By Eunice Menka - GHANA    

A true story is told of a group ofdevelopment  planners  who decided  to  provide  a  small village  with  a  running  tap  in  the middle of the town. It was to alleviate the  sufferings  of  the  women.  These women had to walk long distances to a  polluted  stream  running  on  the outskirts  of  the  town  in  search  of water.

Were  the  women  happy  when  water finally flowed from the tap right in the middle  of  town?  Surprisingly  the answer is No.

They  kept  to  tradition  and  daily journeyed outside of the village to get water,  paying  very  little  attention  to the facility in town. These puzzled the developers.

Apparently,  the  women  enjoyed  the daily  trips  to  the  stream  because  it provided them with an opportunity to walk  in  groups,  catch  up  on  news making  the  rounds,  gossip  and generally  socialize  without  the disapproving  looks  of  the  men  folk  and elders in the small community.

Had the consultants sought the views of the women and studied the real life situation  of  the  village  women  they would  perhaps  have  sited  the  tap  at the outskirts of the village.

The  experts  had  come  face  to  face with  village  sociology.  They  had reckoned without the real life settings of  the  beneficiaries  of  the  project, who though needed a quick source of water,  yet  valued  their  privacy  and their social networks. They preferred
the  social  gesture  provided  by  the journeys back and forth.   

Gathering  real  life  information  and situation  at  the  grassroots  to  drive policy  is  no  doubt  an  important ingredient  in  bringing  development to the people. After all, development  is  about  the  people,  their  lifestyles and choices among others. Collating real  life  information  within  the communities  is  what  a  group  of  experts  would  seek  to  do,  as  they search  for  another  tool  to  deal  a deathblow to malaria.

According  to  Dr.  Alex  Doodo, President  of  the  Pharmaceutical Society  of  Ghana,  the  effectiveness and  efficiency  of  anti-malaria  drugs in real life settings in Africa need to be studied  further  in  order  to  provide better policy options for the array of anti-malaria drugs on the market. It is envisaged that under the INDEPTH Effectiveness  and  Safety  Studies ( I N E S S )   project, a team of researchers would gather information  and  practical  evidence for  effective  treatment  of  malaria  to allow  policy  decision  to  be  based  on assessment  of  effectiveness  of  anti- malarial drugs in real life settings.

The  four-year  project,  to  begin    in Ghana,  Tanzania,  Burkina  Faso  and Mozambique, is to minimize the time gap  between  licensing  and  adoption of  new  anti-malarial  drugs  by providing objective effectiveness and safety  data,  under  real  life  settings  that  would  help  inform  global, regional  and  national  policy  and practice.

There is a strong case that there is a need  for  rigorous  data  to  inform policy in Africa for obvious reasons. “We want people to talk to us. Strong  health systems are needed to roll out interventions.

Artemisinin-based-combination therapies (ACTs)  are  highly  effective, but when you get to real life, it  then  becomes  a  systems issue.

We  are  talking  about  distribution, adherence,  provider  behaviour  and affordability. We would also monitor the  quality  of  the  product  and acceptability. People may not take the drugs well. ” Dr Dodoo says.

At  a  recent  meeting  in  Accra organized  by  the  African  Media  and M a l a r i a   R e s e a r c h   N e t w o r k   (AMMREN),  Dr  Doodo  said  the INESS  project  would  enhance capacity  in  Africa  to  monitor  local health  systems  in  order  to  track a c c e s s i b i l i t y ,   c o s t s ,   e f f e c t i v e   coverage,  and  effects  of  new  or alternative  post-registered  anti- malarial treatments.

During the initial phase of INESS, the current first line ACTs in Ghana and Tanzania  would  be  evaluated.  This would  provide  information  on  the real-life  safety  and  effectiveness  of these  drugs  that  is  still  missing despite their large-scale adoption.

Once a new anti-malarial is registered in a participating country, it would be introduced  initially  into  the  project by  routine  public  health  services  in the districts hosting the  selected sites for the implementation of the project. “We  are  collecting  information  to drive malaria policy. If you can't give people affordable ACTs, you can't ask them  to  use  it.  There  should  be evidence for using ACTs. Why do we use  this  type  of  ACT  and  not  the other? Why are we using artesunate-amodiaquine  in  Ghana?  We  need verifiable  and  rigorous  information for  policy  change.  We  may  have recommendations  about  drug  use internationally,  but  individual countries need to formulate their own decisions”, Dr Dodoo argues.

A $30 million facility is going to drive the  INESS  project  across  Africa  for the  next  four  years  using  the Demographic  Surveillance  Sites (DSS) run by INDEPTH Network, an international organization that works across  19  countries  to  provide c o n t i n u o u s   h e a l t h - r e l a t e d   d e m o g r a p h i c   e v a l u a t i o n   a n d   information  at  household  level  in developing countries.

I n   G h a n a ,   p e o p l e   i n   t h r e e   communities  in  Dodowa,  in  the south,  Kintampo  in  the  centre  and Navrongo in the northern frontier of the country are going to be followed to gather  real  life  information  for  the project.

W h e n   t h e   p r o j e c t   k i c k s   o f f ,   a r t e s u n a t e - a m o d i a q u i n e ,   n   w   Ghana's  first  line  drug  to  treat malaria, would be one of the drugs to be  subjected  to  a  phase  four  trial under the INESS project. The phase one, two, and three clinical trials are carried out under controlled conditions  on  few  patients  to  establish the initial safety and efficacy of such new products or drugs.

A  phase  four  trial  or  post  marketing phase seeks to examine the risks and benefits of the new drug in different s e g m e n t s   o f   t h e   p o p u l a t i o n .   Alternatively,  a  phase  four  study might  be  initiated  to  assess  such issues  as  the  longer-term  effects  of drug  exposure.  Post  marketing surveillance  is  important  because even  the  most  well  designed  phase three studies might not uncover every problem that could become apparent  once  a  product  is  widely  used. Furthermore, the new product might be  more  widely  used  by  groups  that might  not  have  been  well  studied  in the clinical trials and there might be reports of adverse drug reactions.

However,  large  scale  phase  four studies  in  African  health  systems  to determine  effectiveness  or  rare adverse  events  through  real-life systems  or  environments  is  the
m i s s i n g   p i e c e   o f   t h e   d r u g   d e v e l o p m e n t   p r o c e s s   o n   t h e   continent.  In  Dr  Doodo's  words,  the INESS  project  is  a  platform  to introduce  a  phase  four  structure  to gather  evidence  that  would  be valuable for national malaria control programmes in Africa for policies or appropriate  use  of  anti-malaria drugs,  especially  newly  registered drugs.

An assessment of real life situation is always  important  in  policy  and programme  implementation  to  deal effectively with problems at the grass roots and the community level.

Mr Alfred Komabu who works at the DECCON  Pharmacy  and  Health Services,  says  affordability  is  a  big problem, when a clients walks into his pharmacy.  The  pharmacy  is  located around  the  Spintex  Junction  along the  Nungua-Lashibi  road,  in  the Greater  Accra  region. 

People  from communities,  such  as  Sakumono, Spintex and Nungua have easy access to  the  services  of  the  pharmacy, because of its strategic location. The pharmacy has stocks and varieties of anti-malaria  drugs.  They  come  in
different  brands  and  formulations, such as artenex, artemos and alaxin, which  are  monotherapies  and artemisinin-based  combination (ACT)  therapies  such  as  Lonart  and lumether.

Most  of  these  drugs,  especially  the ACTs,  are  expensive  with  prices  as  high as 10 Ghana cedis for a package to treat malaria.    Clients sometimes  ask for  palidan  or  fansidar, a  mono- therapy  costing  around  50  Ghana pesewas  and  they  need  to  be
persuaded to go in for a much better  choice.

With  his  fingers  pointing  at  the Sakumono  estates,  a  middle  class c o m m u n i t y ,   M r   K o m a b u   s a y s   sometimes clients who walk into the pharmacy prefer to go in for the very cheap anti-malarials. Cheaper drugs, such  as  chloroquine,  sulfadoxine-
pyrimethamine  and  a  host  of  others have  been  complemented  by  newer,  more  expensive  ACTs  to  slow  the development of resistance.

The  World  Health  Organization Malaria  Report-2008,  says  that  the  “procurement  of  anti-malarial medicines  through  public  health services increased sharply, but access to  treatment,  especially  of  ACT,  was inadequate  in  all  countries  surveyed in 2006.”

Mr Komabu also has a lot to say about t h e   e n v i r o n m e n t   a n d   d r u g   manufacturing and formulation.

He  argues  that  researchers  should subject drugs being developed to the  geography of the area.

“Drugs  brought  into  Africa  are manufactured  and  tested  based  on  the local environment where they are manufactured.  When  these  foreign drugs  hit  the  African  continent  they might  not  be  effective  against  our disease  causing  agent,  even  anti-
malarials  manufactured  in  the c o u n t r y   h a v e   f o r e i g n - b a s e d   component  and  formulation,”  he explains.

Mr  Komabu  believes  real  life situations, should lead the way in the search  for  effective  management  of malaria.