New York -- Counterfeit goods threaten security,
economic growth and public safety worldwide, U.S. and private
industry officials warn. Of increasing concern, they say,
is the flood of counterfeit medicines into the marketplace.
Trade in counterfeit and fake goods, officially
referred to as intellectual property piracy, "negatively
impacts our society through the loss of profits, jobs, revenue
and poses risks to the community in both consumer safety
through the sale of unsafe products and through the presence
of criminal organizations responsible for the sale and distribution
of those products," says Salvatore Delesandro, deputy
special agent in charge of the New York office of the U.S.
Immigration and Customs Enforcement agency.
"Fakes" most often bring to mind
designer handbags and brand-name foot apparel, but modern-day
pirates counterfeit everything from life-saving drugs to
cell phone batteries, from auto parts to computers, many
posing serious threats to the health and safety of buyers.
Counterfeiting costs $500 billion globally
and an estimated $300 billion in the United States annually,
Delesandro said November 14 at a seminar organized by the
U.S. Chamber of Commerce to call attention to the problem.
(See related article.)
But the cost of counterfeiting goes beyond
money, says John Theriault, vice president of global security
for Pfizer Pharmaceutical Company, the largest drug manufacturer
in the world.
"The very first issue with counterfeit
drugs is that they pose a serious threat to patient health
and safety. It is a very serious health issue," Theriault
said. In the beginning, the most counterfeited medicines
were the erectile dysfunction drug Viagra and malaria medicines,
but now other drugs such as heart and cancer medicines,
cholesterol-lowering products, flu vaccines and contraceptives
are being counterfeited.
"The explosion of counterfeit medicines
into the global marketplace … is a problem that is
a lot bigger and a lot more expensive than people realize,"
Theriault said. It is not a problem unique to Pfizer, but
one that affects every ethical, legitimate, research-based
pharmaceutical company.
The situation became so serious that in
1998, Pfizer set up its own security unit to begin tracing
and documenting the scope of the problem.
Counterfeit medicine is a "shadow industry"
that has grown up because there is so much money involved,
Theriault said. "We have found counterfeit versions
of Pfizer medicine in 65 countries."
The World Health Organization estimates
global sales of counterfeit medicines at $35 billion to
$40 billion a year. The U.S. Food and Drug Administration
(FDA) estimates that counterfeits make up more than 10 percent
of the global medicines market and are present in both industrialized
and developing countries, with up to 25 percent of the medicines
consumed in poor countries being fake.
In 2004, about 10.5 million units of counterfeit
Pfizer products were seized globally and the company expects
that about 10 million units will be seized this year.
SERIOUS THREAT TO PATIENTS' LIVES
The problem ranges from drugs that contain
the same active pharmaceutical ingredients but are produced
in unregulated conditions to those containing lethal ingredients.
Many are produced by criminals with sophisticated equipment
capable of duplicating near-perfect copies of the authentic
packaging.
The problem has been "exacerbated in
the extreme by the Internet," Theriault added. The
anonymity and massive communication capability offered by
the Internet is a prescription for disaster where medicines
are concerned, he said.
"We've had reports of counterfeit products
with high levels of heavy metal, with arsenic, with nickel,"
Theriault said. "We've seen counterfeit product coming
out of Latin America that actually contained boric acid,
highway paint and floor polish. The product looked very
nice. … The contents were disastrous."
Citing another example, he said Canadian
officials are investigating five deaths that may be related
to fake Norvasc, a blood pressure medication.
Pfizer's strategy, Theriault said, "is
to try to convince governments to deal harshly with people
who are engaged in manufacturing and selling counterfeit
goods. We work with regulatory agencies and local law enforcement."
"This is a trade issue among countries,
it is an issue that developing countries have as much interest
in as mature markets," he said. "Private industry
has a huge stake in this, but private industry cannot solve
the problem alone.
"Arrests show that we are making progress
and governments are beginning to take this problem a little
more seriously. In 2004, there were 369 arrests, about the
same in 2005 and over 400 so far in 2006 worldwide,"
he said.
China and India are often referred to as
the epicenters of the counterfeit medicine trade, but the
biggest counterfeit case in the United States was in 2003,
when more than 18 million tablets of the cholesterol-lowering
drug Lipitor, the world's largest-selling medicine, were
recalled from the U.S. market. Those tablets were produced
in Costa Rica, Theriault said.
For more information, see Protecting
Intellectual Property Rights.
Judy Aita
USINFO Staff Writer
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