Monday, September 13, 2010

Who Will Mediate the Medicators? Watching the CERites.

In its lead editorial on Sunday, The New York Times editorial page makes a strong argument for Comparative Effectiveness Research (CER),  the process--part scientific, part budgetary, part political--by which the government and other entities decide how effective medical drugs might be, and whether or not they are worth the cost.  In theory, CER makes good sense, but the sine qua non of CER is trust.  That is, we must be able to trust the people doing the CER, because our lives are at stake.

Yet if we don’t trust the “CERites,” as we might call them--that is, if we, the American people, were to conclude that the CERites are just another opaque, unaccountable, and arrogant group of bureaucrats, operating according to a different agenda than public health--then the whole CER system breaks down. 
For its part, the Times asks us to trust CER as implemented by the Obama administration; indeed, the Times wants to turn the CERites loose, giving them far greater power than they have at present.   

Under the headline, “Is Newer Better? Not Always,” the Times makes a series of points: First, the newspaper concedes that the prime driver of healthcare costs is better technology, and it freely admits that such improved technology is oftentimes a good thing.  But new technology is not always better--that’s the second point.   And then, third, the paper falls back on a familiar refrain, that the real issue in healthcare is keeping costs under control.  As the Times editorial puts it: 

The Congressional Budget Office estimates that an astonishing half or more of the increased spending for health care in recent decades is due to technological, surgical and clinical advances. For the most part, such advances are a cause for celebration. But an expensive new drug is not always better than an older, cheaper drug, and sometimes a new technology or treatment that is highly effective for some patients is unnecessary or even dangerous for others. The system almost seems designed to keep driving up costs.

We might dwell on that last line, on costs.  Controlling healthcare costs has been a major preoccupation of the liberal left for decades now; touting the “cost-cutting measures” thenabout-to-be-passed healthcare bill in March, President Obama himself declared: “My proposal would bring down the cost of health care for millions--families, businesses, and the federal government.”  

There’s nothing wrong with bringing down costs, of course, but the method by which those costs are to be controlled matters a great deal.  Many of us believe, for example, that a line-ahead emphasis on cost-cutting in healthcare is counterproductive, for two main reasons: first, such cuts are extremely unpopular with voters, so that the cost-cutters are likely to be ex-cost-cutters; second, and more profoundly, the easiest healthcare cuts to make in the short run are those that don’t involve helping people directly and immediately, e.g. the speculative research that might lead to a cure.  And so the immediate desire to cut spending, with little regard for the pain, or the backlash, gets in the way of a more patient determination to cut spending by improving health.  In other words, the cost-cutters, going for the fiscal equivalent of immediate gratification, never solve the real issue of healthcare, which is the chronic mismatch between the demand for healthcare and the supply of healthcare.  

Yet the Times editorialists are not Luddites; they recognize that sometimes new inventions--everything from the wheel to the assembly line to a smart phone--can, in fact, drive down costs.  As they observe, 

Even costly therapies can end up saving money as well as lives. Studies by respected economists have shown that spending on new cardiac treatments, neonatal care for low-birth-weight infants, and mental health drugs have more than paid for themselves.

But then the Times cites examples that it sees as wasteful and costly: 

Consider the prostate-specific antigen test, which is widely used to screen men for possible prostate cancer. In an Op-Ed piece in The Times in March, Richard J. Ablin, the doctor who discovered prostate-specific antigen, described the test as “hardly more effective than a coin toss” at distinguishing who is at risk, and lamented that the test’s popularity has led to “a hugely expensive public health disaster.   Each year some 30 million American men undergo the test at a cost of at least $3 billion, and many go on to have surgery, intensive radiation or other damaging treatments that may not have been necessary.

Dr. Albin, through his achievements, has earned a respectful hearing for his views, but others have differing views--starting with the approximately 200,000 American men diagnosed with the disease every year.   Indeed, well-regarded voices in the debate, such as the National Cancer Institute (NCI), a unit of the National Institutes of Health, don’t seem to agree with Dr. Ablin.  On its website, NCI acknowledges that prostate testing is “controversial,” but in discussing that controversy, NCI cites findings that tend to contradict Dr. Ablin, such as a European study that found that testing led to a 20 percent reduction in deaths from prostate cancer.  Such is the nature of a scientific debate, still very much in flux.   (By the way, the NCI site offers a list of seven speculative treatments--seven different ways, a fiscal pessimist might say, to spend money, or, alternatively, as a medical optimist might say, seven different ways to hopefully defeat prostate cancer.)

But what’s perfectly clear is that men with concerns about prostate cancer--and that category should include men over 40 with a family history and every man over 50--are going to want to seek out their own answer, with their own doctor.   Government diktat is not popular on matters of life and death; one needn’t fear the specter of “death panels” to nonetheless fear bureaucratization of life-and-death decisionmaking.   

In fact, the picture of CER, in practice, as opposed to theory, is distinctly mixed.   The Times hightlights the work of the Dartmouth Atlas of Health Care, one of the central texts of the CER movement, which purports to show gross cost-differentials in hospitals across the country, not connected to efficacy or good results.   But in fact, twice now in recent months now, in February and in June, the Times has attacked the quality of the Dartmouth data, pointing out that the Dartmouthians made  elementary mistakes--or, more likely, omissions: 

But the atlas’s hospital rankings do not take into account care that prolongs or improves lives. If one hospital spends a lot on five patients and manages to keep four of them alive, while another spends less on each but all five die, the hospital that saved patients could rank lower because Dartmouth compares only costs before death.  “It may be that some places that are spending more are actually getting better results,” said Dr. Harlan M. Krumholz, a professor of medicine and health policy expert at Yale.  Failing to receive credit for better care enrages some hospital administrators. But for the Dartmouth researchers, making these administrators uncomfortable is the point of the rankings.  “When you name names, people start paying more attention,” Dr. Fisher said. “We never asserted and never claimed that we judged the quality of care at a hospital—only the cost.”

That’s an interesting admission--if that’s the right word--in the last paragraph: that the Dartmouthians never claimed to be judging the quality of healthcare in their mapmaking.   Once again, this article ran in the Times just three months ago; we can be sure that the Times editorialists read it, the question is why they didn’t refer it.  

One major source for Dartmouth critiques is a piece appearing in the February 17, 2010  New England Journal of Medicine  by Dr. Peter B. Bach, “A Map to Bad Policy--Hospital Efficiency Measures in the Dartmouth Atlas,” also not mentioned by the Times editorialists.   One might think that if the Times editorialists are going to praise Dartmouth, then the paper of record at least ought to note the many criticisms and controversies surrounding the Dartmouth data.  

Also not mentioned in the Times editorial is the role of the pioneering CER agency, National Institute for Health and Clinical Excellence (NICE), part of the United Kingdom’s National Health Service (NHS).  To put it mildly, both NICE and NHS are lightning rods in the UK as well as the US.  A sample headline from a major British newspaper reads, “Sentenced to death on the NHS: Patients with terminal illnesses are being made to die prematurely under an NHS scheme to help end their lives, leading doctors have warned.”   Yet the Times editorializers didn’t mention of that CER work, either, even though we know that top Obama healthcare officials, such as Dr. Donald Berwick, head of the Center for Medicare and Medicaid Services, has been open in expressing his admiration of UK-style CER

Indeed, here in the US, we are already seeing the direction in which Obama-style CER, powered by the same mindset as Dartmouth and NICE, is headed.  Last month, Serious Medicine Strategy took note of recent moves by the Obama administration to eliminate federal approval for the anti-breast cancer drug Avastin, on the ground that it costs too much, despite its demonstrated efficacy.  The headline atop the editorial page of The Wall Street Journal last month got right to the point: “The Avastin Mugging.”  

It’s not possible to settle here the debate over the right way to treat breast cancer, any more than it is possible to settle the debate over prostate cancer.  But by the same token, it also won’t be possible for the federal government, either, to settle these debates--because people don’t trust the feds.  And so CER is effectively crippled, because people don’t trust the motives of CERites.   In a democracy, the government doesn't get far, not fo long, without the consent of the governed.  

Unfortunately, the Times editorial didn’t address any of those legitimate concerns, nor even report on the controversies.   

As noted at the beginning of this piece, CER depends on trust.  CERites are the would-be equivalent of Platonic Guardians in the medical world.   To borrow the famous critique of Plato by the Roman poet Juvenal, who asked of Plato's idea, "But who will guard the guardians?"we can ask, in our time, “Who will mediate the medicators?”  Because while CER is a good idea, in theory,  it sure seem as if the CERites, and their editorializing advocates, need to be closely mediated, in practice.  


  1. Cost-control does not equal quality control - unless you bend the definition of quality control from "the highest quality reasonably possible" to "the amount of quality the least amount of expenditure can provide." Toyota found this out the hard way, as internal E-mails showed after its safety woes became the subject of Congressional investigation.

  2. “.... CER makes good sense, but the sine qua non of CER is trust.”
    Yes Jim it is most definitely a two edged sword.

    Maybe the CER should be made up of only Grand Mothers? I certainly would trust them before a “John Q. Public Bureaucrat.”

    NY Times is crazy. We don't turn anyone loose!
    I see a pincer movement when coupled with Gates' recent comments about spending a million dollars on a person in his last month of life versus hiring 10 teachers, etc.
    Wanna cut costs: How about Tort Reform and Health Insurance company’s that can compete across state lines???
    These are just a few of the reasons the Ds are going to have their Keisters handed to them on 11/2. Oh, plus the fact they didn’t read the bill.

    The prostate-specific antigen test needs to be run twice before a possible tentative diagnosis can be made. It’s not a Psat over 4 that is so alarming unless the year before it was 1 or 2, or for that matter a 1 that jumps to a 3 may be worse than a 4.
    All men’s prostates enlarge like a woman's breasts sag, ---with age. Doesn’t mean they have cancer. But 2 annual tests on a comparative basis will tell a doctor if further investigation is necessary with either body part.

  3. This is just one more proof (s if we needed any) that we have to repeal this thing ASAP.


  4. My wife and I independently, of course suffer from mild thyroid dysfunction. The proper regulation of thyroid hormones which contribute in consort with the thyroid gland controls metabolic activity. Therefore as do millions of Americans, we are maintained on the Brand name Synthroid. I have never heard of an endocrinologist prescribing a possibly existing generic drug. Once the proper dose is experienced and the Thyroid Stimulating Hormone which makes a big difference in your symptoms is stabilized, you are 100% normal. Since we cannot cure most any disease, you will be semantically "cured" for life. That is, unless the feds ever determine that because, naturally, Brand Synthroid is very expensive, a cheaper substitute should be tested. I really do not care if they find one as long as it works.Now if there is an attempt or trial to replace Synthroid to save money, my wife and I may face periods of hyperthyroidism or hypothyroidism unless we are on a drug that can regulate the thyroid function properly. Symptoms would include pounding heart, high blood pressure, lethargy, loss of libido, nervousness and much more. As I said you could survive during a switch attempt but it would be very unpleasant.Americans recently began to see that many things were promised and talked about during the debate that simply cannot be delivered as presented.

  5. The mental health field is so nuanced and requires hospital workers and nurses to be trained and experienced, I believe will be extremely difficult to manage if Obama care sticks.I am guessing to save money the stays will be hastened. The worst of it is the very subject of medication. In mental health, especially if the patient is "cured" fooling around with working medicinal regimens would be illogical.

  6. Very useful read. Really you have posted nice article, thanks you for sharing.