Your Weekly Update of News and Reviews
December 6, 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.
No evidence that chelation helps autism. A systematic review of published reports about chelation for autism spectrum disorders (ASD) has identified six reports, all inadequately designed, and concluded:
- The use of chelation therapy represents the ”cart before the horse” scenario in that the “toxic” hypothesis supporting its use has not been validated.
- Because empirical evidence does not support the hypothesis that the core ASD symptoms are associated with specific levels of metals in the body, the use of chelation to remove metals from the body in order to ameliorate ASD symptoms could be seen as unfounded and illogical.
- Even if metal poisoning theories were valid, that would not necessarily mean that chelation would ameliorate current impairments.
- The weakness of the evidence base, the lack of a sound rationale, and the potential negative side effects strongly argue against the use of chelation treatment for ASD. [Davis TN and others. Chelation treatment for autism spectrum disorders: A systematic review. Research in Autism Spectrum Disorders 7:49-55, 2013]
Departing Congressman takes parting shot at vaccination. U.S. Rep. Dan Burton (R-IN), who is retiring from Congress this year, has held his 21st and final hearing on the subject of autism. Burton, who became interested in the subject after his grandson became autistic, has used most of these hearings to promote discredited beliefs, express doubts about vaccination safety, and harass government officials who did not agree with him. This week’s hearing included a diatribe from minute 12:48 to minute 18:06, during which Burton restated his firm belief that mercury in vaccines is a contributing factor to neurological diseases such as autism and that it accumulates in the brain because “the brain tissues do not chelate it.” Steven Salzberg, M.D., has written a brilliant critique of the hearing.
Inspector General expresses concern about dietary supplement regulation. The U.S. Office of the Inspector General (OIG) has expressed concern that claims for dietary supplements are not sufficiently regulated. After reviewing the “structure/function” claims for a sample of 127 dietary supplements marketed for weight loss or immune system support, the investigators (a) evaluated the extent to which they complied with FDA regulations, (b) reviewed substantiation provided by manufacturers, and (c) assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA. [Dietary supplements: Structure/function claims fail to meet federal requirements. OIG report OEI-01-11-00210, October 2012]
The Dietary Supplement Health and Education Act (DSHEA) of 1994 allows dietary supplements to bear “statements of support” that: (a) claim a benefit related to classical nutrient deficiency disease; (b) describe how ingredients affect the structure or function of the human body; (c) characterize the documented mechanism by which the ingredients act to maintain structure or function; and (d) describe general well-being from consumption of the ingredients. Under this law, manufacturers can make “truthful and not misleading” claims that products can affect body structure or function, but they are but not permitted to claim that products can prevent or treat any disease. The OIG investigators concluded:
- Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.
- The FDA could not readily determine whether manufacturers had submitted the required notification for their claims.
- Twenty percent of the products included prohibited disease claims on their labels.
- The FDA should seek explicit statutory authority to determine whether structure/function claims truthful and not misleading.
- The FDA should make the notification system more organized, complete, and accurate.
- The FDA should expand market surveillance to enforce the existing regulations.
The OIG report does not mention that DSHEA was enacted to undermine FDA regulation and that optimal public protection cannot occur unless it is repealed. [Barrett S. How the Dietary Supplement Health and Education Act weakened the FDA. Quackwatch, Feb 7, 2007]
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