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-----On Thu 09 Dec, Phil Tompkins wrote: > 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 > > > Hello Phil, I am fairly certain that the reason that the drug manufacturers append a list of effects observed during testing, is simple self-preservation. By listing out all the reported cases, whether they be Hot Flushes and Chills, of Constipation and Diarrhoea, they all get a mention. What they are doing is simply protecting the manufacturers from future court cases, should a user of the drug develop any abnormal results. It may not save them in every case, but a report of the event would certainly make life more difficult when trying to prove negligence. PS Regarding the meaning of the reports of trials of Permax, where 11.6% of recipients reported dystonia, and 8% of placebo also reported it - Surely the simple conclusion is that the causes of Dystonia are nothing to do with Permax ? Regards -- Brian Collins <[log in to unmask]> (59/39/34)