The safety of drugs continues to be of great concern in Africa. Experts say most deaths on the continent can be prevented if some attention is paid to drugs used in treating various ailments.
The INDEPTH Network Effectiveness and Safety Studies of antimalarials (INESS) in Africa is the recent study that wants to tackle this problem.
Prof. Fred Binka of the School of Public Health, University of Ghana, and a leading member of the INESS team talks more about the project.
Q: Can you please tell us about INESS?
A: INESS is an abbreviation for the INDEPTH Network Effectiveness and Safety Studies of Antimalarial in Africa. This is a study that is trying to look at safety of anti-malaria drugs and their effectiveness in real life situations. For the first time we are trying to collect systematically information on the safety of anti-malaria drugs used in Ghana , Tanzania, Burkina Faso and Mozambique.
Q: Why INESS? People have been taking drugs over the years. Why this study now?
A: Safety of drugs is something that we should not take for granted. As we continue to say, before you register a drug you would have only deployed this drug to about 3000 people maximum but when it goes to the larger population, it’s a different story. It is important that after registration there must be a way to monitor how the drug works in the population. So this is what INESS is about. The study is being done now because there is funding for it.
Q: How long is this project going to be?
A: This project four years. Beyond the study, we want to create a platform on which to monitor the safety of all drugs. If we do this well, there’s no reason why it should not continue because new drugs will be coming on board and as I have indicated elsewhere, it’s not only drugs. We expect the new vaccines to be developed. Someone has to monitor their safety. So when we have this platform, it provides a way of systematically collecting this information for the safety of drugs and vaccines.
Q: How many people are going to be involved in this project?
A: There are going to be many people. This is an international project targeting a number of Districts in Ghana, Tanzania, Burkina Faso, and Mozambique. Strategically for the trials, we are aiming to follow up 10,000 treatments and then we think that within 10,000 treatments we should be able to find whether any hidden side effects can be detected.
Q: Which drugs are you going to use?
A: We are starting first with the atersunate-amodiaquine in Ghana but we want to use the combined one. We don’t want to use the packs. At the moment, when you take the drug, you can tell which one is amodiaquine and which one is atersunate. The type we are going to use are all in one tablet so you cannot differentiate between the atersunate and the amodiaquine.
Q: Do you have a name for that new drug?
A: We haven’t got a name. We don’t want to be the ones to make the name public. We hope that the Ghana Health Service, when it starts deploying the drug, will come up with a name for it. But we will make suggestions.
Q: What do you hope to achieve at the end of the study?
A: We expect that we will have a lot more people trained in the deployment of drugs. We will have the public educated in such a way that they know that drugs are beneficial but they do have side effects and that people will report them. This is important. It’s not to say the drug is bad but we need to address the effects of people suffering quietly and in some cases dying from taking drugs. Something can be done about these side effects if we find them so this study is very important.
Q: Who are going to be involved in the study? Are they children, adults, and patients?
A: At the moment, we are going to look for people across the range of children to adults who seek treatment for malaria at health facilities. In this case, once they are given the anti-malarials, we will follow them up to see what happens to them.
Q: Most people suffering from malaria seek treatment from private health facilities. Is this not a challenge?
A: Yes, it is. In fact this is the biggest challenge. We are going to actively seek public participation. As you pointed out, most people go to the private sector and a smaller proportion goes to the public health facilities. So we are going to work with the local private providers in the districts. In some of the districts, these health facilities are the only ones that provide services. So we are going to recruit them. And the good news is that most of the districts are willing to make available these drugs to the private sector providers. So this will be good. We have good quality drugs being imported by the government. These drugs get to the private sector and the private sector can give them to those who need them most.
Q: Will the drugs be free to both the private and public sector?
A: Yes. What we intend to do actually is to try and have a system where we actually give the drugs to the private sector. They will sell it because they need to make profit to continue to survive. But the prices at which they will sell it will be moderate since they start with zero cost. And then they put the mark-up for their logistics and their profit. But then we expect them to provide us with information. So in a way they don’t provide us with information but now they will provide us with information and we will give them the drugs so we think that that is where we equalize the cost. So the cost of getting that information is important. That is how we hope to start. If it doesn’t work we will come up with some other methods of trying to make this work.
Q: I am wondering whether you will get the correct information from the private sector where their business is just to sell and not to record information.
A: That is so important. And that’s why we are trying to deploy these studies in the districts where there are demographic surveillance systems. The major information we are going to ask the private sector to do is to identify the people. Once we identify the people, we will visit a proportion of those people in their homes and we will corroborate the information that they collect. We’ll go back to check whether they are safe , their safety issues, whether they’ve taken the drugs according to how they were supposed to take them, issues of adherence, issues of compliance. So these are all built into the system. So if we can identify the people there is no reason why we will not make progress with our studies.
Q: Using the same people for several studies, won’t this cause a problem to the health of the participants?
A: The reverse is true. And this has been documented scientifically. The lives of people in these places have improved remarkably compared to those areas where there are no research studies. In fact, Kassena Nankana District will meet the Millennium Development Goals even if Ghana does not. They are almost there. Number two, most of the interventions that are put in place in these districts are different. The third advantage has to do with the training that is provided the young men and women who engage in the various research projects. Most them who took part in the various trials in the Kassena Nankana district have become international researches with high repute It is best to go back to research communities to interview the chiefs, opinion leaders and talk about the transformation that has occurred.
Q: What happens when the drug is found to be unsafe?
A: This is a very important question. If we find the drug to be unsafe, we will be the first to push that it is withdrawn. That is why in deploying the drug we are bringing all the stakeholders on board. There is nothing to hide. The information will be shared constantly. All information will be given to the Food and Drugs Board to share among other stakeholders for all to see what is going on. If we find that the drug is unsafe, it is our duty to protect our people.
Q: Are there any legal implications?
A: Well, there are no big legal implications in finding whether the drug is safe or not. There might be legal implications for those who take the drug and have problems with it. If somebody took the drug and it can be proved that through the drug someone was harmed or lost a limb that is when there will be legal implications.
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