Strike Three for Dietary Supplements?
By: Source: AARP Bulletin Today Date Posted: 2003-07-28 07:57:27
When Baltimore Orioles pitcher Steve Bechler died of heatstroke last February, ephedra, an herbal "fat-burner," was widely suspected as a factor in his death.
While ephedra's exact role in the 23-year-old's death may never be nailed down, the tragedy underscored how little is really known about dietary supplements. Unlike drugs, supplements are subject to little federal oversight, leaving consumers largely in the dark on whether they're safe and effective.
Even so, public demand for dietary supplements—including vitamins, minerals, amino acids, herbal remedies and exotic therapies touted to improve health and longevity—is soaring. So is evidence of serious and sometimes deadly side effects from some products, especially, medical experts say, among older people.
In March the U.S. Food and Drug Administration (FDA) took steps to help consumers get uncontaminated and better-labeled products. The agency proposed a rule, which would take effect next year if approved, requiring good manufacturing practices and labels that list the amount and strength of ingredients.
"This has been a 'buyer beware market,' " FDA Commissioner Mark B. McClellan, M.D., said in announcing the rule. "We need to make sure [consumers] are getting the products they pay for."
But medical experts and consumer advocates, while praising the effort as a step in the right direction, say the proposed regulations do not go far enough.
"The proposed rule is only a quality-control measure," says Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest. "The real issue is that dietary supplements should be shown to be safe and effective just like over-the-counter drugs."
He adds that the proposal "is based on good manufacturing practices for food processing plants, but dietary supplements are more akin to drugs than foods."
Americans seem undeterred by such concerns, lavishing more than $17 billion a year on dietary supplements. According to a 2001 AARP survey, 52 percent of people 50 and older take supplements every day.
"Dietary supplement use is so extensive that one could almost consider it the norm," says Annette Dickinson, president of the Council for Responsible Nutrition, a manufacturing trade group based in Washington.
Despite the concerns, not all supplements are unsafe—some are made by reputable companies and are accurately labeled. And some confer proven benefits.
Many older people fulfill nutritional needs with vitamins and minerals, which are generally safe if taken according to instructions.
But a growing number of older Americans—at least 40 percent, according to a U.S. General Accounting Office report—are using botanicals, a group of supplements that consumer advocates say especially need greater scrutiny.
"It's gratifying that people are taking more responsibility for their health care," says George Gaberlavage, an associate director of AARP's Public Policy Institute. "But we need to know much more about the effect of supplements, and our surveys show that consumers themselves want more safety information on labels."
More than 80 percent of respondents to the AARP supplement survey, Gaberlavage says, said they wanted labels to list safe dosages and possible side effects and drug interactions.
Dietary supplements are not considered medicines, so they are not required to undergo the rigorous testing that drugs do before they can go on the market. Under a 1994 federal law, the FDA monitors their safety primarily by relying on reports of adverse reactions, after the products are already in stores.
"Because dietary supplements are classified as foods under federal law, they are assumed to be safe and are subject to limited federal oversight," says Ron Davis, M.D., a specialist in preventive medicine and public health in East Lansing, Mich., and an American Medical Association (AMA) board member.
"I don't know why we don't call these compounds drugs," says Barry M. Forman, M.D., associate professor at the Beckman Research Institute at the City of Hope National Medical Center in Duarte, Calif. "They are drugs. They're just naturally occurring."
Ephedra, a derivative of the Chinese herb Ma huang that can elevate heart rate and blood pressure, is a case in point. Its synthetic version ephedrine, a treatment for colds and asthma, is categorized as a drug and is regulated. Ephedra, as a dietary supplement, is not.
After Bechler's death and in the light of medical research on the product's dangers—including a RAND Corp. review of 16,000 reports of adverse events—the FDA took what McClellan called "an unparalleled step for a supplement" and called for a strong warning label. The agency also said it would crack down on claims that ephedra boosts sports performance. The American Medical Association and the American Heart Association have called for a ban on ephedra products.
While ephedra has elicited the largest response, adverse reaction reports are on the rise for other dietary supplements. From 2001 to 2002 complaints directed to the FDA rose from 553 to 1,214. But FDA officials say many adverse reactions are never reported. In fact, only 13 percent of participants in the AARP supplement survey said they would notify the FDA of a bad reaction.
Their reluctance may be based partly on the fact that older supplement users do so on their own, with no medical advice. More than half of AARP's survey respondents said they never discussed the issue with their doctors. And many clearly don't want to.
Pamela Haines, associate professor of nutrition at the University of North Carolina, said at a National Institutes of Health (NIH) conference on dietary supplements last winter that older people often say their doctors wouldn't understand or it's none of their business.
Many individuals, Haines says, are the "worried well" who take supplements as insurance and want to maintain control over their health. "This is a group of consumers who crave self-empowerment," she says.
But many of the worried well and others who use supplements may not be aware of potential side effects, which can range from mild to lethal, from nausea and diarrhea to high blood pressure and liver dysfunction.
Supplements may interfere with the action of prescription and over-the-counter medications. Some are toxic, and others are just plain worthless. The downsides:
Interactions with drugs. Many older people take medications with carefully calibrated dosages that if not precisely followed could harm them. Taking, for example, the blood-thinning prescription drug warfarin (Coumadin) along with the herbal supplement ginseng, also a blood thinner, raises risks for bleeding. Adding anything to a drug regimen with narrow dosage range "can dramatically affect the toxicity profile," says David J. Kroll, senior research pharmacologist in the Natural Products Laboratory at the Research Triangle Institute in North Carolina.
Allergic reactions. While peanuts, wheat and soy are well-known plant-based allergy triggers, experts say there are plenty of others. The toxicity in some herbals can cause severe allergic reactions in unsuspecting users.
Misuse. Taking inappropriate dosages without regard to instructions (i.e., "Take with food" or "Take at bedtime.") can have unwanted consequences. Some are serious: While anti-oxidant vitamins are thought to help reduce cancer risk, a well-known study a few years ago found that very high levels of anti-oxidants in smokers can actually raise the risk.
Delayed medical care. Over-reliance on supplements can tempt users to defer needed care. Case in point: While some men say the botanical saw palmetto has helped their prostate problems, experts say that forgoing a consultation with a doctor could be risky.
Ineffectiveness. Some supplements simply don't deliver. Many people, for example, report taking the botanical echinacea, touted as a remedy for warding off colds, with no effect whatever. A study published recently in the Archives of Internal Medicine found that ingredients in echinacea preparations varied widely and that 10 percent of 59 products tested had no measurable echinacea at all.
These downsides exact a high price, in terms of health and money. For every dollar spent on drugs for older people, one to two dollars is probably spent to treat harmful drug reactions, Joseph T. Hanlon, professor of geriatric pharmacotherapy at the University of Minnesota, said at the NIH conference.
"What percentage of this is due to dietary supplements?" he asked. "We don't know."
Peggy Eastman is a freelance writer in Washington, D.C.
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