It’s time to revise the book on infectious diseases

By ReAct: Action on Antibiotic Resistance staff 

As the reader may know, many European Union countries are working individually and together in the battle against drugs resistance. There is new and valuable interest from several European governments in targeting resistance. Additionally, on a regional level, the European Center for Disease Prevention and Control (ECDC) promotes regional strategies to slow resistance emergence and transmission, such as the upcoming 2^nd annual European Antibiotic Awareness  day, on November 18, 2009. The European Medicines Agency (EMEA) contributes to controlling drug resistance, as it is responsible for regular evaluation and supervision of medicines for both human and veterinary use. For its part, the World Health Organization’s 3^rd Patient Safety Challenge, while a global, rather than regional, initiative also has antimicrobial drug resistance as its focus. In this process ReAct is an active contributor.

While all these efforts are encouraging and important, it is clear that much more effort to fuel the resistance battle is needed. Progress has been made in recent years, but is still piecemeal. Efforts are too often uncoordinated, targeting only specific diseases or only specific countries. Funding is too often narrow, project-specific and time-limited. Perhaps most importantly, strong resistance-specific leadership is lacking. Real leadership, at all levels - national, regional and global - is critical and is necessary now. 

It is welcome news therefore that the Swedish Government is using its current position as EU President to draw attention to the drug resistance problem through an expert conference entitled “Innovative Incentives for Effective Antibacterials” held on 17 September, 2009 in Stockholm which brought together a unique mix of representatives from science, health care and policy. The objective of this invitational conference was to explore ways of creating incentives for the development of new drugs, including changes in regulatory mechanisms and use of innovative financial instruments. 

As the audience of this e-newsletter knows all too well, the importance of antibiotics for improving health throughout the world since their introduction some 70 years ago cannot be overestimated.  For decades, bacterial development of resistance to antibiotics did not appear to be a major threat; indeed, the R&D pipeline of new antibacterials seemed more or less infinite.  It is said that, in the late 1960s, William H. Stewart, at the time US Surgeon General, suggested that it was “time to close the book on infectious diseases” and “declare the war against pestilence won”[1].  Apart from being overly optimistic, one must say that the timing for such an assertion was extremely unfortunate. Or did such attitudes in fact influence the decline in antibacterial R&D? Regardless, it was right about that time that the seemingly everlasting flow of new antibacterials came to an abrupt halt. Since then the emergence and spread of bacterial resistance to antibiotics has raged, but, with only two exceptions, no new antibiotic classes have been introduced. And unfortunately, the pipeline is drying up. The gap between the burden of antibiotic resistance and the need for effective treatment is thus intolerably wide.

The reasons behind this lack of new antibacterials are manifold, but to give a somewhat simplified picture: in addition to the scientific barriers there is also a lack of relative profitability in the antibiotics market.  The payoff for industry to make the investment into antibiotic development is simply not there and the market system we have come to rely on has failed in this regard. How might this (dis) incentive environment be re-configured?

At the September 17 Conference in Stockholm several ideas about how to best create incentives to encourage development of new drugs were shared. ReAct, Action on Antibiotic Resistance, was deeply involved in the entire process leading up to and during the Conference.  In 2007 ReAct initiated discussion with the European Medicines Agency (EMEA) and the European Centre for Disease Prevention and Control (ECDC) on the need to document the gap between the frequency of multidrug-resistant bacterial infections and the, practically non-existent, R&D pipeline of new antibiotics.  An EMEA-ECDC joint working group was established to conduct research that would allow determination of reasonable predictions of the extent of this gap in the coming years. ReAct played a substantial role in the development of the scientific methodology for the study and performed part of the actual pipeline analysis.

The result is the report “The Bacterial Challenge – Time to React”. Another report was also prepared by experts at the London School of Economics & Political Science for the September 17 Conference, namely “Policies and incentives for promoting innovation in antibiotic research”. The latter, which will be available online shortly, focuses on possible ways to encourage R&D in this much needed, but not very profitable field, and includes economic push - and pull mechanisms (and hybrids thereof) to reduce and/or share financial risks, alterations of legislation and regulations as well as different versions of private-public partnerships etc.

ReAct considers the efforts of the European Union and particularly the Swedish presidency a promising sign of commitment to fight antibiotic resistance and an example of the global leadership that is needed. We now hope this is the start of a process that can actually spur the development of new antibacterials that will benefit not only the EU and other wealthy countries, but also those where the burden of antibiotic resistance is greatest.