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Fiscal Year 2008 Budget for the National Institutes of Health:
A New Vision for Medical Research
Witness appearing before the Senate Subcommittee on Labor-HHS-Education Appropriations (June 22, 2007)
Ruth L. Kirschstein, M.D., Acting Director National Center for Complementary and Alternative Medicine
Mr. Chairman and Members of the Committee:
I am pleased to be here to present the President's Fiscal Year (FY) 2008 budget request of $121,699,000 for the National Center for Complementary and Alternative Medicine (NCCAM).
In the 7 years since it was established, NCCAM has built a global enterprise of scientific excellence and leadership in research on complementary and alternative medicine (CAM). NCCAM-supported studies, carried out at more than 260 institutions, encompass the wide range of CAM practices and have resulted in more than 1,500 scientific papers published in peer-reviewed journals. The progress that has been made by the research community in understanding the scientific basis of CAM is, in large part, attributable to the leadership of Stephen E. Straus, M.D., NCCAM's director from 1999 to 2006. Under his leadership, CAM research has been established as a legitimate field of scientific inquiry that is laying the scientific foundation for the emerging discipline of integrative medicine.
This effort continues. In the past year, NCCAM has launched studies to: 1) develop innovative tools and technology for studying biologically based and mind-body interventions; 2) assess the potential of community-based primary care research networks to increase scientific knowledge about the safety, efficacy, and cost effectiveness of CAM; and 3) increase scientific understanding of the mechanisms underlying manipulative and body-based practices.
NCCAM'S Role and the Changing Nature of Medicine
Large numbers of American health care consumers are using CAM modalities in an effort to preempt disease and disability or promote health and a sense of well-being. Despite the relative paucity of information about the effectiveness and safety of these uses, Americans are de facto personalizing medicine through approaches that often require their active ongoing participation in a diverse variety of health practices and behavior change approaches.
Driven largely by consumer demand for CAM, integrative medicine—which can be defined as a health care approach that makes use of all appropriate evidence-based disciplines, therapies, and health care professionals to achieve optimal health and healing—is rapidly becoming a major force shaping health care systems in the United States and around the world. At the same time, studies continue to show that open communication between conventional medical practitioners and their patients about CAM use is uncommon. Such communication is vital to ensure well-coordinated, comprehensive, and safe care.
The ultimate goal of NCCAM is to inform, through science, the discipline of integrative medicine. Thus, NCCAM's mission is to support rigorous research intended to fill the CAM knowledge gap; train CAM researchers; and disseminate authoritative information regarding CAM to the public (only one in three of whom consult their physicians about their CAM use), and to physicians and other health care professionals who rarely ask patients about CAM use.
Building the Evidence Base of Integrative Medicine
Because CAM interventions are widely used by the public, NCCAM supports a diverse portfolio of basic, translational, and clinical studies. The benefits of this strategy are well illustrated by the example of acupuncture. Clinical trials supported by NCCAM have documented the efficacy and safety of this widely used CAM practice in many but not all conditions studied. More recently, basic and translational research employing state-of-the-art neuroimaging technology has led to important insights into the mechanisms of action for acupuncture's effects, and has elucidated mechanisms of brain function that will have direct relevance to other approaches to pain relief.
Advances of similar importance are emerging in other areas of CAM research. As is the case with acupuncture, clinical and preclinical information fills gaps in knowledge about a number of CAM practices and builds a fuller understanding of what CAM can offer. Whether a study's result is positive or negative, we expand our knowledge not only about the tested therapy, but also learn more about the condition it is supposed to treat. Several examples from the past year illustrate this point further:
- Arthritis. As the U.S. population ages, the need for better, safer, and more effective treatments for arthritis increases. Through basic studies, NCCAM-supported investigators determined that extracts of the spice turmeric, an important component of Ayurvedic medicine that is used in the treatment of a number of inflammatory disorders, contains specific compounds with anti-arthritic activity, as well as others that can inhibit this activity. This research suggests the need for further investigation of the potential of turmeric, points toward ways in which its use might be optimized, and yields insight into the mechanisms of arthritic disease.
- Neurodegenerative Diseases. Ginkgo biloba is a dietary supplement widely used for its purported beneficial effects on brain function. NCCAM-funded investigators studying it in an animal model of Alzheimer's disease found that it reduces both the formation of the specific brain abnormalities seen in humans, and the resulting paralysis seen in the animals. These experiments lend support to the hypothesis that Ginkgo biloba may be useful in slowing the progression of Alzheimer's disease. That hypothesis is being tested in a large clinical trial of Ginkgo biloba for the prevention of dementia, supported by NCCAM and several other NIH Institutes.
- Yoga for Chronic Low Back Pain. Chronic low back pain is prevalent and has few treatment options. NCCAM supported researchers have concluded a randomized clinical trial studying the effectiveness of yoga, exercise, or a self help book in improving back function and decreasing chronic low back pain. The results of the trial demonstrated that yoga was more effective and produced longer-lasting pain relief than exercise or the self-help book.
- Menopause and Black Cohosh. Given concerns about the use of hormone replacement therapy to treat symptoms of menopause, many women have turned to the dietary supplement black cohosh for relief, although evidence supporting this approach has been scant. In 2006, a clinical trial supported by the National Institute on Aging and NCCAM failed to show relief of menopause-associated symptoms by treatments containing black cohosh. Two other large clinical trials of black cohosh continue.
Training the Next Generation of Cam Researchers
The rigorous basic, translational, and clinical research required to understand integrative medicine must involve collaborations between CAM practitioners and experienced scientists. This multidisciplinary approach is the fundamental tenet of NCCAM's strategy in support of research training and career development. Since its inception, the Center has increased the percentage of funds committed to research training and career development—from 1.3 percent in FY 1999 to 8.3 percent in FY 2006 - to support research training, career development, and educational opportunities. Recipients of CAM doctoral degrees are now among those eligible for National Research Service Awards, as well as for the NIH-wide loan repayment program.
Delivering Authoritative Information
NCCAM is recognized as a source of authoritative, evidence-based information on CAM. Information on CAM treatments, herbs and dietary supplements, advice for consumers, research results, and clinical trials are available in English and Spanish in print and electronic form. In 2006, NCCAM's website, cited by Prevention magazine for “Best Alternative Medical Information,” had more than 2.6 million visitors. CAM on PubMed®, a database developed in partnership with the National Library of Medicine, now indexes more than 467,000 articles related to CAM. NCCAM's online continuing education program offers information on a variety of topics to the public and health professionals. Of particular note is a new patient/provider education initiative – “Time to Talk” – that encourages informed and open communication between patients and physicians about CAM use, to ensure safe, integrated, personalized and participatory care.
NCCAM will build on the foundation of scientific accomplishment and leadership that it has established during its first 7 years. Specific new activities planned for FY 2008 include the following.
- Working in partnership with the Centers for Disease Control and Prevention, NCCAM will support the first national, population-based survey assessing CAM use among the U.S. pediatric population. This study will fill an important information gap in knowledge of CAM use in children and help NCCAM and the broader scientific community in establishing pediatric CAM research priorities.
- A new initiative will examine the potential influence of genetic variation on the likelihood of response to selected CAM interventions. This phenomenon, an important factor in the variation observed in responsiveness to conventional medicine, will be examined through linking new basic research to ongoing clinical trials, maximizing the value of the investment in both.
- A multidisciplinary workshop will bring together scientists from a broad range of the physical, social, and biological sciences to explore novel methodologies for clinical research of complex CAM approaches that make up whole medical systems.
Through these and other activities, NCCAM will continue to provide leadership in establishing the emerging discipline of integrative medicine. Thank you, Mr. Chairman. I would be pleased to answer any questions that the Committee may have.