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CSU 25/2008: ANTIMALARIAL MONOTHERAPY IN THE MOST SEVERELY MALARIOUS PARTS OF AFRICA

Friday, 6th of June 2008 Print

CSU 25/2008: ANTIMALARIAL MONOTHERAPY IN THE MOST SEVERELY MALARIOUS PARTS OF AFRICA

 It is not every day that articles on tropical medicine find their way into
 the pages of   The Economist. It was from that source that this writer traced an article
 by Bate and  colleagues in PLOS/Neglected Tropical Diseases.
  
 This field research shows not only that antimalarials do not always contain
 the  labeled dosage, but that manufacturers and importing countries have paid
  insufficient respect to the WHO recommendation against monotherapy for
 malaria.
 
  The development of chloroquine resistance in falciparum malaria came more
 quickly  because this cheap, effective drug was widely available as a monotherapy.
 Selection   pressure in favor of resistant strains develops more rapidly when the
 patient receives  a single drug. It would be tragic if artemisin therapy, currently safe and
 effective,  became less effective because of widespread disregard of the sound advice
 to avoid  monotherapy.
 
  
 From the authors’ findings:
 
 ‘Artemisinin monotherapy, which the WHO rejects as inherently substandard
 treatment even when its dosage is correct, remains common in Africa. 33%
 (64/195) of all treatment packs tested were artemisinin monotherapies, and
 42% (27/64) failed either TLC or dissolution tests. 78% (50/64) were
 manufactured after the WHO's January 2006 appeal to halt monotherapy
 production. A further sign that certain manufacturers of artemisinin
 monotherapies do not take clinical efficacy seriously was the tremendous
 heterogeneity in expiry dates: 10 listed an expiration date of two years,
 while most (42/64) listed three years. Five listed an expiration date of
 four years, and seven lacked either a manufacture date or both a
 manufacture date and expiration date. Names of the offending artemisinin
 monotherapy producers in this study were forwarded to the WHO.
 
 The authors did not attempt a forensic examination of trademarks or product
 designs to differentiate between products that were merely substandard and
 those which were deliberately counterfeited, as neither is clinically
 suitable. However, there was an apparent trend in that failing products
 more often originated or were claimed to originate from poorer parts of the
 world with weaker regulatory systems: failure rates were 48% (30/63) for
 Africa, 32% (29/90) for Asia and 24% (12/50) for Europe (See Table 2). Only
 four US-manufactured samples were tested; none failed.’
  
 
 Full text at  http://www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0002132
  
 Good reading.
  
 BD

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