Eight months into his tenure as head of the US Food and Drug Administration, Stephen Hahn is trying to press the reset button after he gave a press conference that went so badly wrong he had to spend several days correcting the record.
Last week, Dr Hahn, the man in charge of deciding whether to approve coronavirus treatments and vaccines in the US, removed his Trump-appointed spokesperson Emily Miller from her job after just 11 days. Her ejection followed the bungled press conference at which Dr Hahn overstated the benefits of convalescent plasma, which has been given emergency use authorisation for coronavirus.
In an interview with the FT, Dr Hahn, commissioner of the FDA, hit back at critics who said he is approving coronavirus treatments too quickly because of pressure from Donald Trump who has been accused on mishandling the US response to the pandemic.
“Science and data drive our decisions,” he said. “We have terrific, terrific scientists, doctors, nurses, pharmacists. They make the decisions on the ground . . . and they’re science driven. We need to make sure that the American people know that and have confidence in that.”
The gregarious Dr Hahn is one of a handful of public health officials who have become household faces in the US during the coronavirus crisis, alongside Anthony Fauci and Deborah Birx.
In his previous life as a cancer specialist, Dr Hahn earned the respect of his peers for his intelligence, as well as his open and collegiate style of management.
But as head of the FDA, he has found himself caught between a president who wants to move faster on drug approvals, and public health experts who accuse Mr Trump of abandoning scientific rigour in favour of speed.
In a few weeks’ time, Dr Hahn might have to make the most difficult choice of his career, and one of the most sensitive decisions in public health history: whether to grant fast-track authorisation for a coronavirus vaccine
If he does, it could help start to turn the tide against the pandemic, stimulate the economy and hand Mr Trump a pre-election boost. But he could also end up contributing to growing scepticism among Americans about the safety of vaccines in general, and even end up harming people’s health in the long run.
Already, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, has threatened to quit if he felt the administration was approving a vaccine in response to political pressure.
But the administration’s messaging is confused on the issue. Michael Caputo, a spokesperson for the health department, has said it is “absolutely false” that the FDA was considering authorising a vaccine before the election, but Dr Hahn told the FT this week that he would consider doing exactly that.
Dr Hahn’s critics say he has already bowed to Mr Trump in two key decisions. The first was approving hydroxychloroquine to treat coronavirus patients despite limited evidence that it was effective, before then rescinding that approval after new data showed it was not. The second was appearing to exaggerate the effectiveness of convalescent plasma at the press conference alongside Mr Trump.
“Right now the FDA has less credibility than it’s ever had in my lifetime,” said Ashish Jha, professor of global health at Harvard University. “Stephen Hahn has got to so something to try and restore that credibility. If he doesn’t, I imagine he will face a mass exodus.”
Dr Hahn has admitted he was wrong to say plasma treatment could have saved the lives of 35 out of 100 coronavirus patients when data show the figure is roughly five out of 100. He told the FT: “I certainly regret contributing to any misperception. I could have done a much better job explaining relative risks.”
But he insisted he does not regret authorising either hydroxychloroquine or convalescent plasma, adding that both decisions were supported by the evidence he had available at the time.
And he has a medical analogy for his entire approach to approving new drugs during the coronavirus pandemic. “It is like being a doctor in the emergency room,” he said. “You make the decisions at the time with the best data you have.”
This is the approach Dr Hahn said he will use when deciding whether to authorise a coronavirus vaccine even before phase three clinical trials are fully complete.
Instead of waiting for all the safety information from those trials, Dr Hahn is willing to consider authorising a vaccine earlier if the evidence shows the benefits of doing so outweigh the risks. Such an authorisation might only apply to certain groups for whom the vaccine is shown to be more effective, or safer, he added.
“Let’s say for example, that we have evidence that the vaccine is safe and effective in an elderly population. Well, we all know they’re the ones at risk for deaths related to Covid-19. Should we sit on those data and not act upon them?”
He added: “We are going to apply the standard that’s appropriate for an emergency, just like a doctor would in the emergency room.”
Critics say, however, that while this approach might make sense for treating seriously ill patients, it does not for approving a vaccine.
“It’s totally different for a vaccine,” said Mr Jha. “With a vaccine you are not giving that to sick people, you are giving it to healthy people. You have got to have very strong safety data before you give vaccines to healthy people. That’s totally the wrong analogy.”
Dr Hahn’s decision could come as soon as two months’ time. The FDA has scheduled a public meeting of its vaccine advisory committee for October 22 — two weeks before the election and hours before the second televised presidential debate. If a vaccine developer has applied for authorisation by then, this is will be the first chance for the committee to discuss it, although authorisation will not come until later.
Dr Hahn said Mr Trump has not once tried to put pressure on him to approve a vaccine before the election. The question some are asking is what he would do if the president did.
Jesse Goodman, a professor at Georgetown University and a former FDA chief scientist, said: “For those decisions to be trusted and the FDA to remain strong, people within FDA — including Dr Hahn — need to stand up for its people and mission if they are asked to do things that are wrong or potentially harmful.”
When asked if he would resign if asked to approve a vaccine he did not feel was safe, Dr Hahn said: “I’m not going to speculate on what I would do personally. What I can tell you is we are going to do our job. We are going to follow the science and data.”