Trump administration sought to pressure FDA on COVID vaccines and treatment, House panel finds

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Former Food and Drug Administration Commissioner Stephen Hahn, featured during a coronavirus pandemic briefing in April 2020. (Jabin Botsford/The Washington Post)

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Trump officials have repeatedly blocked the Food and Drug Administration’s plan to expand coronavirus vaccine safety studies into fall 2020, as then-President Donald Trump pressed the agency for a faster timeline so vaccines can be authorized before Election Day, according to emails, text messages and interviews conducted by a congressional panel probing the response to the pandemic.

White House officials such as trade adviser Peter Navarro and outside allies such as TV host and physician Mehmet Oz also pressed federal officials in 2020 to authorize hydroxychloroquine as a coronavirus treatment, Navarro and a deputy working behind the scenes with a hospital to craft a request to the FDA for widespread access to the debunked therapy touted by Trump, the House Select Subcommittee on the Coronavirus Crisis concluded in a report released Wednesday.

The report offers new details on contemporary reports of Trump’s White House efforts to influence the FDA during the first year of the coronavirus pandemic, a pressure campaign that has rattled agency officials and threatened to undermine confidence in vaccines and other medical treatments, former commissioner Stephen Hahn told the panel.

“I was very attached to the fact that our scientists had created this [vaccine] advice, I fully support the science and the clinical data behind it, and I object to any suggested changes,” Hahn said in a January 2022 interview that the panel recently made public. “I also felt that any changes would obviously be flagged and would further reduce confidence in vaccines.”

Through a spokesperson on Wednesday, Hahn declined to comment on the report.

Public health officials and experts have also said Trump’s attacks on the FDA have left lingering scars on the agency and contributed to a loss of faith in health officials responding to the pandemic overall. of the government.

“These attacks on our country’s public health institutions have undermined the nation’s response to the coronavirus – and are precisely why we must never again settle for leaders who prioritize politics over security. of Americans,” said Rep. James Clyburn, DS.C., chairman of the panel. in a report.

Republicans have criticized the work of the Democratic-led panel as politically motivated and have pledged to launch their own investigations into Anthony Fauci, the government’s top infectious disease expert, and the Biden administration’s coronavirus response. whether they take over one or both houses of Congress this fall.

“For more than two years, congressional Democrats have refused to hold a single hearing on the origins of COVID, or on our government’s possible financial involvement in gain-of-function research. That will change when House Republicans take a majority next year,” Rep. Steve Scalise, R-La., the top Republican on the panel, wrote in a statement Monday, after Fauci announced he was resigning in december.

The House report released Wednesday focuses on several FDA decisions in 2020, including officials’ debates over how best to fast-track vaccines while ensuring their safety and effectiveness. Trump has campaigned publicly and privately for the FDA to act faster, accusing it of deliberately delaying decisions until after the Nov. 3 election to undermine his re-election prospects.

“The deep state, or whoever, at the FDA makes it very difficult for pharmaceutical companies to get people to test vaccines and therapeutics,” Trump wrote in an Aug. 22 tweet, identifying the commissioner. of the time, Hahn. “Obviously they are hoping to delay the response after Nov 3. Must focus on speed and saving lives!

A Trump spokesperson did not immediately respond to a request for comment.

Behind the scenes, senior FDA officials concluded in September that they wanted to review two months of safety data after clinical trial participants received their second shots of the Pfizer-BioNTech or Moderna vaccines — a move that would delay the agency’s vaccine licensing decisions until after the election.

“We weren’t going to cut corners on our assessment,” Hahn told the panel during his interview, adding that the agency had already streamlined a vaccine authorization process that typically took much longer and that he feared impact on confidence in vaccines.

“I was concerned about the whole environment: a presidential election, bitter divisions in the country and in Congress. And, for me, that was a pretty big combination of factors that led to a decrease in trust in science and medicine,” Hahn said.

But after the FDA submitted its planned timeline for approval in September 2020, Trump officials delayed the agency’s request, pushing for its justifications, prompting FDA officials to worry about the fallout.

“The ambiguity here actually creates more problems than a decision one way or the other” on finalizing guidance to vaccine makers, wrote Peter Marks, the FDA’s top vaccine official, in a Sept. 29 email to Hahn and the then-head of the agency. staff, Keagan Lenihan.

The FDA finally bypassed the White House on Oct. 6, releasing its vaccine guidelines in briefing documents for the agency’s outside advisers. Later that day, the White House officially endorsed the guidelines – but Trump mocked the decision on social media.

“New FDA rules make it harder for them to fast-track vaccine approvals before Election Day. Just another political success! Trump wrote on Twitter, again tagging Hahn in his tweet.

In his interview with the panel, Hahn acknowledged that the FDA faced a rollback on its timeline from the White House and senior health officials, such as the former Health and Human Services Secretary. Alex Azar. But Hahn, he said he was confident the agency prioritized safety.

“This was the most appropriate and pragmatic way to evaluate vaccines,” Hahn said. “Balancing. . . speed to ensure that we have made the right decision.

Azar did not immediately respond to a request for comment.

The panel’s report also details months-long battles over hydroxychloroquine, the malaria drug that Trump and others have seized on as a coronavirus cure despite little evidence.

Beginning in March 2020, Hahn and other health officials were inundated with messages from pro-hydroxychloroquine commentators, including emails from Fox News host Laura Ingraham and Oz, who called on patients to start immediately. to receive the treatment.

“We have a potential pandemic solution at hand,” Oz wrote to Jared Kushner, senior White House adviser and Trump son-in-law, on March 23. The TV host cited data provided by a French scientist that “after 6 days of treatment, 100% of patients in the trial were virus-free” and said a US study of the drug should be a “national priority”.

“What do you recommend to speed up? Kushner replied

Oz is now running as a Republican candidate for the Pennsylvania Senate. His campaign did not immediately respond to a request for comment.

The FDA initially cleared hydroxychloroquine on March 29, despite skepticism from career scientists worried about scant data on its effectiveness. But the agency revoked authorization for the treatment in June, amid mounting evidence that it hasn’t worked to fight the coronavirus.

“The science is really pretty clear now on the lack of efficacy,” Fauci said on CNN on May 27, warning of potentially heart-damaging side effects.

The reversal frustrated Navarro, one of Trump’s top trade advisers, and Steven Hatfill, a deputy and virologist, who strategized on how to pressure the FDA to reverse its decision, for example. using outside allies such as Senator Ron Johnson, R-Wis. , according to emails obtained by the panel.

In one instance, Navarro and Hatfill worked with a Michigan-based hospital group, Henry Ford Health System, to lobby the FDA. For example, Hatfill drafted a letter of demand that the healthcare system could submit to the FDA, although he demanded that the hospital system conceal White House involvement. Either way, the FDA in August denied the hospital system’s request, after repeatedly warning about safety issues with the drug.

“The FDA has decided not to renew the [emergency authorization] for hydroxy,” Hatfill wrote in an August 2020 email that was obtained by the panel. “It’s OK because Hahn was already scheduled to be on Senator Johnson’s committee to answer some questions. The senator is pissed, and I wrote the questions down – so it should be a good (show).

Through a spokesperson, Hatfill acknowledged his work with Henry Ford Health System and said his actions to encourage hydroxychloroquine were appropriate. “We never wrongfully pressured anyone. We simply followed the science and the overwhelming evidence as detailed in several studies available at the time,” Hatfill wrote in a statement.

In a statement, Navarro also defended his advocacy for hydroxychloroquine, citing excerpts from his memoir, “In Trump Time,” which details his clashes with Fauci, Hahn and other officials over the drug.

“The House Select Subcommittee’s partisan report ‘wrongly perpetuates’ one of the deadliest lies of the pandemic, that the safe and potent therapeutic to treat COVID, hydroxychloroquine, was somehow dangerous,” said writes Navarro.

The FDA did not respond to specific questions about the report.

“Throughout the pandemic, career FDA staff have worked around the clock to make the best science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency,” said FDA spokesman Michael Felberbaum said in a statement. .

Henry Ford Health System said it would launch an investigation into the report’s allegations. “Like other health systems, we participated in a number of studies and clinical trials, including for hydroxychloroquine, at a time when there was no known treatment for COVID-19. When our own studies determined that hydroxychloroquine was not an effective treatment, we suspended the study and all use of the drug. … As always, the safety of our patients is our top priority.

Johnson did not immediately respond to requests for comment.

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