FDA commissioner 'overstated' benefits of convalescent plasma

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US Food and Drug Administration Commissioner Stephen Hahn has apologised for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma. Earlier, in what was seen by some as succumbing to political pressure from President Donald Trump, the FDA issued emergency authorisation for the treatment.

AP News reports that scientists and medical experts have been pushing back against the claims about the treatment since PTrump’s announcement that the FDA had decided to issue emergency authorisation for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.

The New York Times reported earlier that the emergency approval allowed Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention. The New York Times reports that Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the US and left the nation lagging far behind most others in the effectiveness of its response.

It said that the decision would broaden use of a treatment that has already been administered to more than 70,000 patients. But the FDA cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.

No randomised trials of the sort researchers consider most robust have yet shown benefit from convalescent plasma. But the FDA had said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalised patients,” in particular those who receive it early.

No randomised trials of the sort researchers consider most robust have yet shown benefit from convalescent plasma. But the FDA said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalised patients,” in particular those who receive it early.

The NYT said that the FDA delayed the authorisation for about a week after top health officials, including Dr Francis Collins, the director of the National Institutes of Health, and Dr Anthony Fauci, the top infectious disease specialist, questioned whether the data was sufficient.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

AP News writes that Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observations.

The report says Hahn’s mea culpa comes at a critical moment for the FDA which, under intense pressure from the White House, is responsible for deciding whether upcoming vaccines are safe and effective in preventing COVID-19. The 35% figure drew condemnation from other scientists and some former FDA officials, who called on Hahn to correct the record.

“I have been criticised for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” Hahn tweeted.

The AP report says the FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways – and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.

Hahn and other Trump administration officials presented the difference as an absolute survival benefit, rather than a relative difference between two treatment groups. Former FDA officials said the misstatement was inexcusable, particularly for a cancer specialist like Hahn. “It’s extraordinary to me that a person involved in clinical trials could make that mistake,” said Dr Peter Lurie, a former FDA official under the Obama administration who now leads the non-profit Centre for Science in the Public Interest. “It’s mind-boggling.”

The 35% benefit was repeated by Health and Human Services Secretary Alex Azar at Sunday’s briefing and promoted on Twitter by the FDA’s communication staff. The number did not appear in FDA’s official letter justifying the emergency authorisation.

The report says Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will only approve a vaccine that meets pre-set standards for safety and efficacy. Lawrence Gostin of Georgetown University said Hahn’s performance undermined those efforts. “I think the integrity of the FDA took a hit, if I were Stephen Hahn I would not have appeared at such a political show,” said Gostin, a public health attorney.

The report says Hahn pushed back against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention. “The professionals and the scientists at FDA independently made this decision, and I completely support them,” Hahn said.

According to AP, Trump has recently accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”
The administration has sunk vast resources into the race for a vaccine, and Trump aides have been hoping that swift progress could help the president ahead of November’s election.

AP says Hahn did not correct Trump’s description of the regulatory move as a “breakthrough.” He also did not contradict Trump’s unsupported claim of a “deep state” effort at the agency working to slow down approvals. Former FDA officials said the political pressure and attacks against the FDA carry enormous risk of undermining trust in the agency just when it’s needed most. A vaccine will only be effective against the virus if it is widely taken by the US population, the report says.

Full AP News report Full report in The New York Times

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