Considering that tainted heparin sourced from China has killed at least 81 people in the US, the Food & Drug Administration (FDA) should be taking a tough stance towards that country as it investigates the incidents. Yet, US regulators are no closer to finding out how heparin became contaminated with a counterfeit ingredient than they were months ago because the pobe is being bogged down by politics.
American’s first learned of the problems with heparin in January, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after 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.
That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Recently, researchers in the US were able to show that the chondroitin sulfate could produce reactions like those seen in patients in lab animals. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”
While China is the main suspect in the heparin contamination, the FDA has no idea where the chondroitin sulfate entered the supply chain. That’s because, while the FDA has been allowed to inspect Changzhou, the Chinese won’t give the agency access to any of the workshops that made raw heparin ingredients for the facility. The Chinese also won’t let the FDA look at records pertaining to heparin manufacturing and the procurement of ingredients, and the agency has also been barred from interviewing workers in heparin manufacturing.
In spite of its obstructive attitude, the FDA seems more interested in placating the China than getting to the bottom of the heparin mystery. For instance, citing privacy agreements, 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 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. That has some lawmakers upset. Earlier this week, Rep. Bart Stupak (D-Mich.) told The Wall Street Journal that the FDA needs to be tougher on China. “If I was the FDA director, I’d shut down every drug coming in from China” until they were deemed safe, he said.
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