I don’t agree with forcing anything on anyone. I’m simply pointing out that the studies are double blind placebo whereas the evidence for harm comes from retrospective analysis of alleged harm.

Reply to this note

Please Login to reply.

Discussion

Again, there is no double blind placebo controlled safety trial. You can’t just say “they can do both at once” an ignore the fact that they simply didn’t do that.

My point was there are no specific safety trials because they measure effectiveness and safety concurrently. How would a safety specific trial differ from the current standard?

Have you actually not looked at the trials? They explicitly separate them and are required to for pre approval trials. The details of each can be found in all of the package inserts.

Yes. Here is the package insert for Pfizer https://www.fda.gov/media/151707/download the safety data is on pages 6-21. It’s all the same trials they just separate the data because efficacy and safety are concerned with different data points.

Later package inserts got updated safety data once they learned about further risks for specific populations.