This weekend, the Food and Drug Administration granted emergency clearance to convalescent plasma, a treatment in which blood from patients who recovered from Covid-19 is used to treat those who had the disease. The decision is controversial, as are the circumstances around it. STAT senior writers Matthew Herper and Adam Feuerstein sat down together to gather their thoughts. Here is their conversation.

Matt Herper: So for those just back from a tour of Jupiter’s moons, last night the FDA granted emergency use authorization of convalescent plasma to treat patients with Covid-19. Trump characterized the decision as a major breakthrough. FDA Commissioner Stephen Hahn, who joined him at a news conference to announce the decision, backed him up — but he also misspoke, claiming that giving plasma would help 35 out of 100 people treated.

Adam Feuerstein: Misspoke is being kind. Hahn grossly mischaracterized the benefit of convalescent plasma on Sunday night. I’ll just quote him here: “A 35% improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma.”

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The data don’t show that! 

Matt: That number should be at best 5 out of 100 people. To my eye, it’s more like 3 out of 100 people. And all that is from subgroups of an observational study, so it should be taken with a grain of salt.

Researchers didn’t compare patients who got plasma to a control group. They compared those who got the drug early to those who got it late, and between high levels of antibodies in the plasma and low ones. For the main subset in the study, which was led by the Mayo Clinic, mortality at seven days was 11% for those who got lots of antibodies, versus 14% for those who got few. That’s three out of 100 — again, with a grain of salt.

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Adam: I’ll repeat here what I said on Twitter last night. I’ve spent 20 years listening to — and writing about — biotech CEOs making nonsensical, inflated claims about the benefit of their drugs. It was weird and disconcerting to hear the FDA commissioner do the same.

Hahn could have made a convincing case for granting an EUA to plasma without hyping the data. He’s an oncologist. He knows better. 

Matt: That’s exactly it. There is an argument for emergency use — that patients were getting this, but access was spotty and we need to decrease paperwork. Even then, it would be controversial.

I’ve watched the FDA be the steward of high scientific standards in medicine for a long time. I still remember the nuance in the discussions around Vioxx. The agency gets things wrong sometimes. But it feels worse for it to be sloppy. And that’s without bringing politics into it.

Adam: I am sincerely worried about the FDA’s independence. Trump wanted convalescent plasma approved even though the supportive evidence was weak, and Hahn made it happen for him. That’s bad, particularly with the evaluation of Covid-19 vaccines looming right before the election. 

Matt: Everyone is worried about that. Some really prominent researchers — Ezekiel Emanuel springs to mind — have said they are concerned the administration could try to rush a vaccine. As we were talking, Steven Nissen at the Cleveland Clinic called me to say he’s worried about exactly that. “The process is there because the process has a historical record of working in the public interest,” he said. It does.

Which is exactly what’s wrong with the FDA putting out a press release saying this approval is “Another Achievement in Administration’s Fight Against Pandemic.” Even worse, there’s that tweet from the president Saturday, saying that the FDA was slowing down clinical trials for Covid patients because the agency is part of the “deep state” and it wants to hurt his re-election chances. Axios has reported that Peter Navarro was yelling “deep state” at the FDA earlier this week.

That kind of talk is going to make people more skeptical of an eventual vaccine. And, assuming the FDA does its job on vaccine review, that’s exactly what we don’t want.

Adam: I spoke to some current and former FDA employees over the weekend. None would go on the record, of course, but they were demoralized and angry about Trump’s insinuation that they were working against the approval of medicines for Covid-19. They were also angry at Hahn for not stepping up to defend them and their work. 

Did you notice the FDA staffer charged with reviewing the plasma data had his name redacted from the memo? That was unusual, to say the least. 

Matt: I never remember seeing a reviewer’s name redacted before. I’d also add that I have never met an FDA employee who struck me as partisan. A few struck me as people who could never fit in any political party.

It’s definitely possible, with these giant studies that are being run and the number of people getting Covid-19, to develop a vaccine fast. But you need people to really trust the FDA, or many might not take the vaccine. 

Adam: Being the FDA commissioner is a political job. But Hahn is also the leader of an essential government agency that employs 17,000 people. Standing up to Trump is not an easy thing to do, but at some point, Hahn has to tell his employees that he has their back, and that he believes in the scientific independence of the people who work under him. 

FDA employees deserve to hear that. Americans need to hear it, if they’re going to trust the FDA decision making about medicines and vaccines to treat Covid-19.  

Matt: There have been other times where commissioners have had to deal with political pressure and political issues. The controversies over the Plan B morning-after pill going over the counter spring to mind. But this feels different.

Also, let’s not lose sight of the fact that all of this comes from a big failure on the part of the government response: not conducting a convalescent plasma study that can get us a real answer.

We wrote a very optimistic story about convalescent plasma together at the beginning of the pandemic. Would you have believed me then if I’d said we still would not have clear data here?

Adam: As you’ve pointed out numerous times, there have been many missed opportunities to conduct studies that could have yielded answers about Covid-19 treatments. It’s been a serial problem. 

Matt: To me, it’s the problem. We should have answers by now on multiple medicines. The best data has come from the U.K. It means we’re at the mercy of this virus.

Adam: Are you worried about the next few months, specifically about how the FDA handles the review of Covid-19 vaccines? 

Matt: A lot is at stake. Some reasons for confidence: No company wants to launch a problematic vaccine. The FDA review division is strong. An EUA could be very narrow — give it to nursing home workers, for instance — and still be used as a political win. And, as I said, these studies should give us a lot of safety data. But even if the scientists do everything right, the public health messaging matters, too. And this weekend gave us reason to worry about all of it.

Adam: This country has a serious problem with vaccine hesitancy. Even the whiff of politics into the FDA review process for Covid-19 vaccines could be disastrous. 

Matt: This is a conversation about the FDA, so we’re required by law to include a quote from Scott Gottlieb on Twitter.

“I am confident in the science part of the evaluation executed by CBER [Ed: Center for Biologics Evaluation and Research at FDA]. The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you lose it in buckets.”

That’s the nicest thing anyone can say right now.

  • Clearly needed are strong laws against profiting from one’s employment in government, something like the starter measure taken by my home province’s (B.C.) NDP-Green government disallowing lobbying by former cabinet ministers and political staff for two years after leaving their jobs, from which they typically take valuable inside information that can enrich lobbying firms.
    I’ve felt particularly strong about this since reading about the U.S. Food and Drug Administration commissioner, Arthur Hull Hayes Jr, who decades ago permitted the potentially health damaging artificial sweetener Aspartame to be placed in many foods and drinks, before he then left his FDA position for a lucrative job with the public relations firm owned by the Aspartame patent holder and producer, G.D. Searle Company.
    This, despite being urged by credible health academics to refrain from immediately granting FDA approval of the sweetener—a chemical concoction discovered accidently in 1965 while G.D. Searle Company chemist James Schlatter was testing an anti-ulcer drug.

  • Steven had to decide between getting fired or give the EUA and revoke it later ala Hydroxy. I guess he did not fancy getting fired by the desperate man who himself may have few months left on the job for botching up the pandemic response

    • He should have taken the dare. Imagine how bad it would look to fire the FDA chief 2 months before election. Trump could spin, but that one would be hard.

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