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by ClumsyPilot 487 days ago
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
2 comments
forgetfreeman 487 days ago
> 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.

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lmm 487 days ago
> 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.

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forgetfreeman 487 days ago
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?
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lmm 487 days ago
> 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 .

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forgetfreeman 485 days ago
I strongly encourage you to take a half hour and have a look at what goes into preclinical testing and the phases of official trials. An understanding of the data gathered during this process should clear up some of your confusion around safety and efficacy of off-label uses, which parenthetically pharma companies are strictly regulated against encouraging in any way.
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melagonster 487 days ago
This is why FDA requires experiments before company sells any drugs.
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