Section 26 of Final Report of the Advisory Committee on Human Radiation Experiments. This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Recording by Patrick McAfee, Evanston. Part 2, Case Studies. Part 2, Overview. When we began our work, the Advisory Committee was aware of several dozen human radiation experiments and the 13 intentional releases in our charter. Soon, however, we found that these represented a fraction of the several thousand government-sponsored human radiation experiments and hundreds of intentional releases conducted from 1944 to 1974. It was clear that the committee would have to decide how to proceed in examining the experiments. Our ability to review all of the experiments and releases in detail was limited not only by time and resources, but even more so by the information available. For the majority of experiments identified, only the barest descriptions remained. It appeared that the vast majority of experiments involved trace amounts of radioisotopes, as are routinely used today for the study of bodily processes and the diagnosis of disease. However, where reports or other data were available, they did not routinely provide information needed to assess the precise risks to which subjects were exposed. These reports were even less likely to identify what kind of people were chosen as subjects and why and how they were selected. Since the committee could not review all experiments, we decided to prepare a series of case studies focused on groups of experiments. We quickly found that there was no one right way to organize the experiments for purpose of case study. For example, the case studies could have been defined by the type of radiation to which subjects were exposed. This would likely have yielded groupings of experiments with differing purposes, differing populations, and differing risks and benefits. Likewise, grouping all experiments according to the characteristics of the people who were the subjects of the research would have lumped together experiments with differing purposes, risks, and scientific procedures. The Advisory Committee on Human Radiation Experiments, A-C-H-R-E, Experiments Database By cabinet directive on January 19, 1994, federal agencies were ordered to establish forthwith an initial procedure for locating records of human radiation experiments conducted by the agency or under a contract or grant of the agency. The agencies most closely associated with these activities, the DOD, DOE, DHHS, NASA, CIA, and VA, and later the NRC, in cooperation with Advisory Committee staff identified record collections of importance and provided A-C-H-R-E with copies of documents potentially containing information on human radiation experiments. The documents were analyzed to identify individual experiments which were then described according to a protocol developed by A-C-H-R-E members and staff given unique identifiers and recorded in an electronic database. Experiments were also identified by Advisory Committee staff in the published literature discovered through a search of the National Library of Medicine databases and bibliographies and documented by individuals who came forward with information for the Advisory Committee. The database contains records for approximately 4,000 human radiation experiments. Information was collected to the extent it was available on the identity of the experiment, including investigators, location, dates, title, and documentation, funding, program approval, and classification, the type and dose of radiation used, various characteristics of the experimental subjects, and the nature of the consent obtained. The experiments were in addition categorized by various themes and characteristics developed by Advisory Committee members and staff to reflect A-C-H-R-E research interests. Documentation for individual experiments varies widely, sometimes including significant primary protocol documentation, often including only a journal article or abstract and, for the greatest number, just an investigator's name, a location, a date, and a title. As a result, although the database and the records it abstracts constitute an impressive and unique collection of information on human radiation experiments, that collection is not a comprehensive information resource on human radiation experiments, but really just the best place to start to look for information. The supplemental volume, Sources and Documentation, contains a more extensive and detailed description of the database and its sources. After extensive deliberation, the committee settled on eight case studies which together address the charges to and priorities of the committee. For example, we were charged to consider both intentional releases of radiation into the environment and the question of whether any former subjects of human radiation experiments would benefit medically from notification of their involvement. In addition, the committee saw a responsibility to address those experiments that had received significant public attention at the time of the committee's creation, as well as those brought to our attention by members of the public. These experiments either offered no prospect of medical benefit to subjects, or they involved interventions alleged to be controversial at the time. We also, however, recognized the importance of considering the far larger group of experiments that received no such attention, but that also may have involved no prospect of benefit to subjects. We also placed a priority on experiments that were conducted on behalf of secret programs and for national security reasons, experiments that posed the greatest risk of harm, and experiments in which the subjects selected for experimentation were particularly powerless to resist or exercise independent judgment about participation. Together, these considerations formed the basis for the selection of the case studies. In Chapter 5, we look at the Manhattan Project Plutonium Injection Experiments and Related Experimentation. Sick patients were used in sometimes secret experimentation to develop data needed to protect the health and safety of nuclear weapons workers. The experiments raised questions of the use of sick patients for purposes that are not of benefit to them, the role of national security in permitting conduct that might not otherwise be justified, and the use of secrecy for the purpose of protecting the government from embarrassment and potential liability. In contrast to the plutonium injections, the vast majority of human radiation experiments were not conducted in secret. Indeed, the use of radioisotopes in biomedical research was publicly and actively promoted by the Atomic Energy Commission. Among the several thousand experiments about which little information is currently available most fall into this category. The committee adopted a two-pronged strategy to study this phenomenon. In Chapter 6, we describe the system the AEC developed for the distribution of isotopes to be used in human research. This system was the primary provider of the source material for human experimentation in the post-war period. In studying the operation of the radioisotope distribution system and the related human use committees at local institutions, we sought to learn the ground rules that governed the conduct of the majority of human radiation experiments, most of which have received little or no public attention. Also in this chapter we review how research with radioisotopes has contributed to advances in medicine. The committee then selected for particular consideration, in Chapter 7, radioisotope research that used children as subjects. We determined to focus on children for several reasons. First, at low levels of radiation exposure, children are at greater risk of harm than adults. Second, children were the most appropriate group in which to pursue the committee's mandate with respect to notification of formal subjects for medical reasons. They are the group most likely to have been harmed by their participation in research, and they are more likely than other former subjects still to be alive. Third, when the committee considered how best to study subject populations that were most likely to be exploited because of their relative dependency or powerlessness, children were the only subjects who could readily be identified in the meager documentation available. By contrast, characteristics such as gender, ethnicity, and social class were rarely noted in research reports of the day. Moving from case studies focused on the injection or ingestion of radioisotopes, Chapter 8 shifts to experimentation in which sick patients were subjected to externally administered total body irradiation, TBI. The committee discovered that the highly publicized TBI experiments conducted at the University of Cincinnati were only the last of a series in which the government sought to use data from patients undergoing TBI treatment to gain information for nuclear weapons development and use. The experimentation spanned the period from World War II to the early 1970s during which the ethics of experimentation became increasingly subject to public debate and government regulation. In contrast with the experiments that flowed from the AEC's radioisotope program, the use of external radiation such as TBI did not in its earlier years involve a government requirement of prior review for risk. The TBI experimentation raises basic questions about the responsibility of the government when it seeks to gather research data in conjunction with medical interventions of debatable benefit to sick patients. In Chapter 9 we examine experimentation on healthy subjects, specifically prisoners, for the purpose of learning the effects of external irradiation on the testes, such as might be experienced by astronauts in space. The prisoner experiments were studied because they received significant public attention and because a literally captive population was chosen to bear risks to which no other group of experimental subjects had been exposed or has been exposed since. This research took place during a period in which the once commonly accepted practice of non-therapeutic experimentation on prisoners was increasingly subject to public criticism and moral outrage. Chapter 10 also explores research involving healthy subjects. Human experimentation conducted in conjunction with atomic bomb tests. More than 200,000 service personnel, now known as atomic veterans, participated at atomic bomb test sites, mostly for training and test management purposes. A small number also were used as subjects of experimentation. The committee heard from many atomic veterans and their family members who were concerned about both the long-term health effects of these exposures and the government's conduct. This case study provides the opportunity to examine the meaning of human experimentation in an occupational setting where risk is the norm. In Chapter 11 we addressed the 13 intentional releases of radiation into the environment specified in the committee's charter, as well as additional releases identified during the life of the committee. In contrast with biomedical experimentation, individuals and communities were not typically the subject of study in these intentional releases. Rather, the releases were to test intelligence equipment, the potential of radiological warfare, and the mechanism of the atomic bomb. While the risk posed by intentional releases was relatively small, the releases often took place in secret and remained secret for years. The final case study in Chapter 12 looks at two groups that were put at risk by nuclear weapons development and testing programs, and as a consequence became the subjects of observational research. Workers who mined uranium for the Atomic Energy Commission in the Western United States from the 1940s to 1960s, were residents of the Marshall Islands, whose Pacific homeland was irradiated as a consequence of a hydrogen bomb test in 1954. While these observational studies do not fit the classic definition of an experiment in which the investigator controls the variable under study, in this case radiation exposure, they are instances of research involving human subjects. The committee elected to examine the experiences of the uranium miners and Marshallese because they raise important issues in the ethics of human research not illustrated in the previous case studies and because numerous public witnesses impressed on the committee the significance of the lessons to be learned from their histories. Part 2 concludes with an exploration and an important theme common to many of the case studies, openness and secrecy in the government's conduct concerning human radiation research and intentional releases. In Chapter 13 we step back and look at what rules governed what the public was told about the topics under the committee's purview, whether these rules were publicly known and whether they were followed. End of Section 26, Recording by Patrick McAfee, Evanston. Section 27 of Final Report of the Advisory Committee on Human Radiation Experiments. This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Recording by Patrick McAfee, Evanston. 5. Experiments with Plutonium, Uranium and Polonium. In August 1944 at the Secret Los Alamos Laboratory in New Mexico, a 23-year-old chemist was trying to learn what he could about the properties of a radioactive metal. One year later the new product, one of several code words for this three-year-old element with a classified name, would power the bomb dropped on Nagasaki. That day the young scientist, Don Mastic, was working with the entire Los Alamos supply of the material, 10 milligrams. It was sealed in a glass vial several inches long and about a quarter-inch in diameter. Unknown to Mastic, a chemical reaction was causing pressure to build up inside the vial. Suddenly it burst, firing an acidic solution against the wall from where it splattered into Mastic's face, some of it entering his mouth. Realizing the importance to the war effort of the plutonium he had just ingested, Mastic hurried directly to the office of Louis Hempelman, the health director at Los Alamos. Hempelman pumped Mastic's stomach and instructed the young scientist to retrieve the plutonium from the expelled contents. Hempelman expressed a concern related to worker safety. There was no way available to determine how much plutonium remained in Mastic's body. He immediately pressed the lab's director, J. Robert Oppenheimer, for authorization to conduct studies to develop ways of detecting plutonium in the lungs and in urine and feces and of estimating the level of plutonium in the body from the amount found in excreta. Looming over Mastic's accident was the well-known tragedy of the radium dial workers more than a decade earlier. Like Mastic, they had ingested radioactive material through their mouths as they licked the brushes they used to apply radium paint to watch dials. As time passed, many suffered from a gruesome bone disease localized in the jaw and some bone cancers developed. Could plutonium cause a similar tragedy? If so, how much plutonium needed to be ingested before harmful effects might arise? How could one tell how much plutonium a person had already ingested? The answers to these questions were crucial, not only in the case of accidents such as Mastic's, but also in the long run to establish occupational health standards for the hundreds of workers who would soon be mass producing plutonium for atomic bombs. Several pounds of radium, handled without recognition of the dangers, had led to dozens of deaths. What might plutonium cause? A starting point was to examine the available data on radium poisoning, compare the characteristics of the radiation emitted by radium and plutonium, and try to extrapolate from radium to plutonium. However, plutonium had already revealed unexpected physical properties, which were posing problems for the bomb designers. Could plutonium also have unexpected biochemical properties? Extrapolation from radium was a good starting point, but could never be as reliable as data on plutonium itself. Oppenheimer agreed that this research was critical. In an August 16, 1944 memorandum to Hempelman, Oppenheimer authorized separate programs to develop methods to detect plutonium in the excreta and in the lung. With respect to biological studies, which Oppenheimer speculated might involve human experimentation, he wrote, I feel that it is desirable if these can in any way be handled elsewhere, not to undertake them here. The reason Oppenheimer did not want these experiments conducted at Los Alamos remains obscure. Nine days later, Hempelman met with Colonel Stafford L. Warren, medical director of the Manhattan Project and others. They agreed to conduct a research program using both animal and human subjects. Mastic, who reported no ill effects from the accident when advisory committee staff interviewed him in 1995, was not the first alert to the potential hazards of plutonium. Human experiments to study the metabolism and retention of plutonium in the body had been contemplated from the earliest days of the Manhattan Project. On January 5, 1944, Glenn Seaborg, who in 1941 was the first to recognize that plutonium had been created in the cyclotron at the University of California at Berkeley, wrote to Dr. Robert Stone, health director of the metallurgical laboratory in Chicago, a Manhattan Project contractor, and a central figure in efforts to understand the health effects of plutonium. It has occurred to me that the physiological hazards of working with plutonium and its compounds may be very great. Due to its alpha radiation and long life, it may be that the permanent location in the body of even very small amounts, say one milligram or less, may be very harmful. The ingestion of such extraordinarily small amounts as some few tens of micrograms might be unpleasant if it locates itself in a permanent position. Seaborg urged that a safety program be set up. In addition, I would like to suggest that a program to trace the course of plutonium in the body be initiated as soon as possible. In my opinion, such a program should have the very highest priority. Stone reassured Seaborg that human tracer studies, quote, have long since been planned, although never mentioned in official descriptions of the program, end quote. The work began at Berkeley with studies on rats conducted by Dr. Joseph Hamilton. Even as these studies on the biological effects of plutonium were beginning, the amount of plutonium being produced was dramatically increasing. Most of the effort at Oak Ridge was devoted to the separation of isotopes of uranium. However, the X-10 plant at Oak Ridge was a larger version of the very small plutonium producing reactor developed at the University of Chicago. The X-10 plant began operating on November 4, 1943, and by the summer of 1944 was sending small amounts of plutonium to Los Alamos. By December 1944, large-scale production of plutonium began at the Hanford Washington Reactor Complex. By late 1944, in the wake of the mastic accident, the need to devise a means of estimating the amount of plutonium in the body became acute. It seemed that the only way to estimate how much plutonium remained in a worker's body would be to measure over time the amount excreted after a known dose, and from this estimate the relationship between the amount excreted and the amount retained in the body. Maximum permissible body burdened MPBB for plutonium. The plutonium injections were part of a larger research project intended to provide data for an occupational safety program riddled with uncertainty. Not only was there a need for ways to monitor the exposure of personnel, the driving force behind the plutonium injections, but the maximum permissible body burdened MPBB for plutonium, the maximum amount of plutonium that would be permitted in the bodies of workers, was still under debate. The concept of maximum permissible body burden had begun to develop before the war in light of the known hazards of radium. Just prior to the war, primarily at the request of the Navy, a committee of experts was formed to establish occupational health standards for the factories producing dials illuminated by radium paint. After examining the data on radium dial painters, this committee agreed that 0.1 microgram fixed in the body should be the tolerance level for radium, an amount that in the words of the committee chairman Robert Evans would be, quote, at such a level that we would feel comfortable if our own wife or daughter were the subject, end quote. After the war, the term maximum permissible body burden was adopted and defined more precisely as the amount of a radioisotope that, when continuously present inside the body, would produce a dose equivalent to the allowable occupational exposure, the maximum permissible dose. For radioisotopes that, like radium, primarily reside in bone, biological data and mathematical models were used to determine how much of another bone seeker would produce the same dose as the original 0.1 microgram radium standard. Between 1943 and the spring of 1945, based on the body burden for radium and preliminary results of animal experiments, a tentative MPBB for plutonium of five micrograms was adopted by the Manhattan district. This level was derived by direct comparison of the relative energies of plutonium and radium. By the spring of 1945, differences between the deposition of radium and plutonium in the body were becoming clearer. Animal data indicated that plutonium deposited in what was called at the time the organic matrix of the bone, the part of the bone that most associated with bone growth. This was different from radium, which seemed to deposit instead in the mineralized bone. Wright Langham wrote to Heimer Friedel supporting the choice of one microgram as an operating limit in lieu of a more formal policy. Langham wrote that with the adoption of this lower limit, the medical legal aspect will have been taken care of and of still greater importance, we will have taken a relatively small chance of poisoning. Someone in case the material proves to be more toxic than one would normally expect. This level was adopted and held until the tripartite permissible dose conference at Chalk River Canada in September 1949. At this conference, representatives from the United States, United Kingdom and Canada agreed on tolerance doses for many radioactive isotopes including a maximum body burden of 0.1 microgram for plutonium. This reduced by a factor of 10 the value under which Los Alamos production had been operating. This reduction was based on the results of acute toxicological experiments with animals which indicated that plutonium was as much as 15 times more toxic than radium. On January 20, 1950, Wright Langham wrote to Shields Warren, then the director of the AEC's Division of Biology and Medicine, alerting him to the problems caused by the Chalk River conference's new, quote, extremely conservative tolerances which may have a drastic effect on the efficiency and productivity of the Los Alamos laboratory. Their official adoption will undoubtedly force major alteration in both present and future laboratory facilities and may add millions of dollars to the cost of construction of the permanent building program now in the planning phases, end quote. Langham continued with reasons for regarding the Chalk River value of 0.1 micrograms of plutonium as unnecessarily low. He cited among other things differences between acute and chronic toxicity and new analysis of data from the radium watch dial painters. On January 24, 1950, Shields Warren, Austin Bruce of Argonne National Laboratory, Robly Evans, Carl Morgan, and Wright Langham met in Washington. Langham wrote later, quote, as a result of this meeting, Dr. Shields Warren of the Division of Biology and Medicine authorized 0.5 UG 0.033 UC of plutonium 239 as the AEC's official operating maximum permissible body burden, end quote. There were no minutes or transcripts taken of this meeting. The calculation of this level was again based on the body burden for radium, this time modified by the one-fifteenth toxicity factor since experiments had indicated that plutonium was up to 15 times more toxic than radium, by the relative retention of plutonium and radium in rodents, and by the energy ratios modified by radon retention. Thus far the entire debate had occurred behind the closed doors of the AEC. Consideration of all the complex issues applied in setting a permissible body burden had been within a small circle of scientists and administrators. While the MPBB for plutonium accepted at the January 1950 meeting has held until today, its derivation has changed over the years. By March 1945, there was disturbing news that urine samples from Los Alamos workers were indicating based on models developed from animal experimentation that some might be approaching or had exceeded a body burden of one microgram. A March 25 meeting led to Hempelman's recommendation that the project, quote, help make arrangements for a human tracer experiment to determine the percentage of plutonium excreted daily in the urine and feces. It is suggested that a hospital patient at either Rochester or Chicago be chosen for injection of from one to ten micrograms of material and that the excreta be sent to the laboratory for analysis. The overall program, as it was envisioned by Dr. Heimer Friedel, Deputy Medical Director of the Manhattan Engineer District, Oppenheimer and Hempelman, consisted of three parts. Improvement of methods to protect personnel from exposure to plutonium, development of methods for diagnosing overexposure of personnel, and study of methods of treatment of overexposed personnel. On March 29, Oppenheimer forwarded the recommendation to Stafford Warren with his, quote, personal endorsement, end quote. The accident at Los Alamos was part of the prelude to experiments conducted between 1945 and 1947 in which 18 hospital patients were injected with plutonium to determine how excreta, urine, and feces could be used to estimate the amount of plutonium that remained in an exposed worker's body. One patient was injected at Oak Ridge Hospital in Oak Ridge, Tennessee. Eleven were injected at the University of Rochester, three at the University of Chicago, and three at the University of California. The results of these experiments contributed to the development of a monitoring method that, with small changes, is still used today. The experimental data were used to develop a model relating body burden to short-term excretion rate. Known as the Langham model, it was based on short-term excretion data, long-term excretion data that were collected in 1950 from two injection subjects, and worker excretion data. This model has been used almost universally to monitor plutonium workers since 1950, although it has been modified over the years as longer term and more extensive data were accumulated. While now, 50 years later, not every question concerning the quality of the science or the basis for estimating risk can be answered with precision, there is general agreement among radiation scientists that the experiments were useful. Although this would be the first time that plutonium would be injected into human beings, the plutonium experiments were not viewed at the time as being extremely risky and for good reason. Based on experience with other bone-seeking radioisotopes such as radium, the investigators had firm basis for believing, even in the 1940s, that the amount of material to be injected was likely too small to produce any immediate side effects or reactions. No one was expected to feel ill or have any negative reaction to the injection, and apparently no one did. Because acute effects were not expected, the plutonium injections were viewed as posing no short-term risks to human subjects. There was concern, however, about long-term risk. A draft report written by one of the primary investigators within a few years of the injections records that, quote, acute toxic effects from the small dose of PU plutonium administered were neither expected nor observed, end quote. The document also recognized that with regard to ultimate effects, it is too early to predict what may occur. Based largely on the experience of the radium-dial painters, it was recognized that exposure to plutonium could result, perhaps 10 or 20 years later, in the development of cancer in a human subject. This was viewed as a significant risk, but also as a risk that could be minimized by the use of small doses and wholly avoided if the subjects were expected to die well before a cancer had a chance to materialize. Even if the plutonium injections had been entirely risk-free and impossibility in human experimentation, they could still be morally problematic. As we discussed in Chapter 2, it was not uncommon in the 1940s for physicians to use patients as subjects in experiments without their knowledge or consent. This occurred frequently in research involving potential new therapies where there was at least a chance that the patient subjects might benefit medically from being in an experiment. But it also occurred even in experiments like the plutonium injections where there was never any expectation and no chance that the experiment might be of benefit to the subjects. The conduct of the plutonium experiments raises a number of difficult ethics and policy questions. Who should have been the subjects of an experiment designed to protect workers vital to bomb production and wartime? What should the subjects have been told about the risks of the secret substance with which they were being injected? What should they have been told about the purpose of the experiment? What were the subjects told? Did they know they were part of an experiment in which there was no expectation that they would benefit medically? An inquiry initiated by the AAC commissioners in 1974 investigated some of these questions. That inquiry focused on whether consent was obtained from the subjects, either at the time of the plutonium injections or during 1973 follow-up studies funded by the AAC's Argonne National Laboratory in Chicago, designed to determine the long-term effects of the injections. Sixteen patient charts were examined for evidence of consent at the time of injection. The other two charts had been either lost or destroyed. Of the sixteen charts examined, only one chart that of the only subject injected after the April 1947 directive of AAC general manager Carol Wilson discussed in Chapter 1 that required documented consent, contained evidence of some form of consent. The other fifteen contained no record of consent. According to AAC investigators, oral testimony pointed to failure to obtain consent in the case of the Oak Ridge injection and to some form of disclosure to patients for the California and Chicago experiments. The AAC concluded that testimony was inconclusive for the Rochester experiments. With regard to the follow-up studies conducted with three surviving subjects in 1973, the investigation concluded that two subjects had deliberately not been informed of the purpose of the follow-up and that one subject had actually been misled about the purpose. As we will see later in this chapter, the AAC's conclusion that consent was not obtained from the surviving subjects for the 1973 follow-up studies was correct. Moreover, additional documentary evidence and testimony suggests that patient subjects at the universities of Rochester and California were never told that the injections were part of a medical experiment for which there was no expectation that they would benefit and they never consented to this use of their bodies. The rest of this chapter provides a chronological account of the plutonium injection experiments and follow-up studies conducted over the course of many years, assesses the influence of secrecy on the conduct of the experiments, and examines the motivating factors behind the prolonged secrecy of the experiments and the continued deception of surviving subjects. We also consider the conduct of experimentation with uranium and plutonium. Finally, we render judgments where we can about the ethical conduct of these experiments. End of section 27. Recording by Patrick McAfee, Evanston. Section 28 of Final Report of the Advisory Committee on Human Radiation Experiments. This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Recording by Patrick McAfee, Evanston. Final Report of the Advisory Committee on Human Radiation Experiments. Case Studies, Chapter 5, Part 2. The Manhattan District Experiments. The First Injection. A few days after Hempelman's March 26, 1945 recommendation that a hospital patient be injected with plutonium, Wright Langham of the Los Alamos Laboratories Health Division sent five micrograms of plutonium to Dr. Friedel with instructions for their use on a human subject. The subject, as it turned out, was already in the Oak Ridge Army Hospital, a victim of an auto accident that had occurred on March 24, 1945. He was a 53-year-old colored male named Ebb Cade, who was employed by an Oak Ridge construction company as a cement mixer. The subject had serious fractures in his arm and leg, but was otherwise well developed and well nourished. The patient was able to tell his doctors that he had always been in good health. Mr. Cade had been hospitalized since his accident, but the plutonium injection did not take place until April 10. On this date, HP-12, the codename HP Human Product, was later assigned to this patient and to patients at the University of Rochester, was reportedly injected with 4.7 micrograms of plutonium. It is important here to distinguish between administered dose and retained dose. Not all of the injected dose would remain fixed in the body. It was not known with certainty, however, how much of the 4.7 micrograms of plutonium would remain in his body. The small amount of material injected into Mr. Cade would not be expected to produce any acute effects, and there is no indication that any were experienced. However, except for his fractures, Mr. Cade was apparently in good health and at age 53 could reasonably have been expected to live for another 10 to 20 years. Thus, in Mr. Cade's case, the risk of a plutonium-induced cancer could not be ruled out. Dr. Joseph Howland, an army doctor stationed at Oak Ridge, told AEC investigators in 1974 that he had administered the injection. There was, he recalled, no consent from the patient. He acted, he testified, only after his objections were met with a written order to proceed from his superior, Dr. Friedel. Dr. Friedel told advisory committee staff in an interview that he did not order the injection and that it was administered by a physician named Dwight Clark, not Dr. Howland. The committee has not been able to resolve this contradiction. Measurements were to be taken from samples of Mr. Cade's blood after four hours, his bone tissue after 96 hours, and his bodily excretions for 40 to 60 days thereafter. His broken bones were not set until April 15, five days after the injection, when bone samples were taken in a biopsy. Although this was several weeks after his injury, during this era when antibiotics were only beginning to become available, it was common practice to delay surgery if there was any sign of possible infection. One document records that Mr. Cade had marked tooth decay and gum inflammation and 15 of his teeth were extracted and sampled for plutonium. The committee has not been able to determine whether the teeth were extracted primarily for medical reasons or for the purpose of sampling for plutonium. In a September 1945 letter, Captain David Goldring at Oak Ridge informed Langham that more bone specimens and extracted teeth will be shipped to you very soon for analysis. It remains unclear whether these additional bone specimens were extracted at the time of the April 15 operation or later. According to one account, Mr. Cade departed suddenly from the hospital on his own initiative. One morning the nurse opened his door and he was gone. Later it was learned that he moved out of state and died of heart failure on April 13, 1953 in Greensboro, North Carolina. The experiment at Oak Ridge did not proceed as planned. Before and after urine samples were mistakenly commingled so no baseline data on kidney function was available. Thus the subject's kidney function would be difficult to assess. In May 1945, Dr. Stone convened a conference on plutonium in Chicago to discuss health issues related to plutonium including the relationship between dose and excretion rate, the permissible body burden, and potential therapy and protective measures. Wright Langham spoke about the Oak Ridge injection at the conference, carefully qualifying the reliability of the excretion data obtained from Mr. Cade. Langham observed that, quote, the patient might not have been an ideal subject in that his kidney function may not have been completely normal at the time of injection, end quote, as indicated by protein tests of his urine. The Chicago Experiments On April 11, the day after the Oak Ridge injection, Heimer Friedel transmitted the protocol describing the experiment on Mr. Cade to Lewis Hempelman at Los Alamos. Quote, everything went very smoothly, he wrote, and I think that we will have some very valuable information for you, end quote. He then went on to discuss the injection of more patients, quote, I think that we will have access to considerable clinical material here, and we hope to do a number of subjects. At such time as we line up several patients, I think we will make an effort to have Mr. Langham here to review our setup, end quote. Subsequently, between late April and late December of 1945, three cancer patients, codenamed CHI-1, 2, and 3, were injected with plutonium. At least two and possibly all three were injected at the Billings Hospital of the University of Chicago. The doses to subjects CHI-2 and CHI-3 were the highest doses administered to any of the 18 injection subjects, approximately 95 micrograms. However, the amount of material injected was still below what would be expected to produce acute effects. Moreover, unlike Mr. Cade, all three of these patients were seriously ill and at least two of them died within 10 months of receiving the injection. That the injection of seriously ill patients was an intentional strategy to contain risk is indicated in a 1946 report on CHI-1 and CHI-2, quote, Some human studies were needed to see how to apply the animal data to the human problems. Hence, two people were selected whose life expectancy was such that they could not be endangered by injections of plutonium, end quote. It remains a mystery why CHI-3 was not included in this report. On April 26, 1945, CHI-1, a 68-year-old man who had been admitted to Billings Hospital in March, was injected with 6.5 micrograms of plutonium. At the time of injection, he was suffering from cancer of the mouth and lung. The patient reportedly, quote, remained in fair condition until August 1945 when he complained of pain in the chest, end quote. His lung cancer had apparently spread and he died on October 3, 1945. The next injection took place eight months later. CHI-2 was a 55-year-old woman with breast cancer who had been admitted to Billings Hospital in December, 1945, after the cancer had already spread throughout her body. The 1946 report recorded that, quote, the patient's general condition was poor at the time of admission and deteriorated steadily throughout the period of hospitalization, end quote. She was injected with 95 micrograms of plutonium on December 27 and died on January 13, 1946. There is little known about the condition of CHI-3, the other subject who was injected with approximately 95 micrograms. He was a young man suffering from Hodgkin's disease, reportedly injected on the same date as CHI-2. His condition at the time of injection remains unknown, as does his date of death. There is some question whether he was injected at Billings Hospital or at another hospital in the Chicago area. There was no discussion of consent in the original reports on the Chicago experiments. However, a draft report on an interview conducted with ER Russell for the 1974 AEC investigation into the experiments. Russell was co-author of the 1946 report on the Chicago experiments. Summarized Russell's description of consent as follows, quote. He prepared the plutonium solutions for injection and acted together with a nurse as witness to the fact that the patient was or had been informed that a radioactive substance was going to be injected. The administration of this substance, according to what was said in obtaining consent, was not necessarily for the benefit of the patients, but might help other people, end quote. To say that the injection was not necessarily for the benefit of the patient implies that there was some chance these patients might benefit. In fact, there was no expectation that this would occur. Russell's account was obtained in the context of an official inquiry into his conduct and the conduct of the other investigators and officials involved in the plutonium injections, an inquiry that focused on whether consent was obtained from the subjects. We have no way of corroborating this account or of assessing what Dr. Russell's motivations were in explaining the plutonium injections to the subjects in the way claimed. The Rochester experiments. By the time the war began, the University of Rochester, which had a cyclotron, had assembled a group of first rate physicists and medical researchers who were pioneering the new radiation research. Following the selection of the university's Stafford Warren to head its medical division, the Manhattan Project turned to Rochester for an increasing share of its biomedical research, including in particular research needed to set standards for worker safety. The university's metabolism ward at what is now the Strong Memorial Hospital became the central Manhattan District site for the administration of isotopes to human subjects. The two-bed ward headed by Dr. Samuel Bassett was part of the Manhattan District's Special Problems Division, which worked on the health monitoring of production plants, the development of monitoring instruments, and research on the metabolism and toxicology of long live radioactive elements. An experimental plan called for 50 subjects altogether in five groups of 10 subjects each. Each group would receive plutonium, radium, polonium, uranium, or lead. Although the exact number of subjects remains unknown, at least 22 patients were administered long lived isotopes in experiments with plutonium, 11 subjects, polonium, 5 subjects, and uranium, 6 subjects. At the time the experiment was being designed, the main selection criterion for the subjects chosen at Rochester for the plutonium experiment was that they have a metabolism similar to healthy Manhattan engineered district workers. In a work plan for the plutonium study based on a September 1945 meeting with a representative of Colonel Warren's office and the Rochester doctors, Langham wrote, The selection of subjects is entirely up to the Rochester group. At the meeting it seemed to be more or less agreed that the subjects might be chronic arthritics, patients with serious collagen vascular diseases such as scleroderma or carcinoma patients without primary involvement of bone, liver, blood, or kidneys. It is of primary importance that the subjects have relatively normal kidney and liver function as it is desirable to obtain a metabolic picture comparable to that of an active worker. Undoubtedly the selection of subjects will be greatly influenced by what is available. The above points, however, should be kept in mind. Although this protocol specifies cancer patients as potential subjects, evidently the deliberate choice was made later by the experimenters to select patients without malignant diseases in the hope of ensuring normal metabolism. Thus no cancer patients were included among the plutonium subjects at Rochester. Preference appears to have been given to patients the doctors believed would benefit from additional time in the hospital. An additional perspective on the selection of subjects for the plutonium experiments is provided in three retrospective reports written by Wright Langham. In a 1950 report on the plutonium project, including the experiments conducted at Rochester, Langham wrote that, quote, as a rule the subjects chosen were past 45 years of age and suffering from chronic disorders such that survival for 10 years was highly improbable, end quote. In subsequent reports, Langham refers to the plutonium subjects as having been, quote, hopelessly sick, end quote, and, quote, terminal, end quote. Documents retrieved for the advisory committee show that all but one of the plutonium subjects at Rochester suffered from chronic disorders such as severe hemorrhaging secondary to duodenal ulcers, heart disease, Addison's disease, cirrhosis, and scleroderma. One subject, Eda Schultz Charlton, did not have any such condition. According to the draft of the 1950 report, she was misdiagnosed, quote, a woman aged 49 years may have a greater life expectancy than originally anticipated due to an error in the provisional diagnosis, end quote. Most of the subjects at Rochester were not terminally ill, and at least some of them had the potential to live more than 10 years. Three of the Rochester subjects were known to still be living at the time of the 1974 AEC investigation into the plutonium experiments. Whether the inclusion of subjects at Rochester with the potential to live more than 10 years is an indication that the investigators were not using Langham's criterion to select subjects or that they aired in their predictions is unclear. Judgments about the life expectancy of the chronically ill are difficult to make and often in error, even today. The likelihood that long-term risks can be altogether eliminated does exist, however, if the subject is in the terminal stages of an illness and death is imminent. This was recognized by the plutonium investigators, and it led to the observation that the use of a terminal patient permitted a larger dose, which would make analysis easier. The first terminal patient at Rochester was injected toward the end of that series, and the possibility of further injections into terminal patients was discussed explicitly. In a March 1946 letter, Wright Langham wrote to Dr. Bassett, the primary physician investigator at Rochester, quote, In case you should decide to do another terminal case, I suggest you do 50 micrograms instead of 5. This would permit the analysis of much smaller samples and would make my work considerably easier. I feel reasonably certain that there would be no harm in using larger amounts of material if you are sure the case is a terminal one, as was done in two of the three Chicago injections, end quote. As was the case at Oak Ridge and Chicago, there was no expectation that the patient subjects at Rochester would benefit medically from the plutonium injections. The advisory committee found no documents that bear directly on what, if anything, the subjects were told about the injections and whether they consented. The recollections of at least some of those intimately involved have survived, however, and these recollections all suggest that the patients did not know they had been injected with radioactive material or even that they were subjects of an experiment. Milton Statt, the son of a Rochester subject, told the advisory committee the following at a meeting in Santa Fe, New Mexico on January 30, 1995, quote, My mother, Jan Statt, had a number HP8. She was injected with plutonium on March 9, 1946. She was 41 years old and I was 11 years old at the time. My mother and father were never told or asked for any kind of consent to have this done to them. My mother went in to the hospital for scleroderma and a duodenal ulcer and somehow she got pushed over into this lab where these monsters were, end quote. Dr. Hempelman in an interview for the 1974 AEC investigation said he believed that the patients injected with plutonium were deliberately not informed about the contents of the injections. Dr. Patricia Durbin, a University of California researcher who in 1968 undertook a scientific reanalysis of the experiments reported on a visit with Dr. Christine Waterhouse in 1971. Dr. Waterhouse was a medical resident at Rochester at the time of the plutonium injections. Durbin wrote the following regarding the Rochester subjects who were still alive, quote, She, Dr. Waterhouse, believes that all three persons would be agreeable to providing excretion samples and perhaps blood samples, but they are all quite old in their middle or late 70s and cannot travel far. More important, they do not know that they received any radioactive material, end quote. In notes on a 1971 telephone conversation with Wright Langham, Dr. Durbin wrote, quote, He is, I believe, distressed by the fact that the injected people in the HP series were unaware that they were the subjects of an experiment, end quote. This recollection is even more troubling than the recollections of Dr. Waterhouse and Hempelman, as it indicates not only the subjects did not know that they were being injected with plutonium or a radioactive substance, but also that they did not know even that they were subjects of an experiment. Even the doctors in charge of some of the injections at Rochester may not have known what they were injecting into patients. In 1974, Dr. Hempelman suggested that the physician who actually injected the solution quite possibly did not know of its contents. Further evidence suggesting that the patient subjects were never told what was done to them comes from 1950 correspondence between Langham and the physicians at Rochester. These physicians investigators were looking for signs of long term skeletal effects in follow up studies with two of the subjects at Rochester. Langham wrote to Rochester that he was, quote, very glad to hear that you will manage to get follow ups on the two subjects. The x-rays seem to be the all important thing, but please get them in a completely routine manner. Do not make the examination look unusual in any way, end quote. Moreover, a letter from Langham to Dr. Bassett discussed the undesirability of recording plutonium data in the Rochester subjects hospital records, quote. I talked to Colonel Stafford Warren on the phone yesterday and he recommended that I send copies of all my data to Dr. Andrew Dowdy where it would be available to you and Dr. Robert M. Fink to observe. He thought it best that I not send it to you because he wanted it to remain in the Manhattan Project files instead of taking a chance on it finding its way into the hospital records. I think this is probably a sensible suggestion, end quote. Uranium injections at Rochester. Under the Manhattan Engineer District Program, physicians at the Rochester metabolism ward also injected six patients with uranium in the form of uranil nitrate enriched in the isotopes Uranium 234 and Uranium 235 to establish the minimum dose that would produce two patients. This was detectable kidney damage due to the chemical toxicity of uranium metal and to measure the rate at which uranium was excreted from the body. To achieve the first objective, the experimenters used a higher dose with each new subject until the first sign of minimal kidney damage occurred. Damage occurred in the sixth and last subject at a calculated amount of radioactivity of 0.03 micro curies indicated by protein tests of his urine. Unlike the plutonium injections, this was an experiment that evidently was designed not only to obtain excretion data but to cause actual physical harm, however minimal. Thus, although the investigators could reasonably view the plutonium injections as an experiment that was extremely unlikely to produce acute effects, this was not true of the uranium experiment which was intended to produce acute effects. As with the plutonium injections, the uranium injections also posed a long-term risk of the development of cancer. The committee does not know in this case how long subjects survived after injection. There is no documentation of follow-up with these subjects as there is for some of the subjects of the plutonium injections. The subjects of this experiment, like some of the plutonium injection subjects, were not at risk of imminent death but did suffer from chronic medical conditions such as rheumatoid arthritis, alcoholism, malnutrition, cirrhosis, and tuberculosis. According to Dr. Bassett, again the primary investigator, the subjects, quote, were chosen from a large group of hospital patients. Criteria of importance in making the selection were reasonably good kidney function with urine free from protein and with normal sediment on clinical examination. The probability that the patient would benefit from continued hospitalization and medical care was also a factor in the choice, end quote. The 1948 report on the experiment did not discuss the question of consent. We were not able to locate any documents that bear on what, if anything, the subjects were told about the uranium injections, nor have any relevant recollections about the experiment survived. Two 1946 documents, however, discussing whether Dr. Bassett should be permitted to give a departmental seminar on the excretion rate of uranium in humans, illustrate the secrecy that surrounded these injections and suggest that the subjects were not informed of the experiment. By the time of this correspondence the uranium research with animals at Rochester had been declassified. The first document, a letter written by Andrew Dowdy, the director of the Manhattan department at the University of Rochester to a Manhattan district area engineer requesting permission for Bassett to give the seminar included the following. Quote, I feel that there is no reason why he should not discuss this matter, and I believe that the fact that this information was actually obtained on his own patients is of more concern to himself than to the district. In the second document, an interoffice memorandum, the area engineer discussed this point and more. Dr. Dowdy states that the patients were Dr. Bassett's, but it should be borne in mind that all the work performed by Dr. Bassett was performed at the request of the Manhattan district medical section. This seminar is to be conducted for persons who are all doctors of medicine, and it is doubtful if this information would get out to any of the families of the patients or the patients on whom the experiments were performed. At the time these experiments were started, this office was given strict orders that the information should not be released to any but authorized persons. Almost all the correspondence and result of experiments were exchanged between Dr. Wright Langham at Santa Fe and Dr. Bassett of the University of Rochester. This rule is still in effect on some of the material that Dr. Bassett is using, and knowledge of the experiments is kept from personnel at the Rochester area. In addition to the subjects injected with plutonium and uranium at Rochester, five subjects were chosen for an experiment with polonium. The purpose of the experiment was to determine the excretion rate of polonium after a known dose, as well as to analyze the uptake of polonium in various tissues. The primary investigator for these experiments was Dr. Robert M. Fink, assistant professor of radiology and biophysics at the University of Rochester. Four patients were injected with the element, and one ingested it. All five patients selected for this study were suffering from terminal forms of cancer, lymphosarcoma, acute lymphatic leukemia, or chronic myeloid leukemia. It is unclear why patients with malignant diseases were chosen as subjects in this experiment, but excluded from the subject pools for the plutonium and uranium experiments. There was no discussion in the 1950 final report on the polonium experiments of the possibility that patients with malignant diseases might have abnormal metabolism, and the excretion data were employed right away in the establishment of occupational safety standards. The final report, unlike other reports on the Manhattan District metabolism studies, briefly discusses the question of consent. The general problem was outlined to a number of hospital patients with no previous or probable future contact with polonium. Of the group that volunteered as subjects, four men and one woman were selected for the excretion studies outlined below. This statement leaves no clear impression of what the subjects actually were told. Like the experiments with plutonium and uranium, the human polonium experiment was a classified component of the metabolism program. Still, this report provides a contrast to the contemporaneous reports on the Manhattan District plutonium and uranium experiments, which make no mention of consent and which do not refer to the patient subjects as volunteers. End of section 28, Recording by Patrick McAfee, Evanston. Section 29 of final report of the advisory committee on human radiation experiments. This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Recording by Patrick McAfee, Evanston. Final report of the advisory committee on human radiation experiments. Case studies, Chapter 5, Part 3. The California Experiments. While the University of Rochester had been conducting experiments for the Manhattan Engineer District, a related effort was underway at the University of California at Berkeley. Before the war, doctors Joseph Hamilton and Robert Stone had been exploring medical applications of radioisotopes with the aid of the University of California's cyclotron. Hamilton and his colleagues had pioneered in using radioisotopes to treat cancer, in particular iodine, in the 1930s. At the time the United States entered the war, they were investigating another isotope for cancer therapy, Strontium 89. Indeed, it was this area of Hamilton's expertise that attracted the interest of the Manhattan Project. While Stone moved to the Chicago Metallurgical Laboratory during the war, Hamilton remained at the University of California's Radiation Laboratory, or Rad Lab, at Berkeley. A colleague of both men, Dr. Earl Miller, a radiologist at the University of California, reported regularly to Stone on the progress of the Berkeley Plutonium Project. Under the Manhattan District contract, Hamilton's studies originally had involved exposing rats to plutonium in an effort to determine its metabolic fate and thereby project the risk to workers at atomic plants. Toward the end of the war, Hamilton began to conduct plutonium studies on humans for the government. Experiments with humans could be handled expeditiously, Hamilton wrote, because of the close relationship between the Rad Lab and the medical school at the University of California at San Francisco. In January 1945, Hamilton confirmed to the Manhattan District that he planned, quote, to undertake on a limited scale a series of metabolic studies with plutonium using human subjects, end quote. The purpose of this work, Hamilton wrote, quote, was to evaluate the possible hazards to humans who might be exposed to them, either in the course of the operation of the Chicago Pile, or in the event of possible enemy action against the military and civilian population, end quote. Subsequently, three subjects, two adults and one child, known as Cal 1, 2, and 3, were injected with plutonium. In addition, in April 1947, a teenage boy, Cal A, was injected with americium, and in January 1948, a 55-year-old female cancer patient, Cal Z, was injected with zirconium. On May 10, 1945, Hamilton reported he was awaiting, quote, a suitable patient, end quote, for the plutonium experiment. Four days later, 58-year-old Albert Stevens, designated Cal 1, was injected with plutonium, becoming the first human subject in the California portion of the project. Albert Stevens was chosen in the belief that he was suffering from advanced stomach cancer. Shortly after the injection, however, a biopsy revealed a benign gastric ulcer instead of the suspected cancer. The researchers collected excreted daily for almost one year, analyzing them for plutonium content. Evidently, by two months after the injection, Mr. Stevens was considering moving out of the Berkeley area. This would have presented further collection of excretion specimens. Dr. Hamilton proposed to Dr. Stone and Stafford Warren that he be permitted to pay the man $50 per month in order to keep Mr. Stevens in the area. Hamilton recognized, however, that there were possible legal and security situations which may present insurmountable obstacles. In response to this request, Dr. Joe Howland, who was reportedly involved with the Oak Ridge plutonium injection, wrote the following to the California area engineer, quote, A, Pay for his care in a hospital or nursing home as a service. B, Place this individual on Dr. Hamilton's payroll in some minor capacity without release of any classified information. It is not recommended that he be paid as an experimental subject only, end quote. According to a 1979 oral history of Kenneth Scott, an investigator at Berkeley, who evidently was responsible for the analysis of Mr. Stevens's excretion specimens, the patient was paid some amount each month to keep him in the area. However, Dr. Scott also recalled that he never told Mr. Stevens what had happened to him. Quote, his sister was a nurse and she was very suspicious of me, but to my knowledge he never found out, end quote. In addition, an April 1946 report on the experiment records that, quote, several highly important tissue samples were secured, including bone, end quote. It appears that these tissue specimens, which included specimens of rib and spleen, were removed four days after the injection in an operation for the patient's suspected stomach cancer. Four months after Mr. Stevens was injected, Dr. Hamilton told the Manhattan District that the next subject would be injected, quote, along with PU-238 plutonium, small amounts of radioetrium, radio strontium, and radioserium, end quote. The purpose of this experiment was to, quote, compare in man the behavior of these three representative long-lived fission products with their metabolic properties in the rat. And second, a comparison can be made of the differences in their behavior from that of plutonium, end quote. This research would provide data to improve extrapolation from higher dose animal experiments. Despite Hamilton's hope to have a second patient by the fall, Cal II was not selected until April 1946. Simeon Shaw was a four-year-old Australian boy suffering from osteogenic sarcoma, a rare form of bone cancer, who was flown from Australia to the University of California for treatment. According to newspaper articles at the time, Simeon's family had been advised by an Australian physician to seek treatment at the University of California. Arrangements then were made by the Red Cross and the U.S. Army for Simeon and his mother to fly by Army aircraft to San Francisco. Within days, he had been injected with a solution containing plutonium, etrium, and cerium by physicians at the University. Following his discharge on May 25, about a month after his injection, the boy returned to Australia and no follow-up was conducted. He died in January 1947. In February 1995, an ad hoc committee at the University of California at San Francisco, UCSF concluded that probably at least part of the motivation for this experiment was to gather scientific data on the disposition of bone-seeking radionuclides with bone cancers. One piece of evidence indicating that there was a secondary research purpose for the injection of Cal2 was a handwritten note in the boy's medical record saying that the surgeons removed a section of the bone tumor for pathology and for studies to determine the rate of uptake of radioactive materials that had been injected prior to surgery in comparison to normal tissues. It is likely that the Cal2 experiment was designed both to acquire data for the Manhattan District and also to further the physician's own search for radioisotopes that might treat cancer in future patients. The California researchers themselves noted the dual purpose of their research at the time. Hamilton wrote in a report to the Army in the fall of 1945 that there were, quote, military considerations which can be significantly aided by the results of properly planned tracer research, end quote. As the February 1995 UCSF report on the experiments concluded, however, the, quote, injections of plutonium were not expected to be nor were they therapeutic or of medical benefit to the patients, end quote. This corresponds with the evidence of a letter written by Hamilton in July 1946, three months after the injection of Cal2 to the author of an article on the peacetime implications of wartime medical discoveries, quote, to date, no fission products aside from radioactive iodine have been employed for any therapeutic purposes. There is a possibility that one or more of the long list of radioactive elements produced by uranium fission may be of practical therapeutic value. At the present time, however, we can do no more than speculate, end quote. Documentary evidence suggests that consent for the injections likely was not obtained from at least some of the subjects at the University of California. A 1946 letter from T.S. Chapman with the Manhattan District's Research Division said the following regarding preparations for injections, quote, preparations were being made for injection in humans by doctors Robert Stone and Earl Miller. These doctors state that the injections would probably be made without the knowledge of the patient and that the physicians assumed full responsibility. Such injections were not divergent from the normal experimental method in the hospital and the patient signed no release. A release was held to be invalid. The Medical Division of the District Office has referred P. reports for the project 48A to Colonel Cooney for review and approval is withheld pending his opinion, end quote. Chapman does not specify whether the injections referred to in this letter were injections of plutonium or of some other substance. It is unclear whether P. reports refers to Hamilton's overall progress reports on his tracer research which had reported mostly on research with plutonium, but also on research with cerium and yttrium or whether P. referred specifically to reports on work with plutonium. As we noted at the outset of this chapter, Chapman's claim that it was commonplace at the time to use patients in experiments without their knowledge and without asking them to sign a release is correct. In the case of Albert Stevens, Cal 1, no documentary evidence that bears on disclosure or consent has been found. Simeon Shaw's Cal 2's medical file contains a standard form, quote, consent for operation and or administration of anesthetic, end quote. This form, however, was signed by a witness attesting to consent of Simeon's mother one week after the injection and therefore probably applies to a biopsy done a week after the injection, not to the injection itself. On December 24, 1946, at the prompting of Major Birchard M. Brundage, who was Chief of the Manhattan District's Medical Division, Colonel K. D. Nichols, Commander of the Manhattan District, ordered a halt to injections of, quote, certain radioactive substances, end quote, into human subjects at the University of California. Quote, such work, Nichols wrote, does not come under the scope of the Manhattan District programs and should not be made a part of its research plan. It is therefore deemed advisable by this office not only to recommend against work on human subjects, but also to deny authority for such work under the terms of the Manhattan contract, end quote. The following week, the civilian AEC took over responsibility for all Manhattan District research and temporarily reaffirmed the Manhattan District's suspension of human experimentation at the University of California. It is unclear why this action was taken. The AEC's reaction, preserving secrecy while requiring disclosure. When the Civilian Atomic Energy Commission took over for the Manhattan District on January 1, 1947, the plutonium injections provoked a strong reaction at the highest levels. One immediate result was the decision to keep information on the plutonium injections secret. Evidently for reasons not directly related to national security, but because of public relations and legal liability concerns. The other immediate result, as we saw in Chapter 1, was the issuing of requirements for future human subjects research as articulated in letters by the AEC's general manager, Carol Wilson. In December 1946, as the Civilian AEC was about to open its doors, Heimer Friedel, who had been Deputy Medical Director of the Manhattan Engineer District, recommended the declassification of one of the plutonium reports. CH Chicago 3607, the distribution and excretion of plutonium in two human subjects. The report, Friedel argued, quote, will not in my opinion result in the release of information beyond that authorized for disclosure by the current declassification guide, end quote. Friedel's recommendation was soon reversed. Officials with the new AEC had learned of the human injection experiments, and on February 28, 1947, an AEC declassification officer concluded that declassification was out of the question. The reasons are revealed in a previously classified document recently found at Oak Ridge, quote. The document CH 3607 appears to be the most dangerous since it describes experiments performed on human subjects, including the actual injection of the metal plutonium into the body. The locations of these experiments are given and the results, even to the autopsy findings, in the two cases. It is unlikely that these tests were made without the consent of the subjects, but no statement is made to that effect, and the coldly scientific manner in which the results are tabulated and discussed would have a very poor effect on the public. Unless, of course, the legal aspects were covered by the necessary documents, the experimenters and the employing agencies, including the U.S., have been laid open to a devastating lawsuit which would, through its attendant publicity, have far-reaching results, end quote. It is not clear to the advisory committee on what basis the declassification officer who wrote this comment concluded that it was unlikely that consent was not obtained from the Chicago subjects. This statement could be read as careful bureaucratic language intended to leave an appropriate paper trail in the event of subsequent legal problems. On the other hand, the statement does support the claim noted earlier made by one of the Chicago doctors in 1974 that some form of oral consent for the injections had been obtained from the Chicago subjects. It is clear that there was no documentation of disclosure or consent on which the AEC could rely. As a consequence, secrecy was to be maintained, not as a defense against foreign powers, but to avoid, quote, a devastating lawsuit, end quote, and, quote, attendant publicity, end quote. Upon further review, the report was, quote, reclassified, restricted on 3.31.47, end quote. In a March 19, 1947 memorandum, Major Brundage, by that time, Chief of the AEC's Medical Division, explained, quote, The Medical Division also agrees with public relations that it would be unwise to release the paper, distribution and excretion of plutonium, primarily because of medical legal aspects in the use of plutonium in human beings, and secondly, because of the objections of Dr. Warren and Colonel Cooney, that plutonium is not available for extra commission experimental work. And thus, this paper's distribution is not essential to off-project experimental procedures. In July 1947, Argonne National Laboratory's declassification officer, Hoyland D. Young, inquired about possible declassification of this report as well as Hamilton's report on the Cal-1 injection. She stated that the directors of Argonne's biology and health divisions, including J.J. Nixon, one of the authors of the Chicago report on the injections, believed that declassification of these reports would not be, quote, prejudicial to the national interests, end quote. The AEC continued to withhold declassification of these reports, however, on the grounds that they involved, quote, experimentation on human subjects where the material was not given for therapeutic reasons, end quote. Thus, there was clearly no expectation at the time that the plutonium injections would benefit the patient subjects, but some expectation that the general public might be disturbed by human experimentation in the absence of a prospect of offsetting benefit. In 1950, Wright Langham and the Rochester doctors undertook to prepare a plutonium report that would be, quote, the last word on the plutonium situation. It would be the last word to only a select few. In 1947, Rochester's Andrew Dowdy had urged Los Alamos to give advanced notice of declassification of the Rochester part of the experiment, quote, because of possible unfavorable public relations and in an attempt to protect Dr. Samuel Bassett from any possible legal entanglements, end quote. This is likely a reference to the same concern raised in the discussion of Dr. Bassett's seminar about his having experimented upon his own patients, except in this case, the context is the plutonium rather than the uranium injections, quote, we think Langham wrote to Stafford Warren, the classification will be secret and the circulation limited, depending on Dr. Shields Warren's, the head of AEC's division of biology and medicine wishes, end quote. In August, Shields Warren approved the report for confidential classification and limited circulation, as Dr. Langham requested. Even though its data and analysis were the basis for widespread plutonium safety procedures, the report remained unavailable to the public until 1971, when at the urging of Dr. Patricia Durbin, it was downgraded to official use only. This categorization means that while the document was not likely to be released to the public absent specific request, it could be disclosed. What was it that was so potentially embarrassing about the plutonium experiments? The answer appears to lie in the 1947 letters from General Manager Wilson, discussed in detail in Chapter 1. These letters state rules for both the conduct of human experiments and the declassification of previously conducted secret experiments. In his April 1947 letter, Wilson stated the requirements that there be expectation that research, quote, may have therapeutic effect, end quote, and that at least two doctors, quote, 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, end quote. In his November 1947 letter, Wilson reiterated these terms for human experiments, again calling for, quote, reasonable hope that the administration of such a substance will improve the condition of patient, end quote. And this time calling for, quote, informed consent in writing, end quote, by the patient. All of the 17 plutonium injections conducted prior to the letters violated both these terms. As a consequence, they would have to stay secret. The only secret experiments that could be declassified were those that satisfied these requirements. To do otherwise was to risk adverse public reaction. Thus the decision to keep the plutonium reports secret was itself an example of the way in which the AEC's assertion of conditions for human experimentation was coupled with the decision to keep secret. Those experiments that evidently did not adhere to these conditions. See chapter 13. End of section 29. Recording by Patrick McAfee, Evanston.