Anyone who has ever perused the ads for various dietary supplements online or in magazines must be familiar with claims that the product in question is "clinically proven" or is "scientifically proven" to be safe, effective, and a cure for whatever ails one — or at least that "research has shown" this is so. We at ACSH have written in the past about the weakness of the regulatory scheme for dietary supplements. We've noted that supplement manufacturers, unlike producers of pharmaceuticals, don't have to prove their products either safe or effective before marketing them. Thus, they don't have the financial burden of having to do the research that would support real health claims. This doesn't mean that no research is being done, but the validity of the research and the conclusions drawn from it are drawing fire.
A June 24 article in the New York Times describes a $12.5 million judgement against a company that made false advertising claims for an ephedra-containing weight-loss supplement. The judge who ruled on the suit said that not only had the company exaggerated research findings, it had also persuaded some researchers to use false data in published articles. According to the article, three other weight loss supplement manufacturers have lost false advertising cases, and another has been cited by a federal judge for hiding evidence, presumably evidence that didn't support claims they made or wished to make for their products.
Obviously, supplement manufacturers realize that being able to state that clinical research supports their products is a valuable asset. Unfortunately, consumers can't tell whether the claims of clinical research refer to an uncontrolled study of seven healthy young men, or a properly controlled one involving the type of individuals expected to make use of the product. Both can be considered clinical trials, but only the second one — with people in the control group unknowingly taking a placebo or "dummy" pill, and with large enough numbers of participants for adequate statistical analysis — should be considered valid support.
Standard pharmaceutical product manufacturers must not only run appropriate clinical trials of their products before marketing them, they must present their data to the Food and Drug Administration (FDA) and convincingly demonstrate that the products are safe and effective. Supplement manufacturers don't have to do so. This fact means that no one reliably rules on whether the studies are properly designed or the data valid.
No one can claim that the FDA approval route is foolproof — once a drug is approved and being used by many more people than participated in clinical trials, new problems can occur. When they do, and are serious enough, a drug may be recalled, as occurred with the weight-loss drug Redux. If this can happen with a compound that has been studied in legitimate trials, it is as likely, if not more so, to occur when studies are not valid or negative data are suppressed.
Consumers should be aware of the lack of valid research supporting many of the claims made in ads for dietary supplements, and factor this information into their decisions about buying or using these products.
Ruth Kava, Ph.D., R.D. is Director of Nutrition for the American Council on Science and Health.
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| Responses:
July 3, 2003
Dear ACSH:
In the supplement world, just as in the pharmaceutical domain, the bad guys spoil it for the rest of us. So we get a constant barrage of weight loss products, some containing ephedrine (a derivative of ephedra).
But then government overreacts by banning ephedra. So people with asthma, like me, have one less medicine available. (Fortunately, I can still get it in Iowa.
The reality is that supplement makers are scarcely allowed to make any claims, while pharmaceutical makers can say almost anything, approaching "we can revive your dead relatives." Pharmaceuticals are rigorously tested, but many side effects are not known until years after approval, and they are often prescribed for conditions that they are not approved for.
The truth is that natural substances have been safely used for thousands of years by millions of people to treat a variety of ailments. And the safety record is phenomenal. While pharmaceuticals kill at least 100,000 people per year, supplements are not even on the radar screen. So don't hide behind "science" while abusing patient health.
People need to do their own meticulous research. Most illness can be cured and prevented by better nutrition and an active pursuit of health. Drugs are routinely dispensed as if by an impersonal machine, as a substitute for active engagement. Supplements are generally much cheaper, safer, and more effective. But consumers need to get the best brands, which are often not available in chain stores.
So we need to have a healthy skepticism. And to follow Hippocrates' admonition, "Let your food be your medicine!"
—airgun177 |
