Congressional Justification 2012

NATIONAL INSTITUTES OF HEALTH

National Center for Complementary and Alternative Medicine

• National Advisory
  Council for
  Complementary and
  Alternative Medicine

• Office of the Director

  Josephine P. Briggs, M.D.
  Director

  Jack Killen, M.D.
  Deputy Director

  • Office of Clinical and
    Regulatory Affairs

    Catherine Meyers, M.D.
    Director

  • Office of Administrative
    Operations

    Camille Hoover
    Executive Officer

  • Office of Communications
    and Public Liaison

    Chris Thomsen
    Director

  • Office of Policy,
    Planning, and Evaluation

    Karin Lohman, Ph.D.
    Director

  • Division of
    Extramural Research

    Emmeline Edwards, Ph.D.
    Director

    • Manual and Mind-Body
      Medicine Branch

      Emmeline Edwards, Ph.D.
      Acting Chief

    • Natural Products
      Branch

      Emmeline Edwards, Ph.D.
      Acting Chief

  • Division of
    Intramural Research

    Robert B. Nussenblatt, M.D.
    Acting Director

  • Division of
    Extramural Activities

    Martin Goldrosen, Ph.D.
    Director

    • Office of
      Scientific Review

      Dale Birkle Dreer, Ph.D.
      Chief

    • Office of Grants Management

      George Tucker, M.B.A.
      Director

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NATIONAL INSTITUTES OF HEALTH

National Center for Complementary and Alternative Medicine

For carrying out section 301 and title IV of the Public Health Services Act with respect to complementary and alternative medicine $131,002,000.

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Major Changes in the Fiscal Year 2012 Budget Request

Major changes by budget mechanism and/or budget activity detail are briefly described below. Note that there may be overlap between budget mechanism and activity detail and these highlights will not sum to the total change for the FY 2012 budget request for the National Center for Complementary and Alternative Medicine which is $2.2 million more than the FY 2010 Enacted Level, for a total of $131.0 million.

Research Project Grants (+$1.244 million; total $80.501 million): NCCAM will support a total of 197 Research Project Grant (RPG) awards in FY 2012. Noncompeting RPG's will decrease by 10 awards and increase $5.2 million. Competing RPG's will increase by 2 awards and decrease by $3.6 million. The decrease in average cost for competing RPGs between FY 2010 and FY 2012 is the result of two large New Innovator awards that were funded in FY 2010 with no outyear noncompeting continuation costs for FY 2011 and beyond. The NIH Director's New Innovator (DP2) Award program was created in 2007 to support a small number of early stage investigators of exceptional creativity who propose bold and highly innovative new research approaches that have the potential to produce a major impact on broad, important problems in biomedical and behavioral research. The NIH Budget policy for RPGs in FY 2012 is to provide a 1% inflationary increase in noncompeting awards and a 1% increase in average cost for competing RPGs.

Research Centers (-$0.600 million; total $3.200 million): In FY 2010, NCCAM contributed a total of $3.8 million in collaboration with the Office of Dietary Supplements towards Botanical Research Centers. Of the total $3.8 million, $3.0 million funded 5 primary awards and $800 thousand was provided as bridge awards to support the projects pending review of their recompleting applications scheduled for October 2010. NCCAM's commitment to these projects for the duration of the program is $3.0 million per year with an additional $200 thousand for possible administrative supplements. The decrease of $600 thousand represents a 16% decrease in this mechanism from FY 2010 to FY 2012.

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Fiscal Year 2012 Budget Graphs

History of Budget Authority and FTEs

Distribution by Mechanism

FY 2012 Budget Mechanism

Mechanism	Percent of Budget
Research Project Grants	62
Research Centers	2
Other Research	6
Research Training	3
R&D Contracts	9
Intramural Research	6
RM&S	12
Buildings & Facilities	0
Construction	0

Change by Selected Mechanism

FY 2012 Estimate Percent Change From FY 2010 Mechanism

Mechanism	Percent Change
Research Project Grants	1.6
Research Centers	-15.8
Other Research	1.0
Research Training	4.8
R&D Contracts	10.5
Intramural Research	1.0
Res. Mgmt. & Support	0.9
B&F	0.0

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NATIONAL INSTITUTES OF HEALTH
National Center for Complementary and Alternative Medicine
Authorizing Legislation

	PHS Act/Other Citation	U.S. Code Citation	2011 Amount Authorized		FY2010 Estimate	FY2012 Amount Authorized		FY2012 PB
Research and Investigation	Section 301	42§241	Indefinite			Indefinite
					$128,767,000			$131,002,000
National Center for Complementary and Alternative Medicine	Section 401(a)	42§281	Indefinite			Indefinite
Total, Budget Authority					$128,767,000			$131,002,000

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Justification of Budget Request

National Center for Complementary and Alternative Medicine

Authorizing Legislation: Section 301 and title IV of the Public Health Service Act, as amended.

Budget Authority (BA):

Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.

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Director's Overview

The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government's lead agency for scientific research on complementary and alternative medicine (CAM). NCCAM's mission is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their role in improving health and health care. CAM is a group of diverse health-related disciplines, practices, and products that are not generally considered to be part of conventional medicine. Scientific evidence from NCCAM-supported research informs decisionmaking by the public, by health care professionals, and by health policymakers regarding the use of CAM interventions and their integration into strategies for better health care and promoting health.

CAM Use in the United States

CAM is used by many in the United States to treat health problems and promote better health. Data from National Health Interview Surveys¹, developed under NCCAM leadership and conducted by the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC), show that nearly 40 percent of adult Americans and 12 percent of children are using some form of CAM. These data also show that Americans spent $33.9 billion out-of-pocket for CAM in 2007. This amount accounted for approximately 1.5 percent of total health care expenditures, but more than 11 percent of total out-of-pocket health care expenditures. The data also suggest that CAM use is very often for self-care, i.e., not under the advice or supervision of a health professional.

¹ Nahin RL, Barnes PM, Stussman BA, et al. Costs of complementary and alternative medicine (CAM) and frequency of visits to CAM practitioners: United States, 2007 (375KB PDF). CDC National Health Statistics Report #18. 2009.

Identifying Future CAM Research Priorities

Building on more than 10 years of progress, NCCAM is focusing its research efforts on specific areas of scientific promise. For example, research suggests that acupuncture may provide relief for chronic pain such as low-back pain and osteoarthritis of the knee. Established in 1999, NCCAM is shaping its future through its third strategic plan, developed with input from its diverse stakeholder community. The strategic plan nccam.nih.gov/about/plans/2011/ is built around three long-range goals aimed at improving the state and use of scientific evidence regarding the two major reasons for use of CAM in the United States—treating health problems and supporting or promoting better health and well-being. The three goals are to: (1) advance the science and practice of symptom management; (2) develop effective, practical, personalized strategies for promoting health and well-being; and (3) enable better evidence-based decisionmaking regarding CAM use and its integration into health care and health promotion.

(1) Advancing the Science and Practice of Symptom Management

Emerging scientific evidence suggests that some CAM approaches—such as massage, acupuncture, spinal manipulation, and mediation—may be helpful in managing symptoms such as chronic back or neck pain, or pain from arthritis or other musculoskeletal problems. For example, recent research suggests that people with fibromyalgia may benefit from practicing tai chi, which combines meditation, slow movements, deep breathing and relaxation.² Other studies suggest that these interventions may engage innate biological processes involved in pain and emotion. NCCAM plans to support research that aims to elucidate more clearly how such promising CAM interventions could add value to existing health care approaches. This research will include the study of the safety of CAM interventions and identifying the mechanisms by which they exert biological effects.

(2) Developing Effective and Practical Strategies for Promoting Health and Well-Being

Research has shown that sustaining or improving healthy behaviors (such as good eating habits and regular exercise) and reducing or eliminating unhealthy behaviors (such as smoking) can reduce an individual's risk of chronic disease. Many CAM or integrative medicine practitioners encourage use of meditative and other mind/body approaches to help motivate people to adopt and sustain health-seeking behaviors. These approaches may include physical activities like yoga and healthy eating practices that may be grounded in traditional medical systems or incorporate a healthy food philosophy. Emerging evidence suggests that CAM use may be associated with greater degrees of health-seeking behavior. While causal relationships between CAM use and healthy behavior have not been established, the claims and preliminary data deserve investigation given the formidable public health challenges in motivating behavior change. NCCAM plans to sponsor research exploring whether CAM-inclusive approaches are useful in encouraging improved self-care and greater commitment to a healthy lifestyle.

(3) Enabling Evidence-Based Decisionmaking Regarding Use and Integration of CAM

The public, health professionals, and policymakers need reliable, objective, evidence-based information regarding CAM. Providing such information so that they can make informed decisions about CAM use is of paramount importance to NCCAM, and central to the Center's successful fulfillment of its legislative mandate. Importantly, evidence from several sources suggests that CAM research findings do influence CAM use by the public. NCCAM will continue to use state-of-the-art technologies and approaches to improve access to evidence-based information on CAM for the general public and health professionals.

² Wang C, Schmid CH, Rones R, et al. A randomized trial of tai chi for fibromyalgia. New England Journal of Medicine. 2010;363(8):743–754.

Conclusion

A decade of investment in research on a broad array of CAM modalities indicates that some approaches may lead to improved strategies for treating bothersome symptoms or promoting better health. Building on this foundation, NCCAM will continue funding rigorous scientific investigations to advance the body of evidence regarding the safety and efficacy of CAM interventions. Such evidence is also essential to efforts to integrate CAM interventions of proven safety and efficacy into health care and disease prevention strategies. Results from NCCAM-supported research will enable evidence-based decisionmaking by the general public, health care professionals, and health policymakers about CAM use.

Overall IC Budget Policy: Guided by its strategic plan, the advice of the National Advisory Council for Complementary and Alternative Medicine, and input from a diverse community of stakeholders, NCCAM builds the scientific evidence base for complementary and alternative medicine (CAM) by stimulating research and increasing research capacity. In FY 2011, NCCAM will continue to fund multidisciplinary investigator-initiated research, will support new investigators on R01 equivalent awards at success rates equivalent to those of established investigators submitting new R01 equivalent applications, and encourage capacity building across the field of CAM research. Areas of special emphasis include studies examining the effectiveness of CAM approaches to alleviate chronic pain and translational research to improve the quality, reproducibility, and comparability of clinical CAM research. The Division of Intramural Research and Research Management and Support will receive modest increases to maintain staffing levels and ensure responsible oversight of research activities.

Funds are included in R&D contracts to support several trans-NIH initiatives, such as the Therapies for Rare and Neglected Diseases program (TRND), the Basic Behavioral and Social Sciences Opportunity Network (OppNet), and support for a new synchrotron at the Brookhaven National Laboratory.

Program Descriptions and Accomplishments

Extramural Basic Research: Basic research clarifies fundamental biological effects that are central to the development of the evidence base in complementary and alternative medicine (CAM) and underpins the design of clinical research. NCCAM supports investigator-initiated basic research and will increase, through targeted initiatives, its support for translational research on promising CAM interventions. NCCAM funds basic research initiatives such as Mechanistic Research on CAM Natural Products, which will support development of advanced technologies and methodologies to study natural products. Knowledge of the active components as well as the biological effects of natural products is critical for designing clinical studies to determine the efficacy of these products.

Budget Policy: The FY 2012 NCCAM budget estimate for extramural basic research is $47.6 million, an increase of $864 thousand or 1.8 percent above the FY 2010 enacted level. The FY 2012 basic research plan supports an increase of the evidence base on the physiological mechanisms underlying CAM practices, as well as the development and validation of methods and approaches needed to ensure that clinical research has a solid foundation and facilitate the integration of proven CAM approaches into health care. The program portrait listed below describes the Botanical Research Centers program.

Extramural Clinical Research: The NCCAM extramural research program funds multidisciplinary clinical investigations into various CAM modalities at leading U.S. biomedical and CAM research institutions. Clinical CAM research ranges from small pilot studies to large-scale clinical trials and epidemiological studies supported through solicited research initiatives, collaboration between NIH Institutes and Centers and the CDC, and investigator-initiated research. As part of this effort, NCCAM will explore the use of outcomes and effectiveness research in developing practice-based evidence on how CAM approaches could aid in better symptom management and thereby help to reduce the public health burden of chronic diseases and troublesome conditions. The benefits of this research are two-fold: it will help to inform our understanding of CAM use as practiced in the community, and it will provide additional data on the effectiveness of CAM interventions for particular diseases and symptoms.

Budget Policy: The FY 2012 NCCAM budget estimate for extramural clinical research is $48.2 million, an increase of $963 thousand or 2.0 percent above the FY 2010 enacted level. The NCCAM extramural clinical research plan will target the strategic priorities of support for CAM efficacy and effectiveness research, with the ultimate goal to inform the scientific evidence base on CAM for specific indications. The program portrait listed below provides an overview of NCCAM's meditative practices program.

Extramural Research Training and Capacity Building: The basic, translational, and clinical research required to develop the evidence base for CAM is enhanced through the expertise of CAM practitioners working in partnership with conventional researchers. To increase the number, quality, and diversity of investigators who conduct research on CAM, NCCAM supports a variety of training and career development activities for pre-doctoral and post-doctoral students, CAM practitioners, and conventional medical researchers and practitioners. For example, NCCAM supports programs aimed at enhancing CAM practitioners' abilities to evaluate biomedical literature, participate in clinical research, and seek advanced training and career development opportunities. Researchers from many different biomedical and behavioral disciplines have the expertise required for in-depth investigation of the basic biological, physiological, and clinical effects and safety of CAM interventions; therefore, NCCAM supports programs to attract these researchers to CAM research and partnerships with CAM practitioners.

Budget Policy: The NCCAM FY 2012 budget proposal for extramural research training and capacity building is $11.5 million, an increase of $0.182 million or 1.6 percent above the FY 2010 enacted level. To address the ongoing need to build and sustain CAM research capacity, NCCAM will make awards under its ongoing training initiatives that target CAM and conventional investigators at various stages of their careers, including Ruth L. Kirschstein National Research Service Awards, Mentored Patient-Oriented Research Career Development Award (K23), and Midcareer Investigator Award in Patient-Oriented Research (K24). NIH will provide an across-the-board increase in FY 2012 of four percent for stipends levels under the Ruth L. Kirschstein National Research Service Award training program to continue efforts to attain the stipend levels recommended by the National Academy of Sciences. This will build on the two percent increase in stipend levels for FY 2011. Stipend levels have lagged significantly behind inflation, and increases are necessary to sustain the development of a highly qualified biomedical research workforce.

Intramural Research: NCCAM is partnering with other NIH Institutes and Centers to develop innovative investigations that will expand intramural interdisciplinary research collaborations in areas such as neuroscience and neuroimaging. Research supported under this program will focus on ways that different CAM modalities (e.g., acupuncture) modulate pain and other symptoms.

Budget Policy: The FY 2012 NCCAM budget proposal for intramural research is $8.2 million, an increase of $80 thousand or 1.0 percent above the FY 2010 enacted level.

Research Management and Support (RMS): Through its RMS activities, including grants review and management, NCCAM continues to fund meritorious basic, clinical, and translational research and research training efforts. NCCAM is also providing important trans-NIH leadership on the significant public health problem of back pain, for example through workshops aimed at defining a research agenda, or on scientific issues regarding control/comparison groups for trials of non-pharmacologic interventions. Additionally, the Center continues to provide reliable, objective, and evidence-based information to help the public make informed decisions about CAM use and to enable health care providers to better manage their patients' care. For example, the Time To Talk outreach initiative (nccam.nih.gov/timetotalk) encourages patients and their health care providers to discuss CAM use.

Budget Policy: The FY 2012 NCCAM budget proposal for research management and support is $15.5 million, an increase of $146 thousand or 1.0 percent above the FY 2010 enacted level.

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