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Counterfeit Drugs Threaten Americans
If Congress Waters Down Quality Safeguards

By Lisa Yourman

Most residents of New Jersey have seen or are familiar with the HBO TV show “The Sopranos” in which fictional mob boss Tony Soprano presides over a crime family that unleashes a variety of often violent criminal scams on the people of the Garden State.
But some of Tony’s activities aren’t so fictional, according to law enforcement officials. Prosecutors in New York and New Jersey have said some of the plot lines for the TV
shows have come straight out of their files.

I am the mother of a child with Cystic Fibrosis and diabetes. It goes without saying that
I want the best medical care possible for my daughter, Sarah. If you have ever had a
loved one who suffered from this or any other grave illness, I don’t have to say any more because you know exactly what I mean. But one thing you may not have thought about
is that in the future you may have to worry about not only your loved one’s illness, but
also the prospect of their medical care being compromised by counterfeit drugs.

Yes, I mean counterfeit. As in fake, false, forged. A 1998 study by the Department
of the Solicitor General of Canada reported that organized crime had added counterfeit
drugs to its repertoire of crimes. If Canadian government authorities are already warning
of this, it is hardly re-assuring to think that the United States should look to Canada as
a source of medicine. The idea of organized crime entering the drug manufacturing
business conjures up many images, all of them bad.

This could never happen in New Jersey, you may say, because the U.S. Food and
Drug Administration and other agencies are looking out for us. That may be true today
but it would not necessarily be true in the future if Congress changes existing law and
allows prescription drugs to be imported from other countries. A bill to do just that is
working its way through Congress right now and could be voted on any day in the U.S.
House of Representatives.

Advocates of the legislation say we should be able to import drugs because they
are cheaper in other countries. They particularly want to be given the green light
to import drugs from Canada. But there is no assurance that such drugs would meet American standards or even that they would be legitimate. The head of the Food and
Drug Administration has already warned that there is a risk to importing such drugs
even if they are not counterfeit. In comments recently published in The Washington
Post, FDA Commissioner Mark McClellan said, "We still can't assure safety and
quality because the products go outside of our authority.”

Those are sobering words to a parent. When I hear them I can’t help but think of my
children and the many drugs that they must take every day. But I know they are not
the only ones. Cystic Fibrosis is the most common recessive genetic disease. It affects approximately 30,000 children and young adults and it occurs in approximately one of
every 3,300 live births. The median age of survival is only 31 years. I want my child’s
years to be as healthy – and as numerous – as they can be.

I also know that tens of thousands of others face innumerable other diseases that
require regular doses of the latest medicines. All of us expect those medicines to
be beyond question when they reach the patient. But the sad fact is that they may
not be if Congress allows non-American drugs to be imported into the country.

Even if there are no people of ill-will selling these drugs for ill-gotten gains, the fact
remains that the FDA will no longer be able to protect us. The problems with quality
and safety of drugs will not necessarily be generated deliberately, through counterfeiting.
In addition, other countries simply can’t assure that drugs are handled correctly, dosed accurately, or produced safely. For instance, many of the cystic fibrosis and diabetes medications Sarah takes must be refrigerated or they lose effectiveness. Losing
effectiveness means disaster for serious conditions like Sarah’s – but it could also
mean disaster for your family, if your drugs are mishandled or mislabeled.

And let’s go back to flat-out crime. While Commissioner McClellan of the FDA was
speaking of overall quality control in his remarks cited above, other officials have
tackled the drug counterfeiting issue head-on. In an article published in an industry
publication recently, counterfeit expert Adam Scheer said, “the problem of
pharmaceutical counterfeiting, tampering and diversion has been escalating at an
alarming rate as a result of the advent of inexpensive and sophisticated imaging
technologies, [and] the growth of new distribution channels such as the Internet…
This trend is creating a potential world health crisis that could threaten the lives of
millions of people who rely on the authenticity of prescription and over-the-counter

I pray that we don’t turn on our televisions in a couple of years to see Tony and his
henchmen plotting to distribute counterfeit drugs to unsuspecting families who are
doing nothing but trying to find the best treatment for their loved ones, like my little

The threat is real. That is why I wrote this article. And it is why the next thing I write
will be a letter to my elected officials in Congress to ask them not to allow the
importation of prescription drugs. I hope you’ll join me.

Lisa Yourman is a member of Action CF, an advocacy group for those who suffer
from Cystic Fibrosis. She and her family live in New Jersey.

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