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Posted by on Jul 26, 2010 in Ethics, FDA, Pharma

Source of Contaminated Heparin Still Unknown

Source of Contaminated Heparin Still Unknown

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The original source of Baxter’s contaminated heparin, which killed scores of Americans in 2007 and 2008, has still not been identified, according to letters sent between the FDA and Congressmen Joe Barton (R-TX), who is investigating the matter. The heparin, which was intentionally spiked with oversulfated chondroitin sulfate (OCSC OSCS), was traced early to Baxter’s Chinese supplier of crude heparin, Changzhou SPL, but the FDA has apparently not been able to get beyond the company to implicate any of Changzhou’s suppliers. (A colorful expose by the WSJ in 2008 about the unregulated production of raw heparin in China showed just how hard it might be to identify the perpetrator.)

According to the agency’s response letter of June 16, officials of China’s State Food and Drug Administration (SFDA) have stifled the FDA’s investigation beyond Changzhou SPL, and “repeated” follow-up requests to the SFDA have yielded only “general information.” The latest from Chinese officials to the agency: There have been no breakthroughs in the case. However, Congressman Barton, in his latest volley with the FDA, suggests that the US agency has been lax in its follow-up and specifically in its investigation of several suspect Chinese firms, including transparently bogus “front companies.” (For more on these suspect firms, read the letter.)

In its efforts to protect the American public, the FDA posted testing methods for OSCS and initiated a “sampling program” to examine products on entry to the country. In addition, specific Chinese firms, like Changzhou, have been given an “import alert” status, in which products can be confiscated without inspection.

Leading the search for a synthetic version of heparin, which would entirely circumvent any reliance on the crude harvesting process (in China or elsewhere), are investigators at Rensselaer.

SPL = Scientific Protein Labs.

bmartin (1130 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.