Sharing a few threads on whether molnupiravir (new antiviral on the cusp of approval) risks generating new variants because the mutations it induces may, rarely but possibly, not kill the virus but generate viable variants instead. Many on the FDA panel who voted no raised this.https://twitter.com/CT_Bergstrom/status/1467611446053851145 …
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Pfizer antiviral doesn't use the same mechanism, so does not have the same risk. I think antivirals are an excellent addition to our arsenal. That said, so many on the FDA panel raised this issue, and still little news coverage? How do we get more clarity?https://twitter.com/diagionals/status/1467892862092288000 …
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Here's a post by
@Dereklowe on this question, but also highlighting below the part where he wonders (as have others), if the already low reported benefit is there at all? (The trial data is really weird...) https://www.science.org/content/blog-post/rethinking-molnupiravir …pic.twitter.com/tGTd3jcvdb
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I think we can assume that there'll be some patient noncompliance (stopping early, skipping doses, erratic timing) as well as re-targeting (hoarded/left-over pills being shared). How does this affect this tail risk—not to the patient, but to society?https://twitter.com/Dereklowe/status/1467906065882927112 …
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To some asking: This mechanism doesn't apply to vaccines (vaccines aren't drugs—this is a drug specifically mutagenic to the virus), nor to Pfizer's antiviral (which targets enzymes, and is also not mutagenic to the virus). So concerns are only about this (or similar) drugs.
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Do you think this is an instance where the FDA panel is potentially thinking too broadly, rather than pure trial efficacy? Imagine that the reason behind this EUA is to get vaccine refuses some form of treatment that doesn't rely on hospital care even if marginal at best.
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Shouldn’t anti vaxers be saying this is an experimental drug and I am not taking it?
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Has there been any further information on the pfizer antiviral drug?
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Umm… Kinda like antibiotic resistance
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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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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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