Originally published Wednesday, April 30, 2008 at 12:00 AM
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Print viewFDA: Drug tainted deliberately
Federal drug regulators think a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something...
WASHINGTON — Federal drug regulators think a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration (FDA) has only hinted at previously.
"FDA'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 a House subcommittee in written testimony.
One-third of the material in some batches of the thinner heparin was contaminants, "and it does strain one's credulity to suggest that might have been done accidentally," Woodcock said.
Two weeks ago, Food and Drug Commissioner Andrew von Eschenbach told a Senate subcommittee that the contamination was done "by virtue of economic fraud," but he quickly withdrew the remark.
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