Blog | Thursday, June 7, 2012

Dollars and sense, baby and bathwater: the case for CAM research

The May 2 issue of JAMA includes an editorial by Dr. Paul Offit of the University of Pennsylvania suggesting that the budget of the National Center for Complementary and Alternative Medicine might be more productively used by other institutes at the NIH. Dr. Offit runs through a litany of negative study outcomes and implausible interventions to make his case that the $130 million annual budget of NCCAM is of suspect utility.

We will return to the $130 million sum in due order. First, I would like to note that I do not have any particular faith in complementary and alternative medicine (CAM). But I don't have faith in conventional medicine either. Faith has its place, but by and large medical practice isn't it.

Medical practice is not supposed to be based on faith. It is supposed to be based on science. There is art to medicine, certainly, but that's not about faith either. It's about the application of judgment to make the best use of the limited science at our disposal.

One might think that arguments against faith-based practice are preferential arguments against CAM, but that's not so. Much of what is done in conventional medicine is simply time-honored but not truly tested. When time-honored practices are put to exacting tests of evidence, they often fail. And sometimes they fail in a manner that is counterintuitive and pushes at the limits of what we even thought plausible.

There are numerous examples. We long thought that drugs called beta-blockers, which reduce the force of the heart's contraction, would be harmful in congestive heart failure. I was taught adamantly throughout the entire expanse of my training years to avoid these drugs in heart failure like the plague.

It turns out, at odds with time-honored practice and tradition, and intuition alike, these drugs reduce mortality in heart failure, and are now used routinely.

Another example extends well beyond the hospital corridors. We have all heard of CPR, and many of us have learned how to do it. But unless we learned it very recently, what we learned was almost certainly wrong.

Traditional CPR included both chest compressions and breaths. This made sense. Both breathing and a pulse are truly vital to survival.

It made sense, but it was wrong. Chest compressions alone are more likely to result in effective resuscitation outside the hospital than compressions and breaths.

In both cases, since we did gather new evidence and have replaced (or are in the process of replacing) what we thought we knew with what now proves to be true, one might argue this shows that conventional medicine is all about evidence. The problem is that for every practice we have updated based on evidence, there are countless others still being driven by tradition and conviction rather than evidence. Most authorities agree that half or more of all prevailing, conventional medical practice is not truly evidence-based by the standards of our time.

Now, on to other matters. The evidence base underlying complementary and alternative medicine differs from that for conventional medicine by degree, not kind. I know, because colleagues and I have, literally, mapped this evidence and found some areas to be well-studied while other languish.

Dr. Offit argues that negative evidence is ignored, and indeed it may be at times by practitioners of conventional and alternative medicine alike. Right heart catheters were routinely inserted by conventional doctors for years after evidence suggested they were, if anything, increasing mortality in many patients.

Negative evidence should not be ignored, but practitioners of all varieties are reluctant to renounce what they have long believed to be true.

Certainly, CAM-related funding can generate important insights about what doesn't work. My lab has studied chromium supplementation for weight management and control of insulin resistance, expecting it to work. It did not, and we have abandoned the practice.

That some results are negative is not an indictment of CAM any more than of conventional medicine. Some perfectly good ideas prove to be wrong. And sometimes, what works is unexpected. Dr. Offit is correct that echinacea does not seem to work for preventing colds. But North American ginseng does work. Studies of CAM have demonstrated both.

They are also in the process of demonstrating that massage therapy confers lasting benefits when used for osteoarthritis, absent the side effects of anti-inflammatory drugs. This is a line of inquiry my own lab, in collaboration with others, is pursuing now with NCCAM funding.

But perhaps the critical problem with Dr. Offit's one-sided argument is reflected in that $130 million, which he presumably serves up as a big number. In context, it is not. It costs a drug company five times that sum, or more, on average to bring any given new drug to market. Just one drug.

The very modest funding of CAM is problematic. It tends to result in small studies that leave us all uncertain about what works. As an example, in 2001 a paper was published in The Lancet demonstrating the benefits of a drug called carvedilol in heart failure. The study was conducted in roughly 2,000 subjects over a span of several years.

At about the same time, in 2000, the Annals of Internal Medicine published a study of coenzyme Q10 for heart failure, which both the authors, and editorialists who opined, concluded showed that the nutrient was ineffective.

But since coenzyme Q10 is a nutrient no one can patent, it lacked the deep pocket of a patent-owning drug company that carvedilol enjoyed. The study in question followed 52 men for three months. The simple fact is this: If carvedilol had been studied this way, it, too, would have looked utterly ineffective.

What if coenzyme Q10 had been studied in thousands over years? We don't know. Based on my clinical experience over 20 years, I believe it would outperform carvedilol. But for now, that's just an opinion.

The distinction between large and well-funded trial, and small, under-funded trials is of crucial importance. Absence of evidence is not evidence of absence. If the modest support of CAM research goes away, more absence of evidence is what we'll get.

I quite agree with Dr. Offit that taxpayer money should be used wisely. I quite agree that research topics should be chosen carefully. I quite agree that negative evidence should be taken seriously. And I quite agree that we should look carefully, if humbly, at issues of plausibility.

But we also have to be careful when comparing conventional medicine and CAM, and avoid rushing to the judgment that distinctions are about science, or even sense. They may be much about dollars. We want evidence-based practice, but we may have profit-based practice because the more profitable intervention is apt to get studied, while the unpatentable, unprofitable languishes. But the unprofitable, unpatentable may work. We'll never know if no one funds the research.

Dr. Offit's indictment of NCCAM, and CAM, is both compelling and convincing, but it is achieved with a bit of legerdemain. He compares conventional medicine's babies to CAM's bathwater.

If we are prepared to acknowledge the widespread bullying to which both science and sense are subject at the hands of the almighty dollar, we might commit ourselves to the systematic effort of distinguishing the two--no matter the bathtub.

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.