Part 10 (2/2)

Around the time that Eugene Saenger, a young radiologist at the University of Cincinnati, went to listen to a talk given by General James c.o.o.ney, he was beginning to wonder if his medical career was ever going to amount to anything more than doing barium enemas and diagnostic X rays.1 Thanks to the Atomic Energy Commissionas aggressive radioisotope distribution program and its concomitant public relations program, nuclear medicine was becoming a hot field, and Saenger was eager to get in on the action. He had taken a training course on radionuclides at the Oak Ridge Inst.i.tute for Nuclear Studies, where he had learned how to pipette, ahow to dilute, how to count,a but he felt sure there was more to nuclear medicine than that.2 Then he heard the presentation by General c.o.o.ney, one of the nationas foremost experts on atomic energy. Perhaps c.o.o.ney talked that day about how the power unleashed by the atom could be harnessed to cure the ills of mankinda”one of his standard themes as he barnstormed the country in his role as cheerleader for the atom. Whatever he said, Saenger was impressed. He was soon to do his two years of military service and wondered if c.o.o.ney might be able to help him find a placement that would take advantage of his training. Afterward he went up and introduced himself.

aListen, Iad like to [get] into some of this nuclear energy stuff when I get into the Army,a he told the general.3 aSaenger,a the general snapped, ayou come and see me.a When Saenger joined the Army Medical Corps in 1953, he took c.o.o.ney up on his word and visited him. I was treated as if aI was king of the mountain,a Saenger remembered.4 aHis secretary knew I was coming and they made a big fuss, and we became very good friends, the c.o.o.neys and my wife and I.a Saenger was first dispatched to Sandia Air Base in Albuquerque, New Mexico, the field command for the Armed Forces Special Weapons Project. Although Saenger had no interest in attending a weapons test (ayou get all this crud coming down your neck, to me it was uselessa), he did get a good introduction to abombology.a5 Six months later he was transferred to Brooke Army Hospital in San Antonio, where he was made chief of the Radioisotope Laboratory. Saenger remained at Brooke, the Armyas leading burn research center, until he was discharged in 1955. While Saenger spent only two years in the Army, he maintained his military connections for the rest of his life.

After his tour of duty was over, he returned to Cincinnati, a sprawling city on the banks of the Ohio River that has the feel of a sleepy southern town but resembles Detroit. Located across the river from Kentucky, Cincinnati historically has been a major connecting point between the North and South. With some 2,000 industrial plants, the city has long been a destination for poor whites and African Americans from southern states. Racial tensions have occasionally run high, and in 1968 the city exploded in riots following the a.s.sa.s.sination of Dr. Martin Luther King Jr.

Handsome and confident, Saenger had strong ties to the medical school and the city itself. Except for his two-year military stint and four years as an undergraduate at Harvard, Saenger has lived his entire life in Cincinnati. His uncle was the medical schoolas first professor of radiology, and Saenger worked in his lab when he was young. After receiving his medical degree in 1942 from the University of Cincinnati College of Medicine, he went on to do his interns.h.i.+p and his residency at Cincinnati General Hospital, becoming a board-certified radiologist in 1946. Saenger later directed three or four campaigns that raised millions of tax dollars for the hospital. His asmall expertise,a6 he once confessed in a letter to Los Alamosas Wright Langham, was apolitical rather than scientific.a In 1955, the year Saenger was mustered out of the Army, he began preparing a research proposal to study the effects of total-body irradiation on cancer patients. Saenger probably learned of the militaryas interest in TBI when he was in the Army. But his proposal was also fueled in part by the chairman of the pediatrics department, who made the offhand comment one day that no radiologist had ever done any decent scientific research. aThat really upset me.7 That really annoyed me. I have never forgotten that,a Saenger told staffers from the Advisory Committee on Human Radiation Experiments. aI sort of thought, dammit, Iam going to show people I know how to do something, not that itas been very momentous but itas kept me interested.a Saenger had also learned from one of his close friends, John Lawrence, the brother of Ernest Lawrence, that it was better to get contracts than grants. aWe were on a boat one time in Florida and we were talking about grants and contracts and I said to him, aThese grants are really sort of a pain.a8 He said, aYou mean to tell me youare still going after grants?a I said, aJohn, what should I be doing?a He said, aContracts, my boy, contracts.a And it was very interesting because a contract would run forever.a In 1958, Saenger submitted his application to the Research and Development Division of the Army Surgeon Generalas Office.9 The Army seemed like a alogical source of funds,a Saenger told interviewers, because of its interest in the effects of radiation on humans. General c.o.o.ney also happened to be the deputy surgeon general at that time.

The year that Saenger submitted his application, the United States and the Soviet Union had just agreed to temporarily halt atmospheric testing of atomic weapons largely because of strong opposition to fallout. Within eighteen months, though, the troops and the cloud samplers would be back in Nevada and the Pacific Proving Ground for another season before the aboveground tests were finally halted for good.

According to Saengeras original application, ent.i.tled aMetabolic Changes in Humans Following Total Body Radiation,a one of the chief goals of his proposed study was to find a biological dosimetera”the goal that for all practical purposes would elude most of the researchers who ever pursued it, to the great frustration of their military sponsors. Saenger stated that he intended to use well-nourished adult males with widespread cancer and exclude women of child-bearing age because their amino acids fluctuated too much during the menstrual cycle.10 Defense Department officials who reviewed Saengeras application had mixed feelings about his proposal. James Hartgering, a former Armed Forces Special Weapons Project official who was privy to many of the high-level discussions on troop maneuvers at the Nevada Test Site, said he did not believe Saengeras research would yield anything useful but felt the experiment should be supported anyway. Hartgering wrote, aThere are so few radiologists in the country willing to do total body radiation that those that are should be encouraged more.11 His past research experience has been good and I feel that he is a very reliable investigator. If he is supported I am sure he will soon decide that some other phase of the radiation program should be investigated and switch to this.a Arthur Sullivan, another scientist, believed Saengeras experiment would aaugmenta the TBI studies under way at Baylor and Sloan-Kettering and might lead to a apossible biological dosimeter.a12 Only one Army official, Colonel John Isherwood, chief of radiological services, suggested Saengeras work might have a potential benefit to the patient. aAny correlation of tumor response to total dose of irradiation by such means as prepared by this project would be of great value in the field of cancer.13 In addition if by means such as those proposed accurate knowledge of the total dose of radiation received could be determined it would be of inestimable value in case of atomic disaster or nuclear warfare.a The first of several contracts between the University of Cincinnati and the Defense Atomic Support Agency, AFSWPas successor, was signed in early 1960. Saenger headed the TBI project, but he scrupulously avoided choosing the patients who were to be irradiated, leaving that task to others. The first patient who received total body irradiation was a sixty-seven-year-old African American with cancer of the left tonsil.14 The disease had spread to his palate and throat. He received 66 rads and died seventy-three days later. Over the next eleven years, some eighty-nine additional patients were administered TBI.

In the ten reports that Saenger submitted to the Defense Atomic Support Agency or its successor, he says almost nothing about the therapeutic effects of TBI on the cancer patients. aThese studies,a he wrote in his first report, aare designed to obtain new information about the metabolic effects of total body and partial body irradiation so as to have a better understanding of the acute and sub-acute effects of irradiation in the human.a15 In his second progress report, he added, aThis information is necessary to provide knowledge of combat effectiveness of troops and to develop additional methods of diagnosis, prognosis, prophylaxis and treatment of these injuries.a16 Saenger has said he did not include information in his progress reports on the positive medical effects of the TBI because the military was not interested in that portion of the study.17 The total-body irradiation was administered to the apatients for palliative purposes,a he said. In other words, the treatment would not cure the patients but it might shrink their tumors, reduce pain, and possibly extend their lives. However, no written protocol has been found showing that palliation was the primary purpose of the study. Furthermore, Saenger and his colleagues did not publish a scientific report comparing the benefits of TBI to other cancer treatments until 1973, a year after the study had ended and the experiment had received widespread negative publicity. In Saengeras 1973 paper, he states that whole-body radiation and partial-body radiation had some abeneficial effectsa in controlling certain advanced cancers and that its palliative effects compared favorably with those induced by other drugs.18 Saenger initially planned to start with doses of 100 rads, gradually increasing exposures to 150, 200, 250, 300, and finally 600 rads. Like s.h.i.+elds Warren, Saenger was aware that individuals varied greatly in their response to radiation exposure and that some people might die at the higher doses without therapeutic intervention. In a handbook on radiation accidents published three years after the study began, Saenger wrote: Fatalities may begin to occur at 200 rad and possibly approach 50 percent at 450a”500 rad.19 Statements such as these involving percentages serve to emphasize the factor of individual sensitivity which may be of the greatest importance. One man, for instance, may show prostration resulting from a dose of total body irradiation of, say 100 rad, whereas another man may show no appreciable disability.

Saenger never exposed any patient in the Cincinnati study to the higher doses he had proposed in his initial report to the Pentagon. According to Defense Department records, the largest dose of total-body irradiation administered to any one subject appears to have been 200 rads, with a few patients receiving 300 rads of partial-body irradiation.

In a 1962 memo ent.i.tled aAn Appraisal of Human Studies in Radio-biological Aspects of Weapons Effects,a Saenger brought up the possibility of using ahealthy volunteersa in his experiment. aOnce patients from the therapy group are being managed so that their hematologic consequences of radiation have been controlled then it will be advisable to utilize a less ill, more normal group of individuals for study.a20 However, there is no evidence that he went ahead with any plan to irradiate healthy people.

Ultimately, the Defense Atomic Support Agency contributed a total of $671,000 toward the Cincinnati study. Saenger has emphasized repeatedly that the funds were used to pay only for the observational data and extensive laboratory tests. The military was not involved in the choice of patients, doses, treatment, or care. Cincinnati General Hospital spent some $483,000 of its own funds on patient care.21 As in other TBI studies, researchers specifically sought patients with radioresistant tumors who had a stable blood picture and normal kidney function.22 That profile, of course, closely resembles that of a healthy soldier or nuclear worker and would enable scientists to hunt more easily for a biological dosimeter and conduct their psychological tests. But TBI is generally not used for such tumors. Indeed, a year before the study began no less an authority on the subject than s.h.i.+elds Warren himself had written in Scientific American: aRadioresistant tumors are generally not treated with radiation because the damage to surrounding tissue is too great.a Efforts were made to exclude patients who had already received local radiation or chemotherapy in order not to confound the results. Like the School of Aviation Medicineas Herbert Gerstner, the Cincinnati group early on recognized that patients already exposed to radiation suffered more deleterious effects the second time around.

All the patients enrolled in the TBI experiment had widespread cancer, but many were still leading relatively normal lives. In their report for the first year of the experiment, Saenger and his colleagues wrote, aOur patients of course all have incurable and/or metastatic cancer, and although in reasonably good clinical condition, cannot be considered as normal.a23 Later progress reports stated that the subjects were ain relatively good health,a aclinically stable, many of them working daily,a and able to aperform activities of daily living.a242526 Following a long tunnel with overhead, exposed pipes that wound its way through the bas.e.m.e.nt of Cincinnati General Hospital, the patients arrived at the irradiation chamber. Inside was a Cobalt 60 Teletherapy Unit, surrounded by several feet of lead. The experimental subjects were homemakers, seamstresses, maids, salesmen, carpenters, and clerks. Sixty-two percent were African American. Most were poor or had such low-paying jobs they could not afford private physicians. Many had very little formal education.

The patients were led into the room where they were placed in a sitting position 282 centimeters, or about nine feet, from the source.27 Their legs were raised and their head tilted slightly forward. Half the exposure was delivered laterally through one side of the body. Then the patient was turned and the remaining radiation delivered. The treatment usually took one-half to one hour.

Toward the end of the eleven-year study, Saenger informed the Defense Department that he hoped to expose some patients with a blast of radiation from one direction. aWhenever possible unidirectional radiation will be attempted since this type of exposure is of military interest.a28 David Egilman, a physician and professor at Brown University and longtime critic of the experiment, maintained the crouched position and aunidirectionala radiation closely resembled how soldiers would be exposed on the nuclear battlefield. There is no evidence, however, that the unidirectional radiation was given, pointed out R. Joseph Parker, Saengeras attorney.

The subjects, of course, did not feel anything while the radiation was being delivered. But Saenger acknowledged in his 1973 paper that the exposures could have initiated the hematologic form of the acute radiation syndrome in some patients.29 Bone marrow failure is the cause of death in this syndrome, but many other organs of the body are also damaged. In his handbook on radiation accidents, Saenger compared the acute radiation syndrome to a viral infection or an illness caused by chemical poisoning.30 In the aprodromal phasea of the acute radiation syndrome, nausea, vomiting, weakness, and fatigue usually begin several hours after exposure. These symptoms subside two or three days later and then the patients enter a latent period in which they generally feel no symptoms. The latent period lasts about twenty days. Then acute illness sets in. Many symptoms occur during this perioda”vomiting, diarrhea, abdominal pain, fever, disorientation, shock, hemorrhagea”but one of the most dangerous symptoms is infection. This danger period lasts about thirty to forty days, and then recovery usually begins. If exposures are high enough, the various stages of the acute radiation syndrome can be compressed, with the latent period disappearing altogether.

Saenger said in his 1973 paper that the TBI could have contributed to the death of eight patients if the disease and effects from previous therapy were excluded.31 A University of Cincinnati faculty committee that reviewed the experiment later found nineteen patients died between twenty and sixty days after the TBI treatment and acould have died from radiation alone.a32 *

One of the first patients to receive 200 roentgensa”a dose that both s.h.i.+elds Warren and Eugene Saenger said could produce fatalitiesa”was John Edgar Webster, Patient No.33 021, a country musician and custodian at an elementary school. He was examined by doctors at Cincinnati General Hospital in April 1962 and diagnosed with bowel cancer that had spread to his left lung. Several weeks later he returned to the hospital to receive the amiraclea treatment that family members thought would cure his cancer. After the so-called cure, Webster planned to take a trip to California to see his eldest son. aMy mother was extremely excited after hearing the news of this newly discovered treatment,a Websteras granddaughter, Peggy Carboina, said in written testimony to a congressional subcommittee.34 On April 28, 1962, Webster became the third patient bombarded with 200 rads of total-body irradiation.

Webster had a severe reaction to the TBI. He could not get out of bed following the treatment. Nor could he keep down food or water. He began to lose weight rapidly. aHe would cry due to such pain. We heard him pray that G.o.d would take him so the pain would stop,a his granddaughter remembered. Chest X rays showed an invasive substance in the lung that appeared to be either tumor or pneumonia. aHis course was progressively downhill, and he expired June 3, 1962 (36 days post TBR),a a Defense Department report states.35 Websteras relatives told medical officials they did not want an autopsy performed, but years later they discovered that an autopsy was done anyway.

Another patient who had a severe reaction was Patient No. 045, Maude Jacobs. She was a beautiful blond woman who radiated happiness despite a life of severe hards.h.i.+p and continual poverty. Born in Hazard, Kentucky, she was orphaned at ten, married at the age of twelve, and had her first child at thirteen. She washed windows, cleaned houses, and did other peopleas laundry. Her formal education ended after third grade, but she struggled to teach herself how to read and write.

In the summer of 1964, the doctors at Cincinnati General Hospital diagnosed Jacobs as having breast cancer that had spread to the bone. She was forty-nine years old and had seven children, six girls and one boy. Chemotherapy helped the primary tumor, but the bone cancer continued to spread. aI donat think the doctors noes [sic] what is wrong with me,a she said in a letter to her sister, Arlie, two months before her death.

One day Jacobs forced her swollen feet into a pair of dress shoes and took a taxi to the hospital. There she was irradiated with 150 rads. She began vomiting immediately and continued to vomit for the next twenty four hours despite a dose of antinausea medication. aShe went out of her mind,a said daughter Lillian Pagano.36 Jacobs regained her sanity briefly when the priest came to administer last rites. They prayed together and then he asked her, aAre you ready to meet the Lord?a She responded, aYes, I am, Father.a According to a Defense Department report, Jacobs had a normal blood count prior to the treatment.37 Seven days after she was irradiated, her white blood cell count began falling. The platelet count began to fall fourteen days later. She grew short of breath, her heart started to gallop, and chest films showed a diffuse infiltrate in the left lower lung and collapse of the right lower lung. She was started on antibiotics and other medications but nothing helped. She died December 2, 1964, twenty-five days after the total body irradiation had been administered.

Jacobsas death came so suddenly that she was unable to make arrangements for her children. Three of her youngest were sent to an orphanage. Family members said they were never informed of the TBI treatment. aMy version of this is they burned her alive,a Lillian Pagano said. aThey killed her. They actually took part of her life away.a For Grey Spanagel, Patient No. 077, death also came soon after irradiation. Spanagel had throat cancer and had already undergone two surgical procedures and two localized radiation treatments. Nevertheless, he was still working and walking every day when Cincinnati doctors recommended that he be given total-body irradiation.38 Spanagel drove himself to the hospital for the treatment.

He was irradiated with 200 rads on November 9, 1967. Prior to the procedure, some of his bone marrow was removed and stored. Two days after irradiation, the bone marrow was infused back into his body. Spanagel tolerated both the TBI and bone marrow procedure well and was sent home the following day. Twenty days later his blood counts began to fall. aHis condition continued a downhill course,a the doctors wrote, aand on Dec. 9, 1967, he expired, thirty-one days post TBR.a39 Spanagelas wife, Madge, told The Cincinnati Enquirer that she and her husband were informed by doctors in separate interview sessions that the treatment was for the throat cancer. The doctors never told them the results might be used to help soldiers on the nuclear battlefield, she recalled.40 In quiet laboratories far from the day-to-day horrors of the cancer wards, Saengeras team of researchers painstakingly studied urine and blood samples from the patients. Some of the serum was s.h.i.+pped to an Army researcher in Fort Knox, Kentucky. The samples were scrutinized for biochemical changes caused by the radiation. When the researchers could not find a reliable radiation marker in the urinary amino acids, they began studying antibody responses, chromosome abnormalities, and other biochemical and cellular changes. Saenger said many years later that he might have moved on to something else if he had found a clear biological dosimeter in the first ten to twelve patients. aWe kept being on the edge of finding what we were looking for so we kept on treating the patients.aa41 The patientsa nausea and vomiting were carefully observed. Saenger said the military wanted the information not because ayou fall down and vomit and have a fit and become confused and all that, but that your judgment would be impaired, that you couldnat fly the plane through the cloud or you couldnat make it all the way through the cloud and back and so on.a42 The patients were not given antinausea medications for up to three days following the total-body irradiation, a procedure that critics said was consistent with a military experiment but not appropriate for patients undergoing therapy for a disease.

In order to avoid tainting the data, hospital staffers were instructed not to discuss any possible side effects with the patients. aThe patient is told that he is to receive treatment to help his sickness.43 There is no discussion of subjective reactions resulting from the treatment.a Certainly withholding information is not consistent with the principle of informing patients of the possible consequences of their treatment.

Saenger told a congressional subcommittee that he didnat tell the patients of the possible side effects to avoid provoking the symptoms through the power of suggestion.44 aWe found, as I think many of us observe in raising children and so on, if you ask leading questions, you very often elicit responses, particularly for things which are somewhat suggestible such as nausea and vomiting.a The patients were given antinausea medication if they acomplained,a he added.

Often the patients were moved to a private room after irradiation so that their mental state could be better evaluated. Whatas more, the doctors told their military funders, athere are no other patients receiving radiation therapy with whom the patient can exchange experiences.a45 These psychological studies were another important component of the experiment and became more elaborate as the years went on. Tests were administered to measure the patientsa depression, hope, denial, and pessimism. Brief interviews were conducted before and after irradiation and then ascoreda for cognitive dysfunction. Many of the patients were so sick after they were irradiated that they could not complete all the testing. Herb Varin remembers his mother, Nina Cline, complaining about the constant barrage of questioning. aI tell them Iam feeling terrible but they just want to talk to me,a Varin recalled his mother saying.46 The psychological research was pertinent to the military, the Cincinnati doctors wrote, because of the way TBI affected thought processes: Following exposure to acute whole or partial body radiation it is possible that there will be significant impairment of the decision making capability of key personnel who have major command responsibilities.47 This concern has become more important in recent years since the findings that complex electronic systems can be rendered inoperative by very high doses of radiation. Thus it is necessary to maintain dependence on the human being. It is quite possible that even moderately high doses or dose rates could produce impairment of cognitive processes either of an obvious or of a subtle nature which in moments of stress would impair or defeat a military operation. In order to gain understanding of such possible changes it is necessary to seek changes in cognitive processes and decrease in the capability to perform highly technical processes.

The Cincinnati doctors were aware of the life-threatening dangers of TBI, the military reports reveal. Only one year into the study, Saenger and colleague Benjamin Friedman hypothesized that sick patients may be aunusually susceptiblea to radiation. aWe have had two cases, one at 150 and one at 200 rad, expire while manifesting the hematologic abnormalities of group III of the acute radiation syndrome,a they remarked in their 1962 paper to the Defense Atomic Support Agency.48 A progress report summarizing the first five years of the experiment noted that asevere hematologic depression was found in most patients who expired.a49 In the same report, the doctors observed, aSeveral of the patients have had the manifest illness stage of the acute radiation syndrome.a50 Ten of the patients died within thirty-seven days following treatment.a For the report period ending April 30, 1967, the doctors wrote that amarked hematological depression occurred in all eighteen patients who received more than 125 rad total body radiation.a51 And finally, in 1969 the Cincinnati group remarked that under one cla.s.sification system used to describe radiation injury, four of eleven patients who received 200 rads of TBI awould have been cla.s.sified as having sustained avery severea injury; three aseverelya injured and five only amoderatelya injured.a52 Saenger and his colleagues in the early to mid-1960s began to prepare facilities that would allow them to do autologous bone marrow transplants, a procedure in which some of the patientas bone marrow is withdrawn before the irradiation and returned to the body after the treatment is done. The Cincinnati doctors hoped the procedure would prolong the lives of patients whose bone marrow was severely damaged by the radiation exposures they were administering.

Five years were to pa.s.s before the doctors succeeded in performing their first successful bone marrow transplant. In the meantime, they continued to administer high doses of total-body irradiation and partial-body irradiation to numerous patients without the supporting bone marrow transplants. In 1969, just two years before the program was terminated, the physicians admitted, aIn view of the life threatening hematologic abnormalities we have encountered in patients receiving 150a”200 rad (226 to 336R) total body radiation, marrow storage is felt to be mandatory.ay At the time, the process of withdrawing the marrow and reinfusing it back into the patients was itself extremely risky. The subjects were placed under general anesthesia for one and a half to two hours while about a pint of marrow was aspirated from sites in the hips and sternum. The marrow was put into storage and then infused back into the patientsa veins after the TBI treatment. From there the marrow traveled through the bloodstream to the red bone marrow cavities, where it produced new cells.

According to Defense Department or university records, thirteen patients received bone marrow transplants. Margaret Bacon, an eighty-year-old woman who had been diagnosed with bladder cancer and did not want radical intervention, suffered a stroke when she was anesthetized for the bone marrow removal procedure on June 4, 1969. The doctors, apparently unaware of the stroke, proceeded to give her 150 rads total-body irradiation the same day and she died six days later.5354 The informed consent procedures went through a series of changes over the eleven years of the project. Between 1960 and 1964, the hospitalas general consent form for all medical and surgical procedures was used. Members of Saengeras team said the patients were verbally informed of the nature of the experiment and asked for their agreement to partic.i.p.ate in the project.55 The first written consent form for the TBI treatment came into use in 1965. The doc.u.ment contains no specifics on what exactly the patients were told: aThe nature and purpose of this therapy, possible alternative methods of treatment, the risks involved, the possibility of complications and prognosis have been fully explained to me.56 The special study and research nature of this treatment has been discussed with me and understood by me.a The doctors submitted the bone marrow portion of the project in 1966 to the Faculty Committee on Research, which had been created the previous year to oversee human experimentation at the medical center. aThis work,a physician-investigator Benjamin Friedman explained to the Faculty Committee, ais considered to be of vital importance not only for improving the survival of patients with far advanced cancer but for the survival of the citizens of this nation in the event of nuclear warfare or a major peacetime radiation accident.a57 Its avital importancea notwithstanding, the projectas protocol drew harsh criticism from several university reviewers. One doctor, George s.h.i.+elds, withdrew from the subcommittee studying the proposal because of close professional and personal ties with the investigators. In his withdrawal notice, s.h.i.+elds recommended the study be disapproved because of the high risks. aThe radiation proposed has been doc.u.mented in the authoras own series to cause a 25 percent mortality,a he said.58 The consent forms, he advised, should also contain a statement that aa 1 in 4 chance of death within a few weeks due to treatment, exists, etc.a He added: The third purpose, ato determine whether autologous bone marrow therapy may play a role in treatment of bone marrow depression following acute radiation exposure in warfare or occupationally induced accidentsa is not the subject of this experiment because normal individuals are not being tested. It is problematic whether the information gained in this study will apply to normal individuals following acute radiation exposure. Therefore it is my definite opinion that the third purpose of this experiment would not justify the risk entailed.

Another member of the review committee, Thomas Gaffney, also questioned the wisdom of expanding the TBI study given its aconsider able morbidity.a59 Gaffney was also highly critical of the study design and predicted that the experiment would not yield meaningful data: When this deficiency in experimental method is placed next to their previously observed poor result and high morbidity with this type of treatment in a avariety of neoplasmsa I think it is clear that the study as proposed should not be done. I have the uneasy suspicion, sh.o.r.ed up by the revised statement of objectives, that this revised protocol is a subterfuge to allow the investigators to achieve the purpose described in their original application; namely to test the ability of autologous marrow to atakea in patients who have received high doses of total body radiation. This latter question may be an important one to answer but I canat justify 200 rad total body radiation simply for this purpose, aeven in terminal case material.a Despite the reviewersa reservations, the experiment was allowed to proceed. Another thirty to thirty-five patients were irradiated before the experiment became public and was terminated four years later. Edward Radford, one of the faculty members who sat on the review committee, recalled that the panel was a little intimidated by Saenger. aWe hadnat thought through the whole moral mora.s.s quite as thoroughly as people have now,a he told a reporter.60 aAnd Dr. Saenger was irate. He said, Who are these guys telling me how to do my research?a He was still living in the period when the doctor was G.o.d.a The consent forms underwent two more revisions. In a 1967 form, the patients were informed that the experiment might not benefit them but could advance medical knowledge awhich may result for the benefit of mankind.a61 They also were informed that the risks of TBI included the achance of infection or mild bleeding to be treated with marrow transplant, drugs, or transfusion as needed.a The third and final consent form, which came into use in 1971, went into greater detail but still did not disclose that the patient might die from the procedure: aa if you receive a dose of 200 rads or more, which your doctor will tell you, your blood counts will fall to levels where infection or bleeding could be a problem.62 The bleeding can be treated by transfusion of red cells and platelets and the infection by antibiotics. In addition, we prevent such low blood counts with the use of a bone marrow transplant which will be discussed with you in a separate voluntary consent statement.aa In the later years Saenger and his coresearchers said they began a two-day consent process. The TBI treatment was explained to the patient during the first day. The consent form was signed on the following day after the patient talked the matter over with his or her family.

The militaryas oversight of the experiment was virtually nil. Occasionally military representatives would visit Cincinnati and Saenger would show them around, but no specific suggestions regarding the research were offered. During the last six years of the experiment, Saenger was a consultant to a medical advisory committee established by the Defense Atomic Support Agency, the very organization that was funding his project.63 In 1969 the National Inst.i.tutes of Health declined to fund the experiment on aethical grounds.a The NIH again declined to fund the experiment in 1973. Despite the rejections, Donald Chalkley, described in press reports as the NIHas aethics watchdog,a later praised the Cincinnati experiment, noting that it had promised to be aa significant addition to our armamentarium against metastatic cancer.a6465

36.

THE CHAMBERS OF OAK RIDGE.

Woodrow Wilson Litton felt perfectly healthy when he was admitted for the first time to the small research hospital in Oak Ridge, Tennessee.1 His dark eyes and black hair gleamed with vitality and he had the loose, graceful frame of an athlete. He was forty-one years old, a materials dispatcher at one of the uranium production plants, and had missed only three days of work over the past ten years. During a routine physical in the spring of 1961, a plant doctor had discovered that Litton had several swollen lymph nodes in his neck and groin area. The nodes were about the size of peas and not at all painful. Litton had noticed them, too, but wrote them off as harmless. The doctor was concerned, though, and referred him to an Oak Ridge physician, who removed one of the nodes. The physicianas findings came as a shock: Litton, he concluded, had lymphoma, or cancer of the lymph system.

Litton was then referred to the Medical Division Hospital run by the Oak Ridge Inst.i.tute of Nuclear Studies, frequently referred to as ORINS. The hospital was one of the three cancer research facilities established by s.h.i.+elds Warren in the late 1940s and was originally a.s.signed s.p.a.ce in a wing of the former Manhattan Engineer District hospital where Ebb Cade had been injected with plutonium. Eventually the ORINS hospital, related laboratories, and treatment rooms occupied the entire building. The patients were required to sign various papers prior to admittance. The forms disclosed that the treatments were experimental and held no definite promise of benefit or cure, but they did not reveal the possibility that procedures might increase the patientsa pain or hasten their deaths.

One of the first doctors to examine Woodrow Wilson Litton was Herbert Gerstner, the Paperclip specialist from the School of Aviation Medicine, who had gone to ORINS to get his medical license and worked briefly at the Oak Ridge hospital. Gerstner listened to the slow thump of Littonas heart, the clear, un.o.bstructed breathing, and then questioned him about his familyas medical history. Litton was the nineteenth child in a family of twenty-one children. There was no history of cancer or unusual childhood diseases. aPhysical examination reveals a well-developed white male who is very alert and cooperative,a Gerstner remarked.2 Thinking perhaps of his research in Germany, he added that Litton ahears perfectly well.a Litton underwent a series of diagnostic tests over the next two days. aThe findings,a Gerstner wrote, awere not sufficient to establish the diagnosis of malignant lymphoma with absolute certainty.a Litton was discharged, but was to return to the hospital many times over the next four years. Gerstneras name does not show up again in his medical records.

Littonas diagnosis was difficult to verify. ORINS pathologists disagreed among themselves about whether his lymph cells were truly cancerous and decided to do another node biopsy. Some of the biopsy material was forwarded to consultants at the University o

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