The obtainable information appears to satisfy the bar for an EUA.
Right here is his WSJ Op-Ed with McClellan, Straussian all through I think. They may solely trace at their outrage on the course of, noting that each are former FDA heads. Right here is the FDA reality twist.
I discovered this Adam Rogers Wired piece insightful and the perfect single remedy thus far, and in addition fascinating extra usually on RCTs:
“Fifty thousand individuals have been given a remedy, and we can’t know whether or not it labored or not,” says Martin Landray, one of many leaders of the Randomised Analysis of Covid-19 Therapies (or Restoration) Trial in England, a large-scale, multi-center, multi-drug randomized managed trial that confirmed that the corticosteroid dexamethasone saved the lives of Covid-19 sufferers and the autoimmune drug hydroxychloroquine didn’t. (That 50,000 quantity was from just a few weeks again, simply after the plasma preprint got here out.)
The primary arguments towards the choice from Trump/FDA appear to be “do RCTs” and “convalescent plasma isn’t proven to be so nice.” However these factors have it precisely backwards. Sufferers for trials are extraordinarily scarce proper now, and if convalescent plasma isn’t the very best likelihood huge winner (and I think it isn’t), you gained’t need to waste scarce sufferers on doing the RCT. Furthermore, in case you can’t get the RCT finished with 98,000 or so sufferers, perhaps you’re simply lower than doing it interval! (Please do assume on the margin.) Within the meantime, convalescent plasma doesn’t appear to contain harms or dangers, and it might supply some advantages. So why not let extra individuals have simpler entry to it?
And may there be a tiny likelihood that Americans demand stronger cost incentives for the related provides right here and in addition for different remedies?
If all individuals have is “do RCTs and CP isn’t proven to be so nice,” I don’t assume they’ve begun to have interaction with the arguments. And moreover politicizing the FDA is unquestionably an actual price to be reckoned with, however the Twitter noise I’m seeing from public well being specialists appears oblivious to the truth that the FDA’s ex ante risk-averse stance was politicized to start with (which isn’t essentially a nasty factor, however sure this can be a fundamental reality — “politicization for me, however not for thee,” and so forth.).