August 26 2020
With the emergency use authorization (EUA) for convalescent plasma to treat COVID-19, the FDA and Commissioner Stephen Hahn, M.D., touched off a controversy—particularly about his presentation of the evidence and the political pressure from the White House.
Now, Hahn is defending the agency's move even as criticism continues and lawmakers express concern over the agency’s independence.
In a series of tweets late Monday, Hahn said the decision was made by “career scientists” at the agency “based on data submitted a few weeks ago.” Still, the timing was less than ideal, as the day before the announcement, President Donald Trump had accused the FDA of harboring “deep state” employees who are seeking to hurt the administration’s response to the pandemic.
At the plasma press briefing on Sunday, Hahn falsely said that the treatment is associated with a “35% improvement in survival.” In a tweet Monday, he corrected himself, saying the data so far show a “relative risk reduction not an absolute risk reduction.” That didn’t satisfy some experts, including physicians Eric Topol, M.D., and Adam Gaffney, M.D., who said the claims are still inaccurate.
In authorizing convalescent plasma, the FDA cited data from a single-arm observational study. The survival figure was apparently a comparison of benefit for patients who received plasma with a high dose of antibodies versus a low dose. That's not sufficient evidence to claim a survival benefit, experts said.
Following Sunday's EUA, former FDA Commissioners Scott Gottlieb, M.D., and Robert Califf, M.D., said the agency's move was legal, but they stressed the importance of the agency resisting political pressure and clearly presenting its data.
(All Rights Reserved)