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    Mosquitoes around the home can be reduced significantly by minimizing the amount of standing water available for mosquito breeding. Residents are urged to reduce standing water around the home in a variety of ways.


    The best way is to avoid being bitten by mosquitoes.This can be accomplished using personal protecting  while outdoors when mosquitoes are present. Treated bed nets should be used sleeping. Mosquito repellent should be used when outdoor.


    Nearly half of the world’s population is at risk of getting malaria. Pregnant women are particularly at risk of malaria. Children under 5 years are at high risk of malaria.


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INESS so far...

The INDEPTH Effectiveness and Safety Studies (INESS) project is a pioneering phase 4 platform to assess the safety and efficacy of anti-malarials and their effectiveness in treating patients in typical health systems in Africa. Theproject,which began in 2009, is aimed at aiding policy decisions in the evaluation of anti- malarial drugs among the African populations. Researchers on the platform have conducted phase 4 trials into various anti-malarials such as artesunate-amodiaquine and artemether-lumefantrine. These scientists recently gathered some data on the eurartesim drug as part of the process of testing the readiness of the INESS platform to carry out future trials into other drugs, vaccines and other products. Prof Fred Binka, a renowned malaria research scientist and the Principal Investigator on the INESS project, tells the INESS story in an interview with AMMREN Correspondent,Theresa Owusu-Ako.

Q. What brought about the idea of the phase 4 trials into anti malarials in Africa?

A. The phase 4 trials has been part of the package to  actually develop drugs. Drugs are deveoped in 4 phases, phase 1, phase 2, phase 3 and then phase 4 but over the years, the phase 4 part of trials has been relegated to the pharmaceuticals companies and the supervising authority. In most countries, these are post registration issues that are dealt with by Food and Drugs Authorities to make sure there is a place for monitoring the drugs after they are registered. The main reason is that it takes about 3,000 patients to be able to register a drug from phase 1, phase 2 to phase 3.

Q. Can you explain further?
A.Drugs are usually tried on smaller populations when they are being developed but once registered, these drugs are then distributed to millions of people without consideration to the side effects on larger populations. A phase 4 trial is meant to expose many more people to a drug to check for any adverse effects before being widely distributed around  the world. In the case of malaria,  since the move from single dose    treatment (mono-therapy) for malaria to combination therapy, no  trial has been  done to  determine the effect of  combining drugs. Once you combine drugs the chances are that they could create more problems. A phase 4 study therefore becomes necessary to look at how this combination drugs fare within a population and whether they generate any untoward effects.

Q. Why did it take Africa that long to go into that?

A. First of all, you should know that the drugs we are talking about have to do with diseases that afflict the poor and therefore too cheap to attract heavy investment. Secondly, our regulatory authorities, until recently, were too weak to check the importation of foreign drugs that have not been tested in Africa

Q. What were the real objectives of INESS?

A. INDEPTH already has a platform where it monitors population across Africa and Asia. INESS was an addition to overlay another potential of trying to monitor new drugs that are introduced. INESS is a platform that ensured that anytime any new drugs came on board they could be monitored within the population in which the INDEPTH Network was already working.    

Q. Would you say that the objectives you set for INESS have been met?

A. We have partly met them. But we also encountered some challenges we    did not    expect. First, we thought this was a contribution to the development process and  INDEPTH actually raised its own money to monitor these drugs. But we had a major problem with the drug companies. The drug companies were not happy that we were monitoring these drugs.

Q. Why?

A. The drug companies were worried that as independent  monitors, we could find    something negative that would cause the  drug manufacturers to lose millions of dollars. The drug companies therefore thwarted our efforts all the way. The Italian  company that manufactured the anti malarial, Eurartesim, which we used for the study, at first, was not willing to give us enough of those drugs to be able to follow up on the population. But now we are friends because we have done the study and they  are happy with the results.

Q. Why did the Navrongo Health Research Centre use Duo-Cotecxin instead of Eurartesim?

A. Duo-Cotecxin and Eurartesim  have the same chemical structure and compounds of dihydro-artemisinin-piperaquine. The difference is that Duo-Cotecxin is Chinese made and Eurartesim is made in Europe. Chinese products have been in Ghana for so many years but have not been monitored. Eurartesim has just been registered. In fact, we pushed for the registration of Eurartesim in Ghana. The manufacturers were worried about the results of the trial and decided to reduce supplies for the study.    

Navrongo had to  use Duo-Cotecxin because the two drugs actually are the same drug.

Q. All the sites tested Eurartesim for safety but the Navrongo site did a study for Eurar tesim effectiveness. Would Navrongo do a safety test for Duo-Cotecxin and its effectiveness?

A. The drug company supplying Eurartesim was not willing even to sell Eurartesim to Navrongo to do the studies. They were happy with the safety component but they were not happy with the effectiveness component. So Navrongo did safety for Eurartesim and is now doing the effectiveness trial. They will also be monitoring Duo-Cotecxin for its safety.

Q. What were some of the challenges on the Eurartesim platform?

A. First of all, using  funds to get the platform going was a major problem. Secondly, we set it up to look at new drugs and not the existing drugs such as Artesunate Amodiaquine and Artemether Lumefantrine. We had to wait for new drugs to test. The newest drug that came on the market was the Eurartesim and  so we had to wait to test Eurartesim. In fact, we were so frustrated that we nearly started testing Duo-Cotecxin. The third frustration in this particular case was that, the amount of effort that was required to test Eurartesim was more than we anticipated.

Q. Why were you so interested in the Eurartesim drug?

A. When Eurartesim was developed, there was a signal that it could affect the heart. There were fears that the heart could be elongated when one takes Eurartesim. So we had to do a more intense study by buying these ECG machines and making sure that we could test to see whether there was any effect on the heart. We thought this was a win-win situation where the manufacturers were expected to show interest in the phase 4 study, but  that was not the case. Rather they felt we were getting involved in the drug development process. The truth however is that our study prevented the drug from being withdrawn.

Q. What were some of the findings?

A. The major findings were that this drug is safe. In normal life nobody is going to do seven thousand ECGs to check whether a drug will affect people  or not. But we did this  by testing seven thousand people, 99.9 percent of whom were okay. You see the  beauty of it is that these tests were done in Ghana, Tanzania, Burkina Faso and Mozambique. Our monitoring process had covered a wide range of countries, with high and low transmission areas as well as areas with seasonal transmission. The results from these areas showed that the drug was very effective and safe.    

Q. How much does the drug cost?

A. I am not sure about    what the cost is in Ghana now. The drugs will cost differently in different countries and also will depend on whether they are prequalified. So at this stage    the drug is not prequalified. In fact when WHO got  wind of  the fact that we were doing these studies, it decided that they will wait for our results to prequalify the drug.    

Q. When are you expecting the final results of the study?

A. We have submitted the paper for publication and handed over the whole data set to MMV and to the drug manufacturer. The data is needed by the manufacturer for licensure to continue to produce the drug. We submitted it and are waiting for feedback.

Q. What are some of the major contributions of the Eurartesim drug to the treatment of malaria in Africa?

A. The major contribution is    that, this is    now a    new drug that is co-formulated.    Because    this is    a brand    new drug it will take many years before issues of resistance will come    up. The    beauty    of    Eurartesim is    that    there are different dosages for     children, adults and for young    people.    

Q. How involved were the policy makers in the process?

A. Yes we involved the policy makers and there    were two reasons why we    had to do so. First of all, we    worked with the FDA and our data was sent directly to them on    daily basis. In    fact, this is not the type of research where the researchers wait    and take about 3 to 4 years to publish    their data. No,    safety data must be shared on the same day. So we improved the safety data collection    in those parts    of the    sites where we were working.    

The FDA    in each    country  can attest to that. A number of    reports    were submitted because we were monitoring and continuously filling the forms that were submitted to the relevant authorities. We also  had many interactions with the policy makers about the fact that the eurartisim drug needed to be registered.    

Q. What is next after Eurartesim?

A. When a platform is created it is anticipated    that new drugs will be in the pipeline that would be tested. In    fact at the moment, we are in di scus s ion with Shin Poong, another company in South Korea that has developed Pyramax, an ACT, another anti malarial, a Pyronaridine and Artesunate combination. The drug has been registered in Asia. There have been some studies in Senegal, but the drug is  not yet  registered in Africa. Piramax  is therefore likely to be the next drug    that we    may be testing.

Q. What would you say about the cost effectiveness, safety, provider and patient compliance of the other drugs?

A. This is a very important question. If you take the Ghana scene, we started with Artesunate Amodiaquine. Efficacy was ninety nine percent but provider compliance was  very low. People just did not want to take the Amodiaquine component. So we started with the loose parts and then we had the co-formulation. Some people could not also comply with the 24  tablets  over a three-day treatment. They stopped taking the medicine once they felt better, creating the problem of drug resistance because of  not taking  the effective dose over  the period. Manufacturers of Coatem, an anti-alarial, have taken steps to address this challenge by introducing 420/80, a formulation that has compressed four tablets into one. Instead of four tablets, two    times a    day, a    patient    can take one tablet,    two times a day. Hopefully this is going to improve on compliance.    

Q. What would be the legacy of the INESS project for Africa?

A. I think first and foremost the phase 4 trials has come to stay. INESS has contributed to ensuring that drugs made for the population are made safe, even for poor people. In    Europe and in America the law allows people to exact retribution from manufacturing companies in cases of adverse events. In Africa, we don't. So this is the first step to saying that when drugs are introduced in Africa, there must be a plan to look at how they perform  when they are released  into the general population. I know that the FDA now will require a plan, when a drug company comes with drugs on how it intends to monitor the population for adverse events. Because theymay be good drugs, yes,    but sometimes they might have some bad effects    on the    population.

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