EW YORK (AP) -- GlaxoSmithKline PLC committed
fraud by withholding negative information and misrepresenting data
on prescribing its antidepressant Paxil to children, according to a
lawsuit filed Wednesday 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 can
prescribe drugs as they see fit and 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.
Glaxo's U.S. shares fell 94 cents, or 2.2 percent, to $41.83 in
midday trading on the New York Stock Exchange.
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