FDA Chief Under Fire for Distorting Data on Plasma Therapy

President Donald Trump listens as Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration, speaks during a Sunday media briefing in Washington.(AP Photo/Alex Brandon)

WASHINGTON (CN) — After apologizing for misrepresenting data on a Covid-19 treatment, the head of the Food and Drug Administration denied Tuesday that he was offering false hope about convalescent plasma therapy to help the president.

“The professionals and the scientists at FDA independently made this decision, and I completely support them,” said FDA Commissioner Stephen Hahn in an appearance on “CBS This Morning.”

Facing criticism from scientists around the world for announcing misleading results about the success of the plasma therapy Sunday, Hahn had tweeted an apology Monday night.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted Monday night. “The criticism is entirely justified.” 

A day earlier, Hahn had stood at the White House as President Donald Trump announced emergency approval for of the use of plasma based on study results he called “truly historic.”

Joined by Trump and Health and Human Services Secretary Alex Azar at the Sunday briefing, Hahn had said that patients with Covid-19 treated with convalescent plasma had a 35% rate of recovery. 

“What that means is, and if the data continues to pan out, 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma,” Hahn said. 

But the results from that Mayo Clinic study contradict Hahn’s statement, and the scientific community said Hahn had failed to distinguish between concepts known as absolute survival benefit and the relative difference between two treatment groups.

It is a technical difference to be sure, but former FDA officials have called Hahn’s misstatement inexcusable, particularly given his medical background as a cancer specialist.

 “The head of the United States Food and Drug Administration (!) @SteveFDA does not understand the difference between relative and absolute risk reduction — a basic, fundamental concept in medicine, statistics and clinical trial interpretation,” David Steensma, an oncologist at the Dana-Farber Cancer Institute in Boston and a faculty member at Harvard Medical School, tweeted. “It just gets worse and worse.”

Eric Topol, director of the Scripps Research Translational Institute, tweeted that, rather than 35%, the data truly showed that 3 people out of 100 would be saved at seven days of treatment and 5 at 30 days.

Howard Forman, a practicing diagnostic radiologist who is also faculty director of finance at Yale University, also criticized Hahn’s fumble but allowed that there may be a warranted decision for the emergency authorization of blood plasma therapies.

“We need the FDA to be an apolitical arbiter of science. Not politicized,” Forman wrote in an email. “Our president decided to make a political statement on the evening of the RNC and his FDA commissioner consented to play along. This was disgraceful.”

Shortly before announcing the emergency-use authorization, Trump had accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.”

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted Saturday, tagging Hahn in the message. “Obviously, they are hoping to delay the answer until after November 3rd.”

With Trump’s poll numbers sinking continually as the November election approaches, the administration has sunk vast resources into the race for a vaccine against the coronavirus. Hours before the plasma announcement, Trump’s chief of staff Mark Meadows doubled down on the rhetoric by saying FDA scientists “need to feel the heat.”

Unlike Hahn, who was the chief medical executive at the University of Texas MD Anderson Center prior to joining the FDA, Azar at HHS is a lawyer.

“I just want to emphasize this point because I don’t want you to gloss over this number,” Azar said. “We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients.” 

But the FDA’s own letter explaining emergency-use authorization meanwhile does not mention that people responded positively from plasma treatment regardless of the level of antibodies that the plasma contained from a donor who had recovered from the coronavirus.

Experts have also faulted Hahn for failing to make clear that the data applied only to a subset of patients: those under age 80 not already on a ventilator.

Hahn on Sunday 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. 

Facing pressure Monday, the commissioner insisted that the FDA’s decision to push for emergency use of the treatment was made “entirely by FDA scientists.” He also emphasized that emergency-use authorization is not the same as final approval.

“We at FDA do not permit politics to enter into our scientific decisions,” Hahn tweeted Monday. “This happens to be a political season but the FDA will remain data driven.”  

As of Tuesday, Covid-19 has killed over 177,000 Americans and infected more than 5.75 million in the U.S., according to a Johns Hopkins University tracker.

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