FDA’s promotion of post-COVID plasma treatment was as bad as it appeared

Image of a man speaking from behind a podium.

Enlarge / FDA Commissioner Stephen Hahn, speaking at the press conference in which he badly mangled statistics. (credit: Pete Marovich/Getty Image)

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 National Institutes of Health Director Francis Collins and National Institute of Allergy and Infectious Diseases Director 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 statement with an apology on Tuesday. But Hahn pushed back against 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.

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