The price of the Chinese-produced main ingredient used to make the blood thinner heparin doubled last year, just four months before hundreds of American patients began having severe and sometimes fatal allergic reactions to the medication, according to a report from an authoritative drug information company in China. The highly unusual increase of the price within a quarter of a year should have been a red flag to drugmakers that something significant -- and perhaps dangerous -- was happening to the ingredient of a medication widely used in life-threatening situations, industry experts said. Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.
Between November and February, hundreds of Americans experienced serious allergic reactions after taking Chinese-made heparin, and 62 died, the Food and Drug Administration reported this week, sharply increasing its previous estimates. Some patients always respond poorly to heparin, but FDA statistics show three fatal allergic reactions in 2006.
Last month, the agency discovered through chemical testing that heparin made in China and distributed in the United States by Baxter International had been contaminated with inexpensive over-sulfated chondroitin, an altered version of a widely used dietary supplement.
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"This price increase should be, has to be, seen as a signal to purchasing managers," said Guy Villax, chief executive of the European drug company Hovione and a board member of the European trade association for drug ingredient makers. "You have a situation here where the supply chain begins in slaughterhouses and villagers' homes, and a sudden disruption of that supply doesn't raise safety questions? I don't know whether anyone could have detected the contaminant early on, but at least they should have been looking," he said. Villax added that the supply shortage and the steep price increase offered an obvious opportunity for individuals "who don't play by the rules" to make windfall profits by adding cheaper materials to the raw heparin as a way to meet the demand.
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http://www.washingtonpost.com/wp-dyn/content/article/2008/04/12/AR2008041201662.html