Consumer Health Digest #04-06
Your Weekly Update of News and Reviews
February 10, 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.
FDA issues final rule banning ephedra in dietary supplements. The U.S. Food and Drug Administration has issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements "present an unreasonable risk of illness or injury." [FDA issues regulation prohibiting sale of dietary supplements containing ephedrine alkaloids and reiterates its advice that consumers stop using these products. FDA news release, Feb 6, 2004] The rule will become effective on April 6. In December, the agency advised consumers to stop using ephedra products asked companies to stop selling them. The Dietary Supplement Health and Education Act (DSHEA) of 1994, permits the FDA remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use. To meet the required legal standard. the FDA reviewed scientific reports and more than 30,000 public comments. In recent years, ephedrine alkaloids have been extensively promoted for aiding weight control and boosting sports performance and energy, even though the evidence supporting such use is slim. In February 2003, an FDA official informed the Senate Commerce Committee that the agency had warned 26 firms to cease making unproven claims that ephedrine-containing dietary supplements enhance athletic performance. Fourteen of the firms responded to the warning letters by discontinuing the product or the claim. The remaining twelve firms were inspected by FDA. Of those twelve, all but one either discontinued the product or the objectionable claims. The FDA then initiated legal action leading to a seizure of more than 1,000 bottles of Betatrim, Thermbuterol, and Stacker 2 from Musclemaster.com in Northboro, Massachusetts. [FDA seizes ephedra-containing dietary supplements from on-line Massachusetts company for unsubstantiated athletic performance claims. FDA news release, Feb 5, 2004]
"World's Greatest Vitamin" debunked. Quackwatch has posted a detailed investigative report about Don Lapre, a fast-talking huckster who has marketed get-rich-quick schemes for more than a decade. His latest scheme is "The Greatest Vitamin in the World." Lapre promises to pay "independent distributors" $1,000 or "up to $200 a month for life" every time they got 20 people to try the vitamin, but the product is overpriced and the commission numbers don't add up. [Quill T, Barrett S. Be wary of Don Lapre, Doug Grant, and "The Greatest Vitamin in the World." Quackwatch, Feb 10, 2004]
FTC hits "Skinny Pill" marketers. The Fountain of Youth Group, LLC, and its principal, Edita Kaye, have settled FTC charges that they made false and unsubstantiated weight-loss and health claims for their Skinny Pill AM, Skinny Sleep PM, Skinny Carbs, and Skinny Pill for Kids. The proposed settlement, which requires the court's approval, prohibits the defendants from making unsubstantiated weight-loss or health claims for the Skinny Pills or similar products. The settlement also contains a judgment of $6 million, which has been suspended due to the defendants' apparent inability to pay. Ads for the products had claimed that they would cause weight loss; increase fat burning; normalize insulin and blood sugar levels; and block the absorption of carbohydrates and fats. [The "Skinny Pills" do not make you skinny, says the FTC. FTC news release, Jan 2004]
FDA warns "crocodile blood" product marketer. The U.S. Food and Drug Administration has warned the operators of Biologicalmiracle.com to stop claiming that "The Antidote," a product said to be derived from the blood of crocodiles, can fight all known human viruses and bacteria" and is effective against serious infectious diseases such as cancer, AIDS, SARS and many other life threatening diseases. [Masiello SA. Warning letter to Biologicalmiracle.com. Jan 16, 2004] However, the claims remain on the company's Web site.
Canadian organizations oppose cross-border prescribing. The Canadian Medical Protective Association has decided that it will no longer help physicians involved in legal actions resulting from the inappropriate signing or co-signing of prescriptions for persons with whom they have no recognized doctor-patient relationship. Provincial/territorial licensing bodies have advised practicing physicians that proper care requires an an adequate history, physical examination, diagnosis, consent, and follow-up when prescribing medications. Completion and maintenance of an appropriate medical record is also expected. Physicians engaged in the inappropriate signing or co-signing of prescriptions are at risk of sanctions by the licensing bodies. [Sproule J. CMPA assistance in Internet and cross-border prescribing to non-patients—General principles. CMPA information sheet, Feb 2004]
Dubious cancer information provider dies. Patrick M. McGrady Jr., a medical writer who operated the cancer advisory service CANHELP for more than 20 years, died suddenly on December 12th while recovering from knee surgery. Portraying cancer specialists as brusque and ignorant, McGrady claimed that reliable information was difficult to get and that he would supply what is missing. However, he almost always recommended unsubstantiated methods, and he failed to systematically track what happened to his clients. His best known work was The Pritikin Program for Diet and Exercise, co-authored with Nathan Pritikin, which was published in 1979 and was on the New York Times Best-seller list for a year. Quackwatch has described his activities.
Fundraising fraudster gets 15-year sentence. Timothy James Lyons, 35, who fraudulently raised nearly $7 million to help disabled children and research AIDS, has been convicted of mail fraud and money laundering and sentenced 15 years in prison a $25,000 fine. Through telemarketers and mass mailings, he and Gabriel Bernardo Sanchez, 37, promised donors that the money would benefit several causes, including homeless shelters and veterans groups. Instead, the men used 80% of the money to pay expenses and pocketed the rest ($nearly $1.4 million). According to the indictment, Sanchez founded the First Church of Life in Costa Mesa 10 years ago and used it as an umbrella organization to operate several unregistered charitable groups, including American Veterans Help Fund and Americans Against Drugs. Lyons' company, North American Acquisitions, hired telemarketers to call potential donors, then sent couriers to people's homes to collect the money. Sanchez is scheduled to be sentenced next month.