Mass poisonings tied to toxic syrup

A syrupy poison, diethylene glycol, is an indispensable part of the modern world, an industrial solvent and prime ingredient in antifreeze.

It is also a killer, and deaths, if not intentional, often are no accident.

Kidneys fail first. Then the central nervous system begins to misfire. Paralysis spreads, making breathing difficult and often impossible without assistance. In the end, most victims die.

Many are children, poisoned by their unsuspecting parents.

The poison over the years has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — by counterfeiters who profit by substituting the sweet-tasting solvent for a safe, more expensive syrup, usually glycerin, commonly used in drugs, food, toothpaste and other products.

Toxic syrup has figured in at least eight mass poisonings in the past 20 years. Researchers estimate thousands have died. In many cases, the origin of the poison never has been determined. But records and interviews show that in three of the past four outbreaks it was made in China, a major source of counterfeit drugs.

Panama is the most recent victim. Anticipating colds and coughs during the long rainy season, government officials last year unwittingly mixed diethylene glycol into 260,000 bottles of cold medicine. The result was devastating.

Families have reported 365 deaths, 100 of which have been confirmed.

Sparked FDA's creation

Seventy years ago, medicine laced with diethylene glycol killed more than 100 people in the United States, leading to the passage of the toughest drug regulations of that era and the creation of the modern Food and Drug Administration (FDA).

The FDA last week said there was "no reason to believe" that glycerin in this country is tainted, but the agency warned U.S. drug makers and suppliers "to be especially vigilant" in watching for diethylene glycol. The warning did not mention China.

Panama's death toll leads directly to Chinese companies that made and exported the poison as 99.5 percent pure glycerin.

Through shipping records and interviews with government officials, The New York Times traced 46 barrels of the toxic syrup from the Panamanian port of Colon, back through trading companies in Barcelona, Spain, and Beijing, to a beginning near the Yangtze Delta in a place local people call "chemical country."

The counterfeit glycerin passed through three trading companies on three continents, yet not one tested the syrup to confirm what was on the label. A certificate falsely attesting to the purity of the shipment was altered repeatedly, eliminating the name of the manufacturer and previous owner. As a result, traders bought the syrup without knowing where it came from, or who made it.

With this information, the traders might have discovered — as The New York Times did — that the manufacturer was not certified to make pharmaceutical ingredients.

China safety rules lag

An examination of the two poisoning outbreaks last year — in Panama and earlier in China — shows how China's safety regulations have lagged behind its growing role as low-cost supplier to the world. It also demonstrates how a poorly policed chain of traders in country after country allows counterfeit medicine to contaminate the global market.

China already is being accused by U.S. authorities of exporting wheat gluten tainted with an industrial chemical, melamine, that ended up in pet food and animal feed. The FDA recently banned imports of Chinese-made wheat gluten after it was linked to pet deaths.

Beyond Panama and China, toxic syrup has caused mass poisonings in Haiti, Bangladesh, Argentina, Nigeria, and twice in India.

In Bangladesh, investigators found poison in seven fever medications in 1992, but only after countless children died. A Massachusetts laboratory detected the contamination after Dr. Michael Bennish, a pediatrician who works in developing countries, smuggled samples of the tainted syrup out of the country in a suitcase. Bennish, who investigated the Bangladesh epidemic and helped write a 1995 article about it for BMJ, formerly known as the British Medical Journal, said deaths "must be in the thousands or tens of thousands."

"It's vastly underreported," Bennish said of diethylene-glycol poisoning. Doctors might not suspect toxic medicine, particularly in poor countries with limited resources and a generally unhealthy population, he said, adding: "Most people who die don't come to a medical facility."

Makers rarely identified

Makers of counterfeit glycerin, which superficially looks and acts like the real thing but generally costs considerably less, rarely are identified, much less prosecuted, given the difficulty of tracing shipments.

"This is really a global problem, and it needs to be handled in a global way," said Dr. Henk Bekedam, the World Health Organization's (WHO's) top representative in Beijing.

In China, the government is vowing to clean up its pharmaceutical industry, in part because of criticism over counterfeit drugs flooding world markets. In December, two top drug regulators were arrested on charges of taking bribes to approve drugs. In addition, 440 counterfeiting operations were closed last year, the WHO said.

But when Chinese officials investigated the role of Chinese companies in the Panama deaths, they found that no laws had been broken, according to an official of the nation's drug-enforcement agency.

China's drug regulation is "a black hole," said one trader who has done business through CNSC Fortune Way, a Beijing-based broker investigators say was a crucial conduit for the Panama poison.