Study: fake AIDS, and T.B drugs causing thousands of deaths annually

Margaret Hamburg

GLOBALISATION IS PARTLY TO BLAME: Dr.Margaret Hamburg, former US Food and Drug Administration

The trade in fake malaria, HIV, and Tuberculosis drugs is again in the spotlight, amid fears that they are responsible for tens of thousands of deaths in poor countries like Uganda.

The “pandemic of falsified and substandard medicines is pervasive and underestimated, particularly in low- and middle-income countries where drug and regulatory systems are weak or non-existent”, according to Jim Herrington of the University of North Carolina who co-edited a collection of articles.

There are currently around 1 million deaths annually due to malaria worldwide and the World Health Organization estimates that nearly 20 per cent of these deaths are associated with counterfeit ant malarial drugs.

The scale of the problem has been exemplified by recent studies showing high levels of anti-malarial and tuberculosis drugs that failed quality testing – almost 17 per cent of samples in Africa – and showed evidence of deliberate falsification in around 7 per cent of cases.

Tests on samples from Rwanda failed however to reveal any falsified products, according to the authors of the study. The fake treatments have been plaguing many countries – predominantly in Southeast Asia and sub-Saharan Africa where the mosquitoes carrying the disease are abundant , but the widespread use of these fake drugs have become increasingly difficult to distinguish from real ones.

Dr. Godfrey Magumba, the Uganda Country Director for Malaria Consortium told this website that criminals have become highly skilled in replicating the look and feel of real drugs and their packaging.

The more sophisticated counterfeits also contain a small amount of the real active ingredient, so they can deceive some anti-counterfeiting tests. One of the articles claims that falsified and poor quality malaria drugs that contributed to the deaths of an estimated 122,350 African children in 2013 alone.

In another study, scientists examined nearly 17,000 samples of antibiotics, antimalarial and anti-tuberculosis drugs and found that as many as 41% failed to meet quality specifications.

In an essay accompanying the collection of articles, former US Food and Drug Administration (FDA) Commissioner Margaret Hamburg says that globalisation has added layers of complexity to the drug supply chain that require greater oversight.

Dr Hamburg, who was recently named foreign secretary of the Institute of Medicine, said that “today’s medical-product landscape blurs the line between domestic and foreign production, drawing attention to the need for global quality and safety oversight to prevent patient exposure to falsified products”.

On a positive note, the authors of the articles say new methodologies to test drug quality are emerging and scientists reported the results of four investigations.

They found that “simple paper-based test cards proved to be an economical and portable method to identify very low quality anti-malarials”.

More sophisticated approaches using fluorescent and luminescent techniques can measure with greater precision, they note, “but may be difficult to use in remote settings.”

The authors believe that “all of these promising tools require further testing to provide a greater evidence base to guide policymakers”.

The scientists conclude that “an urgent and coordinated international response is required to address the pandemic of poor quality drugs”. Proposals include a global agreement, similar to the Framework Convention on Tobacco Control External Web Site Policy, and stricter national laws to prosecute those who knowingly sell counterfeit medicines.