As FDA tracked poison, trail went cold in China
Tighter global oversight of drug ingredients urged
By Walt Bogdanich, New York Times News Service | June 17, 2007
NEW YORK -- 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 US 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 FDA's mission ultimately failed. By the time an FDA 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 FDA's efforts to investigate the Haiti poisonings, documented in internal FDA 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.
China itself was a victim of diethylene glycol poisoning last year when at least 18 people died after ingesting poisonous medicine made there. In the wake of the deaths, and reports of pet food and other products contaminated with dangerous ingredients from China, officials there announced that they would overhaul the regulation of food, drugs, and chemicals.
Beyond the three incidents linked to Chinese diethylene glycol, there have been at least five other mass poisonings involving the mislabeled chemical in the past two decades -- in Bangladesh, Nigeria, Argentina, and twice in India.
"This problem keeps coming back," said Joshua G. Schier, a toxicologist with the Centers for Disease Control and Prevention. And no wonder: The counterfeiters are rarely identified, much less prosecuted.
Finding a way to keep diethylene glycol out of medicine, particularly in developing countries, has confounded health officials for decades. "It is preventable, and we have to figure out some way of stopping this from happening again," said Carol Rubin, a senior CDC official.
In a global economy, ingredients for drugs are often bought and sold many times in different countries, sometimes without proper paperwork, all of which increases the risk of fraud, the authorities say. The Panama poison passed through five hands, the Haitian poison six. In both instances, the factory's original certificate of analysis, attesting to the contents of the shipment and its provenance, did not accompany the product as it moved around the world.
"Where there is a loophole in the system, a frailty in the system, it's the ability of an unscrupulous distributor to take industrial or technical material and pass it off as pharmaceutical grade," said Kevin J. McGlue, a board member of the International Pharmaceutical Excipients Council.
The United States may not have gotten what it wanted from China, but the crisis in Haiti did bring together health groups to search for ways to stop diethylene glycol poisonings. At a workshop in Washington in February 1997, health officials recommended that certificates of analysis be improved to allow users to "trace the product back through every intermediary, broker, and repackager to the original manufacturer."
Workshop participants also called for better testing of drug ingredients and asked governments to tighten oversight of drug manufacturing.
© Copyright 2007 Globe Newspaper Company. |
