Another drug contamination has been reported in the news lately. This time it's Heparin, a blood thinning drug that is used to prevent clots from forming in renal dialysis machines, administered during open-heart surgery, or to treat deep vein thrombosis.
Here's an interesting (and heavily truncated) article from the Wall Street Journal.
The Heparin Trail:
China 's Role In Supply Of Drug Is Under Fire
By GORDON FAIRCLOUGH and THOMAS M. BURTON
February 21, 2008; Page A1
The activity at Yuan Intestine & Casing Factory is the first step in the poorly regulated process of making raw heparin, the main ingredient in a type of blood-thinning medicine that in recent days has come under suspicion in the deaths of four Americans.
More than half the world
(For a fascinating slide show: http://online.wsj.com/article/SB120352438415380201.html)
Heparin goes through extensive processing in its journey from abattoir to IV bag. Nevertheless, because some of it originates in tiny Chinese factories like these, if there
The lack of a well-documented supply chain for medicines such as heparin is a problem that has come under the spotlight with last week
The growing concern over heparin
Heparin goes through numerous, intensive purification steps before reaching medicine cabinets. However, some doctors and industry executives say it's still essential that even raw materials be consistent, clean and traceable so that if a problem arises it can quickly be contained.
Heparin makers in
'Basically, it goes overseas. It's for foreigners,' he says.
Selling to Middlemen
Like many small producers, Mr. Yuan sells his output to middlemen, making it tough to know where in the world it eventually ends up.
In contrast with the FDA
The raw heparin made by
An ideal system for tracing heparin back to the barnyard would involve tagging individual pigs, then keeping files detailing each animal
A spokesman for the Chinese government
That leaves makers of raw heparin with no regular government supervision, many manufacturers say.
Heparin itself is a molecule related to sugar that
Some drug makers say it
Many Chinese heparin manufacturers say this is a very difficult standard to meet in
His firm uses pig intestines only from slaughterhouses owned by its parent company, he says, so it can keep accurate records.
Mr. Yuan, the owner of the heparin and sausage-casing factory in the
Mr. Yuan himself never graduated from high school because his family was too poor to pay for school.
He launched the original business in the mid-1980s making sausage casings from intestines. Later he added heparin production.
Every day, his company collects barrels of pig intestines from slaughterhouses in the region. 'They give us a commodity. I give them money. We don
In his factory, men in thick aprons untangle intestines at a bench, flush them with water and pass them through a wringer. The resulting slurry is dumped into concrete vats, where it gets heated. Because coal is expensive, the factory sometimes burns rubbish -- old shoes and clothing -- to heat the slurry.
The slurry is later mixed with a resin that adheres to heparin. That mix passes through several more steps. Toward the end of the process the raw heparin is stored in old-fashioned, Chinese-style ceramic pots on the floor.
Mr. Yuan produces about six kilograms of the stuff a month, which he sells to middlemen. Recently it has been selling for 6,500 yuan, or about $900, a kilogram.
Not all factories are so primitive. Mr. Wang, the owner of the
Ellen Zhu in Yuanlou, China, and Anna Wilde Mathews in
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