Herbal Medicine and Botanical Supplements Caveat-Part IV
Governor George E. Pataki, the Republican governor of New York signed into law a ban on the over-the-counter sales of ephedra in the state. The law includes a fine of up to $500 for each sale of the supplement. Ephedra can still be legally sold in the state if a doctor prescribes it. The Ephedra Education Council, an industry-financed group continues to claim that the supplement is safe when used correctly.
Tommy G. Thompson, Secretary of Health and Human Services, has delayed action in declaring whether or not ephedra, the popular weight-loss supplement is dangerous or not. He said the RAND Corporation, a research organization, would finish a "comprehensive review" of the studies that have been done on the supplement. The Rand report would be the basis for further study of ephedra, which is also known as ma huang, by the National Institutes of Health.
Ephedra supposedly increases metabolism and can raise the heart rate. Secretary Thompson stated "It is crucial that we have a full understanding of these dietary supplements" before we act on this matter. Health Canada, which is the Canadian equivalent of our FDA has expressed concern about excessive doses of ephedra.
We had previously written that the November 7, 2000 issue of the New England Journal of Medicine reported on a study of the risks of ephedra. Ephedra is an ingredient that is in natural appetite suppressants. As a natural appetite suppressant it is therefore classified as a dietary supplement, and therefore escapes regulation by the FDA. The article reported on the fact that 140 patients suffered serious side effects, including stroke and seizures, after taking ephedra products. Ten died and 13 % were permanently disabled.
The National Football League recently announced that it had placed the dietary supplement ephedra on its list of banned substances which would result in league action against any player who tested positive for its usage. A consumer advocacy group, the Public Citizens Health Research Group in Washington, and a prominent pharmacologist Dr. Raymond Woosley, vice-president of health sciences at the University of Arizona, have filed a petition with the FDA urging the agency to warn consumers not to use products that contain ephedra.
Ephedra has been linked to deaths, strokes, heart attacks and other health problems. It is also used under the Chinese name of ma huang. Ephedra is like amphetamines in that it stimulates the central nervous system, and is used in many weight loss and increased energy products.
The petition cited data from the American Association of Poison Control Centers, that showed that adverse events linked to ephedra in dietary supplements rose to 407 in 1999 from 258 in 1998, and 211 in 1997. In figures compiled by the FDA the total number of deaths and injuries caused by ephedra from January 1993 to February 2001 was 1,398. Those who defend the supplement claim that it is excessive usage that has caused the problem and feel that products using ephedra merely should state that fact on the label.
The heart of the problem can be traced back to the federal law of 1994 that essentially deregulated the dietary supplements. The law allows companies to make and sell dietary supplements without the same proof of safety and efficacy as is required of drugs. The safety of ephedra was attacked in 1997, but the FDA required only the mandatory warning label and a ban on ephedra's usage in combination with other stimulants.
We have written a number of articles about research on herbal medicine and various botanical supplements. While we take no stand on these alternative or complementary approaches to dealing with disease, we feel obligated to our readers to list the following caveats about the current "popular natural products" sold in over-the-counter settings. This does not imply that they do not work or are not effective as a treatment modality. It is only our attempt to provide a broad range of information to help readers make educated decisions about there approach to any kind of treatment.
A federal court in Utah has ruled that a dietary supplement made by Pharmanex Inc. needs FDA approval to sell its red yeast rice product, because legally it is a drug, not a dietary supplement. Dietary supplements do not need FDA approval in order to be sold.
Red yeast products contain lovastatin, the active ingredient in Merck & Co's cholesterol-lowering drug Mevacor. The FDA stated in a warning letter to the company that "due to potential side effects, drugs containing lovastatin may not be marketed over the counter."
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) announced the availability of the first issue of the "Annual Bibliography of Significant Advances in Dietary Supplement Research". Developed as a joint effort of ODS and the Consumer Healthcare Products Association (CHPA), this publication illustrates how the dietary supplement field is advancing through quality research. Copies of the first "Annual Bibliography of Significant Advances in Dietary Supplement Research" may be downloaded from the ODS website at http://ods.od.nih.gov/publications/publications.html.
Single copies may also be requested by contacting the ODS office (301-435-2920 or ods@nih.gov).
The following provides a list of shortcomings of the use of natural botanical products:
The following abstract is from an article by Simon R. J. Maxwell entitled "Antioxidant Vitamin Supplements: Update of their potential benefits and possible risks." that appeared in Drug Safety 1999; 21(4): 253-266 and would seem appropriate to the above statements.
Oxidate damage to biological structures has been implicated in the pathophysiology of cardiovascular disease and cancer, the 2 most common causes of death in developed countries. This has stimulated interest in the possible role of natural antioxidant vitamins in preventing the development of these diseases. Epidemiological studies have offered support for the notion that high blood concentrations or dietary intake of antioxidants may have a protective effect. On the basis of these findings and powerful marketing strategies, many healthy members of the population are now voluntarily consuming antioxidant supplements. A number of long term, prospective, randomized, placebo-controlled trials examining the protective effect of antioxidant supplements have been completed. The results have been generally disappointing and have provided little evidence of efficacy. Of greater concern, they have unexpectedly raised concerns that antioxidants, notably betacarotine might increase the rate of development of cancer in high-risk individuals. For this reason consumption of antioxidant vitamin supplements cannot yet be advocated as a healthy lifestyle trait.
Another researcher, E. Ernest states "Until more definitive evidence becomes available, we should employ CM (Complementary Medicine) where it seems to benefit the patient, and remaining cautious whenever there is the possibility of doing harm."
Increased research efforts, improved government regulations and long term monitoring of adverse reactions of natural treatment modalities may provide a clearer picture of the value of botanical and complementary medicine, leading to a reduction in devastating diseases. In the meantime, we suggest that people proceed with caution, but do not underestimate a potentially powerful method of treatment.
Caution: Always let your physician know all medications, including botanical medications and supplements or vitamins so that both of you may develop a treatment plan that is optimal for your situation. You want to eliminate any potential toxic drug-herb interaction.
Reference:
Ernst E. Complementary medicine: does it have a role in the medical care of elderly people? Reviews in Clinical Gerontology 1999; 7:353-358
Linde K, Ramirez G, Muirow CD et al. St. John’s wort for depression: an overview and metaanalysis of randomized clinical trials. BMJ 1996; 318: 253-258.
Maxwell Simon RJ. Antioxidant Vitamin Supplements: Update of their Potential Benefits and Possible Risks. Drug Safety 1999; 21(4): 253-266.
Note: This author has been taking vitamins E, C and a one-a-day vitamin for the last 25 years and has added selenium and a daily aspirin to this regimen.
Please See: Herbs and Dietary Supplements-St. John's Wort-Part I
St. John’s Wort -Herbs and Dietary Supplements-Part II-Ephedra
Phytomedicine or Herbalist-What is It?-Part III
Treating Osteoarthritis with Dietary Supplements-Part V
St John's Wort: Does It Help Treat Depression-Part VI
Herbal Products: Use With Caution-Part VII
Kava: Safety Alert-Part VIII
Herbal Usage for Hormone Replacement Therapy-Part IX
Latest Research Questions the Effectiveness of Herbal Supplements-Part X
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Harold Rubin, MS, ABD, CRC, Guest Lecturer
November 14, 2002
http://www.therubins.com
To e-mail: rehabstrat1@aol.com or rubin@brainlink.com