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DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
National Center for Complementary and Alternative Medicine (NCCAM)
This document provides justification for the Fiscal Year 2010. It outlines our plans and priorities, provides details of our budget, and notes our legislative history.
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 [$125,471,000] $127,241,000
(Department of Health and Human Services Appropriation Act, 2009)
Major Changes in the Fiscal Year 2010 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 2010 budget request for the National Center for Complementary and Alternative Medicine which is +$1.770 million more than the FY 2009 estimate, for a total of $127.241 million.
Research Project Grants (+897 thousand; total $75.882 million). NCCAM will support a total of 194 Research Project Grant (RPG) awards in FY 2009. Noncompeting RPG's will increase by 2 awards and increase $3.673 million, of which $0.993 million will be for conversion of Pathway to Independence awards from Research Careers to noncompeting RPGs. Competing RPG's will increase by 2 awards and increase by $1.067 million. The NIH Budget policy for RPGs in FY 2010 is to provide a 2% inflationary increase in noncompeting awards and a 2% increase in average cost for competing RPGs.
Research Careers (+275 thousand; total $6.684 million). NCCAM will support the Pathway to Independence program, by funding 2 additional awards in FY 2010. Total support for the Pathway program in FY 2010 is 4 awards and $360 thousand.
FY 2010 Estimate Percent Change from FY 2009 Mechanism
Mechanism
Percent Change
Research Project Grants
1.2
Research Centers
0
Other Research
3.4
Research Training
1.0
R&D Contracts
1.1
Intramural Research
1.5
Res. Mgmt. & Support
1.7
B&F
0
FY 2010 Congressional Justification
National Center for Complementary and Alternative Medicine
March 13, 2009
Authorizing Legislation: Section 301 and title IV of the Public Health Service Act, as amended.
FY 2008 Appropriation
FY 2009 Omnibus
FY 2009 Recovery Act
FY 2010 President's Budget
FY 2010 +/- 2009 Omnibus
BA
$122,224,000
$125,471,000
$31,728,000
$127,241,000
+$1,770,000
FTE
67
64
0
65
+1
This document provides justification for the Fiscal Year (FY) 2010 activities of the National Center for Complementary and Alternative Medicine (NCCAM), including HIV/AIDS activities. Details of the FY 2010 HIV/AIDS activities are in the "Office of AIDS Research (OAR)" Section of the Overview. Details on the Common Fund are located in the Overview, Volume One. Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.
In FY 2009, a total of $31,728,000 American Recovery and Reinvestment Act (ARRA) funds were transferred from the Office of the Director. These funds will be used to to support scientific research opportunities that help support the goals of the ARRA. The ARRA allows NIH to execute these funds via any NIH funding mechanism. Funds are available until September 30, 2010. These funds are not included in the FY 2009 Omnibus amounts reflected in this document.
Americans in large numbers use complementary and alternative medicine (CAM) in their pursuit of health and wellness. The mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to develop a rigorous evidence base for CAM and to provide the American public with authoritative information on the benefits and risks of these practices. NCCAM (nccam.nih.gov) achieves its mission through basic and clinical research, research capacity building and training, and education and outreach programs.
The 2007 National Health Interview Survey data showed that nearly 40 percent of adults use CAM. The most common reason for the use of CAM is chronic pain, including back pain, headache, and arthritis pain. The modalities used most frequently for chronic pain include manipulative therapies, meditation, yoga, massage, acupuncture, and various botanical and other dietary supplements. NCCAM-supported research applies state-of-the-art neuroscience to the study of mind-body medicine and acupuncture. Additionally, NCCAM-supported research has provided evidence of significant effects of these practices on the underlying biological mechanisms of pain perception and control. Health care guidelines and systematic reviews on pain management, based in part on NCCAM-supported clinical research, increasingly recommend inclusion of CAM approaches as promising options for the management of pain from osteoarthritis, back pain, and post-operative pain.
Developing reliable and useful evidence on botanical and other dietary supplements presents unique research challenges. These challenges include basic research to elucidate biological effects and rigorous attention to details of product characterization. In FY 2008, NCCAM funded two new institutions as part of its Centers of Excellence for Research on CAM program (nccam.nih.gov/news/2008/102008.htm) that focus on herbal supplement research. NCCAM continues to support the Botanical Research Centers Program, in collaboration with the NIH Office of Dietary Supplements. NCCAM's entire research portfolio for botanical and other dietary supplements has been greatly strengthened by its product integrity review process.
NCCAM remains committed to building CAM research capacity by fostering the development of translational and clinical research skills among CAM practitioners and institutions. In FY 2008, one new award was made under the Developmental Centers for Research on CAM initiative, a program to support collaborations between CAM schools and conventional biomedical research institutions. In addition, NCCAM convened a working group of its Advisory Council in March 2008 to consider new ways to enhance research capacity at CAM institutions. Based on their recommendations, the Advisory Council approved a new partnership initiative, planned for funding in FY 2010.
Basic and translational research remains critically important in the design of optimal clinical studies. NCCAM will continue its efforts to identify and understand the mechanisms underlying key chemical compounds and their protein targets in traditional botanical remedies, ensure the integrity of botanical and dietary supplement research products, and bring modern neuroscience to the study of mind-body and body-based interventions in order to capture fully the potential of these practices. The Center is also investing in better translational tools, metrics, and methodologies to improve conducting, reporting, and comparing clinical investigations of mind-body medicine, acupuncture, and manipulative and body-based therapies. In FY 2010, NCCAM will fund awards designed to address some of these key challenges to build the basic and translational research components of the CAM evidence base under the initiative Program for Translational Tools for CAM Clinical Research.
Another priority of NCCAM is developing an evidence base to better guide the American public on the contribution of CAM approaches to pain management. Chronic back pain, along with its associated morbidity and disability, is a major public health problem (annual U.S. expenditures for back pain are estimated at $50-to-$100 billion annually*), and available treatment approaches are not satisfactory. Though evidence suggests that CAM practices can complement conventional pain management and are widely used by Americans, the evidence base does not yet provide clear guidance for patients or providers about which modalities are best, how they should be used, or which patients are most likely to benefit. To strengthen the evidence for promising CAM interventions for pain management as used in "real world " health care settings, NCCAM will fund awards under its new initiative, Effectiveness Research—CAM Interventions and Chronic Back Pain in FY 2010. This research will provide important insights into the effects of CAM approaches, including mind-body and manipulative and body-based practices, across a range of patient outcomes for chronic pain.
* S. Dagenais, J. Caro, S. Haldeman. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J (2008).
In FY 2010, NCCAM will continue to encourage investigator-initiated research on the use of CAM to treat autism spectrum disorders and will collaborate with other NIH Institutes and Centers on trans-NIH autism research via the Interagency Autism Coordinating Committee. NCCAM will continue to support a broad portfolio of investigator-initiated research on the role of natural products in the prevention of cancer.
Overall 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 2010, NCCAM will continue to fund multidisciplinary investigator-initiated research, support the career development of new investigators, 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.
Extramural Basic Research: Basic research clarifies fundamental biological effects that are central to the development of the evidence base in CAM and underpins the design of clinical research. To address these needs, NCCAM will continue investigator-initiated basic research and will increase, through targeted initiatives, its support for translational research on CAM.
NCCAM added two new basic research centers to its cornerstone Centers of Excellence for Research on Complementary and Alternative Medicine (CERC) program during FY 2008 (nccam.nih.gov/training/centers). The University of Chicago's Center for Herbal Research on Colorectal Cancer is studying the biological effects of two forms of ginseng and their potential in preventing cancer. The CERC at Montana State University is exploring the potential for certain biologically based therapies to alter the inflammatory response to infections in the lung and intestines. Several basic research awards were funded under the FY 2007 initiative, Mechanisms of Immune Modulation, studies the ability of various interventions to affect inflammatory processes that underlie many conditions, for which Americans frequently use CAM, such as chronic pain and allergy.
Budget Policy: The FY 2010 budget estimate for extramural basic research is $41.792 million, an increase of $559 thousand or 1.4 percent over the FY 2009 estimate. The FY 2010 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.
In FY 2010 NCCAM will make awards under a new initiative (to be released in FY 2009) entitled Program for Translational Tools for CAM Clinical Research, which will fund research on metrics, standard protocols, and outcome measures aimed at improving the quality, consistency, and comparability of clinical CAM research. The Center will also fund studies under its initiatives Dietary Supplements Research Centers: Botanicals; Exploratory/Developmental Grant for Complementary and Alternative Medicine Studies using Cells, Tissues, and Animal Models of Disease; and Biology of Manual Therapies.
Extramural Clinical Research: The NCCAM extramural research program funds multidisciplinary clinical investigations at leading U.S. biomedical and CAM research institutions on various CAM modalities. 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 investigator-initiated research.
In FY 2008, NCCAM added two new centers on mind-body research to its CERC program. The University of California, San Francisco center is studying the effects of mindfulness-based stress reduction on obesity and the metabolic syndrome. The University of Wisconsin CERC is examining how different forms of meditation affect the brain's regulation of emotion. NCCAM also funded two new projects on Outcomes and Cost Effectiveness studying use of naturopathic care to treat diabetes and CAM approaches to the treatment of chronic fatigue syndrome. NCCAM continued to work collaboratively with other Institutes to support research on pain management.
Budget Policy: The FY 2010 budget estimate for extramural clinical research is $51.093 million, an increase of $683 thousand or 1.4 percent over the FY 2009 estimate. The NCCAM 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.
In FY 2010, NCCAM will continue to fund a portfolio of investigator-initiated clinical research, including new research projects under its initiatives Effectiveness Research—CAM Interventions and Chronic Back Pain; Exploratory/Developmental Grant for Complementary and Alternative Medicine Studies of Humans; Outcomes, Cost-Effectiveness, and the Decision Making Process to Use Complementary and Alternative Medicine; and Omics and Variable Research Responses to CAM: Secondary Analysis for CAM Clinical Trials.
Portrait of a Program: CAM Component of the National Health Interview Survey (NHIS)
FY 2009: $1.750 million
FY 2010: $1.750 million
Change: $0.000 million
To define research needs, priorities, and future directions for CAM research, it is essential to characterize and understand the patterns and trends in use of CAM by Americans. NCCAM leads a trans-NIH initiative to obtain the most comprehensive and reliable information available about CAM use in the United States through the National Health Interview Survey (NHIS). The NHIS, carried out by the CDC, is a national survey that annually monitors the Nation's health through personal interviews of a representative sample of the civilian, non-institutionalized U.S. population. In 2007, CAM-related questions were posed to about 30,000 randomly selected NHIS participants. Data from the survey, which became available late in FY 2008, provide insights into the types of CAM people use, the reasons for which they turn to CAM, and the patterns of use. The 2007 data included information on CAM use among children.
Important observations from the data include the following:
Almost 40 percent of adults surveyed reported using some form of CAM during the previous 30 days.
Back pain was, by far, the most frequently cited reason for CAM use. Pain and pain-related problems make up half of the top 20 reasons for using CAM.
Among specific CAM modalities, the largest increases in use compared to the 2002 NHIS data were reported for meditation, massage, and yoga.
CAM use in the previous 30 days was more common among Whites, Asians, and Native Americans (ranging from 40-50%) than among African American and Latino groups (approximately 25%).
The largest increases in CAM use were among Americans over 85 years of age.
CAM use remains more common among individuals with chronic or serious illness, those with higher educational levels, and those between the ages of 50-59.
Preliminary data indicate that CAM use by children was less than and different in type than adult use, and that children were more likely to use CAM approaches if their parents did also.
Portrait of a Program: Product Integrity in CAM Clinical Research
FY 2009: $0.250 million
FY 2010: $0.250 million
Change: $0.000 million
Herbal medicines, dietary supplements, and probiotics are the most frequently used and widely available CAM products in the United States. However, evidence from rigorous preclinical and clinical research and development to support their use is often lacking. Research on the safety, efficacy, and mechanisms of action of these products present many challenges. First, natural products are inherently variable and may consist of complex mixtures containing many individual components. For example, the time and location of plant growth or harvesting may affect significantly the composition of herbal medicines, which in turn may influence the ultimate biological effects of the product. Second, natural products can be contaminated by substances that alter metabolism or cause adverse effects. For these and other reasons, careful attention to documentation of the sources, composition, and integrity of these products are essential in ensuring that they are safe and that research with them yields valid—and importantly—reproducible results.
To address these challenges, NCCAM has established a quality control program for herbal medicines, dietary supplements, probiotics, and similar products used in NCCAM-supported research. Prior to funding of research grant awards, NCCAM requires that investigators submit information documenting the source, composition, and process of production of the product to be studied. These building blocks of information, critical to the integrity of the research, are reviewed by a panel of scientific experts, the NCCAM Product Integrity Working Group (PIWG). The PIWG's mission is to ensure that the particular product to be used in NCCAM-funded research meets specific criteria of analysis and quality before a grant is issued. Investigators are also required to present a plan to reserve samples for future verification or analyses, should it be needed.
From its establishment in 2006 through the end of FY 2008, NCCAM's product integrity initiative has evaluated product information for more than 220 research projects. The program is now widely recognized for its rigor, and for the standard of excellence that it sets for the field of natural product research. Most important, the program ensures that the ensuing research will be optimally designed, rigorously conducted, and maximally authoritative.
Extramural Research Training and Capacity Building. The basic, translational, and clinical research required to develop the evidence base for CAM cannot be developed without 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. In FY 2008, NCCAM awarded new training and career development awards, and continued the partnership with The Bernard Osher Foundation to support research career development for CAM health professionals. The program's eligibility was expanded to include individuals from a broader range of professional backgrounds.
Budget Policy: The FY 2010 budget estimate for extramural research training and capacity building is $11.368 million, an increase of $152 thousand or 1.4 percent above the FY 2009 estimate. 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 the Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellowship Training in Complementary and Alternative Medicine, Mentored Patient-Oriented Research Career Development Award, Midcareer Investigator Award in Patient-Oriented Research, and The Bernard Osher Foundation/NCCAM CAM Practitioner Research Career Development Award.
Intramural Research. NCCAM's Division of Intramural Research (DIR) conducts basic, translational, and clinical research on a range of CAM modalities, including dietary supplements and acupuncture, and provides a Complementary and Integrative Medicine Consult Service to provide advice on the appropriate role of CAM interventions for patients who are participating in NIH Clinical Center research protocols (nccam.nih.gov/research/consultservice). In FY 2009, NCCAM will carry out a comprehensive assessment by an independent expert panel of the scientific contributions and future directions for the DIR.
Budget Policy: The FY 2010 budget estimate for intramural research is $7.744 million, an increase of $114 thousand or 1.5 percent above the FY 2009 estimate. The DIR will continue to conduct research investigations on selected CAM therapies and provide services through the Complementary and Integrative Medicine Consult Service.
Research Management and Support (RMS). Through its RMS activities, NCCAM continued to fund meritorious basic, clinical, and translational research and research training efforts, and the Center has also continued its health information dissemination and education/outreach activities, such as the Time To Talk outreach initiative nccam.nih.gov/timetotalk.
Budget Policy: The FY 2010 budget estimate for RMS is $15.244 million, an increase of $262 thousand or 2.0 percent above the FY 2009 enacted level. In FY 2010, NCCAM will continue Time To Talk outreach and establish a portal on the NCCAM website (nccam.nih.gov) to provide health care providers with easy access to CAM information, such as research publications and professional societies' CAM practice guidelines.
To order a photocopied version of the Congressional Justification, contact:
NCCAM Clearinghouse
The NCCAM Clearinghouse provides information on CAM and NCCAM, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
Toll-free in the U.S.: 1-888-644-6226
TTY (for deaf and hard-of-hearing callers): 1-866-464-3615
Web site: nccam.nih.gov
E-mail:
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$125,471,000