China hits at Baxter in heparin probe Go back »

2008-05-12 | Tianjin

China hits at Baxter in heparin probe

Chinese regulators accused Baxter, the US drug company, of failing to co-operate in an investigation over deaths linked to impurities in blood thinner heparin.

The charge, swiftly denied by Baxter, marked a fresh escalation in Sino-US trade tensions since reports of at least 81 deaths linked to contaminated heparin in the US have triggered withdrawals in 11 countries.

The State Food and Drug Administration, China’s drugs regulator, said on Tuesday that Baxter had not provided all samples and information requested during a visit last month to its New Jersey plant. The SFDA reiterated its position that there was no proven link between the deaths in the US of patients and “a heparin-like substance” found in the drug.

Baxter replied: “We have been co-operating with all parties in the heparin situation including SFDA and the Chinese government. We plan to continue co-operating with them to help move the investigation forward. We will seek to understand any concerns to the contrary.”

The comments come after the US Food & Drug Administration released a letter last month criticising a Chinese sub-contractor to Baxter for failing to remedy quality problems in supplies.

Robert Parkinson, Baxter’s chief executive, also expressed concern last week that the faulty heparin “appears to be the target of a deliberate adulteration scheme”.

Disagreements over the cause and investigation of safety problems with heparin is the latest blow to Sino-American co-operation over questions of unsafe products made in, or with ingredients sourced, in China. It follows claims over tainted pet food, toothpaste containing antifreeze and lead-painted toys sourced in China and imported into the US. The problems have added to pressure on the US Food and Drug Administration to toughen import processes and step up its inspection of foreign manufacturers, as well as a re-examination by global companies of their sourcing and manufacturing.

The key ingredient in heparin is made from slaughtered pigs intestines, much of which comes from China, often from small family workshops.

Baxter’s withdrawal of heparin made in China included batches containing a chemical, oversulfated chondroitin sulfate, that is similar and cheaper to the main raw material for the drug. The FDA said it has established a potential link between the chemical and allergic reactions and deaths associated with contaminated heparin.

But Chinese authorities said on Tuesday the presence of oversulfated chondroitin sulfate could not be held responsible for the deaths because other countries using the drug had not reported adverse reactions.

“Apart from the United States and Germany, more than 10 other countries using heparin products containing heparin-like substances have not reported any cases of adverse reactions,” the statement said.

Reuters reported that a senior official at a Chinese regulatory agency also said Baxter had destroyed samples of the drug and production records needed for the investigation. “This is extremely regrettable,” said Jin Shaohong, of China’s National Institute for the Control of Pharmaceutical and Biological Products.

Baxter “respectfully disagreed” that it has done anything to impede the investigation adding that it is “seeking to understand the concerns and comments” from China.