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Remember what it felt like as a kid when you went into a candy store and you were overwhelmed with how many choices of sweets lay before you? When I read the New York Times article, U.S. Identifies Tainted Heparin in 11 Countries, I felt that same overwhelming indecision, but in a bad way.  I was baffled by which angle to take. Do I blog about how the Chinese are trying to pass the buck and blame everyone else for the contaminated Heparin. Do I blog about how the FDA is dismally understaffed to even consider inspecting foreign plants. Do I blog  about how huge this Heparin debacle is turning out to be or do I blog about how Baxter International, the manufacturer of Heparin, is more concerned with covering their corporate behinds and is denying that the contaminated drug has caused 81 deaths.


So, I decided to do what any smart kid in a candy store would do…sample a little bit of everything…


In a nutshell, the FDA has found the contaminated drug Heparin, a blood thinner, in 11 countries including, Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Investigators have also established a definite link between the contaminant and the severe reactions that have caused 81 deaths in the Unites States.


Heparin is made from the mucous membranes of the intestines of pigs and the process of rendering the ingredients takes place in Chinese family workshops which are for the most part, unregulated. The contaminant, oversulfated chondroitin sulfate is a cheaper substitute that was able to slip through the usual testing and was not identified until more sophisticated tests were utilized.


There has been speculation that the concentrated number of deaths in the US may be attributed to the practice of American doctors to use large, quickly infused doses of heparin. Additionally, the FDA may be better than its foreign counterparts at tracking serious side effects.


The FDA had reports as early as 2006 that some lots of heparin contained the cheaper additive, which begs the question…why did Baxter International wait until February 2008 to issue a recall?


Up next:  The Heparin Debacle Part Two – Chinese Officials Play the Blame Game

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