Government should watch supplements closely
Widespread use increases danger to patients
By Ralph Hall, MD
Emeritus Professor of Medicine
University of Missouri
Kansas City
(The following is an interpretive news report by a renowned physician in the field of endocrinology. Complementary Therapies in Chronic Care plans regular opinion-oriented columns on issues of interest to our readers. We encourage you to contact the editors with your opinions. The editors particularly encourage any health care professional with an opposing viewpoint to that expressed below to offer a rebuttal column.)
If your patients are not already using herbs, vitamins, or other supplements, they have probably at least given it some thought. There is a dramatic increase in the number of people of all ages who are taking supplements of some type. (See related cover story.)
Because of this explosive increase in supplement use, the Alexandria, VA-based American Diabetes Association (ADA) sponsored a symposium, "Herbal Therapy as Alternative Medicine," at its 60th annual scientific session in San Antonio in June.
The history of herbal medicine use, its vacillating regulatory control, and the increasing use of supplements was discussed by Robert Lutz, MD, a family practice resident from San Diego. In 1939, there were 105 recorded deaths from elixir of sulfonilamide, a preparation used to prevent or treat upper respiratory infections and headaches. As a result of this catastrophe, laws were passed that resulted in stricter federal controls, Lutz noted. Then in 1994, those same controls were relaxed because of the rising public demand for natural remedies.
The precise reasons for the growing use of herbal medicine are not clear. Lutz said that physicians’ inability to successfully treat chronic diseases such as diabetes, cancer, and arthritis has led patients to seek effective treatment outside of traditional medical circles.
In addition, as the population has become more health conscious, patients increasingly perceive herbs and other supplements as preventive measures to ward off infection, to increase energy, and even to stay young. Herbal use by some is not considered an alternative but an integral component of standard medicine.
In October 1994, the U.S. Dietary Supplement Health and Education Act was passed and Bernadette Marriott, PhD, was named director of the Office of Dietary Supplements. Marriott, who directed the office until 1999 when she joined the faculty of the Northern Arizona University in Flagstaff, said during the symposium that the legislation created confusion among those who use supplements. She said that the guidelines are both too few and too complicated for consumers.
Marriott said that the regulations make it appear as though supplements are regulated like over the counter (OTC) drugs. Since OTCs are tested for safety and effectiveness, patients incorrectly presume supplements must be safe and effective as well.
In reality, the regulations, as well as budgetary constraints, prevent the U.S. Food and Drug Administration (FDA) from evaluating content, effectiveness, or safety of supplements until someone dies or becomes disabled by their use.
Manufacturers of supplements are permitted to make claims, often unsubstantiated, about the effectiveness of their preparation as long as the manufacturer does not claim that the supplement is for treating a disease. If a manufacturer claims that the supplement is for treating a disease, it has to take the preparation through the standard new drug application procedure — a costly and time-consuming process.
For example, a product manufacturer can legally claim without proof that the product lowers the blood sugar as long as there is no claim it is a treatment for diabetes. The claim may be made that the product improves immunity, as long as the manufacturer does not state it will prevent infection.
In addition, according to Marriott, many consumers do not understand the variable concentration of the active ingredient in a herb. Variables can result from the changes in the amount of water or exposure to sunshine, which affects the product’s potency and effectiveness.
There are other problems as well, Marriott added. Herbs from the Far East may be gathered by workers who are paid by the pound, and therefore, have little incentive to sort out other plants and separate them from the herb they are supposed to collect. As has been frequently reported, contaminants can be accidentally present or deliberately added, as in a recent case in California in which sulfonylurea and metformin were purposely put into a herbal preparation that was advertised to lower blood sugar.
In addition, the scientific evidence of the efficacy of many supplements is flawed, ADA attendees were told.
Laura Shane-McWorter, PharmD, CDE, of the University of Utah in Salt Lake City, reviewed the pharmacological and experimental studies that have been completed with herbs reported to lower blood glucose.
All the studies involved small numbers of patients and when repeated, used herbs of different species or concentrations of the active ingredients, so comparisons were invalid. The studies were seldom designed with controls or the controls were not blinded to the preparations they were taking.
Shane-McWorter also discussed the side effects of a few of the often-used herbs such as St. John’s wort. When St. John’s wort is added to pharmaceutical antidepressants, such as selective serotonin reuptake inhibitors, it can cause severe reactions, including coma. A number of herbals react with other drugs such as warfarin (coumadin) to increase or decrease their effectiveness, which often results in dangerous blood levels of the standard medications, she said.
The recent tragedy in Belgium, which resulted in acute renal failure in women taking weight-reducing Chinese herbs, caused officials there to ban the importation of Chinese herbs into Belgium. Because of a manufacturing error, a nephrotoxic herb was substituted into the weight-reducing pill.
At least 43 patients developed end-stage kidney disease before the drug was banned, and many of these patients subsequently developed cancer of the urinary tract.1
In short, as per Robbers and Tyler wrote in their 1999 book, The Therapeutic Use of Phytomedicinals, there are no currently consistent, effective herbals for diabetes. Therefore, the authors chose not to include a chapter on diabetes. There are, however, ongoing studies that may lead to worthwhile supplements for use by persons with diabetes.
Many Americans are concerned about the use of genetically altered foods. These foods, however, are far better regulated than supplements. I believe there are strong data to support better control of supplements.
While the FDA currently is reviewing a better system for approving OTCs, providers should be insisting on an improved supervision of approval of herbs and other supplements.
In the meantime, millions of health care dollars are wasted on supplements that do not contain the advertised ingredients, are sometimes ineffective, or are even harmful to health because they have been adulterated with other potentially harmful substances.
Reference
1. Nortier JL, et al. Urothelial carcinoma associated with the use of a chinese herb (Aristolochia fangchi). N Engl J Med 2000; 342(23):1,686.
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