Consumer Health Digest #03-44
Your Weekly Update of News and Reviews
November 11, 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.
Colonic promoters facing legal actions. Jimmy John Girouard, Colon Therapeutics (Girouard's company), operators of the Years to Your Life Health Centers, companies that manufactured various components of Girouard's colonic irrigation systems, and organizations that trained operators of the devices are being sued in connection with the death of a 72-year-old woman who perforated her large intestine while administering colonic irrigation. On October 23, the FDA warned Girouard and his company that their devices require professional supervision and cannot be legally marketed directly to consumers. The warning letter states that Girouard obtain marketing clearance only for use in medically indicated colon cleansing, such as before radiologic or sigmoidoscopic examinations. The suit alleges that the woman was unsupervised when she administered the "colonic," perforated her colon early in the procedure, required surgery the same day, and remained seriously ill for several months before she died from liver failure. The complaint also alleged that Years to Your Life Health Center advertised colonic irrigations as "painless" procedures which provided health benefits including an improved immune system and increased energy, as well as relief from indigestion, diarrhea, constipation, weight loss, body odor, candida, acne, mucus colitis, gas, food cravings, fatigue, obesity, diverticulosis, bad breath, parasitic infections, and premenstrual syndrome. [The Estate of Lavern Burell et al vs Cynthia Pitre et al. Cause No. E-168,700, District Court of Jefferson Texas]
Colonic irrigation has no rational role in the prevention or treatment of any health problem. The Colon Therapeutics Web site actually states that "there are no proven medical benefits from colonics." In 1997, the FDA warned Girouard about safety violations and warned Tiller Mind and Body, Inc. (another defendant) about illegal claims and manufacturing violations.
Class-action suit filed against Laser Vision Institute. A class action suit has been filed on behalf of patients who were injured or subjected to a bait-and-switch sales process by the Laser Vision Institute (LVI), which widely advertises a $299-per-eye rate for refractive surgery. The plaintiffs' lawyer says that he has been unable to find anyone who was offered the $299 rate. [Class action lawsuit filed by injured Lasik eye surgery patients. ABC Action News, Aug 5, 2003] ABC Action News also reported that a former LVI national medical director has left in disgust because LVI was pushing its counselors to recommend punctal plugs to everyone who underwent the surgery. Such plugs, which prevent tears from being drained from the corner of the eye, should only be prescribed to patients who develop dry eyes after surgery, but LVI offered $500 bonuses to counselors who persuaded 50% or more of all patients having surgery to buy them. Last year the former medical director was so concerned that he warned LVI officials that "the pre-operative insertion of punctal plugs in persons with normal eyes is fraudulent" and that operating on patients who have the plugs could cause a serious infection. [Doctor blows the whistle on Lasik eye surgery chain. ABC Action News, Nov 10, 2003] Quackwatch has a detailed report about the company.
BodyFlex charged with false advertising. The Federal Trade Commission has sued the marketers of the BodyFlex+ System ("BodyFlex") for falsely advertising that it causes rapid loss of fat and inches. The defendants named in FTC's complaint are Savvier Inc. and Savvier LP (California companies); their principals (Jack Ching Chung Chang, Jeffrey T. Tuller, and Keith Greer); and BodyFlex "creator"and spokesperson Greer Childers. The recommended BodyFlex 18-to-20-minute "workout" involves several minutes of deep breathing and stretching, followed by exercises with a gym bar. The system has been promoted through a television infomercial and a Web site. The Web site stated:
The power of BodyFlex lies in how oxygen helps burn fat. With BodyFlex breathing you will supercharge your blood with fat-burning oxygen and you'll lose inches fast. So fast that BodyFlex guarantees you'll lose 4 to 14 inches across your six target areas in the first 7 days. That's the upper arms, upper abs, lower abs, waist, hips and thighs. Once you've learned the secret of BodyFlex breathing, the exercises are easy to follow and there are no complicated machines to put together. You can even do it all while sitting on your couch. . .
While BodyFlex and treadmill exercise burn about the same amount of calories during exercise, BodyFlex works better because it continues to burn calories even after your workout. To prove it, we conducted a doctor-supervised clinical study, comparing the two. The results show BodyFlex burns more calories than working out on a treadmill at 3 miles-per-hour (see chart). Here's what the doctor who conducted the clinical study had to say about the power of BodyFlex:
"I think it is surprising how a person can sit in one place and literally be watching TV while they're doing exercise and they can still beat the treadmill. We compared them at the same time on the treadmill and with the BodyFlex system and the BodyFlex system burned more calories. It works better." -- Dr. Daniel Cosgrove, M.D.
The FTC says that the above claims were untrue. Childers has agreed to a temporary restraining order for all defendants to freeze her assets and prohibit the challenged claims, and the FTC has asked the court to issue a similar order for the other defendants. The FTC also is seeking injunctive relief that includes redress for BodyFlex purchasers. According to the FTC, the BodyFlex infomercial has been among the ten most frequently aired infomercials in the U.S. and aired over 2,000 times from February through September 2003 on national cable channels such as Bravo, The History Channel, and Home & Garden Television. The product sold for $39.95 plus $14.95 for shipping and handling. [FTC charges BodyFlex Marketers with false advertising. FTC news release, Nov 10, 2003]
Royal Tongan Limu product destroyed. The FDA has announced that NBTY, Inc., of Bohemia, N.Y., has completed voluntary destruction of approximately 90,000 units (about $2.7 million retail) of Royal Tongan Limu, a dietary supplement promoted to treat various diseases like cancer, arthritis, and attention deficit disorder (ADD). The destruction, witnessed by FDA Chicago District personnel, occurred October 13-17 at a landfill in Illinois. The product was distributed by Dynamic Essentials, an NBTY subsidiary located in Lake Mary, Florida. Dynamic Essentials has ceased operation and no longer promotes or sells the products on its Web site. FDA determined the product was being promoted with unsubstantiated claims for treatment and mitigation of various diseases. The firm was initially warned with an FDA "cyber letter" in 2002 informing them that claims on their Web site caused their products to be in violation of the law. The claims included "Limu Moui may make cancer cells pop (self-destruct) and stop cell division" and "Limu Moui lubricates joints to make them more flexible and thereby eliminating pain of arthritis, etc." After further investigation by the FDA, NBTY decided to voluntarily stop operating of Dynamic Essentials, Inc., and destroy the product. [Royal Tongan Limu dietary supplements promoted to treat various diseases destroyed. FDA news release, Nov 10, 2003]
NBTY sells online through its Puritan's Pride Web site, as well as through pharmacies, wholesalers, supermarkets, and health food stores. In December 2002, it reported operating 544 Vitamin World and Nutrition Warehouse stores in the United States, Puerto Rico, and Guam, and more than 460 Holland & Barrett stores in the United Kingdom. It is also #1 in nutritional mail-order sales. Its gross revenue last year was about $964 million. In 1990, when the company was called Nature's Bounty, U.S. postal officials charged that at least 19 of its products were falsely advertised in its catalog. The products included Cholesto-Flush, Fatbuster Diet Tea, Kidney Flush, Memory Booster, Prostex, and Stress B with 500 mg Vitamin C. The case was settled with a consent agreement under which Nature's Bounty admitted no wrongdoing but agreed to stop making the challenged claims. In 1995, the company signed an FTC consent decree under which it paid $250,000, agreed to stop making claims for 26 products, and pledged not to make unsubstantiated claims for any product in the future.
Low quality found among echinacea products. A study of 59 single-herb echinacea products available in August 2000 in the Denver, Colorado area has found that the amount stated on the label was not found in 28 (48%) of the products, including 6 that contained none at all. Of the 21 preparations said to be "standardized," only 9 (43%) met the quality standard described on the label. The investigators concluded that "Echinacea from retail stores often does not contain the labeled species. A claim of "standardization" does not mean the preparation is accurately labeled, nor does it indicate less variability in concentration of constituents of the herb." The doses recommended on the labels and the cost per dose also varied widely. [Gilroy CM and others. Echinacea and truth in labeling. Archives of Internal Medicine 163:699-704, 2003] A German study published in 2000 yielded similar findings.
This page was posted on November 12, 2003.