Counterfeit drugs latest public health hazard in US
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* Milan Korcok

The recent recall of 130 000 bottles of counterfeit atorvastatin (Lipitor) tablets by a US distributor has signalled a new hazard to public health — the diversion of illegally obtained, mislabelled, diluted, expired and even contaminated drugs into the American pharmaceutical supply system.

The issue is of interest north of the border because American critics of Canadian Internet pharmacies say there is a risk US buyers will be purchasing counterfeit products. But the reality, says Andy Troszak, is different.

“To my knowledge there has not been a single counterfeit issue within Canada,” says Troszak, vice-president of the Canadian International Pharmacy Association. “There's a larger potential for a US citizen to be exposed to counterfeit drugs by purchasing them within the United States than by getting them from within Canada.”

Nevertheless, Health Canada issued a warning about the fake Lipitor July 7. Spokesperson Krista Apse said Canadians could unwittingly buy the drug while visiting in the US or via the Internet. Health Canada's Ryan Baker says counterfeiting appears to be an American phenomenon. “We are not aware of any cases in Canada,” he said.

In alerting consumers about the recent recall, the Food and Drug Administration (FDA) noted that the fake Lipitor posed a “potentially significant risk.”

Where the counterfeit pills originated remains a mystery, but the FDA said they probably did not contain the 10-mg dose their labels claimed.

Neither company involved in distributing the pills would comment, but a spokesperson for Pfizer Inc., which earned US$8 billion through Lipitor sales in 2002, said counterfeiting of its products, including Viagra, is increasing.

Asked if the drug counterfeiting emerging in the US is likely to occur in Canada, Philip Rosenberg, president of the Canadian Association for Pharmacy Distribution Management, said there has been “little if any counterfeit activity to date.”

He attributes this to tougher regulation of distributors, who are governed by the same regulations as drug manufacturers and are inspected regularly by Health Canada. Police background checks are also required for those in charge of any Canadian wholesale drug operation. — *Milan Korcok*, Florida