WASHINGTON – In reaction to the protests of medical experts, Food and Drug Administration commissioner Stephen Hahn apologized Tuesday for exaggerating the important benefits of treating COVID-19 patients with convalescent plasma.
Scientists and medical experts have rejected claims about the remedy since President Donald Trump’s Sunday announcement that the FDA had made the decision to include an emergency authorization for convalescent plasma, taken from patients who have recovered from coronavirus and rich in antibodies to the disease.
Trump praised the resolution as a historic step forward, even though the price of the remedy has not been set. The announcement on the eve of Trump’s Republican National Convention raised suspicions that he was politically motivated to make up for the president’s pandemic management complaint.
Hahn echoed Trump’s saying that another 35 out of 100 people would suffer from coronavirus if treated with plasma. This statement largely overesvalued the initial findings of the Mayo Clinic’s observations.
Hahn’s mea fault comes at a critical time for the FDA, which, under intense pressure from the White House, is guilty of deciding whether long-term vaccines are effective in preventing COVID-19.
The 35% figure led to the conviction of other scientists and former FDA officials, who asked Hahn to correctly order the search.
“I was criticized for my comments Sunday night on the benefits of convalescent plasma. The complaint is entirely substantiated. What I have said greater is that knowledge shows relief in the relative threat and not absolute relief,” Hahn tweeted.
The FDA took the knowledge-based resolution collected through the Mayo Clinic from hospitals across the country that used plasma in patients in an incredibly variable way, and there is no untreated patient comparison organization, meaning no conclusions can be drawn about overall survival. People who gained plasma with the highest levels of antibodies got more results than those who gained plasma with fewer antibodies, and those treated before diagnosis did more than those treated afterwards.
Hahn and other Trump management officials have presented the difference as an absolute survival advantage, rather than a relative difference between two remedy groups. Former FDA officials said the error was unforgivable, especially for a cancer specialist like Hahn.
“It’s normal for me for someone involved in clinical trials to make this mistake,” said Dr. Peter Lurie, a former FDA official in the Obama administration who now runs the Center for Science in the Public Interest, a nonprofit. “It’s mind-blowing.”
The 35% credit was repeated through the Secretary of Health and Human Services, Alex Azar, at Sunday’s briefing and was promoted on Twitter through the FDA communications team. The number did not appear in the official FDA letter justifying emergency authorization.
Hahn has worked to build confidence in the agency’s clinical process, stating in interviews and articles that the FDA will approve a vaccine that meets the predefined criteria of protection and efficacy.
Lawrence Gostin of Georgetown University said Hahn’s functionality on Sunday had undermined his efforts.
“I think the integrity of the FDA was affected, if I were Stephen Hahn, I wouldn’t have given the impression on such a political program,” said Gostin, a public fitness lawyer.
Hahn subsidized Tuesday morning opposing the tips that the plasma announcement scheduled to bring Trump to life before the Republican convention.
“FDA professionals and scientists have taken this resolution independently, and I completed it,” said Hahn, who appeared on “CBS This Morning.”
Trump recently accused some FDA staff members, evidence, of intentionally postponing new remedies “for political reasons.” And Trump staff leader Mark Meadows said over the weekend that FDA scientists “need to feel the heat.”
The administration has invested vast resources in the vaccine race, and Trump’s advisers hoped immediate progress could be only for the president before the November election.
In Sunday’s briefing, Hahn did not correct Trump’s description of the regulatory resolution as a “advancement.” Nor did I contradict Trump’s baseless claim that a “deep state” effort within the company seeks to delay approvals.
Former FDA officials said political tension and attacks on the FDA posed a massive threat of undermining acceptance as true at the firm when it was needed most. A vaccine will only be effective against the virus if widely used in the U.S. population.
“I think the constant tension, the insults, the belief that decisions are made under strain are harmful,” said Dr. Jesse Goodman of Georgetown University, who in the past was the leading FDA scientist. “We want other Americans to be completely convinced that drugs and vaccines are safe.”
Convalescence plasma is a centuries-old technique for treating influenza, measles and other viruses. But the evidence has not been conclusive in terms of its effectiveness, at the time of management and the dose required.
FDA emergency approval is expected to increase availability at other hospitals. But more than 70,000 Americans have already obtained treatment under the FDA’s “extended access” program. This program tracks the patient’s response, but finds out if plasma played a role in his recovery.
Some scientists believe that the FDA’s expanded access to the remedy will make it more difficult to conduct studies to determine whether the remedy actually works. These studies require randomizing patients to obtain plasma or a fictitious infusion.
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Associated Press Lauran Neergaard contributed to the report.
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