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[e-med] Lutte contre médicaments contrefaits: appel de scientifiques à plus de coopérati

Lutte contre médicaments contrefaits: appel de scientifiques �  plus de 
coopération     
PARIS, 12 fév 2008 (AFP)        

Une meilleure coopération entre police et organismes de contrôle des produits 
pharmaceutiques est indispensable pour lutter contre les contrefaçons de 
médicaments en Asie, plaident des scientifiques dans la revue américaine en 
ligne Plos One.

Dans leur article, ils lèvent le voile mardi sur une opération qui a permis le 
démantèlement d'un réseau chinois de contrefaçon de médicaments contre le 
paludisme.

Réalisée avec l'aide d'Interpol et de l'Organisation mondiale de la santé, avec 
la coopération d'experts légistes, de policiers, de médecins et de pharmaciens, 
elle devrait servir de modèle �  de futures opérations contre le fléau de la 
contrefaçon, estiment-ils.

Des experts de l'Université d'Oxford et du Wellcome Trust (Royaume-Uni) ont 
ainsi analysé 391 échantillons de comprimés d'artesunate (molécule active 
contre le paludisme) recueillis en Birmanie, Laos, Vietnam, Cambodge et �  la 
frontière entre Birmanie et Thaïlande.

La moitié des échantillons (195) ne contenaient pas -ou peu- d'artesunate. Les 
emballages, dont beaucoup portaient le logo de "Guilin Pharma", société 
pharmaceutique du sud de la Chine, présentaient des anomalies dans la 
"signature" du laboratoire, un hologramme invisible �  l'oeil nu.

Les experts ont également relevé des traces de pollen sur les échantillons et 
identifié son origine, permettant ainsi d'établir qu'au moins une partie de 
l'artesunate contrefait provenait du sud de la Chine.

Les autorités chinoises ont été alertées en mars 2006 et une opération de 
police a permis l'arrestation dans la province du Yunnan (sud-ouest) d'un homme 
qui avait acheté de fausses boîtes de "Guilin Pharma" auprès d'une fabrique de 
médicaments contrefaits située dans la province du Guangdong (sud).

Des médicaments contrefaits peuvent augmenter la résistance des maladies aux 
traitements, parce qu'ils ne contiennent pas ou pas assez de substances 
actives, et peuvent aussi contenir des produits toxiques. 

*********************

A Collaborative Epidemiological Investigation into the Criminal Fake Artesunate 
Trade in South East Asia

 
<http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050032>
 
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050032
 < 
<http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050032>
 
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050032>
 

Paul N. Newton1,2*, Facundo M. Fernández3, Aline Plançon4, Dallas C. 
Mildenhall5, Michael D. Green6, Li Ziyong7, Eva Maria Christophel8, Souly 
Phanouvong9, Stephen Howells10, Eric McIntosh10, Paul Laurin11, Nancy Blum9, 
Christina Y. Hampton3, Kevin Faure5, Leonard Nyadong3, C. W. Ray Soong5, 
Budiono Santoso8, Wang Zhiguang7, John Newton4*, Kevin Palmer8

1 Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, 
University of Oxford, Churchill Hospital, Oxford, United Kingdom, 2 Wellcome 
Trust—Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Mahosot 
Hospital, Vientiane, Lao People's Democratic Republic, 3 School of Chemistry 
and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia, United 
States of America, 4 Intellectual Property Crime Unit, International Criminal 
Police Organization (INTERPOL), Lyon, France, 5 GNS Science, Lower Hutt, New 
Zealand, 6 Division of Parasitic Diseases, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United 
States of America, 7 Intellectual Property Division, Economic Crime 
Investigation Department, Ministry of Public Security, Beijing, People's 
Republic of China, 8 Western Pacific Regional Office of the World Health 
Organization, Manila, The Philippines, 9 United States Pharmacopeia, Rockville, 
Maryland, United States of America, 10 Therapeutic Goods Administration, 
Government of Australia, Symonston, Canberra, Australia, 11 Royal Canadian 
Mounted Police Forensic Laboratory Services, National Anti- Counterfeiting 
Bureau, Ottawa, Ontario, Canada

Background

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.

Methods and Findings

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 ∼ 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.

Conclusions

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.

Funding: The collection of samples was funded by the Wellcome Trust of Great 
Britain through the Wellcome Trust-University of Oxford South East Asian 
Tropical Medicine Research Programme and the United States Agency for 
International Development (USAID) through its Cooperative Agreement 
#HRN-A-00-00-00017 with the U.S. Pharmacopeia Drug Quality and Information 
Program. The work of DCM was funded by the Western Pacific Regional Office 
(WPRO) of WHO through USAID umbrella grant #AAG-G-00-99-00005. The work of FMF 
was funded by WPRO through the same USAID grant and the United States National 
Science Foundation through CAREER grant #0645094. LN is partially supported by 
a U.S. Pharmacopeia graduate fellowship. PNN is supported by the Wellcome Trust 
of Great Britain. With exception of the funding of the work of DCM by WPRO the 
funding agencies had no role in the study design, data collection and analysis, 
and decision to publish the manuscript.

Competing Interests: The authors have declared that no competing interests 
exist.

Academic Editor: Marcus Reidenberg, Cornell University, United States of America

Citation: Newton PN, Fernández FM, Plançon A, Mildenhall DC, Green MD, et al. 
(2008) A Collaborative Epidemiological Investigation into the Criminal Fake 
Artesunate Trade in South East Asia . PLoS Med 5(2): e32 
doi:10.1371/journal.pmed.0050032

Received: September 4, 2007; Accepted: December 21, 2007; Published: February 
12, 2008

Copyright: © 2008 Newton et al. This is an open-access article distributed 
under the terms of the Creative Commons Public Domain declaration which 
stipulates that, once placed in the public domain, this work may be freely 
reproduced, distributed, transmitted, modified, built upon, or otherwise used 
by anyone for any lawful purpose.

Abbreviations: DRA, drug regulatory authority; HPLC, high performance liquid 
chromatography; INTERPOL, International Criminal Police Organization; MDMA, 
methylenedioxymethamphetamine or ecstasy; MPS, Ministry of Public Security; SE 
Asia, South East Asia; WPRO, Western Pacific Regional Office (of WHO); XRD, 
X-ray diffractometry

* To whom correspondence should be addressed. E-mail: paul@tropmedres.ac (PNN) 
and j.newton@interpol.int (JN)

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