UNIVERSITY OF CINCINNATI MEDICAL CENTER FACULTY COMMITTEE ON RESEARCH FORM FOR DONATION TO A NAMED RECIPIENT OF A HUMAN ORGAN OR PART BY A LIVING DONOR I,_________________________________ of ____________________ (name of donor) (street address) _______________________________, _______________________, (city) (state) do hereby evidence my consent to donate to _____________________________, an organ or part of my body, (name of recipient) namely, __________________________ to be transplanted into the body of _______________________. (name of recipient) I further consent to and authorize the University of Cincinnati through its Department of Surgery and the physician and surgeons designated by and acting for it to perform the necessary operational procedure to accomplish the removal of said _________ ___ of said physicians and surgeons the operational procedure necessary for the accomplishment of my donation and the consequences of me thereof and of such donation as follows: I further certify that I am over the age of 21 years and that I am (unmarried, married) and that the name of my (wife, husband) is ______________________________. I hereby also consent to the practice upon my person of such other medical procedures, although not now contemplated, which in the judgement of the attending physicians is deemed medically advisable due to the development of unforeseen conditions. I acknowledge that no guarantee or assurance has been made as to the results that may be obtained. I hereby assume any and all risks involved with the above described procedure and waive all claims for liability except for negligence, on the part of the medical personnel involved, the University of Cincinnati, its Hospital and its Medical School, which might have otherwise inured me or my heirs, successors and assigns as a result of the involved medical procedure. Dated Time: Witness: Donor: Witness: Page 2 donation to Named Recipient The undersigned, being the (wife, husband) of the above __________________________ (name of donor) does hereby certify that __he has read and understands the above statement made and consent given by said _________________________________ (name of donor) and that the consequences to ________________________________ of the operation and the (name of donor) removal of the ________________________________________ (organ or part to be removed) have been satisfactorily explained to the undersigned who consents to such operation and removal for the purpose of transplanting the __________________________________________ (organ or part to be removed) into the body of (name of recipient) Dated: _____________________________________________ Time: ______________________________ Witness: ________________________________________________ (wife, husband) of Witness: _______________________________________________ (name of donor) NOTE: Copy to Donor, Research File, and Patient's Chart. January 25, 1972 The individuals -- David Logan, Henry Anna, and Martha Stevens -- issuing A Report to the Campus Community today are acting on their own and not in a way duly authorized by the Junior Faculty Association. The JFA membership has not had an opportunity to read and to vote on the report as currently worded. The JFA has not authorized in principle a report with the type of conclusions or judgements included in this report. I as Vice President of the JFA have been denied (by the President, David Logan) the opportunity of a delay and a meeting to have these matters challenged by the membership. Some of the questions in the report are ones which should b e asked and some of the information is relevant. Overall, however, the report should be judged in the context of the above information. Vice President Junior Faculty Association A REPORT TO THE CAMPUS COMMUNITY Since last October a committee of the Junior Faculty Association of the University of Cincinnati has been investigating the radiation experiments at the University Medical Center. We have interviewed doctors involved, and we have studied with care the reports of the research team to the Defense Department, as well as the team's publications on radiation in medical journals, and many other pertinent documents. Our committee has had extensive help from members of the medical community. For reasons that we will present below, we have come to the conclusion that many patients in this project paid severely for their participation and often not even knowing that they were part of an experiment. We feel that the evidence clearly calls into question the manner in which these human experiments were designed and carried out. We therefore urge the president of the University to terminate this project and to instruct the Medical Center to cooperate fully with the congressional hearings to be held next month. We are addressing ourselves in this report to what we believe to be the three most crucial questions to be asked about this project: (1) Was cancer study the main object of the experiments? (2) What were the real risks to the patients? (3) Did the patients give their informed consent to being used as experimental subjects? To begin with, we have been unable to find any evidence of a planned, systematic cancer study. It seems unlikely that the team would not have mentioned, somewhere in the 900 pages of the Department of Defense (DOD) reports, the fact that they were conducting the DOD project in conjunction with a specific cancer research study, had this indeed been the case. Nor has the team made public, even during the recent monthS, a design for cancer study in any way comparable to the detailed proposals for, DOD radiation studies, proposals which have been repeatedly and painstakingly modified and amplified over the eleven years of the project. We also point out that there is no evidence in the DOD reports that any patients were irradiated before the beginning of the DOD project in February 1960; the two projects research on cancer and research on radiation injury (if indeed there were two), seem to have been coterminous. or partial body radiation as cancer treatment. One of the doctors, Dr. Edward Silberstein, wrote to the chairman of the JFA committee last November 14 as follows: I hope I made clear to you on Monday that we have not yet published the results of therapy because of the variable duration of patients' clinical course with cancer following treatment and the need to have an adequate sample of patients before one makes any statements about the efficacy of one's therapy. Since I am limited to treating 7 or 8 patients at a time, I cannot, as a responsible scientist, issue claims about what we can do therapeutically for patients over a short period of time. Is it conceivable that in an authentic cancer research study,no results would be reported after eleven years and the radiation of 87 patients -- indeed after 10 or 20 -- would this in itself not be worth communicating to other cancer specialists? We also question why, if this were a serious study of the effects of radiation on cancer, so few autopsies were performed. We can only conclude that the purpose of irradiating cancer patients at General Hospital was Primarily to study radiation injury for the DOD and that incurable cancer patients were used because (a) they were going to die anyway and (b) they "might" benefit from the radiation in terms of reducing pain or slowing the spread of cancer. We move now to the question of the real risks to the patients, and the effects on them of the radiation. We begin with this crucial statistic: of the 87 irradiated subjects whose histories are given in the DOD reports, 21 died within 38 days or 24%. What is even more serious is that of the first 40 patients given total body radiation before the advent of bone marrow transplants, 7 of the 18 deceiving the higher doses (150 or 200 rads) died within 38 days or 39% That the higher doses were much more lethal than the lower doses is clearly borne out by the fact that of the 22 patients receiving 100 rads or under, only 10% succumbed within the 38 day period. The full statistics on this early period of the project. As we have abstracted them from the reports, are as follows: First 40 total-body subjects (1960-66): Of those receiving 200 rads, 2 of 6 died within 38 days Of those 150 rads, 5 of 12 died within 38 days Of those 100 rads, 1 of 14 died within 38 days Of those under 100 rads, 1 of 8 died within 38 dyas 150 rads or over: 7 of 18 under 150 rads: 2 of 22 Of the total 87 patients, it may be added that 4 died within 10 days, 7 within 20 days. These statistics are all the more alarming when one juxtaposes them with the doctors descriptions of the patients at the time of radiation. Throughout the DOD documents the doctor's report that though all their subjects are patients with incurable cancer they are not in the final stages of disease or close to death. Patients as a group are described over and over again as having "relatively good nutritional status" "normal renal function, and "stable hemograms." We offer this sentence front the DOD report of 1969: "The patients who are irradiated,' all of whom have inoperable, metastatic carcinoma but are in relatively good health, provide us with an opportunity to study multiple facets of the effects of radiation in man rather than in experimental animals," (page l). In the 1970 report the doctors write: Several of the subject's were tumour-free and essentially normal (following radiation-induced tumour regression) receiving prophylactic whole- body radiation. The rest had metastatic carcinomas which were inoperable and not amenable to conventional chemotherapy. Nevertheless, these patients were all clinically stable, many of them working daily. (1970, page 2) Even of the group described above, 2 died within a month-- one on day 31 and one on day 22. In regard to possible benefits, we assume that any benefits that would balance out these enormous risks would have to be very plain and dramatic. Yet this is not at all the case. The American College of Radiology (ACR) team stated that about a third of the patients reported a decrease of pain (the medical histories show, by the way, that some patients had an increase of pain following radiation) and a greater sense of well-being" and that a third had decrease in primary tumor size. Dr. Saenger has said that he feels the statistics for long-term survivors--a small number of patients lived several years after radiation-will show that total and partial, body radiation is "promising" as cancer treatment. but even that much is clouded by (a) the fact that many subjects received other kinds of therapy before or after radiation and (b) the fact that the Saenger team used no control group. The doctors state in the later DOD reports that they are carrying out their experiments in conformity with the Helsinki Code (which dates from 1964); yet the code clearly states that the health of the patient must always be the first consideration in trying out new kinds of therapy: I.4. Every clinical research project should be preceded by careful assessment of inherent risks in comparison to foreseeable benefits to the subject or to others But let us assume for the moment that those we address are not convinced, even by the number of short survivors plus the patients conditions at time of radiation, that many died of radiation injury rather than simply from their disease. There is yet another kind of evidence that radiation injury was a major cause of death. It has been known for some time that a major injurious effect of radiation is bone marrow failure. The bone marrow's ability to make white and red blood cells can begin to fail as early as 6 days post radiation; the critical period for marrow failure then comes from 25 to 40 days post radiation. In summarizing in 1966 the marrow problems for their first fifty patients, the doctors themselves make the following statement: "The total white count falls to a low point 25 to 40 days after irradiation. There was a persistent lymphopenia which persisted for 40 to 60 days" (page 31). Can it be merely a coincidence that the short survivors are bunched in, exactly that critical 25-40 day period? -- that, for instance, no loss than 9 subjects died from 31-38 days? In this same 1966 report, in fact, the doctors state outright that "severe hematologic depression was found in most patients who expired," and they note that because of this, they are beginning work on bone marrow transplants--far too late, in our opinion. In the 1963 report, they write that "Delineation of disease score (a rating for blood problems), radiation score (the rating adjusted after radiation and total continued to be of value in ascribing the importance of radiation in precipitating demise" (page 9) A distressing aspect of the doctors public disclosures about this project has been their misleading statements concerning the protection given the patients by bone marrow transplants. It has not been made clear that of the first 50 patients only 2 received transplants and that neither of these transplants was a clear success (the first subject died, in spite of the infusion, 28 days post radiation). The team from the American College of radiology reported that it felt the research team could not be censured for not giving bone marrow transplants during the early years for the simple reason that the technique had not then been perfected. But since the doctors could not protect the patients from bone narrow failure were they justified in giving the higher doses of radiation? Among those first 50 patients we point out again, 7 of the 18 high-dose subjects did not live beyond 38 days. Why did the doctors not discontinue high dose radiation as soon as they began to lose patients from bone marrow failure? It is perfectly clear that in the first six years of the project, the less radiation given the better the patient was likely to. It has, in fact, only been within the last year or so that the doctors have had much success with the transplants; it is still not completely clear that bone marrow transplants offer a certain way of protecting all patients. We move now to the third question: Did the patients give their informed consent to being used as experimental subjects? We note to begin with that during the first five years of the project no consent form seems to have been used at all; none is mentioned in the DOD reports for these years, and the absence of written consent is corroborated by the ACR. In fact, it is clear from the DOD reports that during theme years the doctors were not attempting to justify the radiation as experimental cancer treatment but simply as "therapy" or "palliation treatment," as it is in these words that the radiation is constantly described. Patients seem to have been told nothing except that the radiation was part of their treatment. Over and over again in the reports we find such lines as these: The patient is told that he is to receive treatment to help his sickness. (1961, page 3) The patient is told that he is to receive treatment to help his disease. (1963, page 4) In 1965 a short consent form was initiated, but it made no mentiCn of specific risks from radiation injury, merely asking the patient to state that "the risks involved" and "the possibility of complications" had been explained and that "the special study and research nature of this treatment has been discussed with me and is understood by me." For what the patients were told we have only the doctors word. Another form, used as late as December 1970, states the risks as follows: "The chance of infection or mild bleeding to be treated with marrow transplant, drugs, or transfusion as needed," and the first line of that form reads as follows: I, the subject) being of the age of majority and of sound mind and body, voluntarily and without force or duress, consent to participate in a scientific investigation which is not directed specifically to my own benefit, but in consideration for the expected advancement medical knowledge, which may result for the benefit of mankind. The latest consent form, a revision of the above made last spring and signed by only a handful of patients, includes under "Risks", a long paragraph regarding bone marrow problems and alters the lead sentence to read "not only directed specifically to my own benefit, but also in consideration for the expected advancement of medical knowledge. It is a very unhappy fact that it was this last.form, only in use for a few months, that Dr. Edward Gall, director of the Medical Center, chose to release to the newspapers. This form was printed entire in the Cincinnati Post, with a statement saying it was signed by "every adult patient" of the project. In our view none of the consent forms properly states the real risk to the patient -- that is the risk of death from bone marrow failure within 40 days. We feel, in fact, that no conceivable consent form, particularly in view of the subjects' low level of education, would have justified the doctors in subjecting the patients to the higher doses of radiation. In conclusion, we want to comment on the recent report by the American College of Radiology, which finds nothing whatever to criticize in these experiments and urges that they be continued. We are confident that this report will not be taken seriously by anyone properly informed about this project. The ACR omits from their report the more damaging statistics on patient survival. The only statistic they give is as follows: "A group of 10 per cent or eight patients died from 20 to 60 days after the whole body exposure." We find 14 total-body subjects who died within this period (not to mention 5 partial body) -- or 23%, and of course this figure takes no account of the 7 subjects who died within the first 20 days. The ACR doctors contribute, in other words, to the deceptive impression that the main side effects from radiation were nausea and vomiting within the first few days. As for the special committee appointed by the president, we regret very much that the existence of such a committee was dept secret for so long and that even today the names of the committee members have not been revealed. It has been impossible for us, or any other party interested in the project or having special information about it, to communicate with the committee. We hope that even in this unpromising context, however, the committee will seriously address itself to the real questions surrounding this project and will make a recommendation that we all can support. The Junior Faculty Association committee has not been secret, and we have asked in the campus newspaper for the assistance of all interested parties. We also succeeded finally in having a full set of the DOD reports made available in the reference room of the UC library for all to inspect, and all are invited to check our facts and figures in these public documents. We are confident that those who examine the evidence for themselves will join with us in urging the president to terminate this project and to assure the public that the Medical Center will make a full disclosure of all the facts at the congressional hearings. printed at JFA expense