Precedent in Heparin Probe. Tainted heparin has killed at least 81 people in the US, and sickened scores more here and in Germany. Yet, the heparin investigation is being bogged down by politics, and as a result, US regulators are no closer to finding out how heparin became contaminated with a counterfeit ingredient than they were months ago.
It first became apparent in January that something was wrong with heparin supply 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 Food & Drug Administration (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
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 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.
For their part, the Chinese are denying that the chondroitin sulfate had anything to do with the reactions and deaths seen in US patients. The Chinese assert that since contaminated heparin has been found in 12 countries, and reactions have only been seen in the US and Germany, the chemical is not to blame. They claim the reactions have also been reported in people who received untainted heparin.
So what is the FDA doing to address China’s uncooperative attitude? It appears, not much. The agency seems more interested in placating the Chinese than getting to the bottom of the heparin mystery.
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. 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.
Instead, Health & Human Services Secretary Michael Leavitt is insisting that heparin sourced from China is now safe. He made that statement earlier this week, while he was visiting China. That Leavitt even made such assurances at a time when the Chinese have blocked the FDA’s heparin investigation is truly astonishing.