China Blames Panama on Tainted Drugs

Thursday, May 31, 2007

By ALEXA OLESEN, Associated Press Writer

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BEIJING —

Businesses in Panama, not China were "mainly responsible" for passing off an industrial chemical as a medical ingredient leading to the deaths of at least 51 people, a senior official in China's product-inspection agency said Thursday.

Wei Chuanzhong, vice minister of the Administration for Quality Supervision, Inspection and Quarantine, said Chinese companies sold the industrial solvent called 'TD glycerin', to Spanish companies who then sold it to Panamanian companies. The product was then used to make cough syrup and other medicine.

"The Panamanian business people are mainly responsible because they changed the scope of use and shelf-life of this product," Wei said.

Wei also dismissed concerns about exported Chinese toothpaste made with diethylene glycol, a chemical cousin of antifreeze and the same substance that caused the deaths in Panama.

Thousands of tubes of Chinese-made "Mr. Cool" and "Excell" branded toothpaste have been seized in the Dominican Republic, Panama, Costa Rica and Nicaragua after a consumer alerted authorities that diethylene glycol was listed as an ingredient.

Wei said there was "no sound evidence" to indicate that the chemical was dangerous in very low concentrations. He suggested that the seized Chinese brands had safe amounts of the chemical but didn't give specifics. He said China would issue clear guidelines for its use.

The deaths in Panama, which began last year, have dramatically added to a growing international alarm about the safety of food and medicines exported by China.

A slew of Chinese exports have recently been banned or turned away by U.S. inspectors including, wheat gluten tainted with the chemical melamine that has been blamed for dog and cat deaths in North America, monkfish that turned out to be toxic pufferfish, drug-laced frozen eel, and juice made with unsafe color additives.

China's dismal drug safety record was underscored this week by a Chinese court's decision to sentence the country's former top drug regulator to death on charges of corruption and negligence.

In the case of Panama's deadly medicine, China admits it was the source of the deadly chemical that ended up in cough syrup and other treatments but insists the chemical was originally labeled as for industrial use only.

Wei acknowledged that the Chinese manufacturer, Taixing Glycerin Factory, and the Chinese distributor, CNSC Fortune Way, "engaged in some misconduct," because they used the name TD glycerin for a mix of 15 percent diethylene glycol and "other substances."

Diethylene glycol, or DEG, is a thickening agent used as a low-cost _ but frequently deadly _ substitute for glycerin, a sweetener commonly used in drugs.

"They used the very confusing name of TD glycerin, which will mislead people to think it's glycerin," said Wei. "The markings on the package also used the name glycerin instead of TD glycerin."

But he said the Panama traders bore the brunt of the responsibility for the deadly substance ending up in medicine.

"The Panama trader changed or altered the paperwork to say the substance was medical glycerin that met U.S. standards for use in medical products and changed the shelf life of the already expired product from one year to four years," Wei said. "The responsibility here is very clear."

He said the agency launched an investigation into the matter last October at the request of the U.S. Food and Drug Administration and another follow-up investigation earlier this month after a swell of media interest in the case.

Those inquiries found that 25,020 pounds of so-called TD glycerin made by the Taixing Glycerin Factory in eastern China's Jiangsu province was sold by state-owned distributor CNSC Fortune Way to Spain's Rasfer company in July 2003 for $10,250.

Rasfer told the agency that the Chinese sellers made it clear that the material they were sold was for industrial, not medical, use.

An investigation by the U.S. FDA found that the material was later resold to a Panamanian company, which relabeled it as medical glycerin and changed its shelf life to four years from one. It was finally sold to Panama's national health system, which used it make cough syrup, antihistamine tablets, calamine lotion and rash ointment.

Wei said Taixing had been punished for its misbehavior but when pressed for details, he said the company was still being investigated.

He said China would not continue to allow the use of the name TD glycerin, but no ban has been formally announced.

The first documented poisonings in Panama were reported in October, but authorities there have said that earlier cases may have gone undetected. Fifty-one people died after taking the tainted medications and 68 were hospitalized.

Former Director of the State Food and Drug Administration Zheng Xiaoyu was sentenced to death on Tuesday by a Beijing court for taking bribes in cash and gifts worth more than $832,000 in return for allowing eight companies to get around drug approval rules.

State media have reported that drugs improperly approved by Zheng's agency included an antibiotic that killed at least 10 patients last year before it was taken off the market.