Amgen says it is trying to rebut idle misinformation and gossip about the safety of a blockbuster product. Specifically, without mentioning the publication, it is angry about the fallout in response to research published in the New England Journal of Medicine in mid-November. Doctors are noticing that two clinical trials, sponsored by Johnson & Johnson and Roche, have cast doubt on aggressive treatment of anemia in undialyzed patients with chronic kidney disease. There will be hearings on the data in Washington this week. One issue is whether the design and results of the trial have any lessons for ordinary clinical practice.

In a news release, Amgen said it was trying “to clarify Amgen’s position on the use of Epogen (Epoetin alfa) and Aranesp (darbepoetin alfa) and to correct what the company believes are misleading and inaccurate news reports regarding the use of its drugs. Amgen’s mission is to serve patients and the company is committed to ensuring the highest standards of patient safety.”

Specifically, Amgen wants the medical world to know that:

• Epogen and Aranesp are effective and safe medicines when administered according to the Food and Drug Administration (FDA) label.
• Amgen only promotes the use of Epogen and Aranesp consistent with the FDA label.
• Hemoglobin maintenance is difficult and physicians are not necessarily acting inappropriately when patients’ hemoglobin levels temporarily exceed the FDA label target range.
• CMS reimbursement guidelines are consistent with the FDA labeling policy and allow doctors to provide patients with the best possible care. Changes to current guidelines should be approached judiciously and based on the rigorous review of data and patient care.