By Shan Juan (China Daily)
Updated: 2008-05-07 07:25

US pharmaceutical producer Baxter failed to cooperate with Chinese experts during a field investigation of its heparin product, which is alleged to have been linked to the deaths of 81 people in the United States, a Chinese official said on Tuesday.

"We express deep regret for that," Jin Shaohong, deputy director of the China National Institute for the Control of Pharmaceutical and Biological Products, said.

"Requests to test samples of the problem drug have been denied and we don't understand why," he said.

Based on the information currently available, the deaths in the US were not directly linked to the heparin-like substance hypersulfated chondroitin sulfate, he said.

The US had earlier said the deaths were caused by the hypersulfated chondroitin sulfate contained in the heparin imported from Chinese company Kaipu, based in Changzhou, Jiangsu province.

But two other US drug companies that used the Chinese-made heparin reported no ill effects, Jin said.

"Every single stage of the drug production process - from manufacturing to delivery and use - can contribute to ill effects," he said.

Baxter Healthcare Corp, which is based in New Jersey, said late last month that Kaipu had deliberately used hypersulfated chondroitin sulfate in its heparin to lower production costs.

At a meeting of the US Food and Drug Administration (FDA), American researchers said the deaths may have been linked to people taking high doses of heparin.

Also, Yan Jiangying, the spokeswoman for China's State Food and Drug Administration, said Kaipu had been contracted by its parent company Scientific Protein Laboratories (SPL) of Waunakee, Wisconsin, US, to supply Baxter with the heparin containing hypersulfated chondroitin sulfate.

Kaipu, however, is a chemical producer, not a drug-maker, she said.

"It is not registered with the SFDA, so its products are subject to quality checks only by itself and SPL," Yan said.

Kaipu was approved by the FDA in 2004 to supply heparin as an active ingredient to US drug makers, according to the administration's website.

"We were not notified of that at that time," Yan said.

"So thereafter, the US was responsible for quality control and inspection.

"But out of concern for people's lives, we are willing to collaborate with the US side to look into the case," she said.