Sunday, May 06, 2007

Adulterated And Counterfeit Chinese Ingredients Sicken And Kill Thousands

A quick math question: If the FDA inspects less than 2% of all imported food and food ingredients (and those are their numbers, not mine), what are the odds that a given Chinese shipment marked Food Grade Glycerin--one that actually held container after container of the cheap, sweet, and lethally poisonous antifreeze diethylene glycol--would be intercepted before its consignors distributed it far and wide, where it would be poured into cough syrups and toothpaste, then shipped to consumers who, along with their children, would be poisoned and killed?

Now consider this: the above scenario has happened, and is still happening, in other countries. I imagine you are quite rightly worried. The FDA would appear to be getting there, too--on March 21, 2007, the agency quietly issued an Import Alert, calling for increased surveillance--not an outright ban or full-scale, mandatory inspections--of glycerin imports. Then, on May 4th, the FDA sent out an advisory to pharmaceutical manufacturers, drug repackers, and other health professionals:

The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.

At the present time, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.

And appearing in today's New York Times is this disturbing, must-read article:

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

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

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

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 precise origin of the poison has never been determined. But records and interviews show that in three of the last four cases it was made in China, a major source of counterfeit drugs.

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 so far. 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 Colón, 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 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 United States 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 asked that all glycerin shipments be tested for diethylene glycol, and said it was “exploring how supplies of glycerin become contaminated.”

It is a long and harrowing piece, one I can't recommend enough.

And in a related story, news on the adulterated food front keeps getting worse. Last week, the FDA began inspecting American food-processing facilities--as in, manufacturers of food meant for humans--and Chinese authorities detained one manager working at Xuzhou Anying, exporters of the tainted wheat gluten that U.S. company ChemNutra resold to Menu Foods and other manufacturers.

Surely I'm not alone in wondering exactly how big the Big Picture really is? Here we are, witnessing the dark and deadly effects wrought by a disturbing new strain of unbound, unchecked capitalism, one that takes the form of opportunistic criminals driving overseas containers through the gaping holes in our regulatory system. Yet only a handful of bloggers--Goldy (who wonders if the fake glycerin may have caused all the renal failure in American cats and dogs), as well as the folks at Ichmo and Pet Connection, for example--and newspaper writers seem to be following through with the developments, observing the connections, pointing out the deeply worrisome implications.

I was particularly struck by this quote in the above-linked Times article:

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 L. Bennish, a pediatrician who works in developing countries, smuggled samples of the tainted syrup out of the country in a suitcase. Dr. 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.”

In the thousands or tens of thousands.

Terrorism attacked us on our own soil in 2001, but human greed would appear to be going one step further, attacking us within our own bodies. Poisoning our food and our medicine; poisoning adults and children and animals--around the world, and here at home. Poisoning us.

Also at Ezra's place and Shakesville.

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