ANALYSIS: Inside Trump’s pressure campaign on federal scientists over a covid-19 treatment

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ANALYSIS: Inside Trump’s pressure campaign on federal scientists over a covid-19 treatment

President Trump’s accusatory tweet barreled in at 7:49 a.m. a week ago Saturday: The “deep state” at the Food and Drug Administration was trying to sandbag his election prospects by slowing progress on coronavirus treatments and vaccines until after Nov. 3.

Shocked and upset, FDA Commissioner Stephen Hahn, who was tagged in the tweet, immediately began calling his contacts at the White House to find out why the president was angry. During his conversations, he mentioned the FDA was on the verge of granting emergency authorization to convalescent plasma as a treatment for covid-19. The agency planned to issue a news release.

The White House would upend those plans, turning a preliminary finding of modest efficacy into something much bigger — a presidential announcement of a “major therapeutic breakthrough on the China Virus,” as White House press secretary Kayleigh McEnany previewed in a tweet late that Saturday night.

At a news conference on the eve of the Republican National Convention, Trump lauded an emergency authorization for convalescent plasma as a “very historic breakthrough.” Hahn, who had rushed back to Washington from a family home in Colorado, was initially restrained but then doubled down on Trump’s talking points. He said that 35 of 100 people with covid-19 “would have been saved because of the administration of plasma”— a gross overstatement denounced by scientists and public health experts.

The misrepresentations became a stunning debacle for the FDA, shaking its professional staff to the core and undermining its credibility as it approaches one of the most important and fraught decisions in its history amid a divisive presidential election — deciding when a coronavirus vaccine is safe and effective. Yet again, the president had harnessed the machinery of government to advance his political agenda — with potentially corrosive effects on public trust in government scientists’ handling of the pandemic.

Hahn apologized the following day for misspeaking, saying on Twitter, “The criticism is entirely justified.” But demoralized employees felt he had allowed the agency to become a prop in the president’s reelection campaign — a bit player in a reality TV show scripted by political operatives, not scientists, according to several people familiar with their thinking who spoke on the condition of anonymity to protect the employees from retaliation....

Last week, the CDC came under fire from a host of medical and public health groups and infectious-disease experts for an abrupt change to its guidelines, which no longer recommend testing for asymptomatic people even if they had contact with an infected individual — a shift that coincides with the president’s stated desire to reduce testing.

“I’ve been following health regulatory decisions for decades and have never seen this amount of White House arm-twisting to force agencies like FDA and CDC to make decisions based on political pressure, rather than the best science,” said Jerome Avorn, a professor of medicine at Harvard Medical School, who decried the “routine policy distortions we now see nearly every week.”

The FDA’s situation is further complicated by an inexperienced commissioner who former agency leaders say failed at a critical task: to clearly explain the complicated “risk-benefit” calculation that goes into every drug authorization or approval. Hahn, a radiation oncologist with no government experience before joining the FDA last December, declined to comment for this report. He has stressed in recent days that he is committed to the independence of FDA scientists and is determined to shore up public trust. ...

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