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NIH Director Collins Says Comparative Effectiveness Research Will Fall Short Without Genetic Strategies

WASHINGTON, DC (GenomeWeb News) - The limited focus on pharmacogenomics strategies in the federal government's comparative effectiveness efforts may be a step backwards for personalized medicine, National Institutes of Health Director Francis Collins cautioned at a meeting here this week.

Studies on genomically defined subpopulations that would advance personalized medicine are "going to get lost in the wash by considering everybody equivalent, which we know they are not," Collins said at a colloquium on personalized medicine hosted by the American Association for the Advancement of Science.

At the AAAS meeting, Collins called for comparative effectiveness research to focus more on pharmacogenomic strategies to investigate the efficacy and safety of drugs in genomically defined subpopulations.

"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins said at the meeting.

As part of the American Recovery and Reinvestment Act, the US Congress granted a total of $1.1 billion for comparative effectiveness research: $400 million to the NIH, $300 million to Agency for Healthcare Research & Quality, and $400 million to the Office of the HHS Secretary to create the Federal Coordinating Council for Comparative Effectiveness Research.

AHRQ said last month that it plans to provide $100 million of that funding in the coming fiscal year to support studies of the effectiveness of treatments and diagnostics, including personalized healthcare approaches, such as pharmacogenetics, clinical diagnostics, and bio-imaging studies.

A report released in June by the Federal Coordinating Council for Comparative Effectiveness Research, which was created by the ARRA, proposed that comparative effectiveness should "complement the trend in medicine to develop personalized medicine," and should use the ability to investigate drug and dosage effects at the sub-group level in ways that are difficult in randomized trials.

Nevertheless, some personalized medicine advocates felt at the time that genomically guided strategies did not receive adequate attention in the report.

For instance, although the report mentioned the need to look beyond randomized-controlled studies to advance personalized medicine, most of the priority areas that it identified corresponded to traditional clinical trials to determine therapies that would work best on average populations.

In addition, the report identified "priority" populations and subgroups as demographic groups that are under-represented in medical research, but did not specifically cite any genetic subpopulations for study.

Personalized medicine proponents this week applauded Collins' remarks on the importance of genetic strategies for comparative effectiveness research.

The Personalized Medicine Coaltion "wholeheartedly supports the comments made by Dr. Collins," Amy Miller, PMC's public policy director, told GenomeWeb Daily News sister publication Pharmacogenomics Reporter this week.

"We are pleased that he is at the helm of NIH and thus are assured that CER that comes out of the NIH will take a personalized approach."

A more comprehensive version of this article appears in this week's issue of Pharmacogenomics Reporter.