The head of the US Food and Drug Administration says he should have been more careful when explaining the benefits of convalescent plasma.
“I was trying to do what I do with patients, because patients often understand things in absolute terms versus relative terms,” Dr. Stephen Hahn told Bloomberg News in an interview Tuesday.
In a series of tweets Monday, Hahn admitted he had mischaracterized the benefits of convalescent plasma at a White House event announcing the emergency use authorization (EUA). He had said studies showed plasma could prevent 35 deaths out of 100 — something that studies did not show.
“What I was trying to get to is that if you look at 100 patients who receive high titre, and a hundred patients who received low titre, the difference between those two particular subset of patients who had these specific criteria was a 35% reduction in mortality,” he told Bloomberg. “So I frankly did not do a good job of explaining that.”
A titer refers to the concentration of something — in this case a specific antibody in a dose of convalescent plasma. The plasma is made using the blood of people who have recovered from coronavirus infections.
The misleading comments have caused concerns about how honest the FDA will be about any eventual authorization or approval of a Covid-19 vaccine.
Hahn admitted to Bloomberg he’s worried that it could hurt the FDA’s reputation with the American public.
“Absolutely, I worry about that. I can only hope that being honest and straightforward lessens that impact,” he said. “We’re in an incredibly politicized time, and these are really difficult concepts to explain to the American people.”
Source : CNN