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Industry Has Influence In Reform Bill's Research Institute

Amid all the hue and cry over the recent mammography guidelines from the U.S. Preventive Services Task Force, and what that portends for the future of healthcare under reform legislation, little attention has been paid to the actual language in the Senate bill regarding comparative effectiveness research. Of course, these are details that are difficult to compress into a sound bite about how reform will inevitably lead to the rationing of care. Nevertheless, it is notable that the Senate bill repeats several times that the findings from government-funded research into the comparative effectiveness of various treatments will not be used to determine coverage or reimbursement under government health programs. Moreover, the bill establishes a governance structure for this research that seems designed to defend the interests of the healthcare industry, which opposes any kind of cost controls.

Commenting in The New England Journal of Medicine on the Senate Finance Committee bill that was one of the current measure's predecessors, Harry P. Selker, MD, and Alastair J. J. Wood, MD, note that the board of the Patient-Centered Outcomes Research Institute that would supervise CER would include representatives of the healthcare industry. Selker and Wood point out that this is not true of other "science agencies" such as the National Institutes of Health (NIH) and the Agency for Healthcare Quality and Research (AHRQ), and they suggest that it would be better to place responsibility for CER in an agency such as AHRQ.

Selker and Wood observe that industry lobbying helped shape the governance of the CER institute. Under the current Senate bill, the institute's board of governors include the directors of AHRQ and NIH; three members representing patients and consumers; five members representing physicians and other providers, including hospitals; three members representing private payers, including insurance companies and self-insured employers; and three members representing pharmaceutical and medical device companies. The payer and pharma/device representatives have diametrically opposed interests: Health plans and employers generally prefer to slow the introduction of new technology, while the drug and device makers want to accelerate it. But the provider and consumer representatives are also likely to raise questions about research that shows new technologies aren't any better or are less effective than old ones.

The authors of the NEJM article point out that the Senate Finance bill would bar any CER investigator who published research "inconsistent with scientific evidence" from receiving CER grants for five years. The provision is also included in the full Senate bill. Noting that this provision was inserted at the insistence of industry lobbyists, Selker and Wood argue that it is a form of intimidation. I agree that it has that potential. One would hope that the scientific community would close ranks and oppose any efforts to censor valid results. But the checkered history of medical research is not encouraging in this regard.

What we need is unbiased comparative effectiveness research to inform the decisions of physicians and patients about which treatments to choose. In reality, many will disregard the evidence for a variety of reasons. But if doctors pay attention to the results of solid research, and if they have incentives to provide high-quality, cost-effective care, patients will benefit and we might even be able to reduce health costs.

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