F.D.A. Tracked Poisoned Drugs, but Trail Went Cold in China

After a drug ingredient from China killed dozens of Haitian children a decade ago, a senior American health official sent a cable to her investigators: find out who made the poisonous ingredient and why a state-owned company in China exported it as safe, pharmaceutical-grade glycerin.

The Chinese were of little help. Requests to find the manufacturer were ignored. Business records were withheld or destroyed.

The Americans had reason for alarm. “The U.S. imports a lot of Chinese glycerin and it is used in ingested products such as toothpaste,” Mary K. Pendergast, then deputy commissioner for the Food and Drug Administration, wrote on Oct. 27, 1997. Learning how diethylene glycol, a syrupy poison used in some antifreeze, ended up in Haitian fever medicine might “prevent this tragedy from happening again,” she wrote.

The F.D.A.’s mission ultimately failed. By the time an F.D.A. agent visited the suspected manufacturer, the plant was shut down and Chinese companies said they bore no responsibility for the mass poisoning.

Ten years later it happened again, this time in Panama. Chinese-made diethylene glycol, masquerading as its more expensive chemical cousin glycerin, was mixed into medicine, killing at least 100 people there last year. And recently, Chinese toothpaste containing diethylene glycol was found in the United States and seven other countries, prompting tens of thousands of tubes to be recalled.

The F.D.A.’s efforts to investigate the Haiti poisonings, documented in internal F.D.A. memorandums obtained by The New York Times, demonstrate not only the intransigence of Chinese officials, but also the same regulatory failings that allowed a virtually identical poisoning to occur 10 years later. The cases further illustrate what happens when nations fail to police the global pipeline of pharmaceutical ingredients.

In Haiti and Panama, the poison was traced to Chinese chemical companies not certified to make pharmaceutical ingredients. State-owned exporters then shipped the toxic syrup to European traders, who resold it without identifying the previous owner — an attempt to keep buyers from bypassing them on future orders.

As a result, most of the buyers did not know that the ingredient came from China, known for producing counterfeit products, nor did they show much interest in finding out.

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– This article is from the NY Times and they insist that folks have an ID and a PW in order to read their stuff. You can get these for free just by signing up. However, recently, a friend of mine suggested the website bugmenot.com :arrow: as an alternative to having to do these annoying sign ups. Check it out. Thx Bruce S. for the tip.

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