For the past eight years, Johnson & Johnson (J&J) has been dealing with lawsuits from women claiming that they developed ovarian cancer after using the company’s talc products. Documents unsealed during these proceedings show that the company was involved in a study in which incarcerated men were paid to be injected with asbestos in order that the company could compare its effect on their skin with that of talc.
That study was just one out of hundreds of experiments that were conducted over the course of more than 20 years by Albert Kligman, MD, a dermatologist with the University of Pennsylvania, according to various reports in the media, including The New York Times.
The inmates were primarily Black men who were incarcerated at Holmesburg Prison in Philadelphia, Pennsylvania. The studies were funded by a variety of sponsors, including Dow Chemical and the US government. The studies were acknowledged several decades ago, but this is the first time that J&J’s involvement has become known to the media after records of the studies were unsealed during the talc lawsuits.
Kligman died in 2010. He is quoted as saying that his experiments, conducted in the 1950s and 1960s, were in keeping with this nation’s standard protocol for conducting scientific investigations at the time.
But just because it was the “standard” at the time doesn’t make it okay, contends Matthew Wynia, MD, MPH, FACP, a professor at the University of Colorado School of Medicine and School of Public Health and director of the Center for Bioethics and Humanities, Aurora.
“If the prisoners were fully informed and in a position where they could easily refuse to participate or to withdraw, then they have nothing to apologize for,” he told Medscape Medical News. “But if not, then it was wrong then, and it’s wrong now.
“Just because others were doing equally bad things doesn’t make it right,” Wynia continued. “And just because it was legal at the time doesn’t make it right, either. If it did, we would have no grounds to criticize slavery or Jim Crow laws, and you would not see so many organizational leaders apologizing for the misdeeds of their predecessors related to racism and discrimination.”
Wynia also pointed out that there were standards for informed consent in the 1970s that were generally based on the Nuremberg Code, which provides a pretty good description of the nature of voluntary and informed consent. “In fact, the Code puts voluntary consent as the first principle, and it provides two paragraphs of further explanatory text ― which sets this principle apart from the other nine, each of which is just a short phrase or sentence,” he said.
Two Decades of Experiments
Kligman was a prolific researcher, and his discoveries led to groundbreaking contributions to the field of dermatology, according to a statement issued last year from the Dean’s Office of the University of Pennsylvania Perelman School of Medicine. This work includes the initial discovery of the effects of retinoic acid on acne (later commercialized as Retin-A by J&J), as well as discoveries regarding aging skin, seborrheic dermatitis, ringworm, and alopecia.
His work was published in more than 1000 research articles and in over 20 textbooks, and millions of people have benefited from his investigations, the university said.
“However, the committee also determined that, while Dr Kligman’s experimental protocols conformed to legal standards of the time, some of this work raised serious ethical concerns that should be addressed,” the statement notes.
These include the experiments Kligman conducted at Holmesburg Prison in Philadelphia.
From 1951 to 1974, hundreds of inmates were paid to participate in studies that generally involved testing a wide range of substances. They were conducted on the behalf of more than 30 pharmaceutical companies and several government agencies, according to a report in The New York Times. The substances included deodorants and shampoos, as well as more toxic materials, including some that were radioactive or hallucinogenic. Inmates were also exposed to pathogens responsible for skin infections, including the herpes virus, Staphylococcus bacteria, and the fungus that causes athlete’s foot.
Kligman repeatedly denied any wrongdoing and said that the research was within the accepted norms of the time. He also said that none of the participants ever suffered long-term harm, as far as he could tell.
However, more than 25 years after the last experiment ended, almost 300 former inmates sued Klingman, the University of Pennsylvania, J&J (the marketer of Retin-A), and others involved for injuries they alleged were from participation in the experiments. The suit was dismissed because by October 2000, when they tried to litigate, the statute of limitations had expired.
Changing Codes of Ethics
More than 16,000 talc-related lawsuits in the United States allege that J&J’s baby powder and other talc-containing products increase the risk for cancer, and J&J has been ordered to pay billions in legal costs and settlements. Some of the lawsuits have been dismissed or thrown out, and litigation related to talc is currently on hold while a J&J unit is in bankruptcy.
Lawyers for talc plaintiffs have for years pushed to get J&J’s testing files made public. The files finally surfaced when a judge allowed jurors to hear testimony about them in a 2021 California case.
A company spokesperson for J&J responded to a request from Medscape Medical News, stating that the “dignity of clinical testing participants must always be the highest moral imperative, which is why this type of testing was discontinued more than 40 years ago. Our ethical code is aligned with today’s advanced protocols and the latest ethical guidelines from leading medical institutions.
“At the time of these studies, nearly 50 years ago, testing of this nature among this cohort set was widely accepted, including by prominent researchers, leading public companies, and the US government itself,” explained the spokesperson. “We deeply regret the conditions under which these studies were conducted, and in no way do they reflect the values or practices we employ today. As the world’s largest healthcare company, our transparent, diligent approach to bioethics is at the heart of all we promise our customers and society.”
A statement issued by Larry Jameson, MD, PhD, dean of the Perelman School of Medicine, goes further. Penn Medicine acknowledges that Kligman’s research involving inmates was “terribly disrespectful of individuals ― many of whom were imprisoned Black men ― denying them the autonomy and informed consent which the medical community now considers to be foundational underpinnings for conducting ethical research. Legality, of itself, does not excuse these activities, which are not now, and never were, morally acceptable, even if Dr Kligman and his contemporaries believed them to be.”
Penn Medicine apologizes for the pain that this work caused to incarcerated individuals, their families, and the community at large. “While we cannot alter this history, the actions we are announcing today as an institution will change significant aspects of how we recognize Dr Kligman and his research, and will also devote substantial resources to research focused on skin of color and to education and patient care for underserved and vulnerable populations.”
These actions include sunsetting an annual lectureship named for Kligman and establishing research funding for diversity and equity in dermatologic research, education, and care, a new dermatology diversity residency position to train more dermatologists interested in skin of color, and three research fellowships for two medical students and one postdoctoral fellow to conduct research related to skin disorders among Black patients.
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