Stumbles Wound FDA’s Reputation as Review of Vaccine Nears

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First, it was President Donald Trump accusing the agency of being part of the “deep state.” Next, it was an embarrassing misstatement about a promising Covid-19 therapy. On Friday, the agency’s new lead spokeswoman was ousted after just 11 days.

It has not been a good week for the U.S. Food and Drug Administration.

At a time when the FDA needs the public’s trust more than ever, the agency has been dragged into the political fray in a series of compounding incidents. Happening in parallel, the drug regulator is preparing to review a Covid-19 vaccine that’s both pivotal for Trump’s re-election and is likely to be one of the most scrutinized and debated medical decisions in the agency’s history.

Trump has piled on much of the pressure himself. On Saturday morning, FDA employees woke up to a tweet from the president accusing “deep state” staff at the agency of slowing vaccine and drug research to hurt his re-election.

The next day, FDA Commissioner Stephen Hahn appeared at a press conference with Trump to announce the agency’s emergency authorization of convalescent plasma, a therapy that uses antibody-laden blood plasma from recovered Covid-19 patients to treat new cases.

Hahn, however, overstated the benefits of the therapy – which are considered promising but still unconfirmed. The press conference came just days ahead of the Republican party’s political convention, at which Trump touted his response to the virus.

Hahn later apologized for his error. And in an interview with Bloomberg, he said of Trump’s “deep state” accusations about FDA staff that “none of them wants to delay getting medical products into the hands of Americans, at least that I’ve seen.”

But even Hahn has acknowledged that the pile-up of incidents pose a risk to the agency’s reputation, saying this week in an interview that it’s something that concerns him.

Inoculation Race

Vaccine research is moving at lightning speed and leading clinical trials are about halfway to their target of enrolling 30,000 patients each. The trials started at the end of July. Even then, National Institutes of Health Director Francis Collins said earlier this month his best guess is a vaccine could be ready by December.

But even as the trials race ahead, Americans have raised doubts. In a Gallup poll earlier this month, about a third of Americans surveyed said that they wouldn’t take a vaccine when it became available. Hahn and other U.S. health officials have emphasized the need for transparency and trust in the rollout of a shot.

The FDA is supposed to be “an independent arbiter of safety and efficacy, and that’s the way it has to be,” said Ron Cohen, chief executive officer of Acorda Therapeutics Inc. who served as chairman of the drugmaker lobby group BIO in 2015 and 2016. “It’s good practice, it’s good medicine and ultimately it’s good business.”

However, the fraught political environment surrounding the FDA as of late “has created a cautionary atmosphere among myself and my colleagues,” Cohen said in an interview.

“That puts a political spin on what should have been a medical issue,” Cohen said of how the blood plasma roll-out. “The issue is how it was done and how it was represented.”

Others outside the agency have been less kind in reviewing the last week.

“This level of sort of direct connection between politics and the agency is a fundamental threat to the legitimacy of the agency,” said Vinay Prasad, an associate professor of medicine at the University of California, San Francisco, who has been critical of the FDA in the past. “Reputation takes decades to build and it can be lost in a moment,” he said in an interview.

Eric Topol, director of the Scripps Research Translational Institute in California, said in an interview that, ”this is a true breach of all confidence in FDA to have the commissioner come out and say there was life-saving data for convalescent plasma.”

Hahn’s misleading statement about blood plasma was amplified by top communications officials in the Trump administration, including FDA’s chief spokeswoman Emily Miller, as well as other Trump administration officials.

Hahn removed Miller from the role on Friday, according to an email obtained by Bloomberg.

Miller had only been in the position for 11 days. She has worked at the conservative, pro-Trump media outlet One America News Network and is a gun-rights advocate, with communications expertise but no health or science background. She wrote a book titled “Emily Gets Her Gun: But Obama Wants to Take Yours.”

“Ms. Miller remains an appointee at the FDA and generally we do not discuss personnel matters,” said Stephanie Caccomo, an FDA spokeswoman. Miller didn’t respond to attempts to reach her.

The FDA’s proximity to politics and Trump have raised alarm bells since the beginning of the pandemic when Trump pushed hydroxychloroquine as a Covid-19 treatment. The FDA granted the drug an emergency authorization to be used against the virus, just days after Trump first mentioned it in March. Then, in June, the agency revoked the authorization saying it didn’t work and could in some cases carry dangerous side effects.

Trump has continued to advocate for hydroxychloroquine, with little push-back from Hahn, who has said that the decision to use a drug is between a patient and a doctor.

Trump has also publicly said he’s pushing the FDA to approve a Covid-19 vaccine as soon as possible and even said one might be ready around election day in early November. The FDA announced Thursday it scheduled a meeting of outside experts to talk about a vaccine on Oct. 22 but said the discussion would focus on vaccines generally and not a specific application from a vaccine manufacturer.

Hahn added in a statement Friday that the agency could schedule additional meetings once they get vaccine applications.

“I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible,” Hahn said in the announcement.

The date of the first scheduled meeting before the election still bothers Prasad.

“It’s hard to feel like that doesn’t reek of naked politics,” said the UCSF professor.

©2020 Bloomberg L.P.

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