From: Reuters
Published February 8, 2008 04:28 PM

Medicare chief stands by anemia decision

By Kim Dixon and Lisa Richwine

WASHINGTON (Reuters) - A senior Medicare official said the case for cutting the use of controversial anemia drugs sold by Amgen Inc and Johnson & Johnson has become stronger since the agency decided last year to cut payments for their use in cancer patients.

The U.S. Centers for Medicare and Medicaid Services (CMS) is reviewing its decision following a storm of criticism from cancer doctors and the drugmakers.

Mounting evidence, including two studies casting more doubt on the drugs' safety, backs the original policy, Dr. Barry Straube, the chief medical officer at CMS, told the Reuters Regulation Summit.

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"I think that our national coverage decision has been shown, with even more evidence coming out since we made it, to have been the right thing to do," Straube said.

The drugs are erythropoietin-stimulating agents, also known as ESAs. They include Amgen's Aranesp and J&J's Procrit, both multi-billion-dollar selling drugs.

CMS issued its payment restrictions in 2007 after four large studies raised safety concerns, and the Food and Drug Administration required a stronger warning on the drugs' labels. The drugs can boost risk of heart problems and even death especially at high doses.

Straube said one likely option he believes the FDA will consider is to restrict use of the drug in some cancer patients.

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