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Fiscal Year 2003 Budget Request
Statement to the House Subcommittee on Labor, DHHS, and Education Appropriations (March 13, 2002) and to the Senate Subcommittee on Labor-DHHS-Education Appropriations (March 21, 2002)
Stephen E. Straus, M.D., Director
National Center for Complementary and Alternative Medicine
Mr. Chairman and Members of the Committee:
I am pleased to present the President's budget request for the National Center for Complementary and Alternative Medicine for FY 2003, a sum of $113,823,000, which reflects an increase of $8,843,000 over the comparable Fiscal Year 2002 appropriation.
The NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH's third annual performance report that compared our FY 2001 results to the goals in our FY 2001 performance plan.
FY2001—NCCAM's third year—was one of exciting growth and productivity. Substantive progress was made towards advancing each of the four primary goals articulated in NCCAM's five-year strategic plan: stimulating and supporting research, research training, outreach, and facilitating integration.
Building for Success
NCCAM's evolving success has depended on our firm adherence to a series of guiding principles. First, we solicit the best research ideas from a wide base of our stakeholders, investigators, and practitioners from the many mainstream and complementary and alternative medicine (CAM) disciplines and fields; we incorporate similarly wide perspectives into peer review; and we invest in only the most competitive, exacting, and important work. Second, our portfolio emphasizes clinical research because CAM practices are already widely used, and the American people need information that is based on scientific evidence so that they can make informed health care choices. Third, the range of clinical conditions addressed by CAM and the cost of clinical studies, especially large trials, dictate that we leverage our intellectual and capital resources through collaboration with sister Institutes, Centers, and agencies. Fourth, CAM products and practices, in spite of their wide use, are often of variable quality. Thus, we must ensure the highest standards of safety and reproducibility of our studies.
The progress made in each of these areas has been facilitated by our creation of programs in international health research, special populations research, and clinical and regulatory affairs (PCRA), as well as the establishment of an Intramural Research Program (IRP), including the appointment of the first NCCAM Director for Clinical Research. The PCRA coordinates and monitors NCCAM-funded multi-center trials, including related Institutional Review Board (IRB) and data and safety monitoring activities. Further efforts to enhance research quality include NCCAM-funded preparation of high-priority clinical research-grade botanical products such as cranberry, Echinacea, saw palmetto, and milk thistle, for which existing supplies sold to consumers are too variable in product content and quality. The IRP creates on the NIH campus an environment for collaborative research, training, and clinical care with CAM modalities.
Evidence of our success over the past 3 years includes a nearly 25-fold increase in grant applications to NCCAM and a commensurate increase in the quality of our awards. Our research portfolio has begun to demonstrate the breadth and complexity typical of work supported by the more established Institutes. We have expanded our support for investigator-initiated studies on the basic mechanisms of action and clinical applications for diverse, widely used CAM therapies. NCCAM manages a substantive Centers program to investigate a range of botanical products, cancer therapies, cardiovascular disease treatments, and women's health approaches, among others, while thousands of research subjects have been enrolled into the most rigorous Phase III studies of CAM treatments ever conducted (Table). We have steadily increased the number of research training awards for pre- and postdoctoral fellows, physicians, nurses, and CAM practitioners. Our outreach efforts have benefitted from an award-winning Web site and an Information Clearinghouse enriched with new fact sheets, reports, and publications for the public and the research and health care communities.
|Phase III Clinical Trials||Status||Cosponsoring NIH Institutes/Centers||Target Enrollment|
|Shark cartilage as adjunctive therapy for lung cancer||Enrolling subjects||NCI||756|
|Ginkgo biloba to prevent dementia||Enrolling subjects||NIA, NHLBI, NINDS||3,000-3,500|
|Acupuncture for osteoarthritis pain||Enrolling subjects||NIAMS||570|
|Glucosamine/chondroitin to treat osteoarthritis||Enrolling subjects||NIAMS||1,588|
|Vitamin E/selenium to treat prostate cancer||Enrolling subjects||NCI||32,400|
|Hypericum perforatum to treat minor depression||Awarded||NIMH, ODS||300 (min)|
|EDTA chelation therapy to treat coronary artery disease||Under review||NHLBI||1,600 (est)|
|Saw palmetto/P. africanum to prevent progression of benign prostatic hypertrophy||Announced||NIDDK, ODS||3,000 (est)|
Allow me to highlight our approaches to and plans for some of the most complex and important facets of human health—cancer, neurosciences, and HIV/AIDS—and international health as illustrative of our overall strategy.
Surveys show that many cancer patients, hoping to improve their prognosis or to reduce the side effects of conventional treatments, use CAM modalities; others choose a CAM therapy as an alternative, especially for those cancers that are not responsive to conventional therapies. This widespread use has made studies of CAM approaches to cancer a high priority for NCCAM, as evidenced by a notable increase in investment in this area. NCCAM is collaborating with the National Cancer Institute and leading cancer specialists to examine diverse complementary and alternative therapies for cancer and its complications, as palliative care treatment, and as options for care at the end of life. We jointly support CAM programs at specialized cancer centers; we co-fund the largest ever studies of the dietary supplements selenium and vitamin E for prevention of prostate cancer and shark cartilage as adjunctive therapy for lung cancer (Table). Our portfolio of recently funded studies ranges from basic molecular and pharmacological studies of herbal products used by cancer patients, to assessments of massage, spiritual approaches, and complex nutritional regimens. We hope to support additional rigorous Phase I and II studies of a variety of popular alternative treatments for which the scientific literature provides limited or no evidence to confirm their safety or effectiveness: high-dose antioxidants (e.g., vitamin C or Coenzyme Q10), herbal mixtures (e.g., Flor-Essence, Essiac, PC-SPES, or traditional Chinese medicines), single whole plant extracts (e.g., mistletoe, oleander, or green tea), biopharmacologics (e.g., MTH-68 or 714-X), or complex regimens (e.g., Revici or Gerson therapies).
Another large component of the NCCAM research portfolio focuses on important public health needs and opportunities in the neurosciences, including studies on pain, mental health, stroke, addiction, and neurodegenerative disorders, as well as the neurobiological effects of placebos and diverse CAM therapies. Together, these studies promise to determine the range of neurological conditions for which CAM therapies may be beneficial and to further elucidate the intricate processes of the human nervous system.
Even though acupuncture has enjoyed millennia of empiric development and widespread use in Asia, it has been poorly explicated or accepted by the standards of contemporary biomedicine. Currently, NCCAM investigators are learning more about acupuncture's mechanisms of action and its value for pain relief. Several different basic science studies are applying powerful new brain imaging techniques (such as functional magnetic resonance imaging and positron emission tomography) to identify physiological linkages between needle insertion sites, ancient acupuncture meridians, and critical brain neurotransmitter and endogenous opioid pathways. Many of NCCAM's studies are dedicated to investigating how effective acupuncture is at managing pain relative to other contemporary approaches. For example, in collaboration with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, NCCAM will complete the largest and most rigorous trial to date of the safety and efficacy of acupuncture for the pain of osteoarthritis of the knee (Table). NCCAM supports smaller studies for other conditions including carpal tunnel syndrome; temporomandibular disorder and postoperative dental pain; and back pain. Collectively, this is the largest ever compendium of formal acupuncture studies.
The dominant theme of research in NCCAM's IRP focuses on the body's cardinal communications network that links the mind/brain and body: neural, endocrine, and immune systems and their responses to significant age-related life stressors, such as depression, chronic pain, cognitive decline, and sleep disorders, all of which are prime targets of CAM approaches. One of the first intramural studies will examine the use of acupuncture to control nausea associated with aggressive cancer therapy.
The placebo effect also hinges on the powerful dialogue between mind and body, representing a change in a patient's condition that occurs in response to administration of otherwise inert substances or participation in a psychophysiological activity in a healing context. Research has shown that placebos affect treatment outcome. In November 2000, NCCAM, the National Institute of Diabetes and Digestive and Kidney Diseases, and 15 other Institutes, offices, and health agencies cosponsored a major international conference to examine social, psychological, and neurobiological contributions to the placebo effect, and the ethical use and evaluation of placebo actions in clinical trials. In response to recommendations from the conference, NCCAM has planned and will fund, in collaboration with nine other NIH Institutes and Centers, new research initiatives aimed at elucidating the neurobiological mechanisms that mediate placebo effects, and supporting studies of social and behavioral factors that facilitate placebo responses in clinical practice settings.
People with HIV/AIDS often incorporate CAM modalities into their treatment strategies. Consequently, NCCAM is building an innovative and broad-based research portfolio to determine the safety and efficacy of CAM modalities used by these individuals. NCCAM plans to solicit studies that build on ongoing in vitro, animal, and early phase clinical studies that address the potential antiretroviral action of a number of CAM therapies either alone (e.g., dehydroepiandrosterone [DHEA]) or in concert with approved anti-HIV drugs (e.g., licorice [Glycyrrhiza glabra] and St. John's wort [Hypericum perforatum]); the amelioration of undesirable side effects of conventional treatments (including garlic to prevent the unusual deposition of fatty tissues under the skin, known as lipodystrophy); or the restoration of the immune system by dietary supplements (e.g., alpha lipoic acid or creatine). Because palliation is one of the purported benefits of many CAM therapies, NCCAM also supports several research projects on improving the quality of life for people with advanced AIDS (parallel studies are being conducted with people who have advanced cancer), including massage therapy to treat depression and improve the quality of life, cognitive behavioral coping and Tai Chi to reduce stress, and the role spirituality plays in sustaining one's will to live.
International Health Research
Recognizing that a global CAM research network would also enhance CAM research activities in the United States by affording investigators access to unique bioresources and traditional therapies, NCCAM established a research program on international health in FY 2001. The goal is to promote the validation of indigenous CAM practices by encouraging their rigorous assessment in their native context in a culturally sensitive manner. Collaborations with the Fogarty International Center, the World Health Organization, and other agencies are facilitating these endeavors. In accord with the strategic plan for this effort, NCCAM has begun by convening international workshops and plans to solicit applications to develop an international site of CAM research excellence.
While many CAM remedies have been employed for centuries, we still have much to learn about them. By continuing our studies on their underlying mechanisms and clinical effects, we will discern which approaches are safe and effective, and therefore suitable for incorporation into medical practice, while well-informed consumers will reject those that are not.
I am now happy to take your questions about NCCAM's activities and plans.