Herbal Dangers

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Consumers are often seduced by the widespread use of the descriptors "safe" and "natural" by producers and marketers at times with quite deleterious health effects. Thus, in 1995, a woman required a liver transplant after overconsumption of tea made from the chaparral plant. And heart transplant patients learned the hard way that supplements of St. John's Wort could interfere with the immune suppressant they must take to prevent rejection of their transplanted organs.

We've been saying it for years at the American Council on Science and Health about five years, to be precise. There's a problem with the way dietary supplements, including herbal supplements, are marketed and sold in this country, a problem that could pose a health hazard to consumers. At last the medical establishment is taking notice, as exemplified by a recent article in the prestigious Journal of the American Medical Association (JAMA).

That article, authored by David W. Kaufman, ScD and colleagues from the Boston University School of Public Health, presents data on the use of prescription and over-the-counter (OTC) drugs in the United States. Their OTC category included not only pain medications like ibuprofen, acetaminophen, and aspirin, but also a host of dietary supplements vitamins, minerals, herbal preparations and the like.

After surveying nearly 2,600 Americans, aged eighteen years and older, the researchers painted a somewhat alarming picture of drug and supplement use in the United States. First, they found that most adults in the U.S. take at least one medication in any given week 81 percent, to be precise. Seven percent took five or more different medications. Women over the age of sixty-five were the heaviest users of medications 12 percent said they took at least ten medications.

Use of prescription drugs did not preclude use of other medications or supplements. Sixteen percent of those reporting use of prescription drugs also reported using herbal and/or other dietary supplements. And there's the rub the potential for dangerous drug-supplement interactions is greatly increased by the concurrent use of these products.

Certainly, it is possible for prescription drugs themselves to interact and have negative health impacts. But such products and their effects are understood, and if the possibility for serious interactions exists this information is published and widely available to physicians, pharmacists, and other health care providers.

Such information is possible, at least in part, because prescription medications are relatively pure compounds whose composition is controlled and known. In addition, they are extensively tested for safety and efficacy before they are permitted to be sold to consumers. Unfortunately, this is not the case with the compounds that are vaguely classified as "dietary supplements."

The dietary supplement category includes a hodgepodge of products. Some of these have been well characterized in scientifically sound studies, while others have only anecdotal evidence to support their use. While we know that vitamin and mineral supplements are safe and effective at appropriate doses, some of the herbal or "metabolite" supplements can be downright dangerous. This is true especially since the compositions of such products are unregulated, and in some cases the contents listed on the label do not accurately reflect the product inside.

This situation is directly attributable to a law passed by Congress in 1994 the so-called Dietary Supplement Health and Education Act, or DSHEA. This law essentially removed a host of products from virtually all regulatory oversight. Normally, in order to market a prescription medication, the manufacturer must prove to the Food and Drug Administration (FDA) that the substance is safe and effective for its intended purpose. Even manufacturers of food additives must show that their products are safe.

But because of DSHEA, a manufacturer of a dietary supplement can simply tell the FDA that they plan to market a product and state that they have data supporting its safety. The FDA can only act to suppress sales of a product after it (the FDA) has evidence that the product is harmful. So, in essence, DSHEA makes the FDA take on a problem-spotting role that in the case of other products is fulfilled by the manufacturers, a role the FDA does not always have the time and resources to fulfill. Only dietary supplement manufacturers get this free ride. And consumers will be the ones who are hurt the most

In 2000, ACSH published a brochure with an extensive list of known or possible drug/supplement interactions. That this list continues to increase in size underscores the seriousness of the problem, and the need for some common-sense regulation of the burgeoning supplement industry.