Bad medicines breed bad bugs: Tackling antimicrobial resistance through medicine quality

This week is the first global Antibiotic Resistance Awareness Week. If you are aware of that – indeed if you are even aware that modern medicine is under serious threat from increasingly common drug-resistant pathogens – you’re probably at least a little in debt to Dame Sally Davies. Professor Davies, the UK’s Chief Medical Officer, has focused much of her considerable energy over the past four years on putting antimicrobial resistance in the global spotlight and on motivating policymakers to take action to combat it.

Speaking at a Strand Group event, the Policy Institute’s at King’s signature seminar series, on Tuesday 17 November, Dame Sally described how she managed to turn an acknowledged but widely ignored problem into one of the hottest topics in global health. Her talk was a masterclass in the strategic use of influence in domestic and international circles. Importantly, she sought allies outside of the echo chambers of health and international development, persuading respected Goldman Sachs economist Jim O’Neill (now a Treasury minister) to chair a review looking at the damage antimicrobial resistance (AMR) might do to the world’s economy, and to suggest solutions that will work for industry as well as for medics.

A global problem

Like terrorism and climate change, antimicrobial resistance is a global problem. In this age of rapid, massive and multi-directional movement of people, pathogens that have been bred into being in one country threaten the health and welfare of people worldwide. The multi-drug resistant New Delhi metallo-beta-lactamase 1 infection (NDM-1), for example, was first identified in a Swedish patient returning from India in 2008. Early cases appeared to be associated with travel to South Asia, but the pathogen has now been identified in 70 countries, and it appears the “superbug” is being transmitted locally.

In short, this is not a problem that can be solved at a national level, however committed the government might be to increasing public awareness, improving diagnosis and reducing over-prescription at home. Prime Minister David Cameron regularly raises the issue of drug-resistant infections at the G7 and G20 summits. The UK government is putting money where its mouth is, starting with the £195 million Fleming Fund, which aims to help lower income countries track and respond to resistant infections.

Other nations are beginning to take notice: the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria convened by US President Barack Obama met for the first time a few weeks ago. Earlier in the month, during Chinese President Xi Jinping’s visit to London, the UK and China announced they would cooperate on research to limit antimicrobial resistance while just last week, in joint communiqué with David Cameron, Indian Prime Minister Narendra Modi pledged to work against the development and spread of untreatable pathogens.

Bad for patients and bad for public health

Prime Minister Modi’s support is especially welcome, and necessary. As a briefing paper published this week by Lord O’Neill’s AMR Review finds, poor quality medicines are an important driver of antimicrobial resistance. The briefing is based on a new study that details the ways in which poor quality medicines contribute to antimicrobial resistance and suggests what might be done about it. The study notes that India is the world’s largest exporter of low-cost generic medicines, and there’s evidence that not all of those medicines are of acceptable quality by the time they reach sick people.

As Dame Sally pointed out in her talk, this is a vexed issue because in countries where the prevalence of infectious diseases is high, many people – usually the poorest – have difficulty getting hold of any antimicrobial medicines at all. Low-cost generic medicines are a vital resource in closing that access gap. But we cannot let the need for low-cost medicines become an excuse for low-quality medicines. Guidance from India’s medicine regulators suggests that manufacturers should not be sanctioned as long as they are using at least 70 per cent of the correct active ingredients — a level that would never be considered acceptable in the UK. Tacitly accepting sub-standard drug production is bad for patients, but it is also bad for public health. Antimicrobial resistance develops most rapidly when medicines have enough active ingredient to kill the weaker strains of a microbe (eg bacteria), but not enough to kill the mutant strains. Sloppily made medicines can be dangerous even if they do contain sufficient quantities of active ingredient because they often don’t dissolve properly, meaning only a fraction of the medicine reaches the bloodstream.

India’s pharmaceutical industry is perfectly capable of producing top-notch medicines; the overwhelming majority of its exports to Western markets meet the highest quality standards. The same is true for manufacturers from China, Brazil and other countries that supply most of the antimicrobial drugs sold in the lower-income countries of Africa and Asia.

There’s much more to antimicrobial resistance than poor quality drugs. But it is one of the most neglected aspects of the problem, as well as one of the most tractable. As the UK, India and other partners work together to combat the spread of antimicrobial resistance globally, they could score a quick goal in favour of patients and against bugs, just by making sure that the antimicrobials that people do take are good quality and up to the job of killing new mutations as well susceptible pathogens. That means focusing on manufacturing processes and quality control systems, especially at factories that are producing drugs that will be used in countries with high levels of infectious disease.

Dr Elizabeth Pisani is an infectious disease epidemiologist and a Visiting Senior Research Fellow at the Policy Institute, King’s College London. Her paper on medicine quality and antimicrobial resistance, commissioned by the Antimicrobial Review chaired by Jim O’Neill, can be downloaded here.

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