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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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The latest G-FINDER report finds that annual investment in neglected disease research and development (R&D) from donors worldwide has been in the decline in recent years. And while the report finds that the United States has maintained its position as the top funder of neglected disease R&D, US funding still decreased in 2011 by $30.6 million. A treatment for sleeping sickness has entered clinical trials in the Democratic Republic of the Congo, and trials will start soon in Central African Republic. The study was initiated by the Drugs for Neglected Diseases initiative (DNDi) and its partners. A new opinion piece argues that sequestration “would significantly delay new, life-saving medical treatments. But what many people don’t realize is that the massive cuts also would put a chokehold on the creation of high-tech jobs and threaten US global competitiveness.” The US Food and Drug Administration approved 35 new medicines in its fiscal year 2012, which ended in September, according to a new report. That number is one of the highest levels in years. Senators Patrick Leahy (D-VT) and Christopher Coons (D-DE) have introduced legislation that aims to bolster the US Patent and Trademark Office’s Patents for Humanity initiative by making certificates awarded through the program transferable to third parties.

In this guest post, Mandy Slutsker, senior project associate with the ACTION Partnership, writes about a new report that calls for increased efforts to fight tuberculosis among children worldwide. When Sipho* was just 18 months old, he began coughing and his feet began to swell. His mother Masia was sent home from a clinic near their home in Swaziland with medicine for a common cold, but his condition only worsened. Eventually, Sipho was diagnosed with a drug-resistant strain of tuberculosis (TB)—and so began an exhausting daily odyssey for him and Masia. Every day for six months, the pair traveled six kilometers so Sipho could receive a grueling treatment regimen of injections and crushed pills. Despite recent progress toward addressing childhood TB at the global level, children like Sipho are still misdiagnosed and subject to harsh treatment regimens meant for adults. Increased investments in research and development are needed to develop new child-friendly TB diagnostics, drugs, and vaccines. Photo credit: PATH As an advocate, I am thrilled to see childhood TB receive this attention—the issue gained recognition at international conferences, served as the theme of this year’s World TB Day, and is the subject of new guidelines from the World Health Organization. But I can’t forget TB takes the lives of 1.4 million people every year—and children remain largely unreached and uncounted. If we want to end TB as a killer of children, we need to do more than just talk. It’s time for action. Unfortunately, many barriers stand in our way—a lack of political will, inadequate funding for TB programs, and failure to invest in research and development (R&D) for child-friendly diagnostics, drugs, and vaccines. The standard microscope method available in many high-burden countries to diagnose TB largely isn’t effective in children, few child-friendly TB drugs exist, and the current TB vaccine fails to protect both children and adults against the most common form of the disease. How do we overcome these challenges? In my opinion, it all comes down to advocacy. It’s time for civil society, healthcare workers, governments, and the private sector to come together and ensure no child dies from this preventable and treatable disease. Civil society must mobilize to ensure governments and donors quickly invest additional resources in R&D to create new child-friendly diagnostics, drugs, and vaccines. In addition to R&D investments, we have to ensure new treatments—and better formulations of existing treatments—can reach children as quickly as possible. So donors, the private sector, and regulatory authorities must all work together to clarify the development pathway for childhood TB drugs. For too long we’ve worked in silos, not communicating with one another. We each have a role to play. We’ve built the momentum, now it’s time to act. Read the full brief, Children and Tuberculosis: From Neglect to Action, at Action.org and join the #kidsTB #putkids1st conversation on Twitter. *Names have been changed to ensure confidentiality

With the results of the presidential and congressional elections now almost two days behind us, there has been increasing reaction and speculation about what President Barack Obama’s second term and new congressional leadership could mean for foreign policy, international development, and global health. Below, we provide a round-up of some of the most interesting reads in the wake of the election results. Devex examines if Obama’s re-election is a “boon for US foreign aid.” While “Obama’s win is good news for the US Agency for International Development (USAID), which could have faced deep budget cuts in a Republican administration,” questions still “linger” over leadership. “Secretary of State Hillary Clinton is not expected to stay for more than a few months into Obama’s second term, if at all. Some Washington insiders also suggest that USAID Administrator Rajiv Shah is interested in pursuing a political career sooner rather than later.” According to the US Global Leadership Coalition (USGLC), the election has resulted in “broad bipartisan support for America’s global leadership and the International Affairs Budget,” although there are “challenges ahead to reconcile commitments to development and diplomacy with the need to address America’s fiscal crisis.” USGLC provides a detailed look at the new players in Washington and the likely playing field for the 113th Congress. The Center for Global Development identifies the “five things that should be at the top of the President’s global health agenda for the next four years.” These priorities include the President’s Emergency Plan for AIDS Relief, strengthening global health partnerships, and sustainability. Both National Journal and Foreign Policy examine how Rep. Howard Berman’s (D-CA) loss and a new Republican chair of the House Foreign Affairs Committee will shake up the foreign policy leadership in Congress. National Journal reports that one day “after the election ensured Republicans will keep their majority in the next Congress, Rep. Ed Royce (R-CA) made his first public play to secure the chairmanship of the House Foreign Affairs Committee.” And according to Foreign Policy, “Berman will be remembered for his decades of tireless work on foreign policy and his reputation as a legislator who sought to build consensus to push forward a bipartisan agenda.” Pharmalot looks at what the US Food and Drug Administration (FDA) will look like after the election results have settled. “Apart from an occasional reference, the agency is not part of the campaign dialogue.” However, the FDA will still be affected by the looming sequester, which would leave the agenda with about $320 million less to spend in Fiscal Year (FY) 2013 than it did in FY 2012. Pharmalot also examines what could happen to FDA leadership in the coming months.