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MALARIA - AFRICA: COUNTERFEIT DRUGS
***********************************
Date: Tue 9 Feb 2010
Source: Canadian Broadcasting Centre (CBC) News, Associated Press
(AP) report [edited]
Bad malaria pills raise resistance fears in Africa
--------------------------------------------------
High rates of the most effective type of malaria-fighting drugs sold
in 3 African countries are poor quality -- including nearly half the
pills sampled in Senegal -- raising fears of increased drug
resistance that could wipe out the last weapon left to battle a
disease that kills 1 million people each year, according to a US
report released Monday [8 Feb 2010]. Between 16 percent and 40
percent of artemisinin-based drugs sold in Senegal, Madagascar, and
Uganda failed quality testing, including having impurities or not
containing enough active ingredient, the survey found.
Artemisinin-based drugs are the only affordable treatment for malaria
left in the global medicine cabinet. Other drugs have already lost
effectiveness due to resistance, which builds when not enough
medicine is taken to kill all of the mosquito-transmitted parasites.
If artemisinin-based drugs stop working, there is no good replacement
and experts worry many people could die.
"It is worrisome that almost all of the poor-quality data that was
obtained was a result of inadequate amounts of active (ingredients)
or the presence of impurities in the product," said Patrick Lukulay,
director of a nongovernmental US Pharmacopeia program funded by the
US government, which conducted the survey. "This is a disturbing
trend that came to light."
The study is the 1st part of a 10-country examination of
antimalarials in Africa by the US and the World Health Organization
(WHO). It follows evidence from the Thai-Cambodian border that
artemisinin-based drugs there are taking longer to cure malaria
patients, the 1st sign of drug resistance.
The 3-country report also found bad drugs in both the public and
private health sectors, meaning governments -- some buying medicines
with donor funds -- are not doing enough to keep poor-quality pills
out. All of the drugs tested from the public sector in Uganda,
however, passed the quality tests. But 40 percent of the
artemisinin-based drugs in Senegal failed.
"There are countries where donated medicines are not subjected to
quality controls, they're just accepted," said Lukulay. "There are
countries in Africa where Chinese products have been donated and
found to be unacceptable later in the public sector."
A total of 444 samples of artemisinin-based combination drugs along
with the antimalarial sulfadoxine-pyrimethamine -- to which
resistance has already developed -- were 1st screened locally using
visual inspection and basic lab tests. Sulfadoxine-pyrimethamine is
still used, mainly for preventative treatment for pregnant women.
Nearly 200 samples then underwent full quality control testing in a
US laboratory to examine the amount of active ingredient present and
drug purity. For both drugs, 44 percent from Senegal failed the full
quality testing, followed by 30 percent from Madagascar and 26
percent from Uganda.
While the study is not the 1st to assess the quality of antimalarials
in Africa, it is the most rigorous and complete. Similar failure
rates were found in previous work, but those did not focus
specifically on artemisinin-based drugs.
"I am alarmed by these results because it means there are many cases
of malaria that are being only partially treated, and that just
guarantees acceleration of artemisinin drug resistance," said Rachel
Nugent, deputy director for Global Health at the Center for Global
Development, a US think tank. "It is the most comprehensive study out
there on antimalarials and should be a wake-up call." Nugent was not
involved in the study.
[Byline: Margie Mason]
--
Communicated by:
HealthMap Alerts via ProMED-mail
[The problems with substandard drugs or even counterfeit drug is
receiving increased attention and is most probably one of the most
important factors driving the development of resistance to
antimalarial drugs. See for instance this study: Bate R et al:
Antimalarial drug quality in the most severely malarious parts of
Africa -- a six country study. PLoS One. 2008; 3(5): e2132; available
at http://www.plosone.org/article/info:...l.pone.0002132.
The new data suggest that quality control in mandatory in each
country and using thin layer chromatography has been suggested to be
easy and reliable in countries without access to HPLC (high pressure
liquid chromatography) (Ioset JR and Kaur H: Simple field assays to
check quality of current artemisinin-based antimalarial combination
formulations. PLoS One. 2009, 30; 4(9): e7270; available at
http://www.plosone.org/article/info:...l.pone.0007270).
The recent development of artemisinin resistance at the Thai-Cambodia
border is also believed to be driven by substandard formulations.
ProMED suggested in December 2009 (Malaria, artemisinin resistance -
SE Asia (02) 20091230.4386) that counterfeit drugs and under-dosing
can only be dealt with in resource-poor countries by providing
malaria treatment free of charge, just as anti-HIV treatment is
provided free of charge (Schlagenhauf P and Petersen E: Antimalaria
drug resistance: the mono-combi-counterfeit triangle. Expert Rev Anti
Infect Ther. 2009 Nov; 7(9): 1039-42; available at
http://www.expert-reviews.com/doi/fu...1586/eri.09.85). - Mod.EP]
[For background information available from the general ProMED-mail
list, the postings below can be found at http://www.promedmail.org.
- Mod.JFW]
MALARIA - AFRICA: COUNTERFEIT DRUGS
***********************************
Date: Tue 9 Feb 2010
Source: Canadian Broadcasting Centre (CBC) News, Associated Press
(AP) report [edited]
Bad malaria pills raise resistance fears in Africa
--------------------------------------------------
High rates of the most effective type of malaria-fighting drugs sold
in 3 African countries are poor quality -- including nearly half the
pills sampled in Senegal -- raising fears of increased drug
resistance that could wipe out the last weapon left to battle a
disease that kills 1 million people each year, according to a US
report released Monday [8 Feb 2010]. Between 16 percent and 40
percent of artemisinin-based drugs sold in Senegal, Madagascar, and
Uganda failed quality testing, including having impurities or not
containing enough active ingredient, the survey found.
Artemisinin-based drugs are the only affordable treatment for malaria
left in the global medicine cabinet. Other drugs have already lost
effectiveness due to resistance, which builds when not enough
medicine is taken to kill all of the mosquito-transmitted parasites.
If artemisinin-based drugs stop working, there is no good replacement
and experts worry many people could die.
"It is worrisome that almost all of the poor-quality data that was
obtained was a result of inadequate amounts of active (ingredients)
or the presence of impurities in the product," said Patrick Lukulay,
director of a nongovernmental US Pharmacopeia program funded by the
US government, which conducted the survey. "This is a disturbing
trend that came to light."
The study is the 1st part of a 10-country examination of
antimalarials in Africa by the US and the World Health Organization
(WHO). It follows evidence from the Thai-Cambodian border that
artemisinin-based drugs there are taking longer to cure malaria
patients, the 1st sign of drug resistance.
The 3-country report also found bad drugs in both the public and
private health sectors, meaning governments -- some buying medicines
with donor funds -- are not doing enough to keep poor-quality pills
out. All of the drugs tested from the public sector in Uganda,
however, passed the quality tests. But 40 percent of the
artemisinin-based drugs in Senegal failed.
"There are countries where donated medicines are not subjected to
quality controls, they're just accepted," said Lukulay. "There are
countries in Africa where Chinese products have been donated and
found to be unacceptable later in the public sector."
A total of 444 samples of artemisinin-based combination drugs along
with the antimalarial sulfadoxine-pyrimethamine -- to which
resistance has already developed -- were 1st screened locally using
visual inspection and basic lab tests. Sulfadoxine-pyrimethamine is
still used, mainly for preventative treatment for pregnant women.
Nearly 200 samples then underwent full quality control testing in a
US laboratory to examine the amount of active ingredient present and
drug purity. For both drugs, 44 percent from Senegal failed the full
quality testing, followed by 30 percent from Madagascar and 26
percent from Uganda.
While the study is not the 1st to assess the quality of antimalarials
in Africa, it is the most rigorous and complete. Similar failure
rates were found in previous work, but those did not focus
specifically on artemisinin-based drugs.
"I am alarmed by these results because it means there are many cases
of malaria that are being only partially treated, and that just
guarantees acceleration of artemisinin drug resistance," said Rachel
Nugent, deputy director for Global Health at the Center for Global
Development, a US think tank. "It is the most comprehensive study out
there on antimalarials and should be a wake-up call." Nugent was not
involved in the study.
[Byline: Margie Mason]
--
Communicated by:
HealthMap Alerts via ProMED-mail
[The problems with substandard drugs or even counterfeit drug is
receiving increased attention and is most probably one of the most
important factors driving the development of resistance to
antimalarial drugs. See for instance this study: Bate R et al:
Antimalarial drug quality in the most severely malarious parts of
Africa -- a six country study. PLoS One. 2008; 3(5): e2132; available
at http://www.plosone.org/article/info:...l.pone.0002132.
The new data suggest that quality control in mandatory in each
country and using thin layer chromatography has been suggested to be
easy and reliable in countries without access to HPLC (high pressure
liquid chromatography) (Ioset JR and Kaur H: Simple field assays to
check quality of current artemisinin-based antimalarial combination
formulations. PLoS One. 2009, 30; 4(9): e7270; available at
http://www.plosone.org/article/info:...l.pone.0007270).
The recent development of artemisinin resistance at the Thai-Cambodia
border is also believed to be driven by substandard formulations.
ProMED suggested in December 2009 (Malaria, artemisinin resistance -
SE Asia (02) 20091230.4386) that counterfeit drugs and under-dosing
can only be dealt with in resource-poor countries by providing
malaria treatment free of charge, just as anti-HIV treatment is
provided free of charge (Schlagenhauf P and Petersen E: Antimalaria
drug resistance: the mono-combi-counterfeit triangle. Expert Rev Anti
Infect Ther. 2009 Nov; 7(9): 1039-42; available at
http://www.expert-reviews.com/doi/fu...1586/eri.09.85). - Mod.EP]
[For background information available from the general ProMED-mail
list, the postings below can be found at http://www.promedmail.org.
- Mod.JFW]