Bill would create center for comparative effectiveness

Over the past year, the idea of a major new center to support studies comparing drugs and other medical interventions in head-to-head research has gained surprising traction. Now there's legislation in Congress to create such an entity.

Another question is whether drug and device manufacturers would have to focus not only on creating an effective product, but also on creating something that would be better than competing products in comparative effectiveness studies.

An Institute of Medicine roundtable in September found the most rapidly growing problem in health care is not about applying what is known, but about knowing how to choose among two or more possible interventions for any particular patient as the pace of innovation speeds up. The report said, for example, "Information on which to compare the results from drugs with the same purpose is often not available. For example, both Lucentis [ranibizumab, Genentech] and Avastin [bevacizumab, Genentech] are promising new drugs for treatment of macular degeneration, but head-to-head information on the relative outcomes is not available-and one costs about 20 times the amount of the other."

Presidential platforms

Comparative effectiveness has also found its way into the healthcare platforms of at least three Presidential candidates: Sen. Hillary Clinton (D, N.Y.), Sen. Barack Obama (D, Ill.), and former Sen. John Edwards (D, N.C.). But most specifically, the House of Representatives passed legislation in August that would create a center connected to the Agency for Healthcare Research and Quality (AHRQ) to conduct and support such studies. The provision is attached to Medicare legislation (H.R. 3162).

Several points of consensus among proponents were reiterated at a conference on the issue sponsored last month in Washington, D.C., by the ECRI Institute. Janet Woodcock, M.D., the Food & Drug Administration's chief medical officer, and acting director, Center for Drug Evaluation & Research, cautioned the ECRI conference audience that often comparative effectiveness findings end up, for example, with a smattering of effects on each side and are not very illuminating about which drug or product is better in what circumstance. She warned: "Comparative effectiveness is really good, we should do this type of work.... But it is no panacea."

Woodcock said, however, that this country has no overall system for evaluating even the basic utility of health care, unlike other industries. She predicted, "I think this will be driven by costs because we are no longer going to be able to bear the costs of the healthcare system."

Steep slope

Stuart Altman, Ph.D., a prominent health economist from Brandeis University, told the conference that over the past seven years, healthcare cost increases have been steeper than at any time in our history. "We are not slowing down.... It is very serious." He said the employment-based, private-based health insurance system is running into serious problems as premiums have gone up over 90% in recent years.

Altman said clearly the nation needs comparative effectiveness research, "so that we can get the kind of care that is appropriate. Appropriate not only in the clinical sense.... It's also a cost issue."

On the other hand, Altman said, "I can appreciate the problems manufacturers are running into. They don't know the environment that they are selling into. They can't plan ahead because things keep changing."

THE AUTHOR is a writer based in the Washington, D.C., area.