Rationale for Drug Development of Herbals in Oncology: Clinical, Industry, and Regulatory Perspectives
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0092-86 15/99 Copyright 0 1999 Drug Information Association Inc.
RATIONALE FOR DRUG DEVELOPMENT OF HERBALS IN ONCOLOGX CLINICAL, INDUSTRY, AND REGULATORY PERSPECTIVES MARYANNRICHARDSON, DRPH Associate Professor, University of Texas-Houston School of Public Health & Center for Alternative Medicine Research in Cancer, Houston, Texas
CARMEN TAMAYO, MD Research Consultant, University of Texas-Center for Alternative Medicine Research, Houston, Texas, and Helixor-Heilmittel GmbH & Co, Germany
AGNESKLEIN,MD, MPH Chief, Gastroenterology, Hematology, Oncology Division, Bureau of Pharmaceutical Assessment, Health Protection Branch, Canada
NORMAN MARCON,MD, FRCP (C) Chief, Division of Gastroenterology and Associate Professor of Medicine, University of Toronto, Toronto. Canada
An estimated 42% of Americans use complementarylalternative medicine (CAM) and some 50% of cancer patients routinely combine them with conventional care, despite Iack of evidence on safety and eflcacy. Herbal products are one of the most frequently used approaches as reflected by the 70% increase in market sales to $3.24 billion in 1997. As cancer incidence and survival time increase, the population seeking herbal therapy approaches is expected to increase also. Thus, scientific evaluation of herbals is critical. This position paper provides a rationale for such evaluations. The perspectives from manufacturers, regulatory agencies, and clinicians are presented, as well as the need for a multidisciplinary collaboration. Wepresent guidelines for developing Investigational New Drug (IND)applications for heterogeneous botanicals and address challenges inherent in the process. Key Words: Cornplementary/alternative medicine; Cancer; Herbal products
INTRODUCTION
with 42% of Americans (1); one fourth of United Kingdom residents (2); and half of THE USE OF COMPLEMENTARY/alterna- Germans, French (2),and Australians (3) ustive therapies is an internationalphenomenon ing these therapies. Public interest in CAM
Presented at the DIA 34th Annual Meeting ‘Thinking Globally: Product Development, Registration, and Marketing in the New Millennium,’’ June 7-1 1, 1998, Boston, Massachusetts. Reprint address: Mary Ann Richardson, DrPH, Associate Professor, University of Texas-Houston School of Public Health & Center for Alternative Medicine Research in Cancer, P.O. Box 20186, Houston, TX 77225.
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M. A. Richardson, C. Tamayo, A. Klein, and N. Marcon
therapies continues to grow, suggesting that previously overlooked practices are experiencing a renaissance and newer therapies are emerging (1,4,5). In 1997, sales in the United States jumped 70% to $3.24 billion for herbs, and some $27 billion was spent in the United States on CAM therapies in general, with two-thirds of that figure paid out-of-pocket (1). Despite limited scientific evidence of efficacy, as many as 50% of cancer patients use CAM (6,7,8). Recent surveys at The University of Texas M.D. Anderson Cancer Center indicate that the most
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