Substance in Heparin Found
A growing trend from China seems to be undermining the integrity of Chinese products. Last year alone, diethylene glycol, a component of antifreeze, was found in cold medicines made or sourced in China and shipped worldwide. More than 100 people died from taking the tainted cold medicines and many dozens more became ill. Melamine, a flame-retardant, was discovered in pet foods that killed many cats and dogs before being traced to a Chinese supplier.
It seems that the current heparin scare, which prompted the US Food and Drug Administration (FDA) to halt all shipments of heparin at US borders for meticulous inspection, is but another example of cost-cutting measures employed by Chinese manufacturers to reduce production costs of products or their component ingredients that are shipped to the US and around the world. In the past week, Baxter International, a supplier of heparin to the US, recalled all its heparin products in response to the growing number of deaths and allergic reactions associated with it. Heparin was also recalled in Germany and Japan.
This time, the cost-cutting contaminant is oversulfated chondroitin sulfate, an altered form of the popular nutritional supplement chondroitin sulfate. In the altered state, the ingredient mimics heparin’s chemical composition but does not supply the blood-clotting effect for which heparin is prescribed.
The active ingredient in heparin comes from the intestines of pigs. Chondroitin sulfate, derived from pig cartilage, is more abundant and less expensive than heparin’s source. China experienced a particularly virulent strain of pig virus last year that reduced the number of pigs in the country by substantial numbers. Chondroitin can be manufactured for 5% the cost of heparin. Some of the heparin tested by the FDA contained as much as 50% of the contaminant.
In each case – heparin, cough medicine, and pet foods – the counterfeit products contained less expensive contaminants that mimicked the active ingredients they were replacing. Whether the heparin contaminant was added by accident or deliberately has not been proven yet but officials at the FDA express little doubt that the contaminant in heparin is an unintended byproduct.
Baxter got its active ingredient in heparin from Changzhou SPL, which, in turn, bought its product from two consolidating companies that purchase the crude ingredients for making heparin from unregulated workshops. Tests run by Baxter indicate the contaminants arrived in the supply line before reaching the Changzhou factory.
China’s State Food and Drug Administration is working cooperatively with US officials to locate the source of contamination but has thus far been denied access to the consolidators and the workshops. There was much resistance on China’s part last year when US officials were trying to locate the source of contamination for the cough medicine and pet food scares. A December 2007 accord between China and the US has allowed speedier response this time.
Heparin is frequently used during dialysis and heart surgeries. Baxter officials have expressed confidence in the safety of the heparin now in circulation within the US, which has all been tested for evidence of contamination.
Source: NYT
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How many new ways can China find to poison Americans, their children, their dogs? I don’t buy anything maid in China anymore, if I can help it. What do they do with the money, besides making tainted products? Let me give you a clue- they will use all the money Americans are giving them to shoot the Tibetans, invade Taiwan, and ruthlessly cling to power, in mainland China. Is this what you want your money to be doing? Couldn’t you patronize India, Sri Lanka, South America, anyplace else but the communists. We don’t NEED anything they make. Give your money to someone who is doing something positive!
India, Sri Lanka, South America, or any poor country would do the same thing David. Try making it in the US, but companies are too greedy to do so.
It’s not the companies’ fault… try dealing with the FDA sometime. Drugs that used to be made here are moved to overseas plants so they can produce without the FDA’s interference in every aspect, no matter how mundane, just because THEY CAN. ((NO, YOU MUST HAVE A BLUE DOOR, NOT A WHITE DOOR, ON THAT ROOM.)) You think I’m kidding? Just ask anyone who’s ever been involved in anything that the FDA has control over, and they’ll back me up on this. It is a cluster**** of the highest magnitude at that agency.
Drugs that are approved by every other major country’s regulatory boards sit waiting for years, even decades, for the FDA to get off their lazy, bureacratic backsides and get the approval through, while Americans DIE waiting. Or they’ll sit in approval limbo because someone on the FDA has a “moral opposition” to the drug. That is NOT their job - but they think it is.
I’ve watched programs showing food being commercially manufactured with my husband, an employee at a pharmaceutical company, and he’s shocked beyond belief at the laxity food companies are allowed in their production as far as control and cleanliness go. The CLEANEST of food companies is a pigsty compared to a pharmaceutical manufacturing company.
Companies take manufacture of drugs overseas because the environment here in the U.S. has made it nearly impossible for them to produce it here. Certainly, there’s a cost savings, but when something like this tainting happens, any cost savings they had prior to the event fly out the window in the face of the lawsuits they’ll eventually face. They’d rather produce here… but the FDA has driven them out, and look at what we’re reaping in return.
HECK NO I don’t want my drugs, food, or anything else made in China. I lost a cat to the melamine tainting a little over a year ago. But we are driving our manufacturers to these extremes with our unreasonable cost and regulatory demands. Before you blame the companies, take a look at why they went there in the first place.