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Only about half of new drugs approved in the last decade had comparative effectiveness data available at the time of their approval by the U.S. Food and Drug Administration, and approximately two-thirds of new drugs had this information available when alternative treatment options existed, according to a study in the May 4 issue of JAMA. http://www.sciencedaily.com/releases/2011/05/110503161400.htm

Numerous unpublished studies submitted to the Food and Drug Administration by pharmaceutical companies have found that many popular antidepressants have little or no effect on patients, according to a new review of the previously hidden findings. A total of 74 studies involving a dozen anti-depressants and 12,564 patients were registered with the FDA from 1987 through 2004. The FDA deemed 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...

Antidepressants are widely believed to be exceptionally effective medications. The data, however, tell a different story. Kirsch et al. (2002a) analyzed the data sent to the U.S. Food and Drug Administration by the manufacturers of the six most widely prescribed antidepressants (fluoxetine [Prozac], paroxetine [Paxil], sertraline [Zoloft], venlafaxine [Effexor], nefazodone [Serzone] and citalopram [Celexa]). Their research showed that although the response to antidepressants was substantial, the response to inert placebo was almost as great. The mean difference was about two points on the Hamilton Rating Scale for Depression (HAM-D). Although statistically significant, this difference is not clinically significant (Jacobson et...