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Heparin Probe Bogged Down By Politics

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US regulators are no closer to figuring out how a counterfeit ingredient got into tainted heparin that has killed at least 81 people in the US, and sickened scores more here and in Germany. That’s because officials in China – where heparin ingredients were sourced – have not fully cooperated with the Food & Drug Administration (FDA) investigation. Yet, the FDA won’t get tough on China, and still allows heparin ingredients to be imported to the US from that country. Instead, Health & Human Services Secretary Michael Leavitt – whose depatment includes the FDA – recently insisted heparin sourced from China is now safe. How Leavitt can be so confident in the face of Chinese obstruction is astonishing.

In January Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactionsafter being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. Recently, researchers in the US were able to show that the chondroitin sulfate could produce reactions like those seen in patients in lab animals.

That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. While China is the main suspect in the heparin contamination, the FDA has no idea where the chondroitin sulfate entered the supply chain. What is known is that Changzhou obtained the pig-derived raw ingredients for heparin from two unregulated workshops. While the FDA has been allowed to inspect Changzhou – something the agency had never done prior to the heparin problems – the Chinese won’t give the agency access to any of the workshops that make raw heparin ingredients. The Chinese are also denying that the chondroitin sulfate had anything to do with the reactions and deaths seen in US patients.

Amazingly, the FDA is being incredibly passive towards the Chinese. For instance, the FDA has denied Congressional investigators access to a list of firms in China that supply heparin ingredients that was requested almost ten days ago. The FDA is citing privacy agreements as its reason for the refusal. The FDA is also going along with China’s refusal to open up the entire heparin supply chain for inspection. While it has barred Changzhou from importing products to the US, other manufacturers are still sending heparin ingredients to the US.

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