28 August 2020 Vol 369, Issue 6507
In plasma OK, critics see politics, not science
By Kai Kupferschmidt, Jon Cohen
Science28 Aug 2020 : 1038-1039 Full Access
FDA’s emergency move raises fears of rushed approval for other experimental medicines.
Flanked at a Sunday evening press conference by Food and Drug Administration (FDA) Commissioner Stephen Hahn, President Donald Trump claimed convalescent plasma, which comes from people who have recovered from COVID-19, was “safe and very effective,” and had been “proven to reduce mortality by 35%”—what he called “a tremendous number.” But that number has received a tremendous amount of scrutiny. It surprised even the researchers who conducted the study, which has been posted as a preprint but has yet to be peer reviewed, on which Trump apparently based the declaration. Researchers’ best guess was that it reflected cherry picking of data from a small subset of the study—and that FDA’s emergency use authorization for the plasma, issued on the eve of the Republican National Convention, represented as much political theater as science. Critics worry the evidence has been overstated and there could be worrisome consequences for the evaluation of other experimental medicines.