Emily Miller and One other P.R. Knowledgeable Ousted At F.D.A. After Blood Plasma Fiasco

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Emily Miller and Another P.R. Expert Ousted At F.D.A. After Blood Plasma Fiasco

The F.D.A. had considered allowing the use of convalescent plasma to treat Covid-19 in an emergency, but last week the New York Times reported that the decision was delayed after leading health officials said Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, expressing concern that the available evidence of the treatment's effectiveness was too weak. F.D.A. Officials argued that although the data were preliminary and further analysis was needed as more patients were treated, the plasma still met the agency's standard for emergency approval.

On Saturday morning, Mr. Trump tweeted that the "deep condition" at the F.D.A. slowed drug development. Late that night, the White House press secretary tweeted that the president would hold a press conference the next day "about a major therapeutic breakthrough."

The announcement should have been a rare win for the FDA, which has spent months criticizing its track record regarding the pandemic and questions about Dr. Hahn, who had previously been pressured by Mr. Trump to approve anti-malarial drugs, turned out to be ineffective for Covid-19 and carries the risk of harmful side effects. But last weekend the agency was finally able to reveal some legitimate good news: convalescent plasma, the antibody-rich plasma donated by Covid-19 survivors, has shown promise for a subset of patients when given early.

The announcement, made at the White House on Sunday, instead has a week of accusations, anger and suspicion between the F.D.A. and H.H.S. Officials' statements on Sunday indicated nuanced and preliminary data as "a very historic breakthrough," as Mr Trump put it. The exaggerated statements were criticized by academics and at least three former agency commissioners.

Within the F.D.A. and H.H.S. Officials have presented conflicting reports on how a single misleading statistic – that plasma resulted in a 35 percent reduction in deaths – in the remarks of Mr Trump, Dr. Hahn and Alex appeared. M. Azar II, the Secretary for Health and Human Services. It was also unclear why Dr. Hahn, a long-time cancer doctor, and Mr. Azar, a former pharmaceutical manager, failed to understand the overrated statistics themselves. No randomized studies have found a survival benefit for convalescent plasma. The 35 percent figure related to a tiny subset of patients and was a relative comparison between two groups, not an absolute reduction in deaths.

Speaking at Congress on Thursday evening, the President again overstated what is known about the benefits of plasma and promised "to save thousands and thousands of lives".

Failures by the FDA, a federal agency long proud of its scientific independence, have increased concerns that the American public may not be ready to take an agency-approved vaccine, especially if the decision is viewed as being under pressure from Mr. Trump.

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