Witness appearing before the House Subcommittee on Labor-HHS-Education Appropriations (March 9, 2005)
Stephen E. Straus, M.D., Director
National Center for Complementary and Alternative Medicine
William Beldon, Deputy Assistant Secretary, Budget
Mr. Chairman and Members of the Committee:
I am pleased to present the Fiscal Year (FY) 2006 President's budget request for the National Center for Complementary and Alternative Medicine (NCCAM). The FY 2006 budget includes $122,692,000, an increase of $587,000 over the FY 2005 enacted level of $122,105,000 comparable for transfers proposed in the President's request.
In 2004 NCCAM celebrated its first 5 years by reflecting on its contributions to the science of complementary and alternative medicine (CAM) and crafting a second strategic plan that articulates the Center's plans for 2005-2009. The plan is a collaborative effort that was developed with extensive input solicited from the public, CAM practitioners, and experienced scientific investigators; it articulates NCCAM's agenda for researching CAM healing practices, training CAM researchers, and conducting outreach.
It is noteworthy that an independent analysis released in January 2005 of the major scientific and policy issues surrounding CAM use, which was undertaken by conventional and CAM investigators for the Institute of Medicine (IOM) of the National Academies, identified many of the same research and training priorities as had NCCAM in its strategic planning process. The IOM report emphasized that evidence-based science must inform all health care practices, both conventional and CAM.
In accord with the philosophy articulated by the IOM, scientific rigor has been and will remain the foundation upon which NCCAM advances its research agenda. In its first 5 years, NCCAM funded more than 1,200 projects at some 260 CAM and conventional research institutions. The results of these projects are being published in leading medical journals, affording the public and their health care providers better data on which to base decisions on CAM use. The following are a few highlights of NCCAM's recent scientific advances, ongoing activities, and plans that illustrate the Center's progress and future directions.
Understanding Who Uses CAM and Why
Understanding who uses CAM and why they do so informs NCCAM's research goals, initiatives, and collaborations. In 2004, NCCAM reported results based on survey data collected in partnership with the Centers for Disease Control and Prevention from more than 31,000 Americans. The data revealed that 62 percent of survey respondents used CAM in 2002. Back pain was the single most common reason respondents used CAM, followed by respiratory infections. To track trends in CAM use, NCCAM and the CDC have agreed to undertake a followup survey in 2007. Additional NCCAM-funded survey analyses are also under way to examine in greater detail CAM use in diverse minority populations.
Determining the Effects of Acupuncture
Acupuncture is among the top ten most popular CAM practices in the United States. In spite of its venerable traditions as a therapeutic practice in Asia, scientific research on acupuncture and how it might work is a relatively recent phenomenon. The recent report on the efficacy of acupuncture for osteoarthritis demonstrates the power and promise of the research strategies developed and implemented by NCCAM.
More than 20 million Americans have osteoarthritis, a frequent cause of pain and disability among aging adults. In 2004, NCCAM-funded investigators, building on the results of previous smaller studies, reported the results of the largest randomized, controlled Phase III clinical trial of acupuncture ever conducted. This study of 570 patients demonstrates that acupuncture is an effective complement to conventional treatments in patients with osteoarthritis of the knee.
Exploring Mind-Body Medicine
Recognizing the important role of social and behavioral factors in illness and health, NCCAM's new strategic plan describes further growth in the Center's investments on mind-body medicine for a range of diseases. One such study already under way is a clinical trial examining the use of meditation to achieve weight loss and enhance overall health and well-being among obese men and women. Also, in 2004 NCCAM funded a mind-body center as part of its research centers program.
To further stimulate the field of mind-body medicine research, NCCAM is co-funding an initiative with the NIH Office of Behavioral and Social Sciences Research to encourage interdisciplinary collaborations to elucidate processes underlying mind-body interactions and health and to develop health promotion and disease prevention and treatment interventions.
Investigating Dietary Supplements and Foods
As reported in the NCCAM/CDC survey, herbal products are among the most popular CAM therapies. Although many believe these products to be safe because they are “natural” or have been used for centuries, few of these products have undergone sufficient study of their safety and effectiveness. Research on botanicals is a priority area, and NCCAM funds numerous studies ranging from basic laboratory investigations to large Phase III clinical trials, to gather data on the nature, safety, and efficacy of popular herbal remedies.
For example, NCCAM supports several interrelated studies of cranberries for preventing urinary tract infections (UTIs), which afflicts approximately 25 percent of women at least once in their lifetime. These include Phase II clinical trials to identify the optimal cranberry formulation, dose, and treatment duration in studies on UTI prevention as well as other smaller studies on the basic mechanisms, pharmacokinetics, and renal clearance of cranberry's major chemical components.
Another priority for NCCAM's dietary supplement research portfolio is chronic liver disease, which claimed the lives of more than 20,000 Americans in 2002 and disproportionately affects minorities. Through the Small Business and Innovative Research program, NCCAM supports development of a standardized milk thistle product, the most promising CAM therapy for liver disease. In collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases, NCCAM will undertake early phase studies of safety and tolerability of milk thistle to determine if a Phase III trial is likely to be successful, and if so, the optimal research design for its implementation.
NCCAM grantees are also examining the potential therapeutic properties of foods such as soy—especially as it relates to alleviating menopausal symptoms and promoting bone health. Last year NCCAM-supported scientists reported that in a study of pain induced by bone cancer, soy-fed mice experienced less pain than those in a control group. A better understanding of how dietary constituents and plant-based nutrients moderate pain may yield further treatments to help patients with chronic pain.
Benefiting NCCAM's botanical research agenda is its partnership with the NIH Office of Dietary Supplements (ODS). This year NCCAM and ODS have renewed their partnership in funding Botanical Research Centers to promote interdisciplinary collaborative studies on dietary supplements.
Meeting the Diverse Needs of Selected Populations
NCCAM has a broad-based research portfolio, reflecting the diversity of individuals who use CAM for help in managing an array of diseases and conditions. For example, understanding how racial and ethnic minorities use CAM is a focus of the Center's research agenda in health disparities. Initiatives are under way to examine the interplay of race, ethnicity, age, gender, and locale to understand how they affect minorities' use of CAM to manage chronic illnesses such as diabetes or asthma. Examining these practices will help direct future research to answer why specific populations use certain CAM practices—for cultural reasons, because of access issues, for economic reasons, or for effectiveness—which in turn will help health care providers better meet the needs of these groups.
Diseases and conditions predominately affecting the elderly are major targets of ongoing investments. For example, NCCAM is supporting the largest randomized Phase III clinical trial to date of Ginkgo biloba to prevent dementia in the elderly. Cardiovascular disease (CVD), the leading cause of death in the United States, is also a research priority for NCCAM. Investigations are ongoing of the ability of green and black tea extracts (Camellia sinensis) to reduce cholesterol absorption and biosynthesis in postmenopausal women and patients at high risk for CVD.
In 2004, NCCAM grantees reported results from a clinical trial in children affected with upper respiratory infections (URI). In the trial, over 400 healthy 2-to-11-year-olds received a placebo or an echinacea product, an herbal identified by the NCCAM/CDC survey as widely used, to determine objectively whether it would reduce the severity of URIs over the 4-month study period. The researchers observed no differences between the two groups in the duration, severity, number of days with fever, and rate of adverse events except for an increased incidence of rashes in children receiving echinacea. Given the widespread use of this product, NCCAM is following up on this research, focusing on prevention of infection, which is how echinacea is usually taken, and studying the mechanisms by which echinacea may have health effects.
In the wake of the Women's Health Initiative, NCCAM is developing a diverse research portfolio to explore use of CAM in treating menopausal symptoms, including hot flashes and osteoporosis. Some studies are examining the safety and efficacy of a range of CAM modalities women now use to treat these symptoms; others address more basic science questions, such as a therapy's mechanism of action. NCCAM's research portfolio also addresses other important health conditions exclusive to women—endometriosis and premenstrual syndrome (PMS)–as well as those that affect more women than men, such as UTIs, osteoporosis, fibromyalgia, osteoarthritis, breast and other cancers, and cardiovascular disease.
Participating in Trans-NIH Initiatives
NCCAM co-chairs a critical component of the NIH Roadmap for Medical Research Activity, Reengineering the Clinical Research Enterprise, to develop a more effective and cost-efficient model of translational research to move basic research into safe, well-designed clinical trials. In addition, NCCAM is actively involved in the NIH Neurosciences Blueprint, a trans-NIH initiative to accelerate the efficiency and pace of neurosciences research. Also, as part of the Trans-NIH Obesity Initiative, NCCAM is co-sponsoring efforts on childhood obesity and obesity prevention and treatment.
Charting NCCAM's Future
NCCAM has accomplished much in its first 5 years. The first NCCAM-supported large-scale clinical trials are nearing completion; these findings are appearing in the nation's leading medical journals. NCCAM also has developed a comprehensive communications program to inform the public and health care professionals about CAM research findings. And the Center has created new opportunities in CAM research training for young scientists and has forged linkages between CAM institutions and conventional research centers. With its second strategic plan as a guide, NCCAM looks forward to making ongoing contributions as the nation's lead CAM research agency.
Thank you Mr. Chairman. I would be pleased to answer any questions that the Committee may have.