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Fiscal Year 2002 Budget Request
Statement to the House Subcommittee on Labor, DHHS, Education Appropriations (May 16, 2001) and to the Senate Subcommittee on Labor, DHHS, Education Appropriations (May 23, 2001)
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 2002, a sum of $100,063,000, which reflects an increase of $10,925,000 over the comparable Fiscal Year 2001 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 second annual performance report which compares our FY 2000 results to the goals in our FY 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify strategies and objectives to continuously improve its programs.
The past year, NCCAM's second, has been exciting and productive. With your generous support we continued to build a new research enterprise dedicated to defining the effectiveness and safety of diverse complementary and alternative medical (CAM) practices. Many Americans turn to these practices to relieve or prevent disease symptoms or the side effects of their treatment, despite a lack of clear and compelling data about them. We have the scientific tools, the commitment, and the resources to begin to guide their decisions regarding these practices. Consistent with our mandate, we have identified priority areas that warrant more immediate action due to pressing public health needs and either a dearth of valid scientific information or sufficient maturation of the science. Allow me to provide some examples of our approach.
Mechanisms of CAM Interventions
Among NCCAM's highest priorities is the conduct of Phase III clinical trials of CAM modalities. NCCAM's Phase III clinical trials are built upon a substantial body of scientific evidence concerning a given modality. While complex enough in design and ambitious enough in scope to address critical scientific issues and patient safety concerns, these pivotal trials are also well poised to address the central question: "Does this therapy work?" In collaboration with other NIH Institutes and Centers (ICs), NCCAM supports the following multiyear, multicenter Phase III clinical trials: St. John's wort for depression, with the National Institute of Mental Health (NIMH); shark cartilage for lung cancer, the National Cancer Institute (NCI); Ginkgo biloba for dementia, the National Institute on Aging (NIA), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Neurological Disorders and Stroke (NINDS); acupuncture for osteoarthritis pain, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); and glucosamine/chondroitin sulfate for osteoarthritis, NIAMS.
NCCAM also funds 15 specialty research centers, completing the research infrastructure platform on which to investigate the mechanisms underlying CAM treatments and their health effects. NCCAM-funded centers cover CAM approaches for many areas of major public health need, including drug addictions, aging and women's health, arthritis, craniofacial disorders, cardiovascular diseases, neurological disorders, pediatrics, and chiropractic research. These centers constitute a major investment of NCCAM's resources and serve as the focal point for initiating and maintaining state-of-the art multidisciplinary CAM research. They develop core research resources, train new CAM investigators, provide community outreach and education, and expand the research base through collaborative research and outreach to scientists and clinicians.
While CAM remedies have been employed for centuries, we still understand little about them. By studying their underlying mechanisms, we could better monitor their actions and develop biomarkers whose changes would correlate with beneficial clinical outcomes. Thus, we would be better positioned to reveal which CAM modalities work and which do not, and inform the public accordingly.
One prospect is acupuncture, which, after millennia of empiric development and widespread use in Asia, has emerged as an exciting but still poorly understood tool for pain management. The ancients imagined pain as a result of imbalances in energy flow through defined body channels, or meridians. By inserting needles at precise points, practitioners attempted to correct the pain-provoking energies. In contemporary neurobiological terms we understand chronic pain as a result of abnormal actions within key nerve-signaling pathways from the periphery to the central brain. NCCAM grantees are testing the value of acupuncture for pain relief and learning more about its mechanisms of action. Studies using remarkably sensitive imaging techniques have pinpointed pain processing centers in the brain and showed that the activity of these centers is altered when needles are inserted at the body sites defined by the ancient Chinese practitioners as affording pain control. Acupuncture-mediated analgesia is not imagined, it is real. Our clinical trials are exploring the range of conditions for which acupuncture may provide effective pain relief. Our largest such study of acupuncture involves the pain of osteoarthritis.
In the largest and most rigorous trial of acupuncture to date, cosponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the short- and long-term safety and efficacy of acupuncture for the pain of osteoarthritis of the knee are being evaluated. In this six-week study, 570 aging Americans are being randomly assigned to 1) true acupuncture; 2) sham acupuncture; or 3) standard education and attention. The goal is to determine whether patients receiving true acupuncture experience significantly less pain and fewer limitations than patients in the other groups. A separate follow-up of the patients in this study will evaluate the long-term outcomes and cost-effectiveness of the acupuncture intervention.
Another key area of interest is the use of CAM to treat coronary artery disease (CAD), which is the leading cause of mortality for both men and women in the U.S. Despite increasingly effective conventional treatments for CAD, many turn to alternative approaches including the use of ethylenediaminetetraacetate (EDTA) chelation therapy, a popular but controversial approach. To date, however, studies of chelation therapy for CAD have been few, very small in size, and poorly designed, affording few conclusions concerning its true safety and effectiveness. To address this important public health issue, NCCAM plans, in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), to fund the first major multi-site, clinical trial to investigate the efficacy and safety of EDTA chelation therapy in individuals suffering from CAD, using rigorous trial design and validated outcomes measures. A solicitation (RFA) has been released.
Cancer
NCCAM is applying this same energy and commitment to studies of cancer. Our rapidly growing research portfolio encompasses both the study of CAM cancer interventions and palliative care. In FY 2000 NCCAM funded two new Specialty Research Centers dedicated to studying the safety and effectiveness of several popular CAM cancer therapies. One center is evaluating the mechanisms of action, safety, and clinical efficacy of hyperbaric oxygen (oxygen at greater-than-atmospheric pressures) treatment for head and neck cancers. The other center conducts studies of breast cancer as well as the first randomized, placebo-controlled clinical trial of a popular mixture of eight Chinese herbs, known as PC-SPES, in men with hormone-refractory prostate cancer. This latter study will evaluate PC-SPES for disease progression, bone pain, and quality-of-life issues, such as changes in sexual function that so often accompany prostate cancers and their treatment. (The name PC-SPES means hope for prostate cancer.)
Some menopausal and postmenopausal women find symptom relief through conventional estrogen replacement therapy (ERT). Research has also shown that ERT benefits cardiovascular, skeletal, genitourinary, and cognitive health. Despite these benefits, less than 20 percent of American women use ERT, in part because it seems to be associated with an increased risk of breast cancer. This dissuades some women from using it and excludes its use for breast cancer survivors. Many women explore alternative approaches to estrogen replacement to eliminate the risks of conventional ERT, with the hope of reaping its benefits while avoiding its potential hazards. Soybeans are rich in naturally occurring compounds with estrogen-like activity. Several preliminary studies of popular soy-derived phytoestrogens (PEs) yielded unclear and contradictory results, leaving open the question of whether soy may protect against breast cancer or, like conventional ERT, promote its emergence. NCCAM intends to conduct Phase II clinical trials to assess the impact of PE supplementation on women's health after a breast cancer diagnosis.
Cancer patients for whom a cure is not an option face not only the prospect of death, but also the diminution of quality of life and dignity, and intractable pain. Perhaps as many as 70 percent of these cancer patients seek complementary and alternative therapies to expand options for end-of-life care. NCCAM is soliciting Phase I and II clinical trials of CAM modalities for the prevention and management of symptoms associated with the end of life, including secondary side effects of chemotherapy and radiotherapy; and the enhancement of the patient's well-being.
Botanicals
Botanicals, among the most popular CAM therapeutics, are relied upon for treatment and prevention of a number of conditions. In collaboration with the NIH Office of Dietary Supplements (ODS), NCCAM funds four Centers for Dietary Supplement Research with an emphasis on botanicals. The Centers identify and characterize botanicals, assess their bioavailability and activity, explore mechanisms of action, conduct preclinical and clinical evaluations, establish training and career development, and help select the products to be tested in randomized controlled clinical trials. Our plans include studying botanical-drug interactions, the developing standardized botanical products, and examining the safety and effectiveness of cranberry products in preventing urinary tract infections.
Health Disparities
In conjunction with the trans-NIH effort to address U.S. health disparities, we have recruited a director for the NCCAM Office of Special Populations and charged him to expand our own research plan in this area. We plan to identify the extent and nature of CAM use among special populations; study the application of CAM therapies to reduce disparities; increase participation of underrepresented populations in NCCAM-supported clinical trials; and enhance the ability of minority institutions to support CAM research. This plan will serve through FY 2005 as a guide for developing new initiatives to address minority health and health disparities. In the near term, NCCAM intends to determine the prevalence of CAM use by different minority and underserved populations, initiate studies on the use of magnesium sulfate in the treatment of acute asthma, and use the National Research Training Award (T32) mechanism to support pre- and post-doctoral trainees in CAM research at minority and minority-serving institutions.
Integrative Medicine and Research Training
NCCAM has initiated a series of specific activities to facilitate the successful integration of safe and effective CAM modalities into mainstream medical practice. We conduct research that provides compelling evidence of efficacy and safety and publish these findings in peer-reviewed journals, study factors that promote or impede integration, support the development of model curricula for medical and allied health schools and continuing medical education programs, and inform the public in a clear and definitive manner. In FY 2001, we launched a new integration initiative to study factors that promote or impede integration, determine whether CAM research results can be translated to real-world settings, and support the evaluation of programs that integrate CAM and conventional care. Integrative medicine is also a key component of NCCAM's Intramural Research Program and a component of NCCAM's Specialized Research Centers.
NCCAM's ability to achieve its research goals depends on the availability of a critical mass of skilled investigators in both CAM and conventional communities. It is our goal to increase the knowledge, experience, and capacity of CAM practitioners to conduct or participate in rigorous research. We also intend to enhance conventional practitioners' and researchers' knowledge and experience in specific CAM areas. We actively support research training by making awards to both institutions and individuals. Likewise, NCCAM supports mentored and independent trainees, from the pre-doctoral level through mid-career and senior faculty members. The research spectrum of these trainees is broad, covering the continuum of basic through clinical studies. NCCAM supports all of the major training mechanisms offered by NIH.
Conclusion
As the graying of America progresses, more of our citizens are choosing CAM approaches when conventional medicine fails to provide complete satisfaction. It is, therefore, imperative that we continue to expand our research portfolio, train researchers, and fund research studies to scientifically establish critical safety and efficacy information for dissemination to healthcare providers and consumers. I am confident that the results of our rigorous research will further enhance the successful integration of safe and effective CAM modalities into mainstream medical practice.
I am now happy to take your questions about these or any other of NCCAM's activities and plans.
