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Treating MDR-TB A Challenge Throughout ECA Public Health Practice II

Treating MDR-TB A Challenge Throughout ECA Public Health Practice II. The Historical Setting. Why is there growing DRUG RESISTANCE in TB… - Long treatment course - Drug side effects - Inappropriate drug use and poor surveillance

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Treating MDR-TB A Challenge Throughout ECA Public Health Practice II

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  1. Treating MDR-TBA Challenge Throughout ECA Public Health Practice II

  2. The Historical Setting • Why is there growing DRUG RESISTANCE in TB… - Long treatment course - Drug side effects - Inappropriate drug use and poor surveillance • POOR COMPLIANCE or BAD DOTS vs. - Poor quality drugs - HIV - War  economic, social and political strife - Poverty

  3. The Historical Setting (cont.) • One Side… • MDR-TB is too expensive to treat in poor countries and it distracts attention and resources from drug susceptible cases • DOTS alone will stop outbreaks • MDR is not as contagious or virulent as drug susceptible TB • Treatment is expensive and lab work difficult

  4. Historical Setting (cont.) • The Other Side… • There is a moral imperative to provide care to individual patients • It is essential to control MDR-TB for fear of its growth • DOTS can amplify resistance • If we have the technology (ie Second-line drugs) we should treat the sick patients

  5. The Vicious Cycle No international consensus on how to treat MDR-TB Primary reason to not start projects Allows high drug prices

  6. Working Group for DOTS-PLUS • Need to generate political will • Need to show manufactuers there is high demand - …So they can still profit? • Need lower prices • Need to avoid making the drugs too widely available - Concern for black market that would breed resistance

  7. Strategy One:Perform a Market Analysis • Who are the manufacturers? • - Monopoly w/ EXPENSIVE patents - Monopoly wo/patents - Multiple • Prioritize most expensive drugs • Check for Quality Assurance

  8. Strategy Two:Unified Approach to Big Pharma • Create single negotiating body • Medecins Sans Frontieres represented ALL buyers for the initial 2000 patients • Plans for the International Dispensary Association to continue

  9. Strategy Three:Establish A Market • Problem = Lack of Competition • Added to Essential Drugs List - Facilitates in-country registration - Under “reserve anti-infective agents” • Stimulate excitement in the generic drug industry • Two Markets: (1) Countries with programs and $$$ (2) Estimated # of global cases (growing!)

  10. Strategy Four:Negotiation • The “Tiered-Tender” System - Biggest contract to manufacturer with lowest price and highest quality - Then smaller proportions to select companies • Long term outcome goals: - Low prices - High quality - More competition

  11. Range of decrease in prices is 38.3% to 98.45%

  12. Strategy Five:Advantages to Suppliers • Ex 1: Monopoly with small second-line TB sales - Humanitarian commitment • Ex 2: Generic drug maker - Involvement in high profile int’l opportunity • Also…- Creation of Green Light Committee- Registration of Drugs- Plan long term continuous production

  13. Green Light Committee • Guarantee low price access to sound pilot projects and also monitors ongoing projects • Minimize black market  further resistance • Requires countries to: - Need functional DOTS program - Government commitment AND funding - Coordinated organization and management - Case-finding strategies - Laboratory diagnosis techniques - Treatment and follow-up strategies - Information Systems

  14. Green Light Committee • Two NGOs - MSF - Royal Netherlands TB Association • Two NTP (National TB Programs) - Estonia - CDC • Academic Institution - Harvard Medical School • WHO 2 replaced q3yrs Each with 1 vote

  15. Additional Strategies: • Research and Development for NEW drugs (Its been 30 yrs!) • Diagnostics for Chest xray neg or extrapulmonary TB? - Serology or PCR? - Goal of 85% case detection • Vaccine Development - BCG with more immunogenicity - Listeria monocytogenes “actin-rocket”

  16. 3 by 5 • Create AIDS Medicine and Diagnostics (AMDS) - Coordinator - No direct purchasing - Information clearinghouse for manufacturers, procurement agents and treatment programs - “Technical” tools to help supply cycle such as expert teams and improve security - Eventual plan to establish buyer networks • Create WHO Procurement, Quality, Sourcing Project - Pre-qualification board to assess manufacturers and products to assure high quality

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