Scientists are increasingly suspicious that the heparin scandal is a case of Chinese fakery [1]. The contaminant found in recalled heparin batches [2] appears to be a chemically altered version of chondroitin sulfate, the joint-pain supplement, that was mixed into real heparin deliberately. "A child could tell you it's counterfeiting," one expert told the New York Times. "This is a deliberate act of chemically manipulating a heparin-like substance with heparin to increase the yield.
But investigators haven't fingerprinted the contaminant exactly, and they haven't proven that it caused the severe allergic reactions--including deaths--linked to the tainted heparin; indeed, some tainted batches apparently didn't set off the reactions. Nor do the experts know who added it to the real thing, or when, or where.
More than a dozen top scientists are working to unravel the mystery. And to keep the mystery contaminant out of the U.S. drug supply, the FDA asked manufacturers to run sophisticated tests [3] n their heparin products and ordered all untested heparin to be stopped at the border for analysis.
- read the story [4] in the New York Times
Related Articles:
Heparin mimic found in suspect samples. Report [5]
Germans ask for heparin testing. Report [6]
FDA moves to allay drug-import fears. Report [3]
China: Buyers on hook for drug safety. Report [7]
Links:
[1] http://www.fiercepharma.com/story/recalls-don-t-put-pharma-off-china/2008-03-14?utm_medium=nl&utm_source=link
[2] http://www.fiercepharma.com/Heparin%2520suspected%2520in%2520more%2520deaths.%2520Report
[3] http://www.fiercepharma.com/story/fda-moves-to-allay-drug-import-fears/2008-03-17?utm_medium=nl&utm_source=link
[4] http://www.nytimes.com/2008/03/19/world/asia/19heparin.html?ref=health
[5] http://www.fiercepharma.com/story/heparin-mimic-found-in-suspect-samples/2008-03-06
[6] http://www.fiercepharma.com/story/germans-ask-for-heparin-testing/2008-03-13?utm_medium=nl&utm_source=link
[7] http://www.fiercepharma.com/story/china-buyers-on-hook-for-drug-safety/2008-02-27