Two months ago, the Food and Drug Administration reversed course on President Trump’s much-hyped drug hydroxychloroquine, revoking its authorization for emergency use to treat the novel coronavirus. Given that Trump had pushed for the drug and then bragged about speeding the initial authorization process along, it raised very valid concerns about whether the FDA had made a hasty decision under political pressure.
Those concerns have to resurface after the spectacle we saw Sunday.
At a news conference, Trump announced a new emergency-use authorization, this time for convalescent plasma, which he characterized as a breakthrough. Some scientists are dubious about its usefulness. Others backed the decision, believing that the treatment at least shows promise.
But it wasn’t difficult to see how overeager Trump was for another coronavirus quick fix — a political win, even — by hyping the treatment. What was particularly notable was the degree to which the health officials next to him, including FDA Commissioner Stephen Hahn, played along.
In Trump’s opening remarks, he claimed that a study by the Mayo Clinic showed convalescent plasma “has proven to reduce mortality by 35 percent. It’s a tremendous number.” He added, “Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective.”
Hahn and Health and Human Services Secretary Alex Azar weren’t quite so definitive, but they did repeat the 35 percent figure multiple times, with Hahn in particular stretching that figure to show something it doesn’t quite show.
“I just want to emphasize this point, because I don’t want you to gloss over this number,” Azar said. “We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.”
Hahn then said: “Many of you know I was a cancer doctor before I became FDA commissioner. And a 35 percent 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 admission of plasma.”
The first thing to note is that Trump’s claim that the treatment is “proven to reduce mortality by 35 percent” isn’t backed up by Hahn’s comments. Hahn is more circumspect, allowing that additional data will shed further light on the true effectiveness. The Mayo study, while finding a statistically significant effect, was not a randomized clinical trial, the gold standard for such studies, nor has it been peer-reviewed yet. Even the FDA in its news release and an accompanying memorandum Sunday said merely that the treatment “may be effective” — and that the possible benefits outweigh the risks — rather than that it has been proved to be very effective, as Trump claimed.
The second point is that Hahn’s attempt to distill the 35 percent claim down doesn’t make sense. Hahn said that among “100 people who are sick with covid-19, 35 would have been saved because of the administration of plasma.”
But that’s not what the data shows. The vast majority of people who get the virus will recover with or without plasma. The 35 percent figure comes into play among those who die — a much smaller group. That would still be a huge development if borne out. But strictly speaking, the treatment would have saved about 3 out of 100 coronavirus patients, not 35. And given the smaller numbers we’re talking about, the finding is much closer to the margin of error — even as the preliminary study finds the effect to be statistically significant.
And even then, the claim doesn’t make sense. The data that he and Trump were referring to compared those receiving plasma treatments not to a control group, but between higher and lower levels of plasma treatments. The group with lower levels died at a rate of 13.7 people out of 100 after seven days, while 8.7 percent died with higher levels. Also, the group transfused four days or later after their coronavirus diagnosis died at a rate of 11.9 people out of 100, while those receiving earlier treatments died at a rate of 8.7 out of 100.
Experts, including former FDA commissioner Robert M. Califf, said Hahn was wrong.
In this statement, @SteveFDA claims 35 per 100 people treated with plasma would be saved. The Mayo observational data indicates that would be 3 people saved at 7 days, or 5 at 30 days. And that was via exploratory analyses. Not only blatantly wrong; an egregious public statement. pic.twitter.com/DlNVHvDJnB— Eric Topol (@EricTopol) August 24, 2020
It may seem like a small point to parse Hahn in this way. But health officials are generally very careful with their claims, especially about unproven treatments. And it’s difficult to divorce this from what has preceded it. Trump has applied tremendous public pressure on the FDA — both on hydroxychloroquine, for which he has sought another reversal to again allow for emergency use, and now on convalescent plasma. Even the day before Sunday’s announcement, Trump alleged that the “deep state, or whoever over at the FDA,” was standing in the way of the treatment.
The problem with Trump tweeting about these things is that, at the very least, they provide the appearance of him leading the kinds of decisions that should be among the most apolitical that the federal government makes. Another type of decision in that category is one made by the Justice Department, where Attorney General William P. Barr at one point acknowledged the appearance problem created by Trump’s tweets about ongoing legal matters. Barr said they made it “impossible for me to do my job.”
The question from there is whether that public pressure has any impact. Barr has certainly made questionable decisions that aligned with Trump’s publicly expressed wishes, but he has denied that they played any role. Similarly, Hahn has said “I have not felt political pressure” to make decisions on hydroxychloroquine.
But at other points, Trump has bragged very publicly about his actions expediting that process, telling Fox News at one point that “hydroxychloroquine is something that I have been pushing very hard. I got the very early approval from the FDA. It was going to take a long time, and Dr. Stephen Hahn, the head of the FDA, gave us an early approval, a very quick approval, a 24-hour approval.”
That past has to weigh heavily on perceptions of the scene we saw Sunday, as does Hahn’s repetition of the 35 percent figure.
That doesn’t necessarily mean that this was the wrong call. But it’s one thing to approve the authorization of convalescent plasma; it’s another to oversell its proved efficacy. Trump certainly did that, and even while being more circumspect, it seemed that Hahn, like many people before him, was straining to say the kind of things Trump wants to hear.
At the end of Sunday’s event, Trump and Hahn were pressed on the differences between Trump’s claim that the FDA found the treatment to be “very effective” and Hahn’s more circumspect comments. Hahn then reverted to his 35-out-of-100 claim.
“So I would say that a 35 — if you’re one of those 35 out of 100 people who these data suggest or show survive as a result of it, this is pretty significant for that person and their family,” Hahn said.
Trump then ended the news conference after three questions.
Correction: This post initially misattributed Azar’s quote to Hahn, due to an incorrect transcript. The death rate for those with lower plasma levels has been corrected from 11.9 percent to 13.7 percent.