THE BLOG
01/28/2015 02:41 pm ET Updated Mar 30, 2015

Holism, Holes and Poles

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Integrative Medicine, now itself officially integrated into the name of its home at the NIH, the newly dubbed National Center for Complementary and Integrative Health, is a rhetorical lightning rod under any of its potential aliases. All related terms- alternative medicine, holistic medicine, complementary medicine, and so on -- are charged and evocative. Inevitably, the sparks and charges emanating from the poles do much to generate heat, and almost nothing to shine light on the promise of common ground in the middle.

At one pole are practitioners of "alternative" medicine inclined to blame modern medicine for every modern ill, and toss the whole enterprise under the proverbial bus. They do so at the public's peril, forgetting and obscuring the stunning benefits of immunization, antibiotics, revascularization, and refinements in chemotherapy.

At the other pole are conventional practitioners who give as good as they get, disparaging any insight not emanating from a multi-million dollar RCT, wary of anything not established in their purview, unwittingly inattentive to the baby awash in bathwater.

Before making that case, and arguing for a better way forward, I note that the middle is where I have long been. I opened an Integrative Medicine Center some 15 years ago, and have directed it, and seen patients in that context, since. I did so not because of any long suppressed desire to practice medicine under that banner, and certainly not because of any inclination to don Birkenstocks.

In fact, I was -- as I remain- a card carrying member of the evidence-based medicine club. I was already running then, as I still am, a federally funded clinical research lab. I was already then, as I am now, routinely publishing studies in the peer-reviewed literature. I was teaching then, as I did for roughly ten years, biostatistics and clinical epidemiology to Yale medical students. And while back then I had co-authored a textbook on epidemiology and biostatistics, I have since co-authored four editions of that textbook, and a textbook on evidence-based medicine as well.

Perhaps at this point it sounds as if I am defending myself, and maybe I am. I have certainly long been subject to harsh criticism from self-proclaimed guardians of the true definition of evidence-based medicine for practicing this way. I was reminded of this recently by a social media current in response to a column I wrote about the importance of immunization. The commentary in question snarkily implied that I myself may have aided and abetted the anti-vaccine movement I oppose by stating that we need a more fluid concept of evidence in clinical practice than yes/no, on/off, black/white.

But of course, we do -- for any number of important reasons.

First, the evidence from any given clinical trial, however methodologically robust, may or may not pertain to any given patient. The application of evidence from trials to the care of individuals not in those trials is itself a product of the art of medicine, not the science. To my knowledge, there has never been a randomized trial examining different ways clinicians might decide if trial results pertain to a specific patient. That may result from the developing field of pharmacogenomics, but we have a ways to go. In other words, for now, the application of the evidence in evidence-based medicine to the actual care of patients is not, itself, evidence-based. That's a fact.

Second, the needs of patients all too often go on when evidence runs thin, or out entirely. This is why I went into "integrative" medicine in the first place -- and why I am now involved in the online delivery of holistic care to a larger population.

By working with colleagues trained differently than I, naturopathic physicians in particular, we had more treatment options together than we did alone. When patients had been everywhere, tried everything subtended by RCTs and still weren't better, they came to us. And we, generally, could come up with something reasonable to try. Admittedly, it wasn't yet in the textbooks -- but that was the point. These were the folks that had already run off the pages of textbooks, and still needed help.

And third, there is the thorny little issue of money.

The horses that pull toward "evidence" pull a cart full of money. The average cost of bringing a new FDA-approved drug to market now approximates a billion dollars. Spending millions, tens of millions, or even hundreds of millions on clinical trials makes sense if a return in the billions is the offing. It's pretty much a non-starter otherwise, and a problem even a budget the size of the NIH's cannot solve. In fact, the price tag for one, new FDA-approved drug is nearly ten times the annual operating budget of the National Center for Complementary and Integrative Health.

The notion that the evidence we have is the evidence we most need, or that it reliably indicates what works best -- puts that cart full of money ahead of those horses. The idea that the pursuit of evidence follows a level track is the triumph of preconceived notions over well considered history. The belief that evidence is equally accessible to all is naïve in the extreme.

There are innumerable illustrations of this, but I will invoke a tale I have already told for ease of reference. Despite the apparent promise of coenzyme-Q10 in the treatment of congestive heart failure, a tiny study of just 50 people followed for just three months was used, back in 2000, to declare that the "final nail" had been driven into the co-Q10 for heart failure hypothesis. Within a year, a study of thousands followed for years established the efficacy of a patented drug, carvedilol, in the treatment of the same condition.

It took more than a decade after that to undo the damage, but eventually it happened: trial data came in to show that co-Q10 could reduce heart failure mortality by about 50 percent. In other words, ten years after being declared defunct, the co-Q10 "hypothesis" was not only vindicated, but seemed to represent the greatest advance in the treatment of heart failure in years.

A rigid, or "non-fluid" conception of evidence would have renounced further attention to co-Q10 once we already had "evidence" showing it didn't work. But the evidence we had was flawed, resulting from a woefully under-powered, under-funded trial. Looking at the results of a clinical trial and recognizing they may not mean what the authors say they mean is, I suppose, a more fluid concept. It also happened to be the truth -- in this, as in many other cases.

And so it is that unconventional practice may at times be less studied not because it is less worthy, but simply because it is less patentable. It may be that it is subject to flagrant bias. Imagine, if you can, a small, brief study being hailed as the final "nail in the coffin" of the hypothesis that some new, patented, and expensive drug might be effective in treating some condition. I cannot even imagine such a thing, and certainly have never seen it. If anything, in the world of patented drugs, we have the opposite problem: they come to market when they shouldn't.

There are many other stories about important misapplications of evidence, such as the one related to hormone replacement at menopause. That, too, is a story I've told before -- so I will simply refer you to it as the spirit moves you.

Let's bring this to closure. Medicine cannot advance as it should if we are not devoted to the principles, and diligent in the applications of good science. But science has always been driven forward by those open-minded enough to challenge convention. Were that not so, the world would still be flat, and the sun revolving around it. What is implausible to any given age of humanity may become established fact to some successive generation. That is true for physicists -- and it is true for physicians.

Holistic, or integrative care, does call for an open mind. But it does not allow for a mind so open that brains fall out. The opposing tendency, a mind so closed that new or unexpected truths are inadmissible, is comparably pernicious. The challenge for us all is the blend of conviction about what we know and humility about what we don't that sets the aperture just right. It isn't easy.

It is a challenge best met by collective acknowledgement of its importance, collective commitment to the need. It's a challenge best met as a common cause, on common ground, for all concerned with both responsible use of evidence, and responsiveness to the needs of patients that go on when evidence runs thin.

My argument for a more "fluid" concept of evidence had nothing to do with research methods; as noted, I have written books on that topic and will let them make that case for me. Rather, I was arguing as a clinician, taking care of challenging patients. In that context, the idea that evidence is simply present, or absent -- is silly. When patient need has exhausted the results of all trials ready for prime time, what does the clinician do? The options, it seems to me, are: (1) say goodbye, and good luck; or (2) adopt that more fluid, and clinically relevant conception of evidence.

I espouse, practice, and defend the latter. The fluidity, as is clear in published material in which the construct is laid out, is all about clinical application of evidence. When really good trial data are not available but patient need goes on, reliable evidence of safety and early hints of potential efficacy may be enough to give something a try. That's... fluid.

When a patient has pain, sleep deprivation, depression, diabetes, drug side effects, and a toxic marriage -- the case for holistic care seems self-evident despite the want of RCTs on the topic. Done right, integrative or holistic care is as responsible about the use of scientific evidence as any other kind of care, but perhaps more responsive to the needs of patients that persist when the obvious choices fail to get the job done.

Nowhere in the argument for a more fluid application of evidence to the care of people is there an argument to reject evidence when it is clear. The evidence in support of immunization is clear. A connection between the two argument is specious; a non sequitur.

The trouble with holistic medicine, or integrative medicine, is less the holes that can be poked in it by self-proclaimed sentinels of evidence, and more our prevailing tendency to gravitate to diametric poles.

The best way forward is the road less traveled, which lies, as it often does, in the middle.

-fin

David L. Katz, MD, MPH, FACPM, FACP has a very nice collection of ties, but no Birkenstocks.

Director, Yale University Prevention Research Center; Griffin Hospital

President, American College of Lifestyle Medicine

Editor-in-Chief, Childhood Obesity

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Author: Disease Proof