There was a flurry of discussion last week over a recent Wall Street Journal blog by their “Numbers Guy”, Carl Bialik, regarding the often quoted “estimate” that 10% of drugs worldwide are counterfeit. On September 10, Bialik posted an essay titled, “Dubious Origins for Drugs, and Stats About Them“. The next day he published an article on the topic called “Counterfeit Drug Count Is Tough to Swallow“. Both essays call into question the origins and the accuracy of the “estimate”. On September 13, Dr. Adam Fein posted an essay titled, “The Counterfeit Counterfeit Drug Count” on his DrugChannels blog, citing the WSJ essays and providing some additional insight.
Don’t miss the many comments left by readers of Bialik and Fein’s postings. It’s surprising how many people don’t want to let go of the “estimate”, even if they might agree that it is a meaningless value. They are more concerned that anyone attacking the “estimate” is also dismissing that the world has a serious problem with counterfeit drugs. On the contrary, both Bialik and Fein acknowledge that some countries around the world have a serious problem with counterfeit drugs.
As Bialik and Fein point out, the problem is that the “10% estimate” appears to have been pulled from thin air back around 2002. It has no basis in fact and so I contend that it should not be referred to as an “estimate”, but is purely a guess. No, from now on, let’s not even refer to it at all. It doesn’t exist.
Coincidentally, I had my own experience with using inaccurate estimates of counterfeit drugs last week. I spoke at the Reconnaissance International Product Authentication + Security Summit (PASS) in New Brunswick, NJ on the topic of U.S. pharmaceutical supply chain security. In my presentation I was going to refer to the estimate by Nigerian Health officials that 70% of the drugs in that country are counterfeit. But prior to delivering my presentation, I struck up a conversation with Jim Chambers of JC Authentication.
It turns out that Jim has had personal experience working on the counterfeit drug problem in several African countries, including Nigeria. He pointed out that the “70%” estimate was at least 16 years old. More significantly, he told me that, since that time, the Nigerian government had implemented a number of counter-measures that had brought the problem down to an estimated 15% of drugs being counterfeit. They still have a real problem on their hands, but Nigerians can rightfully be proud of their results.
The story doesn’t end there. After talking with Jim, I updated my verbal presentation to reflect this new estimate, but I failed to update the slide that still contained the “70%” estimate. At the end of my presentation, who should I find in the audience but Momodu-Seiru Momodu, Director of the Nigerian Ports Inspection Directorate, a branch of the National Agency for Food and Drug Administration and Control(NAFDAC). Director Momodu raised his hand and challenged my reference to the “70%” estimate. Rightfully so.
What we need are scientifically prepared estimates that are done by a credible source on a regular basis so we can agree on the magnitude of the problem in certain countries or regions and within a given timeframe so we can measure progress or regress. If any organization is positioned to take on that challenge it seems to me like it would be the World Health Organization (WHO). The fact that they don’t make estimates everywhere and on a regular basis is an indication of just how hard it would be.
Only when we know the exact characteristics of the problem in a given country can we figure out what technology is best suited to solve that problem in that place. A set of solutions that work in the United States will not work in Nigeria, and vice versa, even if the percentage of counterfeit drugs were the same. The fact that the percentages are far from the same leads to even greater confidence that the respective set of workable solutions will not be the same.
The kind of organizations I can assure you are definitely the wrong type to make estimates like this are technology solution providers. When a solution provider throws around an estimate of counterfeit drugs it is usually done so in a very self-serving way. So it is to you I say, Stop claiming that 10% of drugs worldwide are counterfeit!