1/ Here& #39;s another way to think about @US_FDA emergency use authorization of convalescent plasma. This is OPERATION SLOWDOWN, *not* Operation Warp Speed. You want data on what works and what doesn& #39;t STAT? This was the WRONG way to go about it.
2/ Let& #39;s say hypothetically that convalescent plasma is an effective treatment for COVID. If people don& #39;t have to enroll in a randomized, placebo-controlled clinical trial, they won& #39;t.
3/ If patients have the option to get convalescent plasma outside of an RCT, they& #39;ll make an emotional decision (can you blame them?!) Often that means they& #39;ll want it when they& #39;re super sick, and they won& #39;t if they& #39;re not super sick. This introduces bias and skews the results.
4/ Let& #39;s say hypothetically that convalescent plasma is NOT an effective treatment for COVID. Now lots of people will take on the risks of treatment without benefit. The risks are not insignificant: anaphylaxis, transfusion-related lung injury, blood clots, kidney injury, & more.
5/ How do you scale up access to convalescent plasma to the entire U.S. population? You& #39;d need LOTS of people to donate plasma. You& #39;d need a big PR campaign to encourage and incentivize them to come in and give. That would cost $$$$.
6/ Why exactly should anyone spend that kind of $$$$ in the absence of data showing convalescent plasma is a safe and effective treatment for COVID?
7/ @US_FDA emergency use authorization for convalescent plasma = OPERATION SLOWDOWN because they& #39;ve now banishing this to purgatory. We& #39;ll never have enough data to show it& #39;s safe & effective (or not), and never have the incentive (if it works) to take it to scale.
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