title: Translating epoetin research into practice: the role of government and the use of scientific evidence.
abstract: Spending for epoetin is Medicare's single largest drug expenditure. We chronicle the evolution of epoetin policy based on a lack of well-designed post-Food and Drug Administration approval studies demonstrating clinical benefit; congressional/federal agency reliance on clinical practice guidelines that might have misinterpreted evidence supporting causality; and the premature translation of research into practice and policy. Were the right choices made? Epoetin showcases the risk and benefit conundrum created when evidentiary standards are relaxed. Our review concludes with broad-based policy recommendations for the newly implemented Medicare Part D program.
authors.affiliation: Medical Technology and Practice Patterns Institute Inc., Bethesda, Maryland, USA. dcott@mtppi.org
authors.forename: Dennis
authors.initials: D
authors.lastname: Cotter
authors.forename: Mae
authors.initials: M
authors.lastname: Thamer
authors.forename: Krishnan
authors.initials: K
authors.lastname: Narasimhan
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhang
authors.forename: Kim
authors.initials: K
authors.lastname: Bullock
mesh_terms: D003657:Decision Making; D017277:Drug Approval; D004921:Erythropoietin / Q000191:economics*; D006397:Hematinics / Q000191:economics*; D006801:Humans; D007356:Insurance, Pharmaceutical Services; D006278:Medicare; D017410:Practice Guidelines as Topic; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D006397:Hematinics; D004921:Erythropoietin