|Fig. 1: The boundaries of science - Anatomie des Parties de la Génération d l'Homme et de la Femme, by Jacques F. G. D'Agoty (Source: Wikimedia Commons)|
On November 15, 1993, journalist Eileen Welsome of The Albuquerque Tribune published "The Plutonium Experiment" describing how the United States Government had injected radioactive plutonium into unconsenting patients and listing five of those patient by name.  While the existence of these experiments had been reported on years prior, never before had a journalist uncovered the names of the people affected. In response to the media storm which followed Welsome's article, then Secretary of Energy Hazel O'Leary vowed to make public whatever documents she could, thus beginning the tedious process of declassifying confidential documents within the Department of Defense and the Department of Energy. 
True to her word, O'Leary initiated the "Openness Initiative", a result of which is a publicly-available searchable online catalog of documents pertaining to the human experimentation performed by the United States Government during and after World War II (WWII) and throughout the Cold War. Welsome later went on to publish a comprehensive book on her research. 
Due to the multi-generational timespan and sheer scope of the human experimentation sponsored by the government throughout this era, only a subset of them will be addressed here. Following WWII, the recipients of government-sponsored radioactive experimentation was geographically far-reaching and demographically varied. In Tennessee, at the prestigious Vanderbilt University, hundreds of pregnant women were fed mildly radioactive iron at the university's free clinic.  Elsewhere in Tennessee, at the Oak Ridge Laboratories, cancer patients of varying ages were subject to whole-body irradiation. In Massachusetts, under the supervision of the Massachusetts Institute of Technology (MIT), mentally-challenged students at the local state school were encouraged to consume food and snacks laced with trace amounts of radioactive iron and calcium. In New York, at Columbia University and Montefiore Hospital, terminally-ill cancer patients were injected with radioactive calcium and strontium. Finally, all across the country, from New York to Chicago to California, patients at highly-regarded hospitals were administered injections of plutonium. 
The common thread among patients selected for these experiments was their disadvantaged status, either physically or socioeconomically. Often experimental subjects were the elderly and the terminally-ill, with a common selection criteria of an life expectancy of less than ten years. For obvious reasons, prison inmates were a common choice for test subjects. Inevitably, such scientific studies which have little to no benefit to patients, raise key issues in informed consent. Degrees of informed consent between experiments cannot be broadly generalized and varied from case-to-case. [5,6]
Though much of the information concerning these experiments was kept classified until Hazel O'Leary, there are a number of human radiation studies whose findings were published in the medical literature long before Clinton Administration. For example, the study in which pregnant women were given intermittent doses of radioactive iron at Vanderbilt University had its findings published in American Journal of Epidemiology in 1969. Among mothers who received the doses of radioactive iron, four gave birth to children who would later develop malignancies ranging from acute lymphatic leukemia to synovial sarcoma. All four children died over the span of the study. No malignancies were discovered in the non-exposed children of the control group. The study showed a small, but statistically significant, increase in the propensity of children exposed to radiation towards developing cancer.  Though patient selection and consent is not clearly addressed in the publication, later legal action suggests that the women in the study were lied to.
Similarly, the experiment in which terminally-ill cancer patients were injected radioactive calcium and strontium was also published. The experiment, conducted at Columbia University, studied the metabolic fate of intravenously administered calcium and strontium. It was found that though the isotopes were essentially equally absorbed by the bone and soft tissue immediately after administration, over time, more than 99% of the fraction of both isotopes remaining in the body was found exclusively in the bone. Overall, the net retention of radioactive calcium was found to be higher than that of strontium, 60% to 25%, a function of the kidney preferentially excreting the strontium isotope. The survival length of patients in the experiment ranged from 3 hr to 124 days.  It is unclear whether any of the patients injected consented to the study as no legal action was taken. That being said, the lack of response is likely due to the fact that virtually all the participating patients died within months of the experiment, decades before their existence would be brought to the forefront of the public eye.
When the documents were declassified, individual and class-action lawsuits began to flood organizations affiliated with the human experimentation. The pregnant women treated at Vanderbilt won a $10.3 million lawsuit against the university, along with receiving a public apology issued by the school.  MIT and Quaker Oats agreed to pay a joint settlement of $1.85 million to the mentally-challenged at the Walter E. Fernald State School fed foods containing small amounts of radioactive calcium and iron.  The US Government agreed to pay $4.8 million in suits to 12 of the 18 people injected with high levels of plutonium during the Cold War.  These are just a few of the vast number of lawsuits that erupted due to the efforts of Hazel O'Leary.
While the outcome of the many lawsuits filed against the government and associated bodies suggests a clear cut moral high-grounded concerning these experiments, there are a number of considerations that must be taken into account. The first, and most popular, is whether it is fair to judge the morality of these human experiments through the lens of modern bioethics. While it's often argued that The Nuremberg Code published in 1949 provided clear-cut guidelines as to what was and was not acceptable with regard to human experimentation, and it is undeniably true that many of the experiments whose timeline coincided or surpassed the release of this Code explicitly violated its terms, this argument fails to take into account the tension and temperament of a wartime experience.  Were these experiments performed with a greater good in mind? Morality is easily judged in hindsight. Additionally, while some of these experiments exposed patients to high levels of radiations, many experiments stayed within what was considered to be "safe" levels and among those that did, there is the lingering question - where these practicing in keeping with standard medical procedures of the day? With regard to a few of the cancer patients treated at the Oak Ridge Laboratory in Tennessee, consultations with leading physicians of the time period suggested that while some of the treatment decisions were sometimes odd, they were not necessarily inconsistent with the medical practices of the era. 
The most arousing issue to emerge from the human experimentation of the Cold War Era is the topic of informed consent. Though the Nuremberg Code clearly describes the "absolute" requirement of consent, problems arising from concerns for national security and a lack of clear standards as to what constituted and how to obtain consent created a murky area in which medicine was practiced.  This does not, however, undermine the fact that some patients in physically or socioeconomically disadvantaged positions were quite blatantly taken advantage of and manipulated. The new focus on informed consent, and more broadly, on the proper standards for conducting experiments involving human subjects, shed new light and attention onto the field of bioethics.
The release of millions of classified documents due to the efforts of Hazel O'Leary spurred the creation of the National Bioethics Advisory Commission (later transformed into The President's Council on Bioethics), an organization dedicated to regulating research related to human subjects and protecting the interest of research participants by providing guidelines and increasing awareness of bioethical standards in realm of scientific research.
© Dana Yeo. The author grants permission to copy, distribute and display this work in unaltered form, with attribution to the author, for noncommercial purposes only. All other rights, including commercial rights, are reserved to the author.
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 R. M. Hagstrom et al., "Long Term Effects of Radioactive Iron Administered During Human Pregnancy," Am. J. Epidemiol. 90, 1 (1969).
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