Guest guest Posted June 11, 2000 Report Share Posted June 11, 2000 Stephen: 1. What texts do you think should be used in schools (and on our office shelves) that would address the concerns about this herb and others in the future? 2. What other potential liabilities or hazards with herbal products may we face in the future? 3. When the results are gathered, what steps follow the study you propose? 4. Do you have a website with herbal information? Jim , stephen@b... wrote: > > Would this type of statment from the " professionals " include the fact that > in the two most popular materia medicas used by the " professionals " there is > no mention of the toxicity concerns centered around aristolochic acids? Or > that the Bensky/Gamble MM does not even list aristolochic acid as a " major > known ingredient " in aristolochia? Or that the only Caution or > Contraindication is to " Use cautiously in Deficient Yin patients " ? OHAI > published MM by HSU does not list ANY contraindication. The rather thorough > MM by You Ping Zhu mentions the toxicity of Aristolochia in a note at the > end of its write-up on Stephania. Zhu classifies Aristolochia as Qing Mu > Xiang under " Qi regulating herbs " . Aristolochic acids are listed as > chemical constituents. Mention is made of a study of 56 cases of malignancy > TREATED with aristolochic acid A in combination with chemotherapy and > radiotherapy. Of the 56 cases 54 had stabel blood cell counts during > treatment thus ensuring the successful completion of chemotherapy and > radiotherapy, except 2 which had reduced WBC count. Has there been any news > communicated to the professional community about the potential for CANCER or > KIDNEY FAILURE from the use of Aristolochia? > > The reaction patients in the weight loss clinic in Belgum to Aristolochia > seems fairly suspect. Why then and there? The combination of weight loss > pharmaceuticals and herbs, or some other contributing influence needs to be > assessed. The LD50 of Stephania in Mice is listed at 241g/kg in the > Bensky/Gamble MM. That's obviously very high and communicates high levels > of safety to the professionals who use it. In the same book, the LD50 for > Aristolochia is only stated for a single chemical component, trilobine. Not > enough information to determine the safety of the whole herb. > > The NY Times article mentions that ochratoxin A, a carcinogen, is SOMETIMES > FOUND in Stephania tetrandra. None of the many materia medicas that I have > list this chemical component. > > It is my opinion that the " profession " does not have a leg to stand on in an > arguement with the FDA that we had this all figured out and were using it in > a safe way all along. What evidence is there to support that claim. In > fact the opposite seems to be the case, that the profession was not aware of > any potential danger and did not warn FDA or the public against the improper > use of this ingredient. If the profession wants to do something > professional with this situation, my suggestion would be to obtain samples > of the products in question and do some chemical and toxicology studies on > them. Tox studies can be done in China for much less than the US. I have > worked with labs in Beijing that do this type of work and can provide that > link. Studies should include negative controls using placebo and positive > controls using aristolochia to compare with the products that are said to be > the problem children. LD50 and even an acute tox 28 day feed study will not > be adequate to answer the concerns. I would suggest the following, using a > 90 day feed study: > > Sub-Chronic toxicity Test > Ø Appropriate when toxicity concerns and potential liability problems exist > Ø 90 day or 12 months > Ø AEL and specific target organs can be identified > Ø Weekly body weights and food consumption monitored > Ø Hematology and clinical chemistry on serum at test termination > Ø Neurological behavior evaluations at 8th and 12th weeks > Ø Histology performed on negative control, highest dose group, and positive > controls. > > Funding (roughly $30,000) and samples of the products from Europe would be > needed. > > Stephen Morrissey > > > herb-t@s... [herb-t@s...] > Sunday, June 11, 2000 12:16 PM > > Re: Fang Ji Rx's and Urological > Cancers/regulation? > > > > , " " < > zrosenberg@p...> wrote: > > > > > > I think we need to draft a statement for the profession, act now > before we > > have real trouble. We can start by drafting a statement for the > Chinese > > Herb Academy, on the need to have herbal medicines regulated by the > > profession, and supporting inclusion of herbal medicines from China > in > > state licensing. > > > > > > > I agree, but I think we need the support of AAOM to do this and I am > not sure yet where they stand on this. Dave? > > Perhaps if a consensus statement could be developed, it would be an > appropriate polling question to ask this group. > > something like " members of the CHA support FDA regulation to protect > the public from unsafe herbal medicines as long as the licensed > professionals practicing herbology in their legal scope remain exempt > from all such regulations " > > In the past, I have proposed a new category of regulated substances > such as " crude drugs " to distinguish potentially dangerous " herbs " > from > extremely safe food supplements like vitamins and minerals, > flavonoids, > glucosamine, etc. I have no interest in restricting the latter group > of products at all. However, I would rather see some herbs off the > public market as long as they were still on my shelves. > > And while herbs can certainly be used responsibly by laypeople, that > is > highly questionable here in america without any continuous tradition > of > use and the general perception that herbs are safe and that any > products in the store are probably regulated. I owned a health food > store for a few years and these erroneous perceptions are almost > ubiquitous amongst the general public. > > > > > > > -- ---- > Make PayPal your friend. > Sign up today and get a $5 bonus. > http://click./1/5024/9/_/542111/_/960747376/ > -- ---- > > Chronic Diseases Heal - Chinese Herbs Can Help Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 11, 2000 Report Share Posted June 11, 2000 James Ramholz [OMJournal] Sunday, June 11, 2000 4:34 PM Re: Fang Ji Rx's Cancers/regulation? Stephen: 1. What texts do you think should be used in schools (and on our office shelves) that would address the concerns about this herb and others in the future? TEXTS: ALL OF THEM. THE MORE INFORMATION AND PERSPECTIVES THE BETTER. TOXICOLOGY HOWEVER IS NOT WELL ADDRESSED BY ANY TEXT BECAUSE CHINESE MEDICAL RESEARCH INSTITUTIONS AROUND THE WORLD HAVE NOT PURSUED THIS AREA IN ANY WAY CLOSE TO WHAT WOULD PASS FOR CREDIBLE RESEARCH AT THE FDA OR IN COURT AS A DEFENDANT IN A LAW SUIT 2. What other potential liabilities or hazards with herbal products may we face in the future? ONE CONCERN IS THE LACK OF EDUCATION ABOUT QA/QC METHODS, EXTRACTION MANUFACTURING, AND RAW MATERIAL SELECTION ISSUES IN HERBAL TRAINING. DO YOU KNOW WHAT LEVELS OF HEAVY METALS ARE IN YOUR PRODUCTS, WHAT THE ALLOWABLE LIMITS FOR THESE CONTAMINANTS ARE IN FOODS REGULATED BY THE US GOV.? 3. When the results are gathered, what steps follow the study you propose? I'M NOT PUBLIC RELATIONS OR POLITICALLY INCLINED, BUT BEING A SOURCE OF USEFUL DATA ON THE SAFETY OF OUR PROFESSION COULD BE USED IN BOTH OF THOSE WAYS 4. Do you have a website with herbal information? SORRY. Jim , stephen@b... wrote: > > Would this type of statment from the " professionals " include the fact that > in the two most popular materia medicas used by the " professionals " there is > no mention of the toxicity concerns centered around aristolochic acids? Or > that the Bensky/Gamble MM does not even list aristolochic acid as a " major > known ingredient " in aristolochia? Or that the only Caution or > Contraindication is to " Use cautiously in Deficient Yin patients " ? OHAI > published MM by HSU does not list ANY contraindication. The rather thorough > MM by You Ping Zhu mentions the toxicity of Aristolochia in a note at the > end of its write-up on Stephania. Zhu classifies Aristolochia as Qing Mu > Xiang under " Qi regulating herbs " . Aristolochic acids are listed as > chemical constituents. Mention is made of a study of 56 cases of malignancy > TREATED with aristolochic acid A in combination with chemotherapy and > radiotherapy. Of the 56 cases 54 had stabel blood cell counts during > treatment thus ensuring the successful completion of chemotherapy and > radiotherapy, except 2 which had reduced WBC count. Has there been any news > communicated to the professional community about the potential for CANCER or > KIDNEY FAILURE from the use of Aristolochia? > > The reaction patients in the weight loss clinic in Belgum to Aristolochia > seems fairly suspect. Why then and there? The combination of weight loss > pharmaceuticals and herbs, or some other contributing influence needs to be > assessed. The LD50 of Stephania in Mice is listed at 241g/kg in the > Bensky/Gamble MM. That's obviously very high and communicates high levels > of safety to the professionals who use it. In the same book, the LD50 for > Aristolochia is only stated for a single chemical component, trilobine. Not > enough information to determine the safety of the whole herb. > > The NY Times article mentions that ochratoxin A, a carcinogen, is SOMETIMES > FOUND in Stephania tetrandra. None of the many materia medicas that I have > list this chemical component. > > It is my opinion that the " profession " does not have a leg to stand on in an > arguement with the FDA that we had this all figured out and were using it in > a safe way all along. What evidence is there to support that claim. In > fact the opposite seems to be the case, that the profession was not aware of > any potential danger and did not warn FDA or the public against the improper > use of this ingredient. If the profession wants to do something > professional with this situation, my suggestion would be to obtain samples > of the products in question and do some chemical and toxicology studies on > them. Tox studies can be done in China for much less than the US. I have > worked with labs in Beijing that do this type of work and can provide that > link. Studies should include negative controls using placebo and positive > controls using aristolochia to compare with the products that are said to be > the problem children. LD50 and even an acute tox 28 day feed study will not > be adequate to answer the concerns. I would suggest the following, using a > 90 day feed study: > > Sub-Chronic toxicity Test > Ø Appropriate when toxicity concerns and potential liability problems exist > Ø 90 day or 12 months > Ø AEL and specific target organs can be identified > Ø Weekly body weights and food consumption monitored > Ø Hematology and clinical chemistry on serum at test termination > Ø Neurological behavior evaluations at 8th and 12th weeks > Ø Histology performed on negative control, highest dose group, and positive > controls. > > Funding (roughly $30,000) and samples of the products from Europe would be > needed. > > Stephen Morrissey > > > herb-t@s... [herb-t@s...] > Sunday, June 11, 2000 12:16 PM > > Re: Fang Ji Rx's and Urological > Cancers/regulation? > > > > , " " < > zrosenberg@p...> wrote: > > > > > > I think we need to draft a statement for the profession, act now > before we > > have real trouble. We can start by drafting a statement for the > Chinese > > Herb Academy, on the need to have herbal medicines regulated by the > > profession, and supporting inclusion of herbal medicines from China > in > > state licensing. > > > > > > > I agree, but I think we need the support of AAOM to do this and I am > not sure yet where they stand on this. Dave? > > Perhaps if a consensus statement could be developed, it would be an > appropriate polling question to ask this group. > > something like " members of the CHA support FDA regulation to protect > the public from unsafe herbal medicines as long as the licensed > professionals practicing herbology in their legal scope remain exempt > from all such regulations " > > In the past, I have proposed a new category of regulated substances > such as " crude drugs " to distinguish potentially dangerous " herbs " > from > extremely safe food supplements like vitamins and minerals, > flavonoids, > glucosamine, etc. I have no interest in restricting the latter group > of products at all. However, I would rather see some herbs off the > public market as long as they were still on my shelves. > > And while herbs can certainly be used responsibly by laypeople, that > is > highly questionable here in america without any continuous tradition > of > use and the general perception that herbs are safe and that any > products in the store are probably regulated. I owned a health food > store for a few years and these erroneous perceptions are almost > ubiquitous amongst the general public. > > > > > > > -- ---- > Make PayPal your friend. > Sign up today and get a $5 bonus. > http://click./1/5024/9/_/542111/_/960747376/ > -- ---- > > Chronic Diseases Heal - Chinese Herbs Can Help ------ How about a flat, no-fee long distance rate of 6.7¢ per min. - or less? Join beMANY! Our huge buying group gives you rates which fall monthly, plus an extra $60 in FREE calls! http://click./1/3820/9/_/542111/_/960762847/ ------ Chronic Diseases Heal - Chinese Herbs Can Help Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 11, 2000 Report Share Posted June 11, 2000 << What texts do you think should be used in schools (and on our office shelves) that would address the concerns about this herb and others in the future?>> If Bensky has become the anointed materia medica it is due for an extensive revision that does far more than translate. If we can't get it, we'd better look for another. Duke's USDA database frequently has more information on constituents. Many herbs have been extensively studied in Germany, Russia, the US and other western countries but the information is not referenced in the pharmacological and clinical research sections. For instance, sheng ma's entry contains nary a word obout the hormonal or antispasmodic uses of cimicifuga, extensively referenced in the West, even to mentioning whether or not there is a species difference in this respect. With overestrogenated western patients (meat, dairy, plastics, pesticides and HRT), this information is important. Bo he has no mention in the contraindications sections of the inability of children under two to process menthol. Guang fang ji DOES contain the information that aristolochic acid is a major known ingredient but does not reference toxicological concerns: the toxicity reference is for injected trilobine which is not listed among the major known ingredients. Stephen is right that we are sitting ducks for regulation when our major modern texts omit mention (even for refutation) of widely known side effects or toxilogical concerns, let alone references to modern research. And I would suggest that Kent's _Basics of Toxicology_ be present in all school libraries and referenced in the appropriate herb courses. Karen Vaughan CreationsGarden *************************************** " Medicine...the only profession that labours incessantly to destroy the reason for its existence. " James Bryce 1914 ______________ YOU'RE PAYING TOO MUCH FOR THE INTERNET! Juno now offers FREE Internet Access! Try it today - there's no risk! For your FREE software, visit: http://dl.www.juno.com/get/tagj. Quote Link to comment Share on other sites More sharing options...
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