A recent report on CBS’s 60 Minutes questions whether antidepressants are any more effective than placebos.
The report features an interview with Irving Kirsch, associate director of the Placebo Studies Program at Harvard Medical School, who says clinical trials simply don’t show a clinically significant advantage to antidepressants over dummy sugar pills.
“People get better when they take the drug,” Kirsch acknowledges. “But it’s not the chemical ingredients of the pills that are making them better. It’s largely the placebo effect.”
That assertion is particularly relevant in light of recent clinical evidence that some antidepressants may have harmful side effects. A number of studies have suggested that the class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIS, are linked to birth defects in babies born to pregnant women who take them – including potentially dangerous heart and lung defects.
SSRI antidepressants include Zoloft and Prozac.
Kirsch said he based his conclusion on analysis of all studies submitted to the U.S. Food and Drug Administration, and not simply those that the drug companies published in medical journals.
“What they did is they took the more successful studies, they published most of them,” Kirsch said. “They took their unsuccessful studies and they didn’t publish them.”
He concluded that in cases of mild or moderate depression, there was no real difference at all. The only clinically meaningful difference was at extreme levels of depression.
The report also quotes Dr. Walter Brown, a clinical professor of psychiatry at Brown University’s Medical School, who says the FDA’s approval process is fundamentally flawed.
Brown says the FDA merely requires companies to show a drug is effective in two clinical trials in order to get approval, even if many other drug trials have failed.
“The FDA for antidepressants has a fairly low bar,” Brown says. “A new drug can be no better than placebo in 10 trials, but if two trials show it to be better, it gets approved.”
Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries.
See the report here: