26 Feb 2014 Posted in Opinion By Dr Louise Leong
The fact is, we need to develop new antibiotics to tackle the increase in resistance to antibiotics, and I welcomed the opportunity to address the select committee to highlight the extent of the issue and to outline what now needs to be done to ensure we can strengthen and diversify our armoury against the bugs.
Resistance is no longer a problem confined to hospitals or nursing homes. It’s all around us in response to common infections such as skin infections and gonorrhoea. In many instances, doctors are being forced to fall back on older, more toxic, antibiotics to cure some infections. There is a danger in the future that certain bacteria could resist all available antibiotics. This could result in the surgery/treatment we now take for granted becoming riskier - such as implants, transplants and chemotherapy, which rely upon preventive use of antibiotics to protect against the danger of infection.
I welcome the Government’s strategy and the leadership that the Chief Medical Officer has shown in raising awareness of the issues internationally and building the momentum to tackle the challenges. I am pleased to see that the development of new antibiotics and other novel therapies is a central theme in the Government’s strategy. It also recognises the importance of rapid, point-of-care diagnostics, which would allow doctors to find out exactly which infection needs treating and to match the best antibiotic against it.
There are also encouraging signs that regulatory agencies, such as the European Medicines Agency, the US Food and Drug Administration, as well as the UK medicines agency (MHRA), are moving to enable accelerated clinical development and registration of antibiotics for multidrug resistant bugs, without compromising safety. These regional agencies should also continue to harmonise regulatory requirements to avoid duplication of studies.
The ‘Innovative Medicines Initiative’ (IMI), co-funded by the European pharmaceutical industry and the European Commission, is also helping to turn the tide in research with over £350 million for the ‘New Drugs for Bad Bugs’ programme, and address the bottlenecks in the discovery and development.
Despite these efforts, there remains a key challenge for Government and industry. The reality is that antibiotics are undervalued. Most existing antibiotics have been around for a long time and have become cheap and routine. In most cases they still do their job effectively; but we need the new antibiotics to treat resistant strains.
Good antibiotic stewardship means not using antibiotics widely and unnecessarily, to reduce chances of bugs developing resistance. The quirk of the antibiotics market is that we want to be able to make new antibiotics available to store in the clinician’s medicine cabinet until the day they are needed, but we do not know when they will be needed, where they’ll be needed, or how much they’ll be needed.
While pharmaceutical companies continue to invest millions of pounds in anti-infection therapies, there are particular commercial challenges related to these uncertainties that need to be addressed urgently and speedily in order to incentivise much more research and development in this area. Confronted with the high costs and long lead times of developing new medicines, industry and governments need to work in partnership to overcome the obstacles. Innovative economic incentives need to be developed to decouple return on investment from usage. This way we can restock the clinician’s cabinet so that antibiotics are not confined to the history books.