NEGATIVE REPORTS ON ANTI-DEPRESSANTS KEPT FROM THE PUBLIC

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WALL ST JOURNAL - The effectiveness of a dozen popular antidepressants
has been exaggerated by selective publication of favorable results,
according to a review of unpublished data submitted to the Food and Drug
Administration.

Since the overwhelming amount of published data on the drugs show they
are effective, doctors unaware of the unpublished data are making
inappropriate prescribing decisions that aren't in the best interest of
their patients, according to researchers led by Erick Turner, a
psychiatrist at Oregon Health & Science University. Sales of
antidepressants total about $21 billion a year, according to IMS Health.

Wyeth and Pfizer declined to comment on the study results. Both
companies said they had committed to disclose all study results,
although not necessarily in medical journals. GlaxoSmithKline PLC, maker
of Wellbutrin and Paxil, said it has posted the results of more than
3,000 trials involving 82 medications on its Web site, and also has
filed information on 1,060 continuing trials at a federal government Web
site.

Schering-Plough Corp., whose Organon Corp. unit markets Remeron, and Eli
Lilly & Co., which makes Prozac, said their study results were indeed
published -- not individually, but as part of larger medical articles
that combined data from more than one study at a time. The New England
Journal study counted a clinical trial as published only if it was the
sole subject of an article. . .

Pharmaceutical companies are under no obligation to publish the studies
they sponsor and submit to the FDA, nor are the researchers they hire to
do the work. The researchers publishing in the New England Journal were
able to identify unpublished studies by obtaining and comparing
documents filed by the companies with the FDA against databases of
medical publications. . .

A total of 74 studies involving a dozen antidepressants and 12,564
patients were registered with the FDA from 1987 through 2004. The FDA
considered 38 of the studies to be positive. All but one of those
studies was published, the researchers said.

The other 36 were found to have negative or questionable results by the
FDA. Most of those studies -- 22 out of 36 -- weren't published, the
researchers found. Of the 14 that were published, the researchers said
at least 11 of those studies mischaracterized the results and presented
a negative study as positive.

http://online.wsj.com/article/SB120051950205895415.html?mod=googlenews_wsj


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