Consumer Health Digest #09-25

Your Weekly Update of News and Reviews
June 18, 2009

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.

FDA bans marketing of zinc-containing cold products. The FDA is warning consumers to stop using and discard three zinc-containing nasal products: Zicam Cold Remedy Nasal Gel (a spray), Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size. Since 1999, the agency has received more than than 130 reports of loss of sense of smell and/or taste associated with these products. A recent FDA inspection discovered that the company had received more than 800 other complaints that it did not send to the FDA. Many of the victims reported that their problem occurred with the first dose. The FDA notified the manufacturer that these products can no longer be marketed without FDA approval. Zicam products are marketed by Matrixx Initiatives, a/k/a/Zicam LLC. In a video message to consumers, company president Bill Hemelt states: (a) there is no credible evidence that the products are unsafe, (b) in a spirit of cooperation, the company has voluntarily recalled the three products, and (c) the company wants to meet to meet with the FDA to show its "extensive products safety data." But a doctor at the University of San Diego's Nasal Dysfunction Clinic reported that patients he has seen have told a similar story: They inserted the gel into their nose, took a strong sniff and felt intense burning for hours before realizing they could no longer smell or taste. [Alltucker K, Rough G. Zicam nasal spray can cause loss of smell, FDA says. Arizona Republic, June 17, 2009]

In January 2006 Matrixx settled a class-action suit by people who alleged that its Zicam Cold Remedy Nasal Spray had caused loss or decrease of their senses of smell and taste. At that time, 49 pending lawsuits involved about 400 individuals. The agreement called for payment of $12 million to fund awards to about 340 of the plaintiffs. The settlement did not include 22 plaintiffs who used Zicam's nasal swab product and 39 plaintiffs in 32 suits pending in courts outside of Arizona. The company denied being at fault, continued to market the products, and did not mention any risk on its Zicam Web site. Zicam nasal products are labeled as "homeopathic" even though they deliver potent doses of zinc. This may have helped the company to escape close scrutiny because the FDA traditionally pays little attention to homeopathic products. The recent publicity is likely to trigger more lawsuits.

Device Watch reports on "cold laser" devices. Low-level laser therapy (LLLT) refers to the use of a red-beam or near-infrared laser with a wave-length between 600 and 1000 nanometers and power from 5 to 500 milliwatts. The providers include physicians, chiropractors, physical therapists, and occupational therapists, but devices are also marketed for long-term use at home. The most aggressively promoted LLLT device appears to be the Anodyne Therapy System, which has professional and home versions. The system has FDA clearance for marketing for "relief of minor muscle and joint pain and improvement of superficial circulation" but the company's Web site suggests that it can do more. In 2005, the FDA ordered the manufacture to stop claiming that it could wounds and ulcers, gait and balance impairment, carpal tunnel syndrome, and several other conditions. Aetna, CIGNA, and the Center for Medicare and Medicaid Services (CMS), have critiqued Anodyne's data and other published studies and explain why they do not cover LLLT as a treatment modality. [Barrett S. A skeptical look at low level laser therapy. Device Watch, June 17, 2009]

Quack device operators arrested in Florida. Enrique Vela, and his wife, Ute Marquez, have been charged with practicing medicine without a license. The couple operates the Alternative Therapy Center out of their home in Winter Haven, Florida. Vela is a Spanish citizen who is living in the United States with a Lawful Permanent Residence card (“Green Card”). Marquez was born in Germany. Vela was charged with four counts each of unlawful practice of medicine and unlawful practice of a healthcare professional. Marquez was charged with three counts of each. Under Florida law, both offenses are third-degree felonies. The charges were preceded by an undercover investigation by two agents of the Polk County Sheriff's Department who were tested with an Asyra System device. One agent was told she had hookworm larvae, bilharziasis, intestinal fluke and enzyme deficiencies in her small intestine, and bacteria and anthrax in her body. The other agent was diagnosed with problems of the skin, sinus, and reproductive organs. The Asyra system has FDA clearance for measuring skin resistance to tiny electric currents. It is not approved for use in diagnosis or treatment. Quackwatch has further details.

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This page was posted on June 19, 2009.