Fraudulent and substandard antimalarial drugs could be wrecking the chances of winning the war against malaria in Africa, researchers from the Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration reported in the Malaria Journal. The authors add that millions of lives could be lost over the next twelve months unless urgent action is taken both within the African continent and elsewhere in the world.
Fake medications are coming onto the scene as a result of deliberate criminal activity, while substandard drugs are becoming more common because of poor manufacturing practice. Not only are scores of patients being inadequately treated, but the presence of these undesirable and illegal medications significantly raises the risk of drug resistance among the malaria parasites.
Approximately 781,000 people are thought to have died from malaria in 2009, says the World Malaria Report 2010.
Artemisinin derivatives are the best antimalarials, experts say. They work faster than other medications, such as chloroquine and mefloquine, and also have fewer side-effects. These drugs can be used on their own to treat malaria, but are more commonly administered alongside other medications, mainly because of the rising problem of drug resistance. WHO (World Health Organization) recommends that for uncomplicated falciparum malaria, combination therapies be used.
The researchers set out to determine how prevalent counterfeit and substandard antimalarials were in Africa. They gathered data from 11 nations in Africa between 2002 and 2010.
They found that some fake drugs contained a combination of erroneous active ingredients, many of which only treated malaria signs and symptoms, but did not cure the disease itself. These unsuitable active ingredients were also found to cause potentially serious side-effects, especially when administered in combination with other medications, such as those used to treat HIV.
Some of the fake drugs had small quantities of artemisinin derivatives - experts believe this was so that they could be passed off as authentic medications during authenticity tests. They contain such small quantities of artemisinin derivatives that there are useless in ridding the body of malaria parasites, and highly likely to promote their resistance to artemisinin. Put simply, the patient derives no benefit, and the parasite becomes more difficult to eliminate.
Scientists managed to trace some of the pollen found in the fake medicines to eastern Asia. In 2001, authorities in Guangshou, China, arrested Chinese and Nigerian men who were accused of producing fake halofantrine, an antimalarial. Investigators say that there is no pollen evidence of fake drug production occurring in Africa. Packaging materials for counterfeit antimalarial medications have been confiscated in Nigeria.
Research leader, Dr Paul Newton, said:
"Public health organizations must take urgent, coordinated action to prevent the circulation of counterfeit and substandard medicines and improve the quality of the medicines that patients receive. We must move finally away from the use of single drugs and towards the exclusive use of combination therapies.
The enormous investment in the development, evaluation and deployment of antimalarials is wasted if the medicines that patients actually take are, due to criminality or carelessness, of poor quality and do not cure. Malaria can be readily treated with the right drugs of good quality, but poor-quality medicines - as well as increasing mortality and morbidity - risk exacerbating the economic and social impact of malaria on societies that are already poor.
Worse still, they encourage drug resistance, potentially resulting in the failure of artemisinin treatments, with profound consequences for public health in Africa. Failure to take action will put at risk the lives of millions of people, particularly children and pregnant women."
Dr. Newton says regulatory authorities in Africa need increased investment, so that quality control can be more closely monitored. For the fight against malaria to be effective, people need access to top-quality and affordable artemisinin combination therapies.
Dr Jimmy Whitworth, Head of International Activities at the Wellcome Trust, commented:
"This research is very worrying and should act as an early warning. We have already begun to see the emergence of drug-resistant malaria parasites in South-east Asia; substandard and counterfeit antimalarials and the availability of artemisinin monotherapies threaten to lead to the spread of drug resistance in Africa. If this happens, the effect could be devastating on efforts to control malaria in Africa."