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Tag Archives: Senator Kyl

Trends Update — Comparative Effectiveness and Personalized Medicine: Patient-Centered Outcomes Research Act of 2009 Increases Personalized Medicine Focus

story on GenomeWeb yesterday takes a close look at the Baucus-Conrad Comparative Effectiveness Bill and notes that the influence of personalized medicine that we’ve flagged as a trend in 2009 has shown up in this year’s verison of the bill as

language specifying research approaches such as “molecularly informed trials” and “genetic and molecular sub-typing.”

This year’s version of the bill also

includes more emphasis on involvement with the diagnostics community and calls for an expert in genomics to serve on a methodology committee.

In addition to a focus on personalized medicine, the changes to Baucus’ bill incorporate another idea from Sen. Kyl’s amendment in April – adding some hurdles before CER results could be used (by CMS) for coverage decisions. 

Even so, the bill continues to meet procedural impediments and substantive objections, resisting Baucus’ efforts to re-brand the concept.

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Trends in 2009: Comparative Effectiveness Meets Personalized Medicine in the Senate

Yesterday Senator Kyl (R-AZ) introduced a “comparative effectiveness amendment” (SA 793) to the budget which would have:

  1. required that legislation resulting from the health care reserve fund not use data obtained from comparative effectiveness research to deny coverage under Federal health care programs; and
  2. ensured that comparative effectiveness research accounts for advancements in genomics and personalized medicine, the unique needs of health disparity populations, and differences in the treatment response and the treatment preferences of patients.

As I noted in our earlier Trends post, I believe the comparative effectiveness advocates in the Obama administration are perfectly on board with point (2), a point I made again with further examples when the U.S. Stimulus allocated $1.1 billion to comparative effectiveness research.  It’s point (1) that most likely caused the amendment to be rejected, 44-54. 

Bottom line:  until the research is done, we won’t know how much of what appears to be “comparative effectiveness” is actually accounted for by “personalized medicine” (i.e., individual, genetically-based response variation to the subject medication/treatment), as compared to different “effectiveness” (i.e., response to a medication/treatment in a (relatively) homogeneous population). 

My guess is that the vast majority of apparently differential effectiveness will boil down to underlying genetic differences in patient subpopulations. 

But ultimately, there may be some treatments that are genuinely less effective than others in comparable populations.  As a patient and as a taxpayer, I’d like to know what those are and avoid taking or paying for them.

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