Consumer Health Digest #03-41

Your Weekly Update of News and Reviews
October 21, 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.

California restricts ephedra "supplements." California has enacted a bill (SB582) to ban the sale and distribution of dietary supplements containing ephedrine alkaloids. Licensed practitioners can continue to prescribe or dispense such products (or their drug equivalents) and pharmacists can dispense them for certain medical conditions, but they cannot do so for purposes of weight loss, body building, or athletic performance enhancement. Products of this type that are not for resale within California are exempted. From January 1993 through October 2000, the FDA received nearly 1400 reports of adverse events linked to herbal products containing ephedra, including 81 deaths, 32 heart attacks, 62 reports of cardiac arrhythmia, 91 reports of hypertension, 69 strokes, and 70 seizures. Complaints to the FDA about ephedra have comprised 42% of all dietary supplement complaints and 59% of reported deaths related to dietary supplements. Several months ago, after the much-publicized death of Baltimore Oriole pitcher Steve Bechler, the FDA proposed that ephedra product labels list death, heart attacks, and strokes as possible side effects. Last year, California passed a law banning the sale of ephedra to minors and requires warning labels on such products. New York and Illinois have also restricted sales.

IPT debunked. Dr. Robert Baratz has critiqued insulin potentiated therapy (IPT), in which substandard doses of chemotherapy drugs are given following administration of insulin. Proponents claim that intravenous insulin increases the effect of medications so that lower doses can be used. They also suggest that the insulin somehow makes cells more permeable so that certain drugs enter more easily. However there is no logical reason to believe this is true and no scientific evidence showing that IPT is safe or effective as a cancer treatment. [Baratz R. Why you should stay away from insulin potentiation therapy. Quackwatch, Oct 17, 2003] It appears likely that some IPT providers are submitting misleading reports to insurance companies.

Low lasik fee may be a "come-on." Investigators suspect that the $299-per-eye operation widely advertised by the Lasik Vision Institute (LVI) is intended to lure patients into consultations at which much higher prices are quoted. LVI is subsidiary of Musa Holdings, Inc., of Lake Worth, Florida, which also operates Eyeglass World and has real estate investments [1]. In 2001, the Florida Attorney General announced that Eyeglass World would pay $500,000 and adopt an arms-length relationship with its affiliated optometrists to settle allegations of unlawful marketing practices. In 2003, LVI signed an FTC consent agreement to settle charges that the company failed to substantiate claims that its Lasik surgery services eliminate the need for glasses and contacts for life, eliminate the need for reading glasses, and eliminate the need for bifocals. The FTC's complaint also charged that LVI had falsely claimed that consumers would receive a free consultation to determine their candidacy for Lasik. Instead, after an initial meeting with an LVI representative during which the representative quoted a price for the procedure based on their preferred treatment, LVI required consumers to pay a $300 deposit before they were told of the risks associated with the surgery, or if they were eligible candidates. Two television teams that used hidden cameras have found that the $299 fee is difficult or impossible to get and that the average price per eye is about $1,800. The Better Business Bureau of West Florida reports that the Lasik Vision Institute of Tampa, Florida, has an "unsatisfactory record . . . due to unanswered complaints." Quackwatch has a detailed report.

Medical impostor's career appears to be over. Gerald Barnes, who is serving a 12-1/2-year sentence on his fourth conviction for impersonating a physician has pled guilty to federal charges stemming from his once again posing as a doctor after his escape from prison in 2000. Gerald Barnes, 70, pleaded guilty to mail fraud, identity theft, distribution of controlled substances, and use of a DEA registration issued to another. Barnes, whose current sentence expires in June 2009, faces a maximum possible sentence of 38 years additional imprisonment. Barnes, who was born Gerald Barnbaum, legally changed his name in 1970 to Gerald Barnes, the name of a licensed physician practicing in Stockton, California. Barnes then obtained copies of Dr. Barnes' school records and medical credentials and used them to obtain employment at medical clinics and offices in Southern California. In 1981, Barnes pled guilty to involuntary manslaughter in connection with the death of a 29-year-old patient who died of complications from diabetes after being misdiagnosed by Barnes. He was convicted again in 1984 and 1989 on state charges of grand theft and writing fraudulent prescriptions. Upon each release from prison, Barnes resumed his impersonation of Dr. Barnes. In 1996, Barnes pled guilty to federal charges related to his ongoing impersonation of a physician. Prior to his arrest, Barnes had worked as medical director of Executive Health Group, a Los Angeles clinic with a client list including the Federal Reserve Bank, the Federal Bureau of Investigation, and other major corporations. In August 2000, he escaped from federal custody while being transferred from a prison in California, to one in Illinois. He immediately returned to Los Angeles, assumed the identity of Dr. Barnes, and held a $10,000-a-month job at until he was arrested in September 2000. His sentencing is scheduled for December 8. [Man pleads guilty for impersonating a physician. DOJ press release, Sept 17, 2003]

Telemarketing complaints pour into FTC. Since October 1, the Federal Trade Commission has received more than 15,000 complaints against telemarketers who continue to call people who have registered for the agency's Do Not Call List. Access to the the Registry began on September 2 through a Web site specifically developed for telemarketers. As of October 15, nearly 21,000 organizations have accessed the Registry with 550 telemarketers downloading all area codes in the Registry. For enforcement purposes, consumer complaints received into the FTC database are made available to more than 800 law enforcement agencies, including the offices of all state attorneys general.

FDA warns "live-cell" marketer. The FDA has issued a letter ordering Target Your Health, Inc., of Wildomar, California, to stop making illegal claims that its Live Cell Growth Factors, which are derived from cells from sheep or cattle embryos, "have the potential to adapt and heal organs or body tissue in need of repair." The product line includes "Embryoblaste," "Artery," "Cartilage," "Whole Brain," "Muscle," "Eye," "Pancreas," "Skin," "Lung," "Spleen," "Kidney," "Heart," "Whole Embryo," "Liver," "Pituitary Gland," "Hypothalamus," "Intestine," "Spinal Cord," "Bone Marrow," "Adrenal Gland," "Testis," "Thymus," "Vessel," and "Vein." The warning letter notes that that the intended use of the products makes them unapproved new drugs that cannot be legally marketed without FDA approval. The company also advertised that the cells are "removed from animals in approved slaughterhouses that have passed all health controls" and that "the veterinary controls certify that the animals are healthy, suitable for human consumption and free of any spongiform encephalitis." Calling attention to restrictions on the use of animal-derived tissues in certain biological products, the FDA also warned that biologic products cannot be legally marketed without a license issued after a showing that the product is safe and effective for its intended use. [Masiello SA. Warning letter to Gisella Thomas, Sept 27, 2003] The claims to which the FDA objected have been removed from the company's Web site but can be viewed in the Internet Archive. Live-cell therapy is based on the notion that products derived from young animal cells can enhance the function of corresponding human organs. However, any such products taken by mouth are digested and have no effects on the target organs. [Barrett S. Cellular therapy. Quackwatch, revised Aug 21, 2003]

Dubious homeopathic marketer approved for tax break. The Bernalillo County (New Mexico) Commission has approved a deal under which Heel, Inc., of Albuquerque can obtain an $8 million industrial revenue bond that will be repaid within 20 years. During the repayment period, it does not have to pay property taxes and certain gross-receipts taxes. Proponents argue that subsidies of this type help create jobs and are good for the local economy, but critics have noted that some companies have left the state before such agreements have expired. [Sanchez JW. Duke city company to get IRB. Albuquerque Tribune, Oct 14, 2003 ] Dr. Stephen Barrett, who believes that much of Heel's marketing violates federal laws, wonders whether the Commission knows or cares about the nature of Heel's business. [Barrett S. Heel-BHI: The world's most outrageous homeopathic marketer. HomeoWatch, revised Oct 21, 2003]

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This page was posted on October 21, 2003.