n a novel claim testing the way that the $400
billion worldwide pharmaceutical industry is regulated, the New York
State attorney general, Eliot Spitzer, sued the British-based drug
giant GlaxoSmithKline
yesterday, accusing the company of fraud in concealing negative
information about its popular antidepressant medicine Paxil.
The civil lawsuit, filed in State Supreme Court in Manhattan,
contends that GlaxoSmithKline engaged in persistent fraud by failing
to tell doctors that some studies of Paxil showed that the drug did
not work in adolescents and might even lead to suicidal thoughts.
Far from warning doctors, the suit contends, the company encouraged
them to prescribe the drug for youngsters.
"The point of the lawsuit is to ensure that there is complete
information to doctors for making decisions in prescribing," Mr.
Spitzer said in an interview. "The record with Paxil, we believe, is
a powerful one that shows that GSK was making selective disclosures
and was not giving doctors the entirety of the evidence."
GlaxoSmithKline officials issued a statement yesterday saying in
part that the company "has acted responsibly in conducting clinical
studies in pediatric patients and disseminating data from those
studies."
On Wall Street yesterday, the American depository receipts of
GlaxoSmithKline fell $1.38, or 3.2 percent, to $41.39.
Mr. Spitzer filed his suit at a time that the tendency of many
drug companies to publicize only studies with positive results has
come under increasing criticism.
As he has done in actions involving the financial services and
mutual fund industries, Mr. Spitzer is entering regulatory terrain
that has been largely the preserve of the federal government, in
this case the Food and Drug Administration. This time, though, he
maintains that his suit is not a criticism of federal drug
regulators.
"This isn't Harvey Pitt and the S.E.C.," he said, referring to
the former chief of the Securities and Exchange Commission, whom Mr.
Spitzer criticized as less than vigorous in enforcing federal
securities laws. Instead, Mr. Spitzer said that the F.D.A. had been
hamstrung by court rulings that have used free-speech arguments to
limit the agency's power to regulate what drug companies can say to
doctors. Such rulings do not limit his powers, Mr. Spitzer said.
"You cannot invoke free-speech arguments as a defense to fraud,"
he added.
Similar suits against other drug companies are likely, Mr.
Spitzer said. "This is an area that we're interested in," he said,
"and I think there are other cases out there that are
analogous."
A spokeswoman for the F.D.A. would not comment on the lawsuit but
noted that the agency required companies to submit all data related
to the safety of their drugs. Because so much drug company data
submitted is considered proprietary, it is up to the F.D.A. to
decide when to disclose possible public safety concerns.
That is what it did last year, when it warned doctors on the use
of Paxil for adolescents and children. Earlier this year, it
required antidepressant makers to strengthen suicide warnings on
labels.
British drug regulators have banned the use of all but Prozac for
the treatment of depression in adolescents and children. Prozac,
made by Eli
Lilly & Company, received a major American endorsement this
week when the widely anticipated results of a study sponsored by the
National Institute of Mental Health indicated that Prozac was
superior to talk therapy alone or a placebo in treating depression
among teenagers. The study did not address suicide risks.
Civil suits have been filed against Glaxo and some other makers
of antidepressants by patients or surviving relatives, contending
that the drugs caused violent or suicidal behavior. Some criminal
defendants have contended that violent acts were a result of using
the drugs.
Mr. Spitzer's lawsuit is part of a broad assault by prosecutors
on the drug industry's marketing practices. Last month, for example,
federal prosecutors in Boston announced a settlement with the
world's largest drug maker, Pfizer;
the company agreed to pay $430 million and to plead guilty to
charges that its Warner-Lambert unit promoted the drug Neurontin to
doctors for the treatment of conditions where no benefit had been
proved.
TAP Pharmaceuticals agreed to pay $800 million for inappropriate
marketing practices, and its former executives are facing federal
criminal charges in Boston. Schering-Plough
has acknowledged in regulatory filings that it is likely to be
indicted for improper marketing practices. Other companies are being
investigated.
At issue in most of these investigations, including Mr. Spitzer's
Paxil suit, is the marketing of approved drugs for off-label uses —
those not specifically approved by the F.D.A. While doctors are free
to prescribe an approved drug for any use, the manufacturers are
supposed to limit their marketing to those uses with F.D.A.
clearance.
The new wrinkle in Mr. Spitzer's suit is his argument that a drug
maker is committing fraud if it does not tell doctors about trials
of a medication that raise safety concerns.
