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Tag Archives: NHLBI

Trends Update — Personalized Medicine: No Medicare Funding for Warfarin Testing, For Now

dna_sequenceThe WSJ Health Blog reports that Centers for Medicare and Medicaid Services (CMS) has decided there is not enough scientific evidence for Medicare to pay for genetic testing to customize Warfarin dosing.

CMS proposes paying for more research, and the New York Times story questions the cost effectiveness of a prospective study; but as we reported in February, NIGMS is already working on a prospective study that Frank Torti boosted at the time.

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Warfarin and Personalized Medicine

dna_sequenceThe optimal dose of Warfarin for an individual can vary across a 10-fold range, and depends in part on genetic variation in two genes, CYP2C9 and VKORC1.  In 2007, the FDA required a labelling change to warn of patients with increased risk of bleeding due to these variations.  However, population-wide assessments of outcomes based on genetic testing were not definitive.

A paper in the current issue of the New England Journal of Medicine uses retrospective data to build a new dosing algorithm and predicts significant benefit from the use of the algorithm for the 46% of patients who require lower- or higher-than-normal doses.  The algorithm and data used to derive it will be made available via PharmGKB, a database managed by researchers at Stanford, and the research has prompted a full-scale prospective study of the personalized approach.

Frank M. Torti, M.D., acting commissioner of Food and Drugs said that the prospective study

is precisely what is needed to advance the promise of personalized medicine, ensuring that patients receive the safest and most effective drug dose.

Read our other posts on personalized medicine.

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