Launch of Policy Cures: Improving Access to Diagnostics in the Developing World - Professor Rosanna Peeling


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Launch of Policy Cures: Improving Access to Diagnostics in the Developing World - Professor Rosanna Peeling

  1. 1. Improving Access <br />To Diagnostics in the Developing World <br />Rosanna Peeling<br />Professor and Chair, Diagnostics Research <br />London School of Hygiene & Tropical Medicine<br />
  2. 2. Improving Access To Diagnostics in the Developing World <br />Global landscape of diagnostics<br />Improving access to diagnostic innovation<br />Fast-tracking the translation of evidence to policy<br />
  3. 3. Diagnostics Landscape in the Developing World <br />Lack of investment in diagnostics R&D <br /><ul><li>Little industry interest in diagnostics R&D on diseases prevalent in the developing world, due to a perceived lack of return for investment </li></ul>Lack of Access to diagnostic services <br />- lack of investment in diagnostic laboratories <br /> - laboratories suffer from frequent stock-outs and critical shortage of staff<br />Lack of regulatory transparency<br />-Regulatory approval processes are lengthy and not quality based:<br /> Tests are sold and used without evidence of effectiveness<br />Lack of quality standards for test evaluations<br />- Claimed accuracy on product inserts often misleading<br /> - Control programmes often misled into buying low quality products<br />
  4. 4. Diagnostics are Under-valued<br />In the US, while diagnostics comprise<br /> - less than 5% of hospital costs<br /> - about 1.6% of all Medicare costs,<br /> their findings influence as much as <br /> 60-70% of health care decision-making<br />The Value of Diagnostics, Lewin Report, 2005 <br />
  5. 5. Inequity of Access to Diagnostics<br />The 2004 Health Development Report cited the lack of access and unaffordability as two major reasons why services fail<br />Distance to Nearest Medical Facility for the Poorest 5th of the population: <br />Country Distance (km)<br />Benin 7.5 <br />Bolivia 11.8 <br />Chad 22.9 <br />Haiti 8.0 <br />Madagascar 15.5 <br />Niger 26.9 <br />Tanzania 4.7 <br />Uganda 4.7 <br />Zimbabwe 8.6<br />Selected from the 2004 World Health Report, p.22<br /><ul><li>Patients often self-medicated or </li></ul>purchase drugs from vendors<br /><ul><li> May purchase or be given wrong </li></ul>drugs <br /><ul><li> Drugs are often sub-standard
  6. 6. Clinics may not have drugs or diagnostics </li></li></ul><li>Lack of Regulatory Oversight for Diagnostics<br />TDR survey 2002<br />
  7. 7. How Good are Dengue Rapid Tests?<br />WHO Evaluation (%)<br />SensSpec<br /> 23 99<br /> 18 98<br /> 63 69<br /> 9 100<br /> 65 98<br /> 22 99<br /> 6 99<br />Test Claimed Accuracy (%)<br />Sens Spec<br />Test 1 100 100<br />Test 2 NS NS<br />Test 3 80 >99<br />Test 4 NS NS<br />Test 5 70 100<br />Test 6 93 100<br />Test 7 100 100<br />NS = not stated<br />Blacksell et al. Clin Infect Dis 2006;42:1127<br />
  8. 8. Product Development and Adoption Pathway for Diagnostics <br />Regulatory Approval<br />Diagnostic Targets<br />Proof of <br />Principle<br />Product <br />Prototype<br />Lab & field evaluations<br />Test adoption <br />Policy<br />&<br />Guidelines<br />Product<br />Specifications<br />Technology platform<br />Shared Resources<br />Shared Risks<br />Shared Rewards<br />
  9. 9. Lab on a Chip Platform: <br />Integrated specimen <br />processing, amplification,<br />and detection of MTB and <br />Rif resistance in sputum<br />In < 2 hrs<br />In 1,730 patients with suspected drug-sensitive or multi drug-resistant pulmonary TB at centers in Peru, Azerbaijan, South Africa, and India, Xpert detected 98% of smear +, 90% of smear – ; 98% of RIF resist. <br />and 98% of RIF sens. TB. <br />Boehme et al NJEM Sept 6 2010<br />
  10. 10. How many TB patients will die while we wait for this new technology to be affordable and available?<br /><ul><li>1.7 billion infected worldwide
  11. 11. 9.27 million new cases in 2007
  12. 12. 1.9 million deaths a year
  13. 13. Up to 50 million are infected with drug-resistant forms of M. tuberculosis (MDR-TB)</li></li></ul><li>Technology Transfer and Local Production<br />Promises: increase access and affordable pricing<br />Challenges: <br />Local production capacity<br />TTLP is more attractive to companies if the recipient country has a large domestic market<br />How will smaller countries that contributed to the research benefit from novel technologies? <br />
  14. 14. Fast-tracking the translation of evidence to policy<br />