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Poor quality vital anti-malarials in Africa - an urgent neglected public health priority

Paul N Newton1234*, Michael D Green5, Dallas C Mildenhall6, Aline Plançon7, Henry Nettey5, Leonard Nyadong8, Dana M Hostetler8, Isabel Swamidoss5, Glenn A Harris8, Kristen Powell8, Ans E Timmermans9, Abdinasir A Amin10, Stephen K Opuni11, Serge Barbereau12, Claude Faurant13, Ray CW Soong6, Kevin Faure6, Jonarthan Thevanayagam2, Peter Fernandes2, Harparkash Kaur3, Brian Angus2, Kasia Stepniewska142, Philippe J Guerin24 and Facundo M Fernández8

Author Affiliations

1 Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR

2 Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Churchill Hospital, Oxford, OX3 7LJ, UK

3 Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, WC1E 7HT, UK

4 WorldWide Antimalarial Resistance Network, Churchill Hospital, University of Oxford, Oxford, OX3 7LJ, UK

5 Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA

6 GNS Science, Lower Hutt, 5040, New Zealand

7 International Criminal Police Organization (INTERPOL), Lyon, 69006, France

8 School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, GA, 30332-0400, USA

9 Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, 10400, Thailand

10 Population Services International, Malaria and Child Survival Department, School Lane, Westlands, P.O. Box 14355-00800, Nairobi, Kenya

11 Food and Drugs Board, P O Box CT 2783, Cantonments-Accra, Ghana

12 Réseau Médicaments et Développment (ReMeD), 35, rue Daviel, 75013 Paris 13 France

13 East West Pharmaceuticals, 189 rue Grande, Fontainebleau, 77300, France

14 Mahidol Oxford Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand

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Malaria Journal 2011, 10:352  doi:10.1186/1475-2875-10-352

Published: 13 December 2011

Abstract

Background

Plasmodium falciparum malaria remains a major public health problem. A vital component of malaria control rests on the availability of good quality artemisinin-derivative based combination therapy (ACT) at the correct dose. However, there are increasing reports of poor quality anti-malarials in Africa.

Methods

Seven collections of artemisinin derivative monotherapies, ACT and halofantrine anti-malarials of suspicious quality were collected in 2002/10 in eleven African countries and in Asia en route to Africa. Packaging, chemical composition (high performance liquid chromatography, direct ionization mass spectrometry, X-ray diffractometry, stable isotope analysis) and botanical investigations were performed.

Results

Counterfeit artesunate containing chloroquine, counterfeit dihydroartemisinin (DHA) containing paracetamol (acetaminophen), counterfeit DHA-piperaquine containing sildenafil, counterfeit artemether-lumefantrine containing pyrimethamine, counterfeit halofantrine containing artemisinin, and substandard/counterfeit or degraded artesunate and artesunate+amodiaquine in eight countries are described. Pollen analysis was consistent with manufacture of counterfeits in eastern Asia. These data do not allow estimation of the frequency of poor quality anti-malarials in Africa.

Conclusions

Criminals are producing diverse harmful anti-malarial counterfeits with important public health consequences. The presence of artesunate monotherapy, substandard and/or degraded and counterfeit medicines containing sub-therapeutic amounts of unexpected anti-malarials will engender drug resistance. With the threatening spread of artemisinin resistance to Africa, much greater investment is required to ensure the quality of ACTs and removal of artemisinin monotherapies. The International Health Regulations may need to be invoked to counter these serious public health problems.