China Rejects Responsibility for Tainted Heparin

http://www.washingtonpost.com/wp-dyn/content/article/2008/04/21/AR2008042101085.html?hpid=sec-health
By Marc Kaufman
Washington Post Staff Writer
Monday, April 21, 2008; 2:41 PM

Chinese officials today rejected the Food and Drug Administration's conclusion that a synthetic compound from China found in tainted supplies of the blood thinner heparin was the likely cause of the hundreds of injuries and deaths associated with the drug.

In the Chinese government's first public statements on the controversy, Jin Shaohong, a top official with the Chinese National Institute for the Control of Pharmaceutical and Biological Products, said that the compound -- over-sulfated chondroitin -- could not be "the root cause" of the adverse reactions to heparin, as the FDA has suggested.

Speaking at the Chinese Embassy in Washington, Jin said that some of the batches of heparin associated with severe allergic reactions and distributed by Baxter International did not have the synthetic chondroitin in them. He also said that heparin with the contaminant has been found in more than ten other nations, but that none has reported a similar spike in harmful allergic reactions.

Jin said the Chinese government was conducting its own investigation of the heparin issue that would include a visit tomorrow to Baxter's New Jersey manufacturing plant. He said the allergic reactions could have been created by impurities introduced while the raw heparin from China was further refined by Scientific Protein Laboratories (SPL) of Wisconsin and then prepared for distribution in New Jersey.

Jin said he wanted to visit the Baxter plant and take back some samples of the company's heparin for "further in-depth analysis and investigation," because "when you see it, you believe it."

Baxter spokeswoman Erin Gardiner said that her company disagreed with the Chinese conclusions, and that the over-sulfated chondroitin definitely appeared to be the problem. She also said the Chinese were incorrect when they said some batches of heparin that caused severe reactions did not contain the chondroitin.

Representatives of more than 12 nations, including the Chinese, joined the FDA last week in a closed-door meeting on heparin. This morning, the FDA issued a warning letter to the Chinese supplier of heparin, Changzhou SPL Company Ltd., which is wholly owned by SPL.

"Equipment used to manufacture heparin sodium USP is unsuitable for its intended use," the FDA told the supplier. Agency inspectors, who visited the Chinese facility in late February, also found that the company did not properly evaluate its own suppliers, who provide crude ingredients from pig intestines.

The Chinese plant has been supplying heparin for American patients since 2004. The FDA acknowledged last month that it never inspected the plant because it confused it with another facility with a similar name, and Chinese officials said they did not inspect it because it was listed as a plant producing chemicals rather than pharmaceuticals.

FDA officials scheduled a teleconference for this afternoon to discuss the results.

The sharp spike in allergic reactions to heparin from November through February has become emblematic of the large and growing number of prescription drugs and drug ingredients being imported from lightly-regulated nations such as China and India. It has also highlighted the question of whether the FDA has the resources and will to regulate foreign-made drugs with the same intensity that it does American-made products. Numerous members of Congress have called for greater oversight, and the FDA has announced that it will soon open its first office in China.

The complexity of the issue was apparent at the Chinese embassy press conference. Jin said categorically "that the results of our recent investigation and other available evidence do not support the theory that the root cause" of adverse reactions to heparin has been the over-sulfated chondroitin that the FDA identified as the likely culprit. He said Chinese officials are as eager to find what caused the problems as Americans.