President touts plasma therapy
Seeking good news, Trump acts with emergency approval
WASHINGTON — President Donald Trump on Sunday announced emergency authorization to treat COVID-19 patients with convalescent plasma, a move he called “a breakthrough.”
The announcement came after White House officials complained that there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease caused by the novel coronavirus.
On the eve of the Republican National Convention, Trump put himself at the center of the FDA’S announcement of the authorization at a news conference Sunday evening. The authorization makes it easier for some patients to obtain the treatment but is not the same as full FDA approval.
The blood plasma, taken from patients who have recovered, may provide benefits. But the evidence has not been conclusive.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, said: “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
But Trump had made it clear to aides that he was eager to showcase good news in the battle against the virus.
“This president is about cutting red tape,” White House chief of staff Mark Meadows said in an interview Sunday on “This Week” on ABC. “He had to make sure that they felt the heat. If they don’t see the light, they need to feel the heat because the American people are suffering.”
During Sunday’s press conference, Trump said he thought there had been a “logjam” at the FDA over granting the emergency authorization. He alleged that there are people at the FDA who “can see things being held up … and that’s for political reasons.”
More than 70,000 patients in the U.S. have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines.
Administration officials, in a call with reporters Sunday, discussed a benefit for patients who were within three days of admission to a hospital, were not on a respirator and were given “high-titer” convalescent plasma containing higher concentrations of antibodies.
They were then compared with similar patients who had been given lower-titer plasma. The findings suggest that the number of deaths was 35 percent lower in the high-titer group.