[oldalum]

from an ID specialist's blog post on an NEJM website:

"Never mind that . . . the randomized trials of this treatment have so far been disappointing.
Or that the observational data the FDA used to justify their action come from an unpublished study not yet subject to peer review.
Or that the very experts employed by the government to review plasma’s safety and efficacy have as recently as last week raised important concerns about the lack of convincing evidence for this treatment.
Or that this action by the FDA will almost certainly jeopardize any existing randomized trials of convalescent plasma in the United States.
Or that the person from the FDA who reviewed the plasma data had his name redacted from the memo.
. . . I have not heard from a single ID specialist who believes this action was supported by existing data, and indeed our professional society agrees.
Convalescent plasma may work to help people with COVID-19. But if it does, we don’t know how much, or who are the most likely to benefit, or how to select the right donors. . . .
For the true evidence, we’ll have to wait for the randomized, controlled clinical trials.
The ones going on in other countries."

[oldalum]

from an ID specialist's blog post on an NEJM website:

"Never mind that . . . the randomized trials of this treatment have so far been disappointing.
Or that the observational data the FDA used to justify their action come from an unpublished study not yet subject to peer review.
Or that the very experts employed by the government to review plasma’s safety and efficacy have as recently as last week raised important concerns about the lack of convincing evidence for this treatment.
Or that this action by the FDA will almost certainly jeopardize any existing randomized trials of convalescent plasma in the United States.
Or that the person from the FDA who reviewed the plasma data had his name redacted from the memo.
. . . I have not heard from a single ID specialist who believes this action was supported by existing data, and indeed our professional society agrees.
Convalescent plasma may work to help people with COVID-19. But if it does, we don’t know how much, or who are the most likely to benefit, or how to select the right donors. . . .
For the true evidence, we’ll have to wait for the randomized, controlled clinical trials.
The ones going on in other countries."