Consumer Health Digest #11-26

Your Weekly Update of News and Reviews
August 18, 2011

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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.

Major homeopathic manufacturer facing class-action suits. A class-action complaint has been filed against the manufacturers of Oscillococcinum, a homeopathic product widely claimed to be a flu remedy. The complaint charges that the product (a) is nothing more than a sugar pill, (b) has no impact on the flu or any symptoms that accompany it, and (c) contains no molecules of its allegedly active ingredient. The suit, filed in California against Boiron, Inc., Boiron USA, Inc., and Laboratories Boiron, asks the court to halt the challenged claims and award damages for violating consumer protections laws. The "active ingredient" in Oscillococcinum is prepared by incubating small amounts of a freshly killed duck's liver and heart for 40 days. The resultant solution is then filtered, freeze-dried, rehydrated, diluted 1/100 200 times (shaking it inbetween each dilution), and impregnated into sugar granules. If a single molecule of the original substance could survive the dilution, its concentration would be 1 in 100200—a number vastly greater than the estimated number of molecules in the universe. Last year the FDA and FTC jointly warned a distributor that it was illegal to advertise Oscillococcinum "for fast relief of flu infection symptoms." The Newport Trial Group, which filed this suit, is pursuing a similar one against Boiron USA in connection with its marketing of Children's ColdCalm, a homeopathic product claimed to relieve sneezing, runny nose, nasal congestion, sinus pain, headaches, and sore throat. In July, a federal court judge denied a motion to dismiss that case on grounds that the FDA has primary jurisdiction and the court should defer to the government's enforcement powers. After noting that the FDA has not required that homeopathic products meet efficacy standards, the judge ruled that jurisdiction is proper because the agency has largely abdicated any role it might have had in creating such standards. The Committee for Skeptical Inquiry and the Center for Inquiry have urged Walmart to stop marketing Oscillicoccinum.

Another spinal decompression device marketer warned to stop unapproved claims. The FDA has warned Spinetronics, of Coral Springs, Florida to stop claiming that the posturing features of its Antalgic-Trak spinal decompression machine "provide new treatment options for arthritis, scoliosis, stenosis, spondylosis, segment subluxation, disc bulges, herniations, and pinched nerves." The warning letter said that it was illegal to represent the device as providing treatment of these conditions rather than alleviating the pain associated with them and that some were not included in the indications for use that the FDA had cleared. Spinal decompression devices provide an expensive, high-tech form of mechanical traction that may provide relief in some cases of back pain, but they are widely promoted with unsubstantiated claims that they can repair herniated discs. The FDA has set limits on what manufacturers can claim but has failed to take effective action against violators. [Barrett S. Be wary of spinal decompression therapy with VAX-D or similar devices. Chirobase, Aug 18, 2011]

Sham clinic ownership associated with abuse. Attorney Jim Moriarty and a colleague have spotlighted the problem of investor-owned clinics that strive to maximize profits by providing unnecessary services. Most states ban the "corporate practice of medicine" by requiring that for-profit clinics be practitioner-owned and directed. However, some private equity firms set up sham "owners" who, for a modest monthly stipend, falsely certify to state regulators that they own and control the corporation. Regulatory agencies could easily force disclosure of the true ownership, but they rarely do so. [Moriarty J, Quintana N. Cashing in by cashing out: Small Smiles and the corporate practice of America: A white paper. Moriarty-Leyendecker Web site, July 19, 2011] The most notorious such corporate practice has done business for several years using the name "Small Smiles" for most of its clinics. [Barrett S. Massive dental fraud uncovered. Dental Watch, Aug 18, 2011] Moriarty's law firm represents about 550 victims, 30 of whom are suing the owners and operators of several Small Smiles clinics in New York State. Their complaints [A] [B] [C] describe the sordid history of the company and outrageous practices such as pulling and filling children's teeth without anesthesia and unnecessary root canal procedures done in patients as young as one year old.

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This page was revised on August 23, 2011.