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To The Editor British Medical Journal
We are very concerned that patients with severe malaria admitted to UK hospitals will die needlessly because of the continued recommendation of an inferior antimalarial drug - quinine (1). In adults admitted to hospitals in temperate countries with severe malaria the mortality often exceeds 20%. In the largest trial of severe malaria ever conducted (which enrolled 1461 patients, including 202 children) intravenous artesunate reduced the mortality of severe malaria by one third. In a meta-analysis of all trials comparing artesunate and quinine in severe malaria mortality in quinine recipients was 23% compared with 14% in artesunate recipients (2). As a result the current WHO treatment guidelines recommend artesunate above quinine for the treatment of severe malaria in adults (3). These trials in severe malaria evaluated artesunate manufactured in China (Guilin Pharmaceutical Company). This is the main source of this formulation in the world, but although extensively evaluated, it has not yet been approved as meeting international GMP standards. Yet this drug in this formulation clearly saves lives.
As a pragmatic compromise, while awaiting a fully GMP product, Australia's national antimicrobial treatment advisory group has made artesunate the treatment of choice for severe malaria in their 2006 National Therapeutic Guidelines (4). Australian authorities have obtained parenteral artesunate from Guilin, assessed the quality of a batch (for content, sterility, and stability), and have distributed supplies to over 30 hospitals across the country, making it widely and immediately available under a national Special Access Scheme (5).
We cannot understand why the UK authorities have not taken a similar approach. Do they seriously believe that any minor imperfections in a tested formulation could conceivably outweigh a 35% difference in mortality?
Professor Nicholas J. White, Professor Nicholas PJ Day, Dr Arjen M. Dondorp, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand and Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK Professor Nicholas Anstey, Menzies School of Health Research, Casuarina, Darwin, Northern Territory, Australia.
References 1. Lalloo DG, Shingadia D, Pasvol G, Chiodini PL, Whitty CJ, Beeching NJ, Hill DR, Warrell DA, Bannister BA, For The HPA Advisory Committee On Malaria Prevention in UK Travellers; UK malaria treatment guidelines. J Infect. 2007;54:111-121. [PubMed] 2. Dondorp A, Nosten F, Stepniewska K, Day N, White NJ; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 2005; 366: 717-725. [PubMed] 3. World Health Organisation. Guidelines for the treatment of malaria. WHO, Geneva, 2006. [PubMed] 4. Antibiotic Expert Group. Malaria. In: Therapeutic Guidelines Antibiotic: 13th edition. Therapeutic Guidelines Limited, Melbourne 2006: 145-151. [PubMed] 5. Anstey NM, Price RN, White NJ. Improving the availability of artesunate for treatment of severe malaria. Med J Aust. 2006; 184: 3-4.[PubMed] |
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