Thursday, March 13, 2008
FDA investigators are trying to trace where the raw material for the blood thinner heparin leads. Heparin which is made from pig intestines is contaminated and an unyielding maze of slaughterhouses awaits the unknown American investigator.The president of the American company Scientific Protein Laboratories that owns a majority of the unregulated Chinese company claims that the collection chain for pig intestine suppliers is in place inspectors in China and the United States are not so sure.A pig disease swept over China depleting its stock of pigs. Some farmers sold their sick pigs for heparin production nevertheless. With no regulations and no rules including sanitation there is no foresight into the small village operations.The number of reports of heparin adverse reactions continues to rise and has surpassed 400. So far the authorities have not discovered the problem with the heparin supply chain and no firm findings have been announced.The heparin recall has directed focus on the quality of products from China and the gaps in regulation by both the Chinese and United States governments. Scientific Protein Laboratories’ plant in Changzhou was certified by American officials to export to the United States even though neither the Chinese government nor the American government ever inspected it since 2004.This company is not alone as many companies have fallen between the cracks because it is known as a producer of chemical ingredients not a drug manufacturer.The process of making heparin starts with the intestines of slaughtered pigs, from which the mucous membrane is collected and cooked, eventually producing a dry substance known as crude heparin.Major heparin producers like Scientific Protein Laboratories take that substance, refine it, and sell it to big pharmaceutical companies who make the final product, which is widely used in dialysis and CABG.Most of China’s crude heparin comes from small factories in poor villages where houses double as heparin mining. Working conditions are taxing, dilapidated, and a crap shoot.Source: http://www.nytimes.com/2008/02/28/world/asia/28drug.html?ref=us
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