Taylor Walsh: NCCAM's Direction Clarified in Advisory Council Meeting; Council Member Janet Kahn, PhD Responds

Summary: The strategic plan for NIH National Center for Complementary and Alternative Medicine showed steps toward clarification at the February 5, 2010 meeting of the National Advisory Council. This report from Integrator columnist Taylor Walsh share's the agency's directions, plus a list of the 5 new appointees. The range of initiatives is wide, from reductive approaches to products to engaging lifestyle-change initiatives and mind-body interventions. Council member Janet Kahn, PhD reviewed Walsh's article and offers additional perspectives on the direction. Kahn calls to the practitioner community that is interested in "real world research" to utilize NCCAM's existing health services research initiative.

Taylor Walsh

Taylor Walsh has contributed regularly to the Integrator over the last two years from his base inside the Washington, D.C. Beltway.

Notes from the Advisory Council Meeting: NCCAM's Growing Clarity on Strategic Plan

- Taylor Walsh
Getting to Integrative Health and Medicine

The National Advisory Council of NCCAM gathered in the hours just prior to the beginning of "Blizzard Week" in the mid-Atlantic region. (We'll be digging out deep into March). Their agenda included discussing and approving the new structure and focus for NCCAM research going forward and to review the progress of, and public commentary on, NCCAM's new strategic plan.

Several themes that have been percolating within NCCAM were reinforced during the meeting:

• NCCAM is organizing its research to address high profile health issues that have become serious factors in national health policy, notably lifestyle change initiatives and pain management.

 

• Continued emphasis on research that attempts to identify the biological mechanisms involved in CAM therapies.

 

• A more open approach to mind-body therapies appears to have been elevated in a way that gives NCCAM's historical work in the area a distinctive position at a time when the factors that influence behavior-change are high on the national lifestyle agenda.

 

	The strategic plan is due to be completed in August, according to NCCAM director Briggs.

The most significant aspect of the meeting could well be the composition of the council itself, with the addition of five new members.  In the last 12 months, the complexion has changed substantially. Of the 18 members called for in the enabling legislation, 5 are now from the licensed CAM fields: two licensed acupuncturists, a chiropractic doctor, a naturopathic physician and a massage therapist.      

The new face of the advisory council could be particularly important as NCCAM is in the middle of preparing its Five Year Strategic Plan. The plan is due to be completed in August, according to NCCAM director Josephine Briggs, MD.  The participation of these new council members adds a broader and deeper level of experience with the practicalities of integrative practice, even including the evolution of its position in the health reform legislation. 

New council members include:

• Adam Burke, PhD, MPH, LAc, professor in the Dept. of Health Education at San Francisco State and director of its Institute for Holistic Studies; he served as co-chair of the Alternative and Complementary Health Practices section of the American Public Health Association, as well as leadership position in the Academic Consortium for Complementary and Alternative Health Care.

• Susan Folkman, PhD, professor emeritus in the Dept. of Medicine at USCF where she was also the founding director of the Osher Center for Integrative Medicine and co-director of the UCSF Center for AIDS Prevention Studies.  She was a member of the Institute of Medicine panel on CAM use in the US and served as chair of CAHCIM.

• Steven T. deKoskey, MD, vice president at the University of Virginia and dean of the School of Medicine. He was director of the NCCAM-funded national multi-center trial to assess the potential of Ginkgo bilboa to delay onset of dementia.  His basic research centers on structural and neurochemical changes in the human brain in normal aging and dementia.

• Gary Curhan, MD, ScD, associate professor of medicine at Harvard Medical School, and at its School of Public Health.  He is a practicing nephrologist and is internationally recognized for his work in population epidemiology and the epidemiology of kidney disease, with NIH-funded over the last 15 years.

• Janet Kahn, PhD, executive director of the Integrated Healthcare Policy Consortium (IHPC) and assistant professor in the Dept. of Psychiatry at the University of Vermont.  She is also a faculty preceptor in the Fellowship in Complementary and Alternative and General Medicine at Harvard Medical School.  Dr. Kahn has been a massage therapist for 30 years and has recently focused research on its applications for chronic pain.

"The structure [for NCCAM's funding plan] was presented in the shape of a funnel by which selected proposals will be winnowed through Mechanistic and Early-Phase Clinical studies."

The most intriguing appointment is perhaps that of Janet Kahn, who through IHPC has been deeply involved in the health care reform legislative processes, much of which has been reported here in the Integrator.  The complete NACCAM roster is here and the NCCAM release on the appointments is here.

The council members heard presentations from NCCAM staff that described the new process though which research proposals must pass. The structure was presented in the shape of a funnel by which selected proposals will be winnowed through Mechanistic and Early-Phase Clinical studies, a process that is intended to identify the most promising, and most expensive, large-scale studies.

The mechanistic studies will largely focus on natural products (isolated and multi-component plant, animal, microbial, probiotics) and are intended to "develop hypotheses in a range of clinical indications" by focusing on questions such as:

• What is the bio signature of the response?
• The genetic pathway of the receptor cell?
• The function of the organism?

In explaining the emphasis on these studies, director Briggs said, "NCCAM previously focused on complexity, and (as a result) lost the mechanistic information that is valuable.  For instance: if echinacea affects colds, do you have the information" as to how that happens?  

"Traditional Chinese herbal mixtures," she noted, "are used in a broad range that doesn't map well with western medicine.  NCCAM support has not produced much of promise ... There will be better understanding with biomarkers."

Deputy Director Jack Killen said: "Without a biological understanding -- in a controlled trial that shows ‘no effect' (but) without insight into the biology -- you have nothing. It is a pervasive problem in this field."

	"This approach, described as 'filling in the gaps,' is clearly meant to address the strongest strains of criticism from conventional medicine."

This approach, described as "filling in the gaps," is clearly meant to address the strongest strains of criticism from conventional medicine. Last December, NCCAM celebrated its 10 ^th anniversary in part by holding a daylong "Research Symposium: Exploring the Science of Complementary and Alternative Medicine" that focused heavily on the mechanisms of natural products.

Several council members raised cautions about biomarkers as kinds of endpoints. "Medicinal cure is not the issue," said Steven Barnes, of the University of Alabama. "Disease management can always make (patient experience) better. We don't always want to be judged on cures." 

New member Steven DeKovsky (director of NCCAM's recent Gingko bilboa study) agreed: "If the target is cure, we'll have trouble.  In symptom relief, decline would be a goal good enough for the next horizon."

Several council members raised cautions about bio-markers as kinds of endpoints.

New member Susan Folkman questioned to what degree the mechanistic approach might understate the full measure of a treatment's benefit. 

These and other comments during the meeting underscored a kind of embrace by NCCAM of the historic tensions with which it has always had to deal.  Briggs showed a slide with a remark by former council member Ted J. Kaptchuk from a recent issue of Lancet:

"There is a fundamental human tension between exuberant belief and rational skepticism."

While Briggs repeatedly reinforced the importance of defining the biomarkers, she also hinted that NCCAM might move along new research paths that have been defined by the Comparative Effectiveness Research (CER) program that was set out earlier this year by the Institute of Medicine.  That program gives observational studies a new level of credibility, reflecting the belief that decision makers need broader definitions of "real world" evidence.

Discussing NCCAM's efficacy studies, Briggs said, "Double blind random controlled trials for pharma and natural products are absolutely the gold standard.  But that doesn't work in mind body.  You can't have sham meditation."  Noting the increasingly strong mind-body expertise now part of its advisory council, she added tantalizingly that NCCAM "has to lead the NIH in this area."

	"Noting the increasingly strong mind-body expertise now part of its advisory council, she added  tantalizingly that NCCAM 'has to lead the NIH in this area.'"

Elsewhere inside NIH other initiatives are responding to a rapidly changing health marketplace in which lifestyle improvement is quickly rising to a level of equivalence with disease management on the national attention scale, and in which prevention strategies are finding increasing appeal.  NCCAM could play a significant role coordinating research initiatives that will apply mind-body approaches that are led by other NIH entities."

Reflecting this focus and potential, the next Advisory Council Meeting in June will focus primarily on "The Science of Behavior Change."  In April, a workgroup in the strategic planning process will focus on Mind-Body approaches.

The Strategic Plan

Briggs reported that NCCAM received 400 comments and recommendations in response to the three papers it made available for public comment at the end of last year.  She addressed the responses in terms of "concerns" and ‘areas of support," noting a "certain polarization in the comments."

Concerns:

• NCCAM has delivered no cures
• A lack of real evidence
• NCCAM is an advocate for CAM therapies

Support and recommendations:

• Focus on product integrity
• Distinguish between symptom management and cures
• Focus on healthy behaviors
• Basic and translational research
• Real world outcomes

Although Briggs' specific commentary on the plan was somewhat sparse, she said that NCCAM has to "position ourselves as objective and neutral" and focus efforts where the greatest public impact will be felt.

In addition to the mind-body workshop at the end of April, the planning group will hold workshop in March on natural products, and in May on "Deconstructing Back Pain."

Council member Janet Kahn, PhD

Janet Kahn, PhD has just begun her second term on the National Advisory Council for NCCAM. Her first was when NCCAM began operating in 1999. Informing Kahn's research is 30 years of practice as a massage therapist. Kahn also serves, as Walsh notes, as executive director of the Integrated Healthcare Policy Consortium. I asked Kahn to review Walsh's article and comment. She thought that Walsh's report generally captured the content of the NACCAM public meeting then added these comments.

Regarding the "filling the gaps" strategy: "I think this is an important prioritization process.  In its early years, NCCAM spent millions of dollars on large botanical trials that indicated no significant effect of the herbs.  While in research we always acknowledge that negative findings are as important as positive findings, this is only true (in either case) if you trust the findings and a number of those early studies were roundly criticized. For example, the 2002 study on St. John’s Wort for depression found it to be no more effective than placebo. But the trial was for major depression and the public in general was taking St. John’s Wort for minor depressive symptoms. So one could argue that a lot of money was spent that did not answer the more pressing public health question.  This winnowing process that Dr. Briggs and her staff described at the meeting is planned to help NCCAM spend its available budget wisely.  It is not meant to identify the most expensive large-scale trials. It is meant to identify the most promising trials by making sure we know before we start what the presumed mechanism of action is so that the protocol is designed to test that and the control group reflects what we know about who is actually using it as well as who will be most likely to respond to the treatment. Large trials are an enormously expensive form of research and these decisions should be made with enough preliminary data from small studies and mechanism investigations to be sure we will not be full of “if onlies” when the findings come in."

"Most if not all Council members and NCCAM staff agree that [real world research] is an important area to fund."

Regarding "real world" studies:  "NCCAM has had an initiative since 2008 that called for Health Services Research. The initiative is PAR-08-045: Outcomes, Cost-effectiveness and the Decision Process to Use CAM.  It had 3 submission dates, May 2008, 2009, & 2010.  So the May 2010 date is still possible for folks. Historically very few applications have been submitted.  In 2008, 1 was funded. (Lafferty on CAM Medical Service Utilization and Quality of Care). In 2009 again few came in and only a minority of them got scores that would put them within the normal NCCAM pay-line for this year.  Most if not all Council members and NCCAM staff agree this is an important area to fund.  NCCAMs payline is tough because of our small budget."

Importance of health services  "The NCCAM staff and council are in agreement about the importance of this issue and are seeking good proposals to fund.  It will not serve to fund proposals that are not up to snuff b/c that will only add fuel to detractors from all sides while not adding anything helpful and reliable to our wisdom pool."

Challenges of "real world" settings  "It isn't easy or cheap to do studies that occur in a variety of settings with protocols that vary by person.  It is incumbent upon the CAM research community to create/locate/appropriately tailor the research methods required to answer the questions about use in these contexts.  If NCCAM had received 80 proposals and had the same ratio of good ones, more would be funded.  You can't win if you don't play."

About the research methods and her own background  "I find in Dr. Briggs someone with real appreciation of this problem and a greater knowledge of and respect for a range of  research methodology, including observational, longitudinal, and multiple forms of qualitative research.   Personally, after an early career at the American Institutes for Research during which I did largely survey and program evaluation research, I went to Brandeis for my doctorate in sociology focusing on medical sociology and qualitative research methods.  I knew I was tired of the quantitative trap of having my questions framed by what could be answered using the research methods at hand even when it meant ignoring the most compelling questions, but I wasn't sure if there was really any rigor to qualitative methodology.  After more years getting that doctorate than I should have spent there, I can say that there is rigor, but it isn't always applied.  If the plural of anecdote is not data, it is comparably true that the formal term for well-written opinion is not qualitative research - method matters."