August 26 2020
Hospitalized COVID-19 patients in the U.S. have another treatment option in the U.S. after the FDA’s emergency authorization for convalescent plasma on Sunday. But the decision prompted pushback from experts who questioned the data and wondered whether the FDA granted its green light under pressure from President Donald Trump.
In discussing the emergency use authorization Sunday, FDA Commissioner Stephen Hahn, M.D., said the treatment has been associated with a “35% improvement in survival.”
Experts were quick to point out the inaccuracies in the presentation, however, and point up the poor quality of the data, which came from an observational study, not a placebo-controlled trial. Even the FDA itself says “well-controlled randomized trials remain necessary.”
The approval followed reports last week that NIH chief Francis Collins and NIAID head Anthony Fauci had advised the FDA to hold off on authorizing plasma because so far, the data were weak. Trump on Saturday tweeted that the "deep state or whoever" was deliberately delaying coronavirus therapies until after the election—an unfounded accusation—but by Sunday morning was trumpeting a "breakthrough" announcement at a press conference later in the day.
So far, under an expanded access program, about 70,000 patients have received the plasma treatment, according to the FDA. The U.S. government’s BARDA agency funded the early access program, and Mayo Clinic served as the lead healthcare institution.
The FDA’s data are from a single-arm study, which means the plasma treatment wasn't pitted against any other treatment, not even a placebo—“which hence tells us little," Adam Gaffney, physician and Harvard Medical School instructor, said on Twitter.
The survival improvement number Hahn quoted reflects the difference between patients who received plasma with a low dose of antibodies versus a high dose, Gaffney added. Between those groups, the low dose patients appeared sicker, he added.
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