Nice to hear about some big wins today!

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Approved COVID —> Approved Luvox :-)

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May I say how much I appreciate the fairness: criticism when the FDA seems to be doing harm, praise when it seems to be improving. Neither all-regulation-is-always-bad nor all-regulation-is-always-good. Calling balls and strikes.

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It's a Christmas miracle!

This is proof the FDA can do an EUA without waiting 4 weeks to convene an advisory panel, if they want to.

I signed the letter of support for the fluvoxamine EUA!(https://docs.google.com/forms/d/e/1FAIpQLSc7TATp80UcJiNns1tufyl8G36TQCnib7Sw0vtE2KQ6gAwgmA/viewform)

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Great news. Thank you for the update.

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One problem with all of this is that it is hard to see how to do the incentives right. In the future, not too many people are going to care/remember extra efficiency (say a two week sooner approval of the vaccine) but all of us are going to remember if people grew two noses after they got a shot. The people in charge are way more scared of making a mistake in the direction of not enough caution...but that is probably correctly mirroring public opinion. This particular pandemic is showing how bad public opinion can be for this kind of thing. Seems like an unavoidable problem with an adversary based political system.

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It's important to remember that the FDA is still shit overall even if they've accidentally managed to get a few things (these two issues and opposing boosters for the general population) correct recently.

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I really think Paxlovid will finally end this horseshit.

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When Scott complains, things get done, man.

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Great news about Paxlovid! Does anyone know what the availability timeline will be? Will it be prescribed to people who get sick in the next week in the US? Or is it going to be a few weeks to months before it's generally available?

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Awesome, Well done FDA. Boosted Monday, (flexes muscles), bring on Omicron, I'm ready. (as I'll ever be.)

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Mr. Alexander—

You have surely convinced all your readership that the FDA kind of sucks.

Perhaps next you could study what exactly makes it suck, and what policy changes would improve it.

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Maybe the mechanism is neurolinguistic or kotodamaic - after all fluvoxamine sounds remarkably like flu vaccine. Perhaps this is merely a case of the True Name principle. Differential studies must be carried out immediately.

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Scott, keep pushing for ketamine approval for depression and suicidality. It is ridiculous that it isn't approved for that.

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> According to Metaculus, there was only a 6% chance we would get Paxlovid approved this quickly.

There's a bias in this number: At the time of Metaculus' opinion, it had already updated on Paxlovid having not been approved in the past.

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To quote Scott:

"Here’s my pitch for fluvoxamine (Luvox) for COVID.

In the midst of all the hype about ivermectin and hydroxychloroquine, scientists put together the giant

4,000-person TOGETHER trial, intended to test all these exciting COVID early treatments. You know what

happened next: ivermectin and hydroxychloroquine crashed and burned.

But a different drug, the SSRI antidepressant fluvoxamine, actually did really well!

It decreased COVID hospitalizations by about 30% "

OK. Let's actually look at the report from the TOGETHER trial:


This trial had a primary endpoint of hospitalisation.

"Our primary outcome was a composite endpoint of hospitalisation defined as either

retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19

up to 28 days postrandom assignment on the basis of intention to treat."

The result was about a 30% improvement in this metric with treatment with fluvoxamine. This is encouraging,

but look at the secondary findings:

"Table 3 presents findings from secondary outcome

analyses. There were no significant differences between

fluvoxamine and placebo for viral clearance at day 7

(p=0·090) and hospitalisations due to COVID (p=0·10),

all-cause hospitalisations (p=0·09), time to hospitalisation

(p=0·11), number of days in hospital (p=0·06), mortality

(p=0·24), time to death (p=0·49), number of days on

mechanical ventilation (p=0·90), time to recovery

(p=0·79) or the PROMIS Global Physical (p=0·55) or

Mental Scale (p=0·32; appendix 2 p 8)."

>>>No Difference<<< in

hospitalisations due to COVID (p=0·10)

mortality (p=0·24)

time to death (p=0·49)

Why does anyone care about the primary endpoint when you're going to die just as fast?

So what is the rational argument for approving a drug that has shown no improvement in hospitalisation or death?

I certainly wouldn't fault FDA for not approving a drug on this sort of evidence.

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Thanks for the heads up. I just signed it.

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The paxlovid thing is interesting since it seems like nearly all the delay was the pharma company sending them the study data,the approval came about a week after that. Actually decreased my pessimism about the FDA a decent bit after learning that.

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