The blood-thinning drug, heparin, has been around for more than a hundred years, breaking all records for longevity among drugs. Something went terribly wrong in 2007, and a high number of reports of serious side effects suddenly began arriving at FDA offices. Most people affected had difficulty breathing, were vomiting and nauseated as well as experiencing steep drops in blood pressure, an indicator of oncoming shock.
The bad news is that 100 deaths have been attributed to heparin since 2007, and the tainted heparin taken by a majority of them was traced to Baxter International. Further studies found that an ingredient built into the medicine was contaminated by the suppliers of the component in China. Now the FDA is saying they think the contamination was done on purpose.
Of course the Chinese are balking on this issue. They say maybe the contaminated chemicals came from the US itself. When David Strunce, the CEO for Scientific Protein Laboratories, tried to find out where the contamination originated, the Chinese authorities banned him from investigating. Read this April 30, 2008, report by the US law firm, Parker Waichman Alonso LLP, about the situation.
The offending chemical in heparin is made from animal cartilage, and the factory where the ingredient was manufactured was not regulated, inspected, or licensed by the Chinese government.
Papers and reports related to the heparin disaster…
1. Information sheet with multiple links to reports and news related to the heparin situation by the Federal Drug Administration.
2. Full statement on what the contamination means, by David G. Strunce, CEO for Scientific Protein Laboratories.
3. Scientific report showing that the contaminant is a man-made chemical known as oversulfated chondroitin sulfate.
4. Report explaining why it was possible to bypass safety screening and bring the contaminated medicine into the US.
5. Details about the Chinese manufacturer of the active ingredient that was apparently modified deliberately to cause lethal complications. Read about the company that was never inspected or licensed even by Chinese officials.
