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Council for Responsible Nutrition, 1875 Eye Street, NW, Suite 400, Washington, DC 20006, E-mail: hathcock{at}crnusa.org
edited by D Eskinazi, M Blumenthal, N Farnsworth, and CW Riggins, 1999, 222 pages, softcover, $69.00. Mary Ann Liebert, Inc, Publishers, Larchmont, NY.
Botanical Medicine is a product of the 1994 symposium on this subject organized by the Office of Alternative Medicine of the National Institutes of Health in cooperation with the Food and Drug Administration. The chapters are grouped in the usual (but useful) categories: 1) identity and use, 2) evidence of efficacy, 3) evidence and assessment of safety, 4) quality assurance and its regulation, and 5) effects of regulations on the marketplace and the cost of health care. Participants in the symposium contributed the diverse viewpoints of governments, universities, research institutes, and industry. The authors represent an impressive array of recognized experts in medicine, pharmacognosy, regulatory policy, and the botanical products industry. Accordingly, the book encompasses the strengths and weaknesses of that extensive range of viewpoints. The strengths include a widespread, but not unanimous, inclination to apply the scientific approach of Western medicine to the evaluation of the effects of prospective botanical medicine products. The weaknesses include the apparent belief that bright lines can and should be drawn between "conventional" and "alternative" medicine and between "foods" and "drugs."
The title, Botanical Medicine, clearly reflects the viewpoint that botanical products providing active substances other than nutrients that have desirable health effects are medicines rather than foods. Yet, a substantial part of the volume addresses the unresolved issue of whether such products should be classified for regulatory purposes as foods or drugs. A substantial part of the disagreement relates to whether product composition and characteristics should determine this classification or whether it should depend on intended uses, in conjunction with the definitions in the Federal Food, Drug, and Cosmetics Act. State-of-the-art interpretations of the arguments in both directions, which may be useful to many readers, are provided but no progress is made toward resolution.
Several of the chapters provide highly authoritative and readable information in succinct form. The chapter by Blumenthal provides a handy summary of the uses and effects of 27 botanicals. Others provide personal perspectives about the validity and utility of botanical medicines. The chapters on how botanicals work recognize the difficulty of assessing the effects of the complex mixtures the products represent, and also provide examples of the contrasting failure of single components to have beneficial effects.
Perhaps the most contentious topic addressed is safety. One chapter describes the difficulties in using historical use as evidence of safety. It correctly points out that historical uses may have differed greatly from current uses of botanical medicines or of the same plants marketed as dietary supplements. Another chapter provides detailed documentation of the erroneous conclusions that were reached when the plant species was misidentified. This chapter also clearly illustrates the complexity of safety evaluation because of differences in the specific species that may be included in the common-name category and differences in composition related to maturity at harvest, growing conditions, and processing. The postmarketing surveillance programs for safety assessment in the United States, the United Kingdom, and Germany are described. The difficulties in using adverse event reports to establish cause-effect relations are not given adequate attention by any of the chapters.
Overall, the book provides a useful compendium of the controversies about botanical medicines. Although the symposium was held in 1994, the references indicate that several of the manuscripts were not completed until 1996 or even 1998. Many of the issues remain the same but several new ones have developed.