Killer Heparin linked to Chinese Pigs Identified in 11 Countries / The
New York Times
The New York Times
April 22, 2008
U.S. Identifies Tainted Heparin in 11 Countries
By GARDINER HARRIS
WA****NGTON ¡ª A contaminated blood thinner from China has been found in
drug supplies in 11 countries, and federal officials said Monday they
had discovered a clear link between the contaminant and severe reactions
now associated with 81 deaths in the United States.
But a Chinese official disputed the assertion that the contaminant found
in the drug, heparin, caused any deaths and insisted that his country¡¯s
inspectors be allowed to inspect the American plant where the finished
heparin vials were made. He said any future agreement to allow American
inspections of Chinese firms should be reciprocal.
¡°We don¡¯t have a strong evidence to show that it is heparin or its
contaminant that caused the problem,¡± said the official, Ning Chen,
second secretary at the Chinese Embassy.
Mr. Chen said that illnesses associated with contaminated heparin had
occurred only in the United States, which he said suggested that the
problem arose in this country.
Dr. Janet Woodcock, director of the Food and Drug Administration¡¯s drug
center, said that German regulators uncovered a cluster of illnesses
among dialysis patients who took contaminated heparin. She said Chinese
officials had conceded that heparin produced in their country contained
a contaminant, though they say it was not connected to the illnesses.
¡°Heparin should not be contaminated, regardless of whether or not that
contamination caused acute adverse events,¡± Dr. Woodcock said. ¡°We are
fairly confident based on the biological information that we have had
that this contaminant is capable of triggering these adverse reactions.¡±
The dispute is a sign of growing tensions between China and the United
States over the safety of Chinese im****ts. China has in recent years
ex****ted poisonous toothpaste, lead-painted toys, toxic pet food,
tainted fish and now, contaminated medicine.
Bills to require far more aggressive inspections of Chinese products and
companies are being proposed by members of Congress. Hearings are
scheduled for Tuesday in the House and Thursday in the Senate.
China has lurched between defensiveness and cooperation on issues of
product safety. Last year, it initially blocked the F.D.A. from
investigating tainted pet food and accused foreign forces of
exaggerating the issue. Then in July, China said that it had executed
its former top food and drug regulator for taking bribes and promised
reforms.
The F.D.A. sent a warning letter on Monday to Changzhou SPL, the Chinese
plant identified as the source of contaminated heparin made by Baxter
International in the United States. It warned that the plant used
unclean tanks to make heparin, that it accepted raw materials from an
unacceptable vendor and that it had no adequate way to remove impurities.
Heparin is made from the mucous membranes of the intestines of
slaughtered pigs that, in China, are often cooked in unregulated family
workshops. The contaminant, identified as oversulfated chondroitin
sulfate, a cheaper substance, slipped through the usual testing and was
recognized only after more sophisticated tests were used.
The F.D.A. has identified 12 Chinese companies that have supplied
contaminated heparin to 11 countries ¡ª Australia, Canada, China,
Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and
the United States. Deborah Autor, director of compliance at the F.D.A.¡¯s
drug center, said the agency did not know the original source of all the
contamination or the points in the supply chain at which it was added.
Officials have discovered heparin lots that included the cheap fake
additive manufactured as early as early as 2006, although a spike in
illnesses associated with contaminated heparin began in November and
persisted through February, officials said.
Separately, the Government Accountability Office will release a re****t
on Tuesday showing that the F.D.A. would need to spend at least $56
million more next year to begin full inspections of foreign plants. It
would need to spend at least $15 million annually to inspect China¡¯s
drug plants every two years, which is the domestic standard.
Bush administration officials have acknowledged problems associated with
poor inspection of overseas plants and have plans to improve the
situation. But President Bush¡¯s budget does not provide the F.D.A. with
funds to hire more inspectors.
At its present inspection pace, the F.D.A. would need at least 27 years
to inspect every foreign medical device plant that ex****ts to the United
States, 13 years to check every foreign drug plant and 1,900 years to
examine every foreign food plant.
Proposals circulating on Capitol Hill would increase the agency¡¯s
financing and charge domestic and foreign manufacturers fees to pay for
inspections.
¡°Even the Bush administration seems to understand the potential peril
that these foreign firms pose, but they offer only vague plans to
address the problems and they refuse to spend more than a fraction of
the money needed to protect the public,¡± said Representative John D.
Dingell, a Michigan Democrat who leads the House Committee on Energy and
Commerce.
The F.D.A. has announced plans to open inspection offices in three
Chinese cities, but the agency has yet to get permission from the
Chinese government. Mr. Chen said any inspection agreement should be
reciprocal. ¡°Will the U.S. government accept the Chinese F.D.A. to set
up in the United States?¡± he said.
Dr. Woodcock said the Chinese had agreed to test heparin lots before
allowing them to be ex****ted. But Dr. Moheb Nasr, director of the drug
agency¡¯s office of new drug quality *****sment, said that the Chinese
test might not be sensitive enough to identify the contaminant.
Dr. Woodcock assured patients, however, that all heparin supplies in the
United States had been tested with the most sensitive assays and had
been found to be uncontaminated.
Scientific Protein Laboratories and Changzhou SPL said the company
regretted the agency¡¯s decision to send a warning letter that, it said,
did not reflect the company¡¯s current safety practices. The company said
it had no way of detecting a contaminant present in heparin supplies
throughout China.
Baxter International, which bought heparin ingredients from SPL and sold
the finished drug in the United States, said that its tests confirmed
that the contaminant could cause illness. It disputed the F.D.A.¡¯s
analysis that its product was linked with 81 deaths, saying it had
identified only 5 in which its product ¡°may have contributed to the
adverse outcome, though there is not yet enough medical data available
to draw a firm conclusion that the reaction caused the death.¡±
Deaths linked to the drug may have been concentrated in the United
States because American doctors may be more likely to use large, quickly
infused amounts of the drug, said drug officials. Also, the F.D.A. may
track serious side effects better than its counterparts abroad.
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