he New York State attorney general accused the
British drug giant GlaxoSmithKline
of consumer fraud today, asserting that the company had withheld
negative information and misrepresented data about the efficacy and
safety of prescribing the antidepressant drug Paxil to children.
The civil lawsuit, filed in New York State Supreme Court, says
that starting in 1998, Glaxo suppressed the results of four studies
that did not find the drug effective in treating children and
adolescents and that suggested a possible increased risk of suicidal
thinking and acts.
"By concealing critically important scientific studies on Paxil,
GlaxoSmithKline impaired doctors' ability to make the appropriate
prescribing decision for their patients and may have jeopardized
their health and safety," the attorney general, Eliot Spitzer, said
in a statement.
Paxil has been approved by the Food and Drug Administration for
the treatment of depression in adults. Prozac, which is manufactured
by Eli
Lilly & Company, is the only antidepressant that has been
approved to treat depression in children. However, doctors have
professional discretion to prescribe Paxil for treatment in
children, a so-called "off label" use. Doctors routinely recommend
antidepressants for children suffering from depression and other
psychological disorders.
A recent study sponsored by the National Institute of Mental
Health found that Prozac was more effective than psychotherapy in
treating depression among teenagers and that the two treatments
together yielded the best results.
In April, a European Union advisory panel recommended that Glaxo
strengthen warnings about severe withdrawal symptoms when patients
stop taking Paxil.
European Union regulators also recommended that Paxil not be
given to children because clinical trials had found the drug to be
associated with increased risk of suicidal behavior and hostility.
In this country, the Food and Drug Administration has recommended
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 in children and
adolescents and the possibility of increased suicidal thoughts.
In a statement, Glaxo said it "has acted responsibly in
conducting clinical studies in pediatric patients and disseminating
data from those studies."
"All pediatric studies have been made available to the Food and
Drug Administration and regulatory agencies worldwide," the company
said. "We have publicly communicated data from all pediatric
studies."
In the lawsuit, Mr. Spitzer asserts that an internal
GlaxoSmithKline document from 1998 showed that the company intended
to "manage the dissemination of the data in order to minimize any
potential negative commercial impact."
In its statement, Glaxo said that "as for the 1998 memo, it is
inconsistent with the facts and does not reflect the company
position."
According to the lawsuit, Glaxo's revenue for Paxil prescriptions
in children and adolescents totaled $55 million in 2002.
Mr. Spitzer, who has spent the last few years fighting fraud on
Wall Street and who is widely expected to seek the Democratic
nomination for governor of New York, is seeking the return of all
profits from Paxil obtained by Glaxo as a result of the conduct
alleged in the lawsuit.
