Forest Labs in trouble for marketing Celexa to children, kickbacks

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http://rawstory.com//printstory.php?story=14552Forest Labs in trouble for marketing Celexa to children, kickbacks02/25/2009 @ 10:03 pmFiled by Joe Byrne AdvertisementForest Laboratories Inc., a New York-based pharmaceutical company, has been served with a civil complaint today by the Attorney General of Massachusetts for alleged violations of the False Claims Act related to the marketing of Celexa and Lexapro. Specifically, the statement released by the Department of Justice pointed to a double-blind, placebo-controlled pediatric study that found the common anti-depressant Celexa to be no more effective than a placebo. Furthermore, there was a higher rate of suicidal thoughts and tendencies among the children in the study who took Celexa. For these reasons, the FDA decided that it would withhold approval of Celexa for pediatric use. Ignoring the FDA, “Forest actively promoted pediatric use of the drugs and misled physicians and the public by failing to disclose the results of the negative study,” according to the Department of Justice's statement. It is illegal for a company to promote a drug for uses not approved by the FDA.In addition to the alleged violation of the False Claims Act, Forest Labs was also accused of paying kickbacks to physicians who prescribed the drugs. These kickbacks included cash payments disguised as grants, expensive meals, and lavish entertainment, “all in violation of the federal anti-kickback statute,” the document establishes. “Federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.” This isn't the first time that Forest Laboratories has come into legal trouble for the way it conducts business. 12 years ago, a lawsuit was filed that included Forest in a handful of the nation's largest drug-makers who were allegedly involved in a price-fixing conspiracy. After nine weeks of hearings, the lawsuit was dismissed for lack of evidence.Citalopram, or Celexa, is a selective serotonin reuptake inhibitor (SSRI) prescribed as an anti-depressant. Lexapro is a closely related chemical, escitalopram, and the mechanisms of action are assumed to be the same.Researchers and doctors became increasingly alarmed in 2004 when the study was conducted that suggested Celexa increased the risk of suicide in some adolescents and children. As a result of these studies, the Food and Drug Administration required all anti-depressant medications to carry “black box warnings,” alerting parents and patients of the risks associated with taking anti-depressants.Forest Lab's vice president of investor relations told AP that the investigation, which has been going on for half a decade, had already been disclosed to the SEC. “It's the formalization of that investigation, basically, but it's not new as far as a disclosure issue to the company," he said.Lexapro is Forest's top-selling drug with sales of $585.5 million in the third quarter of fiscal 2009. Celexa lost patent protection and is no longer a major product for the company.