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[e-drug] AFM PLoS One Malaria Drug Study in Africa

E-DRUG: AFM PLoS One Malaria Drug Study in Africa
-----------------------------------------

Dear colleagues,

AFM's study of antimalarial drug quality in six major African cities is now 
live on PLoS One: 
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0002132

Reuters India has provided a nice summary: 

http://in.reuters.com/article/health/idINN0651796020080507

Study finds Africans get substandard malaria drugs
Wed May 7, 2008 6:04am IST
[Copied as fair use]

WASHINGTON (Reuters) - Many Africans are getting substandard malaria drugs, 
with more than a third of the pills tested failing quality tests, according to 
a report published on Tuesday.

Tests of 195 different packs of malaria drugs sold in six African cities showed 
35 percent of them either did not contain high enough levels of active 
ingredient or did not dissolve properly.

"Our study shows that efforts to increase access to quality antimalarial drugs 
in Africa are increasingly important," Dr. Roger Bate of the American 
Enterprise Institute, who led the study, said in a statement.

"Substandard drugs not only endanger lives today, but also jeopardize future 
malaria treatment strategies by accelerating parasite resistance."

Substandard antimalarial drugs cause an estimated 200,000 avoidable deaths each 
year, Bate and colleagues reported in the Public Library of Science journal 
PLoS ONE.

The researchers said they sent agents to pose as customers at randomly selected 
pharmacies. They simply asked for antimalarial drugs and the manufacturers were 
not named in the study.

They said a third of the packs they tested contained only one drug, an 
artemisinin-based drug. The World Health Organization has asked countries to 
stop using these so-called monotherapies.

"The high persistence of substandard drugs and clinically inappropriate 
artemisinin monotherapies in the private sector risks patient safety and, 
through drug resistance, places the future of malaria treatment at risk 
globally," the researchers wrote.

Of these one-drug packs, 42 percent failed the quality tests, Bate and 
colleagues reported.

"The World Trade Organization, which sets the rules of global commerce, should 
enact rules prohibiting the international trade in artemisinin monotherapies 
and reducing the tariffs on proper medicines to zero," they wrote.

"These incidents argue strongly for a rule against purchasing locally 
manufactured medicines, except where those medicines have received regulatory 
approval from a developed country or the WHO's prequalification scheme," they 
added.

The WHO estimates that malaria kills 1.3 million people each year, mostly 
children under age 5.

The disease, transmitted by mosquitoes carrying tiny malaria parasites, has 
been very hard to fight. The parasites have evolved resistance to the drugs and 
the mosquitoes have developed resistance to pesticides.

Combinations of drugs work better to kill the parasites and using a cocktail, 
as well as proper dosing, helps prevent the development of resistance.

(Reporting by Maggie Fox, Editing by Julie Steenhuysen and Eric Walsh)
--------------------------------------------------------

Study Abstract: A range of antimalarial drugs were procured from private 
pharmacies in urban and peri-urban areas in the major cities of six African 
countries, situated in the part of that continent and the world that is most 
highly endemic for malaria. Semi-quantitative thin-layer chromatography (TLC) 
and dissolution testing were used to measure active pharmaceutical ingredient 
content against internationally acceptable standards. 35% of all samples tested 
failed either or both tests, and were substandard. Further, 33% of treatments 
collected were artemisinin monotherapies, most of which (78%) were manufactured 
in disobservance of an appeal by the World Health Organisation (WHO) to 
withdraw these clinically inappropriate medicines from the market. The high 
persistence of substandard drugs and clinically inappropriate artemisinin 
monotherapies in the private sector risks patient safety and, through drug 
resistance, places the future of malaria treatment at risk globally.

AFM's larger policy paper on malaria treatment in Africa is available here: 
http://fightingmalaria.org/pdfs/AFMTreatmentPolicyPaper.pdf

Please feel free to contact me directly with questions.

Sincerely,

Philip Coticelli
Africa Fighting Malaria
africa@fightingmalaria.org
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http://fightingmalaria.org/AFMInAction

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