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Fri, Jun 04, 2004 - Page 12 News List

Drug giant accused of hiding data on anti-depressant

AFP , NEW YORK

New York State Attorney Gen-eral Eliot Spitzer filed a lawsuit on Wednesday against Glaxo-SmithKline (GSK), accusing the British pharmaceutical giant of concealing information about an anti-depressant drug.

The lawsuit alleged that, starting in 1998, GSK engaged in a concerted effort to withhold negative information concerning the drug Paxil and misrepresented data concerning its safety and efficacy when prescribed for depression in children and teens.

Spitzer's office specifically pointed to at least five studies GSK ordered on the use of Paxil in pre-adults.

Only one study was released, while the negative results of the others -- including a possible increased risk of suicidal thinking and acts -- were suppressed, said the suit, filed in New York State Supreme Court in Manhattan.

GSK was also alleged to have failed to disclose this information in Medical Information Letters that it sent to physicians.

"By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety," Spitzer said.

An internal GSK document from 1999, cited in the lawsuit, shows that GSK intended to "manage the dissemination of [the] data in order to minimize any potential negative commercial impact."

Responding to the suit, GSK said in a statement that the company had "acted responsibly" in conducting clinical studies in pediatric patients and disseminating data from those studies.

All the studies "have been made available to the [US Food and Drug Administration] and regulatory agencies worldwide," the statement said.

More than 2 million prescriptions for Paxil were written for children and adolescents in the US in 2002. Nearly 900,000 were for youngsters whose primary diagnosis was a mood disorder.

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