One explanation is that the FDA just has strange epistemology and ethics. They profess belief that claims unsubstantiated by a high-quality RCT should be treated as false until proven otherwise. That sounds like a strawman, but actually fits their justification for second-doses-fist to Alyssa Vance.
I don’t think that’s surprising. It they would allow people to approve a drug based on a single high-quality RCT a company could simply run 20 RCT for different outcomes with the hope one of them being statistically significant and then get their drug approved based on the statistically significant trial.
I agree that this is the FDA’s model. It implies a “strange” unawareness of the underlying statistics. The p-values of the vaccines are really really small because their effect sizes are may orders of magnitudes above most drugs. Also the drug companies in this case could not run many RCTs. So if the FDA were maximizing lives they would authorize them. If they are making an incentive system that requires no deep understanding of statistics, it’s not “strange”.
Importantly, the FDA is “strange” relative to the calculus of politicians, who to survive must be utilitarian and use induction.
I don’t think that’s surprising. It they would allow people to approve a drug based on a single high-quality RCT a company could simply run 20 RCT for different outcomes with the hope one of them being statistically significant and then get their drug approved based on the statistically significant trial.
I agree that this is the FDA’s model. It implies a “strange” unawareness of the underlying statistics. The p-values of the vaccines are really really small because their effect sizes are may orders of magnitudes above most drugs. Also the drug companies in this case could not run many RCTs. So if the FDA were maximizing lives they would authorize them. If they are making an incentive system that requires no deep understanding of statistics, it’s not “strange”.
Importantly, the FDA is “strange” relative to the calculus of politicians, who to survive must be utilitarian and use induction.