Zoloft No Better Than Placebo, Claims Suit

Zoloft No Better Than Placebo, Claims Suit

February 4th, 2013 // 6:46 pm @ jmpickett

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In an unusual gambit, a California woman has filed a lawsuit claiming that the Zoloft antidepressant sold by Pfizer is no more effective than a placebo and that the drugmaker conspired to hide this fact from the medical community and the public in hopes of generating as many sales as possible. For its part, Pfizer contends that studies have shown that Zoloft is effective and maintains the lawsuit is frivolous.

The lawsuit was filed by Laura Plumlee, who maintains that Zoloft failed to help her during three years of treatment. She argues that most clinical trials that were designed to substantiate effectiveness demonstrated that Zoloft was not superior to placebo and that the difference between Zoloft and placebo in “the only two studies” that did show the pill was more effective than a placebo had been obtained through “data manipulation” (here is the lawsuit).

The complaint relies, in part, on research by Irving Kirsch, a director of the Placebo Studies Program at Harvard Medical School, who caused a ruckus last year when ’60 Minutes’ featured his work in a segment about antidepressants and the placebo effect. He filed Freedom of Information Act requests to obtain unpublished trial data and contended that, when combining results with published data, various drugs were no better than dummy pills.

“The only place where you get a clinically meaningful difference is at these very extreme levels of depression,” Kirsch, who is serving as an expert in the case, told 60 Minutes. “…The reason they get better is not the chemical in the drug. The difference between drug and placebo is very, very small, and in half of the studies, non-existent… You can get the same benefit without drugs” (see the clip here).

His conclusions generated considerable controversy. For instance, American Psychiatric Association president Jeff Lieberman, who is also psychiatry department chair at Columbia University, told Medscape that Kirsch “is badly and potentially dangerously misleading people. Using his criteria, he included a relatively small number of the total number of antidepressant studies that have been done and he looked at the mean effects of the different treatments. Clearly, there are some people who received medication who improved tremendously, but there are some who did not improve.”

For its part, a Pfizer (PFE) spokesman sent us this statement: “There is extensive science supporting the safety and efficacy of Zoloft and the medicine carries accurate, science-based and FDA approved information on its benefits and risks. Pfizer believes the lawsuit filed in California is groundless and is based largely on information first published over three years ago that has been widely criticized by many experts in the mental health field.

“Moreover, plaintiffs in this putative class action seek refunds for Zoloft, even though FDA approved the medicine for the treatment of depression and their physicians prescribed it for this same purpose, under a legally unsupportable theory that FDA never should have approved the medicine.”

The spokesman sent one study, which was published in 1998 by the Journal of the American Medical Association, to support the contention that Zoloft was shown to provide a better outcome than a placebo. The lead author, by the way, was Martin Keller, who recently retired as psychiatry chair at Brown University and was lead author on a controversial study of the Paxil antidepressant sold by GlaxoSmithKline (GSK). The study has since been discredited amid charges that primary and secondary outcomes were conflated, selective results were reported and ghostwriting was involved (back story). Keller was a paid consultant to Pfizer at the time (here is the study).

Meanwhile, two law school professors, Benjamin Zipursky at Fordham University and Carl Tobias of the University of Richmond, tell the Associated Press that the lawsuit could be dismissed based on a decade-old US Supreme Court ruling that plaintiffs cannot recover alleged damages by claiming a drugmaker defrauded the FDA to get a medicine approved. “Federal courts have taken different views as to … whether you can use a federal lawsuit to second-guess the FDA,” Zipursky tells the AP, adding that the lawsuit stresses that consumers were harmed financially, so it could get approved as a class action.