Are Prisoners the Only Vulnerable Population?
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EDITORIAL Coercion in Research: Are Prisoners the Only Vulnerable Population? Barbara E. McDermott, PhD J Am Acad Psychiatry Law 41:8–13, 2013 Research plays an essential role in advancing medical (USPHS) commissioned Dr. Joseph Goldberger to and behavioral sciences and in improving our ability study the problem in an effort to find a cure.1 The to understand and treat illness. However, unlike clin- widely held belief at the time was that pellagra was ical care, which is intended for the sole benefit of the caused by some type of micro-organism. Dr. Gold- patient, research has the broader goal of advancing berger began observational studies and formulated knowledge and does not necessarily provide the sub- the hypothesis that diet was primarily responsible for ject with an ensured clinical benefit, raising obvious the disease. To test this theory, he recruited 11 pris- ethics-related concerns and making voluntary con- oners from Rankin State Prison in Mississippi to un- sent to participate essential. For certain participant dergo dietary modifications in an effort to induce populations, consent may be problematic. Such in- pellagra in these otherwise healthy volunteers. In ex- dividuals include those who may be unable to make change for their participation, the prisoners were informed, voluntary decisions about participation in promised a full pardon. After five months, during research, either because of impairments in cognition which time several prisoners began to develop symp- or reasoning or because they live in an environment toms of the disease, the study concluded, with 6 that is potentially coercive. of the 11 evidencing symptoms of pellagra. During those months, inmates who developed the disease History of Research on Prisoners suffered so greatly that some were willing to forgo the Prisoners are considered a group of individuals pardon to discontinue the study. for whom coercion is a major concern, primarily be- A much more extreme example highlighting the cause of the supposition that prisons are inherently subtlety of the coercive process was the malaria study coercive institutions. Previous research conducted at Stateville Penitentiary in Illinois.2 The prison was on prisoners makes the rationale for this evident. built as a panopticon, meaning that the housing units Historically, prisoners have been considered an ideal were arranged in a circle surrounding a central tower. population on which to conduct research because A guard was placed in the tower but was not visible to they are readily accessible and in a controlled envi- the inmates. Thus, the guard could be watching the ronment. As an example, in the early 1900s, pellagra inmates at any time without their knowledge, impos- had reached epidemic levels in the rural southern ing a subtle form of authority. During World War II, United States. The U.S. Public Health Service malaria was devastating U.S. soldiers fighting in the Pacific Ocean theatre. At that time, quinine was the Dr. McDermott is Professor of Clinical Psychiatry, Division of Psy- chiatry and the Law, Department of Psychiatry, UC Davis School of only effective treatment, although supplies were lim- Medicine, Sacramento, CA. Address correspondence to: Barbara E. ited. Between 1942 and 1945, the United States re- McDermott, PhD, UC Davis School of Medicine, Department of Psychiatry, Division of Psychiatry and the Law, 2230 Stockton Bou- portedly lost eight million man-days to the disease. levard, Sacramento, CA 95817. E-mail: [email protected]. In 1944, the malaria studies began at Stateville Peni- Disclosures of financial or other potential conflicts of interest: None. tentiary. Although inmates were not promised early 8 The Journal of the American Academy of Psychiatry and the Law McDermott release initially, the governor of Illinois eventually tested a polio vaccine on prisoners at the Federal guaranteed that all inmate participants would have Reformatory in Ohio because he believed that the their parole decisions reviewed at the end of their vaccine was not yet ready for the general public; Dr. sentences. It ultimately was determined that inmates Jonas Salk’s use of Michigan inmates in his work participating in the malaria studies were released an with the influenza vaccine; and Sloane-Kettering’s average of two years earlier than were nonpartici- collaboration with Ohio State University and the use pants. At the initial announcement of the effort, 200 of prisoners in Ohio for cancer research that involved volunteers were solicited; 487 men offered their ser- injecting live cancer cells into supposed volunteers. vices. Although the prisoners signed consents for Although the Green Committee encouraged the dis- these studies, no risks were mentioned in the consent closure of risks to each prisoner, there were no pro- forms. According to reports from the infamous in- cedures in place to ensure that such a disclosure oc- mate Nathan Leopold,3 each volunteer was fully ap- curred. Researchers were left with the responsibility prised verbally of the risks; one risk was death. Yet, of assuring that participants knew the risks associated inmates volunteered in increasing numbers. As a re- with the studies and were presumed to police them- sult of these studies, brought to light during the selves in this regard. Nuremberg trials as evidence that the United States In 1962, the thalidomide scandal changed Food had also performed atrocious medical studies on pris- and Drug Administration (FDA) regulations regard- oners, the Governor of Illinois (Dwight Herbert ing drug testing. Thalidomide was routinely admin- Green) convened a committee (dubbed the Green istered to pregnant women in Europe for the control Committee) to determine the conditions under of nausea. Although the FDA withheld approval of which prisoners could serve as subjects in medical thalidomide for use in the United States, thousands experiments and whether a reduction in sentence of U.S. women, many of child-bearing age (includ- could be offered as a reward for such service.4 Pub- ing some who were pregnant), participated in studies lished, in part, in the Journal of the American Medical conducted by pharmaceutical companies on its safety Association in 19485 were three rules that the com- and efficacy. When the link between thalidomide mittee proposed for conducting medical research on and birth defects became clear, the FDA modified its prisoners: consent must be obtained in the absence of procedures for drug testing and ultimately required coercion and with knowledge of the potential risks; that such studies be conducted in three phases. Phase the studies must be based on the results of animal 1 studies required the use of healthy subjects to eval- experimentation and on knowledge of the natural uate the safety of experimental medication (Phases 2 history of the disease, and must be expected to yield and 3 were for establishing efficacy). Prisoners were results not obtainable in any other fashion; and the ideal subjects for Phase 1 studies. They were willing study must be conducted by scientifically qualified to accept more risk for less money and, according to personnel and avoid unnecessary physical or emo- the assistant medical director of one pharmaceutical tional suffering, and there should be no reason to company, were guaranteed to show up. Medical re- believe that death or a disabling injury would occur. search in prisons continued to grow. One particu- The ultimate conclusion of the committee was that larly egregious example was a study by Dr. Austin medical research could be conducted ethically with Stough, an Oklahoma physician who used prisoners prisoners if those criteria were met and, to avoid un- in Oklahoma, Arkansas, and Alabama for drug and due influence or coercion, the reduction of sentence blood plasma studies in mostly unregulated condi- was not excessive. tions. One report indicated that in a prison in Ala- With the endorsement of the American Medical bama, 28 percent of the prisoners participating in Association, medical research on prisoners flour- Dr. Stough’s studies developed viral hepatitis com- ished. In the last year of World War II, the National pared with 1 percent of the prisoners who did not Institutes of Health received approximately participate. One inmate was quoted as saying, $700,000 in federal funding; by 1955, this amount “They’re dropping like flies out here.”7 The studies increased to $36 million and reached $1.5 billion conducted in Holmesburg Prison in Pennsylvania by 1970.6 Much of this funding was allocated to further illustrated the abuse of prisoners for medical medical research that was conducted on prisoners. research. Prisoners were routinely used for testing Noteworthy examples include Dr. Albert Sabin, who of cosmetics, details of which were documented by Volume 41, Number 1, 2013 9 Coercion in Research Allen Hornblum in his book, Acres of Skin: Human oping guidelines for the ethical conduct of research; Experiments at Holmesburg Prison.8 The title was de- the Belmont Report,10 named for the conference rived from a comment by Dr. Albert Kligman, a center in which it was penned, was drafted in re- professor of dermatology at the University of Penn- sponse to this charge. The report described three ba- sylvania Medical School. When he first entered the sic principles of ethical research: respect for persons: prison, he reportedly recalled in a newspaper inter- persons should be treated as autonomous, and if au- view: “All I saw before me were acres of skin. It was tonomy is diminished, additional protections should like a farmer seeing a fertile field for the first time” be in place; beneficence: human subjects should not (Ref. 8, p 37). be harmed and the research should maximize bene- Although not conducted on prisoners, the Tus- fits and minimize risk; and justice: benefits and risks kegee syphilis study set in motion a chain of events of research should be distributed fairly.