Who Will Watch the Watchers? The Vitamin Police Investigate the General Accounting Office
by Bill Sardi
In a politically-motivated operation, the General Accounting Office has chosen to launch a witch hunt against dietary supplements, employing frightening headlines that inaccurately warn the public of heavy metals in herbal supplements and of misdirected advice offered by health store clerks, at a time when legislation is pending in Congress to usher in greater enforcement and restrictions over these popularly-used products.
The GAO report itself fails to provide adequate evidence of a public hazard. The GAO report, entitled "HERBAL DIETARY SUPPLEMENTS, Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice," presented before the Special Committee on Aging, U.S. Senate, says:
"Trace Contaminants Found in Selected Herbal Dietary Supplements, but None Pose an Acute Toxicity Hazard to Humans. The levels of contaminants found do not exceed any FDA or EPA regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern regarding any immediate negative health consequences from consuming these (40) supplements."
Poison Control Center data does not suggest herbal supplements pose a significant mortal or morbid risk to consumers (American Association of Poison Control Centers annual reports — 1983 to 2008 — can be found here.) Furthermore, heavy metals like lead, cadmium, palladium and arsenic are ubiquitous (ever-present) in foods and pharmaceutical drugs and it is unfair to single out herbal supplements when the Documentary Standards Division of the US Pharmacopeia in Rockville, Maryland states that "screening for metals in medicines and dietary supplements rarely indicates the presence of toxic metal impurities at levels of concern."
Regardless of the facts, the damage has been done. The news media has lip-synched what the government wanted them to say and the public is led to be wary of dietary supplements. Any level of heavy metals in dietary supplements appears to be unacceptable, yet foods contain far more heavy metals, particularly foods grown in mineral-rich soil.
Given that heavy metals cannot be completely eliminated from the diet, drugs or supplements, the body has natural defenses against heavy metal toxicity in the form of binding proteins (melanin), ferritin (iron), cerruloplasmin (copper), and inborn antioxidants like glutathione and lipoic acid as well as glutathione boosters like vitamin C and dietary mineral chelators such as IP6, curcumin, resveratrol, quercetin, and many others. Heavy metals in dietary supplements are generally found at a parts-per-billion level.
Adverse event data
Analysis of adverse events related to dietary supplement use over a 1-year period of time (2006), reported to poison control centers, shows 275 telephone calls for dietary supplements, with just 8 hospitalizations, and no deaths. Most of these reports involved stimulants (caffeine, yohimbe). The report says "Most supplement-related adverse events were minor." No symptoms were reported in half the cases
Two herbal supplements singled out by the GAO, St. Johns wort and echinacea, underwent a safety review in 2007, and it was found that most of the adverse events occurred among young children, under age 5, who consumed excessive doses of these supplements. A significant percentage of adverse events also emanated from intentional over-consumption (suspected suicide).
As previously stated by this author, dietary supplements are safer than table salt, many over-the-counter drugs such as aspirin, acetaminophen (Tylenol) and ibuprofen, safer than penicillin, digitalis and vaccines. Supplements are even safer than food.
The GAO planted ghost consumers in vitamin shops to inquire about natural products that would help control blood pressure, and a garlic supplement was offered and said to be a replacement for blood-pressure lowering drugs. The GAO report says "it is not recommended that a consumer start or stop a course of treatment without consulting with his or her health care provider." Yet doctors are largely ignorant about the use of dietary supplements and in many instances, store clerks are more knowledgeable than an MD.
While the GAO report assailed the many exaggerated or unsubstantiated advertising and label claims for dietary supplements, the FDA and FTC have ceased their annual sweep of the internet to send correction letters to offenders, thus sending a message to violators that there is no traffic cop on dietary supplement boulevard.
While many dietary supplements use borrowed science to extol the benefits of their products, and their product may not provide the same form, dosage and delivery system employed in a controlled study, this should not be construed that dietary supplements do not treat, prevent or cure diseases.
Drugs or supplements?
Under the ridiculous definitions used by the FDA, any dietary supplement that does treat, prevent or cure a disease is a drug and must run through a gauntlet of expensive human studies that requires years to perform. Many consumers, recognizing the many drawbacks and side effects posted by prescription drugs, search for natural alternatives. This is the reason for the high rate of non-compliance by patients prescribed pharmaceutical drugs. Many times a doctor’s prescription is never even filled due to consumer concerns over their safety. The fact that the FDA has approved many drugs in recent years (Vioxx, Avandia, Baycol, Meredia, etc) that have proven to be injurious or result in mortal side effects, has caused consumers to be wary of any medicine that is "FDA approved."
Many knowledgeable consumers elect to use dietary supplements in place of prescription drugs and the FDA is remiss in advising consumers of supplements that have the same or superior biological action as Rx drugs, without their high cost and side effects.
For example, magnesium is a natural calcium blocker that works in a superior manner to amlodipine (Norvasc). Fish oil slows the heart rate in a safer manner than beta-blockers. Resveratrol may dilate blood vessels in a safer way than nitroglycerin (Nitro-bid). Nattokinase enzyme appears to work in a superior manner to the clot-busting drug streptokinase. Folic acid and SAMe may be more effective than prescription antidepressants. Red ginseng works in lieu of Viagra for male impotency.
The GAO report targets a ginseng product for labeling that states it "can prevent diabetes." While this product may not be the same variety of ginseng used in published studies, and it may not be offered in the same dose, and the study may have only been conducted in animals, not humans, there is a growing body of evidence, found here, here, and here, that red ginseng is potentially beneficial for diabetics
In fact there is a double-blind placebo-controlled human study that red (Panax) ginseng "may be of some benefit in terms of lowering insulin resistance in type-2 diabetic subjects." The dosage used was two 369-mg red ginseng capsules taken 3 times daily, with meals.