Consumer Health Digest #06-09
Your Weekly Update of News and Reviews
February 28, 2006
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.
Glucosamine, condroitin flunk major clinical trial. The long-awaited NIH-funded study of glucosamine and chondroitin sulfate has found that these substances alone or together did not reduce osteoarthritis knee pain more effectively than a placebo. The 24-week study involved 1583 patients who were randomly assigned to receive 500 mg of glucosamine hydrochloride three times daily, 400 mg of sodium chondroitin sulfate three times daily, 500 mg of glucosamine plus 400 mg of chondroitin sulfate three times daily, 200 mg of celecoxib (Celebrex, Pfizer) daily, or a placebo. The drug group did about 17% better than the placebo group. [Clegg DO and others. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. New England Journal of Medicine 354:795-808, 2006]
Proprietor of dubious scoliosis clinic charged with insurance fraud. Arthur L. Copes, who has owned and operated the Scoliosis Treatment Recovery System Clinic in Baton Rouge, Louisiana for many years, has been arrested on 117 counts of insurance fraud for his alleged involvement in a medical billing insurance scam and for practicing medicine without a license. Copes has developed a back brace and treatment system that he claims is successful in the treatment of scoliosis. Attorney General Special Agents who investigated Copes's activities have alleged:
- Even though Copes performed all of the treatment, he submitted numerous bills to insurance companies using the names and signatures of licensed chiropractors, without their knowledge and in many cases long after they had left the clinic.
- Patients were charged a large sum of money, up to $10,000 in one case, and advised that their insurance company would cover a certain percentage of the cost of the treatment. The insurance companies were fraudulently billed more than $138,000 .
The clinic is now closed. If convicted, Copes faces a possible sentence of five years and/or a $5,000 fine per count on the charges of insurance fraud. The possible sentence for practicing medicine without a license includes a fine not more than $3,000 or prison for not more than three months, or both, and each day a violation continues is considered a separate offense. The Louisiana Attorney General has invited people with relevant information to contact his office at 1-800-256-4506. [Owner of Scoliosis Treatment Recovery System in Baton Rouge surrenders to Attorney General Special Agents. Louisiana Attorney General news release, Feb 23, 2006] Copes, who refers to himself as "Dr. Copes," has a Ph.D. in orthotics from nonaccredited Columbia Pacific University, which was closed by court order in 2001. Barrett S. Court orders Columbia Pacific University to cease operating illegally in California. Quackwatch, revised, Feb 26, 2006] Copes's Scoliosis Treatment Advanced Recovery System ("STARS") is less effective and far more expensive than standard methods of scoliosis treatment. [Barrett S. "Dr." Arthur Copes arrested for insurance fraud. Quackwatch, Feb 27, 2006]
Utah poised to undermine consumer protection. Utah's Direct Sales Amendments (S.B. 182), which has been sent to the Governor for signature, would undermine the state's current law against pyramid schemes. [Fitzpatrick RL. Utah legislature passes pyramid scheme“safe harbor" amendments. MLM Watch March 1, 2006] Utah's current Pyramid Scheme Act specifies that in a pyramid scheme, people pay for compensation or the right to receive compensation derived primarily from the introduction of other people into the sales plan rather than from the sale of goods, services, or other property. In other words, if compensation is derived from sales that are primarily to downline participants recruited into the scheme and not from legitimate retail sales by the participants to end users, it is an illegal pyramid scheme. S.B. 182 exempts goods or services sold to anyone for personal use, which would include newly recruited participants who make monthly purchases to become eligible for commissions they mistakenly believe they will earn. Concerned citizens should ask Utah Governor Jon Huntsman, Jr., to veto S.B. 182. Letters, faxes, or e-mails should be sent to him c/o Mike Mower, Legislative Liaison, Utah State Capital Complex, Suite E220, P.O. Box 142220, Salt Lake City, UT 84114. (Fax: 801-538-1557 or 801-538-1344) If Utah really wants to protect consumers, it should require MLM companies to (a) derive most of their income from retail sales to end users and (b) fully and clearly disclose how much (or how little) new distributors are likely to earn.
FDA initiates seizure of more ephedra products. At the FDA's request, U.S. Marshals have begun seizing supplies of "Lipodrene," "Stimerex-ES," and "Betadrene" and raw material used to make them. The products, marketed and distributed by Hi-Tech Pharmaceuticals, of Norcross, Georgia, have been labeled as containing 25 mg of ephedrine alkaloids per tablet. The FDA estimated that the products have a market value of $3 million. The seizure included more than 200 cases of finished product, more than 200 boxes of bulk tablets and nine 25-kilo drums of ephedrine alkaloid raw material. Ephedrine alkaloids are adrenaline-like stimulants that can raise blood pressure and otherwise stress the circulatory system, effects that were linked to heart attacks and strokes at dosages that were commonly used. Based on this and other evidence in the scientific literature, FDA issued a rule in February 2004 declaring that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. Since this rule became effective in April 2004, the government has executed six seizures against various products. Hi-Tech has an ongoing lawsuit seeking to prevent the FDA from enforcing its 2004 rule declaring dietary supplements containing ephedrine alkaloids to be adulterated. The United States recently moved to dismiss that suit, which is pending in the U.S. District Court for the Northern District of Georgia. [FDA requests seizure of more dietary supplements containing ephedrine alkaloids. FDA news release, Feb 24, 2006] In Utah, the FDA is appealing a lower court ruling that would permit the marketing of dietary supplements that contain 10 mg or less of ephedrine alkaloids.
High-Tech and its owners are also facing FTC action. In November 2004, the agency filed charges against National Urological Group, Inc.; National Institute for Clinical Weight Loss, Inc.; Hi-Tech Pharmaceuticals, Inc.; Jared Wheat; Thomasz Holda; Stephen Smith; Michael Howell; and Dr. Terrill Mark Wright. The Commission alleges that the defendants made deceptive claims about the effectiveness and safety of Thermalean and Lipodrene (ephedra-containing weight-loss products) and Spontane-ES, a purported erectile-dysfunction product containing yohimbine. [FTC charges marketers with making deceptive efficacy and safety claims about ephedra and yohimbine dietary supplements. FTC news release, Nov 30, 2004]
Meanwhile, Nutraquest, a New Jersey company that filed for bankruptcy protection in 2003, and various other companies have agreed to pay $34.19 million to consumers or their survivors to settle injury claims stemming from the use of ephedra in its diet pills. The money will settle 138 cases, with Nutraquest contributing up to $4.35 million and dozens of other firms, including CVS and Wal-Mart, paying the rest. To take effect, the settlement requires approval by other creditors and the bankruptcy judge. Nutraquest, formerly called Cytodyne, was known best for its Xenadrine RFA-1 diet pill, which has been partially implicated the death of Baltimore Orioles pitcher Steve Bechler. [Saitz G. Maker of ephedra pills OKs $34M deal: Nutraquest, others resolve 138 claims. Newark Star-Ledger, Feb 22, 2006] Last July, Nutraquest, owner Robert Chinery, and three related companies agreed to pay the State of New Jersey a total of $940,000 and to adhere to strict constraints on their marketing and advertising practices. [Attorney General and Consumer Affairs reach settlement with maker of Xenadrine: Owner and companies agree to pay $940,000. New Jersey Attorney General press release, July 11, 2005] Two class action suits and a civil complaint by the FTC against Nutraquest and owner Robert Chinery involving deceptive advertising claims remain unresolved.
This page was posted on March 1, 2006.