The Cincinnati Radiation Experiments were a series of total and partial body irradiation tests performed on at least 90 patients with advanced cancer at the Cincinnati General Hospital, now University of Cincinnati Hospital, from 1960 to 1971. Led by radiologist Eugene L. Saenger, the experiments were funded in part by the Defense Atomic Support Agency within the Department of Defense to study how soldiers in nuclear war would be affected by large doses of radiation. The experiments were conducted without patient consent in the first five years of the study and with disputed levels of consent thereafter. The irradiated patients experienced nausea, vomiting, cognitive impairment, and death. Twenty one patients died within one month. The contract between the researchers and the DOD terminated in 1972 under pressure from Senator Edward Kennedy, marking the end of major human irradiation experimentation in the U.S. that began after World War II and continued throughout the Cold War Era.
Although initially fading from public eye, the controversy resurfaced in 1993 and was soon investigated by President Bill Clinton's Advisory Committee on Human Radiation Experiments. In 1994, families of the patients filed a class-action lawsuit against the team of 15 researchers. Five years later, the University of Cincinnati settled the case for over $4 million.
Experiments and controversies
Department of Defense funding On September 25, 1958, Saenger sent a grant proposal entitled "Metabolic Changes in Human following Total Body Radiation" to the Department of Defense, requesting $25,085 to analyze the amino-aciduria levels in the urine of total body irradiated patients. Although multiple military researchers, including the Director of the Division of Nuclear Medicine and Chemistry, wrote to the US Army Medical Research and Development Command that they doubted the practical value of Saenger's proposed study, the DOD approved the grant proposal due to its possibility of evaluating the combat effectiveness of soldiers in nuclear warfare. The initial grant proposal evolved into an 11-year contract, in which the DOD provided a total of $671,482.79 in funds. Detailing the progress of the experiment were a series of 10 progress reports sent to the DOD from 1960 to 1972, the first five of which were entitled "Metabolic Changes in Humans Following Total Body Irradiation" and the last five "Radiation Effects in Man: Manifestations and Therapeutic Efforts." The irradiation experiments only began after the DOD funding was received, with the first known experiment occurring on May 24, 1960.
There is controversy regarding how the DOD funds were allocated. Saenger maintained that while the DOD funds were used to buy irradiation equipment, run laboratory tests, and hire personnel, only University funds directly financed the patients' irradiation treatment. However, the Advisory Committee on Human Radiation Experiments held that without the DOD funds, Saenger could not have begun the irradiation tests.
Military purpose As part of the DOD contract, the radiation experiments attempted to imitate nuclear wartime conditions in order to accurately evaluate the cognitive and physiological effects of radiation on a soldier. During irradiation, patients' bodies were positioned to mirror a soldier's defensive position; the radiation was intended, but not proven, to be administered unidirectionally to reflect a soldier's exposure; and the irradiation was administered all at once, which diverged from the standard medical practice at the time, where cancer patients were given small doses cumulatively to maximize destruction of cancer cells. Even so, in the progress reports sent to the DOD and in his testimony to the Subcommittee on Administrative Law and Governmental Relations in 1994, Saenger maintained that the primary goal of the study was to provide palliative and therapeutic care to the patients. According to Saenger, the study of radiation effects on a soldier's performance was a secondary goal.
Patient selection The patients were referred to Dr. Saenger's experiments by the Cincinnati General Hospital's Tumor Clinic. All the patients had advanced stage cancers, including breast, lung, colon, pancreas, skin, sinus, ovarian, lymph, cervical, rectal, liver, stomach, esophagus, bowel, tongue, brain, tonsil, rectum, intestinal, and bone cancers. Although they were all cancerous, Saenger sought patients that were in good nutritional health, and who had not been exposed to previous radiation treatment.
The patient selection process was the subject of another controversy. David Egilman, a doctor practicing in Massachusetts at the time, criticized the patient selection and irradiation processes in a statement to the Advisory Committee on Human Radiation Experiments, writing that many of the cancers were radio-resistant and could not have been treated effectively without killing the patient. On the other hand, the American College of Radiology, after sending representatives to Saenger's laboratory during the irradiation experiments, concluded in a 1972 peer review that the patient selection process and the experiments as a whole "conformed with good medical practice."
Health effects The experiments administered between 25 and 300 rad of Cobalt-60 total body and partial body irradiation, comparable to 20,000 chest x-rays, within hours. There were also plans to increase the radiation dosage to 600 rad. In addition, bone marrow was occasionally extracted prior to the irradiation and later reinfused in an effort to alleviate the debilitating health effects of the radiation.
The irradiated patients experienced a wide variety of side-effects: nausea, vomiting, diarrhea, emaciation, hemorrhaging, fatigue, cognitive impairment, and hallucinations. In the first month 21 patients died. 1/4 of the patients died within 2 months of irradiation, and over 3/4 of the patients died within a year. In his testimony, Dr. Saenger maintained that assessing the direct contribution of the irradiation to the mortality rates is impossible due to the variety of health factors acting as confounding variables: prior chemotherapy treatment, localized radiation treatment, and the advanced stage cancer itself. He claimed that the cancer was the primary factor in the patients' deaths, and that the irradiation had palliative benefits for 31% of the patients.
Consent forms From 1960 to 1965, no written consent forms were used in the experiments, in accordance with the requirements of the Cincinnati General Hospital; the Department of Health, Education, and Welfare; and the Department of Defense. In April 1965, the patients were given consent forms that, according to Dr. Saenger, appropriately discussed the dangers of the irradiation. However, David Egilman claimed that these forms did not mention any relevant side effects of the irradiation.
In 1969, the National Institutes of Health evaluated the Cincinnati General Hospital's ethical practices, prompting Saenger to adopt a new consent form outlining the purpose, procedure, and risks of the irradiation tests to the patients. Even so, no consent form used mentioned possible death.
During the 1994 trial, family members of the patients alleged that the researchers forged certain patients' signatures on the consent forms.
Researchers
Dr. Eugene L. Saenger Dr. Edward B. Silberstein Dr. Bernard S. Aron Dr. Harry Horwitz Dr. James G. Kereiakes Dr. Harold Perry Dr. Ben I. Friedman Dr. Thomas Wright Dr. I-wen Chen Dr. Robert L. Kunkel Dr. Louis A. Gottschalk Dr. Theodore H. Wold Dr. Goldine Gleser Dr. Warren O. Kessler Dr. Myron I. Varon
Patients
Statistics Although only 89 patients have been identified, medical records indicate that at least 90 patients were involved in the experiments. Moreover, the progress reports sent to the DOD suggest that 10 additional individuals were irradiated whose treatments were not included in the medical records.
Approximately 43% of the known patients were female, and 57% male.
The average age of the patients was 59, but three children aged 9, 10, and 13 were also irradiated.
To see a list of the 89 identified patients, see Appendix 1 of The Treatment: The Story of Those Who Died in the Cincinnati Radiation Tests by Martha Stephens.
Socioeconomic status The average patient had 5 years of formal education, with an average IQ of 89. 62% were African-American, and the majority were working class. A report published in 1972 claimed that the socioeconomic status of the patients matched the general makeup of the Cincinnati General Hospital.
Institutional review (1958–1972) From the initial budget proposal in 1958 to 1966, the University of Cincinnati had no institutional review boards (IRBs) that evaluated the ethical practices of the Cincinnati Radiation Experiments, and IRBs were not formally required by law for government-funded research until 1974. In 1966, however, the University created the Faculty Committee on Research (FCR) in compliance with an order from the US Public Health Service,Egilman, David (1998). A Little Too Much of the Buchenwald Touch? Military Radiation Research at the University of Cincinnati, 1960-1972. India: Overseas Publishers Association. p. 88. an IRB that conducted multiple reviews of the experiments' proposed research protocols.Egilman, David (1998). A Little Too Much of the Buchenwald Touch? Military Radiation Research at the University of Cincinnati, 1960-1972. India: Overseas Publishers Association. p. 89.
In March 1966, Dr. Saenger proposed an additional research plan called "Protection of Humans with Stored Autologous Marrow" in an effort to expand his research to investigate the palliative effects of bone marrow extraction and reinfusion. While the FCR initially deemed the plan inadequate for not properly informing the patients of potential risks of the treatment, a revised proposal in 1967 entitled "The Therapeutic Effect of Total Body Irradiation Followed by Infusion of Stored Autologous Marrow in Humans" received varying levels of approval by the members of the FCR. Dr. George Shields claimed the mortality rate of the experiments at that point in the experiments (25%) was too high, stating that if the proposal was to be approved, the patients would have to be explicitly told of the "1 in 4 chance of death within a few weeks due to treatment."Egilman, David (1998). A Little Too Much of the Buchenwald Touch? Military Radiation Research at the University of Cincinnati, 1960-1972. India: Overseas Publishers Association. p. 90.Shields, George. Letter to Dr. Edward A. Gall. March 13, 1967. University of Cincinnati Interdepartmental Correspondence Sheet. Other members of the FCR such as Dr. R. L. Witt and Dr. Edward P. Radford recommended approval of the study only under the provisions that the researchers clearly outline the therapeutic goals and palliative likelihood of the experiments.Radford, Edward. Letter to Dr. Edward A. Gall. April 29, 1967. University of Cincinnati Interdepartmental Correspondence Sheet.Witt, R. L.. Letter to Dr. Edward A. Gall. May 9, 1967. University of Cincinnati Interdepartmental Correspondence Sheet.