Web Date: April 30, 2008
Tainted Heparin Called "A Deliberate Scheme"
Baxter International's recalled blood-thinner heparin appears to have been intentionally contaminated with a similar, but cheaper, chemical, the company's top executive told a congressional panel Tuesday. The admission follows the FDA reports of a link between the oversulfated chondroitin contaminant and severe allergic reactions in humans (C&EN, April 28, page 14).
"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 and that people have suffered as a result," Baxter Chairman Robert L. Parkinson Jr. said in testimony before the House Energy & Commerce Subcommittee on Oversight & Investigations.
"We deeply regret that this has happened, and I feel a strong sense of personal responsibility for these circumstances," he remarked. Baxter, which supplied about half the U.S. heparin market, recalled the drug in February.
David G. Strunce, chief executive of Scientific Protein Laboratories (SPL), also said the contamination appeared deliberate. SPL owns a majority stake in the Chinese plant that makes the active ingredient used in Baxter's heparin. "It seems to us that it's an intentional act," he told the panel.
But Rep. Bart Stupak (D-Mich.), subcommittee chairman, said it is unclear whether contamination with the cheaper chemical was intentional or accidental. He stressed, however, that both companies had a responsibility to ensure that their products were safe. "Baxter and SPL have failed the American public," he said.
Heparin is widely used during kidney dialysis and surgery to prevent blood clots. FDA officials say tests show the chemical could have caused the type of allergic reactions reported in connection with 81 deaths since January 2007, where patients were treated with some brand of heparin.
Strunce said contamination of the crude heparin supply in China appears to be widespread, and it is affecting many manufacturers. Tainted heparin has been detected in 11 countries, according to FDA.
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