Tainted Drugs Tied to Maker of Abortion Pill

[Celebration]

http://www.nytimes.com/2008/01/31/world/asia/31pharma.html?ref=health

BEIJING — A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

Liu Kechen, 29, who also became paralyzed after injections with the contaminated drugs in a Beijing hospital, receives help from his wife, Ma Jingrong, in stretching his legs.
Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour’s drive away.

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

[Warpy]

1. China has no FDA

and no pesky USP standards. Supposedly, lots are spot checked when they come into this country, but who knows about that. Stupid has pretty much gutted the FDA to the point that the spot inspections are very, very spotty.

Remember the hoohaw a couple of years ago about how drugs from Canada and Mexico weren't tested for safety and that all foreign made drugs were suspect?

Well, don't look now folks, but most of the drugs we take are made outside the USA these days, relying on those same FDA spot checks from a gutted agency.

[Ellen Forradalom]

2. A big old hearty FU to the NYT

for that tabloid-worthy headline.

While we should be deeply concerned about the safety of all drugs in this country, to draw 'abortion' into the headline was purely gratuitous.

[Celebration]

3. I think I agree with you

Inevitable, though, probably. Sigh.