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Up the Anti

The spectre of a new ‘dark ages’ for humanity, where common infections begin to kill again, is increasingly making itself felt globally. This vision is being driven by reports such as the April 2014 study by the World Health Organization (WHO), which stated that antibiotic resistance – which occurs when bacteria change, so that antibiotics no longer work in people who need them to treat infections – is causing a serious and worldwide threat to public health.

Based on data from 114 countries, the WHO report warned that antibiotic resistance is not only happening “right now, in every region of the world”, but also has the potential to affect anyone, of any age, in any country.

“Without urgent, coordinated action by many stakeholders, the world is headed for a post-antibiotic era, in which common infections and minor injuries which have been treatable for decades can once again kill,” said Dr Keiji Fukuda, the WHO’s Assistant Director- General for Health Security, at the launch of the report last year.

“Effective antibiotics have been one of the pillars allowing us to live longer, live healthier, and benefit from modern medicine,” Fukuda added. “Unless we take significant actions to improve efforts to prevent infections and also change how we produce, prescribe and use antibiotics, the world will lose more and more of these global public health goods, and the implications will be devastating.”

By way of example, the WHO highlighted that resistance to the last resort treatment for life-threatening infections caused by common intestinal bacteria Klebsiella pneumoniae – carbapenem antibiotics – has spread to all regions of the world. The K. pneumoniae bacteria are a major cause of hospital-acquired infections such as pneumonia, bloodstream infections, infections in newborns and intensive-care unit patients. In some countries, because of resistance, carbapenem antibiotics do not work in more than half of people treated for K. pneumoniae infections.

The WHO report further noted that antibiotic resistance causes people to be sick for longer, increases the cost of healthcare, and increases the risk of death. As a result, individuals with methicillin-resistant Staphylococcus aureus (MRSA) are estimated to be 64% more likely to die than those with a non-resistant form of the infection.

Closer to Home

Concerns are also growing in the UK, as fl agged up in March 2013 by Chief Medical Officer Professor Dame Sally Davies, in a milestone report, Infections and the rise of antimicrobial resistance. In this, she underlined the global threat to public health represented by the rise in drug-resistant bacteria, and pointed to the need for R&D of new therapies to address the crisis of antibiotic resistance.

This report drew support from Big Pharma players such as GlaxoSmithKline (GSK) and AstraZeneca, both of which acknowledged the importance of tackling the crisis. In a statement released that same month, AstraZeneca pointed to the need to “work with governments and regulators globally to help get these much needed antibiotics into the hands of the medical community,” highlighting that, along with its industry partners, it was already working with governments to drive awareness of responsible antibiotic prescribing.

Dr Des Walsh, Head of Infections and Immunity at the Medical Research Council (MRC), says that when antibiotics are not used properly over time, this may start to enable bacteria to become resistant to treatment. “As treatment practices have not been globally harmonised, bacteria are slowly becoming resistant,” explains Walsh. “This is having the outcome that not only are a broad spectrum of treatments not working as well, but also that targeted approaches to treatment are indicating greater potential to become resistant.”

Facing the Threat

Although antibacterial resistance is a relatively small problem for the UK, which does not suffer the burden of a high number of infectious diseases experienced in the developing world, it is a growing and major threat. In 2014, the MRC also calculated that, although £275 million had been spent in the UK on researching the problem since 2007, no effective solutions had been found to date. “We therefore have an opportunity now to galvanise the research communities, pharma and public health bodies to work together – fi rst, to preserve what we have got, and secondly, to develop new approaches,” adds Walsh.

With this in mind, the MRC is working in close partnership with a wide range of organisations and public bodies in the form of a cross-council ‘war cabinet’ backed by eight government bodies, along with the Wellcome Trust. Its goal is to understand antibiotic resistance from a holistic perspective and tackle antimicrobial resistance on all fronts.

Announced by Science Minister Greg Clark in July 2014, the initiative involves all seven of the UK’s research councils. It now coordinates the work of medical researchers, biologists, engineers, vets, economists, social scientists, mathematicians and even designers, in a multi-stranded approach to address all aspects of the multi-faceted problem.

Four-Pronged Attack

The first aim of the initiative’s resistance strategy is to understand resistance formation, and why it is spreading from one bacterium to another. Secondly, attention is being focused on accelerating therapeutics and diagnostics, such as how to help revisit old drugs with new science, and how to find new ways to treat bacteria – for example, by enhancing our own immune systems. The aim is to diagnose bacteria better, from simply differentiating viral from bacterial infection to identifying ‘hyper bacteria’.

In the third prong, work will be carried out with a broad spectrum of experts to observe how bacteria behave in the real world – from outdoors to the built environment, but also in the gut, a highly specialised environment. The fourth and final prong is to comprehend the impact of human behaviours – for instance, why patients go to general practitioners wanting antibiotics, and why doctors do not feel empowered to say ‘no’.

The initiative also recognises that there is no point in imposing a Western solution on the developing world – hence the need for international partners to understand behaviours, social pressures and drivers in different countries.

Pharma Involvement

Pharma's role in combating antibiotic resistance is clearly nothing if not important. According to Walsh, the UK’s pharmaceutical industry has been consistently engaged in the process. Key participants range from small biotechs to major players – all of which, he says, “have been given a bit of a hard time”.

The current challenge for pharma is making an antibiotic drug that is able to kill one type of bacteria without harming others. In addition, Walsh explains, it can take a long time for pharma companies to change direction. Thus, when the 1980s and 1990s saw a drive for antivirals to combat HIV, hepatitis or influenza – leading in turn to significant infectious disease research at a time when antibiotics worked very well – no one had the foresight to challenge the status quo. Indeed, only a handful of companies still have an active pipeline today. “Turning back to antibiotics is a big shift,” says Walsh. “We are asking drug companies to spend billions of pounds on a drug to be used for a week – when they need a return or they risk going bust.”

Despite such obstacles, the industry is now engaging in economic and business modelling, as well as input at a scientific level. GSK, for example, has several antibacterials in very early development. It also has an asset in Phase 2, known as 2140944. This is being developed as part of a collaboration entered into by GSK in 2013 with the US Biomedical Advanced Research and Development Authority, aiming to support the development of several antibiotics to fight antibiotic resistance and bioterrorism.

“Antibiotics research is one of the areas where we believe taking a more open-minded approach to sharing information and engaging in public-private partnerships will help to address some of the key barriers to the development of effective new medicines,” says David Daley, GSK’s Director of Media, Global R&D, Pipeline and Product News. Daley notes that, given the incredible complexity of antibiotics R&D, new approaches are needed on a global scale if more companies are to be encouraged to invest in this area.

Where Next?

The MRC is asking people to align with both pharma and biotechs at this stage through a range of partnerships, such as sharing drugs, providing man hours and, most importantly, engaging at the earliest stages of research to share ideas. It aims to encourage initiatives and academic partnership to focus on alternative therapies and vaccination approaches, for example. “The link with the academic sector may offer new opportunities and new potential, and helps pharma focus on what is really positive,” continues Walsh.

Over the past 5 to 10 years, he says that pharma has already become significantly more engaged in the academic research environment, merging its happy blend of scientific rigour, project management expertise and technology with the blue sky thinking and understanding of basic research areas introduced by academia. “Maybe we can do more in the UK to encourage other companies to come back into antibiotics, by helping people with the anti-infectives pipeline, or by partnering with academic groups and other sectors such as IT, engineering or social media – all of which can contribute,” comments Walsh.

Scientific Hurdles

Pharma faces a number of challenges and requirements, not least the 'double jeopardy' presented by scientifically arduous practicalities – such as trying to kill one cell while maintaining others. “Working with scientists, plus the broader discipline of interested parties, will help us overcome some of these hurdles,” says Walsh.

In light of this, Walsh is sympathetic to arguments by pharma firms, stating they require better incentives, such as tax breaks or R&D credits, in order to create the new medicines required to tackle antibiotic resistance. “It is very expensive to make a drug,” he says. The big question then, he adds, is not only how to make great antibiotics, but also how to make them globally. Models of how to do this do exist – for example, via public partnerships such as the distribution of HIV drugs to sub-Saharan Africa through the US President’s Emergency Plan for AIDS Relief initiative.

Ultimately, says Walsh: “We have to be imaginative. Making a drug is hugely expensive. To de-risk this, we can identify stronger candidates and move forward; improve the business environment; and preserve the drugs we have already got through better usage, better diagnoses and better targeting.”


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