Guest guest Posted March 25, 2008 Report Share Posted March 25, 2008 At 01:27 AM 3/24/08, you wrote: >March 20, 2008 >Heparin Find May Point to Chinese Counterfeiting >By WALT BOGDANICH > >Federal drug regulators, in announcing Wednesday that the mystery >contaminant in heparin was an inexpensive, unapproved ingredient altered >to mimic the real thing, moved closer to concluding that Americans might >be the latest victims of lethal Chinese drug counterfeiting. > >The finding by the Food and Drug Administration culminated a worldwide >race to identify the substance discovered early this month in certain >batches of heparin, the blood-thinning drug that had been linked to 19 >deaths in the United States and hundreds of allergic reactions. > >The contaminant, the regulators said, is a chemically altered form of >chondroitin sulfate, a dietary supplement made from animal cartilage that >is widely used to treat joint pain. The agency's announcement followed a >report Wednesday in The New York Times that was the first publicly to >identify the modified substance as the likely contaminant. That report was >based on nearly two dozen interviews with researchers and scientists in >China, the United States and Canada. > >Federal officials stopped short of saying that the contaminant — >constituting as much as 50 percent of the active ingredient in heparin — >was counterfeit. " At the moment we don't know definitely whether the >contaminant was introduced intentionally or by accident, " said Dr. Janet >Woodcock, director of the Food and Drug Administration's center for drug >evaluation and research. > > >Even so, the authorities left little doubt that they believed that the >contaminant was not an unintended byproduct of some manufacturing process. >In its natural state, chondroitin sulfate does not have anticlotting >properties. But it mimics heparin when altered to form what is called >oversulfated chondroitin sulfate. That is what made it difficult for >Baxter International, the manufacturer of the heparin associated with the >allergic reactions, to detect the impurity. " This compound to our >knowledge is not naturally occurring, " Dr. Woodcock said. " It should not >be in heparin. And it obviously should not be in the form it is in. " > >While identifying the contaminant was a significant breakthrough, >investigators still do not know if it is responsible for causing the >allergic reactions. Nor do they know why the modified ingredient ended up >in heparin, though they have raised the possibility that the substance was >used as cheap filler. > > " The base compound, chondroitin sulfate, is very abundant and an >inexpensive compound, " said Moheb Nasr, director of the agency's office of >new drug quality and assessment. Chemically modifying it, Mr. Nasr added, > " will not be that expensive either. " > >The F.D.A. said it had found the contaminated heparin at Changzhou SPL, >the Chinese plant that supplies the active ingredient to Baxter. Changzhou >in turn buys its heparin from two companies, called consolidators, that >gather crude heparin from workshops that make it from pig intestines. > >Many workshops that make crude heparin are unregulated family operations. > >Erin Gardiner, a spokeswoman for Baxter, said Wednesday that tests found >the supplies were contaminated before they arrived at the Changzhou plant. > " The consolidators and workshops handle the crude material, so that is >where our focus is turning, " Ms. Gardiner said. > >So far, Ms. Gardiner said Baxter's investigators had been denied access to >the consolidators and workshops. " We will continue to seek access. " >Last week, the F.D.A. said it had not yet visited the workshops. > >Some heparin producers in China also sell chondroitin sulfate, which can >be derived from pig cartilage. Traders and producers say it is far cheaper >than heparin, as little as one-twentieth the cost. That could be an >enticement for counterfeiters, especially in the wake of a virulent pig >virus that swept across China last year, substantially reducing the >availability of the starting materials needed to make the active >ingredient in heparin. > >Contaminated heparin sourced from China has also turned up recently in >Germany, where about 80 allergic reactions have been reported. But >investigators there have yet to identify the contaminant. F.D.A. officials >said their discovery of chemically modified chondroitin sulfate came >exactly one year after the discovery that a pet food ingredient shipped >from China contained toxic levels of melamine, which was added to make it >appear higher in protein. Many pets became ill, and some died. >Around the same time, The Times reported that an unlicensed Chinese >chemical plant sold a cheap counterfeit ingredient, diethylene glycol, >that was mixed into cold medicine in Panama, killing nearly 120 people and >disabling dozens more. > >Diethylene glycol mimics its more expensive chemical cousin, glycerine, a >safe ingredient used in medicine, food and toothpaste. >The F.D.A. said its search for answers in the heparin case had been made >easier because of the cooperation it had received from China's State Food >and Drug Administration. That was not the case when United States >officials inquired last year about the melamine and diethylene glycol. > >The agency cited an accord signed in December by the governments of China >and the United States as one reason for the cooperation they had received >recently, which they said allowed American investigators to quickly begin >their investigation of the additive. > > >This email was sent to thehavens. >You can instantly from these emails by >clicking the link below: >http://transferpoint.createsend1.com/t/1/u/pzo/skrthw/ > > > >--- >Incoming mail is certified Virus Free. >Checked by AVG anti-virus system (http://www.grisoft.com). >Version: 6.0.859 / Virus Database: 585 - Release 2/14/05 ****** Kraig and Shirley Carroll ... in the woods of SE Kentucky http://www.thehavens.com/ thehavens 606-376-3363 --- Outgoing mail is certified Virus Free. Checked by AVG anti-virus system (http://www.grisoft.com). Version: 6.0.859 / Virus Database: 585 - Release 2/14/05 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 25, 2008 Report Share Posted March 25, 2008 At 07:22 PM 3/24/2008, you wrote: Ah, yet more wonders out of China............... Lynn At 01:27 AM 3/24/08, you wrote: >March 20, 2008 >Heparin Find May Point to Chinese Counterfeiting >By WALT BOGDANICH > >Federal drug regulators, in announcing Wednesday that the mystery >contaminant in heparin was an inexpensive, unapproved ingredient altered >to mimic the real thing, moved closer to concluding that Americans might >be the latest victims of lethal Chinese drug counterfeiting. > >The finding by the Food and Drug Administration culminated a worldwide >race to identify the substance discovered early this month in certain >batches of heparin, the blood-thinning drug that had been linked to 19 >deaths in the United States and hundreds of allergic reactions. > >The contaminant, the regulators said, is a chemically altered form of >chondroitin sulfate, a dietary supplement made from animal cartilage that >is widely used to treat joint pain. The agency's announcement followed a >report Wednesday in The New York Times that was the first publicly to >identify the modified substance as the likely contaminant. That report was >based on nearly two dozen interviews with researchers and scientists in >China, the United States and Canada. > >Federal officials stopped short of saying that the contaminant — >constituting as much as 50 percent of the active ingredient in heparin — >was counterfeit. " At the moment we don't know definitely whether the >contaminant was introduced intentionally or by accident, " said Dr. Janet >Woodcock, director of the Food and Drug Administration's center for drug >evaluation and research. > > >Even so, the authorities left little doubt that they believed that the >contaminant was not an unintended byproduct of some manufacturing process. >In its natural state, chondroitin sulfate does not have anticlotting >properties. But it mimics heparin when altered to form what is called >oversulfated chondroitin sulfate. That is what made it difficult for >Baxter International, the manufacturer of the heparin associated with the >allergic reactions, to detect the impurity. " This compound to our >knowledge is not naturally occurring, " Dr. Woodcock said. " It should not >be in heparin. And it obviously should not be in the form it is in. " > >While identifying the contaminant was a significant breakthrough, >investigators still do not know if it is responsible for causing the >allergic reactions. Nor do they know why the modified ingredient ended up >in heparin, though they have raised the possibility that the substance was >used as cheap filler. > > " The base compound, chondroitin sulfate, is very abundant and an >inexpensive compound, " said Moheb Nasr, director of the agency's office of >new drug quality and assessment. Chemically modifying it, Mr. Nasr added, > " will not be that expensive either. " > >The F.D.A. said it had found the contaminated heparin at Changzhou SPL, >the Chinese plant that supplies the active ingredient to Baxter. Changzhou >in turn buys its heparin from two companies, called consolidators, that >gather crude heparin from workshops that make it from pig intestines. > >Many workshops that make crude heparin are unregulated family operations. > >Erin Gardiner, a spokeswoman for Baxter, said Wednesday that tests found >the supplies were contaminated before they arrived at the Changzhou plant. > " The consolidators and workshops handle the crude material, so that is >where our focus is turning, " Ms. Gardiner said. > >So far, Ms. Gardiner said Baxter's investigators had been denied access to >the consolidators and workshops. " We will continue to seek access. " >Last week, the F.D.A. said it had not yet visited the workshops. > >Some heparin producers in China also sell chondroitin sulfate, which can >be derived from pig cartilage. Traders and producers say it is far cheaper >than heparin, as little as one-twentieth the cost. That could be an >enticement for counterfeiters, especially in the wake of a virulent pig >virus that swept across China last year, substantially reducing the >availability of the starting materials needed to make the active >ingredient in heparin. > >Contaminated heparin sourced from China has also turned up recently in >Germany, where about 80 allergic reactions have been reported. But >investigators there have yet to identify the contaminant. F.D.A. officials >said their discovery of chemically modified chondroitin sulfate came >exactly one year after the discovery that a pet food ingredient shipped >from China contained toxic levels of melamine, which was added to make it >appear higher in protein. Many pets became ill, and some died. >Around the same time, The Times reported that an unlicensed Chinese >chemical plant sold a cheap counterfeit ingredient, diethylene glycol, >that was mixed into cold medicine in Panama, killing nearly 120 people and >disabling dozens more. > >Diethylene glycol mimics its more expensive chemical cousin, glycerine, a >safe ingredient used in medicine, food and toothpaste. >The F.D.A. said its search for answers in the heparin case had been made >easier because of the cooperation it had received from China's State Food >and Drug Administration. That was not the case when United States >officials inquired last year about the melamine and diethylene glycol. > >The agency cited an accord signed in December by the governments of China >and the United States as one reason for the cooperation they had received >recently, which they said allowed American investigators to quickly begin >their investigation of the additive. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 25, 2008 Report Share Posted March 25, 2008 Oh wonderful - just what I need to read when I'm going in every day to give someone a Heparin injection. - No wonder they've only given him 1 month to live. Jane - Lynn Ward >Federal drug regulators, in announcing Wednesday that the mystery >contaminant in heparin was an inexpensive, unapproved ingredient altered >to mimic the real thing, moved closer to concluding that Americans might >be the latest victims of lethal Chinese drug counterfeiting.>>The finding by the Food and Drug Administration culminated a worldwide >race to identify the substance discovered early this month in certain >batches of heparin, the blood-thinning drug that had been linked to 19 >deaths in the United States and hundreds of allergic reactions. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 25, 2008 Report Share Posted March 25, 2008 > Lynn Ward > >Federal drug regulators, in announcing Wednesday that the mystery > >contaminant in heparin was an inexpensive, unapproved ingredient altered > >to mimic the real thing, moved closer to concluding that Americans might > >be the latest victims of lethal Chinese drug counterfeiting. > > > >The finding by the Food and Drug Administration culminated a worldwide > >race to identify the substance discovered early this month in certain > >batches of heparin, the blood-thinning drug that had been linked to 19 > >deaths in the United States and hundreds of allergic reactions. Here is another example of why the medical route is not a good one. You go there to get better and in reality you are being given things that cause your system to be over taxed. Taking medical drugs can cause all sorts of unhealthy problems. People need to educate themselves in learning how to live healthy. Change in living habits is a good place to start. Edith Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 25, 2008 Report Share Posted March 25, 2008 Sometimes there are no better ways to eliminate clots .... DVTs etc etc which also can be life threatening - my very fit son would be very upset to know about this needing Heparin only due to a cycling accident where he found himself needing some sort of solution for DVTs ............ DVTs are common in very athletic types suddenly being unable to move around due to trauma - so it is not quite as simple as it may appear. Jane Here is another example of why the medical route is not a good one. You go there to get better and in reality you are being given things that cause your system to be over taxed. Taking medical drugs can cause all sorts of unhealthy problems. People need to educate themselves in learning how to live healthy. Change in living habits is a good place to start. Edith Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 25, 2008 Report Share Posted March 25, 2008 At 07:36 AM 3/25/2008, you wrote: Unfortunatley, it never is - simple I mean. While I would prefer going the natural route for everything (and have, for ni on 30 years or more), I know sometimes the wisest course is to go to the doctor and have them help you get things fixed - or at least, better. I had my first abdominal surgery when I was 11 or 12 - they removed a dermoid tumor that was the size of an orange. Often, taking aspirin, even though it can do terrible things to your stomach, can be the difference in someone having a stroke - or another stroke - and having a heart attack. Steroids are very hard on your body, but sometimes, for people who have something like MS, it can be the difference in whether you can walk, or see. If certain symptoms are caught quickly enough in MS, sometimes a course of steroids makes all the difference in the world. I'm sure some people are asking, or saying, won' things get better on their own if you don't take steroids? The answer to that is sometimes - but usually the recovery is not as good as it would have been with the steroids. And, when you have a disease where things are cumulative, the least amount of damage, the better. I've done it both ways. But, on the other side, here's a good example of how one can treat a common condition better than most physicians can: If you get poison ivy, oak or whatever, and even when the rash has gotten really bad where the areas is oozing, apple cider vinegar (mixed with some water) will totally kill what's going on. As opposed to anything you might get from the dermatologist or doc. I dated a dermatologist once, and asked him about it.....he was very honest, and told me that if everyone knew about methods like this, they wouldn't come to the doctor....*smile* I think also, that the issue about the counterfeit Heparin, is more of an issue with what comes out of China....it's a shame so many countries are so dependant on what we get from them. I wish we could stop, but fear there would be severe monetary consequences, which, I suspect, may be the reason why people continue to import so much from them......... Lynn Sometimes there are no better ways to eliminate clots .... DVTs etc etc which also can be life threatening - my very fit son would be very upset to know about this needing Heparin only due to a cycling accident where he found himself needing some sort of solution for DVTs ............ DVTs are common in very athletic types suddenly being unable to move around due to trauma - so it is not quite as simple as it may appear. Jane Here is another example of why the medical route is not a good one. You go there to get better and in reality you are being given things that cause your system to be over taxed. Taking medical drugs can cause all sorts of unhealthy problems. People need to educate themselves in learning how to live healthy. Change in living habits is a good place to start. Edith _ Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.