FDA Commissioner Dr. Stephen M. Hahn speaks as US President Donald Trump listens during the daily briefing on the novel coronavirus, COVID-19, in the Brady Briefing Room of the White House in Washington, DC on April 21, 2020.
FDA pressed to fast-track potential treatments under Trump
03:06 - Source: CNN
CNN  — 

Trump administration officials had a “crusade against (the US Food and Drug Administration that) resulted in damaging consequences for the coronavirus response,” the House Select Subcommittee on the Coronavirus Crisis, led by Democrats, said in a report released Wednesday.

In its second wide-ranging investigation on the coronavirus pandemic, Democratic officials spoke with former FDA Commissioner Dr. Stephen Hahn, who told the committee in an interview that former White House Office of Trade and Manufacturing Policy Director Peter Navarro “exerted inappropriate pressure” on the FDA to reissue an emergency use authorization for hydroxychloroquine, an anti-malaria drug that then-President Donald Trump spent much of March and April 2020 promoting as a potential “game-changer” for Covid-19, according to the report. The President was personally singing the drug’s praises during White House briefings so much that doctors started hoarding it, causing states to enact strict restrictions limiting prescriptions.

The report revealed that Navarro, who is not a medical doctor, and Steven Hatfill, an adjunct assistant professor at George Washington University whom Navarro brought to the White House in January 2020 as a volunteer on Covid-19 research, were fighting with FDA officials including Hahn on the effects and effectiveness of hydroxychloroquine – which has since been found to not work against Covid-19 and potentially cause heart problems and even a greater risk of death – and other drugs throughout the height of the pandemic.

Hahn told the committee Navarro “was very demonstrative about his belief that hydroxychloroquine would work, and was working, and that it had met the statutory standard for an (emergency use authorization) even after FDA revoked its authorization.” Hahn said Navarro selected data to prove the drug worked even though “it made no sense to continue the EUA in the setting of a Phase 1 trial that basically indicated that, in that setting, hydroxychloroquine didn’t work,” according to the report.

In a statement emailed to CNN, Navarro said: “The partisan House Select Subcommittee report ‘wrongly’ perpetuates one of the most deadly lies of the pandemic, namely that the safe and powerful therapeutic to treat COVID, hydroxychloroquine, was somehow dangerous. This lie persists despite abundant scientific evidence now to the contrary.”

Hatfill did not immediately respond to CNN’s request for comment. Asked if he felt the report adequately characterized his comments, a spokesperson told CNN that Hahn has no comment on the report; “his focus is on leading Harbinger Health.” Hahn is chief executive officer of the company, which works to create tests and treatments for cancer.

A study in April 2020 found that there was no evidence the drug reduced the risk of mechanical ventilation of hospitalized patients. In fact it found an association with increased mortality when used alone. Two studies published in May 2020 showed that it did not work on Covid-19 patients and could harm them. Patients who took the drug were more than twice as likely to suffer cardiac arrest during the course of one of the studies. Several subsequent studies showed the drug was not effective and may cause harm.

Hahn also told the committee that National Institutes of Health Director Dr. Francis Collins told him during a White House meeting that Trump “expressed dismay over the National Institutes of Health potentially putting up roadblocks” for the FDA’s authorization of convalescent plasma as a coronavirus treatment.

Convalescent plasma is a treatment created from the blood of those who had recovered from a Covid-19 infection. The FDA gave an emergency use authorization for convalescent plasma to treat Covid-19 at the end of August 2020, but it did so without peer-reviewed gold standard clinical trials that showed the treatment worked. In fact, the treatment was ultimately found to not reduce deaths among Covid-19 patients or prevent moderate disease from becoming severe.

At the time the treatment was authorized by the FDA, well-known scientists speculated that it did so under pressure and “bullying” from the White House. Dozens of hospitals said at the time that they would avoid or minimize the use of convalescent plasma until the appropriate trials were complete. In September 2020, an NIH panel countered the FDA’s decision saying that the therapy “should not be considered the standard of care for the treatment of patients with Covid-19.”

The report also found that the White House had objected to the FDA’s request to vaccine makers that when they requested an emergency use authorization for the vaccine, they submit two months of surveillance data to show that the shots worked. The committee’s report said that the FDA’s guidance to vaccine makers was stalled for weeks by the White House, but the agency found a work around. The committee’s report suggests that the Trump administration had blocked the FDA’s guidance due to objections over how it would slow the authorization of vaccines until after the 2020 election.

“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, who chairs the oversight subcommittee, said in a statement released with the report.

He added: “As today’s report makes clear, senior Trump Administration officials undermined public health experts because they believed doing so would benefit the former president politically—plotting covertly with known conspiracy theorists to dangerously push a disproven coronavirus treatment, bullying FDA to change its vaccine guidance, and advocating for federal investigations into those who stood in their way.”