The latest word on Heparin contamination
The April 22 New York Times reported that the FDA has made progress in tracing Heparing contamination--which has resulted in more than 80 deaths in the United States--to Chinese suppliers. Following this drama points out serious problems in our future relationship with Chinese authorities, as we continue to send manufacturing jobs overseas.
There have been ongoing discussions about the source of contamination in heparin marketed by the Baxter International firm headquartered in Wisconsin. Baxter is one of two major heparin suppliers, and disruption of its product supply created a shortage of this vital medication in the United States. While there is some controversy about the extent of the impact of contaminated heparin, the FDA says it accounted for 81 deaths in the United States between October of 2007 and March of 2008, and that it also can be traced to an outbreak of illness in Germany.
The FDA says that it has traced the contamination to one particular Chinese supplier and as far back as early 2006. While the FDA can't document the matter to Chinese satisfaction, it alleges that a Chinese supplier accepted raw material from contaminated suppliers and used unclean tanks in the manufacturing process. Heparin is made from the mucous membranes of pig intestines and the animal slaughtering and rendering processes are a family/cottage industry in China, highly susceptible to complications. The alleged contaminant is "oversulfated chondroitin sulfate", a cheaper additive improperly substituted by some suppliers. The factory of the particular Chinese supplier identified by the FDA had never been inspected by the FDA prior to this controversy.
The Government Accountability Office estimates that the FDA would need 56 million dollars in additional funding next year in order to begin full inspections of foreign plants. The GAO says the FDA would need to spend 15 million dollars annually to subject Chinese plants to the same level of biannual scrutiny that is imposed on U.S. manufacturers. Needless to say, the Bush administration has no plan to add inspectors or to increase the FDA budget.
In our "race to the bottom" through international trade, we are making yet another unspoken compromise concession--trading adequate inspection for lower cost medicine. It certainly doesn't appear from the cost of prescriptions that those lower costs are being passed on to consumers, however. The lower prices appear to inure only to the benefit of Big Pharma, so the American consumer derives no benefit for its sacrifice in safety. And in the meantime, American producers who are subject to reasonable government scrutiny cannot compete with foreign suppliers who are not--meaning more jobs end up overseas, unregulated, underpaid and probably subject to unacceptable working conditions.
China has agreed to inspect lots of exported heparin, however, American authorities question whether the test to be utilized is sensitive enough to be effective. To make matters worse, at its present pace, according to the government sources quoted by the NYT, it will take the FDA 27 years to inspect every existing foreign medical device plant that exports to the U.S.; 13 years to inspect every existing drug plant. While the FDA has announced vague plans to inspect suppliers in three particular Chinese cities, Chinese authorities are displaying passive aggression toward American regulatory efforts and have not approved the FDA plan: the Chinese authorities are wondering aloud why they should approve American inspections if the Chinese government isn't inspecting American plants? There is an implicit waiver of sovereignty in our insistence upon American inspections of Chinese plants, and this "waiver" will become more and more of a problem for us, as our manufacturing capacity evaporates and we become more and more dependant upon Chinese products.