Swimming Upstream

Excerpt

In recent months, $US1.1 billion in federal stimulus funding has helped to propel a movement to achieve higher-quality, lower-cost healthcare in the US through the conduct and dissemination of comparative effectiveness research (CER). If efficacy is an abstract and intrinsic attribute of a drug — a measurement of how well it works in the clinical petri-dish of the placebo-controlled trial — then effectiveness is a more earthly, networked quality involving the evaluation of drugs in the messier, interconnected and causally over-determined context of clinical practice. Investment in CER is meant to assist clinicians, patients and health systems in comparing the relative real-world value of therapeutic alternatives, and plans for a national CER center have looked to precedents abroad — particularly in the UK (National Institute for Health and Clinical Excellence [NICE]), France (Haute Autorite de Sante [HAS]), Germany (Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) and Australia (Pharmaceutical Benefits Scheme [PBS]) — which vary widely in approach to commissioning prospective research and the degree to which findings are linked to reimbursement policies.[1] Nonetheless, even as this federal programme is still defining its initial priorities,[2] a strong domestic opposition to CER has already appeared.[3] As conservative groups portray federal investment in CER as an entry-point to state control of healthcare, articles in the mainstream press have described CER as a programme of rationing that may threaten the autonomy of the American physician, restrict access to life-saving medicines and intrude on the doctor-patient relationship.[4] Even among those committed to the success of the CER programme, there is considerable controversy over where a center for CER will be housed, whether its findings should be tied to approval and reimbursement decisions, and whether there will be any role for cost in evaluations of comparative effectiveness.[5] …