Washington Editor

WASHINGTON - Various forms of the anti-anemia drug epoetin alfa are taking center stage on Capitol Hill this week at a hearing on the merits, or demerits, of dosing them at levels higher than labels suggest.

The House Ways and Means Committee will consider Wednesday the safety and quality of higher dosing for Medicare beneficiaries with end-stage renal disease (ESRD), an issue that's not exactly new but has taken on some steam in recent weeks in the wake of articles questioning the value and benefit of that practice, given increases in cardiovascular risks associated with higher doses, as well as an associated FDA warning. Agency-approved labels target hemoglobin concentration levels under 12 g/dL for that class of drugs, which includes Amgen Inc.'s Epogen and Aranesp and Ortho Biotech Products LP's Procrit, and just two weeks ago the FDA cautioned against dosing to a target hemoglobin level of 13.5 g/dL.

The Centers for Medicare and Medicaid Services (CMS) reimburses providers for higher doses, up to 13 g/dL, a disconnect from the FDA-approved labels that some patient and physician groups say are warranted in certain instances.

The central question, said a committee spokesman, relates to CMS' policy of paying for higher doses of the drug than the FDA label calls for, even amid questions around the clinical benefit of those higher doses. Chairman Bill Thomas (R-Calif.) and Rep. Pete Stark (D-Calif.) said that encourages "the systemic abuse" of those drugs in a recent letter to Acting CMS Administrator Leslie Norwalk, adding that both taxpayer costs and patient risks are rising as a result.

Officials at Amgen, of Thousand Oaks, Calif., have long maintained that the company's promotional efforts center on the FDA guidelines for hemoglobin levels less than 12 g/dL.

Medicare covers more than 90 percent of dialysis patients in the U.S., and the program spends about $64,000 annually for each person on hemodialysis for all medical services. Those with higher red blood cell counts also have higher drug costs, and in total, CMS' epoetin alfa spending reached $1.75 billion last year, its largest drug expense.

Witnesses for the committee hearing have yet to be named, but will include government officials and so-called experts on Medicare payment and treatment of ESRD beneficiaries, the committee spokesman said. There might also be industry representatives, he added, but as of press time Friday, Amgen officials had yet to receive an invite. In addition, there was no word on whether officials from Ortho, part of New Brunswick, N.J.-based Johnson & Johnson, would testify.

New Law Protects Animal Research

President Bush last week signed a bill to broaden criminal enforcement of animal rights extremists.

Called the Animal Enterprise Terrorism Act (S. 3880), the new law expands criminal prohibitions against the use of force, violence and threats involving animal enterprises and increases penalties for violations of those prohibitions. Clearly, that is of benefit to drug companies and their employees, some of whom have been violently targeted in recent years, mostly in Europe and to a smaller extent in the U.S.

In a statement issued by Jim Greenwood, the president and CEO of the Biotechnology Industry Organization (BIO), he called the measure an "important step to protect researchers and scientists from terror tactics."

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