Vaccine ingredient glycol involved in deaths worldwide.

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May 6, 2007

From China to Panama, a Trail of Poisoned Medicine By WALT BOGDANICH and

JAKE HOOKER

http://www.nytimes.com/2007/05/06/world/americas/06poison.html?th & emc=th

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 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. 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.”

“It’s 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 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 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 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.

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 didn’t know what he was doing,” Mr. Wang’s older brother, Wang Guoping,

said in an interview. “He didn’t 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 didn’t 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 China’s 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 can’t 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, China’s

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 City’s 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. Sosa’s medical specialty had a long, rich history in Panama, once known as

one of the world’s 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 room” in 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. 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 haven’t 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 that’s 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 it’s 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. Sosa’s exhilaration at learning the cause did not last long. “It’s our

medication that is killing these people,” he said he thought. “It’s not a virus,

it’s 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 Panama’s 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.

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.

Renwick McLean and Brent Mc contributed reporting.

Copyright 2007 The New York Times Company

US: 1 in 150 children has Autism

US: 1 in 6 children suffers a developmental disorder

New Jersey: 1 in 94 has Autism

UK: 1 in 86 has Autism

China : Over 20 lakh autistic children,

India : No authentic figures, expected one crore+ (1 in 250)

AUTISM IS NOTHING BUT MERCURY POISONING.

THERE IS MERCURY IN VACCINES!!

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