Dark Legacy: Medical Experimentation in US Prisons

As a starting point for understanding the ethical complexity of medical research conducted on vulnerable subjects, bioethicists point to Nazi-era Germany, where Josef Mengele, the notorious "Angel of Death" of the Third Reich, oversaw an attempt to cure existing and persistent German diseases and to fulfill the Nazi dream of creating a perfected Aryan race.
In doing so, Mengele and his professional peers embarked on a series of gruesome, brutal and deadly experiments on their captive laboratory subjects.

American judges presiding over the trial of many of these Nazi doctors in 1947 convicted 23 Nazi doctors, sentencing seven to death. (Mengele himself escaped to South America, where he died in 1979.) Yet the barbarity of the experiments seemed to warrant a more far-reaching response. In The Nuremberg Code of 1947, it was declared that experimentation on human beings had to be conducted in such a way as to avoid all unnecessary suffering; that it had to be performed toward the good of the society, "unprocurable by other means;" and perhaps most significantly, that such experimentation was never acceptable when subjects did not--or could not--freely consent.

"The voluntary consent of the human subject is absolutely essential," reads The Nuremberg Code. "This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion."

In an attempt to deflect condemnation of their own practices, Nazi doctors facing death sentences pointed toward American experimentation on prisoners--ongoing since the beginning of the 20th century--with little success. Sentences and executions meted out, American doctors condemned the horrors of Nazi medical experimentation, even as they disassociated themselves from the ethical implications of the trial and the code. Without any significant opposition to speak of, all manner of research studies on unsuspecting American citizens, army recruits and the mentally disabled took off in the aftermath of the Holocaust.

Medical research using prisoners in particular flourished amidst a three-decade fiesta of federal, pharmaceutical and cosmetic company funding, leading the president’s 1994 advisory committee on federally-funded radiation experiments to note that, following World War II, the U.S. was the only nation in the world officially continuing to use prisoners in experimental clinical trials. But revelations about the Tuskegee Syphilis study and the publication of Jessica Mitford’s Kind and Usual Punishment about the conditions of imprisonment in the early 1970s put a gradual end to prison experimentation as well as many other forms of unethical research.

Responding to the apparent need for stiffer regulation in the realm of human experimentation, the government convened of a special commission to investigate the protection of human subjects of research. After the subsequent publication of the Belmont Report in 1979, state and federal guidelines regarding research on prisoners took on a more carefully crafted tone; the onus was now placed more directly on researchers to assure informed consent and to prove the merit of any studies conducted on captive, illiterate, uneducated, mentally incompetent or disabled subjects.

As a direct result of the Belmont Report, seventeen federal agencies adopted the "Common Rule," which prohibits, with limited exceptions, nonconsensual use of people in medical research and which requires reviews of proposed studies by institutional review boards. Most prison research withered and died out, extinguished by the dual flames of public outrage and the watchful eye of federal and university-based regulators, until the dawn of a worldwide HIV epidemic by the late 1980s--and an accompanying, insidiously prevalent epidemic of hepatitis C within U.S. prisons--revitalized medical interest in this kind of research.

Research in prisons represents only a fraction of the medical studies conducted on human subjects in the U.S. each year, however, and problems inherent to such research are apparently widespread. At a Medical Research Summit held in Washington, D.C., in late March, more than 200 researchers, medical ethicists and administrators gathered to discuss those problems, stressing the need for full disclosure to patients of the financial ties that researchers might have to their clinical trials, raising question about federal oversight of clinical trials and other research studies.

But change is likely to be slow in coming, as medical research is enjoying a time of heavy pharmaceutical funding and federal government support. Medical centers at leading universities across the nation are still mainly supported by federal dollars. The University of Miami Medical Center, for instance, is one of the largest research facilities in the world with $191 million in research funding, and one of the top universities in expenditure of federal funds for research and development, with more than 1,000 ongoing research studies. The Department of Health and Human Services (HHS) is the Yale School of Medicine’s principle funding source, with $178.7 million (or 67 percent of total funds granted in fiscal year 1998) coming from HHS and its agencies.

In addition to the funding received by federal agencies and pharmaceutical companies, researchers engaged in research involving prisoners also appear to be cost-benefiting from the fact that they conduct much of their research in prison medical wards, utilizing prison resources, transportation service, facilities and possibly even the labor of prison employees. According to Dr. Thomas of the Florida Department of Corrections (DOC), neither the institution nor its inmates receive payment for their assistance or participation in clinical trials.

The Roche drug company-produced newsletter, Positive Populations, mentioned the Florida DOC arrangement with University of Miami researchers by stating that "[t]he DOC ... has been a willing and enthusiastic partner, putting in place policies and procedures to eliminate barriers and give [the researcher] and her staff access to inmates," including the busing of some inmates to a central prison reception center for research.

Silja J.A. Talvi is Co-Editor of LiP Magazine.

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