CER and personalized medicine: Diametrically opposed?

At a recent colloquium sponsored by the American Association for the Advancement of Science (AAAS), US National Institutes of Health Director Francis Collins warned that the focus on comparative effectiveness in proposed healthcare legislation under consideration may not be a good thing for the future personalized medicine.



At a recent colloquium sponsored by the American Association for the Advancement of Science (AAAS), US National Institutes of Health Director Francis Collins warned that the focus on comparative effectiveness in proposed healthcare legislation under consideration may not be a good thing for the future personalized medicine.

Collins is calling for CER to focus more on pharmacogenomic strategies to investigate the efficacy and safety of drugs in genomically defined subpopulations, according to a recent Pharmacogenomics Reporter article.


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. He warned that we must remain mindful of the goal of CER 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.


Healthcare policy and management research organization the Lewin Group says: It is essential that these emerging initiatives evolve to complement, not contradict, each other. But amidst the US push for healthcare reform, CER is getting a big push, while advocates say personalized medicine largely is being ignored.


The Obama Administrations American Recovery and Reinvestment Act (ARRA), more commonly known as the stimulus package, earmarked a total of $1.1 billion for CER. And in a June report by the Federal Coordinating Council proposing priorities for the HHS Secretary to consider when allocating ARRA funding, recommended investment in creating the data infrastructure for CER and to disseminate and translate CER and research into priority populations.  Despite acknowledgement in the report of the need to look beyond randomized control studies, defined funding priorities ignored personalized medicine strategies, advocates say.


Granted while the healthcare debate rages on in the US, theres little certainty of exactly what the bottom line will look like when legislation eventually is enacted. But every indication is that no matter which reform package is eventually adopted in the US Congress, CER is destined to be a much bigger part of the future of healthcare in the US and beyond.


So is personalized medicine about to get lost in the wash as Collins argues? Whats the impact of healthcare reform likely to be on the future of personalized medicine? And what does it mean for pharma?


Wed love to hear your thoughts.