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WASHINGTON (AP) — After expressing frustration at the slow pace of approval for coronavirus treatments, President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID-19 patients.
The announcement came after days of White House officials suggesting there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.
On the eve of the Republican National Convention, Trump issued the emergency order — it would make it easier for some patients to obtain the treatment — in a news conference Sunday evening, according to White House officials.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling with the disease. But the evidence has been inconclusive as to how it works or how best to administer it.
Many scientists and physicians believe that convalescent plasma might provide some benefit, but it is far from a breakthrough. It is rich in antibodies that could be helpful in fighting the coronavirus, but the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, noted: “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.”
The White House had grown agitated with the pace of the plasma approval, but the accusations of a slowdown, which were presented without evidence, were just the latest assault from Trump’s team on the “deep state” bureaucracy. White House chief of staff Mark Meadows did not deal in specifics, but said that “we’ve looked at a number of people that are not being as diligent as they should be in terms of getting to the bottom of it.”
“This president is about cutting red tape,” Meadows said in an interview 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.” ...
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Scientist expresse doubts about coronavirus treatment touted as
The Food and Drug Administration’s decision to give emergency authorization for convalescent plasma as a treatment for novel coronavirus patients — touted as a historic breakthrough by President Trump on Sunday — is raising doubts among some experts who say the therapy hasn’t been adequately tested.
“The urgency of the crisis has elided with a false sense we should skip over rigorous studies of interventions because we don’t have enough time,” Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, told The Washington Post.