Your Weekly Update of News and Reviews
February 12, 2001
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
Magnet study debunked. To justify claims that magnetic products relieve claim, most sellers cite the study performed at Baylor College of Medicine and published in 1997. [Vallbona C and others. Response of pain to static magnetic fields in postpolio patients: A double-blind pilot study. Archives of Physical and Rehabilitative Medicine 78:1200-1203, 1997.] The study involved 50 adult patients with pain related to having been infected with the polio virus when they were children. A static magnetic device or a placebo device was applied to the patient’s skin for 45 minutes. The patients were asked to rate how much pain they experienced when a “trigger point was touched.” The researchers reported that the 29 patients exposed to the magnetic device achieved lower pain scores than did the 21 who were exposed to the placebo device. However, this study was so poorly designed that no beneficial conclusion should be drawn:
- Although the groups were said to be selected randomly, the ratio of women to men in the experimental group was twice that of the control group. If women happen to be more responsive to placebos than men, a surplus of women in the “treatment” group would tend to improve that group’s score.
- The age of the placebo group was four years higher than that of the control group. If advanced age makes a person more difficult to treat, the “treatment” group would again have a scoring advantage.
- The investigators did not measure the exact pressure exerted by the blunt object at the trigger point before and after the study.
- Even if the above considerations have no significance, the study should not be extrapolated to suggest that other types of pain can be relieved by magnets.
- There was just one brief exposure and no systematic follow-up of patients. Thus there was no way to tell whether any improvement would be more than temporary.
- The authors themselves acknowledge that the study was a “pilot study.” Pilot studies are done to determine whether it makes sense to invest in a larger more definitive study. They never provide a legitimate basis for marketing any product as effective against any symptom or health problem.
Vitamin E supplements fail to protect against heart attack. A study of 4,995 people followed for 3 to 6 years has found that 100 mg/day of aspirin reduced the frequency of death and heart attacks, whereas 300 mg/day of vitamin E had no effect. [Low-dose aspirin and vitamin E in people at cardiovascular risk: a randomised trial in general practice. Lancet 357:89-95, 2001 [Download PDF] (Access to the article is free, but registration for the site is required.)
Eyeglass World to pay $500,000 penalty. Florida Attorney General Bob Butterworth has announced that Eyeglass World will pay $500,000 and adopt an arms-length relationship with its affiliated optometrists to settle allegations of unlawful marketing practices. The complaint had alleged that optometrists leasing space in Eyeglass World outlets were pressured by the company to issue unnecessary prescriptions for glasses and contact lenses and to limit time spent with each patient. The complaint also stated that Eyeglass World had intentionally misquoted prices over the telephone, engaged in bait-and-switch advertising, and failed to post its no-refund policy at the point of sale.
“Q-Ray” device maker sued. The Consumer Justice Center, Of Laguna Niguel, California, has filed a consumer-protection lawsuit suit against marketers of the Q-Ray ionized bracelet, which is claimed to relieve pain and provide multiple health benefits by “regulating the imbalance of both positive and negative ions in your body.” The suit, which charges the defendant with falsely advertising in an infomercial and on their Web site, seeks restitution for consumers and/or disgorgement of all funds unfairly obtained by sales based on false claims.
Huge jury award to ephedra stroke vicitm. A jury has awarded $13.3 million to an Alaskan woman who suffered a debilitating stroke after taking a weight-loss product containing ephedrine. It was the first case involving the popular but controversial stimulant to go to trial. The Superior Court jury in Anchorage ordered E’Ola International of St. George, Utah, and its executives to pay Rosalie Talbert $12 million in punitive damages because of “outrageous” behavior in the sales of its AMP II Pro drops. The jury had awarded Talbert $1.3 million in compensatory damages on Friday.The court found E’Ola liable for creating an unsafe product; misrepresenting it as “all natural” when it contained synthetic ephedrine in addition to herbal ephedra; and for being negligent in failing to change the product despite government warnings that it could cause serious illness, including stroke. Between 1994 and mid-1999, supplement companies settled nearly three dozen personal-injury and wrongful-death lawsuits involving ephedra or ephedrine: and dozens more are pending.[Gugliotta GR. Woman wins $13.3 million against dietary company. Washington Post, Feb 8, 2001]
FDA will permit health claims for omega-3 fatty acid supplements. Health claims are permitted on product labels if they are truthful, not misleading, and reflect significant scientific agreement about the underlying facts. Last year, in a suit brought by supplement promoters a federal appeals court ruled that the FDA should not ban health claims it considers misleading unless it also determines that no disclaimer could eliminate the potential deception [Pearson v Shalala, 164 F3d 650 (D.C. Cir 1999)]. In response, the FDA has decided to authorize appropriately “qualified” claims for omega-3 fatty acids and heart disease. In a letter to the plaintiffs’ attorney, an FDA official stated:
- A claim would be acceptable for products whose recommended dosage is no more than 2 grams of eicosapentanoic acid (EPA) and docasahexanoic acid (DHA) per day.
- The relevant elements of such a claim must include:
- Scientific evidence is suggestive but not conclusive for a relationship between omega-3 fatty acids and reduced risk of CHD in the general population
- Studies in the general population have looked at diets containing fish and not at omega-3 fatty acids and have not shown whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD
- It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population.
- One such claim could be: “The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population.”
The FDA has also announced that it will not authorize claims that 0.8 mg of folic acid in a dietary supplement is more effective than a lower amount of food folate in reducing the risk of neural tube defects and that fiber consumption may reduce the risk of developing colon cancer. A claim regarding antioxidants and cancer prevention is under review.
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