Heparin contamination: motivated by greed

By Michael Fraase

Saturday, 03 May 2008 04:47PM CST

Section: ESRD

HeparinUS Food and Drug Administration (FDA) employees have told a US House of Representatives subcommittee they believe the contaminant found in heparin that has caused 81 deaths was added deliberately. Heparin is a blood thinner used during dialysis treatments for end-stage renal disease patients.

Gardiner Harris, writing for the New York Times reports, “‘F.D.A.‘s working hypothesis is that this was intentional contamination, but this is not yet proven,’ Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday [29 April 2008].”

Woodcock explained to the subcommittee that some of the batches of heparin tested by the FDA contained fully one-third contaminants and suggesting that could have been an accident “strains one’s credulity.”

David Strunce, the chief executive of Scientific Protein Laboratories LLC, the company that supplied the contaminated material to Baxter International which manufactured and distributed the heparin also addressed the subcommittee. Strunce stated that he and his Chinese subsidiary, Changzhou SPL Company Ltd., were “deeply distressed by what appears to have been the intentional introduction of a synthetic contaminant into the crude heparin supply in China.”

Strunce testified that heparin is produced from tissue from the small intestines of pigs. In the US, his company buys raw source material from slaughterhouses and facilities in the US and Canada. The company also uses source material from China. In China, pigs are processed at government-regulated slaughterhouses which provide the intestines to workshops which actually produce the crude heparin. The company then further refines the crude heparin for medical use. Strunce claimed that Chinese crude heparin is used because “the global medical demand for heparin products has increased dramatically over the last decade, and there is an insufficient supply of pigs in North America to satisfy that demand.”

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