Transcript Document

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
AN OLD REGIME AND A PREDICTABLE CRISIS
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•Streptomycine 1944
•PAS
1946
•Isoniazide
1952
•Cycloserine
1952
•Pyrazinamide 1952
•Ethionamide 1956
•Kanamycine 1957
•Ethambutol 1961
•Quinolones
1963
•Rifampicine 1966
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
MDR-TB Treatment scale up- only 1% receive treatment in GLC programmes
Gap between requests to WHO Green Light Committee and revised Global Plan, 2006-2015
Thousands
1,800
1,6000,000
1,582
Response Plan
1,600
1,389
1,400
GLC
1,187
1,200
979
1,000
30,000
766
800
548
600
400
328
176
200
1
2
3
7
10
12
25
66
30
0
Adapted from D.Weil, WHO
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
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
TB Liquid Culture now being implemented
BD BACTEC MGIT 960 Mycobacterial Detection System
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)
From Expert Meeting on Defining Test Specifications for a TB point-ofcare test, Paris, March 17 –18, 2009
Innovation – fatal imbalance
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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
Tropical diseases: 15
Tuberculosis: 4
Torreele, Chirac Lancet, 2005
R&D funding gap - TB
Treatment Action Group 2008
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
Innovation prizes – rewards that can
stimulate innovation and ensure access
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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-ofcare test
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
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