Swimming upstream: comparative effectiveness research in the US.

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. Nonetheless, even as this federal programme is still defining its initial priorities, a strong domestic opposition to CER has already appeared. 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. 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. Although widespread attention to CER is fairly new, the political arguments surrounding its implementation are not. Understanding the historical antecedents to current problems in the conduct and implementation of CER can improve our understanding of ongoing policy debates and options. Yet the window of policy memory in this arena is unfortunately brief: many accounts of the rise of CER in American health policy start with the introduction of the Comparative Effectiveness Research Act by Senators Max Baucus and Kent Conrad in 2008, or with the 2007 report from the Congressional Budget Office proposing CER as a key fulcrum for quality improvement and cost containment. Those that dig deeper rarely look past the Medicare Modernization Act of 2003, which authorized the Agency for Healthcare Research and Quality (AHRQ) to create the Effective Health Care (EHC) programme to generate, synthesize and translate research on effectiveness of pharmaceuticals, devices and other therapeutic agents. But the goal of comparing effectiveness among therapeutic alternatives is not new to the 21st century, and 20th-century challenges to COMMENTARY Pharmacoeconomics 2009; 27 (12): 979-982 1170-7690/09/0012-0979/$49.95/0