Psychiatric News July 2, 2004
Volume 39 Number 13
© 2004 American Psychiatric Association
p. 1
Drug Maker Charged With Fraud Over Paxil Marketing
Ken Hausman
The maker of one of the SSRI market leaders is girding for a major legal
battle over charges that it withheld crucial data about the drug's efficacy
and safety in children and adolescents.
Having forced an overhaul
of the way the mutual fund and stock brokerage industries traditionally
conduct business, New York Attorney General Eliot Spitzer has turned his
sights to the pharmaceutical industry, targeting GlaxoSmithKline (GSK), one of
the world's largest drug makers.
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New York Attorney General Eliot Spitzer
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On June 2 Spitzer filed a civil suit against GSK charging the company with
fraud based on its alleged withholding of important data on clinical trials of
its Paxil brand of the antidepressant paroxetine in children and
adolescents.
Spitzer's suit, filed with the Supreme Court of the State of New York,
charges that GSK failed to inform physicians about clinical-trial data that
raised concerns about safety and efficacy when Paxil is used to treat
youngsters with depression.
GSK's chief executive officer, Jean-Pierre Garnier, immediately denied the
charges, adding that lawsuits, particularly in the United States, are
"becoming an outrageous cost of doing business." Paxil is GSK's
biggest money maker.
The U.S. Food and Drug Administration (FDA) has approved Paxil's use in
treating depression, social anxiety disorder, generalized anxiety disorder,
and obsessive-compulsive disorder in adults. Since the FDA has approved the
medication, physicians can, however, prescribe it for so-called
"off-label" uses, such as treating depression in children and
adolescents, if they deem it to be appropriate for a particular patient. In
fact, the suit notes, nearly 900,000 prescriptions for Paxil were written in
2002 to treat children and adolescents, about one-third by psychiatrists. What
the FDA prohibits, though, is marketing a drug for uses not approved by the
agency.
Spitzer alleges that "GSK has allowed positive information about
pediatric use of paroxetine to be disclosed publicly, but has withheld and
concealed negative information concerning the safety and efficacy of the drug
as a treatment for pediatric MDD [major depressive disorder]."
While it conducted five trials of the antidepressant's efficacy in children
and adolescents, it published data from only one of them, he said.
By failing to disclose important clinical information to physicians, the
company has prevented them "from properly and independently exercising
their professional judgment on behalf of their child and adolescent
patients," according to the suit. At press time GSK has not responded to
requests for comment from Psychiatric News. In a June 10 press
release, the company said that its policy "is to ensure transparency of
the clinical data the company collects on its marketed medicines.
Specifically, we endorse the PhRMA [Pharmaceutical Research and Manufacturers
of America] principles that call for timely publication of meaningful trial
results."
GSK promised to make summaries of nine studies it funded of Paxil's safety
and efficacy in children and adolescents available on its Web site, which it
did on June 14. Spitzer applauded GSK's willingness to make these available to
the public and physicians, saying that he hoped this spurs other
pharmaceutical firms to follow suit.
Cover-Up Alleged
In his suit, Spitzer cites documentation produced by GSK indicating that
the company planned to take steps to manage selectively any releases of data
on Paxil clinical trials, so that evidence of ineffectiveness or harm was not
disseminated.
He also charges that GSK "misrepresented" the drug's efficacy
in treating adolescent depression when the company briefed its sales
representatives, whose job is to convince physicians to prescribe the
medication. The company supplied the sales staff with a quote touting Paxil's
"REMARKABLE efficacy and safety in the treatment of adolescent
depression" when, Spitzer says, none of the studies GSK conducted on the
antidepressant's efficacy in this population demonstrated such a
conclusion.
In addition, Spitzer alleges misrepresentation in the "Medical
Information Letters" GSK sent to physicians about Paxil's effectiveness
in children and adolescents with depression and failed to cite a study in
which the drug turned out to be less efficacious than placebo. Through these
actions, the suit charges, the company "controlled physicians' access to
negative information about paroxetine as a treatment for MDD in children and
adolescents...."
The consequences of GSK's marketing decision, the suit concludes, is that
physicians were "misled and deceived" and thus unable to evaluate
the prescribing information they need to provide optimal care for their
patients.
Spitzer wants the court to enjoin GSK permanently from continuing the
"deceptive, fraudulent, and unlawful practices alleged" in his
suit and to order the company to "pay restitution and damages to all
aggrieved consumers" to include "all profits from the sale of
Paxil or Paxil CR in the State of New York for a child or adolescent with
depressive disorder."
Extensive Media Coverage Ensues
The suit has garnered substantial media attention in the United States and
Great Britain, where GSK is headquartered. (GSK is facing a British suit over
an alleged failure to tell health regulators about data pointing to a suicide
risk in teenagers who are prescribed Seroxat, the brand name GSK uses for
paroxetine in that country.)
A June 6 editorial in the New York Times, for example, said that
"bolder action" than a lawsuit is warranted to force companies to
act more responsibly. "The drug companies should be forced to make
public the results of all of their clinical trials the moment they are
completed, and the findings should be disseminated widely to doctors in an
easy-to-understand format," the editorial states. "Only then will
patients be confident that their doctors have enough information to prescribe
medicines wisely."
A GSK press release on June 2 denies the charges, stating that the company
"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 FDA and regulatory agencies worldwide. We have
publicly communicated data from all pediatric studies."
Spitzer has indicated that GSK may not be the only pharmaceutical company
at the receiving end of subpoenas from the aggressive attorney general.
"This is an area we're interested in," he told the New York
Times, "and I think there are other cases out there that are
analogous."
Barry Perlman, M.D., president of the New York State Psychiatric
Association, who appeared with Spitzer in a press conference soon after the
lawsuit was announced, told Psychiatric News that "we need to
have a transparent system" so that doctors and patients can make fully
informed decisions about treatment options. "It's important to have drug
companies make available to physicians the findings of research [the
companies] subsidize, whether revealing them would be positive or adverse for
their commercial interests."
Perlman said he urged Spitzer to propose legislation in New York that would
regulate such disclosure. He suggested that one strategy for such a law would
be to deny inclusion on Medicaid preferred drug lists to any pharmaceutical
company that declined to disclose all clinical field-trial data on one of its
products.
Summaries of GSK's Paxil studies are posted online at
<www.gsk.com/media/paroxetine.htm>.
GSK's related press releases are posted at
<www.gsk.com/media/pressreleases.htm#pdf>.
Spitzer's complaint against GSK is posted at
<www.oag.state.ny.us/press/2004/jun/jun2b_04_attach1.pdf>.
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