China, U.S. spar over heparin

WASHINGTON -- For the Chinese, seeing is believing.

For now, they are rejecting U.S. findings that a contaminant in the blood thinner heparin was introduced in China and is linked to severe allergic reactions that caused up to 81 deaths.

They're seeking heparin samples from Baxter International's Cherry Hill, N.J., plant as part of their own investigation into the heparin problems.

"When you see it, then you believe it," said Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China.

U.S. federal health officials have run their own tests on the suspect heparin and found what they say is a solid link between the contaminant and the allergic reactions that have been reported.

China said the contaminant could not be the "root cause" of the problem.

Raw heparin is derived from pig intestines, often processed by small, unregistered workshops in China. The raw ingredient for Deerfield-based Baxter's recalled heparin came from Wisconsin-based Scientific Protein Laboratories, which in turn owns a Chinese factory -- Changzhou SPL -- and buys additional raw heparin from other Chinese suppliers.

The Food and Drug Administration warned Changzhou SPL on Monday that the company does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed.

The FDA noted that as many as 12 companies in China are involved in the supply chain for heparin. Agency officials don't know at what point the contaminant was introduced.

Hundreds of patients have suffered severe allergic reactions to large doses of the blood thinner. The FDA said it suspects the problems stem from a compound derived from animal cartilage that so closely mimics heparin that routine purity tests can't detect it.