Heparin contamination was fraud, FDA finally admits

The US Food and Drug Administration, after two months of confusion over contaminated batches of the blood thinner heparin (Marketletters passim), has told the Senate Appropriations Committee's Agriculture Subcommittee that it believes foul play was involved. The contaminant, chondroitin sulfate, was prepared in a manner that would make it harder to detect, suggesting a deliberate attempt to swindle drug companies, including the first US firm to withdraw suspect batches, Baxter International (Marketletter March 31).

"It was apparently done, we suspect, by virtue of economic fraud," the FDA's Commissioner, Andrew von Eschenbach, said. Baxter recalled some of its heparin products in February following reports of hundreds of allergic reactions. Question marks are raised over the effectiveness of quality control: Baxter and the FDA said they were "unable" to carry out inspections on the raw material producers of heparin, who extract a mucus from pig intestines. Chondroitin sulfate, a dietary supplement which is used for pain relief and derived from animal cartilage, costs about 5% of the correct ingredient.