The Oprah Moment

Among people who follow the market's counterfeit drugs, it has long been an axiom that eventually we'd see an "Oprah moment," the point at which a real person would die from taking a counterfeit, humanizing and personalizing the debate on drug importation. The moment came July 5, when the coroner of Vancouver Island in Canada reported that Marcia Bergeron had died of ingesting tainted counterfeit drugs purchased on the Internet. Bergeron, 58, was found dead in her home last December. Investigators searching the scene found generic pills that proved to be laced with metals, including aluminum, strontium, uranium, and lead. Computer records showed that they had been purchased from an Internet pharmacy that claimed to be Canadian.

The death was the first documented case of death by Internet-purchased counterfeit drugs.

The case, along with the recent recall of products from China--from toothpaste laced with toxic materials to food products consisting largely of cardboard--has highlighted the risks of purchasing unregulated products.

"I think there has been a change recently in the recognition of the problem of counterfeiting," said John Theriault, Pfizer's vice president of global security. "Certainly the products recalled from China have helped to make people more aware of the need for improved regulation. We at Pfizer have intensified our efforts in an aggressive program to deal with the problem of counterfeit products, and we've encouraged governmental agencies to deal firmly with the problem."

Theriault said that the most effective safety strategy for consumers is to buy medicines from a known source.

"People have to know that when they purchase medications through the Internet, the risk increases geometrically," he said. "And government regulatory agencies need to pay a lot of attention to the integrity of the supply chain."

Counterfeiting is an international issue, but Theriault said the focus should be on identifying individual criminal offenders rather than the countries where counterfeit products originate.

"The pharmacy industry is one of the strongly regulated systems in the United States, so that products manufactured in this country are regulated and ensure safety," said Kristina E. Lunner, senior director for government affairs at the American Pharmacists Association. "The frustrating part is that while there are so many clear dangers in counterfeit products, FDA continues to find hundreds of counterfeit products that are stopped at the border."

One promising strategy in the effort to combat pharmaceutical counterfeiting is the introduction of covert markers that can be woven into drug formulations and packaging. These "inside-out" identification markers allow products to be verified even if the drug itself is separated from its packaging.

One such drug-ID system comes from ARmark Authentication Technologies, based in Glen Rock, PA. The company has developed customizable tags that can be incorporated into drug tablets (as excipient materials), labels, bottles, and blister packs, then scanned with an optical reader.

"Our technology was born out of a need to authenticate materials that help to mitigate risk," said Jeff Robertson, ARmark director and general manager. "Over the past five years, [counterfeiting] has really spread, partially because of the globalization of the economy. What we are manufacturing is microscopic--it's like making dust. But it's an important way to let customers know that the product they're buying is safe."