The New York Times today reported that the Justice Department has sued Forest Labs for defrauding the government of millions of dollars by illegally marketing Celexa and Lexapro, its two blockbuster antidepressants. The fraud complaint is based on allegations that Forest Labs concealed negative findings that showed that these drugs were not only ineffective in children but caused an increased risk of suicidal thoughts and behaviors in some pediatric patients.
Sound familiar? That's because they were same allegations that formed the basis of New York State Attorney General's landmark case in 2004 against GlaxoSmithKline, which became the subject of my book, Side Effects. Just like Forest Labs, GlaxoSmithKline with-held negative findings about its blockbuster drug, Paxil, and instead published and heavily marketed one study that purported to show that Paxil was effective in treating depression in adolescents. It turns out that the data in this study did not show efficacy either (which is one of the reasons why the AG's office sued Glaxo for consumer fraud) and the story of how the detective-attorneys in the AG's office discovered this fraud is quite a tale!
Shortly after the New York AG's office launched the suit against Glaxo, it also began investigating Forest Labs for with-holding the results of several studies that found citalopram, the generic ingredient in both Celexa and Lexapro, to be no more effective than a placebo in treating depression in children. As I report in my book, the AG's office, then under the direction of Eliot Spitzer, used this investigation to force Forest Labs to post the results of all its clinical trials, negative as well as positive, on a publicly available website, from 2000 onward. By then, of course, GlaxoSmithKline had already agreed to do the same in order to settle the AG's widely publicized lawsuit against it. At the time, these settlements were seen as a major victory for health consumers and the next year, Congress passed a law requiring all drug companies to post all the results of their Phase 3 and 4 clinical trials online, putting an end to the widespread industry practice of concealing negative data about drugs from the public.
Now, the Justice Department has put an ambitious new twist on this case by charging Forest Labs with defrauding the government of millions of dollars. It is essentially saying to Forest Labs: you knew these drugs were not effective in treating depression in children and yet you went ahead and illegally marketed them (for off-label use) to minors anyway, costing government health plans like Medicare and Medicaid loads of money. The federal lawsuit is seeking to recover up to three times the amount of money spent by government programs to pay for pediatric prescriptions of Celexa and Lexapro, according to The New York Times .
Federal prosecutors have also charged that Forest Labs paid kickbacks in the form of baseball tickets, gift certificates and paid vacations to doctors who prescribed these drugs and that the company ran seeding trials that were really marketing efforts to promote the drugs' use by doctors.
Just think: if this case is successful, the steep fines levied against Forest Labs (and other drug companies who did the same) could go a long way toward helping fund health care reform.