Posted on 04/21/2008 8:42:07 PM PDT by neverdem
WASHINGTON — 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...
(Excerpt) Read more at nytimes.com ...
Without being more specific, I can't say. Testing can become very technical in chemical or biological assays. What they release for public consumption can be open to interpretation.
Bump.
It's also in the NYT article.
ping to be informed
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