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Comments on NCCAM Draft Strategic Plan from AAAOM, ACCAHC, NPRI and CRN PDF Print E-mail
Written by John Weeks   

Comments on NCCAM Draft Strategic Plan from AAAOM, ACCAHC, NPRI and CRN

Summary: In November of 2009, diverse integrative practice organizations made recommendations to the NIH NCCAM following a call for public input from the agency on its 2011-2015 Strategic plan. In August 2010, the agency again called for comments when it release of its plan that will shape some $600-million in research investments. Some integrative practice organizations have comments and chosen to share their follow-up recommendations with the Integrator for this special post to the community: American Association for Acupuncture and Oriental Medicine (AAAOM), Academic Consortium for Complementary and Alternative Health Care (ACCAHC), Naturopathic Physicians Research Institute (NPRI) and Council for Responsible Nutrition (CRN). Two themes: 1st, credit to NCCAM for some of the new directions; and 2nd, a push to elevate the focus on real-world and health promoting outcomes. Thanks to these organizations for responding, and sharing.
Send your comments to
for inclusion in a future Integrator.

Related Integrator articles in this series:


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Will the final strategic plan show any re-prioritization?
In late August 2010
the NIH National Center for Complementary and Alternative Medicine posted its DRAFT Strategic Plan for 2011-2015. The plan, once finalized and presented in February 2011, is expected to shape some $600-million of research investments. I posted my response on September 2, 2010 (The Real World and Health Ascend: 1st Thoughts on NCCAM's Draft Strategic Plan 2011-2015).

I subsequently communicated with leaders of organizations in the integrative practice field to suggest they respond and to see if, should they do so, they would like their comments shared. The request followed the Integrator publications
here  and here of responses last fall from 11 organizations in the first public comments period. Here are responses from 4 of these organizations. NCCAM plans to roll-out it plan at the meeting of the National Advisory Council on Complementary and Alternative Medicine in early February 2011.
___________________________

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American Association of Acupuncture and Oriental Medicine
1.  American Association of Acupuncture and Oriental Medicine


The AAAOM is the national organization that seeks to represent the nation's roughly 25,000 licensed practitioners of acupuncture and Oriental Medicine. The acupuncture field's first significant response to NCCAM's plan, in November 2009, came through the Society for Acupuncture Research. This response followed a significant dialogue among AAAOM and SAR leaders.
September 30, 2010

Josephine Briggs, MD
National Center for Complementary and Alternative Medicine
National Institutes of Health
31 Center Drive, Room 31, 2B-11
Bethesda, MD 20892

Dear Dr. Briggs:

The purpose of this letter is to provide you with constructive feedback and input regarding NCCAM's draft strategic plan which was posted August 30, 2010.

At the American Association of Acupuncture and Oriental Medicine (AAAOM), our mission is to promote excellence and integrity in the professional practice of acupuncture and Oriental medicine to enhance public health and well-being. Acupuncture and Oriental Medicine (AOM) is a low-cost, safe, and effective form of holistic medicine that has evolved over millennia into its current form today. In the U.S. alone, over twenty-five thousand highly trained, licensed practitioners treat millions of patients each year with AOM. And there is an increasing-but still insufficient-body of evidence from credible research studies that acupuncture is very effective in managing and treating acute and chronic pain, fatigue, anxiety, arthritis, headaches, cancer treatment side-effects, addiction, and infertility, among other ailments.

   
We have reviewed NCCAM's strategic
plan and are extremely pleased with
many aspects of the draft plan.

Specifically, we strongly agree with
and support further exploration and
study of CAM with respect to overall
health promotion, wellness, and disease
prevention (a broader lens than just
focusing on specific illnesses). 

 
Our key objectives at the AAAOM include advancing the profession of acupuncture and Oriental medicine in the integrative healthcare landscape, actively supporting licensed practitioners in the development and management of successful practices, promoting excellence and integrity in AOM education and student learning, and promoting public awareness of the safety, efficacy, and benefits of acupuncture and Oriental medicine. Ongoing research in the basic, translational, efficacy, and effectiveness of acupuncture, herbal medicine, and other traditional Oriental approaches to health and wellness is absolutely essential to broadening the impact of this proven form of medicine among the American public.

We have reviewed NCCAM's strategic plan and are extremely pleased with many aspects of the draft plan. In general, we find the plan to be very clear, well-structured, fact-supported, and pragmatic in much of its coverage of CAM related topics, challenges, and needs.

Specifically, we strongly agree with and support further exploration and study of CAM with respect to overall health promotion, wellness, and disease prevention (a broader lens than just focusing on specific illnesses). Furthermore, we agree with and support a deep investigation of CAM and its impact in chronic pain prevention and management. A third area of agreement and support is the need for more focused research in how the application of acupuncture contributes to the regulation and relief of pain. And finally, we applaud and support the desire to improve the quality and accessibility of CAM-related information to the American public so that, indeed, consumers can make better and more informed decisions regarding their healthcare options.

With respect to opportunities for the further development and refinement of NCCAM's strategic plan, and its support of your mission and NIH/legislative mandates, we have identified four areas of consideration for your review:

   
  The use of "sham" acupuncture
must be re-examined to ensure its
validity as a method of control.


1. Focused areas of AOM research involving "sham" acupuncture and the complex formulas in herbal medicine. The use of "sham" acupuncture must be re-examined to ensure its validity as a method of control. The physiological effects of the general acupuncture "mechanism" along with the influence of specific needling parameters and techniques remains poorly understood, requiring a fresh look at how acupuncture-related clinical research is designed and carried out. With respect to herbal medicine, research must broaden from focusing on single herbs (with a single active ingredient) to the more complex combinations and formulas of herbal mixtures (with multiple active ingredients) that have been commonly used in AOM practice for thousands of years.

   
   For these reasons, AOM as a whole
discipline requires more attention.

2. The practical effectiveness of AOM as a full medical discipline. Acupuncture and Oriental medicine is increasingly viewed with high levels of credibility in the medical community among alternative and complementary medical practices. The practice of AOM is on the precipice of exponential growth in this country and there is strong need for a more comprehensive look at the full discipline of AOM as an integrated practice and its potential for playing a significant role in improving overall health and wellness. This not only includes the prevention and treatment of illness, but also includes the useful and practical applications of AOM, such as its use in sports medicine, pregnancy, addiction and recovery, and performance enhancement, all areas of significant interest by the American public. For these reasons, AOM as a whole discipline requires more attention.

3. The increased involvement of licensed AOM practitioners in research and advisory capacities. In studying CAM modalities, and specifically, AOM interventions and practices, it is critical to include more licensed practitioners (LAcs) in the design and implementation of NCCAM-sponsored research studies. An increased number of LAcs are participating in research which has led to an increase in research literacy and capability within the AOM community, and we see this trend continuing. The current strategic plan is not as explicit as it could be in characterizing the importance of expert LAc input and involvement in research activities. Related, it is also critical going forward to include more LAcs on the NCCAM Advisory Board to not only comply with relevant statute, but again to ensure the representation of this important body of knowledge in the research work NCCAM conducts.

4. The cost-effectiveness of AOM and other CAM practices. As part of ongoing research studies, and/or as a special research focus, there is a need to compare the relative impact and associated cost-effectiveness of various therapies within AOM as well as in comparison with and across other major CAM modalities.
On a final note, upon reviewing NCCAM's framework for priority-setting, which includes scientific promise, amenability to rigorous scientific inquiry, potential to change health practices, and the extent and nature of practice and use, we wish to emphasize the need for AOM to be more fully represented and served in your strategic plan. Acupuncture and Oriental medicine represents an ancient and internationally accepted form of preventing and treating many forms of illness, and we believe there is substantial opportunity for NCCAM to increase its focus and activity on this important discipline of medicine.

We are happy to discuss our feedback and input with you further either by phone or in person. We view NCCAM as one of the most important organizations in the "movement" to help improve the health and wellness of our society, and we therefore look forward to working closely with your organization over time and strengthening our cooperative relationship.

Thank you for the opportunity to share our perspective.

Best regards,

Jeannie Kang
President, AAAOM

Christian Ellis

Executive Director, AAAOM

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Academic Consortium for Complementary and Alternative Health Care
2. Academic Consortium for Complementary and Alternative Health Care


ACCAHC is a consortium 16 national organizations that have as their mission enhancing patient care through fostering more mutual understanding and respect among the healthcare disciplines. The organization was founded as a project of the Integrated Healthcare Policy Consortium in 2004 and was subsequently incorporated as an independent 501c3 charitable organization in January 2008. I serve as the organization's executive director and as a non-voting member of the board.
September 28, 2010

Josephine Briggs, MD, Director
Members, Strategic Planning Team
National Center for Complementary and Alternative Medicine
National Institutes of Health
31 Center Drive. Building 31, Room 2B-11
Bethesda, Maryland 20892-2182

Dear Dr. Briggs:

We thank you and Dr. Killen and your team at NCCAM for the ongoing opportunity to participate in the development of the NCCAM Strategic Plan. These ACCAHC comments offer proposed amendments to the draft of the plan that was released to the public in August 2010. This letter follows our correspondence of November 2009 and May 2010.

Commendation

First, we are very pleased to share that our internal discussions of the draft plan have uniformly included numerous, unsolicited statements of support for key elements of the proposed plan. Most pleasing are the decisions to prioritize "real world research" and the potential value of complementary and alternative medicine therapies and practices as health-promoting and health-enhancing interventions. The draft plan's focus on continued capacity building is also of great interest to the educational institutions associated with the complementary and alternative medicine disciplines that make up ACCAHC's core membership. In each of these areas, our recommendations are reflected. We are pleased with this alignment.

Recommendations  

Our discussions have also identified areas where changes to this draft will help maximize NCCAM's contributions to the improvement of human health. We offer specific amendments in three thematic areas.

Make current Strategic Objective #3 NCCAM's new Strategic Objective #1

   
 Engaging questions relative to health-
enhancement and whole person care
will position NCCAM for leadership when
this agenda ascends more broadly inside
NIH. For all these reasons, Strategic
Objective #3 merits positioning as #1.

 
Proposed Strategic Objective #3 reads: "Increase understanding of ‘real-world' patterns and outcomes of CAM use and its integration into health care and health promotion." This objective encompasses three distinguishing features of complementary and alternative health care as a research endeavor. The first is that, as you note, the leading CAM modalities and disciplines are already in widespread use by consumers and often covered by payers and included in major delivery systems. Second, current Strategic Objective #3 acknowledges that real-world patient use and practitioner delivery of integrative care is typically not via an isolated therapeutic agent or modality but part of multi-modal, whole person care. Reductive, single agent trials do not capture what is practiced. Third, as this draft plan correctly highlights, much of consumer use and practitioner orientation is related to health-promoting and health enhancing outcomes.  Engaging these is to engage the defining characteristics of integrative practices. Doing so will align NCCAM's directions with the top priorities (outcomes/health services) expressed in Section f of the NCCAM enabling legislation. Finally, engaging questions relative to health-enhancement and whole person care will position NCCAM for leadership when this agenda ascends more broadly inside NIH. For all these reasons, Strategic Objective #3 merits positioning as #1.
 
Explicitly include a focus on researching "disciplines"

The document does not at this time mention the importance of focusing on "disciplines" as a unit of research. The critical importance of directly stating this intent is apparent when one considers the choices of citizens and the inclusion decisions of payers and healthcare delivery systems: each frequently includes complementary and alternative medicine through accessing distinctly licensed or trained disciplines such as acupuncturists, chiropractors or massage therapists. To highlight this direction, we recommend some or all of the amendments below. (Additions are in bold.)

  • Page 1 - The mission of NCCAM is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and disciplines and their roles in improving health and health care.
  • Page 1: NCCAM defines it simply as a group of diverse medical and health care systems, disciplines, practices, and products that are not generally considered to be part of conventional medicine.
  •    
     
     Including more reference to researching
    "disciplines" would mirror the explicit
     language in the NCCAM enabling legislation
    which ... routinely turns NCCAM's attention
    to focusing on researching the potential
    of CAM "disciplines" to our payment
    and delivery system.

    Page 2, 4th conclusion: Finally, the strategic planning process forged a realization that although half of CAM use by Americans is aimed at improving general health, most CAM research to date has focused on the application of CAM practices and disciplines to the treatment of various diseases and conditions.
  • Page 3, under Goal #1: There is growing evidence that some modalities and disciplines are helpful-
  • Page 3, under Goal #2: There are also claims and preliminary evidence of success by members of CAM disciplines and integrative medicine practitioners in motivating people to adopt and sustain health-seeking behavior.
  • Page 6, under Scientific Promise: Potential application of specific CAM approaches and disciplines to comprehensive strategies for management of chronic pain.
  • Page 10, the 4 th Guidepost: Fourth, research on the application of CAM modalities and disciplines to health care and health promotion requires use of effectiveness and other "real-world" research methodologies.
  • Page 12 & 23, under Strategic Objective #3: Strategic Objective 3: Increase understanding of "real-world" patterns and outcomes of CAM use of CAM modalities and disciplines and their and its integration into health care and health promotion.
  • Page 25: One of the defining features of CAM modalities and disciplines is their is its widespread use by the public.
  • Page 25:  Descriptive information examining the frequency of and reasons for use of CAM use modalities and disciplines in disease and symptom treatment and in promoting improved health and well-being ...
  • Page 25: "Real-world" outcomes information ... in order to gain insight into the potential or perceived benefits, risks, and comparative effectiveness of the use of CAM use modalities and disciplines.
  • Page 26, Strategy 3.2: Use a range of research methods-for example, epidemiology, surveys, health services research, effectiveness/cost-effectiveness-to study effectiveness (outcomes) and cost-effectiveness of CAM practices and disciplines in "real-world" settings.
  • Page 27, Strategy 3.3: Conduct research on CAM decision making and the role of CAM modalities and disciplines in behavior change.

Such inclusion, in these and other places in the Strategic Plan, would mirror the explicit language in the NCCAM enabling legislation which, rather than referencing merely "CAM" or the researching of CAM "practices" or CAM "modalities," routinely turns NCCAM's attention to focusing on researching the potential of CAM "disciplines" to our payment and delivery system.

Explicitly focus on building capacity, including infrastructure, in CAM disciplines and institutions

We strongly support the emphasis on building of capacity in Strategic Objective #4. One of the most significant successes of NCCAM in its first decade was the relatively vast expansion of research opportunities for members of the licensed CAM disciplines and researchers associated with the accredited CAM schools. These opportunities and programs, especially the CAM R-25s, have begun to transform the content and culture of many of our institutions and the continuing education in our professional meetings.

   
 Present patterns of research investment
and available funding mechanisms often
foster what our schools experience as a
"brain drain."

 
However, present patterns of research investment and available funding mechanisms often foster what our schools experience as a "brain drain." Researchers from CAM disciplines leave our institutions to find employment in conventional academic health centers. While we appreciate the value of collaborating with and connecting to the resources and expertise available in conventional academic health centers, the present pattern has two negative consequences. Our CAM schools are challenged to develop the "intellectual infrastructure" represented by strong cadres of researchers who are onsite, employed, working together, formulating and answering the types of questions that are of greatest significance to our fields. Meantime, the opportunity to impact the educational culture of our institutions is also limited by this exportation of talent. Both, in their ways, have long-term and pervasive effects on appropriate integration of CAM disciplines with mainstream delivery systems.

Investing in this infrastructure development inside our schools and disciplines is critically important to our ongoing research contributions. (One mechanism might, for instance, be funding partnerships in which CAM institutions that have not received R-25 grants could partner with one or more existing R-25 schools in order to take advantage of, and effectively disseminate, the learning from NCCAM's funded programs.) For these reasons, we recommend the following amendments to address the critical importance of building research capacity inside the CAM schools.

Page 29, the introductory section:
These efforts have been successful in attracting many conventional, and CAM-trained and CAM discipline scientists into the field of CAM research.

NCCAM must continue to ensure that the human talent, resources, and infrastructure in conventional and CAM institutions needed to design and carry out the highest quality research are in place,
Page 29, paragraph 1 under section 4.1:
A successful and robust CAM research enterprise must draw from two sources of well-trained, skilled, and experienced talent: CAM practitioners and conventional biomedical/behavioral scientists. CAM practitioners are key holders of knowledge related to CAM therapies. NCCAM has always recognized the need for research training and career development efforts targeted specifically toward this diverse community. Over the years the Center has developed a number of programs aimed at enhancing CAM practitioners' abilities to critically evaluate biomedical literature, develop greater knowledge of the therapies prescribed to their patients by allopathic physicians in integrative medicine settings, become better able to participate in clinical research, and, in some cases, be inspired to seek advanced training and career development opportunities in biomedical research. NCCAM programs have led to the development of infrastructure in some CAM institutions that is enhancing the culture of evidence and enabling an expanded engagement in research. 

Page 30, concluding section 4.1:
... In particular, the Center will focus on:

Postdoctoral students from conventional and CAM disciplines who are interested in pursuing a career in CAM research.

CAM practitioners who wish to gain the knowledge and experience needed to engage in rigorous collaborative or independent research in their field.

Conventional medical researchers and practitioners who need to increase their base of knowledge and experience regarding specific CAM interventions and practices.

Enabling an expanded engagement in research in CAM institutions.

·         Members of populations who are underrepresented in scientific research and are interested in careers in CAM research.
We believe that these recommendations carry the spirit of the Congressional mandate (Section h) to ensure that CAM research centers "shall include accredited complementary and alternative medicine research and education facilities."

Again, we are very pleased with much of the direction in this draft plan and thank you for the work and inclusive process through which it has been engaged. We believe that these additional amendments will allow our graduates, researchers and institutions to significantly enhance their ability to contribute to the understanding of how CAM modalities and disciplines can impact health and healthcare delivery. The ACCAHC CAM disciplines represent roughly 200 US accredited schools and programs accredited by agencies recognized by the U.S. Department of Education-recognized and more than 350,000 practitioners, some 100,000 of whom are first contact providers.  Thank you again for your time. We look forward to the final plan.

Sincerely,
                                                                                                             
Elizabeth Goldblatt, PhD, MPA/HA             Greg Cramer, PhD, DC
Chair, ACCAHC Board of Directors            Chair, ACCAHC Research
On behalf of the Board and ACCAHC         Working Group, on behalf of the
Organizational Members                           Research Working Group Members^

(^) Due to her employment at NCCAM, RWG member Wendy Weber, ND, MPH, PhD abstained from participation in development of the letter.

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Naturopathic Physicians Research Institute
3.   Naturopathic Physicians Research Institute


NPRI is a new organization, founded in 2010, which includes in its leadership many of the leading researchers in the naturopathic medical profession. The director, Carlo Calabrese, ND, MPH, is a past member of the NIH National Advisory Council on Complementary and Alternative Medicine. The website describes it as "a group of academic and community clinicians, clinical researchers and other health scientists whose aim is to increase the amount of original data and analysis on the practice of naturopathic medicine for the purposes of its documentation and improvement, the discovery of potentially generalizable health applications, and to inform policy." I am involved as a member of NPRI's board.


September 29, 2010

Josephine Briggs, MD, Director
National Center for Complementary and Alternative Medicine
National Institutes of Health
31 Center Drive. Building 31, Room 2B-11
Bethesda, Maryland 20892-2182

Re: NCCAM Draft Strategic Plan

Dear Dr. Briggs:

We would first like to commend you and your team on the comprehensive and inclusive process towards the next NCCAM Strategic Plan.  The Draft Plan itself contains a number of important developments that will move the field of CAM research forward in new and potentially revolutionary ways.  We particularly believe that the foci on 1. "real world" CAM, 2. health promotion and enhancement, and 3. capacity building in the field--expressed in Strategic Objectives 3. and 4.--deserve reinforcement and comment.

The Draft Strategic Plan toward "real world" outcomes implies taking wise scientific advantage of the natural experiment of CAM in practice.   The patterns and best practices of CAM professional clinical activity for any condition is a highly practical arena of study for many reasons. Most CAM professional practice individualizes multiple modalities to maximize effect size and response rate.  The best CAM practice is likely to be delivered by the best-trained practitioners. More opportunities for the study of patterns and outcomes of CAM practitioners are available through their growing inclusion in healthcare delivery systems, their participation in practice-based research networks and the emergence of internet-based informatics.  Good pilot work has been done in the last few years on combined whole practices.  The major CAM professions are amenable to rigorous inquiry through comparative effectiveness and pragmatic trials, observational studies, and cost studies. In particular among the CAM disciplines, we believe naturopathic medicine is one of the richest laboratories for CAM research due to the variety of CAM treatment modalities integrated with the routine use of objective medical measures in addressing the range of medical diagnoses.  Studies of practice-based outcomes would provide for evidence-based decision making by patients, legislators and payers as to the integration of CAM practitioners in healthcare.
   
Another place to offer congratulations
and reinforcement is in the focus
on health promotion.

A health orientation is a necessary
part of whole practice.

 
Another place to offer congratulations and reinforcement is in the focus on health promotion. For all major CAM professions in the US, the approach to clinical practice is founded on working with patients to establish the conditions for health and approaching health enhancement with a common scientific knowledge of diet, exercise, and stress management augmented by their unique perspectives.  A health orientation is a necessary part of whole practice. The background of the Strategic Plan alludes to the intriguing preliminary evidence related to the role of CAM health professionals in motivating health behavior change in their patients. All of the disciplines support health concomitantly to treating disease and benefits in overall health (decrease in total number of symptoms and diagnoses, decreases in risk factors, improvements in productivity, increases in subjective well-being and in QALYS) may be the most significant outcomes associated with CAM systems.  The best outcome measures for preventive and health-promoting practices call for longer term studies than have so far been conducted in CAM, using broad measures, perhaps through comparative registries of the chronically ill or even healthy CAM users.

   
  These reasons suggest the efficiency
 of prioritizing real world research
as a preliminary research method.


We strongly encourage a higher prioritization of Objective 3. which would be salutary in the field of CAM research and function as a useful prelude for the other Plan Objectives.  Both of the important research foci cited above--studying the real world of CAM and its integration in health promotion, both critical values for CAM research--are included in Objective 3. Given the number of CAM pharmacological interventions, the extremely common use of combinations, and the need for the spectrum of translational research including the relatively neglected study of effectiveness, safety and context of natural products to better prepare for pharmacological trials, activities fostered by Objective 3. would greatly inform study of Objective 1.'s pharmacological interventions.  The mind/body and manipulative/manual CAM interventions of Objective 2. are largely practitioner-based. The most fruitful CAM approaches to pain, a target of the Strategic Plan, are acknowledged in the Plan to likely be practitioner-based. These reasons suggest the efficiency of prioritizing real world research as a preliminary research method.
 
Finally, we applaud Objective 4.'s far-sighted intent of building capacity in the field and would urge programs that favor the development of CAM practitioner-scientists in CAM institutions.  As research infrastructure is developed in CAM institutions, it changes the educational culture, immediately takes advantage of real world clinical settings, supports committed CAM investigators who will sustain an attitude of critical thinking in the profession while stimulating young researchers, and provides tools for practice-improvement as well as for the identification of CAM practices suitable for generalization to the national healthcare system.
The Naturopathic Physicians Research Institute is an independent 501c3 organization committed to the study of naturopathic practice for purposes of its documentation and improvement, the discovery of potentially generalizable health applications, and to inform health policy.  It is the home of the Naturopathic Physicians Research Network, an AHRQ-recognized primary care PBRN.  Please see our website http://nprinstitute.org for more information. Thank you for the opportunity for input to NCCAM's Strategic Plan for the next five years.  We look forward to working with you to assist in bringing it into being.

Sincerely,

Michael J. Cronin, ND                                             Carlo Calabrese, ND MPH
Chair, NPRI Board of Directors                               Executive Director, NPRI

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Council for Responsible Nutrition
4.  Council for Responsible Nutrition


The C
ouncil for Responsible Nutrition (CRN), founded in 1973, is the leading trade association representing dietary supplement manufacturers and ingredient suppliers. CRN companies produce a large portion of the dietary supplements marketed in the United States and globally. CRN's member companies manufacture popular national brands as well as the store brands marketed by major supermarkets, drug store and discount chains. These products also include those marketed through natural food stores and mainstream direct selling companies. These comments were submitted via the NCCAM web response form.
September 24, 2010

NCCAM Draft Strategic Plan
CRN Comments

CRN will focus comments on Strategic Objective 1: Advance Research on CAM Pharmacological Interventions.

In the United States CAM natural products or CAM pharmacological interventions are the most commonly used category of CAM. Consumers encounter the majority of CAM natural products as dietary supplements and, therefore, the dietary supplement industry is a key stakeholder in the overall mission of NCCAM. CRN is supportive of NCCAM’s proposal to apply greater focus and research priority setting in specific areas where dietary supplements show promise in addressing important public health needs.

   
 To the extent that resources allow, NCCAM
should explore supporting the identification
and validation of biomarkers and surrogate
end points of disease.

 
In the context of limited resources, it is imperative that NCCAM increases support for basic science and mechanistic studies of dietary supplements to better inform the design of clinical efficacy studies. Large clinical efficacy studies are extremely expensive and should not be initiated without insight to biological effect and the potential to measure biological effect via biomarkers, or surrogate markers relevant to the hypothesis. To the extent that resources allow, NCCAM should explore supporting the identification and validation of biomarkers and surrogate end points of disease. In the absence of validated biomarkers as surrogates for disease, study outcomes must assess the disease endpoints directly, rendering assessment of the effects of CAM therapies on disease risk extremely lengthy and costly. Having the ability to rely on surrogate endpoints dramatically improves the feasibility of human trials, both in terms of duration and total cost.

   
  The CAM research community would also
benefit from the development and validation
 of biomarkers that reflect health and wellness.
 

The CAM research community would also benefit from the development and validation of biomarkers that reflect health and wellness. Consumers report one of their primary reasons for using CAM therapies, including dietary supplements, is to maintain and promote health; yet no validated biomarkers of health or wellness exist to allow for the evaluation of the intended effect on consumers. Validated biomarkers of health and wellness would help address a significant challenge faced by CAM researchers and strengthen the research capacity for the entire CAM research community.

CRN is fully supportive of the continued emphasis on product integrity for dietary supplements used as CAM pharmacological interventions. NCCAM’s Product Integrity Policy is of paramount importance to ensure that studies are reproducible. CRN supports continued efforts to develop and improve methodology for characterizing and analyzing CAM pharmacological interventions. On page 28 of the NCCAM Draft Strategic Plan, NCCAM identifies that there a relatively few incentives for private-sector investment in CAM research. We acknowledge that there are limited opportunities to establish intellectual property protection for most CAM natural products such as vitamins, mineral and botanicals and that this creates a disincentive to invest in large clinical trials. However, the dietary supplement industry invests significant resources and has, subsequently, developed extensive expertise in the area of dietary supplement product integrity. NCCAM has stated that it cannot pursue its mission in isolation and has identified collaboration with other NIH institutions, national and international scientific and professional organizations, national governments, and the World Health Organization as instrumental in reaching its goals. CRN opines that NCCAM will also benefit from collaboration with the dietary supplement industry on issues related to product quality and integrity. The industry possesses vast knowledge related to product procurement and ensuring the identity, purity, quality, strength, and composition of the product. Where appropriate, CRN encourages continued collaboration with the dietary supplement industry to help ensure that high quality product is selected for studies on CAM pharmacological interventions. Further, dietary supplement trade associations, including CRN, are well positioned to be instrumental in facilitating NCCAM’s collaboration with the supplement industry.

   
 CRN encourages NCCAM to support research
in [the area of safety] to help identify clinically
relevant interactions and discourage the current
practice of using assumed pharmacological theory,
 incomplete case studies, and other unreliable
 information as evidence of a supplement-drug
 interaction.

 
The NCCAM draft strategic plan cites that limited information exists regarding the safety profile for CAM natural products, including data about interactions with prescription drugs. The current evidence base that is used to inform consumers and health care practitioners about supplement-drug interactions and drug induced nutrient depletions is alarmingly deficient. CRN encourages NCCAM to support research in this area to help identify clinically relevant interactions and discourage the current practice of using assumed pharmacological theory, incomplete case studies, and other unreliable information as evidence of a supplement-drug interaction. NCCAM may also consider supporting systematic analysis of the current evidence base for potential interactions pertaining to dietary supplements and drugs with high use. Such an effort directly supports NCCAM’s mission as it relates to defining the safety of CAM natural products and their potential to improve health by accurately identifying potential risks and benefits from interactions. The relatively high incidence of use for both dietary supplements and prescription medication (as compared to incidence of use for other CAM therapies) justifies giving the topic of interactions a high priority.

CRN strongly advocates that optimal health is obtained through a combination of healthy habits such as healthy diet, exercise, stress management, and the responsible use of dietary supplements. Data suggest that supplement users also engage in other health seeking behavior, such as regular exercise and visiting with their doctors, and they do so at higher frequency than those not taking supplements2. Clinical studies that attempt to isolate one aspect of healthy behavior overlook the potential combined effect of healthy behaviors. CRN is pleased to see NCCAM’s recognition of the complexity of studying CAM in real-world settings and supports efforts to develop better tools to investigate multi-component interventions’ influence on patient outcomes.

In Health,

D. MacKay, ND
VP, Scientific and Regulatory Affairs
Council for Responsible Nutrition
Comment: The kudos to NCCAM are typically in the same area where these stakeholders also recommend higher prioritization. The focus is on the real-world. The focus is on potentially health-promoting outcomes. In fact, to do the former, adequately, requires engaging the other. In the real world of "CAM" practice, professionals typically treat patients through attempting to restore health. A goal is health-promoting outcomes rather than mere suppression.

Notable also is the recommendation from the 3 of these organizations that are from the licensed "CAM" disciplines that NCCAM invest significantly in building the capacity for research inside these disciplines. It is relatively easy to view this request in terms with which the U.S. culture was more willing to embrace before the infamous Bakke decision that protected the rights of white men.

Given the historic prejudice against these fields and past exclusion from federal interest and support, affirmative action is in order. Put differently: If one has real interest in chiropractic physicians, naturopathic physicians, practitioners of acupuncture and Oriental medicine, and massage therapists being involved in the evidence game, then we need to invest in the research infrastructure, including the evidence-related educational content, of these fields.
Though not necessarily an intuitive conclus-on for MD researchers/administrators who have no direct experience in these fields, it's kind of a no brainer once you think about it.

Send your comments to
for inclusion in a future Integrator.



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Issues #108-#109 Jan-March 2013
Issue #105-#107 Oct-Dec 2012
Issues #102-#104 - July-Sept 2012
Issues #99-#101 - April-June 2012
Issues #96-#98-Jan-March 2012
Issues #94-#95 Nov-Dec 2011
Issues #92-#93 Sept-Oct 2011
Issues #90 and #91 - July-Aug 2011
Issues #88 and #89 - May-June 2011
Issues #86 and #87 - March-April 2011
Issues #84 and #85 - Jan-Feb 2011
Issues #82 and #83 - Nov-Dec 2010
Issues #80 & #81 - Sept Oct 2010
Issues #78 & #79 - July August 2010
Issues #76 & #77 - May June 2010
Issues #74 & #75 - March-April 2010
Issues #73 & #73 - Jan-Feb 2010
Issues #69, #70 & #71 - Nov-Dec 2009
Issues #67 and #68 - Sept-Oct 2009
Issues #65 and #66 - July-August 2009
Issues #63-#64 - May-June 2009
Issues #60-#62 - March-April 2009
Issues #57-#59 - Jan-Feb 2009
Issues #55-#56 - Nov-Dec 2008
Issues #51-#54 - Sept-Oct 2008
Issues #47-#50 - July-August 2008
Issues #46 & -#47 - May-June 2008
Issues #43-#45 Mar-April 2008
Issues #41 & #42 - Feb 2008
Issues #39 & #40 - Dec-Jan '08
Issues #37 & #38 - Nov 2007
Issues #35 & #36 - Oct 2007
Issues #33 & #34 - Sept 2007
Issues #30-#32 - July-Aug 2007
Issues #28 & #29 - June 2007
Issues #26 and #27 - May 2007
Issue #25 - April 2007
Issues # 23 & #24 - March 2007
Issues #21 and #22 - Feb 2007
Issues #19 and & 20 - Jan 2007
Issues #17 and #18 - Dec 2006
Issues #15 and #16 - Nov 2006
Issues #13 and #14 - Oct 2006
Issues #11 and #12- Sept 2006
Issues #9 and #10 - Aug 2006
Issues #7 and #8 - July 2006
Issues #5 and #6 - June 2006
Issues #3 and #4 - May 2006
Issues #1 and #2 - April 2006
All Articles by Subject: 2006
All Articles by Subject: Jan-June 2007
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