I recently gave a talk—at Pittcon 2009’s Wright-Williams award session honoring spectroscopy expert Dr. Jerry Workman from Luminous Medical, Inc.—on near-infrared spectroscopy and how it could remain relevant. The crux of the talk was that: 1) counterfeit drugs (and adulterated raw materials) were the largest current threat to the world’s health; and 2) NIR could help if only it were cheaper and easier to use (e.g., it used common parameters and algorithms).
The problems in the drug supply chain have been discussed in detail in this magazine for some time: adulterated raw materials, substituted dosage forms, false materials, and outdated drug lots sold as “good.” The cost (in mere money) is in the multi-billion-dollar range per year. The cost in human lives (not receiving needed medicines, drug-resistant microbes, and outright poisoning) is incalculable. In some countries, the majority of medicines may be counterfeit, largely because of the lack of a good, inexpensive technology for quickly determining the authenticity of the product.
Since the current means we have for detecting counterfeits are low tech (e.g., does the color match the Physicians’ Desk Reference?) or wet chemistry (“in the field” spot tests for barbiturates or opiates, or HPLC back at the lab), there is currently no quick and specific method to show that a dosage form is: a) the correct drug; and b) that it was made by the company on the label.[pullquote] The alternate is a simple, rugged, and inexpensive field NIR unit that could quickly scan a suspected product and check with a library for a spectral signature for an immediate “truth check.”
Well, the number of small, rugged, and, yes, inexpensive instruments becoming available makes the hardware portion a reasonable part of the puzzle. Software is also prolific (once we decide which parameters to use) and could be the second part to fit. But, what about the library where ALL the spectra of true products are to be kept? The library will be a work in progress forever; new companies, new locations, new products, and new equipment will always make subtle changes in the spectral library. A central location (or a few locations, linked by the web) would make sense. It could be updated continuously (sponsored by the industry and governments, but that is merely about money). How do we link the thousands of units in the field with the “mother” library? Actually, somewhat easily.
A recent article in Forbes (April 13, 2009) caught my interest. It was about entrepreneur Dan Colussy and his efforts to resurrect the Iridium satellite network. Iridium made headlines in the 1990’s as a spectacular attempt to enable anyone, anywhere to converse by means of a special phone. 88 satellites were launched in all. The bad news: the phones cost $3000 apiece and the calls $3 to $7 a minute. In nine months, the company was bankrupt.
Said a Wired magazine article in 2000, “Iridium will be remembered for two things. One is that its technology changed the face of the global communications. The other is that it was a miserable failure.”
The technology part got Mr. Colussy and investors to generate $5 billion to get the system up and running again. Instead of focusing only on phones, he uses it to transmit GPS coordinates of hijacked trucks, the size of tsunamis in the Pacific, and the speed of dogsleds in the Iditarod in Alaska. Last year, says Forbes, he made a $54 million profit on an income of $320 million (320,000 customers). And it appears that a new network of satellites will come on line in 2012. The cost of receivers has fallen to around $250 (and is expected to drop to as low as $25) and the cost of a phone transmission dropping to five cents a minute by 2014.
Can we see a possible solution to the last piece of the puzzle? If a (true) world-wide system were available for a minimum expenditure and, if field operatives could quickly connect data from their hand-held NIR units with a central library, then we would have a powerful tool to fight counterfeiting in the field, in real time.
Now, all we have to do is get funding and convince the feuding instrument companies that there would be enough sales in it for them to each produce thousands of these units (shared patents?) and we have a way to combat one of the nastiest plagues since the Black Death in the middle ages.