Appendix C
Partners In Health White Paper—Stemming the Tide of Multidrug-Resistant Tuberculosis: Major Barriers to Addressing the Growing Epidemic



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Appendix C Partners In Health White Paper— Stemming the Tide of Multidrug- Resistant Tuberculosis: Major Barriers to Addressing the Growing Epidemic 

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STEMMING THE TIDE OF MULTIDRUG-RESISTANT TUBERCULOSIS: MAJOR BARRIERS TO ADDRESSING THE GROWING EPIDEMIC A WHITE PAPER FOR THE INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES HARVARD MEDICAL SCHOOL PARTNERS IN HEALTH FRANÇOIS–XAVIER BAGNOUD CENTER FOR HEALTH AND HUMAN RIGHTS BRIGHAM AND WOMEN’S HOSPITAL November 2008 j 1 

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 THREAT OF DRug-RESISTANT TubERCulOSIS AUTHORS Lead Authors Salmaan Keshavjee Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital/ Partners In Health Kwonjune Seung Division of Global Health Equity, Brigham and Women’s Hospital/ Partners In Health Contributing Authors Rajesh Gupta Stanford University School of Medicine Tom Nicholson Partners In Health Julie Rosenberg Talbot Division of Global Health Equity, Brigham and Women’s Hospital Chris Vanderwarker University of Washington Paul Zintl Partners In Health/ Department of Global Health and Social Medicine, Harvard Medical School Other Contributors: Mercedes Becerra Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital Paul Farmer Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital/ Partners In Health Jennifer Furin Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital/ Partners In Health Stephen Hallisey Department of Global Health Equity, Brigham and Women’s Hospital j i

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 APPENDIx C Amy Judd Division of Global Health Equity, Brigham and Women’s Hospital Kathryn Kempton Partners In Health David Kim Division of Global Health Equity, Brigham and Women’s Hospital Jim Yong Kim Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital/ Harvard School of Public Health/ François–Xavier Bagnoud Center For Health And Human Rights/ Partners In Health Carole Mitnick Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital Joia Mukherjee Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital/ Partners In Health Edward Nardell Harvard School of Public Health/ Division of Global Health Equity, Brigham and Women’s Hospital Catherine Oettinger Partners In Health Sonya Shin Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital Valerie Varco Division of Global Health Equity, Brigham and Women’s Hospital Rebecca Weintraub Department of Global Health and Social Medicine, Harvard Medical School/ Division of Global Health Equity, Brigham and Women’s Hospital In-depth Interviews Shalala Akhmedova Coordinator, International Committee of Red Cross (Azerbaijan) Peter Cegielski Unites States Centers for Disease Control and Prevention Agnes Gebhard KNCV Tuberculosis Foundation j ii

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 THREAT OF DRug-RESISTANT TubERCulOSIS Ogtay Gozalov Regional Tuberculosis Control Program, South Caucasus, Azerbaijan Mark Harrington Treatment Action Group Phil Hopewell University of California San Francisco Vaira Leimane WHO Collaborating Centre for Research and Training in Management of MDR-TB (Latvia) Joël Keravec Management Sciences for Health/Brazil Laura Jacobus Jacobus Pharmaceutical Co., Inc. Moses Joloba National Tuberculosis Program, Uganda Fabienne Jouberton Global Fund to fight AIDS, Tuberculosis and Malaria Robert Matiru Global Drug Facility, STOP TB Partnership Fuad Mirzayev World Health Organization Pierre-Yves Norval World Health Organization Madhukar Pai McGill University C. N. Paramasivan Foundation for Innovative New Diagnostics Dmitri Pashkeevich Office of the Special Representative of the WHO Director-General in Russia Trevor Peters Clinton Foundation Alexei Prorekhin Partners In Health, Russia Steven Reynolds Unites States Centers for Disease Control and Prevention--Uganda John Ridderhof Unites States Centers for Disease Control and Prevention William Rodriguez Brigham and Women's Hospital/Harvard Medical School j iii

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 APPENDIx C Tamara Russell Eli Lilly Global Manufacturing Nina Schwalbe Global Alliance for Vaccines and Immunization Alex Sloutsky Massachusetts State Laboratory Institute/University of Massachusetts Thelma Tupasi Tropical Disease Foundation, the Philippines Karin Weyer World Health Organization Abigail Wright World Health Organization Acknowledgement of Support Jaime Bayona Socios En Salud Ernesto Jaramillo World Health Organization Kitty Lambregts KNCV Tuberculosis Foundation Oksana Ponomarenko Partners In Health, Russia Mario Raviglione World Health Organization Peter Stephens IMS Health The authors would like to thank the many other colleagues who participated in numerous discussions on the topics covered in this document over the last year. The views expressed in this document are solely those of the authors and are not meant to represent the position of any individual who was interviewed or gave support to this project, nor the Institute of Medicine, Harvard Medical School, Partners In Health, the François-Xavier Bagnoud Center for Health Human Rights or Brigham and Women's Hospital. HARVARD ME Cover Photo: Open Society Institute/Pep Bonet j iv

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 THREAT OF DRug-RESISTANT TubERCulOSIS TABLE OF CONTENTS EXECUTIVE SUMMARY .............................................................................................................. ...........................1 SPECIFIC RECOMMENDATIONS:...................................................................................................... ..................2 GLOSSARY OF TERMS: ............................................................................................................. .............................4 Section I: THE PROBLEM OF DRUG-RESISTANT TUBERCULOSIS..................................................5 1 Introduction................................................................................................................... ................... 5 2 A General Framework for Understanding Barriers to MDR-TB Scale-up ...................................... 9 Section II: DIAGNOSIS OF MDR-TB...........................................................................................................1 1 1 Introduction................................................................................................................... ................. 11 1.1 The inadequacies of sputum smear microscopy ........................................................................ 11 1.2 Expanding Laboratory Capacity ................................................................................................ 12 2 The Anatomy of a Laboratory Network......................................................................................... 14 2.1 TB laboratory networks ......................................................................................................... .... 14 2.2 Third-party laboratories....................................................................................................... ...... 16 2.3 Drug resistance surveillance (DRS) .......................................................................................... 16 2.4 Capacity gap ................................................................................................................... ........... 18 2.5 Financing gap .................................................................................................................. .......... 19 3 Laboratory Capacity Building........................................................................................................ 20 3.1 Fragmented organization and a poorly defined role in TB control............................................ 22 3.2 Laboratory technical assistance ................................................................................................. 22 3.3 Human resources ................................................................................................................ ....... 24 3.4 The referral network ........................................................................................................... ....... 26 3.5 Data management ...................................................................................................................... 27 3.6 Quality assurance.............................................................................................................. ......... 27 3.7 Lessons learned from the experiences of Peru and Lesotho...................................................... 30 4 New TB Technologies and the Need for Point-of-Care Testing.................................................... 31 5 Recommendations................................................................................................................ .......... 33 j v

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 APPENDIx C Section III: MDR-TB DRUG SUPPLY ...........................................................................................................35 1 Introduction................................................................................................................... ................. 35 2 The GLC Initiative: Actors and Responsibilities........................................................................... 36 2.1 The Green Light Committee (GLC) .......................................................................................... 36 2.2 The Global Drug Facility (GDF) ............................................................................................... 38 2.3 Procurement agent .............................................................................................................. ....... 39 2.4 The WHO Essential Drugs Monitoring (EDM) prequalification system .................................. 40 2.5 UNITAID ........................................................................................................................ .......... 40 3 The GLC Initiative: Institutional Barriers...................................................................................... 43 3.1 Single procurement agent, the GDF, and transparency ............................................................. 43 3.2 Prequalification of second-line anti-TB drugs has been slow at WHO..................................... 44 4 Drug Supply and Engagement of Drug Manufacturers in MDR-TB Response............................. 49 4.1 MDR-TB projects working outside the GLC initiative ............................................................. 49 4.2 Available drug supply through GLC initiative .......................................................................... 51 4.3 Incentives and disincentives for entry into the second-line anti-TB drug market ..................... 52 4.4 New therapies for MDR-TB ...................................................................................................... 5 4 4.5 Governmental health authorities and high quality second-line drugs........................................ 56 4.6 Manufacturers in high-burden countries.................................................................................... 56 5 Redefining the Paradigm of the GLC Mechanism......................................................................... 58 6 Recommendations................................................................................................................ .......... 60 Section IV: MDR-TB TREATMENT DELIVERY........................................................................................62 1 Introduction................................................................................................................... ................. 62 2 Shifting the Paradigm From “Pilot” Projects to an Integrated Strategy......................................... 63 3 Addressing the MDR-TB Treatment Implementation Gap............................................................ 65 4 Expanding Models of Care ....................................................................................................... ..... 68 4.1 Community-based models for MDR-TB treatment ................................................................... 68 4.2 Participation of the private sector .............................................................................................. 72 4.3 Transmission control ........................................................................................................... ...... 73 5 Recommendations................................................................................................................ .......... 76 Section V: References..................................................................................................................... .................78 j vi

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 THREAT OF DRug-RESISTANT TubERCulOSIS EXECUTIVE SUMMARY Every year nearly 500,000 people worldwide fall ill from newly-acquired disease caused by multidrug-resistant tuberculosis (MDR-TB), adding to an estimated global burden of at least 1.5 million prevalent cases. This infectious disease is spread through the air and is caused by strains of Mycobacterium tuberculosis that are resistant to the two most effective first-line anti- tuberculosis drugs. Before they die from the disease, people infected with MDR-TB often transmit the mycobacterium to others. More ominously, tuberculosis strains now deemed extensively drug-resistant (XDR-TB) threaten the progress made to date in the treatment of resistant disease and necessitate an urgent call to action. Though aggressive treatment with second-line drugs has yielded a range of positive outcomes for patients with XDR-TB, the widespread emergence of totally drug-resistant strains (TDR-TB) would return us to the pre- antibiotic era. Confronting MDR-TB is a core goal stated in the WHO’s Global Plan to Stop TB: 2006-2015. Under the original plan, at least 800,000 people with active MDR-TB were to be treated by 2015. A subsequent revision, reflecting the concern over XDR-TB, made a more ambitious call for universal access to treatment for all active MDR-TB patients; this will require the treatment of nearly 1.6 million patients by 2015. At present, only ten percent of new MDR-TB cases are treated each year, and less than two percent are receiving verifiable, quality-assured, second-line anti-TB drugs through WHO’s Green Light Committee (GLC) mechanism. Preventing the further emergence of strains of tuberculosis with broad-spectrum resistance—including those resistant to all first- and second-line anti-tuberculosis drugs—is dependent upon identifying and addressing barriers to effective diagnosis and treatment of drug-resistant tuberculosis without delay. While multidrug-resistant strains of tuberculosis may have first emerged from inadequate treatment and control programs in the recent past, continued spread of this airborne pathogen is directly affected by the following barriers to large-scale, effective treatment delivery: 1. Exceedingly limited capacity to rapidly diagnose drug-resistant TB. True point-of-care testing is practically nonexistent, especially in the areas with the highest tuberculosis burden. 2. Limited supply of quality-assured second-line anti-tuberculosis drugs. The current supply is insufficient, even for the estimated two percent of MDR-TB patients being treated through the GLC mechanism. This is exacerbated by limited demand for quality-assured second-line anti-tuberculosis drugs in countries with high burdens of MDR-TB. These countries are using local manufacturers who often do not meet quality-assurance standards as defined by the WHO. 3. Ambiguous messaging about the importance of integration of MDR-TB into national tuberculosis control programs, perpetuated by a “pilot-program” mentality that has not been encouraging a push for universal access. Page 1 of 88

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 APPENDIx C 4. Inadequate mechanisms for delivering technical assistance to countries in a manner that sufficiently addresses the need and builds local capacity to effectively and safely treat and manage MDR-TB. 5. Lack of focus on interrupting transmission of the tuberculosis bacilli in congregate settings both in the community and in institutions such as hospitals, clinics, and prisons. This paper provides several recommendations to facilitate the expansion of global treatment and prevention of multidrug-resistant tuberculosis. These include: promoting universal access to treatment as part of national tuberculosis control programs; improving and expanding laboratory capacity, including rapid point-of-service testing; reforming the current procurement system to ensure an adequate and accessible supply of quality-assured second-line drugs; providing ongoing, on-site technical assistance; and expanding the delivery of ambulatory-based MDR-TB treatment. It also includes recommendations concerning the development of effective transmission-control programs in resource-limited settings. SPECIFIC RECOMMENDATIONS: Diagnostics Sustainable funding from bilateral and multilateral donors must be increased to support construction of in-country drug-sensitivity testing/rapid-testing laboratories and ongoing external quality assessments by supranational reference laboratories. Creation of a system of long-term on-site technical assistance would help countries build and/or rapidly expand their capacity to perform mycobacterial culture, DST, and rapid molecular genetic tests for drug-resistant tuberculosis. In-country laboratory networks for: specimen transport, data management, and certification and coordination of private laboratories need improvement. Use of excess laboratory capacity for mycobacterial culture and drug-susceptibility testing in wealthy nations should be encouraged while laboratories are being built in poorer regions. Priority must be given to research on—and funding for—the immediate development and rapid deployment of point-of-care testing for drug-susceptible and drug-resistant tuberculosis. Page 2 of 88

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 THREAT OF DRug-RESISTANT TubERCulOSIS 59 Mukherjee JS, Rich ML, Socci AR, et al. Programmes and principles in treatment of multidrug-resistant tuberculosis. Lancet 2004; 363: 474-81. 60 Nathanson E, Lambregts van Weezenbeek CSW, Rich MR, et al. Multidrug-resistant tuberculosis management in resource limited settings. Emerging Infectious Diseases. 2006; 12(9) 1389-1397. 61 Leimane V, Riekstina V, Holtz TH, et al. Clinical outcome of individualized treatment of multidrug-resistant tuberculosis in Latvia: a retrospective cohort study. Lancet 2005; 365(9456): 318-326. 62 Mitnick C, Bayona J, Palacios E, et al. Community-based treatment for multidrug-resistant tuberculosis in Lima, Peru. New England Journal of Medicine. 2003; 348(2): 119-28. 63 Tupasi T, Gupta R, Quelapio M, et al. Feasibility and cost-effectiveness of treating multidrug-resistant tuberculosis: a cohort study in the Philippines. Public Library of Science – Medicine. 2006; 3(9): e352. 64 Shin SS, Furin JJ, Alacantra F, et al. Long-term follow up for multidrug-resistant tuberculosis. Emerging Infectious Diseases. 2006; 12(4): 687-688. 65 Mitnick CD, Shin SS, Seung KJ et al. Comprensive Treatment of Extensively Drug-Resistant Tuberculosis. NEJM, August 7, 2008; 359(6): 563-574. 66 Keshavjee S, Gelmanova IY, Kim JY, Mishustin SP, Strelis AK, Andreev YG, Mukherjee JS, Pasechnikov AD, Atwood S, Rich ML, Furin JJ, Nardell EA, Farmer PE, Shin SS. Extensively drug resistant tuberculosis: Lessons from MDR-TB treatment scale-up in Tomsk, Russia. Lancet. August 25, 2008; 372(9639):early on-line publication. 67 Keshavjee S, Gelmanova I, Pasechnikov A, Mushustin S, Andreev Y, Yedilbayev A, et al. Treating Multi-Drug Resistant Tuberculosis in Tomsk, Russia: Developing programs that address the linkage between poverty and disease. Ann N Y Acad Sci 2007 Oct 22. 68 Raviglione MC and MW Uplekar. WHO’s new Stop TB Strategy. Lancet 2006; 367:952-5. 69 World Health Organzation. The Global MDR-TB and XDR-TB Response Plan. Geneva, Switzerland: World Health Organization; 2007. WHO/HTM/STB/2007.387. 70 World Health Organzation/Stop TB Partnership. Global Plan to Stop TB: 2001-2005. Geneva, Switzerland: World Health Organization, 2003. WHO/HTM/STB/2003.23. 71 World Health Organzation/Stop TB Partnership. Progress Report on the Global Plan to Stop TB: 2001-2005. Geneva, Switzerland: World Health Organization, 2004. WHO/HTM/STB/2004.29. 72 World Health Organzation/Stop TB Partnership. Global Plan to Stop TB: 2006-2015. Geneva, Switzerland: World Health Organization, 2006. WHO/HTM/STB/2006.38. 73 Amadottir T, Reider H, and D Enarson. Tuberculosis Programs: Review, Planning, Technical Support. International Union Against Tuberculosis and Lung Disease: Paris, 1998. 74 Squire, SB, Belaye, AK, Kashoti A, et al. 'Lost' smear-positive pulmonary tuberculosis cases: where are they and why did we lose them? Int J Tuberc Lung Dis 2005. 9 (1): 25-31. 75 Improving the Diagnosis of Tuberculosis through the Optimization of Sputum Microscopy. World Health Organization: Geneva, 2005. 76 Improving the Diagnosis of Tuberculosis through the Optimization of Sputum Microscopy. World Health Organization: Geneva, 2005. 77 Hamid Salim A, Aung KJ, Hossain MA, et al. Early and rapid microscopy-based diagnosis of true treatment failure and MDR-TB. Int J Tuberc Lung Dis, 2006. 10(11): p. 1248-54. 78 Pai M, Kalantri S and K Dheda. New tools and emerging technologies for the diagnosis of tuberculosis: part II. Active tuberculosis and drug resistance. Expert Rev Mol Diagn 2006; 6(3): 423-32. 79 Palomino, J.C., Newer diagnostics for tuberculosis and multi-drug resistant tuberculosis. Curr Opin Pulm Med, 2006. 12(3): p. 172-8. Page 81 of 88

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 APPENDIx C 80 New Technologies for Tuberculosis Control: A Framework for their Adoption, Introduction, and Implementation. World Health Organization: Geneva, 2007. 81 Aziz M, Ryszewska K, Blanc L, et al. Expanding culture and drug susceptibility testing capacity in tuberculosis diagnostic services: the new challenge. Int J Tuberc Lung Dis 2007. 11(3): p. 247-50. 82 Ridderhof, JC, van Deum, A, Kam KM, et al. Roles of laboratories and laboratory systems in effective tuberculosis programmes. Bull World Health Organ 2007; 85(5): p. 354-9. 83 Strategic Approach for the Strengthening of Laboratory Services for Tuberculosis Control: 2006-2009. World Health Organization: Geneva, 2006. 84 Blondal K. Barriers to reaching the targets for tuberculosis control: multidrug-resistant tuberculosis. Bull World Health Organ, 2007; 85(5): 387-90; discussion 391-4. 85 Raviglione MC and IM Smith. XDR tuberculosis--implications for global public health. N Engl J Med 2007; 356 (7): 656-9. 86 The Stop TB Strategy. Building on DOTS to Meet the TB-Related Millenium Development Goals. Stop TB Partnership: Geneva, 2006. 87 The Global MDR-TB & XDR-TB Response Plan 2007-2008. Stop TB Partnership: Geneva, 2007. 88 Migliori GB, Loddenkemper R, Blasi F and MC Raviglione. 125 years after Robert Koch's discovery of the tubercle bacillus: the new XDR-TB threat. Is "science" enough to tackle the epidemic? European Respiratory Journal 2007; 29:423-427. 89 The Global MDR-TB & XDR-TB Response Plan 2007-2008. In. Geneva: Stop TB Partnership; 2007. 90 Garner P, Alejandria M, and MA Lansang. Is DOTS-plus a feasible and cost-effective strategy? PLoS Med 2006;3 (9): e350. 91 Portero JL and M Rubio. Cost-effective control of drug-resistant TB: listening to other voices. PLoS Med 2006; 3 (12): e542. 92 World Health Organization (2008). Global Tuberculosis Control 2008: Surveillance, Planning, Financing. Available at http://www.who.int/tb/publications/global_report/2008/en/index.html (accessed on 11 August 2008). 93 Keshavjee, S, Seung, K, Satti H, et al. Building capacity for multidrug-resistant tuberculosis treatment: health systems strengthening in Lesotho. Innovations. 2007 Fall; 2(4):87-106. 94 Uplekar M, Pathania V and M Raviglione. Private practitioners and public health: weak links in tuberculosis control. Lancet 2000; 358(9285): 912-6. 95 Centers for Disease Control and Prevention. National plan for reliable tuberculosis laboratory services using a systems approach: recommendations from CDC and the Association of Public Health Laboratories Task Force on Tuberculosis Laboratory Services. Morbidity and Mortality Weekly Report 2005; 54(RR-6). 96 Pascopella L, Kellam S, Ridderhof J, et al. Laboratory reporting of tuberculosis test results and patient treatment initiation in California. J Clin Microbiol, 2004. 42(9): p. 4209-13. 97 Interim Recommendations for the Surveillance of Drug Resistance in Tuberculosis. World Health Organization: Geneva, 2007. 98 The Public Health Service National Tuberculosis Reference Laboratory and the National Laboratory Network: Minimum Requirements, Role and Operation in a Low-Income Country. International Union Against Tuberculosis and Lung Disease: Paris, 1998. 99 Guidelines for surveillance of drug resistance in tuberculosis. World Health Organization: Geneva, 2003. 100 Anti-tuberculosis drug resistance in the world: the WHO/IUATLD Global Project on Anti-tuberculosis Drug Resistance Surveillance. World Health Organization: Geneva, 1997. 101 Anti-tuberculosis drug resistance in the world: the WHO/IUATLD Global Project on Anti-tuberculosis Drug Resistance Surveillance, Report No. 2. World Health Organization: Geneva, 2000. Page 82 of 88

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0 THREAT OF DRug-RESISTANT TubERCulOSIS 102 Anti-tuberculosis drug resistance in the world, third global report. World Health Organization: Geneva, 2003. 103 World Health Organization/International Union Against Tuberculosis and Lung Disease. Global Project on Anti- Tuberculosis Drug Resistance Surveillance. Anti-tuberculosis drug resistance in the world: report no. 4. Geneva, Switzerland: World Health Organization, 2008. 104 Stop TB Working Group on DOTS-Plus for MDR-TB Strategic Plan 2006-2015. World Health Organization: Geneva, 2005. 105 Zignol M, Hosseini MS, Wright A, Weezenbeek CL, Nunn P, Watt CJ, et al. Global incidence of multidrug- resistant tuberculosis. J Infect Dis 2006;194:479-485. 106 Gopinath K, Manisankar M, Kumar S, et al. Controlling multidrug-resistant tuberculosis in India. Lancet 2007. 369(9563): p. 741-2; author reply 742. 107 Dye C, Williams BG, Espinal MA, Raviglione MC. Erasing the world's slow stain: strategies to beat multidrug- resistant tuberculosis. Science. 2002 Mar 15;295(5562):2042-6. 108 de Gourville, E, Duintjer Tebbens RJ, Sangrujee N, et al., Global surveillance and the value of information: the case of the global polio laboratory network. Risk Anal 2006; 26(6):1557-69. 109 Featherstone D, Brown, D and R Sanders. Development of the Global Measles Laboratory Network. J Infect Dis, 2003; 187 Suppl 1: S264-9. 110 Cohen GM. Access to diagnostics in support of HIV/AIDS and tuberculosis treatment in developing countries. Aids 2007; 21 Suppl 4: S81-7. 111 Diagnostics for Tuberculosis: Global Demand and Market Potential. World Health Organization: Geneva, 2007. 112 Maher D, Dye C, Floyd K, et al. Planning to improve global health: the next decade of tuberculosis control. Bull World Health Organ 2007. 85(5): p. 341-7. 113 Ridderhof, JC, van Deun, A, Kam, KM, et al., Roles of laboratories and laboratory systems in effective tuberculosis programmes. Bull World Health Organ 2007; 85(5): 354-9. 114 Bates I and K Maitland. Are laboratory services coming of age in sub-Saharan Africa? Clin Infect Dis 2006; 42 (3): 383-4. 115 Muula AS and FC Maseko. Medical laboratory services in Africa deserve more. Clin Infect Dis 2006; 42(10): 1503. 116 Martin R, Hearn TL, Ridderhof J, et al. Implementation of a quality systems approach for laboratory practice in resource-constrained countries. Aids 2005. 19 Suppl 2: p. S59-65. 117 Dukes Hamilton, C, Sterling, TR, Blumberg HM, et al., Extensively drug-resistant tuberculosis: are we learning from history or repeating it? Clin Infect Dis 2007; 45(3): 338-42. 118 Harries AD, Zachariah R, Bergstrom K, et al. Human resources for control of tuberculosis and HIV-associated tuberculosis. Int J Tuberc Lung Dis 2005. 9(2): p. 128-37. 119 Chen, L, Evans, T Anand S, et al. Human resources for health: overcoming the crisis. Lancet 2004; 364(9449): 1984-90. 120 Narasimhan V, Brown H, Pablos-Mendez, A, et al. Responding to the global human resources crisis. Lancet 2004. 363(9419): p. 1469-72. 121 Hanvoravongchai, P. Scaling up health workforces in response to critical shortages. Lancet 2007; 370(9605): 2080-1. 122 Mullan F and S Frehywot. Non-physician clinicians in 47 sub-Saharan African countries. Lancet 2007; 370(9605): 2158-63. 123 Hongoro C and B McPake. How to bridge the gap in human resources for health. Lancet 2004; 364(9443): 1451- 6. Page 83 of 88

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 APPENDIx C 124 Yagui M, Perales MT, Asencios L, et al. Timely diagnosis of MDR-TB under program conditions: is rapid drug susceptibility testing sufficient? Int J Tuberc Lung Dis 2006. 10(8): p. 838-43. 125 Petti, CA, Polage CR, Quinn TC, et al. Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis 2006; 42(3): 377-82. 126 Blaya JA and HS Fraser. Development, implementation and preliminary study of a PDA-based tuberculosis result collection system. AMIA Annu Symp Proc 2006: 41-5. 127 Blaya, JA, Shin SS, Yagui MJ, et al. A web-based laboratory information system to improve quality of care of tuberculosis patients in Peru: functional requirements, implementation and usage statistics. BMC Med Inform Decis Mak 2007; 7: 33. 128 Global Tuberculosis Control 2007. Surveillance, Planning, Financing. World Health Organization: Geneva, 2007. 129 Rojpibulstit M, Kanjanakiritamrong J and V Chongsuvivatwong. Patient and health system delays in the diagnosis of tuberculosis in Southern Thailand after health care reform. Int J Tuberc Lung Dis 2006; 10(4):422-428. 130 Lonnroth K, Thuong LM, Linh PD and VK Diwan. Delay and discontinuity—a survey of TB patients’ search of a diagnosis in a diversified health care system. Int J Tuberc Lung Dis 1999; 3:992-1000. 131 Liam CK and BG Tang. Delay in the diagnosis and treatment of pulmonary tuberculosis in patients attending a university teaching hospital. Int J Tuberc Lung Dis 1997; 1:326-332. 132 Rajeswari R, Chandrasekaran V, Suhadev M, Sivasubramaniam S, Sudha G and G Renu. Factors associated with patient and health system delays in the diagnosis of tuberculosis in South India. Int J Tuberc Lung Dis 2002; 6:789- 795. 133 Cheng G, Tolhurst R, Li RZ, et al. Factors affecting delays in tuberculosis diagnosis in rural China: a case study in four counties in Shandong Province. Trop Med Int health 2005; 99:355-362. 134 Lorent N, Mugwaneza P, Mugabekazi J, Gasana M, Van Bastelaere S, Clerinx J, et al. Risk factors for delay in the diagnosis and treatment of tuberculosis at a referral hospital in Rwanda. Int J Tuberc Lung Dis 2008; 12(4):392- 396. 135 World Health Organization/International Union Against Tuberculosis and Lung Disease. Global Project on Anti- Tuberculosis Drug Resistance Surveillance. Anti-tuberculosis drug resistance in the world: report no. 4. Geneva, Switzerland: World Health Organization; 2008. Pg 14 136 Summary: Strategic Plans 2006 - 2015 of the Partnership, Working Group and Secretariat (Stop TB) http://www.stoptb.org/globalplan/plan_p3main.asp?p=3 137 The Global MDR-TB & XDR-TB Response Plan 2007-2008. In. Geneva: Stop TB Partnership; 2007. www.stoptb.org/resource_center/assets/documents/Global%20MDR-TB_and_%20XDR- TB_Response%20Plan_2007-08.pdf 138 Mattelli, Migliori, Cirillo, Centis, Girardi, Raviglioni Multi-drug Resistant and Extensively-drug Resistant Mycobacterium Tuberculosis: Epidemiology and Control. Future Drugs, 2007. Pg 865 139 World Health Organization, “Stop TB Partnership delivers treatments for 10 million people in six years” http://www.who.int/mediacentre/news/releases/2007/pr25/en/index.html 140 Interview with GDF, November 2007 141 Request for Proposals for second-line anti-TB Drugs Procurement Agent(s), August, 2006 Available: http://www.stoptb.org/gdf/newsevents/newsarchive.asp 142 Unitaid Homepage http://www.unitaid.eu 143 Unitaid Homepage http://www.unitaid.eu 144 Interviews with GLC representatives Page 84 of 88

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 THREAT OF DRug-RESISTANT TubERCulOSIS 145 Tropical Disease Foundation, Manila, Philippines. Permission for use of this material was obtained from Dr. Thelma Tupasi. 146 Interviews with GLC-approved project procurement managers 147 WHO list of prequalified medicinal products. http://healthtech.who.int/pq/ Site accessed on August 12, 2008. 148 World Health Organzation. The Global MDR-TB and XDR-TB Response Plan. Geneva, Switzerland: World Health Organization; 2007. WHO/HTM/STB/2007.387. 149 TB infections by country, 2003, WHO estimate 150 Russian Ministry of Health and Social Development 2007 151 Russian Ministry of Health and Social Development 2007 152 From IMS Health, conveyed to the Drug Management Sub-Committee of the Stop TB Partnership, MDR-TB Working Group 153 Keravec J. Implementation of a National Program for TB Drugs Quality Assuaranc in Brazil, Projeto MSH/Rational Pharmaceutical Management Plus Program (RPM Plus) Rio de Janeiro, Brazil 2007. 154 Currently offered through GDF, though not listed on GDF 2006 chart of medications 155 Stop TB Partnership, Global Drug Facility Drugs, Diagnostics, and other TB supplies, list of 2nd line drugs. http://www.stoptb.org/gdf/drugsupply/drugs_available.asp#2nd%20Line%20Drugs 156 Gupta R, Kim JY, Espinal MA, et al. Responding to Market Failures in Tuberculosis Control. Science 2001 Aug 10;293(5532):1049-51. 157 Interview, GDF November 2007 158 Interviews with pharmaceutical industry representatives. 159 From IMS Health, conveyed to the Drug Management Sub-Committee of the Stop TB Partnership, MDR-TB Working Group. Cited with permission from IMS Health and the WHO. 160 Feuer C (2006) Tuberculosis research and development: A critical analysis. Treatment Action Group. Available: http://www.aidsinfonyc.org/tag/tbhiv/tbrandd.pdf. Accessed 7 October 2007 161 Glickman et al. “A Portfolio Model of Drug Development for Tuberculosis” Science. March 3, 2006. pg 1246. 162 Ginsberg, Ann. “Emerging Drugs for Active Tuberculosis” Seminars in Respiratory and Critical Care Medicine. 2008. 29(5) 163 Sacks, Leonard and Behrman, Rachel E. “Developing new drugs for the treatment of drug-resistant tuberculosis: a regulatory perspective” Tuberculosis (2008) 88 Suppl 1. 164 Mitnick CD et al. Randomized trials to optimize treatment of multidrug-resistant tuberculosis. PLoS Med 4(11): e292. doi:10.1371/journal.pmed.0040292 165 Glickman et al. “A Portfolio Model of Drug Development for Tuberculosis” Science. March 3, 2006. pg 1246. 166 Farlow, Letter to Science, February 23, 2007; in response to “A Portfolio Model of Drug Development for Tuberculosis” Science. March 3, 2006. pg 1246. 167 This workshop was convened in Cambridge, Massachusetts, USA on June 10 to 12, 2008, by partners of the MDR-TB Working Group of the Stop-TB Partnership. It was sponsored and organized by: Boston University School of Public Health, International Union Against TB & Lung Disease, KNCV Tuberculosis Foundation, MDR-TB Working Group of the Stop-TB Partnership, Médecins Sans Frontières, Partners In Health/Harvard Medical School, Potts Memorial Foundation, Treatment Action Group, World Health Organization. 168 Sun Q, Santoro MA, Meng Q, et al. Pharmaceutical Policy in China. Health Affairs 2008 Jul-Aug;27(4):1042-50. Page 85 of 88

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 APPENDIx C 169 PSU Pharma Companiess May be Kept Out of Price Control for Now http://economictimes.indiatimes.com/Economy/PSU_pharma_cos_out_of_price_control/articleshow/3266374.cms 170 Ibid 171 Lilly MDR-TB Partnership Facts http://lillymdr-tb.com/facts.html 172 Interviews with Eli Lilly, Aspen Pharmacare October 2007- January 2008 173 Ibid. 174 Ibid. 175 Ibid. 176 Interviews with Eli Lilly, October 2007 177 Park SK, CT Kim and SD Song. Outcome of chemotherapy in 107 patients with pulmonary tuberculosis resistant to isoniazid and rifampicin. Int J Tuberc Lung Dis 1998. 2:877-884. 178 Telzak EE, Sepkowitz K, Alpert P, et al. Multidrug-resistant tuberculosis in patients in patients without HIV infection. New Engl J Med 1995.333:907-903. 179 Farmer PE, Kim JY, Mitnick CD, et al. Responding to Outbreaks of Multidrug-resistant tuberculosis: Introducing DOTS-Plus. In: Tuberculosis: A comprehensive International Approach, 2nd edition. 2000. Reichman L. and Hershfield ES ed. 447-69 Marcel Dekker, Inc. New York, NY. 180 Leimane V, Riekstina V, Holtz TH, et al. 2005. Clinical outcome of individualised treatment of multidrug- resistant tuberculosis in Latvia: a retrospective cohort study. Lancet 365(9456):318-26. 181 Farmer PE, Furin JJ and SS Shin. Managing multidrug-resistant tuberculosis. Journal of Respiratory Diseases 2000. 21(1), 53-56. 182 World Health Organization (2006). “Opportunities for Global Health Initiatives in the Health System Action Agenda,” Department of Health Policy, Development and Services Evidence and Information for Policy, World Health Organization (WHO) Working Paper No. 4. 183 Coker RJ, Atun RA and M McKee. Health-care system frailties and public health control of communicable disease on the European Union's new eastern border. Lancet 2004. 363(9418):1389-92. 184 See: Global Fund, eleventh board meeting (28-30 September 2005). “Report of the Technical Review Panel and the Secretariat on Round Five Proposals,” (accessed 2 Jan 2008). 185 Opportunities for Global Health Initiatives in the Health System Action Agenda, Department of Health Policy, Development and Services Evidence and Information for Policy, World Health Organization (WHO) Working Paper No. 4. 2006. 186 Keshavjee S, Gelmanova I, Pasechnikov A, Mushustin S, Andreev Y, et al. “Treating Multi-Drug Resistant Tuberculosis in Tomsk, Russia: Developing programs that address the linkage between poverty and disease,” Ann N Y Acad Sci. 2007 Oct 22; epub ahead of print. 187 Keshavjee S, Seung K, Satti H, Furin J, Farmer P, Kim JY, Becerra M. Building capacity for multidrug-resistant tuberculosis treatment: health systems strengthening in Lesotho. Innovations 2007 Fall; 2(4):87-106. 188 World Health Organization. 1999. Global Tuberculosis Control, WHO Report 1999. Geneva: World Health Organization. 189 Nardell E. Tuberculosis in homeless, residential care facilities, prisons, nursing homes, and other close communities. Semin Respir Infect 1989.4:206. 190 Moore M, McCray E and I Onorato. Cross matching TB and AIDS registries: TB patients with HIV coinfection, United States, 1993-1994. Publ Health Rep 1999.114:269-77. Page 86 of 88

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 APPENDIx C 213 Singla N, Sharma PP, Singla R, Jain RC. Survey of knowledge, attitudes and practices for tuberculosis among general practitioners in Delhi, India. International Journal of Tuberculosis and Lung Disease. 1998; 2: 384-389. 214 Kimerling ME, The Russian equation: an evolving paradigm in tuberculosis control. Int J Tuberc Lung Dis 2000. 4(12 Suppl 2): p. S160-7. 215 Willingham FF, Schmitz TL, Contreras M, et al. Hospital control and multidrug-resistant pulmonary tuberculosis in female patients, Lima, Peru. Emerging Infectious Diseases 2001. 7(1): p. 123-127. 216 Gelmanova IY, Keshavjee S, Golubchikova VT, Berezina VI, Strelis AK, Yanova GV, Atwood S, Murray M. Barriers to successful tuberculosis treatment in Tomsk, Russia; non-adherence, default, and the acquisition of multi- drug resistance. Bull WHO 2007 Sep; 85(9):703–711. 217 Li X, Zhang Y, Shen X, Shen G, Gui X, Sun B, Mei J, Deriemer K, Small PM, Gao Q. Transmission of drug- resistant tuberculosis among treated patients in Shanghai, China. J Infect Dis 2007 Mar 15; 195(6):864–9. 218 Wells CD, Cegielski JP, Nelson LJ, et al. HIV infection and mutlidrug-resistant tuberculosis--the perfect storm. The Journal of Infectious Diseases 2007. 196(supplement 1): p. S86-S107. 219 Basu S, Andrews JR, Poolman EM, et al. Prevention of nosocomial transmission of extensively drug-resistant tuberculosis in rural South African district hospitals: an epidemiological modeling study. Lancet, 2007. 370(9597): p. 1500-7. 220 Excerpted from: Keshavjee S, Seung K, Satti H, Furin J, Farmer P, Kim JY, Becerra M. Building capacity for multidrug-resistant tuberculosis treatment: health systems strengthening in Lesotho. Innovations. 2007 Fall; 2(4):87-106. 221 See: World Health Organization (2007) “WHO Report: Global Tuberculosis Control: Africa.” (accessed 6 Jan 2008). 222 See: World Health Organization (September 2005). “Summary Country Profile for HIV/AIDS Treatment Scale- up: Lesotho.” (accessed 6 Jan 2008). 223 Ministry of Health and Social Welfare, Government of Lesotho, 2006 Page 88 of 88

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