A whistleblower has filed a complaint in federal court saying that Forest Pharmaceuticals paid the principal investigator of a federally finded antidepressant study to fix the results in favor of its drug Celexa. Edmund Pigott, a psychologist living in Maryland, says the violations happened during the company’s management of a $35 million clinical trial fuinded by the National Institute of Mental Health. In his lawsuit, Pigott says there was bias in the study as a result of kickbacks, bribes and other improper financial inducements, paid by Forest to Dr, John Rush, the principal investigator. This, he says, resulted in in selection of Celexa and also to the overstatement of the effectiveness of the drug in the published result. This resulted in significant increases in sales of Celexa and its second generation, Lexapro to patients covered by federal and state health care programs. 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. The study in question, called 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. 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.