Fake drugs, real worries
High prices and the Internet are making U.S. patients easy prey
One evening last year, Paul Dumas, 57, an attorney in Mexico, Maine, was watching the local television news when he heard something about Lipitor, the drug he takes to lower his cholesterol. The news report warned customers to return unused Lipitor to their local pharmacies, including any purchased from the drug counter in the supermarket where Dumas and his wife, Cindy, fill their prescriptions. But the report was vague about the reasons.
Cindy Dumas, who also takes Lipitor, returned their drugs. Paul Dumas had already taken about 60 pills of his 90-pill supply. The supermarket pharmacy merely exchanged the remaining 30 pills for 30 new ones. "I never got a letter or a recall notice," says Dumas. "My wife asked at the drugstore what was happening, but they wouldn't say. We had no idea, really, until I got on the FDA website and found out: The Lipitor was counterfeit. To this day, I don't know what was in the drugs I took."
Paul and Cindy Dumas were not the only ones swallowing hard about swallowing mystery drugs. The recalls of fake "Lipitor" that began in May 2003 eventually involved more than 18 million "Lipitor" tablets. The sheer size of this counterfeiting operation, according to the real Lipitor manufacturer, Pfizer, meant that more than 600,000 U.S. consumers may have received "Lipitor" from pharmacies, health plans, in the mail, or over the Internet.
Holes in the safety net. Long considered impenetrable to the average fake pill pusher, the U.S. drug supply system is in a potentially dangerous transition. For over 65 years, selling medications to the public has been governed, above all else, by the need to provide safety. But today, every part of the system is increasingly preoccupied with price. As a result, the once tightly controlled, $216.4 billion U.S. drug market is being internationalized, and its safety net is increasingly full of holes. Americans are buying drugs freely and more cheaply over the Internet, often from foreign sources, but this brave new pharmaceutical world is exposing them to the dangers of unapproved and counterfeit medicines, the greed of unscrupulous doctors and pharmacists, and a shadowy world of small "secondary" drug wholesalers, "street brokers," drug "repackagers," and experienced criminals who see more profit in prescriptions than in pushing pot.
Americans pay more for drugs than residents of many other developed countries: They pay 60 percent more than the British or the Swiss for the same drugs, according to testimony before the Senate Committee on Government Affairs, and two thirds more than Canadians. It's well known that senior citizens, underinsured or uninsured individuals, and some states and local governments are turning to the Internet and foreign pharmacies, particularly what they believe to be safe, reputable Canadian pharmacies, to find less costly medications. What many don't realize, however, is that Internet pharmacies, even licensed ones in Canada, are increasingly buying from foreign sources themselves to meet American demand.
Drug imports to Canada increased 22 percent in the first eight months of 2003, including some from countries like Iran and Ecuador, where Canada has no agreement that the country's drug makers will abide by good manufacturing practices. CanadaRX, a large Canadian Internet site that buys drugs from other pharmacies, recently sent letters notifying customers that their drug shipments originated from the Bahamas, where one of the main brick-and-mortar pharmacies that supplies CanadaRX had opened a branch. The letters also indicated that recent restrictions imposed by drug manufacturers on the amount of medicine they send to Canada meant that to fill American orders, CanadaRX would have to obtain medications in New Zealand, Australia, the United Kingdom, and other European nations. It urged customers not to be alarmed by new drug names, packaging, or labels pasted over labels on their drug packages.