Statement by Dr. Mario Raviglione
Director, Stop TB Department
World Health Organization
The Global Threat of Drug-Resistant TB: A Call to Action for World TB Day
U.S. House of Representatives
Sub-Committee on Africa and Global Health
Washington, D.C.
21 March 2007
I. INTRODUCTION
I would like to begin by thanking Chairman Donald Payne and Ranking Member Chris Smith and the committee staff for organizing today's hearing The Global Threat of Drug-Resistant TB: A Call to Action for World TB Day. This is an incredibly important issue; it is an honor to join you today and to represent the World Health Organization in providing this briefing on the TB epidemic, TB control progress and challenges, including Extensively Drug-Resistant TB, known by its acronym, XDR-TB. I also will address, as requested, the impact of WHO and partners' efforts in fighting this global killer. This includes efforts via the Stop TB Partnership, representing over 500 institutions today, and in which US institutions play a key role. I am also pleased to be asked to note in what ways the U.S. Government can contribute further in preventing and treating all forms of TB.
For more information on the status of the TB epidemic, overall TB control efforts, and global response to XDR-TB, I ask that the following documents be entered into the record of this session as references[1]
II. THE GLOBAL TB EPIDEMIC
The global burden of tuberculosis is enormous despite this being a disease which is preventable and curable. It is a disease present in all regions of the world, but the developing world is most affected as are the poorest and most vulnerable communities in high-income and low-income countries. Most affected are young adults in their most productive years. The 2007 WHO Global TB Control Report will be launched officially tomorrow in lead up to World TB Day, 24 March. Our data and trend analysis are embargoed until tomorrow, but I would like to share some critical information. In 2005, 8.8 million persons fell ill with TB, and that 1.6 million people died due to TB. Nearly 200,000 deaths were among HIV-infected persons. While 60% of the global burden is in Asia, the highest burden per capita is in sub-Saharan Africa. The total number of new cases continues to rise worldwide. Based on 2004 data, last year we reported that incidence was stabilizing or falling in most regions worldwide, except Africa. We will report further on changes in global and regional trends tomorrow. Multidrug-resistant TB (MDR-TB) has emerged in most countries worldwide, with the highest levels in countries of the former USSR and in parts of China.
XDR-TB, which is a more deadly form of MDR-TB, has been reported so far in 35 countries, including the Group of 8. Importantly, XDR-TB has been reported in Southern Africa among people living with HIV infection (PLHIV) is cause for serious concern due to very rapid spread and case fatality rates of above 90%. Most low-income countries worldwide lack the capacity to diagnose XDR-TB, let alone clinically manage the disease.
XDR-TB is a wake up call that there are serious consequences from failure to implement effective TB control and treatment for all forms of the disease. Strengthened TB control must happen alongside expanded HIV care, infection control, and bolstering of general health systems in the countries most affected. The global public health and security consequences will be serious if multidrug-resistant TB is not controlled now.
III. THE IMPACT OF COORDINATED STRATEGY AND RESPONSE
Overall, there has been considerable progress in global TB control this last decade. This year, WHO reports to the World Health Assembly on how well the world did against global 2005 TB control targets. In 1995, only 16% percent of estimated infectious TB cases were detected under effective TB control programs, and for the vast majority of patients no information was available on whether they lived, died or were cured. In 2005, the picture was dramatically different: 60% of estimated TB cases worldwide were detected, but still short of the targeted 70%, and global treatment success was 84%, instead of 85%. 26 countries in all regions, and the Western Pacific Region as a whole, have achieved the 2005 targets. Although a near-miss, these results have had an impact on the TB burden with stabilization and decline in burden already reported for five of six regions in our 2005 report. This is largely the result of an expansion of access to effective treatment. 26 million patients have been treated in 11 years under DOTS, the WHO-recommended TB control approach. DOTS has five elements: political commitment with increased and sustained financing; case detection through quality-assured bacteriology; standardized treatment, with supervision and patient support; an effective drug-supply and management system; monitoring and evaluation system, and impact measurement.
The World Health Organization has worked intensively over the past 15 years to support its Member States to adopt effective TB control practices and achieve measurable progress. WHO develops policies, standards and strategies for TB control; provides direct support to countries in their control efforts; monitors and evaluates TB control progress and impact, supports relevant research; and fosters advocacy and partnerships. Worldwide, in the last 10 years, 187 countries have adopted DOTS.
In 2001, to speed up TB control action worldwide, the Stop TB Partnership was established and its Secretariat housed in WHO. It consists of 500+ institutions committed to a world free of TB; it has a Coordinating Board, a Global Drug Facility and 7 Working Groups. It has proved, as noted in independent evaluations, a model of collaboration and consensus-building. WHO is fully committed to its sustained success. The first Global Plan to Stop TB, 2001-2005, resulted in achievements in all areas addressed, from service delivery to research. The second Global Plan, 2006-2015, proposes actions across all regions and all seven major areas of work of the Partnership, from DOTS expansion, to TB/HIV and MDR-TB response, to development of diagnostics, drugs and vaccines and overall advocacy, communication and social mobilization. The Plan received the endorsement of world leaders, including the G8 nations. If fully financed at US$ 56 billion over ten years, it could save 14 million lives and enable access to new tools to fight and eliminate TB. However, the Plan remains woefully under-funded with a budget gap of $30 billion.
The Partnership's Global Drug Facility which enables financing as well cost-effective pooled procurement to ensure access to anti-TB drugs and innovative patient treatment kits. It has supplied over 9 million patient treatments in six years in DOTS programs. The Partnership and WHO share roles in supporting the Green Light Committee which is enabling access to safe and effective treatment for multidrug-resistant TB in over 40 countries to date. Technical assistance, coordinated by WHO, has enabled support to countries to develop proposals to the Global Fund to Fight HIV/AIDS, TB and Malaria, with an unprecedented 62% success rate in the last round. All of these new supply and collaboration mechanisms work closely with agencies financing TB control including USAID, other bilateral agencies, the Global Fund to Fight HIV/AIDS, TB and Malaria and the World Bank.
To build on DOTS successes, and explicitly address the new challenges of HIV/TB and MDR-TB, WHO developed the new Stop TB Strategy. This was done in collaboration with a wide range of Stop TB partners. The Strategy aims to meet 2015 TB targets. It recognizes that millions more patients, often the poorest and most vulnerable, need access to early detection, care and support. The Strategy calls for active engagement in overall health system strengthening efforts, especially those aimed at resolving the human resources crisis in the health sector in many low-income nations. The World Health Assembly called for this new approach in its resolution on TB in 2005 and has been asked by its Executive Board to consider a draft resolution this May which endorses the Stop TB Strategy, including urgent response by all Member States and WHO to HIV-associated TB, MDR-TB and XDR-TB, and calls for increasing TB diagnostic capacity worldwide and TB monitoring and surveillance, among other concerns.
Key HIV-TB collaborative efforts are defined within the Strategy. Furthermore, the Strategy provides guidance for the mainstreaming of treatment for multidrug-resistant TB. It aims to widen the collaboration between public and private providers which can expand TB case detection by up to 36% in cases documented to date. The Strategy promotes the International Standards of TB Care, an evidence-based set of norms that has been endorsed by national TB programs and over 40 medical associations around the globe.
The empowerment of persons with TB and communities is central to the Strategy. We are seeing in the last few years the important impact of enabling a voice for those affected to express their needs, and to participate in TB control planning and care.
Lastly, the Stop TB Strategy calls for enabling and promoting research. WHO is working with the Stop TB Partnership to foster a "TB Research Movement" to fill the major gaps along the continuum of basic to applied research, and rapid development of diagnostics, drugs and vaccines. All areas of research are needed to reach patients faster, fight new forms of TB and to eliminate this age-old disease.
IV. PREVENTING AND TREATING XDR-TB
I would now like to return to the new threat posed by XDR-TB. In March 2006, CDC and WHO reported for the first time on XDR-TB. XDR-TB is defined as a disease resistant to the most effective classes of second-line drugs, in addition to first-line drugs. Treatment is complex, and given available drugs, cure rates for XDR-TB rarely exceed 40-50%. A cluster of XDR-TB cases in a hospital in South Africa, was identified during the period January 2005-March 2006. It was characterized by extremely high case fatality rates. 52 of 53 patients died. Of the 44 patients tested for HIV, all were positive. Given high case fatality rates and low cure rates, preventing transmission raises a host of challenges for public health practice, medical ethics and patient care.
In October, 2006, WHO urgently convened a task force on XDR-TB. The Task Force devised a framework with priorities for XDR-TB response. First and foremost was the immediate strengthening of TB control in countries as reflected in the Stop TB Strategy and Global Plan to Stop TB, alongside the scaling-up of universal access to HIV treatment and care. Other recommendations focused on improved diagnostic and treatment approaches, laboratory strengthening, infection control and protection of health workers, surveillance and advocacy, communications and social mobilization.
Based on this framework, first priority was given to planning for response in Southern Africa. Over the last months, WHO has been guiding development of a global XDR-TB response plan, with inputs from all regions.
To pursue immediate XDR-TB response this year, full implementation of TB control measures laid out for this year in the Global Pan is needed. The funding gap is close to US$ 3 billion for implementation, technical support and research. Furthermore, for MDR-TB and XDR-TB response specifically, WHO estimates $650 million is needed this year. This includes about $250 million originally planned under the Global Plan plus $400 million more for the urgent requirements of affected countries. This will help jumpstart response through provision of newer diagnostics, drugs, surveillance, training and initiation of treatment programs, and infection control practices. However, this also depends on support for the strengthening of public health services, lab and personnel, and for expanding the availability of human resources.
Throughout Africa, there are DOTS-based TB programs and some served as model national programmes in the 1980s and early 1990s. However, their capacity now is depleted, fragile and insufficient, due to weak health systems, political and social instability, the HIV epidemic and related weakening of the health workforce and services. In Africa today, the 74% TB treatment success rate is 10 points below the global average, and only 50% of estimated infectious TB cases are detected. While new financing is helping expand TB-HIV joint interventions and service delivery, TB control budgets are far below those required to make progress towards the targets, as mapped out in the Global Plan. Increased investment is needed in the mechanisms that are enabling fast access to life-saving drugs, and also needed is more investment in the systems to support their safe and effective use.
In all of Africa, there are only 25 reference laboratories with capacity to conduct cultures and related drug-sensitivity testing. Laboratory capacity is essential for drug-resistant TB treatment and surveillance. There are only two "supranational" laboratories currently assisting African countries to enable capacity-building and quality assurance of their functions. At least five must be fully functional to enable adequate support. Financing sources, such as the Global Fund, USAID, and PEPFAR, are helping but further investment in implementation, technical assistance and research is critical now.
V. ROLE FOR EXPANDED US GOVERNMENT ENGAGEMENT
The last item that you requested that I address is the role the US Government has and can play in TB control, including preventing the spread of XDR-TB. WHO is highly appreciative of the substantial financial support provided by the US Government annually for TB control since the late 1990s to affected countries, WHO, the Stop TB Partnership, and technical partners. The officials for USAID, CDC, and the Office of the Global AIDS Administrator who will be speaking today I am sure will describe in detail their commitments to date. In addition, the NIH is a major source of finance of TB research today.
However, the Global Plan and MDR and XDR-TB Response Plans require that all partners expand their support substantially. We therefore encourage the U.S. Government to consider increased financing through all of its institutions currently engaged in TB control. Increased disease control financing already committed this year for PEPFAR and the Global Fund to fight HIV/AIDS, TB and Malaria has been tremendously important. However, scaled-up support for TB implementation, technical assistance, surveillance and research via USAID, CDC, OGAC and NIH and collaborators will also be essential to reach affected countries and to prevent global spread of all forms of TB.
N.B. For more information on the status of the TB epidemic, global response to XDR-TB, and overall TB control efforts, I ask that the following documents be entered into the record of this session as references - the 2007 WHO Global Report on TB Control, WHO fact sheets on the TB epidemic and response, and the report of the October 2006 WHO Task Force on XDR-TB.
[1] WHO. Global tuberculosis control: surveillance, planning, financing. WHO report 2007. Geneva, WHO, 2007 (WHO/HTM/TB2007.376). Available as of 22 March at http://www.who.int/tb
Stop TB fact sheets: http://www.stoptb.org/resource_center/fact_sheets.asp
The Stop TB Strategy. Geneva, WHO, 2006 (WHO/HTM/TB/2006.368) http://www.who.int/tb/features_archive/stop_tb_strategy/en/index.html
Stop TB Partnership and WHO. Global Plan to Stop TB 2006-2015. Geneva, WHO, 2006
http://www.stoptb.org/globalplan/assets/documents/GlobalPlanFinal.pdf
WHO. Control of XDR-TB Update on progress since the Global XDR-TB Task Force Meeting, 9-10 October 2006 http://www.who.int/tb/xdr/globaltaskforce_update_feb07/en/index.html
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