Consumer Health Digest #10-25
Your Weekly Update of News and Reviews
June 24, 2010
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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.
Boyd Haley ordered to stop marketing illegal drug. The FDA has issued a warning letter ordering CTI Science, Inc. and its president, Boyd E. Haley, Ph.D. to stop marketing OSR#1. Haley, a retired chemist, is a professor at the University of Kentucky. OSR#1 contains an industrial chemical called N,N'-bis(2-mercaptoethyl)isophthalamide. In January 2010, the Chicago Tribune reported that the chemical is part of a family of chelators developed for industrial purposes [Tsouderos T. OSR#1: Industrial chemical or autism treatment? Chicago Tribune, Jan 17, 2010] Literature on the CTI Web site has suggested that OSR#1 is effective against thyroid conditions, hypertension, and diabetes. However, its main target market appears to be parents of autistic children. During the past two years, Haley has promoted OSR#1 at conferences and indicated that it would initially be supplied only through doctors who treat autistic children. The FDA letter states:
- N,N'-bis(2-mercaptoethyl)isophthalamide cannot be marketed as a "dietary supplement" because it is not a food component.
- Claims that OSR#1 can alter body structure or function make it subject to regulation as a drug.
- It is illegal to market a new drug without FDA approval as safe and effective for its intended use.
- The FDA is concerned about the risk of adverse reactions.
- Failure to promptly correct these violations can result in legal action, without further notice, including seizure and injunction.
The "Find a Doctor" directory on the CTI Web site currently lists 743 providers, about 20% of whom are chiropractors and 10% are dentists. Autism Watch has additional information about OSR#1.
New dietary guidelines draft released. The Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010, has released its preliminary report for public comment. The main general guidelines are:
- Reduce the incidence and prevalence of overweight and obesity of the US population by reducing overall calorie intake and increasing physical activity.
- Shift food intake patterns to a more plant-based diet that emphasizes vegetables, cooked dry beans and peas, fruits, whole grains, nuts, and seeds.
- Increase the intake of seafood and fat-free and low-fat milk and milk products and consume only moderate amounts of lean meats, poultry, and eggs.
- Significantly reduce intake of foods containing added sugar and solid fats because these dietary components contribute excess calories and few, if any, nutrients.
- Reduce sodium intake and lower intake of refined grains, especially refined grains that are coupled with added sugar, solid fat, and sodium.
- Meet the 2008 Physical Activity Guidelines for Americans.
The above guidelines are similar to those of the past but, the report includes major policy recommendations intended to help Americans follow the recommendations. In addition, the report is more negative than previous reports about about the use of supplements:
A daily multivitamin/mineral supplement does not offer health benefits to healthy Americans. Individual mineral/vitamin supplements can benefit some population groups with known deficiencies, such as calcium and vitamin D supplements to reduce risk of osteoporosis or iron supplements among those with deficient iron intakes. However, in some settings, mineral/vitamin supplements have been associated with harmful effects and should be pursued cautiously.
Chiropractic groups sued by stroke victims. Victims of Chiropractic Abuse, Inc. (VOCA) has initiated a class-action lawsuit charging the Connecticut Chiropractic Council, the Connecticut Chiropractic Association, and their members with knowing that neck manipulations are associated with strokes and can cause stroke but refusing to inform patients of the risks in order to maximize profits. The suit also accuses the chiropractors of employing a strategy of misrepresentations or omissions designed to mislead patients by violating state laws that require they clearly identify themselves as chiropractors in advertising and marketing materials when using the title of "Doctor." VOCA is seeking financial damages; an injunction forbidding the use of the deceptive tactics; and other equitable relief, including but not limited to an order requiring chiropractors who have engaged in these deceptive tactics to pay appropriate fines. The suit was filed immediately after the Connecticut State Board of Chiropractic Examiners refused to grant VOCA's request to order chiropractors to warn patients that neck manipulation entails a risk of stroke.
This page was posted on June 24, 2010.