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NCCAM's Mandate and Mission

• Provide Comments
• Paper 2: NCCAM Priority Setting — Framework and Other Considerations
• Paper 3: Information and Communication About CAM Research and Decisionmaking About CAM Use

Introduction

Since its creation as an independent Center in 1998, the National Center for Complementary and Alternative Medicine (NCCAM) has twice developed strategic plans (2000-2004; 2005-2009) to help guide the implementation of its legislative mandate. As NCCAM embarks on its third strategic planning process, it is important to 1) assess whether and how recent developments in science, medicine, and health care have affected the Center's strategic approaches to its mission and legislative mandate, and 2) identify opportunities that will maximize the impact of its activities on the public and the public good. This paper provides a brief overview of some of the most important of these developments, and it invites public comment on how they should be viewed in the context of NCCAM's next strategic plan.

Legislative Mandate

The legislative mandate of NCCAM has remained constant since the Center was created in 1998. Specifically, Congress felt that the public health and policy implications of the widespread use of complementary and alternative medicine (CAM) by the American public warranted a focused effort at the National Institutes of Health (NIH). In 1998, NCCAM was established through legislation as an independent Center with an Advisory Council and grantmaking authorities (Public Law 105–277, Title VI, Sec. 601).^[1] The 1998 statute tasked NCCAM with the following specific major responsibilities (among others):

(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. The Center shall be headed by a director, who shall be appointed by the Secretary. The Director of the Center shall report directly to the Director of NIH.

[ . . . ]

(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.

[ . . . ]

(g) DATA SYSTEM; INFORMATION CLEARINGHOUSE.—

(1) DATA SYSTEM.—The Director of the Center shall establish a bibliographic system for the collection, storage, and retrieval of worldwide research relating to complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems. Such a system shall be regularly updated and publicly accessible.

(2) CLEARINGHOUSE.—The Director of the Center shall establish an information clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of alternative medical treatment, diagnostic and prevention practices by health professionals, patients, industry, and the public.

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:^[2] "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."

NCCAM Mission and Vision Statements

Since the development of its first strategic plan^[3] NCCAM has summarized its mission and vision in the following ways:

Mission: "We are dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professional communities."

 

Vision: "NCCAM will advance research to yield insights and tools derived from CAM practices to benefit the health and well-being of the public, while enabling an informed public to reject ineffective or unsafe practices."

Since its inception, NCCAM has focused its efforts on developing the evidence base regarding CAM, building CAM research capacity by enhancing and facilitating collaborative multi-disciplinary research, and providing accurate and timely evidence-based information to the public and to health care providers.

Epidemiology of CAM Use

The most current and comprehensive picture of Americans' use of CAM has been developed under NCCAM leadership through the 2002 and 2007 National Health Interview Surveys (NHIS).^[4] Across both surveys CAM use remained generally constant, with approximately 38 percent of adults reporting use of some form of CAM. The 2007 NHIS^[5] found that Americans spent $33.9 billion out-of-pocket on CAM over the previous 12 months, accounting for approximately 1.5 percent of total health care expenditures ($2.2 trillion) and 11.2 percent of total out-of-pocket expenditures on health care in the United States.

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.

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. Increasingly, the evidence base is permitting systematic reviews that point toward helpful conclusions regarding safety and efficacy or lack thereof, rather than simple statements that more or better quality research is needed. 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.

Perhaps most important, accumulating research evidence points toward a number of specific areas of promising opportunity for future research. These are described in more detail in the related background paper "NCCAM Priority Setting—Framework and Other Considerations." It is also noteworthy that 3 of the top 100 topics identified by IOM as priorities for comparative effectiveness research involve CAM approaches.^[6]

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.

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.

The CAM Research Enterprise and Research Capacity

There are few incentives for private-sector investment in research and development related to NCCAM's legislative mandate and mission. As a consequence, NCCAM's investment in this area is particularly important both in informing the evidence base regarding safety and efficacy and in building the capacity for rigorous CAM research.

Growth in the quality and quantity of the CAM evidence base reflects substantial growth in CAM research capacity, much of which is a direct result of NCCAM-led and -supported activities to attract scientists to the field, establish multidisciplinary research collaborations, and train investigators in CAM research. State-of-the-art research methods and tools are being employed to assess and develop both botanicals/herbals and mind/body/manipulative modalities. 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, as well as various national governments (e.g., China and India) and the World Health Organization.

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 ^[7] and the Bravewell Collaborative^[8] 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. Both share the need for better evidence regarding various CAM modalities and dietary supplements. Both fields also share strong research interests in the role of factors such as the patient-provider relationship and expectancy effects, and in the effectiveness of their approaches and practices in engaging the patient/client in health-promoting behaviors and practices. Finally, both share a need for research approaches (e.g., comparative effectiveness methodology) for examining systems and complex multimodal approaches. Thus, integrative medicine centers located at research-intensive institutions can be important venues for the collaborative multidisciplinary approaches needed to fully investigate and develop promising CAM interventions. Overlap is not total, however. For example, integrative medicine often employs complementary approaches, behavior interventions, or healthy lifestyle practices that are more "mainstream" than CAM. Also, research-intensive integrative medicine centers may not be optimally suited to the study of some promising CAM interventions.

INVITATION: PUBLIC COMMENT

NCCAM invites comment from its stakeholder community and other interested parties on the points raised in this brief summary document. Of particular interest are comments on:

• Major features of the current CAM research landscape that are important in considering future strategic directions for NCCAM and the field of CAM research in general
• Particular needs and opportunities of importance to NCCAM's efforts in research capacity building
• Opportunities, obstacles, and NCCAM's future role in supporting research on approaches to improved states of general health and well-being.

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