Consumer Health Digest #04-29
Your Weekly Update of News and Reviews
July 20, 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.
Judge bans sales of shark cartilage and two other questionable cancer products. A U.S. District Judge has ordered Lane Labs-USA of Allendale, New Jersey and its president Andrew J. Lane to stop selling three alleged cancer remedies under their current name or any other name. Federal law prohibits the marketing of health products with unapproved claims that they can prevent, treat, mitigate, or cure disease. The FDA began warning the defendants in 1997 and initiated the lawsuit in 1999 because the company continued to illegally market the products as dietary supplements with claims that:
- BeneFin, which is produced from shark cartilage, was effective against cancer and other diseases;
- SkinAnswer, a glycoalkaloid skin cream, was effective against skin cancer;
- MGN-3, a rice-bran extract treated with shitake mushroom was effective against cancer and HIV, the virus that causes AIDS.
The judge ordered all inventory of these products destroyed except for a quantity of BeneFin that may be needed for research purposes. The court order permanently enjoins the company from selling any unapproved new drugs and orders it to make restitution to anyone who purchased the products since Sept. 22, 1999. [U.S. District Judge issues permanent injunction against Lane Labs-USA, Inc. and orders firm to refund money to purchasers of illegally marketed unapproved drugs. FDA news release, July 13, 2004] The court denied FDA's request for disgorgement of profits but reserved the right to reconsider after restitution is completed.
Shark cartilage came to public attention in February 1993 when CBS TV's" 60 Minutes" aired a program promoting the claims of biochemist/entrepreneur I. William Lane, Ph.D., co-author of the book Sharks Don't Get Cancer. The program highlighted a Cuban study of allegedly "terminal" cancer patients who received shark-cartilage preparations. Narrator Mike Wallace filmed several of the patients doing exercise and reported that most of them felt better several weeks after the treatment had begun. The fact that "feeling better" does not indicate whether a cancer treatment is effective was not mentioned. Nor was the fact that sharks do get cancer, even of their cartilage. NCI officials subsequently reviewed the Cuban data and concluded that they were "incomplete and unimpressive" Nevertheless, a large market was created for shark cartilage products as a "cancer treatment." Lane Labs-USA, was founded in 1994. Its president is Dr. Lane's son Andrew J. Lane.
In June 2000, Lane Labs-USA, Inc., Andrew J. Lane, Cartilage Consultants, Inc., and I. William Lane, Ph.D., agreed to settle FTC charges that they had made unsubstantiated claims that BeneFin and SkinAnswer were effective against cancer. The FTC alleged that in addition to the unsubstantiated efficacy claims, the defendants falsely represented that clinical studies have shown that BeneFin and SkinAnswer are effective in preventing, treating, and curing cancer, and falsely represented that the FDA had evaluated the effectiveness of BeneFin. The settlement required Lane Labs to pay $550,000 to the FTC and an additional $450,000 to subsidize a clinical trial of shark cartilage cosponsored by the National Cancer Institute. [Operation Cure.all" nets shark cartilage promoters: two companies charged with making false and unsubstantiated claims for their shark cartilage and skin cream as cancer treatments. FTC news release, June 29, 2000]
The marketing of MGN-3 was centered around research published by B. Mamdooh Ghoneum, Ph.D., an associate professor and Chief of Research in the Department of Otolaryngology at Charles R. Drew University. The judge's order noted that Lane Labs used Ghoneum and his writings for marketing purposes and had agreed to pay him a 9.5% royalty plus an 8.5% research allocation on all MGN-3 purchases that the company made from its Japanese distributor. Quackwatch has additional background information about shark cartilage and MGN-3.
FTC attacks phony "memory enhancer" supplement. Nutramax Laboratories, Inc., of Edgewood, Maryland, has settled Federal Trade Commission charges that it violated federal law by making unsubstantiated claims that its product, "Senior Moment," could prevent memory loss and restore memory function in adults. Nutramax claimed that the "Senior Moment" supplement "contains a proprietary blend of brain specific nutrients," including DHA and cerebral phospholipids. The FTC charged that Nutramax did not possess a reasonable basis to support its claims and had misrepresented that scientific studies prove that Senior Moment restores lost memory function in adults of all ages. The consent agreement requires Nutramax to have competent and reliable scientific evidence substantiating all claims about the benefits of any product sold for cognitive function, or for the treatment or prevention of any related disease or disorder. ["Senior Moment" maker neglects to prove its claims. FTC news release, July 13, 2004]
Patient protection law struck down. The U.S. Supreme Court has struck down a Texas law that enabled patients to sue their HMOs for damages in state court. Two plaintiffs had brought separate Texas state-court suits alleging that their health maintenance organizations (HMOs) had refused to cover certain medical services in violation of an their duty "to exercise ordinary care" under the Texas Health Care Liability Act, and that those refusals "proximately caused" respondents' injuries. The defendants argued that the suits belonged in federal court, where the 1974 federal Employee Retirement Income Security Act (ERISA) preempts suits that enable subscribers from recovering money beyond the cost of the procedure. The Supreme Court sided with the insurance plans. The American Medical Association and other groups that filed friend-of-the-court briefs say that HMOs now face much less risk in denying medically necessary care, which means they will be freer to deny it. Health plan officials counter that their subscribers can appeal decisions and that preventing lawsuits will help keep insurance costs affordable. [Albert T. Supreme Court strikes down landmark patient protection law. American Medical News 47(16):1-2, 2004]
"Tanning pill" sellers told to stop. The FDA has ordered at least six companies to stop claiming that use of their canthaxanthin product would tan the skin, and protect against sunburn and cancer. The letters were sent to Affordable Supplements of Wichita, Kansas; Higher Power, Inc. of Boise, Idaho; Prime Nutrition of Fort Worth, Texas; RPM Total Vitality of Yorba Linda, California; SmartBodyz Nutrition of Fort Worth, Texas; and World Class Nutrition of Amelia, Ohio. Canthaxanthin is a fat-soluble carotenoid that the human body cannot convert to vitamin A. It is legal to use as a coloring agent in foods or drugs, but only in tiny amounts. Large amounts can temporarily dye the skin orange or yellow by coloring the fat cells under its outer layer. The FDA's warning letters said that health claims make the products unapproved new drugs and tanning claims make them adulterated cosmetics, none of which are legal to market. In 1990, a case was reported of a 20-year-old woman who took high doses and developed aplastic anemia, a serious condition in which the production of blood cells is impaired. Other reports have linked canthaxanthin use to hepatitis, generalized itching, hives, and eye problems. The FDA Web site has additional information.
This page was posted on July 20, 2004.