Consumer Health Digest #12-40

Your Weekly Update of News and Reviews
November 15, 2012

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.

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Tainted chelation study results announced. Results from the controversial NIH-sponsored Trial to Assess Chelation Therapy (TACT) were announced at the annual meeting of the American Heart Association in November 2012. The study was intended to evaluate the use of chelation therapy against atherosclerotic cardiovascular disease. In 2008, critics reported numerous ethical violations and asked the Office of Human Research Protection (OHRP) to stop the study. [Atwood KA. and others. Why the NIH Trial to Assess Chelation Therapy (TACT) should be abandoned. Medscape Journal of Medicine 10(5):115, 2008] The OHRP expressed various concerns but permitted it to continue with modification. The TACT study measured five endpoints (death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina). The authors reported that, when the endpoints were combined the patients who received chelation did slightly better overall than those who received a placebo. However, none of the outcomes reached statistical significance when measured alone and there was also a high dropout rate. (Only 65% of patients completed all of the planned infusion and 30% dropped out.) The TACT authors concluded correctly that the results "did not constitute evidence to recommend the clinical application of chelation therapy." Kimball A. Atwood, M.D., the leading critic, expects chelationists to claim the study validates what they have been doing even though it demonstrates that their claims of "improvement" or "marked improvement" in 80% to 90% of patients are bogus. It remains to be seen whether the TACT results will deter state boards from disciplining doctors who chelate patients for heart disease. Chelation Watch has additional information about the study. See Quackwatch for an overview of chelation therapy.

Chelationist charged with inadequate infection prevention. Carol Roberts, M.D, who operates the Wellness Works clinic in Brandon, Florida, has been charged with failing to maintain acceptable infection control procedures at her clinic. In 2010, it was determined that an outbreak of hepatitis C was caused by a nurse who improperly administered intravenous chelation therapy. The complaint states that the intravenous solutions got contaminated by vitamins taken repeatedly from single-use vials without cleaning the tops of the vials. The complaint mentions only one patient, but press reports indicate that there were at least eight. [Martin R, Lehman H. Hepatitis C outbreak at Brandon holistic clinic blamed on syringes. St. Petersburg Times, March 20, 2010] Wellness Works was a TACT study site.

New Hampshire naturopaths get "insurance equality." The New Hampshire state legislature has passed a law intended to force insurance companies to pay for services within the scope of naturopathy "if the insurer would reimburse for that type of service when performed by any other type of provider." Chiropractors have gained passage of similar laws in more than 40 states. Insurance companies help protect our society against senseless practices by refusing to pay for methods that have not been proven safe and effective. Laws of this type make it much harder for companies to provide this "gatekeeper" function. Aberrant providers like them because it is much simpler to get laws passed than to develop scientific evidence to support what they do.

Quack device museum available. The Turn of the Century Electrotherapy Museum Web site has posted fascinating collection of pictures and other information about quack devices.

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