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.
"I'm certainly not the person to determine whether Paxil is appropriate
or not for any given patient," Mr. Spitzer acknowledged. "But what I can
do is ensure the information to doctors is fair and complete so that those
equipped to make this determination can do so."
Dr. Barry Perlman, president of the New York State Psychiatric
Association, said in an interview that his organization supported a
crackdown on the failure to disclose negative information on drugs.
"Whenever we don't have the complete picture," he said, "we can't
prescribe ethically and appropriately, and that's an enormous obstacle to
good care."
Richard Merrill, a University of Virginia law professor and a former
general counsel at the F.D.A, compared Mr. Spitzer's suit to
product-liability lawsuits by individuals. He said the suit was the first
by a public official against the drug industry.
Pharmaceutical companies sponsor most clinical trials of drugs and, in
many cases, they jealously guard the data that results. If a test suggests
that a drug is effective in treating a certain condition, the company will
push to get its results published in a prestigious journal. If the results
reflect poorly on the drug, they often never appear in public.
Experts have long criticized the tendency in the industry to publish
only positive clinical trials, arguing that this distorts medical practice
and undermines the scientific process. Some have suggested that the
results of all clinical trials should be published in a federal
registry.
But some say that doctors are unlikely to consult such a registry and
will continue to be influenced by trial results published in leading
journals.
Mr. Spitzer's suit is the first to suggest a way of resolving such
matters. If a company's marketing message is at odds with the results of
its own, suppressed clinical trial, he argues, the company is liable for
damages under consumer fraud laws.
In the case of Paxil, GlaxoSmithKline sponsored five trials of the drug
in adolescents suffering from major depression. The company undertook the
trials to qualify for a six-month extension of Paxil's patent granted
under a federal law that encourages the testing of drugs in children. But
it published only one of the trials, which showed mixed effect. The
unpublished trials failed to show any benefit for the drug and suggested
that it might increase the risk of suicide.
An internal memo cited in the suit said the company should have
"effectively managed the dissemination of these data in order to minimize
any potential negative commercial impact."
And, according to the suit, the company told its sales representatives
that "Paxil demonstrates remarkable efficacy and safety in the treatment
of adolescent depression." The suit contends that sales representatives
passed this on to doctors.
The company's statement yesterday said the memo, written in 1998 —
before the merger of SmithKline Beecham and Glaxo Wellcome of Britain that
created the current company — "is inconsistent with the facts and does not
reflect the company position."
