The head of the U.S. Food and Drug Administration (FDA), Andrew von Eschenbach, said that he believes that the raw heparin supply to the United States may have been tainted due to economic fraud. The FDA has attributed 62 deaths to allergic reactions from raw heparin obtained from China.

FDA comments

Eschenbach told an Senate Appropriations Committee’s agricultural subcommittee that he believes the contaminated heparin supply to the United States contained oversulfated chondrotin sulfate, an altered version of chondrotin sulfate made from animal cartilage often found in dietary supplements. He claims that economic fraud may have been involved as the altered version is similar to the active ingredient in heparin, but less expensive to produce. The raw ingredient in heparin is derived from pig intestines.

Who’s to blame?

That question is still being considered. Many of the large heparin suppliers such as Baxter Healthcare, B. Braun Medical and Covidien obtain their raw heparin from Scientific Protein Labs (SLP) – a Wisconsin based company with plants in China. However, that company doesn’t seem to be involved in the fraud. Rather, fingers seem to point to the suppliers of the raw heparin in China – those involved even before it reaches the Chinese factories owned by SLP.

Uncertainty remains

Even with this new information, the FDA says that it still isn’t absolutely certain whether the contaminated heparin is directly responsible for the increase in deaths over the product, a prescription injectable blood thinner used in cardiac procedures. Eschenbach told the committee that the FDA inspects some of the Chinese factories, but rarely does a second inspection. He said that he hopes to open up additional FDA offices in China by October 2008, as well as offices in other parts of the world that provide the United States with food and drugs to correct that problem.

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