plained this to him, he might have said, well, you know, go ahead and do it. But with him not knowing, no. He was a man that loved his wife and he loved his family, and he would have wanted to spend as much time as he had left with his-with my mother. Because he hated-did he not want to leave her behind. That was his one main thing of getting better; is he did not want to leave her behind. Mr. PORTMAN. Just one specific question. It relates to the letter he wrote to your sister, Isabell. He says in the letter that the doctor is not giving out the right news to the family. Chairman Bryant talked about the timing of this. I understand this is in relation to the initial operation that never took place. But how did you read that? Does that mean that he thought the doctors were trying to mislead the family, or that the doctors just didn't have good news for the family concerning his condition? Ms. HAGER. What he didn't know was the doctors were not telling the family anything. The doctors did not tell us about the operation that he was going to have. The doctors never told us anything. This letter that my sister showed me, she showed me the week we had the meeting with David Mann. Í knew no idea of this letter. I could have told him, dad, the doctors are not telling the family nothing. We know nothing. They are not keeping us informed at all. I asked the nurse every night I left his room, I would make it a point to go to the nurse's station and say, if my father gets worse, please call me, no matter what time, call me, because I want my mother there, and I want to be there. We lived 10 minutes from Cincinnati General Hospital. I never received one phone call, nothing. When my dad passed away, my brother made a trip to the hospital. He found him in a private room. When we left him the night before, he was in a ward. We left him; they let me stay there that night until 9:30, quarter to 10, to be with him. When my brother went back the next day, he was in a private room. He said, my father was in a private room-my dad was in a private room. I said, your dad has never been in a private room. But they moved him when they know that he was dying. But they never picked up the phone and they never called me to let me know that my dad was dying. And I begged them to let me know. Two days before he died, he begged me to bring him out of that hospital. He said, they are not doing what is right with me. Take me home. And the nurse pulled me aside and said, just agree with your dad, go along with what your dad said, because he can't go home. And I had to leave him. They didn't do what was right by my dad and by any other patient that was in there connected with this treatment. They were wrong. They know they were wrong. And it is about time they stand up and they say they were wrong. Mr. PORTMAN. Thank you, Ms. Hager. Mr. BRYANT. On behalf of the subcommittee, I would like to thank each of you for coming forward and giving us a personal angle on this whole matter and taking the time to take off in the middle of the week and come up here and let the subcommittee see exactly how this has impacted your individual families. I thank each of you for being here. Mr. BRYANT. At this time we would like to ask the second panel to come forward, which consists of Dr. Gordon K. Soper, Principal Deputy to the Assistant to the Secretary for Atomic Energy in the Department of Defense; Dr. James Cox, professor of radiotherapy, M.D. Anderson Cancer Center, and chairman, Radiation Therapy Oncology Group; and Dr. Joseph Steger, president of the University of Cincinnati. Dr. Steger, you are also accompanied by Mr. Stan Chesley, correct? Mr. STEGER. Yes. Mr. CHESLEY. I am here as counsel, Mr. Congressman, Congressman Bryant, just here as an assistant, to assist Dr. Steger in any way I can. Dr. Soper, please proceed. Mr. BRYANT. Dr. Soper, can we begin with you? STATEMENT OF DR. GORDON K. SOPER, PRINCIPAL DEPUTY TO THE ASSISTANT TO THE SECRETARY FOR ATOMIC ENERGY, DEPARTMENT OF DEFENSE Mr. SOPER. Thank you very much, Mr. Chairman, members of the subcommittee. I am Gordon Soper and I represent the Department of Defense at this hearing. With me are two of my colleagues from the Department of Defense. Capt. Robert Bumgarner, Medical Corps, U.S. Navy, is the Director of the Armed Services Radiobiology Research Institute and is an expert in military medicine. It may also be useful to hear from Col. John Fraser Glenn, who is an expert on the Federal, Department of Defense, and Army's rules on human use experimentation. You have already commented on the extensive effort the administration is conducting to uncover the facts surrounding past radiation experiments. I can only tell you, the Department of Defense pledges to you our unqualified commitment to a thorough and complete search of all of the records. My purpose today is to provide you with a summary of the role that the Department of Defense played in the human radiation studies conducted at the University of Cincinnati from 1960 to 1972. My report to you is based upon reports, files and documents that we have been able to locate from wide and varied sources. Most of the official Department of Defense records were retired and then destroyed long ago as part of the normal regulatory instructions for disposal of contract files. And as such, what I am going to tell you or summarize for you is not newly uncovered information. The entirely unclassified University of Cincinnati studies have been extensively reported in the open literature. They have been a subject of peer review, review by the American College of Radiology, congressional hearings, and as all of you know, a series of news articles starting as far back as 1971; all of these reviews have in one way or another addressed the Department of Defense's involvement. Now these studies will be further reviewed by a blue ribbon advisory committee on human radiation experiments, which was just recently established by President Clinton. This committee is composed of eminent scientists, physicians, legal experts, and medical ethicists; and their purpose is to advise and guide the Government on the larger questions of ethical and scientific standards of any Government-sponsored experiments which involved the intentional exposure of humans to ionizing radiation. A major goal of what we have been doing in DOD is to retrieve as many of the records as we possibly can of all DOD involvement in human experimentation, particularly that of the University of Cincinnati, and to provide a complete record of this to the advisory committee for their review. I would like to give you a brief summary of the Department of Defense support to this research, and for those of you who are interested, a more detailed chronology is attached to my submitted testimony. As you all know, in September 1958, Dr. Eugene Saenger of the Department of Radiology, University of Cincinnati College of Medicine, as the principal investigator, submitted what was called an unsolicited proposal to the Research and Development Division of the Army Surgeon General's Office; and as you have already stated, the application proposed to research metabolic changes in humans following total body irradiation, so that we could develop a simple urine or blood test to detect how much radiation an individual had received. This unsolicited proposal was reviewed over the next year within the Department of Defense, and the available remaining documentation reveals that at least five Army Medical Corps officers reviewed the proposal and recommended approval of the contract application. In October 1959, staff elements of what we call the Defense Atomic Support Agency recommended that they negotiate a contract with the University of Cincinnati for the study. So in early 1960, I think it was the first of January 1960, a contract was entered into between the Defense Atomic Support Agency, now called the Defense Nuclear Agency, and the University of Cincinnati board of directors. The contract provided $25,058 for the initial study, and over the contract period-there were three separate contracts-between 1960 and 1971, a little more than $650,000 was spent on this effort. Let me say just a few words about the reason for the Department of Defense involvement. The search for a biological marker of radiation exposure was one steadfast aim of the University's research for the Department of Defense over the life of these contracts. And I will also say that the results of the research contributed in a general way to a better understanding of the influence of radiation exposure on the combat effectiveness of military personnel, and it provided a more suitable method for diagnosis, prophylaxis and treatment of radiation effects on the nuclear battlefield, a very fearful possibility at that time. Department of Defense funds were used for laboratory studies and psychological and psychiatric tests of cancer patients that received this whole or partial body radiation for treatment of their disease. No Department of Defense funds were used for direct pa tient care, nor did the Department of Defense play any part in patient selection or their choice of treatment. The University of Cincinnati submitted 10 reports to the Department from 1961 to 1972; they are a part of the record. I have provided a copy of these reports to your offices along with other relevant documents in our possession. Certainly, in reviewing these materials, Mr. Chairman, we at DOD can understand the controversy that arose in the early 1970's and continues to this day. Some of the records, as Congressman Mann said, especially from the viewpoint of 30 years later, are troubling and raise understandable concerns. Examples include statements in the University's early progress reports to the DOD that only nonradiosensitive tumors were selected for the research which some see as an indication of nontherapeutic purpose. Some see the inadequacy of the informed consent procedures. On the other hand, for example, in 1972 the American College of Radiology concluded that the research was validly conceived and carried out, the patient selection conformed with good medical practice, and that consent procedures complied with applicable standards. We in the Department do not at this point seek to resolve these apparent contradictions. Our main focus, Mr. Chairman, is to compile as complete a record as we can, make it available to the President's Advisory Committee and to the public for their study. Today, DOD-supported research is governed by the so-called common rule the Federal Policy for Protection of Human Subjectsand a copy of this regulation is attached to my statement. DOD is a full partner in the Government's commitment to this standard. Under these regulations, today, a proposal like that from the University of Cincinnati in 1958 would require much more supporting documentation and justification to be considered for funding support by the Department of Defense. During the course of these hearings, perhaps I could have the opportunity to expand upon this point more thoroughly. So, Mr. Chairman, I have given you a very top-level summary of what we know so far. We are continuing to track down further information. We sincerely appreciate the openness of the University of Cincinnati in sharing with us their records. We appreciate the local press sharing their records with us also. This hearing will also be a contribution to the knowledge-gathering process. We agree, in the Department of Defense, with the need to air once again the issues surrounding this early chapter of our Government's human use research. Our sincere goal is to pull together as complete a record as we can of our involvement and provide it to the President's Advisory Committee for their detailed study and ultimate release to the public. Thank you for your attention, sir. Mr. BRYANT. Thank you. [The prepared statement of Dr. Soper follows:] 84-514 094 - 2 STATEMENT GORDON K. SOPER, PRINCIPAL DEPUTY SUBCOMMITTEE ON ADMINISTRATIVE LAW CINCINNATI, OHIO APRIL 11, 1994 Mr. Chairman and Members of the Subcommittee, I am Gordon Soper the Principal Deputy in the Office of the Assistant to the Secretary of Defense for Atomic Energy. I am here to support your request of March 24th to conduct hearings on radiation experiments performed by the University of Cincinnati Medical School which were funded in part by the Department of Defense (DoD). If I may, Mr. Chairman, I'd like to provide a prelude to my testimony in order to put our efforts into context. Since early January, when the White House called for the formation of a senior level Interagency Working Group to coordinate the government-wide effort to uncover the nature and extent of any government sponsored experiments on individuals involving intentional exposure to ionizing radiation, the Department of Defense has been engaged in an extensive effort to discover the facts surrounding DOD sponsored human radiation experiments. It goes without saying that the Department takes this action seriously, that it has the complete support of Secretary Perry and that we pledge to you our unqualified commitment to a thorough and complete search of all available records and the full public release of the pertinent information in those records. As Dr. Harold Smith, the Assistant to the Secretary of Defense for Atomic Energy, and the DoD focal point for this action, testified to you at your February 2 hearing on this subject, the retrieval of records is a discovery process requiring time intensive "detective work"--we are well into that process now and beginning to make excellent headway. I would be glad to take any questions that you might have regarding the Interagency Working Group process and the results we have obtained so far. With that as background, I'd like to provide you with as complete a report as I can on the role that the Department of Defense played in the human radiation experiments conducted at the University of Cincinnati College of Medicine from 1960-1972 which were led by the principal investigator, Dr. Eugene L. Saenger, MD. My report to you is based on documents, reports and files that we have thus far been able to locate from wide and |