FDA Chief Walks Back Claims About Convalescent Plasma Touted by Trump

On Monday night, Food and Drug Administration (FDA) Commissioner Stephen Hahn corrected comments he had made the day before, responding to critics who suggested he had overstated the benefits of a possible treatment for coronavirus.

Members of the Trump administration, including the president himself, announced on Sunday that the infusion of convalescent plasma from COVID-19 survivors to patients afflicted with the disease would be granted authorization for emergency use.

“This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help patients battling an infection,” President Donald Trump said during the press briefing. “It’s had an incredible rate of success.”

Other officials, including Hahn, touted the treatment as a huge step forward for treating coronavirus, but after criticisms began to mount over the words Hahn used to push that narrative, he recognized his mistake.

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

Hahn noted in earlier tweets, too, that the emergency use of convalescent plasma did not imply a “final approval” of the treatment. That hasn’t stopped other administration officials from boasting about it, however.

“What we have is really a historic achievement here, a historic milestone, which is authorizing convalescent plasma for emergency use,” Health and Human Services Secretary Alex Azar said during an interview with NPR.

However, both Azar and Trump appear to be exaggerating the treatment’s efficacy. Trump officials have cited a Mayo Clinic study that suggests convalescent plasma is, by their reading of the data, “beneficial” for 35 percent of patients that used it. However, a number of health experts have said the administration is overly optimistic about the treatment, and that the study they cited had limitations, including lacking a comparative placebo group.

“While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of the disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment,” Thomas File, president of the Infectious Diseases Society of America, said.

Even the lead authors of the study the Trump administration is citing have expressed their doubts about the White House’s conclusions.

“Do I know where the 35 percent comes from? No,” one of the authors of the study, Arturo Casadevall of Johns Hopkins University, said.

The emergency use authorization itself came about in a controversial way. Officials from the National Institutes of Health tried to stop the FDA from granting the authorization last week, stating that more data was needed before it should be considered. The president responded to that delay by suggesting on Twitter, without evidence, that a “deep state” operation within the agency was conspiring to make him look bad.

Hahn responded to those accusations from the president while speaking to reporters from Reuters. “I have not seen anything that I would consider to be ‘deep state’ at the FDA,” he said.