By John T. Aquino
A whistleblower's complaint from 2011 that was unsealed Jan. 20 in a federal district court alleged that Forest Pharmaceuticals paid the principal investigator of a federally funded antidepressant drug study to fix the results in favor of the company's drug Celexa (United States ex rel. Pigott v. Forest Pharmaceuticals Inc., D. Md., No. 1:11-cv-00717, unsealed 1/20/12).
The whistleblower litigation was filed in the U.S. District Court for the District of Maryland by H. Edmund Pigott, a psychologist who resides in Clarksville, Md. The alleged False Claims Act violations occurred during the company's management of the largest antidepressant drug trial ever conducted: the $35 million STAR*D (Sequenced Treatment to Relieve Depression) study, which was funded by the National Institute of Mental Health. The study enrolled 4,041 patients who were provided with 12 months of continuing antidepressant care.
In the article by J. Boren, A. Leventhal, and H.E. Pigott, “Just how effective are antidepressant medications? Results of a major new study,” Journal of Contemporary Psychotherapy, 39 (2), 93-100 (2009), Pigott had alleged there was bias in the STAR*D study in favor of Forest's drug Celexa. In the litigation, he alleged that the bias was the result of kickbacks, bribes, and other improper financial inducements that were paid by Forest to Dr. John Rush, the principal investigator of the study, and to one or more of the project's other investigators.
The complaint alleged that this conflict of interest not only caused the selection of Celexa as the only antidepressant employed in the first part of the study, but also led to falsification and overstatement of the effectiveness of Celexa in the study's published result.
The end result of the kickbacks and bribes, Pigott claimed, was a significant increase in the sales of Celexa and its second generation version, Lexapro, to patients covered by federal and state health care programs in violation of the FCA, 31 U.S.C. §378, and comparable state statutes, which impose liability on persons and federal contractors who defraud government programs.
According to the complaint, the NIMH initially entered into a contract for the STAR*D study with the University of Texas in September 1999 with Rush as the P.I.
Celexa is a selective serotonin reuptake inhibitor or SSRI. SSRIs prevent the body's reuptake or removal of a naturally-occurring neurotransmitter that it is believed to have a positive impact on mood.
STAR*D was designed as a comparative effectiveness study of different treatment options for people with major depression and included 12 pre-specified research outcome measures and a detailed analytical plan for evaluation. According to the complaint, Celexa was selected for the study even though it was the least prescribed of all SSRIs. Pigott argued that the least-prescribed status was either because Celexa was less effective than other SSRIs or had a greater risk continuation syndrome or drug-to-drug reaction. Patients in the study were first given Celexa and, if they failed to get relief from Celexa, they received one of three other antidepressant treatments.
The complaint stated that even after the passage of four years since the publication of STAR*D's major summary article and the publication of over 70 peer-reviewed articles on the STAR*D findings, none of the articles published by the STAR*D authors have reported the outcomes of any of the 12 pre-specified measures of the study, nor have they reported any findings in a manner consistent with the study's analytical plan as presented in STAR*D's research protocol.
The authors' articles also did not discuss the main purpose of the study, which was to evaluate the cost-effectiveness of the various antidepressant treatments, Pigott claimed.
The article for which Pigott was coauthor, the complaint stated, documented that, in contrast to the positive results in STAR*D's published findings, only 108 of STAR*D's 4,041 patients (2.7 percent) had an acute-care remission and neither relapsed nor dropped out during the 12 months of continuing care that followed. The article also documented how STAR*D changed its research outcome measures and analyses, which resulted in an inflation of STAR*D's remission rates by 44.9 percent.
The complaint reported that 10 of STAR*D's authors, including Rush, have disclosed in journal articles that they had received money from Forest and that in the summer of 2008 Rush left the University of Texas, moved to Singapore, and was replaced as the STAR*D P.I.
The complaint stated, “The relator has concluded and therefore alleges that the only reasonable explanation for the false and biased reporting of the study results is that Dr. Rush received significant financial remuneration from Forest that Forest paid to him for the purpose of influencing his actions.”
In September 2010, Forest Pharmaceuticals Inc. agreed to pay $313 million to resolve criminal and civil liability arising out of a guilty plea on obstruction of justice charges and to settle FCA allegations relating to three of its drugs including Celexa.
The Maryland district court complaint asserted 30 counts, including anti-kickback and false statement violations of federal and state false claims acts. Also asserted were violations of the Medicaid fraud false claims acts of Arkansas, California, Colorado, and Georgia; false claims acts of Connecticut, Delaware, Florida, Hawaii, Massachusetts, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, Rhode Island, Tennessee, and Texas; and statutes of the District of Columbia, Illinois, Indiana, Louisiana, Michigan, Oklahoma, Virginia, and Wisconsin.
For each count, the complaint asked that penalties be imposed on Forest for the maximum amount allowed by law for each claim presented to the court.
Frank J. Murdolo, vice president of investor relations of Forest Laboratories, of which Forest Pharmaceuticals is a subsidiary, told Bloomberg BNA in an e-mail that the company does not comment on matters of pending or threatened litigation.
The complaint was filed by George G. Tankard, of Waters & Kraus LLP, Baltimore, and William Paul Lawrence, of Waters & Kraus LLP, Middleburg, Va.
The complaint from 2011 can be found at http://op.bna.com/hl.nsf/r?Open=jaqo-8qvqcd.
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