The F.D.A. had been considering allowing the use of convalescent plasma as a treatment for Covid-19 on an emergency basis, but last week The New York Times reported that the decision had been delayed after top health officials Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened and expressed concern that the available evidence on the effectiveness of the treatment was too weak. F.D.A. officials argued that although the data was preliminary and needed continued analysis as more patients are treated, plasma still met the agency’s standard for emergency use authorization.
On Saturday morning, Mr. Trump tweeted that the “deep state” at the F.D.A. was slowing drug development. Late that night, the White House press secretary tweeted that the president would have a news conference the next day “concerning a major therapeutic breakthrough.”
The announcement should have been a rare win for the F.D.A., which for months had fended off criticism of its track record on the pandemic, and questions about the independence of Dr. Hahn, who was previously pressured by Mr. Trump to authorize malaria drugs that turned out to be ineffective for Covid-19 and carried risks of harmful side effects. But last weekend, finally, the agency could reveal some legitimate good news: convalescent plasma, the antibody-rich plasma donated by Covid-19 survivors, showed promise for a subset of patients when given early.
The announcement, made at the White House on Sunday, has instead spurred a week of recriminations, anger and mistrust between the F.D.A. and H.H.S. The officials’ statements Sunday cast nuanced and preliminary data as “a very historic breakthrough,” as Mr. Trump put it. The exaggerated statements drew criticism from scientists and at least three former agency commissioners.
Within the F.D.A. and H.H.S., officials have offered conflicting accounts for how a single misleading statistic — that plasma led to a 35 percent reduction in deaths — appeared in the remarks of Mr. Trump, Dr. Hahn and Alex. M. Azar II, the health and human services secretary. It was also unclear why Dr. Hahn, a longtime cancer doctor, and Mr. Azar, a former pharmaceutical executive, did not themselves catch the overstated statistic. No randomized trials have found a survival benefit for convalescent plasma. The 35 percent number referred to a tiny subset of patients, and was a relative comparison between two groups, not an absolute reduction in deaths.
At a speech at the convention on Thursday evening, the president again overstated what’s known about the benefits of plasma, promising it “will save thousands and thousands of lives.”
Missteps by the F.D.A., a federal agency that has long prided itself on its scientific independence, have heightened concerns that the American public may not be willing to take a vaccine approved by the agency, particularly if the decision is seen as having been made under pressure from Mr. Trump.
Be the first to comment