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HerbalEGram: Volume 8, Number 3, March 2011
NCCAM's New 5-Year Plan: A Real-World Approach to Integration and Health Promotion
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On February 4, 2011, the National Center for Complementary and Alternative Medicine (NCCAM) revealed the updated and final version of its third strategic plan, Exploring the Science of Complementary and Alternative Medicine: Third Strategic Plan 2011–2015.1
In the agency’s 5-year plan, earlier research priorities are revised, and in the matters of herbs and dietary supplements, the plan is centered on research strategies that help determine mechanisms of action. The function of NCCAM’s Strategic Plan is to outline definitive objectives and intentions for upcoming years and demonstrate a structure that will allow the organization to prioritize all future research in complementary and alternative medicine (CAM). A previous draft version of the 5-year plan, which outlined the research goals of NCCAM’s upcoming finalized plan, was released to the public in August of 2010; since then, numerous discussions, interviews, and commentary regarding the new directions of NCCAM have taken place.2-4
A New Focus on Outcomes
NCCAM Director Josephine Briggs, MD, said in a message on NCCAM’s website that the plan’s focus remains centered on the importance of using basic and clinical research as the building block for a CAM evidence base.5 However, the new plan more specifically accentuates translational and outcome-based research focused on effectiveness and “real-world” settings.1,5-7
On NCCAM’s “Director’s Page,” Dr. Briggs shared more insight about the plan after it was unveiled at the meeting of the National Advisory Council for Complementary and Alternative Medicine on February 4, 2011.6
The 3 long-term goals that originated from this process are as follows: to advance the science and practice of symptom management; to develop effective personalized strategies for promoting health and well-being; and to enable better evidence-based decision making regarding the use of complementary health practices and their integration into health care.6
The plan asserts the necessity of collaborative multidisciplinary research, substantial public information, and support for evidence-based decision making by healthcare providers, health policymakers, and the public.6 Dr. Briggs stated on the center’s website that the Strategic Plan “calls for sharper focus on opportunities that show the greatest scientific promise and greatest potential for improving either symptom management or health promotion and disease prevention.”
The clearly-outlined objectives in the plan are as follows:1
3. Strategic Objective 3: Increase Understanding of "Real-World" Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion
5. Strategic Objective 5: Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions
The center’s recalibrated 5-year plan has made a commitment toward developing “promising” science, and probiotics are one area designated as worthy of extensive research in the plan.1 NCCAM will focus on other areas of scientific promise and opportunity as well, such as omega-3 fatty acids.1,9 Duffy MacKay, ND, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), said NCCAM, through collaborating with CRN, has set “very reasonable” goals for the natural products area of the plan (oral communication, January 22, 2011). The plan’s goal to integrate CAM more efficiently into conventional medical practices involves working with funding research on how the basic science of natural products (including botanicals) works, and how to investigate mind-body interposition.1,8
NCCAM stated in the plan that in order to develop an evidence base for clinical trials, there is a need for support “across the continuum of basic, translational, and clinical research.”1 The Strategic Plan’s new clinical research model moves from basic science and translational research to efficacy studies and outcomes and effectiveness research. In the past, NCCAM has spent 10% of its funding on large randomized-controlled trials (RCTs), including large herbal trials; however, the center is not planning on beginning any new such studies.2-4 Instead, NCCAM will focus on funding many smaller, basic science, and characterization-style studies in order to address concerns about large herbal RCTs. “That way,” said Dr. McKay, “if NCCAM chooses to fund an RCT—which is expensive and time-consuming to do—the mechanisms of action and materials or compounds in natural products will be well-understood.” This allows NCCAM to prove the results of the trial are either a solid negative or a solid positive, he said.
According to John Weeks, editor and publisher of The Integrator Blog, the Congressional mandate that established NCCAM in 1988 never aimed to create an agency that concentrated on large herbal RCTs. NCCAM did not originally follow Congress’s priorities and the language of the mandate, which underscores outcomes and basic science research, he said, but now the agency has taken a new direction that is beginning to follow more closely Congress’s mandate.
Dr. Briggs has indicated in the past that NCCAM needs to focus on developing a stronger basic understanding of how compounds work within natural products, including botanicals.3 NCCAM has clearly stated within the plan that it will not be funding RCTs until the translation from basic sciences and research on effectiveness of CAM approaches (including mechanisms of action and translational research) to the best-designed clinical trial occurs.1,3
According to Dr. MacKay, this will not affect NCCAM’s natural products research portfolio in a negative manner.3 “NCCAM wants to make the [natural products] portfolio more robust,” he said, noting that natural products that the industry is significantly knowledgeable about still require further research and examination. Many botanicals are being researched within the Botanical Centers of Excellence that NCCAM will continue to fund, such as echinacea (Echinacea spp.) and ashwagandha (Withania somnifera). Other high-priority CAM natural products (including herbals) on which NCCAM plans to do mechanistic research, such as milk thistle (Silybum marianum), can be found in an extensive online list.9
Dr. Cara Welch, the Natural Products Association’s scientific and regulatory affairs manager, commented on the plan in an article on NutraIngredients.com, indicating her approval of NCCAM’s logical approach of continuing to work closely with industry in outlining and conducting trials.10 NPA was also pleased with NCCAM’s success in dispersing scientific data to the public, the influence of which can be seen in the rising or falling sales of various CAM products.10 “Like NCCAM, industry is ready to take on this responsibility,” she said in the article. “This document is only going to help an industry that is fundamentally working toward the same goal.”
A Real-World Focus on Health Promotion
Weeks recently wrote that the February 4th release of NCCAM’s plan “will be remembered as a big day for integrative practitioners and for research on advancing quality integrative care.”7 With the 5-year plan, NCCAM is moving into outcomes research and health-services research “in an explicit way,” said Weeks (oral communication, February 18, 2011). According to Weeks’s recent blog post, the plan is “the first significant alignment of government-backed research with discovery of whether integrative practices can live up to their health-focused promise.”7
What stuck out most to Weeks within the plan was Strategic Objective 3. He said it is remarkable that this objective is a combination of real-world focus and interest in health-promoting outcomes of multidisciplinary integrative therapies and clinicians. “We need to shift our paradigm to one that focuses on health rather than the treatment of disease,” said Weeks, “and the promotion of health in the Strategic Plan is a great step forward.”
NCCAM was previously uninterested in the methods used by integrative practitioners and the services they provided to the community, said Weeks, and there was minimal investment in “real-world” questions asked by NCCAM—such as what would happen if these practitioners were included in work-force planning, or what would result from a practitioner treating the whole person/patient with the intent of helping them move toward more enduring, total health. Although it has taken the center a long time to sidle up to these important concerns, Weeks said NCCAM has admitted to the mistakes it has made in the past and shown newfound leadership in its attempt to start addressing these questions, mostly within the third Strategic Objective. NCCAM is looking from all angles at the effects of combining various integrative disciplines with the conventional primary care system. “This is a significant accomplishment,” said Weeks.
The Strategic Plan’s real-world focus is the result of the examination of new models of treatment based on combining the actual person-oriented practices that consumers are choosing, Weeks said. “People normally do not seek out chiropractors, for example, as a sole method of treating a symptom or condition... they are integrating numerous holistic practices and multiple clinicians. Looking only at mechanisms of action doesn’t help insurance companies, hospitals, employers, and so on to answer the question, ‘What happens relative to conventional primary care?’” For instance, Weeks noted that NCCAM saw hospitals and other stakeholders in mainstream medicine closely studying consumer use of these various integrative practices, therapies, and clinicians, as well as the health outcomes of these disciplines. “It would be wonderful if they focused significantly on these health outcomes [in their approach]," Weeks said. "Doing so could result in momentous social benefit."
Reshaping Priorities of the Plan
In September of 2009, members of NCCAM’s advisory council took part in an initial Strategic Planning Workshop, and the research goals of NCCAM’s 5-year Strategic Plan were released in the draft plan in August 2010.2 A “measurable reshaping” of NCCAM's priorities has taken place since then, said Weeks.
Weeks said the draft plan hardly referenced the impact of looking at effective disciplines and modalities. After the draft of the plan was announced, NCCAM significantly revamped the language in 35 places in order to stress the word disciplines—which Congress used multiple times throughout NCCAM's mandate—and to underscore real-world perspective. He noted that this shows a newly sharpened focus on the whole practice. "It's quite a change [from the draft plan], and a good sign."
Another change in the model of the plan lies in the natural product objective, which was originally the first objective in the plan, but is now Strategic Objective 2.1 The language of this objective has been revised to read: "Advance research on CAM natural products" instead of “Advance research on CAM pharmacological interventions.”7
Weeks said Dr. Briggs, and NCCAM in general, displayed notable listening skills throughout the development of the plan, really paying attention and responding to the concerns and questions raised by the integrative practice community and the public after the draft plan was released. Dr. MacKay, who shares Weeks’s opinion of NCCAM’s director, said Dr. Briggs has proved to be “very open-minded and wonderful about listening, filtering, and translating the language of the plan in order to maximize this avenue of research.”
“Dr. Briggs is a rigorous scientist by training and heart, and she has been instrumental in the successful development of this plan,” said Dr. MacKay. The NCCAM director has been “strategically smart” in numerous decisions, he said, such as hiring pharmacognosists and naturopaths, and seeking the proficiency of other meticulous scientists and experts within the CAM field, many of whom have now joined NCCAM’s team. The federal agency has sought counsel from the voices of numerous industries, universities, government institutions, and other organizations (such as CRN) in order to cultivate diverse multidisciplinary collaborations, said Dr. MacKay. Weeks agreed that Dr. Briggs initiated extensive discussion with NCCAM’s multiple constituencies.7
Steven Dentali, PhD, chief science officer of the American Herbal Products Association (AHPA), said he has continually seen NCCAM refine and add detail to basic ideas or concepts within areas of the plan in need of improvement (oral communication, February 21, 2011.) Dr. Dentali referred to NCCAM’s approach in the Strategic Plan as “sensible.”
According to Dr. Dentali, the approach NCCAM has taken to effective integration of CAM into conventional medical practices involves revisiting basic principles, as well as funding research on the best methods of studying mind-body interventions and how natural products work. Dr. Dentali said focusing on basic science is the most effective way to attain knowledge that will apprise future clinical trials and other studies. “[The center] is truly focusing on promising areas and driving it back to basic research,” he said. By focusing on natural products and mind-body interposition, “they’re pulling both barrels of the shotgun,” he added.
According to an article published on NutraIngredients.com, the natural products industry is “singing the praises” of the practical and realistic approach of NCCAM’s Strategic Plan, which has supposedly paid close attention to its remonstrations regarding the appropriation of CAM science into the marketplace.10
Like Weeks, Dr. MacKay stressed the importance of the third Strategic Objective, and how the most important key factors of the plan are entwined within its language. “NCCAM is beginning to look at how to study alternate ways to get people healthy,” said Dr. MacKay. In the natural product realm of the plan, Dr. MacKay said NCCAM has recognized the need to study more properly specific individual materials within products; this means an emphasis on characterizing material and understanding mechanisms of action in order to ensure product quality.
American Botanical Council Founder and Executive Director Mark Blumenthal, interviewed in a recent NutraIngredients.com article, said the plan reflects a welcome shifting of NCCAM’s research directions. “Some critics have pointed to the negative outcomes citing them as the basis for their proposed defunding and closure of NCCAM itself,” he said in the article. “Fortunately, cooler heads have prevailed. The new 5-year plan shows that NCCAM has modified its earlier research priorities and, at least insofar as herbs and dietary supplements are concerned, will focus more on research strategies related to determining mechanisms of action.”
Challenges and Criticism
NCCAM has faced numerous challenges throughout the development of the plan, said Dr. MacKay, including a limited budget and other resources, having to work within the confines of NIH (of which NCCAM is a designated center), pervasive criticism (from consumers, academics, scientists, and various other fronts), and the inability to fit CAM therapies and products into the RCTs for which the agency is well known. The benefits of CAM therapies and products stem from the whole practice, said Dr. MacKay, or a combination of factors that help a patient move back to total health, such as diet and lifestyle changes, therapies, and doctor-patient relationship. Therefore, it is difficult to determine which individual factor or variable qualifies to be isolated for study in clinical research. NCCAM indicates within the plan that “better understanding of the contributions of both specific and nonspecific effects influencing outcomes and the potential for insight into exploitation of either or both to improve symptom management or general health and well-being is needed.”1
According to Weeks, frustration has existed among many people throughout NCCAM's former years. NCCAM operates in a political environment, Weeks said, and there are those who would rather see the agency completely shut down than succeed with appropriately incorporating CAM science into mainstream healthcare in the United States.
Dr. MacKay agreed that NCCAM has shown a responsible approach to CAM science regardless of the challenges and criticism NCCAM has continuously faced. “While prioritizing their research directions, they need to consider this—they have to balance out that kind of environment by being scientifically vigorous.” He said this is where the greatest challenge exists—learning the proper ways to study CAM with scientific rigor. “They have been figuring it out as they go. There are variables that science has not learned to account for in its study patterns.”
The 5-year Strategic Plan can be downloaded or viewed online by section here.
—Christina Korpik
References
1. National Center for Complementary and Alternative Medicine. Exploring the Science of Complementary and Alternative Medicine: Third Strategic Plan 2011–2015. Available via PDF at: www.nccam.nih.gov/about/plans/2011/NCCAM_SP_508.pdf or viewed online by section at: www.nccam.nih.gov/about/plans/2011/. Accessed February 14, 2011.
2. Weeks J. Why we should seek to influence NCCAM’s next 5-year Strategic Plan. Integrative Practitioner. Available at: www.integrativepractitioner.com/article_ektid16408.aspx. Accessed February 16, 2011.
3. Weeks J. Roadmaps for our future—interview with NIH NCCAM Director Josephine Briggs, MD. Integrative Practitioner. Available at: www.integrativepractitioner.com/article_ektid13196.aspx. Accessed February 18, 2011
4. Stafford L. NCCAM’s New direction emphasizes real-world research. HerbalGram. 2010;86:17-18. Available at: www.cms.herbalgram.org/herbalgram/issue86/article3517.html.
5. Briggs J. A message from the director. National Center for Complementary and Alternative Medicine website. Available at: www.nccam.nih.gov/about/plans/2011/message.htm. Accessed February 15, 2011.
6. Director’s Page: NCCAM Strategic Plan—Moving Forward. National Center for Complementary and Alternative Medicine website. Available at: www.nccam.nih.gov/about/offices/od/director.htm. Accessed February 16, 2011.
7. Weeks J. Jaded by past NIH NCCAM past priorities? The 2011-2015 Strategic Plan says think again. Integrative Practitioner. Available at: www.theintegratorblog.com/index.php?option=com_content&task=view&id=731&Itemid=189. Accessed February 16, 2011.
8. Starling S. P-Day: Could US research save probiotics in Europe? NutraIngredients website. Available at: www.nutraingredients.com/Industry/P-Day-Could-US-research-save-probiotics-in-Europe. Accessed February 17, 2011.
9. National Center for Complementary and Alternative Medicine. NCCAM High-Priority Topics for Mechanistic Research on CAM Natural Products (R01) RFA-AT-11-001. National Center for Complementary and Alternative Medicine website. Available at: www.nccam.nih.gov/grants/CAMNP/priorities/. Accessed February 21, 2011.
10. Starling S. Industry welcomes NCCAM five-year plan. NutraIngredients website. Available at: www.nutraingredients-usa.com/Industry/Industry-welcomes-NCCAM-five-year-plan. Accessed February 16, 2011.
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