Tackling the threat of antibiotic resistance
Picture a world where people routinely die from minor infections, where invasive surgery like organ transplants can’t be performed because it’s too risky, and where hospital wards are breeding grounds for disease.
With an alarming growth of antibacterial resistance and few new antibiotics in development, this almost unthinkable scenario is becoming increasingly likely. And it is happening only 70 years since the introduction of antibiotics.
There are many causes of this scenario. One is the ability of bacteria to evolve and mutate, developing and sharing with other organisms a resistance to antibiotics. The widespread global use of antibiotics has helped to accelerate growth of resistance.
Today, the world is seeing isolated infections of multi-resistant bacteria that are untreatable with current drugs. It is estimated that each year about 25,000 people in the European Union die as a result of infections cause by multi-drug resistant bacteria.1
The challenges of developing new medicines
Despite this critical need for new options, the current antibiotic pipeline is not healthy. Many companies are leaving this important area because of the challenges in seeking out new antibiotics, a complicated regulatory environment, and the limited opportunities for financial reward.
There are enormous scientific difficulties in finding new compounds to target bacteria. For example Gram-negative bacteria - such as Pseudomonas, Klebsiella and Acinetobacter species - are common causes of hospital-acquired infections like pneumonia and septic shock. These bugs have an additional protective layer that inhibits a medicine from crossing the cell wall and getting into the cell where it has an effect. This added challenge has to be overcome in order to find new drug classes for these difficult to treat infections.
From a business perspective, there are also financial challenges for healthcare companies. New antibiotics created today will be kept in reserve and used as infrequently as possible, so that they can be used to fight infections that have failed to respond to other antibiotics. Also, patients generally only need a two-week course to treat bacterial infections.
These two factors make antibiotics less financially rewarding than longer-term treatments, meaning a smaller return on investment in research and development. As a result, research has diminished over the past 15 years and few pharmaceutical companies remain active in this area.
Despite the challenging scientific, regulatory and commercial environment, we are committed to delivering new antibacterials to help address the growing threat of antibacterial resistance.
This commitment includes:
- A dedicated R&D team focused on antibacterials for serious and life‐threatening infections
- Activities that support the appropriate use of antibacterials, aiming to reduce resistance by ensuring that the right medicine is prescribed at the right dose, for the right duration (antibacterial stewardship)
- Ongoing efforts to engage with scientific and medical communities and share the experience we gain in our R&D work, to contribute to the progress of medical science
- Recognising that high levels of antibacterial use in farming has the potential to cause resistance, we commit not to license our new antibacterials for agricultural use
A pioneering approach
There is a growing recognition that new approaches to stimulate research and reward innovation are going to be needed if antibacterial R&D is to be stimulated and the resulting medicines conserved.
To this end, governments, public health bodies, industry and academia are increasingly working together to ensure future generations are not faced with untreatable infections.
In 2012 we became part of a pioneering approach to antibiotic research in Europe that sees pharmaceutical and biotechnology companies working alongside public partners to address some of the key barriers to the development of effective antibiotics. This research programme includes a range of measures, including improving our underlying scientific understanding of antibiotic resistance, designing and implementing efficient clinical trials, and taking novel drug candidates through clinical development.
In 2013, we entered into a first-of-its-kind collaboration in the USA with the Biomedical Advanced Research and Development Authority. The collaboration will support the development of several antibiotics to fight antibiotic resistance and bioterrorism. It will provide flexibility to move funding around our antibacterial portfolio - rather than focus on just one drug candidate - and allow medicines to be studied for the potential treatment of both conventional and biothreat pathogens.
Commenting on the challenge facing the industry, Patrick Vallance, GSK President, Pharmaceuticals R&D said: "This is a challenging research area, and there are unique characteristics for this market, which do not always provide the financial incentives for ongoing research.
"In the long term if society wishes to encourage sustainable investment and appropriate use of new antibiotics, alternative approaches to reward successful innovation need to be considered by all stakeholders."
Our public policy statement, Incentivising antibiotic research, examines some of these options and the challenge of de-coupling medicine use and financial reward.
For more information on GSK's product pipeline and clinical studies, visit these resources:
1. European Centre for Disease Control and Prevention/European Medicines Agency Joint Working Group. The bacterial challenge: time to react. 2009.
2. Roberts RR, Hota B, Ahmad I, et al. Hospital and societal costs of antimicrobial‐resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship. Clin Infect Dis 2009; 49:1175–84