THE HUNTfor
C OU N T E R F E I T MEDICINE
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Drugs manufactured by counterfeiters are infiltrating markets worldwide. Investigators are harnessing a variety of analytical techniques to catch as many of the fakes as they can.
JUPITERIMAGES
Rajendrani Mukhopadhyay
n early 2006, officials in the U.K. seized 5000 packets of the flu medication Tamiflu. They were counterfeit, estimated to be worth £500,000 (~$980,000). In the late summer of 2006, the U.S. Food and Drug Administration (FDA) warned consumers not to purchase medicines from websites associated with the Canadian Mediplan Prescription Plus Pharmacy or Mediplan Global Health. Counterfeit versions of Lipitor, Nexium, and other prescription drugs were being sold via those websites. But those examples of counterfeit drugs are relatively benign. In 1995, a meningitis epidemic spread throughout Niger. To fight the epidemic, the West African country accepted a donation of vaccines. Upon receiving the vaccinations, 2500 people died. The vaccines were fake. In 1998, 30 infants died in India after they were given cough syrup that contained diethylene glycol, a toxic chemical used in antifreeze. In 1999, at least 30 people in Cambodia died after taking older and less effective antimalarials that were packaged and sold as the more potent and expensive drug artesunate (1). Counterfeiting medicines has been around for years—Graham Greene’s 1948 novel The Third Man was a story about a search for a smuggler of counterfeit penicillin in postwar Vienna. The business is lucrative because of the high demand for © 2007 AMERICAN CHEMICAL SOCIETY
medicines and low production costs. The lack of proper legislation and stringent regulation in many countries also works as a form of encouragement. In addition, the literature on counterfeit medicines in the medical and scientific communities isn’t vast. “There’s not much scientific literature, but there’s a lot in newspapers and magazines” because journalists have picked up high-profile stories, says Paul Newton at Oxford University (U.K.). “The health community, I would suggest, is not very active in pointing out the problem.” (For a detailed review of counterfeit medicines, see Ref. 2.)
How big is the problem? It’s hard to get a handle on the size of the global racket, because estimates are based on “very scanty data,” says Valerio Reggi of the World Health Organization (WHO). “Most of the counterfeits are detected largely by accident. It means that we are just seeing the tip of the iceberg. We presume there is an iceberg to be found somewhere under the tip, but no one has been able to put their head under the water.” It’s conservatively estimated that >10% of the global medicine market consists of fakes, but the estimate can’t be applied equally to all countries. “We know that in industrialized countries with effective regulatory systems, like the U.S., Canada, A P R I L 1 , 2 0 0 7 / A N A LY T I C A L C H E M I S T R Y
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the European Union, Japan, Australia, and New Zealand, one says Tom Layloff of the Supply Chain Management System. Reggi drives home the point. “For a grossly unqualified prodcan safely assume that counterfeits reflect 80% of active ingredient, and if the wax sinks in the second solution, the tablet contains 90% since 2005 (1). Sales won’t be restricted to countries with weak drug regulation—better counterfeiting methods will allow fake drugs to slip increasingly into more tightly controlled markets. And the fact that drugs can be easily bought from the Internet isn’t helping matters. Although some counterfeits, such as dummy Viagra pills, may only make fools out of consumers and the pharmaceutical companies, others, such as the antimalarials, antiretrovirals, and anticancer drugs, certainly mean death for unsuspecting victims. “There’s been very little scientific research on how common counterfeits are, what types there are, how they can be detected, or how they can be prevented,” says Newton. “There’s very little information, considering the size of the problem.” Rajendrani Mukhopadhyay is an associate editor of Analytical Chemistry.
References (1) (2) (3)
World Health Organization Fact Sheet No. 275, Feb 2006, www.who.int/mediacentre/factsheets/fs275/en. Newton, P. N.; et al. Lancet Infect. Dis. 2006, 6, 602–613. Nyadong, L; et al. Anal. Chem. 2007, doi 10.1021/ac062205h.
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