How scientists saved Trump's FDA from politics

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Scientists around the country looked at the Food and Drug Administration last August and saw trouble.

© Greg Nash How scientists saved Trump’s FDA from politics

New FDA Commissioner Stephen Hahn, less than a year into his job and months before an election that polls showed President Trump was trailing, had just approved an emergency application to allow physicians to use blood plasma from those who had recovered from COVID-19 to treat those who were still suffering.

Trump called the emergency use authorization a “very historic breakthrough,” but scientists who had been critical of the administration’s bungled handling of the coronavirus pandemic worried the decision sidestepped science and was motivated by politics.

They feared it signaled a race to give final approval to a vaccine in the weeks ahead of November’s presidential election, racing through safety checks that could undermine public trust and make a mess of the federal government’s last best hope to end the pandemic.

And they worried Hahn was overmatched and overwhelmed.

This is the story of a group of top scientists from across the nation who helped guide Hahn through a political tempest they feared could undermine a monumental scientific and medical achievement – one that is now resulting in more than 1.5 million people being vaccinated for COVID-19 every day.

It’s also an inside story of Hahn’s own survival in an administration riven by infighting, turf wars and the constant pressure from his superiors to deliver a vaccine on a timeline unprecedented in medical history.

In interviews with The Hill, Hahn, senior administration officials and half a dozen of the nation’s leading scientists who became members of Hahn’s informal kitchen cabinet described the tense months leading up to the December decisions to authorize two promising vaccine candidates.

“All of us were deeply concerned about making sure that the vaccine research development and review process could go forward as swiftly and smoothly as possible and that the integrity of the process wouldn’t be compromised by political intrusions,” said Peggy Hamburg, who ran the FDA for six years during the Obama administration and who sat on the unofficial kitchen cabinet.

That group came together after scientists had grown alarmed at the growing politicization of the FDA, an agency that oversees massive parts of the American economy and that would be tasked with giving the final stamp of approval to any vaccines and therapeutics to treat COVID-19. If it became another casualty of the nation’s political polarization, they worried that public trust would erode along with the FDA’s independence, forestalling an end to a pandemic that has already killed almost half a million Americans.

Hahn himself was a subject of scrutiny and suspicion.

An oncologist who had no previous experience running a government agency, Hahn had taken over the FDA just weeks before the first COVID-19 cases were identified in the U.S.

A week after the emergency authorization press conference, Eric Topol, the editor of the medical publication Medscape and an influential cardiologist and infectious diseases expert, called on Hahn to resign.

The backlash served as a wake-up call to Hahn.

Through an intermediary, he reached out to Michael Osterholm, director of the Center for Infectious Disease Research and Prevention at the University of Minnesota, and asked him to set up an informal group of top experts to give him advice and to act as a sounding board.

“After a series of events, including [the decision to authorize] plasma, I realized that in addition to the counsel I was getting from folks up to that point, both internal and external, I really would benefit from having more input,” Hahn said in an interview with The Hill. “It always helps as a leader to get as much outside information as you can, and you have to sift through it.”

Osterholm included Topol, who just days earlier had called on Hahn to step down, on the prestigious list of invitees.

The group met by Zoom, on Osterholm’s account. Hahn wanted their meetings kept quiet, so members blocked off time on their calendars and shared it as a “party planning meeting” with colleagues in their various organizations to disguise it.

As data from late-stage vaccine trials loomed, Hahn faced a choice: stick to the rigorous process of analyzing and eventually approving a vaccine that would be both safe and effective, or race to deliver Trump a political win.

“He could take the path of political expediency or the path of a robust process to ensure the integrity of the agency, to ensure the efficacy and safety of the vaccine,” said Ruth Berkelman, an emeritus professor of epidemiology at the Rollins School of Public Health and another member of Hahn’s kitchen cabinet. “It became clear that he had already in my mind made the decision to do what he thought was right for the agency and the country.”

Trump and his top advisers, seeing the then-president trailing Democrat Joe Biden in the polls, pressed for the therapeutics and vaccines that would show they had wrestled the pandemic under control. Trump himself continued downplaying the virus, even after he contracted it himself and spent several days in the hospital, where his oxygen levels dropped dangerously low.

But Hahn said he had little opportunity to rush a vaccine, even if he had opted to speed ahead.

“There was no way that decision could be rushed. To me, all I could tell them was, we’re waiting for data. When we have data, we’ll make a decision,” he said. “To me it was pretty straightforward. We didn’t have the data in hand. The data came to us after the election.”

He acknowledged the huge pressure to deliver a vaccine, but in the interview he said Trump had never demanded an approval by a specific date.

“Although I think there was significant pressure, it was never explicitly stated to me that you must do this by this time,” he said.

Then-Health and Human Services Secretary Alex Azar was also feeling the heat.

He told Hahn he supported the scientists who would gather and analyze the data, but Hahn got the feeling Azar was saying something else to Trump and White House chief of staff Mark Meadows.

Topol, now privy to Hahn’s tenuous position, said Hahn faced enormous pressure from Azar and the White House.

“There was a war with Azar, and that was just absolutely ridiculous,” Topol said. “There’s a lot of on-the-job training, but for Steve, he got in the deep side of the pool and they just keep trying to drown him every few minutes.”

A senior administration official with knowledge of Azar’s thinking disputed the characterization that Azar was pressuring Hahn. Instead, the official said, Azar saw it as his job to act as a bulwark between the politicians and the scientists.

The official said Hahn developed close ties to Meadows, Vice President Pence and other members of the coronavirus task force. While Trump yelled at Azar over delays, Azar would try to delay pressure on the FDA.

But the official said White House officials would then call Hahn directly to put the pressure on him and blamed Hahn for not putting a stop to it.

“There were White House people who were directly interacting with FDA, but Hahn was allowing that to happen,” the official said.

Hahn said he spent months batting away the White House’s demands for action on therapeutics and vaccines.

He insisted on withdrawing the emergency use authorization for hydroxychloroquine, a drug that Trump had embraced and routinely touted even as scientific studies showed it had little impact. He delayed approving the use of plasma until his chief scientists, Peter Marks and Janet Woodcock – now the FDA’s acting commissioner under President Biden – signed off.

Trump’s team chafed at strict guidelines for vaccine approval, published Oct. 6, that all but guaranteed there would be no approved vaccine before voters went to the polls.

“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump tweeted, tagging his own FDA commissioner.

“I absolutely refused to change any wording in that because I felt like that would very much hurt the credibility of our scientific approach and I thought that it was wrong scientifically to do anything other than that,” Hahn said.

Health officials and experts already worried about public acceptance of vaccines that were being developed in record time. The FDA and National Institutes of Health had set up a process that would gamble billions of dollars on manufacturing some of the most promising candidates even before they were approved, while maintaining the safety standards they could not elide.

Several members of Trump’s coronavirus task force, including National Institute of Allergy and Infectious Disease Director Anthony Fauci, hated the White House’s preferred term for the development process – Operation Warp Speed – because they worried it conveyed a rush that put safety last.

“It doesn’t take much public perception or misperception for a vaccine to get voted off the island, even if it’s a good vaccine. The goal became, come as close to the full approval process as possible, recognizing that if [the vaccine] were held back for a full year the human cost would be staggering,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and another member of Hahn’s kitchen cabinet. “Nobody wanted to see this fail. We were all terrified for the country to see what was happening.”

Hahn considered resigning, though he never explicitly threatened to quit. Like others, Hahn feared what might happen if he stepped down and Trump got the chance to replace him with someone more compliant.

“It’s a hard job balancing the different pressures coming in, and even more difficult in this national and international crisis. The toxic political environment in which he had to work certainly made everything more difficult,” Hamburg said.

Osterholm and the kitchen cabinet urged Hahn not to quit. If he were asked to go beyond his own boundaries, they told him to force Trump to fire him. They were increasingly conscious that Trump was promising an October surprise.

“If it was someone else other than Steve or someone like Steve, we would have seen, come hell or high water, those two mRNA vaccines would have been released under emergency use authorizations prior to the election, no question about it,” Hotez said.

Once Pfizer and the German pharmaceutical company BioNTech submitted their vaccine candidate for approval, Trump was incensed when the United Kingdom’s regulatory body approved its use before the FDA had a chance to review 10,000 pages of data.

The FDA “is still a big, old, slow turtle. Get the dam [sic] vaccines out NOW, Dr. Hahn,” Trump tweeted on Dec. 11.

Hahn withstood the pressure. The FDA approved the Pfizer-BioNTech vaccine on Dec. 12. Six days later, it approved another candidate developed by Moderna. Candidates submitted by Johnson & Johnson and AstraZeneca are under late-stage consideration after successful trials.

As the first health care workers were filmed receiving their shots, Hahn’s kitchen cabinet breathed a collective sigh of relief.

“I’m quite supportive of the process that was taken. The two months that he insisted on and releasing those draft guidelines were important steps,” Berkelman said. “The pressure was evident.”

“He went from kind of a goat in my view to the hero by standing up to Trump and Azar and Mark Meadows and everybody,” Topol said. “Poor Steve. What he went through, unbelievable.”

Trump tweeted at Hahn or his agency 25 times in the months between the beginning of the pandemic and the end of the year. Each tweet sent a wave of trolls into Hahn’s timeline, though he said his background allowed him to ignore the attacks.

“I’m a cancer doctor. There are so many worse things in the world than getting tweeted about negatively by the president or someone calling for your resignation,” he said. “My kids are not in line getting chemotherapy for cancer. It’s a pretty damn good day.”

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