GlaxoSmithKline PLC committed fraud by withholding negative information and misrepresenting data on the off-label prescribing of its antidepressant Paxil to children, according to a lawsuit filed today by New York Attorney General Eliot Spitzer.
The lawsuit, filed in New York State Supreme Court, said Glaxo suppressed four studies that failed to demonstrate the drug was effective in treating children and adolescents and suggested a possible increase of suicidal thinking and acts.
It also said an internal 1999 Glaxo document showed that the company intended to "manage the dissemination of data in order to minimize any potential negative commercial impact."
Glaxo spokeswoman Mary Anne Rhyne said 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 have been made public in medical meetings, journals and letters to doctors. She said the internal document referenced in the suit "is inaccurate and inconsistent with the facts and doesn't express the overall company position."
The lawsuit touches on two pharmaceutical and medical controversies: whether antidepressants increase suicidal tendencies in children, and if drug companies should be required to disclose all studies they conduct on their medicines.
Paxil is not approved for use in children, but doctors routinely recommend antidepressants for children suffering from depression and other psychological disorders.
Only Prozac, which is made by Eli Lilly & Co., has been approved for use in children. According to Spitzer, Glaxo's revenues for Paxil prescriptions in children and adolescents totaled $55 million in 2002.
The lawsuit seeks the return of all profits obtained by Glaxo as a result of conduct alleged in the suit.