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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