Thursday, June 11, 2009

CER's definitive maybe

Comparative Effectiveness Research. CER. It’s coming soon and to believe some of the things that have been written about it, one would expect it to loom on the horizon like a dark storm cloud, spitting lightning and damaging medical care wherever it goes.

Some hate its impact on the growth of personalized medicine and some think it represents the first step to an invasive and paternalistic regulatory system in which the government controls every doctor’s decision. Being the die hard skeptic that I am, hearing this kind of wailing tends to lead towards asking the question of whether any of this is true. In the case of CER I can answer with a definitive… it depends.

I say "it depends" because CER is not attatched to any policy platform yet. Right now, it's a study to see what kind of data we can get. It isn't definitely one thing or the other until we see what the government chooses to do with that data. The concerns being expressed are policy problems based on what might be done with the CER data.

Personalized Medicine
When people look at CER they see a world in which studies determine what the best mode of care for 51% of the people and apply it to 100% of the population. This would appear to be a rollback of all of the gains made in individualized care. However, this fear makes strong assumptions about what the goals and means of CER.

Rather than assuming CER is a monolithic study designed to produce only one “effective” treatment, it is also possible to view CER as being a large scale work of clinical epidemiology. It can be used as a way to determine which of the myriad personalized medicine options are going to be more effective. Viewed in this light, CER becomes a tool that would allow physicians to spend less time on unproductive treatments. It COULD be a monolithic means of determining best care, but it hardly has to be.

Dr. Big Brother
The idea that CER will be used to dictate medical care is based on a similarly unfounded assumption. It assumes that the data from CER studies will be used by both the government and private insurers to dictate an exact plan of care by reimbursing patients only for CER rated “best” treatments.

This fear again assumes that CER will be used to rate “best” treatments and also makes some assumptions about the present and the future. It assumes that in the present these health entities don’t already make reimbursement decisions based on effectiveness data and assumes that there would be no protection of personalized medicine in the future.

For the present, given that insurance entities are already making these same determinations, it seems possible that their information would be better with a comprehensive CER regime. The concern for the future is a valid one and does require that, if CER expands in the future, there will be some necessary protections based on the data that comes out, but to assume that it will be used in the most underhanded manner has no basis in the current legislation.

So that’s a very clear maybe. My point in this is not suggest that those people concerned about CER have no point, but rather to show that it’s based on sizeable assumptions about a program that hasn’t even gotten off the ground yet. It’s this indeterminacy which suggests that, rather than fight against CER, these groups should be active in shaping the future of it. Yes, it could be disastrous for American health care, but it doesn’t have to be. CER is coming, but what it does depends on what we do… maybe.

This is Part 2 in the New Voices discussion of comparative effectiveness research (CER).
Part 1 - What is Comparative Effectiveness Research?

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