~ Barriers to Herbal Medicine Research in the United States

Barriers to Herbal Medicine Research
History of Herbal Medicine
Key Research Issues
Research Base

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The regulatory lockout of natural remedies has crippled natural products research in U.S. universities and hospitals. There is no dedicated level of support by the Federal Government for herbal medicine research. Herbalists may apply under existing guidelines for approval of new pharmaceutical drugs, but this burden is unrealistic because the total cost of bringing a new pharmaceutical drug to market in the United States is an estimated $140 million to $500 million (Wall Street Journal, 1993). Because botanicals are not patentable (although they can be patented for use), an herbal medicine manufacturer could never recover this expenditure. Therefore, herbal remedies are not viable candidates for the existing drug approval process: pharmaceutical companies will not risk a loss of this magnitude, and herb companies lack the financial resources even to consider seeking approval.

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Another major barrier is that the academic infrastructure necessary for proper study of ethnomedical systems has seriously eroded in recent decades and must be reinvigorated to accommodate the newly recognized need for preserving traditional medical systems and ~biological diversity. Pharmacognosy and other academic studies of medicinal plants have declined alarmingly in the United States. North American scientists, once at the forefront of this research, lag behind their European and Japanese colleagues, reducing the likelihood that they will discover useful new medicines from plants. This problem is exacerbated by the fact that much of the discipline of botany has moved away from field studies and into molecular and laboratory approaches. Today only a handful of active full-time ethnobotanists are trained to catalog information on the medicinal properties of plants.

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In contrast to the United States, many European and Asian countries have taken a more holistic approach to researching the efficacy of herbal remedies. In Germany, France, and Japan, the past 20 years have seen a rapid increase in research into and use of standardized, semipurified (still containing multiple individual chemicals) herbal extracts called phytomedicines. In Europe and Japan, phytomedicines treat conditions ranging from serious, life-threatening diseases such as heart disease and cancer to simple symptomatic relief of colds, aches and pains, and other conditions treated by OTC drugs in the United States. Phytomedicines include preventive medicines, an often-neglected area of medicine in the ~United States. The FDA has approved many plant-derived "heroic" cures, but never a plant-derived preventive medicine.

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