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...year, after reports of a spike in deaths and illness, Ruihua Biomedical stiff-armed the investigators. It refused to let them inspect its processing lab and declined to provide a list of crude-heparin suppliers. Before last summer, SPL's China facility had never been inspected by Beijing's drug-safety agency because, says a spokesman, the agency thought "it was a chemical plant." A source close to the FDA's heparin investigation puts it bluntly: "China simply has no regulatory regime to speak...

Author: /time Magazine | Title: Heparin's Deadly Side Effects | 11/13/2008 | See Source »

...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...

Author: /time Magazine | Title: Heparin's Deadly Side Effects | 11/13/2008 | See Source »

...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...

Author: /time Magazine | Title: Heparin's Deadly Side Effects | 11/13/2008 | See Source »

...last episodes of the Shield, whose series finale airs Nov. 25, corrupt former L.A. cop Vic Mackey (Michael Chiklis) takes a meeting with a drug boss. Mackey has brought him a big dope deal with another gang--secretly setting him up in order to secure for himself an immunity deal with the feds for a list of crimes that starts with murder and continues the length of your arm. The kingpin offers him a drink to take off the "edge." Mackey refuses. "The edge is where we live," he says. "People try to convince themselves otherwise. It's just...

Author: /time Magazine | Title: A Fitting End for The Shield | 11/13/2008 | See Source »

...seven intense seasons, The Shield (FX, Tuesdays, 10 p.m. E.T.) has not just lived on that edge. It's sprinted along it, panting and veins bulging. In the pilot, Mackey--who with his antigang unit, the Strike Team, has been skimming seized drug money--learns that one of his crew is an undercover fed. Mackey puts a bullet in his head...

Author: /time Magazine | Title: A Fitting End for The Shield | 11/13/2008 | See Source »

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