R&D hurdles
Raising awareness of antibiotic resistance is aimed at preserving the effectiveness of the currently available agents, but
there is an urgent need to develop a new generation of antibiotics for the future. While some of the major pharmaceutical
companies, such as Pfizer, GlaxoSmithKline and Merck, have maintained some interest in antibiotic R&D, most innovative research
in this field is now being carried out by smaller companies.9
During the mid- to late-1990s, many large pharmaceutical companies reduced or abandoned antibiotic R&D programmes because
the market was considered too crowded and financially unrewarding.9 The experience of Lilly, who developed daptomycin, convinced some companies that their efforts would be better spent in
other areas.9 Daptomycin proved to have antibacterial activity, but was not considered particularly potent compared with existing agents
on the market. In addition, it was found to have a narrow therapeutic window. During trials to examine higher doses, some
volunteers developed muscle damage. Since Lilly already marketed vancomycin, an immensely popular broad-spectrum antibiotic,
there was limited interest in funding another risky antibiotic R&D project. Even if successful, a new antibiotic might have
ended up eroding the market for vancomycin.9 As a result of commercial nervousness, Lilly shifted its emphasis to other therapeutic areas considered more financially
secure.
At the end of 2009, the Swedish government commissioned a study by the European Observatory on Health Systems and Policies
to look at ways to provide new R&D incentives to pharmaceutical companies to carry out antibiotic research.3 As well as confirming that antibiotic R&D was considered a financially unattractive field for companies, it revealed underlying
problems that would hamper any attempts to set up new research programmes.
According to the study, apart from commercial factors, antibiotic research in the pharmaceutical industry began to tail off
partly due to a feeling that bacterial infectious diseases had been "conquered." As a result, many scientists chose to pursue
research in other areas, believing them to be medically under-served. Over time, this shift in emphasis left a lack of industry
personnel with the scientific experience to maintain the focus on antibiotic research.3 A number of well-funded training programmes have been initiated to give European scientists the necessary training to pursue
antibiotic research, but trainees will still lack hands-on experience in dealing with infectious bacterial diseases. The European
Observatory on Health Systems and Policies report concluded that as well as recruiting new scientists, efforts must be made
to leverage the experience of older scientists. This may even necessitate asking retired scientists to mentor the next generation
of antibiotic researchers. Only then will the pharmaceutical industry have the necessary pool of scientific talent to draw
upon for new antibiotic R&D projects.
The report authors supported the idea that tax incentives could stimulate new industry antibiotic research.3 They recommended incentives to be focused on the earlier stages of R&D, as they felt that any measures linked to marketing
or sales would weaken efforts to preserve current antibiotics on the market. As an example, it cited the policy approach of
the French government in 2008, which was designed to make the country a more attractive environment for pharmaceutical R&D.
The French Finance Act featured a reduced rate of corporation tax, but also provided preferential tax measures for various
activities involved in the R&D process. For example, outsourced activities, expenses related to compliance with regulatory
standards and social costs for employees with the necessary R&D expertise all had the potential to qualify for tax relief.
The author says
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The study also identified a lack of information over how much new antibiotic research programmes might cost, which therefore
complicates efforts to develop government policies for financial incentives. Generally, clinical trials for antibiotics are
considered less complex than in other therapeutic areas, as the therapeutic endpoint is clear i.e., patient recovery from
infection.3 This would suggest that R&D costs for antibiotic trials are less than say, for example, an oncology programme. Future trials,
however, might involve additional costs as they might need to include a significant number of subjects with resistant pathogens.3 Since industry critics believe that pharmaceutical companies already generate excessive profits, financial incentives to
kickstart antibiotic research might be publicised in the media as being unnecessary. However, the conclusions regarding the
financing of antibiotic R&D programmes are based on historical data.
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