From the Mouths of Babes, or The Emperor is Wearing What?!

April 10, 2009

I have the pleasure of working from home as does my wife. I, the chemist, and she, the business-person, have a lot of common interests, just not science all that much. Working in close proximity, we overhear each other’s work conversations…and grumblings about our respective industries (she is in telecommunications). We both work on complex problems and tend to see most answers to problems as multi-tiered and, sometimes, intractable. But, it is not uncommon for each of us to make snide remarks about the other’s problem at hand. 
One such incident occurred last week. Whilst we were watching a news program, she suddenly paused the show (ain’t TiVo great?) and commented on the story being told. The story in question was about counterfeit drugs in the hospitals and pharmacies around the world. And just what was my wife’s answer? OK, but first, let’s examine the problem, as we know it. According to recent surveys, the cost to the industry (by WHO) is “low-balled” to be at least $32,000,000,000 (that’s billion USD) last year and could easily be several times that. 
What is the industry doing about the problem? Well, some things are being tried; RFID (radio frequency ID; similar to EZ Pass on the highway) chips on bottles and cases seems to have a head start, but others are gaining. This seems all well and good, but as traffic control personnel have found, it is difficult to prove who was in a car when it was caught speeding by an automated device. By extension, while the box or bottle may say “good drugs,” it does not show what’s in the bottle. If the counterfeiters are willing to risk the lives of patients, they certainly will not hesitate in re-filling legitimate bottles with illicit drugs.
Unfortunately, as I commented recently, we are being scientifically too clever, by half. Re: the recent heparin adulteration problem. The masterful work done by the FDA and several universities has resulted in extensive and expensive compendial tests being inserted in the USP. They work and are specific, but (think there wouldn’t be a “but?”) the lab-based tests are just that: lab-based! There seems to be a trend to collect potentially bad samples and send them to the labs for confirmation…and wait for results.
Other than there are only a few dozen teams for this work and results could take weeks from the time of confiscation; I can’t see any problems here.
There are some projects underway to “mark” the products by, for instance, deliberately varying Excipients in a pre-ordained manner and marking each batch with known variations that will act as fingerprints, but this, too will require samples being read on the spot or sent back to a central lab. Somewhere along the line we lost sight of the K.I.S.S principle: keep it simple, stupid!With hundreds of counterfeiters and thousands of warehouses and tens of thousands of pharmacies (local and hospital) to protect, we are expected to have a handful of inspectors/investigators seek bad drugs, sample them, and wait around for results. This results in legal problems as most counterfeiting takes place in foreign countries…with varying laws and customs. Worst case scenario: the locals might well be in league with the “bad guys,” leaving us in the cold.
Now, in all this information, where does my wife come in? Well, her comment was simply, “Why don’t they simply supply each pharmacy with a small NIR instrument to examine the product before paying for it?” I was about to argue, but couldn’t. As they say at the in the Six Million Dollar Man, “We have the knowledge; we have the technology to rebuild him.” In this case the “him” would be our supply chain and way of dealing with counterfeits. Having designed and seen numerous small, inexpensive units, I know it is possible to crank out thousands for a minimum cost. In bulk, fairly sophisticated NIR units could be built for well under $1000. These could have an embedded library or a Bluetooth to communicate with a central computer; one or two doses from each lot could be checked for “goodness.” The goodness would be based on supplied doses from each supplier. The software and hardware could be distributed in a matter of a few years…at a cost far less than the cost of counterfeiting. And that ignores the human cost of pain, suffering, and death caused by the tainted products.
The biggest challenge would be convincing the money-people. After recent stories of not revealing clinical er, uh, um “difficulties” with side effects in a timely fashion, the commitment to the human condition on the part of Pharma management might be called into question. More likely would be petty squabbles over who gets credit, who’s in charge, who makes a buck, who wins the Nobel Prize, etc. So, while the ability to do testing in every dispensing point is available today, we have to question the will of the industry.
Can we come together to fight one of the worst plagues in history or will we allow the whole Pharma supply chain go the way of our banking industry?

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