The U.S. Department of Justice has accused Forest Laboratories of
conducting a "fraudulent scheme to market and promote" unapproved
indications for its antidepressants citalopram and escitalopram and paying
kickbacks to induce physicians to prescribe those medications.
The civil suit, which was filed February 13 in the U.S. District Court for
the District of Massachusetts, alleges that Forest Laboratories and its
subsidiary, Forest Pharmaceuticals, violated the federal False Claims Act and
engaged in "illegal marketing schemes" to promote the use of
citalopram (Celexa) and escitalopram (Lexapro) for treating pediatric
patients, even though the drugs are not approved by the Food and Drug
Administration (FDA) for this population. The suit charges that the company
disseminated "false and misleading information to doctors and the public
about the safety and efficacy of Celexa and Lexapro in treating pediatric
(At press time, the Food and Drug Administration approved Lexapro for the
treatment of depression in adolescents. Details will appear in a future
One of the complaints involved two large, randomized, placebo-controlled
clinical trials of pediatric depression treatment with citalopram that were
conducted in 1999 as part of Forest's application for expanding citalopram's
indication to include pediatric use. One of the trials was conducted in Europe
by Lundbeck, the Denmark-based manufacturer that owns rights to the
medications in Europe, and the other was conducted in the United States by
Karen Wagner, M.D., Ph.D., the Robert L. Stubblefield Professor and vice chair
of the Department of Psychiatry and Behavioral Sciences at the University of
Texas Medical Branch in Galveston and director of its Division of Child and
The Lundbeck study produced negative results, showing that citalopram was
not significantly more effective than placebo in treating pediatric
depression. It also suggested an increase in the risk of suicidal thoughts and
behaviors in the citalopram-treated patients compared with those on
The Wagner study, however, demonstrated that citalopram was significantly
more efficacious than placebo in pediatric patients. Data from both studies
were submitted to the FDA in 2002, and the agency denied the application for
citalopram's pediatric indication.
The lawsuit accuses Forest of disseminating "half truths" in
that it "aggressively promoted" the Wagner study while suppressing
the negative Lundbeck study from the public and psychiatrists and others who
might prescribe the drug. Without naming specific people, the complaint stated
that the company's "Executive Advisory Board of leading
psychiatrists" was presented with the Wagner study results without any
mention of the negative Lundbeck study.
The Wagner study was published in the June 2004 American Journal of
Psychiatry (AJP) with no mention of the Lundbeck study. In addition,
Forest arranged for Wagner to give a series of presentations to professional
groups, including APA and the American College of Neuropsychopharmacology, and
continuing medical education programs to discuss her study of citalopram's
effectiveness in pediatric depression.
Meanwhile, the Lundbeck study was unknown to Wagner, the psychiatrists on
Forest's advisory board, the medical community, AJP, and the public.
They asserted that only a few senior executives of the company and the FDA had
full access to the Lundbeck study results. Allegedly, even Forest's own sales
representatives and Professional Affairs Department (which is responsible for
answering medication-information inquiries from physicians and the public)
were not given information on the Lundbeck study results. Thus prescribers,
payers, patients, and the public were misled with only information favorable
to citalopram use in children without knowing about the unfavorable safety and
efficacy data, according to the government.
"From 1998 through at least 2005, Forest engaged in a widespread
campaign to promote Celexa and Lexapro for pediatric use" and violated
the federal antikickback statute, the government alleges. To induce physicians
to prescribe both drugs for more pediatric patients and more patients in
general, Forest directed sales representatives to target specific physicians
in certain U.S. regions, including "thousands of child psychiatrists,
pediatricians, and other physicians who specialized in treating
children," the lawsuit says, citing company internal memos.
Among other accusations, the complaint maintains that Forest gave"
extensive payments and gifts to physicians to induce them to prescribe
Celexa and Lexapro." The kickbacks were provided as honoraria for
thousands of physicians who participated in hundreds of advisory board
meetings and clinical trials, as well as in the form of gifts, travel,"
lavish entertainment," and grants to individual physicians.
The government is seeking to recover from Forest treble damages and
penalties attributable to what the alleged marketing and other violations had
cost Medicaid and the TRICARE program for the military and veterans.
On February 26, Forest Laboratories released a statement in response to the
lawsuit indicating that the company is "continuing its discussions with
the government about the investigation" and is "reviewing the
complaint and will respond to this action at the appropriate time." The
statement also asserted that "off-label promotion and improper payments
to medical providers have consistently been against [company]
[United States and Christopher R. Gobble v. Forest Laboratories Inc.
and Forest Pharmaceuticals Inc. Civil Action No. 03-10395-NMG]