Push is on for research on comparative effectiveness

May 7, 2007

Comparative effectiveness research needed to find the best in drugs, devices, biologicals, and procedures to improve healthcare, contain costs

"We need to find ways to spend smarter," said Gail Wilensky, Ph.D., a senior fellow at Project Hope and a former administrator of the Health Care Financing Administration (now the Centers for Medicare & Medicaid Services, or CMS). She has been a proponent of this research for some time. Such a center, she said, would not be one where decisions are made but would instead "provide data so that good decision-making can occur."

John Rowe, M.D., who until last year was CEO at Aetna, said, "I would expect wide adoption of any recommendations that came out of an organization like this in the commercial and the not-for-profit health plans in the United States.... They are really hungry for this."

Companies providing drugs and devices should embrace this kind of research, said Kathleen Buto, M.P.A., VP of Johnson & Johnson, because it will "cause more research to be directed, we think, to those things that matter-and, by the way, to have the evidence produced at an early stage that appropriately looks at the value-added of these technologies." Referencing the current rate of healthcare cost increases, which the speakers agreed is almost unsustainable, she said that having information on what works best will be better than undertaking "draconian" measures like across-the-board cuts and "even direct negotiation with pharmaceutical companies."

Most of the current information about safety and efficacy, Wilensky emphasized, comes from the approval process for drugs and devices at the Food & Drug Administration. But the problem with that research, she posited, is that it is either "against placebos or whatever the single standard of care is." More significantly, she added, that information is only on pharmaceuticals and devices. Although she would include those things in the new research center, she said, "the money is much more in medical procedures."

Where such an agency should be placed is still under discussion. Wilensky said that decision will be made in the political process. It could be part of the Department of Health & Human Services, it could be a freestanding agency like the Federal Reserve Board, or it could be an independent agency related to the government, like the Institute of Medicine.

Rowe, however, pointed to other evaluative centers that have disappeared from the federal constellation in past decades. Many people in the healthcare industry feel the center should be completely outside government.

There are concerns within the device and pharmaceutical industries that such a center will become yet another hurdle, along with the FDA, for products to clear. Buto maintained that guidelines based on the research should include flexibility for the differences among individual patients.

Asked why the center should not do comparative effectiveness research on drugs before they come to market, Rowe indicated that it was a bad idea, since a variety of drugs for the same condition can be useful because of differences in patients.

While there is also a need for cost-effectiveness research, Wilensky believes it should not be connected to the comparative effectiveness center, for fear that political implications would kill the nascent effort.

The researchers and others also presented the ideas in a one-day meeting, last fall, sponsored by Merck, Kaiser Permanente, and AHIP in connection with Brandeis University's "Health Industry Forum." There are also Web-exclusive papers on it in the journal Health Affairs.

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