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Drug Busters: Tracking Down Counterfeiters

Novartis deploys a global team to track down counterfeit drugs and help authorities prosecute counterfeiters.

WHO began collecting data on counterfeit drugs around 1982, but a number of years passed before the problem gained the attention of the industry and governments. Christian says drug companies began to take notice in the early 1990s, particularly in Asia. He credits John Glover, then the head of security at Bristol-Myers Squibb (BMS), with proposing that drugmakers' security departments should join together to address the issue, and five did. "That was the first cooperative working that I was familiar with," says Christian.

The group, which called the project the Pharmaceutical Security Initiative, conducted market sweepspurchasing products, then shipping them to the companies to analyzein nations such as China, Indonesia and the Philippines. (Christian says the percentage of counterfeit product was small.) In 1996, that group became the Pharmaceutical Security Institute. Christian sits on its board.

The counterfeit problem spiked in the late 1990s; the folks at Novartis refer to 1999 as a "breakout season." That year Brazil listed 137 pharmaceutical products, such as Bactrim, Amoxil and Tylenol, on the market that had counterfeit versions, and by that time in Colombia, the activity in counterfeit medicines began to rival the illicit drug trade. The problem was growing in Asia as well, and new hot spots were emerging in Russia, India and the Middle East. After lying dormant or at least evading detection for years, the counterfeiting problem was becoming a fast-spreading cancer worldwide, with the lure of easy money and the ability to evade prosecution (both appealing incentives for organized crime) helping to fuel its growth.

Developed countries were not immune. In 2000, according to WHO, 240,000 packs of medicines and two tons of raw materials worth $1 million were seized in Italy; in 2003, 18 million tablets of the cholesterol-lowering drug Lipitor, the world's best-selling prescription drug in 2004 with sales of $10.86 billion, were recalled by Pfizer in the United States after fake pills were found in pharmacies; in 2004, fake Cialis, an erectile dysfunction drug, was found in the U.K. supply chain; and this year 120,000 packets of Lipitor were recalled in the United Kingdom after 73 counterfeit packets were found. Those are just a few examples of what's been found; plenty of counterfeit or substandard medicines have made their way into patients' bodies undetected.

Finding counterfeit pills, however, can be a crapshoot. "The only way I can tell a pill or tablet or capsule [is counterfeit] is to destroy it in a lab," says Christian. And detection has become noticeably more difficult due to the mixing of genuine product with bad product. "In the '90s, when you saw a counterfeit, whether in a plant, shipment or truckload, if you pulled one capsule, pill or tablet and tested it, if it was counterfeit you could pretty safely say everything was counterfeit," says Christian. Starting around 1999, the mixing began. "So now if you do a raid, you generally run into counterfeit, genuine, expired and stolen product. If someone reached into your container and took out one Lipitor capsule and tested it, and it turned out to be genuine, it does not mean the rest of the capsules in that container are genuine," Christian adds.