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【drug-news】肝素问题中美之争
China and U.S. Clash Over Cause of Heparin Deaths (Update6)
By Justin Blum
April 21 (Bloomberg) -- U.S. and Chinese officials argued publicly 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 today in Washington. U.S. 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 announced earlier this month, according to data released today 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, during the news conference 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 in an interview, referring to the contaminant. ``Why only Baxter?''
FDA's Response
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.
The contaminated heparin has been found in 11 countries, according to the FDA. People in Germany suffered similar reactions to those in the U.S., Woodcock said. The reactions may be linked to the use of large doses of heparin, a practice that is more common in the U.S. 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 was introduced.
The tainted heparin was made as long ago as 2006, though it appears to have entered the market in 2007, Woodcock said.
Baxter Disputes China
Deerfield, Illinois-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 U.S. and China disagree, the countries are ``working in what I think is a productive way,'' said Health and Human Services Secretary Michael Leavitt in a briefing for reporters today.
Baxter, which sold about half the heparin in the U.S., announced a recall in January. Heparin's 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.
Over-sulfated chondroitin sulfate is generated in laboratories for experimental purposes, according to the FDA. It is chemically altered to add additional sulfates.
Baxter has said the contamination appears to have happened before the product reached the company's supplier, Scientific Protein Laboratories.
Warning Letter
The FDA today issued a warning letter to the Scientific Protein plant in China, called Changzhou SPL, saying the company hadn't adequately responded to ``deficiencies'' identified during a February inspection by the agency.
The FDA's letter doesn't reflect the ``actual state of compliance'' with manufacturing standards, Scientific Protein said in a statement. The contaminant was introduced in China before the raw ingredient reached the Scientific Protein plant, according to the statement.
Scientific Protein, based in Waunakee, Wisconsin, is majority owned by American Capital Strategies Ltd.
U.S. Suspicions
U.S. regulators suspect heparin was intentionally contaminated to increase profit, FDA Commissioner Andrew von Eschenbach told lawmakers at an April 15 hearing. He later told reporters that the agency had no evidence the contamination was intentional.
The U.S. last week hosted a two-day meeting of international regulators to discuss heparin. About 10 countries, including China, were represented, according to the FDA.
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作者:admin@医学,生命科学 2010-12-21 17:11
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