China Gets Serious About Heparin Contamination
China’s State Food and Drug Administration has issued a directive to the makers of heparin and heparin-related products to purchase supplies from only registered suppliers and to strengthen quality control standards. The safety of the raw ingredients has come under fire lately, prompting many recalls around the world, including the United States.
The initial response of the Chinese government was that it is the responsibility of the receiving country, not China’s, to make sure the heparin being shipped was safe.
Tainted heparin has led to hundreds of allergic reactions and no less than 19 deaths in the US alone. The US Food and Drug Administration (FDA) has identified oversulfated chondroitin sulfate in the recalled products although it is not an ingredient used to make heparin. Instead, it looks like the active ingredient in heparin under chemical analysis but it does not produce the anti-blood-clotting effect for which heparin is prescribed. There have been no conclusions drawn as to whether or not the oversulfated chondroitin sulfate did, in fact, cause the allergic reactions and the deaths but it is a contaminant in the product nevertheless.
Baxter International, the Wisconsin-based maker of the recently recalled heparin, gets its raw ingredients from another US-based company, Scientific Protein Laboratories (SPL). SPL, in turn, imports the ingredients from its factory in China, Changzhou SPL.
Changzhou SPL buys its raw ingredients from a system of consolidators who buy the ingredients from thousands of small, unregulated, producers, which are often family-operated, home-based businesses. Tests conducted by SPL indicate the contaminant was in the crude heparin before it was sold to the Changzhou factory.
The active ingredient in heparin is made from pig intestines which are dried in homes and small factories before sending it further along the supply line. China is the world’s largest supplier of this ingredient.
Most of the shops that produce the crude heparin are not licensed or regulated by the State Food and Drug Administration. The Chinese government considers them chemical companies, not drug makers, and therefore not subject to meeting the standards for making drugs in China. The current directive from the agency, strengthened by a similar announcement from the Chinese Ministry of Commerce, calls for the development of a system capable of tracking the raw ingredients from the initial workshop all the way up the supply line to the factory.
Meanwhile, the heparin recalls continue. On Friday, B. Braun Medical recalled 23 lots of heparin infusion bags that contained heparin that could be traced back to the Changzhou factory. The infusion bags are used when a hospitalized patient needs the drug for an extended period of time. No reports of ill effects have been reported but one lot of the bags tested positive for the contaminant.
Source: New York Times
- Has the recent “heparin scandal” affected the way you buy products from China?
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There needs to be a law that labels every drugs ingredients to a country of first origin and beyond. We need it now not next year.
We shouldn’t import anything from China. This has been a bad idea from the beginning… Thanks Clinton…
Wouldn’t it be VERY easy for terrorist to contaminate a huge number of drugs coming into the USA?
Screw Chinese Products
How many consumers will have to die before people stop buying Chinese made products.
The big companys are only interested in profit,first it was lost jobs to the cheap labor produced products.
Now it is death to the people who buy these cheap Chinese made products.
How many people have to die of be maimed before we the people stop the companys in there tracks buy putting them out of business by not purchasing there MADE IN CHINA junk.
Remember ? Cell phone batteries that explode !
Remember ? Children who swallow magnets !
Remember ? Anti Freeze in toothpaste
Remember ? Dead pets from tainted dog food!
Remember ? Fake test strips for Diabetic patients
This list could as you well go on forever.
I agree with what you guys said……We have no strict regulators here ,even “the State Food and Drug Administration”in china is something an empty vase…….
However U.S has to import almost everything from china ……..cause it’s the most economical way,even has
virous observation fees add on…….
I’m a chinese ,forgot to say
The prospect of drugs produced from Chinese-made unregulated ingredients is a frightening thought. What other drugs will cause bad reactions or deaths? We have no assurances that Chinese regulate their industries with the same scrutiny that the West uses. Wasn’t the toy scare and tainted pet food bad enough?
If China wants to be a world player, then she should play by the world’s rules which include thoroughly checking out anything substances used for human consumption.
Importing has become the number one loophole to eliminate U.S. regulations and laws. It is the preferred way to eliminate or reduce corporate liability. The number one way to increase profits. The number one way to export democracy, religion, and western power. The number one way for presidents to set up plush travel plans to exotic places and eat first-class meals and make power deals and become famous.
There are certain similarities between the market practices of China and America. Both can be extremely clever, and creative. Intellectually brilliant, and just as emotionally immature. The infection of greed provides an attraction between the people of China, and the CEO’s of industry that is nearly impossible to resist.
While China does indeed produce the most economical products, there is no guanatee that the goods will be in demand when the clientel has been dispatched with poison. The rest will shop elsewhere. Even if it cost’s a little more. As different as our cultures may be it is apparent that neither are slaves to ethics.
Actually China imports to the US and have risen dramatically under the Bush Administration. Say no to imported goods from China and charge American CEO’s with treason.
Heparin Contamination happened in Germany, Japan, China…,Baxter needs to strengthen their supervision.
If 40,000+ American dogs (including ours) murdered by Chinese dog food poisoning doesn’t get our attention, will it take 40,000 humans (from some innocuous ingredient that all of us consume) before we take this issue seriously? What is an acceptable “loss” for our government, our corporations, or our families?
The entire supply chain from raw ingrediant creation to finished goods point-of-sale needs to be inspected and tested, regardless of origin. Mandatory federal prison terms for corporate executives who use tainted ingredients in their food and drug products would certainly improve corporate QA/QC programs. The US Government’s job (among other things) is to provide for the common defence and promote the general Welfare of its people and, therefore, needs to step up immediately and do their job regarding food and drug safety of all imported items and components that we consume.
Keep buying China’s products America, you are slowly becoming the slaves you desirve to be. China is not the problem, the United States Government is the problem. Ignorance is the problem. Keep sending your kids to public school and vote for your favorite government approved candidate.
Walmart is an Americna company. The dollars went to Americans! What are you trying to blame? Why are you so good at blaming your own problems on others?
clintons + china - perfect together
The problem is that we want cheap things and businesses want to make money. In order to do this, the labor must be cheap, therefore the companies outsource to places like China.
This is capitalism at work. With competition, now it is the cheaper product that is desirable. It is not to say that capitalism is bad, just that it is currently flawed. If we want to regulate everything, then these products would have to be manufacture in the US. But that is where the problem lies, people are not willing to work for such low wages, and it is illegal to charge such low wages, thus if it was made in the US, then it would be much more expensive, and no one would buy it.
Looking at the wage differences, a worker in China would only be paid about $0.20-0.60 an hour, compare that to the minimum wage in the US of $6.55 an hour, that is 16 times the average wage in China. Now think about that translated into the goods manufactured. For example, we buy a pair of pants for about $25, the cost is about 1-2 hours of pay, and materials, which for a very liberal estimate of about $5, most likely even less than that. Which makes the profit $20 per pair. Now think about how much it would cost if it was manufactured in the US. 2 hours worth of pay is 2×6.55 = 13.1, and materials cost of about $4 yields $17.10 just to make the pair of pants. Now the companies still want to make the same amount of profit, so factor in the $20 profit per pair and it costs the consumer $37.10 for the same pair that they would have gotten for $25, a difference of $12.10, more than a 48% increase in price, which the consumer is not willing to pay. That is why foriegn countries such as China are getting all the manufcaturing type jobs. We are not willing to pay more for the things that we buy, and I doubt that will ever change. And compies will never stop trying to make as much money as possible, therefore as things are now, nothing will change, even wtih all these things making news headlines.
Americans love to cry foul but none of them have the moral integrity to boycott those goods that they rail against. Sorry bloated ones, but you can’t have it both ways. I love to watch morbidly obese Americans use courtesy electric carts to slowly drive down the junk food aisles in Wal Mart and other stores while they fill their baskets with chips and similar nonsense. Only in this milksop nation can a 600 person that eats 20,000 calories a day get pity by describing themselves as “handicapped.” A nation without discipline or a work ethic deserves to eventually be ruled by others. Street beggars make as much as three hundred dollars a day in this country, pay no taxes, get free health from moronic hand wringing liberals as well as free food, clothing, shelter. Millions of able bodied men roam US streets and simply refuse to work, knowing that naive people and their government will cater and pander to them. America you have lost your frontier spirit and discipline and now your dollar is depreciating against laughable currencies around the world. In less than a hundred years every American will be working for a Chinese boss so get ready to work for a change.
Boycott anything from China until they return Tibet to its rightful people.
Keep condoning their behavior by buying their cheap poisonous products that enslave children and steal bread off the American workers table.
We invade and occupy Iraq in the name of freedom and democracy, yet we turn a cheek to the injustice and genocide of the Tibetan people.
This is the evil, the greed, and the scourge of power that will inevitably destroy America.
Our fore fathers are spinning in their graves…
I ‘d loved to buy north american made products, especially cars, if the Big Three fire all current engineers and hires people who can think outside of the box, who can produce cars with that japanese/european looks and reliability. They copied us and made better products, it’s about time to copy them. For everyone who buys $0.99 stuff and cheap imports, you only have yourselves to blame. It’s like shooting yourself in the foot. Short term gain, long term pain.
People who scream ‘Boycott chinese products” should throw their computers away right now because hello? The computer you’re using to browse right now have half of its parts made in China.
Junks from China? From my MacBook, iPod, to my Wilson rackets, almost everything I use and purchase, and yes, that includes organic produces, is made in China. Just imagine how convenient it will be if you set out to boycott all Made-in-China products! It’s inevitable for something tragic/unpleasant to happen, and China is trying very hard to be responsible, and is catching up fast. Remember they actually executed their top food and drug official last year for bribing and failing to keep some of the medicines safe.
And China is paying a heavy environmental price as well — the World Factory is polluting China’s air, water, soil, and more. In the long run, I am not even sure it is good for China.
Yeah! Let’s boycott everything from America until the “Indians” regain their land that was ruthlessly taken away from them in the name of what? Freedom? Look in the mirror before mouthing off. Capitalism is at work here. Americans are benefiting with low cost goods. American companies are making the profits taking the greater share of the pie. Sue the US companies that forsake safety over greed. In the meantime, do not buy shoddy products from China or anywhere else. Let the mighty dollar speak (although, nowadays, with the financial meltdown, it is only a whimper). China or any manufacture has to learn that quality rules in capitalism. They are new at this game. You can cry all you want but best to speak with your dollar and not your false sense of misplaced arrogance.
China is a nation with a rogue government which thinks itself beyond reproach. They subjugate their people with an oppression cruel beyond measure and would treat the rest of the world with the same impunity. We who accept this treatment in silence or condone their sovereign right to impose forced annexation, denial of human rights, lack of quality control and safety measures — not to mention a brutal military which murders it’s own citizens in the name of that government; deserve exactly what we are getting: poisoned medicine, deadly children’s toys, and a reputation for accepting anything as long as it profits someone in our extended chain of money grubbing middle men. Shame on us.
Heparin does not produce a blood clotting effect. It is an anticoagulant. It prevents blood clots.
You can thank bush for all the chinese crap. HE gave them most favored trading status, illegally, and now they have no accountability. They can poison us with impunity and we’ll never even know if they punish them or give them a bonus for killing our dogs, and poisoning our medicines and toys.
so much china bashing going on. the fact is that it really should be the consuming companies doing their own fact checking. not only that but china’s able to conclusively trace the bad batch to a singular factory. remember what happened here with our contaminated foods these past few years? not quite so specific. not only that, china’s willing to put in place a system for tracing all of its ingredients. that’s more than I can say for us. all of this shit about poor quality chinese products is solely the fault of you we dimwits and the us companies we’re retailed goods through. not china’s. get fucking real.
[...] people died after developing a severe allergic reaction to the blood thinner heparin. The resulting investigation found that Chinese suppliers added a cheap, dangerous compound to the raw ingredient. The Chinese [...]