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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Kathy Neuzil, director of Vaccine Access and Delivery at PATH, reflects on the lessons learned from Meningitis Vaccine Project (MVP) in light of the achievement of its final milestone: World Health Organization prequalification of an infant version of the meningitis A MenAfriVac® vaccine. MenAfriVac® was approved for people aged 1 to 29 years in 2010, and has since been used to effectively protect 215 million people in sub-Saharan Africa. Neuzil attributes MVP’s success to the tenacity of its team and the inclusion of country partners at every stage from product development to distribution. A new type of antibiotic may be the key to treating drug-resistant infections, according to a study published in Nature last week. The antibiotic, teixobactin, was extracted from dirt, and fights infections by targeting the fatty molecules that bacteria use to build their cell walls. While most antibiotics target the bacteria’s DNA, which can be easily mutated, the study’s lead researcher, Kim Lewis, believes it would take at least 30 years for the fatty molecules to mutate and thus develop resistance to teixobactin. The antibiotic has been successfully tested on mice with no side effects, and could be available for use in humans in five to six years. Johnson & Johnson has started human trials of an experimental Ebola vaccine in the United Kingdom, and hopes to expand testing to approximately 2,000 people by mid-February. Johnson & Johnson has produced over 400,000 courses of the vaccine and has invested significantly in the Danish pharmaceutical company Bavarian Nordic to develop a booster shot to enhance the efficacy of the vaccine and to promote long-term protection against Ebola. Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), sat down with Ryan Hohman of Friends of Cancer Research last week to discuss hot topics in FDA drug policy. Hamburg affirmed the FDA’s commitment to expediting research and development of new treatments, stating that in this “critical time for biomedical research and innovation” the FDA has a role to play in “translating all of the exciting new discoveries and opportunities and science into real world products that matter for people.”

There are many reasons why US policymakers should support global health R&D. Photo: NIAIDAt the Global Health Technologies Coalition, our mission is to advance—through advocacy—the research and development (R&D) of new tools to prevent, diagnose, and treat global diseases. So in that spirit, here’s our list of the top ten reasons why US policymakers should support global health research and development: Global health R&D saves lives Thanks to US support for global health R&D, millions of people around the world are living longer and healthier lives. Breakthrough technologies have led to the elimination of smallpox and the near eradication of polio, and they have dramatically extended the lives of those living with HIV and AIDS. The fruits of investment in global health innovation are undeniable—since 1990, the under-five child mortality rate has been cut in half, maternal deaths have declined by 45 percent, and deaths from infectious diseases have dropped by around 25 percent. Global health R&D creates jobs and drives economic activity in the United States Around 64 cents of every dollar spent by the US government on global health R&D goes directly to US-based researchers and product developers, creating jobs, building US research and technological capacity, and providing a direct investment into the US economy. Across the nation, the life sciences field is responsible for more than seven million jobs and contributes US$69 billion annually to the US gross domestic product. Global health R&D improves our nation’s security and keeps Americans safe Infectious diseases like Ebola, HIV and AIDS, and pandemic flus know no borders. In today’s increasingly globalized world, the health of Americans and the health of populations abroad are interdependent. To keep Americans safe, it is essential that we have the tools to detect, prevent, and treat global diseases. To achieve this, the United States must invest in R&D now so we are fully prepared to tackle global health threats when they emerge in the future. Global health R&D is a smart investment that promotes cost-savings The development of global health innovations like vaccines can product cost savings long term. Photo credit: PATHInvestments in global health research not only saves lives but also produces cost savings and efficiencies in the long term. For example, past research has led to the creation of a polio vaccine that has nearly eradicated the disease globally. It is estimated that polio vaccinations have saved over US$180 billion in direct treatment costs in the United States alone over the last half century. A new meningitis vaccine introduced in 2010 is expected to save about US$570 million over the next decade, and new treatment regimens under development for drug-resistant tuberculosis (TB) could reduce the costs of treatment by up to 90 percent. Global health R&D drives economic growth in developing nations By producing technologies that make people healthier and increase their productive years, global health research can drive economic growth in developing nations. The Lancet Commission on Investing in Health found that nearly one quarter of all economic growth in low- and middle-income countries between 2000 and 2011 was attributable to increases in individual health and productivity brought about through improvements in health systems and investments in health innovation. As developing nations continue to work in partnership with the United States to strengthen their health systems and economies, the need for US assistance will be reduced over time. Global health R&D protects US troops and citizens who work or travel abroad US investments in the development of new tools to prevent, diagnose, and treat diseases such as TB, dengue, and malaria can help protect US citizens serving in the military, traveling, or working abroad in regions that put them at risk. The US Department of Defense (DoD) has been instrumental in advancing a variety of global health technologies for that purpose. For example, the agency supported the development of the first vaccine for Japanese encephalitis and the malaria vaccine candidate RTS,S. DoD programs also conduct ongoing research toward the development of an HIV and AIDS vaccine and new prevention and treatment options for malaria and other tropical diseases. Investments in global health R&D demonstrate America’s character and strengthen US relations around the world Investments in global health R&D demonstrate our nation's character. Photo: PATH/Gabe BienczyckiThe United States is the largest supporter of global health R&D in the world. US investments in global health research are an expression of our nation’s compassion and dedication to improving human lives worldwide, as well as an important instrument of foreign policy and diplomacy. US-led global health knowledge-sharing and capacity-building activities enhance our diplomatic relations with other nations, and US-supported global health innovations can strengthen fragile states by promoting improved health, economic development, and stability. US investments in global health R&D have a multiplier effect To support global health product development, the US government works in partnership with the pharmaceutical and biotechnology industries and academic and philanthropic sectors to leverage US investments in global health R&D and enable partners to bring their complementary skills, capabilities, and comparative advantages to bear. Investments made by the United States are matched with inputs from other sectors, meaning the impact of each US government dollar invested is multiplied. Global health R&D helps the Unites States maintain its long-term competitiveness in medical innovation While the US is undoubtedly the global leader in medical innovation, other traditional funders—and emerging nations like China—are increasing their investments and competitiveness in the industry. For example, China’s share of the global pharmaceutical industry output increased seven-fold between 1995 and 2010—from 2.5 percent to 18.3 percent—while America’s share remained steady around 26 to 27 percent. If the United States wants to remain the global leader in medical innovation, our government must continue to support strong investments in medical research, including funding global health research and product development. A majority of Americans support US investment in global health R&D There is strong support among both the American people and businesses for the United States to invest in new global health advancements. A 2011 poll commissioned by Research!America found that 78 percent of Americans believe it is important for the United States to support global health research. The same poll found that 76 percent of Americans believe that global health research and development is important to the US economy.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Independent examined what’s known about the effectiveness of an experimental Ebola treatment involving blood transfusions from survivors of the virus to current patients. The treatment—known as passive immunotherapy—was first tested by doctors in 1995 during an outbreak in what is now the Democratic Republic of Congo. Of the eight patients who received blood transfusions, only one died, while the rest recovered completely, a 12.5 percent mortality rate during an epidemic with an 80 percent mortality rate. While some researchers argue these results make a case for wider use of passive immunotherapy, others note that very little is known about the efficacy and safety of the treatment, particularly in the current epidemic. The race to develop an Ebola vaccine is gaining momentum. The results from the first African trials of an Ebola vaccine—which ended in 2010—were published last week. The US National Institutes of Health had used knowledge gained from these trials to develop a more potent vaccine candidate, which recently completed Phase 1 trials and will begin Phase 2 trials in West Africa early this year. Another vaccine candidate, developed by NewLinks Genetics Corp and Merck & Co., is undergoing trials in Geneva and has been granted US$30 million from the US Biomedical Advanced Research and Development Authority for further testing. Mitchell Warren, executive director of AVAC, highlights some of the advancements in HIV prevention research that will be forthcoming this year. In the first quarter of the year, results from the FACTS001 study—which is looking at the effectiveness of tenofovir antiviral gel in preventing HIV transmission before and after sex—will be announced. Results from two other microbicides trials are also expected to be released in late 2015 or early 2016. This year, an AIDS vaccine trial will begin in South Africa which will follow up on 2009 vaccine trial in Thailand which demonstrated some level of protection against HIV. It was a strong year from drug approvals at the US Food and Drug Administration. The agency approved 41 new drugs in 2014, a 52 percent increase from the 27 approved in 2013, and the highest count since 1996. Approximately 40 percent of the new medicines approved were for rare diseases, which highlights the industry’s focus on this research area for which the competition is limited and the cost per patient is high. Kat Kelley is GHTC's Senior Program Assistant.

Congress passed an omnibus spending bill which largely flat funds global health R&D programs. Photo: Tim Evanson Working over a rare weekend session and racing against the clock to keep the government open, Congress finally came to an agreement on a year-long spending plan to fund the government through September 30, 2015 (with the exception of the Department of Homeland Security, which only goes through February 27). The package sustains budgets for global health research and development (R&D) and includes policies which we hope will improve coordination across the government to ultimately strengthen the impact of US investments. State, foreign operations, and related programs (SFOPS) For the most part, global health programs funded through the State Department and the US Agency for International Development (USAID) were essentially flat funded. Total fiscal year (FY) 2015 funding for USAID and State was US$8.44 billion, slightly above FY2014’s $8.454 billion. While most programs remained the same, Gavi, the vaccine alliance received a boost of $25 million, and malaria was increased by $4.5 million. While there was a $300 million decline in US contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria, bilateral funding for HIV and AIDS received a $300 million increase. One thing we were watching closely was how the bill would handle the White House’s proposed cut to tuberculosis funding—thankfully appropriators rejected the proposed cut and went with the higher House number of $236 million—which was the same as last year. In addition to tracking final funding levels, we were anxiously watching to see how appropriators would handle report language. The SFOPS explanatory statement noted that unless specifically stated, all report language put in the FY2015 House and Senate report still stands. As noted in our previous blog on report language, we are thrilled to see the Committee direct USAID to coordinate across the government with other agencies involved with global health R&D to ensure efforts are efficient and coordinated. Health and human services (HHS) The FDA received a 2 percent increase in FY 2015 funding over FY 2014 funding. Photo: FDA/Michael J. Ermarth At just over $30 billion, funding for the US National Institutes of Health (NIH) increased by $150 million in base funding from 2014, but still came in below both the White House and Senate request. Within the NIH, the National Institute of Allergy and Infectious Diseases, the Fogarty International Center, and the National Center for Accelerating Translational Science (NCATS) were essentially flat funded with NCATS receiving a slight increase of $2 million. Overall funding for global health at the US Centers for Disease Control and Prevention (CDC) remained the same. Within the CDC’s global health programs, the global immunization program overall, and specifically polio, saw slight increases of 3.8 percent and 5.8 percent respectively. Finally, the US Food and Drug Administration (FDA) was funded at $4.43 billion, which reflected the higher Senate request and was just over a 2 percent increase from FY2014 (note this number includes user fees). We were pleased to see appropriators include strong HHS report language around the need for coordination among agencies. Included in the joint explanatory statement was a request for a global health strategy that would direct the CDC, FDA, and NIH to “jointly develop, coordinate, plan, and prioritize global health research activities.” Defense The peer reviewed medical research program at the US Department of Defense (DoD)received funding at $247.5 million—$47.5 million more than FY 14 levels. This program funds important research for dengue and malaria. We were pleased to see that the final omnibus also includes language submitted by the GHTC affirming the DoD contributions to global health R&D, and asking the agency to improve upon current reporting on its work in infectious disease research. The report language also noted the importance of DoD’s research around malaria, dengue and Chikungunya and encouraged continued research and partnerships with other federal agencies and non-profit organizations. Ebola emergency funding Congress provided $5.4 billion in additional funding for US agencies to tackle Ebola. Photo: CDC/Sally Ezra Included in the $1.1 trillion omnibus agreement was $5.4 billion in additional funding for Ebola response at home and abroad (as a reminder, the president requested $6.2 billion). Out of that $5.4 billion, $2.5 billion is for the Department of State, $2.7 billion for HHS, which includes $1.78 billion for the CDC’s work in the US and around the world (including $597 million for the CDC to set up and strengthen National Public Health Institutes), $238 million for NIAID’s research (including its work on Ebola vaccines), and $157 million for research through the Biomedical Advanced Research and Development Authority (BARDA) at HHS. This funding for Ebola is on top of previously noted funding levels. We’re glad to see that appropriators heard our call that funds to meet the Ebola crisis must be made in addition to other global health funds and not at the expense of other spending. While we would have liked to see higher increases overall, we’re glad funding for global health R&D has been sustained and that important policy shifts are taking place to ensure increased efficiency and coordination, and ultimately making sure that we are seeing maximum bang for our buck.