After Trump claimed Saturday that FDA employees were engineering delays to sabotage his re-election, Meadows said the president’s tweet reflected “frustration” with bureaucrats in the agency.
“They want to do things the way they’ve always done it,” Meadows said on ABC’s “This Week.” “This president is about cutting red tape. That’s what the tweet was all about.
Meadows suggested part of the reason Trump tweeted about the FDA is that he wants to make federal health agencies “feel the heat” to deliver results. On “Fox News Sunday,” Meadows said “the announcement that’s coming today should have been made several weeks ago.”
“It was a fumble by a number of people in the federal government that should have done it differently, and having been personally involved with it, sometimes you have to make them feel the heat if they don’t see the light,” he said.
Former FDA Commissioner Scott Gottlieb, who left the Trump administration in April 2019, said Sunday on CBS that there were “perceived delays” in making the authorization for blood plasma because of worries among top health officials.
“It was reported this week that [the National Institutes of Health] had misgivings about FDA going forward with that authorization. But there’s reasons people have some questions,” Gottlieb said on “Face the Nation.” “The trial that -- that’s going to be based on, 70,000 patients, wasn’t a very vigorously done trial.”
The emergency use order will probably allow more commercial distribution “and it will allow manufacturers of plasma products to more easily recoup the cost,” he said. “But the bottom line is, it’s widely available right now. Patients are getting it.”
Separately, the Financial Times reported on Sunday that Trump is considering whether to bypass normal U.S. regulatory standards to fast-track an experimental coronavirus vaccine from the U.K. for use in the U.S. before November’s election, via an EUA.
A spokesman for HHS, which oversees the FDA, told the newspaper any claim that an emergency-use authorization would be issued before the election was “absolutely false.”
The Mayo Clinic’s data, posted on a website used by researchers to disseminate their results before they are ready to be formally published, showed that patients getting convalescent plasma with the highest levels of antibodies were 35% more likely to survive than those who got lower levels. While treatment with higher antibody levels improved survival, all of the patients received convalescent plasma.
That distinction was papered over during Trump’s news conference, where the president said the therapy was proven “very effective” and Hahn said the product itself -- not its precise composition -- was saving lives.
“A 35% improvement in survival is a pretty substantial clinical benefit,” Hahn said. “What that means is that, if the data continue to pan out, 100 people who are sick with Covid 19, 35 would have been saved by the administration of plasma.”
What the study actually showed was that treating those 100 people who would have otherwise died with higher antibody levels saved 35 lives, compared with giving all of them plasma units with lower doses of antibodies. It doesn’t shed any light on how they would have fared compared to standard treatment.