The Hideous Truths Of Testing the Hepatitis Vaccine On Humans

Sixty years ago, a monstrous hepatitis experiment was performed on mentally disabled children at Willowbrook State School that raises serious ethical questions about vaccine challenge trials for Covid-19.

As we discuss the possibility of human challenge trials of COVID-19 vaccines, this article should be required reading. This historical example rivals the Tuskegee Syphillis study in its moral obscenity, this time with disabled children as victims rather than African Americans.

“It’s almost 50 years and speaking about it still makes me cry,” says Rivera, now a roaming correspondent-at-large at Fox News. “The conditions were so horrible.” Rivera remembers seeing children naked, smeared in their own feces and hitting their heads against the wall. “I would imagine that the situation I had was similar to the GIs that freed the concentration camps.”

The Last Great Disgrace: As a result of Geraldo Rivera’s 1972 investigation of Willowbrook, a federal law was passed to protect people in institutions.

MICHAEL OCHS/ GETTYIMAGES

At roughly the same time, a whistleblower exposed the infamous Tuskegee syphilis study in which researchers deliberately let hundreds of Black men go untreated and several died from the disease, even though there was a known cure. Willowbrook was one in a long line of human experimentations on children, prison inmates, people in mental health facilities, and minority communities, and Tuskegee was the tipping point.

Dr. Krugman, however, was rewarded for his work at Willowbrook. That year, he became president of the American Pediatric Society.

It is important to remember.

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Events like this only serve to diminish trust between the public and health agencies. Some people are too scarred to forget these horrors and it forever shapes their perception.

Its important to remember, so that we can remember not to let these horrid mistakes repeat themselves.

This piece asks but does not answer a question that is at the heart of all clinical trials, of every kind, every day, but most especially it is the question that has already been answered by anyone who believes that Phase I clinical trials should exist. That question is “Is it really necessary—or right—to risk the health of a few for the benefit of many?”

Every other question in the piece, about whether a trial will be informative or whether it will help, is similarly typical of Phase I trials and of several other interesting situations in biomedical ethics (most notably live organ donation, in my opinion). All of the questions are about risk and benefit, and all of these situations are the same in that one person (the volunteer or the donor) derives no benefit, and indeed a risk of harm, in order to potentially benefit others.

So. A Phase I clinical trial is a “safety trial” in which an agent is given to human volunteers to assess toxicity. The volunteers incur risk. The risk can be predicted from animal studies and it can be “managed” by doing the test (you can call it an experiment) in a carefully managed environment, overseen my health care specialists. But the risk is necessarily unknown, hence the need for the experiment in the first place. Readers of the Forbes piece should ask how a Phase I clinical trial of a new drug is different from a challenge trial with a coronavirus. If these two things are different, this is not revealed in the question in my first paragraph.

Nor is there any difference in potential for exploitation of vulnerable people. That’s true of Phase I trials, and there are real concerns about compensation, “sourcing” to the developing world, and other aspects of the process that seem to me to raise obvious and serious concerns about exploitation. Even if these concerns are legit re the SARS-CoV-2 trial (I don’t see any evidence for this), they are not remotely unique to it.

The Forbes piece is a strange place to start when considering the challenge trial in the UK. I recommend that people read it, not to learn anything at all about the SARS-CoV-2 trial but about how ethical lapses have evolved in general, and why.

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