Update on the tainted heparin investigation:
The Milwaukee Journal Sentinel website has posted a report that gives an explanation for how the tainted heparin caused injury and deaths, and how it evaded detection:
Baxter International Inc.’s blood thinner heparin killed patients because a hard-to-detect contaminant produced toxins and triggered dangerously low blood pressure, researchers said. Two new reports show how the contaminant evaded detection with current screening approaches and caused a chemical cascade that ultimately led to the death of 81 patients. The contamination occurred within heparin’s long and complex chains of sugars, a defect that wouldn’t be found with tests that look for proteins, fats and genetic traces of outside substances. The raw ingredient for Baxter International’s recalled heparin came from Waunakee-based Scientific Protein Laboratories, which in turn owns a Chinese factory – Changzhou SPL – and buys additional raw heparin from other Chinese suppliers.
United States health officials have identified oversulfated chondroitin sulfate (OSCS) as the likely chemical culprit. Two scientific papers offer theories on the mechanism of the toxic changes. The FDA head has offered his speculation that the contaminated heparin was produced by economic fraud.
Meanwhile, it has been reported that the tainted Heparin reached 11 countries.
Despite Heparin manufacturer Baxter’s CEO’s declaration that not many heparin lawsuits are expected, these product liability cases would appear to have great merit. This is not an instance of a drug acting as expected, with certain known risks. This is a case of flaws in the manufacturing process. A drug that is released on the public with hidden dangers like this is defective and unreasonably dangerous. We’ll be following this story.