Advisers to former President Donald Trump pressed the FDA to reauthorize a drug as a Covid-19 treatment even after the agency said it lacked efficacy and posed safety concerns, according to a congressional report obtained by Bloomberg Law.
The report from the House Select Subcommittee on the Coronavirus Crisis argued that officials in the Trump White House “executed coordinated pressure campaigns” to influence actions at the Food and Drug Administration, including efforts to promote hydroxychloroquine.
Trump repeatedly touted the immunosuppressive drug, which the FDA initially authorized in March 2020 as a treatment for certain hospitalized Covid-19 patients. The agency revoked the emergency use authorization in June 2020 after determining the drug’s benefits didn’t outweigh its risks.
The subcommittee’s document, which also alleges other efforts to promote convalescent plasma as a Covid-19 treatment ahead of the 2020 Republican National Convention, marks the second in a series unveiling findings from an investigation into Trump administration interference with federal health agency responses to the pandemic.
The latest report is based on thousands of pages of internal correspondence from top administration officials and other previously unreleased documents, as well as an interview with former FDA Commissioner Stephen Hahn.
The report shows 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,” Committee Chair James Clyburn (D-S.C.) said in a press release.
“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,” he added.
Hahn, who led the FDA from December 2019 to January 2021, told subcommittee staff in a January 2022 interview that he had several discussions about hydroxychloroquine with Peter Navarro, the policy director for the White House Office of Trade and Manufacturing under Trump, according to a previously unreleased committee transcript.
Hahn said Navarro “was very demonstrative about his belief” that it “would work, and was working, and that it had met the statutory standard for an EUA,” even though the FDA had revoked the drug’s emergency authorization.
“There were discussions that I had with Mr. Navarro that I would say probably rose to the level” of “pressure,” due to “how many times and almost how relentless it was,” Hahn told House subcommittee staff.
Navarro said in an emailed statement Wednesday that the FDA “wrongly” determined that using hydroxychloroquine to treat Covid-19 was “somehow dangerous.” The FDA has cited several adverse events associated with the drug in hospital and outpatient settings when treating or preventing Covid-19, including abnormal heart rhythms and some fatalities.
The latest findings come about two months after the subcommittee released a report detailing how proponents of a widely discredited strategy of herd immunity via mass infection attempted to influence the Trump administration’s pandemic response.
The first report drew from internal documents and committee interviews with several senior administration officials, including former White House Coronavirus Response Coordinator Deborah Birx and former Centers for Disease Control and Prevention Director Robert Redfield.
“It is very disturbing to see all the details of a coordinated campaign to overturn the scientific decisions at FDA,” Joshua M. Sharfstein, a former second-in-command at the FDA during the Obama administration, told Bloomberg Law Wednesday.
Sharfstein, now vice dean for public health and community engagement at Johns Hopkins University’s public health school, said it’s not “wrong for White House political appointees or others to understand what’s going on at the FDA,” and “there are some broad policy directions that an administration should be able to set.”
“But when it comes to reviewing a particular scientific regulatory judgment, I never saw anything like what’s described in here,” he said of the committee’s latest report.
The subcommittee in its report detailed alleged efforts by Navarro and other officials to influence thinking on hydroxychloroquine by mobilizing support both within and outside the administration.
Hydroxychloroquine is currently approved by the FDA to treat or prevent malaria, as well as autoimmune conditions like rheumatoid arthritis. Since revoking the emergency use authorization, the agency has said the drug should only be used to treat Covid-19 in clinical trial settings.
According to internal documents and emails obtained by the subcommittee, Navarro enlisted the help of Steven Hatfill, who was an adjunct assistant professor at George Washington University and worked as a volunteer for the White House’s Covid-19 response. Hatfill spoke of a “knife fight scheduled with the FDA” over hydroxychloroquine in an email with an individual outside the White House.
The subcommittee also said it identified more than 35 previously unreleased emails revealing that Navarro and Hatfill used personal email accounts to conduct official business on the federal pandemic response. The Department of Justice sued Navarro earlier this month over alleged violations of the Presidential Records Act, which prohibits the use of private email accounts to conduct official business without taking steps to make record of the communications.
Navarro said Wednesday that “all my White House records are digitally preserved pending the resolution of a civil suit filed by the National Archives,” which he added “increasingly appears to have been unlawfully weaponized by the Department of Justice against both me and President Trump.”
Emails obtained by the subcommittee also showed Hatfill sought to gauge interest among researchers on launching a study to demonstrate the purported benefits of hydroxychloroquine. According to the report, Hatfill wrote in an August 2020 email to a University of Florida professor that he expected to “shortly have access” to millions in government funding for clinical trials on the treatment.
Hatfill also allegedly pushed for Fauci, Hahn, and other officials who refused to support hydroxychloroquine to be fired and federally investigated, and claimed in an email to Navarro that Fauci and Hahn “have blood on their hands” for not supporting the widespread use of hydroxychloroquine.
Navarro reiterated this criticism Wednesday, citing his 2021 memoir on his time in the White House that he said details why “hundreds of thousands of Americans would needlessly die because of Stephen Hahn, Janet Woodcock, Rick Bright, Tony Fauci, and the broader FDA bureaucracy.”
“The result will forever be a stain on the FDA,” he said.
Hahn said in his committee interview that he wasn’t familiar with Hatfill nor calls for him or Fauci to be replaced.
Members of the Trump administration also reportedly sought to push for the authorization of convalescent plasma as a Covid-19 treatment, and officials’ objections to FDA vaccine authorization guidance in part delayed its release to the public, according to the subcommittee’s report.
The FDA issued an EUA for investigational convalescent plasma to treat Covid-19 in hospitalized patients in August 2020. The agency has since updated the authorization to include additional testing requirements during manufacturing, and has limited its use to hospitalized Covid-19 patients early in their disease course.
On Aug. 22, 2020, Trump tweeted criticism of the FDA, accusing it of being part of the “deep state” and deliberately stalling decisions on therapeutics like convalescent plasma. Hahn said in his interview with the subcommittee that he was “disappointed” by Trump’s tweet, and initiated a call with the president to tell him “we either were nearing a decision or had made a decision” on an authorization for plasma. This decision was issued the following day.
Hahn said Francis Collins, then director of the National Institutes of Health, had told him during a White House meeting in the weeks before the GOP convention that Trump had “express[ed] dismay over NIH potentially putting up roadblocks.” The day before the convention began, the White House convened a press conference to promote the authorization of convalescent plasma.
The subcommittee previously released an email showing that FDA Associate Commissioner for Media Affairs Emily Miller advised Hahn to “[m]essage positive always” and to “phrase it in real language.” Hahn shortly after the press conference issued an apology for misrepresenting certain data on the treatment’s efficacy.
Hahn told subcommittee staff that he issued the apology “on my own,” and “didn’t ask for permission to do that from the normal channels.”
“I wanted to move quickly, and I wanted to correct the record on behalf of the agency,” Hahn added, according to the interview transcript.
Hahn also told subcommittee staff of “objections” from Chief of Staff Mark Meadows and other White House officials to 2020 Covid-19 vaccine authorization guidance, including the FDA’s call for at least two months of surveillance data from manufacturers.
Hahn said he “objected” to attempts to change the guidance because “any changes would be obviously reported and would further reduce vaccine confidence.”
—With assistance from Jeannie Baumann
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