Addressing the Threat of Drug-Resistant Tuberculosis A Realistic Assessment of the Challenge: Workshop Summary (2009) / Chapter Skim
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From page 1... ...
While MDR TB has been under control in the United States since it was first recognized, worldwide an estimated 4.8 percent of all new and previously treated TB cases diagnosed in 2006 -- nearly half a million cases -- were MDR according to the World Health Organization (WHO, 2008b)
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From page 2... ...
Forum on Drug Discovery, Development, and Translation held a workshop in Washington, DC, on November 5, 2008. The goals of this workshop were to understand the magnitude and nature of the drug resistance problem; to assess the adequacy of the current global response; and to examine key obstacles to effective diagnosis and treatment, including inadequate diagnostic capacity, a lack of new drugs, bottlenecks in the supply chain of existing drugs, drugs that are counterfeit or of poor quality, suboptimal treatment regimens and patient management practices, inadequate infection control, inadequate in-country health systems, and a lack of resources.
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First, drug resistance surveys have not been conducted in 25 of the 46 countries in Africa. Second, in many countries, the availability of diagnostic laboratories is limited; for example, 9 African countries lack even a single reference laboratory capable of culturing TB and making a diagnosis.
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From page 4... ...
In one study, for example, about half of those patients who died from highly resistant forms of TB had never before been treated for the disease, and 85 percent had a genetically similar strain, indicating that resistance was likely transmitted rather than acquired. Other studies using molecular fingerprinting have shown that patients who relapsed with MDR or XDR TB had different genotypes in their relapse isolate compared with their initial isolates, suggesting that their relapses occurred as a result of primary transmission rather than acquired resistance.
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It is estimated that a mere 5 percent of all MDR TB cases are currently being detected. While current global capacity allows for the conduct of approximately 10 million culture tests, WHO has estimated that the actual need is at least 60 million (Weyer et al., 2007)
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Current programs are often fragmented and limited in scale, and it is frequently difficult to scale up successful programs to the regional or country level. Effective public health models, such as providing patients with housing as an alternative to hospitalization and training villagers to serve as community health workers, have yet to be widely adopted.
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From page 7... ...
The lavender portions indicate the number Figure 3-1 of patients treated in non-GLC-approved projects; the purple portions indicate the number of patients treated in GLC-approved projects; and the yellow portions rep resent patients receiving no treatment. GLC = Green Light Committee.
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From page 8... ...
The latter figure includes a rapid ramp-up in the African region from 0 to 15 projects, as well as a large number of projects in Eastern Europe. Despite this recent growth, GLC projects represent only a tiny fraction of the more than 400,000 MDR TB cases estimated to occur each year.
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About two-thirds of drugs that make it all the way to pivotal clinical trials will ultimately be registered. Ann Ginsberg of the TB Alliance identified a number of strategies for addressing the challenges facing TB drug development: • Focus on developing multidrug regimens rather than individual drug candidates.
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From page 10... ...
Development of effective vaccine and chemotherapy prevention strategies for all forms of TB. Fauci cited several critical success factors for accelerating the development of new TB drugs and vaccines: a commitment of substantial financial resources, enlistment of the best and brightest investigators, engagement of the affected communities, collaboration with industry and global organizations, and support from leaders and policy makers.
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Push mechanisms stimulate the supply or production side of the market, while pull mechanisms stimulate the demand side. The Orphan Drug Act of 1983 is an example of a push mechanism because it is aimed at making the development of an orphan product easier, less costly, or less risky for a company.1 BioShield2 represents another form of push mechanism that involves directly funding research and development for terrorism countermeasures.
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She remarked on the workshop presentations indicating the high degree of primary transmission, in stark contrast to what has generally been believed in the past about the ability of these organisms to spread. Despite these growing concerns, she observed that the diagnostic capabilities, resources, treatment and infection control policies, data collection mechanisms, and research capacity needed to understand the MDR and TB crisis effectively still are not in place.
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From page 13... ...
2008b. Anti-tuberculosis drug resistance in the world, fourth global report by the WHO/IuATlD global project on anti-tuberculosis drug resistance sureillance.
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