The New York Times reported, “The biotechnology giant Amgen has been accused by New York and some other states of engaging in illegal kickbacks to promote sales of its anemia drug Aranesp [darbepoetin alfa].” The states filed a lawsuit Friday alleging that “Amgen, in effect, provided free samples to doctors and clinics by putting tiny extra amounts of the drug in each vial. The medical practices could then make a profit by billing insurers…for the extra drug.”
The scheme, “which the suit contends was known to Amgen’s upper management, allegedly cost taxpayer-funded Medicaid programs and other insurers millions of dollars in overpayments,” the Los Angeles Times reported. The company is also accused of conspiring “with two other defendants — drug wholesaler ASD Healthcare and group drug-purchasing network International Nephrology — to offer ‘illegal inducements’ to medical providers to increase sales of Aranesp.”
According to the Wall Street Journal, the suit was filed in connection with a whistleblower complaint against Amgen over the marketing of Aranesp, which was brought on behalf of the US government and several states.
Commenting on the suit, New York Attorney General Andrew Cuomo said, “Drugs should be prescribed to patients on the basis of need, effectiveness and safety, not on a corporate giant’s promise of an all-expense paid vacation,” Bloomberg News reported. But, for its part, Amgen stated that “the allegations are without merit.”
The AP reported that “states involved in the lawsuit include California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, and Virginia, along with the District of Columbia.”
Study finds Aranesp nearly doubles risk of stroke. The AP reported, “A new study” published online Friday by the New England Journal of Medicine “raises fresh safety concerns about widely used anemia medicines, finding that the drug Aranesp [darbepoetin alfa] nearly doubled the risk of stroke in people with diabetes and chronic kidney problems who are not yet sick enough to need dialysis.” The study of “4,038 people with type 2 diabetes, kidney problems, and moderate anemia” found that strokes “occurred in 101 patients given Aranesp and 53 patients given” a placebo shot. The study’s authors concluded that for many patients, “this risk will outweigh its potential benefits.”
The Boston Globe noted that this is the “first trial to compare this class of anemia drugs with a placebo in the ability to prevent death and serious complications — even though the drugs have been in use for decades.”
According to Bloomberg News, the researchers “also found that among patients with a history of cancer, 60 of 188 patients taking Aranesp died, compared with 37 of 160 on placebos.” Amgen, the maker of Aranesp, said it will share the “information with drug regulators and expects the results of the study will lead to changes in the official prescribing information guiding Aranesp’s use.”
From the American Association for Justice news release.