Brian Edwards CBE
Emeritus Professor of Healthcare Development
University of Sheffield
With only two new classes of antibiotic entering the market in the last 30 years, a very serious point of crisis is approaching, at least according to a group of distinguished experts at an EU conference in Birmingham in December 2005. All existing antibiotics have a growing resistance profile, which makes them clinically ineffective for an increasing number of patients. For a few patients, an active antibiotic is no longer available. The resistance problem has a number of dimensions, starting with widespread and indiscriminate use in primary care. Most physicians prescribe without a confirmatory test and are therefore guessing about the nature of their patient’s illness and the most appropriate clinical response. Most of the time their guess is correct, but, in a time of evidence-based clinical practice, something is wrong here. In some European countries, antibiotics can still be purchased by the public without a prescription. None of this is new. The European Commission made recommendations to health ministers four years ago [2002/77/EC] “on the prudent use of antimicrobial agents in human medicine focused on the importance of using antimicrobials prudently to contain the problems of antimicrobial resistance, primarily by containing the emergence of resistance in the first place”.(1) Not a lot has happened since, except for some low-key advice on surveillance, education, infection control policies and antibiotic stewardship.(2)
What has raised the profile of the problem is the growing number of hospital patients (one in 10) who pick up the infection whilst in hospital. This not only complicates and sometimes limits patient treatment options, but it also increases the length of hospital stay, thus impacting directly on costs. The European Commission estimates that there are three million healthcare-associated infections in the EU each year, and 50,000 attributable deaths.1 Highly resistant strains that are proving difficult to manage are also emerging in some hospitals. Interestingly, there are wide variations within Europe, with the highest rates of MRSA appearing in southern European countries, the UK and Ireland, and the lowest in Northern Europe, where aggressive “search and destroy” policies have been successfully adopted. Patients have become aware of the problem and, when a choice is available to them, they are electing not to be treated at hospitals with infection problems. In the UK, this is driving patients to select small private-sector providers who appear to have escaped the problems experienced by the large public hospitals with heavy emergency loads. Measures can be taken to slow down the buildup of resistance. The economic case for investing in infection control is strong. The Commission calculated that if infection control teams were effective in preventing only 7% of infections they would have paid for themselves.(1) Trouble is, most hospitals have little scope for new investment, no matter how strong the business case, until such time as the problem reaches crisis level. Success depends upon concerted investment by hospitals and their commissioners or health insurers.
Given the scale of this problem and the huge market for new classes of drugs, one wonders why no new compounds have emerged. Perhaps there are none to be found, but a more likely explanation lies in the economics of the pharmaceutical sector. According to the experts, this is really tough science and the economic case for a huge investment in research does not add up. Most antibiotics are now out of patent and so have entered the generic market where sales are high but prices are low. Some companies have trimmed back research investment in this area in order to focus on products with a better chance of economic return. It needs somebody to shift the economic incentives. A world without effective antibiotics and a hospital sector that is considered by its patients to be dangerous does not bear thinking about. If the industry cannot solve the problem then governments will have to intervene using the powerful economic and legal levers only they possess. Ideas worth debating are research subsidies, exemptions to the research regulatory environment, tax credits and extensions to patent life. All have their downsides, but none greater than doing nothing.(3) This is an issue that needs to capture the attention of the European Parliament.
- European Commission. Directorate C – public health and risk assessment. Public consultation on strategies for improving patient safety by prevention and control of health associated infections.
- CORDIS. Combating resistance to antibiotics and other drugs. Available from: http://www.cordis.lu/ lifescihealth/major/drugs.htm
- Tickell S. The Antibiotic Innovation Study: expert voices on a critical need.REACT; 2005.