The CEO of Cleveland Clinic weighed-in on the impact comparative effectiveness research (CER) may have on innovation. More specifically, his concern is whether, "manufacturers and investors would still be willing to make financial bets on unproven devices and drugs. He used the example of a heart valve, saying it now takes two decades to bring a new valve product to market and then assess the effectiveness" and what insurers and the government will do with CER study results.
His concerns mirror those expressed by others from both industry and academia and this question -- how will CER results be used? -- will have significant implications for both patient care and research and development as health care reform regulations roll out. With the intense focus on health care cost-containment in the US, there are legitimate worries that rather than being used as an educational tool, CER will be used as a tool to justify care decisions.
Given the limitations of even well-designed studies and the time course over which knowledge is accrued, it would be short-sighted to support care decisions based on these data. And in the long-run, the clinical benefits and applications that are often generated in post-approval studies, and from real-world use, will likely suffer.
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