Food and Drug Administration underesourced to monitor overseas drug manufacture - heparin problems become global.
The worldwide effects of Chinese heparin blood thinner products deliberately contaminated with low cost over sulphated Chondoitin Sulphate becames more apparent every day.
Dr. Janet Woodcock, director of the Food and Drug Administration's drug center, has announced that German regulators have uncovered a cluster of illnesses among dialysis patients who took contaminated heparin.To date the contaminated product is directly related to 81 deaths and a large number of severe reactions in many patients.
Woodcock also claimed that Chinese officials had conceded that heparin produced in their country contained a contaminant, though they deny its connection to the reported problems and insist that Chinese inspectors be allowed to inspect the American plant where the finished heparin vials were made.
"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.
This dispute, resulting in human fatalaties comes on top of poisonous toothpaste, lead-painted toys, toxic pet food laced with melamine, and tainted fish.
The FDA 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.
The FDA 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 FDA'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.
Lots of heparin going back to 2006 have been found to be contaminated. The current spike in illness and death first became apparent in November 2007 and continued for several months as the product was withdrawn and substituted.The severe reactions seem to be related to patients who were given high doses of the drug, Woodcock said.
She said she would not detail the suspected problems with the contaminant in heparin until the information is published in scientific literature and other researchers have had a chance to contribute to the results.
"We are not able to rule out the fact that there could be other problems leading to these adverse events," Woodcock said.She did tell Reuters that "We have data in vitro, in test tube ... as well as animal data that shows that this contaminant can trigger events that would lead to these type of reactions. That doesn't tell us everything or the whole story but it establishes a link."
The Government Accountability Office (GAO)is to release a report showing that the FDA will need to spend at least US$56 million more in 2009 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 required minimum standard for drug manufacturers in the US.
The FDA could spend the next 27 years at the current rate inspecting every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, GAO say.