US, China clash over contaminated heparin
Foreign officials want to inspect N.J. facility where drug was made
WASHINGTON - US and Chinese officials argued publicly about whether a contaminant from China in Baxter International Inc.'s blood-thinner heparin caused allergic reactions and deaths.
China determined the contaminant isn't to blame, and its scientists intend to inspect Baxter's heparin factory in New Jersey, said Jin Shaohong, a Chinese regulator, at a news conference yesterday in Washington. US regulators concluded the contaminant can trigger the side effects, said Janet Woodcock, a Food and Drug Administration official, in a call with reporters hours later.
Some samples of Baxter's heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated with the cheaper substance, over-sulfated chondroitin sulfate, Baxter and the FDA said last month. Eighty-one people given heparin died since January 2007 after suffering allergic reactions, up from 62 disclosed this month, according to data released yesterday by the FDA.
"The over-sulfated chondroitin cannot be the root cause," said Jin, deputy director general of China's National Institute for the Control of Pharmaceutical and Biological Products, at the Chinese embassy.
Some other companies' versions of heparin sold overseas included the contaminant and didn't cause side effects, suggesting another ingredient in Baxter's heparin may be to blame for the allergic reactions and deaths, Jin said.
"If this is the root cause, it would be universal," Jin said, referring to the contaminant. "Why only Baxter?"
Woodcock, head of the FDA's drug division, responded that "this contaminant is capable of triggering these types of reactions." The FDA hopes to have additional discussions with the Chinese over the scientific differences, Woodcock said.
Senator Edward M. Kennedy, chairman of the Health, Education, Labor and Pensions Committee, said he will hold a health committee hearing Thursday on the heparin issue.
The contaminated heparin has been found in 11 countries, according to the FDA. People in Germany suffered similar reactions to those in the United States, Woodcock said. The reactions may be linked to the use of large doses of heparin, a practice that is more common in the United States than in some other countries where contamination was found, she said. Twelve companies in China handled tainted heparin, according to the FDA. The agency doesn't know where in the supply chain the contamination occurred.
The tainted heparin was made as long ago as 2006, though it appears to have entered the market in 2007, Woodcock said.
Deerfield, Ill.-based Baxter also disputes the Chinese conclusion. The contaminant is "likely the cause" of the increased number of side effects, said Norbert Riedel, Baxter's corporate vice president and chief scientific officer, in a statement. Lab tests show no unusual reactions to Baxter's uncontaminated batches of heparin, according to the company.
While the United States and China disagree, they are "working in what I think is a productive way," said Health and Human Services Secretary Michael Leavitt.
Baxter, which sold about half the heparin in the United States, issued a recall in January. Its uses include preventing blood clots during dialysis and heart surgery.
Chondroitin sulfate is taken orally as a dietary supplement to treat joint pain. The over-sulfated version found in the heparin was chemically modified to act like heparin, according to the FDA. The contaminant isn't approved by the FDA for use in heparin.
Baxter has said the contamination appears to have happened before the product reached the company's supplier, Scientific Protein Laboratories. The FDA yesterday issued a warning letter to the Scientific Protein plant in China saying the company hadn't adequately responded to "deficiencies" identified during a February inspection.
