For-profit dialysis chains in the United States give patients larger doses of the expensive antianemia drug Epogen compared to nonprofit clinics, according to a study to be published today in the Journal of the American Medical Association.
In many cases, the larger doses boost red blood cell levels beyond what is recommended by the Food and Drug Administration, the study said.
The article suggests the increased use of Epogen is the result of financial incentives built into the federal Medicare reimbursement rate for the drug, and volume discounts offered by its manufacturer,
In an accompanying editorial, a kidney specialist writes that his colleagues around the country too often leave Epogen dosing decisions to dialysis clinic staffs, instead of tailoring doses for individual patients.
The editorial urges doctors to take a more active role in limiting dosing, particularly in light of recent clinical trials that have shown that patients whose red blood cell counts exceed FDA limits are at greater risk of death from heart attacks and strokes. The drug, known as erythropoietin, is a hormone that stimulates production of oxygen-carrying red blood cells.
"Physicians need to challenge industries that appear to be using patients as profit centers based on bad science," said the editorial, written by Dr. Daniel W. Coyne, a professor at Washington University School of Medicine, in St. Louis.
Responding to the suggestion that volume discounts contribute to excessive use, Amgen spokesman Dan Whelan said, "We believe our dialysis organization contracts support appropriate anemia management."
The JAMA article was based on Medicare insurance claims data, and was authored primarily by researchers from the Medical Technology and Practice Patterns Institute. The nonprofit group, based in Maryland, has frequently criticized government Medicare reimbursement policies for Epogen.
Co-authors included a kidney specialist and well-known anemia-management specialist at the Veterans Affairs health system in Boston, Dr. James Kaufman; and Dr. Miguel A. Hernan , an epidemiologist at the Harvard School of Public Health.
Dialysis clinics generate about 25 percent of their revenue through Epogen reimbursements from the federal Medicare system, which pays for most dialysis treatments in the United States. Despite the heavy reliance on the reimbursements, however, dialysis clinics say dosing is not driven by financial considerations.
The FDA last month placed its most severe warning on the labels of erythropoietin products, which in addition to Epogen include Aranesp , another drug manufactured by Amgen, and Procrit , which is manufactured by Amgen and sold under license by Johnson & Johnson. The FDA said the drug should be used to boost red blood cell counts just high enough to prevent the need for blood transfusions in patients with kidney failure or cancer.
The country's largest for-profit dialysis chains yesterday disputed the JAMA article's conclusions. They said the more important story was that a greater percentage of their patients met red-blood cell target guidelines issued by Medicare. Michael Lazarus , medical director of Fresenius North America, said the number of patients whose anemia is adequately treated has increased dramatically in the p ast 10 years.
To reach that level of anemia treatment for the entire dialysis population -- more than 325,000 -- it is inevitable that some patients will have their red blood counts boosted above FDA recommendations, he said.
Lazarus and Dr. David Van Wyck , a member of a National Kidney Foundation panel that sets recommended guidelines for anemia treatment, said physicians in their chains sign off on individual treatment plans for patients. Wyck, a University of Arizona physician, is also a consultant for the dialysis chain
"A doctor signs every single order, for every single dose," he said.
Christopher Rowland can be reached at email@example.com.