To regulate or not to regulate

BALTIMORE (Map, News) - Herbs such as echinacea have been used all over the world for centuries to cure disease and keep people healthy, but modern medicine is just beginning to understand how.

“I challenge you to show me the plant that only has one gene and only [affects] one gene or protein function in your body,” said Kevin Spelman, a biochemist with Tai Sophia Institute for the Healing Arts in Baltimore. “New research shows many genes need complementary action in other genes or proteins to function.”

Echinacea, he said, has three varieties, each with different combinations of active compounds. The pharmaceutical model is to isolate the compound they share in common, but Spelman said that won’t give you the same effect. “I think they all work because they’re activating multiple genes in the body. It’s a network response.”

At the same time, the modern marketplace has turned food supplements into a $5 billion a year industry in this country, pushing the question: Are you getting what you pay for?

“It doesn’t help the United States public — which has free access to these products — to not investigate,” said Josh Berman, clinical and regulatory affairs director of the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health in Bethesda.

Several hundred herbalists, researchers, industry representatives and government regulators met in Rockville last week to discuss regulating herbal medicine.

Testing the herbs and supplements poses unique problems, Berman said, because of the complexity of plant compounds and an individual’s response.

In the United states, herbal products can carry claims to affect the “structure or function” of systems in the body, said the Food and Drug Administration’s Vasilios Frankos, director of dietary supplement programs. But they cannot claim to diagnose, cure, mitigate, treat or prevent diseases.

As of Dec. 31, 2007, the FDA had reviewed 352 clinical claims of herbal products. So far only one has been approved — a certain green tea extract to treat genital warts.

On the other hand, many herbal practitioners are not interested in controlled clinical trials. Everything from standardization of herbs to differences in soil conditions and even patients’ personalities throw clinical trials into doubt, said Robert Duggan, president of Tai Sophia Institute.

“Can we take as fact that this plant is used in several different cultures in various parts of the world for thousands of years and that is valid outside of any other scientific research?” he asked.

khille@baltimoreexaminer.com