Therapeutic Dose: You Can’t Cheat an Honest Man [1]

May 22, 2007
. . . or fabrum esse suae quemque fortunae [2] (translation: “Each man the architect of his own fate”)

I was rereading an editorial from this magazine in which the subject was drug counterfeiting. It occurred to me that the U.S. government is approaching the problem much as it approaches illegal drug smuggling — by attacking the producers. When a person complains that the $25 Rolex watch he purchased from a street vendor in New York is worthless, we chase the seller (ditto for $10 Prada shoes and on-line Viagra tablets). The 800-pound gorilla that we are ignoring is the customer and his responsibility for the situation.

When a person purchases anything at far-below-retail levels, logic tells him that one of the following must be true: either the item is stolen or it is phony. That means that the customer is abetting a crime, be it larceny or copyright infringement. One who buys from a purveyor of bad materials either is obtuse or has larceny in his heart: hence the title of this piece. [I will, for the moment, refrain from addressing the other two dictums of W.C. Fields: “Never give a sucker an even break” and “Never smarten up a chump.” I will allow the milk of human kindness to flow.]

I really have little sympathy for someone who buys “knock-off” handbags in the city. I do, however, worry about (some) people who purchase bad drugs. Not those who get bad cocaine or heroin (or even legal drugs such as OxyContin procured from illicit sources), as this is self-destructive behavior and needs to be addressed elsewhere. But in the case of prescription drugs, honest people are sometimes driven to look for these medications outside standard retail channels because they have no insurance or the prescriptions are not covered (for example, Viagra may be listed as a “lifestyle drug” and not reimbursed). Now, we have people who are truly victims.

Counterfeit drugs are a large and growing problem. A recent TV exposé showed a Chinese source for fake Viagra where the drug was, in reality, ground-up wallboard, pressed and coated to look like the real thing. Counterfeiters seldom care about the health of the patient; they use materials ranging from outdated drug lots to placebos to outright toxic materials. Thus, at best, we get a lower potency. At worst, we get no protection and can actually be poisoned.

Markers that use radio frequency ID (RFID) promise some relief. However, as with any defensive measure, the “enemy” is out there looking for counter-measures. Like hackers generating new viruses, drug counterfeiters are always seeking ways around security technologies. The problem I have with RFID tags is that they are on the bottle or case, not the product itself. Having worked in the industry longer than many of you readers have been breathing, I am aware of how easy it is to repackage products.

There is little to stop a group from hijacking a legitimate shipment of a controlled substance, emptying the product for diversion, and refilling the bottles with placebos (for insertion into the retail stream). These cases of bottles, still bearing the correct RFID tags, are distributed to pharmacies throughout the region, while the diverted product is sold to street pushers or made available online.

Before you start wringing your hands in dismay (who wrings their hands nowadays, anyway?), I have a humble suggestion. One of the benefits of PAT/QbD is the discovery of what is called the “process signature.” It is this process signature that allows us to predict a drug product’s performance vis-á-vis such things as dissolution, hardness, etc. This identifying characteristic of the product is our best defense against counterfeiters. With the advent of small, inexpensive, hand-held spectrometers (NIR and Raman), it is feasible for agents from the DEA, FDA, ATF, FBI or any other government entity to spot-check drug products in seconds.

Even if the miscreants were to invest the effort to use the correct APIs and approximate the excipients, they would seldom have the wherewithal to duplicate the large, modern tableting machines used by legitimate drug manufacturers. (It is not likely that counterfeiters would make knock-offs of generic products, the profit being too small.) That makes the key element of the “Design Space” concept a key element in law enforcement, too. If another reason for PAT was needed, we may have just discovered it, thanks to the counterfeiters. Thank you — I think . . .


  1. W.C. Fields, from the movie of the same title, 1939, Universal Studios
  2. Appius Caecus, Rome, 4th century BC
About the Author

Emil W. Ciurczak | Contributing Editor