Consumer Health Digest #06-30
Your Weekly Update of News and Reviews
July 25, 2006
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.
Obesity surgery reported to have high complication rates. An HHS Agency for Healthcare Research and Quality (AHRQ) study has found that about 40% of 2,522 patients who had obesity surgery at 308 hospitals developed a significant complication during the six months after they left the hospital. [Encinosa WE and others. Healthcare utilization and outcomes after bariatric surgery. Medical care 44:706-712, 2006] The researchers reported:
- The overall complication rate increased from 21.9% during hospitalization to 39.6% by the end of the study period.
- The five most common complications were dumping syndrome, which includes vomiting, reflux, and diarrhea (nearly 20%); leaks or strictures resulting from the joining of the intestine and stomach (12%); abdominal hernias (7%); infections (6%); and pneumonia (4%).
- The overall death rate was only 0.2 percent, but 7.2% required hospital readmission.
The study, which followed non-elderly patients with private insurance, is the most extensive to date on postsurgical complications from obesity operations based on insurance claims data. Most studies have been limited to complications that occur before hospital discharge or up to 30 days post-discharge. Bariatric surgery produces weight loss by mechanically restricting the size of the stomach, which limit the amount of food that can be consumed in a single meal. It is intended for people who are morbidly obese (about 100 pounds over desirable weight) and in danger of dying as a result. This study illustrates how important it is to consider potential complications when considering whether to undergo a bariatric surgical procedure. Another AHRQ study found that the number of Americans having obesity surgery rose from 13,386 in 1998 to 71,733 in 2002.
Seasilver facing huge penalty. A federal court judge has ordered Seasilver USA Inc., Americaloe, Inc., and its principals, Jason and Bela Berkes, to comply with a default clause in their 2004 stipulated settlement with the Federal Trade Commission. In 2004, the defendants agreed to pay $3 million in consumer redress to settle FTC charges that they had made false and illegal claims for their mineral product. The settlement provides that if they fail to pay the $3 million, the amount due would be $120 million. In February 2006, the FTC asked the court to impose the full obligation because the defendants had paid only $763,000 and had not made a significant payment since May 2005. The defendants claimed that they had been unable to do so because revamping their products and advertising materials was expensive, the number of distributors had dropped from about 8,000 to about 1,500, and the company's annual sales had dropped from about $200 million to $10 to $12 million. The defendants told the court that they expected to be able to pay in a year or two. The FTC countered that since Seasilver USA was forced to stop making false claims for its product, it has been losing money and appears headed for extinction. In June 2006, the court ordered payment of $119,237,000 plus interest. The defendants have filed a notice of appeal, but their chance of prevailing looks slim. At various times before the FTC clamped down, Seasilver and its distributors had falsely claimed that their product was effective against hundreds of diseases and conditions. The FDA also took vigorous enforcement action. Quackwatch has a detailed report on Seasilver's history.
Laser therapy for smoking cessation attacked. Public Citizen's Health Research Group has petitioned the FDA to stop five companies from illegally promoting low-power laser therapy as a means to quit smoking. The petition states:
- Freedom Laser Therapy Inc., the Anne Penman Laser Therapy clinics, New Beginnings Laser Therapy, Laser Concept, and the Stop Smoking Laser Center, are marketing laser therapy for smoking cessation treatment despite the lack of FDA clearance or any evidence of effectiveness.
- Laser therapy, also known as laser acupuncture, aims a low-power laser beam rather than needles at various points of the body. The FDA has approved it only for the temporary relief of pain. For all other uses, the therapy may be used only for investigational clinical trials or studies.
- A thorough review of the medical literature reveals only one well-designed study that addresses laser effectiveness for smoking cessation; and this study found “no difference” between laser acupuncture and placebo.
Source: Companies must stop fraudulently promoting laser therapy as a treatment to quit smoking, Public Citizen tells FDA. Public Citizen news release, June 22, 2006.
ACSH artificial sweetener report updated. The American Council on Science and Health has revised its report on acesulfame-K, aspartame, neotame, saccharin, sucralose, and three other artificial sweeteners that are approved for use in other countries. The report states that these products may enable people to improve their diet by getting calories from more nutritious foods rather than from sugar in soft drinks. It notes, however, that whether sugar substitutes help people lose weight is not scientifically settled. Sugar alcohols are also discussed. The report, Sugar Substitutes and Your Health, can be ordered in booklet form for $5 or can be read online free of charge.
This page was posted on July 25, 2006.