January 16, 2008
Analysis suggests unfavourable studies of antidepressants aren't published
by Alison Fischer
An analysis published in the New England Journal of Medicine suggests that studies of antidepressants that had positive results were more likely to be published in medical journals compared with those that had negative or questionable results. The findings showed that 94 percent of all published trials appeared to have positive results, while FDA reviews determined that 51 percent of all trials, both published and unpublished, had positive outcomes.
In the analysis, the researchers examined data for 74 antidepressant studies submitted to the FDA between 1987 and 2004. The results showed that 37 of the 38 trials the agency considered as having positive results were published, compared with 14 of the 36 trials that the FDA considered negative or questionable. Additionally, of the 14 negative or questionable studies that were published, 11 "conveyed a positive outcome" that was not justified by the FDA review, lead author Erick Turner stated.
Editor-in-chief of the NEJM, Jeffrey Drazen, said "we know publication bias exists" and indicated that the analysis "shows that what's reported is really a much more rosy situation than actually exists." The researchers suggested that "selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health."
In response to the news, Alan Goldhammer, PhRMA's deputy vice president for regulatory affairs, noted that "this is all based on data from before 2004, and since then we've put to rest the myth that companies [have] anything to hide." He added that the government and the pharmaceutical industry have already taken steps to make information from clinical trials more transparent.
Some drugmakers also commented on the analysis. Pfizer, which markets the antidepressant Zoloft, stated that it is "committed to the communication of results of all registered clinical studies, regardless of outcome." GlaxoSmithKline, which sells Paxil, indicated that the company believes "public disclosure of clinical trial results for marketed medicines is essential."
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