Consumer Health Digest #04-21

Your Weekly Update of News and Reviews
May 26, 2004

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.

IOM debunks alleged vaccine-autism link. An Institute of Medicine (IOM) expert committee has concluded that neither thimerosal nor the measles-mumps-rubella (MMR) vaccine are associated with autism and that the hypotheses connecting them are not worth further study. The committee report updates two IOM reports published in 2001 that found no association but recommended further research. Since that time, five large epidemiologic studies conducted in the United States, the United Kingdom, Denmark, and Sweden have found no association between thimerosal-containing vaccines and autism, and 14 large epidemiologic studies consistently showed no association between the MMR vaccine and autism. Thimerosal is an organic mercury compound used as a preservative in some adult vaccines. It began to be removed from vaccines for children in 1999, and as of mid-2000, vaccines that are recommended for universal use in infants and young children are available in forms that have no or only trace amounts of thimerosal. The IOM report Immunization Safety Review: Vaccines and Autism can be read online free-of-charge or purchased at a discount from the National Academy Press Web site. The report dovetails with the prevailing scientific belief that autism does not have a toxic basis.

Mexican clinic operators arrested. William R. Fry, Geronimo Rubio, M.D., Debbie LaRue, and John Ditredici have been charged with conspiracy and health care fraud related to the operation of the American Metabolic Institute (AMI) in Tijuana, Mexico. [United States Attorney, Southern District of California. News release, May 20, 2004] The indictment also alleges that the foursome submitted health insurance claim forms for medical procedures, services,, and supplies that were not provided and fabricated medical reports and hospital bills to support those claims. Fry and Rubio were also charged with filing false tax returns, and Fry was further charged with illegally structuring financial transactions (by withdrawing more than $200,000 in cash from accounts in transactions of $9,900, just below the $10,000-per-transaction level that requires federal reporting). AMI is the parent company of Hospital San Martin, which does business as St. Joseph Hospital. Fry and Rubio are co-owners of AMI. LaRue, who is Fry's niece, managed the AMI business office and processed insurance claims which falsely represented that St. Joseph Hospital was located in San Diego. (This was done because many insurance plans exclude coverage of treatment done outside of the United States.) On its Web site, AMI has offered lymphatic massage, laetrile, colonics, "bioelectrical medicine," and a long list of other dubious treatments that it has characterized as "The most advanced alternative health care system for cancer and other degenerative diseases."

FDA challenges illegal claims for "Supreme Greens." The U.S. Food and Drug Administration has ordered ITV Direct to stop claiming in labeling and on its Web site that Supreme Greens with MSM™ is effective against a long list of diseases and conditions. [Costello GT. Warning letter to Donald W. Barrett, Jr., April 19, 2004] The FDA warning letter also identified nine "structure/function" claims and one nutrient claim that FDA officials believe are not supported by reliable scientific evidence:

Supreme Greens with MSM has also been promoted through infomercials featuring an interview with acupuncturist Alex Guerrero who claims:

After a "caller" to the program states that Supreme Greens caused her to shed 81 pounds in 8 months, Guerrero explains that weight loss occurs because the body no longer needs to have a layer of fat to protect itself against the effects of acidic body fluid. Web sites promoting the product also claim that a serving is equivalent to approximately two pounds of fresh vegetables, which is certainly not true. It contains some of the nutrients, but the pills do not contain the dietary fiber that accounts for much of the benefit obtained by eating vegetables. Like Robert Barefoot, who promoted coral calcium products in infomercials, Guerrero recommends frequent testing of one's saliva to see whether the body is too acidic. However, saliva testing has no practical value in evaluating general health status.

Medical Letter warns against cosmetic "penis enhancement." The Medical Letter for Drugs and Therapeutics has warned that various cosmetic phalloplasty procedures for patients with normal anatomy have not been proven effective, have a high complication rate, and are "generally disappointing" because:

Procedures that can lengthen the penis 2-3 inches in the flaccid state do not make it bigger when erect.

Health Canada curbs unapproved erectile aid. Health Canada is warning consumers not to use Bell Magnum Bullet capsules, after it was found to contain an unauthorized substance similar to tadalafil, a prescription drug approved for male erectile dysfunction, sold under the brand name Cialis®. Because the substance in Bell Magnum Bullet has close chemical similarity to tadalafil, Health Canada believes that risks associated with tadalafil could also occur with use of this product. Tadalifil should not be used by people who are taking any nitrate products. Nitrate medications are commonly used for some types of heart disease such as angina. Concurrent use could result in the development of potentially life-threatening low blood pressure. In rare instances, tadalafil can cause penile tissue damage and permanent loss of potency. Health Canada has ordered the distributor to immediately cease sale of this product and has requested a recall. [Health Canada warns public not to use Bell Magnum Bullet News release, 5/21/04]

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This page was posted on May 26, 2004.