Jerry Avorn in the May 7 NEJM has an excellent discussion of the ridiculous campaign by the usual gang of pathological wingnuts against Comparative Effectiveness Research. Inexplicably, although NEJM usually makes this kind of material of broad public interest open access, they've hidden this one behind the subscription wall. I'll have to yell at them louder, I guess.
Anyway, as I discussed here when the American Recovery and Reinvestment Act passed it included a big increase in federal funding for so-called Comparative Effectiveness Research. Columnist George Will checked in from his alternate universe to characterize the provision this way:
The stimulus legislation would create a council for Comparative Effectiveness Research. This is about medicine but not about healing the economy. The CER would identify (this is language from the draft report on the legislation) medical "items, procedures, and interventions" that it deems insufficiently effective or excessively expensive. They "will no longer be prescribed" by federal health programs.
The CER, which would dramatically advance government control – and rationing – of health care, should be thoroughly debated, not stealthily created in the name of "stimulus."
As Avorn enumerates for us, Will was hardly the only right wing bloviator to oppose the provision on similar or even more horrifyingly apocalyptic grounds. For example, Rep. Tom Price sent out an "alert" claiming that the legislation would create "a permanent government rationing board prescribing care instead of doctors and patients. . . Every policy and standard will be decided by this board and would be the law of the land for every doctor, drug company, hospital, and health insurance plan."
Uh, actually no. As in hallucinatory. The bill contains no provision establishing any governmental body or regulatory authority or health care reimbursement policy of any kind. All it does is fund research. So why the right wing war on knowledge? As always -- whether it's global climate change, tobacco, or mercury emissions, you name it -- it's because accurate information might compromise the ability of some rich criminals to get even richer at the expense of the common good.
Currently, in order to get a new drug approved, companies only have to show that it works better than placebo (generally speaking) in fairly short-term trials using homogeneous samples who are unrepresentative of real patient populations in such characteristics as comorbidities, age range, ethnicity, etc. They don't have to prove that it's better than standard, cheaper treatments, and they don't have to prove anything about the product in the real world. For medical devices, approval is even easier, and imaging procedures and surgery basically need no approval at all. In general, believe it or not -- despite the reputation of medicine as being very scientific and learned -- doctors actually do not base their treatments on good evidence about what works best, or even what works at all.
As Avorn puts it, "Vigorous marketing of the costliest new approaches fills this informational vacuum." And that is the essence of the threat posed by CER.
So one way to start to get a handle on health care costs, before health care turns into the Blob that Ate the Economy, is to learn more about what works best and for whom, and whether or not it's worth paying for the most expensive treatments and diagnostic procedures.
Some people argue that this will lead to faulty conclusions, and compromise "personalized medicine," by prescribing one-size-fits-all approaches that ignore variation among individuals. But as Garber and Tunis argue in the same issue of NEJM, the exact opposite is true. Well conceived and well designed CER is the way to find out who will benefit the most from which treatments, and what tests intended to personalize treatment are really worth doing.
With all the rage for genetic testing to personalize drug administration, for example, it turns out that the vast majority of identified variations have only a tiny relationship to outcomes and are not useful in tailoring treatment. Yet they cost money.
Now, ultimately results of these studies will have to be translated into guidelines, and it is likely that insurers will structure their reimbursement policies to encourage evidence-based practice. But that will only help your doctor and you to decide on the best course of action, save you money, and make you healthier. It will hurt Pfizer's bottom line, leaving some of what would have been their profits in your pocket.
It makes a lot of sense, in my view, to create a body similar to the UK's NICE, which is charged with systematically developing such guidelines. Since the UK in fact has socialized medicine, the NICE guidelines do sometimes result in identifiable individuals being denied treatments that they think they ought to get. Well, society's resources are not infinite. Right now we ration by who happens to have what insurance or none at all. That hardly seems better.
How our NICE might work, and exactly how it's guidelines would be implemented out in our more complex world of multiple payers, is a battle we may have to fight in the future. But for now, the claim that even knowing the truth abridges freedom is all the Republican party has going for it. I am inclined to believe the precise opposite.