NIH Funds Epoetin Survival Study; CMS Launches ESRD Quality Initiative
Executive Summary
The National Institutes of Health has awarded a two-year grant to explore the causal relationship between the anemia drug epoetin and survival among hemodialysis patients
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The National Institutes of Health has awarded a two-year grant to explore the causal relationship between the anemia drug epoetin and survival among hemodialysis patients. The study will be conducted by the Medical Technology & Practice Patterns Institute in collaboration with the Harvard School of Public Health. According to MTPPI, it is unclear whether published associations, produced with conventional statistical techniques, between epoetin and survival can be accepted as causal. "The current evidence base for evaluating the impact of epoetin on survival is flawed, consisting almost entirely of retrospective studies that did not even consider use or dosage of epoetin," MTPPI said. The institute plans to employ an advanced statistical model developed by Harvard researchers in order to produce a more state-of-the-art estimate of the effect of epoetin on survival. The retrospective study will look at data from the U.S. Renal Data System. Epoetin's safety profile has also been the subject of a meeting of FDA's Oncologic Drugs Advisory Committee; the panel assessed proposals from Amgen and J&J to conduct survivability studies for Aranesp (darbepoetin) and Procrit (epoetin alpha), respectively (1 (Also see "Aranesp/Procrit Trial Tumor Biopsy Collection Not Feasible, Cmte. Says" - Pink Sheet, 10 May, 2004.), p. 14). Amgen recently added cautionary language to Aranesp labeling regarding the treatment of patients to high hemoglobin levels, joining manufacturers of other epoetin products. A new program to improve the quality of hemodialysis care is underway at the Centers for Medicare & Medicaid Services. The agency recently released end-stage renal disease clinical performance measures in order to identify and track opportunities for improvement associated with hemodialysis, peritoneal dialysis, anemia management and vascular access management. The main focus of the quality initiative is to ensure that end-stage renal disease patients have safer access to hemodialysis through a fistula, a connection created by surgically joining a vein and an artery in the forearm. |