Money, Medicine and Myopia

I can't say, on the basis of evidence, that NIH is misdirecting vast fortunes from where they could do the most good within our lifetimes. But I certainly do believe it. What I can say is that biomedical research dollars are subject to the same myopia that tends to dominate our personal lives.
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An opinion piece in the New York Times of April 4 makes the case that health care policy tends to lag well behind the imperatives of practice. The particular example highlighted is bariatric surgery. Bariatric surgery, so goes the argument, is now extremely prevalent and of proven value in the treatment of severe obesity yet still subject to antiquated restrictions.

The case made is that bariatric surgery became increasingly popular before much research was done. When research caught up, it showed a relatively high rate of complications. This, in turn, led to restrictions in Medicare reimbursement in 2006 so that bariatric surgery would be covered only at Centers of Excellence.

But a recent study in JAMA, featured in the New York Times piece, shows that complication rates since 2006 for privately-insured patients do not differ between such Centers of Excellence and their counterparts. Centers of "Mediocrity," I guess. The apparent reason for the absence of any gap is advances in surgical technique since 2006 that makes the Medicare restrictions obsolete.

Dr. Pauline Chen lays out just this case in her column in the New York Times. The punch line is that a "Center of Excellence" designation may outlive its utility. If bariatric surgery is every bit as excellent at centers with, and without, such a designation, the designation is at best useless and at worst misleading.

But while this is where Dr. Chen's argument ends, it's where mine begins. Because there is far more wrong here than a label of "excellence" that outlives its utility.

First, how do we account for the fact that over a span of years and decades, bariatric surgery did, indeed, become increasingly prevalent -- the rate of operations rose "exponentially" -- before systematic study and publication of outcomes and complications? How, in particular, do we account for this in an age of so-called "evidence-based" medicine?

The answers aren't hard to discern, but they are disturbing. One is that -- and most colleagues with whom I've discussed this tend to concur, provided the conversation takes place in a cone of silence -- we don't really have evidence-based medicine. We have reimbursement-based medicine. What gets studied is what gets done, and what gets done is what gets paid for. We like to think we figure out what works and then cover it. But we can't figure out that something works if it never gets any traction in the first place. In the pursuit of evidence, cart and horse routinely swap positions -- and money cracks the whip.

A serious and fundamental problem resides where the tendency to medicalize meets inside-the-box myopia. That tendency to medicalize, symptomatic no doubt of living in an age of technology and pharmacology advancing much faster than wisdom, is a matter of increasing attention and concern. A poignant column in the New York Times of April 1 made that very point. I have long lamented the modern inclination to bolt normally rambunctious children to chairs all day long, then prescribe Ritalin when they can't sit still. Yes, there really is ADD/ADHD that warrants medication. But the proper remedy for rambunctiousness in young children is recess, not Ritalin. And yes, we have actual data to show the substitution can work.

The related myopia is that once we medicalize everything from restlessness to weight gain, we tend to look for solutions within the walls of medicine -- and neglect the world of opportunity outside that box. The reality is that lifestyle is the best and most powerful medicine we have. But it tends not to be on the Medicare radar.

So, for instance: Why is it that bariatric surgery was routinely reimbursed long before data collection was robust, but a boarding school that can produce comparable or better results at lower overall cost won't be? Because our culture has told us that all health problems are medical problems, and medical problems warrant medical solutions. Despite our ostensible fervor for evidence, we are culturally indoctrinated to presume that drugs and operations are the right ways to fix health problems. They are to some extent presumed effective until proven otherwise.

The very opposite is true of non-medical, lifestyle-based interventions that are ultimately far more powerful. One good example is the widely-known heart disease reversal program developed by my friend, Dr. Dean Ornish. Some 15 years of study were required to establish this as a reimbursable alternative to coronary bypass surgery. In contrast, coronary bypass surgery was reimbursed from the start. There are many other examples, but no need to belabor the point.

Back to bariatric surgery. I would like to be clear that I support its availability to all who need it; that position is long a matter of public record. Bariatric surgery is effective and often works when nothing else does. If anything, reimbursement for it is -- as Dr. Chen argues -- unduly restricted. But I oppose a cultural orientation that seems cavalier about rerouting the gastrointestinal tract to fix what a genuine commitment to better use of feet and forks could prevent. If we can, for instance, impart to our teenage sons and daughters the skillpower to lose weight and find health through education, should we really be so willing to send them through the OR doors instead?

If there is a counterargument of any merit, it's that we have too little evidence to support the real-world utility of lifestyle-as-medicine approaches. That's true -- but it is a symptom of our medical myopia, not an excuse for it.

And so the second great conundrum here is a potentially massive misallocation of money. It's not just that we reimburse for surgery while neglecting non-medical approaches that could work as well or better. It's that our entire system of biomedical advance, and the investments that underlie it, favor the... well, biomedical.

What I mean is that the somewhat more than $30 billion annual budget of the National Institutes of Health is overwhelmingly directed at promoting basic science advances and clinical intervention trials. Another huge sum of money is provided by pharmaceutical and device companies to study -- you guessed it -- drugs and devices.

A vanishingly tiny portion of the NIH budget is allocated to figuring out how to turn what we already know into what we routinely do. Since what we already know would allow us to eliminate fully 80 percent or more of all chronic disease -- heart disease, cancer, stroke, diabetes, dementia -- that seems a potentially serious oversight.

I am a scientist -- I run a clinical laboratory -- and so I don't just trust my intuition and convictions; I respect the need to verify. To that end, colleagues and I -- including one of the world's preeminent health economists -- developed a protocol to study allocations of NIH money and determine how they might best advance the human condition over some specified time horizon (e.g., a decade, or two, or three). So far, we haven't been able to get funding for the study.

So I can't say, on the basis of evidence, that NIH is misdirecting vast fortunes from where they could do the most good within our lifetimes. But I certainly do believe it. What I can say is that biomedical research dollars are subject to the same myopia that tends to dominate our personal lives. There is a saying of uncertain origin that most of us spend more time planning a two-week vacation than the upcoming decades of our life. In the case of the NIH, I can say -- as both a grant applicant and reviewer -- that individual research applications are scrutinized just like that vacation. But the whole budget is rather like those decades. To the best of my knowledge and that of every expert colleague with whom I have conferred, there has been virtually no systematic study of how the whole sum is allocated across an array of potential projects to establish what would do the most good.

The restriction of Medicare reimbursement for bariatric surgery to Centers of Excellence may well be obsolete, and that's a problem. But fussing over which centers to reimburse for weight loss surgery while neglecting the opportunities to prevent that weight gain in the first place is a far bigger problem. Worrying about how best to direct scalpels while neglecting opportunities to make better use of feet and forks routine is a far bigger problem. Choosing among biomedical solutions while ignoring all options outside those walls is a far bigger problem.

The bad news is we have bigger problems. The good news is we have corresponding solutions. But we will find our way to them only if we climb the entanglements of money and medicine, overcome our prevailing myopia, and take in the landscape of neglected opportunity outside the box.


Dr. David L. Katz;

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