Consumer Health Digest #03-33
Your Weekly Update of News and Reviews
August 19, 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.
Clinical trials registry needed. A special communication in the Journal of the American Medical Association has called for a comprehensive effort to register all clinical trials when they are launched. [Dickersin K, Rennie D. Registering clinical trials. JAMA 290:516-523, 2003] The authors state:
- Scientists tend to publish their positive findings more often than their negative findings (publication bias). A comprehensive registry, with each trial assigned a unique identifier, would directly address this problem.
- Patients and their clinicians could know which trials are open for enrollment, thus speeding medical advances.
- Participants often provide consent because they believe they will contribute to medical knowledge. But if the knowledge gained is never reported, this trust is violated.
- Registry listings would help prevent unnecessary research.
Cell Tech loses false advertising case. In February 2003, a California judge ruled that 30 claims made by Cell Tech International about the nutritional value, character, and alleged benefits of its Super Blue Green algae products "constitute advertising which is deceptive as untrue, unfounded or likely to mislead" consumers. The lawsuit challenged claims that the American food supply is deficient, that that alga products can supply what is missing, and that the products are effective against many health problems. The judge indicated that the plaintiff (Teachers for Truth in Advertising) is entitled to (a) an injunction prohibiting the company from making any of the specified representations in California, (b) an order requiring the company to refund the purchase price paid by California customers over a four-year period, and (c) recovery of attorneys fees and costs. In May, the parties negotiated a confidential settlement agreement that has been presented to the court for approval. MLM Watch has posted a detailed report about the lawsuit.
Guggul extract fails to lower abnormal cholesterol levels. An double-blind, randomized, placebo-controlled trial has found that eight weeks of treatment with standardized guggul extract (2.5% guggulsterones) did not improve levels of serum cholesterol and might raise levels of LDL-cholesterol. The guggulipid probably also caused a skin rash in some patients. The study involved 103 adults with high blood cholesterol levels who took 1000 mg or 2000 mg of guggulipid or a matching placebo three times a day. [Szapary PO and others. Guggulipid for the treatment of hypercholesterolemia: A randomized controlled trial. JAMA 290:765-772, 2003]
New Zealand homeopath may lose license. New Zealand's Medical Practitioners' Disciplinary Tribunal has found Richard Warwick Gorringe, MB, ChB, of Hamilton, New Zealand guilty of two charges of professional misconduct and one of disgraceful conduct in relation to his care of two patients he treated in 1998.. Gorringe is a general practitioner who uses homeopathy and other methods that he refers to as "complementary." Documents in the case indicate that Gorringe based his diagnoses on "peak muscle resistance testing (PMRT)," a procedure in which he observed whether the subject's opposed thumb and fourth fingers can be pulled apart before and after exposure to glass vials containing various substances. Proponents PMRT, which is also referred to as bi digital O ring testing (BDORT), claim that "weakness" of the fingers means that test substance is problematic. Gorringe is facing penalties that could include a fine of up to NZ$20,000 and removal from the medical register, which would mean he could no longer legally practice medicine. Quackwatch has additional details.
Health Canada warns against alleged mental help supplement. Health Canada has advised consumers not to use Empowerplus (also known as EM Power+ and EM Power), a dietary supplement claimed to help people with bipolar disorder, anxiety disorder, panic attacks, attention deficit disorder, schizophrenia, autism, and several other disorders. The product, which contains vitamins, minerals, antioxidants, amino acids, germanium, and a few other substances, is marketed by Truehope Nutritional Support Limited (also known as Synergy). [Health Canada's actions against Empowerplus. Health Canada Online, July 6, 2003] On July 15, the agency seized records from the company and posted an explanation to its Web site:
We have indicated to Truehope and Synergy on more than one occasion that we would evaluate any health benefits that may be offered by Empowerplus through a new drug submission. A new drug submission has never been filed and Truehope and Synergy continue to illegally sell the drug in Canada. Health Canada has informed Synergy and Truehope that the advertising and sale of Empowerplus contravenes the Food and Drugs Act and Regulations and that Empowerplus poses potential risks to public health.
Because Synergy and Truehope have not complied with requests to stop selling Empowerplus without first demonstrating its safety and effectiveness in a new drug submission, Health Canada is now increasing compliance and enforcement activities and taking steps to mitigate the risk to the Canadian public from the sale of this unapproved drug. [Health Canada executes search warrant related to Empowerplus. Health Canada Online, July 15, 2003.]
This page was posted on August 19, 2003.