Policy Documents

Promoting and Using Comparative Research

Scott Gottlieb, M.D –
February 1, 2009

Federal efforts to underwrite and promote research comparing different drugs and medical devices continue apace, even in the stimulus plan passed by the House of Representatives.[1] These policies are aimed at furnishing government programs like Medicare with better data on the clinical and cost considerations that inform the agencies' coverage decisions. At face value, it makes perfect sense that the government should want more information on the "comparative effectiveness" of the medical products it purchases. But like many other seductively simple ideas, enthusiasm for comparative effectiveness research (CER) outpaces its practical promise and obscures the downside of having governments take on these sorts of studies and the clinical considerations that go into them. Additionally, the government is no ordinary payer. Its size and authority mean it often sets the entire market. Government decisions on coverage of new medical products reverberate through the entire health care market. This kind of influence demands that the government agencies take great care in how they approach decisions to pay for medical products and afford access to them. Thus far, the discussion around creating a federally directed CER effort is not being handled with appropriate prudence or precision.