This seems like as classic a case of Pascal's wager as I've ever seen in drug development. Theoretical arguments from smart people in either direction, no way to be sure… but Omicron moved the window for me on how I think about error tolerance of spike, at least.
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Replying to @roby_bhatt
I'm just trying to imagine a post-approval withdrawal because of this, and the damage it would do. Seems prudent to get some clarity, especially given the benefit itself is low to potentially non-existent. (I couldn't parse the trial data progression. Looks like noise at times).
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Replying to @zeynep
Right. Though it's not easy to imagine how to get "clarity" on the viral mutagenesis issue: it'll happen (that's how the drug works!), but will it drive functional mutants? Is mutation rate limiting in evolution, or not? ¯\_(ツ)_/¯ More clarity on efficacy would be welcome.
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Replying to @roby_bhatt
Yeah, clearly need more info on efficacy. On the other clarity part: I'm hoping someone will tell us! But the assumption has to be that many people will not complete the course as prescribed, will not quarantine, some will be immunocompromised (especially if it expands globally).
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Replying to @zeynep @roby_bhatt
With so many on the FDA panel raising this, specifically, as a significant enough concern, I'd like someone to tell us more about all this before approval, including how we'd get that kind of data/clarity.
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Replying to @zeynep
And while Omicron has affected my thinking on flexibility of ACE2 interface (bad for mutagenesis hypothesis), it's also prob compromised our best antivirals: mAb's. Therapies that mimic vaccines = not ideal. Orthogonal targets (protease, polymerase) = better. Nothing's easy.
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Replying to @roby_bhatt @zeynep
I'm not sure who can "tell us" more, but I'd sure love to learn from them!
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Replying to @roby_bhatt
Haha! The part here (from page 32 on) doesn't end with a conclusion. It just says uncertain! (There must be some monitoring mechanism for ongoing use, right?) https://www.fda.gov/media/154418/download …
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Replying to @zeynep
I mean, that conclusion sounds right to me. I'm not an expert in this subsubfield, but I know some folks who come close, and as far as I can see it's unknowable. And as you said, it's societal costs at play here, not individual - not sure we have a regulatory framework for that.
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Replying to @roby_bhatt @zeynep
I don't say "unknowable" nihilistically - I think it's worth thinking really hard about and modeling and etc - I just think there's likely to be a limit to the certainty one can achieve on the question. And I don't know who even asks the questions. Right… back to grant writing.
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zeynep tufekci Retweeted zeynep tufekci
Heh. Speaking of which, last thing, I'm guessing you saw the Omicron/epistasis paper? Evolution, generating fascinating conversations since the first person asked wait how did the eye evolve then?
Good luck with your grant(s)!https://twitter.com/zeynep/status/1467629606505222161 …
zeynep tufekci added,
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