White House officials like trade adviser Peter Navarro and outside allies like TV host and physician Mehmet Oz also pressed federal officials in 2020 to authorize hydroxychlorine as a treatment for the coronavirus, with Navarro and a deputy working behind the scenes. with a hospital to create a request to the FDA for broad access to the debunked therapy defended by Trump, the select House subcommittee on the coronavirus crisis concluded in a report released Wednesday.
The report provides new details on contemporary reports about the Trump White House’s efforts to influence the FDA in the first year of the coronavirus pandemic, a pressure campaign that rattled agency officials and threatened to undermine confidence in vaccines and other treatments. medical, former commissioner Stephen Hahn told the panel.
“I felt very strongly about the fact that our scientists had created this [vaccine] guidelines, I fully supported the science and clinical data behind it and opposed any suggestion that it be changed,” Hahn said in a January 2022 interview that the panel made public. “I also felt that any changes would definitely be reported and further reduce vaccine confidence.”
Public health officials and experts have also said that Trump’s attacks on the FDA left lasting scars at the agency and contributed to eroding confidence in health officials responding to the pandemic across the government.
“These attacks on our nation’s public health institutions undermined the nation’s response to the coronavirus — and are precisely why we must never again put in place leaders who prioritize politics over keeping Americans safe,” Rep. James E. Clyburn (DS.C.), panel chair, said in a statement.
Republicans have denounced the Democratic-led panel’s work as politically motivated and vowed to launch their own investigations into Anthony S. Fauci, the government’s top infectious disease expert, and the Biden administration’s response to the coronavirus if they retake 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 our government’s potential financial involvement in profiteering. That will change when House Republicans take over the majority next year,” Rep. Steve Scalise (R-La.), the panel’s top Republican, wrote in a statement Monday after Fauci announced he would leave in December. Gain-of-function research involves using laboratory techniques to improve a virus that some argue without evidence led to the coronavirus pandemic.
The House report released Wednesday focuses on several FDA decisions in 2020, including officials’ debate over how best to speed up vaccines while ensuring they are safe and effective. Trump has publicly and privately campaigned for the FDA to move faster, accusing it of deliberately delaying decisions until after the Nov. 3 election to hurt his re-election prospects.
“The deep state, or whoever, at the FDA is making it very difficult for drug companies to get people in order to test vaccines and therapies,” Trump wrote in an Aug. 22 tweet, tagging the commissioner of then Hahn. “Obviously, they hope to delay the response until after November 3rd. We must focus on speed and save lives!”
A Trump spokesman did not immediately respond to a request for comment.
Behind the scenes, top FDA officials concluded by September that they wanted to review two months of safety data after clinical trial participants had received the second shot of the Pfizer-BioNTech or Moderna vaccines — a decision that would delay the agency’s vaccine authorization decisions until after the election.
“We weren’t going to cut corners in our evaluation,” Hahn told the panel in his interview, adding that the agency had already streamlined a vaccine authorization process that typically took much longer and he feared ramifications for vaccine confidence. .
“I was worried about the whole environment: the presidential election, the bitter divisions in the country and in Congress. And, to me, it was a pretty significant combination of factors that led to a decrease in trust in science and medicine,” Hahn said.
But after the FDA presented its planned September 2020 timeline for approval, Trump officials delayed the agency’s request, pressing for its reasoning, leaving FDA officials worried about the fallout.
“The ambiguity here is actually creating more problems than a decision one way or the other” for finalizing guidance for vaccine makers, Peter Marks, the FDA’s top vaccine official, wrote in a Sept. 29 email to Hahn and the then head of the agency. of staff, Keagan Lenihan.
The FDA finally bypassed the White House on Oct. 6, publishing its vaccine guidelines in briefing papers. for the agency’s external advisors. The White House later that day formally approved the guidance — but Trump mocked the decision on social media.
“The FDA’s new rules make it harder for them to fast-track vaccines for approval before Election Day. Just another successful political job!” Trump tweeted, again tagging Hahn in his tweet.
In his interview with the panel, Hahn acknowledged that the FDA faced pushback from the White House and top health officials, such as former Health and Human Services Secretary Alex Azar. But Hahn said he was confident the agency had prioritized security.
“This came about as the most convenient and pragmatic way to evaluate vaccines,” Hahn said. “Balancing speed with making sure we made the right decision.”
Through a spokesman Wednesday, Hahn declined to comment on the report. Azar did not immediately respond to a request for comment.
The panel’s report also details the months-long battle over hydroxychlorine, the malaria drug that Trump and some others have seized on as a cure for the coronavirus despite scant 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 urged patients to begin treatment immediately.
“We have a potential pandemic solution at our fingertips,” Oz wrote on March 23 to Jared Kushner, a senior White House adviser and Trump’s son-in-law. The TV host cited data provided by a French scientist that “after 6 days of treatment, 100 percent of trial patients were virus-free” and said that an American study of the drug should be a “national priority.”
Oz is now running as the Republican candidate for Senate in Pennsylvania. Through a campaign spokeswoman, Oz defended his work on hydroxychlorine, saying that at the start of the pandemic, he “spoke to health experts around the world who were looking at hydroxychlorine and azithromycin as possible treatment options for patients with desperate Covid and he offered to fund a clinical trial at Columbia University.”
The FDA initially authorized hydroxychlorine on March 29, despite skepticism from career scientists concerned about the scant evidence that it was effective. But the agency revoked authorization of the treatment in June amid mounting evidence that it did not work to fight the coronavirus.
“The scientific data is really quite clear now about the lack of efficacy,” Fauci said on CNN on May 27, warning of potentially heart-damaging side effects.
The reversal frustrated Navarro, a top trade adviser to Trump, and Steven Hatfill, a lawmaker and virologist, who strategized how to pressure the FDA to reverse its decision, such as . the use of external allies such as Sen. Ron Johnson (R-Wis. ), according to emails obtained by the panel.
In one case, Navarro and Hatfill worked with a Michigan-based hospital The group, Henry Ford Health System, to pressure the FDA. For example, Hatfill drafted a request letter that the health system could submit to the FDA, though he instructed the organization to “never mention the White House along with my name,” in a May 2020 email to a physician who leads system performance for hydroxychlorine. Despite this, the FDA in August denied the hospital system’s request, repeatedly warning of safety concerns about the drug.
“The FDA has decided not to renew it [emergency authorization] for hydroxy,” Hatfill wrote in an August 2020 email to himself that was obtained by the panel. “That’s okay because it was already arranged for Hahn to go before Senator Johnson’s Committee to answer some questions. The senator is upset and I wrote the questions – so it should be a good show.”
Through a spokesman, Hatfill acknowledged his work with Henry Ford Health System and said his actions to encourage hydroxychlorine were appropriate. “We have never pressured anyone badly. We simply followed the science and overwhelming evidence detailed in the few studies available at the time,” Hatfill wrote in a statement.
In a statement, Navarro also defended his advocacy of hydroxychlorine, 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, namely that the safe and powerful therapy for treating COVID, hydroxychloroquine, was somehow dangerous,” Navarro wrote.
The FDA did not respond to specific questions about the report.
“Throughout the pandemic, FDA career 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 will launch an investigation into the report’s claims. “Like other health systems, we participated in a number of studies and clinical trials, including hydroxychlorine, during a time when there were no known treatments for COVID-19. When our studies determined that hydroxychlorine 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.”
Alexa Henning, a spokeswoman for Johnson, wrote in a statement that the Wisconsin senator was being falsely attacked by “the COVID cartel.”
