Early man, confronting the manifestations of malaria, attributed fever to supernatural influences: evil spirits, angered deities, or the black magic of sorcerers. The ancient Chinese believed the frightening symptoms and signs to be the work of three demons, one with a hammer, one with a pail of cold water, and a third with a stove. The ancient Romans worshiped a fever goddess, three demons rolled into one.

The connection between malaria and swamps was known even in antiquity and the evil spirits or malaria gods were believed to live within the marshes. Indeed, malaria could be said to be as ancient as the earth itself because the parasites spread and follow man anywhere he has pitched a tent to live.

The history of the treatment of malaria is as equally old. Fevers have always haunted mankind and several ingenious remedies were tried to combat the fevers. In the ancient times, limb blood-letting, vomiting, amputation and skull operations were tried in the treatment of malarial fever. Humankind has been determined to find a lasting cure for malaria and even eradicating it from the face of the earth. For this reason malaria has always been the subject of research for medical practitioners from time immemorial.
The need to keep troops healthy during the Second World War led to the development of a number of drugs to fight malaria. Foremost amongst them was Chloroquine and Quinine. Other drugs that followed on their heels are Sulfadoxine-Pyrimethamine (SP) and now Artemisinin-based Combination Therapies (ACTs).

What is striking about the production of these drugs is the rapidity of changing them. This raises mind boggling questions that beg for answers. Is it an issue of efficacy or effectiveness of the drugs or a combination of both? Are there questions that have not been addressed by scientists? Does human behaviour have anything to do with how effective a drug is?

The issue took centre stage once again at a forum of journalists, scientists and researchers in Dar es Salaam, Tanzania, organized as part of this year's commemoration of World Malaria Day.

The situation was vividly captured by this question posed by one of the journalists: “People were comfortable with Chloroquine, but the government suspended the drug and came up with SP as the first-line drug for treating uncomplicated malaria. SP did not stay long enough in the market. In 2006 we were introduced to yet another drug famously known as ‘dawa ya mseto’ (Artemisinin-based combination therapies ACTs). Why is the government and perhaps scientists doing this? In other words: why are anti-malarial drugs changed so quickly?”

Similar concerns were raised recently when members of the African Media and Malaria Research Network (AMRREN) and some Communication Officers from two research sites met in Tanzania.
The three-day meeting, sponsored by the INDEPTH Effectiveness and Safety Studies of Anti-Malarials (INESS) project, was meant to sensitize participants on the project. The project is gathering data and practical evidence on anti-malarials in real life for effective treatment of the disease to allow policy decisions to be based on evidence.

From the presentations on INESS, it was clear that the project has come at the right time to answer many unanswered questions about anti-malarials.

Dr. Aziza Mwisongo, INESS Project Manager

The INESS project was launched in Tanzania in 2009 and is also underway in Ghana. Two other countries - Mozambique and Burkina Faso - will soon join the project.

INESS is to study the safety and effectiveness of medications that are in routine use. The focus is on the evaluation of drugs that have passed through the licensure examination commonly called Phase Three Trial (Phase III). Prior to product registration and marketing, data about the safety and efficacy of drugs are limited to observations from pre-clinical animal studies and initial clinical trials.

Scientifically speaking, information gathered about drugs in Phases I through III trials do not provide a sufficient basis for final conclusions about the clinical value of medications after marketing. INESS Phase IV trial will provide a mechanism for participating countries to monitor the performance of anti-malarial drugs after they have been approved by regulatory bodies. While Phase III has a single study design in a controlled, randomized, double-blind study, Phase IV requires different designs such as spontaneous reports, stimulated spontaneous reports, comprehensive observation studies, case control studies, prescription event record linkage, and data bank comparisons.

According to the INESS Project Manager, Dr. Aziza Mwisongo, the project will make it possible for countries to carefully assess the safety and efficacy of drugs in the market. Currently there is little information available on rare but severe side effects of anti malarial drugs. The information that would be gathered through INESS project will reveal determinants of effectiveness in real life condition in African countries to build a reliable framework for development of malaria treatment policies.

“The setup of the INESS project in Tanzania is complete and all the modules are running,” She said. The modules, according to Dr. Mwisongo include therapeutic efficacy, accessibility of drugs, targeting the community, systems to check the compliance, adherence and effectiveness. The concept of INESS is linked to health systems since the project basically studies effectiveness and safety of the anti malarial drugs that are in the market. The project uses existing platforms such as the demographic surveillance system sites where health observatories are conducted.

“While efficacy of drugs is about testing the therapeutic performance of a drug in a controlled laboratory setting, the effectiveness studies monitor the performance of drugs in a real world setting. It is here that factors other than clinical ones are monitored. A drug may be 98% efficacious but may be 0% effective depending on the health system factors in place. Issues of cost of a drug, distance to a facility, patient compliance issues, gender related issues, traditional beliefs and many other factors may contribute to the failure of African countries to beat the malaria eradication target of 2025” says Dr. Mwisongo.