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by drderidder 2242 days ago
Nobody seems to be talking much about favipiravir, which seems a bit like not-invented-here syndrome. If it stood to make a lot of money for some US big pharma company I suspect we'd be hearing more about it.
4 comments

At least this China-based RCT isn't underwritten by GILD?

That's something.

There's a Japanese Phase III trial ongoing or about to start, last time I checked.
Studies are extremely expensive, so there either has to be a payoff for the investment, or Bill Gates has to fund it.
It seems to me like people "talking much about" unproven drugs is the problem, and that favipiravir (and its patients) is lucky to have been spared much of that nonsense.

People want to talk about this stuff because it feels like a magic bullet. Viral infections don't have magic bullets[1], they just don't. We have to beat this with elbow great: huge amounts of testing and tracing once the outbreak is at a manageable baseline, and high uptake of mitigation strategies like social distancing until it gets there. And yes, that costs a lot of money.

[1] Rather: they do, but they're called vaccines and take time.

Viral infections don't have magic bullets

They do. Consider HIV/AIDS. Nowadays, someone who gets HIV-positive at the age of 20 can expect to live to 70. It's quite astounding what modern combination therapy can do.

And the current treatments for hepatitis C have mild side effects and usually eradicate the infection even if the infection has been going on for 20 years.
Tests to prove effectiveness in FDA terms takes years. This virus is 6 months old.

So, by definition, we will only have unproven drugs to use for the foreseeable future.

Not if the effect size is large. That would be proved in no time. The problem is so far all effect sizes are small, so it will take trials with large power (and longer term) to discern any positive benefit.
You can prove really good drugs quickly in a scientific sense, so you and I would be convinced.

But in the legal sense, my impression is that FDA never approves anything in under 2 years. Happy to be proven wrong!

It is likely that due do the NIAID trial, remedisivir will be granted an Emergency Use Authorization (EUA) to allow the use in the clinic.