The vitamin and herbal supplement industry has endured its share of critics and now here comes another particularly virulent one. New York Times health and medical writer Dan Hurley in his book, Natural Causes: Death, Lies and Politics in America's Vitamin and Herbal Supplement Industry (Broadway Books), accuses the industry of just about everything short of causing the black plague. It is billed on the cover as a look at an industry that sells products that are "untested, unproven, and often tragically unsafe." It is a disturbing book (it was intended to be -- that makes it sell well) that has created concern including among people who take supplements regularly. Should we be worried? Does this book make valid claims? To find out I went to an expert in vitamin and herbal supplements, who is highly knowledgeable about the industry in general, naturopathic physician Mark Stengler, ND. His take: Half-truths are never the real story.
Much of Hurley's vitriol is aimed at the Dietary Supplement Health and Education Act (DSHEA) of 1994. In his book, Hurley says, "Breathtaking in its dimension, DSHEA would end forever the simple legal dichotomy between 'food' and 'drug' to create a third, hermaphroditic category that was both yet neither: the dietary supplement. And beyond the usual suspects -- vitamins, minerals, herbs, amino acids -- the law would permit the manufacturers to define a product as a 'dietary supplement' merely by saying so, no matter if it were artificially derived." But this is not entirely correct. Here is an excerpt taken straight from the FDA Web site: "The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations."
Hurley went on to say that DSHEA turned the clock back 100 years when it comes to regulation of these products, which he also refers to as remedies "redolent of the snake oil era." He picks the act apart, suggesting it lets anyone sell anything, regardless of how ineffective or even dangerous it might be, and says the industry doesn't have to answer to potential side effects or dangers (called "adverse events") experienced by consumers because the industry is not required to report them to the government.
INCOMPLETE RESEARCH BY HURLEY
Dr. Stengler finds all that "astonishing." He says that far from deregulating the industry, DSHEA elevates FDA industry regulation to nearly match the heavily regulated food industry. While far from perfect, this is the standard currently used. Dr. Stengler supports this assertion by listing numerous FDA controls, including its ability to ban supplements, oversee good manufacturing practices, review health claims and hold manufacturers responsible for mislabeled or unsafe products. The government also requires manufacturers to supply the FDA with adequate safety information at least 75 days before introducing any "new dietary ingredient" not in the food supply before the passage of the DSHEA. And yet another government agency, the Federal Trade Commission, regulates all dietary supplement advertising.
Dr. Stengler goes on to say that many ideas Hurley suggests for cleaning up the industry are already in place. Hurley calls for better labeling, but DSHEA already requires dietary supplement labels to list the name and quantity of each dietary ingredient and to identify the part of the plant used for herbal supplements. Hurley calls for FDA regulation of manufacturing standards. Yet, currently, good manufacturing practice regulations are modeled after current food regulations. Furthermore, the FDA inspects dietary supplement plants. Where Hurley makes much of the claim that manufacturers do not have to report adverse events caused by their products to the FDA, Dr. Stengler notes that in December 2006, a bill passed amending the Federal Food, Drug and Cosmetic Act -- requiring manufacturers, distributors and packers of nonprescription drugs and dietary supplements to report serious adverse events to the US Department of Health and Human Services.
JUST PLAIN SILLY
But Hurley also devotes space to detailing the obviously silly, notes Dr. Stengler. He harps on the USDA seizure of a snake oil liniment in 1915 but doesn't point out that conventional medical practices from decades ago included X-ray therapy for facial acne and choosing shoe size -- not to mention blood-letting for yellow fever and dosing with mercury to treat diseases such as syphilis and gonorrhea.
Also, the book prominently features the sad tale of a nurse who self-medicated what she believed was a cancerous skin lesion on her nose. Hurley spares no adjectives describing her painful disfigurement as a result of using creams available over the Internet. What he doesn't focus on enough is the fact that she never sought professional oversight of use of those creams, either from a medical or naturopathic physician, ignored the advice of her dermatologist and did not inform any doctor before using the various creams. He also does not question her judgment in using not one but two creams she had obtained on-line, using each product right after another. Is it fair that Hurley indicts the natural products industry for flawed judgment on the part of this poor woman?
STATISTICS SPEAK FOR THEMSELVES
The cloud hovering over all of this is, quite simply, the safety and efficacy of vitamins and herbal supplements. On the issue of safety let the record speak, says Dr. Stengler. Popular household painkillers, called nonsteroidal anti-inflammatory drugs (which include ibuprofen, aspirin and naproxen) are responsible for about 16,500 deaths annually. Prescription drugs, in spite of extensive testing and copious usage directions, cause more than 106,000 deaths annually. For a stark comparison of relative risk, consider this comparison of reported adverse events -- in 2005, the FDA received more than 300,000 serious adverse event reports about drugs... in the same year, it received just 500 reports regarding dietary supplements.
Hurley demeans the efficacy of vitamins, such as vitamin E, based on studies that "prove" they don't work. Dr. Stengler points out that Hurley blatantly omits other large studies that demonstrate the effectiveness and safety of vitamins, E in particular, including these:
MISSING THE POINT
Perhaps the most egregious flaw in the book is Hurley's reporting of the 1989 FDA recall of L-tryptophan, an amino acid nutritional supplement used as a sleep aid and to help depression, stating that it caused a rare and deadly condition that produces some flu-like symptoms (Eosinophilia-Myalgia Syndrome/EMS). As it turns out, he leaves out large parts of the story. On March 22, 1990, the FDA banned the public sale of dietary L-tryptophan completely... four days later, Newsweek magazine's cover article touted the virtues of the anti-depressant drug Prozac, calling it "A Breakthrough Drug for Depression." The fact that the FDA ban of L-tryptophan -- which was being used by many thousands for depression -- and the Newsweek Prozac cover story occurred within days of each other went unnoticed by both the media and the public.
Epilogue: Just four years later, amazingly, the
Hurley fails to provide this follow-up, and also didn't mention the fact that, during the ban, L-tryptophan was still available under a physician's order, for a whopping price of about $75 for 100 500-mg capsules -- approximately five times more than what it had been sold for as a dietary supplement.
BEWARE YELLOW JOURNALISM
As noted before, Hurley's scare tactics sell books, for sure, but they too often miss the point. His anecdotes and examples are drawn from dramatic and tragic experiences of people who used potent products, often without supervision -- for instance, the deaths that resulted when dieters took supplements containing ephedra. Used in the proper doses, Dr. Stengler says this substance has a long record of safe usage in Chinese medicine for thousands of years, mainly for colds and asthma. There is no verifiable historical evidence of its use as a diet aid. Professional monitoring is vital when it comes to using potent supplements, natural or otherwise. "Natural" doesn't automatically equal "safe" -- as Dr. Stengler and all credible physicians trained in natural medicine always caution. (For more on the discussion regarding the safety of natural products, see the article from Daily Health News, 2/19/07.)
The vitamin and herbal supplement industry continues to develop standards for regulating itself internally. Dr. Stengler fully supports all of these efforts. In addition, the FDA just announced a new rule requiring manufacturers to evaluate the purity, strength, composition and ingredient identity of their dietary supplements... this will help ensure that dietary ingredients are free of contaminants and contain the proper amount of each ingredient.
With the by-now familiar caveat that it is vitally important to seek professional oversight for the use of vitamins and natural supplements, consumers can now use them with confidence. As for Hurley and his book? In Dr. Stengler's view, Hurley's true calling is fiction -- not journalism.
Mark A. Stengler, ND, a naturopathic physician and leading authority on the practice of alternative and integrated medicine. He is director of the La Jolla Whole Health Clinic,