By Linda Johnson
Originally published January 31, 2013
The maker of Zoloft is being sued in an unusual case alleging the popular antidepressant has no more benefit than a dummy pill and that patients who took it should be reimbursed for their costs.
Zoloft's maker, Pfizer Inc., the world's biggest drugmaker by revenue, disputes the claim, telling the Associated Press Thursday that clinical studies and the experience of millions of patients and their doctors over two decades prove Zoloft is effective.
The lawsuit was described as frivolous by Pfizer and four psychiatry experts interviewed by the AP.
Not so, according to plaintiff Laura A. Plumlee, who says Zoloft didn't help her during three years of treatment. Her attorney, R. Brent Wisner of the Los Angeles firm Baum Hedlund Aristei Goldman, argues the Food and Drug Administration shouldn't have approved Zoloft because Pfizer didn't publish some clinical studies that found the drug about as effective as a placebo.
Kirsch, associate director of Harvard Medical School's Program in Placebo Studies, has published a book and several medical journal articles on the effect. With colleagues, he reviewed numerous studies of popular antidepressants, including unpublished studies obtained using the Freedom of Information Act.
"The difference between drug and placebo is very small," below the level that benefits patients, Kirsch concluded.
He said Pfizer produced two studies showing Zoloft worked better than placebo — the FDA's requirement for approval — but most Zoloft studies showed its effect was the same as a placebo.
Dr. Michael Thase, who heads the mood and anxiety disorders program at the University of Pennsylvania's medical school, said research by others using the same unpublished studies concluded antidepressants have "a modest effect over placebo," on average about 15 percentage points.
That's partly because the rate of study participants improving when they're taking a placebo has been rising, said New York University's Sussman.
The entire story is here.