Comparative Effectiveness Research

by hilzoy

Reading this post by Merrill Goozner (it's very good) reminded me that I meant to write about the articles on comparative effectiveness research in the recent New England Journal of Medicine. One, by Jerry Avorn, concerns the backlash against CER:

"The contested provisions were designed to support studies comparing the efficacy and safety (and, by extension, the cost-effectiveness) of alternative ways of addressing common clinical problems. Interventions to be evaluated will include pharmaceuticals, devices, procedures, and diagnostic approaches, such as imaging studies. This research will fill important information gaps facing clinicians, patients, and payers concerning what works best. Currently, the Food and Drug Administration (FDA) often approves new medications on the basis of modest-sized studies involving patients with relatively few coexisting conditions who are followed for brief periods. Sometimes the only efficacy requirement is a demonstration that a new product works better than placebo in improving a surrogate outcome measure, such as a laboratory-test result, rather than achievement of an actual clinical benefit. The bar is set even lower for medical devices such as pacemakers and implantable defibrillators, which may only have to be shown to be similar to previously approved products or simply not to be dangerous. For new surgical procedures or imaging studies, there may be almost no evidentiary bar at all.

Vigorous marketing of the costliest new approaches fills this informational vacuum, encouraging the widespread use of goods or services that may be no better, less safe, or more costly than usual care — or all of the above. Of course, many new interventions clearly are better in one or more of these domains, but we have no systematic way of collecting or disseminating such information. It is these lacunae that the funding for comparative-effectiveness studies was designed to help fill. At 1/20 of 1% of our $2 trillion annual health care expenditure, the CER funding amounts to a fraction of what any corporation would spend to find out whether it was getting its money's worth from its purchases. It represents one of the best investments we can make to edge the health care system away from the fiscal catastrophe it faces, since such studies will help to reduce spending on poorer clinical decisions and to spare resources for expenditures that will help patients most (and most affordably). This research is a public good, like highways and clean air. The private sector is no more likely to identify badly mispriced or potentially toxic treatments than it was to spot badly mispriced or potentially toxic products of the banking industry. (...)

In calmer times, fiscal conservatives might have been expected to support a plan to generate information about treatment benefits, risks, and costs so that physicians, consumers, and payers could use this knowledge in making purchasing decisions. But these are not normal times. On January 23, Representative Tom Price (R-GA), a physician, sent out an "alert" through the Republican Study Committee, falsely warning that the CER legislation would create "a permanent government rationing board prescribing care instead of doctors and patients." The true intent of the CER provision, Price warned, was "to enable the government to ration care" (emphases in original). "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."

Parallel arguments appeared in a letter sent January 26 to several influential members of Congress, cosigned by more than 60 advocacy groups, and again in a January 29 editorial in the Wall Street Journal. In an op-ed by columnist George Will that appeared in the Washington Post the same day, CER had morphed from a form of research into an imaginary new federal body with broad powers. Will named the agency "the CER" and claimed that with such a system, "Congress could restrict the tax exclusion for private health insurance to 'insurance that complies with the Board's recommendation.' The CER," he went on, "which would dramatically advance government control -- and rationing -- of health care, should be thoroughly debated, not stealthily created in the name of 'stimulus.'" In fact, unaffordability rations care far more than comparative studies ever could."

You'd think that doing research to figure out which treatments are most effective would be an obviously good thing. But no: it is, apparently, the first step on the road to socialized medicine. A lot of the attacks rely on this "first step" argument. For instance, the Heritage Foundation wrote that "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 could be used to do bad things! At least, if a board that doesn't exist were created and told to use this information! Pass me my smelling salts. I await with eager anticipation the Heritage Foundation's realization that this very same logic could be used to ban guns: after all, they too can be used to do very bad things, and (unlike comparative effectiveness research) actually are so used. Do you think consistency will oblige Heritage to come out in favor of a ban on all guns? Me neither.

But the Heritage Foundation is a marvel of sanity and good sense compared to John Griffing in the American Thinker, who describes the language providing for CER as "a line that would sentence millions of people to death", and adds, by way of explanation: "If you are picturing Germany circa 1930, you're right on. With the passing of this bill, government, not doctors, will decide who receives care and who doesn't, in essence, who lives and who dies." Deacon for Life, for his part, calls it "Mengele-esque". The idea that Hitler and Mengele's great sin was conducting research into the comparative effectiveness of various medical treatments is, shall we say, peculiar.

More seriously, there is something about the arguments against CER that I have never understood. The opponents of CER claim that it will inevitably be used to make decisions about care. Insurers will not want to pay for care that is not effective, and so people will be deprived of the care they need. But notice what "deprived of care" means here. No one is seriously proposing to make it illegal to purchase whatever medical care you want on your own. 

This means that even if your insurance company decides that it will not pay for some treatment that has been shown to be ineffective, you will, under any proposal being seriously considered, still be able to get that care; you just won't be able to get someone else to pay for it. If not having someone else pay for your medical care counts as being "deprived of care", then 46 million people are being deprived of care even as we speak -- and that's just the uninsured; it doesn't include people who have insurance that doesn't cover the treatments they need. And yet, strange to say, the opponents of CER generally do not see this as a problem.

Moreover, once you notice that what the opponents of CER describe as "being deprived of care" just consists in someone's deciding not to pay for some treatment, the idea that decisions about who gets what treatment are currently made by your physician is true only if you pay for your care out of your own pocket. If, like most of us, you rely on medical insurance, then someone other than your doctor is already making decisions about your care. All CER would do is allow this person to do so on the basis of actual knowledge about what works and what doesn't.

Comments

[DCA]

I think that the line "there will be a bureaucrat between you and your doctor" will have less impact than it did during the Clinton health-care effort--because, in the ensuing 16 years, many more people have been in HMO's, and so have had just this experience with private insurance. Congresscritters, since they have their own plan, probably have not had this affect them.

[kid bitzer]

bottom line:

we have an appallingly inefficient health-care system, because many of those appalling inefficiencies make certain people appallingly rich.

the pharmaceutical companies and device manufacturers have a vested interest in inefficiency: "inefficiency" is where they make their profits.

the insurance companies have a vested interest in inadequate and irrational coverage: "not covered" is where they make their profits.

these people are going to fight any improvements in the health care system, because improvements mean lower profits for them.

and they are going to tell a lot of lies to do it.

thank you, hilzoy, for fighting back against the lies.

[Warren Terra]

John Griffing in the American Thinker, who .. adds, by way of explanation: "If you are picturing Germany circa 1930, you're right on."

I generally consider myself fairly well informed about history, although it's been a while since I read any histories of that period focusing on Germany. Still, I have absolutely no idea what provision of healthcare was like in Germany in 1930, and I suspect Griffing doesn't either. For that matter, I'm not aware that the German government of 1930 was especially dictatorial or authoritarian (or effective); usually the period is portrayed as being relatively anarchic, with the population facing the global economic collapse and street battles between supporters of the left and right wing fringes. Not a paradise, except perhaps compared to what followed, but somehow I doubt Griffing meant to invoke a confused, divided, and ineffectual government in his comparison. Perhaps he meant to invoke the Germany of a half-decade later?

[Hartmut]

But, Hilzoy, you are blind! Once it is clear what treatement will be paid for, all other kinds will be banned, forbidden, made illegal, not allowed to be used, declared anathema, done away with, interdicted, prohibited, outlawed, enjoined, barred. This is an ex-treatment!

[John Miller]

The true irony is that insurance companies have been applying these techniques, of a sort, for years. There are certain treatment protocols, for example, that must be followed for treatment of back pain unless there is overriding evidence that the normal course of treatment would be ineffective.

There is also the refusal to pay for "experimental" treatment, even though it may be very effective, but costly. Applied Behavioral Analysis for treatment of autism is an example. Although around fro 20 years, ti is just now beginning to be covered by insurance on a regualr basis.

[Point]

The conservative response to this in general certainly seems to be incredibly paranoid and/or delusional. (Just to be clear.)

But, while having a board just looking at the effectiveness at forms of health care has a strong logic behind it, I can also see why many people wouldn't want other options to be unaffordable to them (by means of not being covered by their plan).

So, as long as CER has no real authority outside of publishing its findings to the public at large, I'm supporting it as part of a new health care plan. If Germany and Japan are any indication, "excessive" health care need not conflict with fair and functional health care.

[Brett Bellmore]

" For that matter, I'm not aware that the German government of 1930 was especially dictatorial or authoritarian "

That's usually the point when somebody likens something to 1930's Germany: The suggestion is that it might not look bad, but it will lead to 1940's Germany.

I don't think this kind of research is problematic in of itself, but it could certainly be abused.

[cleek]

The conservative response to this in general certainly seems to be incredibly paranoid and/or delusional.

it seems, to me, to be typically cynical and demagogic: lies for votes.

[JeanHitaro]

The situation is worse than described.

I work for a large hospital as a physicist and part of my job is to evaluate what imaging equipment the hospital would buy. I asked some friends at the FDA at a conference which PET scanner was the best. Their response was basically, "We know, but we are not allowed to tell you." There is some information coming from Britain, whose government actually performs tests to see what equipment works, but absent real information about the performance of complicated instruments, most of these decisions are based on the personal relationship between the physicians, administrators, and the salespeople from the manufacturers. Hospitals end up developing a brand loyalty to GE or Siemens or Philips the way some families would be Ford or Chevy families. I know more about buying a car from reading Consumer's Report than I can about buying major medical imaging equipment from reading the Radiology Journal.

[Sebastian]

CER sounds good to me, but when using it people need to remember that different drugs have difference side effects on different people. So the fact that drug A is 20% effective for 90% of people doesn't mean that you aren't in the 10% of people for whom drug B is more effective.

[russell]

cherchez l'argent.

[The Crafty Trilobite]

Not to mention, insurance companies are heavily regulated as to at least the general classes of services they must provide, by each state. The states either make those decisions at the legislative level based on information compiled by an Insurance Commissioner/Bureau/Department, or delegates the decisions to that body. Information like, say, what kind of treatments work and how they are provided. For example, my own state passed a Mental Health Care Parity law recently. In short, not just private but even government bureaucrats are already deciding what kind of care you can get insured for.

Difference is, this proposal might allow more fine-tuned & flexible decisions.

But don't count on it, because the real problem with federal CER reports are that, like the preposterous "food pyramid" chart most of us grew up with, they are perfect targets for lobbyist influence.

Since Congress already refuses to fund independent FDA safety studies, it surely won't fund independent comparison studies. Based on the way it generally handles large-scale research needs, it would rely on the manufacturers to provide the raw data and rely for the evaluations on academics -- who make most of their living from industry grants. The peer review system in the U.S. has been pretty thoroughly corrupted, so the government will get corrupt results, even assuming the bureaucrat in charge has not been influenced to push for some particular result.

There are ways to reduce this effect, of course, but they all cost money and require Congress to create a detailed bill instead of punting to the agency as usual, so don't expect it. To me, this proposal looks like a gift to Big Pharma.

[russell]

they are perfect targets for lobbyist influence.

Here's my modest proposal.

Any natural human person who is a citizen of the USA can make contributions from their personal funds to any public office holder up to some limit. Make it a big fat generous limit, say $10K a year. Hell, make it $20K, or $50K, so the rich folks who think money is speech won't feel all put upon.

Nobody else can do so. No corporation, no union, no PAC, no lobbying organization, no government domestic or foreign, no Springfield Cat Fanciers Association.

Individual natural human persons who are citizens of the US. Not a dime from anyone or anything else, ever, for any reason.

[russell]

And no cloning yourself to get around it, either!!!

[Jen]

Clearly Griffing has never heard of Godwin's Law.