Guest guest Posted February 10, 2002 Report Share Posted February 10, 2002 The following paragraphs detail the level of contamination. So far, they claim only a very small amount of warfarin was discovered; no other pharmaceuticals. It sounds like a problem of the manufacturing process in China. Jim Ramholz How was Warfarin discovered in PC SPES? Several lots of PC SPES were tested by DHS for the presence of drugs, including Warfarin. No other drug finding was reported to BontanicLab by DHS. What is the level of Warfarin that DHS found in PC SPES? The highest level of Warfarin that DHS found in one capsule of PC SPES was 0.211 milligrams. Recommended dosage for PC SPES (as identified on the product label) is 3 capsules in the morning, and for additional benefit, another 3 capsules in the evening. If a user consumed the maximum recommended 6 capsules per day of PC SPES, the amount of Warfarin ingested per day would be 1.27 milligrams, which is approximately 63% of the lowest maintenance dosage recommended by the PDR. , " jramholz " <jramholz> wrote: > Consumers Told to Stop Using Two Herbal Products > > > WASHINGTON (Reuters) - Consumers should stop taking two herbal > supplements promoting prostate and immune system health found to > contain prescription drug ingredients that need medical supervision > and may cause serious problems such as bleeding, U.S. health > officials said on Friday. > > BotanicLab, based in Brea, California, has issued a nationwide > recall of the capsules, called PC SPES and SPES. > > The Food and Drug Administration (news - web sites) (FDA) is > investigating whether the products have harmed any users, FDA > official Dr. Victor Raczkowski said. BotanicLab is not aware of any > health problems caused by the products, spokesman John Sonego said. > > The products were available through stores, mail-order and the > Internet. Worldwide, at least 3,000 people have used PC SPES while > fewer have used SPES, according to Sonego. > > Tests by the California Department of Health Services found PC SPES, > marketed to help ``prostate health,'' contained warfarin, a > prescription anti-clotting medicine sold under the brand name > Coumadin. > > Warfarin can cause serious bleeding, particularly when combined with > other medicines such as aspirin, antibiotics, antidepressants and > cholesterol-lowering drugs. > > BotanicLab, in a statement on its Web site > (http://www.botaniclab.com), said further testing was needed to > determine whether the ingredient was warfarin or a natural compound > that may mimic warfarin in laboratory tests. > > SPES was promoted as strengthening the immune system. It contains > alprazolam, an anti-anxiety drug known by the brand name Xanax, > health officials said. Alprazolam exacerbates effects of alcohol and > other depressants and may be addictive. > > BotanicLab said its tests verified the presence of alprazolam in > some samples of SPES. The company said the contamination may have > occurred in China, where the company obtains raw materials. > > Consumers should stop taking the products and seek medical advice, > especially if they are using other prescription medications, health > officials said. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 10, 2002 Report Share Posted February 10, 2002 Anyone know of any studies comparing the effectiveness of warfarin [or aspirin] to any herbs? Jim Ramholz , " jramholz " <jramholz> wrote: > What is the level of Warfarin that DHS found in PC SPES? > The highest level of Warfarin that DHS found in one capsule of PC > SPES was 0.211 milligrams. Recommended dosage for PC SPES (as > identified on the product label) is 3 capsules in the morning, and > for additional benefit, another 3 capsules in the evening. If a user consumed the maximum recommended 6 capsules per day of PC SPES, the amount of Warfarin ingested per day would be 1.27 milligrams, which is approximately 63% of the lowest maintenance dosage recommended by the PDR. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2002 Report Share Posted February 11, 2002 Does anybody have a sense of how these adulterants would potentiate the intended effect of the formula? Is it consisitant with the treatment of prostate cancer? Prostatic hypertrophy? jramholz wrote: > > The following paragraphs detail the level of contamination. So far, > they claim only a very small amount of warfarin was discovered; no > other pharmaceuticals. It sounds like a problem of the manufacturing > process in China. > > Jim Ramholz > > How was Warfarin discovered in PC SPES? > Several lots of PC SPES were tested by DHS for the presence of > drugs, including Warfarin. No other drug finding was reported to > BontanicLab by DHS. > > What is the level of Warfarin that DHS found in PC SPES? > The highest level of Warfarin that DHS found in one capsule of PC > SPES was 0.211 milligrams. Recommended dosage for PC SPES (as > identified on the product label) is 3 capsules in the morning, and > for additional benefit, another 3 capsules in the evening. If a user > consumed the maximum recommended 6 capsules per day of PC SPES, the > amount of Warfarin ingested per day would be 1.27 milligrams, which > is approximately 63% of the lowest maintenance dosage recommended by > the PDR. -- Al Stone L.Ac. <AlStone http://www.BeyondWellBeing.com Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2002 Report Share Posted February 11, 2002 Interesting that on the website for the PC SPECS company, it discusses rumors that DES was in the product, and denying it. But, if DES is not there, one has to wonder how side effects of gynomastia (male breast enlargement) could be caused by the herbal ingredients? On Monday, February 11, 2002, at 10:51 AM, Al Stone wrote: > Does anybody have a sense of how these adulterants would potentiate the > intended effect of the formula? Is it consisitant with the treatment of > prostate cancer? Prostatic hypertrophy? > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2002 Report Share Posted February 11, 2002 Interesting that on the website for the PC SPECS company, it discusses rumors that DES was in the product, and denying it. But, if DES is not there, one has to wonder how side effects of gynomastia (male breast enlargement) could be caused by the herbal ingredients?>>>>Could be another hormone. I am sure that PC SPECS has some type of modern pharmaceutical in it. Perhaps novel drugs that come from herbs etc. But it works way too well and too predictable to be purely herbal and what's on the label. Alon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2002 Report Share Posted February 11, 2002 Has anyone ever made up this or an equivalent herbal formula and had the same side effects? Jim Ramholz , " ALON MARCUS " <alonmarcus@w...> wrote: > Interesting that on the website for the PC SPECS company, it discusses rumors that DES was in the product, and denying it. But, if DES is not there, one has to wonder how side effects of gynomastia (male breast enlargement) could be caused by the herbal ingredients? > >>>>Could be another hormone. I am sure that PC SPECS has some type of modern pharmaceutical in it. Perhaps novel drugs that come from herbs etc. But it works way too well and too predictable to be purely herbal and what's on the label. > Alon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 12, 2002 Report Share Posted February 12, 2002 Has anyone ever made up this or an equivalent herbal formula and had the same side effects?>>>>I have but did not have enough time to really evaluate alon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 14, 2002 Report Share Posted February 14, 2002 Alon, not only is there an estrogenic action from the probable DES, but several of the herbs listed as ingredients are noted phyto-estrogens, and there are also herbal anti-androgens present in the formula as well! In a formula that probably does have DES, as well as high percentages of both phyto-estrogens and anti-androgens, is it surprising to find gynomastia developing? Actually, I am surprised that there is not a higher incidence than has been reported. The issue here, of course, is not that there is a significant estrogenic and anti-androgenic component to the formula (as estrogenic therapy is recommended for many prostate patients), but that it is not an advertised aspect of the therapy (as there are a number of prostate patients who should not be given estrogen therapy due to other medical issues). By not advertising these products as being estrogenic in nature (they say they are tonifying) there is a percentage of prostate patients who can be put at greater health risks by taking these products. One of the issues that we must deal with in this country is exactly this sort of contamination of our herbal medicines by manufacturers making use of unlisted 'additives'. This is, of course, why we either make our own custom made formulas, or make use of ITM Patents in our clinic. While I am sure that there are other companies making just as good patent formulations, at least with ITM we know that if it is on the label it is in the bottle, and just as importantly if it is not on the label, it is not in the bottle. (BTW, I have no association other than as a user/prescriber of ITM products) Products with 'hidden' additives have no place in the medical community. The larger issue is what will the FDA finally do to control this, and what are the effects on our profession going to be? If we are heading in the direction of the European Codex, we may as well all hang up our shingles and forget about being able to practice Herbal Medicine. However, we do need some sort of controls to eliminate the abuse of Herbal Medicine by unscrupulous manufacturers who are more than willing to jump on the herbal bandwagon, but for purely monetary reasons. Perhaps this is an area where the National Boards need to establish some sort of certification for the manufacture of Herbal Patent medications. Like a "Good Housekeeping Seal of Approval" sort of thing. If we do not develop some sort of self-monitoring system for our Herbal Medicines, the FDA will do it for us in the end, and I doubt that we would be very happy with their solution. Just some food-for-thought... Mel Krueger, L.Ac. M & M's TCM Clinic Flagstaff, AZ ninjadrs - ALON MARCUS Monday, February 11, 2002 4:04 PM Re: Quote from the BotanicLab Website Interesting that on the website for the PC SPECS company, it discusses rumors that DES was in the product, and denying it. But, if DES is not there, one has to wonder how side effects of gynomastia (male breast enlargement) could be caused by the herbal ingredients?>>>>Could be another hormone. I am sure that PC SPECS has some type of modern pharmaceutical in it. Perhaps novel drugs that come from herbs etc. But it works way too well and too predictable to be purely herbal and what's on the label. AlonChinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 14, 2002 Report Share Posted February 14, 2002 Mel, In my experience, there are a number of American companies making unadulterated ready-made Chinese medicines besides ITM. These companies tend to be owned and operated by second or more generation Americans who understand the wants, needs, laws, and mores of this society. Eight such companies I personally know of are Golden Lotus, Health Concerns, China Herb, K'an Herbs, Modular Solutions, Zand Herbal, Three Treasures, and Blue Poppy Herbs. I'm sure there are others. Frankly, I've never been very impressed with ITM formulas in terms of Chinese medical theory or their marketing which tends to take a disease-specific as opposed to a pattern discrimination approach. This is also a problem with Health Concerns' marketing from my point of view. As for regulation of herbal manufacturers and suppliers, such a trade association has been created in the U.K. and is promulgating industry standards. We tried to initiate a similar trade association here in the U.S. two years ago, but it seemed to me that some of the first generation companies working from a more Asian point of view were not committed to this process. One notable exception was Sam Cheung at Qualiherb/Finemost. I should also say that I think the people at Nuherbs and Mayway are ever more aware of and concerned about issues such as adulteration, CITES compliance, aristolochic acid, etc. In fact, I think most of the companies that are run by members of this profession, whether they be first or more generation Americans, try to do a good job and are honest and sincere. From where I sit, it's the " outsiders " who see this as a ripe market ready for the picking and who are only interested in making a buck which are the problem. These people/companies typically do not attend our state and national meetings and do not advertise regularly in AT, TCM World, JCM, etc. In other words, they don't inhabit the same professional universe I do. I guess what I'm reacting to in your posting is the impression that there is only a single company with clean, unadulterated products when, in fact, most of the products marketed to our niche by those within our niche are clean and unadulterated. Bob , " Mel Krueger " <ninjadrs@i...> wrote: > Alon, not only is there an estrogenic action from the probable DES, but several of the herbs listed as ingredients are noted phyto-estrogens, and there are also herbal anti-androgens present in the formula as well! In a formula that probably does have DES, as well as high percentages of both phyto-estrogens and anti-androgens, is it surprising to find gynomastia developing? Actually, I am surprised that there is not a higher incidence than has been reported. The issue here, of course, is not that there is a significant estrogenic and anti-androgenic component to the formula (as estrogenic therapy is recommended for many prostate patients), but that it is not an advertised aspect of the therapy (as there are a number of prostate patients who should not be given estrogen therapy due to other medical issues). By not advertising these products as being estrogenic in nature (they say they are tonifying) there is a percentage of prostate patients who can be put at greater health risks by taking these products. > > > > One of the issues that we must deal with in this country is exactly this sort of contamination of our herbal medicines by manufacturers making use of unlisted 'additives'. This is, of course, why we either make our own custom made formulas, or make use of ITM Patents in our clinic. While I am sure that there are other companies making just as good patent formulations, at least with ITM we know that if it is on the label it is in the bottle, and just as importantly if it is not on the label, it is not in the bottle. (BTW, I have no association other than as a user/prescriber of ITM products) Products with 'hidden' additives have no place in the medical community. > > > > The larger issue is what will the FDA finally do to control this, and what are the effects on our profession going to be? If we are heading in the direction of the European Codex, we may as well all hang up our shingles and forget about being able to practice Herbal Medicine. However, we do need some sort of controls to eliminate the abuse of Herbal Medicine by unscrupulous manufacturers who are more than willing to jump on the herbal bandwagon, but for purely monetary reasons. Perhaps this is an area where the National Boards need to establish some sort of certification for the manufacture of Herbal Patent medications. Like a " Good Housekeeping Seal of Approval " sort of thing. If we do not develop some sort of self-monitoring system for our Herbal Medicines, the FDA will do it for us in the end, and I doubt that we would be very happy with their solution. > > > > Just some food-for-thought... > > > > Mel Krueger, L.Ac. > > M & M's TCM Clinic > > Flagstaff, AZ > > > > ninjadrs@i... > > > - > ALON MARCUS > > Monday, February 11, 2002 4:04 PM > Re: Quote from the BotanicLab Website > > > Interesting that on the website for the PC SPECS company, it discusses rumors that DES was in the product, and denying it. But, if DES is not there, one has to wonder how side effects of gynomastia (male breast enlargement) could be caused by the herbal ingredients? > >>>>Could be another hormone. I am sure that PC SPECS has some type of modern pharmaceutical in it. Perhaps novel drugs that come from herbs etc. But it works way too well and too predictable to be purely herbal and what's on the label. > Alon > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2002 Report Share Posted February 15, 2002 Mel Remember that DES was not substantiated so far. Normal levels of phytoestrogens have not been shown to decrease androgens to a great extent. And that is partially why I have to think there is other stuff in the formula. I am sure that PC has been analyzed many time by FDA and so far no smocking gun. Alon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2002 Report Share Posted February 15, 2002 The big question is how good are the Chinese GNP companies. So far it looks like they are doing a good job. Alon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2002 Report Share Posted February 15, 2002 Bob, I must certainly apologize if I made the impression that I thought that only ITM provided unadulterated patent formulations. As I said in the post, I realize that there are others. I am very familiar with the ones that you mention, not only by reputation, but also through use of some of their products. I mentioned ITM simply because I have personally received an apology from Subhuti when a specific formula was not available because an in-house test showed that it did not match his specifications, and a new batch had to be prepared. It is the fact that he runs an in-house testing program that struck me as the correct way for an herbal supplier to do business instead of 'assuming' that the product was as he specified. It is this sort of control that will finally allow herbal medicine to be accepted more widely in the US. BTW, while I also would like to see ITM organize its product line more traditionally, I must point out that while ITM makes reference to Western Diagnostics, in order to correctly use the full potential product line, the practitioner must be able to understand the full Chinese Differentiation as well. For the most part, there are multiple formulations listed for specific Western diseases, in order to correctly prescribe them, you must understand the Chinese Patterns in order to select the one or two that are correct for the specific case. However, this is irrelevant to the topic of adulterated patent formulations, and is a philosophical issue that I believe has been discussed here and elsewhere previously, and will likely be again at some point. I must agree that we are finally seeing the suppliers of Asian made herbals becoming more aware of the issues of adulteration of the products. The problem is that it is coming very slowly from the manufacturers supplying the adulterated products. Both Mayway & NuHerbs now have a significant number of patent formulas that they can no longer bring into the country. As Oriental Herbal Medicine becomes more widespread in its use in the US, the FDA will become ever more involved in our Medicine. Unfortunately, the FDA is highly controlled by the Allopathic model, and we are beginning to see formulas that have been safely used for generations being restricted. While in many cases this is due to a single herb within the formula that has known health issues, in some it is only because of Americas infatuation with the 'drug war'. has been safely using Ma Huang and Hou Ma Ren for longer than this country has been existent, but because Ephedra tablets can be processed down into a powerful stimulant, the bulk herb is no longer useable in patent formulas, or because there is such fear regarding any Hemp product that this Administration is attempting to even ban hemp garments, we must loose the use of Ma Ren. (When in actuality we need to initiate commercial hemp production in this country for clothing, housing, and the potential of the oil for energy is simply staggering.) In an atmosphere such as this, we are just a short step from joining the European Codex, which will effectively end our abilities to make full use of the Materia Medica, and many classical formulations. (Could you actually consider yourself to be an Oriental Herbalist if you were restricted to the Codex list?) We, as individual Oriental Physicians, can do little without national support. This support needs to come from the leaders of our profession, the National Boards, and concerned manufacturers coming together to develop some type of self-regulating body to assure the FDA that patent formulas, made in the US, meet stringent requirements for such an " Herbal Seal of Approval " . Actually, we need recognized leaders of our profession to be setting on the FDA Board of Directors, but I doubt that I will see this in my lifetime. Although OM has been fairly well accepted in the US, it will still be a long time before we are accepted equally with our Allopathic colleagues, at least by them. Once again, please accept my apology for being unclear in my earlier post. Mel Krueger, L.Ac. M & M's TCM Clinic Flafstaff, AZ Ninjadrs Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2002 Report Share Posted February 15, 2002 Perhaps this is an area where the National Boards need to establish some sort of certification for the manufacture of Herbal Patent medications. Like a "Good Housekeeping Seal of Approval" sort of thing. If we do not develop some sort of self-monitoring system for our Herbal Medicines, the FDA will do it for us in the end, and I doubt that we would be very happy with their solution. Mel Krueger, L.Ac. Mel, There are two organizations that are currently competing to become the "seal of approval" for botanical and nutritional supplements in the US market. One is NSF International (www.nsf.com) and the other is the US Pharmacopeia (www.usp.org). Manufacturers would pay a sizeable fee per product to either of these organizations to have them review their operations and products, after which, assuming they don't have or correct any deficiencies, they would be able to use their respective seals on product labels. I anticipate that few if any companies that sell supplements wholesale to practitioners would be willing to cough up the fees and undergo the inspections given that the consumers of the products from health care professionals presume their knowledge and trust in the practitioner to make good decisions regarding products they provide to their patients. Unfortunately there is very little if any training that provides practitioners with the information/knowledge to discern good natural health products from mediocre or lousy ones. There's the gap. I can suggest ways to fill that gap if interested. Stephen Morrissey OMD Botanica BioScience Corp P.O. Box 1477 Ojai, CA 93024 Ph: 805-646-6062 Fx: 805-646-3026 email: stephen web: www.botanica-bioscience.com Chinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 16, 2002 Report Share Posted February 16, 2002 I mentioned ITM simply because I have personally received anapology from Subhuti when a specific formula was not available because anin-house test showed >>>Personally I prefer independent testing Alon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 17, 2002 Report Share Posted February 17, 2002 Dear Stephen, Let's talk about the proposed California legislation which would create the " Green Seal " for Asian Traditional Medicines. DHS (Dept.of Health Services) would certify and/or test Chinese herb companies for heavy metals with the initial standard being WHO (German standard in 3-7 years depending on industry consensus). This would be a " voluntary " program and companies could have their testing methods for other things (ie pesticides, biologics,etc). Given the Prop.65 heavy metal standards issue, this CA DHS certification would present the positive standards that herb companies (should) have in place. Keep in touch, Bill > Perhaps this is an area where the National Boards need to establish some >sort of certification for the manufacture of Herbal Patent medications. >Like a " Good Housekeeping Seal of Approval " sort of thing. If we do not >develop some sort of self-monitoring system for our Herbal Medicines, the >FDA will do it for us in the end, and I doubt that we would be very happy >with their solution. > > > Mel Krueger, L.Ac. > > > > > > Mel, > > > > There are two organizations that are currently competing to become the > " seal of approval " for botanical and nutritional supplements in the US >market. One is NSF International (www.nsf.com) and the other is the US >Pharmacopeia (www.usp.org). Manufacturers would pay a sizeable fee per >product to either of these organizations to have them review their >operations and products, after which, assuming they don't have or correct >any deficiencies, they would be able to use their respective seals on >product labels. I anticipate that few if any companies that sell >supplements wholesale to practitioners would be willing to cough up the fees >and undergo the inspections given that the consumers of the products from >health care professionals presume their knowledge and trust in the >practitioner to make good decisions regarding products they provide to their >patients. Unfortunately there is very little if any training that provides >practitioners with the information/knowledge to discern good natural health >products from mediocre or lousy ones. There's the gap. I can suggest ways >to fill that gap if interested. > > Stephen Morrissey OMD > Botanica BioScience Corp > P.O. Box 1477 > Ojai, CA 93024 > Ph: 805-646-6062 > Fx: 805-646-3026 > email: stephen > web: www.botanica-bioscience.com > > Chinese Herbal Medicine, a voluntary organization of licensed >healthcare practitioners, matriculated students and postgraduate academics >specializing in Chinese Herbal Medicine, provides a variety of professional >services, including board approved online continuing education. > > > > Quote Link to comment Share on other sites More sharing options...
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