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    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 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. The lawsuit was described as frivolous by Pfizer and four psychiatry experts interviewed by the AP. Plumlee, who says Zoloft didn't help her during three years of treatment. 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. "It's about Pfizer deliberately withholding this information from consumers and then advertising this drug as very effective," Wisner said. The suit accuses Pfizer of consumer fraud and other offenses, including quietly paying prominent doctors to tout Zoloft to colleagues or to be listed as authors of positive medical journal articles the company prepared for publication. New York-based Pfizer did not specifically respond to those allegations. "Pfizer believes the lawsuit filed in California is groundless and is based largely on information ... Selective serotonin re-uptake inhibitors (SSRI) antidepressants burst on to the scene in 1988 with the introduction of fluoxetine/Prozac, hailed as a wonder drug that will make people feel “better than well” with no side effects. This Eli Lilly blockbuster is soon followed by similar medications: The line between marketing and science blurs as drug makers try to expand both the uses for these medications and the populations taking them. They do pretty well, in a lax regulatory environment. In 2000-01, GSK is the second fastest growing drug company, and Paxil is its #1 seller at $2.68 billion US worldwide. With Prozac now off patent, Paxil is also the #1 selling SSRI, beating out Zoloft by sales of $340 million. The publication of Study 329 in July 2001 provides a major boost to this cause. This Keller et al article includes data that is obviously incompatible with the conclusion reached. It may represent the greatest divide in all of medicine between what the academic literature says and what the data show.

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