Friday, January 16, 2009
More on the Eli Lilly fines/settlement
There is an interesting article in the The Legal Intelligencer (via Law.com) today about Eli Lilly’s agreement to pay "the largest criminal fine in history” and plead guilty to violating the Food, Drug, and Cosmetic Act, settling charges for illegal marketing of Zyprexa, an anti-psychotic drug, for off-label use. Here is an excerpt: Zyprexa was approved by the Food and Drug Administration only as a treatment for schizophrenia and bipolar disorder, prosecutors said, but Lilly allegedly set out to market the drug to elderly patients as a treatment for dementia, Alzheimer's, agitation, depression and generalized sleep disorder. In doing so, prosecutors said, Indianapolis-based Lilly ignored explicit warnings from the FDA that Zyprexa should not be so widely prescribed because of side effects such as weight gain that could lead to obesity and even the onset of diabetes in some patients. . . . .In a press conference Thursday, Acting U.S. Attorney Laurie Magid . . . said Lilly knew that its patent for Prozac was expiring and "wanted Zyprexa to be their new blockbuster drug." Magid said Lilly mounted an "elaborate marketing campaign" and deployed an "army" of sales representatives who were trained to persuade doctors to use Zyprexa for a much larger patient base than the relatively narrow category of schizophrenics and manic depressives. Because one of Zyprexa's side effects is sedation, Magid said, Lilly instructed its long-term care sales force to tell doctors in nursing homes that Zyprexa would help patients with sleep problems, behavioral issues and dementia. "They claimed this side effect was a therapeutic benefit, not an adverse event, with the sales slogan '5 at 5,' meaning that five milligrams of Zyprexa at 5 p.m. would help their patients sleep," Magid said.