Healthcare

House panel details Trump pressure on FDA for discredited COVID treatment, vaccines

Top Trump administration officials pressured the Food and Drug Administration (FDA) to reauthorize the discredited COVID-19 treatment hydroxychloroquine, and to speed up the release of the first COVID-19 vaccines, according to a new report Democrats on the House select coronavirus subcommittee released Wednesday.

Emails, text messages and testimony obtained by the committee show the Trump White House “exerted extreme and inappropriate pressure” on the FDA to reauthorize hydroxychloroquine even after it was shown to be ineffective and potentially dangerous.

The report found administration officials like trade adviser Peter Navarro enlisted outside allies like Fox News host Laura Ingraham and daytime TV talk show host Mehmet Oz — now the GOP nominee for Senate in Pennsylvania — to amplify pressure on the FDA to authorize hydroxychloroquine, a drug normally used to treat malaria and lupus, as a COVID-19 treatment.

Hydroxychloroquine has been heavily promoted as a treatment for the virus by Trump allies despite almost no evidence.

Navarro and Steven Hatfill, an adjunct assistant professor at George Washington University brought on by Navarro as an adviser to the coronavirus response, led coordinated attacks on FDA Commissioner Stephen Hahn, infectious disease expert Anthony Fauci and other health officials who refused to support hydroxychloroquine.

“Newly released evidence shows that Dr. Hatfill and Mr. Navarro used their direct access to top public health officials in an attempt to strongarm them into supporting hydroxychloroquine,” the report stated. 

The FDA issued an emergency use authorization for hydroxychloroquine in late March 2020, but then revoked it less than three months later.

The report also details how the Trump administration influenced the FDA to deliver misleadingly positive news about convalescent plasma as a coronavirus treatment on the eve of the 2020 Republican National Convention (RNC) and White House attempts to block the FDA from collecting additional safety data on the first coronavirus vaccine in an attempt to ensure that it could be authorized before the 2020 presidential election. 

Trump later attacked Hahn, without evidence, for deliberately slowing down the authorizations of the vaccine and convalescent plasma because of politics.   

“The Select Subcommittee’s findings that Trump White House officials deliberately and repeatedly sought to bend FDA’s scientific work on coronavirus treatments and vaccines to the White House’s political will are yet another example of how the prior Administration prioritized politics over public health,” Rep. James Clyburn (D-S.C.), the panel’s chair, said in a statement.

The efforts by members of the Trump administration, including the former president, to meddle with public health agencies has been well documented. However, the report offers new levels of detail on the pressures put on the FDA in 2020. 

Clyburn noted the Trump administration’s attacks on public health officials helped contribute to a politicization of science, and reduced the public’s trust in the government.

“These assaults on our nation’s public health institutions undermined the nation’s coronavirus response—and are precisely why we must never again settle for leaders who prioritize politics over keeping Americans safe,” Clyburn said.

In testimony before committee staff, Hahn said he felt pressure because of Navarro’s “persistence” in insisting that hydroxychloroquine worked and should be reauthorized, despite strong evidence to the contrary.

“We took a different stance at the FDA,” Hahn said. “So that disagreement, which of course ultimately became somewhat public, was a source of pressure.” 

In an emailed statement, Navarro said the select subcommittee was “wrongly” perpetuating that hydroxychloroquine “was somehow dangerous.”

Navarro also cited excerpts from his memoir that chronicled his clashes with what he described as the “never-Trump FDA.”

The subcommittee report also details how the FDA wanted to advise vaccine manufacturers that the FDA wanted 60 days worth of follow-up patient safety data before applications for emergency use authorization were filed. That request would mean authorization wouldn’t occur until after the November 2020 election.

Trump had repeatedly said the shots would be authorized before Election Day, despite experts and agency scientists signaling it was unlikely.

Hahn told the committee the agency faced “pushback about the issue” from multiple officials, including Trump’s chief of staff, Mark Meadows. Meadows said the White House wouldn’t sign off on the guidance, because of the 60-day requirement. 

The agency eventually circumvented the White House by quietly publishing the 60-day data request as part of a larger set of background documents for industry. Meadows later that day told Hahn the White House had cleared the release of the guidance.

Trump later attacked the FDA on Twitter.

“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump wrote, tagging Hahn.

Tags Coronavirus COVID-19 COVID-19 hydroxychloroquine James Clyburn Mehmet Oz Peter Navarro Stephen Hahn Trump administration Trump COVID-19 response
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