EU body may provide ‘solution’ to antibiotics resistance threat, says UK medical chief

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The Chief Medical Officer (CMO) for England, Professor Dame Sally Davies, has pointed to the danger of bacteria's growing resistance to antibiotics, saying an EU funded medical initiative may be the solution to the problem.

Davies issued this week the stark warning on against antibiotic resistant bacteria, saying it should be ranked along with terrorism on a list of national threats.

Speaking to the Guardian newspaper, Davies said that routine infections could become deadly in just 20 years if we lose the ability to fight them with antibiotics. This, she warned, would pose "a catastrophic threat" to the population.

Davies urged the British government to raise the issue during next month's G8 Summit in London, describing it as a "ticking bomb."

"If we don't take action, then we may all be back in an almost 19th century environment where infections kill us as a result of routine operations. We won't be able to do a lot of our cancer treatments or organ transplants," she said.

Davies added that governments needed to encourage pharmaceutical companies to develop new drugs, since they do not view the manufacture of antibiotics as profitable.

According to Davies, the problem is that patients only need antibiotics for a week or two at a time before resistance starts to develop, whereas they use medicines to treat high blood pressure or diabetes every day, making antibiotics less profitable and therefore uninteresting for pharmaceutical companies to develop.

EU-funded initiative an 'ideal platform'

To overcome the "market failure", Davies has pointed to the Innovative Medicines Initiative (IMI), an EU-funded body whose aim is to promote the development of new medicines.

The initiative is worth over €2 billion split between the industry and the European Commission, with an envelope available for antimicrobial resistance (AMR) between €200 and €400 million. A programme on AMR called New Drugs for Bad Bugs (ND4BB) has been launched.

Michel Goldman, executive director at IMI, told EURACTIV that to address the issues the entire antibiotic research community must work together to reinvigorate research into new antibiotics. As a private-public initiative, IMI is the ideal platform, he said.

Goldman highlighted the €194.6 million "Combacte" project which he hopes will result in a new model for clinical research and the development of antibiotics.

This project will see academic investigators work together with industry scientists to combine knowledge and expertise, thereby increasing the probability of developing effective new medicines and addressing the public health threat of antimicrobial resistance.

A key outcome of the project will be a pan-European clinical trial network capable of recruiting patients and of conducting efficient, high quality multinational trials at all stages of development.

Another project called "Translocation", worth €29.3 million, will focus its efforts on identifying new ways of getting antibiotics into bacteria and preventing bacteria from expelling the drugs before they can take effect.

Right timing

Goldman said that a number of scientific and regulatory hurdles hamper efforts to develop novel antibiotics in a way that cannot be tackled by any individual organisation alone.

He said there was urgent need for a greater understanding of how the science of how antibiotics work, how bacteria develop resistance to them, and what molecular mechanisms could be exploited to get round bacterial defence mechanisms.

Running clinical trials on new antibiotics is also problematic due to regulatory requirements and the large pool of patients required to ensure the effectiveness of the new antibiotic to compared to other antibacterial drugs.

"These issues mean that the costs of carrying out a clinical trial on a new antibiotic are extremely high. At the same time, because some antibiotics will only be used on a very small number of patients, the costs of development often exceed the potential return on investment," IMI's executive director said.

"In other words, antibiotic development is simply no longer a financially viable option for pharmaceutical companies, and just a handful of pharmaceutical companies remain in the field," he added.

Goldman agreed with Davies in her timing as only two new classes of antibiotics have been brought to the market in the last three decades.

"In terms of timing, the situation is critical," Goldman said. "If no action is taken, we risk leaving society in a situation where doctors will have few, if any, options to treat ability to fight infection."

Positions

The European Federation of Pharmaceutical Industries and Associations (EFPIA) agreed that antimicrobial resistance (AMR) is now a major global public health threat. The industry is looking into the problem through a partnership with the Commission on the Innovative Medicines Initiative:

"We believe that the Public Private Partnership model is one of the best ways to deal with this upcoming health threat as it brings together the best of both worlds bringing the best outcomes for all European citizens," EFPIA told EURACTIV.

Background

Antimicrobial agents – such as antibiotics – have dramatically reduced the number of deaths from infectious diseases during the 70 years since their introduction.

However, through overuse and misuse of these agents, many micro-organisms have become resistant to them.

Antimicrobial resistance (AMR) is a global threat. It happens when organisms are able to survive medicines aimed to destroy them.

Bacteria can become resistant to antibiotics, viruses to antivirals and parasites to drugs like antimalarials.

The World Health Organization (WHO) says 150,000 deaths a year are caused by multi-drug resistant tuberculosis.

The European Centre for Disease Prevention and Control estimates that AMR results each year in 25,000 deaths in Europe and related costs of over €1.5 billion in healthcare expenses and productivity losses.

The situation is all the more serious because antimicrobials have become an essential tool for modern medicine. Many surgical operations could not be performed without them.

Further Reading

European Commission

Organisations

  • European Federation of Pharmaceutical Industries and Associations (EFPIA): Website

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