Posted by Larry Hoover on August 28, 2004, at 7:57:12
In reply to Re: pediatric suicidality and SSRIs, posted by Ilene on August 26, 2004, at 17:01:07
> My understanding is that there were no suicides. In other words, there is no evidence that SSRIs increase the risk of completed suicides in adolescents. I believe the suicide rate in adolescents is going down, but I don't know to what that is attributed.
Glaxo (GSK) put complete documentation for their pediatric trials online. I only reviewed one, but it was one from which the press was publishing headlines such as "paxil causes 700% increase in suicidal behaviour in adolescents" or such like.
The complete documentation for each incident of serious emotional lability was given in the appendices, so I read them. Turns out that the only serious suicide attempt was in the placebo group. For that individual, the blind was broken, as the attempt was so serious they needed to know what (if any) medication she was taking. There were no serious suicide attempts in the paxil group. There was no parasuicidal behaviour attributed to the med in the paxil group. (There were two incidents, but the blind was not broken, and the incidents were attributed to non-drug circumstances.)
It kind of gets my back up when data are misrepresented so. The study showed that paxil was superior to placebo at every point in the study, but it was not significantly better at the a priori cut-off point of 40% better than placebo. It was significantly better at 10, 20, 30, and 50 percent cutoffs, but not at 40, so they couldn't say it was better. All the press did was trumpet that it was not only not significantly better, but that it caused a seven-fold increase in suicide. Bollocks.
Lar
poster:Larry Hoover
thread:382578
URL: http://www.dr-bob.org/babble/20040825/msgs/383250.html