The patient went to a rural hospital in East Burma with a fever and was diagnosed as having a straightforward case of falciparum malaria. He was treated with the vital antimalarial drug artesunate, labeled as made by the company Guilin Pharmaceutical in China. This drug is usually extremely effective, yet the patient went into a coma and died.
The researchers, led by Paul Newton (University of Oxford), analyzed the artesunate tablets that had been used to treat the patient and found that they were fake, containing just 20% of the amount of active drug present in a genuine artesunate tablet.
When genuine artesunate was given to 600 patients with straightforward falciparum malaria in a study in East Burma, every single patient survived. Newton and colleagues conclude that the 23-year old man died from being given fake artesunate.
"Counterfeit artesunate continues to circulate on a vast scale in mainland Southeast Asia," say the authors. So far, only the Guilin Pharmaceutical brand of artesunate has been counterfeited.
Genuine artesunate is relatively expensive, creating a demand among poor, vulnerable people for cheaper alternatives--the counterfeiters, say the authors, are thus preying upon the poor.
Newton and colleagues fear that an epidemic of fake artesunate may also follow in the wake of the genuine artesunate that is being imported for use in sub-Saharan Africa, where the burden of malaria is greatest. The high cost and the shortage of genuine artesunate in Africa provide a favorable situation for the spread of fakes, which could put the lives of thousands of children at risk.
Fake artesunate was found in Cameroon in 2005, and fake dihydroartemisinin (a related antimalarial drug) was reported in Tanzania in 2001.
"Because of inadequate systems for the monitoring of the quality of antimalarial medicines in Africa," say the authors, "and because few have looked for it, counterfeit artesunate may already be widespread."
"We make no apology for the use of the term manslaughter to describe this criminal lethal trade," they say. "Indeed, some might call it murder. Somewhere, people are directing a highly technical and sophisticated criminal trade."
Preventing an epidemic of fake artesunate in Africa, they say, will require concerted global action, including ensuring that genuine artesunate is made affordable to the poorest.
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Citation: Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, et al. (2006) Manslaughter by fake artesunate in Asia--Will Africa be next? PLos Med 3(6): e197.
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Caption: Genuine (left) and counterfeit (right) Cotexcin (Dihydroartemisinin) from Tanzania (Photograph by Manuela Sunjio)
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Caption: Genuine (right) and counterfeit (left) Arsumax (Artesunate) from Cameroon (Photograph by Manuela Sunjio)
Wellcome Trust-Mahosot Hospital
Vientiane, Vientiane 0
Lao People's Dem. Rep. (Laos)
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