> 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?
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.
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.