Who's Who in the TB Zoo
Joan Leavens
Oct. 17, 2011, 5:02 p.m.
There are many organisations working in the TB field. Our selection of which ones to describe is open to criticism, but these do appear to be influential organisations on the international stage. We have deliberately left out local advocacy groups as well as the organisations that host the TB Online website.
Global Fund to Fight AIDS TB and Malaria
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The [Global Fund to Fight AIDS, TB, and Malaria](http://www.theglobalfund.org/en/ "Global Fund"), often referred to as the Global Fund, was founded in 2002 as a multilateral organisation that raises and distributes funds for HIV/AIDS, TB, and malaria programs in low- and middle-income countries. Its founders aimed to add to, rather than duplicate, existing global health institutions like the World Health Organization (WHO) and UN, and to create a faster and more “business-oriented” funding mechanism. The Global Fund provides funding based on proposals designed by countries themselves, and does not engage in project implementation. In addition, the Fund incorporates a broader set of actors than most traditional programs, as it partners with civil society and the private sector in addition to governmental actors. The Global Fund is often confused with the WHO and the UN, partly because these institutions are intimately involved with Global Fund activities through the provision of expertise and direction. Until 2009, Global Fund staff were officially WHO staff members, and the WHO continues to provide administrative services to the Fund.
The Global Fund is organized into different structural levels. Based in Geneva, Switzerland, the Secretariat manages the grant portfolio, screens project proposals, and provides strategic direction. The Technical Review Panel is an independent group of international experts that meets regularly to evaluate proposals and provide funding recommendations to the Board. The Board, composed of a variety of stakeholders, is responsible for establishing strategies and policies, making funding decisions, and setting budgets. At the country level, the Country Coordinating Mechanisms (CCMs) consist of partnerships between the Global Fund and key actors involved in a given country’s response to the three diseases, including some or all of government, NGOs, the UN, and faith-based and private sector stakeholders. CCMs are responsible for project implementation, and they designate one or more in-country Principal Recipients to direct implementation or channel funding to other organisations. The Global Fund’s Trustee, which is currently the World Bank, manages the institution’s money. The Global Fund is thus a collaboration between developed countries, developing countries, the private sector, civil society and affected communities.
Soon after its creation, the Global Fund became the chief multilateral global health funding organisation. Its international funding comes primarily from national governments, and it channels two-thirds of this funding to fight TB and malaria and a fifth to fight HIV/AIDS. The Global Fund now provides 20% of global funding for HIV/AIDS and 66% of funding for TB and malaria. From 2002 to the end of 2010, the TB programs financed by the Fund supported DOTS for a total of 7.7 million people. Its funded projects support more than 600 health programs in 150 countries.
Stop TB Partnership
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The [Stop TB Partnership](http://www.stoptb.org/ "Stop TB Partnership") (STBP) consists of more than 900 countries, national and international organisations, governmental institutions, NGOs, donors, and academics, working together to reduce the toll of TB worldwide and eliminate the disease as a public health problem. Established in 2001, STBP grew out of the Stop TB Initiative launched by the WHO in 1998. It was formed following the Amsterdam Ministerial Conference in 2000, which produced the Amsterdam Declaration to Stop TB.
The organisation is structured into four main components. The Stop Partners’ Forum consists of a large number of collaborating governmental and non-governmental organisations and institutions - including The Union and the Foundation for Innovative New Diagnostics (FIND) - which come together every three to four years primarily for the purpose of information exchange. The last Forum was held in 2009 in Rio de Janeiro. Partner organisations have come together into 7 Working Groups (WGs), which form the second component of the Partnership. These WGs implement research, advocacy and/or operational activities in their specific area of expertise, and include: DOTS Expansion; TB/HIV; MDR-TB; New TB Drugs; New TB Vaccines; New TB Diagnostics; and Advocacy, Communications and Social Mobilization.
The STBP also consists of a Coordinating Board, which provides governance, and the Secretariat, which is housed at the WHO in Geneva. The WHO is closely associated with STBP. As the housing institution, the WHO provides rules and regulations for organisational management. Secondly, as a leading agency in STOP TB with permanent representation in the Coordinating Board, the WHO provides guidance on global policy. The WHO’s Stop TB Strategy, which built on the success of its Directly Observed Treatment Short course (DOTS strategy, underpins the Stop TB Partnership's Global Plan to Stop TB 2006-2015. This plan provides a framework for engaging countries on action needed to implement the WHO’s Stop TB Strategy.
The STBP has established collaborative relationships with a number of countries, for which it provides assistance that ranges from advocacy and resource mobilization to coordination of service delivery. The organisation also runs a Global Drug Facility (DGF) that provides TB drugs at low cost to developing countries.
Global Drug Facility
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The [Global Drug Facility](http://www.stoptb.org/gdf/ "GDF") (GDF) was established by the Stop TB Partnership in 2001 to facilitate the WHO’s DOTS strategy. It is housed in WHO headquarters in Geneva and managed by a small team in the Stop TB Partnership Secretariat. The GDF connects demand for TB drugs with supply and monitoring. Its Direct Procurement service provides first and second-line TB drugs to clients at low cost, while requiring adherence to DOTS. Both governments and NGOs, in collaboration with their respective Ministries of Health, can apply for GDF assistance. The provision of assistance is limited to programmes that have been approved by the Green Light Committee.
All GDF services are provided by competitively outsourced partner companies. A six-month course of first-line TB treatment can be obtained at a price of between US$ 14 -18. In addition to low-cost, quality-assured TB medicines, the GDF also provides in-country technical support on drug management, registration, and supply issues; TB diagnostic kits; and grants consisting of free adult and paediatric anti-TB drugs to countries unable to secure these medications through government or alternative sources of funding. These grants are linked to TB programme performance. Currently, 93 different countries are receiving GDF drugs. The GDF has also recently begun working with the WHO, the Global Laboratory Initiative, and the Foundation for Innovative Diagnostics (FIND) to accelerate access to diagnostics for patients at risk of MDR TB. In this collaboration, the GDF’s role is to procure MDR diagnostic commodities.
Green Light Committee
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The [Green Light Committee](http://www.who.int/tb/challenges/mdr/greenlightcommittee/en/ "GLC") (GLC) is a component of the GLC Initiative, which was started in July 2011 by the WHO and the Stop TB Partnership out of a need to expand access to MDR TB treatment. The Initiative is comprised of the GLC, the WHO, the Stop TB Partnership’s Global Drug Facility (GDF), and organisational partners that provide financial and technical assistance. These partners include the Global Fund and UNITAID.
The GLC Initiative is designed to support countries in the management of MDR TB. It aims to increase access to preferentially priced second-line drugs for the treatment of drug-resistant TB. The Committee is an expert advisory body that provides technical review of proposed drug-resistant TB treatment projects for the Initiative. The WHO is a permanent member of the Committee, while other representatives are normally drawn from the Stop TB Partnership’s Working Group on MDR TB. After reviewing proposals, the Commitee ‘green-lights’ projects that meet certain specifications, including adherence to WHO guidelines. Approved projects then receive access to quality-assured drugs at reduced prices. These drugs are procured through the GDF, which coordinates all procurement and delivery functions for GLC-approved programmes. In addition, the Initiative provides monitoring services to track the performance of all approved MDR TB programmes through annual site visits.
Today, only programmes that have been approved by the GLC are allowed to obtain drugs from the GDF. In 2010, an estimated 13% of the market for second-line TB drugs was channelled through the GDF, while 6,000 patients were enrolled in GLC-approved treatment programmes. This is compared with an estimated 440,000 new cases and 150,000 deaths that year. To expand treatment for MDR TB, MSF recommends that procurement for GDF medicines no longer be restricted solely to GLC-approved programmes, in the recognition that all treatment programmes should be able to obtain quality-assured medicines at a reasonable cost.[^MSF]
The Union
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The Union (www.theunion.org/), formerly known as the International Union Against Tuberculosis and Lung Disease, is the oldest NGO dealing with health in the world. Its origins stretch back to 1867, when health experts convened in Paris to discuss TB, one of humanity’s oldest diseases. It was founded in the 1920s the International Union Against Tuberculosis when 31 countries came together to create a central resource for TB education, research, and advocacy. In the 1990s, the organisation underwent a period of expansion, and in 2002 became known as The Union.
Today, The Union has 3,000 members in 152 countries and 12 offices worldwide. The organisation is headquartered in Paris and has offices around the globe that serve the Africa, Asia-Pacific, Europe, Latin America, Middle East, North America and South-East Asia regions. Regional experts in TB and lung disease come together in regional conferences that are held every two years. The Union is organized into a dual structure: the scientific institute pursues research, education, and technical assistance and is comprised of 300 experts working out of 12 different offices that. The federation is made up of 3,000 organisations and individuals grouped into several categories: constituent members (one per country), organisational members, and individuals. Members of the institute and federation come together to participate through the General Assembly.
The Union expanded its activities beyond TB to include HIV, tobacco control, lung disease, and other issues. It provides technical assistance, education, and training, and conducts research in more than 70 counties each year through five scientific departments: Tuberculosis, HIV, Lung Health & Non-Communicable Diseases, Tobacco Control and Research. In 2004, the organisation created the International Management Development Programme in 2004 to build the capacity of public health programmes in low-and middle-income countries.
FIND
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The [Foundation for Innovative New Diagnostics](http://www.finddiagnostics.org/ "FIND") (FIND) is a non-profit foundation with headquarters in Geneva, and regional offices in Kampala, Uganda, and New Delhi, India. The organisation was launched at a meeting of the World Health Assembly in 2003. FIND aims to provide developing countries with innovative, affordable, and efficient diagnostic products, which are the tools that identify which patients are sick with which disease. Currently, the most widely used TB diagnostic is sputum smear microscopy, but there is an urgent need for the development and implementation of more accurate and efficient diagnostic tools to accelerate the diagnosis of non-resistant and drug-resistant TB infections. The creators of FIND recognized that the lack of effective diagnostic tests is one of the greatest obstacles to the control of diseases like TB in the developing world.
FIND is a Product Development Partnership (PDP) that collaborates with public, private, and academic sectors to drive the development of diagnostics. A large component of FIND’s work consists of supporting the research and development of promising diagnostics by providing expertise, capacity, and facilities, and by overseeing the evaluation and demonstration of these diagnostics in laboratory and field trials. After the WHO approves a diagnostic technology, FIND works with its partners to collect evidence for expansion and supports the widespread implementation of the diagnostic method. FIND also collaborates with public health authorities in developing countries to assist with the investigation of the feasibility and impact of new technologies. The design, development, manufacture, evaluation and demonstration of diagnostic tools, however, are achieved entirely through its partner organisations.
FIND has contributed to efforts to develop the Gene Xpert diagnostic TB test. The organisation initially focused its efforts solely on TB diagnostics, but has since expanded its activities to include malaria and human African trypanosomiasis (HAT), also known as African sleeping sickness. With the financial support of the Bill & Melinda Gates Foundation, FIND and the WHO have recently begun collaborating in the development of much needed diagnostic tests for sleeping sickness.
TB Alliance
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The [Global Alliance for TB Drug Development](http://www.tballiance.org/ "TB Alliance"), commonly called the TB Alliance, was established in 2000 as a non-profit Product Development Partnership (PDP) engaged in the search for and development of TB cures and experimental drugs. The organisation was conceived at a February 2000 meeting in Cape Town, South Africa, where 120 representatives from industry, academia, donors, and NGOs came together to discuss the urgent need for new TB treatments. At the time, efforts to develop TB drugs had stagnated and there were no medicines undergoing clinical testing. The TB Alliance has helped reinvigorate efforts to develop new cures. Today, the organisation leads the advancement of the most comprehensive portfolio of TB drug candidates in history, which includes more than 20 active development programmes and 3 compounds in late-stage clinical testing.
Headquartered in New York and with regional offices in Brussels, Belgium and Pretoria, South Africa, the TB Alliance builds partnerships with a broad range of public and private stakeholders, including pharmaceutical companies, universities, and other research laboratories around the world. The organisation conceives of itself as a neutral third party able to broker partnerships between relevant actors, and has had particular success in developing innovative collaborative relationships with pharmaceutical companies. As a PDP, the TB Alliance retains direct oversight of its projects, although much of the laboratory and clinical work is done though external research facilities and contractors. It manages a portfolio of experimental drugs using a variety of licensing agreements.
The TB Alliance currently has several experimental TB drugs in the pipeline. It has global exclusive rights to PA-824 for the treatment of TB in an agreement with Chiron (now part of Novartis) in 2002. The TB Alliance is currently conducting phase II clinical testing of PA-824. In addition, the TB Alliance gained a royalty-free license to develop TMC207 for drug-sensitive TB from the pharmaceutical Tibotec. TMC207 is also undergoing phase II clinical testing.
SATVI
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The [South African Tuberculosis Vaccine Initiative](http://www.satvi.uct.ac.za/ "SATVI") (SATVI) is the largest TB vaccine research group on the African continent. Established in 2001, SATVI is housed within the Institute of Infectious Disease and Molecular Medicine of the University of Cape Town. Its field site is located in the Boland region outside of Cape Town, which has one of the highest recorded TB rates in the world. It is comprised of professors, clinicians, epidemiologists, immunologists, and other professionals and students.
SATVI aims to develop new and effective vaccination strategies against TB, and is currently conducting standard clinical trials of several novel TB vaccine candidates, including MVA85A. Its recent projects include a phase II study, published in 2010, that evaluated the safety and immunogenicity of MVA85A in healthy children and infants after BCG vaccination at birth. SATVI is currently conducting a phase IIB, double-blind, randomized clinical trial of MVA85A/ AERAS-485 to evaluate the safety and efficacy in preventing TB amongst BCG-Vaccinated, HIV-negative Infants. In addition to conducting clinical trials, the organisation engages in research to address clinical, epidemiological, immunological, and human genetics questions in TB vaccine development.
BCG World Atlas
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The [BCG World Atlas](http://www.bcgatlas.org/ "BCG World Atlas") is an informational, interactive website on the BCG vaccine for TB. The website was originally developed out of a need to provide accessible, up-to-date information on the vaccine; while most experts agree that BCG is effective against severe forms of childhood TB, its efficacy against TB in adults is highly variable. As a result, countries have divergent policies with regard to BCG vaccination. The website creators launched the first searchable, online database of global BCG vaccination policy and practices in 2008. By 2010, the database contained information on current and previous policy and practice for 180 countries. BCG World Atlas serves as a resource for clinicians, policymakers, researchers, and the public, providing information that could be useful for interpreting TB diagnostics and developing new TB vaccines.
TB Drug Resistance Mutation Database
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The [TB Drug Resistance Mutation Database](http://www.tbdreamdb.com/ "TB Drug Resistance Mutation Database") was established by health experts at the Harvard School of Public Health in 2009. Its creators recognized the urgent need for better and more rapid diagnostics for drug resistant TB. In particular, they aimed to facilitate the development of diagnostic methods based on genetic sequencing of specific mutations associated with resistance to certain TB drugs. The website makes information about these mutations accessible to the public through a comprehensive database of the genetic polymorphisms associated with first- and second-line drug resistance in TB bacteria. The most common mutations and the frequency of each mutation have been compiled and organised according to major groups of TB drugs. The website serves as a useful tool for the development of sequence-based TB diagnostics that detect mutations, and for the structural mapping of mutations to illuminate bacterial mechanisms of drug resistance.
[^MSF]: DR-TB Drugs Under the Microscope. MSF Report. March 2011.