E-DRUG: Kenya starts growing artemisia annua for malaria
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[As the malaria world is preparing to shift to artemisinine combination
therapy (ACT), the first hurdle is that farmers need to grow sufficient
quantities of it. So far most comes from China and Vietnam, with a little
bit from Tanzania. This Kenyan message shows local interest. But the problem
is big!
For each 100 million malaria treatments, one needs to produce 60,000kg of
artemisine (in artesunate form). WHO needs estimates for 2005 approach 184
million treatments for Africa alone, thus requiring 110,000kg of artesunate.
Current world production is estimated at 30-40,000 kg of artesunate. This
needs to quadruple in 2005 at least!
As Novartis produces only 5 million treatments of co-artem in 2004, and
plans to increase to 20-30 million next year, you can easily predict a
massive problem for malaria in Africa! With artesunate of Sanofi, these are
the only two prequalified sources of artesiminine.
Tanzania produces 5 million treatments in 2004, mainly from imported(!)
artemisia leaves. Anyone knows how many kg are really produced inside
Tanzania, and how much they plan to produce in 2005?
Also, the artemisinine needs to be COMBINED with another drug, eg
amodiaquine (incorrectly attacked in this article!), mefloquine or other
antimalarial. Anyway, good that Kenya starts production!
Copied as fair use; Wilbert Bannenberg]
dear E-druggers,
Interesting local efforts to Roll Back Malaria.
Lombe Kasonde
Ass Technical Officer
UNICEF Supply Division
Freeport, DK-2100 Copenhagen, Denmark
Tel: +45 35 27 30 30
Fax: +45 35 26 94 21
http:www.unicef.org/supply
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Farmers Grow New Malaria Drug for Research and Export
The Nation (Nairobi)
May 6, 2004
Arthur Okwemba
Nairobi
A major component of the newly recommended first line malaria drug -
Coartem - is being grown locally and will soon be in the market at a much
lower cost.
The plant, Artemesia annua, imported from China, is being grown at Kenyatta
University for research while several Kenyans are growing it for export to
European pharmaceutical firms. In Arusha, Tanzania the plant is is now a
respected cash crop with plans to build an extraction factory underway.
Coartem, the drug that has now been approved by the government as first
line treatment for malaria, is a combination of artemether, a compound
derived from artemisinin, and Lumefantrine, a non-artemisinin compound also
developed in China in the 1970s.
If Kenyatta University goes ahead and makes their drug widely available in
the country, this will pose serious challenges to the Government drug
policy. Since it is likely that most of the poor may opt for the cheaper
option the government will have to address the issue
To be used in its crude form, the drug in the satchet will be free from
resistance that is now bedevilling conventional drugs.
Researchers say the price of three satchets of 5mg each, which is a full
dose for the treatment of malaria, is also going to be cheaper by a certain
percentage compared to the conventional artemisinin-based malaria drugs.
Kenyatta University, which is to manufacture the satchets and put them in
the market before the end of this year, say the price of each pack of three
will be much cheaper than over Sh 400 charged for a single dose of
artemisinin-based combination therapy (ACT). But the exact price is to be
known as soon as other costings are completed.
Researchers at the University's Centre for Complementary Medicine and
Biotechnology Research, say the satchet will contain a combination of two
herbs known to manage malaria effectively, Artemesia annua and Wanjiru
Warurie, the Kikuyu name for a short herb found in Kenya which has a
chloroquine flavour when put in water. The combination is going to be
flavoured with Ginger Ale.
Whereas the artemisinin herb is well known to cure malaria effectively in
China, Wanjiru Warurie remains the best source of malaria treatment among
the Agikuyu.
According to Prof Alloys Orago, the director of the Centre, the combination
of artemisinin and Wanjiru Warurie herbs is double-pronged: To help clear
the parasite in the body very fast and help the patients recover rapidly.
Results in the laboratory show that the combination works. Experiments in
animals, says Prof Orago, showed that one satchet is enough to clear high
numbers of the parasite in the bloodstream within 24 hours. The cure rates
too were found to be over 90 per cent.
Prof Orago argues that resistance does not develop easily against a drug in
its crude form, explaining why the Chinese have managed to use the
artemisinin herb for about 200 years without a single case of resistance
being recorded.
This is echoed by scientists at the International Centre for Insect
Physiology and Ecology (ICIPE) who are conducting similar research.
Professor Ahmed Hassanali of Icipe says that the crude artemisinin they are
using is from Arusha. The Arusha plants have been shown to have a higher
content than even Chinese plants.
"Our hypothesis is that because the extract contains other structural
analogues of artemisinin apart from Artemether and Artesunate, the
synthetic derivatives used in ACT, these will prevent resistance by
competitively binding to sites of any resistance enzyme produced by the
malaria parasite. This has been a recurring phenomenon in phytochemical
studies and could be the basis for herbal medicine's efficacy," says the
professor.
The university is now in the process of purchasing from a Chinese company a
machine worth Sh 600,000, which will be used in preparing the sachets. Next
on the plan is to acquire another machine to covert the herb into solutions
and syrup.
However, the ICIPE scientists warn that such methods may have the drawback
of lacking quality control. "It is known that plants growing in different
ecological zones may have different artemisinin content and that this may
also differ seasonally, and this has been demonstrated in neem, " cautions
Prof Hassanali.
He says that in their research, the leaves are ground to a very fine powder
and then mixed very thoroughly before being made into tablets. "This
ensures that each tablet has a standard dose and tests show that this has
been achieved," he says.
Prof Hassanali says that they will also conduct research to look at the
relationship between growth conditions of Artemesia annua and artemisinin
content.
The ICIPE scientists told Horizon that a clinical trial on the efficacy of
the crude blend in treating uncomplicated malaria is being conducted in
collaboration with KEMRI and that results are "very encouraging." This work
is going on in Mbita Field Station.
The news about the university's and ICIPE's products comes at time when the
government has changed its policy on the drugs to be used as first line in
the treatment of malaria.
Costing over four US dollars per dose, the artemisinin-based drugs are
expensive and their cheaper generic versions may not in the market soon as
the drugs are still under patent.
Doctors are worried that the cost element and availability of the drugs may
affect compliance to recommended dosage and at the moment, the government
has to work out how to make an artemisinin combination, which is so far a
prescription only drug, available to a majority of Kenyans at the lowest
level of the society.
It is also comes at time when there is damning information that resistance
is rising on the second line and fall-back drug, amodiaquine.
In Bungoma, a study done about two years ago by AMREF indicated the
resistance to be seven per cent. Matters might be worse by now.
In the larger Western Kenya region, recent studies by other organisations
show the resistance to amodiaquine to be between 12 and 15 per cent.
The World Health Organisations recommends the removal from the market of a
drug used for first line treatment once the resistance levels hit the 25
per cent mark.
Yet the government has limited choices of how to move once resistance to
amodiaquine spirals out of control. Some experts have recommended that
amodiaquine monotherapy be wiped out.
Although one of the ways out for the government would be to combine
amodiaquine with artesunate, a study by Amref in Entasopia show such a
combination does not give good results. This combination is already
available as Arsucam, manufactured by the French company Sanofi-Synthelabo
and was poised to be launched this month.
According to an officer at the Ministry of Health, "the next bitter pill
for the government is to phase out amodiaquine, which may plunge this
country into problems."
The whole issue of potential runaway resistance to amodiaquine-based drugs
stems from the fact that the government has allowed second line drugs to be
sold over the counter, contrary to policy requiring such drug to be given
only on prescription.
Yet some of the amodiaquine-based drugs have been advertised heavily
resulting in their increased use and abuse. Many people are said to take
quarter or half doses of the drug when they buy them from kiosks.
Recently, when we enquired from one of the senior officers at the Ministry
of Health why they have allowed amodiaquine based drugs to be sold over the
counter, he complained then apportioned blame.
Even I do not understand how some of the amodiaquine-based drugs are
allowed to be advertised and sold over the counter. This thing has been
going for a long time and is giving us problems too.
The officer blamed those in the Drugs and Poisons Board of allowing this to
happen. His assertion has left a disturbing question lingering for
sometime: Is the government abetting resistance to malaria drugs?
Doctors are again warning that advertising and selling of amodiaquine-based
drugs over the counter are fuelling the next resistance calamity awaiting
this country.
Meanwhile, the introduction of artemisinin may also herald the
reintroduction of chloroquine, a drug to which majority of Kenyans had
developed massive resistance to, but which remains in use on prescription
basis because some people still respond to it very well.
Prof Orago says this is an area they want to research on to see how they
can combine the impure form of artemisinin with the conventional form of
chloroquine.
"Our belief is that the parasite do not know how to deal with impure
compounds. So if we combine a little of artemisinin with recommended
chloroquine dosage, the results may be impressive."
To meet all these expectations, the University is now cultivating
artemisinin plants in its botanical garden.
Through tissue culture, scientists at the university claim they can
reproduce millions of seedlings for sale to Kenyan farmers who want to
plant them.
Recent studies show that the artemisinin plant can do better in areas like
Eldoret and other parts of the Rift Valley. One farmer in Eldoret, known as
Mbugua, is already growing the herb and is said to be exporting it to a
German firm. Another farmer in Naivasha is also said to be exporting his to
several pharmaceutical companies abroad.
At Kenyatta University, the first harvest, which took place two months, has
been ground, combined with Wanjiru Warurie, and packaged into small packs.
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