President Trump announced [August 23] that he had helped break through a regulatory “logjam” to grant emergency authorization of convalescent plasma to treat covid-19, a “powerful therapy” that he claimed “had an incredible rate of success,” despite the fact that his own scientists are calling for more studies to definitively show it works.
The announcement, at a news conference where Trump was flanked by Food and Drug Administration commissioner Stephen Hahn and Health and Human Services Secretary Alex Azar, drew criticism from physicians and scientists, who said their statements misled the public by overstating the evidence behind a therapy that shows promise but still needs to be rigorously tested.
“I watched this in horror,” said Eric Topol, an influential physician and scientist and director of the Scripps Research Translational Institute. “These are basically just exploratory analyses that don’t prove anything. It’s just extraordinary to declare this as a breakthrough … All this does is jeopardize ever getting the truth.”
[T]he United States has given the treatment to more than 70,000 patients through an expanded access program facilitated by the FDA and the Mayo Clinic, instead of testing it rigorously in a clinical trial. Many have pointed out that if even a small fraction of those patients had gone into such a trial, physicians and scientists would have a much better idea of how well it worked.