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Chinese officials have finally acknowledged that there is a contaminant in heparin produced in China, but it is not connected to the illnesses. Ning Chen, second secretary at the Chinese Embassy claims, “We don’t have a strong evidence to show that is heparin or its contaminant that caused the problem.” Mr. Chen asserts that since the adverse reactions and deaths only occurred in the United States, the problems originated here.


According to the director of the FDA’s drug center, Janet Woodcock, German officials have found adverse reactions in dialysis patients who took contaminated heparin.


Dr. Woodcock continues, “Heparin should not be contaminated, regardless of whether or not that contamination caused adverse events. We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”


And we all know, the best defense is a good offsense…Chinese officials are now insisting that the United States’ request for American inspections of Chinese company’s be a two way street and China be allowed to inspect US facilities.


In light of China’s history of exporting toys containing lead, tainted rice, poisonous toothpaste, toxic pet food, tainted fish and now contaminated drugs, you would think China would be bending over backwards to fix this latest debacle. And you would think in light of the FDA’s track record lately (Vioxx ghosted studies, Vytorin and Zetia) they would make it a priority to hold China to a minimum safety standard.


So, what does the FDA do? They send Changzhou SPL, the Chinese plant that supplied the contaminated heparin to Baxter International a warning letter. The letter warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities.  I’m sure that based on that warning letter, Changzhou SPL will never, ever, ever produce a contaminated product ever again.


China also claims that they can/will/have been testing heparin for contaminants. The FDA counterclaims China technology is not sensitive enough to detect the contaminant.


So, the blame game continues…



Up Next:  The Heparin Debacle Part Three –  The FDA Falls Flat

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