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Unpublished (suppressed) studies and 41% efficacy

Posted by BobS. on August 9, 2003, at 18:50:41

In reply to NYTimes:Debate on SSRIs and Suicide risk continues, posted by jrbecker on August 7, 2003, at 9:47:43

The most important issues raised in this article are as follows. I know because I work in human clinical trial arena....

"Even in adults, S.S.R.I.'s have been found to offer only modest benefits. In about half of all adult tests, the drugs prove no more effective than placebos. On average, they reduce symptoms of depression by about 41 percent on a widely used scale, versus a 31 percent reduction among those taking placebos, according to a survey in 2000 of studies used by the F.D.A. in approving the drugs.

Researchers, moreover, have not been able to analyze much of the data on the drugs, because they have not been made public.

GlaxoSmithKline, for instance, has acknowledged that just one of its nine studies of Paxil in children and adolescents has been published — a study that made only passing mention of suicide and concluded that the drug was effective against depression. According to the F.D.A., the combined results of all nine trials show that the drug is not effective against depression in patients under 18. Of the S.S.R.I.'s, only Prozac is approved by the F.D.A. to treat depression in children and teenagers, although doctors also widely prescribe the others."


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poster:BobS. thread:248910
URL: http://www.dr-bob.org/babble/20030807/msgs/249631.html