To: Health Freedom,Codex Issues
From: John Hammell jham@iahf.com
Date: Thu, 06 Sep 2001 21:34:28 -0400
IAHF List: Although IAHF appreciates this solid rebuttal by CRN of a recent bogus attack on Ginkgo, IAHF reminds you that although CRN might have the APPEARANCE of being on our side, that is illusory. CRN, heavily dominated by multinational pharmaceutical interests (see http://www.crnusa.org is also greatly assisting FDA's efforts at Codex to set us up to lose in a WTO Trade Dispute which would force us to harmonize our domestic vitamin laws to Codex standards. Whats in it for them? The Cartel wants high potency vitamins and many other dietary supplements to only be available by prescription. That way they can make more money off less product, they can downsize their vitamin divisions which would please investors, and they can stop vitamins from cutting so much into the sale of their other products, toxic ineffective drugs. They really don't care what they sell as long as they can have a monopoly. Through control of the vitamin trade associations, mergers, buy outs and acquisitions via such trade shows as "Nutracon" they're attempting to lead us down the primrose path, but we don't HAVE to take it. Please forward this to more people. Anyone can be on the IAHF list by signing up at http://www.iahf.com
WASHINGTON, DC, August 29, 2001 (CRN) — Multiple analyses of ginkgo powdered raw material and extract from several sources by third party laboratories have effectively discredited the purported major findings of a study reported in the journal Chemical Research in Toxicology. Laboratory analyses of five different ginkgo sources have been analyzed by three different methods including the one used in the study, "Identification of Colchicine in Placental Blood from Patients Using Herbal Medicines" by Petty et al. No trace of colchicine has been found in any of the samples.
The study is a perfect example of the confusion that can be generated by not adhering to the principles of scientific objectivity, because the manuscript suffers from numerous omissions and deficiencies, several of which undermine the credibility of many of the authors' statements and conclusions. Thomas L. Kurt, M.D., M.Ph., clinical professor at the University of Texas Southwestern Medical Center, summarized his review of the study, "There are numerous problematic errors in the work as reported that are simply untenable."
John Cardellina, Ph.D., vice president, botanical science and regulatory affairs at the Council for Responsible Nutrition (CRN) finds the report puzzling, "Ginkgo has been examined in more than 30 randomized, blinded, controlled studies, and more than 100 other clinical and pharmacological studies and found to be safe and efficacious, with no mention of colchicine. Data indicating high daily doses of up to 1600 milligrams per kilogram in animal studies did not elicit teratogenic effects (malformation of fetus) or affect reproduction, nor was there any evidence of mutagenicity in any in vitro tests."
Beyond the unsubstantiated claim of colchicine in ginkgo supplements, there are serious concerns about the actual blood analyses and results. There is a considerable body of published data on the bioavailability, pharmacokinetics and toxicology of colchicine in humans. The vast majority of those reports, which includes data on pregnant women chronically treated with therapeutic doses of colchicine for Familial Mediterranean Fever, conflicts directly with the findings reported in the study. Dr. Richard Kingston of the PROSAR International Poison Center and the University of Minnesota, reviewed the paper in question and noted that the levels of colchicine reported in placental blood "…would likely be incompatible with life for the fetus and the mother, if they were accurate."
"For the authors to say 'such supplements should be avoided by pregnant women or those trying to conceive because the colchicine in them could affect the viability of a fetus' as quoted in Chemical and Engineering News, is an unacceptable leap, given the questions raised about this report, and its conflict with the existing scientific literature with colchicine," said John Cordaro, president and chief executive officer of CRN. "Even so, warning statements, especially in regard to pregnancy and nursing, are already included on most ginkgo products. As always, the dietary supplement industry remains committed to full resolution of any questions about the safety of products in the marketplace," Cordaro added.
In addition to CRN's analysis of ginkgo raw materials and extracts, the American Herbal Products Association and the National Nutritional Foods Association have begun analyses of finished ginkgo products, and have not yet found a product with colchicine present.
The authors do themselves and any potential readers a disservice by stating that dietary supplements are unregulated and that the safety and efficacy of herbal medicines have not been verified by appropriate randomized, controlled clinical studies. There is a considerable body of clinical and pharmacological evidence supporting the safety and benefit of the leading herbals in the marketplace, including ginkgo, perhaps the most studied of all the herbals. Dietary supplements are vigorously regulated by the Food and Drug Administration and the Federal Trade Commission.
The Council for Responsible Nutrition (CRN) is a science-based, trade association founded in 1973 and represents more than 110 companies in the dietary supplement industry, including ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.