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Fiscal Year 2001 Budget Request
Statement by Stephen E. Straus, M.D., Director,
National Center for Complementary and Alternative Medicine
before the Senate Appropriations Subcommittee on Labor, DHHS, Education, and Related Agencies on the Fiscal Year 2001 President's Budget Request for the NCCAM
Thursday, March 30, 2000
Mr. Chairman and Members of the Committee:
I am pleased to present the President's non-AIDS budget request for the National Center for Complementary and Alternative Medicine for FY 2001, a sum of $71,362,000, which reflects an increase of $3,381,000 over the comparable Fiscal Year 2000 appropriation. Including the estimated allocation for AIDS, total support requested for the National Center for Complementary and Alternative Medicine is $72,392,000, an increase of $3,381,000 over the Fiscal Year 2000 appropriation. Funds for the National Center for Complementary and Alternative Medicine efforts in AIDS research are included within the Office of AIDS Research budget request.
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 first performance report that compares our FY 1999 results to the goals in our FY 1999 performance plan. As our performance measures mature and performance trends emerge, the GPRA data will serve as indicators to support the identification of strategies and objectives to continuously improve programs across the NIH and the Department.
At the outset, I should note that NCCAM's work reflects the growing public interest in complementary and alternative medicine (CAM) and the belief that various CAM therapies may play a role in improved public health. Approximately 42 percent of U.S. healthcare consumers spent $27 billion on CAM therapies in 1997. CAM enjoys particular popularity among baby boomers. A number of practices, once considered unorthodox, have proven safe and effective and been assimilated seamlessly into current medical practice. Diet and exercise are today commonly used to prevent and control disease. Acupuncture is routinely applied to manage chronic pain and nausea associated with chemotherapy. Some of our most important drugs—digitalis, vincristine, and taxol—are of botanical origin.
Additional CAM practices have the potential to prevent and treat chronic disease, to improve understanding of how healing works, and to be integrated into the routine practice of medicine. Absent definitive evidence of effectiveness, however, alternative practices may impart untoward consequences for large numbers of people.
As the NCCAM's first permanent director, I am excited by the challenge afforded me to help provide the American public the guidance it deserves. As CAM use by the American people has steadily increased, many have asked whether reports of success with these treatments are valid. It is critical that untested but widely used CAM treatments be rigorously evaluated for safety and efficacy. It is similarly important to identify promising new approaches worthy of more intensive study. The promising areas for future investments are numerous.
In order to best seize these opportunities, the NCCAM's strategy must differ from that used by other NIH Institutes and Centers. Others' projects are usually driven by basic science discoveries. In contrast, the NCCAM must focus first on definitive clinical trials of widely utilized modalities that, from evidence-based reviews, appear to be the most promising. Credible, not anecdotal, data must be provided to the public, and we must educate conventional medical practitioners about the panoply of effective CAM practices, so they can be integrated into patient care. In recognition of these needs, Congress responded in 1998 by elevating the NIH Office of Alternative Medicine (OAM), expanding its mandate, creating the NCCAM, and affording it administrative authority to design and manage its own research portfolio. The Congress continued to reflect the growing interest in CAM by further increasing funding for the Center in FY 2000 to $68.4 million. We are indeed appreciative of this support. The Congress vested the NCCAM with a broad statutory mandate to conduct and support CAM research, support research training, and disseminate information on validated CAM therapies. Accordingly, the NCCAM is currently developing a strategic plan to ensure that our continued growth, development, and research directions are consistent with these responsibilities. Five strategic areas have been identified: investing in research; training CAM investigators; expanding outreach; facilitating integration; and practicing responsible stewardship.
In seeking to fulfill its mandate, the NCCAM has undertaken a number of initiatives, established critical contacts with CAM practitioners, and begun to fashion the scientific underpinning that will enable future research discoveries.
Before describing these activities, I want to share with the Subcommittee my vision of where I expect complementary and alternative medicine to be in the years to come. As a result of rigorous scientific investigation, several therapeutic and preventative modalities currently deemed elements of CAM will prove effective. Therefore, in future years, these interventions will be integrated into conventional medical education and practice, and the term “complementary and alternative medicine” will be superseded by the concept of “integrative medicine.” The field of integrative medicine will be seen as providing novel insights and tools for human health, and not as a source of tension that insinuates itself between and among practitioners of the healing arts and their patients. Advances in neurobiology will reveal more about ancient practices such as acupuncture and meditation, as well as the phenomenon of “the placebo effect” as we tap the healing power of the mind. The medical basis for effectiveness of selected herbal and nutritional supplements will be clarified, leading to their standardization and routine use. Other modalities will be found unsafe or ineffective, and an informed public will reject them.
My vision is an optimistic one. However, I am confident that, as it is realized, the NCCAM will have not simply expanded in those ways required to meet its research mission. Rather, owing to a tradition of superb science and consumer service, the NCCAM will become the leader—and recognized as such—within a vibrant, and global CAM research community.
Already, I have begun to recruit key experts to join me in developing our programs in intramural research, clinical research, international and traditional health studies, and traditional medicine and indigenous systems. We will continue to grow our intellectual capital and research capacity. Setting these cornerstones in place will enable us, together with our partners in CAM research, to provide definitive answers regarding CAM treatments.
Current Research Studies
In its first year, NCCAM has developed a diverse research portfolio in partnership with the other NIH Institutes and Centers. I am pleased to highlight for you our support of some of the largest, and certainly the most definitive Phase III clinical trials ever undertaken for a range of CAM therapies.
For centuries, extracts from the leaves of the Ginkgo biloba tree have been used as Chinese herbal medicine to treat a variety of medical conditions, including age-related decline in memory. A new NCCAM study, in collaboration with the National Institute on Aging (NIA), may help resolve these questions. This study includes four clinical centers and will enroll almost 3,000 participants who will receive either Ginkgo biloba or a placebo.
Arthritis is a major public health problem for older Americans. Accordingly, in collaboration with NIAMS, NCCAM has mounted two critical clinical trials for the treatment of osteoarthritis. One is the first U.S. multi-center study to investigate the dietary supplements glucosamine and chondroitin sulfate—two natural substances found in and around joint cartilage. The other study is an evaluation of acupuncture for the treatment of pain associated with osteoarthritis.
I am pleased to report that our study of St. John's wort for depression is nearing completion. This study, sponsored by the NCCAM, NIMH, and the NIH Office of Dietary Supplements (ODS), represents the largest and most rigorous assessment of the effectiveness and safety of St. John's wort. Investigations of St. John's wort illustrate the complex challenges afforded by some CAM modalities. A recent study reported in The British Medical Journal showed that St. John's wort is more effective than placebo in treatment of depression, and perhaps as effective as an older generation anti-depressant drug, imipramine. NCCAM's study, which is considerably larger than the European trial, compares St. John's wort with placebo and with Zoloft, currently one of the most commonly used anti-depressants. However, the therapeutic promise of St. John's wort and of botanical products like it, is accompanied by risks that the public has largely ignored. An NIH study published February 12th in the Lancet found that St. John's wort, when taken together with the important HIV protease-inhibiting drug, indinavir, increased the rate at which indinavir was eliminated from the bloodstream, to the extent that blood levels fell below the acceptable level for effective AIDS treatment.
NCCAM continues support for four Specialized Research Centers (cardiovascular disease, substance abuse, pediatrics, and chiropractic) funded originally by the Office of Alternative Medicine. By the end of FY 1999, NCCAM made five additional Specialty Research Center awards. The nine Center grants total approximately $63 million. Each focuses on one of several areas, including pediatrics, addiction, cardiovascular disease (CVD), minority aging and CVD, aging, neurological disorders, craniofacial health, arthritis, and chiropractic medicine. In addition to these nine Centers, NCCAM and ODS jointly established two Dietary Supplements Research Centers to advance the science of botanicals, including issues of their composition, safety, and biological action. Another request for Center grant applications focusing on asthma and cancer recently was released for FY 2000. This, coupled with our anticipated solicitation of one more botanical center in FY 2000, will likely bring our total number of NCCAM-supported centers to as many as 15.
Benign prostatic hyperplasia (BPH), or non-cancerous enlargement of the prostate, is the most common benign tumor found in men. Anecdotal reports suggested that the botanical product saw palmetto decreases prostate swelling. To determine the validity of these observations, NCCAM, in collaboration with National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK), is supporting the first rigorously designed, placebo-controlled study to evaluate the effect of saw palmetto extract on symptoms and quality of life in men.
Future Scientific Plans and Projects
Because of the dearth of credible scientific evidence on CAM practices, there is unprecedented opportunity for determining the efficacy and safety of CAM modalities. We have developed the following initiatives to address them:
NCCAM has planned a collaboration on the treatment of liver disease with the NIDDK and the National Institute of Allergy and Infectious Diseases (NIAID). The project will examine the efficacy of milk thistle extract–Silybum marianum–when used to treat hepatitis C and other hepatic diseases.
NCCAM has already begun a number of activities that will serve to facilitate the integration of validated CAM therapies into conventional medical practice. The NCCAM plans to make awards to foster incorporation of CAM information into the curricula of medical and allied health schools and continuing medical education programs. Also, the NCCAM must educate eager medical students about CAM so that they may knowledgeably guide an avid patient base toward safe and effective CAM applications. We must also work to overcome the reluctance of conventional physicians to consider validated CAM therapies and to assimilate proven ones into their practice. The Center has established a Clinical Research Curriculum Award (CRCA) to attract talented individuals to CAM research and to provide them with the critical skills that are needed.
A majority of the CAM modalities practiced in this country have arisen from the traditional healing practices of other nations. Some of the practices have “evolved” or been adapted to work within the context of our society, and often in parallel with conventional medical practices. Moreover, most of these practices are not well documented within the context of their native cultures or understood within the context of our own. Unraveling these issues will provide some important insights into how these CAM modalities are practiced and impact upon the health of U.S. minority populations—new immigrants like Hmong (from southeast Asia) and established groups like the Navajo. Likewise, the development of culturally sensitive studies will enable NCCAM to establish methodological feasibility and strengthen the scientific rationale for proceeding to full-scale, randomized, clinical trials on the application of traditional, indigenous systems. The ability to validate some of these therapies will also expand healthcare options for those who are primarily consumers of conventional medicine. The international character of CAM necessitates that the NCCAM develop a broad-based international research program that reaches out to CAM practitioners across the world. Therefore, in collaboration with several other ICs, NCCAM is committed to support locally based, traditional, indigenous research projects in countries where the opportunities for promising CAM research are greatest. That process will ensue with the forthcoming appointment of a Director for International and Traditional Medicine Studies, who will develop a long-range plan for the pursuit of studies on a global scale. Foreshadowing this appointment, I have already authorized NCCAM support, in collaboration with the NICHD, for international studies of traditional medical approaches to the health of women and children.
The NCCAM will establish an Intramural Research Program that will develop a critical mass of CAM research to stimulate collaboration in the NIH Clinical Center with other Institutes and Centers, our Federal research partners, and others. The intramural program will serve as a focus for training future CAM researchers. Last month I formed a search committee to identify the Director of this program.
Specific statutory authority enables the NCCAM to disseminate information regarding the safety and effectiveness of CAM therapies to healthcare providers and the public. A focal point for information about NCCAM programs and research findings, the NCCAM Information Clearinghouse develops and disseminates fact sheets, information packages, and publications to enhance public understanding about CAM research supported by the NIH. Its quarterly newsletter, Complementary & Alternative Medicine at the NIH is distributed to 6,000 subscribers. The NCCAM's award winning World Wide Web site, first established two years ago, reflects the NCCAM's growth in size and stature. Averaging more than 460,000 hits per month, the site includes links to NCCAM program areas, news and events, research grants, funding opportunities, and resources. Assembled by NCCAM from the National Library of Medicine's (NLM) MEDLINE database, the CAM Citation Index (CCI) affords the public access to approximately 175,000 bibliographic citations searchable by CAM system, disease, or method. Also, in February 1999, NCCAM joined the federally supported Combined Health Information Database (CHID), which includes a variety of health information materials not available in other government databases, including nearly 1,000 CAM citations not available elsewhere.
To facilitate our outreach to the general public, I have initiated a series of town meetings; the first was held on March 15 in Boston, in conjunction with the Center for Alternative Medicine and Education of Beth Israel Deaconess Medical Center. Over 500 attendees heard presentations on the importance of CAM research. Many substantive issues were raised in the public forum portion of the program. The opportunity for dialog at the local level is important for us, not only for disseminating key research findings, but also for the public to provide perspective and help us shape our overall research strategy.
I am now happy to take your questions about these or any other of NCCAM's activities and plans.