20 October 2003

U.S. Prescription Drug System Under Attack

U.S. Prescription Drug System Under Attack (washingtonpost.com): "A Vast, Unregulated Shadow Market

U.S. Prescription Drug System Under Attack
Multibillion-Dollar Shadow Market Is Growing Stronger

By Gilbert M. Gaul and Mary Pat Flaherty
Washington Post Staff Writers
Sunday, October 19, 2003; Page A01

First of five articles

For half a century Americans could boast of the world's safest, most tightly regulated system for distributing prescription drugs. But now that system is undercut by a growing illegal trade in pharmaceuticals, fed by criminal profiteers, unscrupulous wholesalers, rogue Internet sites and foreign pharmacies.

In the past few years, middlemen have siphoned off growing numbers of popular and lifesaving drugs and diverted them into a multibillion-dollar shadow market. Crooks have introduced counterfeit pharmaceuticals into the mainstream drug chain. Fast-moving operators have hawked millions of doses of narcotics over the Internet.

The result too often is pharmaceutical roulette for millions of unsuspecting Americans. Cancer patients receive watered-down drugs. Teenagers overdose on narcotics ordered online. AIDS clinics get fake HIV medicines.

Normally, drugs follow a simple route. Manufacturers sell them to one of the Big Three national wholesalers -- Cardinal Health Inc., McKesson Corp. and AmerisourceBergen -- which sell to drugstores, hospitals or doctors offices. Regulators and industry officials have long considered this straightforward chain to be the gold standard.

The shadow market exploits gaps in state and federal regulations to corrupt this system, creating a wide-open drug bazaar that endangers public health."

This is just one example of how our distribution chains are being hijacked. The pharmaceutical companies have been aware of the problem for years and have tried several ways to mitigate this operational risk. In some drugs, they are placing "inert" ingredients in the pills themselves that can be tested in the field with a special "test kit" to determine if a pill is counterfeit. Unfortunately, the test kits are only being used by the people who are catching the bad guys, like the DEA and other law enforcement. See Biocode

Other diversion of controlled substances have made their way to the Internet to be sold on web sites. For example, the tobacco companies have acknowledged the fact that minors are buying cigarettes via web sites developed and operated from American Indian reservations. These sites sell cigarettes at discounted prices and the consumer is avoiding steep taxation on these types of controlled products. Again, the problem is not about a lack of awareness about the issue, it is about the lack of resources and funding to stop the problem.

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