By Steven E. Nissen, MD

There is a national catastrophe brewing that no one is expecting. I can't tell you when it will happen, but its occurrence is a virtual certainty. The source will be a range of products that most Americans and some physicians consider harmless—dietary supplements. We have all experienced the phenomenon. A patient arrives at the office and our nurse records their medications. Along with a few prescription products, the patient meticulously reports that they are taking red yeast rice, Coenzyme Q10, gingko biloba, policosanol, and several more dietary supplements we didn't know existed. The patient is convinced that these supplements are critical to their health. The patient's source of wisdom: a clerk behind the counter in his or her local health food store or an article posted on a website.

The potential for harm is real and imminent. A few years ago I saw a middle-aged man following an myocardial infarction (MI). His risk factors included high LDL cholesterol (157 mg/dL) and a very low HDL cholesterol (28 mg/dL). After three months of statin treatment, his LDL was 78 mg/dL, but his HDL was persistently low. Although controversial now, at the time we treated him with slow-release niacin, gradually titrated to 1,500 mg daily to avoid flushing. His HDL increased to 42 mg/dL, an unusually robust response, and his LDL fell to <70 mg/dl. The patient moved to Florida. Two years later, he sent a panicked e-mail: his lipids and his HDL were back to 29 mg/dL.

We asked the patient, "Had you changed your brand of niacin?" Yes, he was browsing in a local health food store when he saw a product labeled "no-flush niacin." The proprietor explained that this was an "improved" form of niacin, with all the benefits but no side effects. The patient explained that his physician had prescribed the brand Niaspan™, to which the proprietor replied, "All those physicians and drug companies are alike—they just want to sell you their expensive brands. What we have here is far better and safer." Of course, "no-flush niacin" doesn't contain any niacin—it's actually nicotinamide. You can guess the rest. After substituting "no-flush niacin" for the prescription drug, our patient didn't flush, but his HDL-C doesn't increase either! Unfortunately, the story doesn't end there: three weeks later he was admitted for another MI complicated by cardiogenic shock but died before could be considered for transplantation.

Putting Control in the Wrong Hands
Unbelievably, what happened with our patient was perfectly legal, thanks to a law known as DSHEA, the Dietary Supplement Health and Education Act of 1994. Incredibly, this law places responsibility for ensuring the truthfulness of advertisements for dietary supplements with the Federal Trade Commission (FTC), not the Food and Drug Administration (FDA). The FTC knows nothing about drugs, so manufacturers commonly imply benefits never confirmed via formal clinical studies. The DSHEA's principal sponsors (including a current powerful senior U.S. senator) were Congressional representatives from states where companies selling supplements are headquartered. Nearly two decades after DSHEA, the marketed array of worthless or harmful dietary supplements is growing daily, reaching sales of $30 billion annually. An internet search for "dietary supplements for heart health" yields 1.1 million hits. Alternatively, you can visit the vitamin section of a pharmacy and count hundreds of supplements, many labeled with the claim that they "promote heart health."

Author Stephanie Mencimer wrote in The Washington Monthly¹: "Since DSHEA became law, substances as varied as paint stripper, bat sh*t, toad venom, and lamb placenta have all been imported from overseas, bottled up—often by people with no scientific or health backgrounds—and marketed as dietary supplements to unsuspecting American consumers. Many supplements have been tainted with salmonella, arsenic, lead, pesticides, unapproved foreign prescription drugs, as well as garden-variety carcinogens. And despite their New-Age health aura, a significant portion of these 'natural supplements' are stimulants, depressants, and other mood enhancers that some medical experts believe would be classified as drugs if they were synthetic. A surprising number of these products are addictive."

The FDA retains limited regulatory authority. If the agency can prove that a dietary supplement is dangerous, it can be removed from the market, but this is exceedingly difficult and can be challenged in court. The bigger problem is that most supplements, like "no-flush niacin," are simply ineffective. The harm comes when patients are diverted from legitimate and needed medications to ineffective substitutes. The DSHEA law does not permit claims that a supplement treats a disease, but was artfully written to allow statement such as these: "Green tea extract helps support healthy cholesterol levels." The supplement industry feeds patient perceptions that physicians are aligned with a greedy pharmaceutical industry to promote expensive, dangerous prescription products.

What actions can thoughtful physician take? Educate patients about dietary supplements, warn them that they are unproven and may interact with their prescription medications resulting in toxicity or lack of effectiveness. What about regulatory reform? It won't occur until there is a mass catastrophe that kills or injures thousands of Americans. Unfortunately, it took the thalidomide tragedy to modernize laws governing the pharmaceutical industry and FDA. And unfortunately, such a tragedy with dietary supplements is coming.

References

1. Mencimer S. The Washington Monthly. September 2001. http://www.washingtonmonthly.com/features/2001/0109.mencimer2.

Steven E. Nissen, MD, is Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic and co-author of Heart411: The Only Guide to Heart Health You'll Ever Need.

Keywords: Vitamins, Cholesterol, Health Food, Dietary Supplements, Prescription Drugs, Lipids, Niacin

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