Consensus Emerging On Need To Mesh CER And Personalized Medicine

Article preview  reprinted from "The Gray Sheet" - November 2, 2009

A distinct consensus is emerging in Washington that comparative effectiveness research needs to be done in a way that does not threaten the progress of personalized medicine. Read more...

Consensus Emerging On Need To Mesh CER And Personalized Medicine

Article preview  reprinted from "The Gray Sheet" - November 2, 2009

A distinct consensus is emerging in Washington that comparative effectiveness research needs to be done in a way that does not threaten the progress of personalized medicine.

At first blush, the two appear to work at odds. Comparative effectiveness studies examine alternative treatments for a condition to see which works better, on average, across a broad patient population. Personalized medicine, by contrast, is all about discovering which individual patients or subgroups respond well to a treatment and which don't, and tailoring their care accordingly.

Personalized medicine recognizes, for example, that while a large majority of patients may do best with treatment A, a distinct, identifiable minority may do poorly or even suffer adverse effects with that same treatment and instead do well with treatment B.

Many health care experts worry that if comparative effectiveness findings are used to identify and promote the approach that works best for most, it will mean inappropriate or inferior treatment for subgroups whose genetic makeup, sex, race or other personal traits differ from the majority.

Moreover, there is a risk that incentives for developing diagnostics and other strategies for use in personalized medicine will disappear if treatment decisions become more and more influenced by overly simplistic comparative effectiveness studies.

Harold Sox, co-chair of the Institute of Medicine's Committee on Comparative Effectiveness Research Priorities, frames the question this way: "Does the study of what works best for populations mesh or clash with the study of what works best for individuals and subpopulations?"

NIH, FDA, AHRQ Leaders Voice Optimism

In multiple forums last week, top health care policy makers - including National Institutes of Health Director Francis Collins, FDA Center for Drug Evaluation and Research Director Janet Woodcock, and Agency for Healthcare Research and Quality Director Carolyn Clancy - all spoke about the critical need to meld the goals of comparative effectiveness research and personalized medicine.

"Is there a potential collision here?" asked Collins, speaking Oct. 26 at a Washington, D.C., meeting on personalized medicine sponsored by the American Association for the Advancement of Science and the Food and Drug Law Institute.

As Collins, a geneticist who helped lead the international Human Genome Project, described the problem, important subgroup findings will "get lost in the wash by simply considering everybody to be equivalent, which we know they are not."

Collins continued: "The antidote to that seems pretty straightforward, in that if you're going to be conducting comparative effectiveness, you need to be sure you are doing appropriate genotyping to look for subsets of individuals who may have a response to a therapy which in the overall average seems slightly inferior but for that subset might have been considerably superior."

- Mary Houghton

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