| U.S. Government Organizations Sponsor Alternative Medicine Research |
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| by Daniel Eskinazi & Freddie Ann Hoffman |
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article provided by: Since the creation of the Office of Alternative Medicine (OAM)-now elevated to center status and renamed Center for Complimentary and Alternative Medicine-at the National Institutes of Health (NIH) in 1992, mandated to "investigate and validate" alternative therapies, substantial progress has been made in evaluation and clinical and scientific acceptance of "complementary and alternative" medicine (CAM). Two initial meetings sought to define CAM and describe its domestic and foreign use, and to identify and examine evidence for various practices and categories of CAM (see Table 1). A published report to NIH in 1995 reviewed the fields of CAM practice and recommended research priorities. Contacts with the CAM community suggested that, in addition to developing scientific information, CAM researchers needed instruction in administrative and regulatory requirements in order to properly evaluate CAM practices. Due in part to initiatives conducted jointly by NIH and the Food and Drug Administration (FDA), two CAM practices in particular (acupuncture and botanical medicine) have seen strong advances. Legalization of acupuncture needles in 1996 (considered as Class III investigational devices since 1973), was a result of workshops sponsored by OAM and the FDA, in which data were presented to support clinical use of acupuncture for acute and chronic pain, antiemesis, substance abuse, pulmonary disease such as asthma, and post-stroke rehabilitation. "Citizens' Petitions" filed in 1994 by workshop participants sought reclassification of the needles. While the FDA did not consider the clinical data sufficient to approve any particular use, the safety information was deemed adequate to support the needles' reclassification to a Class II device. "Botanicals"-products that contain ingredients of vegetable matter or its constituents as a finished product-may include whole plants, plant parts, or juices, gums, or oils, but not products such as Taxol(r), which, although originally isolated and purified from the Pacific yew tree (Taxus brevifolia), has been purified and standardized to homogeneity. In the U.S., use of botanicals to treat medical conditions is considered CAM. Botanicals are a unique class of products for regulators, because they may be classified as foods, drugs, biologics, or devices. Most drugs in the recent past in the U.S. have been homogenous substances. Most heterogeneous botanicals sold in the U.S. are classified as foods, including dietary supplements. This is in sharp contrast to foreign markets, where many botanicals are sold-and reimbursed-as drugs. Prompted by these regulatory issues, OAM, along with the NIH, FDA, and others, conducted five international meetings to examine evidence for and the role of botanical medicine in the U.S. At the first international symposium, panels addressed these issues: 1) What are botanicals and how are they currently used? 2) How can we know that they work? 3) How can we know that they are safe? 4) How can we ensure good quality of botanical preparations? 5) What are the incentives and barriers to marketing botanicals in the U.S.? [The primary author of this article, Dr. Eskinazi, was formerly a deputy director of OAM. He chaired the conference referred to here, and is the main editor of the proceedings, recently published as Botanical Medicine: A European Professional Perspective, published by Mary Ann Liebert Publications, 1996. Available from the ABC Herbal Education Catalog, 393 pp, item #B319, $35.] A series of workshops followed that first symposium, sponsored by the Drug Information Association (DIA) and U.S. Pharmacopeia (USP), in conjunction with NIH and FDA, to explore scientific, regulatory, and policy issues. [The second author of this article, Dr. Hoffman, is a physician with the FDA who co-chaired these DIA conferences.] Use of botanicals worldwide, botanical nomenclature and chemical identification, standard-setting, and pharmacological and toxicological themes structured each workshop, which also included discussion of clinical data needed in the varied regulatory routes a product may take to the U.S. market. Of 42 original investigator-initiated exploratory research grants funded by OAM in 1993, three clinical trials proposed to evaluate the therapeutic usefulness of combinations of botanicals: to treat postmenopausal hot flashes, plantar warts, and chronic human immunodeficiency virus (HIV). These are noteworthy as the first evaluations of combinations of botanicals that have not been purified to homogeneity. Currently, a large multi-center trial is being sponsored by the National Institute of Mental Health (NIMH) on St. John's wort, used to treat depression. OAM is funding 11 academic centers in the U.S. to conduct research on CAM (see Table 2). Also, a number of field investigations are being undertaken to observe CAM practitioners at work, for the purpose of designing prospective outcomes studies and, eventually, clinical trials. In 1994, OAM sponsored a workshop on alternative cancer treatment and a symposium on CAM and health care reform. Some states, such as Washington, now require healthcare providers to offer CAM, along with conventional therapies, to policyholders. In 1995, OAM organized a conference on behavioral and relaxation therapy. And in 1997, OAM and others organized meetings to discuss the Practice Outcomes Monitoring and Evaluation System (POMES), to develop clinical methodologies for studying CAM, and to develop clinical practice guidelines for CAM practitioners. Since the establishment of OAM, the U.S. has experienced strong progress in mainstream acceptance of acupuncture and botanical medicine. The interest of both academia and the government in exploring these practices will continue to be important in gaining additional acceptance within the mainstream. - Mariann Garner-Wizard |
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