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Hello, I have questions about the collection and meaning of drug side effects data. The prescribing information that accompanies a drug normally contains a table of data on adverse events observed while the drug was tested. The table lists numerous adverse events, the percent of patients experiencing each effect who were taking the drug, and the percent of patients experiencing each event who were taking the placebo. Regarding the adverse events: Do the researchers use in every drug trial a common master list of all possible adverse events that may occur, or is a list developed for each trial based on complaints that patients volunteer, or is the list a combination of both? Regarding the percents: Are the patients asked about adverse events which occured prior to taking part in the trial? That is, do the data show new events which the patients experienced as a result of taking the drug or the placebo? I would guess that most lay people would interpret the data in this manner. Or do the percents merely show a comparison of adverse events among patients taking the drug vs. the placebo regardless of whether the patients ever experienced these events previously? If the latter is what the data really show (can anyone confirm this?), that would explain why dystonia was observed for the placebo when Permax was tested, as noted by Joe Bruman below. That would also mean that many (perhaps most?) people are misinterpreting side effects data. J. R. Bruman wrote: > The Physicians' Desk Reference (PDR) description of each approved > drug is supposed to include *all* reports of adverse effects. In > controlled trials for the FDA of Permax, 11.6% of recipients > reported dystonia (4th highest among the neurological effects)- but > then 8% of those getting placebo also reported it, an insignificant > difference. Go figure. Phil Tompkins Hoboken NJ age 61/dx 1990