(2021-12-01) ZviM FDA Votes On Molunpiravir

Zvi Mowshowitz: FDA Votes on Molunpiravir. While Paxlovid Remains Illegal and is expected to remain illegal for at least several weeks, the FDA did manage to finally meet to discuss whether or not to legalize the other Covid-19 treatment pill, Merck’s Molunpiravir

one might naively think that after sufficient stalling for appearances this would be easy. One would be wrong. The vote was 13-10, was restricted to those at high risk, and could easily have failed outright.

an interesting mix of good and bad thinking

I’m glad this didn’t cause a veto for enough voters, but consider that if this wasn’t an emergency situation, it might have caused one, despite being good news since it opens up the possibility of doing better once we know more.

Of course, same as it ever was, we stopped the study when the early results looked so good, and now we’re saying the results are at most barely good enough…

OTOH, they also said if there’s “another oral medication” with higher efficacy with less side effects (think Paxlovid!), then the FDA should reconsider Molnupiravir. So Molnupiravir may get approved for like a month or so until Paxlovid blows it away? They so carefully didn’t mention Paxlovid that I wonder if there was some legal constraint.

So the recommended EUA only for high-risk individuals, mostly the unvaccinated or those who had suboptimal response to vaccination.

When they tried this insanity with boosters, limiting who can have access without legal liability to life saving medicine and thus allowing people to die, in order to satisfy arcane ‘ethical’ requirements, the states increasingly overruled the FDA. I very much hope that they do this again.

There’s always a lot of good information at these meetings. What is it important to know?

Treatment must start within 5 days from symptoms

This also means that if you catch the problem quickly, we would probably see much better than 30% efficacy. This effect has to be continuous, there’s nothing special about five days in particular.

It’s not just making people feel better, it’s doing so by a mechanism that makes sense and is related to the disease process.

have we considered that these sample sizes are too low and that’s why everything’s so noisy?

It’s good to have a reference handy of how everyone voted, to compare with other votes in the future, or for other reasons.

“I think we need to stop and acknowledge that the whole reason we’re having this discussion is because the efficacy of this product is not overwhelmingly good,” said W. David Hardy

What is ‘overwhelmingly good?’ I’m guessing that if it were standard of care, and someone were suggesting not using it, the 30% would be enough to make this seem completely crazy and unacceptable

Takeaways

When you stop a trial early, you sometimes don’t get enough data. This lack of data can then endanger approval. We have a concrete example

The FDA is even more willing to deny us life saving medicine than we previously expected.