This is utter BS. @US_FDA had decided not to issue an emergency use authorization for #ConvalescentPlasma. Then @realDonaldTrump intervened, and @SteveFDA caved. Hahn has betrayed the American people and failed as @FDACommissioner. He should resign now. https://sciencebasedmedicine.org/does-convalescent-plasma-work-against-covid-19-who-knows/ …https://twitter.com/SteveFDA/status/1298071603675373569 …
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Not only that, but this was a retrospective study. There was no control group, and it wasn’t randomized. WTF,
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Doing critical appraisal of the medical literature for decades. Using relative rather than absolute risk has been a way to “spin” the data.pic.twitter.com/2XjnFsb1in
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Regardless of the magnitude of the point estimate of effect size, it’s an association (observational study) not causation (RCT). The UK is doing an RCT to try to determine if this Tx has a net POO (patient-oriented outcome)
@KirstyChallen - Show replies
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This puts CDC and FDA in place where they cannot be trusted. How long until this can be reversed?
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That's bad. The whole thing also sets a bad precedent for future regulation regarding drugs.
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I think that’s the intent. I now agree with
@PeterHotez.#ConvalescentPlasma is likely a warmup for an EUA for a#COVID19 vaccine before the election. - Show replies
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One thought is that Hahn caved on this as a compromise and in return he won't authorize any vaccine that will not go through all the necessary steps of approval. We shall see, but I am not optimistic that he won't cave to Trump very dangerous political stunt on the vaccine.
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