I do not believe this specific part of the broader story ever got much traction here at dailykos or was reported widely in the blogosphere; the details of this story surprised me. I was not aware that 81 Americans died as a result of this specific drug contamination.
I guess one must add these sad stories to the litany of the Bush Crime Family Wall of Shame.
http://www.naturalnews.com/...
FDA Protects Chinese Supplier of Tainted Heparin, Refuses to Release Names
"Earlier this year [2008], the FDA issued its first alert over tainted supplies of the blood thinner heparin. To date, the contaminated drug has caused allergic reactions that have led to more than 1,000 adverse events in the United States, including 81 confirmed deaths since January 2007. The tainted drugs have also been detected in 10 other countries."
The agency says that confidentiality agreements with the producers bar it from revealing any of their names.
Background here:
http://www.nytimes.com/...
As indicated in the NYT article, the Chinese reacted belligerently, even when presented with the facts that 11 nations found contamination of this widely used drug. Not only was bacterial contamination found, additional contamination by another drug was indicated, as well.
Congress did finally force the FDA into action:
http://online.wsj.com/...
FDA Cites Two Chinese Heparin Makers
This is the first public disclosure that the two Chinese firms were involved in the heparin affair, which started in late 2007 when federal regulators began receiving reports of allergic reactions and deaths in U.S. patients who had been given heparin.
The FDA lots of heparin were contaminated with over-sulfated chondroitin sulfate. The agency inspected the plants in July and August 2008 and, with respect to Shanghai No. 1 Biochemical, "uncovered untrue statements and information by your firm to the agency" relating to the actual maker of heparin. The agency determined that the blood thinner was made at two other plants, Qingdao Kangyuan or Qingdao Jiulong, and were relabeled and shipped.
The FDA told the Chinese suppliers that the agency can refuse to grant new drug applications or allow shipments to unload.
The FDA finally implemented mandatory screening.
http://www.fda.gov/...
Heparin Test Results
To ensure safety of heparin products in the United States, FDA asked manufacturers of heparin-containing products to test the heparin active pharmaceutical ingredient (API) used in these products with the two screening methods posted to FDA's website, capillary electrophoresis (CE) and proton nuclear magnetic resonance (H-NMR). FDA wants to extend its appreciation to all companies who expeditiously adopted these methods and provided monthly updates. These methods have been included in the United States Pharmacopeia monograph since June 2008, and are to be used for all products intended for the U.S. market. Adherence to an appropriate testing regimen will be monitored by our inspection program and enforced by FDA.
Beginning with the month of March 2009, monthly updates on heparin test results are no longer required. However, please continue to notify FDA of any positive results within 3 days of the testing. Provide your positive results, with the associated H-NMR spectra and CE electropherograms to support the test results, using the below template via email to cderrecalls@cder.fda.gov
If you have ever been in a hospital and had surgery, you've probably had heparin or something like it. I'm surprised I had not heard of this story, I discovered this as I invest as part of my Roth IRA extensively in bio tech, and own stock in a new transgenic drug which works in conjunction with [and can replace] heparin. In the process of doing some technical research, I stumbled across this whole mess.
One has to wonder how many other stories like this are buried in the overall noise of news media. While it is good to know that Congress and the Obama Administration finally have got some control back over the process, the tasks facing agencies like the FDA are enormous.
To those who might think the title for my diary seems a bit hyperbolic, I refer you to this ..
http://energycommerce.house.gov/...
What lessons have we learned from this experience should be used to legislate proper controls, but I fear that much of what we have seen will soon be forgotten.
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update: Deaths attributed to the use of heparin continue.
http://online.wsj.com/...
It is unclear what the causes of these problems are, but apparently it is not due to Chinese counterfeiting or contamination.