Simple and inexpensive methods to prevent botanical misfortue

Abstract

Botanical dietary supplements are often targeted by the mainstream media and scientific/medical communities as being unscientific and unsafe relative to prescription pharmaceuticals and over-the counter drugs. However, the relative risk of botanical medicines is largely overestimated and causal relationships between botanical remedies and significant adverse reactions pale in comparison to the frequency and magnitude of those observed with normal use of FDA-approved pharmaceuticals. Historically, a greater premium has been placed on demonstrating the safety of health-related products as opposed to confirming therapeutic efficacy; in fact, the required standards for prescription drug efficacy were implemented in the U.S. more than 50 years after standards for purity and safety were firmly in place. An argument will be made that botanical manufacturers can support their place in the national health agenda and generate significant goodwill by voluntarily subjecting supplements to relatively simple and inexpensive preclinical studies, and even limited phase I clinical trials, employing the basic tenets of pharmacology and toxicology (i.e., dose-response relationships) to support the relative safety of specific products. Moreover, many of the unfortunate adverse events of drug-herb interactions over the last 10 years could have been prevented by relatively simple hepatic metabolism and drug transport studies that have become commonplace in even the smallest of academic laboratories, due in large part to the increased availability and lower cost of previously scarce and cumbersome biological reagents. Demonstrating the safety of semi-pharmaceutical formulations of herbal products now requires more than simple reliance on the historic folk record of safe use; real health risks and negative publicity can be successfully mitigated with a modest, prospective investment in basic preclinical toxicology testing. A model is presented for a non-profit research center that focuses on botanical quality and safety as a first step toward this goal.