Consumer Health Digest #03-17
Your Weekly Update of News and Reviews
April 29, 2003
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.
Massive dietary supplement recall ordered in Australia. The Therapeutic Goods Administration (TGA) has suspended the manufacturing license of Pan Pharmaceuticals for six months and ordered withdrawal from the market of 219 products, mostly sold under the Pan brand. Thousands of other health products made by Pan and marketed under other names are also expected to be recalled. Pan is Australia's largest contract manufacturer of vitamin, mineral, and herbal products and represents about 30% of the country's market for these products. They also manufacturer a few nonprescription drugs. In January, the TGA launched an investigation after faulty batches of Pan's Travacalm Original Tablets (an anti-travel-sickness medication) caused at least 87 reactions and 19 hospitalizations. TGA inspectors then found serious safety and quality breaches that included substitution of ingredients, manipulation of test results and substandard manufacturing processes. [National medicines regulator suspends drug company's manufacturing licence. TGA news release, April 28, 2003]
Libel suit settled. The libel suit involving Stephen Barrett, M.D., and a physician who disseminated a libelous message about him has been settled amicably. The defendant is an osteopathic physician who practices family medicine in Schaumburg, Illinois, and operates a heavily trafficked Web site. The suit arose after the defendant posted an article by Patrick "Tim" Bolen which falsely stated that Barrett (a) was de-licensed, (b) had committed extortion, and (c) had been disqualified as an expert in a malpractice suit. In settling the case, the defendant acknowledged that he had investigated these allegations and concluded that he could not substantiate them. The settlement also included payment of $50,000 to Barrett for legal expenses. Bolen issued his article while serving as a "publicist" for Hulda Clark, an unlicensed naturopath who claims she can cure cancer and other diseases with herbs and a simple electrical device. Quackwatch has additional information about Bolen, Clark, and the libel campaign.
Chiropractors lose major lawsuit. A U.S. District Court Judge has dismissed a lawsuit which charged that Trigon Healthcare had set "unconscionably inadequate reimbursements" and conspired in various ways to restrict payments for chiropractic services." The suit, filed in August 2000, charged that Trigon, which is Virginia's largest managed-care company, had unfairly (a) issued clinical practice guidelines; (b) maintained a $500 reimbursement cap on spinal manipulations; (c) reduced payment rates for other services; leveled payments for manipulating multiple regions of the spine; and (d) avoided negotiating with chiropractors about their payment terms. The judge concluded that Trigon's efforts to control its costs had been appropriate and that the company had done nothing illegal. [Jones JP. Opinion. American Chiropractic Association et al v. Trigon Healthcare et al. U.S. District Court for the Western District of Virginia, Abingdon Division, Case No. 1:00CV00113] Census Bureau statistics indicate that the average income of chiropractors has been falling steadily for more than ten years. Chiropractic leaders had predicted that the suit's outcome would substantially affect what chiropractors earn. Meanwhile, several states are cutting or contemplating elimination of chiropractic coverage under Medicaid. [More Medicaid cuts loom for chiropractic. Dynamic Chiropractic 21(11):15, 2003]
FDA warns Avacor marketer. The U.S. Food and Drug Administration has warned Global Vision Products, Inc., that it cannot legally market its Avacor Hair Care System without FDA approval. The system includes a "detoxifying shampoo"; a topical formula; and capsules of an herbal "DHT blocker" claimed to "combat the bad chemicals in our body that causes thinning and balding." The topical formula has contained minoxidil, the active ingredient in the approved drug Rogaine. The FDA's etter notes that the presence of minoxidil and the nature of the manufacturer's claims make the components "new drugs" that require proof of safety and effectiveness before marketing. [Woyshner JG. Letter to Anthony Imbroglio, April 2, 2003] Ads for the product have claimed that the capsules work by blocking the follicle-shrinking effect of dihydrotestosterone (DHT), a hormone made from testosterone. The UC Berkeley Wellness Letter is skeptical about the capsules and has warned that although minoxidil may help some people grow a little hair, its success rate is far less than the 90% claimed for Avacor. Moreover, nonprescription Rogaine costs much less. [Avacor. UC Berkeley Wellness Letter, March 2003] The doctor featured in Avacor infomercials (David L. Gordon, M.D.) lost his medical license in 1995 after being convicted of defrauding Medicaid. [Gifford B. There's a price on your head. Men's Health, Sept 2002] Global Vision's Web site does not identify minoxidil as an ingredient.
Australian agency curbs claims for "passive exercise" device. An Australian federal court has ordered The Buyers Group Pty Ltd to make AU$1.2 million available for refunds to people who bought its the Feminique Slimming System between October 1999 to August 2001. The product, an electronic muscle stimulation (EMS) device, had been marketed with false claims that it could (a) exercise, tone, firm or pull back into shape any part of the user's body without effort by the user; (b) burn up fat; (c) flatten the stomach without any effort by the user; and (d) result in the user losing three kilograms in weight and reducing the user's waist measurements by three centimeters in four weeks; and (e) that it is ideal for those who want to see effective and immediate results. The court ordered that corrective advertisements be broadcast for two weeks on Network Ten's Good Morning Australia (which had broadcast advertorials) and on the company's Web site. Consumers who believe they have been misled have 28 days from the conclusion of the advertisements to apply for a refund. The court also found that The Buyers Group's sole director, Josephus Schoonenberg, and an employee, Marianne Schoonenberg, were knowingly responsible for the misconduct. The enforcement action was initiated by the Australian Competition and Consumer Commission, which became concerned that " everyday people were being conned" into believing that by using the Feminique they too could look fit, slim and toned like the people featured in the advertisements. [ACCC obtains $1.2m refunds for misled consumers. News release, April 29, 2003] The U.S. Food and Drug Administration has noted that EMS devices can cause muscles to contract but do not increase muscle size enough to affect the user's appearance. [Consumer information on electronic muscle stimulators. FDA Center for Devices and Radiological Health, April 10, 2002]
This page was posted on April 29, 2003.