Breaking down the tug of war over the FDA and convalescent plasma

A big story that slipped under the radar during last night’s RNC: The FDA commissioner apologized for overselling the benefits of convalescent plasma for treating the coronavirus.

Why it matters: The FDA is supposed to be a Switzerland of neutrality within government, able to act based on science instead of pressure from politicians and big business.

  • “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” said FDA Commissioner Stephen Hahn.

The big picture: The Trump administration has publicly pressured the FDA on granting an emergency use authorization for plasma.

  • President Trump and trade adviser Peter Navarro have privately and publicly criticized the FDA for holding up authorization, accusing staffers of being part of the “deep state.”
  • Trump said plasma “has proven to reduce mortality by 35%” in a Sunday press conference.
  • Hahn echoed Trump’s comments, which he apologized for last night, saying what he “should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

Between the lines: Public health leaders made a public outcry against quick approval of the treatment.

  • That includes top NIH scientists Francis Collins, Anthony Fauci and H. Clifford Lane.
  • “The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the New York Times.
  • Hahn said yesterday that the final decision “was made by FDA career scientists based on data submitted a few weeks ago.”

The bottom line: Hahn’s predecessor Scott Gottlieb tweeted: “I am confident in the science part of the evaluation executed by CBER. The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you loose [sic] it in buckets.”

Originally published: 2020-08-25 16:06:20

Source link – www.axios.com

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