California Suit Alleges Blockbuster Pfizer Drug Has Little Benefit

2/5/13Follow @tanseyverse

New York drug giant Pfizer is again responding to allegations that its former blockbuster drug Zoloft is an ineffective product that reaped billions of dollars by dint of aggressive marketing.

A California patient who claims that Pfizer misled her and other consumers about the effectiveness of its anti-depressant Zoloft is suing the company for a refund of the millions spent by Californians on the drug.

The plaintiff, Laura Plumlee, also sought permission to represent the interests of consumers nationwide in the class action law suit filed in federal court in San Jose on Jan. 30 by the Los Angeles law firm Baum Hedlund Aristei & Goldman.

The lawsuit revives claims aired last year on a 60 Minutes program in which Harvard Medical School psychologist Irving Kirsch said that much of the perceived benefit of anti-depressants can be linked to the placebo effect. That is, when patients believe that a drug will work, they may report an improvement in symptoms.

Plumlee’s suit alleges that Pfizer knew that Zoloft was scarcely better than a sugar pill, or placebo, yet used deceptive marketing practices and other means to generate $30 billion in sales for the drug after its market debut in 1991. The complaint challenges Pfizer’s right to continue to sell the drug under its current FDA label, charging that the company downplayed study results that showed scant evidence of benefit to subjects battling depression. Zoloft revenues dropped sharply after it lost patent protection in 2006.

Pfizer maintains that Zoloft’s label is well-supported by evidence.

“Zoloft was first approved by the FDA in 1991 based on the agency’s review of the efficacy and safety data from more than 20 clinical studies involving more than 5,000 patients,” the company said in a written 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 pointed to a letter from the American Psychiatric Association to 60 Minutes producers, in which it criticized Kirsch’s conclusions. The APA quoted Dr. Jeffrey Lieberman, a psychiatrist who said Kirsch had misinterpreted the data on anti-depressants. “There is abundant evidence that supports the efficacy of antidepressants above and beyond the effects of placebo,’’ Lieberman said. He did not comment specifically about Zoloft.

Whether a federal court will allow the private litigants to challenge the contents of an FDA label remains an open question.

Pfizer and other big drugmakers have recently sustained some significant court judgments over marketing practices challenged by state prosecutors rather than private plaintiffs.

In December, Pfizer agreed to pay $42.9 million to settle claims by a consortium of state attorneys general that it unlawfully promoted its drugs Zyvox and Lyrica, according to the office of Arkansas Attorney General Dustin McDaniel.

Arkansas also won $1.1 billion in a marketing case against Janssen, a unit of Johnson & Johnson of New Jersey, according to a Bloomberg report. An Arkansas judge ordered J & J last week to pay an additional $181 million to cover attorneys’ fees, the Associated Press reported.

Bernadette Tansey is a freelance journalist based in Berkeley, CA. Follow @tanseyverse

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  • Calandar

    Pfizer’s statement that there were “more than 20 clinical studies involving more than 5,000 patients” is misleading in the context of the lawsuit discussed, which concerns efficacy. The initial FDA new drug application did contain 20 (or more) studies, but only six dealt with efficacy, the subject of the Zoloft lawsuit. The rest were safety studies.