[afro-nets] Fake antimalaria drugs in africa

["Anayo Austin" <vip4162003@yahoo.co.uk>]

Fake Antimalaria Drugs in Africa, a Biological Terorrism

Ref: http://www.aei.org/publications/pubID.27972,filter.all/pub_detail.asp

Roger et al (2008) studied the quality of antimalaria drugs sold in six African countries- Accra, Lagos, Kampala, Kigali, Nairobi and Dares Salem. They reported that of 195 antimalaria drugs studied, 35% failed both efficacy and quality tests (did not contain enough active ingredients or failed dissolution test). To worsen the situation, they also found that 1/3 of the drugs studied contained only artemisinin, years after the World Health Organization has banned its production as a singe entity in order to prevent resistance. 
The report also had it that nearly all the drugs that were made in Africa and Asia (assuming that their package was legitimate) also failed the tests, while those from Switzerland, passed.

From their study, they concluded that the high persistence of substandard drugs and clinically inappropriate artemisinin monotherapies risk patients safety, drug resistance and places the future of malaria treatment at risk globally.

Africa has over the years battled the existence and shipment of low quality drugs to her domain. The Nigeria NAFDAC for example has spent so much money fighting this monster. Drug resistance has being the bane of African health system. Drug resistance and poor quality drugs are the major cause of treatment failures, long stay in hospitals and loss of man hours, economic loss, death and high cost of treatment both locally and globally. This can be said to be a type of terrorism since most attacks by terrorists are targeted towards loss and destruction of lives, economic systems and structures. .Africa has suffered globally from inequalities in health distribution. The report presented above gives credence to this.

From this report, certain questions become pertinent. 
Who are the makers of these drugs? Drugs are manufactured by pharmaceutical companies. It is therefore the responsibilities of the companies to produce drugs that will meet all internationally acceptable standards. The principles of Good Manufacturing Practice (GMP) as inscribed in the Helsinki declaration must be followed. Company SOPs must be adhered to strictly. Good quality assurance systems must be put in place. Failure to follow these, the company must be held responsible for any unethical, antihuman and unprofessional practice.

Did these drugs undergo testing? Over the years, majority of people have called on the FDA to overlook efficacy testing and concentrate on safety testing. The question therefore is: of what use is a drug that is safe but therapeutically deficient? This has formed the basis by which FDA insists that all products to be marketed in US and her regions must undergo efficacy testing irrespective of country of origin. The therapeutic activity of a drug can be measured by the amount of active ingredients contained in the drug. When a drug contains less active ingredient, it becomes therapeutically deficient. This implies that the maximum therapeutic level will not be achieved on time. More tablets/doses more than the number of doses required will therefore be needed to achieve the required therapeutic level, if possible. 

The regulatory activities of FDA has been said to be the toughest and the tightest in the world. This is not the same with most regulatory agencies in Africa. The enabling environment has not been created by the respective governments to enable the agencies carry out their responsibilities. Lack of adequate funding to non availability of equipments has been the major problem. At other times, political inclinations have also played major roles to achieving the required results.

Most regulatory agencies in African countries only conduct safety testing on pharmaceutical products with little or no emphasis on efficacy testing. Efficacy testing can only be evaluated using thorough, standardized and controlled clinical evaluations or trials. This therefore calls for African countries to ensure that all drugs sent to her continent undergo efficacy testing. Efficacy testing should not only be restricted to new generic drugs. A batch to batch analysis of safety and efficacy of all medicinal products must be carried before its importation or marketing in Africa. This becomes necessary since different drugs from different continents have varying effects on people due to differences in body composition and climatic changes. 

Implementations of Health policies: In January 2006, the WHO issued new treatment guidelines for the first time in 20 years recommending ACTs for the treatment of uncomplicated malaria. The WHO further called to end the production and marketing of artemisinin monotherapies in order to protect these formulations against parasitic resistance. It is sad that years after the directives had been given, some companies have defied the instruction. These drugs are shipped to and marketed in Africa where regulatory agencies, immigrations and custom activities are the poorest. This is a clear cause of economic sabotage aimed at destroying all global efforts targeted towards the eradication of malaria in Africa, a major MDG priority for health

From the report, it could be inferred that most of the drugs lacking in quality were imported. The fight against poor drug quality sent to Africa cannot be fought by Africans alone, but by global effort and contribution. Rules and regulation become mere paper documents if not implemented. The above research finding is a good case study!
It therefore becomes the responsibilities of all local and international regulatory agencies to ensure that international and local directives, targeted toward improving the public health are monitored and implemented to the letter.

Pharmaceutical companies identified to be responsible for producing low quality drugs should be black-listed, punished by available local and international trade laws, since their actions are targeted towards the destruction of global and local efforts for the eradication of malaria.

The writer is a Clinical Research Scientist/Biomedical Scientist

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Anayo Austin 
mailto:vip4162003@yahoo.co.uk