We asked a CECON Pharmaceutical
Consultant and former FDA Director of the Science
Branch of the Philadelphia District for his perspective on this
troubling issue:
Most
counterfeit drugs* are just plain fake; they have no active ingredient.
These counterfeits are simply placebos and not good ones at that. A placebo is
a “sugar pill” used for comparative clinical testing and psychological effects
on a patient. A placebo has no active ingredient in it. The inert ingredients
are usually of low quality and purity. The bulk of the work is put into copying
the labels and making the product look like the real thing. The drugs most counterfeited are blood
pressure medications, cholesterol lowering medications, and male enhancement
drugs.
*“The term ‘counterfeit drug’
means a drug which, or the container or labeling of which, without
authorization, bears the trademark, trade name, or other identifying mark,
imprint, or device, or any likeness thereof, of a drug manufacturer, processor,
packer, or distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and which thereby falsely
purports or is represented to be the product of, or to have been packed or
distributed by, such other drug manufacturer, processor, packer, or
distributor.” (The United States
Food, Drug, and Cosmetic Act (F D & C Act)).
Some counterfeit drugs have a small amount of active
ingredient in them… just enough to make the patient think they are real.
However, not only is the active ingredient less than stated, the product is
usually contaminated. Some “factories” have been raided and had broken windows
letting in the air, dust and pollen from outside. In one case I heard about
there was a birds’ nest in the factory. The birds would leave through the
broken window and bring back food for the young ones, returning through the
same broken window.
Counterfeit drugs may be made in the U S or may be
imported from places like China or India. There are unfortunately some fake
cancer drugs in the market. They sell at hundreds of dollars per single dose vial.
The genuine drugs are stolen, usually from the delivery trucks, and then diluted
by a factor of 20. Even before dilution, the drugs are rendered worthless since
they are stored at temperatures well above the limiting temperature and have thus
degraded. Occasionally, such fakes are simply water with no medicine. Those who
produce counterfeit drugs for cancer and HIV drugs are the worst. In my opinion
they are the lowest form of life on this planet.
Regarding
cancer and HIV drugs, if the side effects are none or are minimal there is a
possibility that the drug is a fake. Fortunately or unfortunately, the side
effects of such drugs confirm that they are likely real.
It is estimated that 10% to
20% of the drugs in the U S are counterfeit. In third world countries
the figure is 50%. No one knows the level for
sure. To know that figure accurately, all the drugs on the pharmacy shelf would
have to be tested. It’s like trying to guess how many counterfeit twenty
dollars bills are in circulation, or if you have had some and passed them on.
These
fakes get into the system because the system is unregulated.
Once the drugs leave the pharmaceutical firms’ shipping docks, the path to the
consumer/patient is not regulated. A drug can pass among more than a dozen
wholesalers and other representatives. This is where they enter the system. A
wholesaler gets a “good deal” from someone and sees that much more money can be
made by buying at a lower price and selling at the same price, maybe sometimes
hoping that they are legitimate drugs…but deliberately forgetting that “you get
what you pay for.”
The FDA has been assigned the task of
regulating the distributors and “secondary wholesalers” since 1992. This way, distributors would have to be
accredited by a suitable authority to be in the system. The members of the
supply system keep saying that it would be an unreasonable cost to fulfill the
requirements. As yet, nothing meaningful has been done.
Why hasn’t the FDA or Congress done much about
this counterfeit drug situation? The answer is that “it’s all about money.” The pharmaceutical firms and
the distributors are major contributors to congresspersons’ campaigns. What is
expected in return for those contributions? What is expected is simple. Instead
of “do this” which requires work, it is simply “don’t do this” which requires
no work. The “don’t do this” is don’t implement a tracking system that records
the paths of the drugs completely from manufacture to the pharmacies and
hospitals. The premise is that it will cost too much to implement, when in
reality no one had evaluated the costs and with today’s computer programs, it
would add little cost to the legitimate product and would save many lives.
I sent letters to three Senators and three
Representatives saying that I would help them - for free - to design a system
to combat counterfeit drugs. One of the Senators had, a few days before, said
on a television interview that “something must be done to stop counterfeit
drugs from getting into our system.” None of them answered or even acknowledged
receipt of the letter.
I sent a letter to the FDA Commissioner saying that I am
a former FDA person and would help her - for free - to combat counterfeit drugs
and also assist in any other areas. I stated directly that there would be no
fee. Just under a half a year later I received an e-mail from a staff member saying
that “...the Commissioner says that there are no jobs available at this time.”
I had not asked for a job. I offered to help, gratis.
What can we do
to prevent counterfeit drugs?
Have an awareness that they are out there, of course.
Then additionally:
•
Implement a pedigree
system. This is simply keeping track of all owners and possessors of
something. We have
been doing this with houses, other buildings, land, and cars for years. In some
states, it’s done with boats. Adapt it to include all who handle the drugs even
if they don’t actually purchase them, for example, trucking companies
The pedigree system would simply keep
track of all who come in contact with the drugs after they leave the
manufacturer. That is, not only those who take ownership but also those who
have possession but not ownership, such as the trucking companies and others
who transport the drugs. Then, if something is determined to be wrong, the
system can identify all who had access to the drugs. This will help ensure that
real drugs are in the system.
Of course, the system would have
to be checked periodically, much like a business checks its books.
•
Test products.
Who, what, when. Testing the actual product can be done. It will have to be
determined who will conduct the testing, what products will be tested, and when
they will be tested.
•
Impose strict
laws and penalties. Such laws will be both a deterrent and a just
punishment for criminals of this type.
Suggested additional reading:
Dangerous Doses: How Counterfeiters Are Contaminating
America's Drug Supply, by Katherine Eban. Houghton Mifflin
Harcourt; First Edition (May 9, 2005). This is a true account written by a New York Times best selling author.
THE PLACEBO EFFECT: Counterfeit Drugs - A Crime Novel, by James J Farley. Western Star
Publishing. January 2012. This is fiction. However, it is based on some situations
encountered when Jim was Director of the Science Branch of the Philadelphia District
of the FDA.
The author is a Former FDA Employee, Regulatory Consultant, Expert
Witness and Pharmaceutical Chemist. He has written management textbooks,
works of fiction, and short stories. The
views and opinions expressed in this article are those of the author and do not
necessarily reflect the views and opinions of The CECON Group, Inc.
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