Amgen To Pay $762 Million Fine For Improper Drug Marketing

Los Angeles Times: Amgen Pleads Guilty To Improper Marketing Of Anemia Drug Aranesp
Biotech giant Amgen Inc. pleaded guilty in federal court to improper marketing of its anemia drug Aranesp and has agreed to pay $762 million in criminal fines and civil settlements to resolve complaints from company whistle-blowers. Federal prosecutors in New York said the Thousand Oaks company was "pursuing profits at the risk of patient safety" by encouraging doctors to use its popular anemia drug for unapproved uses to boost sales and to take market share from a rival drug maker (Terhune, 12/18).

Medpage Today: Amgen Agrees To Pay $762 Million In Aranesp Case
The biotech drug giant Amgen pled guilty Tuesday to promoting its blockbuster anemia drug darbepoetin alfa (Aranesp) for off-label dosing regimens, agreeing to pay more than $760 million in fines. The drug, administered once weekly, was initially approved in September 2001 to treat anemia caused by chronic renal failure. Knowing it would have trouble competing with the well-established epoetin alfa (Procrit), which is used every other week, Thousand Oaks, Calif.-based Amgen used to its advantage a statement in the product's labeling that said darbepoetin had a longer serum half-life than epoetin alfa, which the company thought might suggest a less-frequent dosing regimen. Amgen sales representatives promoted darbepoetin for the off-label dose of once monthly, according to the complaint filed Tuesday by the U.S. Attorney's Office in the Eastern District of New York (Pittman, 12/18).

Meanwhile, the Milwaukee Journal Sentinel and MedPage Today look into the influence of drug companies on treatment guidelines.

MedPage Today: Guidelines: Guides To Profit?
Doctors with financial ties to drug companies have heavily influenced treatment guidelines, an analysis by the Milwaukee Journal Sentinel and MedPage Today has found. Critics say those financial relationships have corrupted the guideline process so that the end products, make dangerous or ineffective recommendations. Industry and some doctors counter that those with conflicts are often top experts in their field. The Journal Sentinel/MedPage Today examined 20 clinical practice guidelines for conditions treated by the 25 top-selling drugs in the U.S.  (Fauber and Gabler, 12/19).

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