Word: heparin
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That judgment gains credence from a simple fact: the heparin disaster goes beyond Baxter, SPL and their suppliers--none of whom have been charged with wrongdoing and all of whom say they are cooperating with regulators to find out where problems arose in the supply chain and why. French pharmaceutical giant Sanofi Aventis told French regulators and the FDA that it too had found and recalled tainted heparin last spring. (Baxter pulled all its heparin from the market last January.) In April, deputy FDA commissioner Janet Woodcock said the agency had traced the contaminated heparin api, which ultimately found...
...intentional? To cut costs. Heparin suppliers substituted a chemical--oversulfated chondroitin sulfate, or OSCS--that is derived from animal cartilage and used only in dietary supplements, not in medicines. The compound's key advantages: it is, as a Baxter spokeswoman puts it, a "virtual mimic of heparin" in most tests and, according to a congressional investigator, costs only $20 per kg, vs. $2,000 for crude heparin. The suppliers, investigators believe, colluded to substitute OSCS in the crude heparin they passed along for the standard price and pocketed the $1,980 difference for each kilogram they sold...
Working with Baxter, the FDA devised a test that now identifies OSCS in heparin. The FDA will deploy eight full-time staffers in China, including four inspectors and a senior technical expert in foods, medicines and medical devices. And working with its counterpart agency in Beijing--which FDA commissioner Andrew van Eschenbach acknowledges is primarily responsible for drug safety there--the FDA will now be able to do "more timely" inspections in China. In 2008 the FDA did all of 30 inspections in China...
...where agencies may lack muscle, the personal-injury bar doesn't. To date, plaintiff attorneys have filed 60 suits against Baxter and SPL in federal court. SPL CEO Strunce can claim his company's heparin met Chinese standards, but that's probably a meaningless defense in a U.S. trial. For American drug companies using sources in China, quality control is not just China's problem--it's also their problem...
...event, it's too late for Johanna Staples, a kindergarten teacher whose husband Dennis, a popular disc jockey in Toledo, Ohio, died of a reaction to tainted heparin in January, a day shy of his 60th birthday. She says she's still afraid. "There are so many variables in how we receive our drugs that it's amazing there hasn't been a worse problem. Now look at all these kids sick in China because of tainted milk. Sometimes I get in a sheer panic thinking about...