Heparin Problems Not Our Fault, Chinese Official SaysApr 21, 2008 | Parker Waichman LLP
A counterfeit ingredient found in batches of recalled heparin is not to blame for the deaths and reactions seen in U.S. patients treated with the drug, a Chinese government official claimed today. 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 International originated in the U.S. and said regulators from China will soon arrive here to inspect the New Jersey plant that finishes processing Baxter heparin.
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. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 62 to be exact - were associated with contaminated batches of heparin.
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. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. 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.”
However, the Chinese are disputing that the chondroitin sulfate has anything to do with the heparin injuries seen in the US. Shaohong said that Chinese investigators tested batches of heparin used by patients who reported health problems, and only some contained chondroitin sulfate. "The oversulfated chondroitin can therefore not be the suspected root cause of heparin ADE (adverse events)," he told reporters at a news conference this morning.
Shaohong also said Chinese officials are focusing on the whole product and planned to visit Baxter's plant in New Jersey later on Monday. "They will cooperate with us, no problem," he told reporters. Shaohong speculated that other contaminants, problems with the device used to inject the heparin, or health factors with the patients who used the drug could also be causing the reactions.
Despite Shaohong's insistence that Chinese manufacturing is blameless in the heparin debacle, counterfeit ingredients have caused problems with Chinese imports in the past. The news of heparin contamination came almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.
China has also made efforts to crack down on heparin producers since it became apparent that something had gone wrong with the drug. According to a report in The Wall Street Journal, the Chinese State Food and Drug Administration issued an order in a notice seen on its Web site that requires heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers, meanwhile, are required to improve their management and tests on their products, it said. This was a reversal of the Chinese government’s earlier position, as the agency had earlier insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.