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Consumer Health Digest #10-41
October 14, 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. 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.
###
FDA attacks "oral chelation" marketing.The FDA has warned eight companies that their over-the-counter (OTC)
chelation products are unapproved drugs and that making unproven
claims about them is illegal. The companies have been claiming that
their products treat a range of diseases by removing toxic metals
from the body. Some also claim to treat autism spectrum disorder,
cardiovascular diseases, Parkinson's disease, Alzheimer's disease,
macular degeneration, and other serious conditions. Four of the
companies also sell unapproved screening test kits that they claim
will detect the presence of heavy metals in urine and thus justify
the need for chelation therapy. The companies and their products are:
**Artery Health Institute, LLC: Advanced Formula EDTA Oral Chelation
**Cardio Renew, Inc.: CardioRenew and CardioRestore
**Evenbetternow, LLC: Kids Chelat Heavy Metal Chelator, Bio-Chelat
Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline
Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear
Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and the Heavy
Metal Screen Test
**Rhonda Henry: Cardio Chelate (H-870)
**Hormonal Health, LLC: Kelatox Suppositories, METALDETECTOR Instant
Toxic Metals Test
**Longevity Plus: Beyond Chelation Improved, EndoKinase, Viral
Defense, Wobenzym-N
**Maxam Nutraceutics/Maxam Laboratories: PCA-Rx, PC3x, AFX, AD-Rx,
AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell,
Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion,
NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe,
Heavy Metal Screening Test
**World Health Products: Detoxamin Oral, Detoxamin Suppositories,
Metal Detector test kit
Links to the letters are posted at
http://www.casewatch.org/fdawarning/prod/2010/index.shtmlThe FDA has noted an increase in "chelation therapy" products
marketed on the Internet that claim to cleanse the body of toxic
chemicals and heavy metals. The products come in various dosage
forms, including transmucosal sprays, suppositories, capsules, liquid
drops, and clay baths. Although some are marketed as "dietary
supplements," they are unapproved drugs because they are claimed to
treat, mitigate, prevent, or diagnose disease. The FDA advises
consumers to avoid all nonprescription products offered for chelation
or detoxification. The only FDA-approved chelating agents are
available by prescription only and have limited use.
The warning letters state that failure to promptly correct the
violations could subject the companies to legal action that includes
seizure and injunction.
###
FDA curbs black salve marketers.Toby McAdam and Greta Armstrong, doing business as Risingsun Health
and The Center for Complementary and Alternative Health (TCCAH, Inc)
of Livingston, Montana, have signed a consent decree that will
permanently enjoin them from illegally marketing unapproved new drugs
and adulterated or misbranded dietary supplement.
http://www.casewatch.org/fda/court/risingsun/consent.pdf The agreement settles a complaint that the defendants were marketing more
than 40 such products. The complaint indicates that, beginning in
2006, the FDA had repeatedly warned the defendants to stop marketing
illegally and that the defendants had repeatedly promised to do so
but did not. Several of the products were escharotic skin salves
(commonly referred to as "black salves)" that contain bloodroot and
other caustic substances. Other products included oils and capsules
claimed to be therapies for breast cancer, asthma, anemia, epilepsy,
and other serious diseases.
http://www.casewatch.org/fda/court/risingsun/complaint.shtmlCorrosive salves are not safe for use against skin cancers because
(a) they can indiscriminately burn whatever the tissue they encounter
and (b) it is not possible to be certain whether cancer remains under
the skin where it can continue to grow without immediate detection.
[Barrett S. Don't use corrosive cancer salves (escharotics).
Quackwatch, Oct 14, 2010]
http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/eschar.html###
Vaccine critic "Dr. Bob" Sears blasted again.Rahul K. Parikh, M.D., has looked closely the irresponsible advice
given by "Dr. Bob" Sears in his book, The Vaccine Book." The book's
centerpiece is "Dr. Bob's Alternative Schedule," which spreads
vaccines over 21 visits instead of the standard 13. Parikh notes that
Sears repeatedly uses "soft science, circular logic, rumors, and
outright falsehoods" and that his book is "nothing more than an
anti-vaccine book blanketed in a soft, sympathetic and homespun
style." [Parikh RK. Face-off with the bestselling vaccine guru.
Salon.com, Oct 13, 2010]
http://www.salon.com/news/autism/?story=/mwt/feature/2010/10/13/vaccine_book_sears Last year, in a stinging editorial, Paul Offit, M.D. and a colleague
pointed out that Sears's schedule is dangerous because it
significantly increases the time during which children are
susceptible to vaccine-preventable diseases. [Offit P, Moser CA. The
problem with Dr Bob's alternative vaccine schedule. Pediatrics, Jan
2009]
http://pediatrics.aappublications.org/cgi/content/full/123/1/e164###
Classic health survey report posted.The full text of A Study of Health Practices and Opinions has been
posted to the Consumer Health Sourcebook Web site.
http://www.chsourcebook.com/articles/health_practices_and_opinions.pdf The FDA-sponsored survey, published in 1972, investigated
questionable and fallacious health beliefs and why people are
susceptible to them. The covered areas include vitamin pills, other
dietary supplements, weight-reduction practices, cancer-related
practices, arthritis-related practices, laxatives, self-diagnosis,
self-medication for common ailments, types of practitioners used, and
general health-related attitudes and opinions. It is the largest
survey of its type ever conducted.
###
In June, Doctor's Data filed suit against Dr. Barrett because it
didn't like what he wrote about them on Quackwatch and in this
newsletter. The events leading up to the suit are described at
http://www.quackwatch.org/14Legal/dd_suit.html Contributions to his defense fund can be made by mail or through
http://www.quackwatch.org/00AboutQuackwatch/donations.html###
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--
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Stephen Barrett, M.D.
Consumer Advocate
Chatham Crossing, Suite 107/208
11312 U.S. 15 501 North
Chapel Hill, NC 27517
Telephone: (919) 533-6009
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Editor, Consumer Health Digest
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