Part 2
Behind the scenes, senior FDA officials concluded by September that they wanted to review two months of safety data after participants in clinical trials had received their 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 were not going to cut corners in our assessment,” Hahn told the panel, adding the agency had already streamlined a vaccine-authorization process that typically took far longer, and he feared fallout on vaccine confidence.
“I was concerned about the entire environment: a presidential election, 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 … confidence 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, pressing for its justifications, prompting FDA officials to fret about the impact.
“The ambiguity here is actually creating more problems than a decision one way or the other” on finalizing the guidance to vaccine makers, Peter Marks, the FDA’s top vaccine official, wrote in a Sept. 29 email to Hahn and the agency’s then-chief of staff, Keagan Lenihan.
The FDA ultimately
circumvented the White House on Oct. 6, publishing its vaccine guidance in briefing documents for the agency’s outside advisers. The White House later that day formally approved the guidance — but Trump mocked the decision on social media.
“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump wrote on Twitter, again tagging Hahn in his tweet.
The tweet
In his panel interview, Hahn acknowledged the FDA faced pushback over its timeline from the White House and senior health officials, such as former Health and Human Services secretary Alex Azar. But Hahn he said he was confident the agency had prioritized safety.
“It came down to this as the most appropriate and pragmatic way to assess the vaccines,” Hahn said. “Balancing … speed with making sure we got the decision right.”
Through a spokesman Wednesday, Hahn declined to comment on the report. Azar did not respond to a request for comment.
The panel’s report also details the months-long battles over hydroxychloroquine, the malaria drug also used to treat some autoimmune conditions that Trump and some others seized on as a coronavirus cure 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 called for patients to immediately begin receiving the treatment. Randomized studies
later showed that patients given the drug did no better than those receiving a placebo.
“We have a potential pandemic solution at our finger tips,” Oz
wrote March 23 to Jared Kushner, then a White House senior 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 free of virus” and said that a U.S. study on 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 hydroxychloroquine, saying that at the start of the pandemic, he “spoke with health experts worldwide who were seeing hydroxychloroquine and azithromycin as viable treatment options for desperately ill covid patients and [Oz] offered to fund a clinical trial at Columbia University.”
The FDA initially authorized hydroxychloroquine March 29,
despite the skepticism of career scientists worried about the scant data that it was effective. But the agency revoked authorization for the treatment in June, amid mounting evidence that it did not work. “The scientific data is really quite evident now about the lack of efficacy,” Fauci
said on CNN on May 27, warning of 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 strategized on how to get the FDA to reverse its decision, such using allies including Sen. Ron Johnson (R-Wis.), according to emails obtained by the panel.
In one instance, Navarro and Hatfill worked with a Michigan-based hospital system, Henry Ford Health, to bring pressure. For instance, Hatfill crafted a
request letter that the health system could submit to the FDA, although he instructed the organization “NEVER mention the White House together with my name” in a May 2020 email to a physician leading the system’s work on hydroxychloroquine. Regardless, the FDA in August
denied the hospital system’s request, having repeatedly
warned about safety concerns related to the drug.
“FDA decided it will not renew the [emergency authorization] for hydroxy,” Hatfill wrote in an August 2020 email to himself that was obtained by the panel. “That’s OK because it was already arranged for Hahn to be pulled into Senator Johnson’s Committee to answer some questions. The Senator is pissed off and I wrote the questions -so it should be a good s---show.”
Through a spokesman, Hatfill acknowledged his work with Henry Ford Health and said his actions to encourage hydroxychloroquine were appropriate. “We never wrongly 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 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.,” he wrote.
The FDA did not respond to specific questions about the report, but said in a statement that career staff had worked round-the-clock throughout the pandemic “to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency.”
Henry Ford Health 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, during a time when there were no known treatments for COVID-19. When our own studies determined that hydroxychloroquine was not an effective treatment, we suspended the study and any 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 senator from Wisconsin was being wrongly attacked by the “COVID cartel.”