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by petra 482 days ago
So pharmaceutical research is largely an engineering problem, of running experiments and synthesizing molecules as fast, cheap and accurate as possible ?
2 comments

I wouldn't say it's an engineering problem. Biology and pharmacology are very complex with lots of curveballs, and each experiment is often different and not done enough to warrant full engineering-scale optimization (although this is sometimes the case!).
It also seems to be a financial problem of getting VC funds to run trials to appease regulators. Even if you’ve already seen results in a lab or other country.
We could have an alternative system where VC don’t need to appease regulators but must place X billion in escrow for compensation of any harm the medicine does to customers.

Regulator is not only there to protect the public, it also protects VC from responsibility

> VC don’t need to appease regulators

Regulations around clinical trials represent the floor of what's ethically permissible, not the ceiling. As in, these guidelines represent the absolute bare minimum required when performing drug trials to prevent gross ethical violations. Not sure what corners you think are ripe for cutting there.

> Regulations around clinical trials represent the floor of what's ethically permissible, not the ceiling.

Disagree. The US FDA especially is overcautious to the point of doing more harm than good - they'd rather ban hundreds of lifesaving drugs than allow one thalidomide to slip through.

Yeah that's not how anything works. Compounds are approved for use or not based on empirical evidence, thus the need for clinical trials. What's your level of exposure to the pharma industry?
> Compounds are approved for use or not based on empirical evidence, thus the need for clinical trials.

But off-label use is legal, so it's ok to use a drug that's safe but not proven effective (to the FDA's high standards) for that ailment... but only if it's been proven effective for some other random ailment. That makes no sense.

> What's your level of exposure to the pharma industry?

Just an interested outsider who read e.g. the Omegaven story on https://www.astralcodexten.com/p/adumbrations-of-aducanumab .

This is why FDA requires experiments before company sells any drugs.