This post addresses a couple of themes that are coming up with some regularity in comments posted to this blog. They include: 1) questions about what makes something “specifically complementary and alternative medicine (CAM),” or why other NIH Institutes or Centers (ICs) can’t do what NCCAM does, since the scientific methods and approaches are the same; and 2) a perspective that CAM borrows from other science-based fields “to lend false legitimacy to pre-scientific magical thinking.”
As it is generally defined, the term CAM encompasses an extremely large and eclectic assortment of substances, interventions, practitioners, approaches, theories, and dogmas that share only one common denominator: they once were or still are—by virtue of origin or use in the real world—somehow “out of the box” of modern, scientific biomedicine. While generally useful in describing attributes of health care, such definitions by exclusion pose challenges for NCCAM and the field of research we support. Among them are the plethora of potential research topics, vagaries about when or whether something is in or out of “the box,” and issues highlighted in my previous post on “Plausibility”.
Frankly, we do not spend much time wrestling with questions about whether something is “specifically CAM.” Instead we look at the wide range of things that fall more or less under the CAM umbrella from a much more pragmatic perspective on real-world health practices, and see four things. First, the public is using many of these interventions on a large scale, very often “off the shelf” or otherwise without professional guidance. Second, health care providers of all sorts are integrating some of these interventions into their health care practices on a substantial scale. There are many reasons, some good and others less so, but the fact that this is happening more and more is clear. Third, consumers and providers are, in some instances, perceiving benefits; in other instances, consumers are experiencing harms. Finally, everyone is confronted, routinely, with a paucity of reliable scientific evidence concerning safety and usefulness. NCCAM’s congressional mandate and our strategic approach rest squarely in the highly pragmatic need to bring more, objective, reliable scientific evidence to the most important of these evidence gaps.
The “Plausibility” post addressed how we use the first two of our four criteria for priorities in our decisions about investing public resources most prudently. The third and fourth criteria relate much more specifically to the practical matters of what is actually going on in the real world of peoples’ health practices and health care, and how to shape research so it will be most useful to consumers, providers, and policymakers.
- Scientific Promise:
- How strong is the body of evidence supporting the concept?
- Amenability to Rigorous Scientific Inquiry:
- Are there reliable and reproducible methods—e.g., diagnostics, outcome measures, biological effects, quality control, etc.?
- Potential To Change Health Practices:
- Is it reasonably likely that the results will make a difference to consumers, providers, or policymakers?
- Relationship to Use and Practice:
- Do the methods and approaches actually address the most important questions about use or practice in the real world?
Hence the priorities of our strategic plan, which include study of selected nonpharmacological approaches in managing chronic pain and other symptoms; basic and safety-related research on herbal medicines, dietary supplements, and probiotics; and exploring the potential of some mind and body practices as adjuncts in promoting or sustaining healthy behavior change. These priorities, very well reflected in the research we are actually funding, are all grounded in realistic assessment of potential benefit and risk, and the scope or urgency of public health need for better evidence.
There are two points to make about NCCAM’s ecological niche within NIH at large. First, we consult and collaborate all the time with our colleagues in other ICs. For example, we routinely seek advice on proposed intervention trials to ensure that the study is clinically relevant and employs state-of-the-art methods and measures. Second, NCCAM’s primary scientific identity, now honed by more than a decade of actual experience, lies in understanding how best to address the specific scientific challenges of studying interventions that fall under the CAM umbrella. For example, NCCAM has evolved a set of policies and practices for applying the tools and methods of pharmacology and pharmacognosy to investigation of herbal medicines, dietary supplements, and probiotics (nccam.nih.gov/research/policies/naturalproduct.htm). These set the pace at NIH for research on these products because they specifically address a variety of issues related to the often unusual regulatory status of these products. Similarly, we have learned through extensive experience about the challenges confronting study of procedure-based mind and body practices (nccam.nih.gov/about/plans/2011/objective1.htm), including how to ensure scientific rigor when double-blind experiments are not possible, and the need to understand and specifically explicate the role of placebo or other such context effects and confounders.
It may be unavoidable that some choose to see the existence of Government investment by NIH in this research as lending false legitimacy to interventions before it is due. We see things differently, believing very strongly that the net benefits of more, reliable, objective scientific evidence—whether or not it favors use—far exceed any risks of “false legitimacy.” NCCAM is simply not about legitimizing anything unless that is where the evidence points. As the track record of NCCAM-funded research demonstrates clearly, it sometimes does and often does not.