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Wednesday, September 30, 2020

FDA ousts spokeswoman after Covid-19 therapy misstatements

Reliable and accurate information about drugs and science is widely considered a crucial part of the FDA’s role.

By: Bloomberg | August 30, 2020 11:12:34 am
FDA, FDA ousts official, FDA official fired, FDA news, Indian ExpressThe Food and Drug Administration headquarters on July 20, 2020 in White Oak, Maryland. (Photo via Bloomberg)

The US Food and Drug Administration has ousted its chief spokeswoman, said a person with knowledge of the move, days after the head of the agency exaggerated the benefits of an experimental coronavirus therapy and others in the Trump administration promoted the erroneous statements. The spokeswoman, Emily Miller, joined the agency this month. She came to the job with communications experience in past government positions, a stint at conservative media outlets, and work advocating for gun rights, but little to no health-care experience.

“Emily Miller is no longer the head of OMA,” according to an email that was circulated to members of the FDA’s office of media affairs, and has been obtained by Bloomberg News. “We are working through next steps in terms of what our team structure looks like. We appreciate your hard work and will continue to keep you informed as we learn more.”

Miller still has a job at the FDA while the White House, which appointed her to the agency, decides her employment status, an administration official said on Saturday.

It’s unclear what role Miller will perform in the meantime. She didn’t respond on Friday to attempts to reach her.

The news of Miller’s ouster as FDA spokeswoman was first reported by the New York Times.

Miller’s removal from her role as chief spokeswoman came after a press conference Sunday at which FDA Commissioner Stephen Hahn said that convalescent blood plasma — an experimental treatment that uses plasma from recovered Covid-19 patients to treat those currently infected — could save 35 out of 100 people.

That was incorrect. The FDA only had data showing that a higher concentration of the treatment was better than a lower one. While the therapy is considered promising, there is no hard evidence yet that it actually saves lives.

Hahn’s misstatement about the proven effectiveness of blood plasma was repeated by others in the Trump administration, including Miller, on social media. On Thursday night, she posted a Tweet from her personal account quoting President Donald Trump making a similar claim, that blood plasma would save “thousands and thousands of lives.”

Reliable and accurate information about drugs and science is widely considered a crucial part of the FDA’s role. The agency is relied upon to regulate drugs, including the provision of information to doctors and patients about how well they work. It also polices exaggerated claims about products.

The exaggeration of the known benefits of blood plasma haven’t been limited to Miller. As of Friday morning, the FDA’s official Twitter account also hadn’t deleted a video of Hahn’s erroneous statement from the press conference with Trump.

Michael Caputo, a Trump appointee who leads communications at the Department of Health and Human Services, also posted a similar claim about the therapy and has not removed his post.

Caputo didn’t respond to calls and emails asking for comment on Friday. A spokeswoman for the Health and Human Services Department declined to comment.

On Friday afternoon, Caputo moderated a briefing with reporters during which government officials highlighted the importance of ensuring there is complete and accurate information about the government’s evolving plans to distribute a vaccine.

Drugmakers, backed by the government, have been racing to develop a Covid-19 inoculation. Clinical trials are underway, but any vaccine is likely to be first available under a limited, emergency authorization.

At least one poll, by Gallup, has shown that a third of Americans surveyed would be hesitant to get the shot, even if it were free. Hahn, in an interview earlier this week, said that he was worried that the blood plasma episode, combined with a period of strained U.S. politics, could hurt public perception of the agency.

“I worry about that. I can only hope that being honest and straightforward lessens that impact,” he said in the interview.

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