WHO Approves Artemisinin for Malaria in Africa

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WHO Approves Artemisinin for Malaria in Africa

JoAnn Guest Dec 20, 2004 17:22 PST

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WHO Approves Artemisinin for Malaria in Africa

 

http://www.herbalgram.org/herbalgram/articleview.asp?a=2733

 

HerbalGram. 2004;64:19-20 © American Botanical Council (Buy This Issue)

 

 

by Katherine Purcell

 

Times are changing for sweet Annie, an herb that has been used in

traditional Chinese medicine and noted for its compounds that can

effectively treat malaria. Sweet Annie (Artemisia annua L., Asteraceae),

also called sweet wormwood, is sometimes referred to by its Chinese name

qing hao (green herb).

 

Artemisinin, and some of the related compounds derived directly from

the herb, are sometimes referred to as quinghaosu (extract of green

herb). These compounds, and their synthetic derivatives, have been

described in The New York Times as “strikingly effective against

malaria.”1

 

The antimalarial artemisinin-derived compounds include, but are not

limited to, artesunate, artemether, and dihydroartemisinin. Artemisinin,

used in the semi-synthesis of related compounds in Artemisinin-based

Combination Therapies (ACT), are found mainly in the leaves and flowers

of sweet Annie (little artemisinin is found in the stems, and none is

found in seeds or roots).2

 

Drug manufacturers utilize the dried aerial part of sweet Annie,

divested of the older stems,3 to create the useful artemisinin

compounds. It takes a minimum of six months to cultivate the sweet Annie

plants, and depending on the intended product formulation, it can take

an additional two to five months of extraction, processing, and

manufacturing phases to create the pharmaceutical grade artemisinin

compounds.4

 

Artemisinin was first isolated in 1972 by scientists working for the

Chinese Military (People’s Liberation Army). The herb qing hao (sweet

Annie) has been used in Traditional for more than 2000

years to treat fevers.

 

The Pharmacopoeia of the People’s Republic of China states that quing

hao (Herba Artemisiae Annuae, its pharmacopeial name in the

Pharmacopoeia monograph) is indicated to treat malaria with chills and

fever.

 

Because of the plant’s traditional use, it has not been a surprise for

the herb and medicinal plant research community to learn that, when used

in ACT, artemisinin and its synthetic derivatives are finally gaining

international acceptance and recognition as an effective alternative in

eliminating susceptible and multi-drug resistant Plasmodium falciparum

malaria.

 

The need for an effective treatment for malaria in Africa is great.

 

Malaria infects more than 500 million people and kills more than a

million people each year. Ninety percent of malaria deaths occur in

Africa, where the disease accounts for one in five of all childhood

deaths. In addition, the illness contributes to anemia, which affects

growth and development in children, contributes to low birth weight in

babies, and causes maternal illness and anemia in pregnant women.5

 

“Malaria, in tandem with HIV/AIDS, stands in the way of social progress

and better standards of life at every level, from children’s

intellectual and physical development to the growth of national

economies,” states Carol Bellamy, Executive Director of UNICEF.5

 

The name malaria (from the Italian words mala and aria ) literally means

“bad air,” and derives from a time when people mistakenly believed that

the disease was caused by “bad air” in marshy areas.6 Incidentally, the

name for the disease in French ( paludisme ) and in Spanish ( paludismo

) are derived from the Latin palus , meaning swamp. The term malaria

entered the English medical literature in the first half of the

nineteenth century.2

 

Malaria is caused by four species of Plasmodium . The two most common

forms are Plasmodium vivax and P. falciparum , the latter being the most

deadly form. The illness is transmitted from infected to uninfected

humans through the bite of an infected female Anopheles mosquito.7

 

The malaria parasite’s complex life cycle eludes detection and

destruction by the body’s immune system. The parasite takes 10-14 days

to fully mature in its host’s liver; then it is able to transmit the

illness to another host via another mosquito. About 9 to 14 days after

an infectious mosquito bite, malaria symptoms appear, including fever,

headache, vomiting, and other flu-like symptoms. If malaria is left

untreated or the parasites are resistant to the antimalarial drug used,

the infection can progress rapidly and become life threatening.

 

Malaria can kill by infecting and destroying hemoglobin in red blood

cells, leading to severe anemia, and by clogging the capillaries that

carry blood to the brain (cerebral malaria) or other vital organs.7

 

The malaria epidemic is not new. Global campaigns to eradicate the

illness have been in place since the 1950s. These early initiatives used

anti-malarial drugs to treat the illness and eliminate the parasite in

humans and used the highly controversial pesticide DDT against

mosquitoes.

 

By 1967, the campaign succeeded in eradicating endemic malaria in all

developed countries and parts of tropical Asia and Latin America.

However, success was not universal.

 

These campaigns were unable to sustain and achieve these same results

using DDT and anti-malarial drugs on a global scale in undeveloped and

underdeveloped countries.8

 

During the 1990s, malaria deaths and illnesses escalated in Africa

because of increased resistance to conventional malaria drugs like

amodiaquine and the less-expensive monotherapies like chloroquine and

sulfadoxine-pyrimethamine.4

 

Certain factors have compounded the resistance problem in the

population.

 

“Antimalarial drugs were deployed on a large scale, always as

monotherapies, introduced in sequence, and were generally poorly managed

in that their use was continued despite unacceptably high levels of

resistance.

 

In addition, there has been over-reliance on both quinoline

compounds…and antifolate drugs…with consequent encouragement of

cross-resistance among these compounds.”4

 

As a result, the health organizations realized that they needed a new

strategy focused on the disease rather than parasite control. The goal

was to make a program that could be adapted to suit local conditions and

meet local needs.8

 

The ACT drugs offer new hope because they have a rapid therapeutic

effect in reducing the parasite and diminishing symptoms, they are

active against the multi-drug resistant strain of malaria, they are thus

far well tolerated in patients, and they have the potential to reduce

transmission of the illness.4

 

The United Nations’ Roll Back Malaria (RBM) initiative reports another

key benefit: “To date, no parasitic resistance has been

detected…Furthermore, there is some evidence that use of such

combinations can greatly retard development of resistance to the partner

drug.”4

 

As a result, world health organizations like the WHO and the United

Nations Children’s Fund (UNICEF) have begun to consider using the

purified bioactive substances from this herbal remedy as a first-line

treatment for malaria in Africa.

 

This is a significant change in policy. In previous years, health

officials were opposed to using ACTs to treat malaria in Africa for the

following reasons: (1) due to the potential for the public to misuse the

artemisinin derivatives (like some of the previous and now ineffective

drugs) in treating severe malaria, (2) because of the potential for the

public to create and use non co-formulated combinations (i.e.,

unapproved combinations) of the drugs, (3) the greater expense of using

ACTs instead of the cheaper conventional first-line treatments, and (4)

because the side effects and efficacy of ACTs were under-tested on

children.2, 9

 

The health organizations were also concerned with lack of evidence for

the ACT drugs’ ability to delay resistance in areas of higher

transmission and because of the increased effort and high cost of

changing existing policy.

Finally, they were hesitant to change because some of the existing

conventional medications were still effective in treating the illness

for some people, in some areas.2,9 The bias against ACTs began to change

when the efficacy of the front-line treatments began to fade and,

consequently, resistance to standard treatments continued to develop.

 

The current commercial ACT is Coartem®, a combination of artemether, a

derivative of artemisinin and a synthetic substance, lumefantrine. The

drug was developed by the pharmaceutical giant Novartis with the

Institute for Microbiology and Epidemiology in Beijing,10 and it is

recommended by WHO. Out of 13 African countries that have changed their

national policies to require more effective antimalarial treatment, four

(South Africa, Tanzania, Zambia and Burundi) have adopted ACTs as

first-line treatment.11

 

The International Federation of Pharmaceutical Manufacturers Association

(IFPMA) Web site describes a recent health initiative using Coartem:

“The resulting oral, fixed-dose artemisinin based combination therapy

(ACT) is the fastest acting anti-malaria medicine—destroying parasites

in 48 hours—with highly documented cure rates.”10

 

“KwaZulu Natal was the first Department of Health in Africa to agree

upon a malaria treatment policy with artemether/lumefantrine as the

first-level drug…The result was a dramatic 78% reduction in the total

malaria cases by the end of 2001 (41,786 cases in 2000 and 9443 cases in

2001). During this period, the number of malaria deaths decreased by

87%.”12 The WHO estimates that it will need at least 30,000,000 adult

ACT treatment courses in 2004, and 132,000,000 treatment courses by the

end of 2005.4

 

A WHO Policy Implication sheet outlines the dosage and recommended

treatment of artemether-lumefantrine, the same ACT combination used in

Coartem. The artemether-lumefantrine-based combination therapy treatment

course consists of tablets containing 20 mg of artemether plus 120 mg of

lumefantrine (blenflumetol).13

 

The policy sheet states that, “Artemether-lumefantrine can be used for

the treatment of uncomplicated infections with P. falciparum, including

strains from multi-drug resistant areas.” The policy goes on to

recommend treatment: “In semi-immune patients, the manufacturer

recommends the 4-dose regimen, consisting of 1, 2, 3, or 4 tablets taken

at 0 h, 8 h, 24 h and 48 hours. The total course for an adult is 16

tablets, which gives a total dose of 320 mg of artemether plus 1920 mg

of lumefantrine.”13

 

WHO’s policy sheet offers recommendations for areas with multi-drug

resistance, non-immune patients, and children. It recommends that

artemether-lumefantrine should not be used to treat malaria in pregnant

women because the safety of the ACT chemotherapy is still a concern. It

also indicates that the drug combination should not be used for

chemoprophylaxis (prevention), and it gives the specifics of the drug

disposition, adverse effects, and contraindications.13

 

An agreement between WHO and Novartis stipulates that Coartem will be

available at a cost price of $0.90 per child and $2.40 per adult, per

treatment course, for use in the public sector in malaria-endemic

countries.4

 

 

 

References:

 

1. McNeil DG Jr. Herbal Drug is Embraced in Treating Malaria. The New

York Times . May 10, 2004. Available at: www.nytimes.com. Accessed July

16, 2004.

 

2. Ferreira JFS, Simon JE, Janick J. Artemisia annua: botany,

horticulture, pharmacology. Horticultural Reviews. 1997;19:319-371.

 

3. Guoshi T, Chen C, Fang Q, Jiang H, et al., eds; Cheng S, Feng M, Guo

J, trans. Pharmacopoeia of the People’s Republic of China. English Ed.

Beijing, China: The People’s Medical Publishing House; 1988:63.

 

4. The World Health Organization. Roll Back Malaria Infosheet. Facts on

ACTs (Artemisinin-based Combination Therapies), An update on recent

Progress in Policy and Access to Treatment. Available at:

http://www.rbm.who.int/cmc_upload/0/000/015/364/RBMInfosheet_9.htm.

Accessed July 20, 2004.

 

5. UNICEF. Malaria. Available at:

http://www.unicef.org/health/index_malaria.html. Accessed July 20, 2004.

 

 

6. Harper D. Malaria. Online Etymology Dictionary. Available at:

http://www.etymonline.com/index.php?search=malaria & searchmode=none.

Accessed September 15, 2004.

 

7. World Health Organization. Roll Back Malaria Infosheet. What is

Malaria? Available at:

http://www.rbm.who.int/cmc_upload/0/000/015/372/RBMInfosheet_1.htm.

Accessed July 20, 2004.

 

8. Trigg PI, Kondrachine AV. Commentary: malaria control in the 1990s.

Bulletin of the World Health Organization . 1998;76(1):11-16.

 

9. Olumese P. Antimalarial combination therapy in Africa. Africa Health

.. September 2001. Available at:

http://mosquito.who.int/cmc_upload/0/000/015/270/ah_therapy_ po.htm.

Accessed September 17, 2004.

 

10. The International Federation of Pharmaceuticals Manufactures

Associations (IFPMA). Novartis Coartem. Available at:

http://www.ifpma.org/Health/malaria/health_coartem_mal.aspx. Accessed

July 20, 2004.

 

11. World Health Organization. Africa Malaria Report 2003. Available at:

http://www.rbm.who.int/amd2003/amr2003/amr_toc.htm. Accessed September

24, 2004.

 

12. World Health Organization. Review of Application for Inclusion of a

Drug in the WHO Essential Drug List. Fixed combination of artemether and

lumefantrine (Coartem®). Available at:

http://www.who.int/medicines/organization/par/edl/coartem.doc. Accessed

September 24, 2004.

 

13. World Health Organization. Part II: 1.3 Artemether-Lumefantrine. The

Use of Antimalarial Drugs. Available at:

http://mosquito.who.int/cmc_upload/0/000/014/923/am2_1-13.htm. Accessed

September 17, 2004.

 

 

 

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