In this guest post, Eleonora Jiménez-Levi—senior researcher at the Treatment Action Group (TAG)—writes about the latest report on the state of funding for tuberculosis (TB) research and product development. Mycobacterium tuberculosis (MTB) is one of the oldest known human pathogens that continues to pose a global public health threat in the 21st century. The World Health Organization reports that MTB—the bacterium that causes TB disease—was responsible for 1.4 million deaths in 2011, including 430,000 deaths among people with HIV. Current strategies and tools cannot effectively prevent and control TB. BCG, the only vaccine approved for TB, is over 100 years old. BCG cannot offer protection against pulmonary TB, and cannot be used among HIV-positive infants. The most widely used diagnostic tool—sputum smear microscopy—detects roughly 50 percent of pulmonary TB cases, and fares far worse among people with immature or compromised immune systems. Treatment against drug-sensitive TB involves 6–9 months of first-line drugs, and drug-resistant TB requires 20 months or more. The lengthy treatment regimen results in suboptimal and, at times, deadly outcomes because of several challenges including difficulty of adhering to treatment, drug stock-outs, toxic side effects, treatment costs, and incompatibility between TB drugs and antiretroviral medicines for people with HIV. A doctor examines the chest x-ray of a TB patient. Photo credit: PATH. For the seventh year, TAG and the Stop TB Partnership have published the latest investment data and analysis on the state of global TB research and development (R&D) funding. The 2012 Report on Tuberculosis Research Funding Trends: 2005–2011 builds on seven years of investment data to report on annual funding trends and gaps among the leading TB R&D donors. The report analyzes current spending levels across six research areas to assess how they compare to the R&D funding targets in the Global Plan to Stop TB 2011-2015. The new report found that in 2011, 81 donors invested $649.6 million in TB R&D. This is an 82 percent increase from the baseline year of 2005, but only a 3 percent increase over 2010 funding. The top ten donors disbursed $506.7 million of the $649.6 million total, or 78 percent of the global share. Despite the small funding increase observed between 2010 and 2011, the world continues to fall $1.35 billion short of the annual $2 billion funding target recommended by the Global Plan. To accelerate global TB R&D and capitalize on the scientific gains achieved in the last decade for drug, vaccine, and diagnostic development, more financial resources are needed, particularly in: Biomarker discovery to modernize TB drug and vaccine development by demonstrating the progress and effects of treatment or immunity early on, which in turn radically reduces the time and costs of the clinical trials. Biomarker discovery for the development of a point-of-care diagnostic test that can identify people with latent TB at risk of developing active TB, as well as biomarkers associated with infection, treatment response, cure, and drug susceptibility or resistance. TB sample banks that support biomarker discovery with well-characterized specimens. Late-stage drug and vaccine clinical trials, many of which will take place in high-burden countries with limited laboratory capacity or infrastructure that meet good clinical practice standards. Basic science research to enhance our scientific understanding of TB disease and the MTB pathogen. The global TB community should also give further consideration to: Establishing access plans to optimize the rational use of new TB drugs and regimens when they become available, as well as prevent the emergence of resistance to new TB treatments. Developing pediatric investigational plans to ensure child-friendly formulations are available as quickly as possible. Conducting drug-drug interaction studies for novel TB drug regimens. Providing compassionate use and expanded access, which are particularly important for people with drug-resistant TB who have limited treatment options. Modernizing TB regulatory guidelines and streamlining regulatory requirements across and within regions. All of these recommendations and more can be accomplished if policymakers, researchers, activists, clinicians, donors, implementers, and people affected by TB pledge their commitment to achieve zero TB deaths, zero new TB infections, and zero suffering from TB. The Zero Declaration, created by a worldwide group of TB stakeholders in June 2012, is a new strategy that calls on the international community to embrace a “new global attitude in the fight against TB … and mobilize sufficient political will and resources to prevent needless transmission, sickness, and death.” The goal of the campaign is to organize and inspire people to work toward eliminating TB as a public health threat with greater urgency, more political will, and increased investments. Promising new tools are on the horizon, but without political will and adequate funding to support the development of new vaccines, diagnostics, and drugs, the world will not be able to contain the growing problem that drug-resistant TB poses, much less eliminate TB as a public health threat by 2050.

Eleonora Jiménez–Levi is a senior researcher for the Treatment Action Group (TAG), a GHTC member, and wrote this blog post in conjunction with the release of a new report from TAG about funding for tuberculosis (TB) research and development (R&D). TAG has released a new report in collaboration with the Stop TB Partnership, which finds that in 2010 the world invested just $617 million in TB R&D—less than one-third of the estimated $2 billion annual investment needed to eliminate TB as a public health threat by the year 2050. The report, Tuberculosis Research and Development: 2011 Report on Tuberculosis Research Funding Trends, 2005-2010, tracks annual research spending across six TB R&D areas against funding targets set by the Global Plan to Stop TB 2011-2015. The report offers year-to-year data on the leading TB research funders and underscores the urgency of adequate and sustained funding. Dr. Lucica Ditiu, Executive Secretary of the Stop TB Partnership, emphasized this critical need for sufficient funding by saying “with current levels of funding it will be impossible to meet the research targets of the Global Plan to Stop TB 2011-2015. This is a completely unacceptable situation, because those targets are, I would dare to say, even modest. Where is the funding to push ahead research for a point-of-care diagnostic test accessible to all, new drugs for a shorter treatment time and a fully effective vaccine?” For the sixth consecutive year, R&D for TB treatment was the most well-funded research area—growing by 19% from $192 million to $227 million. However, this was just 31% of the $740 million annual Global Plan target for TB treatment research. The report also documents significant funding declines in basic science and vaccines research, which dropped 27% and 29%, to $126.6 million and $78 million, respectively. TB diagnostics accounted for 7% of global total spending with $44.6 million—a 15% increase from 2009. The infrastructure/unspecified category grew 46% to $83 million and operational research rose 17% to $58.1 million in 2010. Measuring these totals against the Global Plan targets, the only category to come close to its annual target was operational research and the farthest one was TB diagnostics. According to the World Health Organization, there were 8.8 million people newly diagnosed with TB and 1.45 million deaths in 2010, including 1.1 million new cases and .35 million deaths among people with HIV. Resources to develop new tools to prevent, detect, and treat TB have never been more urgent. “Recent progress in TB research is clearly threatened by stagnating funding,” said TAG’s executive director, Mark Harrington. “After several years of increasing investment, TB research is finally making headway with two new promising drugs for the treatment of multi-drug resistant TB and a new drug combination active against both drug sensitive and drug resistant TB. Cutting investments now will cost lives in the future.”