-----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)