHAIRMAN FADEN: Jay? MR. KATZ: Ms. Fenn, what a moving story. CHAIRMAN FADEN: Speak into your mike, please. MR. KATZ: A very moving story. I understand that your father was a physician. Did you tell him about what you observed? What was his reaction? What did he tell his late- adolescent daughter? MS. FENN: I wish I had a direct quote for you. I told everyone I knew about this. My Dad had Parkinson's disease, as you would see if you read the rest of the record, and was very depressed about the death of my mother, and we didn't have the kind of conversations that we would have had in the past. In fact, it was precisely because he had Parkinson's and surgery for Parkinson's that I was so thrilled with what was happening at Mass. General, and so confused by what I saw. MR. KATZ: At the time did you talk to other doctors, friends of your father, about this? MS. FENN: Oh, friends of my father? No, because when he had Parkinson's, my father was so ashamed, he stopped seeing patients and stopped seeing his friends, but I talked about it with other people in the hospital, and in my testimony there's a story about Art Baue, who was a surgical resident, complaining bitterly about what Dr. Sweet did to one of his patients. The reason Art Baue told me that was because I had told him about my experience with Dr. Sweet. Basically, he was saying, you know, that's what this guy does. MR. KATZ: Thank you. CHAIRMAN FADEN: Lois. MS. NORRIS: I take it, that because you tell us that you discussed this with a number of people, you were never cautioned about secrecy then? Don't discuss it when it was reported to the hospital officials? MS. FENN: I didn't discuss it with the people who would have been concerned to keep it secret. I was -- I mean, the underlings and nobody's an earthling, you know. I mean, there's a great caste system in a hospital. As I say, the medical student went to the head of the hospital, as I did once about something else, and he obviously responded in a very responsible way when he knew these things were going on. MS. NORRIS: So I take it then that the medical student was not led to believe that the hospital administration was aware of what was going on until he reported it. MS. FENN: Right. I think that's very important. I mean, you were talking yesterday so much about what standards existed and the clandestine quality of this is very powerful testimony to me, and the fact that it stopped on a dime is very powerful testimony that standards existed. CHAIRMAN FADEN: I cannot -- Oh, I'm sorry. Ruth. DR. MACKLIN: Yes. Unfortunately, I didn't get a chance to read in detail the other episodes that you recounted here, but I'm looking now at Number 3 that you've recounted here, and especially the part where you describe at the bottom of the page, "Medical students, student nurses and people like me were given financial incentives to participate in research with ionizing radiation. You got $20 for a liver scan, $50 for drinking a certain potion, etcetera." These raise a lot of questions, obviously, and to make the question very general, can you provide us with anymore information about this? That is, were these Dr. Sweet's studies? What was the nature of the studies? What were people told? I mean, since they were medical students and you describe it, they undoubtedly knew that they were drinking radioactive cocktails, but what else did they know, and what was explained to them, and who was carrying it out, and was there a protocol? I mean, if you don't know these things now but could possibly supply us with information -- MS. FENN: There was an area of the hospital, you know, called nuclear medicine. I went along to earn $20 one day, and a medical student called Henry said, Lenore, you don't want to do this; you've go a healthy body, don't mess around with it, this is dangerous. I conceivably could find out who he was. I'm not sure how, but Scott Allen, a journalist in the Boston Globe, did track down Jim Ryan and talk about that. I'm sure he could give more details. That's a name and a place. He's at Columbia. MS. NORRIS: Thank you. MS. FENN: I wish I could. I wish -- I really wish I had it all. DR. MACKLIN: As a person who was yourself attempted to be induced into this, did you talk to any researchers or who was it who asked you or invited you, and could you say anything about those circumstances? MS. FENN: Yes. In the lunchroom, the word went around, you could earn $20, and I was trying to save -- I was a scholarship student in college. I was trying to save money. So I was right up there to earn $20, but in terms of who ran the nuclear lab at that time or, you know, the infrastructure, the administrator, the structure -- I was 18 or 17 or something, in another world. CHAIRMAN FADEN: Ms. Fenn, we thank you very much. MS. FENN: Thanks for listening. CHAIRMAN FADEN: It's very important, obviously, what you've shared with us, and particularly the description of the procedure as that person experienced it is the kind of information, as awful as it is to hear, that we rarely have access to. MS. FENN: I very much sympathize with all of you on the committee for having to hear so much stuff you would rather not know about, and I wish you courage in being able to really hear it. CHAIRMAN FADEN: Thank you. We're trying. Our next presenter is Mr. Peter Lewis, if he is in the audience. Thank you for coming, Mr. Lewis. MR. LEWIS: Good morning. My name is Peter Lewis. I'm from Uniontown, Pennsylvania. Thank you for the opportunity to speak. I believe that as a child I was used in radiation experiments at Walter Reed Army Medical Center. I came here yesterday fully intending to testify about what was done to me. However, yesterday I was advised by my attorneys that it would be inappropriate to say anymore publicly about this case at this time, in light of a private investigation now underway. However, I do fully intend to testify at length about this situation at a later date, perhaps in January, if the Committee is willing to invite me back. My apologies for not being able to say anymore at this time. Thank you. CHAIRMAN FADEN: Thank you, Mr. Lewis, and you're certainly welcome to come back, and we hope you will find a context in which you can share your information with us. MR. LEWIS: Thank you. I accept the invitations. CHAIRMAN FADEN: Our next presenter is Professor Robert Proctor. Good morning. MR PROCTOR: Good morning. CHAIRMAN FADEN: Thank you for coming. DR. PROCTOR: My name is Robert Proctor. I am Professor of the History of Science at Penn State University and the Shapiro Senior Scholar-in-Residence at the United States Holocaust Memorial Museum in Washington, D.C. I want to discuss here two separate topics: First, the Atomic Energy suppression of uranium epidemiology in the late 1940s and early 1950s, and secondly, the importance of attributing blame for past abuses as a symbolic and moral act. Knowledge of the health hazards of uranium mining go back a long time. The first epidemiological studies in 1879 in the ore mountains, the Erzgebirge of Bohemia. By the 1920s it was recognized that radiation was the most likely etiology of the so called Schneeberg Krankheit, the uranium mine-induced lung cancer that was very prevalent in southeastern Germany and northern Czechoslovakia. By the end of the 1930s there were several dozen epidemiological and animal experimental studies showing that, again, radiation was the most probable cause of uranium mine- induced lung cancer. Given the European experience, the emergence of a radon hazard in U.S. uranium mines should not have been difficult to predict. Wilhelm Heuper in 1942 presented an elaborate historical review of the discovery of the radon lung cancer link in European mines, along with a convincing refutation of efforts to attribute the disease to other factors like inbreeding. A 1944 review by Egon Lorenz for the Journal of the National Cancer Institute concluded that, and I quote, "the radioactivity of the ore and the radon content of the air in the mines are generally considered to be the primary cause" of the European Bergkrankheit or mountain disease. In 1947, Fred Stewart, an expert on occupational cancer, predicted, and I quote, "One will see cases of cancer and of leukemia in our newest group of industrialists, workers in the field of fissionable materials." In the late 1940s several scientists tried to alert the Federal government of the uranium mining hazard, but had relatively little success. Bernard Wolf and Merril Eisenbud traveled to Colorado in April of 1948 to inspect the mines and make recommendations for remediation, but were told by Atomic Energy authorities in Washington that the health problems of the mines were not the responsibility of the Atomic Energy Commission. The most chilling, in my view, rebuff of efforts to expose the uranium mine lung cancer problem in the United States were the experience of Wilhelm Hueper, head of the National Cancer Institute's Environmental Cancer Section and the world's foremost authority on occupational environmental cancer in the middle decades of the century. In April of 1948, Hueper had begun a project to study United States uranium miners, well aware that European uranium miners had long suffered from very high rates of lung cancer, up to 50 percent, actually, mortality, in some cases at the end of the 19th Century. His efforts in this area were stymied, however, by the fact that the Atomic Energy Commission had the power at this time to vet all NIH papers dealing with radiation, and the power to determine clearance or non-clearance. When Hueper sought to present evidence of the threat at a 1952 meeting of the Colorado State Medical Society, Shields Warren ordered the head of the National Cancer Institute to instruct Hueper to delete all reference in his paper to the hazards of uranium mining. Hueper initially refused on the grounds that he had not joined the Institute to become what he called a scientific liar. Pressed with the demand, however, he felt he had no alternative but to withdraw from the conference. He did send a copy of his paper to the Society's President, prompting Warren again to write to the Director of the National Cancer Institute, this time asking for Hueper's dismissal. Hueper continued on at the Institute, but was soon thereafter barred from all epidemiological work on occupational cancer. The order came from the Surgeon General. As Victor Archer recalls the incident, Hueper was essentially barred from research travel west of the Mississippi, and required to do only at that time animal experimentation, interestingly. Hueper later complained that government censorship of studies on the health effects of uranium mining had delayed measures to remedy the situation, leaving hundreds of men to die who otherwise could have been saved. The Public Health Service did begin to study the environmental hazards of the mines and health of underground miners in 1949 and 1950, but this agency, too, was hamstrung by apathy, bureaucratic conservatism, and government suppression of certain types of important data. The Service launched an educational program to inform mining companies and state agencies of the danger, but incredibly, the miners themselves were never informed of the hazard. A Public Health Service report of 1957 called for immediate corrective measures, but as late as 1961 29 percent of all U.S. uranium miners were still breathing more than 1,000 picocuries per liter at work. The problem, as we're all familiar with, is that nuclear authorities were reluctant to push for anything that might impede the flow of uranium from mines to mills to weapons. Duncan Holaday, the PHS health physicist responsible for monitoring the radiation in U.S. uranium mines, became frustrated by the failure of the AEC to warn the miners or to force the industry to clean up its act. In 1953 he complained that, and I quote, "the only way we can ever get anything done is to collect dead bodies and lay them on somebody's doorstep." Victor Archer, the epidemiologist who from 1956 to 1968 supervised the PHS study of cancer among the uranium miners, used similar language to express his own frustration, testifying that he and his colleagues had caved in to AEC and PHS pressures not to publicize the hazard. As he put it, "We did not want to rock the boat. We had to take the position that we were neutral scientists trying to find out what the facts were, that we were not going to make any public announcements until the results of our scientific study were completed." Official pressures to monitor the disaster without informing those at risk or forcing the companies to reduce the hazard led Public Health Service scientists to characterize their study as a death watch or a dead body approach. I would argue that this was one of the more deadly radiation experiments, if you can consider experimental epidemiology a kind of experiment. That's a kind of question of definition. By 1990 nearly 400 of the 3,400 miners from the Public Health's experimental epidemiology study had died of lung cancer, about five times more than expected, and if you figure that there were about 30,000 to 40,000 underground uranium miners in the United States, one can expect about 3,000 to 4,000 premature deaths from lung cancer by the time the epidemic takes its full course. Interestingly, the numbers are about five to ten times higher in Czechoslovakia and Eastern Germany which had, interestingly, very parallel stories except on a much grander scale, a much more catastrophic scale that I've documented in my forthcoming book called Cancer Wars. Finally, I want to say something about the importance of attributing blame and recommending compensation, not so much for the uranium miners, which has already been recognized by law, but for victims of the most egregious radiation experiments. I think it's important to attribute blame, both out of a sense of fairness to those injured, or their relatives, but also as a symbolic act, to send a message to present and future investigators of the gravity of such actions. I realize this is not always easy, and I tend to agree with those who say that we should not ride into the past like some victorious time traveling army, but we should recall that the Nuremberg trial itself was an effort to project justice onto a culture that had evolved some rather inhumane standards of human decency. American prosecutors could surely have done more to appreciate the subtleties of the ethical and social context within which Nazi medicine was practiced, employing professional ethicists and the like, but surely it would have been wrong to allow this to cloud our revulsion and condemnation. We mustn't let our faculties for sympathy and understanding undermine the courage we need to recommend justice. Nuremberg, after all, was a lesson for the future, and so perhaps will be the judgments of the present committee. For this reason, I would encourage you to take a strong moral stand, recognizing blame where blame is due. Bygones can become bygones, but only if justice has been done. Thank you. CHAIRMAN FADEN: Thank you very much, Professor Proctor. I'm sure we'll benefit from your scholarship and from your insights. Are there questions or comments? Yes, Jay? DR. KATZ: Thank you, Bob. Tell me, do you have these documents on Shields Warren's involvement? We've been looking for them. The only place where I found a reference for it was in Stewart Udall's book. Do you have these? DR. PROCTOR: I haven't checked his diaries. I know Gil Whittemore has looked at them for other purposes, but they're available, I guess, in Boston, and I mean to do that. The source I have are primarily from Hueper's autobiography, where this whole story is detailed at great length, and he gives a very rich account -- a rich account of his experiences in that regard. DR. KATZ: Oh, he describes the interaction with Shields Warren? DR. PROCTOR: Yes. He also does it -- DR. KATZ: I wasn't aware of that. DR. PROCTOR: He also does it contemporaneously in 1962 in a number of other papers in the early 1960s. DR. KATZ: Thank you. CHAIRMAN FADEN: Phil? MR. RUSSELL: The study that you referred to as the Public Health Service experimental epidemiology study -- did it have an official title, and were there publications that refer to that? DR. PROCTOR: There are a whole series of publications that emerge out of that, that I have thorough documentation for. I guess the first publication on it is 1962, but it's this well known, ongoing PHS epidemiological study of 3,400 white miners, and there's a separate one, I think, that Roscoe did at NIOSH for the Navajo miners, but there's a steady stream of publications through the Sixties, and they're ongoing and at the present are still being followed. I can't remember the official title, but it's usually just referred to as this uranium mine epidemiological study. CHAIRMAN FADEN: Ruth and Duncan? DR. MACKLIN: Yes. Robert, you addressed a topic that I think you heard the Committee talking about yesterday, which was ascribing blame to past actors, and you use as an example of the appropriateness of doing so the Nuremberg trials. Do you think there was a lot more evidence, factual evidence, of just who was responsible for what in the -- that was available at Nuremberg than we either now have or are likely to have? I mean, since you're a historian, I'm just asking you to speculate on what we are likely to have by way of the ability to assign particular responsibility or blame to individuals who could be held culpable. DR. PROCTOR: Well, it's true that Germany was a conquered country, and certain things were captured; but there are certain ways, I guess, in which -- and, of course, the magnitude of what was done was, in a way, much greater in Nazi Germany. Certainly, in certain ways the magnitude was less, but it seems to me that, given the fact that the Nuremberg trial was so rushed in certain ways that you have more the leisure to investigate things. It's not -- It maybe doesn't have the inherent adversarial character that the conquered country phenomenon had. So you might have certain -- It might be easier in certain respects, I would think, to attribute blame in these cases, but simply because you have more time. There's not a -- Well, maybe you do have a deadline. I don't know, but I would think that it's not in principle different in this respect. CHAIRMAN FADEN: Duncan. DR. THOMAS: I guess I mainly wanted to thank you for your detailed wealth of knowledge and information that you've communicated to about the history of the uranium miner story. It's a sad chapter in our history. Our staff is also in the process of trying to write a history of this period as well, and some of the information that you've conveyed to us fills in some of the gaps in our own account. I just invite you to speak to Faith Weiss, who is spearheading our own attempt to try to tell this story, so we can get out of you whatever information you know that we don't know. DR. PROCTOR: Okay. Thank you. CHAIRMAN FADEN: Can we get -- In addition to, hopefully, other things we'll be able to get from you, could we get a written copy of your comments? DR. PROCTOR: Yes. Yes. CHAIRMAN FADEN: That would be very helpful. Thank you. Also helpful for the transcription process. Thank you very much. Our next speaker -- and, please, I should apologize to all of you if I mispronounce your names. I'm not always comfortable with this, but our next speaker is Mr. William -- I believe it's Jackling. Is there a Mr. Jackling? Thank you. We do have some written material from Mr. Jackling -- Is it Jackling? MR. JACKLING: Yes, it is. CHAIRMAN FADEN: -- at our places. It's Attachment 3 in your stack of stuff for this morning. MR. JACKLING: I'm William Jackling. I'm from Rochester, New York, and I represent the Rochester Radiation Victims Survivor's Association. I sent a brief statement. I listened to the committee yesterday, and I listened to the witnesses this morning, and the more I listened, the more I get -- oh, what do I want to say? -- appalled that this goes on, but I'd like to read my statement into the record. I come to you today to talk about the experiments that government has conducted from the early Forties to the present. As I read the medical records and interview the survivors, and I'm talking about the Rochester group, I say to myself, how could this happen in the United States. Let me express some of my feelings and give you a little background as to why I say this. First, I taught radiological defense for 22 years and was a Chemical Biological Radiation Noncommissioned Officer for the 98th Division. I did this all as a volunteer. I maintained my own job. I put in something like 22,000 hours teaching radiological defense. The government hoodwinked me. The darn charts, the stay times, the doses, and things that I taught were wrong. I used a cobalt 60 source, very potent. I could give - - I could charge people their dosimeters. I could put a rate on there. We read in Roentgens on our portable meters, and those portable meters would get 5 Roentgens per hour. I'm telling you, we handled some pretty potent stuff, but let me go on with this. Secondly, the group I represent had mothers, uncles and great-uncles injected. Some survived; some didn't. The injections were given without consent and with no logical reason to be given as a treatment of medical conditions. What we did is take the records of these people and extracted -- these are the medical records. We extracted what the diagnosis was back in the Forties or when they were injected. We put it before five prominent physicians today and said, one, is this a -- In other words, is this disease or whatever they had going to kill them; and, two, in the Forties would there be any reason to give them radiation? We asked those two questions, very prominent, big organization, five doctors. The answer was, one, no, they weren't terminal, any of the patients. Three, no rhyme or reason to give any type of radiation back then or today. In reading the records of some of the people which are available to me, I believe the experiment is still going on today. Fact: HP-9 is a case in point, exhumed in 1975, reburied in 1981, but they're still testing the parts of this man in '86- 87. This shows in the medical records. I don't understand. You as a committee, I urge to lay the groundwork so this never happens again. Moreover, I hope that the committee would recommend some type of compensation to the people who were severely affected by this unauthorized experimentation on the victims. As I listen to the case by case history, I'm just appalled that this would happen within the United States. It is little wonder that the public grows even more skeptical of the government's concern for its individual citizens. A couple of things that I heard yesterday I would like to comment on, if I can find my notes. CHAIRMAN FADEN: Yes, please do. MR. JACKLING: It looked like, as you talked about ethics and you talked about some memo which is 1962, the Wilson memo -- It seems to me before that the ethics standards would be something that you didn't talk about, and I think you have to consider, because to go back into the past, it's hard to put a standard on today to back then; but I think you have a doctor- patient relationship you must consider, a doctor's oath, and one more which I was always taught, "I shall not kill." If you apply those standards back to then, they really have harmed these people and harmed the people that have survived today. I wish the committee or somebody from the committee could travel to Rochester. Two in our group are sons which the mother survived this, but came out of the hospital very, very sick, and it was very devastating to the family, what it did. Only by those people really telling their story to yourselves and you hearing it could you understand the effect it had on these people. It really destroyed their lives. I mean no college, no vacations, 24-hour care, so on and so forth. Yes, the university has written letters of apology to these people. Yes, the university has paid medical bills, but that doesn't help. They destroyed some of these people's lives. Yesterday as I heard the committee discussing remedies, I did not hear anybody talking about protecting the rights of the victims in courts. My family and others at Rochester are talking with attorneys about legal representation. A big problem, they tell us, is the sovereign immunity that may protect the government from being sued in court. If this committee wants to truly do justice for the experimental victims, then one of your recommendations to the President and Congress must be with the experiment issue, sovereign immunity defense should be waived. Full justice for the experimental victims must include the right to our day in court. That's the end of my statement. Any questions, I'd be happy to answer. CHAIRMAN FADEN: Thank you, Mr. Jackling. Please stay. Duncan? DR. THOMAS: At the beginning of your testimony, you commented on your experience in the chemical, biological, radiological defense program. You seemed to express some remorse about having been misinformed and spread -- as a result of your training activities, you would have been spreading incorrect information. I'd sort of like to hear you elaborate a little bit about this. Were you serving in the military at the time? MR. JACKLING: Yes. DR. THOMAS: What was the training that you were given? What did that consist of? MR. JACKLING: Okay. It was two types of training. I was in the military, and I was also in civil defense. Okay? In the military, because I had taken training with the civil defense, I went to a Navy school first, and then on to an Army school for chemical, radiological, biological training. In the Army back then, basically, all we taught was the gas mask, and then we got involved with a couple of tests with atomic bombs. So we taught stay times, so on and so forth. Biological, we didn't have much. In the Army we taught a lot about nerve gas. I got to go back in time a little bit. In the beginning we taught about mustard, chlorines, phosphates. There were different things. It changed as I was in. I was in 34 years. With the radiological defense, my training was with Cornell University, and my training was to teach instructors. In other words, they go out in the field, find a science teacher or somebody like this, and I would put them through the training, so they in turn could teach their workers how to protect themselves. My job, because it was -- It wasn't a lot of volunteers available. Most of the people that helped me were Army officers, Air Force officers which were doing it for points in the evening. We taught fire companies, nurses, doctors, U of R staff, hospital staff, anybody who would take the training. To get the equipment, they had to take the training. We placed a lot of radiological equipment. I was the only one to handle the Cobalt-60. The stay times, the doses we gave, the accumulative effects -- it all ended when they found that the charts were wrong. I mean, we exposed -- We gave people a pretty good dose. We would set up a field like this here, and people would go through and plot the field or we would take a fire truck, and we would plant the sources on the fire truck, and the firemen would go in, and they got a dose. They got a pretty good dose. DR. THOMAS: Were records of these doses retained? MR. JACKLING: Yes, they were, and they all knew they were getting doses. DR. THOMAS: Would these all be military personnel that were -- MR. JACKLING: No, all civilians. We did -- The radiological equipment in the Army all the time I was there was - - No. About the most thing we ever had was dosimeters. You take the division, which was pretty near 10,000 strong. We had one radiological meter. DR. THOMAS: Did you, by chance, happen to have saved any of the training materials that you received? Do you still have that? MR. JACKLING: Yes, I do. I have the whole sets. DR. THOMAS: That would be very interesting to look at. MR. JACKLING: And the equipment. You know, there was a lot of equipment. I don't know what happened to all that equipment, but it was furnished to most anybody who would take the training. We would furnish dosimeters, chargers, Roentgen meters, and gamma, you know, for higher reading. Those records are available. DR. THOMAS: My reason for wanting to pursue this story is a peripheral connection with another story that we're pursuing, namely, biomedical experiments in connection with nuclear weapons tests. There, we see repeated reference to "indoctrination programs" aimed at the military participants, and in which information about the safety or the hazards that they were going to be exposed to. So I'm trying to learn more about the kinds of information that was being given out in these days. MR. JACKLING: Let me say this. The stay charts, cumulative dose charts, and so on and so forth were basically the same what the Navy had and the Army. Now I'm talking probably '56-57, that time, and I probably still have the Navy charts, and I probably still have the Army charts. That's another thing that I was going to mention. Yesterday you talked about ARs in the Army. One of my jobs in the Army was a First Sergeant and an Administrative Specialist for the Division. You normally have somebody in charge of the ARs and, when they come in, they -- and I think any of you who have been in the military know this. You pull the old AR, put in the new one, but before it goes in there -- you were thinking about people not knowing. There's usually a sheet of paper where that goes around to everybody. So they have to read that or they should read it. So I don't think they can say they didn't know when new ARs came out. CHAIRMAN FADEN: Mr. Jackling, thank you. Oh, I'm sorry. Lois, I didn't see you. MS. NORRIS: Do you have a feel for whether -- or do you feel that you were deliberately misled or that this was simply based on the state of knowledge at the time? MR. JACKLING: Are you talking about the Cobalt or the survivors -- or the people that were injected? MS. NORRIS: I'm talking about the Cobalt. MR. JACKLING: Well, giving them the benefit of the doubt, I would say maybe they just didn't know. You know, maybe the information they collected, and somebody would work with those things, they thought it was right; but I want to say one other thing about the survivors or about the people that were injected in Rochester. My mother was very sick -- and I know my time is up. CHAIRMAN FADEN: Why don't you finish your comment. MR. JACKLING: Okay. My mother was very sick, and they came to her in '75 to dig up Mr. Sowers. They told her he was radiated. CHAIRMAN FADEN: I'm sorry. They told her what? MR. JACKLING: They told her that they had injected him with radiation. Mother didn't think too much of that, because they added a couple of words to it: As part of his treatment. As part of his treatment. The man had just like psoriasis, and they had injected him with plutonium. If you read the medical records today, every bone in his body -- Have you seen the medical records? I mean, it's all radioactive. I mean, you know, they tried -- The doctors tried to say, well, they put it on your watch, but the plutonium is outside your body, and it's shielded by the back of your watch. Turn the watch around or put it like this here, and see what happens. I mean, you know, people got to understand that they tricked my mother and, if they had not put those words on, they probably could have kicked her over into a very severe depression, maybe even killed her. It just amazes me that our government -- and, you know, again you say -- It's not really government; it's people, because people are the government, and they make decisions. They get a little authority, and they make decisions and get outside of what they're supposed to do. I'm sorry. I'll quit. CHAIRMAN FADEN: That's fine. Mr. Jackling, thank you. I just wanted to clarify one thing. Did you say there are two sons in Rochester of a woman who was plutonium-injected? MR. JACKLING: Yes. Their mother survived. CHAIRMAN FADEN: And there are two still surviving sons, you were saying, who would be interested in -- MR. JACKLING: Yes. One of them is not -- I tried to get both of them to come, but one was -- is not physically able, and the other just doesn't have any money. I think there's other people there, too. If you could send somebody from the committee, it would be greatly appreciated. CHAIRMAN FADEN: We'll do our best to see if we can arrange to do exactly that. MR. JACKLING: We might even help financially. CHAIRMAN FADEN: No, no. I don't know what we can do, but we'll figure out the best we can. We really need to hear from the people you're speaking about. So we'll have to find a way to do it. Thank you very much. MR. JACKLING: You're welcome. CHAIRMAN FADEN: Our next presenter is Mr. Fred Boyce. Is Mr. Boyce there? Good morning, Mr. Boyce. Thank you for coming. MR. BOYCE: Well, my name is Fred Boyce, and I was a patient at the Walter Fernald State School. I want to first thank the committee for allowing me the opportunity to speak. First, let me tell you a little about the Fernald School for the Feeble Minded. That was our title at the time during the Forties and Fifties. I was put in the institution April 26, 1949 at the age of seven, paroled out as if I was a criminal on March 29, 1961 at age 19. I was one of 36 children, crammed like cattle into a ward about half the size of a basketball court. In an abnormal environment such as this, even a normal child would take on the characteristics of being retarded. You lose the little sense of reality you may have, and you give up thinking for yourself and conform to the horrendous conditions. I won't tell you now about the severe physical and mental abuse, but I can assure you, it was no Boy's Town. The idea of getting consent for experiments under these conditions was not only cruel but hypocritical. They bribed us by offering us special privileges, knowing that we had so little that we would do practically anything for attention; and to say, I quote, "This is their debt to society," end quote, as if we were worth no more than laboratory mice, is unforgivable. To choose a segregated institution, to do experiments on us, is very disturbing to me. It was cruel and unusual punishment in the name of science. Keep in mind, we didn't commit any crimes. We were just seven-year-old orphans. Last winter I went to an auction at the late Dr. Benda's estate. He was the leading research physician at the time, and bought personal papers and books. I recently sat and read some of the papers. In one, I found an interesting document with a list of Down's syndrome patients listed as having bone marrow puncture tests done on them, most likely painful and unnecessary. I would like to have these papers examined, and also the Fernald Task Force Commission failed to mention the room full of very important documents from the Benda's estate that has been donated to the Fernald library. These papers, which may contain information, should be investigated and protected by this committee. Even though I was told I was not on any list, I have information that I was, and contradicts my memory of the various experiments performed on me. I'll sum it up by saying, it is now your debt to society to correct this injustice, and see that it never happens again. I would like to thank everybody, especially the committee, for allowing me to speak my mind. Special thanks to Secretary O'Leary. We owe you one, and thanks to Sandra Marlowe, The Boston Globe, Massachusetts Representative Ed Markey, Massachusetts Senator Ted Kennedy and family; last but not least, Wally Cummins and Cooper Brown of RADLAW. P.S. The Fernald is a much better place today, and in no way does it operate like it did then. That's very important to know that. Also, I want to mention that Quaker Oats, which upset me quite a bit, had not only let them put the isotopes in their oatmeal for us, but they also helped fund it. That really, you know, is an enterprise business. Also, I was wondering if you would let -- Sandra Marlowe was the librarian at the Walter Fernald State School during the time, and she was instrumental in breaking the story. If you could take a couple of minutes of my time and let her make a quick talk, I would really appreciate it. CHAIRMAN FADEN: Oh, she's here with you now? MR. BOYCE: Yes, she is. CHAIRMAN FADEN: Yes. MR. BOYCE: Also, I was wondering. They have field trips, I guess, and I wonder if they could have a field trip up in Massachusetts where, you know, that's where all the universities that were involved with these experiments up there. So I don't know if you -- CHAIRMAN FADEN: We have been sending people up investigating in that area. MR. BOYCE: Oh, have you? CHAIRMAN FADEN: We can do more. We can clearly do more, and certainly you're directing us to particular document sources. It's very important. We have some questions, please. We'll make time for your colleague. Ken? MR. FEINBERG: Just a quick question. Am I right that Congressman Markey or Senator Kennedy held hearings up there in the last few months, where a lot of this was discussed. Is that correct? MR. BOYCE: Yes. What they did, they had a task force up there to investigate this, but what happened was -- It was funny, because we found out -- Me and a friend of mine that was at the institution found out that there was an auction at the late Dr. Benda's. He had died 20 years prior to this, and his wife who also was a doctor, not at the Fernald, had just died this past winter. So we decided to do our own little investigation, as best we could, and we went to the auction and bought every kind of thing we could get our hands on. After the auction was over with, we thought that, well, what's going to happen to these other papers that he had. So we alerted -- Ms. Marlowe alerted the commission that it was there, and they had it donated over. Not all of it -- I should add also, a lot of his material was donated through the years to Harvard University, and the sons also kept a lot, you know, things, papers and things it might be, you know, but at least we got that, and it is sitting -- It's a whole room full of documents and stuff. MR. FEINBERG: That was made available to the Senate and House committee when they held the hearings? MR. BOYCE: No, no. It came in late, and probably because of that reason, the investigation was practically over. So, you know -- CHAIRMAN FADEN: But you're saying we can have access to that? MR. BOYCE: Please do. Yes, please try. I don't know. It's at the library, which used to be the old laboratory. CHAIRMAN FADEN: We'll figure it out. Thank you. MR. BOYCE: Please. I think those papers should be looked into. CHAIRMAN FADEN: You said Ms. Marlowe is here? MR. BOYCE: Yes. Could I, please. Thank you very much. I really appreciate it. CHAIRMAN FADEN: Why don't you stay, Mr. Boyce? Ms. Marlowe, if you could just keep your comments to about five minutes, if that would be okay. If you've got extra material to provide us, that would be excellent. MS. MARLOWE: Thank you very much, and thank you, Freddy. Something is very rotten or probably has been very rotten, I feel, in my own country. I'm the daughter of a Colonel -- CHAIRMAN FADEN: Could you speak into the mike, please? MS. MARLOWE: Oh, sure. I'm the daughter of a Air Force Colonel, Colonel Nicholas Caine, who happened to have been at Desert Rock in 1955. Often I -- and I think this is part of what Freddy and all the other people who have had the misfortune to live in what is a Kafkaesque state right now, is what we feared about what happened either to my father. To find out information, we were denied and refused by practically every agency in the United States government, and probably up until now. I did write an article in Library Journal called "Suppression of Nuclear Information," but after seeing the material that made me suspicious, not because I have degrees but because I happen to be a humanist and concerned and feel about what is right and what is wrong with our protocol or policy, there is much in practically every university that is involved with a medical school or a psychiatric institution that should be looked into. At Fernald there were papers, one from 1968 from Australia about asylums to be used as transplant farms. Dr. Benda, who was one of many of the researchers at Fernald, wrote an article on the biology of psychology, and I'll just quote one or two things and say, there is more information in oral history of the ordinary people who have experienced these events than probably most of the histories that you have read that have been very much whitewashed. This was written as part of a paper he gave, Dr. Benda, in Philadelphia in the Fifties. "Recently, together with Dr. Max Renkell, I had an opportunity to study an artificial psychosis produced through LSD in an outstanding American artist. LSD and mescaline represent the most feasible means of studying artificial psychosis, because the etiological agents can be controlled." I don't know how much of other drugs were used along with radiation at Fernald, but there is evidence of it in many of the papers, and I will be delighted to show the committee some of the leads that are there, but a lot of the misuse of medicine to help people must be addressed by this committee, as well as radiation which probably was also used in pharmaceuticals, in germ warfare, in chemical warfare, as well as in nuclear weapons. Please help the people, which means please help the citizens of this country. Thank you. CHAIRMAN FADEN: Thank you very much, Ms. Marlowe, and thank you for your assistance with the scholarship and the research. We appreciate it. It's very important. Thank you, Mr. Boyce, too. Thank you for your comments. Our last presenter is Ms. Broudy. Good morning, Ms. Broudy. MS. BROUDY: Good morning again. I'd like to make my written statements first. That will take about five minutes, and then I have a few other statements to make, if I have time. This is not -- This five-minute presentation is not the one that I had sent. I think this is the third one I've done. So I think Kris is now passing out the latest version. The intentional exposures of approximately 300,000 veterans to ionizing radiation falls within the parameters of your charter by: (1) Deliberately placing the servicemen in harm's way by ordering them to participate in experiments at nuclear test sites at the Pacific Proving Ground, Nevada test site and any other testing area, both foreign and domestic, and detonating nuclear bombs in their close proximity. (2) Ordering pilots to fly through the mushroom cloud of an experimental nuclear device, thereby sustaining large amounts of ionizing radiation, which was measured. (3) After detonation of the Hiroshima/Nagasaki atomic bombs, American servicemen were ordered to occupy the two cities, thereby absorbing residual radiation which we consider an opportunistic experiment. (4) Servicemen ordered aboard vessels, both target and non-target, were experimentally contaminated in some cases during clean-up detail and in radiological defense schools. They were forced to undergo special physical examinations, both before and after their contamination. The medical records of these men were kept in separate medical files, as well as their record of ionizing radiation Form DD-1141. (5) Any other exposures of servicemen and women during the nuclear testing era to ionizing radiation in subsequent clean-up details in the 1970s. In furtherance of your charter, the atomic veteran records, although initially designed to investigate the extent of human exposure to ionizing radiation, were subsequently rendered useless by fire, shredding and classification. As a consequence of the above, few veterans or widows (only 414) have been accorded VA benefits from the presumptive laws, Public Law 100-321 and Public Law 102-578. Now this is out of over 300,000 people who were exposed. Because we have been unable to obtain a truthful mortality study of atomic veterans, Trinity Post 7-45 and NAAV have conducted our own. The results show for atomic veterans a cancer death rate of 78.72 percent for 379 confirmed deaths, and average age at death 58.6 years. My husband was 57. A copy of letter from Trinity Post to NAAV, December 4, is enclosed. Also enclosed are recently received documents re the Japanese and Marshallese compensation systems for their victims of ionizing radiation exposures. I've got to excuse the fact that the Japanese study is not included, but I have a copy which you may copy, if you wish. Our contention over the years that the nuclear defense and nuclear power lobbies are responsible for our dilemma re the flawed studies is borne out in the enclosed 1981 letter from the General Counsel of the DoD. Roadblocks encountered by radiation victims are: 1. Inability of most to qualify under any of the laws involving exposure to ionizing radiation; 2. Destruction of military records necessary for prosecuting claims; 3. Classification of records and documents necessary for prosecution of claims; 4. Four flawed studies of atomic veterans by the National Academy of Science, Medical Follow-up Agency, Defense Nuclear Agency, and Centers for Disease Control. Secretary Jesse Brown is still using false information and obfuscation in response to queries from law makers and atomic veterans and widows; 5. Many sites of radiation exposure are not included in the laws; 6. Duplicate and classified medical records of radiation victims; 7. Necessity of dose reconstruction. The contractors hired by the DNA do not include Alpha and Neutron exposures, 20 and 10 times respectively more harmful Rad for Rad than Gamma; 8. Conflict of interest, the Department of Defense and the SAIC. SAIC is the -- Oh, boy. Give me a hand here, Oscar -- Science Applications International Corporation, which the Secretary of Defense William Perry was part owner, and the Under Secretary part owner, John Deutch. So was Mr. Inman. 9. The loss of Constitutional rights to a trial by jury of our peers because of six exceptions to the Federal Torts Claims Act; 10. Civil War era law forbidding payment to attorneys of more than $10.00 to represent veterans before the Veterans Administration. I'd like to comment on a few statements that were made yesterday regarding injection of plutonium. I need to know the definition of injection. Is injection only by needle or can it be by inhalation, and can it be by infiltrating an open wound? Can it be ingestion, because if it can, all of the veterans were exposed to plutonium in this fashion, not only plutonium but all the other nasty elements. Regarding an apology: I don't want an apology. There's nobody in this world that is capable of apologizing for my country that murdered my husband, deprived my children of a father, deprived my grandchildren and our future progeny of a father and grandfather figure and a great-grandfather, and in addition, imposing upon our future progeny genetic damage. We do not -- We haven't even delved into this issue. I intend to do a big paper on that for your edification. I'm sure you're looking forward to that. I'd like to speak to you also just a little bit about the depleted uranium issue that the Gulf War veterans have been plagued with. Depleted uranium is another name for Uranium-238. Uranium-238 was the principal component of the thermonuclear bomb. Our veterans, our atomic veterans, were exposed to very large amounts of this element, in addition to all of the other radionuclides. They now call it depleted, because I guess that indicates that it's harmless, which it is not, of course. When we get to the sovereign immunity, the Farris doctrine, the Warner Amendment, and all the other exceptions to the Federal Tort Claims Act, we have no protections. My husband laid down his life so that every citizen in this United States could have their Constitutional right to a trial by jury except the atomic veterans and the people who were exposed in any fashion to radiation during that horrible era, civilian and military alike. I want to thank you for all of the work you've done, and I'd like to leave with you these copies for your information. If you have any questions, I'd be very happy to answer. CHAIRMAN FADEN: Thank you very much, Ms. Broudy. We appreciate it. Are there comments or questions? Duncan? DR. THOMAS: You referred in your testimony to the mortality studies that have been undertaken by -- I believe it's Robert Campbell on behalf of your organization. MS. BROUDY: Yes. DR. THOMAS: Can you tell us a little bit more about the status of that study? The only information that you provided is this letter which gives some preliminary results for. Is there any intention to publish this in a form which would let us look at the methods of the study and the results in some more detail? MS. BROUDY: Dr. Irwin D. Bross who is a renowned biostatistician is our person that is handling the scientific part of this, and he will be publishing when it is completed. We have also furnished him about 400 names of test site workers, and they're working on that issue right now. We obtained death certificates, and we did not furnish the names to Dr. Bross, and then he performs the study, and this is the end result for the first 400 that he has undertaken. If you're familiar with Dr. Bross's work, you know that he's a reliable -- DR. THOMAS: I'm familiar with his work, but this description doesn't really tell me what we need to know about how those death certificates were collected or -- MS. BROUDY: I can tell you. DR. THOMAS: There's much more that we'd like to know about the analysis so the data could be interpretable. CHAIRMAN FADEN: Could you provide the committee with more information? MS. BROUDY: Yes. CHAIRMAN FADEN: That would be great. MS. BROUDY: I can tell you right now. We obtained the death certificates by announcing in our newsletter that we would like to have the widows send the death certificates of their husbands, their deceased husbands, and also the proof that they - - which tests they were in and all this other information. DR. THOMAS: The difficulty with conducting a study in this manner is that you have no assurance at the end that you're getting a representative sample of all the deaths, and it's not implausible that the sample that you obtained might, for example, over-represent cancer deaths. MS. BROUDY: Well, I suppose that's possible. We used as a control group veterans who were not exposed in the nuclear tests, and we obtained these names and the information from obituaries, and we culled the newspapers from all over the country in obtaining the information. DR. THOMAS: That's, I think, exactly my point. If you proceed in that fashion, the obituary deaths might well be more representative and, hence, you would see an apparent difference in the proportion of mortality that's due to cancer, comparing a self-reported group relative to what is perhaps a more representative sample obtained from obituaries. MS. BROUDY: Well, I can ask Robert Campbell and Dr. Bross to furnish you -- DR. THOMAS: Well, it might actually be more useful to actually try to get a dialogue established between your organization and ours, so that we can ask them more pointed questions. MS. BROUDY: Okay. DR. THOMAS: And they know exactly what it is that they're trying to get -- we'd like to get out of them. I meant amongst the scientists. CHAIRMAN FADEN: Thank you very much, Ms. Broudy. This, as always, has been a very important time for us. We're going to take a break, and we can regroup. We're pretty much okay. We're about -- Given that we started 15 minutes late, we're 15 minutes off schedule. So that's fine. We'll convene at 10:30. (WHEREUPON, the Committee recessed briefly at 10:16 A.M. and reconvened at 10:45 A.M.) CHAIRMAN FADEN: If we could all please come to the table so we could get started, that would be helpful. This is the coffee break that doesn't want to end, it's clear, the endless coffee break, the never ending coffee break. Okay, we're going to, I presume, pick up where we left off, wherever that was, with some momentum, I think. My current thinking is, rather than continue down the DoD trail for a while, since we have worked that one to at least some point, not all the way through, perhaps we should turn to the AEC and see where we - - what progress we might be able to make with respect to the Atomic Energy Commission. Is that congenial? Is that all right? We're now in the dark. I just got used to it. Thank you. Is that better or worse? Not so good for your eyes, right, because it's in your eyes, not mine. Well, you want it turned off? I'm sorry. Thank you very much, though. Now it will go in my eyes. Thank you, though. Thanks. We'll adjust. It's very dim. It's mood lighting like for a wedding or something. Maybe we could get somebody to open the curtains in the back and get some natural light. All right. So we should probably have -- I've forgotten now what these memos are called, but Jonathan, the one that has the two scenarios in it? DR. MORENO: Is this the one on government culpability? CHAIRMAN FADEN: Right, the one on government culpability. So that everybody can be refreshed, we are now continuing to struggle down the path of government culpability. We will, either later today or our next meeting, struggle with the question of culpability with respect to either other institutional communities like the medical profession or, ultimately, whether we want to go to the level of individual agents; but right now we're down the trail of government culpability. We'll stay there until we've got a tentative position worked out. What we need from staff and Valerie Hurt has joined Jonathan at the table, and Dan is here as well -- is an argument about the presentation of the evidence in support of the view that either scenario 1 or scenario 2 applies to the AEC. We've basically adopted at least tentatively the scenario 1 interpretation for the Department of Defense, grounded in the existence of the Wilson memo, and worked down the path there, and we'll make sure our minutes are very good so we can see what we've all tentatively -- almost all of us tentatively agreed to. Now let's see where we can get with AEC. I think here it would be good to have staff sort of walk us through the few critical documents. It's not as simple as the DoD where there's one piece of paper ultimately signed by the Secretary of the Department. Jonathan, do you want to -- DR. MORENO: Okay. As yesterday, we wanted to begin to establish a structure of policy in the DoD. It's a rather -- Regardless of one's views about the extent to which the Wilson memo reflected a lot of philosophical consideration in the Department at the time, it does represent a fairly clear demarcation in the development of DoD policy. The same cannot be said about the AEC, because there were a couple of different statements in 1947 that I want to call the Advisory Committee's attention to, and Valerie will help me since she's been living with this document more than I have in the last couple of weeks. I said yesterday, probably in a much too hurried fashion, that it seems clear to the staff that's been working on these documents that following the cessation of the plutonium injections, and indeed before they ended -- They ended in January '47, the last one being the AEC injection, as it were -- that there was a degree of consternation about the legal and public relations status of the injections, consternation that was expressed by counsel and others during the interim period when the Manhattan Engineering District was being -- many of its functions were being transferred to the new Atomic Energy Commission. Following the conclusion of the injection series, there were exchanges between the General Manager of the AEC Carroll Wilson, not Charlie Wilson -- this is another Wilson -- and Stafford Warren who was at that time Chairman of the interim Medical Advisory Committee of the AEC and was also dean of the UCLA Medical School. There were meetings between April 3 and April 5, 1947, and those meetings that dealt with the issue of "clinical testing" were summaries in a letter from Wilson to Warren dated April 30, in which Wilson expressed his understanding of the agreement that was reached. I must say that one has the impression that General Manager Wilson was, to some extent, in a negotiating posture with the physicians on this issue, and I think the tone is expressive of the imputation that I have just made to the letter itself, which I will -- if you will permit me to read to you. This appears on page 7 of the memorandum from the staff that's titled "Department of Energy, Atomic Energy Commission Ethics Policy History." CHAIRMAN FADEN: Jonathan, let me just stop to make sure, so that everybody can get it. It should be in the blue folder, the memo. It was also in that separate big binder that you got that's marked. Does everybody have it? DR. MORENO: The passages that are relevant to this seem to me to establish the understanding between Wilson and Warren in his capacity as Chair of the Interim Medical Advisory Committee. CHAIRMAN FADEN: Are you directing us to a particular page? DR. MORENO: Page 7 in which the passages are reproduced. "It is understood that your committee, the Interim Medical Advisory Committee, has recommended a program for obtaining medical data of interest to the AEC in the course of treatment of patients, which may involve clinical testing. The Commission wishes to make clear to your committee its understanding of the program which is being approved. "The Commission understands that in the course of the approved program: (a) Treatment which may involve clinical testing will be administered to a patient only when there is expectation that it may have therapeutic effect; (b) the decision as to the advisability of the treatment will be made by the doctor concerned" -- an interesting, paradoxical arrangement, it seems to me. "The Commission does not intend to influence in any way the exercise of judgment by the doctor as to the administration of any particular treatment authorized under the approved program. Indeed..." -- This seems to me to be a laconic remark, if ever there was one -- "...from the discussion at the meetings of April 3-5, it seemed evident to me that doctors would not allow their judgment on this matter to be influenced by anyone." The fact that, on the one hand, only when there is expectation of therapeutic effect is the understanding, is the policy, and on the other hand, that the advisability of whether that's the case will, being made by the doctor concerned puts the doctor in the traditional kind of double agent position that is at least very awkward; namely, that on the one hand, the doctor is deciding what is therapeutic and, on the other hand, the doctor has to make the judgment about when, going beyond therapeusis perhaps in the interest of the advancement of science, is no longer appropriate. Physicians who functioned both -- DR. THOMAS: It's shifting the burden of making this decision. DR. MORENO: That's right, to the physician without - - and giving the physician the unfair responsibility, arguably, from our point of view today at least, of having to play both roles. DR. THOMAS: But, surely, that's preferable to having the agency lean upon the physician and say, you know, despite whatever your clinical judgment is, we want you to go ahead and do -- DR. MORENO: Oh, absolutely. DR. THOMAS: That's my original reading of this paragraph. DR. MORENO: "In any such clinical testing, the Commission continues to request that the same procedure be followed which was agreed upon early in March. That procedure contemplated that it should be susceptible of proof from official records that, prior to treatment, each individual patient, being in an understanding state of mind, was clearly informed of the nature of the treatment and its possible effects, and expressed his willingness to receive the treatment. "In view of your recommendation, the Commission does not request that written releases be obtained in such cases." I think it's perhaps worth underlining that passage: "...the Commission does not request that written releases be obtained in such cases, but it does request that in every case at least two doctors should certify in writing, made part of an official record, to the patient's understanding state of mind, to the explanation furnished him, and to his willingness to accept the treatment." This is essentially the standard according to which the last plutonium injections, so far as we know, was conducted. Now we can talk more, if you like, about the significance of this letter, and we can talk more about Duncan's interpretation of the significance of physician discretion. In this context, my own view is that, since this arose out of a period of concern about the extent to which physicians were arguably being too aggressive with respect to the use of radioisotopes, I would tend to defend the hypothesis that the concern was among the physicians here that they not be reigned in from doing more than the AEC wanted them to do, rather than the reverse. So I think it has to be put in context, but I'm willing to be disabused of that view. Now the reason that I say that the policy situation is a little more complicated than the DoD is that in a 1951 letter to Leslie Redman, Shields Warren quoted another note from General Manager Wilson that was written later in 1947, November of 1947, to Robert Stone. We don't have the letter itself. We have Shields Warren's letter of '51 that quotes this '47 letter. In that letter, according to Warren's quotation of Wilson, Wilson wrote to Stone that the Interim Medical Advisory Committee had made a statement that "substances" -- This is on page 9 now of the same memo, the same staff memo -- that "substances known to be or suspected of being poisonous or harmful" -- that's the quote -- that those kind of substances should not be used in humans unless the following conditions are fully met: (a) That a reasonable hope exists that the administration of such a substance will improve the condition of the patient; (b) That the patient give us complete an informed consent in writing; and (c) That the responsible next-of-kin give in writing a similarly complete and informed consent, revokable at anytime during the course of such treatment. What's curious about this standard is we don't see any of the references to it anywhere. In any case, it's a higher standard than the April '47 standard. Next-of-kin's consent in writing is a high standard, even by our own policies today, to say the least. Now the question -- I'm going to conclude this in the next couple of minutes, because I know that the committee wants to discuss this point. The question that Pat raised yesterday was could we tie these policies to specific cases in which questions could be raised, and there is one in this staff memorandum, and maybe I'll let Valerie speak to it, because she's the one who, I think, really has been -- has teased out the significance of this case. This is a case that we discuss on page 12 of the memorandum. It has to do with a memorandum to Paul Aebersold of the Isotopes Branch of the AEC from Dr. Earl Miller who made a request to administer iodine, and if one looks at the -- As Valerie will explain, if you look at the nature of the request, which we gather was granted because there is more than one request -- it's a continuation of the same series of studies using iodine -- it's curious, because it seems not to be consistent with the standard of nontherapeutic use that was established in '47. Want to talk about that? MS. HURT: Sure. I think what's significant about Dr. Miller's request is that he specifically states that patients with diseases are used in order that high doses may be administered, implying that perhaps his studies were more than tracer studies. It goes on to say that the fact that they have diseases incidental and the medical aspects of these patients are cared for outside of the project, which implies to me that it's -- there -- it is unlikely that there was therapeutic benefit in mind when he did the studies, when he requested the isotopes to do the studies. That seems to apparently contradict what was being discussed as a requirement to use radioisotopes. DR. MORENO: If you look on the previous page, the Subcommittee on Human Applications which was in charge of distributing radioisotopes essentially took the same position, that there should not be use of isotopes by investigators for nontherapeutic purposes without the consent of the patient. So there does seem to be a fairly consistent position on nontherapeutic use, that it has to meet a high standard in order to be acceptable. DR. STEVENSON: When I read this passage, you read the first paragraph, but if you move on to his April 16 request, he's talking about using large doses of I-131 for thyroid cancer patients, and that seems like entirely appropriate and therapeutic. So, you know, we don't know the nature of the diseases in the preceding paragraph, but one gets the feeling that, in fact, much, if not a lot, of this iodine is actually being used for therapeutic -- appropriate therapeutic purposes. So I'm not clear exactly what the first paragraph -- if the first paragraph is or isn't consistent with the policies. MS. HURT: I don't know. DR. MORENO: It is hard to tell from these passages, I grant you. DR. MACKLIN: Could I just understand what Mary Ann just said, because I was going to ask -- CHAIRMAN FADEN: Is your mike on, Ruth? DR. MACKLIN: It is now. Can you hear me? CHAIRMAN FADEN: Yes. DR. MACKLIN: You just read the second paragraph on page 12 from the April 16 -- I mean the April 16th quotation. Right? DR. STEVENSON: Right. DR. MACKLIN: When you say it's entirely appropriate, does this mean -- I mean, I didn't understand this, because it's a medical question. The fact that these patients have carcinoma of the thyroid makes the administration of such large doses permissible. Are those therapeutic purposes? DR. STEVENSON: Yes, and we don't know what the doses are, but it was appropriate then, and it's appropriate now to use iodine-131 in reasonably high doses for appropriate treatment for carcinoma of the thyroid. We don't know what those doses are, but reading this, it's entirely consistent with the therapeutic procedure. DR. MACKLIN: Is the -- In the preceding paragraph where it refers to fairly large doses to patients in order to determine their uptake, distribution, and excretion. Are those for diagnostic purposes or for therapeutic purposes? DR. STEVENSON: You can't tell from reading this. DR. ROYAL: Ruth, what may have been happening is iodine may have first been used to treat functional disorders of the thyroid like an overactive thyroid, and they were now moving on to treat cancers of the thyroid, and maybe the reason that the first paragraph says that they were other diseases, maybe they meant that they were other diseases of the thyroid other than these functional disorders. They were cancer. I mean, as we said yesterday, the terseness of these little blurbs and trying to figure out what exactly people were referring to, I think, is very difficult. One of the questions I have for Jonathan is: I'm confused about where the diagnostic use of radionuclides fell in all of this. I think it's a universal truth that diagnostic radionuclides result in radiation doses much less than therapeutic uses. DR. MORENO: Yes. DR. ROYAL: So one could argue, well, that would be very appropriate to use radionuclides for diagnostic use, because we're talking about much smaller risk. So I'm very confused now about were diagnostic uses permitted or not permitted? DR. MORENO: They were permitted, and I get the impression that there was no objection to the use of diagnostic radioisotopes or tracer levels without consent, that that was not considered to be a matter about which the Human Applications Committee had to establish any special rules, so long as they -- I think we were -- We report at previous meetings that they had this licensing process for institutions. So long as the institutions met their requirements necessary to be licensed to receive isotopes, there were a lot of things that they could do without specific permission from the Distribution Committee. I think it's the case that those low doses fell under the category of things that could be done without specific application to the committee. DR. ROYAL: So on page 7, the first section of that indented part that has in parentheses "treatment" and then in parentheses it says "which may involve clinical testing," the "which may involve clinical testing" is not the blurring between what's a treatment and what's diagnostic testing. I don't understand what that parenthetical phrase means at all. DR. MORENO: Often when in this period -- and I think we've seen other documents along these lines. There is not consistent use of language about clinical research, and sometimes when people talk about clinical testing, they mean clinical research. They mean generalizable knowledge. They're not talking about testing the patient for specific conditions. My read of that phrase is that it has to do with what we would call clinical research. DR. ROYAL: So a diagnostic test that's being used for clinical research would fall under these guidelines? DR. MORENO: A diagnostic test that is being tested, that is being tried, that is being developed -- thank you. I think if it's a tracer level, as diagnostic tests would be, I don't think it would fall under the intention of these rules. DR. ROYAL: You made one other interesting statement that I'd like you to expand on, and that was that you said that your interpretation of these paragraphs were that the AEC was trying to rein in physicians that were using radionuclides too aggressively. I was curious about how you came to that conclusion. DR. MORENO: I thought you might ask that question. The reason -- DR. ROYAL: Let me expand upon the question a little bit. Was that due to some quantitative assessment of the risk/benefit of using radionuclides in medical research, compared to the risk/benefits of some other endeavors in medicine, in medical research? Is that what you meant by too aggressive? DR. MORENO: No. I think this is part of the history of the concern that people at the AEC had about what they called the legal and public relations threat posed by the plutonium injections. I think this has to be read as part of that series, that series of incidents, and that one of the things that Wilson and his staff were trying to accomplish with Stafford Warren and his committee is a kind of modus operandi for proceeding in the future to try to avoid those kind of issues. DR. ROYAL: You specifically mentioned the plutonium experience. Did you come to the conclusion that the risk/benefit of the plutonium injections was greater than the risk/benefit of other medical research that was going on at that time? DR. MORENO: I'm not making any statement about risk/benefit on this, Henry. This is a -- DR. ROYAL: I'm trying to understand what the "too aggressive" -- what the basis was. DR. MORENO: The "too aggressive" -- the risk being what they called legal liability and public relations, not talking about risk to individuals. DR. ROYAL: Oh, I see. DR. MORENO: This exchange, I think, has to be understood partly in a political framework, with a small "p." MR THOMAS: Can I return to Henry's concern about diagnostic use of radionuclides. Normally, diagnostic use of radionuclides would be indicated in the case of a symptomatic person and you wanted to verify the diagnosis. One wouldn't, I presume, normally apply it in asymptomatic individuals, even in a screening mode. In this case, I can see the language which says that expectation that it would have a therapeutic effect would not apply. So the question is: Can this paragraph be construed so as to involve an explicit prohibition on tracer studies in healthy individuals for purely research purposes? DR. MORENO: Duncan, I think the paragraph could be, but knowing what else we know about what was permitted at the time, either there's a contradiction between what else was permitted in this paragraph or the paragraph should be re- construed so that it doesn't -- but -- DR. THOMAS: Conversely, it would appear to permit the use of radionuclides for diagnostic purposes -- DR. MORENO: Yes. DR. THOMAS: -- in which one might then further have an add-on to study the bio-distribution in that setting. CHAIRMAN FADEN: Excuse me, but what paragraph are we talking about? DR. THOMAS: Back on page 7, paragraph (a). DR. MORENO: Page 7, paragraph (a). CHAIRMAN FADEN: I think the whole context here is in the course of treatment of patients. I mean, it's clear that this is a policy for research or application of radioisotopes to patients. It doesn't speak at all to the healthy volunteer or the healthy subject. This is all predicated -- These are the specified conditions for going forward when the subject population is a patient population. DR. THOMAS: But then -- I agree. I had forgotten that first proviso, but the second part of my question, that it does explicitly permit the use of tracer studies as add-ons to the diagnostic -- a diagnostic work-up -- CHAIRMAN FADEN: In patients. DR. THOMAS: -- would be appropriate. CHAIRMAN FADEN: In patients? DR. THOMAS: That's right, if we construe the language, clinical testing, to -- CHAIRMAN FADEN: Right. I would think that that's what that meant. DR. ROYAL: I would just like to remind you that doing a test in -- a diagnostic test in patients isn't helpful unless you know what the normal values are. CHAIRMAN FADEN: So you would have to. DR. ROYAL: So one of the problems faced in all of medical science is finding out what the normal values are for things. So I wouldn't know how to use a diagnostic test in an abnormal patient population without knowing what the results were in normal people. CHAIRMAN FADEN: I think that, if we could maybe parse this back a little bit, maybe Jonathan and Valerie and Dan could answer some specific questions. The first question, very bluntly, is: Are there any specific AEC policies that speak directly to the conditions under which research may be done with healthy persons or is all the stuff we have speaking to the patient context? Yes, I'm looking for an answer. MR. GUTTMAN: What we're all seeing -- The first point that I think we're making, John, to the staff is that there are documents with policies with standards. The question is how you put them altogether. What seems clear -- We had the same problem yesterday with the Wilson memo. Even if you got the most declarative document in the world, it seems to be peculiar in its noncomplete coverage. What I guess we're seeing is the AEC and the DoD are reacting to different situations, and you've got different pieces of the bureaucracy reacting in different ways. So you've got -- I mean, as a lawyer, what strikes me is that in both of the seemingly contradictory and not all encompassing 1947 memos, they are seeming to say let's get something on paper for the record, whether it's the patient signing it or the doctor signing it. There's something they need by way of, you know, recordation of somebody agreeing to something. The other piece is that they're reacting -- This is the struggle about were they covering healthy volunteers, therapeutic, nontherapeutic. Clearly, you see again and again in the documents that there is this terrible concern about a nontherapeutic setting, and what does that mean. What do we mean by nontherapeutic? Jay Katz is going to say that's a big question, but there is that kind of concern. Then there's the healthy volunteer concern, and then there's a secrecy concern about, well, if this isn't secret, do we have to make sure that certain things can get out, and then there's the liability of the public relations. One piece that Jonathan hasn't focused on, but it's in the memo, that's very important is a lot of the concern that we might call ethical today comes out through the isotope allocation committee in the risk standards. There is intense, continued -- this is Henry's point -- scrutiny of, well, exactly how much can we give a patient, and before we give it to them, we have to make sure that there is a doctor who knows about radioisotopes that's in that room, and that there's a local human use committee. So you don't have one overall -- one policy fits all, but you've got different pieces. The isotope allocation committee -- What's peculiar to us, there is no clear linkage between what you would call an ethics policy about consent, which is stated in these '47 letters, and the isotope guys who are giving out the isotopes. The isotope guys are concerned with risk and how much can be given out, and at some point there is a little, kind of connection, because they're also talking about we can't give out stuff to children and, when you have very sick people, you're giving high doses. So there's a backing into it. I guess the point I want to make is that we should sort of in some sense feel comfortable that there were standards, policies, concerns, and the question is what's the best you can do to connect the common thread, given what we understand about what they were concerned about and reacting to. CHAIRMAN FADEN: Nancy? DR. OLEINICK: On that note, can I ask about a phrase on page 10 in the middle which indicates that the delegation of distribution, administration to research institutions who would form local committees to pass upon all isotope requests originating from their institutions. It's right in the middle of page 10. Do we know, are there any guidelines that we have uncovered that -- where the AEC had established any kind of a policy for what -- on what basis should these committees distribute the isotopes? Do we know anything about what these local committees were doing, because a lot of the radioisotope research was being conducted at universities, other institutions? DR. MORENO: I think we know something about what the AEC said they were supposed to be doing for nontherapeutic doses, that they were supposed to be getting consent, making sure that the local institutions were getting consent from the subjects, and there were rules on pregnant women and children as well. Dan, do you want to add to that? MR. GUTTMAN: Actually, this is a -- Actually, the University of Michigan, which is extremely forthcoming -- We were in their files a week or two ago. They actually have their isotope committee records from the early Fifties, not the Forties, and we're in Massachusetts. So we're trying to go through some of the university files to see what it looks like. The Fernald case is one of the few cases that they were able to reconstruct painstakingly some of the back and forth with the isotope committee people. The other thing I want to point out: In the document you have, there is, to me, a very interesting exchange. The one instance that we have where there's this question. Here at the AEC biology and medicine level, they have these great statesmen of science making these policy statements, and here are the guys giving out the isotopes. So where is the connection? In this document we did get -- One of the actual public witnesses brought to our attention. Someone from MCV, Medical College of Virginia, wrote in to the statesmen of the Division of Biology and Medicine, saying I'm doing this as an experiment; I'm concerned about medical/legal stuff; what do I do? He gets bumped over to the Isotope Distribution Division who says, you know, go consult your -- It's in there. In other words, there didn't seem to an efficiently functioning transmission belt of all these policies. DR. MORENO: I wanted to go back to Ruth's question. I was looking up the answer to your question, which was did they say anything about normal subjects and tracers. The Subcommittee on Human Applications in its March 22- 23, 1948 meeting recorded the following statement: "All tracer studies in normal humans must be approved by the local radioisotopes committee before consideration of the application will be made by the Subcommittee on Human Applications." So the local radioisotopes committee was supposed to approve. DR. OLEINICK: But do we know anything about what guidelines these local radioisotope committees were using? Is that written down anywhere? That's what we're trying to get. DR. MORENO: That's what we're trying to get. Oh, yes. CHAIRMAN FADEN: Is it fair to say that -- abstracting is confusing, but there are -- and to use the distinction that Ruth introduced yesterday, focusing more on standards and less on execution type practices, worrying about whether it should be witnessed or whether it should be written consent or whatever. Out of these documents, I come away with a clear sense that the AEC had a policy that consent needed to be obtained, at least from patients, for the administration of isotopes. That seems fairly clear. What that meant exactly is the sort of second order problem, that they have -- They don't seem to back away from the consent issue. PROFESSOR KING: Ruth, is it a policy or is it a generally understood standard? You see, in my mind those two are different. When I think of generally understood, looking at the minutes of the meetings you could say that among those people in attendance at various meetings and in various situations, that there certainly was an appreciation -- I'm searching for a word. I don't have it. There's no magic in these words -- that consent was required. I think that policy, for me, is a stronger term, because it carries with it the idea that it was deliberately acted upon by a senior official and maybe even promulgated, but how would you characterize -- I mean, it's really a question to you. CHAIRMAN FADEN: I think that's a very important -- I don't know how important it is, but it's a very interesting question. I don't know what to do when you get a letter from General Manager Wilson, the head of the -- that's someone in some leadership position, but it's a letter from him as opposed to a signed -- PROFESSOR KING: Policy statement? CHAIRMAN FADEN: -- policy adopted by the Department of Defense, such and such a date, stamped with distribution and dissemination orders at the end of it. I agree with you. MR. GUTTMAN: Let me focus, Pat, on the exact problem. Jonathan can add in. The staff doesn't have any difficulties with the notion that when General Manager Wilson writes to the Universities, major research institutions, and says this is what you do, that's a policy. That's easy. I mean, it's relatively easy. CHAIRMAN FADEN: Right. MR. GUTTMAN: The question we have is the one that is the most interesting and severe, this November 1947 one where he actually says informed, written consent plus the family members. The only reference to that is in a 1951 letter where Los Alamos, for reasons that we don't know why -- Los Alamos has tried to interview the recipient of the letter, who doesn't recall why. Los Alamos has inquired about what's the policy. We don't know why they inquired, and gets this thing back where Shields Warren, who should know the policy -- right? I mean, he's the guy who's the -- He's now running the Division. He doesn't say, this is the policy. He writes back and says in 1947 General Manager Wilson wrote this to Stone, and he doesn't say, this is the policy. He says, we urge you to follow it. So that's a very obviously peculiar formulation of it. Gregg Herken found a document, a lovely document of '52 where the Division of Biology and Medicine says, well, basically, you got to appreciate, our whole house is a complete free-floating operation, and there are no formal policies and rules. So it may have reflected the absence of formalization, but it's clearly an interesting question of how something written by the General Manager and then recited quickly by the head of that operating party agency can be put across as policy but not referred to or not in any guidelines or rules or grant manuals; but that's the particulars in relation to that. PROFESSOR KING: Well, that doesn't surprise me, because often in government agencies they haven't gotten around to official anything. When people ask inquiries, you often say, this is what we told other people and, you know, until we get around to doing it differently -- So the question is how do we want to think of those things. Should it be on the same level as something that is presumably thought about sort of carefully by relevant officials and where some agreement is reached that this is it or do we want a term policy to also apply to something that may indeed have provided guidance for how operations should be carried out, but did not go through the same kind of process? So when I asked, do we want to call this a standard or a policy, what I'm really trying to say is -- ask, not say -- Are we trying to do gradations in the way we think about this or are we trying to put them all at the same level? I sort of lean in terms of gradations, because I don't want to claim too much, although I don't have any problem seeing from these documents that you can certainly say a strong "it was in the air." I mean, everybody seemed to understand that this is the way we do things, but that's a sort of a different kind of -- You certainly can hold people to the standards of the time when everybody seemed to think that this is what we should have done at the time, but I see that as different perhaps in other documents; but I'd be interested to hear -- MR. GUTTMAN: Right. One important fact that I should know. We interviewed an individual who was in the General Counsel's office at the time of the AEC's creation who said that he was crystal clear that the lawyers would have insisted on informed, written consent. He was sure this would be in Commission minutes. We haven't found it yet. So there may be more formalization of this thing than we have now. We don't know. CHAIRMAN FADEN: Ruth? DR. MACKLIN: I think Pat is asking an important question here,but I'm not sure that the relevant distinction is as you put it. That may be also relevant, namely, whether people sat down, deliberated, and then came up with something as policy; because I can imagine policies that are just kind of thrown out there by somebody in authority who had the authority to do it, but didn't think and didn't talk to other people. What seems more relevant to me is the opportunity for everyone to whom a policy might and should apply to know about it. I mean, if an institution has a policy, it's either written or published or there's a statement we have such and such a policy, and it should be knowable or discoverable by someone; whereas, something that is said in a letter to someone else where, when someone inquires what should I do -- and aside from the fact, as Dan just pointed out, it doesn't say this is our policy. It says, well, this is what somebody said a couple of years ago or something. It's in response to an inquiry that one person is making. How could anybody else outside that communication possibly even know it? So whether you call it a standard or a policy, it seems to me, it cannot be thought of as a policy if it's something someone says in a letter to someone else, since some other person to whom a policy might apply is saying, how am I supposed to know what you have as a policy if the only time it was ever articulated was in a letter that A wrote to B? MR. GUTTMAN: Just to contrast two things, we're talking about these two seminal letters. That's correct, but the one that gets to Los Alamos in '51 -- we don't know what the original letter was or who else it was disseminated to. The first one, the April or March '47 -- Jonathan can comment, but it was sent at the onset of the AEC to these major contractors, and that was more of something that you would think of as, you know -- It's more in the line of formal. We're starting up, and these are the rules. DR. MACKLIN: Well, but I mean, then it's a question of who's -- If it's a letter from Person A to Person B, it's one thing; but if it's a letter or a memo sent out to a lot of people, as was the Wilson memo, and then there's a thing that says, send this out to everybody and make sure that the addressees get it, you know, that's a statement about dissemination. Whereas, a letter that Shields Warren writes to someone about what someone else said two years ago is not something intended for dissemination. It's a letter in reply is all. MR. GUTTMAN: All I'm saying is that there were two letters in '47, the first one of which went to people as apparently part of the contract operating procedures. So there was more -- CHAIRMAN FADEN: Now where is that? MR. GUTTMAN: Jonathan, that's the -- CHAIRMAN FADEN: Are you saying the letter on page 7 went to -- MR. GUTTMAN: That was part of their starting up the contracts. Right, Jonathan? PROFESSOR KING: I generally agree with Ruth, and I certainly would like to hear Phil on this, but in trying to push my own experience in government agencies, it seems to me that being able to cite something that looks like guidance for how you should behave is an indication that -- putting the dissemination question aside -- is in fact what is then being used as guidance with respect to similar issues by those who seem to be in charge of those policies. I mean, I can think of litigation policies that were not widely disseminated in some of my past experiences, and not even put down in handwriting, but I'm confident that that's what guided a course of action that an agency took over a period of time. So this question about what we're talking about seems to me to be a difficult one, because there are formal policies, and those are easy because they carry some of the characteristics that you're talking about, but there are also informal policies that exert just as much guidance or control, sometimes maybe more, that may also be relevant. What I'm trying to tease out here is: I think we need to make a distinction just so that we don't merge the two. With that, I agree, and I am struggling for the distinction, and dissemination is one; but I also don't want to lose the idea that it may be guidance -- now shifting to a different word -- that establishes standards for how people ought to behave that may not have been formally disseminated or even perhaps capable of that. I'm not sure if I'm clear. Then I might also want to view as having force and strength to look back on. DR. MORENO: I think I -- To go back to Nancy's question of how these local committees operated -- I didn't want to rely on my memory, and there is the following in the Subcommittee on Human Applications minutes from 1948: "It is recognized that there may be instances in which the disease from which a patient is suffering permits the administration of larger doses for investigative purposes. Applications for such uses of radioisotopes will be given special consideration by the Subcommittee, providing: (1) Full responsibility for the conduct of the work is assumed by a special committee of at least three competent physicians..." -- I guess there must be at least three -- "...in the institution in which the work is to be done. This will not necessarily be the local radioisotope committee." So that was the first point. DR. THOMAS: What are you reading from? DR. MORENO: You don't have this. We'll give it to you. DR. MACKLIN: Could you read the -- I mean, what are these three physicians supposed to do, supervise, or what's their role? DR. MORENO: This is work that involves -- This is a local committee, I've speculated, almost the beginning of the IRB tradition -- DR. STEVENSON: What year? DR. MORENO: 1948 -- a local committee composed of at least three competent physicians. DR. KATZ: What constitutes a competent physician? DR. MORENO: I don't know, but I'm sure that we could speculate on that. I don't know how they certified that either, Jay. It's just a question. At least three competent physicians at the local institution who will take full responsibility for conduct of the work. This will not necessarily be the local radioisotopes committee, but I guess it, obviously, could be. Secondly, the subject has give his consent to the procedure; and thirdly, there is no reasonable likelihood of producing manifest injury by the radioisotope to be employed. Now I gather -- I take these, roughly, as rules that the Subcommittee on Human Applications expected the local committee, however it was composed, to follow, again, for relatively high doses for investigative purposes on sick people. DR. OLEINICK: I guess one assumes then that in place of prior review, we have three competent physicians who presumably have carried out some kind of a review of what is going to happen. I mean, this is all trying to read into a very short phrase what we would like to see there, but -- DR. MORENO: Yes. DR. OLEINICK: -- it isn't there. Is that it? DR. MORENO: Not quite. CHAIRMAN FADEN: I'm struggling with a way to formulate what we're dealing with now. On the one hand, it seems to me, we're going -- If we drop the word policy for a minute, we're going to standards. The backdrop is government culpability, for the moment, and we're trying to establish whether we have a contemporaneous base for holding the AEC culpable if research funded or done -- in this case, funded or with AEC released isotopes failed to be conducted in line with some standards. The real issue is was there some sort of standard that the AEC had, either for consent or for acceptable risk or for who would be an appropriate subject or for all of those. Then I guess the issue is how much would we understand -- to get to the distinction of how official was this standard, how officially was this the standard of the AEC, such that you could say the AEC would be culpable if it failed to assure that research that it conducted or facilitated by the distribution of the radioisotopes didn't actually get conducted that way. So that's the enterprise here, and at the risk of reintroducing something we talked about yesterday, we may be talking about degrees of culpability linked to something like degrees of the officialness of the standard. On the other hand, there's this problem of the AEC's a new organization, is trying to figure out how to get organized. The DoD, by contrast, is an established organization, knows how to set up policies, knows how to make standards official, knows how to implement them. The AEC is just getting going and sort of figuring out which of the two units should be responsible for what. I don't kind of know what to do with that, but -- Phil and then Henry. DR. RUSSELL: It's quite clear that the DoD had a much stronger need for clearly explicit policies, since they were trying to regulate the behavior of the three departments of the Army, Navy, and Air Force who hadn't fully agreed to be regulated by the DoD at the time. CHAIRMAN FADEN: That's a good point. DR. RUSSELL: The absence of clearcut policy documents from the AEC is neither surprising in this context nor does it mean that there wasn't an acceptance of a standard and a responsibility among the senior leadership. I think these letters indicate that there was knowledge of an ethical issue, of ethical medical/legal issues. I'm not sure that the interpretation that you folks had that it was al medical/legal an avoidance of law suits. I think it's quite clearly stated that there were moral and ethical issues involved. So I think that the senior -- there is evidence that the senior leadership had cognizance of these issues and that they appreciated the need for consent. Now they didn't have or they didn't keep records of a bureaucratic transformation of this into explicit policy documents, but they did seem to recognize some level of responsibility for that. I think it's also quite clear that they were vigorous proponents for biomedical research to exploit the potential of isotopes for medical purposes and, I think, had a higher level of expectation of the medical research community than might have been -- than turned out to have been warranted. Nonetheless, I think they did seem to put a lot of value on allowing the biomedical research community to exploit their intellectual freedom, and I think they also put the responsibility on them to be the keepers of the moral and ethical reins, as it were; but I do think there was a community standard evident here. DR. MORENO: I didn't mean to suggest, Phil, that they weren't interested in ethical issues, only that in the wake of anxiety about the significance of the plutonium injections, they tended to focus on liability and public relations issues. It is true, however, that the word ethical doesn't appear a lot. The word ethical, for whatever that means, doesn't appear a lot in the transcripts we have of the Subcommittee on Human Applications, though it does appear when they talk about children, interestingly. I think children is the context in which they use the word. DR. RUSSELL: It also appears in this pro and con discussion. DR. MORENO: Yes, that's right. DR. RUSSELL: Right at the top. DR. MORENO: Yes. DR. RUSSELL: It's the first word, matter of fact. DR. MORENO: Yes. Yes. PROFESSOR KING: Could I ask Phil a question, based on his last statement? CHAIRMAN FADEN: And then we have two people waiting, but go ahead. PROFESSOR KING: Just sort of related to what he said: Did your last statement about community standards cover the other two areas that Ruth mentioned? It clearly covered, the way you stated it, consent, the question of consent. Were you also intending that, in your view, there was sort of a community standard to cover the area of risk? What was the third area you named, Ruth? CHAIRMAN FADEN: Selection of subjects. PROFESSOR KING: Just consent? DR. RUSSELL: Just consent, and informed consent. PROFESSOR KING: And informed consent. Thank you. CHAIRMAN FADEN: We have Henry and Jay, in whatever order. DR. KATZ: Two things: It's interesting about your talking about the community standard of consent and informed consent. I'm most dubious about the informed consent standard, because the word didn't really exist in those days, the term. I'm even very dubious about there being a consent -- community consent standard, but if we can find evidence for that, that would be very interesting; but, you know, what we really talked about earlier or just a few minutes ago, it seems to me, you know, again going back to the Wilson document very briefly, it was, you know, very fortunate, it may be now unfortunate, that Jackson discovered the Nuremberg code. You know, he discovered the Nuremberg code and, my God, then he had something, and it became official policy. It was serendipity of the best or maybe now worse kind of proportions. Now do we have any evidence with respect to the Department of Energy that -- because they may have been unlucky or lucky that they didn't discover the Nuremberg code, because otherwise they might just as well have enacted it also as its official policy; but do we have any evidence of whether they knew about the Nuremberg code, looked at it, and rejected it or not? DR. MORENO: I don't remember it. Valerie is shaking her head. I don't remember any reference in the AEC documents from this period to the Nuremberg code. There have been -- There are references to what you might consider to be more generic ethical issues, even in 1945. If you look on page 18 of our memo under the heading "Ethical Considerations," there's a memorandum concerning ethical considerations in light of civilian physician's obligation to disclose to Manhattan Engineering District workers that if have developed nephritis or tuberculosis. DR. KATZ: Yes, but -- Go ahead. DR. MORENO: In that letter, they raise, and it's sort of rhetorical, and that memorandum raised in rhetorical fashion that we would recognize today questions that have to do with the obligations of -- ethical obligations of physicians. DR. KATZ: But I think here a distinction has to be made which we, of course, know from our experience. These kinds of statements are often very easily written about, but then when it has to be put into guideline fashion, people have greater difficulties, and the same thing happened to Jackson. Then when he found the Nuremberg code, he was very, very happy. So did they have any kind of official code of that kind or particularly the Nuremberg code that they had knowledge of, because it's quite clear, you know, it comes out in the interviews that I've read so far of the past actors. A number of them hadn't even heard of the Nuremberg code at all at the time. DR. MORENO: Well, there is this memorandum to the Advisory Committee on Biology and Medicine in 1947 that we reprint on page 17 of our memo, and I think, Phil, you might have just referred to this. I'm not sure. We don't know who the author of this memo is. This is just to respond to Jay in the sense that it was in the air. This seems to be the express committee of the medical board of review, under "Con." Number one, moral, ethical, and medical/legal objections to the administration of radioactive material without the patient's knowledge or consent. Now this doesn't go exactly to the -- This is it. Con is right, but it does go to a reference to ethical standards that were in the air. DR. RUSSELL: I don't think they had the level of sophisticated understanding of all the issues involved in either informed or consent, but they used the terms, and they used them in a kind of a self-evident mode in at least two documents here that indicated that the community that was working here was aware of those issues, and that was an ethical standard that they seemed to accept. Now they didn't broaden it to a sophisticated extent, but they certainly understood that informing them and obtaining consent was important. CHAIRMAN FADEN: I've got -- Just as a point of order, I have Pat. I wouldn't mind saying something, Dan and Susan and Henry. All after Henry who -- Is there anybody else? Ruth Macklin. Okay, now Henry, did Jay say what you were going to say or not? DR. ROYAL: No. CHAIRMAN FADEN: Not this time. Okay. DR. ROYAL: We're agonizing over whether or not we should accept that the AEC had some standard, and it's unclear to me, even if we were to say that they had a standard based on, for example, the directions to the isotope allocation committee, that it would be possible to use those standards to decide whether or not a particular experiment did or did not meet that standard. By that, I mean that the standards are written in such a general way that it's just very unclear that they are specific enough that you could make some judgment on them. CHAIRMAN FADEN: Well let's take an example, a real quick response and going out of order here. If we agreed that the AEC had a standard requiring consent, if we found an experiment in which it is written we did not tell the patient what was going on and got no consent -- let's say we had such a circumstance, or is the other way around? MR. GUTTMAN: What's remarkable about it, it says there has to be proof from official records. CHAIRMAN FADEN: Yes, but that's going -- MR. GUTTMAN; No, no, no. In other words, it would have to be affirmatively provable. CHAIRMAN FADEN: Because they wanted written consent or they wanted -- MR. GUTTMAN: No, no. The question is not whether it has to be -- that the patient has to -- being of an understanding mind, that procedures contemplated that it should be susceptible of proof from official records. In other words, this is actually a statement of -- CHAIRMAN FADEN: Dan, what I was going to was a broader formulation. If we wanted to say that the standard was not only a standard of consent but a standard of consent with proof that consent was obtained, that would be easier to establish. MR. GUTTMAN: That's in the letter. CHAIRMAN FADEN: That's a letter. We haven't said that that's the -- I'm going to the hypothetical first. I don't know how far the committee is going to go in saying that was the standard; but let's say we went to the looser situation first and simply said, there's enough of a body of evidence here to say that the AEC had a standard that you cannot do this research with patients without consent. If that -- If we agree that that was the case and we found an experiment in which there was evidence that consent had not been obtained, then we would say, okay, the AEC is culpable in this case for failing to live up to the standard of consent. If you go to Dan's formulation and we say that the AEC standard not only was consent but proof of consent, and we fail to find proof of consent, and on and on -- So it would be dependent -- but that's how it would, in my mind, operate for purposes of government culpability for right now. We want to hold that it's wrong to do research without consent, by contemporary standards. We're looking by our standards, but we're looking for contemporaneous standards that would bolster the argument about government culpability. DR. RUSSELL: I'm not sure that failing to find written evidence for informed consent, if that were the standard, fifty years later would mean that informed consent-- CHAIRMAN FADEN: That's why I wanted to go to the first one, the sort of general sense of consent must be obtained, and we found a document that said we did this to these patients, and we didn't tell them what was going on, and we even made efforts - - go further -- to make sure they didn't find out, and then we could say, well, we know that's wrong by today's standards, but we could then say the stronger thing is, not only is it wrong by today's standards, but we know it violated the standards of the AEC at the time. That would, of course, be a strong statement. DR. RUSSELL: I think, even if the AEC didn't have any standards at the time, we would come to the conclusion that it was wrong if we discovered that -- CHAIRMAN FADEN: Oh, certainly. That, I think, goes without question, but I mean the issue is, then pushing back from the defense to become, well, but the government isn't culpable, because at the time the consent standards of the community were much laxer. Then we could say, no, but the AEC itself had adopted a standard requiring consent, even in the 1950s. So that's where the moral force would go. It would bolster the claim of culpability on the part of the government and not merely our moral condemnation that this was a wrong thing to have done. So I think that's the force, at least in my mind, of the exercise right now, is on an exercise of the charge before us right now with respect to government culpability. I've got Pat. I'll take myself off. Dan, Susan and Ruth Macklin. Phil, did you want the floor, or Susan? I'm sorry, Pat is actually next on the -- Unless somebody wants to jump right in, I'm going to keep to the order. So I'm just relying on you, my colleagues here. If you really want to jump right in, go ahead. If not, I'm going to just call on people in the order in which I've spotted them. Pat? PROFESSOR KING: One other thought about where we go from what we've said so far, and it might in fact already be here in this written document which I've been madly searching through for, but I don't quite find it: That is, it seems to me that it would be useful to me to see what the staff's conclusions were about what the standard was that they glean from these various documents, and then what supports that conclusion. I actually am looking for a conclusion. I like the pro and con. You can see, I was an old bureaucrat. I actually like some of those pro and con memos. They have a usefulness and I would actually like it if we could have something like that next month. I'm not trying to foreclose anybody else's discussion, but that was where I was going. My second comment is that a lot of the current memoranda really is written in terms of medical/legal reasons, and we have made much of legal liability concerns. I almost raised this yesterday, but I will raise it again as a caution today. That is, if you are in a bureaucracy today, not to mention all these many years ago, and if you have concerns that are value concerns in a bureaucracy and you're dealing with hardheads, you do not state your concerns as value concerns if you have a strong, legal argument that will do the work for you. I have done it myself numerous times. One of the things, I think, that we might do is keep in mind that I think, actually, the legal concerns can be viewed every bit as much as a value concern and a concern about what we're doing as not; because I think it's very mixed, and part of the documents that I've been looking at seem to suggest something to the contrary that it undercuts there sometimes, I think, the fact that they could have been -- Notice I'm not using the term ethics either -- that there could have been genuine value concerns that often came out this way, and that's just a caution or other documents as well. DR. MORENO: I think that's right, Pat. DR. RUSSELL: I would agree, yes. DR. MORENO: I don't think any of us would on the staff would disagree with that. The reason that the flavor of the documents come in somewhat differently, I think, is that the -- or the memoranda comes out differently, is that the documents themselves, the original ones in the AEC case, a lot of them their lawyers were very prominent in those discussions. In the DoD it was mostly physicians, people in the medical corps and others, and really only one lawyer, namely Jackson. So I think that's why the flavor of what you get when you try to give a narrative recounting of the documentation in each case comes out with a different tone; but I think none of us would disagree with your point. DR. RUSSELL: The underlying point that just because they're stated in medical/legal terms they weren't the strongly held moral positions, is very correct. Why bother with a moral argument when you have a legal argument that's going to carry the day. PROFESSOR KING: Right. DR. RUSSELL: Every time. PROFESSOR KING: Every time. MS. NORRIS: However, in legal terms is it easier to override a judgment based on legal and public relations risks than it is to override a judgment which is expressed in terms of ethics. In other words, they can have made the decision that we have these concerns, it's unwise to do these things, but on the other hand, the need to know justifies assuming the risk of legal liability and bad PR. CHAIRMAN FADEN: Dan, did you want to say something? You're next on the list. MR. GUTTMAN: Obviously, the lawyers are the repository of all the other professions' moral residue which, of course, we knew. CHAIRMAN FADEN: I wouldn't go that far, Dan. MR. GUTTMAN: Right, but we understand the point. Let me briefly reply to Jay. Where you find the closest link to the Nuremberg code -- You recall we've all talked about the debates about the atomic airplane which involved both the AEC scientists and the DoD scientists, and then the Stone memo is about the human experimentation. What was striking is he cites the '46 AMA and the '48 Ivy thing; in other words, that train of scholarship or whatever you want to call it that led or was connected to Nuremberg is connected. The DoD, AEC folks connect that in the NEPA debate. They don't reference Nuremberg expressly, but it's that -- Right? The other point I want to make is this point. It just struck me in this conversation, because I had been focusing on this question of whether it's the patient who consents or the doctors who do it for them, and that is a clear distinction between the two November '47 letters, but what you do see is the common thread, and this is that whatever is done here should be susceptible of proof by people like us fifty years later. That is, you know -- I mean, I don't think it's what they -- the writing part of it. In other words, it's not necessarily who signs it or who doesn't, but that there's something that is regular and not up for speculation. CHAIRMAN FADEN: Susan, then Ruth Macklin. DR. LEDERER: Going to this issue about agency culpability, I guess I find No. 2 on page 17 in the list of "cons" from that 1947 memo particularly interesting, raising the question, if there is greater responsibility if a Federal agency condones human guinea pig experimentation, which brings me to the second question. I feel like we almost need a glossary for many of the words, just for the code words that are being used here. I mean, for example, what is human guinea pig experimentation? Is that different than use of volunteers or use of patients? I would also like to raise the question of what -- Based on your reading of the documents relating to the AEC, what is the precise fear that they have in terms of public relations? Do we know anything more about that? What is it that they are afraid of that's going to be so damaging to their enterprise? DR. MORENO: Well, to the latter, you know, I can't give you informed historical response, but I don't think one stretches too far in saying that what they're afraid of is exactly the reason that the Advisory Committee is here, and that the way they used the term guinea pig as a shorthand in those days is probably much the same way we would use it today, and it covers a multitude of different possibilities, I suppose. DR. LEDERER: What about this issue about greater responsibility if a Federal agency condones? DR. MORENO: Well, we know that the AEC -- AEC officials, Shields Warren, in particular, was preoccupied with the paradox that this is a civilian -- to be a civilian agency, but dealing with Secret issues, operating in secrecy; and he as especially concerned about the fact that they were going to be doing human experiments or funding human experiments in secret. So I think that this is part of the whole kind of soul searching that the AEC was going through about its status in the early years. After the war is over, you don't have the same kind of national crisis anymore. It's supposed to be a period of peace, and yet you have this civilian agency doing secret things and doing it in a medical context often. So I think this is part of the same anxiety that they have about that. Otherwise, I think it sort of speaks for itself. CHAIRMAN FADEN: Ruth? DR. MACKLIN: Dan's comment, I take it, was sort of off the cuff about who does the consenting, the patient or the doctor. It brings to mind something that people -- not everyone around this table may have heard, and that is a transformation of the language today of informed consent. It is very common now to hear doctors refer to consenting the patient. "Did you consent the patient," and in some instances the need to "reconsent the patient." This is brand new in the vocabulary, but it says something about who is the agent and who does the consenting. I just wanted to remind or point out to Jay what, I think, Phil pointed out when Jay said the words informed consent didn't exist then. These words are here in this document, this AEC document. I mean, whether we're to take that to mean exactly the same thing that it allegedly means today is not the point. Here were these words, and those words were intended to convey something about the information. Now the -- One thing is very puzzling to me here, and that is the -- Well, before I get to the puzzle, which goes to the heart of our question, one other point. In some respects, as I read these quotations from these letters written then, they are requesting practices or procedures that are stronger that the ones we have today. For example, it requests that in every case at least two doctors should certify in writing to the patient's understanding state of mind. Today, we presume that the patient is competent unless there's some indication of lack of capacity. One doesn't have to testify for the purpose of research. I mean, there may be for other purposes, but not in the research context. There is no procedure. There's nothing written in -- I mean, there's something written in the Federal regulations, but there's no procedure specified whereby somebody has to come -- two doctors, no less. I mean, two doctors are what they use for DNR orders -- Right? -- or for capacity for the patient, if it's uncertain for DNR today, but in no research context that I know is there a procedure or a practice that requires that doctors certify to the patient's understanding state of mind, which is the capacity to consent, not the understanding. Of course, even today -- and then it goes on that the doctors must testify -- certify to the explanation furnished the patient and his willingness to accept the treatment. Well, the explanation can be in medical jargon or gobbledegook, of course. It doesn't require that anybody certify to the fact that the patient actually understands, but that's no different today. That's no different than from today. Nobody is there. There's no part of the procedure of obtaining consent that requires anyone to certify that patients actually understand what they've been told. So -- I mean, if we're looking at what ideas people had in mind and what was ethically important, it seems to me there's a lot of stuff in here. Now let me just say what my puzzle is, and that's in the way this is written on page 8 here. The AEC adds a request that it should be susceptible of proof from official records that the patient understood the treatment offered, etcetera, etcetera, and then the memo says, "It is interesting that this 'request' was not part of the conditions for an approved research program outlined early in the letter." So this -- I mean, if we're trying to debate here whether something was a standard or a policy, to say it was a request but not part of the conditions for an approved research program, certainly for something to be -- if it were a part of a condition, one could say, then they had a policy. How they implemented it or enforced it might be a separate question. So what's a puzzle to me is I don't understand how to - - what to say about a request, if in fact that request was not transformed into conditions for an approved research program. CHAIRMAN FADEN: Phil? DR. RUSSELL: The advisory community, medical science board, had on it some of the real giants of biomedical research of the time. It was quite clear that they were representing a point of view and a philosophy and a set of values that were embedded in the aspects of biomedical research that they had been involved in. Alan Gregg's name appears here, making comments about the standards; Wally Fenn, who had done this tremendous amount of physiologic research with volunteers early in World War II; Detlev Bronk, the great biophysicist. So what we see here is not only a reflection of what was the dominant thought or at least the ethical considerations within the agency, but also in some way represents what the major leaders in the academic world were thinking at the time. CHAIRMAN FADEN: That's actually a very interesting point to develop, though. We have to get -- At least, I need to get a richer sense of who these actors are and how they -- what communities they come from in sort of making claims, but the issue is -- The issues that you raised are very important. Were these standards with respect to consent those of the officials of the Atomic Energy Commission kind of atomized and separated from the standards of the professional biomedical community or were they integrated reflections of standards that had a reach outside of the bureaucratic world? DR. RUSSELL: If you remember how militarized the whole nation was from 1940 through '45, and then many of these people who had done work for and in the military, some in uniform and some not, go back to civilian, but they're still working with the agencies who have picked up another level of research responsibilities. Dr. Fenn, for example -- He was involved heavily in research that related to the limits of human physiology and how you could improve or sustain human capability under adverse conditions such as desert warfare. That was one of their big issues early on, and his physiologic research was done for the Army early on. Later on, he became involved in these studies. I think there were a large number. The infectious disease community was the same way. They were all in uniform in the early Forties, and then they all went to work for the AFEB immediately after. So the military standards -- military research standards were that of that leadership community. CHAIRMAN FADEN: We are up to lunchtime, and the question is whether anyone wants to comment right now before we break? Break for lunch? We'll break for lunch. There's eye contact indicating lunch. So we're going to break for lunch. (WHEREUPON, the committee recessed for lunch at 12:04 P.M.) A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N Time: 1:35 P.M. CHAIRMAN FADEN: Okay. Will the committee please come to the table? We need to start. If we could start, that would be helpful. Thank you. We have a slight change in the agenda in that, timewise, checking airport schedules it looks like we may lose a few folks between 4:30 and 5:00. So we're going to end at 4:30, if that would help. If it turns out that we have some business that can be done and it's not too many people that leave us, that we'll continue; but I'm going to try to structure it so that we end at 4:30 so that we stay as a full committee until the end. We're trying to locate Phil Caplan so he can come and officially close us a half-hour earlier, since we can't close. I mean, if you have to go to the airport, you have to go, but we can't close ourselves. We have to have Phil come and close the meeting. Okay, we just found out that Phil can't make it, but Dan will close us. We'll be closed by Dan, apparently, and that will be okay for purposes of today. All right. Here is some thinking as to what we might do with the afternoon. What I'd like to propose with respect to the AEC, and I think this follows up on a suggestion -- I think it was of Pat's, but I'm not sure which -- that we leave the AEC discussion at this point and ask staff to essentially restructure the content in the AEC memo as we have it now around the three themes of research standards; namely: What are the documents that bear on the AEC's having had standards or a standard with respect to consent, to sort of line up the argument and make the case that there was a standard and to what kinds of research it applied and what the force of it was, a kind of analysis by staff that crystallizes staff's thinking on the subject of the extent to which there was an AEC standard on consent, how it was articulated, and what its reach was, and similarly, an analysis of the same sort with respect to any standards the AEC may have had bearing on the question of how to determine acceptable risk levels, since apparently, from the documents, it appears that there was some discussion of what would be an acceptable level or dose in particularly contexts; and finally, whatever can be assembled by staff on this question of selection of subjects, because there seems to be, at very least, a reference to the treatment of children as different from the treatment of other persons coming from the AEC guidelines, and we should at least get that enumerated. At some point, the AEC must have adopted "official" official, sort of formal policies. However the staff wants to trace it out, but take it up to such point as we can -- at whatever point the AEC starts to have -- as far up as you, in your wisdom, think we need to see it. Also, in line with that and following the decision we made yesterday about a staff request to do an analysis on dual purpose research in the context of the DoD policy, give us examples. Give us illustrations of experiments or groups of experiments that would fall under the different AEC standards, so we can see what the cash value is of taking the position that this standard held or not. I didn't mean it literally. I meant the significance, the reach, the reach of our -- again, with a view towards the committee not spending three hours debating an issue that turns out to have no practical relevance, because we have no cases that fall under that issue. So if we can get a sense of what dimensions of the AEC standard or debate about the AEC standard are worth debating about where worth is defined as there actually are cases with real human beings where whether what position we took might have an impact on whatever recommendations we make. We need to know that so we know where to put our energy. Is that congenial with everyone, that that then would be the charge to staff that will move us along. Obviously, that becomes part of what will -- as later this afternoon we talk about the outline. It will presumably written in a style that could then become part of the report, because this is something we need to do. So the language shouldn't be wasted at this point. As you're writing, be writing with a voice that's -- with an eye towards -- You're not writing for the committee now. You're writing to the committee but through text that could be used as part of the report. Jay, did you want to comment? DR. KATZ: I'm sure you mean to include -- including any evidence about this dismissive of any standard. CHAIRMAN FADEN: If we find any, sure. DR. KATZ: And that, if there's evidence in any of the documents, that would be important to know also. CHAIRMAN FADEN: Absolutely. If we can find connections between AEC and DoD on standard, that would be excellent, and on the DoD issue we're asking you to do similarly with respect to the dual purpose -- flesh out the arguments for the extension to dual purpose research in the context of some concrete cases, whether they are the TBI cases or some other cases, so we can start to play with how to interpret multiple purpose research. We will not do HHS or HHS predecessor agencies today. Staff hasn't prepared a memo for us on the HEW clinical center context at this point, but we do have a memo on the VA which is quite short. What I was thinking we might do is continue the kind of discussion we've had for some short period of time first thing this afternoon, see what we want to ask staff to do further with respect to the VA, and staff will come back to us with the HHS or HEW context in January, and then perhaps return before the break this afternoon, if we choose to take a break, to two of the memos that we received before the committee began: (1) the culpability memo, maybe return to a little bit -- return to it for a little bit of reconsideration of where we are in understanding the remedies memo in the light of what we have been doing with respect to government culpability since we first looked at the remedies memo; and then if there is time and if it's useful, look at the memo that I produced that was an attempt to link back or forward, depending on how you take it, from remedies to retrospective moral judgment type analyses. That we can do, depending on how the time goes. We need to reserve a block of time -- Right now it would be scheduled for from 3:00 to 4:30. Hopefully, that is enough time -- to look at staff's suggestions with respect to the structure of the final products of the committee. We really need to start thinking about that, because, obviously, the clock is winding down, whatever the right image we want. So I think, at all costs, however the discussion is going, we should stop at roughly 3:00 and turn to the homework reading for last night, the memos from staff about the feel for the committee. Could we start with the -- Is that agreeable as a way to use the rest of the afternoon? Could we start with the VA then? The VA memo is -- Jonathan and Denise? We need Jonathan and Denise, and the memo itself is where, Anna? It's in the blue folder again, and it's a thin one, relatively to -- So the goal is, again, to see if we can establish whether there were any AEC standards of the time that bore on questions of how to conduct research involving human subjects. MS. HOLMES: VA standards. CHAIRMAN FADEN: VA, I'm sorry, VA standards. Maybe we -- Should we have staff do a short summary again? I think that would be good. So, Denise, Jonathan, if you could just -- Denise? DR. MORENO: Let me introduce my colleague. CHAIRMAN FADEN: Denise, could you just very briefly summarize -- what's in the memo, I know, but your sense of what could be said about VA standards at the time, if there were any. MS. HOLMES: It's a brief summary, because the memo is brief, because our knowledge is limited. As best staff can tell right now, the earliest document that we are aware of is a 1958 General Counsel opinion, which is attached. I, unfortunately, do not have any of the three attachments to this memo with me, but there is a General Counsel opinion which was apparently drafted in response to a request about two specific projects. This General Counsel's opinion has previously been discussed by persons within the Department of Veterans Affairs as establishing a very broad agency-wide standard for obtaining consent. My interpretation of this -- Staff's interpretation is that it was really a much narrower opinion, and it was responding only to those two specific projects that were proposed. It is possible that the reason why that opinion was drafted was because these two projects would have involved non-VA people, and there's a short discussion of that. The earliest document now in our possession that does seem to establish agency-wide standards is a 1967 circular, and that was attached to this memorandum. The form -- A copy of a form with that made a notation at the bottom that it superseded a form from 1964. Since this memorandum was drafted and circulated to the committee, we have found an indication that there was, in fact, a 1964 circular which, for the first time, established standards for informed consent. So as best staff is aware at this point in time, 1964 is the beginning of an agency-wide VA standard. Prior to that, everything was locally directed, locally drawn, and VA's central office is sending a directive to the field to find out more information from the individual field sites about any locally drawn or established policies. CHAIRMAN FADEN: Okay. The floor is open for discussion. PROFESSOR KING: I know there are a lot of VA research protocols, but how much of what we have been concerned about in terms of the experiments that took place are VA sponsored experiments? So what are we talking about here in terms of a policy that may have come into existence later? MR. GUTTMAN: We're talking about an extraordinarily large number. The VA has gone through these details sort of periodically for us and, for a fraction of the pre-'74 period, pulled out 3500. The problem of the VA, as Denise is more capable of stating than anybody who would ever want to state it, is that you can't find much out about most of these, which are primarily, obviously, going to be tracer. Denise, do you have any -- MS. HOLMES: Yes. In addition to this memorandum on the history of ethics policies of VA, we also included -- and I don't know which briefing book it was in or folder or wherever it is, but somewhere in the material that was sent to committee members is a series of documents that will give you some sense of the kinds of things that we're finding out about VA. We included minutes from an early Central Advisory Committee on Radioisotope meeting. We included some abstracts of reports, progress reports, from the various field sites, some information from 1954 and 1955 about the biosciences information exchange, and those were reports from one specific site, Boston, that had done some tracer studies involving radioactive food, eggs, chicken, vegetables and so forth; but as Dan said, a lot of it is tracer studies. Much of the information that we have is very fragmentary, and the list of 3500 that they've sent us -- Some of those we can find a little bit more information about, but very often all that we have is a title, possibly a PI, and the VA Medical Center, where it occurred, and the year. Some of those appear to be ongoing studies for three or four years. So the 3500 may not be 3500. It might be a much smaller number. It also appears from the title of some of those that they involved animals or were in vitro studies or some other non-human radiation experiment. PROFESSOR KING: Does it look like we're going to have an opportunity to say very much about VA at all? MS. HOLMES: In the early years or completely? PROFESSOR KING: In the early years. I'm sure we can do post-Sixties, but in the early years are we going to be in a position, do you think, by the time we come up with the report to be able to say very much about VA? MS. HOLMES: I think that most of what we -- We have learned much of what we're going to learn. They have gotten their investigator -- Inspector General's office involved in the search for documents, and I spoke with someone in the IG's office earlier this week who said that there were a few additional leads that they had found that they're going to follow up. We will probably have more of an overview of what happened at VA in the early years rather than a series of letters back and forth, as we do with the plutonium injections: Here's what we're going to do; here's what happened; what are we going to do next, and so forth. I think it will be much more sketchy. CHAIRMAN FADEN: Dan and then Ruth. MR. GUTTMAN: The point here -- This is really Phil's point. Really, the question the committee will have with the VA is this community question. So that the atomic isotope division that Denise's memo documents, the other memo, was created in '47 when General Groves from the Manhattan Project came over to the VA and told the VA, follow the advice of these wise men, who included Stafford Warren, Hymer Friedell and Stafford Warren's deputy at Crossroads, George Lyon. MS. HOLMES: Shields Warren as well. MR. GUTTMAN: No, Stafford -- MS. HOLMES: Shields and Stafford Warren were both on the committee. MR. GUTTMAN: So that, basically, if you are going to look at the world in the way that Phil is suggesting, then the VA is going to be a classic case, because the community of wise men -- and, of course, the other side of it is that not only are they connected at one end to the AEC and the Defense Department. At the other end, they're connected to all the medical schools. In some cases, for example, Ms. Fenn's testimony this morning -- I think that some of Dr. Sweet's experiments with the comatose patients may have involved not only Oak Ridge but also VA. So that the question with the VA is how you piece together this community of -- you know, the particulars of the community of interest to the committee. PROFESSOR KING: Well, does that answer what you need to do in January with respect to the VA? MR. GUTTMAN: In some respects, the best we can do is to take a couple of cases where the VA is kind of on the fringe or -- Yes, we're not going to get much -- PROFESSOR KING: I mean, use the VA as an example of what can we do, if we were trying to talk about -- It seems to me, it goes to two questions. There's the community standard, but it also goes to the question of whether the government is the government. MR. GUTTMAN: Right. That's right. PROFESSOR KING: That question. So that it would be interesting in thinking about the government as the government question to have a case -- and it's going to be VA. That's going to be one of the cases. HEW may be another -- and to see what that looks like. MR. GUTTMAN: Right. PROFESSOR KING: Is there a case to be made for saying government is government or do we really need to think about it in terms of agency by agency, and this sort of sounds like the first one where this may be a real issue. So it might be appropriate to try to assemble what data we have on both sides of that question, if we had to answer it with respect to the VA. Is that doable? CHAIRMAN FADEN: Yes, it's doable. PROFESSOR KING: I shouldn't put it that way. MR. GUTTMAN: Will you do it? CHAIRMAN FADEN: It's doable. Ruth, and then Nancy. DR. MACKLIN: Mine is just a brief factual question. Of this number, however many, whether it's the larger number or the small number of experiments sponsored by the VA, is it likely that many, most or all were initiated before the 1964 date which is the first date for which you have anything that looks like a policy? MS. HOLMES: I would say at least many, if not most. CHAIRMAN FADEN: Nancy? DR. OLEINICK: As we've seen, there's often many of the same players wearing different hats, and some of the people that Dan was just talking about as being involved in advising and setting up this secret committee at the VA were taking off that hat and going back to their own labs or going to another committee in which they were the AEC. Certainly, we know that with the AEC there was at least at that level some discussion of all of these ethical issues. So even in the absence of finding the documents we're looking for concerning ethical standards within the VA -- I mean, can't we just make some broad sweep -- I mean, is it proper to do that? This is a little bit about what you're saying here, to say, well, look, these same people, when they were wearing the hat of the AEC, were involved. CHAIRMAN FADEN: I think that's exactly what needs to happen. What needs to happen is we need to look at -- and I'm in favor of things like decision memos. I like them. It's sort of one decision memo that says here are the arguments why we should take the one government approach in general, and in particular with respect to VA here are the arguments that the AEC approach or the DoD approach ought to have applied to should be taken to have applied, because the same cast of characters were involved, because the same distribution mechanism was involved for the isotopes, or whatever argument can be made for that, and then the other side. What are the arguments against holding VA research to the same standard as -- assuming we don't have great success in locating VA-specific documents, and there may not be any. Are there -- What else can we do with VA right now? PROFESSOR KING: Not a whole lot. CHAIRMAN FADEN: Not a whole lot, I guess. So that -- It's clear -- Well, we're sort of clear on what has to happen between now and January in terms of using -- trying to figure out what would make sense in terms of alternative ways of saying what the policies should have -- what it would be reasonable to impute should have been the standards for research supported by the VA. This gets to the issue that Henry raised earlier. If an agency has no articulated standard, how does it fare with respect to an assessment of culpability? This then is do you take the one government analysis or do you say, no, somehow it has a lower -- less culpability or more culpability or whatever. So if we don't find anything more for VA, we can, as Pat suggested, use it as a test case to explore the different ways in which we might interpret it. Similarly, if we find that HEW did not have any articulated standards in any period, we could make that same line of argument. DR. MACKLIN: Just one observation about that. I think the way Henry phrased it, but correct me if I'm wrong, was does it mean that, if they didn't have a standard or an articulated standard, then they were perforce less culpable because there was no standard to which people had to adhere and, therefore -- was that essentially -- Yes. There is another point, which is, if everybody else had a standard and they didn't have a standard -- CHAIRMAN FADEN: They should be culpable. DR. MACKLIN: -- then their culpability lies in not having a standard when other governmental agencies did. So it's not going to be automatic that without the standard people could go and do things and not be culpable, because especially with all this cross-fertilization, inter-agency and the same personnel. I mean, one might argue that that's a reason for them to have had a standard, and they were dragging their feet. CHAIRMAN FADEN: Right. MS. HOLMES: Ruth, if I may, I think there's a third possible approach, which is maybe there was some articulated standard -- CHAIRMAN FADEN: We didn't find it. MS. HOLMES: -- but we just don't have it, that they've not been able to ever find it, and we are getting things through staff's research from other agencies. There are materials that tell us something more about what VA was doing, but it could very well be that maybe there was something there which we just don't have in front of us, and the committee will need to determine how to work with that as well. CHAIRMAN FADEN: We always have to be mindful of the difference between saying that we have no evidence that bears on something and the claim that we have evidence that says that something wasn't there, which is the problem we have throughout since we have this huge evidentiary problem generally as a backdrop. Dan, did you want to get in? Phil, I'm sorry. I didn't see. DR. RUSSELL: What do we know about the publication by Regan on doctor/patient and the law that's cited here? When was that published? Do we know anything about its impact on the society? It's a law journal article? DR. KATZ: I think Tennessee or one of the southern -- DR. RUSSELL: It's stated here that it was -- '47-48? MS. HOLMES: There were several editions, and Regan apparently changed his mind as he went through the various decisions. DR. RUSSELL: Apparently, it was regarded by the lawyers as authoritative. DR. MORENO: I think it was a book, Jay. I think it's a book. It might have originally been an article, but I think it went through a couple of editions and actually Harkness, who is unfortunately not here anymore, has traced changes in some of the language in the book. This paragraph, obviously, contains Nuremberg code-like elements. I think the tip-off is the research in animals and so forth. DR. RUSSELL: It's a General Counsel's opinion. So, I mean, it came from the legal community. There's no evidence that any researcher or physician ever read it. DR. MORENO: No, that's right. DR. RUSSELL: It doesn't speak to community perception standards. DR. MORENO: It does not. CHAIRMAN FADEN: Okay. So more work for January. That's it for the VA for now, I think. Then we'll return to the VA in January, pushing this forward. Can we move -- return to -- If we could return to the remedies memo -- Oh, I'm sorry, Mary Ann. Did you want Denise to -- Does Denise need to be up to answer it? DR. STEVENSON: About the Atomic -- that Atomic Medicine Division. When they're citing the commendation to Dr. Lyon and they actually specify why he should be honored and given this commendation, there's reference to the fact that an important part of his duties was development of context between all these other agencies, AEC, Civil Defense, etcetera, etcetera. I mean, do we -- I presume you're still looking, but that may be a link to where policies may have been shared. MR. GUTTMAN: It's quite clear. I mean, George Lyon was Stafford Warren's deputy on the safety, if you read Jonathan Weisgall's book. This was a small world, and this was not -- LeRoy who was -- We can go -- Denise will go in the next session in January -- LeRoy of the VA -- MS. HOLMES: George LeRoy was at Hines in Illinois. MR. GUTTMAN: George LeRoy was at Hines. I think he was Dean of the Chicago Medical School. MS. HOLMES: That, I'm not sure about. MR. GUTTMAN: He was on the Joint Panel. I mean, the connections are -- You know, it was a small world. MS. HOLMES: There are many. There periodically is various people -- We do have some early correspondence, much of it from George Lyon to Stafford Warren after Warren went out to UCLA, and there are statements like, I'm so glad that George Meneely has agreed to sign on at Nashville. Meneely had worked at Rochester with George Whipple. It's a very small group in the very early years, and Lyon did as much as he could and was very successful at attracting various people to VA. Again, a reminder that VA only set up radioisotope units in VA facilities that were affiliated with medical schools. So that's another lure for people to come and work at a particular VA site. MR. GUTTMAN: But to answer Mary Ann's more direct question, those files that are referred to in that commendation, as much as we ask DoD and VA and DOE today, we still haven't been able to figure out what those files were, because that's the problem looking back at this record collection. We know there was a small world, and there were these contacts and files, but most of these files are hard to find. CHAIRMAN FADEN: Thank you. Okay, should try our hand at revisiting the remedies memo? We have Duncan and Pat here. We don't have Ken. Ken was expected after lunch, but it looks like he's detained. What I'd like us to do is look again at guideline 3. If you recall, yesterday when we were going through the remedies memo, it was a context of will we be able to speak meaningfully about government culpability? Do we still want guideline 3 or how do we understand guideline 3 as bearing on any recommendations we might make about guidelines for remedies. The issue is how should we think about -- Is there any reason to think differently about the government culpability access in the light of our discussion about the Department of Defense, AEC? Duncan? DR. THOMAS: I guess my view is that the principles which were laid out in guideline 3 still apply, and we actually made some headway yesterday afternoon in trying to circumscribe those principles a little more precisely in terms of the conditions under which we could find the government liable for -- culpable for its own actions or the actions of its contractors. There are still many open questions that we haven't addressed, such as the culpability of the contractors themselves and this question of unified government and quite a number of other questions which still need to be addressed; but I'm pretty comfortable with the decisions that we reached yesterday, and still feel like the principles that are outlined here are relevant. Now what has occurred to me is that what this memo lacks is another guideline on evidence, the kinds of evidence that we would need in order to reach these judgments in various special circumstances. That's, clearly, going to be, in the light of yesterday's discussion, a very contentious one to write, and yet I think we'd better start thinking about that question. PROFESSOR KING: Why do you think we need a guideline on evidence? I'm just not clear. DR. THOMAS: Specifically, to address the questions of -- Well, several questions comes up. The first question was touched on just a moment ago when we asked the question, does the absence of any evidence that there was an ethical standard promulgated at the VA before 1964 -- was that the date? -- imply that there were indeed no standards in that agency? That's one type of piece of evidence that we would have to grapple with. The other type of evidence question has to do with what was actually done in any particular experiment. The focus of that discussion yesterday was on investigator culpability, questions like, for example: Without actually being there and seeing what was said, how can we establish whether or not adequate informed consent was obtained? It seems to me that similar questions of evidence are very likely to come up in judging government culpability, questions like: What did the government project officers that were supposed to be monitoring the conduct of these studies actually know? PROFESSOR KING: In other words, you say we need guidelines to help us decide where experiments fit into the categories in other parts of the guidelines? Is that what you're saying? DR. THOMAS: Yes. I think so. Under what circumstances do we conclude that we have adequate information in order to reach a moral judgment? DR. RUSSELL: Some rules about how we're going to implement each of these scales? What's going to -- What evidence is going to be required in order for us to say that this fits into A, B or C? PROFESSOR KING: Well, what is A, B or C? That's what I'm missing. A, B and C is clearly knowing negligence, that kind of thing, but they have their own definitions in them of what constitutes knowing, negligent and reckless. So for that it's a more refined sort of evidence if there's any kind of evidence needed at all. DR. THOMAS: But, you see, those criteria under guideline -- What is it, guideline 5 that addresses culpability? -- are evidences about the true state of nature. What was in the investigator's mind or the government's mind regarding whether it was in a knowing state? That's different from what I'm asking. I'm asking what can we infer now, based on the documentary record, as was the true state of mind? You see the distinction I'm making? PROFESSOR KING: No, but that's all right. We can talk about it in private. I won't take up committee time. DR. THOMAS: It doesn't seem that hard a distinction. DR. MACKLIN: Let me try this, Duncan. PROFESSOR KING: She says it's because I'm a lawyer that I don't understand. That's probably right. I'm locked into my own terminology. DR. KATZ: You can't get away from it. PROFESSOR KING: That's true, too. CHAIRMAN FADEN: Ruth and then Jay. DR. MACKLIN: There are different things from which we might need evidence and need to develop standards of evidence. One we've been talking about for the last 24 hours, in other words, evidence that there were policies or standards or that people thought about these things or -- I mean, that's one set of things. That goes to the question of government capability. The others appear on the grid, the culpability/harm grid. What I want to know is, is it those kinds of things? For example, here's the list: Failure to obtain adequate informed consent in the absence of material harm or risk of harm, and even the fear of latent disease and acute side effects. I mean, is it those elements that are on the harm part of the grid that are also things for which -- DR. THOMAS: There are certainly evidentiary standards that are going to be needed in judging that axis of the grid as well and, for that matter, the causality axis of the grid, if we admit that that's another dimension to our problem. I was focusing my remarks a few moments ago, however, on the culpability axis, and it's related to the two elements which you specified, the element of were there standards, in the first place, and second, do we have evidence that those standards were violated. It seems to me we have major evidentiary problems there in establishing both of those questions. CHAIRMAN FADEN: Jay. DR. KATZ: We probably don't want to discuss this today, but Duncan's comment just stimulated a thought when he talked about evidence and taking us back to guideline 3. After all, if I understand it correctly, the DoD's culpability is based on not having implemented its own regulation of the Nuremberg Code; but is there a problem here since, for example -- and there is more to it -- the informed consent requirements of the Nuremberg Code are much more stringent than the informed consent requirements in existence today. So we are getting here into -- We may have to think it through. It just occurred to me right now an issue of can we judge them by the present, by the past, by a past that never existed, etcetera? I would say, you know, that if one takes seriously -- that if one looks at the Nuremberg Code's informed consent requirements, almost no informed consent process or only very rarely would meet muster. I think it creates -- I hope you get the drift of what I'm saying. It raises all kinds of questions which I only 30 seconds ago started thinking about. Maybe we all should think about it. CHAIRMAN FADEN: Ruth? Pat, did you want to -- PROFESSOR KING: Maybe the committee should meet again or maybe the committee should give this some clear guidance. My understanding of what we were thinking about in doing the remedies, I think, is not as specific as other people's understanding. I think of this as helping us to reach some determination about culpability in moral terms. That's more broad than it is detailed. So that the detailed work that I think Duncan is talking about I wasn't anticipating that the committee was going to do with respect to every experiment that we've covered. Therefore, I think that's where my confusion is about evidentiary standards, because I can understand in some instances where you would need them, but I didn't think the committee was going to get into very detailed -- We might have examples of what we mean by knowing, so that we can give that guidance to future bodies who might pass legislation or might not; but that we wouldn't have to tell them how to make the cuts. We would give them an example and our thinking about how we decided that we think some action is knowing or some is negligent, but we weren't going to go further than that. Maybe I'm wrong in that, because if I'm right about that, we probably don't need an evidentiary standard. DR. THOMAS: This is actually one of the divisive issues which the subcommittee has tried to grapple with. It's my recollection that an earlier draft of this document made reference to some language to the effect that the committee wasn't in a position to make recommendations for remedies in individual cases. I don't recall the exact wording of whether or not, by individual cases, I'm referring to specific people or to specific experiments; but anyway, the point is we have had some discussion about the development of test cases, case studies along the lines of some of the case studies that we have been through in the last couple of meetings, as a way of working through what these guidelines actually mean in specific concrete examples. I am, for one, still in favor of doing that. I don't think it was ever my plan that we would exhaustively go through all the experiments that are discussed in the report one by one and make specific remedies, recommendations for each experiment; but I do think the rather abstract language in these guidelines does need to be brought down to earth by trying to figure out what it actually means, one case to another. Now as it relates to this question of evidence, I can see us arguing for many years over exact rules of evidence, and indeed I'm sure law libraries are filled with rows and rows and shelves of books on standards of evidence, and we're not about to try to come up with our own rules of evidence that would deal with all possible situations; but perhaps by working through a few case studies we might be able to come up with some operational guidelines that would help us understand whether or not we think there is enough information in the historical record to pass a judgment and recommend a particular remedy in this situation or that situation. PROFESSOR KING: I agree with that, but I don't think about that in terms of evidence. What I think about that in terms of is an analysis of a case study with trying to pull out as we analyze it elements that would say that we think this is properly a case of negligence or this is recklessness or this should be strict liability. I guess I don't think about those in terms of evidentiary standards, because I think about the process, I guess. I mean, I think I don't think in terms of needing a guideline for that. I sort of think that we will do that as a group when we look at some of these case studies. DR. THOMAS: Clearly, what we do in these case studies serves one purpose, which is to try to make concrete our recommendations through a sequence of examples; but on the other hand, it does -- It's an empty exercise if it doesn't lead to some sort of process recommendations, so that those who follow in our footsteps, be that Congress or whoever -- yet, heaven help us, another advisory committee -- can look at each of those experiments that we think are meritorious of further consideration and remedies and will know what to do with them. So we ought to provide them with some guidance on that respect. Part of our guidance is do we think there's enough evidence -- or what kinds of evidence should one be trying to find, so that you can resolve these questions. CHAIRMAN FADEN: I guess my problem with it is I really am kind of lost at what's at issue here. Maybe it would make the most sense to see whether, as we work through some case examples, it emerges that we could make a useful recommendation in the form of a guideline as to how to proceed in analyzing cases from the perspective of questions of evidence, but not attempt to do it in the abstract. Would that be all right, Duncan? DR. THOMAS: That may be the only practical way to proceed. CHAIRMAN FADEN: If something comes out of that experience that we can distill and leave for others, then we will. DR. THOMAS: I think it doesn't hurt, though, for us to try to think a little bit before we get into the case studies in much the same way that, when we did the ethical analyses in the last couple of meetings, we tried to think in advance what were our standards, what are the facts, and now apply them. Well, let's think a little bit. Maybe even if we can't get a consensus on a written document, think amongst ourselves as to what are the pieces of information that we're looking for. I'm reacting very much in the light of Henry's comments of yesterday about his general level of skepticism that we will ever know enough in order to pass recommendations. My response was I think there are instances that we can point to where we'll know it when we see it, even if we can't write down specific guidelines. CHAIRMAN FADEN: Ruth? DR. MACKLIN: I think this is especially important. I know we're talking about culpability, but we're also talking about remedies in the broader sense, and Ken has been reminding us that we've discussed remedies that are future looking, future oriented remedies rather than blame or backward looking remedies. To that extent, it seems to me especially important to try to think -- I mean, I don't like it when people say abstractly, because we're all thinking concretely about something. It's very important to try to figure out what, if anything, could be recommended as a change or as an improvement in order to prevent bad things from happening in the future. I mean, what is -- What kind of assurance can we get or what kind of mechanisms could be put in place, if we want the remedies to be forward looking? Jay never ceases reminding us that informed consent today is an imperfectly realized concept in practice. If we think that needs some shoring up, then how would the recommendations or the findings, if we found that informed consent was even worse off in the past and maybe we're a little better off. If we think it's still not good enough, we should have in mind what kinds of mechanisms could be put in place. After all, if we're calling the government culpable, the government then is equally culpable if we're thinking of a wide array of NIH sponsored research today and in the future. So I think it's important to try to think of not only what would count as evidence for past wrongs or harms but what kind of mechanism could be put in place to prevent those same kinds of wrongs or harms from occurring in the future. DR. THOMAS: Ruth, can I direct your attention to footnote 1 on page 1, the remedies memo, which says exactly what you said. This is important that we do this, and that will be the substance of another memo at a later point. It's one that I think we ought to get cracking on, because I think it's very important. DR. MACKLIN: Yes, and I'm agreeing. I was trying to make my comment, which I think I didn't say too clearly, about the nature of evidence. In other words, if we're having trouble looking at what could count as evidence for past violations, we may similarly have difficulty if we want to -- if we're thinking about the future, whatever is going to come into those perspective measures, in order to try to mitigate harms and wrongs in the future. That is, it's related to what would count as evidence that they occurred in the past, because then we'll also uncover that evidence, to uncover or discover or confirm that evidence. Then how are you going to know what to improve or recommend by improvement in the future, because you're going to have the same problem of seeing what evidence there is that in the present or in the future there are harms or wrongs. MR. GUTTMAN: Looking at this discussion from the point of view of the staff, I think there are two comprehensible things being discussed. One is, I guess when I hear you, and maybe Pat -- One way of looking at what Duncan is saying is, well, evidence of informed consent, then you're into Henry's question of, well, what do mean by informed consent. You know, from one perspective, as long as we establish the standard, then anybody out in the country can then say, well, in my case I have evidence that there is or is not. That's a mechanical approach. I guess the thing that I think Duncan and we're all getting to, and Ruth is getting to, is as staff is doing the case studies, what we are trying to find, in some cases, it appears, are finding, is that it's what's wrong with this picture. It's not simply a question of, well, was there a piece of paper, right, but why is it significant and what's going on here? You know, if there was a piece of paper in, say, some of the TBI cases, would it have made any difference in relation to the process by which that piece of paper got there. There's two things going on. One is the consent document or whatever as a surrogate piece of evidence. The other is the totality where you then talk about we've looked backward and seen the process. We can look forward and see what -- you know, why is consent -- what is consent about? What are the things that are -- So that in that sense, the case studies will link up. Whether finding the piece of paper is really the significant thing, it's going to help look forward. I'm not sure -- You really need to do both. You need to sort of hypothesize, here's a piece of specific evidence, but you have to understand the picture to see whether that's really looking forward. PROFESSOR KING: I would describe what you are just describing -- what you just said, Dan, as a two-step process. One, you have to make the case for why remedies are justified, in general. That is a big picture function. That's a broader function. Making the case why a remedy is justified and a particular remedy is called for with respect to specific individuals or groups is a second order. It assumes that the case has been made for a remedy in general, and now what you're trying to do is to see if a general case that you have established that has been convincing, hopefully, can be made with respect to specifics. That's when you need to have -- It is my lawyer training getting in the way, I'm sure, but when you say standards of evidence, that is where I think of standards of evidence as coming in. When you are looking for the piece of paper in the individual case, that gets to establish whether there was specific consent here or what was lacking, etcetera. So I think it's useful to think of this as doing two things. MR. GUTTMAN: There are two things. Right. PROFESSOR KING: Yes, there are two things going on here. CHAIRMAN FADEN: In light of the way Pat has just framed it, in effect, as I would respond, what we have done yesterday and today with respect to the DoDo anyway was the big picture analysis, that, yes, there's a case for culpability on the part of the Department of Defense. We have not started to look to see are there specific cases where, in fact, the DoD failed and can be held culpable, where we found that the standards have not been satisfied, which then gets to Jay's concern about how are we really going to come to operationalize the Nuremberg Code as we look for evidence about consent practices in particular research experiments. The enterprise of the past two days has been towards the goal and, I think, the agreement that, at least with respect to the Department of Defense, we now have a background that says, okay -- Well, we haven't resolved that yet, but we're getting there -- that, yes, there is justification for holding that the government would be culpable if violations were found, because we have a standard and we're going to now look at the cases to see if anything fits. PROFESSOR KING: As I understand what Ken has been trying to say, and God knows you are always in trouble when you try to speak for Ken, but -- CHAIRMAN FADEN: Well, he's not here. PROFESSOR KING: The way I always took what he was saying about this chapter was this chapter was in itself a form of guidelines if the case is established for sort of an interim step. It's not even getting down to the details. It's to give you some guidance about how to deal with the -- how to think about the individual cases in terms of how to think about culpability, and how to think about the range of harms. Now that's all -- We had a big argument in the Remedies Committee about this is not a grid where you find your little place on the grid and you say, aha, I belong here. So if that is the case, because there are grids that are like that and lawyers are familiar with them -- My favorite example is Social Security disability grids, because that's what they look like. You actually go to a little spot and say, aha, this is where you are based on the evidence for your case, and you either get a disability check or you don't, essentially. As I understood what Ken was offering here is this is not supposed to be that, that this is supposed to be a way of organizing the considerations that go into what you think about with respect to specific cases. Now I may be unclear about this. That's why I say I hesitate to speak for Ken, but that's been my operating assumption about what I thought I was doing. I'm not sure that that's exactly what Ken thought he was doing. CHAIRMAN FADEN: Phil? DR. RUSSELL: I just wanted to comment on the fact that, although I agree with you that we've established the potential for culpability with the DoD, for example, but it's more or less limited to the informed consent issue. It doesn't speak to the other elements of ethical behavior. I would say the risk/benefit analysis -- We haven't even seen any evidence of concern or consideration or setting of standards or whatever, and I'm sure that you could come up with a scenario where the risk/benefit may be totally inappropriate, but the culpability issue then becomes a little more complex. So our agreement is with regard to the informed consent. CHAIRMAN FADEN: I would say that's -- Ruth, did you want to get in here? DR. MACKLIN: Yes. I wanted to respond. It seems to me that the discussion yesterday and the judgment was anchored on the Wilson memo and the incorporation into that memo of the Nuremberg Code. Now I mean, that's the basis for which we said, yes, they had something that was articulated, and it was said it should have been disseminated to all these other people. Now the fact that we keep using informed consent as an example -- I think you're perfectly right that we used informed consent as an example and, as Jay pointed out, the only element or item in that Nuremberg Code that is spelled out in exquisite detail as to -- that is articulated as to what it means is number 1, because it has a lot of items underneath it. However, there are other elements in that code. I mean ones that do have to do with the probability of death and the science and the knowledge of the scientific and the animal experimentation and all those other things. So even though we have only been discussing informed consent, I would think that if we're taking as the relevant document that showed the articulation of ethical standards, the Nuremberg Code as incorporated in the Wilson memo, then when we're talking about risk/benefit or preparation of the scientists to do the work or the nature of the experiment, we would have to look at the other elements on the code, at least to see whether they were flagrantly violated, and then do it item by item. DR. RUSSELL: Yes, but informed consent-- There's a presence or absence issue. With risk, it's all relative. DR. MACKLIN: Well, sure, it's all relative. DR. RUSSELL: I agree with you. It's in there. DR. MACKLIN: It's in there. I mean, if it's hard to make those things, I think it's just hard to make those relative judgments even today when the wording in the Federal regulations says that the benefits must -- the risks must be reasonable in proportion to the benefit -- the anticipated benefits. That's just as hard to do. I mean, there are some specific statements in here about death being anticipated and other things about the animal experimentation. So I'm not saying it's easy, but there are elements that are at least named in the Nuremberg Code that are relevant to things other than the informed consent. CHAIRMAN FADEN: My sense is this may be as far as we can take this right now. DR. RUSSELL: Yes. CHAIRMAN FADEN: And I just want to emphasize that, by landing on DoD, that's only because that's as far as we got clear, almost clear consensus with the proviso that we could change our mind. The AEC, because it is less straightforward, we've asked staff to come back with a more structured way of looking at the AEC; and with VA -- HHS, we haven't looked at all. VA, we're going to return to, and then the whole thing may be superseded essentially by a one government interpretation, if we take the one government interpretation. Then we would stop talking the language of agencies, and we would start talking the language of the government; but we have not. That will be part of what will happen in January. So I don't want to leave the impression that the DoD is out, because the other ones were -- MR. GUTTMAN: Actually, DoD may be the standard setter. Look at it that way. CHAIRMAN FADEN: That, in fact, is what it's looking like, that the DoD is one agency where, at least right now, that there were standards is the most clear at this early period. Then the rest may fall out or not, and then we'll figure out what we're doing with it. At this point we have two options. We could go to a discussion of the memo that I circulated or we could go to the discussion of the final report and its companion volumes. I'm not sure what it would be better to do, get a read? I'm looking for as to what it would be most useful to do at this point. Ruth? DR. MACKLIN: The one thing we haven't discussed -- I mean, much of your memo, which is important, we're going to have to revisit in light of the things we're going to look at in January. CHAIRMAN FADEN: I'm beginning to think we should put that off until January. DR. MACKLIN: Because that's really the linking of these two. We've discussed the culpability. We've discussed the remedies. We've discussed those things, but the one thing we did not really talk very much about that is in your memo are the considerations of national defense. I don't know if you want to raise those at all now, but that's number 4 in the memo. CHAIRMAN FADEN: My intuition is let's do the final report, see how much time it takes to do it, and because that is a new notion -- not a new notion for us, but a new topic for today, if we do -- if we have our discussion of the final report and we it's 3:15 or something, we'll then revisit that. If not, we'll take that memo and bring it up in January in the context of our now more refined discussion of government culpability and as we move from government culpability to questions about making assessments about the culpability of other communities or individuals or what have you. So should we turn now -- It's 2:30. We can dispense with the break or have a break at about 3:15. We'll see how it goes. We've got the homework reading from last night somewhere. I hope everybody is better organized than I am and knows where they put it. Dan, it's your memo. All right. We've got before us a memo from Dan to me, and it's sort of gone back between several of us, actually, which is an attempt -- Dan's attempt to give a sense of a potential flavor for the final volume, and then what's appended as well is a proposition that, in fact, our findings emerge as one report with several companion volumes, in fact, four companion volumes so that we can adequately make publicly available the huge amount of largely staff work that's been done but couldn't possibly be expressed adequately in the space of a 300 page final report. So the floor is open for discussion. Perhaps we should focus first on the conception, sort of thematic conception or treatment of the final report, the core volume. PROFESSOR KING: Well, I'll leap, as always. My impression from reading it, and I said this, was I'm ready to see Dan try to draft it, because I think, actually -- This is really quite selfish. One, it looks good, but my second conclusion was it was quite hard for me to critique it. This is, again, I think, the difference between the amount of knowledge in the staff. If you push me, I'm sure I can, but -- MR. GUTTMAN; Well, you're right. We know that. PROFESSOR KING: -- but the amount of knowledge in the staff versus the amount of knowledge in the committee as a whole. One of the things that I'm confident about is that, if we saw even the most preliminary, more fleshed out version of this, it would be clear to us what we're going to do, what we're not going to be able to accomplish, and how we intend to integrate it. I don't think anything would be lost, because what we are talking about, basically, is if we saw it more fleshed out, it would be because we don't like the organization and we pull it apart and put it together in a different kind of configuration; but my overall impression -- this is my general judgments. My overall impression was that it worked for me, and it worked far enough to be able to make that judgment about go to it. My only question is, can it be done, and I think it probably can. CHAIRMAN FADEN: Of course, it can be done. PROFESSOR KING: Yes. I would go to it. Now you may be surprised at my response, but without nit-picking, which only comes out in the writing, then -- MR. GUTTMAN: Well, I assume you reserve the right to alter your -- PROFESSOR KING: Always, always, but without nit- picking, I'm really saying that in general I think that this is a good thrust, a good direction, and I can't say a lot more, because it emerges in the words to whether it hangs together, but conceptually, I liked it. CHAIRMAN FADEN: Nancy? We're looking for the feel of the group here. DR. OLEINICK: I fully agree with that. I thought it was a good start. My attitude about these kinds of outlines is you write one to begin to organize your thinking, and then you modify it as you go along and you find out that, when you're writing, something doesn't work or it isn't expressing what you want to, but it sounded like an excellent overall -- I mean, I had a few little comments throughout, but as an overall outline, I liked it. I have some comments on individual parts, which I thought needed some difference in balance, but I think that would come out in the course of writing. CHAIRMAN FADEN: We could just go down the row here. Ruth? DR. MACKLIN: I agree with the first two comments in an entirely positive vein about what we've seen. I think we might want to talk together a little bit about what's the proper order of introduction of material. I don't have a conception about what is the best order, but it's one thing to see it on the paper and it looks good. If we start then questioning the implications of starting with one thing or another thing from the standpoint both of readers, the ability to follow it, the flow of the material, how much background you have to give at first so people can understand anything in what follows -- I mean, I think that requires a little more discussion. That's not to say that I have an objection to the way it now stands, but I think we need to discuss those things and elaborate on them a little bit. CHAIRMAN FADEN: Well, we can go to that in just a minute, to some extent. We have really the two documents. The first is the conceptual overview, and then there's the thought on report chapters. Maybe we might look at the report -- I'm sorry. We may be -- If we could get a sense about the conceptual overview, does this sort of tone and theme sound like the way in which Dan has laid it out worth trying. What I'm starting to hear is that several of you are saying, yes, it's worth trying this way, and then there's the next order level of comment on some of these thoughts with respect to how the material might be organized, which is the memo entitled "Final Report," thought on report chapters where we might start brainstorming a little bit about why some of us have intuitions that it would be better to start with this than with that. That would give Dan and staff some direction, but if we could stay on this conceptual overview for a minute, are there others who want to either take exception with the direction or endorse this. Jay? DR. KATZ: Well, it's -- Coming from Dan, it's laid out right. You know, you accused me yesterday that I only write superlatives, you know, when I made comments about people's stuff, and you accused me that I have a special key on the computer that prints it out, but I don't have a computer. I only have two thoughts, one question. I think, and it probably will go somewhere within Section B, because you do talk about the history of human experimentation, etcetera -- I think that we also need to have a section, because it has implications for all this, for what we are investigating, what is the tradition of medical practice in terms of doctor/patient communication, and the whole imposed shift since the 1970s with informed consent. It's been a minor shift, but at least there's something new on the books now. Anyway, that whole tradition of medical practice, the authoritarianism of medical practice throughout the ages and in modern times. Here, probably we also have to say something that it was since the beginning of the Second World War that really research for the first time came into its own. Susan, in the paper she presented to us, of course, was quite correct, that there's a long history of human experimentation dating back, and it began to take up since the days of Pasteur, but it really didn't come into its own until the War and the end of the War, and huge sums of money suddenly became available for the first time. Physicians for a long time, and maybe not until today, have really taken a close look of the extent to which medical practice and medical research have become intertwined, need to be differentiated. The ready transfer from one way of thinking to the other -- I think that, too, must be -- CHAIRMAN FADEN: We've having a little side comment about how we have been having this discussion. We were having a little side comment, Jay, about how we have in fact been having exactly that discussion. I think it's very important as well. Jay, could you try and speak in the mike more, just for the rest of us? DR. KATZ: Yes. Let me stop right here for now. CHAIRMAN FADEN: Are there other reactions, comments? Eli? DR. GLATSTEIN: Let me -- More or less of a spin-off of what's already been said, but I just want to be sure that the ultimate tone of the final product acknowledges the good that's come out of the experimentations. We've been focusing on a lot of negative things, appropriately so, and I don't want to see them pushed under the rug, but at the same time I don't want to lose sight of the positive side of the experimentation on humans. There's been an awful lot that's been good, and we're not spending a lot of time on that, nor should we, but the final product has to acknowledge that. MR. GUTTMAN: Let me -- The two important things in this document -- Of course, there are plenty of things that, if seemingly perfect now, will be changed in two weeks -- are the overall concept -- I guess I wrote it. So I can say. What struck me about all of the experience I've had here, plus reading what I have had the horror or the privilege to read about the Nazi Germany experiments, is that what we're looking at in our case are people who are trying to do good, and that's what it says. It's to win the war and to do medical research. We're delegating that to the most trusted professions in the society or what used to be anyway, generals, public servants and doctors. At the same time -- this is the discussion we had earlier -- these people were not unaware at the highest levels of leadership of the importance of individual dignity. So the question is, you know, how come -- you know, looking backward, we hear all these people who come before us and say things happened or I don't trust government. So that the only way it's going to affect the story and the way it's going to be a powerful story is when we fully comprehend that this is all set in a good setting, and we don't like big government, and we don't like medicine and medical progress, in some respects. That gives it the power of the story, and that's right, you know. So that was the general notion. The other thing here is, of course, the particular sections and whether each one fits into that set of -- CHAIRMAN FADEN: Duncan, and then Jay. DR. THOMAS: I'm very comfortable with the discussion in Part 2 of all the case studies. It seems to me they are a nice comprehensive categorization of all of the major categories of things that we want to study, and you've hit on all of the right themes. So that the capsule descriptions here give me a great deal of confidence that we're going to end up saying the things that we want to say about most of the major classes of experiments. So I commend you for that part. I have a little harder time relating to Part 1 and Part 3, and in part it's just the sketchiness of what we have to work with right now. I'm sure we'll have a better feel for this once we get into it. I often find that in trying to write big documents, the introduction is often the hardest thing to do, and it's often the thing that's best done last, once one has a clear idea as to what it is, the points that you really want to make, but I think we do need to think a little bit more about what should go into that introduction. Was it September, I think, or maybe the November meeting, we came up with a rather pedestrian outline for the whole thing. It had none of the inspirational qualities of this one, which are wonderful. I like the inspirational tone to this thing, but I didn't have that outline in front of me to review. It seemed to me, however, that there are a number of sort of preliminary things that need to be said that I don't see said here. Maybe they're in the back of your mind, but they weren't quite communicated. What I seem to be missing is there's a discussion of the evolution of ethical standards, but I don't see anywhere enumerated what are the ethical criteria that we're going to have in the back of our minds when we look at the case studies. Now maybe it was your intention that we should do that by way of summing up at the end. MR. GUTTMAN: That's why -- This was written by a lawyer, Duncan. That's the problem. When Ruth takes this, all that will be in there. CHAIRMAN FADEN: There's a paragraph under Part 1(a), the two lines, that suggest that the introduction is the place to set the stage for the ethics -- DR. THOMAS: Well, again, it's the terseness of the outline that maybe causes me to miss a lot of things which are in here, but it seems to me, we have now had almost two whole days discussing ethical criteria, and -- CHAIRMAN FADEN: It was a retrofit. I mean, it was sort of put in. DR. THOMAS: Anyway, I mean, this is a big discussion we've had, and it needs to feature in a big way in our report. It seems to me, to make sense, that that should be done up front as part of the introduction. You may want to go back and revisit it again by way of conclusions afterwards. CHAIRMAN FADEN: Exactly. DR. THOMAS: But you've got to get the criteria out, in the first place. The sort of -- The story of the Cold War context may be, again, implicit in some of the things that you're planning, but I can't quite figure out exactly where it fits in this. As part of that, the whole secrecy thing is addressed finally at the end of Section 3, and yet that needs, to me, to be moved up into the front as well. MR. GUTTMAN: Hear a comment on that, Duncan. As we think about it, we've been struggling with this notion of, you know, do you tell discrete bits or the interrelated bits? It looks like what we will probably end up doing is sort of -- you know, the tell the plutonium story in one place, but then you're talking about University of California, and you're referencing plutonium, and the plutonium story includes secrecy, and University of California includes secrecy. The Part 3, as conceptualized, was laid out, because it's either something that makes sense or not. You think through this. There are about four ways to look at the way the world works and the way that you can make it better. Way Number 1, and this isn't of particular importance, is the balance between secrecy and openness. If more things are made open, then people will know more. That's what disclosure and consent are about. The other side of that is we know there are reasons for keeping secrets, in that we know in the real world people do, you know, whether national security or not, keep secrets. You know, you keep confidences. So there's a limit to that. Number 2 is the ethical code or professional standards. As Jay has written in the book, there's a problem with that, because you may have some inherent conflicts under the hat of people who are doing two things. Well, number 3 is will there be institutional checks and balances. So do you want to put a regulator outside the doctor's door or an IRB. The problem with that is what the public decided last month, that regulators and institutional checks and balances have their limits. Then you come to the fourth thing, which is the one that probably is the one that's ultimately -- This is, I think, the sense of the committee's discussion yesterday morning. It's some sense of public understanding. The power of telling a story and people understanding how the world works may ultimately be more effective in making things better than any particular code or any particular -- you know. So that those are the four Part 3 sections, after we've gone through all these stories and set the stage with the ethical policies, looking forward, you know, what kind of past questions are raised that suggest, for example, that maybe you shouldn't have the lawyers running the show and, if you're going to have the lawyers running the show, the institutional balance should be such and such or maybe the ethical code should cover this where they previously covered that or maybe that these things should be open when they were previously secret or maybe that this is simply a complicated world, but here it's a story, and now that you know the story, you know, we will all -- So that's the sense in which secrecy is in the third part, not as the treatment. DR. THOMAS: I don't object to a single thing you said. It was all beautiful. I'd like to see Section 3 fleshed out a little bit more to capture some of these ideas you've just discussed. MR. GUTTMAN: Actually, we have a memo. Patrick is working on a memo with Gary on secrecy, which would have been ready for this, but you've got enough. So it will be ready for, clearly, the next meeting. DR. THOMAS: I mean an elaboration of the outline of Part 3. CHAIRMAN FADEN: Duncan means treatment as it's going to be in the final report. MR. GUTTMAN: We have a working draft of the final report section of secrecy. That's what I'm saying. We're much further along on the secrecy. DR. THOMAS: The point is the titles of the subsections in Section 3 aren't sufficient to indicate to me all that's in your head as to what's going to go there, but -- DR. OLEINICK: What do you mean by public understanding, exactly? DR. THOMAS: Right. MR. GUTTMAN: To me, it's telling the story, in some -- CHAIRMAN FADEN: I think the intent here was to see that there was sort of three -- At first it was three, and then it became four themes or dimensions or elements. I don't know what we want to label these things. It seemed to be critical in both looking backward and in organizing prospective remedies. I mean, the notion here is let's see if we can't impose some sort of overarching conceptual thematic approach. It was originally three, and then it became four by adding this public understanding. I don't know what the right labels are yet by which you could both look backward and organize the story and the issue, and then organize or structure the recommendations for the future, the prospective remedies, and they seem to fall in these four categories. One was this balance between openness and secrecy and what can we say about how it was set up in the past, what didn't we like about it, and what might we suggest looking forward for how that balance might be struck differently, with what sort of procedural safeguards, or however you want to set it up. Then there is the issue of research standards and their articulation and their dissemination and their enforcement, which links to the question of institutional checks and balances. None of these things are discrete. They're all interrelated. They're all of a piece, and then the new dimension that was added. All these other three we have debated and discussed, and they actually are pulled from a combination of the themes when we started out with nine themes and then sort of distilled to three themes. The fourth one of public understanding is to express the view that, as Dan just has said it, the more the public understands about all of these things, the better the public is positioned to make changes in the world if the public wants to do so. It's the kind of missing piece in all of these that, rather than just us deciding and making recommendations about where to strike the balance between secrecy and openness and then Congress and the White House deciding whether they like our recommendations or not, that if you clue the public into all of this history and make everyone more sensitive about what to watch for in the future, maybe we leave a legacy that's bigger than just our own recommendations, that kind of thing. MR. GUTTMAN: Two kind of lightning rod points that come immediately to mind as Ruth is talking. One is the thing that we started with, which is why are people scared of radiation? I mean, you know, you can have more openness. You could have more professional codes, and you could have institutional balances, and will that address this question of, well -- you know, not necessarily radiation. It could be any of that kind of risk, but it's the public's understanding of technical, complex risk. That -- Where do you address that? That's some -- It's public understanding. A second related, critical point, which is, to me, obviously a profound theme of all we've heard is the general notion that experts such as you all, and Dr. Norris, you know, aren't able to make decisions on matters where you're talking about, you know, victims and subjects. There is this basic question which, at the least, we're being asked to deal with, and you don't necessarily -- you're not necessarily able to deal with that by more openness, by -- Let's say that Henry has got to take four more continuing legal education or continuing medical education or continuing ethical education courses or let's separate -- you know, whatever it is. That question doesn't seem -- That clear message doesn't seem to be addressable simply, maybe in combination, but simply by saying let's make more things open, because -- or let's have more professional codes of ethics, although that may be a part of it, or let's have, you know, a national IRB. Where or how do you address that question? That's something that, you know, is -- Ruth and I were discussing. It's not novel. I thought this was, wow, what a great insight, and Ruth says, oh, this is the old question of such and such. Right? That's question Number 3, right, but where does that fit in? Where do we treat that? How do, you know, talk about that? DR. THOMAS: That's gone a long way to educating me as to what you meant by public understanding. CHAIRMAN FADEN: It's a little cryptic, the two words themselves. MR. GUTTMAN: Does that help, Duncan? DR. THOMAS: I'm a firm believer in the themes. I loved them when you first outlined them at the beginning of our very first meeting, and I was glad to see them carried through into the interim report. CHAIRMAN FADEN: They're not new. The one that is new in a sense is this public understanding you mentioned that was unarticulated, but the other three have been really with us from the beginning. DR. THOMAS: Maybe it's kind of pedantic, but I'm finding it difficult to connect the themes as outlined in Part 3 with the material that's in Part 1 I don't quite see the logical structure of Part 1, and it may be really pedantic. I was sort of always taught that the way you give a talk or something -- or is, you tell people what you're going to tell them, and then you tell them, and then you tell them what you told them. MR. GUTTMAN: Duncan, there's a structure to Part 1. Obviously, it may not be logical, but here's the structure, a moral oppositional structure. We're saying that here was the good that the country set out to do. We set out to win the war and to describe all the medical research programs and the Cold War purposes and so forth. At the same time, these people were concerned about dignity, and this is the history -- This is the contemporaneous ethics policies. So it's the kind of -- CHAIRMAN FADEN: Duncan is asking about the relationship between those four themes and introducing them and the structure of Part 1, the need to introduce them. It's a stylistic -- DR. THOMAS: It's not that I'm objecting in the least to the material that's laid out in Part 1. CHAIRMAN FADEN: It's a stylistic matter. DR. THOMAS: In addition, I sort of want to see -- It's really pedantic, but I sort of want to see the themes introduced in Part 1. MR. GUTTMAN: Okay. DR. THOMAS: And ditto for the case studies. Before launching right into the case studies, I want to get an overview as to what the universe of experiments consists of and what the rationale, the logic, was for grouping them in this particular fashion. With that, I relinquish the floor. CHAIRMAN FADEN: Jay, you were -- DR. KATZ: Two things: First, only a suggestion. I think back in January you have a similar memorandum, Dan, on thoughts of the process of the writing of the report. What are your thoughts about that, and to what extent in the first draft do you want to rely totally on staff. To what extent do you want and in what ways do you want -- should one consider getting committee members involved with various staff members, etcetera, etcetera, etcetera. CHAIRMAN FADEN: I'm teasing. We tell Dan he's going to write it overnight or over a weekend. MR. GUTTMAN: I say Jay and Duncan and Henry and Ruth volunteered last night, if called upon. DR. KATZ: Okay, but the only other thing I wanted to mention, and it's one thing that you -- Who knows how it's going to work out, and it's something, mercifully, that you are going to have to write. There has to be a Part 5, namely -- It's very, very likely, I would think, that some of us may want to add some additional statements to the report, and that will also raise certain process questions that we can get to later on, but it's probably unavoidable. Maybe it will be. Who knows? It's too early to tell, but there has to be that Part 5 or whatever it's called, unless you have some different thoughts. CHAIRMAN FADEN: That's a simple matter. I mean, it's a simple matter, Jay. You're right about the process issue, but it's -- You're right about the questions of how to develop process issues for dealing with potential dissents or personal statements or so on, but clearly, the doing of it is not a difficult problem. MR. GUTTMAN: Jay, an important point. The mechanics of this, which are, of course, the essence: What we had talked about internally is that you'll note that most of the chapters if you want to use that term, correspond to projects that the staff has been working on with the subcommittees, such that, for example, we just had Jonathan and Denise, et al., and Valerie talking about the ethics policies. That's one of the sections. We've got TBI and biodistribution. So the notion we talked about internally is that the people on the staff who are working on each of these areas write the best, fullest treatments of each of these areas. So at the least, that will be an appendix section. So you'll have a blow by blow of, you know, plutonium or biodistribution. Then we can take that and see how we can work with that as sort of the material that then gets to be in the report. CHAIRMAN FADEN: I think, if we could refine that a little bit, Dan. It's not as if the writing of the final report is going to wait in each instance for the finalizing of the sections. If you go to the very last page, here's this proposed appendix volumes or companion volumes, depending on how you look at them. I'm now thinking of the language of companion volume rather than appendices. There are really four companion volumes. We've got the volume which is the final report, and then the four proposed companion volumes. In each of these companion volumes, with the exception of 4 which is technical -- it's essentially the technical material that some people will be very interested in, but will have a different sort of an audience. The content of volumes 1, 2 and 3 will also find their way in abbreviated and different stylistic ways into the final report. So there's a process of thinking that says the staff is being urged to get as quickly as they can to chapter-like expressions of their work, as indicated under volume 1, 2 and 3. The thought was that the first draft of the final report, the core volume, whatever we want to call it, the final report as opposed to the companion volumes, would be done by staff, and committee members would respond to it; but the first draft would come from staff and, insofar as possible, wold flow from the more detailed treatments of the issues that are also being done by staff in conjunction with the different subcommittees, volumes 1, 2 and 3. DR. KATZ: Ruth is going to be like one of my law students. They always ask me that question, and I said it's such a difficult question to answer. In the past, I didn't used to answer it, but now I have given in. How many pages does my paper have to be? MR. GUTTMAN: Single spaced or double spaced? DR. KATZ: What do you sort of technically envision, you know, for a page bias for Part 1-4, forgetting about the appendices? CHAIRMAN FADEN: For the final report we've been talking 300 pages. MR. GUTTMAN: We don't know what that means, because we don't know the print size. CHAIRMAN FADEN: Well, 300 manuscript pages, basically. DR. KATZ: It will be looking like the interim report. CHAIRMAN FADEN: Three hundred real pages. I'm sorry, a book that would be about 300 pages long, a book. The final, finished, printed book, whatever that corresponds to in manuscript pages, would be about 300 pages, something that's reasonable and readable by a human being. The notion is the tone and so on that would be struck is one that would be an accessible, available report and not a report -- DR. KATZ: It's a good idea, you know. It's a manageable number, but let's assume it might have to go to 400 pages. Would that create a problem? Not that we should -- MR. GUTTMAN: You're going to write 100 pages in Part 5, Jay? DR. KATZ: No, no. I'm just talking about -- because we have so much to say in the -- MR. GUTTMAN; If we do it by January, then we can do it; but if it takes -- CHAIRMAN FADEN: I don't know the answer to that question, Jay. It partly depends on the vehicle by which the final report is published. By January, we should be able to give a report to the committee, I hope, about what our options are with respect to the publication of the final report. These are issues that we have to figure out about how it can come out, you know, in what form it can be and who can publish it and all that kind of stuff, which may set some constraints. We're also exploring innovative ways to make Volumes 1- 4, the companion volumes, widely accessible and available as well. The key thing is to get it all out, to get as much of what we've got out. Ruth? DR. MACKLIN: Can I go back to some of the substance here? Do you want to do that? CHAIRMAN FADEN: Sure. Yes, absolutely. DR. MACKLIN: Okay. CHAIRMAN FADEN: That's the general idea. DR. MACKLIN: I mean, because the more I look at it and the more we have a discussion here, the more things come to mind. I had a question similar to the one that Duncan asked, but it's gotten more complex now. First let me ask first things first. The outline begins in the middle of the first page that we have here, and it says Part 1(a), Introduction and Overview. Then the two proceeding paragraphs that begin the memorandum refer to what should come first. Now does that mean - - I don't understand that. Does that mean that something will precede Part 1(a)? MR. GUTTMAN: I guess what it means to me is -- This is something that, we hope, is going to be read by people who haven't paid, you know, much attention to what we're doing. So we are here into the details of 1947 correspondence about ethical standards. So the question, if I were a reader, I might ask is why? Why ask? What's the world we're in here? So this is what -- you know, how do we present, you know, the story. DR. MACKLIN: I understand your question. I think the suggestions or the questions meant by way of possible suggestions are excellent, but I'm really asking whether in asking those questions, you're asking whether or not Part 1(a) as written here shouldn't be Part 1(a). In other words, there will be a beginning of this book that will not be called preface or introduction, because nobody reads those things. MR. GUTTMAN: Right. DR. MACKLIN: The book will start with something -- I mean, they don't often read them. They seem dispensable, just as the way they feel about appendices, too. That's why they have to be called companion volumes. So in other words, what's here now -- This is just a mock-up. Part 1(a) may turn out to be Part 1(b), because something else will precede it that will suck the reader in. Right? MR. GUTTMAN: Part 1(a) could be -- you know, January 30 Ruth Macklin was watering the lawn and got a call from Washington, you know. DR. MACKLIN: Right. Anything to draw the reader in. Okay. Now I want to endorse the idea of not starting with introduction and overview and have people yawning before they get caught up in the story. MR. GUTTMAN: You've got the sense of it. DR. MACKLIN: Okay. So something should come first, and whatever that is you have some suggestions. I think the statements from witnesses are excellent. I think a case study that will draw the reader in and motivate the whole project. Okay. So that's my point, and then we'll have to say either Part 2 or Part 1(b) or whatever. Now my second point goes to the -- I mean, I want to move backwards here. On page 5 you have a category that says, "Ethics Standards and Policies: What Has Been Found and What Can Be Learned?" In Part 1 on page 2, Part 1(c), is much of which, not entirely, is going to be devoted to the origin and evolution of Cold War human research ethics policies. CHAIRMAN FADEN: Or standards or whatever. DR. MACKLIN: Or whatever, policies or standards or whatever it is we're referring to. So -- I mean, part of the -- and that, presumably, you can draw on that in everything that follows. I mean, anything that comes first is something that you can draw on. So it then puzzles me a little bit to ask what more then is going to be said by what has been found and what can be learned? That is, that sounds like a summary and perhaps things that are not yet discovered or known, but there's a way that we might want to take that farther; in other words, not what has been found or what can be learned, but -- because I think you will have already said what's been found in the course of, say, not only -- I'm sorry, forgetting the numbers -- Part 1(c), but perhaps all the way through as this threads through. So I know that this is here for a kind of a balance, because (b) and (c) both say what has been found and what can be learned, but I wonder -- I mean, that may need rethinking as we see what has been said all along, unless it's just a brief summary and a wrap-up. CHAIRMAN FADEN: And ideally, it ought to be a distillation then of what we've learned about how these standards succeeded or failed. You have the articulation of what the standards are. You have the examination of all of these cases of the reach or the relationship between the practices and the standards, and then some distillation in this section of, well, look, just sort of how did it work or how did it fail to work. DR. MACKLIN: At the end. At the end part. Right. CHAIRMAN FADEN: At the end. DR. MACKLIN: Now one more point along these line: If you do in fact start with something that draws the reader in dramatically, I'm not sure that the appropriate next section -- I mean, why examine the past? Yes, but current moral standards for the conduct of research presented as the backdrop -- I'm not sure that's right. I'm not sure why I'm not sure, but -- CHAIRMAN FADEN: That's the best place to start. DR. MACKLIN: That's right. In fact, as the evolution -- In any case, the evolution is going to come up to the present, and we're going to be asking prospective questions as well, but the reader has to come into the material before being presented with the question of how to judge the past. It's going to seem not only abstract, to use a word that doesn't bother me as much as it does others, but not contextually linked. So I agree that it's an important -- certainly, an important element, and at some point something has to be said to inform readers that there are some things as ethical standards. It's not just what any particular person happens to believe is right is right, but I don't know that laying them out in a way that might require referring to CFR 46 is the best way to do it, especially given the fact that that will sort of fool the reader. I mean, you draw them in by a good story, and then all of a sudden, you're plunging into the Federal regulations. Now I'm not being critical. I'm just trying to think aloud. CHAIRMAN FADEN: Well, there's a tension, I think, and Dan and I and Jeff and Anna and Steve -- I can start listing all the people who have been working on this -- in thinking that goes just between Duncan's comment and your comment, and it's the tension of going back and forth. On the one hand, this is an ethics committee. We clearly are putting our hardest collective thinking as a group into thinking through these normative questions. That's what we've been struggling with today. It's what we'll be struggling with in January and in December and so on. On the other hand -- and you want to lead with that, in a sense, because it frames who we are, but -- and it may be in the end some of our best contribution is the work that we do on this issue. On the other hand, it's not a real catchy way to bring the reader into the story. So there's that tension between writing a volume that's intended to be something that people would like to read, on the one hand, and communicating the work of the committee, on the other hand. So it's gone back from the back to the beginning to the middle. I don't know how to resolve that. Exactly the difference between the two of you is the tension that, I think -- It's sort of a metaphor for the problem of the whole report. DR. MACKLIN: I think that the current standard -- I mean the why examine the past is the important question, and it says now this committee is empaneled to do this work, because we now have a motivation for examining the past; but it's not necessary at that point to talk about current moral standards for the conduct of research. That can be embedded in the context if, for example, when any particular case or case study is brought up by way of example, it can be pointed out how this would look or how this might be judged or how it would or would not fail to be approved or approvable under today's research, without -- I mean, how are you going to talk about those things? You can certainly talk about things like consent, but those are going to emerge from the stories, and I think in a more contextually relevant way. Anyway, it's just some thoughts. CHAIRMAN FADEN: It's a struggle. I see Phil and Mary Ann. DR. RUSSELL: That's a point of contention of whether the objective is to write an engaging description of the issues and our conclusions versus as honest as possible description of the thought processes and the discussions and how we got to those conclusions. I would tend, perhaps not unexpectedly, to lean towards the bureaucratic answer, and that is be as honest and as procedurally precise as possible. I think to understand the conclusions that we reached, there has to be an understanding of the process. I think that we need to follow, at least to the extent that it's not going to be a total yawner, and some of it is, the evolution of thought on this committee; because I think there's been a tremendously interesting evolution of thought as we've gone through these discussions, and I think that's an important thing to convey, and I don't see how you can do it unless you, in a sense, follow the order. We had a lot of discussions about how we were going to judge the past and, in so doing, we had to elucidate our understanding of where we are now, and then look back, and then try and -- I don't have to explain to you what we've done, but I think we have to capture that in the report. MR. GUTTMAN: Let me ask you: You're not saying, I don't think, that all writing has to be -- There's a difference between being dutiful and honest and being dull. DR. RUSSELL: No. Yes, I don't think we -- We also have to write a report that's readable. MR. GUTTMAN: Right. So that the public wants to know - - I mean, in my mind, for example, just as one person, I think about this in part as a detective story. So you take Ruth's question. This is just my, you know -- You all get to edit this, and Ruth will have edited it first. Why look at the past? Well, when this became an issue in 1993 you got several different kinds of reactions. You got some people saying, my God, I didn't know our government did these things in deep, dark secrets. You get some people saying, what's the secret here? You got some people, who are the experts in ethics, saying, well, you got to understand, they didn't have any ethics policies back then, some real basic questions. So a committee was set up, and this is what -- You know, in other words, I don't know that there's an inconsistency, at least by the way I've described it, by raising this as an interesting story and explaining the process by which it was then -- Yes, we've got to tell the people what we did and how we did it, especially if we're reporting to the interagency committee. They don't want to be mystified by 300 pages. They want to know what the bottom line is and what the process was. We can do it -- You're saying we can do it, as long -- We've got to do both, but we can do it. It's not -- CHAIRMAN FADEN: We want a really boring - MR. GUTTMAN: Okay. CHAIRMAN FADEN: Mary Ann? DR. STEVENSON: I don't want to break the flow of the discussion, because I'm going to bring up something else. So I can hold off if people want to keep going. CHAIRMAN FADEN: But about the report? DR. STEVENSON: Oh, yes, about the report, but it's more going back to Dan's conceptual overview memo than your thoughts on report chapters. So I don't want to mix up the discussion. CHAIRMAN FADEN: So we'll go back to Mary Ann. Duncan? DR. THOMAS: I don't think we need to aim to put anybody to sleep before they even get started here. I had in mind, in order to try to lay out the criteria in the introduction, was not a deep philosophical discussion, by any means. All I'm saying is that we should be trying to get the major themes laid out in advance so that people have it in the back of their minds as they're reading the narratives and stories in Part 2. Otherwise, they won't know what they're looking for when they're reading this stuff. That can be done in a rather terse fashion, I think, you know, possibly even with just a sequence of these boxes which lay out the basic criteria that we're using. Some of us have now seen an outline of one of the subsections in Part 2, and I would point out that that outline -- I'm thinking now of an outline for the intentional releases section -- is predicated on the idea that it's not necessary to go into great detail about the specific ethical criteria that we're going to use to evaluate intentional releases, only the things that are special about intentional releases, and under the assumption that the general principles have already been laid out in some previous section. So if you're not going to do that, then we've got to rethink that specific subsection outline. The other thing about that outline is that there is very -- at least as it's presently cast, very little of the way of narrative. It's mainly an analysis section with the thinking that the narrative is going to be primarily -- We'll have a major section in Volume -- Appendix Volume 1 as a case study. That was the concept we were working to in terms of how each of those other sections would be -- In other words, there wouldn't be that much narrative in Part 2. It would be more analytical in nature. We, I think, need to address that aspect as well as to what your concept of what Chapter 2 subsection is going to look like. CHAIRMAN FADEN: Jay. DR. KATZ: Two things, and it was triggered by what Phil said about the tone of the report. Of course, it shouldn't be a boring report, and as far as reports go, the second Presidential Commission report and the various volumes -- I thought they were very well written and very readable. I don't know what you have in mind about publication, and it's going to come up in January, but the question -- I'm sure you've already started thinking about the question. To whom is this report addressed? Is it addressed to the President, to begin with? Of course, and to Congress. Is it addressed to the public? That can create a problem for you to write the kind of book which actually needs to be written that sort of focuses more on the public, but people then may say -- and Congress -- you by-passed us, etcetera, etcetera. So we haven't talked about that yet, and I'm sure you'll tell us more about it in January. DR. STEVENSON: I think -- Sorry for jumping in. The companion volumes allow you to give that kind of detail away from the main narrative of the report. So that you can perhaps reach all those audiences in particular sections in the detail that's appropriate, but I think -- My own personal opinion is that the main report should be very accessible to the public or we've missed our mission. MR. GUTTMAN: One of the things we were thinking is do we have like two reports, one interagency, cabinet members. The answer to question 2 in the charter is this or on page 32, you know. The other is the public. The thing that strikes me as the spirit -- Obviously, you've got to answer the questions that are laid out in the charter and, obviously, we have to do this in a way that the interagency cabinet committee knows exactly what those answers are and where they are located; but the other point, which is what was the essence of the discussion yesterday, is I perceived that, when we went to the White House, the President said the number one thing is tell the story to the people. This is not an arcane, you know -- To me, I think that's consistent, therefore, with -- you know, you're in synch with what the President actually, you know, told us. DR. KATZ: Whatever, but it would be nice to hear more about it. CHAIRMAN FADEN: I'm not sure there is much more to say. The publication issue we're just checking out to see what our options are in terms of being an advisory committee, what can we do. DR. KATZ: I'm sorry? CHAIRMAN FADEN: The question about specifically vehicles for publication, we're now checking out what are our options as a Federal Advisory Committee Act. Can we go to a private press? Do we have to go to GAO, that kind of stuff? So in January we can tell you about the vehicle. That's separate from the issue of tone and style and audience, but one set of issues has to do with how will it be published and available, and we are investigating what our options are as an advisory committee in terms of how are we free to publish our report or are there constraints on how we must make our report available. The issue about what you're just saying, we can discuss now. There's -- Why delay it? DR. KATZ: Okay. CHAIRMAN FADEN: You know, what's to delay it for? There's nothing to wait for. I mean, we got to decide. Nobody else has decided but us. I would take what -- My personal view is the same as Dan's and Mary Ann's, that we have an obligation to answer -- to fulfill our charter, including making recommendations about prospective and retrospective remedies. They must appear in the major report, the final report, but the telling of the story, which is also part of our mandate from the administration, is a story to be told to the public, to the American people. So I would see it as a combined effort, and then -- I agree with Mary Ann that the companion volumes -- the purpose of that is to provide, first of all, a complete -- a vehicle for the extent of the scholarship and investigation and the research that's been done, so that the scholarly community and journalists and particular interest groups have benefit of all of the work that's been done and the kind of detail that we could never put into a 300-400 page book; but I would think that the principal charge to both the interagency working group and us to the President and to the American public would be satisfied in the report, you know, in that main volume. Then the people who might want to execute, whether it's Congress or the Executive branch, and want further our recommendations or debate our recommendations and want further and more detailed documentation could then go to the companion volumes for the more detailed evidence or discussion that bears on why we have fashioned the recommendations a certain way, but we would have to write the final report like a stand-alone book. I mean, we couldn't say, you know, rely on -- say, "see page 26 in companion volume B," because nobody is going to do that. DR. KATZ: Just as a point of reference, you've read many of the Presidential Commission reports. Did you feel that, in a sense, they probably went a little bit further -- a little bit more scholarly, but I don't think they even were that scholarly either. An intelligent person could understand it. CHAIRMAN FADEN: Yes. Not all of us have read -- Actually, parts of some President's Commission reports, I think, have been distributed or are going to be distributed. Have we ever distributed any? What we could do is make -- For other members of the committee, we can circulate some samples of different ways in which this has been done, so we could see, but I think that one of the differences between some -- I think all of the previous bioethics commission reports is that we have this story dimension to this that is quite different. DR. KATZ: That, of course, can be addressed to anyone. I mean, the storytelling is, hopefully, written that the public, maybe even a Congressman, etcetera, can understand it. CHAIRMAN FADEN: We hope. Right, and staff, especially staff members. The real key, though, is so Congressional staff can look at what we're saying and then make recommendations to their bosses, basically, about whether our recommendations are worth entertaining. I think our two principal audiences are the interagency working group and, through them, the President, on the one hand, and the American public, on the other. MR. GUTTMAN: And Congress, on the third. CHAIRMAN FADEN: Congress, on the third. Okay. DR. KATZ: Let me bring up then a second point, and here, of course, we can discuss it today; but I think we should think about it and talk about it in January and maybe -- Probably Ruth, too, would have to tell us more about it also. I don't really believe that we can finish the final report by May. I appreciate there are problems with getting an extension, and the kind of extension that I at the moment envision is that we finish probably by March or April all the investigative work, that we have to sort of put a termination date on that, in any case. Until that time, many of us will really be very, very busy, too, with reviewing documents and pursuing further leads. So even members of the committee will have little time to really think seriously about the final report. However written, the final report, to have a meaningful impact, will require a great deal of thought, working through, reworking, etcetera, discussion, and I would suggest that we consider asking the President for an extension not of the committee as it has existed until April. Indeed, probably a great many of the staff members might leave us but, of course, those staff members intimately connected with the writing of the report would have to remain, that for four to six months after May when this report is being written and finalized, that we have the opportunity to meet here and go over sections and do that also by telephone conversations, etcetera; but to have a four to six month period of time to really worry about the final report and bring it into the best possible shape we can. I don't think, and I would be very surprised -- I might be surprised -- that we can come up with a document by May. I doubt it, but this is something to think about, to consider, if the committee feels that it wants to do something, that it is in favor of such a proposal, I think I'll be able -- I'm not sure, but I'll be able to get the President's ear. He recently called me on another matter. So I could do that, but of course, I would only do that if that is what the committee's wishes are, and I think Ruth, of course, should begin to initiate that kind of discussion. I think we can make a good argument for that kind of an extension if we are so inclined, and I would strongly favor it. CHAIRMAN FADEN: I think we should do the following: It's now 3:30. I want to return to Mary Ann's comment. What you raised, Jay -- the problem is we can't keep putting it off. DR. KATZ: Pardon me? CHAIRMAN FADEN: We can't keep putting off that issue. If we're going to have a discussion about it, we might as well have it, because -- DR. KATZ; You think you are ready for it? CHAIRMAN FADEN: Well, we don't have much choice. The point is we're at the point now where we're not going to decide in April that we're going to get an -- DR. KATZ: We could do it in January. CHAIRMAN FADEN: Well, we could, but we could have some -- I don't know. I mean, I'm really not sure exactly what to do about it. I just want to get a sense of whether we want to take a break. The plan is to end at 4:30. We could take a quick break now for ten minutes, come back, do a little thinking about what Jay has raised, and then return to Mary Ann's comments and any other comments on the final report, and end at 4:30. Would that be congenial, something to do? So it's now 3:35. If we come back at quarter of four, come back in ten minutes, and then we can pick up. (WHEREUPON, the committee recessed briefly at 3:34 P.M. and reconvened at 3:48 P.M.) CHAIRMAN FADEN: We need to come together. I forgot that there were things we needed to happen today. We should have a short discussion about the point that Jay raised. Mary Ann still had a comment about the report, and there may be other comments as well, but what I forgot is that we also need to get a report very quickly to the full committee with respect to -- from the Outreach Committee, which I suppose we could do by mail, but we might also want to hear from the group that did go to the Department of Defense with respect to the Green Run classification issue. I know lots of people are wanting to know the outcome of that session. Anna, maybe we could take the outreach thing and put it in the form of a memo and not have a -- Just leave it there and not have a discussion of it. Okay, it's there. If everybody is comfortable with that, it's self- explanatory and, if we have questions, bring it back. It's four o'clock, more or less. No, it's ten of four. So how about if we spend until 4:00 on the issue that Jay raised, and from 4:00 to 4:15 we'll cover the Green Run issue, and then from 4:15 to 4:30, begin with Mary Ann and then finish up with whatever comments. Would that work for timing? So from now until, more or less, four to talk about the time frame question, and then four o'clock a report on what happened with respect to the Green Run document and declassification, and then 4:15 to 4:30 Mary Ann will be -- She's been patient -- her comment and any other last minute comments on how to deal with the report, and then we end at 4:30. Okay. So we have on the table this very painful question about timing and time frame. I guess the question before us is whether we ought to be doing anything to seek an extension beyond where we are. You should -- Pardon? You should know that we have been having discussions about this issue, obviously, and the tentative plan is for the report to come out end of May, just at the tail end of what is our charter. With any luck, we might have a little residual time to get out, just to close the operations down of the committee, which will not be a small matter since we, obviously, have a large staff and lots of documents and lots of material; but that is the operative plan, and what Jay is raising is whether we should be seeking an extension. This is, obviously, a very difficult topic to discuss. There are lots of arguments that would suggest that we ought to be seeking an extension, and lots of arguments that suggest that we should live with what we've got and get the best report we can out under the circumstances. I don't know where to start. I mean, Jay has asked for, I guess, a sense of the group on that question. So I want somebody to start talking. Thank you, Mary Ann. DR. STEVENSON: Well, I can appreciate Jay's point of view, and you know, I sense the same concerns, that we have so much data, how can we do justice to it in the time remaining, but I also have concerns that we may well not get an extension in the present political climate. If we proceed at the rate that assume we'll get one and we don't, we'll be in terrible shape. You know, I think to some degree, in the pragmatic sense, we just have to assume that it does have to be in by May and work accordingly. It may not be as polished or refined as a report that would come in a year from May, but if that's what we have to do, that's what we have to do, but I think it really will determine our -- I mean, we need to sort of determine our feelings on this and, no matter what the committee decides, get an answer on it very soon, because it's going to determine the pace and direction of the staff work from now on out very dramatically. CHAIRMAN FADEN: I think it's rather the other way -- I appreciate what you're saying, but it's sort of rather the other way around. In some respects, we have had an answer. The issue is whether we want to -- DR. STEVENSON: Pursue it further? CHAIRMAN FADEN: Yes. I mean, the sort of operative answer is we're to be done by the end of the charter, which is the end of May. The issue that Jay has put out before us is do we go back and say -- DR. STEVENSON: I mean, does anyone on the staff have a sense of whether or not, theoretically, we would even be -- have a chance of even being granted an extension or is it just something that probably wouldn't happen? Is it even worth going through the process of asking for one? Anybody? It doesn't have to be Ruth. CHAIRMAN FADEN: It's complicated. I mean, I think that it would not be -- It's a very difficult time. It's a very difficult time. Duncan? DR. THOMAS: There's a piece of data that would really help inform my decision -- my thinking about this question. I think, if we were simply to stop right now and start writing up what we already know, we could write a damn nice report, and we could get it done, if we really worked our tails off, by April or May. The piece of information that I don't know the answer to is are the two contemporary research projects reasonably on track, and is there any hope that we can get meaningful data out of them in time for inclusion in this report? CHAIRMAN FADEN: I think we'll be better positioned to answer -- The answer to that question is I can't answer it until January. The letters have gone out on both projects, the letters requesting information back from the universities in the case of the protocol review project and requesting permission to interview subjects in the subject interview project, have gone out. They are all now out. With respect to the protocol review project, even if we got -- We have work to do, regardless of the level of cooperation from the universities, because at the very least, we have the grant proposals from the funding agencies. They are in house, and some of you will have already received or are receiving packets to begin your reviews. So I think on the protocol review project we probably can bring it home on time. It depends, in part, on how quickly we do our reviews, how much agreement or disagreement it turns out we have as a community about how to interpret what we're seeing. So we will again have a better sense of that in January. In part, we'll know how many universities are sending us materials, but even if we don't get the cooperation we hope for, we would still have our work to do, because we have all the grant proposals, plus we have the grant proposals and the IRB materials from the intramural program. So that's more under our control is what I'm suggesting. It's a matter of how quickly and how hard committee members and staff work on that project whether we can get findings from it in time for a report that came out at the end of May. The protocol -- the project -- The subject interview project, we are totally dependent on the cooperation, the willingness of local sites, hospitals and university administrators, to let us in, and we are just beginning to learn how much that's going to happen. By January, we should have a sense of whether it's a project that can be brought home on time, which we very much hope, a project that can be brought home if it has extra time, or a project that is going to be difficult to do because there is less interest and willingness to cooperate than we had hoped and expected. So that one is -- but I think by the January meeting we can give -- we'll have very good readings on those two questions. DR. THOMAS: In light of that response, my personal suggestion is that it's kind of academic to discuss the question of timetable any further today. CHAIRMAN FADEN: Do you want to wait until January? DR. THOMAS: Wait until you report back to us in January, and then revisit the question. CHAIRMAN FADEN: Ruth? DR. MACKLIN: -- is properly concerned about is ample time and work on the part of the committee and staff together in the actual writing of the final report. I think we heard today in Duncan's comment just a moment ago, and we see from the material that we have that much of what has been written all along is now being reshaped into something that can be part of the final report. Duncan, when you said you think we could do a pretty good job if we had to stop right now -- that is, we've done a lot of conceptual work, and the projects that we don't yet have data or answers to are more a function of writing up results. I mean, those don't require quite as much -- well, some analysis, but not in the same way that getting the conceptual framework and thinking through what the committee has been about and these very hard questions about respective judgment. So I don't see any reason why the beginning and continuation of writing the final report could not go on simultaneously with the ongoing research projects and whatever other conceptual discussions we have to draw us to an end. Isn't that what you plan to do anyway? MR. GUTTMAN: That's what we've theoretically been doing for the last month. DR. MACKLIN: All right. Well, theoretically -- maybe actually. CHAIRMAN FADEN: About a month ago, the sort of mindset shift went to now we're writing for the final report. DR. MACKLIN: well, having revealed that -- disclosed that to us -- MR. GUTTMAN: Ruth said, don't tell the committee. DR. MACKLIN: Pardon? MR. GUTTMAN: Just kidding. Just kidding. CHAIRMAN FADEN: Friends like these. Right? Okay. DR. MACKLIN: Secrecy. Sounds like secrecy to me. I mean, I want to then go back to Jay's question. If we, in the course of the next few months at the same time that we're continuing what were going to be the planned agendas but that a portion of every meeting is given over to review and discussion of chunks of the final report that are already written, won't that in part or in large part satisfy the concern that we will have to do a very big rush job at the end with the report? CHAIRMAN FADEN: So what we're hearing is -- and, actually, some people were talking about this, apparently, at the break, the need to start getting pieces of the final report very early, primitive draft, so that people don't have to worry so quickly to the committee. In any event, but certainly the sense is that to try to get it home by the end of May, that we in January should be seeing a piece if something, and by February should be seeing a much bigger piece. Dan? MR. GUTTMAN: Yes. A small but important point you're going to have to provide for, maybe by way of a subcommittee: There has been a continued sense, and publicly stated, that we want to have this reviewed either by -- or certainly by the -- you know, either by the interagency people and/or by, you know, peer -- etcetera, etcetera. That mechanism -- From my perspective, that's going to be one of the -- That's a real time problem. I mean, you've been saying we could do something by May, but to get that something done and then have it reviewed and by whom, that's the -- Ruth, what's the mechanism by which we're going to figure out who to get to do what kind of review processes and when? CHAIRMAN FADEN: This is the question of whether and under what conditions we're going to have drafts of the report reviewed by experts outside of or people with valued perspectives outside of the committee itself on an embargoed basis, basically, to give us reactions and things of that sort. I think we should have that -- We should have thought that through with some options and bring that to the committee in January. I don't think that's anything that we can -- That's the question that's emerged. DR. MACKLIN: What about the people who are already here as consultants to the project? I mean, they're consultants to it, but they're not, most of them, attending these meetings. I mean the ethics experts and the people in the history of ethics world. CHAIRMAN FADEN: I mean, that includes people like that. DR. MACKLIN: Yes. I would think those are the same people, the same people or kinds of people to whom you would be sending it for outside review. I mean, isn't that a possibility? MR. GUTTMAN: That's a question, whether there are areas that we have now seen that we -- you know, the areas where there are controversial technical science areas, right, and you want to get more people than we've had. CHAIRMAN FADEN: Assuming the report even goes in that direction. We don't know that. MR. GUTTMAN: Or whatever it is, yes. Right. CHAIRMAN FADEN: I think we should hold off and in January we can have a set of time to think about how to structure this and what the options are before the committee. I think without options and without an appreciation of what the disadvantages and advantages are -- and it also ties up with the issue of timing. How quickly can you get all of this done, which is how you got to it, in the first place. I'd like to hear from a few more members. Henry? DR. ROYAL: One of the things that I've been struck with is that documents still continue to appear. Important documents still continue to appear, and I'd like to get a better sense from the committee staff about how confident they are that the document discovery phase is winding down. MR. GUTTMAN; Let me say a couple of things here. DR. ROYAL: Because I think that has an important effect on how long we want to be in business. MR. GUTTMAN: A couple of things here: We all know this is a cliche, that we aren't going to discover everything. We're trying to lay out a roadmap, and it could well be the day after the final report comes out we discover the missing blah- blah-blah. DR. ROYAL: Yes. MR. GUTTMAN: The operative question is: To write the report that we hope to write to be a terrific report, what do we need for each one of these chapters? So I can just tell you -- I mean, we can go blow by blow through the Department of Energy and Los Alamos and all those sites, but by way of example, I think we've just gotten in material on the biodistribution -- I told some of you -- plutonium stuff which we hope to get out to you all very shortly. This is part of the process. Similarly, informing the whole body radiation -- that should be kind of meaty enough that you'll have the really interesting two chapters there. The way staff is thinking about it is not when we get all the documents, but when are we going to get a critical mass that we'll feel this is not just a routine description, but we're telling something that's interesting, new, different, significant. At what point -- You know, then you'll always get new information about that section, but you'll have something that's the beginning of a history. So the way I can do it, and we don't have to do it now, but we can do it with all of you in whichever fashion, section by section. You know, what are the kinds of things that are missing? Is it likely we'll get them in the next two months? That's the way I would look at that question, rather than do we have all the documents from Oak Ridge? Does that make sense? DR. ROYAL: Yes. I mean, I have some specific things in mind like the Green Run document. MR. GUTTMAN: We can answer that. Duncan and Nancy can -- CHAIRMAN FADEN: You know what? We'll go to that. Why don't we go to that one, but I think that it might not be a bad way, whether we take committee time or we do it by way of a memo from -- MR. GUTTMAN: Actually, we could do that very quickly. What would be useful probably -- I can do a memo, you know, over the weekend which will go through the report outline -- CHAIRMAN FADEN: And say where we are, where we would like to be. MR. GUTTMAN: Where the gaps are, where are the kinds of things I'd like to find, and what the likelihood, you know, not the specific answers but the kind of -- you know, not what the answer but whether -- that kind of thing. CHAIRMAN FADEN: That would be helpful, I think. MR. GUTTMAN: Yes, that can be good. CHAIRMAN FADEN: We'll appreciate seeing that. I think that -- I mean, Jay needs -- raised a question, and I don't think we have a sense. Should we just -- PROFESSOR KING: I didn't think I should speak, since I haven't changed my views from early on, which has been get this report out when it's due and not seek an extension, and I don't have any reason to change my mind about that. Now I could rehearse a lot of reasons with you again, but I would say that the political situation makes me feel even more strongly than I did before that the likelihood of an extension is next to nil. I can't see it. I mean, I just -- unless we were able to demonstrate that we were onto something that was really important and terribly critical that we knew was in hand, and we actually could project we needed another month or another six weeks. We're not sort of in that kind of situation, it seems to me. I hate doing a useless act, and I don't think one wold be granted nor do I think an additional request would be welcome, particularly. If we're thinking about lowering taxes and cutting budgets, extending the life of this committee and the money we spend is not high on a list of priorities. CHAIRMAN FADEN: Phil? DR. RUSSELL: I agree with Pat. I think we would be running a great risk of having a very incomplete, hastily written report if we bet on the possibility of an extension. If you say that risk is way too big to take, and I believe it is, then the best strategy is to start now and get draft material put together for a committee reaction as quickly as possible, recognizing that we're going to have to wait until the end of the game to put the final analysis in and to write the evaluations of the ongoing studies. We have to overlap the -- write what we can write and then fill in the blanks as we get to the end. I think that's the only strategy that we can -- I think that's the strategy that is most likely to lead to the best possible report. CHAIRMAN FADEN: Eli? DR. GLATSTEIN: I agree. I think the chance of us getting an extension isn't worth going to the two dollar window for. We need to get going. CHAIRMAN FADEN: Jay, what I'm hearing is not a -- is the sense that we ought to try, and that's, clearly, then what we're going to do to get this project completed by the timetable that we've discussed, since the report would come out in May. To do that, that means we need -- This is a terrible thing to do, but it seems like there's no alternative. We need to start seeing drafts of the final report, obviously not the whole drafts, but sections of it, beginning right away, so that there's something to look at in January and something to look at in February. It will be an iterative process of response and reactions from the committee and, as staff finalizes the corresponding section in the companion volume, going back and maybe fleshing out or making more rich the treatment in the report. Then can we adopt the terminology of the report and companion volumes, so when we say report, we mean the report, and then other things are the companion volumes? Yes, Ruth? DR. MACKLIN: This is just a procedural question, the answer to which I believe I know, and that is, from the standpoint of being able to make efficient and detailed comments on drafts, it would be wonderful if they could be on E-Mail, because you can interlineate and do a lot of things on E-Mail in less time than it takes to scribble and go in the margins and go all other kinds of cutting and pasting. However, from my experience, and Jeff can attest to this, on more than one occasion from our repeated failures to send documents rather than just E-Mail messages, it may not be doable, especially those of us who don't -- Well, if we're on different systems. Whatever the failure is on our inability to transfer files and documents rather than just write messages to one another, which we can do very readily, but I'm just wondering if there's a way of exploring it and doing it, if feasible. CHAIRMAN FADEN: Why don't we make that a-- We'll try to figure out a system, and it's going to be problematic. Some people are on E-Mail. Some people are not. Then there's the issue of Ruth sends an E-Mail -- DR. MACKLIN: Well, look, it's only for those who are, I mean now, obviously. CHAIRMAN FADEN: Right, but it's a matter of you send an E-Mail message. Someone who is not on E-Mail might want to see it. PROFESSOR KING: What about on a disk? Would that help you, Ruth? DR. MACKLIN: No, because the idea of being able to suggest changes in a document and do it through the E-Mail -- MR. GUTTMAN: These are the kind of details -- CHAIRMAN FADEN: We have 10 more minutes together, everybody together. I appreciate -- We'll take it on as a challenge to figure out how to come up, and we'll screw it up, and then we'll come up with a better way of doing it, and we'll probably screw it up again, but we will try to figure out a way to facilitate the process whereby committee can give feedback to staff and committee to colleagues and all this kind of stuff. I saw Jay and Henry. DR. RUSSELL: I was just going to say that I installed Lotus Notes on a MacIntosh at work, and I can access all of the stuff at the committee office, and Lotus Notes runs on an IBM over the Internet, and I would suggest that anyone who is interested in ready access look into that mechanism. CHAIRMAN FADEN: It works. Jay? DR. KATZ: Very briefly. We have little time, and I promise you, this is the last time I will bring up that issue, and I now bow to the will of the majority, and we will finish by May. I think, and in case I need to repeat that we are making a mistake, I don't think we should second guess the political process. Who knows what will happen. We might be turned down, but if we feel strongly about going against the current, then we should try -- then we should have tried, so called politically, our peace notwithstanding. We cannot be second guessed. In the light of the discussions we've had in the last few days, in particular, I know that we will write a good report. I mean, it has to be a good report, because the material that we have doesn't allow for our not writing a good report, however much we might even try to the contrary, but at the same time, the complexities of the issues and the differences amongst us, and substantial difference amongst us, that we possibly could resolve not completely to a considerable amount of and to considerable expense over the next four months. I think that opportunity, particularly with respect to what to recommend for the future, that will most likely, to my mind, elude us. To that extent, it will not be as good a report as it might have been, but maybe by -- But be that as it may, we've made a decision. CHAIRMAN FADEN: Jay, I think you're points are well taken. I can't tell you how torn I am on this point. It's a very tough one. DR. KATZ: I know. CHAIRMAN FADEN: Let's go. DR. KATZ: And the next thing. CHAIRMAN FADEN: We'll go, and we'll see. We have now fifteen minutes. Duncan, you have to leave. Can you or can Nancy or both of you real quickly just tell us what happened with respect to the Department of Defense? DR. THOMAS: I think I can do it in about a minute and a half. Nancy and I, together with three of the staff members, attended a meeting at the Pentagon on Wednesday afternoon, at which we were provided with a fully declassified version of the Green Run document, with the exception of about 20 words. Those 20 words that remain classified concern the identity of a particular military unit and certain individuals which, for reasons that were well explained to us -- There is compelling reason why they ought to remain classified, and are really quite irrelevant to our purpose anyway. I can also add that there is really no major bombshells in the new material which was recently declassified. As it was explained to us on several occasions before, the total amount that had been classified amounted to maybe a total of about a page and a half, and is largely technical details about instrumentation and things that are again of no particular concern to us. If you want, I can read the couple of sentences from the introduction which do shed light on the purpose of Green Run or you can just wait and read it for yourself. It's now public document. It can be made available to anyone. CHAIRMAN FADEN: Well, we will now all have the new version of the document with the now lifted available text. I should indicate to you that I think that in the January meeting we will give over a block of time to intentional releases. So maybe then would be the discussion we can get into detail about. Now what do we do know about the Green Run, and how are we going to get this document inside that, but that's very helpful. I just want to express my appreciation to Nancy and to Duncan and to the members of the staff who went. This is not a fun -- You know, no one likes to do this sort of thing. Ruth? DR. MACKLIN: You don't have to read it now. I just want the answers to our two fundamental questions. Does this material answer the questions, however brief -- Does it answer the questions that we had that were unanswerable about who ordered it and why was it ordered? DR. THOMAS: Actually, we spent quite a lot of time discussing this point. In brief, no, the documents don't really answer that. As I say, the couple of sentences sheds a little bit of additional light, but basically not things that we didn't already know about from other sources. So the thrust of the investigation now is what other sources, either documentary or people that we ought to be interviewing, might ultimately answer those questions or will those questions never be answerable? Staff is still continuing to pursue that line. CHAIRMAN FADEN: Nancy? DR. OLEINICK: Let me just add one other thing. We did ask the question also in terms of what -- could such a release happen today, and Gordon Soper felt, at least from what he knew, that chances are the answer to that was no. However, they are going to look into whatever regulations and whatever documentation they would have that would shed some light on that issue. We don't really have any documented answer to it. MR. GUTTMAN: The specifics are that we know there are, from Mark and Patrick's inquiry to DoD, classified, Secret environmental impact statements. I think, Nancy and Duncan, what they are looking into is do those black box environmental impact statements, say in the last five years, the period we gave them, ten years, include things that are radiation releases. Ruth has said maybe it should be a broader question, but they are apparently prepared to look into that for us. CHAIRMAN FADEN: We will give over a chunk of the January meeting to where we are with respect to intentional releases, using the chapter now on unintentional releases, to try to get that going and maybe get a draft of it, see what we can do, see where we can fill in the gaps. Susan, and then I want to let Mary Ann and anybody else who has a comment. DR. LEDERER: May I just ask, Nancy, is that an answer that we're likely to get? DR. OLEINICK: I don't know. I don't know the answer to your question. I don't know whether we're going to get an answer or not. When we posed the question, Gordon Soper asked -- I don't remember the name of the gentleman that came into the room at that point, but he asked somebody who sounded like he was knowledgeable on the regulatory -- DR. THOMAS: He asked one of the guys who deals with the special access, the real secret program. DR. OLEINICK: And he was going to look into it, whether there was any documentation on -- you know, classified or otherwise, as to whether there were releases going on or whether there was even the possibility. We've asked the question. I think he understood the question, what our concerns were; but whether we're going to get an answer or not, I have no idea. I guess the staff will follow up on it. CHAIRMAN FADEN: We'll keep watch on it. It's an important question. I mean, to me, that's the most important question. DR. LEDERER: Right, because it goes to recommendations that we would want to -- CHAIRMAN FADEN: Oh, absolutely. I mean, it's the number one question. Whether we're going to get an answer, I don't know. MR. GUTTMAN: We can -- It's remarkable from the staff's and now Nancy and Duncan have asked it -- It's remarkable that there don't seem to be a whole lot of people you think would know the answer off the top of their head who know the answer. That's the thing that's interesting. CHAIRMAN FADEN: That's right. Maybe it's classified. Who knows. MR. GUTTMAN: Right. Yes. CHAIRMAN FADEN: We don't know, but we'll work on it, and we will certainly make a priority of updating everyone on this issue in January. We can get clear on that. Henry, is it on the Green Run point? DR. ROYAL: Yes. CHAIRMAN FADEN: Go ahead, and then we'll go to Mary Ann. DR. ROYAL: Even if we knew that there was a policy saying that there couldn't be secret releases now, that doesn't give me great confidence; because tomorrow they could make another policy that said we can do releases. I don't -- These policies on -- MR. GUTTMAN: Well, one of the things that staff is looking at which will be the subject is this practical, real world question, such that, while people are operating good in faith now, presumably, it isn't clear there are institutional mechanisms. For example, to be very specific, EPA technically is supposed to be overseeing the DoD's secret process. Mark will, hopefully, with Patrick have some information about whether that's an actual, real world practice above and beyond the policy. CHAIRMAN FADEN: I think it still goes to the force of what we could do. Even if we don't know, we can certainly articulate what we think should be. We'll see how that goes. Mary Ann, you've been very patient. You may yet have the last word. DR. STEVENSON: This almost feels like a non sequitur, but it's going back to Dan's conceptual overview. One thing that I thought wasn't completely acknowledged or maybe acknowledged at all is it will be some talk about the uncertainty or lack of knowledge that they had then about the biological effects of radiation. I mean, clearly, a lot was known, but an awful lot wasn't known, and still isn't known, as a matter of fact. I think that's something important that the public needs to know about in the final product, especially because, really, in practical terms the scientists were often setting standards at the same time they were collecting data to determine what those might be. MR. GUTTMAN: I can lay your concerns to rest, and let you all know that Gil is responsible for that part of the work. CHAIRMAN FADEN: Eli? DR. GLATSTEIN: I think what you say is right, Mary Ann, but at the same time, every time a new drug comes out, you can say the same thing. We think we know a mechanism of action. You find out five years later that it's a different mechanism of action. You find out five years later there's additional side effects. Our knowledge is always -- you know, got some limitations on it. DR. STEVENSON: No, I absolutely agree, but I think that you don't want to leave a perception that the scientists were omniscient, and they just metered out what they wanted the public to know and kept what they didn't. I mean, there may have been some of that, but there may have been some real lack of knowledge and ignorance, and they were being pushed by the pressures of the Cold War and the pressures of the government to develop the nuclear weapons industry, and they just had to jump in and find out later whether they could swim. I mean, I think there has to be some acknowledgement of that. DR. GLATSTEIN: I think that's true, but at the same time, I think the astonishing thing, to me, is their guesses and estimates -- DR. STEVENSON: Were very good. DR. GLATSTEIN: -- were right on the money. DR. STEVENSON: I agree, but I think you still have to acknowledge that, and I think also it has to be acknowledged that the debate of the effects of low dose radiation is still going on today. I mean, that is still a debate. You know, what's going on in that small section between zero and whatever you want to take as your top threshold. I mean, that is still not a decided issue today, and that has to be acknowledged as well. DR. LEDERER: Well, let me ask Dan and Ruth, is that a feature of the public understanding section? MR. GUTTMAN: Well, yes. To me -- DR. LEDERER: Sort of the process of how medical knowledge is generated? MR. GUTTMAN: Well, this whole question of sort of what I call backdoor ethics regulation, because you're talking about the risk part and the benefit part of the ethics equation. So here are the scientists going along and saying the -- this is what we're talking about. The Isotope Allocation Committee may have no clue or interest or whatever about consent, but their focused quite directly on risk and benefit. DR. LEDERER: Right. MR. GUTTMAN: Then Gil, of course, is one of the country's only experts, leading experts, in this question of, well, where do these numbers come from. Right? Do they come from the rad experiments? Do they come from plutonium experiments? Do they come from six guys in a room saying we need a number for the General? Right? DR. LEDERER: Right. MR. GUTTMAN: Gil, do you have any comments? CHAIRMAN FADEN: Wisely, Gil will reserve his comments for his carefully crafted, written response. So we'll see, but I think -- My response to what you say, Susan, is yes. I mean, that's that fourth missing piece. MR. GUTTMAN: It's in the outline under this whole question of Item -- I can show you exactly where it is. It's Science Standards, D, Part 1-D. It may not be clear, but that's sort of the place. CHAIRMAN FADEN: Well, are there other -- I think we have the agenda for next -- for January pretty much lined up. Can I just get a sense of the group? This amount of time for committee discussion, I take it, is desirable, that we want to have lots of time for us to talk and for staff to talk with us? DR. MACKLIN: Are you referring to the extended hours? CHAIRMAN FADEN: No, no. I wasn't asking about that. I'm not giving you a choice on that one. I meant the fact that we noticed we had almost no presentations in the past two days or very limited ones, and that was in response to comments from several of you saying we now need to be talking to each other and not merely absorbing and listening and reacting. I'm getting a sense -- I'm taking it that that is a satisfactory shift, and that we will need to continue with that model of running the committee. DR. MACKLIN: But I think, though, the one thing that maybe was missing -- I mean, I agree, we didn't need as much presentation from staff as we had in the past on the material that was in the briefing book, I mean just a brief introductory comment or two. I also think we didn't need all the subcommittee reports each time, but as the questions asked near the end, particularly as we are drawing our work to a close or have to do so, questions about the status of various projects are critical. So, I mean, although it wasn't on the agenda, just a brief update -- where is the subject interview project? Where are we in the oral history project and the research proposal, since we're all sitting here waiting for the proposals to begin arriving? I mean, I happen to know where we are on that, but I mean, a question was raised to me, too. So I think, at any meeting at which there are projects where the work of the whole committee or members of the committee who haven't been on one of the subcommittees are affected by it, I think we should just have an update; you know, where are we, what's happened. I mean, as you said, we sent out the letters, and now we're at this point or at that point. So that -- I mean, if there are any things like that, and the ones that I mentioned are probably the projects for which it would be useful to have that information in January. PROFESSOR KING: And I have only one special plea. I think it's inherent in a lot of things I was saying, and that is, I do think that we need to deliberate and that everything that comes to us - not everything. The things that you want us to deliberate about, if they're in a form that points us in the direction of shaping how we are thinking about answering before we get here while we go through the materials, or at least the points we want to raise in the discussion, it would be very helpful rather than in a more neutral, so that we can start thinking analytically and moving toward some kind of decision for ourselves, as well as for the committee. CHAIRMAN FADEN: Okay. Are we ready to close? We're ready. Dan, could you close the meeting? MR. GUTTMAN: As the apparently designated Federal official, I hereby declare the meeting -- the last meeting for the year closed. CHAIRMAN FADEN: Oh, that's right. Happy New Year. Happy Holidays. (WHEREUPON, the meeting of the Advisory Commission on Human Radiation Experiments was adjourned at 4:27 P.M.) - - -