Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend


President Trump appears to be like on whereas FDA Commissioner Stephen Hahn speaks throughout an Aug. 23 press convention.

Finding himself in a good spot after a weekend of occasions that drew sharp criticism of his efficiency, Food and Drug Administration Commissioner Stephen Hahn took to Twitter Monday night time to defend his report and supply a mea culpa for misrepresenting the good thing about a Covid-19 therapy.

On Saturday, President Donald Trump tweeted, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test vaccines and therapeutics. Obviously, they are hoping to delay the answer until November 3rd. Must focus on speed, and saving lives.”

But regardless of Trump tagging Hahn in the tweet, the defamation of 18,000 profession FDA staff, whose job it’s to make sure that medication and vaccines are secure and efficient earlier than getting into the market, met no criticism or pushback from the commissioner.

A day later, the company granted, with nice fanfare, an emergency use authorization for convalescent plasma as a therapy for Covid-19, calling it “another achievement in administration’s fight against pandemic” in the headline of the press launch. That determination got here regardless of an earlier transfer to show down the EUA resulting from what federal well being officers noticed as inadequate robustness of the information, however there was no rationalization for the reversal. Moreover, Hahn claimed erroneously that one in every of the fundamental sources of knowledge supporting the EUA, from a Mayo Clinic-sponsored expanded entry protocol – not a randomized, managed trial – posted to a preprint server, confirmed a 35% discount in mortality, a gross misstatement on which the FDA nonetheless doubled down in a subsequent tweet.

Harsh criticism quickly adopted.

In an op-ed Monday morning, Los Angeles Times enterprise columnist Michael Hiltzik wrote that “Thanks to Trump, the FDA just had the worst day in its history” and questioned why Hahn was nonetheless in his job. While Hahn has acknowledged he would resign if Trump sought to approve a Covid-19 vaccine prematurely, “His kowtowing to Trump suggests he can’t be trusted to do so,” Hiltzik wrote.

STAT biotech columnist Adam Feuerstein compared Hahn’s remarks to the “nonsensical, inflated claims” he has lengthy heard from biotech CEOs touting the advantages of their medication.

In a series of tweets Monday night time, Hahn – former chief medical government of The University of Texas MD Anderson Cancer Center and a political novice who has served as FDA commissioner since final November – acknowledged the error, calling criticism for it “entirely justified” and clarifying that he ought to have stated the information present a relative threat discount reasonably than an absolute threat discount. He sought to reassure the public that FDA selections in what “happens to be a political season” will stay data-driven.

“Media coverage of FDA’s decision to issue emergency use authorization for convalescent plasma has questioned whether this was a politically motivated decision,” Hahn wrote. “The decision was made by FDA career scientists based on data submitted a few weeks ago.”

But that didn’t assuage critics.

Scripps Research Translational Institute founder Eric Topol recommended a press convention to appropriate the report, together with a repair to the press launch’s headline, including that such “serious mistakes” undermine his and the FDA’s credibility. Andy Slavitt, performing administrator of the Centers for Medicare and Medicaid Services below the Obama administration, called for Hahn to resign and inform “the story of interference” in an effort to “protect” the company.

Photo: Pete Marovich, Getty Images