Consumer Health Digest #07-35
Your Weekly Update of News and Reviews
September 11, 2007
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.
Two reports blast non-surgical spinal decompression therapy. Two major reviews have concluded that spinal "decompression" performed by motorized traction devices has not been proven safe or effective for treating back pain.
- One report concluded, "Currently available evidence is too limited in quality and quantity to allow for the formulation of evidence-based conclusions regarding the efficacy of decompression therapy as a therapy for chronic back pain when compared with other non-surgical treatment options." [Tiller MJ and others. Decompression therapy for the treatment of lumbosacral pain. Agency for Health Care Research and Quality, April 26, 2007]
- The other report said, "Considering the cost-benefit relationship, many better researched and less expensive treatment options are available to the clinician." [Daniel DM. Non-surgical spinal decompression therapy: Does the scientific literature support efficacy claims made in the advertising media? Chiropractic & Osteopathy 15:7, May 18, 2007]
Non-surgical spinal decompression therapy uses a motorized traction device to stretch the lower back. The devices are two-part tables in which the upper part is fixed to the table frame and the lower part slides back and forth to provide intermittent traction. The patient is anchored to the lower part by a pelvic harness. The devices can provide relief in some cases of back pain but are widely promoted with unsubstantiated claims that they can correct degenerated and herniated discs without surgery. In clearing the first such device (VAX-D), the FDA set limits on what the manufacturer could claim. Individual providers, provider associations, and the manufacturers have exceeded these limits. Anesthesia & Pain Coder's Pink Sheet, Dec 2005] Besides the VAX-D, the devices include the Decompression Reduction Stabilization (DRS) System, Accu-Spina System, DRX-3000, DRX9000, SpineMED Decompression Table, and Lordex Traction Unit. Billings in the United States have been estimated to exceed $100 million per year. [Vogenitz W. Miscoding advice causes financial troubles, liabilities for unsuspecting anesthesia, pain offices Anesthesia & Pain Coder's Pink Sheet, Dec 2005] Chirobase has additional information.
Oregon Attorney General curbs DRX9000 marketing. The Oregon Department of Justice (DOJ) has announced that Axiom Worldwide, Inc. of Tampa, Florida, and Altadonna Communications, Inc. and its owner Benjamin A. Altadonna of Danville, California, signed agreements to settle charges that the company had made deceptive claims in the marketing package it provided to buyers of the device.
- DOJ lawyers found deceptive claims throughout the advertising package including statements that the DRX 9000 had an 86% success rate for the treatment of degenerative disc disease, disc herniations, sciatica and post-surgical pain; in fact, the companies did not possess competent and reliable evidence to substantiate the claim.
- The companies stated that the FDA had approved the devices and substantiated their claims of effectiveness. DOJ found the device had merely been cleared as similar to preexisting devices.
- Axiom also falsely claimed that the DRX9000 was a scientific and medical breakthrough that resulted from NASA discoveries when, in fact, NASA discoveries had no relationship with the device.
The settlement agreement calls for payment of $75,000 and prohibits Axiom from misrepresenting scientific studies and patient testimonies. [AG stops out-of-state companies from using "junk science" to promote chiropractic devices: Oregon chiropractors disseminated deceptive advertisements. Oregon Department of Justice news release, June 29, 2007] Florida newspapers have reported that in March the FBI raided Axiom's headquarters. [Zayas A. FBI agents search offices of medical equipment maker. St. Petersburg Times, March 9, 2007] Shortly afterward, in an unrelated case, a Florida federal court judge ordered Axiom to stop claiming that its device was based on NASA discoveries or is FDA-approved. [Order. North American Medical Corporation et al v. Axiom Worldwide, Inc. Civil case No. 1:06-CV-1678-JTC, U.S. District Court for the Northern District of Georgia, March 29, 2007]
FTC stops phony weight-loss patch marketers. Transdermal Products International Marketing Corporation and William H. Newbauer have been banned from selling weight-loss patches in the future and will pay $180,000 to settle FTC charges that advertising claims for their weight-loss patches were false and unsubstantiated. They are also prohibited from making false or unsubstantiated claims about any alleged weight-loss product in the future. The products were sold under several brand names (LePatch, Revo Patch, Svelt Patch, and Z Patch) and in an unmarked version that retailers could sell under their own brand names. The advertising made false or unsubstantiated claims that the products caused weight loss and that their main ingredient, sea kelp (Fucus vesiculosus), had been approved by the FDA for that purpose. [Weight-loss patch manufacturer banned from selling weight-loss patches, Will pay $180,000. FTC news release, Aug 20, 2007]
Chiropractic publisher sentenced for investment fraud. Richard E. Busch, Jr., 64, a nonpracticing chiropractor, has been sentenced to serve five months in federal custody and five months of home detention. He was indicted in January 2003 and was a fugitive until his capture in March 2007. The indictment charged that Busch, James Michael Hanks, R. Stephen Bowden, Brian Burgdorf, and Jacques Latourette conspired to sell unregistered securities through an investment fund known as “the Millennium Fund.” [Richard Busch back in the public eye. Dynamic Chiropractic May 21, 2007] Busch pled guilty to one count of conspiracy to sell an unregistered security. Hanks, Bowden, and Burgdorf had previously pled guilty and were sentenced to home detention, payment of restitution, and probation terms. The defendants were jointly ordered to pay $5,611,959 in restitution to nine victims. Latourette remains a fugitive. Busch founded and published The American Chiropractor, a popular magazine distributed free of charge to chiropractors throughout the United States. A chiropractic newspaper has reported that Busch left the United States in 1993 after several states issued cease-and-desist orders against an unlicensed malpractice insurance company for which Busch served as president. [Who's minding the CARE store? Managing director of malpractice insurance co. arrested: President out of country. Dynamic Chiropractic Jan 14, 1994]
Dubious Mexican clinic open again. Tijuana-based Hospital Santa Monica appears to be back in business. The clinic's founder and director, Kurt W. Donsbach, is an unlicensed chiropractor with a long history of illegal activity. Last year, in response to massive publicity about the death there of Coretta Scott King (widow of former civil rights leader Martin Luther King), the Mexican Government ordered Hospital Santa Monica to shut down. This week the San Diego Union-Tribune reported:
- The hospital reopened at the same location with no name displayed outside but with the name "Centro de Atención Integral" on a health department certificate displayed inside. The hospital's Web site still identified it as "Hospital Santa Monica."
- Mexican officials said the facility is not authorized to treat serious diseases or to offer "alternative" treatments.
- Several patients and patient family members at the clinic said that Donsbach represented that he ran the clinic.
- During a 2006 deposition, Donsbach said that he had sold the clinic in 2002 to a former employee and that went there to "visit the sick" and pray for them but was not compensated for these visits. However, during another deposition, his office manager said Donsbach received a percentage of revenue from the American patients.
- A suit by a former patient who alleged that Donsbach had duped him was settled under confidential terms. [Crabtree P, Cearley A. Baja clinic shut down for unorthodox care reopens: Embattled founder's role open to question. San Diego Tribune, Sept 9, 2007]
This page was revised on September 25, 2007.