Consumer Health Digest #03-18
Your Weekly Update of News and Reviews
May 6, 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.
Australian product recall expands. The Therapeutic Goods Administration (TGA), which has suspended the manufacturing license of Pan Pharmaceuticals for six months, has expanded its recall, which now encompasses 1,546 products. In January, the TGA launched an investigation after faulty batches of Pan's Travacalm Original Tablets (an anti-travel-sickness medication) caused at least 87 reactions and 19 hospitalizations. TGA inspectors then found serious safety and quality breaches that included substitution of ingredients, manipulation of test results and substandard manufacturing processes. The Sydney Herald Sun has reported that during an inspection, a Pan employee "wiped the computer hard-drive that held vital information" on Travacalm but the agency obtained a police warrant, seized the computer, and restored the files. [Riley R. Disk wiped during raid. Sydney Herald Sun, May 4, 2003]
IOM "CAM" committee improved but still not balanced. Antiquackery activists remain concerned about the committee the Institute of Medicine (IOM) has appointed to identify major scientific and policy issues in "complementary and alternative medicine" ("CAM") research, regulation, training, credentialing and "integration with conventional medicine." Although 2 of the original 15 appointees have been replaced by others who are more qualified, at least 7 still have a direct or indirect economic interest in the project's outcome, and at least 5 of these have actively promoted quack methods. Among those who appear qualified to make scientific judgments, none appears to have detailed knowledge of "CAM" activities. Quackwatch has posted a detailed analysis of the situation.
Bogus "growth-hormone releaser" destroyed. Nature's Youth, LLC, of Centerville, Massachusetts, has voluntarily destroyed approximately 5,700 boxes of "Nature's Youth HGH" with a market value of about $515,000. The destruction took place after the FDA notified the company that claims made for the product were unsubstantiated and therefore illegal. [Misbranded dietary supplements destroyed. FDA news release, May 1, 2003] The company had claimed that the product would enhance the body's natural production of Human Growth Factors and Insulin-like Growth Factor-1; improve physical performance; speed recovery from training; increase cardiac output, and increase immune functions; and was "your body's best defense against aging." When asked for substantiation, the company cited a 1990 article in New England Journal of Medicine. However, the journal's editors have stated that the article does not support the claims. [Drazen JM. Inappropriate advertising of dietary supplements. New England Journal of Medicine 348:777-778, 2003] The product's leading promoter has been G. Gordon Liddy, the former Watergate conspirator who served five years in prison and now hosts a talk show syndicated to 160 radio stations. Quackwatch has additional information about HGH products.
Florida warns against unlicensed nutrition advisors. The state of Florida has started an active campaign to help protect the public from unlicensed nutrition practitioners. Billboards are going up around the state saying: "Are you losing more than weight? Unlicensed diet and nutrition advice is dangerous. Follow the advice of a licensed dietitian/nutritionist or nutrition counselor." This campaign is financed from licensure fees. The Florida Dietetics and Nutrition Practice Council oversees the licensure of about 3,000 dietitian/nutritionists (who have accredited degrees and at least 900 hours of supervised training) and 280 nutrition counselors (less qualified individuals who were grandfathered when the law was passed). As of January 2003, 42 states, Washington DC, and Puerto Rico have some level of licensure or certification for nutrition professionals, but Florida appears to be the first to warn against using unlicensed practitioners.
Chiropractors penalized for Workers Compensation fraud. Two Salinas, California chiropractors have been assessed $479,115 by a California court for fraudulently billing the Monterey Mushrooms packing company for treatments allegedly provided to its employees. The company, which is the largest mushroom distributor in the U.S., sued the pair under the California Insurance Fraud Prevention Act, which permits district attorneys to grant permission to private firms to sue on behalf of the state. The suit charged that the defendants had set up sham medical corporations that relied on the credentials of out-of-state medical doctors so they could increase the amounts billable under the state's medical fee schedule, which limits chiropractic charges. Company officials became suspicious after they began receiving double and triple billings from former chiropractic offices that had begun practicing as medical corporations. In some cases, more than one claim was filed for a single treatment session. Charles Salzburg, M.D., an accomplice who lives in Hawaii, cooperated with the prosecution and admitted that he had given out his license to at least 21 clinics in California..The total penalty was derived by tripling the total paid for 703 fraudulent claims and adding $141,240 for legal expenses, $101,022 for disability payments based on the fraudulent claims, and 20% to each item to reflect "societal costs." [The People of the State of California ex rel. Monterey Mushrooms, Inc. v. Steve Thompson, D.C., Aster Thompson, D.C., Peninsula Medical Group, Integrated Family Medical Group, Clinica Quiropractica Guadalupe, and Practice Management Systems dba Nevada Practice Management Systems. Superior Court of Monterey County, No. M47300 ] Three other defendants reportedly settled before trial.
"Skin Zinc" marketer warned. The FDA has warned Selfworx.Com, LLC that its "Skin Zinc Spray" and "Skin Zinc Cream" cannot be sold as nonprescription drugs without modifying their claims. The spray, which contains pyrithione zinc 0.25% as the active ingredient, has been claimed to "helps eliminate skin and scalp redness, scaling, itching, flaking and irritation associated with psoriasis, eczema, seborrheic dermatitis and dandruff." The cream, which contains salicylic acid 2% as the active ingredient, has been claimed to "help eliminate flaking, itching, irritation, redness & scaling associated with psoriasis, eczema & seborrheic dermatitis." The warning letter, sent to the company's president, Jeffrey V. Kral, stated that pyrithione zinc is illegal to market as a nonprescription ingredient for controlling eczema or psoriasis and that salicylic acid is not acceptable for eczema. [Costello GT. Letter to Jeffrey V. Kral, April 17, 2003] The company's Web site, which still contains the violative claims, describes the products as "revolutionary."
This page was posted on May 6, 2003.