1/ Here'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't STAT? This was the WRONG way to go about it.
2/ Let's say hypothetically that convalescent plasma is an effective treatment for COVID. If people don't have to enroll in a randomized, placebo-controlled clinical trial, they won't.
3/ If patients have the option to get convalescent plasma outside of an RCT, they'll make an emotional decision (can you blame them?!) Often that means they'll want it when they're super sick, and they won't if they're not super sick. This introduces bias and skews the results.
4/ Let'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'd need LOTS of people to donate plasma. You'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've now banishing this to purgatory. We'll never have enough data to show it's safe & effective (or not), and never have the incentive (if it works) to take it to scale.
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