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Developing New Medicines: Herbal Supplements and Safety (May 5, 2000, Two)

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Program Summary

Plants have been used effectively as remedies for illness and injury for thousands of years. Today’s herbal medicines must be safe, since they are made from natural products, right? Not necessarily.

As part of this discussion on new medicines and clinical trials, the issue of using botanical supplements is raised. One concern is that some herbal remedies can interfere with the action of synthetic drugs. Another problem is that herbal products have been classified as food rather than drugs and are therefore not subject to the same scrutiny from the US Food and Drug Administration as are synthetic medicines. Yet some herbals can be downright dangerous. St. John’s wort, commonly taken for depression, is known to reduce the efficacy of drugs used to prevent transplanted organ rejection. Ephedra, once used in over-the-counter diet aids, is banned in the U.S. because it has caused injury and death from heart attacks.

One caller, a physician, points out how difficult it is for doctors to keep up with all the latest drug developments, let alone herbal products that patients may or may not admit to using and which could be an important factor in designing a treatment plan. Nevertheless, the use so-called “dietary supplements” is on the rise, in part because some products do provide relief from symptoms. The National Institutes of Health has recently created an Office of Alternative Medicine, which is looking into the safety and usefulness of these products. More research is needed. In the meantime, patients are advised to know as much as they can about the medications they have been prescribed, along with all the over-the-counter medications and supplements they are taking. And yes, talk to your doctor!

Guests

Dr. Gillian R. Woollett, associate vice president for biologics and biotechnology with the Pharmaceutical Research and Manufacturers of America in Washington DC

Robert Finn, author of "Cancer Clinical Trials" (O'Reilly & Associates) and freelance ccience and medical journalist in
Half Moon Bay, California

Dr. Joseph Betz, pharmacognosist at the American Herbal Products Association in Silver Spring, Maryland

Related Links and Resources

American Herbal Products Association
Council for Responsible Nutrition
Federal Clinical Trials database (clinicaltrials.gov)
FDA Summary of the Dietary Supplement Health and Education Act of 1994
Food and Drug Administration
National Center for Complementary and Alternative Medicine (NIH)
PhRMA, the Pharmaceutical Research and Manufacturers of America

For Discussion:

• What are some of the popular herbal supplements in the U.S.? What are they used for? Are any of them considered dangerous?
• Why are herbal supplements classified as food rather than drugs?
• What federal entity oversees dietary supplements? How do regulations for these supplements differ from regulations pertaining to drug development?
• How has the herbal supplement lobby affected the regulation of these products?
• Would you use an herbal supplement? Why or why not? What would you use it for?

Activities

Bogus or believable? The Alternative Fix (PBS “Frontline”) is an excellent investigation of alternative and complementary medicine that aired in September 2003. It updates the controvery that continues to surround alternative treatments and dietary supplements, interviewing doctors and researchers on both sides of the fence. Some hospitals are offering alternative treatments alongside traditional ones, while the FDA is being beefed up in the aftermath of the deaths from ephedra and other incidents. The teachers guide provides lesson plans on alternative medicine, the history of the FDA and more.

Be-leaf it or not. Herbs: Healthy Alternative or Bad Medicine? (New York Times Learning Network lesson plan) compares and contrasts traditional and alternative medicine and addresses the issue of the need for closer regulation. Activities include visiting a health food store and pharmacy, researching how alternative practitioners are trained, and studying pharmaceuticals derived directly from plants.

Mother Nature’s medicine. Visit the Medicinal Plants and Alternative Medicine pages at Thinkquest for student-designed sites about alternative medicine and treatment.

Why not? The Whyfiles includes the placebo effect at Alternative Medicine: All inYour Mind?, which takes a look at the power of the mind in assisting cures, as well as research on St. John’s wort and quack medicines.

Use the search box below to perform a Google search within any of the specifc sites or general domains mentioned in this Activities section.

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