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