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by cstross 4290 days ago
There are pros and cons for both sides of this argument.

The question is whether to suspend normal precautionary procedures during an extraordinary situation, not whether to ditch normal precautionary procedures which exist for very good reasons (see the Elixir Sulfanilamide disaster for why):

http://www.fda.gov/aboutfda/whatwedo/history/productregulati...

You're rightly concerned for the possible side-effects of using untested treatments on people during an emergency. But flip the question around: who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data?

1 comments

> who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data?

No one, that's exactly the point.

There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability.

So the reality is that there is no good way to send only useful drugs there while skipping the filtering process.

If you're okay with some people being poisoned or lied to for money in the hope that some people will get a real drug, then we could make that work, but I'm not sure we want to go down that path.

There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability.

I'm ready to assume that medics treating an emergency epidemic are unlikely to knowingly turn to quack remedies -- homeopathic or bogus ones -- as opposed to items like ZMapp, a monoclonal antibody treatment by a well-regulated pharmaceutical company that just happens not to have been approved for human clinical trials yet.

http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimenta...

Furthermore, let me add that conducting a randomized controlled clinical trial (for effectiveness and safety) when dealing with a pathogenic infection with a > 50% fatality rate is arguably unethical: you can collect data on clinical applications and apply a retrospective control sample of patients to determine whether it improved the outcome where it was used, but withholding a potentially effective treatment becomes extremely problematic under some circumstances -- the historic classic example was zidovudine for HIV, which was rushed through human trials into use in just 27 months because it was the first effective treatment for a then-100% fatal disease (HIV). (Some of the double-blind trials were short-circuited when it became apparent that continuing to alternate patients with placebo controls was likely to be injurious.)

http://en.wikipedia.org/wiki/Zidovudine