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Paxil Maker Sued for Withholding Negative Studies of Drug

BY Admin  June 2, 2004 at 5:11 PM EDT

Spitzer accused Glaxo of suppressing four studies that failed to demonstrate the drug effectively treated children and adolescents and suggested a possible increase of suicidal thinking and acts.

The lawsuit also cites an internal 1998 Glaxo document showing that the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.”

Glaxo said in a statement issued Wednesday that the 1998 memo “is inconsistent with the facts and does not reflect the company position.”

Glaxo spokeswoman Mary Anne Rhyne told the Associated Press the company “has acted responsibly in conducting the studies in pediatric patients and disseminating results. All of our studies have been made available to the [U.S. Food and Drug Administration] and regulators worldwide.”

Rhyne also said the studies referred to in the suit were made public in medical meetings, journals and letters to doctors.

According to Spitzer, Glaxo’s revenues for Paxil prescriptions in children and adolescents in the United States totaled $55 million in 2002.

The lawsuit seeks the return of all profits obtained by Glaxo from the use of the drug by children in New York. The suit asks for unspecified damages for affected consumers.

More than 2 million prescriptions for Paxil were written for children and adolescents in the United States in 2002. Although U.S. regulators have only approved Paxil to treat adult depression, doctors are still allowed to prescribe it to children.

Eli Lilly & Co.’s Prozac is the only drug approved for treating childhood depression. A government-funded study released Tuesday found the drug to be effective in treating young people with depression.

In March, the U.S. Food and Drug Administration asked manufacturers to change the labels on Paxil, Prozac and eight other antidepressants to include larger and more prominent warnings about patient monitoring.