Autoimmune disease and the environment.

are there, Blumenthal said; it's just a matter of knowing where and how to find them. But Schardt defended the desire to reproduce such studies in U.S. labs, pointing out that, for example, European studies on the efficacy of St. John's wort for treating depression average a length of only five weeks-even though St. John's wort can take as long as four weeks to have any effect. He also asserted that the results of certain studies may not be as compelling as some daim. For instance, in response to a claim that some 28 controlled trials of various forms of echinacea have been conducted in Europe, Schardt said that most of those studies used parenteral echinacea, which is not available in the United States, or proprietary products that also are not available to U.S. consumers. Furthermore, Schardt said, the results of several controlled trials testing the effects of oral echinacea supplements on the common cold and influenza are inconclusive. Still, there was general agreement among the participants that the United States must display more willingness to cooperate with and participate in international research on standardization, efficacy, and safety. Financial support. Many speakers felt that the money for testing, analyzing, and evaluating the published safety and efficacy data on medicinal herbs should come from the government, and looked to the FDA as the natural choice for initiating such studies. But Yuan-Yuan Chiu, deputy director of the Office of New Drug Chemistry at the FDA Center for Drug Evaluation and Research, claimed the agency has barely enough resources to maintain the programs already in place, and called on the other government agencies represented to share their funds and resources. Others felt that industry bears the burden of responsibility for supporting research. Pharmaceutical companies routinely spend 10-20% of their profits on research and development, a figure that is not borne out in the botanical industry. But, said Loren Israelsen, executive director of the Utah Natural Products Alliance, contrary to an editorial in the 17 September 1998 issue of the New England Journal of Medicine in which editors Marcia Angell and Jerome Kassirer suggest the botanical industry is not interested in research, the industry very much wants to conduct and collaborate on botanicals research. Israelsen described some of the dilemmas faced by the industry in terms of research incentives versus expenditures. In order to receive FDA approval as a nonprescription drug, each substance within a given plant-not just those within the extract used in the botanical preparationwould need to be studied in a lengthy, expensive process. In addition, the FDA review process for nonprescription drugs does not allow consideration of foreign data. Therefore, many studies that have already been done overseas would need to be duplicated. Another issue is the Dietary Supplement Health and Education Act of 1994, which for the first time allowed botanical manufacturers to label their products with claims of how the product may affect the structure or functioning of the body. With the passage of the act, many manufacturers began conducting legitimate research in order to formulate their daims, but some manufacturers indulge in "borrowed science"applying the results of another company's studies to their own products, often leading to inaccurate daims (the resultant mislabeling is addressed under the Federal Food, Drug, and Cosmetic Act). Finally, most synthetic drugs are developed with the goal of being patented. But with the countless varieties of botanical products being sold, it is impossible to daim market exclusivity as a research incentive.