Consumer Health Digest #05-45
Your Weekly Update of News and Reviews
November 8, 2005
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.
Anti-fraud activity increased for new Medicare drug program. The Centers for Medicare & Medicaid Services (CMS) is warning consumers to be wary of identity theft and other scams related to the recently announced Medicare prescription drug plan. [Medicare expands efforts to fight fraud: New work with law enforcement; more consumer awareness planned as prescription drug coverage enrollment nears. CMS press release, Oct 7, 2005] Noting that some seniors have been asked for bank numbers by scammers pretending to be drug plan representatives, the agency is warning:
- No legitimate seller can begin enrollment until November 15.
- No legitimate seller should come to anyone's door uninvited or ask for personal information during marketing activities.
- Medicare, credit card, and bank numbers should be safeguarded.
- Personal information should not be disclosed unless it is certain that the seller and product are approved by Medicare.
- For questions or concerns that arise, call 1-800-MEDICARE.
- Patients or physicians who suspect fraud should report it to their local law enforcement agency or the Health and Human Services Office of the Inspector General at 1-800-HHS-TIPS. [Quick facts about Medicare prescription drug coverage and protecting your personal information protect yourself from identity theft and fraud. CMS fact sheet, Sept 2005]
CMS has also hired eight private firms to help weed out fraud in the new program. [The new Medicare prescription drug program: Attacking fraud and abuse. CMS press release, Oct 7, 2005]
ACOG warns against "bioidentical hormone therapy" and saliva testing. The American College of Obstetricians and Gynecologists (ACOG) has warned against the use of compounded "bioidentical" hormone products and the saliva hormone tests typically advocated by prescribers of these products. The term "bioidentical hormones" refers to products claimed to be biochemically similar or identical to those produced by the ovaries or body. Compounded "bioidentical hormones" are plant-derived hormones that are prepared and labeled as a drug by a pharmacist. The products are promoted as safer than the estrogen or progesterone products made by drug companies. However, any risk involved in prescribing a hormonal product depends on its chemical composition and biochemical properties, not on how it was made. In a strongly worded news release, ACOG stated:
- There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies.
- Hormone therapy does not belong to a class of drugs with an indication for individualized dosing. Salivary hormone level testing used by proponents to "tailor" this therapy isn't meaningful because (a) salivary levels are not as accurate as blood levels and (b) they can vary within each woman depending on her diet, the time of day, the specific hormone being tested, and other variables.
- Most compounded products have not undergone rigorous clinical testing for either safety or efficacy. There are also concerns regarding their purity, potency, and quality.
- Given the lack of well-designed and well-conducted clinical trials of these compounded hormones, all of them should be considered to have the same safety issues as those hormone products that are approved by the FDA and may also have additional risks unique to the compounding process.
FTC stops another diet pill scam. Tustin, California based Natural Products, LLC, All Natural 4 U, LLC and their owner, Ana M. Solkamans, have signed a consent agreement settling FTC charges related to their marketing of a product they marketed as "Bio Trim,” “Body-Trim/Bio-Trim,” and “Body-Trim.” In November 2004, the FTC charges that the defendants claimed falsely that the product (a) causes users to lose substantial weight, while eating unlimited amounts of food; (b) causes substantial weight loss by blocking the absorption of fat or calories; (c) works for all overweight users; and (d) is clinically proven to cause rapid and substantial weight loss without reducing calories. The settlement prohibits the defendants from making unsubstantiated weight-loss or health claims for any product. The agreement also includes a $2,158,490 judgment (representing the amount of consumer injury) that will be suspended due to inability to pay but will be imposed if the defendants are found to have misrepresented their current financial status. [FTC stops bogus ads for "bio trim" and other weight-loss products. FTC news release, Nov 7, 2005]
Another alleged chelation death reported. The Texas Medical Board has temporarily suspended the license of Kenneth W. O'Neal, M.D. The suspension was triggered by the deaths of three patients whom he treated with intravenous therapy. One received chelation therapy; the others got infusions of other substances. O'Neal became medical director of the Texas Institute of Functional Medicines in 2002 but is no longer listed on its Web site. According to newspaper reports, he says that the patients died of conditions for which they were being treated by other doctors and that his treatments had nothing to do with their deaths. The temporary suspension order is posted on Casewatch.
Maryland medical center site loaded with misinformation. Dr. Stephen Barrett has concluded that the University of Maryland Medical Center, whose mission includes "quality in education and research," has hundreds of low-quality articles posted on its Web site. Searching the site with Google, Barrett found articles that promote homeopathy for about 300 health problem that the site discusses. Homeopathy is based on a 200-year-old delusional system which claims that (a) substances that produce symptoms in a healthy person can cure ill people with similar symptoms; and (b) the more dilute the remedy, the greater the effect. [Barrett S. Homeopathy: The ultimate fake. Quackwatch, Dec 28, 2003] Most of the bad articles also include unsubstantiated recommendations for dietary supplements and herbs.
This page was posted on November 10, 2005.