Tuesday, October 19, 2021

Challenge trials in Britain and (not) in the U.S.

 The NY Times has an excellent piece on Covid vaccine challenge trials, and the different traditions (and repugnance) in Britain and the U.S.

Britain Infected Volunteers With Covid. Why Won’t the U.S.? By Kate Murphy

"In an age of masking, compulsive hand sanitizing and plexiglass dividers, it seems inconceivable that for more than 40 years people enthusiastically signed up — and were often put on a waiting list — to have respiratory viruses, including coronaviruses, dripped into their noses.

"They were volunteers at the Common Cold Unit, set up in 1946 by the British government’s Medical Research Council.

...

"the Common Cold Unit established and refined a model for so-called human challenge studies that paved the way for the first Covid-19 human challenge study just completed in Britain, where young, healthy and unvaccinated volunteers were infected while researchers carefully monitored how their bodies responded.

"Then, as now, there were those who decried deliberately infecting or “challenging” healthy volunteers with disease-causing pathogens. It violates the medical principle of “do no harm.” The trade-off is a unique opportunity to discover the causes, transmission and progression of an illness, as well as the ability to more rapidly test the effectiveness of proposed treatments.

...

"“The key benefit of human challenge studies is that they are controlled — everyone gets the same virus, the same amount and they are in the same environment,” said Dr. Christopher Chiu, professor of infectious diseases at Imperial College London and chief investigator in Britain’s Covid challenge study.

...

"In the United States, the regulatory hurdles to conduct challenge studies mean there are precious few, mostly for finding better treatments for malaria, cholera and influenza. Ethicists and regulators are more comfortable approving clinical trials where subjects are given a treatment, say a drug or vaccine, to see if it helps improve a condition volunteers already have, or could prevent them from developing later.

...

"Dr. Fauci’s office said the institute has no plans to fund Covid-19 human challenge trials in the future. Many bioethicists support that decision. “We don’t ask people to sacrifice themselves for the good of society,” said Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. “In the U.S., we are very much about protecting individual rights and individual life and health and liberty, while in more communal societies it’s about the greater good.”

"But Josh Morrison, a co-founder of 1Day Sooner, which advocates on behalf of more than 40,000 would-be human challenge volunteers, argues it should be his and other people’s right to take risks for the greater good. “Most people aren’t going to want to be in a Covid challenge study, and that’s totally fine, but they shouldn’t project their own choices on other people,” he said."


HT: Axel Ockenfels

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