A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.

<h4>Background</h4>Since 1998 the serious public health problem in South East Asia of counterfeit artesunate, containing no or subtherapeutic amounts of the active antimalarial ingredient, has led to deaths from untreated malaria, reduced confidence in this vital drug, large economic los...

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Main Authors: Paul N Newton, Facundo M Fernández, Aline Plançon, Dallas C Mildenhall, Michael D Green, Li Ziyong, Eva Maria Christophel, Souly Phanouvong, Stephen Howells, Eric McIntosh, Paul Laurin, Nancy Blum, Christina Y Hampton, Kevin Faure, Leonard Nyadong, C W Ray Soong, Budiono Santoso, Wang Zhiguang, John Newton, Kevin Palmer
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2008-02-01
Series:PLoS Medicine
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/18271620/?tool=EBI
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author Paul N Newton
Facundo M Fernández
Aline Plançon
Dallas C Mildenhall
Michael D Green
Li Ziyong
Eva Maria Christophel
Souly Phanouvong
Stephen Howells
Eric McIntosh
Paul Laurin
Nancy Blum
Christina Y Hampton
Kevin Faure
Leonard Nyadong
C W Ray Soong
Budiono Santoso
Wang Zhiguang
John Newton
Kevin Palmer
author_facet Paul N Newton
Facundo M Fernández
Aline Plançon
Dallas C Mildenhall
Michael D Green
Li Ziyong
Eva Maria Christophel
Souly Phanouvong
Stephen Howells
Eric McIntosh
Paul Laurin
Nancy Blum
Christina Y Hampton
Kevin Faure
Leonard Nyadong
C W Ray Soong
Budiono Santoso
Wang Zhiguang
John Newton
Kevin Palmer
author_sort Paul N Newton
collection DOAJ
description <h4>Background</h4>Since 1998 the serious public health problem in South East Asia of counterfeit artesunate, containing no or subtherapeutic amounts of the active antimalarial ingredient, has led to deaths from untreated malaria, reduced confidence in this vital drug, large economic losses for the legitimate manufacturers, and concerns that artemisinin resistance might be engendered.<h4>Methods and findings</h4>With evidence of a deteriorating situation, a group of police, criminal analysts, chemists, palynologists, and health workers collaborated to determine the source of these counterfeits under the auspices of the International Criminal Police Organization (INTERPOL) and the Western Pacific World Health Organization Regional Office. A total of 391 samples of genuine and counterfeit artesunate collected in Vietnam (75), Cambodia (48), Lao PDR (115), Myanmar (Burma) (137) and the Thai/Myanmar border (16), were available for analysis. Sixteen different fake hologram types were identified. High-performance liquid chromatography and/or mass spectrometry confirmed that all specimens thought to be counterfeit (195/391, 49.9%) on the basis of packaging contained no or small quantities of artesunate (up to 12 mg per tablet as opposed to approximately 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.<h4>Conclusions</h4>An international multi-disciplinary group obtained evidence that some of the counterfeit artesunate was manufactured in China, and this prompted a criminal investigation. International cross-disciplinary collaborations may be appropriate in the investigation of other serious counterfeit medicine public health problems elsewhere, but strengthening of international collaborations and forensic and drug regulatory authority capacity will be required.
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spelling doaj.art-1acc39735dff409d868c69e96c9dfd8b2022-12-21T19:27:04ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762008-02-0152e3210.1371/journal.pmed.0050032A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.Paul N NewtonFacundo M FernándezAline PlançonDallas C MildenhallMichael D GreenLi ZiyongEva Maria ChristophelSouly PhanouvongStephen HowellsEric McIntoshPaul LaurinNancy BlumChristina Y HamptonKevin FaureLeonard NyadongC W Ray SoongBudiono SantosoWang ZhiguangJohn NewtonKevin Palmer<h4>Background</h4>Since 1998 the serious public health problem in South East Asia of counterfeit artesunate, containing no or subtherapeutic amounts of the active antimalarial ingredient, has led to deaths from untreated malaria, reduced confidence in this vital drug, large economic losses for the legitimate manufacturers, and concerns that artemisinin resistance might be engendered.<h4>Methods and findings</h4>With evidence of a deteriorating situation, a group of police, criminal analysts, chemists, palynologists, and health workers collaborated to determine the source of these counterfeits under the auspices of the International Criminal Police Organization (INTERPOL) and the Western Pacific World Health Organization Regional Office. A total of 391 samples of genuine and counterfeit artesunate collected in Vietnam (75), Cambodia (48), Lao PDR (115), Myanmar (Burma) (137) and the Thai/Myanmar border (16), were available for analysis. Sixteen different fake hologram types were identified. High-performance liquid chromatography and/or mass spectrometry confirmed that all specimens thought to be counterfeit (195/391, 49.9%) on the basis of packaging contained no or small quantities of artesunate (up to 12 mg per tablet as opposed to approximately 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.<h4>Conclusions</h4>An international multi-disciplinary group obtained evidence that some of the counterfeit artesunate was manufactured in China, and this prompted a criminal investigation. International cross-disciplinary collaborations may be appropriate in the investigation of other serious counterfeit medicine public health problems elsewhere, but strengthening of international collaborations and forensic and drug regulatory authority capacity will be required.https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/18271620/?tool=EBI
spellingShingle Paul N Newton
Facundo M Fernández
Aline Plançon
Dallas C Mildenhall
Michael D Green
Li Ziyong
Eva Maria Christophel
Souly Phanouvong
Stephen Howells
Eric McIntosh
Paul Laurin
Nancy Blum
Christina Y Hampton
Kevin Faure
Leonard Nyadong
C W Ray Soong
Budiono Santoso
Wang Zhiguang
John Newton
Kevin Palmer
A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.
PLoS Medicine
title A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.
title_full A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.
title_fullStr A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.
title_full_unstemmed A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.
title_short A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia.
title_sort collaborative epidemiological investigation into the criminal fake artesunate trade in south east asia
url https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/18271620/?tool=EBI
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