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How to address the need for innovation and access for tuberculosis

How to address the need for innovation and access for tuberculosis. Tido von Schoen-Angerer, MD, MSc. TB and Médecins Sans Frontières. 32,068 TB patients in 80 countries (138 projects) in 2008 900 MDR patients in 18 projects in 2008 3360 children < 15 years. TB DIAGNOSIS AND TREATMENT.

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How to address the need for innovation and access for tuberculosis

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  1. How to address the need for innovation and access for tuberculosis Tido von Schoen-Angerer, MD, MSc

  2. TB and Médecins Sans Frontières • 32,068 TB patients in 80 countries (138 projects) in 2008 • 900 MDR patients in 18 projects in 2008 • 3360 children < 15 years

  3. TB DIAGNOSIS AND TREATMENT AN OLD REGIME AND A PREDICTABLE CRISIS • Streptomycine 1944 • PAS 1946 • Isoniazide 1952 • Cycloserine 1952 • Pyrazinamide 1952 • Ethionamide 1956 • Kanamycine 1957 • Ethambutol 1961 • Quinolones 1963 • Rifampicine 1966

  4. Multi and extensively drug resistant TB • 440,000 new cases a year, 150,000 deaths • Highest proportion of MDR TB: North Western Russia 24-28% of all new TB cases • China and India account for 50% of all cases • Treatment possible but 18-24 months long, complex, severe side effects, drug cost 50-200 times higher than for drug sensitive TB • Cost: €11 billion over next six years, funding needs to increase 16 times Source: WHO M/XDR-TB 2010 Global Report

  5. 1,6000,000 30,000 MDR-TB Treatment scale up- only 1% receive treatment in GLC programmesGap between requests to WHO Green Light Committee and revised Global Plan, 2006-2015 1,800 1,582 Response Plan Thousands 1,600 1,389 1,400 GLC 1,187 1,200 979 1,000 766 800 548 600 400 328 176 200 66 30 25 10 12 3 7 1 2 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Adapted from D.Weil, WHO

  6. New TB drugs – how close are we? • Pipeline still weak: number of compounds in the pipeline needs to double or triple • A completely new regimen will take time: Likelihood to introduce a novel TB regimen with at least 2 new drugs by 2015 is < 1% (Glickman et al., Science 2006) • Improvement of MDR treatment therefore most be immediate objective • 2 new drugs in phase IIb trials in MDR-TB (Tibotec/J&J, Otsuka) • Need accelerated approval mechanism, then additional trials to determine best new MDR-TB regimen

  7. TB Diagnostics Smear microscopy the frontline TB test detects 40-60% of cases, even less in HIV infected and children. Requires at least 2 expectorated sputum

  8. TB Liquid Culture now being implemented BD BACTEC MGIT 960 Mycobacterial Detection System

  9. From Expert Meeting on Defining Test Specifications for a TB point-of-care test, Paris, March 17 –18, 2009 Diagnostics: the TB test we need ! (and feasible in 5 – 10 years) • Point-of-care: easy to perform in peripheral health centres • Detect active TB in adults regardless of HIV status • Improved diagnosis of TB in children • Result that allow decision on treatment initiation • Patient can receive result on the same day • DST (preferable but not minimum requirement)

  10. Tropical diseases: 15 Tuberculosis: 4 Innovation – fatal imbalance • 1,556 new chemical entities were marketed globally between 1975 and 2004. • Only 20 of these (1.3%) were for tropical diseases and tuberculosis, which account for 12 per cent of the total disease burden Torreele, Chirac Lancet, 2005

  11. R&D funding gap - TB Treatment Action Group 2008

  12. TB R&D funding contributions – according to fair share • EC (2007): € 35.8 M for all neglected diseases; €18.7 M for TB – fair share would be € 101 M/yr MSF 2008, 2009

  13. Innovation prizes – rewards that can stimulate innovation and ensure access • Large financial reward at the end – paying for success • Principle of crowdsourcing • Successfully used in many technology fields • In return for prize reward: sell at low price and allow competition from day one • Needed: a prize fund for a TB point-of-care test

  14. Not just money but right policies:WHO Global Strategy and Plan of Action on Public Health, Innovation & Intellectual Property • Among others: • WHO to explore innovative ways for stimulating R&D, such as Prize fund, and that do not cause high prices • Explore utility of an essential health and biomedical R&D treaty as a mechanism for sustainable financing of essential R&D • Report of WHO Expert Working Group on R&D Financing for World Health Assembly 2010

  15. Recommendations to the EC • Put TB high on the political agenda! • Boost contribution to TB and other neglected disease R&D • € 100 million for TB per year • Mid-term review of FP7 • Include TB and neglected diseases within IMI, ERC • Invest in alternative mechanism for R&D • Invest in a prize fund for a point-of-care TB test • Implement WHO Global Strategy and Plan of Action

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