Drug Counterfeiting: A Bitter Pill

Article excerpt

San Diego, a city of roughly 1.25 million inhabitants, has about 125 pharmacies. As of a year ago, according to the San Diego Weekly Reader, Tijuana, Mexico, with a population about the same size of San Diego's, had 1,000 pharmacies. Tijuanans probably weren't eight times more likely to need pharmacies than San Diegans; these retail operations opened up in response to a growing demand among U.S. citizens for more affordable prescription drugs.

Unfortunately, as experts recently testified before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, many of the pills sold are counterfeit and dangerous. In fact, an estimated 5 to 8 percent of worldwide trade in pharmaceuticals is counterfeit, according to the World Health Organization, a figure that John D. Glover, vice president of corporate security for Bristol-Myers Squibb Company, told the committee is probably an underestimate.

The numbers and anecdotal evidence on diversion and counterfeiting are staggering. Donald deKieffer, an attorney who represents many pharmaceutical companies, told the subcommittee that since 1997, more than 4,600 foreign drug manufacturers have shipped product to the United States without its being inspected by the Food and Drug Administration FDA). In addition, new counterfeit drugs are found in the United States all the time. For example, two counterfeit growth hormones (Serostim and Nutropim) and a cancer drug (Neupogen) were recently found within a 30-day period. Making the problem particularly difficult is the profusion of Internet sites through which counterfeiters can now market their bogus goods.

James Christian, vice president and head of corporate security for Novartis International AG, recounted his company's efforts in the uphill battle: In the last five years, the company has been involved in more than 100 investigations of counterfeiting operations in more than 30 countries. They involved more than u Novartis products and more than 200 products manufactured by other companies. In one raid of a counterfeiter's facility, Novartis turned up "tens of thousands of vials of a drug whose expiration date had long since passed." New labels were being attached to update the expiration date.

Novartis came across an-other product, Christian testified, that closely resembled Novartis's own but was made of floor wax, boric acid, and a lead-based yellow paint used for road markings. …