Drugs Threaten Americans
If Congress Waters Down Quality Safeguards
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.
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.
I mean counterfeit. As in fake, false, forged.
A 1998 study by the Department
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
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.
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
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.
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.
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 means disaster for serious conditions
like Sarah’s – but it could also
mean disaster for your family, if your drugs are
mishandled or mislabeled.
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
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
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
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.