by Gregory J. Dober
In December 2022, the University of California at San Francisco (UCSF) offered an apology for unethical research conducted on prisoners during the 1960s and 70s led by two of their researchers: Howard Maibach, MD, and William Epstein, MD. Both doctors were on the faculty of UCSF’s Department of Dermatology. Epstein was a former department chair. The research was performed on prisoners located primarily at the California Medical Facility (CMF) in Vacaville. The report indicated that many of the prisoners at the hospital were “being assessed or treated for psychiatric diagnosis” at the time. However, Drs. Maibach and Epstein were conducting experiments that had nothing to do with therapeutic psychiatric studies for the benefit of the prisoners.
They also were not strangers to unethical research before their dalliance with medical experimentation at UCSF. Both men were trained under Dr. Albert Kligman at the University of Pennsylvania in Philadelphia. Kligman’s unethical experiments at Holmesburg Prison were documented in Allen Hornblum’s groundbreaking book, Acres of Skin (Routledge, 1999.)
Kligman conducted many unethical experiments on prisoners and children from the 1950s to the 1970s. Much of the funding came from corporate giants such as Johnson & Johnson (J & J) and Dow Chemical. For Dow Chemical, Kligman exposed prisoners to high doses of dioxin, the fundamental ingredient in the Agent Orange warfare chemical. For J & J, Kligman did many studies exposing prisoners to various dermatologic agents to determine the irritability or usefulness of the chemical. From experiments that left Holmesburg prisoners scarred — for payment of just pennies a day and without proper informed consent — Kligman and J & J reaped discovery of the dermatological drug, Retin-A, which went on to result in hundreds of millions of dollars of sales, profits and royalties for the firm and its researcher.
It should be noted, after Hornblum’s book exposed the trials, courts ordered that the statute of limitations had closed on any recourse for the prisoners enrolled in the trials from Kligman, the University of Pennsylvania or their corporate sponsors. It wasn’t until decades later, in 2021, that the University of Pennsylvania finally apologized to the victims.
Maibach and Epstein would not forget their mentor’s earlier teachings and experiments at the University of Pennsylvania and Holmesburg. The pair also conducted many studies on California prisoners using chemicals and irritants. The report, issued by the UCSF Program for Historical Reconciliation, noted that the researchers used “experimental methods which included the topical application and intravenous dosing of pesticides and herbicides, placing small cages with mosquitos ‘one cm from the arms’ of human subjects to observe ‘host attractiveness of humans to mosquitos.”
Much like Kligman’s experiments at Holmesburg, the UCSF research tested many chemicals and toxins that were not therapeutic or beneficial to the prisoner-subjects. For example, prisoners were exposed to various toxins, including Hercules 9007, a trade name for carbamic acid, which is used to produce fertilizers and insecticides.
The UCSF committee investigating the Maibach/Epstein trials also found improper and uninformed consent. The committee noted that in 1977, Dr. Epstein testified at state hearings in California that researching prisoners should be supported. The report noted that “[i]n an unpublished interview” Maibach defended the use of prisoners in research as a “catalyst for knowledge.” Ironically, his mentor Kligman never apologized on record for his unethical use of prisoners and usually defended the practice, as well.
The use of prisoners for biomedical research was common during much of the 20th century, peaking from the 1950s to the early 1970s. The practice received a boost in 1962 when the U.S. Food and Drug Administration (FDA) required the three stages of clinical testing for any new drug: Phase I, Phase II, and Phase III. Phase I, the most risk-laden, is used to test the safety and toxicity of the compound at different dosages in healthy individuals. There is no therapeutic benefit to the participant, and it may be the first time the drug was introduced into the human body. As a result, after FDA approval of drugs for three-phase testing, up to 85% of participants in Phase I clinical trials were performed on inmates between 1962 and 1980.
Today there are more stringent guidelines for using incarcerated individuals in biomedical research. Many state departments of corrections have banned the practice. However, as recently as 2008, there was a push by researchers to reopen prisons to conduct research that isn’t therapeutic for the prisoner-subject. The idea was studied, but the recommendations did not result in federal regulation changes to allow and liberalize the practice. However, that doesn’t mean the practice won’t get reviewed in the future by zealous researchers.
For more on research using prisoners, see PLN, Mar. 2008, p.1.
Gregory J. Dober is the author, along with Allen M. Hornblum and Judith L. Newman, of Against Their Will: The Secret History of Medical Experimentation on Children in Cold War America (St. Martin’s Press, 2013).
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