A recent article in Consumer Reports, "Dangerous Supplements, Still at Large, names several herbs and supplements which have a theoretical toxic effect. These include Aristolochic acid, comfrey, androstenedione, chaparral, germander, kava, bitter orange, organ/glandular extracts, lobelia, pennyroyal oil, skullcap and yohimbe. In most cases, there are few, if any, actual reports of negative health effects to humans caused by these supplements.
Careful review of the recent deaths that have been linked to ephedra, demonstrates that it was probably used in higher than recommended amounts, and often in combination with other recreational drugs. Here is one consumer's response to the recent restriction of sales of ephedra, and is typical of hundreds of comments I have received. "For fifteen years, I have been using Ephedra as a medicine to control asthma attacks. I am outraged that this country is no longer selling it because some people abused it. They should not sell alcohol or cigarettes because people die every day from using those drugs. (C.B., Akron, Ohio)"
This is not to say that all natural substances are always safe, far from it. For example, 50 to 100 deaths per year occur in the United States due to the ingestion of peanuts (N Engl J Med. Mar 13, 2004). As a practicing herbalist for over 35 years, I always recommend that people discuss the use of herbs with a knowledgeable health care practitioner. The particular supplements named in this article have strong active ingredients, have a real possibility of causing an adverse effect, and should indeed be used with caution. However, Consumer Report's main point is not health, but regulation. The premise is that supplements are unregulated while Pharmaceutical drugs are regulated. The article states that Pharmaceutical drugs are 1) tested for hazards 2) disclose risks 3) ensure product quality and 4) report adverse events.
Actually, if you purchase supplements from quality manufacturers, they follow similar procedures. If the company is pharmaceutically licensed and Kosher certified, you have further assurance of quality and efficacy. The article goes on to discuss the Dietary Health and Education Act of 1994 (DSHEA), which outlines the FDA's role in regulating supplements. According to the article, the FDA is understaffed and underfunded. It has a mere $10 million to enforce the DSHEA act, while 43 times ($43 million) is spent on regulating pharmaceutical drugs. This is EXACTLY the point. REGULATION DOES NOT EQUAL SAFETY. In fact, according to the authors of an article in the Journal of the American Medical Association, (April 15, 1998) "the overall incidence of fatal adverse drug reactions, makes pharmaceutical drugs the fourth to sixth leading cause of death in the United States!" It seems to me that this shocking statistic is worthy of a cover story in Consumer Reports!
Many commonly used drugs are linked to disease. For instance, the use of antibiotics is associated with an increased risk of fatal breast cancer (JAMA, Feb 4, 2004). Regular use of painkillers such as ibuprofen and acetaminophen increases the risk of chronic kidney failure. (New Engl Jour Med Dec 20, 2001) Another research study notes that medications pose a significant risk to patients, with 1.9 million adverse drug events occurring each year, and up to 180,000 of these are life threatening or fatal (JAMA, Mar 5, 2003). Note the severity and astronomical numbers associated with adverse drug events, vs. the small incidence of adverse events due to supplements. Clearly, the 43 million dollars spent on FDA drug regulation does not make drugs safe. The Consumer Report article supports two bills that are now before Congress, introduced by Richard Durkin (IL) and Susan Davis (CA), which would give the FDA much more power in its control over supplements. However, I wonder how that would help, since they do not have enough manpower or money to enforce the laws that are already in place?
Another, more reasonable bill is being introduced by Orin Hatch (UT) and Tom Harkin (IA) that would give the FDA additional funding to enforce the powers it already has under DSHEA, and would also reclassify steroid precursors such as androstenedione as controlled drugs. This moderate measure makes more sense. The entire regulatory issue is part of a disturbing international trend called The Codex Alimentaris, in which the European Union, a powerful block of countries, is supporting the position that pharmaceutical drugs should be used for prevention and treatment of diseases, whereas food supplements should not. For more information, visit www.Codexinfo.org. Although the Consumer Report article has some valid points, it may steer consumers away from herbs/supplements that may be helpful for health care issues, which are safer, and in many cases, more effective than pharmaceutical drugs.
Ellen Kamhi PhD RN; The Natural Nurse, has been a Natural Health Care Practitioner for over 30 years. Radio: 90.1 fm (Friday 6pm); 90.3f m (Tues 6:30 pm, Thur 12 noon, Fri 5:30 am). Dr. Kamhi is the author of Cycles of Life, The Natural Medicine Chest, Arthritis, The Alternative Guide and The Natural Guide to Great Sex. She answers consumer questions at www.naturesanswer.com. For more info: www.naturalnurse.com, 800-829 0918