FDA Says 35%…but NO Published Evidence?
The next day, Commissioner Hahn rushed back from a family home in Colorado to join the president and the secretary of Health and Human Services to announcing an EUA (emergency use authorization) for a use of blood plasma from patients who have recovered from COVID-19. All three said, according to research, the treatment “would save the lives of 35 in 100 coronavirus patients.”
Great news. The problem was that it wasn’t accurate. Even some of the authors of the study said, “Huh?”
“I don’t know where the 35% number comes from,” says Arturo Casadevall of Johns Hopkins University’s Bloomberg School of Public Health, the last author of the study, which has been posted as a preprint but has yet to be peer reviewed.
Eric Topol, M.D., founder and director of the Scripps Research Translational Institute, tweeted that it was “outrageous” to claim a 35% improved survival from that study. “There’s no evidence to support any survival benefit. 2 days ago, FDA’s website stated there was no evidence for an EUA,” he wrote. And Rachel Sachs, an associate professor of law at Washington University in St. Louis, wrote that given the political pressure on the FDA, issuing the EUA without publishing the evidence and without a supporting randomized trial “risks further damage to public trust in the agency.”
“The FDA was once again bullied into doing something that initially it wasn’t going to do,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Unnamed sources within the FDA told the Washington Post that employees of the agency felt “demoralized” that the commissioner had allowed the agency to become a prop in the presidential race. They wondered how the agency would have any credibility on an upcoming vaccine decision “if it bungled something much simpler?”
Hahn’s Contrition
By late Monday night, in a series of tweets, Hahn said the criticism he received about his blood plasma statement was “entirely justified,” and he sought to “reassure the American public” that the FDA “will remain data driven.”
Hahn didn’t clear his apology with HHS leadership and further aggravated a reportedly, contentious relationship with his boss, Alex Azar, the HHS secretary. The two had previously disagreed over HHS overruling the FDA and blocking the agency from regulating laboratory-developed tests.
Jerome Avorn, M.D., a professor of medicine at Harvard, told the Washington Post he’s been following health regulatory decisions for decades, but had “never seen this amount of arm-twisting to force agencies like the FDA and CDC [Centers for Disease Control and Prevention] to make decisions based on political pressure, rather than the best science.”
White House Denounces “False Narrative”
A White House spokesperson denied the charges, saying “this false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is dangerous to the American public.”
“You saw convalescent plasma. You saw remdesivir. You’ll soon see vaccines pouring out years ahead of what they would have been under a ‘more traditional’ administration, where they would have taken years to come up with this stuff,” said the president.
The White House chief of staff, Mark Meadows, said the president “had to make sure that they felt the heat,” during an interview on ABC’s “This Week.”
“If they don’t see the light, they need to feel the heat because the American people are suffering. This president knows it, and he’s going to put it on wherever—the FDA or NIH or anybody else—to make sure that we deliver on behalf of the American people,” Meadows said.
