Fifteen states, including New York and California, are accusing biotech giant Amgen Inc. of offering kickbacks to medical providers in order to increase national sales of Aranesp, an anemia drug known to have safety concerns. Aranesp is one of Amgen’s top-selling drugs, but has decreased in sales over the past few years due to health concerns. Studies discovered high doses of the medication could lead to an increased risk of heart attack, stroke, heart failure and tumor growth in some patients. A new study has also shown that patients with diabetes and chronic kidney problems who are not yet sick enough to need dialysis had nearly double the risk of having a stroke after using Aranesp. In 2007, the Food and Drug Administration (FDA) issued a "black-box warning" for Amgen’s anemia medications, which is the strongest warning possible regarding potential side affects.
The states filed suit in federal court accusing Amgen sales representatives of encouraging physicians and other healthcare providers to bill insurers for Aranesp products they received for free. Physicians are provided excess medication known as “overfill” that the suit alleges were above the recommended amounts, which allowed physicians to overbill insurers. This practice, which the suit alleges upper Amgen management knew about, would cost taxpayer-funded Medicaid programs and other insurers millions of dollars in overpayments. It would also put patients at risk since doctors are encouraged to administer higher doses of Aranesp to patients without any clinical need for that dose.
According to a report on a 2006 congressional hearing, anemia drugs are one of Medicare’s biggest expenses since it is used to boost red blood cell production and raise hemoglobin levels in kidney disease and cancer patients. The suit also claims Amgen conspired with two other defendants, drug wholesaler ASD Healthcare and group drug-purchasing network International Nephrology, to offer illegal incentives to medical providers in order to increase sales, such as weekend retreats and other rewards.
Amgen argues the claims are not true. The states involved in the suit argue that Amgen violated many state laws, including unjust-enrichment statutes, fraud and false claims. The suit is seeking triple damages and civil penalties, which in some states will amount to $10,000 per violation.