Witness appearing before the House Subcommittee on Labor-HHS-Education Appropriations (March 5, 2008)
Josephine P. Briggs, M.D., Director
National Center for Complementary and Alternative Medicine
Richard J. Turman, Deputy Assistant Secretary, Budget
Mr. Chairman and Members of the Committee:
I am pleased to present the President's Fiscal Year (FY) budget request for the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health. The FY 2009 budget includes $121,695,000, which is $118,000 more than the comparable FY 2008 appropriation of $121,577,000.
The public's concept of health is broader than preventing and treating disease. Increasingly, Americans are using strategies that they can employ themselves to improve their health, maintain wellness, and improve quality of life. As part of this participatory approach to health, millions of people are using complementary and alternative medicine (CAM). Many of the leading U.S. medical institutions now offer integrative medicine services. These programs include personalized CAM interventions such as yoga, meditation, massage, and acupuncture. However, we know relatively little about the true potential of CAM to improve health and well being or to preempt disease, or about how best to use most CAM modalities. We also need to understand how CAM practices interact with other therapies and whether they are safe.
Given this consumer-driven call for better approaches to improved health and wellness, the medical research community has begun to explore promising CAM approaches and develop the scientific evidence base for CAM modalities that can be integrated as part of comprehensive health care. Using proven scientific methods and rigorous standards, NCCAM is building the research enterprise and the evidence base to better understand CAM. Through scientific investigation, research training programs, and outreach activities, NCCAM's efforts will support the rational integration of proven CAM approaches with conventional medicine.
Developing the Evidence Base of CAM
The scientific evidence base for integrative medicine will rest on data from both clinical trials and basic research that elucidates biological mechanisms. In 2007, NCCAM supported The Status and Future of Acupuncture Research: 10 Years Post-NIH Consensus Conference, which reviewed the current state of acupuncture research and charted future directions. This workshop showcased research on the effects of acupuncture and its clinical application for a number of health conditions, including pain control for osteoarthritis and back pain. It also highlighted advances in understanding the physiological processes involved in chronic pain and its response to acupuncture. Using state-of-the-art imaging technology, investigators found differences in the responses to acupuncture between healthy individuals and others with chronic pain from carpal tunnel syndrome. These differences point to the role of specific neurobiological pathways in the response to acupuncture, and to more effective approaches for the management of chronic pain. There is increasing acceptance of acupuncture by conventional medicine: the American Pain Society and the American College of Physicians have published new clinical treatment guidelines for persistent back pain that include acupuncture as a treatment option.
Increasingly, the successful paradigm employed by NCCAM in supporting rigorous basic, preclinical, and clinical research on acupuncture is being extended to other CAM modalities. Guided by its strategic plan, Expanding Horizons of Health Care, NCCAM's research agenda balances support for a broad range of investigator-initiated basic, translational, and clinical research with targeted initiatives to fill gaps in the CAM knowledge base. In FY 2009, NCCAM will continue to build the scientific framework for the rigorous evaluation of CAM with new collaborative activities:
- the FY 2008 initiative, CAM Approaches in the Management of HIV Disease and Its Complications (R01), part of the Trans-NIH Plan for HIV-Related Research; and (2) collaborations with the Centers for Disease Control and Prevention on CAM use surveys and the Agency for Healthcare Research and Quality on evidence-based reviews of CAM therapies.
Improving the Conduct of CAM Research
There are special challenges inherent in the conduct of rigorous CAM research. Experience has taught us that basic and non-clinical CAM research, including mechanistic, dose-ranging, pharmacokinetic, and bioavailability studies, are essential building blocks in designing successful clinical trials that can yield clear results concerning the efficacy, optimal application, and safety of CAM interventions. NCCAM has incorporated these principles in its Centers of Excellence for Research on CAM (CERC) program. Three new CERCs will focus on basic and clinical research on compounds derived from plants for the prevention and treatment of chronic diseases. To better understand the composition, purity, and stability of biological products used in CAM research, NCCAM developed policies and review procedures to ensure that botanical and other materials used in clinical trials are research grade. Botanical and herbal medicine researchers regard the Center's policies as a “gold-standard” for ensuring the quality and reproducibility of research results.
Additional clinical research methods are needed to study the safety and efficacy of CAM practices. The Institute of Medicine concurs with this perspective. One particularly promising approach draws upon health services research methodology and resources to study effectiveness of CAM use. Awards under an FY 2008 NCCAM initiative, Outcomes, Cost-Effectiveness, and the Decision Making Process (R01), will support studies on the effectiveness and cost-effectiveness of CAM therapies used in “real world” health care settings. It is important that CAM practices be tested in a manner that respects their integrity as they are practiced in the field. The more complex an intervention, the more difficult it is to design a clinical trial of the therapy's benefits and risks. In the first of a series, NCCAM recently funded a workshop at Georgetown University that explored methods drawn from systems biology and complexity science for their potential in CAM. NCCAM's initiative, Omics and Variable Responses to CAM: Secondary Analysis of CAM Clinical Trials, will support genomics, proteomics, and metabolomics studies on the biological basis for differences in individual responses to CAM. Such innovative scientific tools and technology hold great promise in advancing predictive CAM research.
Training CAM Researchers
Rigorous basic, translational, and clinical CAM research cannot be accomplished without the sustained collaboration between CAM practitioners and experienced scientists. To increase CAM research capacity, NCCAM supports a variety of research training and career development programs as well as supplements for pre-doctoral and post-doctoral students, CAM practitioners, and conventional medical researchers and practitioners. In collaboration with the Bernard Osher Foundation and the Foundation for the National Institutes of Health, NCCAM will fund research career development awards that provide up to 5 years of clinical research career development to individuals holding CAM health professional doctoral degrees, including doctors of naturopathy, chiropractic, and acupuncture and oriental medicine. This is the first NIH training program that is expressly for CAM practitioners.
NCCAM continues as the leading source of authoritative scientific information on CAM, both for the public and health care professionals. Participatory health care depends on an open and respectful dialogue between patients and their health care providers. Numerous studies have documented that a dialogue on CAM use is frequently lacking. To help address this problem, in 2007, NCCAM launched a new educational campaign, Time to Talk. The program provides physicians and other health providers and their patients with a range of educational materials aimed at ensuring that providers know the full extent of CAM being used by patients, and that an environment is created in which this information can be shared and discussed openly. In FY 2009, NCCAM will partner with AARP on a pilot program to disseminate Time to Talk information to the public.
NCCAM is also directing communication efforts toward students in training for careers in medicine, dentistry, nursing, and allied health professions. NCCAM funded 15 education project grants that incorporated basic CAM health education information into established curricula and continuing education programs. These projects were highlighted in the October 2007 issue of Academic Medicine, the journal of the Association of American Medical Colleges.
It is clear that CAM research is an evolving scientific enterprise requiring collaboration across many scientific, medical, and CAM disciplines. More must be done to develop the capacity to conduct basic, translational, and clinical CAM research that incorporates state-of-the-art scientific methods and respects fundamental tenets of CAM practice. Researchers, CAM practitioners, patient advocates, and the public concurred with this assessment at the NCCAM Stakeholder Dialogue, held in June 2007. As the new Director of NCCAM, I am looking forward to building new collaborations among the CAM and medical research communities, CAM practitioners, and other constituencies that will expand the potential of CAM to prevent and treat disease and to improve people's quality of life. Through these and other activities, NCCAM will fulfill its obligation to the American public and health care providers to determine how, when, and under what circumstances CAM works.
Mr. Chairman, thank you for the opportunity to testify. I would be pleased to answer any questions that that the Committee might have.
Department of Health and Human Services
National Institutes of Health
National Center for Complementary and Alternative Medicine
Josephine P. Briggs, M.D.
Dr. Briggs is Director of the National Center for Complementary and Alternative Medicine (NCCAM). She received her A.B. cum laude in biology from Harvard-Radcliffe College and her M.D. from Harvard Medical School. She was a professor of internal medicine and physiology at the University of Michigan from 1993 to 1997. From 1997 to 2006 she was director of the Division of Kidney, Urologic, and Hematologic Diseases in the National Institute of Diabetes and Digestive and Kidney Diseases. From 2006-2007, she was senior scientific officer at the Howard Hughes Medical Institute. She was appointed NCCAM's Director in January 2008.
Dr. Briggs has published more than 125 research articles and is on the editorial boards of numerous journals. She is an elected member of the American Association of Physicians and a fellow of the American Association for the Advancement of Science. She is also a recipient of the Volhard Prize of the German Nephrological Society. Her research interests include the renin-angiotensin system, diabetic nephropathy, and the effect of antioxidants in kidney disease.
Department of Health and Human Services
Office of Budget
Richard J. Turman
Mr. Turman is the Deputy Assistant Secretary for Budget, HHS. He joined federal service as a Presidential Management Intern in 1987 at the Office of Management and Budget, where he worked as a Budget Examiner and later as a Branch Chief. He has worked as a Legislative Assistant in the Senate, as the Director of Federal Relations for an association of research universities, and as the Associate Director for Budget of the National Institutes of Health. He received a Bachelor's Degree from the University of California, Santa Cruz, and a Masters in Public Policy from the University of California, Berkeley.