Lilly-palooza

The $1.415 billion settlement that pharmaceutical giant Eli Lilly & Co. reached today with federal prosecutors includes the largest criminal fine ever paid by a single American corporation. But is it big? Depends on how you measure it. The settlement certainly involves large numbers. The criminal fine portion alone is $515 million. Added to that is Lilly's forfeiture of $100 million in assets—DESCRIBE—and a civil settlement with the federal government and several states that could be worth up to $800 million. The actual total will depend on how many states opt into this settlement rather than pursuing their own civil case against Lilly. Alaska wrung $15 million out of Lilly last year in a case it pursued on its own, for example. The federal share of the civil settlement is $438 million. Big numbers, to be sure, but $1.4 billion represents Zyprexa sales over only a bit more than one year. The government says Lilly began promoting off-label sales to old-age homes about a decade ago. The total settlement also amounts to less than three months' of the company's operating profit, which was $1.735 billion in the quarter ending September 30. The settlement stems from allegations that Lilly sales representatives knowingly encouraged doctors to prescribe Zyprexa to treat some illnesses for which the company hadn't proven the drug to be safe and effective. The Food and Drug Administration had accepted Lilly data showing that Zyprexa is effective in treating psychosis, manic-depression, and schizophrenia. Lilly has now admitted it instructed its sales force to also promote Zyprexa to treat much more common maladies without showing that it would work safely on them. These so-called off-label uses include Alzheimer’s disease, anxiety, depression—even general symptoms like agitation, aggression, or hostility, the Department of Justice said. Adding these maladies greatly expanded Zyprexa sales. "Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining that a drug is safe and effective for a particular use before it is marketed," said Gregory G. Katsas, Assistant Attorney General for the Civil Division. Doctors have the right, on their own, to prescribe drugs as they see fit, even if that means using them to treat conditions not approved by the FDA. Only the active marketing of off-label uses by drugmakers is illegal because that practice exposes patients to "unnecessary risks," said Laurie Magid, acting U.S. Attorney for the Eastern District of Pennsylvania. "People have an absolute right to their doctor’s medical expertise," she added, "and to know that their health care provider’s judgment has not be clouded by misinformation from a company trying to build its bottom line." In a statement, Lilly chairman and CEO John C. Lechleiter said: "We deeply regret the past actions covered by the misdemeanor plea."Related LinksLife, Death and New DrugsStatins, Heart Attack and GenesHPV Vaccine Inspires Yellow Health Journalism