“For the first time ever, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Over the next couple of months, as data emerges from vaccine clinical trials, the safety of potentially millions of people will rely on the scientific judgment of the F.D.A. “That’s a problem if they’re starting to exaggerate data,” Dr. Gellad said. On Monday, Dr. Peter Marks, the director of F.D.A.’s center for biologics, evaluation and research, said that the agency reviewed published studies of plasma and conducted its own analysis of data from the Mayo Clinic’s program of hospitalized patients who received plasma.

Source: New York Times August 25, 2020 00:09 UTC