Sunday, May 06, 2007


Syrupy killer in medicine bottle (excerpt)

Read the whole article at www.chron.com....

Records show in 3 of last 4 global cases, the poison sold as glycerin was made in China

A syrupy poison, diethylene glycol, is an indispensable part of the modern world, an industrial solvent and prime ingredient in antifreeze. It also is a killer. And the deaths, if not intentional, are often no accident.

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

Many of them are children, poisoned at the hands of their unsuspecting parents.

Over the years, the poison has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — a result of 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 around the world in the past two decades. Researchers estimate that thousands have died. In many cases, the origin of the poison hasn't been determined.

But records and interviews show that in three of the last four cases it was made in China.

Panama is the most recent victim. Last year, government officials there unwittingly mixed diethylene glycol into 260,000 bottles of cold medicine — with devastating results. Families have reported 365 deaths from the poison, 100 of which have been confirmed.

With the onset of the rainy season, investigators are racing to exhume as many potential victims as possible before bodies decompose even more.

Panama's death toll leads directly to Chinese companies that made and exported the poison as 99.5 percent pure glycerin. Forty-six barrels of the toxic syrup arrived via a poison pipeline stretching halfway around the world.

Through shipping records and interviews with government officials, The New York Times traced this pipeline from the Panamanian port of Colon, back through trading companies in Barcelona, Spain, and Beijing, to its 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 of them tested the syrup to confirm what was on the label. Along the way, a certificate falsely attesting to the purity of the shipment was repeatedly altered, 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.

An examination of the two poisoning cases 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.

Last week, the U.S. Food and Drug Administration warned drug makers and suppliers in the United States "to be especially vigilant" in watching for diethylene glycol. The warning did not specifically mention China, and it said there was "no reason to believe" that glycerin in this country was tainted.

Even so, the agency called for all glycerin shipments to be tested for diethylene glycol, and said it was "exploring how supplies of glycerin become contaminated."

China is already being accused by U.S. authorities of exporting wheat gluten 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 in the United States.

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 brands of fever medication 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 that given the amount of medication distributed, 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."

The makers of counterfeit glycerin, which superficially looks and acts like the real thing but generally costs considerably less, are rarely identified, much less prosecuted, given the difficulty of tracing shipments across borders. "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 top representative in Beijing.

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.

The FDA has tried to help in poisoning cases around the world, but there is only so much it can do.

When at least 88 children died in Haiti a decade ago, FDA investigators traced the poison to the Manchurian city of Dalian, but their attempts to visit the suspected manufacturer were repeatedly blocked by Chinese officials, according to internal State Department records. Permission came more than a year later, but by then the plant had moved and its records were destroyed.

"Chinese officials we contacted on this matter were all reluctant to become involved," the American Embassy in Beijing wrote in a confidential cable. "We cannot be optimistic about our chances for success in tracking down the other possible glycerine shipments."

In fact, The New York Times found records showing that the same Chinese company implicated in the Haiti poisoning also shipped about 50 tons of counterfeit glycerin to the United States in 1995. Some of it was later resold to another American customer, Avatar Corp., before the deception was discovered.
"Thank God we caught it when we did," said Phil Ternes, chief operating officer of Avatar, a Chicago-area supplier of bulk pharmaceuticals and nonmedicinal products. The FDA said it was unaware of the shipment.

In China, the government is vowing to clean up its pharmaceutical industry, in part because of criticism over counterfeit drugs flooding the 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 down last year, the World Health Organization 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, the Beijing-based broker that investigators say was a crucial conduit for the Panama poison.

Yuan Kailin, a former salesman for the Glycerine Factory, said he knew what the TD meant because a friend and former manager of the factory, Ding Yuming, had once told him. TD stood for the Chinese word "tidai" (tee-die), said Yuan, who left his job in 1998 and still lives about a mile from the factory.

In English, tidai means substitute. A clue that might have revealed that the poison was hiding in plain sight.

It was in the product name.