Consumer Health Digest #08-03

Your Weekly Update of News and Reviews
January 15, 2008

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.

Southern California fluoridated. California's largest water agency, Metropolitan Water District (MWD) of Southern California, has completed its efforts to fluoridate the water that reaches some 18 million residents in Southern California. The MWD serves 26 cities and water systems in Los Angeles, Orange, Riverside, San Diego, and Ventura counties. The California Dental Association Foundation subsidized the effort with $5.5 million to design and construct fluoridation facilities at MWD's five treatment facilities. [Crozier S. Fluoridated water comes to 18 million southern Californians. ADA news, Jan 7, 2008] Since 1995, California state law has required fluoridation of any public water supply with at least 10,000 customers, provided funding is available. Los Angeles and Santa Monica proceeded without outside funding. Long Beach, Beverly Hills, Fountain Valley, Huntington Beach had fluoridated water prior to passage of the law. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately 67% of Americans who receive water from a public water supply now drink water with optimal fluoride levels for preventing decay.

FDA blasts "bio-identical hormone" compounders. The FDA has ordered seven pharmacy operations to stop making illegal claims about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products. The FDA regards this use of "bio-identical" as a marketing term that implies a benefit for which there is no medical or scientific basis. The pharmacy operations also make unsupported claims that their drugs are better than FDA-approved menopausal hormone therapy drugs and can be used to prevent and treat serious diseases such as Alzheimer's disease, stroke, and various forms of cancer. Some products contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. The seven companies are:

FDA issues chelation therapy warning. The name "EDTA" is often used to refer to two separate drugs: Disodium EDTA (edetate disodium, also known as Endrate® and generic versions); and Calcium disodium EDTA (also known as Calcium Disodium Versenate and Versenate®).The FDA has issued a public health advisory to warn patients and healthcare professionals about misuse of these drugs and confusion about "EDTA." [Edetate disodium (marketed as Endrate and generic products), FDA Public Health Advisory, Jan 16, 2008] Both drugs bind to (chelate) certain molecules to speed their excretion from the body. When edetate disodium is injected into the blood stream, it binds to calcium and improper administration can cause fatal decreases in blood calcium levels. Edetate disodium is approved for only treating critically high blood calcium levels, which are rare. Even for that, it is seldom used nowadays because safer methods of reducing serum calcium are available. Calcium Disodium Versenate strongly binds to lead and is approved only for serious cases of lead poisoning. Lesser cases of lead poisoning are treated in other ways.

Several people have died when edetate sodium was used for "chelation therapy" or other uses that are not FDA-approved. A few children have died when given it by mistake. As a result, the agency is reviewing its status. [Questions and answers on edetate sodium. FDA Center for Drug Evaluation and Research, Jan 16, 2008]

Both drugs have been used in chelation therapies that are falsely claimed to improve the cardiovascular system, and treat autism and various other diseases that practitioners falsely attribute to heavy metal poisoning. [Barrett S, Baratz RS. Chelation therapy and insurance fraud. Quackwatch, May 11, 2000]. Neither drug is approved for treating "heavy metal toxicity." The recommended administration of Calcium Disodium Versenate is intramuscular, not intravenous as used by "chelation therapists."

At least 20 deaths have been reported with use of intravenous edetate disodium for allegedly treating vascular disease. The patients were not warned about the danger and were misled to believe that this agent was safe, effective, and a "chemical roto-rooter" for treating cardiovascular disease. None of these subjects had heavy metal intoxication. Because chelation therapists generally prefer to use edetate sodium, removing it as an approved drug or restricting its use to hospitals would make it much more difficult to market "EDTA chelation therapy."

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This page was revised on January 18, 2008.