Until recently, the quality of medicines was what we sometimes call a “Three monkeys” problem, after the folk tale in which monkeys cover their ears, eyes and mouth, so that they “hear no evil, see no evil and speak no evil”. Many governments and global health institutions have prefered not to pay attention to the issue at all, fearing that a true understanding of the prevalence of medicines that don’t work (because they are poorly made, or outright fakes) could undermine public trust in the health system.

The COVID-19 pandemic began to change that, as even the wealthiest countries scrambled to get medicines (and later vaccines) they believed could help against the virus; the market for fakes boomed, and stories of substandard medicines and protective equipment were rife. Early in the pandemic, Elizabeth Pisani was a guest on the BBC Radio 4 program “The World Tonight” and discussed the issue in brief (3 minutes 12 seconds):

Well before the pandemic, however, Ternyata was working with the World Health Oganization to try to understand the drivers of markets for substandard and falsified medicines. Our first step was to analyse cases reported to WHO from around the world (full pdf report here). We then dug a bit deeper, tracking the economic and political drivers of markets for substandard and falsified medicines in four middle-income countries. You can read the results of that research here:
Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania, or, if you prefer to follow the results in a presentation, watch this short video.

Many more recent publications from research built on those foundations are listed on the publications page. These include a paper describing our ideas for how to improve surveillance systems for medicine quality, so that we can begin to make systematic estimates of the true extent of the problem. We’re trying out these methods through STARmeds, a research collaboration based at Universitas Pancasila in Jakarta.

We also occasionally communicate about medicine quality related issues and research over at MedsWatch.

We first became interested in medicine quality because we were thinking about antibiotic resistance.
It’s hard to believe that antibiotics have been around for less than a century. In that time, they have transformed medicine, making all sorts of more complex treatments like chemotherapy possible. But we’ve been careless with this precious resource, more or less ignoring the threat that bugs will get the better of medicines, even as we’ve seen antimicrobial resistance spread.

That, too, has started to change. Global leaders, including then UK Prime Minister David Cameron and U.S. President Barack Obama, set up special commissions to consider possible responses to the threat posed by antimicrobial resistance (AMR). Most of the early reports on AMR talked of its complex roots: doctors are too eager to prescribe antibiotics, and patients are too eager to take them (including when they are not prescribed). But they often take them sloppily, not finishing a whole course. Added to that, antibiotics are over-used in farming. We need to limit their use, but that in turn limits the interest of pharmaceutical companies in developing new antibiotics. Other antimicrobials are often most needed by poor patients in poor countries, so they’re not that attractive to industry either. Etc., etc.

These issues were much discussed. But there was something else promoting the development and spread of resistant pathogens, sometimes mentioned but rarely analysed in any depth: bad medicine. Ternyata Ltd was asked to look at this issue for the UK government’s Antimicrobial Review.

Our report on medicine quality and antimicrobial resistance found that sloppily made medicines churned out by low-cost producers for markets where oversight is low probably contribute far more to antimicrobial resistance world-wide than out-and-out fakes, although it is the latter that get more attention from the press and regulators. You can download the full report here (.docx – 2.54MB).

A partial summary by the AMR Review team is available here.(pdf)

Our report on medicine quality and antimicrobial resistance is also available from Google Drive here

A less technical (and much shorter!) discussion of the same issues was published in Prospect Magazine: Why we are losing the war on bugs (January 21, 2016). Archived .pdf available here