Thursday, January 31, 2008

Tainted Drugs*

A state-owned Chinese pharmaceutical company is at the heart of an international drug scandal after it's been revealed that over 200 patients were paralyzed or otherwise hurt by tainted leukemia drugs last summer. But in what we sometimes cynical Westerner's might consider a surprise, given recent cover-up history (especially regarding lead in toys), China's Food and Drug Administration has been at the heart of chasing down the pharma company managers, and responsible for closing the plant when the tainted drugs were discovered.

This would be alarming news to receive about any major pharma company, regardless of their involvement in the import/export industry, but the fact that Shanghai Hualian is the sole supplier of mifepristone (RU-486) for the United States raises even bigger concerns.

So far, the contaminated medications have been isolated to a factory about an hour away from the one that makes RU-486, but obviously when a company has one manufactoring problem, concern spreads to the entire system.

The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.

When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, a leading consumer advocate and frequent F.D.A. critic, said American regulators ought to be concerned because of accusations that serious health risks had been covered up there. “Every one of these plants should be immediately inspected,” he said.

The director of the Chinese F.D.A.’s drug safety control unit in Shanghai, Zhou Qun, said her agency had inspected the factory that produced mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou said, “but these two plants are in two different places and have different quality-assurance people.”

And while I do see this point, and agree with it to a degree, but given recent concerns both about the FDA and it's process, as well as China covering up manufacturing and health issues... I would certainly feel a lot better if the FDA released something more concrete than a no comment. That the FDA won't reveal what other medications are made/imported by the company also is worrisome. Again, on the one hand, I can understand not wanting to run consumers off by fear - but on the other hand, a lot of pets died because of contaminated food. Do we want to see the same health risks in our medications?


(*And as an aside, apologies to anyone else who now has Soft Cell's Tainted Love spinning 'right round in their head.)

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