CER: Separating fact from fiction

August 15, 2010

The 2,400-page healthcare reform bill included language establishing the Patient Centered Outcomes Research Institute, a group grounded in the tenets of comparative effectiveness research. Its mission is significant, but whether it has the power to effect change remains to be seen.

Key Points

PCORI has been tasked with advancing research and scientific evidence "to assist patients, clinicians, purchasers, and policy-makers in making informed decisions" about how key health conditions can "effectively and appropriately be prevented, diagnosed, treated, monitored, and managed."

It's difficult to argue with the logic behind such an approach, but the bill also prohibits the Institute's findings from being "construed as mandates, guidelines, or recommendations for payment, coverage, or treatment; or used to deny coverage." It is these very limitations that could stifle PCORI's ability to positively impact both the practice of healthcare and the escalating costs associated with providing care.

The origins of CER date back to the late '70s, so it is not a new concept. Regrettably, much of the media coverage surrounding this subject neglects to mention how CER positively informs healthcare practice and instead associates this field of research with terms such as "death panels." (It is little surprise that Congress sidestepped the phrasing "comparative effectiveness" when choosing PCORI's name). Nowhere have you read, for example, that the guidelines for treating newly diagnosed cases of hypertension were revised largely due to the findings of the CER-based ALLHAT study.

The prospect of a healthcare system structured around the most effective treatments has led some to alternatively label CER as enabling "the rationing of healthcare." Such statements ignore the fact that CER will help bring improved patient care and reduced costs to many more Americans than it affects adversely. CER will also help encourage true advances in areas such as novel drug development, rather than marginal changes that may or may not yield substantial additional health benefits over existing alternatives.

In the absence of the kind of data provided by CER studies, healthcare professionals are often forced to rely on the results of an imperfect set of clinical trials to help make decisions on the best ways to treat patients. The reality is that patients, as opposed to the carefully screened individuals who participate in clinical trials, have a variety of complex conditions. CER fills a critical gap in the collective knowledge base by providing data on the success or failure of treatment options administered in actual clinical practice.

Congress' creation and funding of PCORI represents an important step in the right direction for helping further the nation's health and our ability to pay for it. But if we place too many restrictions on the group's ability to influence policy, it will be a case of one step forward and two steps back.

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Leon E. Cosler, PhD, is director, Research Institute for Health Outcomes, Albany College of Pharmacy and Health Sciences. He can be reached atleon.cosler@acphs.eduor 518-694-7223.

Patrick D. Meek, PharmD, MSPH, is assistant director, Research Institute for Health Outcomes. He can be reached at patrick.meek@acphs.edu or 518-694-7873.

The opinions expressed by guest editorial writers are their own and do not necessarily represent the views of Drug Topics' staff or the staff of Advanstar Communications.