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Testimony on Access to Medical Treatment Act by Wayne B. Jonas, M.D.
Director, Office of Alternative Medicine
National Institutes of Health
U.S. Department of Health and Human Services

Before the Senate Committee on Labor and Human Resources
July 30, 1996


Introduction

Complementary, alternative, and unconventional medicine (CAM), much of it imported and adapted from various times and cultures, is becoming increasingly popular in the industrialized world. A report from the Council of Europe in 1984 said, "It is not possible to consider this phenomena (unconventional medicine) as a medical side issue. It must reflect a genuine public need, which is in urgent need of definition and analysis." Indeed, over a decade later, the need for "definition and analysis of these various practices both alone, and in combination with conventional Western medicine is continuing to gro w-- especially as the pace of communication across cultures and countries increases.

According to the World Health Organization, between 65 to 80 percent of the world's health care services are classified as traditional medicine. These traditional practices become complementary, alternative, or unconventional when used in Western countries. Even in countries where modern Western biomedicine dominates, the public makes extensive use of unconventional practices. In Western Europe, for example, regular use of complementary and alternative practices range from 20 to 70 percent. In the United States, one out of every three Americans saw an alternative health care practitioner in 1990, constituting more visits than to conventional primary care physicians. As a result over 13 billion dollars were paid for these services. Ten billion dollars of this expense was out-of-pocket and not reimbursed.

The public uses these practices for both minor and major problems. Surveys show 50 percent of patients with cancer will use unconventional practices at some point during the course of their illness. Alternative medicine is an area of great public interest and activity, both nationally and world-wide.

There is not only public but professional interest in complementary and alternative practices. Over 50 percent of conventional physicians use or refer patients for complementary and alternative medical treatments in the United States. Forty percent of Dutch physicians use homeopathy, 70 percent of German pain clinics use acupuncture, and some of the most frequently written prescriptions by conventional physicians in Europe are written for herbal products.

Physicians in training want information about complementary and alternative practices. Over 80 percent of students in medical schools would like further training in these areas. Currently, almost a third of family practice residencies in the United States instruct in some type of complementary and alternative practice. Over 32 medical schools offer courses in CAM.

Research though still small by conventional standards is increasing. The rate of citations tagged "alternative medicine" in MEDLINE, the National Library of Medicine's bibliographic database, has grown at a rate of 12 percent per year since 1966.

Defining Alternative Medicine

Complementary and alternative medicine rides the border between conventional and vernacular practices. Currently, CAM is defined as those practices used for the prevention and treatment of disease that are not taught widely in medical schools, nor generally available inside hospitals. The themes dealt with by complementary and alternative medicine are cross-cutting, ranging from molecular biology to preventive and primary health care. CAM involves practices that are both complementary to, and integratable with conventional medicine as well as practices that represent true alternatives or substitutes for conventional care in situations where no conventional care exists. CAM practices may require highly specialized and competent practitioners, over-the-counter products, or self-care techniques. Just as there is a diversity of health care needs, there is a diversity of health care practices available to address those needs.

The history of complementary and alternative medicine is long. While the average half-life of a new drug introduced in the conventional community is about 20 years, homeopathy, for example, has been around, essentially unchanged for 200 years; acupuncture for more than 2,000 years; prayer, spiritualism, and shamanism for at least 20,000 years. If one believes reports of monkeys using plant products to regulate their offspring's gender, herbalism, is the oldest, having been in use for greater than 200,000 years. Likewise, the scope of CAM practices is broad. There are at least 12 conceptually independent health care systems developed world-wide. These fall into at least 27 major categories of practice involving over 200 methods, with thousands of techniques for applying those methods. Examples of major health care systems include Traditional Chinese Medicine, Ayurveda, Unan, Kampo, Native American Medicine, and Tibetan Medicine. Some "modern" systems include chiropractic, osteopathy, homeopathy, anthroposophical medicine, and naturopathy.

Unlike the practices, patients who use alternative medicine are not alternative patients. Over 80 percent of those who used unconventional practices in 1990 used these practices along with conventional medicine. These were the same patients seen in the offices of conventional physicians. Thus complementary and alternative practices are not used to replace conventional medicine, but instead, to fill in where conventional medicine requires supplementation and support. CAM patients are you and me -- patients who look for options and seek out optimal and customized care.

Establishment of the NIH Office of Alternative Medicine

Viable and valid options in health care require research and knowledge about the risks and benefits of medical practices. Research provides the tools for practitioners to execute their art. To address the increasing need for research in complementary, alternative, and unconventional medical practices, Congress created the Office of Alternative Medicine (OAM) in 1992, at the National Institutes of Health (NIH). The legislation also called for the establishment of a Program Advisory Council. Funds allocated for the Office were $2 million in 1992 and 1993, $3.5 million in 1994, $5.4 million in 1995, and $7.4 million in 1996.

The Congressional mandate outlined the purpose of the OAM to be:

  • Facilitate the evaluation of alternative medical,

  • Investigate and evaluate the efficacy of alternative treatment modalities

  • Establish an information clearinghouse to alternative medicine; and to

  • Support research training in alternative medical practices.
    OAM Organization and Functions

    After assuming directorship of the Office of Alternative Medicine in July 1995, I began to assess the scope, needs, and strategies required to support and carryout research in these diverse and often complex areas. I decided to reorganize the office into six functional sections, in order to address specific aspects of the Congressional mandate. These sections and their objectives include the following:

    1. The Public Affairs and Clearinghouse Sector, develops and disseminates information to educate and promote public awareness about complementary and alternative medical research and responds to multi- media.

    2. The Database and Evaluation Section, critically evaluates and categorizes research studies in CAM areas, provides a method for continually accessing and updating this critically appraised literature, and channels much of this information to the Clearinghouse.

    3. The Research Development and Investigation Section, proactively screens, prioritizes, and provides technical support to the most promising research opportunities in CAM from around the world.

    4. Development, review, funding and execution of specific CAM research projects. They coordinate this effort with other NIH Institutes, Centers, Divisions and Offices.

    5. The Intramural Research Training Program operates a coordinated, comprehensive research training program for conducting basic and clinical research in complementary and alternative health care practices.

    6. The International and Professional Liaison Section, coordinates and supports cooperative efforts in research and research education in CAM approaches world-wide.

    Finally, the OAM Director and the Office program support staff provide direction and provide operational support for these functional areas.

    Office Accomplishments

    Among the accomplishments of the Office are the following:

    1. In the area of Extramural Affairs, the Office funded 42 exploratory grants. The final results these are just coming in and will be disseminated through the Clearinghouse. We have recently funded 10 Clinical Research Centers around the country, at places such as Stanford. Harvard, University of Maryland, University of Virginia, University of California at Davis, University of Texas/M.D. Anderson. and others. These Centers were co-funded with four other Institutes, Centers, and Offices at the NIH, including the National Cancer Institute, the National Institute of Child Health and Human Development, the National Institute of Dental Research, and the Office of Research on Women's Health. The Office supports a post-doctoral training awards program, has participated in program announcements for bio-behavioral pain research in cooperation with 10 Institutes, Centers, and Divisions and has provided collaborative funding of selected Institute, Centers, and Divisions CAM research.

    2. In the area of technical assistance, the office has assisted in obtaining investigational new drug approval for various herbal and homeopathic products, helped with protocol development, grant proposal workshops, and has performed over 30 site visits to provide research technical assistance and support. The Office is exploring methods to assess and monitor the results of individual practices.

    3. In the area of public information, the OAM averages over a thousand inquiries per month about alternative and complementary medical practices and research and over 100 inquires monthly from the news media. A report to the Office by the alternative medicine community, known as the Chantilly Report (Alternative Medicine: Expanding Medical Horizons), was published in March of last year.

    4. In the area of database and evaluation, the OAM has worked with the National Library of Medicine to add medical keywords and MESH headings to their MEDLINE electronic database and has performed analyses of MEDLINE citations in alternative medicine. In addition, the OAM has supported the Cochrane Collaboration Field Group, for the purpose of collecting and evaluating randomized controlled trials in complementary and alternative medicine, and conducting systematic reviews and meta-analysis in these areas. The Office has an electronic database with over 150,000 citations and has collected and is reviewing over 2,600 controlled trials in alternative medicine.

    5. In the area of Professional and International Liaison, the OAM has made international contacts in China, India, Vietnam, Europe, Japan, Africa, South America, Australia, and many other countries. It has worked closely with the Food and Drug Administration, American Association of Medical Colleges, Health Care Financing Administration, Agency for Health Care Policy and Research, Department of Defense, Federation of State Medical Board Examiners, and numerous hospitals and managed care providers. The OAM has corresponded with over 150 alternative medical organizations providing them with information about research support and development.

    Among the conferences and workshops supported by the Office were 11 workshops on grant writing and the NIH grant evaluation process; conferences on methods in cancer research; botanicals; acupuncture; and research methodology. Additionally, the OAM staff has made over 50 presentations to a variety of audiences about the office and its functions.

    Current Activities and NIH Support

    Among its current activities, the Office has more than doubled its staff since July 1, 1995; including the addition of a new Director, and several new staff. The Office has been reorganized into functional areas, and developed an Institutes, Centers, and Divisions Coordinating Committee to coordinate its activities with other NIH components. The OAM has funded 8 new national research centers around the country; co-sponsored a technology assessment conference with the Office of Medical Applications of Research and eight other institutes; an educational conference with the Uniformed Services University for the Health Sciences; and moved to the main NIH campus in February 1996.

    Support from the NIH Office of the Director, as well as members of the NIH community as a whole has been outstanding. In fact, the scope of activities currently underway could not have been accomplished without such support. Considerable research already exists in complementary and alternative areas at the NIH. I look forward to continuing cooperative work with all programs at the NIH in conducting rigorous scientific research into complementary and alternative practices.

    Examples of Alternative Medicine Research

    Information about CAM practices with potential value in the way we treat and manage chronic disease come into the OAM everyday. For me, as a researcher and physician who cares for patients this information is the most exciting aspect of my job. Therapies that become popularized are often not the most interesting prospects. In botanical medicine, for example, there is research showing the benefit of herbal products such as ginkgo for improving dementia due to circulation problems; benign prostatic hypertrophy with saw palmetto preparations; and arthritis pain with extracts of the hot chili pepper (capsicum). Fourteen randomized, placebo-controlled trials have been done showing that hypericum (the St. John's Wort) is effective in the treatment of depression. Additional studies have compared it to conventional antidepressants. These studies report that it is not only equally effective as antidepressants, but produces one-fourth the side effects and is one-third the cost of conventional therapy. There is research reporting improvements in arthritis, using homeopathy, acupuncture, vitamin supplements, herbal products and diet therapies.

    An important area in need of research is the evaluation of integrative approaches to the treatment of cancer. These approaches use a combination of the best of conventional therapies with optimal complementary support strategies, such as nutrition and mind-body approaches. So often, it is not the magic bullets as developed in pharmacology, but combination approaches that prove most useful for problems with complex causes. Chronic pain, asthma, drug addiction, vascular disease, heart failure, frailty, stroke, diabetes, high blood pressure, and other conditions have been treated, usually in small trials, with a variety of alternative and complementary approaches, such as nutritional, mind-body and behavioral interventions, acupuncture, homeopathy and healing. Usually these therapies have fewer direct toxic side-effects than conventional treatments and may have lower costs. If they prove to be as effective, they may be preferable to patients.

    Increasing Access to Medical Treatments

    Accelerating access to potentially useful therapies, while simultaneously protecting the public from harm, is the goal of many research and regulatory agencies. The OAM would be happy to work closely with the Food and Drug Administration (and other organizations) in continuing to evolve and develop expeditious access efforts. The Office currently has no mechanism to assess and monitor the results of individual practices, but is exploring several possible methods for monitoring such as practice-based research networks. Other processes for accelerating access, which allow for reasonable public protection, include: single patient INDs, treatment INDS, parallel track efforts, expedited review, and accelerated approval mechanisms. Especially important for many complementary aid alternative practices might be adaptation of the three-tiered review process, with a one-tiered exemption option in which review mechanisms are more specifically tailored to the risk level of the therapy. If such developments were accompanied by methods for systematic data collection of selected unapproved therapies, a situation allowing access, assuring public safety, and furthering research could be accomplished.

    Conclusion

    The evaluation of complementary and alternative medicine will require flexibility, creativity, and rigor in research application. It will require the best of molecular and cellular biology, basic science research, surveys and epidemiological approaches, detailed case reports and best case series, multi-disciplinary and cross- cultural research, randomized and placebo controlled trials, prospective parallel outcome studies, cost-benefit evaluation, research summaries, meta-analyses, and direct comparisons of complex therapeutic systems. In all cases, the importance of objectivity, rigor, clarity of research goals, and the reduction of bias are paramount. If quality research in complementary and alternative medicine is supported and effectively carried out, it may solve many of our most burdensome and difficult problems in medicine today. It is the goal of the Office of Alternative Medicine to foster both rigor and realism in CAM research. It is the vision of the Office of Alternative Medicine to bring together the best of hearing and the best of science.


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