Heparin contamination looks deliberate
Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was deliberately added.It appears someone was trying to make money off a contaminated drug by cutting a key ingredient and substituting a cheaper contaminate. This is looking more like some other cases of Chinese drug manufactures acting dishonestly. The last time this happen the Chinese official responsible for it got the death penalty. I would not be surprised to see the same thing happen again.
“F.D.A.’s working hypothesis is that this was intentional contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the agency’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony on Tuesday.
Some heparin batches made by Baxter International consisted of more than 30 percent of the contaminant, “and it does strain one’s credulity to suggest that might have been done accidentally,” Dr. Woodcock said.
David G. Strunce, chief executive of Scientific Protein Laboratories, the company that supplied the contaminated heparin material to Baxter, described the contamination as “an insidious act” that “seems to us an intentional act upstream in the supply chain.”
Robert L. Parkinson, Baxter’s chairman and chief executive, 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.”
... Baxter bought contaminated heparin ingredients from Changzhou SPL from 2004 through 2008 but did not inspect the facility itself until September 2007.
The company sent one person who spent one day in the plant, Mr. Nelson said. Five months later, the F.D.A. discovered myriad problems, he said.
“It really is impossible for a plant to have fallen that far out of compliance in five months,” Mr. Nelson said.
Mr. Nelson told the panel that the contaminant, known as oversulfated chondroitin sulfate, cost roughly $20 per kilogram versus $2,000 per kilogram for real heparin.