Heparin News

 

U.S. Identifies Tainted Heparin in 11 Countries

-NY Times

04/22/2008 -- A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States.

But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be reciprocal.

“We don’t have a strong evidence to show that it is heparin or its contaminant that caused the problem,” said the official, Ning Chen, second secretary at the Chinese Embassy.

Mr. Chen said that illnesses associated with contaminated heparin had occurred only in the United States, which he said suggested that the problem arose in this country.

Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had conceded that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

“Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events,” Dr. Woodcock said. “We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

The dispute is a sign of growing tensions between China and the United States over the safety of Chinese imports. China has in recent years exported poisonous toothpaste, lead-painted toys, toxic pet food, tainted fish and now, contaminated medicine.

Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for Tuesday in the House and Thursday in the Senate.

China has lurched between defensiveness and cooperation on issues of product safety. Last year, it initially blocked the F.D.A. from investigating tainted pet food and accused foreign forces of exaggerating the issue. Then in July, China said that it had executed its former top food and drug regulator for taking bribes and promised reforms.

The F.D.A. sent a warning letter on Monday to Changzhou SPL, the Chinese plant identified as the source of contaminated heparin made by Baxter International in the United States. It warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities.

Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.

The F.D.A. has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Deborah Autor, director of compliance at the F.D.A.’s drug center, said the agency did not know the original source of all the contamination or the points in the supply chain at which it was added.

Officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February, officials said.

Separately, the Government Accountability Office will release a report on Tuesday showing that the F.D.A. would need to spend at least $56 million more next year to begin full inspections of foreign plants. It would need to spend at least $15 million annually to inspect China’s drug plants every two years, which is the domestic standard.

Bush administration officials have acknowledged problems associated with poor inspection of overseas plants and have plans to improve the situation. But President Bush’s budget does not provide the F.D.A. with funds to hire more inspectors.

 

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