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www.chicagotribune.com/news/chi-china-tainted-drugs-

jan31,1,4239367.story

chicagotribune.com

 

Tainted drugs tied to Chinese factory

Shanghai company also supplies U.S. with abortion pill

By Jake Hooker and Walt Bogdanich

 

New York Times

 

3:06 AM CST, January 31, 2008

 

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.

 

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 Shanghai

police had begun a criminal investigation and two officials,

including the head of the plant, had been detained.

 

The drugmaker, Shanghai Hualian, is the sole supplier to the United

States of the abortion pill mifepristone, known as RU-486. It is made

at a different factory than the one that produced the tainted cancer

drugs.

 

The U.S. 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 FDA inspection in May.

 

" FDA 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 Wolfe, a leading

consumer advocate and frequent FDA critic, said U.S. 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 FDA 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, " Zhou said, " but these two

plants are in two different places and have different quality-

assurance people. "

 

The investigation of the contaminated cancer drugs comes as China is

trying to restore confidence in its tattered regulatory system. In

the past two years, scores of people around the world have died after

ingesting contaminated drugs and drug ingredients made in China. Last

year, China executed its top drug safety official for accepting

bribes to approve drugs.

 

Shanghai Hualian is a division of one of China's largest

pharmaceutical companies, the Shanghai Pharmaceutical Group, which

owns dozens of factories.

 

Last week, The New York Times asked the FDA whether the Shanghai

Pharmaceutical Group exported to the United States any drugs or

pharmaceutical ingredients other than the abortion pill. The agency

declined to provide that information.

 

On at least two occasions in 2002, drug shipments from Shanghai

Hualian were stopped at the U.S. border, FDA records show. One

shipment was an unapproved antibiotic and the other a diuretic that

had " false or misleading labeling. "

 

Records also show that another unit of Shanghai Pharmaceutical Group

has filed papers declaring its intention to sell at least five active

pharmaceutical ingredients to manufacturers for sale in the United

States.

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