Heparin Contaminated on Purpose, Congress ToldApr 30, 2008 | Parker Waichman LLP
Tainted heparin that has killed 81 people in the U.S. may have been intentionally contaminated, witnesses appearing before a congressional committee said yesterday. In written testimony, a Food & Drug Administration (FDA) official told lawmakers that it "does strain one’s credulity" to think that the heparin contamination was accidental. The head of Baxter International, the company that issued a massive recall of heparin earlier this year, said that he was also of the belief that the heparin contamination was deliberate.
In March, the FDA confirmed that it had found a counterfeit ingredient, oversulfated chondroitin sulfate, in samples of the active ingredient used in Baxter heparin. The chemical had been molecularly changed to mimic heparin's blood thinning properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Since then, companies in several other countries have issued heparin recalls, and a cluster of heparin reactions has been reported in Germany. In the US, some other manufacturers have issued precautionary recalls.
Due to a computer error, the FDA never inspected the Changzhou plant as is required by law. When heparin problems finally prompted the agency to conduct an inspection, it found a multitude of problems. The FDA has since issued Changzhou a warning letter, and it has been barred from exporting to the US until corrections are made.
The FDA has not determined when the chondroitin sulfate entered the heparin supply chain, but suspicion rests on China. 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. Earlier this month FDA Commissioner Andrew von Eschenbach has 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.” The reason for the counterfeiting may have been economic. According to The New York Times, a Congressional investigator said oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.
Yesterday, Dr. Janet Woodcock, director of the FDA’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony that a third of the ingredient found in some batches of heparin contained contaminant. She said the agency was working on the hypothesis that the contamination was intentional, although that has yet to be proven.
Robert L. Parkinson, Baxter’s chairman and chief executive, concurred with Dr. Woodcock. He told the committee, “We’re alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a life-saving medication.”
Lawmakers also heard from the family members of patients who died after being administered tainted heparin. LeRoy Hubley of Toledo, Ohio, described how both his 65-year-old wife and his 47-year-old son died within a few weeks of each other. Both suffered from a genetic kidney disease that required constant dialysis, for which heparin is routinely used. “As Christmas music softly played in the background, we each said our goodbyes,” Hubley said, breaking down in tears. “Then my wife and love of 48 years drifted away.” Hubley said it was weeks before he found out that either death was due to contaminated heparin.
Last week, the FDA said it had evidence that the chondroitin sulfate did, in fact, cause the reactions and deaths. However, the Chinese are disputing this, and say the heparin problems could have originated in the US. David G. Strunce, chief executive of Scientific Protein Laboratories, said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.