February 1, 2013

Counterfeit Drugs: Not Just a Third World Problem?

In November, a NY Times editorial raised the issue of  “Fake & Useless Drugs” aka counterfeit drugs, appearing in developing nations. How are counterfeit drugs defined?  Are they present in the U.S.?  How do they get into the supply chain?  Can the FDA do anything to stop them?

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.