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Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was deliberately added.
“F.D.A.’s working hypothesis is that this was intentional contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the agency’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony on Tuesday.
Some heparin batches...consisted of more than 30 percent of the contaminant....
But Mr. Nelson was even more critical of Baxter International, the company that sold contaminated heparin in the United States. Baxter bought contaminated heparin ingredients from Changzhou SPL from 2004 through 2008 but did not inspect the facility itself until September 2007.
www.nytimes.com...
CEO Parkinson said at the hearing: "We're alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result."
The contaminant was an altered form of chondroitin sulfate, a drug that mimics the affects of Heparin. The company said during the hearing that the drug was in the batches before it reached Baxter's supplier, Scientific Protein Laboratories.
www.forbes.com...
“Our investigations have revealed an F.D.A. woefully lacking in the personnel, effective policies and the will at the highest level to perform the duties entrusted to it by the Congress and the American people,” said Representative John D. Dingell, a Democrat from Michigan who is chairman of the House Energy and Commerce Committee. “Our citizens can no longer trust that their food, drugs or medical devices are safe when F.D.A. says they are.”
Even Republicans say that the agency’s budget needs a substantial increase.
www.nytimes.com...
Originally posted by sc2099
I doubt there's any way to find out.
Originally posted by sc2099
reply to post by 44soulslayer
But, you have no way of knowing where the ingredients in the medications were produced. Yes they were assembled in a decent place, but do they contain Chinese gelatin, or worse, Chinese produced drug content? I doubt there's any way to find out.