title: Current assessment of risk-benefit by regulators: is it time to introduce decision analyses?
abstract: Regulatory risk-benefit assessments may overweight small but serious risks relative to benefits. Using terfenadine and torsade de pointes as an exemplar, we illustrate how a different decision may result when outcomes are assessed using quality-adjusted life-years within a decision-analytical framework. The adoption of common measures of health outcome and the use of decision analyses, which will allow uncertainty to be characterized and evidence to be compiled from disparate sources, may inform complex risk-benefit decisions and should be used in conjunction with qualitative assessments.
authors.affiliation: Centre for Economics and Policy in Health, IMSCaR, University of Wales, Bangor, Gwynedd, UK. d.a.hughes@bangor.ac.uk
authors.forename: D A
authors.initials: DA
authors.lastname: Hughes
authors.forename: A M
authors.initials: AM
authors.lastname: Bayoumi
authors.forename: M
authors.initials: M
authors.lastname: Pirmohamed
mesh_terms: D000465:Algorithms; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003661:Decision Support Techniques; D033161:Government Regulation; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D016593:Terfenadine / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D018926:Anti-Allergic Agents; D016593:Terfenadine