FDA: Deadly blood-thinning drug produced in China may contain bogus ingredient Mike Sheehan

Published: Wednesday March 5, 2008



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Print This Email This A blood thinner tied to the deaths of at least 19 people in the U.S. has a "possibly counterfeit ingredient," a federal agency revealed. Raw components of the drug, heparin, are produced in China, reports The New York Times in a story set to appear on their Thursday front page. "Routine tests failed to distinguish the contaminant from [heparin]," write Gardiner Harris and Walt Bogdanich for the Times. "Only sophisticated magnetic resonance imaging tests uncovered that as much as 20 percent of the product's active ingredient was a heparin mimic blended in with the real thing." Officials with the Food and Drug Administration (FDA) say they have not yet identified the contaminant and, according to the Times, do not know whether the presence of the contaminant "was accidental or ... deliberate." Heparin is among the oldest drugs still in widespread use, according to Wikipedia, predating even the establishment of the FDA itself. The drug is derived from tissues of slaughtered pigs and cows. Chinese-made products--among them the world's largest supply of pharmaceutical ingredients--being imported into the U.S. have come under increased scrutiny in recent times, most prominently after the tainted pet food and lead paint toy scandals of last year. Excerpts from the Times article, available in full at this link, follow... # The F.D.A. admitted last month that it had violated its own policies by failing to inspect Scientific Protein's China plant before approving the drug for sale. The agency sent inspectors to the plant last month who found that at least some heparin was made from "material from an unacceptable workshop vendor." ... In addition, Panamanian investigators have concluded that at least 174 people were poisoned, 115 of them fatally, by counterfeit cold medicine linked to an unlicensed Chinese chemical plant. A series of independent assessments, including one by the agencys own Science Board, have found that the F.D.A. is increasingly overwhelmed by its many responsibilities and is incapable of protecting the public from unsafe drugs, medical devices and food  particularly from China. The Government Accountability Office recently discovered, for example, that over a six-year period, the F.D.A. inspected just 64 of the nearly 700 medical device plants registered in China. Medical devices can include items like stents and spinal screws. ... The Chinese heparin market has been in turmoil over the past year as pig disease swept through the country, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material. #



