Heparin Mess Leads to US, China DisputeApr 22, 2008 | Parker Waichman LLP
Tainted heparin has officials from the U.S. and China at odds, with each blaming the other country's manufacturing for problems with the drug. U.S. regulators say they have now found a direct link between a contaminant found in heparin from China and severe, allergy-type reactions seen in some patients. The announcement by the Food & Drug Administration (FDA) contradicts assertions made by a Chinese official yesterday that adverse reactions to tainted heparin were not tied to a counterfeit ingredient found in some batches of the drug, and were not the fault of the Chinese manufacturer that supplied raw ingredients for heparin.
The FDA has linked tainted heparin with 81 deaths in the US, and hundreds of adverse reactions. Baxter International recalled nearly all its heparin injections in the U.S. 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. Last week, 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.”
According to The New York Times, the FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. The FDA has not determined the original source of all the contamination or the points in the supply chain at which it was added. The Times also said officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February.
Meanwhile, Baxter International confirmed that tests had shown that the chondroitin sulfate could cause illness, but disputed the FDA assertion that tainted heparin was associated with 81 deaths. Baxter's own numbers indicate only 5 deaths linked with heparin, and the company insists that the tainted drug may have only "contributed" to, rather than caused, the fatalities.
Yesterday, Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, insisted that problems with heparin sold by Baxter originated in the U.S. He also insisted that there was no proof the chondroitin sulfate was responsible for the problems. Shaohong told reporters at a news conference that the Chinese were planning to send inspectors to Baxter's New Jersey plant to see if the problems started there.
Another Chinese official, Ning Chen, second secretary at the Chinese Embassy, told The Times that, “We don’t have a strong evidence to show that it is heparin or its contaminant that caused the problem." Chen insisted that heparin reactions had only been seen in the US, indicating that neither the chondroitin sulfate or Chinese manufacturing was at fault.
But Dr. Janet Woodcock, director of the FDA's drug center, disputed Chen, pointing out that a cluster of heparin reactions had been reported in Germany, and that China had conceded that the drug involved in those reactions was contaminated. She also said the FDA was "fairly confident" that the chondroitin sulfate was capable of causing the adverse heparin reactions seen in the past year.