“These are the studies that showed no benefit of the antidepressant over the placebo. What they did is they took the more successful studies, they published most of them. They took their unsuccessful studies and they didn’t publish them,” Kirsch explained.
Dr. Michael Thase, a professor of psychiatry at the University of Pennsylvania and a paid consultant to a number of antidepressant manufacturers, disagreed with Kirsch. Thase told 60 Minutes that Kirsch was confusing the results of clinical trials conducted by the companies themselves (which the companies have consistently argued are the gold standard of medical proof) versus what goes on in practice (i.e., anecdotal evidence, which the companies have decried for years as unscientific).
Nonetheless, a number of studies validate Kirsch’s conclusions, including two co-authored by Dr. Walter Brown, a clinical professor of psychiatry at Brown University. Dr. Brown talked to 60 Minutes about the proliferation of antidepressant prescriptions and explained that “the biggest increase [in antidepressant prescriptions] is in the mildly depressed, who are the ones who are least likely to benefit from them.”
Brown went on to criticize the FDA’s drug approval process. “The FDA for antidepressants has a fairly low bar. A new drug can be no better than placebo in 10 trials, but if two trials show it to be better, it gets approved,” Brown pointed out. Thomas Laughren, director of the FDA’s division of psychiatry products, who was interviewed for the 60 Minutes segment, admitted the difference between medication and placebo is “modest.”
Brown’s opinions are corroborated by the FDA itself. In fact, one FDA official candidly explained: “How do we interpret … two positive results in the context of several more studies that fail to demonstrate that effect?” As he explained, “I am not sure I have an answer to that, but I am not sure that the law requires me to have an answer to that – fortunately or unfortunately. That would mean, in a sense, that the sponsor [drug manufacturer] could just do studies until the cows come home until he gets two of them that are statistically significant by chance alone, walks them out and says he had met the criteria.” (Melody Petersen, Our Daily Meds (2008), http://www.ourdailymedsthebook.com/).