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Wait . . . Trump's big presser coronavirus "breakthrough" was plasma therapy?
Seriously??
Like they were doing in April? https://www.pnas.org/content/117/17/9490
Seriously??
Like they were doing in April? https://www.pnas.org/content/117/17/9490
Let's see what th . . . oh. "The decision to issue an emergency use authorization, which President Trump’s press secretary heralded ahead of time as a 'major therapeutic breakthrough,' likely falls far short of that description." https://www.statnews.com/2020/08/23/fda-under-pressure-from-trump-expected-to-authorize-blood-plasma-as-covid-19-treatment/
An FDA staffer who reviewed the data on convalescent plasma — and whose name was redacted from a memo released by the agency — was far less enthusiastic, writing that the data . . . (cont)
(cont.) . . . “support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of an EUA. "
MAY be. So that 35% effectiveness in use that isn't from proper clinical trials is what? A big maybe.
MAY be. So that 35% effectiveness in use that isn't from proper clinical trials is what? A big maybe.
That's because 35% of the people who got plasma therapy didn't die.
So 65% who did get plasma therapy did die.
And since these weren't randomized clinical trials, no one can say for certain what, if any, effect the plasma therapy had.
Marvy.
So 65% who did get plasma therapy did die.
And since these weren't randomized clinical trials, no one can say for certain what, if any, effect the plasma therapy had.
Marvy.
Back to the FDA staffer, "Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.”
Plasma therapy for treatment of COVID-19 is not new, but it's also not proven. Here's a breakdown of that in this thread: https://twitter.com/EricTopol/status/1297583093285494785
