Counterfeit Drugs Leave U.S. Supply Vulnerable
By: David J. Gibson, MD

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The concern about another terrorist attack on American soil is palpable. Alert levels have been raised and defensive resources deployed. Amid all of this activity, it is worth taking a moment to reflect upon the terrorists' known past behavior to predict their next initiative. Terrorists have consistently sought to strike us where we were not looking. From a terrorist's point of view, the ideal attack would occur in an unexpected manner, meet minimal resistance and cripple one of our essential industries. Such an attack would not only injure, it would also demonstrate that our government is incapable of protecting its citizens.

Remember, from a terrorist's perspective, the ability to discredit the government is much more important than causing physical damage. This ability to discredit is significantly enhanced if a known threat has been ignored. That is what happened on Sept. 11, 2001. That is what is likely to happen again.

It has been known for some time that the ability of the U.S. Food and Drug Administration (FDA) to protect the deployed drug inventory within the United States has been compromised.

As far back as 1996, the FDA warned that it had lost control over bulk drug shipments that enter the U.S. market. A 2003 FDA/U.S. Customs spot check of imported pharmaceutical drugs found that 88 percent contained drugs that were counterfeit or otherwise not approved for U.S. use.

There is mounting evidence that counterfeit drugs have permeated the U.S. drug inventory.

Former FDA Commissioner Mark B. McClellan warned that the FDA is increasingly seeing large supplies of counterfeit versions of finished drugs being manufactured and distributed by well-funded and elaborately organized criminal networks.

Unfortunately, drug counterfeiting primarily occurs with the most expensive products. These are the medications upon which individuals' lives depend. Drugs used to treat AIDS, transplants, malignancies and chronic debilitating diseases are generally the targets of counterfeiters.

Terrorists and the drug inventory: This summer, acting FDA Commissioner Lester Crawford warned of the risk of a terrorist attack on this country through the U.S. drug supply. That warning was met with skepticism, as the remarks focused on Internetbased purchasing of imported drugs.

His warning is valid but incomplete. Counterfeit drugs are already deployed in the U.S. and now contaminate inventories at both the wholesale and the retail level.

Remember the Tylenol scare? That episode, occurring in 1982, involved the lacing of Tylenol bottles on pharmacy shelves with cyanide. Seven people died and Tylenol's manufacturer, Johnson & Johnson, was forced to recall 31 million bottles at a cost of more than $100 million. This tragic episode involved only a handful of bottles. Terrorists could contaminate thousands of bottles of multiple counterfeit pharmaceutical products with chemical or biological toxins from their bases in countries outside the U.S. These counterfeit products would arrive in the United States, be inserted into the drug distribution system and patients would begin to die. It would take several days if not weeks to establish the connection.

The casualty count, and the fear generated from such an attack, would have incalculable consequences. The reliability of the entire deployed pharmaceutical inventory in the United States would immediately be called into question.

What could be more efficient from a terrorist's point of view than the inadvertent recruitment of your physician and community pharmacist into the nefarious plot? Not only could the terrorists inflict injury and death upon America's civilian population through prescription medications; they could also demonstrate that our government is incapable of protecting its citizens from a known threat.

Why would the terrorists engage us in a frontal attack on the streets of New York, where we have prepared, when they can remain safe in unstable countries and inflict chaos upon the healthcare system here in the United States?

What should be done? For openers, we need to think more creatively as we prepare for the next terrorist attack. Protecting America's vulnerable healthcare system must be addressed -- now.

We need to immediately implement the recommendations contained in the FDA's February 2004 report entitled "Combating Counterfeit Drugs." America also needs an independent organization that will sample deployed inventory at both the wholesale and the retail level of the distribution system. The results of this organization's monitoring should be made public so that the magnitude of the counterfeit-product problem can be known and monitored.

The Fraud Prevention Institute is now starting to collect deployed drug samples. These samples are being supplied by concerned community pharmacists to determine the extent of the counterfeit drug problem here in California.

In essence, we are creating the equivalent of an "Underwriters Laboratory," to give California consumers the information they need to protect themselves and their families at the point-of-dispensing. This is a community-based response to a clear and present danger that must be recognized and addressed immediately.

Printed in the October 15, 2004 print edition of the Sacramento Business Journal