CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

December 18th, 2012

Amgen Pleads Guilty to Misbranding Anemia Drug Aranesp

Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices.

The judge deferred a decision on the plea until Wednesday. When the final settlement is announced further details about pending civil suits against Amgen will be unveiled. The acting U.S. Attorney said that the terms of the agreements will include multiple measures to insure that Amgen complies with regulations. The measures will mean that Amgen “won’t view this as the cost of doing business,” he said in a press conference.

The agreement includes $150 million for criminal fines and penalties and an additional $612 million civil settlement. In 2011 Amgen reported $2.3 billion in sales for Aranesp.

Aranesp is approved to treat anemia in chemotherapy patients and in anemia patients with chronic kidney disease (CKD). The label now includes a black box warning that it can increase the risk of death, MI, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.

Although it had been the subject of earlier questions, serious criticism emerged with the publication in 2009 of the TREAT trial, which found no clinical benefit for the drug in patients with CKD. Results of TREAT prompted a dramatic FDA advisory committee meeting in 2010 followed by a major label revision in 2011.

For a PDF of the U.S. Attorney’s Explanation of the Charges, click here.

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One Response to “Amgen Pleads Guilty to Misbranding Anemia Drug Aranesp”

  1. Thomas Kline md, md phd says:
    December 19, 2012 at 11:56 am

    only a percentage of the annual take which is probably running
    50% profit or 1 billion just write it into the business plan and go
    on cheating and lying. The problem is there are real people out there
    being harmed – so they have a stroke. “oh well they had kidney disease”.