New York State Attorney General Eliot Spitzer filed a civil lawsuit against the British-based pharmaceutical giant GlaxoSmithKline last week, accusing the company of concealing information about the safety and efficacy of its popular anti-depressant drug Paxil.

The lawsuit, filed in New York State Supreme Court in Manhattan, alleges that GSK engaged in repeated and persistent fraud by concealing and failing to tell doctors that some studies showed that Paxil was ineffective for the treatment of depression in children and adolescents and potentially increases risk of suicidal thoughts in adolescents. Furthermore, the lawsuit contends that GSK misrepresented the results of its research on Paxil to its sales representatives who encouraged doctors to prescribe Paxil to children and adolescents.

“Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients,” Mr. Spitzer said in a prepared statement. “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.”

Specifically, GSK conducted at least five studies on the use of Paxil in children and adolescents. However, GSK only published and disseminated one of these studies, which showed mixed results on efficacy. The lawsuit accuses GSK of suppressing the negative results of the other studies, which failed to demonstrate that Paxil is effective and that suggested a possible increased risk of suicidal thinking and acts. GSK is also alleged to have failed to disclose this information in “Medical Information Letters” that it sent to physicians.

“The ability of drug companies to pick and choose the research they provide doctors in support of their product is an outrageous conflict of interest and puts us all in harm’s way,” said Arthur Levin, Executive Director for the Center for Medical Consumers.

The Food and Drug Administration has approved Paxil for the treatment of depression in adults only. Doctors may prescribe Paxil for treatment in children on an “off-label” basis, meaning uses not approved by the FDA.

The lawsuit seeks the confiscation of all profits obtained by GSK as a result of the conduct alleged in the suit.

GlaxoSmithKline officials issued a statement that says the company, “has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies.”

More than two million prescriptions for Paxil were written for children and adolescents in the United States in 2002. Nearly 900,000 of these prescriptions were for youngsters whose primary diagnosis was a mood disorder, the most common of which is depression. Prescriptions for Paxil to treat mood disorders in children and adolescents translated into US sales for GSK of approximately $55 million in 2002 alone.

In the last year, the use of Paxil for children and adolescents for the treatment of major depressive disorder has come under scrutiny by the FDA and regulatory agencies in the UK, Ireland, Europe and Canada. The FDA has advised caution in prescribing Paxil in children and adolescents for the treatment of major depressive disorder and is currently conducting an analysis of the data related to the use of Paxil and the possibility of increased suicidal thoughts. Regulatory agencies in the UK, Europe, Ireland and Canada have recommended that Paxil not be prescribed for adolescents and children with depression.

(via Office of New York State Attorney General)