- The Washington Times - Wednesday, April 30, 2008

From combined dispatches

Baxter International Inc., a maker of the blood thinner heparin, and the supplier of its main ingredient told a House panel that the drug appears to have been deliberately contaminated.

The contaminant, linked to deaths and allergic reactions, was added before the ingredient reached the Chinese factory of Baxter’s supplier, Scientific Protein Laboratories of Waunakee, Wis., executives of the companies testified at a House hearing yesterday. The Food and Drug Administration suspects that the contamination was deliberate, although there isn’t proof, according to the agency.

Baxter recalled heparin, used to prevent blood clots, in January after reports of harmful side effects. Since January 2007, a total of 81 people have died after allergic reactions, the FDA said April 21. Tainted heparin made by other drug makers has been found in more than a dozen countries since Baxter’s recall, and regulators have said they don’t know how it was introduced.

“We’re alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a lifesaving medication,” Baxter Chief Executive Officer Robert Parkinson told the House Energy and Commerce Committee’s investigative subcommittee.

Some samples of Baxter’s heparin were found contaminated with a substance known as oversulfated chondroitin sulfate, according to the company and the FDA.

“It seems to us that it’s an intentional act upstream in the supply chain,” said David Strunce, the chief executive officer of Scientific Protein. “We don’t know specifically where.”

Baxter, based in Deerfield, Ill., sold about half of the U.S. supply of injectable heparin before the recall. APP Pharmaceuticals Inc., a Schaumburg, Ill., company whose products remain on the market, produced the other half. The FDA says the heparin currently on the market is safe.

Separately, five officials from a Chinese pharmaceutical company that sold a tainted antibiotic responsible for more than a dozen deaths have been sentenced to up to seven years in prison, a Chinese state newspaper reported yesterday.

The longest sentence of seven years was given to Zhu Chenghua by the Guangzhou Intermediate People’s Court for being “directly involved in this serious crime,” the Yangcheng Evening News said.

Zhu was vice chairman of the Qiqihar No. 2 Pharmaceutical Co. Ltd. Four other employees of the northeast China-based company were given jail terms of four to six years.

The court convicted the five of being responsible for the deaths of 13 patients because of a lack of safety precautions in the drug company’s inspection process, the newspaper said.

The victims developed acute kidney failure at a hospital in the southern city of Guangzhou after using the company’s Armillarisini A drug.

The official Xinhua news agency reported earlier this year that a 14th patient had died.


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