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Development of a Comprehensive, National Research Strategy for Complementary and Alternative Medicine
Statement of Stephen E. Straus, M.D., Director National Center for Complementary and Alternative Medicine
Testimony before the House of Lords, United Kingdom
Before the Subcommittee on Complementary and Alternative Medicine
Select Committee on Science and Technology
House of Lords
United Kingdom
Tuesday, July 11, 2000
My Lord Chairman:
I appreciate this opportunity to appear before the House of Lords Select Committee on Science and Technology's Subcommittee on Complementary and Alternative Medicine. I am here today to discuss the organization I direct, the National Center for Complementary and Alternative Medicine (NCCAM), and our efforts to develop a comprehensive, national research strategy for complementary and alternative medicine (CAM).
So that I may describe adequately the unfolding American dialogue on CAM, as it may be relevant to your own deliberations, please allow me to clarify briefly the role of NCCAM in this context.
Introduction
NCCAM is one of the 25 Institutes and Centers that presently comprise the National Institutes of Health (NIH). The Center's budget for fiscal year 2000 is $68.4 million. You may be familiar with names like the National Cancer Institute or the National Institute of Allergy and Infectious Diseases, which are older and larger siblings of NCCAM. Like NCCAM, their names provide some sense of the scope of their individual missions within NIH. NIH is one of several agencies within the Department of Health and Human Services (DHHS). The Secretary of Health and Human Services reports to the President of the United States.
The NIH, with a budget this year of $17.8 billion, is the largest government-sponsored supporter of medical research worldwide. Its role is limited to research. The myriad other critical health care issues is managed by other agencies within the DHHS. For example, ensuring the quality and safety of medications falls under the purview of the Food and Drug Administration, while health care for those who cannot afford private insurance is covered by the Medicaid program of the Health Care Financing Administration.
Although jurisdictions of the various health agencies within the U.S. Government are well documented, the national dialogue on CAM has raised a host of issues transcending the various Federal players. For example, licensing of physicians, as well as CAM practitioners, is an authority that is reserved for the individual States. Confronted by such challenges, the U.S. Congress decided to initiate a review of the spectrum of CAM-related issues, other than research. In 1998, the same law that established the NCCAM also established the White House Commission on Complementary and Alternative Medicine.(1) The Commission, a separate administrative entity from NCCAM, is charged with making recommendations to the President on how these issues would be best addressed. The Commission is not yet operational. The White House is currently in the process of constituting its members and staff. Because the Commission's mandate and organization are clearly distinct, I will confine my comments today to the development of NCCAM's research strategy.
Growing Consumer Interest in CAM
The establishment of NCCAM by the U.S. Congress was precipitated by a growing interest in CAM, and a common belief that various CAM therapies may play a role in improving health. In 1997, approximately 42 percent of U.S. healthcare consumers spent $27 billion on CAM therapies.(2) 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 have been assimilated into current medical practice. Acupuncture is commonly applied to manage chronic pain and nausea associated with chemotherapy. Meditation and support groups are now accepted as important allies in our fight against disease and disability. While many CAM approaches rely on plant products, it is important to recall that some of our most effective drugs, such as digitalis for heart disease, and vincristine and taxol for cancer, are of botanical origin. Additional CAM practices have the potential to prevent and treat disease, to improve understanding of how healing works, and to be integrated into the routine practice of medicine.
Lessons from St. John's Wort
For example, extracts of the botanical, St. John's wort, have become quite popular as a treatment for depression. In fact, by some accounts, St. John's wort is the number-one-selling nutritional supplement.(3) Because of this intense interest, NCCAM and its research partners are collaborating on a study of the safety and effectiveness of St. John's wort in treating depression.
A recent report 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 antidepressant drug imipramine.(4) NCCAM's ongoing larger and longer-term study compares St. John's wort with placebo and with sertraline, currently one of the most commonly used anti-depressants. We have recently completed patient recruitment and look forward to results of the trial in 2001.
The potential benefit of St. John's wort, however, comes with previously understudied and unappreciated risks. One study published in February 2000 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.(5) Preliminary evidence indicates that St. John's wort lowers the therapeutic activity of some types of oral contraceptives(6) and cyclosporin A, a drug used to prevent the rejection of transplanted organs.(7) One study noted that the use of St. John's wort may also increase an individual's sensitivity to sunlight.(8) These findings illustrate vividly both the promise and challenges presented by CAM therapies. Through rigorous research, we will be able to determine not only to what extent each therapy is safe or effective, but under what circumstances an effective CAM modality may be contraindicated.
Underpinnings of the NCCAM Research Strategy
As the example of St. John's wort shows, a widely used botanical drug may impart unexpected adverse consequences. It is critical that untested but widely used CAM treatments be rigorously evaluated both for safety and efficacy. Likewise, promising new approaches worthy of more intensive study must be identified. The NCCAM mandate is to 1) conduct and support CAM research; 2) support research training; and 3) disseminate information on validated therapies. As the NCCAM's first permanent director, I am energized by this challenge.
In order to best seize the opportunities before us, we have developed a research strategy based on the well-established tools of rigorous scientific design, conduct, and oversight. Currently, many CAM therapies used by the public are supported only by anecdote and by small case studies. One might construe a hierarchy of evidence with anecdote at its base, and as we move upwards, case studies, observational studies, uncontrolled trials, small randomized clinical trials, large randomized clinical trials, and systematic reviews. In striving to elevate CAM research to a higher standard, we view randomized, double-blind controlled trials as the "gold standard." While we intend to foster creativity and flexibility, our clinical trial designs will be the most rigorous possible.
The extensive use of untested CAM practices by the American public has dictated that NCCAM make clinical research its highest priority and the centerpiece of its research portfolio. In this respect, NCCAM's approach differs significantly from that of the medical research community at large. While their research agenda is driven primarily by basic scientific discoveries, CAM consumers and healthcare practitioners want to know now whether available options are safe and effective in humans. Thus, NCCAM must study promising CAM substances and modalities even before knowledge is available about their active ingredients, mechanisms of action, stability, and bioavailability.
To help identify fertile areas for clinical investigation and the appropriate level of investment in these areas, the NCCAM relies on evidence-based reviews. Other factors, such as utilization by the American public, the potential for public impact, the strength of preliminary data, the opportunity to expand the science base, feasibility, and cost, are also considered.
To ensure that we remain true to our mandate and that our research is directed, we have developed a draft strategic plan. Among our programmatic priorities, we have identified the following issues as critical to our future success:
- investing in research;
- training CAM investigators;
- expanding outreach; and
- facilitating integration.
We have also made a firm commitment to practice responsible stewardship--that is, to maintain a level of excellence in our administrative practices and fiscal management.
Following a period of public comment, this draft plan is currently undergoing final revision this summer. The version will be posted to our Web site (nccam.nih.gov).
Concurrently, we have joined the NIH effort to reduce or eliminate health disparities in minority and underserved populations. NCCAM's effort will focus on
- identifying the extent and nature of CAM use among special populations;
- studying therapeutic interventions to reduce disparities;
- increasing participation of minority and underserved populations in NCCAM-supported clinical trials; and
- enhancing the ability of minority institutions to support CAM research.
These efforts have already contributed to our direction and, together with our research partners, we have developed a diverse research portfolio. Allow me to discuss a few of these activities.
Highlights of the NCCAM Research Portfolio
In addition to the study of St. John's wort for depression, NCCAM is conducting the largest and most definitive Phase III clinical trials ever undertaken for a range of CAM therapies. Among them are placebo-controlled multicenter trials of
- glucosamine and chondroitin sulfate for osteoarthritis;
- shark cartilage for non-small cell lung cancer;
- Ginkgo biloba for the prevention of dementia;
- saw palmetto for benign prostatic hyperplasia; and
- acupuncture for osteoarthritis.
For other, less well-studied, but still promising approaches, NCCAM is funding smaller, pilot studies to establish the scientific rationale and methodological feasibility needed to justify large, randomized clinical trials.
NCCAM also supports a program for Specialized Research Centers. These Centers enlarge considerably the infrastructure for conducting innovative CAM scientific investigation. Each supports a broad range of basic, clinical, and intervention studies in CAM research and development; evaluates research opportunities in their speciality areas; develops a corresponding research agenda; and conducts research training. Their research focuses on the examination of the potential efficacy, safety, and validity of diverse CAM practices, as well as the physiological or psychological mechanisms that underlie them. Currently, we fund Centers specializing in botanicals; cancer; cardiovascular disease; substance abuse; pediatrics; chiropractic; minority health; aging; neurological disorders; arthritis; and craniofacial health at an average level of $1.5 million per year, each.
Another priority within our research portfolio is our Frontier Medicine Research Program. We define frontier medicine as CAM practices for which there is no plausible biomedical explanation. Examples include such interventions as magnet therapy, energy healing, homeopathy, and therapeutic prayer. Despite the fact that these therapies are extensively used by the American public, little high-quality research has investigated their efficacy and safety. This fledgling program has been designed to involve collaboration between conventional and CAM institutions, practitioners, and researchers. Research projects will test novel hypotheses for which there are minimal preliminary data or lack of a conventional biological rationale. These hypotheses, if confirmed, could extend our current understanding of biological systems.
A majority of the CAM modalities practiced in the United States 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, 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, for example new immigrants like the Hmong (from Laos) and Native American 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, we have 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 NCCAM's Director for International and Traditional Medicine Studies, who will develop a long-range plan for the pursuit of studies with interested international partners, on a global scale.
The Need for Research Training
NCCAM's ability to achieve its research goals critically depends on the availability of a cadre of skilled investigators in both the CAM and conventional communities. Thus, NCCAM must encourage skilled researchers to investigate CAM approaches, and train CAM and conventional practitioners to conduct or participate in rigorous studies.
Through several funding mechanisms, the NCCAM supports a full spectrum of pre-doctoral, post-doctoral, and career awards to encourage the development of excellent investigators. We have established a Clinical Research Curriculum Award to attract talented clinicians to pursue careers as investigators and to provide them with the skills required for CAM research. NCCAM also plans to fund development of model curricula for students to foster their interest in and understanding of CAM research. The challenge is to train a critical mass of individuals who will apply rigorous scientific research standards to CAM systems and modalities.
Facilitating Integration
Only by holding CAM modalities to the highest standards of evidence will we best facilitate the creation of an integrated healthcare delivery system in which conventional physicians and CAM practitioners work as an interdisciplinary team. As the Prince of Wales commented in 1998, "This isn't a question of orthodox medicine taking over, or of complementary and alternative medicine diluting the intellectual rigour of orthodoxy. It is about reaching across the disciplines to help and to learn from one another for the ultimate benefit of the patients you all serve."(9)
NCCAM has already begun a number of activities toward that goal. The Center plans to make awards to foster the incorporation of CAM information into the curricula of medical and allied-health schools and continuing medical education programs. Likewise, we plan to support the education of eager medical students about CAM so that they may knowledgeably guide their patients toward safe and effective CAM applications. NCCAM has also pledged to evaluate the attitudes of conventional physicians towards integration of CAM therapies; support demonstration projects focusing on translating CAM research findings into practice; and disseminate CAM research findings to healthcare providers.
In this regard, I am pleased to report to you that in January 2001, the NCCAM is cosponsoring, with the Royal College of Physicians, a workshop on CAM, here in London. Attendees will include both U.S. and U.K. scientists who will discuss and broadly consider integrated medicine with regards to patient care, medical education, regulation and certification, and scientific evidence, as a means of advancing research in this field.
The Commitment to Dialogue with Our Stakeholders
Specific statutory authority enables us 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. The NCCAM Public Information Clearinghouse plays an important role in information dissemination. It develops and disseminates fact sheets, information packages, and publications to enhance public understanding about CAM research supported by the NIH. Our quarterly newsletter, Complementary & Alternative Medicine at the NIH, is distributed to 6,000 subscribers and is also posted on our Web site. Currently, our Web site averages more than 460,000 hits per month and includes links to NCCAM program areas, news and events, and research funding opportunities.
In addition, NCCAM manages two bibliographic databases: the CAM Citation Index (CCI) and the Combined Health Information Database (CHID). The first database, CCI, provides access to over 175,000 bibliographic citations, produced by the National Library of Medicine, that are of interest to consumers and the scientific research community. The second database, CHID, includes a variety of health information materials not available in other databases, including nearly 1,000 CAM citations.
Another strategy we employ in communicating with our constituencies is sponsorship of national meetings, consensus conferences, and workshops. Recently, NCCAM initiated a series of town meetings to reach research and medical professionals, CAM practitioners, and the public. The opportunity for dialogue at the local level is important to us, not only for disseminating key research findings, but also for our stakeholders to provide perspective and help us shape our overall research strategy.
Conclusion
In closing, I would like to share with this distinguished body my vision of the future for complementary and alternative medicine. This vision is firmly anchored in an ideal of Prime Minister Benjamin Disraeli 130 years ago, "The secret of success is constancy to purpose."(10) In this case, our constancy to providing steadfast leadership and demanding diligent service will stimulate both the conventional and CAM communities to conduct compelling and open-minded 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. 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. A well-informed public will reject readily those modalities found to be unsafe or ineffective.
My vision is an optimistic one. However, I am confident that we and our research partners can create a vibrant and global, CAM research community. We look forward to the best and most committed scientists and clinicians of the United Kingdom joining us in this quest.
References
1. Public Law 105-277. The Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999. [Return to Testimony]
2. Eisenberg, D.M. et al. Trends in Alternative Medicine Use in the United States, 1990-1997. JAMA. 1997; 280:1569-75. [Return to Testimony]
3. Nutrition Business Journal. San Diego, CA: Nutrition Business International, 1998. [Return to Testimony]
4. Philipp, M. et al. Hypericum extract versus imipramime or placebo in patients with moderate depression: randomised multicentre study of treatment for eight weeks. British Medical Journal. 1999; 319:1534-39. [Return to Testimony]
5. Piscitelli, S.C. et al. Indinavir concentration and St. John's wort. Lancet. 2000; 355:547-8.[Return to Testimony]
6. Baede-van Dijk, P.A. et al. Drug interactions of Hypericum perforatum (St. John's wort) are potentially hazardous. Ned Tijdschr Geneeskd. 2000; 144(17):811-2. [Return to Testimony]
7. Ruschitzka, F. et al. Acute heart transplant rejection due to Saint John's wort. Lancet. 2000; 355(9203):548-9. [Return to Testimony]
8. Woelk, H. et al. Benefits and risks of the hypericum extract LI 160: drug monitoring study with 3,250 patients. Journal of Geriatric Psychiatry and Neurology. 1994. 7 (Supplement 1):S34-8. [Return to Testimony]
9. The Prince of Wales. Speech before the Integrated Healthcare Conference. May 28, 1998. [Return to Testimony]
10. Benjamin Disraeli. Speech. June 24, 1870. [Return to Testimony]
