FDA Grants Emergency Authorization for Covid-19 Plasma Treatments Because Science Schmience

Illustration for article titled FDA Grants Emergency Authorization for Covid-19 Plasma Treatments Because Science Schmience
Photo: Saul Loeb (Getty Images)

The Food and Drug and Administration has issued an emergency use authorization for convalescent blood plasma as an experimental treatment for covid-19 patients. And President Donald Trump, per his usual M.O., found a way to put himself at the center of the announcement—no doubt in a bid to drum up some good press on the eve of the Republican National Convention.

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“Today’s action will dramatically expand access to this treatment,” Trump said at a last-minute press conference Sunday. “We’re removing unnecessary barriers and delays.”

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This experimental treatment uses the blood of recovered covid-19 patients who have built up antibodies against the virus and infuses it into people with severe cases of covid-19, with the idea being that those antibodies will keep them from getting even sicker, according to the Mayo Clinic, which is currently conducting studies on convalescent plasma treatment.

But it still remains very much an experimental treatment, one of many being studied in the rush to create a vaccine. Clinical trials have a long way to go in establishing whether or not convalescent plasma therapy works, and just earlier this month the FDA postponed its plans to announce an emergency use authorization pending further study, with Dr. Anthony Fauci and other top federal health officials arguing that the emerging data was still too weak for such a definitive move.

In a very on-brand response, Trump took to Twitter and accused the FDA of being run by “the deep state” and impeding the vaccine approval process, which is far from the first baseless conspiracy theory he’s tweeted. Another supposed covid-19 cure he touted online and in-person, hydroxychloroquine, had its emergency use authorization later revoked after additional studies found it largely “unlikely to kill or inhibit the virus that causes COVID-19.”

In an announcement following sustained pressure from the White House, the FDA issued a statement Sunday saying it had determined “the known and potential benefits of COVID-19 convalescent plasma when used to treat COVID-19 outweigh the known and potential risks of such products.” However, the FDA also warned that convalescent plasma treatment “should not be considered a new standard of care for the treatment of patients with COVID-19,” and that ongoing clinical trials would proceed throughout the coming months to gather additional data. The FDA previously said that 70,000 patients have been treated with convalescent plasma therapy to date.

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FDA Commissioner Stephen Hahn, who spoke at the briefing, said the decision was made in the “independent judgment” of medical experts at the agency, and that data so far had shown a 35% improvement in survival for patients treated with convalescent plasma. Health and Human Services Secretary Alex Azar echoed these findings.

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“Convalescent plasma has been a tried-and-true therapeutic treatment in prior outbreaks. We dream in drug development of something with a 35% mortality reduction. This is a major advance in the treatment of patients,” Azar said.

An emergency authorization order typically opens up experimental therapy to a wider variety of patients, but the FDA’s decision in this case has a much more limited scope given the lack of controlled clinical trials to prove the treatment’s effectiveness. But I suppose the announcement did what it was intended to do: put Trump front and center on everyone’s radar for doing something about the ongoing coronavirus pandemic, which has killed more than 176,000 people in the U.S. to date. Even if that something is still woefully inadequate.

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Gizmodo weekend editor. Freelance games reporter. Full-time disaster bi.

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DISCUSSION

Dr Emilio Lizardo

Studies have obviously not been definitive or it would have been approved before now and approved with much stronger language. Basically this amounts to “it might work (hey, anything is possible!) and it probably won’t hurt you,” which is a very weak approval from the FDA. This was obviously done due to political pressure from a desperate man looking for any kind of win he could overhype.

The study was not even designed to test efficacy, just safety. In their analysis, they noticed that people who got it within 3 days of diagnosis had an 8.7% death rate, after 4 days it was 11.9%. That doesn't mean it saves 35% of people who got it as has been reported. We don't know if it saves anybody since there is no control group. Anybody who says otherwise doesn't understand how research works or how statistical analysis is done.

One thing is for sure. Making it available off trial means fewer people will participate in trials, meaning it will take longer to figure out whether or not it actually helps. But Donny doesn’t care about that. He just needs something positive because he’s got an election coming up. If it works, great! But it is more important that he have something to spin.

This is just one more example of magical thinking and the politicization of science. We need to vote this clown out of office.