Convalescent plasma?

Here is the FDA press release.  Here is StatNews coverage.  Scott Gottlieb tweets:

The available data seems to meet the bar for an EUA.

Here is his WSJ Op-Ed with McClellan, Straussian throughout I suspect.  They will only hint at their outrage at the process, noting that both are former FDA heads.  Here is the FDA truth twist.

I found this Adam Rogers Wired piece insightful and the best single treatment so far, and also interesting more generally on RCTs:

“Fifty thousand people have been given a treatment, and we cannot know whether it worked or not,” says Martin Landray, one of the leaders of the Randomised Evaluation of Covid-19 Therapies (or Recovery) Trial in England, a large-scale, multi-center, multi-drug randomized controlled trial that showed that the corticosteroid dexamethasone saved the lives of Covid-19 patients and the autoimmune drug hydroxychloroquine did not. (That 50,000 number was from a few weeks back, just after the plasma preprint came out.)

The main arguments against the decision from Trump/FDA seem to be “do RCTs” and “convalescent plasma isn’t shown to be so great.”  But those points have it exactly backwards.  Patients for trials are extremely scarce right now, and if convalescent plasma is not the highest probability big winner (and I suspect it isn’t), you won’t want to waste scarce patients on doing the RCT.  Moreover, if you can’t get the RCT done with 98,000 or so patients, maybe you’re just not up to doing it period!  (Please do think at the margin.)  In the meantime, convalescent plasma does not seem to involve harms or risks, and it may offer some benefits.  So why not let more people have easier access to it?

And might there be a tiny chance that American citizens demand stronger payment incentives for the relevant supplies here and also for other treatments?

If all people have is “do RCTs and CP isn’t shown to be so great,” I don’t think they have begun to engage with the arguments.  And additionally politicizing the FDA is definitely a real cost to be reckoned with, but the Twitter noise I am seeing from public health experts seems oblivious to the fact that the FDA’s ex ante risk-averse stance was politicized to begin with (which is not necessarily a bad thing, but yes this is a basic fact — “politicization for me, but not for thee,” etc.).


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