The Case for Why the EC Needs to Fund Small Molecule TB Drug Discovery

My previous post may have been too refined..so let me revert to a drier scientific style. In the last few weeks Iain Old, Giovanna Riccardi, myself and several others from the MM4TB project have been lobbying MEPs and basically anyone who will listen to try to raise awareness of the lack of funding for TB drug discovering in the Horizon 2020 project. We have summarized the dire situation in the following which we have shared by email.
Tuberculosis (TB) is a truly ‘global health crisis’ and a persistent threat in high income countries [1], affecting more than two billion people around the world [2, 3]. On an annual basis, nearly 9 million people are infected, with 1.5 million of them dying. In 2013, The UK, a country with a population of over 60 million had over 7800 tuberculosis cases. Although effective TB drugs have existed for over 50 years, multidrug resistant (MDR) strains have spread across the globe (including Europe [4, 5]) which hinders treatment and increases costs [2, 6-11]. Each year, at least half a million new MDR TB cases occur. Although incidence, prevalence and mortality rates are falling in African, Eastern Mediterranean and European regions it is not fast enough to meet the 2015 global targets of the Millenium Development Goals. At least $8bn is required to deal with this epidemic and that excludes the estimated $2bn that is needed for drug and diagnostic discovery. There are currently 15 vaccines in clinical trials [3]. TB vaccines are widely used in Europe and elsewhere and seem to offer some protection from the disease but have proved a dismal failure in developing countries, like India and in Africa, where the disease is endemic.  In contrast there are only 10 drugs for TB in clinical development [3] which is inadequate to address drug resistance to existing drugs. Trials of drug combinations have so far proved inferior to the current 6 month standard of care [3]. Therefore it is widely supported that there needs to be more early stage drug discovery to feed the clinical pipeline to address this disease [1, 3]. While there is extensive work on new vaccine approaches being undertaken; some supported by the EU, it seems likely that it will take two generations to reach widespread success, if indeed this can ever be achieved. Thus, there will be a continuing need for drugs to treat TB and particularly ones that are effective against currently virulent strains and mutations of these, particularly those that are already multi-drug resistant.
In the past the European Commission has funded TB research in FP7, with over €100 million (€16.3 million euros in major vaccine projects (NEWTBVAC), €20.2 million in drugs (MM4TB and ORCHID), €6.3 million on diagnostics and €19 million on epidemiology (TB PAN-NET)) [13]. We are concerned with the lack of funding from the European Commission for TB drug discovery in Horizon2020. For example In the EC’s own press release for World TB Day 2015 they made no mention of Tuberculosis drug development in Horizon2020 [12] and the only two projects funded (€26.2 million) concern vaccines (EMI-TB and TBVAC2020). While there is some work on TB being done in IMI, the lack of big pharma interest in Tuberculosis drug development means that IMI is unsuited for Tuberculosis drug development projects. If we are to retain the talented international research teams working to find drugs for TB which could help fight the rapidly advancing drug resistance, we must fund them in Horizon2020 rather than putting all EC money on vaccines and hoping it will pay off one day.
1.         Lonnroth, K., et al., Towards tuberculosis elimination: an action framework for low-incidence countries. Eur Respir J, 2015. 45(4): p. 928-52.
2.         WHO, Global Tuberculosis Report. 2013, World Health Organization: Geneva.
3.         WHO. Global Tuberculosis Report 2014. 2014; Available from: http://apps.who.int/iris/bitstream/10665/137094/1/9789241564809_eng.pdf?ua=1.
4.         Jakab, Z., et al., Consolidated Action Plan to Prevent and Combat Multidrug- and Extensively Drug-resistant Tuberculosis in the WHO European Region 2011-2015: Cost-effectiveness analysis. Tuberculosis (Edinb), 2015.
5.         Zignol, M., et al., Drug-resistant tuberculosis in the WHO European Region: an analysis of surveillance data.Drug Resist Updat, 2013. 16(6): p. 108-15.
6.         Velayati, A.A., P. Farnia, and M.R. Masjedi, The totally drug resistant tuberculosos (TDR-TB). Int J Clin Exp Med, 2013. 6(4): p. 307-309.
7.         Abubakar, I., et al., Drug-resistant tuberculosis: time for visionary political leadership. The Lancet Infectious Diseases, 2013. 13(6): p. 529-539.
8.         Dheda, K. and G.B. Migliori, The global rise of extensively drug-resistant tuberculosis: is the time to bring back sanatoria now overdue? The Lancet, 2012. 379(9817): p. 773-775.
9.         Gothi, D. and J.M. Joshi, Resistant TB: Newer Drugs and Community Approach. Recent Pat Antiinfect Drug Discov, 2011. 6(1): p. 27-37.
10.       Udwadia, Z.F., et al., Totally Drug-Resistant Tuberculosis in India. Clinical Infectious Diseases, 2012. 54(4): p. 579-581.
11.       Velayati, A.A., et al., Emergence of new forms of totally drug-resistant tuberculosis bacilli: Super extensively drug-resistant tuberculosis or totally drug-resistant strains in iran. CHEST Journal, 2009. 136(2): p. 420-425.
13.       Commission, E. World Tuberculosis Day 2015: EU Research to Fight Tuberculosis. 2015; Available from: http://ec.europa.eu/research/index.cfm?pg=world-tuberculosis-day-2015.

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