There is a process in place that’s meant to capture a certain number of potential problems. I didn’t make that process. The people who are making drugs safe designed the process. There is never zero risk of a treatment behaving badly, of course but when a drug gets fast tracked and doesn’t go through the regular approval process, it just hasn’t been proven to be safe by the regular standard of what experts deem safe.
Would that large trial have shown the cancerous effect of smoking?
If not, do you then agree that some possible adverse effects were not checked for and could have slipped through?
Don't know. But would standard smaller trials have captured it?
We are kind of back to my initial question that is conceptually unrelated to the vaccine trial: do you need trials to run into millions or billions of participants or into decades if you want to capture certain (rare) things?.
It’s not very complicated.
trials ok => drug most likely ok
trials not done => we don’t really know.