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FDA ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

The New York Times: “…Although there have been some positive signs that it can reduce deaths in Covid-19 patients, no randomized trials have shown that it works. A popular access program set up this spring by the F.D.A. and run by the Mayo Clinic has provided the treatment to more than 70,000 people, but it has also, some researchers said, hindered enrollment in the more rigorous randomized trials that could definitively prove whether it works. The emergency authorization released on Sunday broadens that access. Statisticians and scientists said that Dr. Hahn, in saying at the news conference that 35 out of 100 sick Covid-19 patients would have been saved by receiving plasma, appeared to have overstated the benefits. Dr. Robert Califf, who was F.D.A. commissioner under President Barack Obama, said on Twitter on Sunday that Dr. Hahn should correct his statement. The publicly released data from the Mayo Clinic shows that, among the larger group of more than 35,000 patients, when plasma was given within three day of diagnosis, the death rate was about 22 percent, compared with 27 percent when it was given four or more days after diagnosis. Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif. and a longtime expert in clinical trials, said that convalescent plasma has not yet shown the benefit that Dr. Hahn described — and that he should issue a correction…”

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