The primary failure, however, appears to be the convoluted and disparate “categories” one must select to report–which leads to a world of confusion and obfuscation, allowing plenty of room for pharma to deny that there was “significant” reporting of problems, and also giving FDA a goodly amount of wiggle room. Consider, for example, a report addressing “pain” as an adverse event: a “twitch” is not the same thing as a “twinge” which differs from an “ache” or “dull pain” and of course is much different from “intense pain.” So until ALL categories have been addressed and reports allowed to accumulate till significant numbers are attained, pharma, FDA, MD’s can all “truthfully” state that there was not enough data to signify that Drug X causes unexpected “pain” as an adverse event.

As seen with Vioxx, Avandia, etc. –it takes a pile of bodies to attract notice.

One surprising experience of my own. I experienced an AE seven years ago on an eyedrop that was reconfirmed on three rechallenges. It was more or less ignored at the time. But I have recently heard from the opthy I was then seeing. He is having one of his fellows do some research on this - it turns out more of the same AEs are “showing up” since my own.

An article in a major Opthy journal, as could happen with this, would almost certainly mean more than something buried at CDER or in a company file.