The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: CYP2C19

Preventing Bias in Comparative Effectiveness Research

Comparative effectiveness research has the potential to avoid wasteful spending and create net benefits for patients if approached properly, but it’s expensive.  Many of the large-scale comparative effectiveness studies include industry funding, and benefits managers are no strangers to the game, but giving those partners a say in study design risks introducing bias. 

An interesting example comes from today’s report that pharmacy benefits giant Medco is planning a head-to-head study of nearly-off-patent Plavix versus brand-new Effient.  The interesting tweak here is that the study will exclude people with a genetic variant (of the CYP2C19 polymorphism) who can’t metabolize Plavix.

This seems like another great example of personalized medicine informing a comparative effectiveness decision.  But, as the In Vivo Blog pointed out in an August post about Plavix and Effient, the effect of the CYP2C19 polymorphism on Effient efficacy is unknown.

So the PBM, with cost-saving incentives, is setting up a study to make payment decisions in which the efficacy of the (cheap) generic is boosted by excluding patients with the CYP2C19 polymorphism, with the validity of the comparison based on the untested assumption that there is no systematic bias to the branded product’s efficacy in the excluded population.  Am I missing something here?

The moral of the story: fund comparative effectiveness research through neutral parties and keep a careful eye on genetic and phenotypic subgroups to maximize the value of these important studies.

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