Consumer Health Digest #03-22
Your Weekly Update of News and Reviews
June 3, 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.
FTC hits top mail-order scammer. The U.S. Federal Trade commission has charged A. Glenn Braswell, and four of his corporations with making unsubstantiated advertising claims for dietary supplements marketed under the Gero Vita and Theraceuticals brand names. According to the FTC, the defendants have deceptively touted their products as "scientific breakthroughs" that can treat or cure many serious illnesses. The products identified in the FTC's complaint are: Lung Support Formula (claimed to cure or ameliorate nearly all respiratory problems); Antibetic Pancreas Tonic (claimed to treat or cure diabetes and to lower blood sugar levels by repairing the pancreatic cells that produce insulin); G.H.3 and Theraceuticals GH3 Romanian Youth Formula (claimed to reverse and prevent Alzheimer's disease and other forms of dementia, and to increase lifespan); Chitoplex (purported to cause weight loss and reverse obesity without diet or exercise); and Testerex (claimed to treat erectile dysfunction in 62% to 95% of men). The FTC complaint also targeted corporate officer Ron Tepper, who edited magazine-like publications distributed to promote the products. The FTC estimates that Braswell's operations have grossed more than $800 million since 1998. [A. Glenn Braswell's dietary supplement enterprise targeted: FTC challenges false and unsubstantiated claims. FTC news release, May 27, 2003] During the late 1970s and early 1980s, Braswell was subjected to 140 civil regulatory actions related to false advertising claims. In 1983, he was convicted for mail fraud, perjury, and tax evasion, for which he served several months in prison. In 1999, shortly before leaving office, President Bill Clinton pardoned Braswell for the 1983 conviction. Since January 2003, Braswell has been in prison awaiting trial for conspiring to evade payment of millions of dollars in income tax. He was able to sustain high sales because the Postal Service stopped its fight against mail-order quackery about 12 years ago. Quackwatch has detailed reports on Braswell's activities.
Q-Ray marketers charged with deceptive advertising. The FTC has charged QT, Inc, Q-Ray Company, Bio-Metal, Inc., and their principals, Que Te Park and Jung Joo Park, with making false and misleading claims about their Q-Ray Ionized Bracelets. Through infomercials and Web sites, the promoters have been claiming that the bracelets are "ionized," which enables them to alter the body's "positive and negative energy" to relieve painful musculoskeletal problems, sciatica, headaches, tendinitis, and injuries. The Q-Ray Bracelets cost from $49.95 to $249.95. A federal district court has issued a temporary restraining order freezing defendants' assets and prohibiting misleading or deceptive claims. [Marketers of Q-Ray ionized bracelet charged by FTC: FTC seeks to halt deceptive pain relief claims and provide consumer refunds. FTC news release, June 2, 2003] A recent Mayo Clinic study found that Q-Ray bracelets are no more effective than placebo bracelets at relieving muscular and joint pain. [Bratton RL and others. Effect of "ionized" wrist bracelets on musculoskeletal pain: A randomized, double-blind, placebo-controlled trial. Mayo Clinic Proceedings 77:1164-1168, 2002] Class-action and false advertising suits have been filed in California against Q'Ray's marketers. Quackwatch has additional details.
Another review finds no evidence that herbal "bust-enhancers" work. A review published in Obstetrics and Gynecology has found no published evidence that herbal products marketed for breast enhancement are effective. The reviewer also warns that some products contain substances that have pharmacologic activity and may be unsafe. The review concluded:
There is no published evidence for efficacy of bust-enhancing herbal supplements. Products marketed for "bust enhancement" contain herbs that may have pharmacological effects. There are no long-term safety data on any of these herbs, singly or in combination. Some products contain substrates for Fusarium, a zearalenone-producing fungus associated with breast enlargement in humans and pigs. Physicians should discourage the ingestion of pharmacologically active substances with unknown safety risks for the purpose of breast enlargement. [Fugh-Berman A. "Bust enhancing" herbal products. Obstetrics and Gynecology 101:1345-1349, 2003.]
ConsumerLab.com, which evaluates the quality of herbal and dietary supplement products, reached similar conclusions in 2002.
Refractive surgery pioneer disciplined for questionable glaucoma treatment. The Arizona Medical Board has reprimanded Leo Bores, M.D., for commercial activities related to pneumatic trabeculoplasty (PNT). In 1997, while Bores was medical director, the Arizona Glaucoma Institute advertised PNT as a new noninvasive treatment that used a vacuum-ring device to lower pressure within the eyes of patients with open-angle glaucoma. Devices of this type are FDA-approved for stabilizing the eye during refractive surgery, but they are not approved for use in treating glaucoma. The institute's parent company, Coronado Industries, marketed the device through another subsidiary called Ophthalmic International. In March 1999, Bores retired from clinical practice but continued to direct PNT research.
Federal regulations state that during clinical studies, no investigator or sponsor can commercially distribute an unapproved device, charge subjects more than the amount needed to cover costs, or represent that the device is safe or effective for its intended purpose. According to the Arizona Medical Board, Bores did all of these things, lacked FDA approval to conduct any PNT studies, and improperly collected Medicare payments for patients treated between December 1997 and February 1999. In April 2003, the board reprimanded Bores and placed him on two years' probation under which he is barred from conducting studies within Arizona that do not meet FDA criteria and must reimburse Medicare for $15,539.81 that received for the 1997-1999 treatments. [Consent agreement and order for letter of reprimand and probation. In the matter of Leo Bores, M.D. Arizona Medical Board Case # MD-97-0948, April 4, 2003] Bores originated radial keratotomy, which triggered the development of refractive (lens) surgery. Local ophthalmologists have charged that PNT is ineffective and lacks a plausible rationale. It remains to be seen whether additional research will demonstrate benefit. [Barrett S. Pneumatic trabeculoplasty (PNT) for glaucoma. Quackwatch, May 31, 2003]
Physician penalized for improper online prescribing. The Arizona Medical Board has censured Marvin L. Gibbs, Jr., M.D., for prescribing narcotics and managing chronic pain patients over the Internet without establishing a face-to-face doctor patient relationship. Records from the case indicate that: (a) Gibbs worked for two Web site pharmacy consultation services before starting his own at Expressmedcare.com; (b) during a 10-month period he issued or authorized prescriptions and refills over 9,000 times for a total of over 700,000 dosage units for about 2,600 people; (c) visitors to the Web sites filled out a questionnaire about their medical history and complaint and then telephoned for a 5- to 10-minute consultation; (d) Gibbs kept no records on the patients; (e) Gibbs could not explain how he could tell the difference between drug-abusers and patients who may have had a legitimate need for pain medication; and (f) the Board assessed a civil penalty of $10,000 and placed Gibbs on probation for 10 years. [Findings of fact, conclusions of law, and order. In the matter of Marvin Gibbs, M.D. Board case No. MD-01-0861, May 14, 2003]
This page was posted on June 3, 2003.