DO WE REALLY NEED TO DEFEND THE VERY CONCEPT OF "EVIDENCE?"
I don't really like writing defenses of "comparative effectiveness review." It makes me despair for our country. We're literally talking about the process of gathering evidence so we know how well various medical treatments work. It's worth saying, however, that there are two types of objections to gathering evidence, and they're being unfortunately conflated.
The first is the ideological objection. Some conservatives worry that the "the type of information collected by CER could eventually be used inappropriately if a 'Federal Health Board' was created to decide which types of treatment would be available to whom and when." It's worth parsing this for a moment: The apparent fear here is that the evidence from comparative effectiveness will be, well, used to make treatment decisions. But that can't be quite right. We use evidence all the time. Your insurer won't pay for a leg amputation when your symptom is a headache. Medicare doesn't cover a wheelchair if you're diagnosed with acute constipation. No one whines about that.
The fear, rather, is that the existence of more evidence will somehow qualitative change the way government uses evidence. The government will decree, in other words, that their testing shows back surgery ineffective, and back surgery is now illegal. Put slightly differently:
Step 1: Comparative effectiveness review.
Step 2: ????
Step 3: Authoritarian medical system
It's sort of what would happen if you applied The Road to Serfdom to the comparative effectiveness debate.
The industry's fear is quite different: This is the profit objection. Right now, most research on, say, drug effectiveness is funded by the pharmaceutical industry. That presents obvious advantages for them and problems for us. The concern here is that if they cease controlling the flow of evidence, then new studies will show that certain treatments don't work. For instance: Claritin goes off patent. Generic versions emerge. They're very cheap. Claritin's manufacturer changes the chemical composition slightly and comes up with Clarinex. They apply for a new patent. They sell it at a heavy mark-up. But it probably doesn't work much better. If there's credible evidence out there showing that it doesn't work much better, that's the end of that business strategy.
But this is the debate. Supporters of comparative effectiveness reform want information on whether medical treatments work. Some conservatives are worried that the government will take that evidence and use it to craft a totalitarian health care system. They are worried about anything that could further empower government. Some members of the medical device and pharmaceutical industry are worried that the existence of that evidence will reduce their profit margins. They are worried about anything that would hurt profits. But what's important about these objections is that they have nothing to do with comparative effectiveness review. Conservatives don't want to empower government. Industries don't want to sacrifice profits. This is an argument over principles that's simply taken the form of an argument over policy.
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COMMENTS (49)
I think you're giving "conservatives" too much credit. This notion of a "totalitarian health care system" is an essentially crackpot talking point to disquise the fact that they are putting an "ideological" veneer on what is simply a bald defense of the private "health" industry's profitability. I don't believe they take their own public argument seriously.
Posted by: brucds | May 12, 2009 2:03 PM
"They are worried about anything that would hurt profits."
That's all that needs to be said, except you can add "short term." Poverty, uninsured, deficits, global warming, pollution -- all are irrelevant to short-term profit. Even any concern about "government" is just a sham to cover the desire for private gain.
We don't need to make anything any more complicated than that.
Posted by: Obama / Steelers / etc | May 12, 2009 2:04 PM
Please god no more underpants Gnomes references.
It was fun while it lasted.
Posted by: will | May 12, 2009 2:04 PM
There are more than two major reasons why people are wary of the concept. One of the reasons people are afraid of comparative effectiveness reviews is that in some instances, such as treatments for mental illness, what works well for a majority may not work at all for a significant minority. And there is also the question of how the information is collected: will they be studies of all white guys? Will there be appropriate percentages of women and minorities represented, since treatments may affect populations differently? And what constitutes "effectiveness"? There are some treatments that may be "effective" but cause some pretty heinous side-effects that people getting the treatment may not be willing to put up with. It's not as cut and dried as it may seem, although I do agree that these reviews need to be done, but there does have to be some necessary flexibility in the results.
Posted by: kath | May 12, 2009 2:23 PM
Claritin goes off patent. Generic versions emerge. They're very cheap. Claritin's manufacturer changes the chemical composition slightly and comes up with Clarinex. They apply for a new patent. They sell it at a heavy mark-up. But it probably doesn't work much better. If there's credible evidence out there showing that it doesn't work much better, that's the end of that business strategy.
If it doesn't work much better, then prescribing expensive Clarinex instead of cheap Claritin knockoffs is exactly the kind of wasteful health care spending that Obama and Gingrich both say they want to save trillions of dollars by eliminating. That's what wasteful health care spending looks like - an expensive brand-name drug that doesn't outperform the generic.
Furthermore, Clarinex is exactly the kind of medical innovation we *don't* need - if it really doesn't work significantly better than the previous state of the art.
Posted by: chris | May 12, 2009 3:02 PM
Let's say my back hurts. I am bound and determined to get a spinal fusion. Today, I can shop around and find an in-network doc who will authorize/justify/perform a spinal fusion, rather than shuffling me off with a recommendation to exercise or go through a round of chiropractic treatments.
Or let's say a woman has found a lump in her breast, and the biopsy shows a malignancy. She wants a radical mastectomy; the CER says that, for a tumor of that size and malignancy, all that's effective--and all the gov't will pay for--is a lumpectomy.
That's the fear: what kath said, combined with people's experience with governmental rule-making with meat axes.
Of course, the other side is that CER will also lead to denial of benefits by the insurance companies.
Rather than made-up examples (amputation for headache) advocates of CER should come up with real-world examples: I bet Ezra, at his age, did not have a routine tonsilectomy--even if he got a lot of colds etc. as a wee lad. That is an example of changed practice norms even without CER. Another could be the wildly variable rates of Cesearian deliveries by metropolitan area, an area that cries out for CER and national norms. But there is also the fear, and, while not entirely rational (right now, my back's fine!), it is nevertheless real: that some faceless, unresponsive bureaucracy will someday deny YOU the treatment that YOU want/need/can't do without.
Posted by: wendell | May 12, 2009 3:24 PM
Wendell,
using your first example, I'd point you towards Ultrasonic Bone Growth Stimulators as a real world example. The research on Ultrasonic Bone Growth Stimulators is dubious at best and they're expensive as hell. For every study showing they work, there's usually another study showing that they perform the same as the placebo. Or, since they're often prescribed in tandem with some other kind of therapy, the studies are sometimes not designed to differentiate between which treatment modality was really doing the heavy lifting of, you know, stimulating bone growth. Also, you know, people's bones sometimes grow back on their own, irrespective of devices.
CER could put all this data under one roof and we'd be able to get data that was at least better if not perfect.
Posted by: ThomasEn | May 12, 2009 3:50 PM
But there is also the fear, and, while not entirely rational (right now, my back's fine!), it is nevertheless real: that some faceless, unresponsive bureaucracy will someday deny YOU the treatment that YOU want/need/can't do without.
If the treatment is ineffective, then you don't need it. In fact, nobody needs it. It's ineffective. It doesn't work. That's what "ineffective" means.
That's what makes it so surreal to see people defending ineffective treatments. What part of "ineffective" don't they understand?
(In the meantime, of course, faceless bureaucracies are already denying people effective care that they *do* need.)
Posted by: chris | May 12, 2009 4:25 PM
(In the meantime, of course, faceless bureaucracies are already denying people effective care that they *do* need.)
I think you misunderstand: the fear is that faceless bureaucracies will deny effective care to the rich people who deserve it.
Posted by: LittleMac | May 12, 2009 4:48 PM
I fully support comparative effectiveness research but you're being willfully naive by citing examples like, your insurer won't pay for a leg amputation when you have a headache. Obviously doctors and patients don't really give a damn in those instances. Medicine is a vast and ever changing field, the stricter the guidelines, the more limited the options. We're not talking about leg amputations, we're talking about administering a drug versus some sort of surgical procedure or undergoing treatment versus waiting and seeing. It's subtle and often subjective.
Also your mystery step two is not so mysterious. I think it's pretty obvious - comparative effectiveness research is employed by public and private payers to make coverage decisions and produce strict guidelines on evidence based care. Frankly, it's long overdue, but let's not pretend we can't possibly understand where these notions come from.
Posted by: B | May 12, 2009 5:07 PM
As I understand it, a clinical trial for a new drug usually compares that drug to a placebo, not the state of the start. I.e., Clarinex is better than doing nothing, not Clarinex is better than generic Claritin. Comparative effectiveness research could quickly put an end to this. Right now, in the absence of hard data, doctors can be swayed to prescribe new drugs through marketing, to them and to patients. Once a policy of requiring comparative data starts, who knows where it might end?
Posted by: Donsig | May 12, 2009 5:31 PM
But there is also the fear, and, while not entirely rational (right now, my back's fine!), it is nevertheless real: that some faceless, unresponsive bureaucracy will someday deny YOU the treatment that YOU want/need/can't do without.
This is not only the fear, it's the whole point. It's using data to make sound decisions rather than being driven by the whims and fears of people who have little to no knowledge of medicine.
Posted by: TW Andrews | May 12, 2009 5:44 PM
There is a huge misunderstanding among the public and your commenters about how treatment decisions are made by insurers, public or private. They are not faceless bureaucrats. They are usually well trained physicians who rely on whatever evidence they can obtain. They are also constrained by the benefit contracts themselves, that identify services that are not covered or are considered experimental.
There is also a huge misunderstanding among the general public about evidence itself. Which makes it so easy for the Betsy McC's and the Rush L's of the world to scare everyone to death about evidence and CER (which by the way is comparative effectiveness "research" not 'review"). Everyone who reads you, Ezra, is pretty well informed and generally well educated. But whoa...there are tons of people ready to be stirred up on this issue that don't read you. So don't be quite so cavalier about the need to defend evidence.
Posted by: LindaB | May 12, 2009 6:10 PM
There's no point to doing CER if you arent going to give it teeth by denying payments to groups who dont follow the guidelines. Why waste the money on the CER board if it doesnt have the power to do what it NEEDS to do?
CER is a good thing for this country AS LONG as you dont do something foolish like Canada did and try to outlaw all private healthcare (which was thankfully stricken down by the Supreme Court of Canada). If I want to waste my money on worthless treatments, I should be able to pursue that option, as LONG AS taxpayer dollars/infrastructure is not used. As long as that caveat is in place, I think the american public will accept CER.
Posted by: joe blow | May 12, 2009 10:22 PM
Having recently been party to an evidence review, let me just second that the idea of evidence review is great, but the practice of it is very difficult and dependent on the level of expertise of the reviewers.
A good evidence review requires grappling not just with what the data says and how much of it there is, but how to even gather and evaluate data in the first place. For marquis diseases and technologies (e.g., diabetes, breast cancer, coronary arterial blockage), evidence reviews can attract the funding and quality of thought to be done well. But for less well-known diseases or weaker treatment options, effectiveness (meta)studies can easily be starved for funding and done without careful thought. Even as someone who believes in CER and thinks medicine ought to b a lot more evidence-driven, it's hard not to foresee a lot of initial interest and excitement about CERs, followed by slow slide into a plodding and cumbersome bureaucracy.
This is where a lot of harm can happen, particularly if the effectiveness review is then taken as writ by the payors. The US is still largely the nexus of medical innovation. Part of the price of that is paying for proving out new technology. We ought to have a serious debate about whether we want to be that nexus - and not just platitudes about "retaining innovation while cutting waste".
Posted by: Eric | May 13, 2009 8:10 AM
The *real* problem of "comparative evidence review" is that is practice, it stifles new and effective treatments for older, less expensive and less effective treatments.
Great Britian's N.I.C.E board which the Democrats are modeling after is a big, big problem. Take a look at this article from a practicing oncologist about the practical problems of a review board of this nature.
http://tinyurl.com/odghhp
Partly as a result of these restrictions on new medicines, British patients die earlier. In Sweden, 60.3 percent of men and 61.7 percent of women survive a cancer diagnosis. In Britain the figure ranges between 40.2 to 48.1 percent for men and 48 to 54.1 percent for women. We are stuck with Soviet-quality care, in spite of the government massively increasing health spending since 2000 to bring the United Kingdom into line with other European countries.
Posted by: El Viajero | May 13, 2009 12:58 PM
The *real* problem of "comparative evidence review" is that is practice, it stifles new and effective treatments for older, less expensive and less effective treatments.
And the real problem of cars is that people crash them into each other and die. Even for trolling, this is a terrible excuse for an argument.
The fact that something can be done badly, or that there are horrible consequences if it is done badly, does not mean that it can't also be done well, or that it shouldn't be done at all. It just means that you have to be careful how you do it.
Posted by: chris | May 13, 2009 5:10 PM
I think it's pretty obvious - comparative effectiveness research is employed by public and private payers to make coverage decisions and produce strict guidelines on evidence based care. Frankly, it's long overdue, but let's not pretend we can't possibly understand where these notions come from.
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