中国製医薬品とペットフードから毒性物質


  

2007年05月09日 asahi.com

中国製医薬品とペットフードから毒性物質 100人死亡

 中国外務省などは8日、パナマ向けに輸出された薬用甘味料のグリセリンと、米国とカナダへ輸出されたペットフードにそれぞれ毒性物質が混入していたと発表した。6日付米ニューヨーク・タイムズ紙はパナマで100人の死亡が確認されたと報道。同省の姜瑜副報道局長は8日の会見で「グリセリンの代わりに医薬品には使用できない化学薬品が使われた」と述べ、因果関係を認めた。

 ニューヨーク・タイムズ紙などによると、パナマで昨年、内臓の機能低下などの不調を訴えた多数の患者が原因不明で死亡。患者らが服用したかぜ薬の原料として「グリセリン」と表示があったが、パナマ政府の依頼で米食品医薬品局(FDA)が調査したところ、ジエチレングリコールが含まれていたことが判明した。

 ジエチレングリコールはグリセリンと比べて格段に安価。江蘇省にある化学薬品会社がグリセリンに混ぜて製造し、スペインや中国の貿易会社を通じて輸出されたという。

 同紙によると、パナマでは365人の死亡報告があり、うちこれまでに100人の死因がジエチレングリコールと確認されているという。同紙は昨年判明したパナマと中国の例は製造元が中国企業と確認できたが、確認できなかった「有毒甘味料」による被害が過去にハイチやバングラデシュ、アルゼンチン、ナイジェリア、インドでもあったと報じている。

 一方、中国の国家品質監督検査検疫総局は8日、江蘇省と山東省の2社が製造して北米に輸出されたペットフードからも、樹脂などに使われるメラミンが違法に添加されていたと発表した。

 米国とカナダでは今年3月、これらのペットフードを食べた数百匹の犬と猫が原因不明で死亡。FDAが中国側に調査を依頼していた。同総局は2社の責任者らを立件する方針。

 同総局はさらに、179社の食料品輸出企業について緊急立ち入り検査をしたほか、粉ミルクやめん類など12種類の小麦製品のサンプル調査も実施。いずれも異状はなかったという。

 

記事入力 : 2007/05/07 11:24:18
中国産毒性物質、風邪薬として売られていた
パナマで被害相次ぐ

 昨年9月、パナマシティの公衆病院に特異な症状を訴える患者らが押し寄せた。この患者らは、身体の一部の機能が停止または麻痺し、中には呼吸困難に陥った患者までいた。死亡者も続出したが、はっきりとした原因は分からないままだった。

 唯一の手がかりは、患者らがある風邪シロップを飲んだ後に異変を見せ始めたという点だけだった。そこでついに米国の医療陣までもが急きょ派遣され、1カ月余りの調査の結果、風邪シロップに含まれていた「ディエチレン・グリコール」が原因であることが判明した。産業用に幅広く使用されているこの化学物質は、食用が禁止されている毒性物質。現在までに申告された死亡者数は365人で、このうち当局の調査で確認された死亡者数は100人余りに達し、被害者の大半は母親が与えたシロップを飲んだ幼い子供たちだった。

 さらに問題の風邪薬は、政府が配布したものだっただけに大きな衝撃が走っている。昨年5月、パナマ保険当局は長期にわたる雨期を控え、26万本の風邪シロップを製造・配布していた。

 ところで、政府が配布した医薬品に毒性物質が混入するなどということが、なぜ起きたのだろうか。

 その最大の原因は中国で製造された偽造薬だった。米紙ニューヨーク・タイムズは6日付で、中国で製造された毒性物質が、どのようにして地球の裏側のパナマに風邪薬と偽って流通したのかについて、そのルートを追跡、報道した。

 当初、パナマ当局が風邪薬の材料を調達する際、シロップのビンに記されていたのは、せき止め薬や解熱剤によく使用される「グリセリン」だった。しかし、グリセリンは価格が高いため、一部の悪徳業者らが、価格が半分程度の産業用「ディエチレン・グリコール」を使用することがあるという。

 こうした毒性シロップは、これまでにもハイチやバングラデシュ、アルゼンチン、ナイジェリア、インドなど、世界各地で発生した多くの毒物・劇物集団死亡事件の原因として推定されてきた。しかし、毒性物質の出どころはこれまで謎に包まれていた。

 ニューヨーク・タイムズは、パナマ事件に関連する書類や役人らの証言を通じ、この毒性薬品の出どころの逆追跡調査を行った。その結果、パナマ・コロン港を通じて輸入された偽造の「99.5%純粋グリセリン」薬ビンが、北京の貿易会社とスペイン・バルセロナの貿易会社を経て輸入されていたことが判明した。また、この偽造シロップは、アジア、欧州、中米の3大陸を経て売買されていたが、この間書類だけを交わし、誰も薬の内容をきちんと確認していなかったことも明らかになった。

 そして、この偽造薬を製造したのは、上海近郊の恒祥に位置するある化学薬品工場だったことも分かった。工場が位置する揚子江三角州工業団地では、無許可の偽造薬品製造工場らとブローカーらが公然と活動している、とニューヨーク・タイムズは暴露した。

 ニューヨーク・タイムズは、今回のケースが▲中国製商品が世界市場で占める比重に比べ、安全に関する規制がどれほど遅れているか、▲国家間の通関・検疫手続きが偽造薬品の流通にどれほど無力なのかを示す代表的なケースと指摘した。

 

May 7, 2007

FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to Humans
from Food Containing Melamine
USDA Releases Some Swine and Poultry for Processing

There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds, according to an assessment conducted by scientists from five federal agencies.

In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe. In other words, it was well below any level of public health concern.

 

2007-04-29 www.chinaview.cn

100 die of diethylene glycol poisoning in Panama

A total of 100 people have died from taking medicines contaminated with diethylene glycol since the first documented poisonings were reported last October, Panama's Ministry of Health said on Saturday.

    The investigation into the deaths of another 203 people is still under way to make clear if diethylene glycol poisoning is behind the deaths, prosecutors said.

    The poisonings first surfaced in the summer of 2006 as many people died mysteriously with symptoms such as kidney damages and physical paralysis.

    Investigators confirmed in October that the people had died of diethylene glycol poisoning.

    Panama's Medicom company allegedly sold tainted ingredients to a pharmaceutical factory, which used them to produce medicines.

    Panama could become the country with the most deaths caused by diethylene glycol poisoning, authorities said.

    A total of 200 people died in Bangladesh earlier in the 1990s and 105 people died in 1937 in the United States from diethylene glycol poisoning.


May 6, 2007 New York Times

From China to Panama, a Trail of Poisoned Medicine

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.

Chemical country The Taixing countryside in eastern China, near the Yangtze Delta. Forty-six barrels of toxic syrup followed a path from a factory in the nearby small town of Hengxiang to Panama.

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."

China is already being accused by United States authorities of exporting wheat gluten containing an industrial chemical, melamine, that ended up in pet food and livestock feed. The F.D.A. 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 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."

Its vastly underreported,Dr. 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 dont 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 Organizations 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 F.D.A. 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, 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.

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 nations drug enforcement agency. Chinas 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.

Cheating the System

Mr. Wang spent years as a tailor in the manufacturing towns of the Yangtze Delta, in eastern China. But he did not want to remain a common craftsman, villagers say. He set his sights on trading chemicals, a business rooted in the many small chemical plants that have sprouted in the region.

He didnt know what he was doing,Mr. Wangs older brother, Wang Guoping, said in an interview. He didnt understand chemicals.

But he did understand how to cheat the system.

Wang Guiping, 41, realized he could earn extra money by substituting cheaper, industrial-grade syrup - not approved for human consumption - for pharmaceutical grade syrup. To trick pharmaceutical buyers, he forged his licenses and laboratory analysis reports, records show.

Mr. Wang later told investigators that he figured no harm would come from the substitution, because he initially tested a small quantity. He did it with the expertise of a former tailor.

He swallowed some of it. When nothing happened, he shipped it.

One company that used the syrup beginning in early 2005 was Qiqihar No. 2 Pharmaceutical, about 1,000 miles away in Heilongjiang Province in the northeast. A buyer for the factory had seen a posting for Mr. Wang
s syrup on an industry Web site.

After a while, Mr. Wang set out to find an even cheaper substitute syrup so he could increase his profit even more, according to a Chinese investigator. In a chemical book he found what he was looking for: another odorless syrup - diethylene glycol. At the time, it sold for 6,000 to 7,000 yuan a ton, or about $725 to $845, while pharmaceutical-grade syrup cost 15,000 yuan, or about $1,815, according to the investigator.

Mr. Wang did not taste-test this second batch of syrup before shipping it to Qiqihar Pharmaceutical, the government investigator said, adding, He knew it was dangerous, but he didnt know that it could kill.

The manufacturer used the toxic syrup in five drug products: ampules of Amillarisin A for gall bladder problems; a special enema fluid for children; an injection for blood vessel diseases; an intravenous pain reliever; and an arthritis treatment.

In April 2006, one of southern Chinas finest hospitals, in Guangzhou, Guangdong Province, began administering Amillarisin A. Within a month or so, at least 18 people had died after taking the medicine, though some had already been quite sick.

Zhou Jianhong, 33, said his father took his first dose of Amillarisin A on April 19. A week later he was in critical condition. If you are going to die, you want to die at home,Mr. Zhou said. So we checked him out of the hospital.He died the next day.

Everybody wants to invest in the pharmaceutical industry and it is growing, but the regulators cant keep up,Mr. Zhou said. We need a system to assure our safety.

The final death count is unclear, since some people who took the medicine may have died in less populated areas.

In a small town in Sichuan Province, a man named Zhou Lianghui said the authorities would not acknowledge that his wife had died from taking tainted Amillarisin A. But Mr. Zhou, 38, said he matched the identification number on the batch of medicine his wife received with a warning circular distributed by drug officials.

You probably cannot understand a small town if you are in Beijing,Zhou Lianghui said in a telephone interview. The sky is high, and the emperor is far away. There are a lot of problems here that the law cannot speak to.

The failure of the government to stop poison from contaminating the drug supply caused one of the bigger domestic scandals of the year. Last May, Chinas premier, Wen Jiabao, ordered an investigation of the deaths, declaring, The pharmaceutical market is in disorder.

 

At about the same time, 9,000 miles away in Panama, the long rainy season had begun. Anticipating colds and coughs, the government health program began manufacturing cough and antihistamine syrup. The cough medicine was sugarless so that even diabetics could use it.

The medicine was mixed with a pale yellow, almost translucent syrup that had arrived in 46 barrels from Barcelona on the container ship Tobias Maersk. Shipping records showed the contents to be 99.5 percent pure glycerin.

It would be months and many deaths later before that certification was discovered to be pure fiction.

A Mysterious Illness

Early last September, doctors at Panama Citys big public hospital began to notice patients exhibiting unusual symptoms.

They initially appeared to have Guillain-Barré syndrome, a relatively rare neurological disorder that first shows up as a weakness or tingling sensation in the legs. That weakness often intensifies, spreading upward to the arms and chest, sometimes causing total paralysis and an inability to breathe.

The new patients had paralysis, but it did not spread upward. They also quickly lost their ability to urinate, a condition not associated with Guillain-Barré. Even more unusual was the number of cases. In a full year, doctors might see eight cases of Guillain-Barré, yet they saw that many in just two weeks.

Doctors sought help from an infectious disease specialist, Néstor Sosa, an intense, driven doctor who competes in triathlons and high-level chess.

Dr. Sosas medical specialty had a long, rich history in Panama, once known as one of the worlds unhealthiest places. In one year in the late 1800s, a lethal mix of yellow fever and malaria killed nearly 1 in every 10 residents of Panama City. Only after the United States managed to overcome those mosquito-borne diseases was it able to build the Panama Canal without the devastation that undermined an earlier attempt by the French.

The suspected Guillain-Barré cases worried Dr. Sosa. It was something really extraordinary, something that was obviously reaching epidemic dimensions in our hospital,he said.

With the death rate from the mystery illness near 50 percent, Dr. Sosa alerted the hospital management, which asked him to set up and run a task force to handle the situation. The assignment, a daunting around-the-clock dash to catch a killer, was one he eagerly embraced.

Several years earlier, Dr. Sosa had watched as other doctors identified the cause of another epidemic, later identified as hantavirus, a pathogen spread by infected rodents.

I took care of patients but I somehow felt I did not do enough,he said. The next time, he vowed, would be different.

Dr. Sosa set up a 24-hour war roomin the hospital, where doctors could compare notes and theories as they scoured medical records for clues.

As a precaution, the patients with the mystery illness were segregated and placed in a large empty room awaiting renovation. Health care workers wore masks, heightening fears in the hospital and the community.

That spread a lot of panic,said Dr. Jorge Motta, a cardiologist who runs the Gorgas Memorial Institute, a widely respected medical research center in Panama. That is always a terrifying thought, that you will be the epicenter of a new infectious disease, and especially a new infectious disease that kills with a high rate of death, like this.

Meanwhile, patients kept coming, and hospital personnel could barely keep up.

I ended up giving C.P.R.,Dr. Sosa said. I havent given C.P.R. since I was a resident, but there were so many crises going on.

Frightened hospital patients had to watch others around them die for reasons no one understood, fearing that they might be next.

As reports of strange Guillain-Barré symptoms started coming in from other parts of the country, doctors realized they were not just dealing with a localized outbreak.

Pascuala Pérez de González, 67, sought treatment for a cold at a clinic in Coclé Province, about a three-hour drive from Panama City. In late September she was treated and sent home. Within days, she could no longer eat; she stopped urinating and went into convulsions.

A decision was made to take her to the public hospital in Panama City, but on the way she stopped breathing and had to be resuscitated. She arrived at the hospital in a deep coma and later died.

Medical records contained clues but also plenty of false leads. Early victims tended to be males older than 60 and diabetic with high blood pressure. About half had been given Lisinopril, a blood pressure medicine distributed by the public health system.

But many who did not receive Lisinopril still got sick. On the chance that those patients might have forgotten that they had taken the drug, doctors pulled Lisinopril from pharmacy shelves - only to return it after tests found nothing wrong.

Investigators would later discover that Lisinopril did play an important, if indirect role in the epidemic, but not in the way they had imagined.

A Major Clue

One patient of particular interest to Dr. Sosa came into the hospital with a heart attack, but no Guillain-Barré-type symptoms. While undergoing treatment, the patient received several drugs, including Lisinopril. After a while, he began to exhibit the same neurological distress that was the hallmark of the mystery illness.

This patient is a major clue,Dr. Sosa recalled saying. This is not something environmental, this is not a folk medicine thats been taken by the patients at home. This patient developed the disease in the hospital, in front of us.

Soon after, another patient told Dr. Sosa that he, too, developed symptoms after taking Lisinopril, but because the medicine made him cough, he also took cough syrup - the same syrup, it turned out, that had been given to the heart patient.

I said this has got to be it,Dr. Sosa recalled. We need to investigate this cough syrup.

The cough medicine had not initially aroused much suspicion because many victims did not remember taking it. Twenty-five percent of those people affected denied that they had taken cough syrup, because its a nonevent in their lives,Dr. Motta said.

Investigators from the United States Centers for Disease Control and Prevention, who were in Panama helping out, quickly put the bottles on a government jet and flew them to the United States for testing. The next day, Oct. 11, as Panamanian health officials were attending a news conference, a Blackberry in the room went off.

The tests, the C.D.C. was reporting, had turned up diethylene glycol in the cough syrup.

The mystery had been solved. The barrels labeled glycerin turned out to contain poison.

Dr. Sosas exhilaration at learning the cause did not last long. Its our medication that is killing these people,he said he thought. Its not a virus, its not something that they got outside, but it was something we actually manufactured.

A nationwide campaign was quickly begun to stop people from using the cough syrup. Neighborhoods were searched, but thousands of bottles either had been discarded or could not be found.

As the search wound down, two major tasks remained: count the dead and assign blame. Neither has been easy.

A precise accounting is all but impossible because, medical authorities say, victims were buried before the cause was known, and poor patients might not have seen doctors.

Another problem is that finding traces of diethylene glycol in decomposing bodies is difficult at best, medical experts say. Nonetheless, an Argentine pathologist who has studied diethylene glycol poisonings helped develop a test for the poison in exhumed bodies. Seven of the first nine bodies tested showed traces of the poison, Panamanian authorities said.

With the rainy season returning, though, the exhumations are about to end. Dr. José Vicente Pachar, director of Panamas Institute of Legal Medicine and Forensic Sciences, said that as a scientist he would like a final count of the dead. But he added, I should accept the reality that in the case of Panama we are not going to know the exact number.

Local prosecutors have made some arrests and are investigating others connected to the case, including officials of the import company and the government agency that mixed and distributed the cold medicine. Our responsibilities are to establish or discover the truth,said Dimas Guevara, the homicide investigator guiding the inquiry.

But prosecutors have yet to charge anyone with actually making the counterfeit glycerin. And if the Panama investigation unfolds as other inquiries have, it is highly unlikely that they ever will.

A Suspect Factory

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. There, under the words About Us,they would see a picture of a modern white building nearly a dozen stories tall, adorned by three arches at the entrance. The factory, the Web site boasts, can strictly obey the contract and keep its word.

But like the factorys syrup, all is not as it seems.

There are no tall buildings in Hengxiang, a country town with one main road. The factory is not certified to sell any medical ingredients, Chinese officials say. And it looks nothing like the picture on the Internet. In reality, its chemicals are mixed in a plain, one-story brick building.

The factory is in a walled compound, surrounded by small shops and farms. In the spring, nearby fields of rape paint the countryside yellow. Near the front gate, a sign over the road warns, Beware of counterfeits.But it was posted by a nearby noodle machine factory that appears to be worried about competition.

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 Chinas 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 Chinas 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 manufacturers 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 Factorys - at the top of the document, before shipping the barrels to a second trading company, this one in Barcelona.

Li Can, managing director at Fortune Way, said he did not remember the transaction and could not comment, adding, There is a high volume of trade.

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, Rasfers 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.

A lawyer for Medicom, Valentín Jaén, said his client was a victim, too. They were tricked by somebody,Mr. Jaén said. They operated in good faith.

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.

The toxic pipeline ultimately emptied into the bloodstream of people like Ernesto Osorio, a former high school teacher in Panama City. He spent two months in the hospital after ingesting poison cough syrup last September.

Just before Christmas, after a kidney dialysis treatment, Mr. Osorio stood outside the citys big public hospital in a tear-splattered shirt, describing what his life had become.

Im not an eighth of what I used to be,Mr. Osorio said, his partly paralyzed face hanging like a slab of meat. I have trouble walking. Look at my face, look at my tears.The tears, he said apologetically, were not from emotion, but from nerve damage.

And yet, Mr. Osorio knows he is one of the lucky victims.

They didnt know how to keep the killer out of the medicine,he said simply.

While the suffering in Panama was great, the potential profit - at least for the Spanish trading company, Rasfer - was surprisingly small. For the 46 barrels of glycerin, Rasfer paid Fortune Way $9,900, then sold them to Medicom for $11,322, according to records.

Chinese authorities have not disclosed how much Fortune Way and the Taixing Glycerine Factory made on their end, or how much they knew about what was in the barrels.

The fault has to be traced back to areas of production,said Dr. Motta, the cardiologist in Panama who helped uncover the source of the epidemic. This was my plea - please, this thing is happening to us, make sure whoever did this down the line is not doing it to Peru or Sierra Leone or some other place.

A Counterfeiters Confession

The power to prosecute the counterfeiters is now in the hands of the Chinese.

Last spring, the government moved quickly against Mr. Wang, the former tailor who poisoned Chinese residents.

The authorities caught up with him at a roadblock in Taizhou, a city just north of Taixing, in chemical country. He was weak and sick, and he had not eaten in two days. Inside his white sedan was a bankbook and cash. He had fled without his wife and teenage son.

Chinese patients were dead, a political scandal was brewing and the authorities wanted answers. Mr. Wang was taken to a hospital. Then, in long sessions with investigators, he gave them what they wanted, explaining his scheme, how he tested industrial syrup by drinking it, how he decided to use diethylene glycol and how he conned pharmaceutical companies into buying his syrup, according to a government official who was present for his interrogation.

He made a fortune, but none of it went to his family,said Wang Xiaodong, a former village official who knows Mr. Wang and his siblings. He liked to gamble.

Mr. Wang remains in custody as the authorities decide whether he should be put to death. The Qiqihar drug plant that made the poisonous medicine has been closed, and five employees are now being prosecuted for causing a serious accident.

In contrast to the Wang Guiping investigation, Chinese authorities have been tentative in acknowledging Chinas link to the Panama tragedy, which involved a state-owned trading company. No one in China has been charged with committing the fraud that ended up killing so many in Panama.

Sun Jing, the pharmaceutical program officer for the World Health Organization in Beijing, said the health agency sent a fax to remind the Chinese government that China should not be selling poisonous products overseas.Ms. Sun said the agency did not receive an official reply.

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. Im 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.

Wan Qigang, the legal representative for the Taixing Glycerine Factory, said in an interview late last year that the authorities had not questioned him about the Panama poisoning, and that his company made only industrial-grade glycerin.

I can tell you for certain that we have no connection with Panama or Spain,Mr. Wan said.

But in recent months, the Glycerine Factory has advertised 99.5 percent pure glycerin on the Internet.

Mr. Wan recently declined to answer any more questions. If you come here as a guest, I will welcome you,Mr. Wan said. But if you come again wanting to talk about this matter, I will make a telephone call.

A local government official said Mr. Wan was told not to grant interviews.

A five-minute walk away, another manufacturer, the Taixing White Oil Factory, also advertises medical glycerin on the Internet, yet it, too, has no authorization to make it. The companys Web site says its products have been exported to America, Australia and Italy.

Ding Xiang, who represents the White Oil Factory, denied that his company made pharmaceutical-grade glycerin, but he said chemical trading companies in Beijing often called, asking for it.

They want us to mark the barrels glycerin,Mr. Ding said in late December. I tell them we cannot do that.

Mr. Ding said he stopped answering calls from Beijing. If this stuff is taken overseas and improperly used. ...He did not complete the thought.

In chemical country, product names are not always what they seem.

The only two factories in Taixing that make glycerin dont even make glycerin,said Jiang Peng, who oversees inspections and investigations in the Taixing branch of the State Food and Drug Administration. It is a different product.

All in a Name

One lingering mystery involves the name of the product made by the Taixing Glycerine Factory. The factory had called its syrup TDglycerin. The letters TD were in virtually all the shipping documents. What did TD mean?

Spanish medical authorities concluded that it stood for a manufacturing process. Chinese inspectors thought it was the manufacturers secret formula.

But Yuan Kailin, a former salesman for the 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(pronounced tee-die), said Mr. Yuan, who left his job in 1998 and still lives about a mile from the factory.

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

It was in the product name.

FDA says beware of glycerin imported from China


Pharmaceutical News 7-May-2007

The Food and Drug Administration (FDA) in the United States has issued a warning to drug manufacturers, suppliers and health professionals that counterfeit drug additives have been using diethyline glycol, or DEG as a substitute for glycerin in cough medicine, fever medication and injectable drugs.
DEG is an industrial solvent commonly used in antifreeze and in recent years has caused deaths in Panama and Haiti when it was used as a substitute for glycerin, a more expensive sweet syrup, in cough medicine.
The FDA says some Chinese suppliers are using the poisonous DEG instead of glycerin and is warning manufacturers and suppliers of the importance of testing glycerin for DEG.
The FDA says although they have had no reported contamination cases as yet in the U.S. regarding DEG the most recent incident in Panama in September 2006 involved DEG-contaminated glycerin used in cough syrup and resulted in dozens of hospitalizations for serious injury and more than 40 deaths.
DEG is a chemical cousin of antifreeze that can cause kidney and neurological damage if ingested and though the source was eventually traced back by investigators in four countries to the Taixing Glycerine Factory factory in China, no one in China has ever been charged with causing the Panamanian deaths.
Previously in late 1995 and early 1996, at least 80 children also died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup.
Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths.
It was an incident in 1937 when more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections which led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation's primary statute on the regulation of drugs.
The FDA is reminding pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP).
The guidance provides recommendations for complying with CGMP and is intended to help them avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.
Apparently manufacturing and pharmacist organizations are working with the FDA to ensure controls are in place which guard against such a problem ever happening again in the U.S. or elsewhere.
Officials in the U.S. are currently investigating the contamination of pet foods with the chemical melamine again from China, which is normally used to make plastic kitchen utensils and fertilizers.
The poison has killed or sickened an unknown number of dogs and cats and led to the recall of more than 100 brands of pet food.
The incidents have raised concerns about the safety of imports from China to the U.S. and highlights the frequent lack of transparency on the part of Chinese officials.

 

May 9, 2007 shanghaiist.com

First it was our pets, now it's us! Chinese additive scandal grows

The term 'food poisoning' is taken to the next level in China, with reports that not only have ingredients from China been killing pets, but have now killed up to 365 humans too. The New York Times reports that a safe additive used in cough syrup was substituted with diethylene glycol (an industrial solvent and a prime ingredient in anti-freeze) by Chinese companies. When exported from China, the syrup was labelled as 99.5 percent pure glycerin (a safe ingredient). It passed over three continents without being quality tested, and arrived in Panama to be used in cough medicine. Most of the victims have been children, unwittingly poisoned by their parents.

The New York Times says:

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....

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

Diligence China, one of the more interesting sites lingering in our RSS feed reader, commented on this emerging scandal.

"There was a time when ex-pats and wealthy locals in China living in the Mainland bought foreign brands to avoid inferior products and dangerous, unregulated food and medicine. But now that practice has been flipped on its head. The danger is climbing the value chain and reaching our shelves - and our brands."

This latest report comes after it was discovered that melamine, the poisonous additive used in American pet foods that sickened thousands of animals, was exported as "non-food" and shipped through a third-party textile company. The New York Times has also reported that cyanuric acid, a common pool chemical, has also been added to animal feeds that may be involved in this pet food scandal.

As with the Panamanian diethylene glycol scandal, pets aren't only at danger from spiked foods. Low, and apparently harmless levels of melamine have also been detected in Canadian farmed-fish that were fed meal supplemented with contaminated constituents originating from China.

Shanghaiist isn't surprised by this turn of events given the bounty of assorted stomach ailments we've endured during our time in China. We wonder how our pooches and kitties have been faring as well.

 


May 11, 2007 ConsumerAffairs.Com

Chinese Companies Blamed for Pet Poisonings Closed Down

U.S. Inspectors Find the Plants Deserted; One Executive Detained

 

The two Chinese companies that exported the tainted -- and mislabeled -- ingredients linked to the deaths of thousands of pets in the United States are now closed and all their equipment is dismantled.

The Food and Drug Administration (FDA) sent food inspectors to China nearly two weeks ago to investigate the companies that made the melamine-tainted ingredients -- Xuzhou Anying Biologic Technology Development Co. and Futian Biology Technology Co. Ltd.

We visited the two facilities, but there's essentially nothing to be found in that they are currently closed down, not operating,Walter Batts, deputy director of the FDAs Office of International Programs, told reporters Thursday.

There's essentially nothing, as they have determined, that is available to be seen at the facilities. They've been closed down, machinery dismantled, nothing to really get access to.

All Ingredients Traced

The FDA traced all the tainted ingredients that triggered one of the largest pet food recalls in U.S. history to those two Chinese companies. Eighteen companies have recalled more than 5,500 pet food products since March.

The FDA on Thursday also reiterated that those Chinese companies mislabeled the melamine-tainted ingredients shipped to the United States. Those ingredients -- labeled as wheat gluten and rice protein -- are really wheat flour.

When our forensic chemistry center specifically looked into thatthey were able to measure the starch level of this product and determine that it wasn't in fact wheat gluten, but the wheat flour,said Dr. David Acheson, the FDAs new assistant commissioner for food protection.

He added: I can tell you that some of our testing has indicated that some of the melamine-positive material labeled as rice protein concentrate was not rice protein concentrate. It was indeed the ground up wheat flour with melamineso certainly some of the rice protein concentrate that we tested was mislabeled.

The FDA said the mislabeled melamine-tainted rice protein entered the U.S. in August of 2006; the mislabeled wheat gluten first came into the country in November 2006.

Those are the only two companies that we are aware of that sold this contaminated protein concentrate,said the FDAs Dr. Stephen Sundlof, director of the Center for Veterinary Medicine.

The FDA also confirmed that China has detained at least one official from these companies. U.S. food inspectors -- who are expected to return to the U.S. next week -- have not interviewed any officials with the Chinese manufacturers.

More Contaminated Fish Feed

In related news, the Oregon Department of Fish and Wildlife says additional hatcheries have received fish feed that is potentially tainted with melamine ? the same chemical found in the pet food linked to the deaths and illnesses of thousands of pets in the United States.

Melamine is used to make plastics and fertilizers. It is not approved for use in pet or human food in the United States.

Earlier this week, the FDA confirmed the presence of melamine in fish feed from the Canadian company, Skretting. FDA tests revealed one sample of fish feed at the Marion Forks Hatchery in Oregon contained that chemical.

The Skretting company recalled all the tainted fish feed -- made with contaminated rice protein from China -- earlier this week.

Recent testing by the USFDA has found a very low level of melamine in a batch of Bio-Oregon brand fish feed shipped to the United States,the company said in a written release. To date, Skretting has received no complaints related to unusual fish health issues.

Oregons Department of Fish and Wildlife said the following hatcheries received the tainted feed: Sandy, Willamette, Cole Rivers, Oak Springs, Oxbow, Salmon River, Butte Falls, Cascade, Wizard Falls, Marion Forks, Bonneville, Leaburg, South Santiam, Bandon, Elk River, Rock Creek, Fall River, Nehalem, Trask, McKenzie, Gnat Creek, Umatilla, Cedar Creek, Klamath, Looking Glass and Big Creek.

Based on our initial review it does not appear that any legal-sized rainbow trout from our hatcheries were fed any of the recalled product,said Steve Williams, Oregons deputy fish division administrator. However, we are working with the Oregon Department of Agriculture to test a sampling of fish that received the Skretting feed to determine if they contain melamine and in what levels.

Fish and Wildlife officials said the tainted product is a starter feed given to juvenile salmon and trout -- usually for a short time. These fish are eventually released and caught by anglers.

I want to emphasize that none of the fish appear to have any ill effects and there are no plans to destroy any of the fish,said Williams, adding his department is getting certification from all fish feed manufacturers to verify the products contain no melamine.

Minimal Risk to Humans

The FDA said the risk to humans who eat these fish is minimal.

Earlier this week, scientists from several federal agencies said the risk to humans who eat meat from the thousands of hogs and millions of chickens that consumed melamine-tainted feed is also minimal.

"We do not believe this poses any significant human-health threat," the FDAs Dr. Acheson said.

Regarding the specific health risks associated with these fish, Acheson added: Federal scientists from multiple agencies concluded that humans who may have eaten fish fed the melamine-containing feed face a very low health risk.

The FDA, however, will continue to sample fish that received the tainted feed.

Critics in Congress

Congresswoman Rosa L. DeLauro (D-Conn.) continues to criticize what she calls the countrys antiquated food safety system.

When the FDA announced last week that million of chickens in the U.S. may have consumed melamine-tainted feed, she said: The FDA initially tried to minimize the impact of the pet food recall and dismissed claims that the contaminated pet food could threaten the human food supply. And they were wrong.

"This discovery that as many as 20 million chickens on farms across the country may have been fed melamine contaminated feed highlights the egregious holes in our food safety system. Had this situation been approached with an open mind, these connections to animal feed could have been made sooner. We finally need to acknowledge that our antiquated food safety system has collapsed and is unable to protect the public health.

She added: This latest disclosure in the pet food recall demonstrates that our food safety system needs to be reformed. It is time to grant the FDA and other food safety agencies clear mandatory recall and inspection authority. These initial steps would help create a modern, comprehensive food safety agency that will be capable of protecting our food supply and restoring consumer confidence.

In other pet food recall news:

All vegetable protein products -- like wheat gluten or rice protein concentrate -- imported from China cannot come into the United States unless they've been tested for melamine, cyanuric acid, or other melamine-derived compounds, the FDA said.

The FDA is sampling pet food imported from China to see if those products contain melamine or melamine-related compounds. The agency said it will soon start sampling animal feed and fish feed imported from China;

FDA officials are visiting manufacturers in the United States that use protein concentrates in human, pet, or animal foods?and testing samples of the companiesproducts for melamine and melamine-related compounds. The agency said it will also sample some of the finished products;

The FDA said there are no indications that melamine-tainted bulk products were shipped directly to firms that manufacture products for humans;


2008/5/13 Platts

China quake causes ammonia leaks from chemical plants in Sichuan

A strong earthquake in China's Sichuan province on Monday caused liquid ammonia to leak from two chemical plants in Shifang city 十方市, the State Administration of Work Safety said late-Monday, without identifying the companies.
At least two chemical plants in Shifang were damaged, causing large amounts of liquid ammonia to sill, and up to 100 plant workers have been buried under debris, the work safety office said.
Shifang city is home to chemical plants operated by Hongda Chemicals, Shuangsheng Chemicals, Yongchang Chemicals and Yunxi Chemicals, among others.
The companies did not answer telephone calls on Tuesday. Their corporate web sites said they manufactured phosphoric acid, ammonium phosphate and other phosphorus-related chemical products. Shifang is rich in phosphorus ore.
The earthquake measuring 7.8 occurred at around 2:30 pm (0630 GMT) on Monday, striking 93 km (58 miles) from Chengdu, the capital of Sichuan province in southwest China. Tremors could be felt across the nation including Beijing and Shanghai, where thousands of people were evacuated from buildings.
The earthquake was China's worst in 30 years, the Financial Times said Tuesday.
China has closed several major highways and expressways in Sichuan and Shaanxi provinces, due to landslides caused by the earthquake, Xinhua news agency said Tuesday. The death toll from the earthquake was nearly 10,000 in Sichuan alone, local media said early-Tuesday.

512日の地震の震源から南西に50キロの四川省十方(Shifang)で500人が死亡、2000人ががれきの下に生き埋めとなっていることが明らかになった。国営テレビが13日、地元の救援当局の話として伝えた。


2008/5/14 Platts

China orders shutdown of oil, gas wells in quake-stricken areas

China has taken the precautionary measure of ordering companies operating coal mines, chemical plants and oil and natural gas wells to immediately halt production in regions hit by a devastating earthquake Monday that killed at least 12,000 people and has left tens of thousands still unaccounted for.
Sichuan province, where the 7.9 magnitude earthquake was centered, is rich in natural gas reserves. It accounted for 27% of the country's 58.55 billion cubic meters (2.07 Tcf) of gas output in 2006, according to figures released by the National Bureau of Statistics.
In a directive issued Tuesday, the State Administration of Work Safety said companies should evacuate all personnel from the affected regions and not resume production until conditions allow for safe operation.
Chinese state-controlled oil giants PetroChina and Sinopec both operate upstream subsidiaries in the affected regions.
Sinopec Southwest Company, based in Sichuan's Chengdu city, had shut most of its wells late-Tuesday, according to Chinese state media reports. The Sinopec wholly-owned subsidiary has also shut operations in areas worst affected by the earthquake, the China News Service reported. All personnel are safe and no serious financial losses reported so far, the report added.
The company operates more than 1,000 oil and gas wells, 310 gas stations and a 3,000 km gas pipeline grid. In 2007, it produced 2.7 Bcm of natural gas.
PetroChina Southwest Oilfield Branch Company, also based in Chengdu, produced 12.5 Bcm of natural gas and 145,000 mt of crude oil in 2006.
PetroChina's 10.5 million mt/year (210,000 b/d) Lanzhou refinery in northwestern China's Gansu province, its nearest refinery to the earthquake's epicenter, was not affected, a refinery source said Tuesday. PetroChina's other major refineries are further northwest, in Xinjiang, and in the northeast provinces of Heilongjiang, Jilin and Liaoning. All were unaffected.