“It is simply not possible to identify all the side effects of drugs before they are marketed. The difficulty is not a failure of the drug – development process or of the drug-approval process; it is the expected consequences of the biological diversity of humans and the fact that low-frequency adverse effects are unlikely to be detected in the few hundred or thousand patients studied in trials before a drug is approved”. Wood A.J.J!

African Scientists are once again poised to lead in a research to investigate the effectiveness and safety of anti malarial drugs in use in Africa. The project known as the In-depth Effectiveness and Safety Studies of Anti-malarial Drugs  (INESS) in Africa is a platform that will create the missing final section (phase iv) of the drug development process for Africa and ensure rapid access to practical evidence on treatment effectiveness and safety. Disclosing this in an interview with AMMREN, the Dean of the School of Public Health, Prof. Fred Binka said the purpose of the  project is to minimize the time gap between licensure and adoption of new anti-malarials by providing objective effectiveness and safety data, under real life settings that will help inform global, regional and national policy and practices. The project will also enhance capacity in Africa to monitor local health systems in order to track costs, effective coverage, and effects of new or alternative post-registered anti malarial treatments.
The malaria burden in Africa is so huge that a combination of tools and methods are being employed to deal with the pandemic. Currently, malaria is one of the leading killer diseases in the world. Ninety per cent of all deaths due to malaria occur in Africa. According to the newly released WHO Malaria Report 2008, “there were an estimated 247 million malaria cases among 3.3 billion people at risk in 2006 causing nearly a million deaths, mostly of children under 5 years. One hundred and nine countries were endemic for malaria in 2008, 45 within the African region”.
 
To combat the malaria burden therefore, a number of strategies are being used in Africa including long-lasting insecticide treated bed nets (LLIN) and artemisinin-based combination therapy (ACT), supported by indoor residual spraying (IRS) and intermittent preventive treatment in pregnancy (IPT). One of the greatest challenges facing Africa in malaria eradication is drug resistance which has led to increase in malaria cases. Cheaper drugs such as chloroquine and a host of others have been complemented by newer and more expensive drug combinations such as the ACTs to slow the development of resistance. The ACTs currently recommended by WHO in its treatment guidelines include “arthemether-Lumefantrine, a first ling anti-malarial drug for Tanzania, artesunate + amodiaquine, first line anti-malarial drug for Ghana, artesunate + mefloquine and artudnate + sufadoxine-pyreimethamine (SP). For vulnerable groups such as pregnant women and children, the SP and artemisinin based suppositories are used. But in severe malaria, artesunate/amodiaquine or tablet quinine is given in the first and second trimesters while rectal artesunate is used for pre-referral treatment at the primary level of care.
The introduction of the ACTs in some African countries however has not been without problems. For example in Ghana, there had been reported adverse reactions with the drug policy change. It was linked to the co-formulation of locally manufactured AS + AQ with 200 mg artesunate and 600mg amodiaquine in a single tablet. This led to the withdrawal of the locally manufactured product from the Ghanaian market.
Again recently in Western Cambodia, there has been evidence of artemisinin-resistant malaria where the malaria parasite is already showing resistance to the ACTs meaning that different types of ACTs will have to be introduced to deal with the problem.
Apart from this, other challenges including geographical and financial access to safe, efficacious and quality ACTs, poor clinical diagnosis and prescriber non-adherence to the treatment policy and guidelines, poor patient compliance with treatment regimen and inadequate reporting (active and passive) of adverse reactions to anti-malarial drugs have led to many resorting to monotherapies, which has also made the monotherapies no longer effective thereby giving fears of another parasite resistance and   the introduction of many more ACTs.
 With the deployment of the many new anti-malarial drugs into African markets, the need has arisen for African scientists to investigate the effectiveness and  safety of these drugs in real life settings in order to provide better policy options for the array of anti-malarial drugs currently on the African markets.
The African Scientists-led initiative, INESS PROJECT will monitor the products throughout the products’ life cycle; look at availability of background levels of acceptability and availability and management of fevers and or malaria. Four countries are involved in the project – Mozambique, Burkina Faso, Tanzania and Ghana.   The project will begin first in Ghana and Tanzania and later move to Mozambique and Burkina Faso. Three health research centers in Ghana which are running demographic surveillance systems under INDEPTH’s Network, Kintampo, Dodowa and Navrongo, will provide the platform for the studies. The INESS Project is another key project under INDEPTH’s Network apart from the Malaria Clinical Trials Alliance (MCTA). The Deputy Executive Director, Dr. Ayaga Bawah said INDEPTH’s Network started with 18 sites but today it can boast of 34 sites. “We are working together to understand population dynamics. Vital statistics are unavailable in parts of our world so INDEPTH’s is helping countries to understand them”, he added.
INESS will investigate all anti-malarials in the system to put them in proper public health system context to ensure that they are safe and used appropriately. Protocols have been developed and submitted to the Ghana Health Service for ethical review before the project takes off by the last quarter of this year. Malaria Medicine Ventures, the Gates Foundation among other local partners such as the School of Public Health of the University of Ghana collaborate to ensure the implementation of the project.  
Prof. Binkah was happy that “African scientists once again will contribute towards looking at how effective we can reduce the burden of malaria, one of the major burdens on the continent”. 
This statement by Wood AJJ et al (1998) emphasizes the need to monitor the drugs to ensure their safety, “It is simply not possible to identify all the side effects of drugs before they are marketed. The difficulty is not a failure of the drug – development process or of the drug-approval process; it is the expected consequence of the biological diversity of humans and the fact that low-frequency adverse effects are unlikely to be detected in the few hundred or thousand patients studied in trials before a drug is approved”. INESS indeed is a must for Africa