2 June 2015

Innovation and risk taking are the key to tackling antibiotic resistance


Antibiotic-resistant bacteria is one of the greatest threats to human health. If there are no effective antibiotics in health care, humanity will be thrown back to the time when urinary tract infections and pneumonia were dangerous diseases and common operations would be risky to perform. In Europe alone antibiotic resistant bacteria are estimated to kill about 25,000 people, compared with 48,000 who die each year in traffic accidents.

The forthcoming World Health Assembly of the WHO will discuss the development of a global strategy to combat antibiotic resistance. This debate must highlight the individual’s freedom of choice and the right of doctors to prescribe, as they drive innovation, the only true way to defeat the superbugs.

It has been said that doctors lack sufficient knowledge of the wider situation to be able to prescribe antibiotics without restriction. But they are the ones who have the knowledge of individual cases and who make a diagnosis and ultimately decide whether antibiotics are appropriate.

Unclean hospital environments have been identified as vectors. Improvements involve complex new procedures for doctors and nurses. Overall, the best policy is simply to keep patients out of the hospital environment as much as possible. Innovations in digital health will lead to better care at home without the risk of infection.

It is equally difficult to monitor antibiotics in a complex food production chain. A clear connection between antibiotic use in animals and resistance in humans has not been proven in practice, although there are good theoretical reasons to assume that this may be a problem. Despite a reduced use of antibiotics in agriculture resistance has not diminished.

Antibiotic resistance is a simple consequence of their existence and of the evolutionary process. Evolution gradually kills off the bacteria unable to withstand antibiotics, those that survive adapt and reproduce.

Jim O’Neill, former chief economist at Goldman Sachs and appointed by PM David Cameron to find solutions for the “market failure”, puts the blame on “Big Pharma” in for not contributing to global efforts.

In fact, Mr. O’Neill misses that in this area it is the inefficient pharmaceutical market that blocks new antibiotics and smart innovations. Only one of ten substances tested becomes a drug. Of the antibiotics currently on the market 75 per cent were developed before the 1970s. Today it takes eight years before a drug is approved. Europe is characterized by overloaded and outdated healthcare systems where antibiotic resistance is only one of many symptoms of their decline.

In yet further government-led approaches to this problem, it has been said that the EU must create conditions for the development of new medicines. The European Commission has been giving grants to the pharmaceutical companies trade association EFPIA to conduct research on antibiotics. However, success in drug development is seldom achieved without large-scale risk-taking by companies with an incentive to succeed, and ploughing large amounts of subsidies into Big Pharma is even less effective.

Government-led approaches to this problem have not succeeded and it is pointless trying more of the same. We need to encourage innovation by allowing more risk-taking through reducing regulation.

Would Alexander Fleming’s haphazard discovery of the penicillium fungus have been approved today by the FDA and EMA? Probably not. It takes about 10-15 years to develop a new medicine from the time it is discovered to when it is available for treating patients. The average cost to develop each successful drug is estimated to at least $4 billion. This includes the cost of the thousands of failures.

We need better diagnostic methods, a smoother drug approval system focusing on benefits rather than mere precaution, and we need to facilitate the shift from drug centered care to therapies. This will require a more open market for both drugs and medical care. Rather than regulations and subsidies we need to make better use of data-intensive health care, and offer the capability to analyze observational data of actual drug treatment outcomes and patient health information through the use of Big Data.

Developing new antibiotics is particularly difficult commercially as new varieties are limited to the most serious cases so that bacteria do not develop resistance to the new drugs. Researchers investigate which genes encoding a bacterium DNA to be antibiotics. Companies like IBM explore how nanotechnology can target the bacteria. Bacterial therapy with feces could prove to be a good alternative to antibiotics for some infections. Regulation must open up to radical new solutions.

Antibiotic resistant bacteria highlight the problems of the present’s centralized public health policies. There is no single solution to such a complex problem of antibiotic resistance. When we open the field to more solutions, and use the people’s creativity, we will not put all our eggs in one basket.

Waldemar Ingdahl is a science and technology journalist living in Stockholm, Sweden. He is currently writing a policy study on antibiotic resistance.