FDA Commissioner botched risk numbers when talking about post-COVID plasma
John Timmer · news.movim.eu / ArsTechnica · Tuesday, 25 August, 2020 - 21:00 · 1 minute
After several days of rumors with ever-growing hype, the Trump administration announced on Sunday that the Food and Drug Administration was granting an Emergency Use Authorization (EUA) for a COVID-19 treatment. The move was controversial from the start, with reports indicating that the EUA was opposed by a number of health experts, including Francis Collins and Anthony Fauci. The press conference didn't settle matters, with a growing chorus of scientists saying that the data presented in support of the EUA had been misrepresented .
On Monday night, FDA commissioner Stephen Hahn acknowledged that he had made a significant error in presenting the benefits of the treatment, and he followed that with an apology on Tuesday . But Hahn pushed back on indications that the approval of the treatment on the eve of the Republican National Convention was motivated by political pressure.
Wrong kind of risk
The treatment at issue involves taking the antibody-containing plasma from those who have recovered from a SARS-CoV-2 infection (convalescent plasma) and giving it to those currently suffering from COVID-19 symptoms. At Sunday's press conference, the principle justification for allowing this treatment under an EUA was a 35 percent drop in mortality for those receiving plasma in the first three days of treatment—specifically, Hahn said 35 of 100 people "would have been saved" by this treatment.