NEJM report finds negative FDA reviews of antidepressants did not get published


WALTHAM, Mass. The New England Journal of Medicine published a report Thursday regarding a study involving reviews from the Food and Drug Administration for studies of 12 antidepressant agents and the published outcomes based on the FDA reviews.

The results showed that among 74 FDA-registered studies, 31 percent were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published.

“Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies),” the report stated.

According to the published literature, it appeared that 94 percent of the trials conducted were positive. By contrast, the FDA analysis showed that 51 percent were positive. The Journal did state that the results could have been due to any number of factors, but concluded its abstract saying, “selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients.”

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