Feb
12
2008

Since 1998 there has been a serious public health problem in South East Asia of counterfeit antimalarial drugs containing no or minimal amounts of the active antimalarial ingredient, this has led to deaths from untreated malaria, reduced confidence in this vital drug, created large economic losses for the legitimate manufacturers, and led to concerns that this antimalarial drug might cause resistance. As the situation continues to deteriorate, a group of police, criminal analysts, chemists, palynologists (people who study pores, pollen and certain algae), and health workers collaborated to determine the source of these counterfeits.

What did they find?
Red blood cells infected with Plasmodium falciparum: This thin film Giemsa stained micrograph reveals ring-forms, and gametocytes of Plasmodium falciparum.
Red blood cells infected with Plasmodium falciparum: This thin film Giemsa stained micrograph reveals ring-forms, and gametocytes of Plasmodium falciparum.Courtesy cdc
They analyzed a total of 391 samples of genuine and counterfeit artesunate (the anti-malarial drug) collected in Vietnam (75), Cambodia (48), Lao PDR (115), Myanmar (Burma) (137) and the Thai/Myanmar border (16). They found sixteen different fake types of the drug. High-performance liquid chromatography and/or mass spectrometry confirmed that all specimens thought to be counterfeit (195/391, 49.9%) contained no or small quantities of artesunate (up to 12 mg per tablet as opposed to ∼ 50 mg per genuine tablet). Chemical analysis demonstrated a wide diversity of wrong active ingredients, including banned pharmaceuticals, such as metamizole, and safrole, a carcinogen, and raw material for manufacture of methylenedioxymethamphetamine (‘ecstasy'). Evidence from chemical, mineralogical, biological, and packaging analysis suggested that at least some of the counterfeits were manufactured in southeast People's Republic of China. This evidence prompted the Chinese Government to act quickly against the criminal traders with arrests and seizures. Go to PLoS Medicine for the full scientific article and a very well written editor’s summary.

What Do these Findings Mean?
From the PLoS editor’s summary…
The results were crucial in helping the authorities establish the origin of the fake artesunate. For example, the authors identified two regional clusters where the counterfeit tablets appeared to be coming from, thus flagging a potential manufacturing site or distribution network. The presence of wrong active pharmaceutical ingredients (such as the older antimalarial drugs) suggested the counterfeiters had access to a variety of active pharmaceutical ingredients. The presence of safrole, a precursor to the illicit drug ecstasy, suggested the counterfeits may be coming from factories that manufacture ecstasy. And the identification of minerals indigenous to certain regions also helped identify the counterfeits' origin. The researchers concluded that at least some of the counterfeit artesunate was coming from southern China. The Secretary General of INTERPOL presented the findings to the Chinese government, which then carried out a criminal investigation and arrested individuals alleged to have produced and distributed the counterfeit artesunate.
The collaboration between police, public health workers and scientists on combating fake artesunate is unique, and provides a model for others to follow. However, the authors note that substantial capacity in forensic analysis and the infrastructure to support collaborations between these different disciplines are needed.

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