13. What is the contaminant? (new question and answer added 6/18/2008)
Oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin, was identified as the contaminant.
14. Where is the contaminant found? (new question and answer added 6/18/2008)
The contaminant was found in samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products.
15. Is oversulfated chondroitin sulfate unsafe by itself or in combination with heparin? (new question and answer added 6/18/2008)
The adverse events were reported in patients who received heparin contaminated with oversulfated chondroitin sulfate. The lab studies suggest that when oversulfated chondroitin sulfate is given alone or in combination to animals, similar adverse events occur (N Engl J Med 358;23 June 5, 2008 p2457) .
For a catastrophe the potential magnitude of the swine flu, that is pretty polite language. What the FDA doesn’t say about OSCS above is that OSCS got in Heparin by the intentional actions of some Chinese individuals trying to make an extra profit by cutting Heparin, like a street drug might be cut with sugar. OSCS was used to cut the drug because it chemically looked enough like Heparin that it would pass the crude testing that Baxter and SPL were doing to determine the purity of this drug.
What the FDA also doesn’t say is that OSCS got into Heparin because some American corporate executives also were motivated by greed. More on that tomorrow.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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