Thursday, January 31, 2008

What NYT Missed in Dangerous Chinese Drug Story

The New York Times ran a story on a dangerous drug made by a Chinese manufacturer. Their leukemia drug harmed 200 patients, leaving many paralyzed. Chinese drug regulators accused the manufacturer of a cover-up and have closed the factory that produced the tainted drugs. This prompted the F.D.A. to look at other drugs produced by this same company.

Guess which one hit the public spotlight? In the era of the ever present permanent campaign, how could this story be twisted to further key Republican aims? The FDA transferred the taint of Shanghai Pharmaceuticals' leukemia drug to their morning after contraception pill.

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.

Guess what got left out of the above sentence? It would be the name of the company who contracted out manufacturing to China. Danco Laboratories incorporated in the Cayman Islands in 1995. Danco has a clear responsibility to ensure safe drugs are made for its patients. Where is their data on the quality of production runs?

Back to China and it's horrific management practices, sure to cause quality problems. (It happens the White House practices the same sorry leadership, only it calls their bad outcomes "glitches".) Both U.S. and Chinese leaders practice substitution and suboptimization to the detriment of their employees and customers. Both use fear to motivate, but instead it distorts. Workers at the plant systematically covered up the tainting's cause. Did they remember the Chinese drug official executed for his poor quality service to the people? Who wants to lose their life for a job paying a couple dollars a day?

The FDA's actions are telling. 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. Why would a Chinese manufacturer be at risk from U.S. hot heads? China as a state enforces population limits and has practices to control reproduction. If the FDA were truly concerned, this story wouldn't have hit the pages of the Times.

The paper asked the F.D.A. whether the Shanghai Pharmaceutical Group exported any drugs or pharmaceutical ingredients other than the abortion pill to the U.S. But after repeated requests, the agency declined to provide that information; it did not cite a reason. D'oh! The Times did find evidence of numerous other Shanghai Pharmaceutical drugs being imported to the U.S. Why didn't the FDA talk about other risks to patient care from a manufacturer known for making poor quality drugs?

This story is a tool to discredit a particular drug, one with no record of harming patients but clearly hated by the Bush administration. The facts behind the story should serve as an indictment of American leadership, in business, in government and the newspaper industry. But once again, nobody's watching, or they might be too afraid to speak up.