Healthy Skepticism Library item: 13536

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Publication type: news

FDA sees possible fraud behind tainted heparin
Reuters 2008 Apr 15
http://www.reutershealth.com/archive/2008/04/15/eline/links/20080415elin015.html

Full text:

The contamination of Baxter International Inc’s recalled blood thinner heparin likely was done for economic reasons, the head of the U.S. Food and Drug Administration said on Tuesday.

“It was apparently, we suspect, done by virtue of economic fraud,” FDA Commissioner Andrew von Eschenbach told a Senate hearing.

Baxter recalled most of its heparin products in February after reports of allergic reactions and deaths. An FDA investigation later uncovered a heparin-like substance in some batches of the drug’s active ingredient, which is made in China.

The contaminant was identified last month as a modified form of chondroitin sulfate, a chemical FDA officials have said is likely cheaper to make than real heparin, which is derived from pig intestines.

Speaking to reporters after the hearing, von Eschenbach said the altered chemical would not have occurred during any normal processing. While the agency has no specific evidence of fraud, “the concern is that it had to be by design,” he said.

Von Eschenbach added that the agency is not investigating motive, but would leave that to Chinese officials.

Representatives for Baxter could not be immediately reached for comment.