Let’s do some real science for a change! The NCCAM Strategic Plan 2011-2015

I’ve made no secret about the fact that I am not a fan of the National Center for Complementary and Alternative Medicine (NCCAM). I consider it a useless, redundant center within the National Institutes of Health because it does nothing that could’t be done as well or better in the institutes and centers of the NIH that existed before woo-friendly Senator Tom Harkin (D-IA) created NCCAM’s precursor and then saw to it that it grew to a full center, with a budget in the $125 million a year range. Personally, if something has to be cut fromt the government in this time of fiscal austerity, I couldn’t think of any better place to start in the NIH than to eliminate NCCAM. True, it’s only about 0.5% of the NIH budget, but that would be 0.5% that could be saved for real science. In these times of pay lines at the 7th percentile range (yes, that’s what I’ve been hearing from my colleagues in the study sections), every little bit helps, particularly if we could get rid of the National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine as well, which has the most inappropriate acronym ever (OCCAM). OCCAM has a budget on par with that of NCCAM; so if we could eliminate them both that would save 1% of the NIH budget without losing any detectable scientific progress.

I bring all this up because last week NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly. Either that, or: We were only kidding before. Now, let’s do some real science. Really. I’m not kidding anymore. And, no, I promise not to pull the football away before you kick it, Charlie Brown.

The Good (more accurately: The Least Bad)

Let’s start by listing the goals of the NCCAM Strategic Plan 2011-2015:

• GOAL 1: Advance the science and practice of symptom management.
• GOAL 2: Develop effective, practical, personalized strategies for promoting health and well-being.
• GOAL 3: Enable better evidence-based decision making regarding CAM use and its integration into health care and health promotion.

To accomplish these goals, NCCAM proposes five Strategic Objectives:

• Strategic Objective 1: Advance Research on Mind and Body Interventions, Practices, and Disciplines
• Strategic Objective 2: Advance Research on CAM Natural Products
• Strategic Objective 3: Increase Understanding of “Real-World” Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion
• Strategic Objective 4: Improve the Capacity of the Field To Carry Out Rigorous Research
• Strategic Objective 5: Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions

As much as I detest NCCAM as a political tool foisted upon the NIH by quackery-friendly legislators, in particular Senator Tom Harkin (D-IA), even I have to admit that there is some good in NCCAM’s strategic plan, specifically Objective 4: Improve the Capacity of the Field To Carry Out Rigorous Research. If you’re a scientist, arguing against improving the capacity to do rigorous science is akin to arguing against mom and apple pie; no serious scientist would do it. Of course, implicit in this NCCAM objective is an admission that the CAM research NCCAM has tended to fund in the past has not been very good, and, worse, it is very telling that NCCAM should even find it necessary to make improving the quality of its funded research a strategic objective. After all, improving the the capacity of a field to carry out rigorous research should be part of the mission of every NIH institute and center, so much so that it should almost go without saying. Unfortunately, how NCCAM proposes to go about improving the scientific rigor of its work isn’t exactly the way it should go about improving the scientific rigor of its work. For example, one key method proposed by NCCAM is to “support a variety of high-quality research training and career development opportunities to increase the number, quality, and diversity of CAM researchers”:

A successful and robust CAM research enterprise must draw from two sources of well-trained, skilled, and experienced talent: CAM practitioners expert in their respective disciplines and biomedical/behavioral scientists expert in cutting-edge scientific methods. CAM practitioners are the key holders of knowledge related to the potential application of CAM interventions and disciplines. NCCAM has always recognized the need for research training and career development efforts targeted specifically toward this diverse community. Over the years the Center has developed a number of programs aimed at enhancing CAM practitioners’ abilities to critically evaluate biomedical literature, participate in clinical research, and, in some cases, seek advanced training and career development opportunities for careers in the field of CAM and integrative medicine research.

All of this sounds very nice, but where the rubber meets the road, what this means is listening to reiki practitioners, acupuncturists, therapeutic touch practitioners, and homeopaths (in other words, believers in unsupported modalities based on magical thinking) when setting priorities, in addition to listening to less unreality-based CAM practitioners, such as herbalists or even chiropractors who stick with musculoskeletal disorders and don’t claim that chiropractic can cure asthma or other unrelated diseases. Using such practitioners to set research priorities and to collaborate with real scientists is what Harriet Hall would call Tooth Fairy science. It’s putting the cart before the horse. Implicit in this strategy is the assumption that there is an actual phenomenon to be studied in modalities like reiki, which, let’s face it, is nothing more than faith healing stripped of its Christian religious background and replaced with Eastern mysticism. If I knew that NCCAM was in actuality trying to determine whether these phenomena exist, rather than “how” they work, perhaps I’d be less critical. Another part of me can’t help but note that trying to suck real scientists into the study of pseudoscience, NCCAM is blatantly trying to cloak various modalities in the mantle of scientific respectability before they deserve to wear it.

Whether I’m being cynical or realistic I leave to the reader to judge. Certainly, given that Objective 3 (Increase Understanding of “Real-World” Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion) seems custom-designed to develop a case for “integrating” CAM into science-based medicine, rather that determining which modalities actually have some utility supported by science and therefore should cease being “alternative” and become just “medicine.”

Less irritating is Strategic Objective 2: Advance Research on CAM Natural Products. Actually, it’s not so much “good” as least objectionable and even somewhat scientifically defensible. Here are the strategies proposed by NCCAM:

Strategy 2.1: Harness state-of-the-art “omics” and other high-throughput technologies and systems biology approaches of the sciences of pharmacology and pharmacognosy to:

• Elucidate biological effects, mechanisms of action, and safety profiles of CAM natural products
• Study interactions of components with each other and with host biology
• Build a solid biological foundation for translational research needed to carry out clinical studies.

Strategy 2.2: Support translational research to build a solid biological foundation for research on CAM natural products to:

• Develop and validate sensitive and reliable translational tools to detect and measure mechanistically relevant signatures of biological effect and to measure efficacy and other outcomes
• Conduct preliminary/early phase studies of safety, toxicity, dosing, adherence, control validation, effect/sample sizes, ADME (absorption, distribution, metabolism, and excretion), and pharmacokinetics
• Build upon established and proven product integrity policies and processes.

Strategy 2.3: Support targeted large-scale clinical evaluation and intervention studies of carefully selected CAM natural products.

Of course, the reason that I label this as being part of “the good” is because, of all the aspects of CAM, natural products represent the area with the most scientific plausibility. On the other hand, it’s hard not to point out that there is nothing here that natural products pharmacologists haven’t been doing for decades. Nothing. What NCCAM is in essence describing is nothing more than pharmacogonosy, the study of natural products pharmacology. It’s the sort of thing that our very own David Kroll does. It’s the sort of thing that thousands of pharmacologists do every day. Heck, it’s even the sort of thing that a lot of pharmaceutical companies do when they try to isolate drugs from natural products. There are many examples of drugs that have come from natural products, including taxol (Pacific Yew tree); vinca alkaloids (periwinkle plant); related drugs like campothecin, irinotecan, and topotecan (Camptotheca acuminata, a.k.a. Happy tree); and, of course, aspirin. The list is extensive, arguably longer than the list of synthetic drugs.

In fact, what NCCAM is doing here, whether Dr. Briggs realizes it or not, is the classic “bait and switch” that I discussed when kvetching about Dr. Oz’s promotion of various Ayruvedic medicines and “detox” diets. In essence, NCCAM has claimed for itself all of natural products pharmacology as being “CAM.” The difference is that there is a layer of belief slathered on it, specifically the CAM belief that somehow the natural plant is superior to purified components or molecules found to have medicinal value. The assumption is that the mixture of unpurified compounds somehow allows the components in the plant or natural product to be “synergistic.” While this sort of synergy is possible, it is actually pretty implausible, with precious few examples known. Worse, it’s very hard to demonstrate true synergy between only two or three components, much less the hundreds — or even thousands — of components in many plants used in CAM. In reality, for all practical purposes and even when a plant does have an active compound (or active compounds) in it that function as a drug, using whole plant extracts, as most CAM practitioners do, substitutes adulterated active ingredients whose purity and potency can vary wildly for well-characterized, predictable, purified active drug.

Actually, I don’t mind this sort of research so much, as long as it’s testing hypotheses that are supported by sound basic science and preclinical data. Certainly, that’s what NCCAM appears to be trying to do, and if NCCAM can’t be dismantled (as I would prefer), its components absorbed into the appropriate institutes and centers of the NIH, then I suppose this is the sort of research that is least likely to cause harm and might actually produce useful results, far more so than much of the rest of the research that NCCAM funds. However, I continue to question why such research should now be considered “CAM” when natural products research has long been a major area of “conventional research.” After all, the study of natural products and herbs with useful pharmacological activity has been an active area of research in pharmacology since time immemorial. There’s no scientific rationale why such studies should be segregated away as “alternative”; they could and should be evaluated just like any other scientific study. Worse, trying to segregate natural product pharmacology at NCCAM devalues pharmacognosy, and by association with the other woo (see below) also being funded under the rubric of “CAM” makes it look like woo too.

In fact, the entire set of goals set forth by Dr. Briggs in the introduction are a “bait and switch.” Notice how two out of the three of these have nothing to do with CAM. Seriously. Why is it that symptom management is CAM? Take the example of oncology. Considerable research and effort go into trying to develop strategies to minimize the effects of therapy. A whole branch of anesthesiology is devoted to the management of chronic pain. If that’s not “symptom management,” I don’t know what is. So what does CAM bring to the science and practice of symptom management? Very little, I would argue, that can’t be studied outside the context of CAM. Unfortunately, what CAM really does bring to symptom management is pseudoscience and prescientific ideas of how the body works. It brings qi. It brings human energy fields. It brings vitalism. Do we really need to “integrate” nonsense with science in symptom management? Perhaps NCCAM can help us understand placebo effects better, for example, but that is research that can and should be the bailiwick of other NIH institutes and centers.

And don’t get me started on Goal 2, which, similarly, is a province of science-based medicine. One might argue that medicine hasn’t done as good a job of developing personalized strategies to promote health and well-being, but the solution to that problem is to emphasize such strategies more in science-based medicine, not to bring in pseudoscience.

The Bad and The Ugly

Let’s take a look at all the strategic objectives. I only discussed Strategic Objective 2 above, but that’s just because I wanted to discuss the least objectionable objective. Actually, in and of itself, Strategic Objective 2 is not objectionable. After all, natural products pharmacology is something I consider fascinating. So here are the five Strategic Objectives in the NCCAM Strategic Plan 2011-2015. Neither would Objective 4 be objectionable if the science were truly rigorous and subject to analyses of Bayesian prior probability before highly improbable modalities like homeopathy or reiki are tested in human beings.

So let’s look at Strategic Objective 5 (Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions). These sound rather benign, don’t they? I mean, who could argue with disseminating “objective, evidence-based information on CAM interventions,” for example? Certainly not me. And I actually do hope that NCCAM does do that, that it really is serious about it. If so, it would tell people that homeopathy is nothing but water, that there is no evidence that reiki practitioners can manipulate a “universal energy field” to heal, and that there’s no scientifically convincing evidence that practitioners of therapeutic touch practitioners can detect or manipulate human energy fields. Let’s look at the key points NCCAM emphasizes about reiki:

• People use Reiki to promote overall health and well-being. Reiki is also used by people who are seeking relief from disease-related symptoms and the side effects of conventional medical treatments.
• Reiki has historically been practiced as a form of self-care. Increasingly, it is also provided by health care professionals in a variety of clinical settings.
• People do not need a special background to learn how to perform Reiki. Currently, training and certification for Reiki practitioners are not formally regulated.
• Scientific research is under way to learn more about how Reiki may work, its possible effects on health, and diseases and conditions for which it may be helpful.
• Tell your health care providers about any complementary and alternative practices you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care.

Pointing out:

Reiki is based on the idea that there is a universal (or source) energy that supports the body’s innate healing abilities. Practitioners seek to access this energy, allowing it to flow to the body and facilitate healing.

Although generally practiced as a form of self-care, Reiki can be received from someone else and may be offered in a variety of health care settings, including medical offices, hospitals, and clinics. It can be practiced on its own or along with other CAM therapies or conventional medical treatments.

I could provide other examples, such as the entry on NCCAM for Ayruvedic medicine. However, perhaps the most instructive example is the entry for homeopathy. A truly science-based assessment of homeopathy would point out that the principles of homeopathy violate multiple well-established laws of physics and chemistry and that, for homeopathy to work, these well-established laws would have to be found not to be just wrong, but spectacularly wrong. It would also point out that, for that to happen, the amount of evidence in support of homeopathy would have to start to approach the level of evidence that tells us that homeopathy can’t work. While NCCAM does concede that homeopathy is “controversial” and that its tenets violate known laws of physics, it does so in a weaselly, wishy-washy way:

Homeopathy is a controversial area of CAM because a number of its key concepts are not consistent with established laws of science (particularly chemistry and physics). Critics think it is implausible that a remedy containing a miniscule amount of an active ingredient (sometimes not a single molecule of the original compound) can have any biological effect–beneficial or otherwise. For these reasons, critics argue that continuing the scientific study of homeopathy is not worthwhile. Others point to observational and anecdotal evidence that homeopathy does work and argue that it should not be rejected just because science has not been able to explain it.

Three of its “key points” about homeopathy are:

• The principle of similars (or “like cures like”) is a central homeopathic principle. The principle states that a disease can be cured by a substance that produces similar symptoms in healthy people.
• Most analyses have concluded that there is little evidence to support homeopathy as an effective treatment for any specific condition; although, some studies have reported positive findings.
• There are challenges in studying homeopathy and controversies regarding the field. This is largely because a number of its key concepts are not consistent with the current understanding of science, particularly chemistry and physics.

Yes, NCCAM presents a classic “tell both sides” false equivalence argument. On the one hand, established laws of science tell us homeopathy can’t work. On the other hand, anecdotal evidence tells us it does work and therefore we should study it. Never mind that the two principles upon which homeopathy is based (“like cures like” and the law of infinitesimals) have no real basis in science, particularly the law of infinitesimals, which states that diluting and succussing a remedy to the point where not a single molecule is likely to remain somehow makes it stronger.

This brings us to the meanest, ugliest, nastiest one, the meanest Strategic Objective of them all, Strategic Objective 1 (Advance Research on Mind and Body Interventions, Practices, and Disciplines). Personally, I find it telling that this is Objective 1 on the list, and NCCAM even lists examples of CAM mind-body interventions:

• Acupuncture
• Breath practices
• Meditation
• Guided imagery
• Progressive relaxation
• Tai chi
• Yoga
• Spinal manipulation
• Massage therapy
• Feldenkreis method
• Alexander technique
• Pilates
• Hypnosis
• Trager psychophysical integration
• Reiki
• Healing touch
• Qi gong
• Craniosacral therapy
• Reflexology

Here’s the “bait and switch” again. If NCCAM had restricted itself to modalities that, right or wrong, fall under “mind-body” interventions, such as meditation, guided imagery, breathing practices, hypnosis, and the like, I would have had little problem with proposing to study them as a major strategic initiative of NCCAM. Unfortunately, that’s not what NCCAM did. Notice how NCCAM also throws in there all manner of pure quackery, such as reiki, healing touch, craniosacral therapy, and even reflexology. Seriously, reflexology! You know, the idea that every organ and part of the body “maps” to parts of the foot or hand, an idea that is not supported — and, in fact, is contradicted — by what we know about human anatomy and physiology. Placing these forms of quackery next to forms of interventions such as guided imagery that could well turn out to be science-based and useful implies, either wittingly or unwittingly, that “mind-body” interventions already known to be quackery are somehow worthy of study. Also note how NCCAM includes modalities like Tai Chi, yoga, and Pilates in the mix as well. These are, in essence, forms of relatively gentle exercise, at least for most people. (Yes, I realize that some yoga workouts can become quite intense.) What makes them more “mind-body” than other forms of low impact exercise? Finally, I’m really puzzled about the inclusion of massage therapy on this list. No doubt about it, massages feel good, and they are probably even useful for some musculoskeletal disorders, but what makes massage therapy a “mind-body” interaction? It’s a body-body interaction!

In fact, this very list looks to me like a blurring of the line between things that might be true mind-body interventions (meditation, progressive relaxation, guided imagery, etc.) and so-called “energy medicine” (reiki, healing touch or therapeutic touch, acupuncture, and qi gong). In fact, this is intentional, as there is a notice after the list that states, “As used in this plan, mind and body encompasses interventions from the three domains of mind/body medicine, manipulative and body-based practices, and energy medicine.” The problem here is that certain forms of what is called “mind-body” medicine might actually have value, whereas “energy healing” is pure religion or pseudoscience. Yet they are lumped together.

Truly, Strategic Objective 1 is The Bad and The Ugly.

It’s also evidence that neither Dr. Briggs nor the NCCAM leadership understand the problem that is at the heart of CAM. For example, look at this statement from Dr. Briggs in her introduction:

My experience as a physician who has cared for patients struggling with chronic, painful, and debilitating symptoms greatly informs my perspective on our work. When I began medical school, one of my teachers taught that “the secret of care of the patient is in caring for the patient.”* I took these words to heart. Symptoms matter, and few would dispute the fact that modern medicine does not always succeed in alleviating them. Few would also dispute the need for better approaches for encouraging healthy lifestyle choices. These are places in which I believe CAM-inclusive approaches offer promise, and I look forward to exploring the possibilities in the years ahead.

No one, of course, is arguing that symptoms don’t matter, although I note with some amusement that some CAMsters might not be too happy with Dr. Briggs’ emphasis on symptoms given how they like to claim that “Western medicine” treats only the symptoms and CAM treats the “root cause” of disease. Or maybe they don’t care as long as they can claim the seeming mantle of scientific respectability that the very existence of NCCAM offers. Be that as it may, upon reading this, I can’t help but ask: How can “CAM-inclusive” practices offer promise above and beyond science-based medicine in encouraging healthy lifestyle choices, particularly when so much of CAM bases its recommendations on a prescientific understanding of how the body works? You have to know what the body needs before you can encourage healthy choices, and to a large degree we already do know what most American bodies need: More exercise, more fruits and vegetables in their diets, and less fat and calories. To add to that knowledge, we don’t need CAM. We need science-based medicine. More importantly, I would wonder on what evidence, specifically, Dr. Briggs bases her assessment.

Inquiring minds want to know!