Consumer Health Digest #03-47
Your Weekly Update of News and Reviews
December 2, 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.
Wisconsin chelationist signs stipulation. The Wisconsin Medical Examining Board has ordered Eleazar M. Kadile, M.D. to (a) implement a strict mandatory disclosure procedure for patients contemplating chelation therapy; (b) undergo an evaluation to determine his fitness to continue practicing medicine, (c) fulfill certain educational requirements; (d) have his practice monitored for at least two years by an independent expert approved by the Board; and (e) pay costs related to the disciplinary process for an amount determined by the Board. [Final decision and order. In the matter of disciplinary proceedings against Eleazar M. Kadile, M.D. Nov 21, 2003] The agreement was obtained in responses to charges of unprofessional conduct filed in 2001. One of the charges involved involved unsubstantiated advertising claims that chelation therapy is effective against coronary artery blockage. Kadile's defense was assisted by other chelation providers who fear that they might also be vulnerable to disciplinary action. The prosecuting attorney is also trying to force Kadile's wife Genia Kadile, who has worked in Kadile's office, to stop using the title "Certified Clinical Nutritionist" or "Clinical Nutritionist" or any other title that falsely suggests that she is licensed to practice nutrition in Wisconsin. [Petition for injunction. In the matter of Genia Ileki Kadile, filed April 22, 2003]
FDA warns Metagenics about "medical food" promotions. The U.S. Food and Drug Administration has ordered Metagenics, Inc., of San Clemente, California, to stop making claims that certain products are "medical foods" that are effective against various medical conditions. The letter stated:
Your products UltraClear®, UltraMeal®, UltraInflamX, and UltraGlycemX are not medical foods because the diseases and conditions described in the product labels do not have distinct nutritional requirements and because the products do not have any unique impact on the dietary management of those diseases and conditions beyond that which could be achieved by modification of the normal diet alone.
Because UltraClear, UltraMeal, UltraInflamX, and UltraGlycemX do not meet the definition of a medical food, they are not subject to the exemption from nutrition labeling afforded medical foods. Therefore, your products are misbranded . . . because the labels do not bear nutrition labeling in the appropriate format. . . . . In addition, your products bear label claims suggesting that they are useful in the treatment of various diseases. These claims include:
- UltraClear is formulated to nutritionally support overall liver detoxification activity and the removal of potentially harmful toxins associated with health conditions such as food allergies, chronic fatigue syndrome, . . . and migraine headaches.
- "UltraMeal is . . .designed to nutritionally support the management of conditions associated with altered body composition, including . . . hypertension . . . ."
- "UltraInflamX NUTRITIONAL SUPPORT FOR INFLAMMATION" and "UltraInflamX is designed to nutritionally support patients with chronic inflammatory conditions, such as osteoarthritis, rheumatoid arthritis, psoriasis and eczema, as well as other conditions associated with excessive inflammation."
- "Designed to provide nutritional support for those with insulin resistance, or type 2 diabetes, UItraGIycemX promotes a healthy insulin and glucose response."
The presence of the above referenced claims indicates that the products are intended to treat, cure, or mitigate diseases. Such claims are evidence that the products are intended for use as drugs within the meaning of Section 201(g)(1)(B) of the [Federal Food, Drug and Cosmetic] Act. The products are new drugs under section 201(p) of the Act because there is no evidence that these products are generally recognized as safe and effective for their intended uses. [Cruse AE. Warning letter to Jeffrey J. Katke, Oct 1, 2003]
As of December 2, 2003, the claims to which the FDA objected remain in the company's online catalog of "medical foods." The products involved were originally marketed by HealthComm, of Gig Harbor, Washington, whose president, Jeffrey S. Bland, Ph.D., also offers many educational programs for professionals. In 2000, Metagenics merged with HealthComm and Bland became president and chief science officer for Metagenics. In 1991, Bland and HealthComm agreed to pay $30,000 for redress and to refrain from making claims the FTC had challenged about a weight-loss product. In 1995, they settled new charges related to weight-loss products and UltraClear. [Barrett S. Some Notes on Jeffrey Bland. Quackwatch, Dec 2, 2003] Metagenics has also faced regulatory action. In 1997, it settled FTC charges with a consent agreement prohibits the company from making unsubstantiated claims for calcium products. [Metagenics and FTC settle deceptive advertising charges. FTC news release, April 22, 1997]
Medical board confronts leading prolotherapy advocate. In October 2003, William J. Faber, D.O, who practices in Milwaukee, Wisconsin, was reprimanded in connection with his care of a woman whom he treated with injections into her pubic area. The Wisconsin Medical Examining Board concluded that his care was substandard because when she developed a severe infection in that area, he prescribed an antibiotic over the telephone rather than examining her in person. However, in December 2003, the board held a rehearing after which it withdrew its reprimand and Faber agreed to be evaluated by the American College of Osteopathic Pain Management and Sclerotherapy and to follow any recommendations the group makes for continuing education.
Prolotherapy is based on the questionable premise that "lax" ligaments and tendons are a common cause of painful conditions and that relief can be obtained by injections of irritant solutions that shorten these structures. In 1999, following an extensive review, the agency that administers Medicare concluded that prolotherapy should not be covered because its use has not been substantiated. In making its ruling, the board did not appear to judge prolotherapy itself.
Australia curbs colloidal silver sales. The Australian Therapeutic Goods Administration has amended its rules so that water-treatment products containing substances like colloidal silver for which therapeutic claims are made must meet the requirements of medicines included in the Australian Register of Therapeutic Goods. This means that such products can no longer be legally marketed without proof that they are safe and effective for their intended purpose. The amendment was based on conclusions that:
- There is little evidence to support therapeutic claims made for colloidal silver products.
- The risk to consumers of silver toxicity outweighs the value of trying an unsubstantiated treatment, and bacterial resistance to silver can occur.
- Efforts should be made to curb the illegal availability of colloidal silver products, which is a significant public health issue. [Regulation of colloidal silver and related products. Therapeutic Goods Administration Web site Aug 19, 2003]
Viagra ingredient found in two more "dietary supplements." Health Canada is warning consumers not to use "Stamen" and "Bell Magicc Bullet," after both were found to contain an unauthorized ingredient, sildenafil, which is the active ingredient in Viagra. Inappropriate use of sildenafil could cause severe adverse reactions. Neither product has been approved for sale by Health Canada, and neither is labeled to indicate that it contains sildenafil. One adverse drug reaction associated with the use of Stamen was reported to Health Canada. Stamen is distributed by RandA Foods, Ontario. Bell Magicc Bullet is distributed by Bell Lifestyle Products Inc. in Mississauga. The agency is working with distributors to remove both products from the market. [Health Canada warns public not to use Stamen and Bell Magicc Bullet. Health Canada news release, Nov 26, 2003]
Google pledges to stop accepting ads from unlicensed pharmacies. Google Inc., has announced that it will no longer accept advertisements from unlicensed pharmacies. The move was made because these companies typically sell potentially dangerous drugs without an appropriate medical evaluation and prescription. Google's action was reportedly precipitated after a father whose teenage son was hospitalized for drug abuse complained that the boy had used Google's search engine to locate and later buy Vicodin (a narcotic) from a Google advertiser. AOL, Yahoo Inc., and Microsoft MSN site have adopted similar policies. Despite these measures, searching Google for "Vicodin 'no prescription'" brings up over 300,000 links.
This page was revised on February 17, 2004.