by Eike Blohm, MD
The City of Philadelphia formally apologized on October 6, 2022, for medical experiments conducted on some 300 men — mostly Black, many of them pretrial detainees — incarcerated at the now-shuttered Holmesburg Prison over 50 years ago.
Interest revived in the ancient torture at the notorious prison known as the “Terrordome” after a pair of product-liability lawsuits in California courts were paused in February 2022 for bankruptcy proceedings by manufacturing giant Johnson & Johnson (J&J) to shunt its now-shuttered North American baby powder business into a separate corporation — but not before exhibits were unsealed revealing the company used Pennsylvania prisoners to test the product for cancer-causing asbestos.
J&J’s current corporate shell-game, known as the “Texas two-step” for the state in which its bankruptcy is proceeding, is an attempt to corral costs from the two pending suits and about 38,000 others accusing the firm of deliberately hiding the fact that the one-time bathroom staple contained the carcinogen.
A natural compound that co-occurs with asbestos, talc — the main ingredient in baby powder — can be contaminated with it during mining. J&J was a major producer of talc-based baby powder until it withdrew the product from U.S. and Canadian markets in 2020. By then the firm had paid over $3.5 billion in settlements and verdicts in asbestos exposure suits, plus another $1 billion in litigation costs. The new corporate shell that now owns J&J’s baby powder business, LTL Management LLC, was immediately placed in bankruptcy by the Texas court, along with about $2 billion in assets. Legal experts estimate that is just one-third of the liability J&J potentially faces from the outstanding suits.
Researchers and doctors discovered in the 1950s that inhaling asbestos causes a cancer called mesothelioma. It was less clear if harm resulted from skin exposure. In 1971, J&J commissioned a research study to assess the effects of injecting talc and asbestos into the skin. The study’s principal investigator was dermatologist Albert Kligman, a former physician at Holmesburg Prison in Pennsylvania, where he had conducted numerous experiments on prisoners over the two preceding decades.
Dr. Kligman paid prisoners up to $300 to participate in his experiments, a princely sum in a prison where regular jobs paid 25 cents a day. Ten prisoners were research subjects for the asbestos study, injected with the carcinogenic chemical and their bodies’ reactions meticulously documented. The experiment left them scarred and disfigured with granulomas.
Until his death in 2010, Kligman — who developed the acne treatment Retin-A — maintained that the experiments adhered to research standards at that time. But his former employer, the University of Pennsylvania, apologized for backing his research in 2021, while J&J said it “deeply regret[ed] the conditions under which these studies were conducted.” Family members of prisoners subjected to the experiments have demanded reparation. Yet the central question remains unanswered: Should experiments be conducted on prisoners at all?
The law clearly permits research involving humans. It is regulated by the federal Department of Health and Human Services under 45 CFR 46(c). Any institution receiving federal funds that conducts research must have an Institutional Review Board (IRB) composed of both researchers and community members to review and approve projects involving human subjects. For research involving incarcerated individuals, a prisoner or prisoner advocate must be part of the IRB.
IRB approval is based on internationally standardized research ethics. Participants must be fully informed of all reasonably foreseeable risks and consent voluntarily without coercion or enticement, a key issue in Kligman’s research, given the outsized influence of the pay offered. Prisoners’ participation also cannot impact release, probation, or parole. Correctly applied, the process safeguards prisoners from exploitative, deceptive, or abusive research practices. Yet the laws in place establish only that research can be done on prisoners, not that it should.
There are major arguments against it. After an adverse outcome such as toxicity from an experimental medication, incarcerated individuals are at the mercy of prison officials to access medical care, which is too often delayed and inadequate.
Another problem is the scientific concept of generalizability: For study findings to be valid across the U.S. population, a research group must resemble that population. But prisoners are mostly young and male, with minorities disproportionally represented.
Yet there are at least two arguments for prisoner participation in research. First, there are some things that can be studied only in prisoners, such as the impact of incarceration on lifetime risk for cancer or heart disease (spoiler alert: it raises both). More crucially, a prisoner with an incurable disease may have a chance of survival with an experimental drug as part of a research protocol. What’s important to avoid is abusing prisoners as guinea pigs by ensuring their participation in research is voluntary and fully informed.
Source: Bloomberg Law
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