Drugmaker Amgen recently agreed to a $762 million settlement of criminal penalties and whistleblower lawsuits related to its illegal marketing of Aranesp, an anemia drug. Federal prosecutors say that the drugmaker marketed its pharmaceuticals for uses that the U.S. Food and Drug Administration (FDA) explicitly ruled out.
"Promoting drugs for unapproved purposes is beyond wrong; it jeopardizes the health and safety of the public," said FBI Assistant Director in Charge George Venizelos.
The bulk of Amgen's off-label marketing was through the promotions of its anemia drug Aranesp to cancer patients who were not undergoing chemotherapy. The FDA explicitly ruled out this class of patients for Aranesp because Amgen had insufficient data to show that the drug was effective in treating them. A follow-up study done by the drugmaker found that Aranesp was a defective pharmaceutical for these patients because it worsened their mortality rates.
"Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease. Americans expect - and the law requires - much more," said Marshall L. Miller, acting United States attorney for the Eastern District of New York.
Prior to the release of Aranesp, the only drug prescribed for anemic cancer patients was Procrit, made by Johnson & Johnson. The criminal complaint against Amgen alleges that its sales strategy was aimed at targeting cancer patients by misbranding Aranesp to steal Procrit's market share.
Amgen pursued its misbranding of Aranesp through a tactic called "reactive marketing." Amgen sales agents were taught to induce a doctor to ask a question regarding an off-label use of Aranesp and then use this as a selling point for the drug.
"Amgen thus trained its sales representatives to intentionally elicit questions from doctors about off-label uses as legal cover to then provide the doctors with studies supporting the off-label use, thereby promoting the drug for that unapproved use," the criminal complaint against the company states. "The studies Amgen provided to doctors to support off-label uses were often the very same studies that the FDA had rejected as insufficient to support the safety and efficacy of those off-label uses, when Amgen had applied to expand Aranesp's label to encompass them."
It is unclear how many patients suffered premature death due to the intentional actions of Amgen to promote its drugs for unapproved uses. The fact that Amgen targeted an already vulnerable population of sick patients with life-threatening illnesses makes the exact impact of its corporate malfeasance as unquantifiable as it is egregious.
Source: New York Times, "Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use," Andrew Pollack, Dec. 18, 2012