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Researcher Criticizes FDA's Exaggeration Of Plasma's Efficacy In COVID-19 Treatment

ARI SHAPIRO, HOST:

The Food and Drug Administration's mission is to protect public health by assuring the American people of the safety and efficacy of drugs. Now many scientists are saying that mission has been compromised after a Sunday news conference in which the head of the FDA, Stephen Hahn, stood beside the president and made this false statement about the efficacy of plasma for treating COVID-19.

(SOUNDBITE OF ARCHIVED RECORDING)

STEPHEN HAHN: Thirty-five 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 administration of plasma.

SHAPIRO: After many scientists criticized that statement, Hahn corrected himself on Twitter late yesterday and said that criticism was justified. One of those critics is Dr. Eric Topol of the Scripps Translational Research Institute in La Jolla, Calif., and he joins us now. Welcome.

ERIC TOPOL: Thank you, Ari.

SHAPIRO: You tweeted at Hahn saying serious mistakes undermine your credibility. How serious is this mistake?

TOPOL: Extremely serious. This is about treatment that has no proven benefit. And we have the FDA, as well as the secretary of HHS, the president, all claim that it's a breakthrough. And that could not be further from the truth. There is no evidence for that.

SHAPIRO: It's still inaccurate to say 35 of those 100 who would die would be saved by plasma, right?

TOPOL: Right. So that's the next level of the problem. This was based on a Mayo Clinic pre-print that has not been peer reviewed and will not, currently as it stands, hold up to peer review. It's a tortured analysis from 35,000 people who got the convalescent plasma, which drill down to 1,000 people at Mayo Clinic who got the plasma early, of a certain age, all these cherry-picking subgroups of subgroups. And that's where they came up with this 35%. A careful review of the pre-print from which it is based suggested that number would equate to three or four lives saved out of 100 people who would otherwise die. So, basically, what it is is a 10 times - that's how much exaggeration it is, an order of magnitude 10 times more than the data from an exploratory analysis indicate. This is so extraordinary to take the number of three or four and to make it into 35.

SHAPIRO: So you're saying this is an overstatement, the numbers are wrong. He made a mistake, and he admitted that mistake. Does that mean that this plasma treatment should not have been approved, is not safe?

TOPOL: Well, I don't think the problem here is the approval on an emergency authorization basis. The problem is the hyperbole and the false statements that are not supported by facts or evidence. So in order to get this straight, Dr. Hahn needs to also talk to the public and say that he erred and that there is no established evidence for survival advantage of convalescent plasma. That has to be determined through randomized trials that are ongoing. And as you know, Ari, you know, millions of people tuned into this breakthrough press conference and have read the outgrowth of it. So this has to get corrected.

SHAPIRO: You know, Dr. Topol, this administration often makes misleading statements. Why does this one stand out to you?

TOPOL: Well, in two important ways. First of all, it's completely false. There is no evidence to support these statements of a major advance or fulfilling any dream. But the other thing that's especially troubling is the fact that a vaccine could also be given emergency authorization without sufficient data for it working or being safe. And so when politics mixes with science, as is evidenced here, that could be the precursor to an even worse situation with the vaccine in imminent weeks.

SHAPIRO: Eric Topol is executive vice president of the Scripps Translational Research Institute in La Jolla, Calif. Thank you for speaking with us today.

TOPOL: Oh, thank you, Ari.

SHAPIRO: And we reached out to the FDA for comment. They did not reply by airtime. Transcript provided by NPR, Copyright NPR.

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