Killer Drug Linked with Chinese Pigs May contain Counterfeit Ingredient
-- Contaminant found in China-linked blood thinner/IHT
International Herald Tribune
Contaminant found in China-linked blood thinner
By Gardiner Harris and Walt Bogdanich
Thursday, March 6, 2008
WA****NGTON: U.S. government drug regulators have discovered that a
critical blood thinner that has been linked to at least 19 deaths and
whose raw components are produced in China contained a possibly
counterfeit ingredient that mimicked the real drug.
Routine tests failed to distinguish the contaminant from the drug,
heparin. Only sophisticated magnetic resonance imaging tests uncovered
that as much as 20 percent of the product's active ingredient was a
heparin mimic blended in with the real thing.
"At this point, we do not know whether the introduction was accidental
or whether it was deliberate," said Deputy Commissioner Janet Woodcock
of the Food and Drug Administration.
Heparin is made from pig intestines. Scientific Protein Laboratories,
based in Wau****, Wisconsin, bought raw heparin produced in some cases
in small, unregulated family workshops in China and processed it in
plants in Wisconsin and China, according to heparin traders and
producers in China. Baxter International purchased the active ingredient
from Scientific Protein and sold the finished drug.
Wayne Pines, a spokesman for Scientific Protein Laboratories said that
nothing sinister had been proven about the contamination. "There is no
evidence of counterfeiting or tampering or anything of that nature,"
Pines said. "No one really knows what happened here."
Beginning in November, public health officials received re****ts of
patients experiencing severe allergic reactions after being given
Baxter's product. Baxter initiated a series of recalls that culminated
last week in a withdrawal of nearly all of Baxter's heparin production.
The FDA has now received 785 re****ts of serious injuries associated with
the drug's use. Forty-six deaths have also been re****ted to the agency,
but Dr. Woodcock said that just 19 of these appear related to the
suspect heparin. Baxter executives said that the total death toll was
actually four.
APP Pharmaceuticals, which previously split the heparin market with
Baxter, has been ramping up production to meet demand. So far, APP's
products show no signs of similar contamination, Woodcock said, although
some of APP's production is also based in China.
Most of the world's heparin supply originates in China, according to
Baxter. The FDA will soon make public the test used to distinguish
between real heparin and its mimic in hopes that regulatory bodies
around the world will adopt the test.
"We don't know if any of the heparin products worldwide might contain
this contaminant, and that is something we are going to be looking
into," Woodcock said.
The FDA has yet to prove that the heparin contaminant is the cause of
the deaths and illnesses now associated with the use of Baxter's
product. But heparin batches associated with illnesses, all of which
were produced with ingredients made in China, were found to contain the
contaminant while batches not linked to illnesses proved to be untainted.
Scientific Protein Laboratories said in a statement that "it is
premature to conclude that the heparin active pharmaceutical ingredient
sourced from China and provided by SPL to Baxter is responsible for
these adverse events."
Since tainted batches were produced by Scientific Protein's plants in
both Wisconsin and China, "either both plants have problems with
processing or there's something wrong further up the stream," said Peter
Arduini, president of Baxter's medication delivery business.
The FDA admitted last month that it had violated its own policies by
failing to inspect Scientific Protein's China plant prior to approving
the drug for sale. The agency sent inspectors to the plant last month
who found that at least some heparin was made from "material from an
unacceptable workshop vendor."
Baxter undertook last fall its own inspection of the China plant. "A few
of our observations touched on the same areas as FDA's inspectional
findings," said Ray Godlewski, vice president of quality for Baxter's
Medication Delivery Business. Godlewski refused to be more specific
because, he said, of a confidentiality agreement with Scientific Protein.
Pines of Scientific Protein said that he did not know what problems
Baxter uncovered last fall or why those problems were not corrected by
the time U.S. inspectors arrived last month.
China has become by far the largest supplier of pharmaceutical
ingredients in the world, but there is growing concern about the quality
of the products made there. Last year, the FDA discovered that a pet
food ingredient ****pped from China contained toxic levels of melamine,
which was added to make it appear higher in protein. Many pets became
ill, and some died.
A series of independent *****sments, including one by the agency's own
Science Board, have found that the FDA is increasingly overwhelmed by
its many responsibilities and is incapable of protecting the public from
unsafe drugs, medical devices and food ? particularly from China.
The Government Accountability Office recently discovered, for example,
that over a six-year period, the FDA inspected just 64 of the nearly 700
medical device plants registered in China. Medical devices can include
items like stents and spinal screws.
There is a growing bipartisan consensus on Capitol Hill that the agency
needs a rapid infusion of money. The Bush administration has proposed an
increase in the agency's allocated budget next year of just 3 percent ?
not enough to keep up with increased expenses. But the FDA commissioner,
Andrew von Eschenbach, said in a recent interview that the agency needs
more money.
Von Eschenbach said Wednesday that even if the agency had adequately
inspected the China plant, it might not have caught a problem resulting
when "someone either intentionally or unintentionally manipulates a
product."
He said that the agency needs to approach its inspections program "in a
more strategic way" and that it needs "good surveillance" of adverse
events associated with unsafe drugs "so that we can respond and mitigate
that outcome."
But the FDA has for years had a drug safety surveillance system that
relies on voluntary re****ts by patients and doctors to re****t problems.
The agency itself estimates that these re****ts represent as little as 1
percent of the actual number of drug problems.
Even in the case of heparin, the agency's announcement that it has
received re****ts of 785 serious illnesses and 19 deaths represents
little more than a wild guess at the actual disease burden.
Problems re****ted to the agency include difficulty breathing, nausea,
vomiting, excessive sweating and rapidly falling blood pressure that in
some cases led to life-threatening shock.
The Chinese heparin market has been in turmoil over the past year as pig
disease swept through the country, leading some farmers to sell sick
pigs into the market and forcing heparin producers to scramble for new
sources of raw material.
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