Consumer Health Digest #04-37
Your Weekly Update of News and Reviews
September 14, 2004
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
Medical journals press for clinical trial registry. Eleven medical journals have announced that next year they will stop considering reports of clinical trials that have not been registered in a public trials registry before or at the time they begin to enroll patients. This policy will apply to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, the journals will require registration by September 13, 2005. The registration will include disclosure of the study's purpose, design, starting data, expected length, and sponsor. The participating journals include the Annals of Internal Medicine, Canadian Medical Association Journal, Croatian Medical Journal, Journal of the American Medical Association, Journal of the Danish Medical Association, Lancet, Medical Journal of Australia, Nederlands Tijdschrift voor Geneeskunde, New England Journal of Medicine, New Zealand Medical Journal, and Norwegian Medical Journal. The new policy, described in the box below, is intended to prevent "selective reporting" and "publication bias" in which positive results are reported but negative ones are not. It will also prevent surreptitious changes in study design or data analysis after the data come in. The need for the policy was underscored by a recent study of 122 journal articles which concluded that about half of them were incompletely reported, harm was more likely to be unreported, and 65% had inconsistencies between primary outcomes defined in the most recent protocols and those defined in published articles. [Chan A-W and others. Empirical evidence for selective reporting of outcomes in randomized trials comparison of protocols to published articles. JAMA 291:2457-2465, 2004]
Local chiropractic survey finds 100% offer bad advice. High school students who contacted chiropractic offices in metropolitan Portland, Oregon found evidence of unscientific practice in every one. Following a script, they posed as a prospective patient and telephoned 42 local offices. All questions were answered by a member of the chiropractor's office staff, who sometimes consulted with the chiropractor. The students reported that all routinely or usually took x-rays during the first visit, 40 said they treated "subluxations," 41 recommended "maintenance" adjustments, 38 offered craniosacral therapy, 37 recommended treatment for newborn infants, 29 treated newborns, and at least 28 did not recommend routine vaccination for children. [Laidler JR. Telephone survey of chiropractic practices (2004). Chirobase, Sept 13, 2004]
CortiSlim marketer told to stop illegal claims. The FDA has ordered Stephen Cheng, president of Window Rock Enterprises of Brea, California to stop making unsubstantiated claims for CortiSlim. [FDA warning letter to Stephen Cheng, Aug 19, 2004] CortiSlim contains vitamin C, calcium, chromium, "Cortiplex Blend" (magnolia bark extract, beta-sitosterol, theanine), "Leptiplex Blend" (green tea extract, bitter orange peel extract), and "Insutrol Blend" (banana leaf extract, vanadium). Its developer, Shawn Talbot, Ph.D,, has been claiming in widely broadcast infomercials that by adjusting cortisol levels, CortiSlim removes a key physiological signal for weight gain, may help balance blood-sugar to reduce cravings, and can maximize metabolism to boost energy expenditure and fat-burning. The FDA's warning letter referred to printed promotional materials collected during an FDA inspection of Window Rock Enterprises as well as material on the company's Web site. The letter states that claims such as "eliminates cravings," "controls appetite," enhances metabolism through thermogenesis," and "controls cortisol levels" were not supported by reliable scientific evidence and must be stopped.
Australian TV star admits role in advertising fraud. The Australian Competition and Consumer Commission (ACCC) has settled its case against Ian Turpie, a former host of the game show "The New Price is Right," whom the commission charged with falsely stating in ads that a nasal spray containing apomorphine had improved his sexual potency. Under the settlement, Turpie acknowledged that he had lied about suffering from erectile dysfunction and had never used the product. [ACCC resolves court action with Ian Turpie for alleged misleading claims. ACCC news release, Sept 1, 2004] The ads, headlined "TV Star's amazing CONFESSION!," appeared for five weeks in major Australian newspapers and promoted the services of Sydney-based Advanced Medical Institute (AMI), which operates 38 clinics that offer treatment for impotence. Legal proceedings continue against the company and publicist Philip Somerset of ColbyCo Media.
In 2003, in response to ACCC action related to previous advertising, AMI and its managing director, Jacov Vaisman, signed an undertaking and were ordered to give refunds to 160 customers and to publish corrective notices. [Noble T. Impotent to get money back. The Age, Dec 4, 2003]. According to a newspaper report [Noble T. Owner defends impotency clinics as trial draws near. The Age, Oct 13, 2003]:
- In 1996, another Vaisman company, On Clinic Australia, pleaded guilty to charges related to importing injectable drugs not registered with the Therapeutic Goods Administration.
- In March 2003, another company associated with Vaisman, Australian Momentum Health Pty Ltd, was convicted of two counts of supplying unregistered therapeutic goods.
- Vaisman said his company had acquired Australian Momentum Health's assets after the incidents that led to the charges.
"Biological dentist" surrenders license. Anthony G. Roeder, D.D.S., of Paoli, Pennsylvania, has permanently surrendered his dental license to settle charges of unprofessional conduct. The settlement agreement indicates that the dental board was concerned with his substandard treatment of two women. One case concerned a woman who suffered severe pain after he (unnecessarily) removed amalgam fillings in 11 of their teeth. At his direction, the woman also underwent electrodermal screening, which is a quack test. In the other case, he injected homeopathic "remedies" into the patient's gums. The surrender took place last year but has not been publicized.
This page was revised on September 18, 2004.