BOSTON (AP) – Boston’s largest hospital system plans to cut doses of antianemia drugs given to chemotherapy and kidney disease patients after federal warnings that large doses may increase the risk of heart attacks and strokes, according to a published report.
The Boston Globe reported Thursday that Partners HealthCare, the nonprofit parent of Harvard-affiliated Massachusetts General Hospital and Brigham and Women’s Hospital, would be the first hospital network in the country to order the dose reductions in the epoetin class of drugs.
The drugs have been debated by kidney specialists, dialysis clinics and federal regulators since the New England Journal of Medicine reported last month on a halted clinical trial that indicated one of the drugs, Procrit, was responsible for more deaths when administered in larger doses. The Food and Drug Administration warned doctors not to overuse the drugs.
“Too much of a good thing can have bad side effects, and that seems to be what’s happening with epoetin,” said Dr. Jessica Dudley of Brigham & Women’s, who is part of Partners’ task force examining the network’s use of some costly, frequently prescribed drugs.
The drugs are given to people with kidney failure or undergoing chemotherapy because their bodies do not produce enough red blood cells. Besides Johnson & Johnson’s Procrit, the epoetin drugs include Amgen Inc.’s Epogen and Aranesp. Under Amgen’s patent, dialysis clinics can only use Epogen.
The FDA urged doctors not to use the drugs to raise red blood cell counts above 12 grams per deciliter of blood. In the trial that was halted, researchers tried to raise the red blood cell counts above 13 grams. About half the nation’s dialysis clinics give patients epoetin doses that raise their red blood cell counts above 12 grams, according to federal Medicare data.
Partners said its new dosing guidelines, expected to be in place early in 2007, meet the FDA recommendations.
For-profit dialysis kidney clinics are not expected to change their policies. Medical directors for the two largest clinic chains, Fresenius North and America and DaVita Inc., said they don’t believe the data in the halted study, which tested earlier-stage kidney patients, apply to dialysis patients.
“These are different populations of people,” Dr. J. Michael Lazarus, medical director for Fresenius, told the Globe.
Medicare pays for most dialysis treatment in the United States, and last spring changed its reimbursement guidelines to allow doctors to prescribe Epogen in doses high enough to raise red blood cell counts to 13 grams per deciliter. Medicare said its policy accounts for how individual patients respond to treatment.
At a Congressional hearing earlier this month in Washington, House Ways and Means Committee Chairman Rep. Bill Thomas, R-Calif., said he believes Medicare’s reimbursement policy does lead to overuse of certain medications for chronic kidney disease, primarily Epogen, for which it spends about $2 billion a year.
Amgen said it has always recommended following the lower FDA guidelines for Epogen. The company said Medicare’s policy change has not encouraged more use of the drug. Amgen declined to comment on Partners’ plan.
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