Tainted Heparin Never Investigated by Chinese AuthoritiesJul 22, 2010 | Parker Waichman LLP
A congressional probe has found that Chinese authorities never bothered to investigate tainted heparin ingredients manufactured in that country, even after officials from the US Food & Drug Administration (FDA) repeatedly asked them to do so. Between 2007 and 2008, tainted heparin, which was made with a raw ingredient manufactured in China, was linked to 81 deaths and hundreds of illnesses in the US.
According to The Wall Street Journal, Reps. Joe Barton and Michael Burgess, both of Texas, say FDA officials old them that the agency’s investigation into the faulty heparin has been “severely hampered” by the lack of cooperation from China in finding those responsible.
In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China. The congressmen also said Chinese security authorities told a US official in Beijing that China wasn’t investigating the heparin issue as either a criminal or administrative matter.
“It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Barton, the top Republican on the House Energy and Commerce Committee, said.
The criticism comes just as FDA Commissioner Margaret Hamburg prepares for her first trip to China. According to the Journal, Barton called on her to raise the issue with Chinese officials.
In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactions, after being administered the products. There were similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
In March 2008, 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.
Changzhou used two consolidators to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
The FDA investigation has never identified the culprits in the contamination, with the agency maintaining that there were too many sources to trace.