Fake Medicine, Genuine Risk

In April 2015, the American Journal of Tropical Medicine and Hygiene (AJTMH) published over a dozen papers, alerting the world that falsified and substandard medicines risk the lives of up to four billion people (1). The supplement – “The pandemic of falsified medicines: laboratory and field innovations and policy perspectives” – presented 17 scientific articles that offered data and recommendations on developing a coordinated and effective response. Falsified and substandard medicines are a recognized problem on virtually all continents, and so can certainly be considered a pandemic. Moreover, the increasing global scientific awareness of the problem is evident by the number of articles on “fake drugs” cited in PubMed, which has increased ten-fold over the last 50 years (Figure available online) (3). Furthermore, government, public, company and surveillance reports of poor-quality medicines have been increasing in volume; however, it is likely just the tip of the iceberg – many cases still go un-, under-, or mis-reported (4). And poor-quality medicines are not just limited to anti-infective medications for developing countries, developed countries are also affected. Of course, there is debate on the extent and size of the problem, but ‘murder by medicine’ continues to be profitable (by some estimates a $75 billion criminal enterprise) with only minimal punishable consequences in many countries (5).

For a prime example of how we are losing a decade of public health progress to drug resistance, consider antimalarial medication. Timely access to quality antimalarials is the difference between life and death in pediatric populations in endemic countries. Recent surveys show a third of poor-quality antimalarials in Southeast Asia are falsified and an equal proportion of antimalarials in sub-Saharan Africa are substandard (6). Another paper estimates that in 2013 alone, approximately 122,350 deaths in children under five years of age in 39 sub-Saharan African countries were associated with exposure to poor-quality antimalarials (7). Over the last decade, the progress in malaria control and elimination are truly unprecedented, but past experiences have shown that reductions in malaria incidence are difficult to sustain (8). Poor-quality antimalarials can encourage drug resistance by exposing parasites to sub-therapeutic levels of drug, and fake medicines allow resistant strains to spread unchecked even when medicines are provided. Indeed, poor-quality medicines are putting millions of dollars of investment to control and eliminate malaria at risk. The locus of any epidemic response is the diagnostic or detection tools that can reliably identify the problem and its extent. In the AJTMH supplement we showcase new and promising technologies ranging from paper cards to field assays that can detect falsified and substandard medicines. However, the need to cross compare and test these technologies for validity and then scale them up for widespread application has never been more pressing. The persistent barrier of limited funding for field evaluations of such technologies is being addressed by organizations like the United States Pharmacopeial Convention (USP), who have been pioneers in launching field evaluations of select technologies (9). Unfortunately, the bulk of data on the prevalence of poor-quality medicines is convenience sampled, fragmented and collected using different measures, and thus does not represent the true extent of the problem.

There is no silver bullet to curb the pandemic of poor-quality medicines, but we need to focus on three main areas: i) develop and compare accurate and affordable technologies to identify high-quality medicines at all levels of distribution; ii) use a top down and bottom up response with an international convention and national legislation to ensure production and distribution of quality assured medicines, thus protecting patients from perpetrators; and iii) set standards for data collection and testing, coordinate surveillance, and strengthen regulatory systems. Poor-quality medicines injure and kill the most vulnerable of patients, lead to distrust in the healthcare system, promote drug resistance, and threaten decades of progress in global public health. To tackle the problem, we need to combine political willpower with industry engagement.

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