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New York Times
June 17, 2007
F.D.A. Tracked Tainted Drugs, but Trail Went Cold in China
By WALT BOGDANICH
After a drug ingredient from China killed dozens of Haitian children a
decade ago, a senior American health official sent a cable to her
investigators: find out who made the poisonous ingredient and why a
state-owned company in China exported it as safe, pharmaceutical-grade
glycerin.
The Chinese were of little help. Requests to find the manufacturer
were ignored. Business records were withheld or destroyed.
The Americans had reason for alarm. "The U.S. imports a lot of Chinese
glycerin and it is used in ingested products such as toothpaste," Mary
K. Pendergast, then deputy commissioner for the Food and Drug
Administration, wrote on Oct. 27, 1997. Learning how diethylene
glycol, a syrupy poison used in some antifreeze, ended up in Haitian
fever medicine might "prevent this tragedy from happening again," she
wrote.
The F.D.A.'s mission ultimately failed. By the time an F.D.A. agent
visited the suspected manufacturer, the plant was shut down and
Chinese companies said they bore no responsibility for the mass
poisoning.
Ten years later it happened again, this time in Panama. Chinese-made
diethylene glycol, masquerading as its more expensive chemical cousin
glycerin, was mixed into medicine, killing at least 100 people there
last year. And recently, Chinese toothpaste containing diethylene
glycol was found in the United States and seven other countries,
prompting tens of thousands of tubes to be recalled.
The F.D.A.'s efforts to investigate the Haiti poisonings, documented
in internal F.D.A. memorandums obtained by The New York Times,
demonstrate not only the intransigence of Chinese officials, but also
the same regulatory failings that allowed a virtually identical
poisoning to occur 10 years later. The cases further illustrate what
happens when nations fail to police the global pipeline of
pharmaceutical ingredients.
In Haiti and Panama, the poison was traced to Chinese chemical
companies not certified to make pharmaceutical ingredients. State-
owned exporters then shipped the toxic syrup to European traders, who
resold it without identifying the previous owner - an attempt to keep
buyers from bypassing them on future orders.
As a result, most of the buyers did not know that the ingredient came
from China, known for producing counterfeit products, nor did they
show much interest in finding out.
China itself was a victim of diethylene glycol poisoning last year
when at least 18 people died after ingesting poisonous medicine made
there. In the wake of the deaths, and reports of pet food and other
products contaminated with dangerous ingredients from China, officials
there announced that they would overhaul the regulation of food, drugs
and chemicals.
Beyond the three incidents linked to Chinese diethylene glycol, there
have been at least five other mass poisonings involving the mislabeled
chemical in the past two decades - in Bangladesh, Nigeria, Argentina
and twice in India.
"This problem keeps coming back," said Dr. Joshua G. Schier, a
toxicologist with the Centers for Disease Control and Prevention. And
no wonder: the counterfeiters are rarely identified, much less
prosecuted.
Finding a way to keep diethylene glycol out of medicine, particularly
in developing countries, has confounded health officials for decades.
"It is preventable and we have to figure out some way of stopping this
from happening again," said Carol Rubin, a senior C.D.C. official.
In a global economy, ingredients for drugs are often bought and sold
many times in different countries, sometimes without proper paperwork,
all of which increases the risk of fraud, the authorities say.
The Panama poison passed through five hands, the Haitian poison six.
In both cases, the factory's original certificate of analysis,
attesting to the contents of the shipment and its provenance, did not
accompany the product as it moved around the world.
"Where there is a loophole in the system, a frailty in the system,
it's the ability of an unscrupulous distributor to take industrial or
technical material and pass it off as pharmaceutical grade," said
Kevin J. McGlue, a board member of the International Pharmaceutical
Excipients Council.
Uncovering that deception can be difficult. "It's impossible to get
anyone to do the trace-backs," said Dr. Michael L. Bennish, co-author
of a 1995 medical journal article on a poisoning epidemic in
Bangladesh.
One reason, Dr. Bennish said, is the clout of local manufacturers. "We
tried to follow up as amateur Sherlocks, investigators, but you don't
go down to the wholesale market and ask questions," he said. "You are
going to get your fingers burnt."
A Crisis in Haiti
By the end of June 1996, the F.D.A. knew it might have an
international crisis on its hands. A poison had found its way into
fever syrup in Haiti, and the F.D.A. wanted to know if more of the
same might be heading to the United States or, for that matter, to any
other country. But to learn that, the agency needed to find the
manufacturer.
This was not just any poison. Virtually every young poisoning victim
who showed up at the main hospital in Port-au-Prince, Haiti's capital,
died.
Labeled pharmaceutical-grade glycerin, the toxic syrup was mixed into
thousands of bottles of fever medicine. For months, parents gave it to
children, then watched them die, in agony, from kidney failure. No one
suspected the medicine until much later.
Officially, at least 88 children died, nearly half under the age of 2.
But those 88 were only the ones doctors remembered or for whom
hospital records could be found.
The F.D.A. traced the poison to a German broker, Chemical Trading and
Consulting, but the company's records were not much help. "They cannot
trace glycerine lots to their manufacturer," David Pulham, an F.D.A.
investigator, wrote on June 30, 1996.
Chemical Trading had arranged for a Dutch company, Vos B.V., to sell
72 barrels of the suspect syrup to Haiti, records show. The agency
dispatched an investigator, Ann deMarco, who made an unsettling
discovery: sitting in Vos's warehouse near Rotterdam were 66 more
barrels labeled glycerin, all containing lethal concentrations of
diethylene glycol.
"Some of this second shipment has been sold," Ms. deMarco wrote in a
memorandum on July 4, 1996. Although the missing barrels had gone to
an industrial user, not a drug maker, the F.D.A.'s worries grew.
Ms. deMarco learned that another broker, Metall-Chemie, a German
trader, had arranged for Vos to buy the barrels from Sinochem
International Chemicals Company, a giant exporter in Beijing owned by
the Chinese government.
But Metall-Chemie also did not know the manufacturer, and one of its
officials predicted that the F.D.A. would have trouble finding that
out. "It is difficult to get any information from Chinese traders,"
Ms. deMarco wrote.
More complete shipping records would have identified who made the
poison. But in this case, records provided few clues.
"The original source of the material had been obliterated on documents
and product containers," Ms. deMarco wrote to senior F.D.A. officials.
"One trader referred to this practice as 'neutralization.' I was
advised that neutralization is a common practice among traders in
order to protect their business interests."
With no paper trail, American officials turned to Sinochem for help.
Initially, they took an indirect approach. In July 1996, the American
Embassy in China contacted the company and asked for a list of Chinese
glycerin makers, without saying that it was investigating the Haiti
poisonings. Sinochem, however, "would not reveal the names of actual
manufacturers in order to prevent the prospective foreign customer
from bypassing Sinochem," an embassy official reported to Washington.
In early August, American officials asked Sinochem representatives
specifically about the origin of the Haiti poison. "They want to
investigate further and were unable (or unwilling) to give the name of
the manufacturer at this time," the officials reported.
Federal investigators sought help from senior Chinese drug regulators,
who promised to help find the manufacturer, but said it "will take
time," records show.
When another month passed without any word from either regulators or
Sinochem, the embassy tried again. Chinese regulators said they had
done nothing to find the factory, according to a confidential State
Department telegram from September 1996.
Sinochem did finally offer the manufacturer's name: the Tianhong Fine
Chemicals Factory in the city of Dalian in northeastern China. But
Sinochem "refused" to provide an address, saying it was illegible. A
telephone number would have to suffice, it said.
That, too, was unproductive. When American investigators called the
plant manager, Zhang Gang, they were told he was not available. Send a
fax, they were told. That did not work either. "The phone was always
busy," investigators reported.
Finally, they got Mr. Zhang on the phone, but he, too, refused to give
out his factory's address. He said that tests had found no signs of
diethylene glycol, adding that "there had been no cases in China of
poisoning resulting from the ingestion" of glycerin contaminated by
diethylene glycol, investigators wrote.
After months of trying to trace the poison to its source, United
States investigators were at a dead end.
"The Chinese officials we contacted on this matter were all reluctant
to become involved," a State Department official wrote in late
September 1996, saying that drug regulators and the plant manager had
insisted on communicating only on the telephone "to avoid leaving a
paper trail."
He added, "We cannot be optimistic about our chances for success in
tracking down the other possible glycerine shipments."
The following May, Mr. Pulham, who was part of the original F.D.A.
investigative team in Haiti, tried to revive the investigation. "Is it
possible to block-list all Chinese pharmaceutical products until we
gain cooperation?" he asked.
The suggestion went nowhere. Five months later, Ms. Pendergast of the
F.D.A. wrote her memorandum, imploring investigators to keep digging.
"China is turning into one of the major bulk pharmaceutical producers
in the world," she wrote. "Unless they have an open, transparent and
predictable system for dealing with problems and other countries, it
is going to be rough sledding in the years ahead."
On Nov. 17, 1997, federal investigators once again questioned Sinochem
officials. They denied any wrongdoing, saying that two certificates of
analysis showed that the suspect shipment was safe, pharmaceutical-
grade syrup. But when the F.D.A. asked to see them, Sinochem refused.
"The officials were not willing to explain why they could not provide
the copies," an American official reported at the time.
Chen Liusuo, who handled the glycerin sales, strongly disputed the
F.D.A.'s account. In an interview with The Times, Mr. Chen said
Sinochem cooperated. "We gave them everything they wanted," Mr. Chen
said, adding that the agency was satisfied.
"The product we sold was glycerin," he said. "It passed through three
or four companies after us. To find the problem you need to look at
every link in the supply chain."
A Chinese government official familiar with the F.D.A.'s inquiries
said the Americans' frustration might have stemmed from their
misunderstanding about who regulated chemical companies, which led
them to seek help from the wrong officials. "This was a truly tragic
event, and we expressed our sadness and sympathy," said the official,
who asked not to be identified.
At the end of 1997, a year and a half after the F.D.A. began tracing
the poisonous shipments, one of its investigators, Ted Sze, finally
got inside the Tianhong chemical plant in Dalian. But glycerin was no
longer made there, and Mr. Sze had no records to inspect. The plant
manager, Mr. Zhang, told investigators that he had received no
complaints about his products and that his company had not produced
the poison.
Mr. Sze, now retired from the F.D.A., said in an interview that he had
no choice but to accept the manager's word and clear the company of
wrongdoing. "By the time I went there, the plant was already shut
down," he said. "The agency can only do so much."
The Experts' Recommendations
The United States may not have gotten what it wanted from China, but
the Haiti crisis did bring together health groups to search for ways
to stop diethylene glycol poisonings. At a workshop in Washington in
February 1997, health experts recommended that certificates of
analysis be improved to allow users to "trace the product back through
every intermediary, broker and repackager to the original
manufacturer."
The workshop participants also called for better testing of drug
ingredients and asked governments to tighten oversight of drug
manufacturing.
The next year, the World Health Organization offered many of the same
recommendations. And a 1998 article in JAMA, the Journal of the
American Medical Association, warned that failure to strictly follow
the guidelines could cause poisonings "even in countries where quality
control procedures are usually strictly applied."
Much of this had been said before, yet the poisonings have continued.
Just as the JAMA article was being published, three dozen children
began dying of acute renal failure at two hospitals in Delhi, India. A
local drug maker had unwittingly mixed diethylene glycol into
acetaminophen syrup, much as the Haitian pharmacist had.
The drug maker was prosecuted, but according to interviews and
government records no progress had been made in identifying the
supplier of the poison.
"My experience as an investigator tells me that many of these things
will not be proven," said Dr. M. Venkateswarlu, the drug controller
general of India.
Finding counterfeiters often means pursuing leads across foreign
borders, and no international authority has the power to do that. Dr.
Howard Zucker, who helps to oversee drug issues for the W.H.O., said
individual countries must conduct their own trace-back investigations.
But if the United States could not do that on behalf of Haiti, poorer,
less influential nations would have little chance of tracking down
counterfeiters.
After the Haiti poisoning, a more accurate, less expensive test for
diethylene glycol was developed, but last year's case in Panama shows
that suppliers and governments do not always use it.
And as long as counterfeiters do not fear prosecution, the poisonings
are likely to continue, experts say.
Dr. Mohammed Hanif, a prominent physician in Dhaka, Bangladesh, said
the foreign suppliers of diethylene glycol were never prosecuted for
the deaths of thousands of children from 1982 to 1992. "The
traumatizing memories of those days still torment me," said Dr. Hanif,
who wrote a paper about the deaths from toxic medicine.
In Argentina, a court official said no one had been prosecuted for
supplying the diethylene glycol that ended up in a health supplement,
killing 29 people in 1992.
David Mishael, a Miami lawyer, knows the difficulty of assigning blame
in these deaths. For 10 years, Mr. Mishael has unsuccessfully pursued
legal claims in the United States and Europe against European traders
that helped to arrange the shipment of toxic syrup to Haiti. "You can
imagine the cost," said Mr. Mishael, who is representing Haitian
parents whose children died from the fever medicine.
He said Dutch authorities assessed a $250,000 fine against Vos, which
tested the counterfeit syrup, found it impure and did not alert anyone
in Haiti. But given how many died, he called the size of the fine "a
joke." A lawyer who represents Vos, Jeffrey B. Shapiro, declined to
comment.
A few children survived after being flown to the United States by
humanitarian groups. One of them, Faika Jean, was 2 months old at the
time and nearly died en route. Now 11, she has learning disabilities
as a result of the poisoning, said her father, Wislin Jean.
Ms. Pendergast, now a private lawyer and consultant, said China had
the most to answer for. "Everybody else is just reacting to initial
failures," she said. "It needs to take steps to protect not just its
own consumers but also consumers all around the world."
After The Times reported in May that the Panama poison had been made
and exported by Chinese companies as 99.5 percent pure glycerin,
Chinese regulators said they would reopen their investigation of the
incident. Three weeks later, the officials acknowledged some
"misconduct" in how Chinese companies labeled the toxic syrup.
But most of the blame, they said, rested with a Panamanian importer
who changed the paperwork to make the syrup look safer than it
actually was.
The F.D.A. disagrees, saying the deception began with Chinese
companies falsely labeling a poisonous product glycerin. "If the drums
had been 99.5 percent glycerin, the deaths in Panama would never have
occurred," the F.D.A. said in a statement.
A Dissatisfied Customer
The F.D.A.'s Haiti investigation never did find more counterfeit
glycerin from China, despite a global hunt. But its concerns, it turns
out, were not unfounded.
In 1995, the same year babies began to die in Haiti, 284 barrels of a
chemical labeled glycerin arrived in New York on container ships.
Although the chemical was not intended for use in drugs, it was
labeled 98 percent pure. An official with the company that bought the
barrels, Dastech International, of Great Neck, N.Y., would later say,
"It smelled like glycerin, it looked like glycerin." But after one of
its customers complained, Dastech took a closer look.
Although the chemical was labeled 98 percent pure glycerin, Dastech
said in court records that the syrup actually contained sugar
compounds - as well as diethylene glycol.
The exporter was Sinochem. Claiming that it was fleeced, Dastech tried
to get its money back from the broker who arranged the sale, court
records show.
It never did.
------
Reporting was contributed by Jake Hooker from Beijing, Hari Kumar from
New Delhi, Anand Giridharadas from Mumbai, and Julfikar Ali Manik from
Dhaka, Bangladesh.
June 17, 2007
F.D.A. Tracked Tainted Drugs, but Trail Went Cold in China
By WALT BOGDANICH
After a drug ingredient from China killed dozens of Haitian children a
decade ago, a senior American health official sent a cable to her
investigators: find out who made the poisonous ingredient and why a
state-owned company in China exported it as safe, pharmaceutical-grade
glycerin.
The Chinese were of little help. Requests to find the manufacturer
were ignored. Business records were withheld or destroyed.
The Americans had reason for alarm. "The U.S. imports a lot of Chinese
glycerin and it is used in ingested products such as toothpaste," Mary
K. Pendergast, then deputy commissioner for the Food and Drug
Administration, wrote on Oct. 27, 1997. Learning how diethylene
glycol, a syrupy poison used in some antifreeze, ended up in Haitian
fever medicine might "prevent this tragedy from happening again," she
wrote.
The F.D.A.'s mission ultimately failed. By the time an F.D.A. agent
visited the suspected manufacturer, the plant was shut down and
Chinese companies said they bore no responsibility for the mass
poisoning.
Ten years later it happened again, this time in Panama. Chinese-made
diethylene glycol, masquerading as its more expensive chemical cousin
glycerin, was mixed into medicine, killing at least 100 people there
last year. And recently, Chinese toothpaste containing diethylene
glycol was found in the United States and seven other countries,
prompting tens of thousands of tubes to be recalled.
The F.D.A.'s efforts to investigate the Haiti poisonings, documented
in internal F.D.A. memorandums obtained by The New York Times,
demonstrate not only the intransigence of Chinese officials, but also
the same regulatory failings that allowed a virtually identical
poisoning to occur 10 years later. The cases further illustrate what
happens when nations fail to police the global pipeline of
pharmaceutical ingredients.
In Haiti and Panama, the poison was traced to Chinese chemical
companies not certified to make pharmaceutical ingredients. State-
owned exporters then shipped the toxic syrup to European traders, who
resold it without identifying the previous owner - an attempt to keep
buyers from bypassing them on future orders.
As a result, most of the buyers did not know that the ingredient came
from China, known for producing counterfeit products, nor did they
show much interest in finding out.
China itself was a victim of diethylene glycol poisoning last year
when at least 18 people died after ingesting poisonous medicine made
there. In the wake of the deaths, and reports of pet food and other
products contaminated with dangerous ingredients from China, officials
there announced that they would overhaul the regulation of food, drugs
and chemicals.
Beyond the three incidents linked to Chinese diethylene glycol, there
have been at least five other mass poisonings involving the mislabeled
chemical in the past two decades - in Bangladesh, Nigeria, Argentina
and twice in India.
"This problem keeps coming back," said Dr. Joshua G. Schier, a
toxicologist with the Centers for Disease Control and Prevention. And
no wonder: the counterfeiters are rarely identified, much less
prosecuted.
Finding a way to keep diethylene glycol out of medicine, particularly
in developing countries, has confounded health officials for decades.
"It is preventable and we have to figure out some way of stopping this
from happening again," said Carol Rubin, a senior C.D.C. official.
In a global economy, ingredients for drugs are often bought and sold
many times in different countries, sometimes without proper paperwork,
all of which increases the risk of fraud, the authorities say.
The Panama poison passed through five hands, the Haitian poison six.
In both cases, the factory's original certificate of analysis,
attesting to the contents of the shipment and its provenance, did not
accompany the product as it moved around the world.
"Where there is a loophole in the system, a frailty in the system,
it's the ability of an unscrupulous distributor to take industrial or
technical material and pass it off as pharmaceutical grade," said
Kevin J. McGlue, a board member of the International Pharmaceutical
Excipients Council.
Uncovering that deception can be difficult. "It's impossible to get
anyone to do the trace-backs," said Dr. Michael L. Bennish, co-author
of a 1995 medical journal article on a poisoning epidemic in
Bangladesh.
One reason, Dr. Bennish said, is the clout of local manufacturers. "We
tried to follow up as amateur Sherlocks, investigators, but you don't
go down to the wholesale market and ask questions," he said. "You are
going to get your fingers burnt."
A Crisis in Haiti
By the end of June 1996, the F.D.A. knew it might have an
international crisis on its hands. A poison had found its way into
fever syrup in Haiti, and the F.D.A. wanted to know if more of the
same might be heading to the United States or, for that matter, to any
other country. But to learn that, the agency needed to find the
manufacturer.
This was not just any poison. Virtually every young poisoning victim
who showed up at the main hospital in Port-au-Prince, Haiti's capital,
died.
Labeled pharmaceutical-grade glycerin, the toxic syrup was mixed into
thousands of bottles of fever medicine. For months, parents gave it to
children, then watched them die, in agony, from kidney failure. No one
suspected the medicine until much later.
Officially, at least 88 children died, nearly half under the age of 2.
But those 88 were only the ones doctors remembered or for whom
hospital records could be found.
The F.D.A. traced the poison to a German broker, Chemical Trading and
Consulting, but the company's records were not much help. "They cannot
trace glycerine lots to their manufacturer," David Pulham, an F.D.A.
investigator, wrote on June 30, 1996.
Chemical Trading had arranged for a Dutch company, Vos B.V., to sell
72 barrels of the suspect syrup to Haiti, records show. The agency
dispatched an investigator, Ann deMarco, who made an unsettling
discovery: sitting in Vos's warehouse near Rotterdam were 66 more
barrels labeled glycerin, all containing lethal concentrations of
diethylene glycol.
"Some of this second shipment has been sold," Ms. deMarco wrote in a
memorandum on July 4, 1996. Although the missing barrels had gone to
an industrial user, not a drug maker, the F.D.A.'s worries grew.
Ms. deMarco learned that another broker, Metall-Chemie, a German
trader, had arranged for Vos to buy the barrels from Sinochem
International Chemicals Company, a giant exporter in Beijing owned by
the Chinese government.
But Metall-Chemie also did not know the manufacturer, and one of its
officials predicted that the F.D.A. would have trouble finding that
out. "It is difficult to get any information from Chinese traders,"
Ms. deMarco wrote.
More complete shipping records would have identified who made the
poison. But in this case, records provided few clues.
"The original source of the material had been obliterated on documents
and product containers," Ms. deMarco wrote to senior F.D.A. officials.
"One trader referred to this practice as 'neutralization.' I was
advised that neutralization is a common practice among traders in
order to protect their business interests."
With no paper trail, American officials turned to Sinochem for help.
Initially, they took an indirect approach. In July 1996, the American
Embassy in China contacted the company and asked for a list of Chinese
glycerin makers, without saying that it was investigating the Haiti
poisonings. Sinochem, however, "would not reveal the names of actual
manufacturers in order to prevent the prospective foreign customer
from bypassing Sinochem," an embassy official reported to Washington.
In early August, American officials asked Sinochem representatives
specifically about the origin of the Haiti poison. "They want to
investigate further and were unable (or unwilling) to give the name of
the manufacturer at this time," the officials reported.
Federal investigators sought help from senior Chinese drug regulators,
who promised to help find the manufacturer, but said it "will take
time," records show.
When another month passed without any word from either regulators or
Sinochem, the embassy tried again. Chinese regulators said they had
done nothing to find the factory, according to a confidential State
Department telegram from September 1996.
Sinochem did finally offer the manufacturer's name: the Tianhong Fine
Chemicals Factory in the city of Dalian in northeastern China. But
Sinochem "refused" to provide an address, saying it was illegible. A
telephone number would have to suffice, it said.
That, too, was unproductive. When American investigators called the
plant manager, Zhang Gang, they were told he was not available. Send a
fax, they were told. That did not work either. "The phone was always
busy," investigators reported.
Finally, they got Mr. Zhang on the phone, but he, too, refused to give
out his factory's address. He said that tests had found no signs of
diethylene glycol, adding that "there had been no cases in China of
poisoning resulting from the ingestion" of glycerin contaminated by
diethylene glycol, investigators wrote.
After months of trying to trace the poison to its source, United
States investigators were at a dead end.
"The Chinese officials we contacted on this matter were all reluctant
to become involved," a State Department official wrote in late
September 1996, saying that drug regulators and the plant manager had
insisted on communicating only on the telephone "to avoid leaving a
paper trail."
He added, "We cannot be optimistic about our chances for success in
tracking down the other possible glycerine shipments."
The following May, Mr. Pulham, who was part of the original F.D.A.
investigative team in Haiti, tried to revive the investigation. "Is it
possible to block-list all Chinese pharmaceutical products until we
gain cooperation?" he asked.
The suggestion went nowhere. Five months later, Ms. Pendergast of the
F.D.A. wrote her memorandum, imploring investigators to keep digging.
"China is turning into one of the major bulk pharmaceutical producers
in the world," she wrote. "Unless they have an open, transparent and
predictable system for dealing with problems and other countries, it
is going to be rough sledding in the years ahead."
On Nov. 17, 1997, federal investigators once again questioned Sinochem
officials. They denied any wrongdoing, saying that two certificates of
analysis showed that the suspect shipment was safe, pharmaceutical-
grade syrup. But when the F.D.A. asked to see them, Sinochem refused.
"The officials were not willing to explain why they could not provide
the copies," an American official reported at the time.
Chen Liusuo, who handled the glycerin sales, strongly disputed the
F.D.A.'s account. In an interview with The Times, Mr. Chen said
Sinochem cooperated. "We gave them everything they wanted," Mr. Chen
said, adding that the agency was satisfied.
"The product we sold was glycerin," he said. "It passed through three
or four companies after us. To find the problem you need to look at
every link in the supply chain."
A Chinese government official familiar with the F.D.A.'s inquiries
said the Americans' frustration might have stemmed from their
misunderstanding about who regulated chemical companies, which led
them to seek help from the wrong officials. "This was a truly tragic
event, and we expressed our sadness and sympathy," said the official,
who asked not to be identified.
At the end of 1997, a year and a half after the F.D.A. began tracing
the poisonous shipments, one of its investigators, Ted Sze, finally
got inside the Tianhong chemical plant in Dalian. But glycerin was no
longer made there, and Mr. Sze had no records to inspect. The plant
manager, Mr. Zhang, told investigators that he had received no
complaints about his products and that his company had not produced
the poison.
Mr. Sze, now retired from the F.D.A., said in an interview that he had
no choice but to accept the manager's word and clear the company of
wrongdoing. "By the time I went there, the plant was already shut
down," he said. "The agency can only do so much."
The Experts' Recommendations
The United States may not have gotten what it wanted from China, but
the Haiti crisis did bring together health groups to search for ways
to stop diethylene glycol poisonings. At a workshop in Washington in
February 1997, health experts recommended that certificates of
analysis be improved to allow users to "trace the product back through
every intermediary, broker and repackager to the original
manufacturer."
The workshop participants also called for better testing of drug
ingredients and asked governments to tighten oversight of drug
manufacturing.
The next year, the World Health Organization offered many of the same
recommendations. And a 1998 article in JAMA, the Journal of the
American Medical Association, warned that failure to strictly follow
the guidelines could cause poisonings "even in countries where quality
control procedures are usually strictly applied."
Much of this had been said before, yet the poisonings have continued.
Just as the JAMA article was being published, three dozen children
began dying of acute renal failure at two hospitals in Delhi, India. A
local drug maker had unwittingly mixed diethylene glycol into
acetaminophen syrup, much as the Haitian pharmacist had.
The drug maker was prosecuted, but according to interviews and
government records no progress had been made in identifying the
supplier of the poison.
"My experience as an investigator tells me that many of these things
will not be proven," said Dr. M. Venkateswarlu, the drug controller
general of India.
Finding counterfeiters often means pursuing leads across foreign
borders, and no international authority has the power to do that. Dr.
Howard Zucker, who helps to oversee drug issues for the W.H.O., said
individual countries must conduct their own trace-back investigations.
But if the United States could not do that on behalf of Haiti, poorer,
less influential nations would have little chance of tracking down
counterfeiters.
After the Haiti poisoning, a more accurate, less expensive test for
diethylene glycol was developed, but last year's case in Panama shows
that suppliers and governments do not always use it.
And as long as counterfeiters do not fear prosecution, the poisonings
are likely to continue, experts say.
Dr. Mohammed Hanif, a prominent physician in Dhaka, Bangladesh, said
the foreign suppliers of diethylene glycol were never prosecuted for
the deaths of thousands of children from 1982 to 1992. "The
traumatizing memories of those days still torment me," said Dr. Hanif,
who wrote a paper about the deaths from toxic medicine.
In Argentina, a court official said no one had been prosecuted for
supplying the diethylene glycol that ended up in a health supplement,
killing 29 people in 1992.
David Mishael, a Miami lawyer, knows the difficulty of assigning blame
in these deaths. For 10 years, Mr. Mishael has unsuccessfully pursued
legal claims in the United States and Europe against European traders
that helped to arrange the shipment of toxic syrup to Haiti. "You can
imagine the cost," said Mr. Mishael, who is representing Haitian
parents whose children died from the fever medicine.
He said Dutch authorities assessed a $250,000 fine against Vos, which
tested the counterfeit syrup, found it impure and did not alert anyone
in Haiti. But given how many died, he called the size of the fine "a
joke." A lawyer who represents Vos, Jeffrey B. Shapiro, declined to
comment.
A few children survived after being flown to the United States by
humanitarian groups. One of them, Faika Jean, was 2 months old at the
time and nearly died en route. Now 11, she has learning disabilities
as a result of the poisoning, said her father, Wislin Jean.
Ms. Pendergast, now a private lawyer and consultant, said China had
the most to answer for. "Everybody else is just reacting to initial
failures," she said. "It needs to take steps to protect not just its
own consumers but also consumers all around the world."
After The Times reported in May that the Panama poison had been made
and exported by Chinese companies as 99.5 percent pure glycerin,
Chinese regulators said they would reopen their investigation of the
incident. Three weeks later, the officials acknowledged some
"misconduct" in how Chinese companies labeled the toxic syrup.
But most of the blame, they said, rested with a Panamanian importer
who changed the paperwork to make the syrup look safer than it
actually was.
The F.D.A. disagrees, saying the deception began with Chinese
companies falsely labeling a poisonous product glycerin. "If the drums
had been 99.5 percent glycerin, the deaths in Panama would never have
occurred," the F.D.A. said in a statement.
A Dissatisfied Customer
The F.D.A.'s Haiti investigation never did find more counterfeit
glycerin from China, despite a global hunt. But its concerns, it turns
out, were not unfounded.
In 1995, the same year babies began to die in Haiti, 284 barrels of a
chemical labeled glycerin arrived in New York on container ships.
Although the chemical was not intended for use in drugs, it was
labeled 98 percent pure. An official with the company that bought the
barrels, Dastech International, of Great Neck, N.Y., would later say,
"It smelled like glycerin, it looked like glycerin." But after one of
its customers complained, Dastech took a closer look.
Although the chemical was labeled 98 percent pure glycerin, Dastech
said in court records that the syrup actually contained sugar
compounds - as well as diethylene glycol.
The exporter was Sinochem. Claiming that it was fleeced, Dastech tried
to get its money back from the broker who arranged the sale, court
records show.
It never did.
------
Reporting was contributed by Jake Hooker from Beijing, Hari Kumar from
New Delhi, Anand Giridharadas from Mumbai, and Julfikar Ali Manik from
Dhaka, Bangladesh.
