Pfizer is being sued by a woman who says the company’s popular anti-depressant Zoloft doesn’t work. Plaintiff Laura A. Plumlee claims that the drug failed to work in the three years she took it. Her suit argues that patients who took Zoloft should be reimbursed for their costs.  ()

Pfizer Inc., the world’s biggest drugmaker, told the Associated Press last week that clinical studies and the experience of millions of patients and their doctors in more than two decades prove Zoloft effective. Pfizer called the lawsuit frivolous and was backed in the AP story by four psychiatry experts.

Plumlee’s attorney, R. Brent Wisner of the Los Angeles firm Baum Hedlund Aristei Goldman, argues that the FDA should not have approved Zoloft because Pfizer failed to publish the clinical studies that found Zoloft about as effective as a placebo.

“It’s about Pfizer deliberately withholding this information from consumers,” Wisner said, “and then advertising this drug as very effective.”

The suit accuses Pfizer of consumer fraud and other offenses, including paying prominent doctors to tout Zoloft to colleagues or to be listed as authors of positive medical journal articles the company itself prepared for publication.

Pfizer did not respond to those allegations, but countered that the FDA approved Zoloft in 1991 after reviewing “efficacy and safety data from more than 20 clinical studies involving more than 5,000 patients.”

Pfizer was backed by the president-elect of the American Psychiatric Association, Dr. Jeffrey Lieberman, who called the lawsuit’s claims “ridiculous.” Lieberman claimed that, as a class, “antidepressant medications alleviate substantial amounts, if not complete symptoms, in 50 to as high as 80 percent of patients treated who suffer from major depression.”

Meanwhile, a New York University psychiatry professor, Dr. Norman Sussman, said there’s only about a 35 percent chance a particular antidepressant will help a given patient.

Filed last week in federal court in San Jose, Calif., the lawsuit asks a judge to approve two class-action cases: one for California residents who took Zoloft, one for all U.S. users. It also asks the judge to order Pfizer to correct “misleading” information in Zoloft’s package insert and refund everything California patients paid for Zoloft. Consumer fraud laws differ from state to state.

The lawsuit escalates the debate about just how effective and safe the newer-generation antidepressants are – drugs that include blockbusters Zoloft, Prozac, Paxil and Effexor.

Plumlee was apparently stirred to action after she saw a “60 Minutes” news program in which Irving Kirsch, the key expert witness (since hired for her case) said his research on antidepressants indicated most improvement in depressed patients was from the placebo effect.

For related reading, please see Mother Jones’ excellent 2003 story:  Is it Prozac? Or Placebo?

by Matthews & Associates