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Many medicines are too costly for Asia's rural poor (Cambodia's Leng Bo with her five children), who unknowingly turn to counterfeits. (Jack Picone)

The Fatal Consequences of Counterfeit Drugs

In Southeast Asia, forensic investigators using cutting-edge tools are helping stanch the deadly trade in fake anti-malaria drugs

Bogus medicines are by no means limited to malaria or Southeast Asia; business is booming in India, Africa and Latin America. The New York City-based Center for Medicine in the Public Interest estimates that the global trade in fake pharmaceuticals—including treatments for malaria, tuberculosis and AIDS—will reach $75 billion a year in 2010. In developing countries, corruption among government officials and police officers, along with weak border controls, allow counterfeiters to ply their trade with relative impunity. Counterfeiting is "a relatively high-profit and risk-free venture," says Paul Newton, a British physician at Mahosot Hospital in Vientiane, Laos. "Very few people are sent to jail for dealing in fake anti-infectives."

When the fake artesunate pills first appeared in Southeast Asia in the late 1990s, they were relatively easy to distinguish. They had odd shapes and their packaging was crudely printed. Even so, Guilin Pharmaceutical, a company based in southern China's Guangxi autonomous region and one of the largest producers of genuine artesunate in Asia, took extra steps to authenticate its medication by adding batch numbers and holograms to the packaging. But the counterfeiters quickly caught on—new and improved fakes appeared with imitation holograms.

Then, in May of 2005, with the counterfeiters gaining ground, a number of physicians, officials, researchers and others gathered at the WHO regional office in Manila. Public health experts agreed to join forces with the International Criminal Police Organization (Interpol). They would try to track down the sources of the bogus artesunate and disrupt the trade. They would launch an investigation like no other, drawing on an extraordinary range of authorities in subjects from holography to pollen grains. They would call it the Jupiter Operation.

Paul Newton attended that first meeting in Manila, which he recalls was held in an atmosphere of "some desperation." He would coordinate the scientific investigation, which included experts from nine countries. "No one had tried to bring diverse police forces, forensic scientists, doctors and administrators together before," he says.

The goal was to gather enough evidence to halt the illicit trade by putting the counterfeiters behind bars. But first they had to be found. The investigators collected 391 "artesunate" samples from across Southeast Asia and subjected each pill packet to a battery of tests. "We were all working on pieces of a puzzle," says Michael Green, a research chemist at the Centers for Disease Control and Prevention in Atlanta. "When these pieces—chemical, mineralogical, biological, packaging analysis—were compared and assembled, a picture of where many of these counterfeits were coming from began to emerge."

The investigators pored over each package. In some cases, a mere glance was sufficient to spot the fakes: lettering was misaligned or words were misspelled ("tabtle" instead of "tablet"). Most of the time, though, the flaws were more subtle.

To examine the holograms, Newton called in a British holography expert named David Pizzanelli. The son of a Florentine painter, Pizzanelli had studied holography at London's Royal College of Art, and his artwork has been exhibited at top British galleries. He has lent his expertise to the Counterfeiting Intelligence Bureau, part of the anti-crime unit of the Paris-based International Chamber of Commerce.

The Jupiter Operation "was extreme in several ways," Pizzanelli says. "It was the first time I'd seen such an abundance of counterfeits, probably with the exception of Microsoft." (Bogus versions of Microsoft software blanket the world, costing the company billions of dollars.) Piz­zanelli identified 14 types of fake Guilin Pharmaceutical holograms. "It's a unique case in terms of how many counterfeit holograms there are. The real one just gets lost in the avalanche of images."

The hologram that Guilin itself puts on its artesunate packages—two mountains above a coastline with rolling waves—was fairly rudimentary to begin with. Some counterfeit copies were "deeply awful," he recalls. "The first two weren't even holographic," in­cluding an illustration etched into rainbow-colored foil. Some of the bogus holograms were well crafted but had clear errors: the waves were too flat or the mountains sprouted extra plateaus.

But a couple of the fake holograms exhibited flaws that defied easy detection: the colors were just slightly brighter than the genuine article, or the 3-D image had slightly more depth than Guilin's hologram. One hologram Pizzanelli studied was actually more sophisticated than the real article. Buyers would be "guided towards the fake," he says, "because the fake was better made than the genuine." That troubled Pizzanelli, who says he'd never before done holography detection with a "life-or-death implication."


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