White House officials such as trade adviser Peter Navarro and outside allies such as TV host and physician Mehmet Oz also urged federal officials in 2020 to approve the antimalarial drug hydroxychloroquine as a coronavirus treatment, with Navarro and a deputy behind it. the screens worked. a hospital has filed a petition with 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 provides new details to concurrent reports of Trump’s White House efforts to influence the FDA in the first year of the coronavirus pandemic, a press campaign that rocked agency officials and confidence in vaccines and other medical devices. treatments threatened to undermine, former Commissioner Stephen Hahn told the panel.
“I felt very strongly about the fact that our scientists had made this [vaccine] guidance, I fully supported the science and the clinical data behind it, and I objected to any suggestion to change it,” Hahn said in a January 2022 interview the panel recently made public. “I also felt that any changes would be clearly reported and further reduce vaccine confidence.”
Public health officials and experts have also said Trump’s attacks on the FDA left lasting scars on the agency and contributed to dwindling confidence in health officials responding to the pandemic across the administration.
“These attacks on our country’s public health institutions undermined the country’s response to the coronavirus — which is exactly why we must never again settle for leaders who prioritize politics over protecting Americans,” said Rep. James E. Clyburn (DS.C.), the panelist chair, said in a statement.
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Republicans have labeled the work of the Democrat-led panel as politically motivated and pledged to launch their own investigation into Anthony S. Fauci, the government’s chief infectious disease expert, and the Biden administration’s response to the coronavirus, should they recapture one or both chambers of Congress this year. fall.
“For more than two years, Congressional Democrats have refused to hold a single hearing on the origins of COVID, or our government’s possible financial involvement in job gain investigations. That will change when House Republicans take the majority next year,” Rep. Steve Scalise (R-La.), the panel’s top Republican, in a statement Monday, after Fauci announced he would step down in December. Gain-of-function research involves using lab techniques to amplify a virus, which some say led to the coronavirus pandemic without evidence.
The House report, released Wednesday, focuses on several FDA decisions in 2020, including officials’ debates about how best to speed up vaccines while ensuring safe and effective vaccines. Trump publicly and privately campaigned for the FDA to act more quickly, accusing it of deliberately delaying decisions until after the November 3 election to undermine his reelection prospects.
“The deep state, or anyone else, at the FDA makes it very difficult for drug companies to get people to test the vaccines and therapies,” Trump wrote in an Aug. 22 tweet, tagging then-Commissioner Hahn. “Of course they hope to postpone the answer until after November 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 injection of the Pfizer-BioNTech or Moderna vaccines — a decision that affected the agency’s vaccine authorization decisions. would delay until after the election.
“We wouldn’t skimp on our review,” Hahn told the panel in his interview, adding that the agency had already streamlined a vaccine approval process that typically took much longer, and he feared ramifications for vaccine confidence.
“I was concerned about the whole environment: presidential elections, bitter divisions in the country and in Congress. And for me, it was a pretty significant combination of factors that led to a decline 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 and pushed for its justification, leaving FDA officials concerned about the fallout.
“The ambiguity here actually creates more problems than a decision one way or the other” about finalizing the guidelines for vaccine makers, Peter Marks, the FDA’s top vaccine official, wrote in a Sept. 29 email to Hahn and the then agency chief of staff, Keagan Lenihan.
The FDA finally bypassed the White House on Oct. 6 and published its vaccine guidelines in briefing documents for the agency’s external advisers. The White House formally approved the guidelines later that day, but Trump mocked the decision on social media.
“New FDA rules make it harder for them to speed up vaccines for approval before Election Day. Just another political hit!” Trump wrote on Twitter and again tagged Hahn in his tweet.
In his panel interview, Hahn acknowledged that the FDA faced pushback over the timeline from the White House and senior health officials, such as former Secretary of Health and Human Services Alex Azar. But Hahn said he was sure the agency had prioritized security.
“It came down to this as the most appropriate and pragmatic way to assess the vaccines,” Hahn said. “Balancing…speed to make sure we make the right decision.”
Hahn declined to comment on the report through a spokesperson on Wednesday. Azar did not immediately respond to a request for comment.
The panel’s report also details months of battles over hydroxychloroquine, the ancient malaria drug that Trump and some others seized as a coronavirus treatment despite little evidence. As of 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, urging patients to begin treatment immediately.
“We have a potential pandemic solution at our fingertips,” Oz wrote on March 23 to Jared Kushner, senior White House adviser and Trump’s son-in-law. The TV host quoted data from a French scientist that “100 percent of trial patients were virus-free after 6 days of treatment” and said a US trial of the drug should be a “national priority”.
Oz is now running as the Republican nominee for the Pennsylvania Senate. Through a campaign spokeswoman, Oz defended his work on hydroxychloroquine, saying that at the start of the pandemic, he “talked to health experts around the world who saw hydroxychloroquine and azithromycin as viable treatment options for desperately ill covid patients and he offered to run a clinical trial.” trial at Columbia University.”
The FDA initially approved hydroxychloroquine on March 29, despite skepticism from career scientists concerned about the sparse data that it was effective. But the agency withdrew its authorization for the treatment in June, amid mounting evidence that it was not working to fight the coronavirus.
“The scientific data is now really clear about the lack of efficacy,” Fauci said May 27 on CNN, warning about potentially harmful side effects to the heart.
The reversal frustrated Navarro, a top trade adviser to Trump, and Steven Hatfill, a deputy and virologist, who devised a strategy to get the FDA to reverse its decision, such as using allies such as Senator Ron Johnson (R-Wis. ), according to emails obtained by the panel.
In one case, Navarro and Hatfill worked with a hospital in Michigan group, Henry Ford Health System, to apply pressure. For example, Hatfill made a letter of request for the health system to submit to the FDA, even though he instructed the organization to “NEVER call the White House along with my name,” in a May 2020 email to a physician who led the work of the system to hydroxychloroquine. Regardless, the FDA rejected the hospital system’s request in August, after repeatedly warning about safety concerns related to the drug.
“FDA has decided that it is the [emergency authorization] for hydroxy,” Hatfill wrote in an August 2020 email to himself obtained by the panel. “That’s okay, because it was already arranged for Hahn to join Senator Johnson’s committee to answer some questions. The senator is pissed and I wrote the questions, 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 have never put any unfair pressure on anyone. We just followed the science and overwhelming evidence described in several studies available at the time,” Hatfill wrote in a statement.
In a statement, Navarro also defended his advocacy of hydroxychloroquine, citing excerpts from his memoir, “In Trump Time,” detailing his clashes with Fauci, Hahn and other officials over the drug. The House Select Subcommittee’s partisan report ‘wrongly’ perpetuates one of the most deadly lies of the pandemic, which is that the safe and potent drug to treat COVID, hydroxychloroquine, was somehow dangerous. Navarro.
The FDA did not respond to specific questions about the report.
“During the pandemic, FDA staff has been working 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,” FDA spokesman Michael Felberbaum said in a statement. declaration .
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 were no known treatments for COVID-19. When our own studies found that hydroxychloroquine was not an effective treatment, we discontinued the study and all use of the drug. … As always, the safety of our patients is our top priority.”
Alexa Henning, a spokeswoman for Johnson, wrote in a statement that the Wisconsin senator was falsely attacked by the “COVID cartel.”