Consumer Health Digest #07-15
Your Weekly Update of News and Reviews
April 10, 2007
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.
Tobacco company "preventive" campaign criticized. A survey examining the effects of two tobacco-company-sponsored smoking prevention campaigns has cast doubt on their value. The study focused on parent-directed ads from at Philip Morris USA's Youth Smoking Prevention Program and youth-directed ads from Philip Morris and Lorillard Tobacco Co. The researchers compared commercial television ratings data from 75 U.S. media markets on exposure to the ads with school-based survey data from more than 100,000 youth from 1999-2002. After adjusting for other factors that could influence youth smoking, researchers found few links between exposure to the ads and youth smoking attitudes and behavior. During the four months before the survey, among children in grades 10 and 12, each additional viewing of a tobacco company parent-targeted advertisement was, on average, associated with (a) lower perceived harm of smoking, (b) stronger approval of smoking, (c) stronger intentions to smoke in the future, and (d) greater likelihood of having smoked in the previous 30 days. The researchers concluded:
Exposure to tobacco company youth-targeted smoking prevention advertising generally had no beneficial outcomes for youths. Exposure to tobacco company parent-targeted advertising may have harmful effects . . . especially among youths in grades 10 and 12. [Wakefield M. Effect of televised, tobacco company–funded smoking prevention advertising on youth smoking-related beliefs, intentions, and behavior. American Journal of Public Health 96:2154-2160, 2006]
FDA issues draft guidelines for regulating "CAM" products. The FDA has drafted a 14-page guidance document intended to help marketers tell which "complementary and alternative medicine products" and practices are within its jurisdiction and how various types of claims are relevant to this question. [Guidance for industry: Complementary and alternative medicine products and their regulation by the Food and Drug Administration. December, 2006] The document is based on the uncritical "CAM" classification system developed by the National Center for Complementary and Alternative Medicine. The key points are:
- Products claimed to diagnose, prevent, treat, mitigate, or cure disease are generally subject to FDA regulations as drugs (or devices).
- Dietary supplement and herbs claimed to "maintain" or "promote" are generally regarded as dietary supplements.
- Practitioner services are generally regulated by the states and not subject to FDA jurisdiction.
Public comments are welcome through April 30.
FDA curbs dubious magnetic device "research." The FDA has warned the marketers of an "electromagnetic treatment device" that a study it is sponsoring does not comply with federal research regulations. [Ulatowski TA. Warning letter to KSM, Inc., March 14, 2007] The warning letter states that the device was not properly labeled and that the study's Institutional Review Board (a) was not properly constituted, (b) failed to submit progress reports, (c) failed to ensure adequate monitoring of the study, (d) and failed to keep appropriate records. In response to the letter, the company stated that the research project would stop recruiting new subjects.
Last year, a local newspaper reported that the device's inventor (Clifford W. Hunter) said that he felt obligated to provide free treatment because the device was "gift from God." [Roosevelt S. Mystery surrounds activities at former Comanche School. Fort Stockton Pioneer, Sept 8, 2006] The patent application for the device states:
The system exposes blood cells to a magnetic field and then permits circulation of the treated blood cells throughout the person's body. . . .
Successful treatment of various conditions by the invention has been clinically witnessed, including successful treatments for ameliorating the symptoms of diabetes, abnormal blood pressure, skin cancer, and prostate cancer, as well as other cancers, multiple sclerosis, lupus, arthritis, epilepsy, Alzheimer's Disease, Parkinson's Disease, arterial sclerosis, strokes, angina, leukemia, Lou Gehrig's Disease, fibroid tumors, neuropathy, sinus abnormalities, sprains, trauma, vision deficiencies, migraine headaches, AIDS related illnesses and complexes, sickle cell anemia, fibromyalgia, cerebral palsy, and other symptoms. Various forms of circulation have been improved, including blood and lymph circulation.
KSM has said that it plans to set up an assembly plant so it could sell the machine in Europe while awaiting FDA approval in the United States. However, because exposure to magnetic forces will not cure any of the above-mentioned conditions, the FDA will never approve the device for treating them.
North Carolina issues Medicare insurance warning. North Carolina's Senior Consumer Fraud Task Force sent out a statewide trade practices alert about aggressive marketing of Medicare policies to older people, some with dementia. Hundreds of older people across North Carolina have been persuaded to replace their traditional coverage with private insurance that may cost more and do less. The state's Seniors' Health Insurance Information Program is also investigating several cases in which residents of rest homes and low-income housing were targeted. [Goldsmith T. N.C. looking into Medicare scam. Myrtle Beach Sun News, March 30, 2007]
This page was posted on April 10, 2007.