Drug Maker Charged With Fraud Over Paxil Marketing

The maker of one of the SSRI market leaders is girding for a major legal battle over charges that it withheld crucial data about the drug's efficacy and safety in children and adolescents.

Having forced an overhaul of the way the mutual fund and stock brokerage industries traditionally conduct business, New York Attorney General Eliot Spitzer has turned his sights to the pharmaceutical industry, targeting GlaxoSmithKline (GSK), one of the world's largest drug makers.

On June 2 Spitzer filed a civil suit against GSK charging the company with fraud based on its alleged withholding of important data on clinical trials of its Paxil brand of the antidepressant paroxetine in children and adolescents.

Spitzer's suit, filed with the Supreme Court of the State of New York, charges that GSK failed to inform physicians about clinical-trial data that raised concerns about safety and efficacy when Paxil is used to treat youngsters with depression.

GSK's chief executive officer, Jean-Pierre Garnier, immediately denied the charges, adding that lawsuits, particularly in the United States, are "becoming an outrageous cost of doing business." Paxil is GSK's biggest money maker.

The U.S. Food and Drug Administration (FDA) has approved Paxil's use in treating depression, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder in adults. Since the FDA has approved the medication, physicians can, however, prescribe it for so-called "off-label" uses, such as treating depression in children and adolescents, if they deem it to be appropriate for a particular patient. In fact, the suit notes, nearly 900,000 prescriptions for Paxil were written in 2002 to treat children and adolescents, about one-third by psychiatrists. What the FDA prohibits, though, is marketing a drug for uses not approved by the agency.

Spitzer alleges that "GSK has allowed positive information about pediatric use of paroxetine to be disclosed publicly, but has withheld and concealed negative information concerning the safety and efficacy of the drug as a treatment for pediatric MDD [major depressive disorder]."

While it conducted five trials of the antidepressant's efficacy in children and adolescents, it published data from only one of them, he said.

By failing to disclose important clinical information to physicians, the company has prevented them "from properly and independently exercising their professional judgment on behalf of their child and adolescent patients," according to the suit. At press time GSK has not responded to requests for comment from Psychiatric News. In a June 10 press release, the company said that its policy "is to ensure transparency of the clinical data the company collects on its marketed medicines. Specifically, we endorse the PhRMA [Pharmaceutical Research and Manufacturers of America] principles that call for timely publication of meaningful trial results."