Translating epoetin research into practice: the role of government and the use of scientific evidence.
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.
Cotter
Dennis
D
Medical Technology and Practice Patterns Institute Inc., Bethesda, Maryland, USA. dcott@mtppi.org
Thamer
Mae
M
Narasimhan
Krishnan
K
Zhang
Yi
Y
Bullock
Kim
K
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
D006397:Hematinics; D004921:Erythropoietin