The National Center for Complementary and Alternative Medicine (NCCAM) has posted three essays about its latest “strategic planning process,” and has invited “stakeholders” to make comments. I have previously made my own opinions clear,* as have fellow bloggers Gorski, Novella, Lipson, and Sampson: the best strategic plan for the NCCAM would be to extinguish itself. Since politics makes that plan unlikely, there are strategies that could minimize the considerable harm now done by the Center, while possibly offering a modest benefit. In summary:
- For both scientific and ethical reasons the NCCAM must dispense with trials of highly implausible claims. It should start by abandoning the ongoing Trial to Assess Chelation Therapy (TACT), its largest and most expensive trial yet, and one that has proven to place experimental subjects in considerable danger. It should publicly acknowledge such mistakes and explain why they must not be repeated—no matter how much political pressure there may be to do so.
- The Center should use its website’s Health Information function to explain what’s known, rather than continue its customary practice of putting the best possible slant on most “CAM” claims, no matter how absurd or disproven.
- The Center should address aspects of “CAM” advocacy that it has previously avoided, the most important being the close affiliation of such advocacy with the anti-vaccination (and autism quackery) movement. The NCCAM should consider itself an important source of rational information for a public that is currently, and dangerously, misled about immunizations. A related example of mischievous “CAM” advocacy, so far also ignored by the Center’s website, involves an imagined, sinister cartel of physicians, the AMA, pharmaceutical companies, and the FDA. The NCCAM should vigorously debunk such myths by providing facts and data.
- The Center should pursue the question of why some people are stubbornly attracted to implausible, unproven, and/or inert treatments. Wally Sampson suggested this idea years ago. It is one of many legacies of the late Barry Beyerstein, among others, whose writings could serve as a template for legitimate NCCAM research topics.
The NCCAM’s Charter and its boosters in Congress make such strategies exceedingly unlikely, as explained here. Therefore, in this and two subsequent postings I’ll address a few of the assertions made in each of the Center’s three “big picture” essays. These will not be comprehensive critiques of those essays, which would require deconstructions of nearly every sentence.
Essay #1: NCCAM’s Mandate and Mission
The essay quotes from the Center’s “legislative mandate”:
(a) The general purposes of the National Center for Complementary and Alternative Medicine are the conduct and support of basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems.
(c) In carrying out subsection (a), the Director of the Center shall, as appropriate, study the integration of alternative treatment, diagnostic and prevention systems, modalities, and disciplines with the practice of conventional medicine as a complement to such medicine and into health care delivery systems in the United States.
The words “validating” and “integration” imply that the authors of the 1998 legislation, e.g., Senator Tom Harkin, were already certain of the value of “CAM” and expected the Center to promote it even prior to the results of investigations. That is exactly what happened.
The essay attempts to tackle the “definition of CAM”:
Definition of CAM
Many definitions of CAM have been suggested, but a precise or consensus definition has not emerged. Nonetheless, most definitions share the common themes of 1) broad inclusivity of health practices that emerge outside of or beyond the socially dominant paradigm of health care and 2) indistinct boundaries between CAM and the dominant health care paradigm. Definitions of CAM from several interested organizations are representative.
NCCAM Web site: “CAM is a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine. Complementary medicine is used together with conventional medicine, and alternative medicine is used in place of conventional medicine. Some health care providers practice both CAM and conventional medicine.”
2005 Institute of Medicine (IOM) report, Complementary and Alternative Medicine in the United States: “A broad domain of resources that encompasses health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the dominant health system of a particular society or culture in a given historical period. CAM includes such resources perceived by their users as associated with positive health outcomes. Boundaries with CAM and between the CAM domain and the domain of the dominant system are not always sharp or fixed.”
Cochrane Collaboration: “A broad domain of healing resources that encompasses all health systems, modalities, and practices, and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. These practices complement mainstream medicine by 1) contributing to a common whole; 2) satisfying a demand not met by conventional practices; and 3) diversifying the conceptual framework of medicine.”
The repeated use of the term “socially dominant paradigm of health care” and its variations, not only by the NCCAM but by the reputedly trustworthy IOM and Cochrane Collaboration, is dishonest and disturbing. The implication is that modern medicine became “dominant” not because its marriage with science resulted in unprecedented effectiveness (and the promise of much more), but because of arbitrary “privileging.” This kind of post-modern language distortion has been a staple of NCCAM propaganda since its inception, as previously discussed here.
Regarding a concise and accurate definition of “CAM,” here is one that you’ll not find offered by the NCCAM or any other advocacy organization:
A spectrum of implausible beliefs and claims about health and disease. These range from the untestable and absurd to the possible but not very intriguing. In all cases the enthusiasm of advocates vastly exceeds the scientific promise.
The essay next discusses
Epidemiology of CAM Use
NHIS data also have provided important insights into reasons for CAM use, which fall into two approximately equal categories 1) treating a variety of health problems—particularly chronic pain and other difficult symptoms and 2) promoting general health and wellness. Much of this use is “self-care” (i.e., not provided or administered by a health care provider). Notably, use of CAM to completely replace effective and safe treatments for serious conditions appears uncommon.
Notice the begged questions: NHIS data have provided no insights into the issue addressed in the final bullet at the beginning of this posting. It is reasonable to assume that people who are drawn to implausible or ineffective treatments think that they work. Insight would come from investigating why they think so. To the first category—”treating a variety of health problems”—Dr. Beyerstein’s views are pertinent. Regarding the second, “promoting general health and wellness,” we must invoke an additional Madison Avenue component, for which the NCCAM is at least as culpable as any other source.
The Current State of CAM Research
Over the past decade the evidence base regarding efficacy and safety of CAM practices has grown substantially in both quality and quantity. Basic research and clinical trials, both large and small, have yielded results—both “positive” and “negative”—that inform consumers’ use of and health care providers’ recommendations concerning CAM…There is also evidence that this body of research has influenced consumers. For example, both NHIS data and industry sales figures suggest that the results of several large clinical trials have affected both the frequency of use and sales of nonvitamin/nonmineral dietary supplements. In addition, the U.S. Food and Drug Administration has taken actions to address concerns about the safety of some CAM products as a direct result of CAM research…
Well, no: results have really been only “negative” (remember the NCCAM’s customary practice of putting the best possible slant on most ‘CAM’ claims? We’ll see more of this in subsequent posts). What, though, is the “evidence that this body of research has influenced consumers”? If true it would be a good thing, but I don’t buy it. It’s amusing that the essay credits the beleaguered FDA for trying to put out the same fires that the NCCAM fans.
Although approximately half of CAM use by Americans consists of practices aimed at improving general health, most CAM research to date has focused on the application of CAM practices to the treatment of various diseases and conditions. Better health, wellness, and well-being are terms that allude to a concept important to everyone and are the focus of current debates about the future of health care in America. However, research on interventions aimed at improving general health and well-being presents very significant scientific and logistical challenges, including difficulties defining their meanings and their multi-dimensional and dynamic qualities. In considering future strategic directions for NCCAM and the field of CAM research, it is important to consider carefully the opportunities at hand and the resources and research tools needed to pursue those opportunities. It also is important to consider carefully the role that NCCAM should play in promoting and developing a body of research at NIH regarding this complex arena.
Other than the begged questions already mentioned, I’m not sure what to make of that paragraph. On the one hand it appears to be a segue to special pleading about designing trials of ‘CAM’ claims for “improving general health”; on the other it may be a preliminary apology, to certain “stakeholders,” for an eventual decision NOT to “develop a body of research at NIH regarding this complex arena.” Here’s hoping for the second interpretation.
Criticisms of CAM Research and NCCAM
There has been a spectrum of critical opinion regarding the NCCAM-funded research enterprise. It is important to examine these points of view—which are often contradictory—in considering NCCAM’s mission and its future strategic directions.
At one end of the critical spectrum are claims that CAM approaches are inherently implausible and justified only by “pseudoscience,” that peer-review processes are inferior to those of the rest of NIH and that NCCAM funds proposals of dubious merit, that the field suffers from insularity, that the research agenda is driven by political pressures rather than scientific considerations, and that the research could be better carried out under the aegis of other NIH institutes and centers.
At the other end of the spectrum are claims that NCCAM research fails to evaluate CAM as it is actually used in “real-world” CAM practice settings, that there is insufficient support of CAM practitioner involvement in the research process, that the field is dominated by reductionist scientific approaches or inappropriate methodology, that the peer-review process is biased against CAM, that most NCCAM research is designed or conducted with a goal of “debunking” or disproving value, and that there has been insufficient focus on health and wellness.
Well, yes: many ‘CAM’ approaches are inherently implausible and justified only by pseudoscience; NCCAM peer-review processes are inferior to those of the rest of NIH; the NCCAM funds proposals of dubious merit; the field suffers from insularity; the ‘CAM’ research agenda at the NIH is driven by political pressures rather than by scientific considerations; the research could be better carried out under the aegis of other NIH institutes and centers, which usually begin by considering scientific and medical promise rather than ideological correctness, and which are unlikely to hire convicted felons and other scoundrels as investigators.
Such charges do not come from “one end of the critical spectrum.” They come from the center of the science-based critical spectrum. Some of them are simple facts, as the linked essays demonstrate. Both the Gonzalez trial and the Trial to Assess Chelation Therapy resulted largely from pressures applied by Rep. Dan Burton to the National Cancer Institute and the National Heart, Lung and Blood Institute, shortly before the creation of the NCCAM—which subsequently embraced both trials.
Each trial bypassed the usual preliminary investigations necessary to justify a Phase III human trial. In the case of the TACT, which the NCCAM shepherded from the Request for Applications onward, the Center also contradicted language in its own report, “FY 2003 Research Priorities” (a precursor to the current “Stategic Plan”):
Cardiovascular diseases–Preclinical and early phase studies of approaches to manage hypertension, heart failure, stroke, and peripheral vascular disease, including studies of the biology of EDTA chelation therapy in animal models.
That passage was written months before the first (human) TACT subject was infused with disodium EDTA, but there is no evidence that such animal studies were ever done. The TACT peer-review process was further tainted by the presence of a key “stakeholder,” L. Terry Chappell, on the pertinent scientific review committee. Chappell was not competent to review NIH scientific research protocols, as the linked report demonstrates. That his presence was in clear violation of the NIH conflict of interest policy is shown by his having been named as a participant in the TACT, on page 284 of the very application that he would be reviewing, and by language at the bottom of the meeting roster on which his name appears.
The NCCAM’s portrayal of such charges as extreme—”one end of [a] critical spectrum” whose “points of view…are often contradictory” (the other end pleading that it isn’t fair to subject ‘CAM’ to scientific scrutiny at all)—seems to call for ‘balance.’ The truth, it implies, must lie somewhere in between. How convenient, and how utterly dishonest. It suggests a twist on a logical fallacy; perhaps we should call it The Fallacy of the Fallacy of the Excluded Middle.
The CAM Research Enterprise and Research Capacity
…CAM research is now a specific focus of several international organizations, including the Consortium of Academic Health Centers for Integrative Medicine, the International Society for Complementary Medicine Research, and the Society for Integrative Oncology…
In the context of charting NCCAM’s future strategic directions, it is important to consider the relationship and boundaries between the field of CAM research and the emerging field of “integrative medicine.” A 2005 IOM report on CAM concluded that the goal for integrative medicine should be the provision of comprehensive medical care based on the best scientific evidence available regarding benefits and harm; that encourages patients to share in decision making about therapeutic options; and that promotes choices in care that can include CAM therapies, when appropriate. In early 2009, IOM and the Bravewell Collaborative described integrative medicine as “orienting the health care process to engage patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health.”
There is considerable overlap between integrative medicine research and CAM research…
Well yes, I suppose there is. The deadline for submitting comments to the NCCAM is November 19, 2009. I hope that some of you will offer your opinions.
In the next post I’ll discuss the second essay in the NCCAM’s Strategic Planning series: NCCAM Priority Setting — Framework and Other Considerations
* Selected NCCAM screeds by KCA: