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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
March 28, 2000
Mr. Chairman and Members of the Committee:
I appreciate the opportunity to appear before you today to address the Subcommittee’s interests in complementary and alternative medicine (CAM), training of CAM researchers, NCCAM’s plans for facilitating integration of CAM modalities with conventional health care, and our support of mind-body research.
Accompanying me is Dr. Peter Kaufmann, Acting Director of the NIH Office of Behavioral and Social Science Research (OBSSR). He will be pleased to respond to any questions you may have regarding the overall NIH portfolio of research on behavioral and mind-body research supported across the NIH Institutes and Centers.
My presence here today, and moreover, NCCAM’s very existence, reflects the growing public interest in complementary and alternative medicine (or CAM, as we call it), 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. In recognition of this growing consumer trend, Congress in 1998 elevated the NIH Office of Alternative Medicine (OAM), expanded its mandate, creating the NCCAM, and affording it administrative authority to design and manage its own research portfolio. The Congress has 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.
As the NCCAM’s first permanent director, I am excited by the challenge put before me. As CAM use by the American people has steadily increased, many have asked whether reports of success with these treatments are valid. A number of practices, once considered unorthodox, have proven safe and effective and been assimilated seamlessly into current medical practice. 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. Practices such as meditation and support groups are now accepted as important allies in our fight against disease and disability.
In the absence of definitive evidence of effectiveness, however, alternative practices may impart untoward consequences. It is critical that untested but widely used CAM treatments be rigorously evaluated for safety and efficacy. Likewise, promising new approaches worthy of more intensive study must be identified. I am energized by this challenge to help provide the American public the guidance it seeks.
NCCAM’s strategy for taking on this challenge is different from that used by other NIH Institutes and Centers (ICs). While the research of other ICs is usually driven by basic scientific discoveries, NCCAM has chosen to focus most heavily on definitive clinical trials of widely utilized modalities that, from evidence-based reviews, appear to be the most promising. Compelling and rigorous data and not just anecdotes 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.
Accordingly, the NCCAM is developing a strategic plan to ensure that these responsibilities are consistent with our continued growth, development, and research directions. Five strategic areas have been identified: investing in research; training CAM investigators; expanding outreach; facilitating integration; and practicing responsible stewardship.
St. John’s Wort—Opportunities and Challenges
Already, NCCAM has developed a diverse research portfolio in partnership with the other NIH Institutes and Centers. Among these are some of the largest, and certainly the most definitive Phase III clinical trials ever undertaken for a range of CAM therapies. Allow me to highlight one of these studies to illustrate both the promises and the challenges presented by CAM therapies.
Extracts of St. John’s wort, a widely distributed flowering plant, have become quite popular as a treatment for depression. In fact, by some accounts, it is the number-one selling nutritional supplement. Because of this intense interest, NCCAM, the National Institute of Mental Health, and the NIH Office of Dietary Supplements are collaborating on a study of the safety and effectiveness of St. John’s wort for the treatment of depression. While that study is now nearing completion, those of other groups have underscored our interest in learning more about this botanical.
A recent report in The British Medical Journal, for example, 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 desired level for effective AIDS treatment. Interestingly, other studies have suggested that St. John’s wort has a similar effect on cyclosporin A, a drug used to prevent the rejection of transplanted organs. The use of St. John’s wort may also increase an individual’s sensitivity to exposure to the sun.
As these studies demonstrate, the dearth of credible scientific evidence on CAM practices provides unprecedented opportunity for determining the safety and efficacy of CAM modalities. Included in our already very broad research agenda are studies of mind-body medicine.
NCCAM’s Mind-Body Research
Mind-body medicine encompasses a spectrum of behavioral, biomedical, social, and spiritual components of our makeup that interact on a continuing basis in health and disease. This broad discipline overlaps partially with the NCCAM mission. The CAM community does not consider it a priority for NCCAM to study mind-body approaches that have a well-documented theoretical and evidence base such as patient education, biofeedback, and cognitive-behavioral approaches that are all addressed extensively by the other ICs working in concert with OBSSR. On the other hand, the types of projects NCCAM supported are rigorous studies of mind-body modalities involving 1) still undocumented CAM techniques; 2) modalities for which there is little evidence in the conventional medical research community; and 3) unorthodox uses for otherwise conventionally accepted mind-body techniques, such as hypnosis.
In keeping with this approach, the NCCAM portfolio already contains studies on
- efficacy of relaxation/guided imagery and chamomile tea for treating bowel disorders in children;
- self-hypnosis, acupuncture, and osteopathic manipulation for children with cerebral palsy;
- palliative benefits of hatha yoga on cognitive and behavioral changes associated with aging and neurological disorders in multiple sclerosis patients and in the healthy elderly;
- reducing hypertension and other cardiovascular disease (CVD) risk factors through meditation;
- a combination of relaxation training, hypnosis, and guided imagery employed during radiologic procedures to reduce the need for intravenous drugs and improve patient safety;
- improvement in well-being and immune function as a result of self-transcendence in members of a breast cancer support group;
- biofeedback and yoga to treat asthma; and
- Tai Chi, compared to western exercise, in preventing frailty in the elderly.
One key aspect of mind-body research involves studies of the “placebo effect.” Later this year, NCCAM, in collaboration with NIDDK and other ICs, will convene a trans-NIH conference on this subject. Goals of the conference include providing a scholarly assessment of the state of the field; identifying areas for which there is scant research, but considerable opportunity; and recommending a research agenda to move the field forward, in particular projects to be pursued by interested ICs through individual or joint initiatives with NCCAM. Elucidating the nature of the placebo effect will help us better harness the healing power of the mind.
Integrative Medicine, Research Training, and Communications
Medicine is an ever-evolving discipline. It integrates or rejects approaches based on scientific evidence. The results of rigorous research in CAM, including studies of mind-body medicine, will enhance the successful integration of safe and effective modalities into mainstream medical practice. NCCAM initiated a series of specific activities to facilitate this. On December 13, 1999, NCCAM solicited applications 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 their patients toward safe and effective CAM applications. In addition, we must work to overcome the reluctance of conventional physicians to consider validated CAM therapies and to assimilate proven ones into their practice. To this end, on December 13, 1999, the Center 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. NCCAM also plans to solicit applications for applied research focusing on identifying barriers to the use of CAM modalities by conventional physicians; developing strategies to incorporate validated CAM interventions into standard medical practice; and evaluating the effects of this incorporation.
Integrative medicine is also a key goal of NCCAM’s planned Intramural Research Program and a component of NCCAM’s Specialized Research Centers. Each of the Specialized Research Centers 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 the NIH Office of Dietary Supplements 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 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. Research training is conducted by these Centers, in part to advance our goals in integrative medicine, but also to assist us in building a cadre of skilled CAM investigators. Some of NCCAM’s Centers spend as much as 10 percent of their budget on training. In this regard, in 2 weeks I will be addressing the Deans of all U.S. medical schools on the subject of NCCAM’s research and research training agenda.
Specific statutory authority enables the NCCAM to reach out directly to the public and practitioners to provide them with critical and valid information regarding the safety and effectiveness of CAM therapies. This provides another vehicle for facilitating integration. A focal point for information about NCCAM programs and research findings is the NCCAM Information Clearinghouse, which 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 2 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.
NCCAM sponsors national meetings, consensus conferences, and workshops. As outreach to research and medical professionals, CAM practitioners, and the health care consuming public, NCCAM has initiated a series of town meetings. The first of this series was held on March 15 in Boston, in conjunction with the Center for Alternative Medicine Research 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.
In closing, I would like to share with the Subcommittee my vision of where I expect complementary and alternative medicine to be in the years to come. I am confident that NCCAM’s leadership will stimulate both the conventional and CAM communities to conduct compelling scientific research. Several therapeutic and preventative modalities currently deemed elements of CAM will prove effective. Based on rigorous evidence, 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. Modalities found to be unsafe or ineffective will be rejected readily by a well-informed public.
I would be pleased to answer your questions on NCCAM’s activities and plans.