Statement to the Senate Subcommittee on Labor-DHHS-Education Appropriations (April 1, 2004)
Stephen E. Straus, M.D., Director
National Center for Complementary and Alternative Medicine
William Beldon, Acting Deputy Assistant Secretary, Budget
Mr. Chairman and Members of the Committee:
I am pleased to present the President's Fiscal Year (FY) 2005 budget request for the National Center for Complementary and Alternative Medicine. The FY 2005 budget includes $121.1 million, an increase of $4.2 million over the comparable FY 2004 appropriation of $116.9 million.
Five years ago, recognizing the increasing public health opportunities of complementary and alternative medicine (CAM) and the challenges to research in this area, Congress elevated the NIH Office of Alternative Medicine to the National Center for Complementary and Alternative Medicine (NCCAM). Several months later, as NCCAM's first Director, I articulated a set of priorities for the Center that emphasized growth in the portfolio of rigorous research project grants, enhanced investments in research training and careers awards to build an effective CAM research collective, creation of an intramural research program (IRP), and commitment of stable funding for research centers. As we embark on planning our second 5 years of work, I am pleased to report that NCCAM has achieved these and many other critical objectives.
NCCAM's success to date is evident in some of its vital statistics:
- Under the President's proposed FY 2005 budget, NCCAM's investment in research project grants will have increased from approximately $10 million in 1999 to almost $76 million, while funding for research training and career awards will have increased from under $1 million in 1999 to approximately $8.8 million.
- In collaboration with other NIH Institutes and Centers (ICs), NCCAM has launched nine multi-center Phase III clinical trials of popular CAM interventions for chronic illnesses that affect so many Americans, including osteoarthritis, dementia, cancer, and coronary artery disease.
- NCCAM established an intramural research program in 2001, which studies CAM approaches to diseases of aging, including arthritis, depression, muscle wasting, cancer, pain, and diabetes.
- Based on a comprehensive external review, NCCAM refined its research centers program to support rigorous investigations at both traditionally research-intensive and CAM institutions. In 2003, NCCAM made its first round of revised center awards in three categories: Centers of Excellence for Research on Complementary and Alternative Medicine, Developmental Centers for Research on Complementary and Alternative Medicine, and Planning Grants for International Centers for Research on Complementary and Alternative Medicine. NCCAM's Centers program will foster capacity in CAM research, catalyze more effective and essential partnerships between CAM institutions and research-intensive universities, and facilitate the integration of effective CAM therapies with conventional medical approaches.
Already, the nearly 800 projects that NCCAM has supported since 1999 have yielded over 700 scientific publications, including some that were published in the most prestigious journals–Journal of the American Medical Association, New England Journal of Medicine, and Proceedings of the National Academy of Sciences. Complementing these research and research training activities are extensive efforts to communicate research results and other critical information about CAM to the public and practitioners. NCCAM's award-winning Web site is visited over 1.5 million times each year for its 90 fact sheets, consumer alerts, news releases, and announcements of new research initiatives. In a partnership with the National Library of Medicine, NCCAM helped create a CAM subset on the reference database PubMed that now hosts nearly 400,000 reports about CAM studies, which are available to anyone with Internet access. In the aggregate, the investments made in NCCAM's first 5 years are already informing the health care decisions Americans make at home and in consultation with their practitioners.
In its first 5 successful years, NCCAM has become fully integrated within the NIH, developing a research agenda that is responsive to its mission, fiscally accountable, and supportive of rigorous CAM research. NCCAM's research priorities today encompass six thematic areas in which CAM can have a public health impact: obesity, botanicals, brain-body interactions, acupuncture, neurodegenerative diseases, and HIV/AIDS. The next section highlights some of the advances and activities in three of these priority areas.
Addressing the Obesity Epidemic
An alarming 65 percent of American adults¹, 16 percent of adolescents, and 10 percent of American children are now overweight². Obesity results from complex interactions among human biology, behavior, and the environment and, therefore, requires a multidisciplinary approach to prevent and treat it. NCCAM is contributing to the trans-NIH strategy to address this epidemic by supporting studies of the safety and efficacy of popular, but unsubstantiated, dietary approaches to obesity and its many complications. One of the most popular approaches today is the diet plan championed by the late Dr. Robert Atkins, which emphasizes a low-carbohydrate, high-fat, high-protein regimen.
In FY 2003, NCCAM-sponsored researchers reported in the New England Journal of Medicine on a groundbreaking 1-year, multi-center trial about the effects of the Atkins diet on weight loss and risk factors for cardiovascular disease. At 6 months, those on the low-carbohydrate diet had lost more weight and had reduced levels of blood lipids more than those on the conventional diet. At the end of 1 year, however, the differences between the two groups of dieters lessened, leading investigators to call for larger and longer-term studies. NCCAM is working with its NIH partners to support a larger and more definitive study.
In its intramural program, NCCAM researchers are testing whether the dietary supplement glucosamine, used by over 4 percent of older Americans for degenerative arthritis, causes resistance to insulin, a condition that predisposes one to diabetes - a disease linked to obesity. Other IRP studies are evaluating carnitine, a nutrient essential for the normal metabolism of fats, to see whether it can reduce abdominal fat content, stimulate weight loss, and improve glucose utilization.
In FY 2005, as part of the overall trans-NIH focus on obesity, NCCAM will cosponsor two major initiatives in obesity research, Neurobehavioral Basis of Obesity and Prevention and Treatment of Pediatric Obesity in Primary Care Settings. The first seeks to bridge the gap between understanding the molecular and genetic regulation of food intake and behavioral influences on obesity. The pediatric initiative will evaluate preventive and therapeutic strategies for obesity that could be recommended for children and adolescents in primary care settings, such as a physician's office, primary care clinic, or HMO.
¹Journal of the American Medical Association, 288 (14): 1723-1727, Flegal et al., “Prevalence and trends in obesity among U.S. adults, 1999-2000.”
²Journal of the American Medical Association, 288 (14): 1728-1732, Ogden et al., “Prevalence and trends in the overweight among U.S. children and adolescents, 1999-2000.”
Examining the Safety and Effectiveness of Botanical Products
Approximately 14 percent of Americans use herbal supplements to prevent disease, maintain wellness, or treat illness or pain³. Many of these people also take prescription drugs. NCCAM-supported research is identifying herbal products that interact with drugs and the underlying biochemical mechanisms of these interactions. For example, studies have shown how St. John's wort and PC SPES (a botanical mixture that had been used to treat advanced prostate cancer) induce the activity of a key liver enzyme that is responsible for the metabolism of some 80 percent of all drugs. This finding shows how herbal supplements have the potential to either enhance a drug's toxicity or reduce a drug's effectiveness when a patient takes both dietary supplements and prescription medication.
Each year in the United States, an estimated 70,000 people are diagnosed with head and neck cancers, which are typically resistant to multi-drug chemotherapy. In FY 2003, NCCAM-sponsored researchers examined extracts from the root of Scutellaria baicalensis, a Chinese herb, for activity against head and neck cancers. The new study is promising because it shows that the herbal extracts strongly inhibit the growth of human head and neck cancer cells in vitro as well as in mice with tumors composed of human cells. Future studies will determine the herb's effects on regulating the cell replication cycle and whether it can be translated into a safe and effective intervention for head and neck cancer patients.
While some research studies confirmed the promise of certain botanicals, others have found herbs that do not deliver on their claims. One example is guggulipid, a botanical extracted from the resin of the mukul myrrh tree, that is marketed in the United States as a dietary supplement to help control blood cholesterol levels and maintain a “healthy heart.” In an 8-week placebo-controlled study involving over 100 subjects, NCCAM-funded scientists found that neither the standard or even higher doses of guggulipid significantly lowered the levels of the key low-density lipoprotein (LDL) form of cholesterol in people with high blood cholesterol. This study highlights the need to study popular botanicals that the public is using so that individuals can make informed decisions regarding their own care.
In FY 2005, NCCAM will co-sponsor three important initiatives on the use of botanicals as dietary supplements. Through a newly refined Botanical Research Centers Program being mounted with the NIH Office of Dietary Supplements and the National Institute of Environmental Health Sciences, NCCAM will support interdisciplinary studies of botanicals to generate evidence regarding their safety and potential public health benefits. NCCAM also plans to establish a Phase I Resource Center (PRC) to define the pharmacology and optimal dosing of botanical products and functional foods. Finally, in FY 2005, NCCAM plans to initiate in vitro, animal, and preliminary clinical studies of Silybum marianum (milk thistle) and its derivative silymarin as a treatment for chronic hepatitis and cirrhosis of the liver, conditions that affect millions of Americans for whom, to date, there is no effective treatment.
Through these programs, NCCAM thoughtfully is investing in programs of basic research to discover natural products and food supplements that could open new avenues for prevention and treatment of conditions that affect the health, well being, productivity, and quality of life of millions of Americans.
³Journal of the American Medical Association, 287 (3): 337-344; Kaufman et al., “Recent patterns of medication use in the ambulatory adult population of the United States: the Slone survey.”
Investigating Brain-Body Interactions
NCCAM scientists are exploring ancient practices such as meditation, Tai Chi, hypnosis, and yoga to understand their abilities to harness the healing effects of the mind on the body. For example, NCCAM grantees are conducting pilot studies of yoga as a behavioral intervention for the management of chronic obstructive lung disease, insomnia, and chronic low back pain, as well as investigating whether one's spirituality and religiosity have a significant influence on immune system functioning.
In 2003, NCCAM-funded researchers reported that a traditional Chinese meditative exercise regimen, Tai Chi, could enhance physical performance and immune responses in older people. As people age, immunity to the virus that causes chicken pox wanes until the infection can reactivate from its dormant state in nerves and develop into the painful condition shingles. The study concluded that older adults who participated in a form of Tai Chi for 15 weeks experienced statistically significant increases both in cellular immune responses to the virus and in physical performance. This is the first scientific study to show that a CAM approach is responsible both for improvements in physical function and in virus-specific immunity and provides the basis for a larger study of Tai Chi currently being supported by NIH.
To further stimulate research in the field of brain-body interactions, NCCAM is a cosponsor of several NIH research initiatives. The first effort, entitled Mind-Body Interactions and Health: Exploratory/Developmental Research Program, will foster program development at institutions that have high potential for advancing mind-body and health research. The second initiative, Research on Mind-Body Interactions and Health, will support interdisciplinary collaborations and innovations to understanding the underlying processes of mind-body interactions and health and translating basic knowledge into interventions and clinical practices.
Five years ago, the discipline of rigorous CAM research was in its infancy. Absent precedents for the field, NCCAM's initial efforts led to supporting an array of studies spanning numerous CAM practices and health conditions. In these first years, NCCAM found that to better ensure that its funds yield compelling results, it needed to encourage studies on mechanisms of action of CAM approaches, well-developed Phase I and II clinical trials as a foundation for future definitive studies, and collaborations between CAM and research-intensive institutions. In the coming years, the Center will refine its research priorities even more, to emphasize those areas and conditions for which CAM can have the greatest health impact. To this end, in 2004, NCCAM began a formal process to seek input from its many stakeholders, including the scientific community, health professionals, and the public to further target its research, training, and communication goals and to craft a long-term plan to guide the way toward its tenth anniversary.
Complementing this strategic planning process are the trans-NIH Roadmap for Medical Research activities in which NCCAM leadership has a significant role. Core themes of the Roadmap resonate strongly with NCCAM because they promise to provide NCCAM grantees access to more sensitive technologies, richer environments for learning and conducting interdisciplinary research, and a re-engineered platform for clinical trials, all in ways that small institutes and centers could never achieve on their own.
In the coming months and years, I look forward to sharing with members of the Committee, the scientific community, practitioners, and the public our second strategic plan and the results of the research and training investments that we have made. Thank you for your interest in NCCAM's progress and plans. I would be pleased to answer any of your questions.