Consumer Health Digest #09-41
Your Weekly Update of News and Reviews
Oct 8, 2009
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.
New England Journal publishes supplement warning. An editorial in the New England Journal of Medicine has expressed great concern about the dietary supplement marketplace. The editorial noted:
- Lenient regulatory oversight over dietary supplements, combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity.
- Although manufacturers have since 2007 been required to report serious supplement-related adverse events to the FDA, the great majority of the estimated 50,000 adverse events that occur annually remain unreported.
- A 2002 Harris Poll found that most consumers mistakenly belied that dietary supplements are approved by a government agency
- A recent survey of internal medicine residents found that one third mistakenly believed that dietary supplements require FDA approval and the majority did not know that adverse events suspected to have been caused by supplements should be reported to the FDA.
- In an attempt to evade detection, some manufacturers have spiked products with modified forms of drugs, the safety of which is unknown.
The author concluded:
Congress should give the FDA the requisite authority and resources to regulate dietary supplements so that the public can make well-informed decisions regarding the potential risks and benefits of consuming such supplements. Until that happens, millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits. [Cohen PA. American roulette—contaminated dietary supplements. New England Journal of Medicine, Oct 8, 2009]
Sanum therapy debunked. Quackwatch has published a skeptical report about Sanum therapy, a relatively obscure form of "homeopathic" treatment administered by offbeat practitioners. Sanum therapy is based upon the medically disputed concept of pleomorphism, which holds that microorganisms can shift from one form to another in response to environmental influences. It was developed by Günther Enderlein (1872-1968), who theorized that tiny microorganisms called "protits" normally circulate harmlessly throughout the body but can change into disease-producing bacteria or fungi if exposed to various internal or environmental triggers. Sanum remedies are dilutions of bacteria or fungi that are claimed to reverse the harmful changes. They are claimed without substantiation to be effective against more than 300 diseases and conditions. They pose the risk of use instead of appropriate treatment. Their use also reflects very poor professional judgment. Four state licensing boards have taken action against dentists who included them in their practices.
Shari Lieberman dies. Shari Lieberman, Ph.D., a major promoter of nutrition misinformation, has died of metastatic breast cancer at age 51. Her most notable achievement was a defamation suit that discouraged the American Dietetic Association from trying to stop registered dietitians from promoting or engaging in unscientific practices. Quackwatch has published an account of her activities.
"Bio-identical" hormone provider disciplined. Cheryle Hart, M.D., who for several years has operated workshops combined with personal consultations about women's hormones, has been disciplined by three medical licensing boards. In 2007, she signed a stipulation under which she was fined $1,000 and barred from diagnosing or treating patients in Idaho unless she maintained a regular medical office within the state. In 2008, rather than face charges that she had practiced improperly, Hart voluntarily surrendered her Montana license. In 2009, she agreed to a stipulation and order with the Washington Medical Quality Assurance Commission under which was reprimanded and agreed that:
- She will be subject to the Commission's oversight for four years or until released from the Idaho and Montana orders.
- She must perform proper medical examinations, maintain adequate records, and bill patients or their insurance carriers with accurate and bone fide billing codes,
- If she intends to serve patients within Washington, she must have an actual office where she will be subject to unannounced compliance inspections
- If she performs counseling and education services within Washington, she must not lead patients to believe that insurance companies will cover her services.
Hart's Web site states that she specializes in "bio-identical hormone replacement, brain health, stress management and weight control." The Montana case was triggered by complaints from four patients who had attended her workshops. All four reported that (a) their phone calls were not returned, (b) Hart's prescriptions were incorrect, (c) follow-up was nonexistent, (d) Hart's diagnoses were wrong, and (e) Hart asked them to pay high fees to continue her services. The FDA has cautioned against the use of "bio-identical" hormones.
This page was posted on September 25, 2009.