Sunday, May 06, 2007

Poisoned medicine: Even I am stunned.

[updated to include a link to the 2/07 story.]

I've written relentlessly about the Melanine pet food poisoning for four reasons. One is personal - our pack includes a dog. Another is personal - our pack includes children who eat food. A third is personal - our pack includes dogs and children who take medicines. A fourth is moral - even in the age of the GOP (the waning days we pray) we are still somewhat more protected than many others.

Now, in a Pulitzer Prize class story, Bogdanich and Hooker of the NYT have dropped the next bombshell. This is one of a series of related NYT exposes, including a 2/07 story on how Chinese counterfeit medications in Africa may have killed over a hundred thousand people.

This is not only a story of "foreign" suffering. Did you know that in 1995 50 tons of poisonous glycol was shipped to the US from China and was barely stopped from entering our medication supply? Another instance of how the stories not told are far more important than the average celebrity headline.

Any resemblance between this story and the recent pet poisoning story is, of course, fundamental. Emphases mine.
From China to Panama, a Trail of Poisoned Medicine - New York Times
Published: May 6, 2007

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.

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 [jf: they thought it was glycerin] mixed diethylene glycol into 260,000 bottles of cold medicine — with devastating results. Families have reported 365 deaths from the poison...

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 [jf: note "asked", not required] that all glycerin shipments be tested for diethylene glycol, and said it was “exploring how supplies of glycerin become contaminated.”...

... 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 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.”..

... 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...

...When at least 88 children died in Haiti a decade ago, F.D.A. 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 was granted more than a year later, but by then the plant had moved and its records had been 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 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 Corporation, before the deception was discovered. [jf: what the #$!#$@?]

“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 F.D.A. 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.

In this environment, Wang Guiping, a tailor with a ninth-grade education and access to a chemistry book, found it easy to enter the pharmaceutical supply business as a middleman. He quickly discovered what others had before him: that counterfeiting was a simple way to increase profits.

And then people in China began to die...

... Panamanians wanting to see where their toxic nightmare began could look up the Web site of the company in Hengxiang, China, that investigators in four countries have identified as having made the syrup — the Taixing Glycerine Factory...

... The Taixing Glycerine Factory bought its diethylene glycol from the same manufacturer as Mr. Wang, the former tailor, the government investigator said. From this spot in China’s chemical country, the 46 barrels of toxic syrup began their journey, passing from company to company, port to port and country to country, apparently without anyone testing their contents.

Traders should be thoroughly familiar with their suppliers, United States health officials say. “One simply does not assume that what is labeled is indeed what it is,” said Dr. Murray Lumpkin, deputy commissioner for international and special programs for the Food and Drug Administration.

In the Panama case, names of suppliers were removed from shipping documents as they passed from one entity to the next, according to records and investigators. That is a practice some traders use to prevent customers from bypassing them on future purchases, but it also hides the provenance of the product.

The first distributor was the Beijing trading company, CNSC Fortune Way, a unit of a state-owned business that began by supplying goods and services to Chinese personnel and business officials overseas.

As China’s market reach expanded, Fortune Way focused its business on pharmaceutical ingredients, and in 2003, it brokered the sale of the suspect syrup made by the Taixing Glycerine Factory. The manufacturer’s certificate of analysis showed the batch to be 99.5 percent pure.

Whether the Taixing Glycerine Factory actually performed the test has not been publicly disclosed.

Original certificates of analysis should be passed on to each new buyer, said Kevin J. McGlue, a board member of the International Pharmaceutical Excipients Council. In this case, that was not done.

Fortune Way translated the certificate into English, putting its name — not the Taixing Glycerine Factory’s — at the top of the document, before shipping the barrels to a second trading company, this one in Barcelona...

...Upon receiving the barrels in September 2003, the Spanish company, Rasfer International, did not test the contents, either. It copied the chemical analysis provided by Fortune Way, then put its logo on it. Ascensión Criado, Rasfer’s manager, said in an e-mail response to written questions that when Fortune Way shipped the syrup, it did not say who made it.

Several weeks later, Rasfer shipped the drums to a Panamanian broker, the Medicom Business Group. “Medicom never asked us for the name of the manufacturer,” Ms. Criado said...

...In Panama, the barrels sat unused for more than two years, and officials said Medicom improperly changed the expiration date on the syrup.

During that time, the company never tested the product. And the Panamanian government, which bought the 46 barrels and used them to make cold medicine, also failed to detect the poison, officials said...

... Last fall, at the request of the United States — Panama has no diplomatic relations with China — the State Food and Drug Administration of China investigated the Taixing Glycerine Factory and Fortune Way.

The agency tested one batch of glycerin from the factory, and found no glycerin, only diethylene glycol and two other substances, a drug official said.

Since then, the Chinese drug administration has concluded that it has no jurisdiction in the case because the factory is not certified to make medicine.

The agency reached a similar conclusion about Fortune Way, saying that as an exporter it was not engaged in the pharmaceutical business.

“We did not find any evidence that either of these companies had broken the law,” said Yan Jiangying, a spokeswoman for the drug administration. “So a criminal investigation was never opened.”

A drug official said the investigation was subsequently handed off to an agency that tests and certifies commercial products — the General Administration of Quality Supervision, Inspection and Quarantine.

But the agency acted surprised to learn that it was now in charge. “What investigation?” asked Wang Jian, director of its Taixing branch. “I’m not aware of any investigation involving a glycerin factory.”

Besides, Huang Tong, an investigator in that office, said, “We rarely get involved in products that are sold for export.”...
This is not a system that's broken in a small way.

This is not a problem of "just" food or "just" medication or "just" lead poisoned tree ornaments or "just" fake fur that isn't or "just" contaminated herbal remedies. This is the return to our life of the conditions of 1930s America, an age before effective regulation and effective government. This is not a "China problem", though China because of its scale and power is at the center of it today.

We have a global trading system that's in crisis, colliding with a US government that's incompetent and paralyzed. Whoever takes over after Bush shuffles off will need to address this extremely aggressively.

Can we have a world trading system without the beginnings of a world legal and governmental system?

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