Marissa Chmiola

21st Century Cures.Last week, the House Energy and Commerce Committee unanimously voted to approve the 21st Century Cures Act—a bill that aims to speed the development, approval, and introduction of new health technologies.Clocking in at over 300-pages, the legislation is packed full of proposed changes to the way health products are developed by the US National Institutes of Health (NIH) and regulated by the US Food and Drug Administration (FDA). Below, GHTC breaks down a few of the proposed changes that could matter most to global health researchers, product developers, and advocates.NIH receives boost in funding The legislation would reauthorize the NIH for the next three fiscal years (FY) and boost funding over that period, starting with US$31.8 billion in FY 2015 and increasing to $33.3 billion and $34.8 billion in FY 2017 and 2018 respectively. (As a reference, current NIH funding is around $30.3 billion.) It is important to note this boost is in discretionary spending, rather than mandatory spending, so these increases could still be subject to spending caps and sequestration cuts which in the past have significantly reduced NIH’s budget.The legislation would also provide $10 billion in new NIH funding over the next five years through the establishment of a new “NIH Innovation Fund.” This pot of money is mandatory spending, and thus would NOT be subject to spending caps and sequestration. The legislation mandates that at least $500 million per year of the fund would go to a new Accelerating Advancement Program, which seeks to address unmet medical needs in the United States including infectious diseases and neglected tropical diseases and antibiotics.The legislation would also mandate that the NIH, and the centers and institutes within it, develop five-year strategic plans to guide research activities. The language defining how NIH must use portions of the funding is unlike current NIH funding allocations and has some concerned that Congress is being too prescriptive with scientific research.NCATS permitted to expand into later stage research Photo: National Institute of Allergy and Infectious DiseasesThe Cures Act would remove current restrictions that prohibit the National Center for Advancing Translational Sciences (NCATS) at NIH from supporting clinical trials beyond phase IIA—the first round of trials to test efficacy, rather than just safety of a treatment in humans.NCATS was created to help advance translational science, particularly for rare diseases in the United States. At the time it was created, Congress prohibited the center from conducting later stage clinical research out of fear that it would then be competing with and duplicating private-sector product development activities. This legislation lifts that prohibition, extending NCATS ability to conduct trials through stage III—the final pre-market stage where safety and efficacy of a treatment are tested in in large groups of individuals.Many global health conditions qualify as rare diseases under the program’s definition because they impact fewer than 200,000 people in the United States, meaning this legislation change could permit NCATS to support later stage clinical research for many neglected diseases and other global health conditions.Bill promotes pediatric research Under the legislation, NIH would be required to establish a national pediatric research network to pool resources and coordinate activities on pediatric diseases. This legislation also encourages the NIH and FDA to work with the European Union, industry, and other partners to establish a global pediatric clinical trials network.Drugs often react differently in children than they do in adults, and creating pediatric-specific treatments has proved challenging for researchers and product developers producing treatments to be used both domestically and globally. This legislation seeks to overcome some of these challenges by promoting development and testing of pediatric formulations of drugs.Congress acknowledges importance of agency participation in scientific conferences The act includes a sense of Congress acknowledging the importance of participation in scientific conferences and meetings for both NIH and FDA employees. While the legislation doesn’t go so far as to lift existing restrictions or provide funding for participation, Congress’s recognition of this importance is a critical step forward.A GHTC analysis found that many agency representatives cite a lack of funding for participation in scientific conferences as a serious hindrance to enhancing coordination and collaboration among agencies engaged in global health research and development (R&D).Increases use of biomarkers and surrogate endpoints as clinical evidence at FDA Photo: FDA/Michael J. ErmarthThe legislation paves the way for the FDA to rely on biomarkers and other surrogate endpoints to accelerate product approval for a broader category of products. Proving that a product or treatment can successfully produce the desired clinical endpoint—may not be feasible in certain circumstances or can often require clinical trials that are large, long, and costly. So in some cases, trial sponsors have proposed using biomarkers—or biological indicators—that are correlated with the clinical endpoint as a substitute to assess the efficacy of a treatment or product more easily. For example, to measure whether a treatment prolongs cancer survival—a clinical endpoint—one might assess a surrogate endpoint like whether the treatment succeeds in shrinking tumors.At the moment, the FDA permits use of surrogate endpoints for accelerated approval for drugs intended to treat a narrow category of patients with life-threatening illnesses and unmet needs. The bill calls on the FDA to establish guidance for use of qualifying biomarkers and work with sponsors to establish parameters that would allow for approval of a broader set of products using surrogate endpoints.Use of surrogate endpoints poses both benefits and challenges. It could lower R&D costs and reduce the length of time needed to conduct clinical trials, thereby accelerating the availability of treatments. However, at the same time, it can often prove difficult to determine if a surrogate endpoint or biomarker is a reliable indicator that the product has the intended clinical benefit. For example, elevated cholesterol levels are linked with heart disease, but at the same time, it is possible that a drug that reduces cholesterol will have no measurable impact in preventing deaths from heart disease.Spurring antibiotic drug development If enacted, the Cures Act would create a new expedited FDA review pathway for antibiotics intended to treat “a serious or life-threatening disease, condition, or indication” and intended for use in a limited target population. This new pathway could allow the FDA to approve a product based on earlier Phase II trials and surrogate endpoints, rather than larger, later-stage Phase III clinical trials.Some organizations support this new pathway, arguing that it would expedite patient access to new antibiotics and help tackle growing antibiotic drug resistance. Others argue that this new pathway would allow products to be approved based on lower FDA standards, which could in turn put patient health and safety at risk.The bill would also increase Medicare payments to hospitals who use certain new antibiotics as a way to financially incentivize private-sector development of critically-needed new antibiotics. However, some critics of this provision argue that it would be counterproductive to the intended goals and would instead encourage overuse of new antibiotics, which would in turn hasten the development of drug resistant strains and further exacerbate the problem of antibiotic resistance.Changing the way medical devices are reviewed and approved Photo: FDAUnder the legislation, medical devices would be eligible for “breakthrough” designation by the FDA, which allow them to receive priority, expedited review.This new priority review program for devices is modeled after the breakthrough therapies program for drugs and is intended for “breakthrough technologies” for either conditions “for which no approved alternatives exist” or that would offer “significant advantage over existing approved or cleared alternatives.”In addition to creating this priority review pathway for medical devices, the legislation would also direct the FDA to take steps to ensure clinical trial designs for medical devices are “as efficient as practicable,” by exploring options such as the adoption of shorter or smaller trials, use of surrogate endpoints, or adaptive trial design.In an effort to further accelerate approvals of medical devices, the legislation would significantly alter the type of evidence the FDA could consider when reviewing a device for approval. This bill would allow the FDA to consider as valid scientific evidence case histories, registry data, studies published in peer-reviewed journals, and data collected in countries other than the United States. While this change could help speed the testing and approval of critically needed devices, critics argue it could also undermine FDA’s ability to ensure medical device safety and efficacy— citing the fact that case histories are anecdotal and lack a control group, while journal articles can often leave out critical information or can include mistakes, misrepresentation, or fraud, which the FDA may not become aware of if it relies solely on the published articles.Expansion of market exclusivity, but less than originally anticipated The legislation would extend by six months market exclusivity for drugs approved for a new indication or use for a rare disease or condition, extending a drug’s exclusivity period not only for the new indication, but for all of the drug’s indications.The purpose of market exclusivity is to help companies recoup the investments they made into R&D for a product or therapy and encourage future private-sector investment in research and product development. However, critics also note that extending market exclusivity delays entry of generics into the marketplace which can lead to increased costs for patients and limit affordable access to lifesaving health technologies. Product price can pose a significant barrier to access particularly in low- and middle-income countries.Earlier versions of the legislation featured additional provisions extending market exclusivity that were taken out of the version approved by the Committee. These included provisions which would have permitted the sale of market exclusivity to other companies and extended exclusivity for follow-on drugs and first-to-file American-made generic drugs.FDA receives increased funding To ensure FDA has the capacity to carry out its programming, the legislation would increase FDA funding by $550 million over the next five years. The bill would also exempt FDA user fee programs from sequestration spending cuts.While passage of the legislation through the Committee is a critical milestone, the act still has a long journey before it can become law. The legislation is expected to be voted on by the full House of Representatives in June. Meanwhile, parallel legislation is under development in the Senate. If both pass their respective chambers, the two versions will eventually have to be reconciled by both chambers before the legislation can be passed and then sent to the President for consideration. GHTC will continue to monitor this legislation as it develops.

Breakthrough ideas are like children—they start small, they need constant nurturing, they don’t always develop according to schedule, but they change lives forever. In honor of Mother’s Day, GHTC is highlighting the stories of five mothers who have given birth to scientific discoveries or bold ideas that have transformed global health. 1. Ruth Bishop (b. 1933), Discoverer of Rotavirus Ruth Bishop at work in her lab. Photo: Stepping Stone Pictures As a young bacteriologist working in the 1970s, Ruth Bishop was on a quest to find the root cause of diarrheal disease—the most common illness among children worldwide. After much research, Bishop concluded that the disease was likely not caused by a bacterial agent, but instead by a virus. To continue her search, Bishop teamed up with two colleagues at the University of Melbourne – virologist Ian Holmes and electron microscopist Brian Ruck. In 1973, using an electron microscope, the team uncovered a previously unidentified virus in the biopsy sample from an intestinal lining. Bishop and her team went on to confirm presence of the virus in other samples. Their published results elicited a global response and confirmation of the virus’s presence in samples around the globe. The virus identified by Bishop and her team would come to be named rotavirus for its wheel-like shape. Rotavirus is the leading cause of severe diarrhea in children worldwide and affects nearly every child in their first three years of life. Bishop and her team went on to develop a diagnostic test for the virus, and their continued research helped pave the way for the development of a rotavirus vaccine which was introduced more than three decades after their initial discovery. Today there are two rotavirus vaccines commercially available with additional candidates in the research pipeline. Gavi, the Vaccine Alliance estimates that by 2030, 2.4 million lives could be saved through rotavirus immunization. Bishop, who is the mother of one son and is now officially retired, has watched these vaccine developments with excitement. “Rotavirus will always be around,” she said, “but we can stop it from being a killer.” For more information on Ruth Bishop, check out this Science in Public article. 2. Rosalyn Sussman Yalow (1921-2011), Unlocked breakthrough diagnostic technique Rosalyn Yalow at Bronx Veterans Administration Hospital in October 1977. Photo: US Information Agency Rosalyn Sussman Yalow knew by the age of eight that she wanted to be a scientist. Despite living in a time when few scientific opportunities were available to women, Yalow remained undeterred in her pursuit. After completing her master’s degree and PhD in physics while working as an electrical engineer and college instructor, Yalow decided she wanted to be a full-time researcher. Unable to find a research position, Yalow decided to volunteer at a Columbia University radiological research laboratory. There she was introduced to the emerging field of radiotherapy. A few years later in 1950 while working at the Bronx Veterans Affairs Hospital, Yalow would meet and begin working with her lifelong research collaborator Solomon Berson. Together the two would develop radio-immunoassay, a technique that used radioactive isotopes as markers to trace and measure concentrations of hormones, viruses, enzymes, and other substances in the body. Their discovery of this technique revolutionized biological and medical research and made possible the development of diagnostic tests for infertility, hypothyroidism, and dwarfism; and screening tests for infectious diseases such as hepatitis and HIV and AIDS in blood donations. In 1977 Yalow became the second woman to earn a Nobel Prize in medicine. A mother of two children, Yalow advocated for the advancement of women in sciences. In her Nobel Prize banquet speech, she said of women, “We must believe in ourselves or no one else will believe in us; we must match our aspirations with the competence, courage, and determination to succeed, and we must feel a personal responsibility to ease the path for those who come afterward.” For more information on Rosalyn Sussman Yalow, check out her bio on the American Chemical Society website or her obituary that appeared in The New York Times. 3. Flossie Wong-Staal (b. 1947), Leading HIV and AIDS researcher Flossie Wong-Staal at the National Cancer Institute. Photo: National Cancer Institute/Bill Branson At the age of 18, Flossie Wong-Staal left Hong Kong to pursue her passion for biology in the United States. After completing her PhD in molecular biology in 1972, Wong-Staal moved to Bethesda, Maryland to study retroviruses with pioneering AIDS researcher Robert Gallo at the National Cancer Institute. Together they searched for the cause of AIDS, which was by then spreading in the United States. In 1983, Wong-Staal, Gallo and their team discovered HIV, the virus that causes AIDS. Two years later, Wong-Staal became the first scientist to clone and produce a genetic map of the virus, both of which were critical steps toward the development of blood tests for HIV. Wong-Stall continued her research on the HIV virus for over a decade, and today she help leads a biopharmaceutical company she co-founded which is working to develop improved drugs for Hepatitis C. Wong-Staal, who is the mother of two daughters, said of her interest in research, “For me, as for most researchers, the main motivation is simply the satisfaction of making discoveries, finding things out that no one knew before.” 4. Dorothy Hodgkin (1910-1994), Mapped the structure of penicillin Dorothy Hodgkin demonstrates the structure of vitamin B12 with a model. Photo: C&EN Archives Born in the early twentieth century, Dorothy Hodgkin was a trailblazer for women interested in the sciences. As a teenager, Hodgkin received as a birthday gift from her mother a book by Nobel Prize–winning physicist William Henry Bragg that discussed using X-rays to “see” the three-dimensional structure of molecules. This present would change the course of her life. Fascinated by the ideas presented in the book, Hodgkin would make the study of this field her life’s work. After graduating from college, Hodgkin found a position in an x-ray crystallography lab where she went to work studying the complex organic molecules that help a living organism function. The technique she used involved crystallizing the substance she was studying, shooting X-rays at it, and then studying the ways the X-rays refract off the structure in order to determine its shape. In 1946, after four years of studying the antibiotic penicillin using this technique, Hodgkin determined its structure, marking an important advancement which would help manufacturers create semisynthetic penicillin. Over the course of her career, Hodgkin also determined the structure of vitamin B12 and insulin. In 1964, she became the third woman to win the Nobel Prize in chemistry. A mother of three children and grandmother of three grandchildren, Hodgkin said of her career, “I was captured for life by chemistry and crystals.” For more information on Dorothy Hodgkin, check out her bio on the Chemical Heritage Foundation website or Nobel Prize website. 5. Margaret Sanger (1879-1966), Birth control pioneer Birth control pioneer Margaret Sanger. Photo: public domain Margaret Sanger devoted her life to expanding the availability of birth control and contraceptive options for women. Sanger’s devotion to this cause was born out of personal tragedy. At age 19, Sanger watched her mother—who gave birth to 11 children and suffered seven miscarriages—die of tuberculosis. Sanger believed that her mother’s repeated pregnancies had weakened her body’s ability to fight the disease. Wishing to build a different life for herself, Sanger became a nurse. Serving the people of New York’s Lower East Side, Sanger tended to the needs of impoverished women who lacked effective options to prevented unwanted pregnancies and often resorted to back-alley abortions in desperation. This experience deepened Sanger’s resolve that women needed access to safe and effective contraceptives so they could stay healthy, limit their family size as desired, and break the cycle of poverty. As a young mother of three children, Sanger switched her focus from nursing to advocating for the legalization of birth control and making it universally available to women. Although Sanger experienced several legal victories over the next three decades which expanded contraceptive access, she remained frustrated by the lack of birth control options available to women and dreamed of a contraceptive pill that would be as easy to take as a vitamin. To make that dream a reality, she recruited reproductive health researcher Gregory Pincus and raised the needed funding from heiress Katharine McCormick. This collaboration would lead to the development and introduction of the first oral contraceptive in 1960. Today Sanger’s vision of a world where all women have the ability to prevent or space their pregnancies remains only partially realized. Although more than 99 percent of American women have used a contraceptive method in their lifetime, an estimated 222 million women in developing countries want to limit or control the timing of their pregnancies but lack access to modern contraceptives. Said Sanger, “No woman can call herself free until she can choose consciously whether she will or will not be a mother.” For more information about Margaret Sanger, check out her bio at the National Women's History Museum website or PBS website.

Trying to navigate and understand the post-2015 negotiations can be a challenge, so to help add some clarity, last week the Global Health Technologies Coalition (GHTC) convened a panel of experts to help explain the ongoing debates and where the negotiations stand and how health innovation is reflected in the agenda.Here are my seven takeaways from that discussion.1. There are still a lot of TBDsSix essential elements of the SDGs. Credit: UNAlthough we’re only five months away from September 2015 when the Sustainable Development Goals (SDGs) will be approved by United Nation (UN) member states, there is still much to be determined and worked out. While it’s expected that the goals and targets will look similar to those proposed by the Open Working Group (OWG)with some refinement of the targets, the process for determining the indicators has just begun and will likely continue through March 2016.While member states work to finalize the goals, targets, and indicators, countries are also discussing financing and means of implementation for the agenda and how to build an effective monitoring and accountability framework.2. The proposed SDG framework is comprehensive in a way the MDGs were notThe process for determining the SDGs was much more inclusive and consultative than the process for determining the Millennium Development Goals (MDGs). There were a range of opportunities for all member states, civil society representatives, nongovernmental organizations, other stakeholders, and even individuals to have their ideas and voice heard. The result is a proposed agenda that is much more comprehensive (and bigger) than the MDGs (17 goals and 169 targets in SDGs, compared to 8 goals and 21 targets in MDGs).This inclusive process has also produced an agenda that is supposed to be universal and apply to all nations, representing a major conceptual shift. Broadly speaking, the MDGs were 7 goals focused on low- and middle-income countries (LMICs) implementing changes and an 8th goal focused on high-income countries (HICs) footing the bill. The SDGs are meant to be universal with all nations collectively responsible for their implementation and success. However, given that some nations have more capacity and means to contribute to implementation and some targets and indicators are more applicable to certain categories of nations, it’s not clear how this concept will actually be translated into action.3. The agenda will succeed or fail based on the strengths of implementationGetting the global community to agree on a set of development goals is only half the battle. Once the agenda is codified, it will be up to each nation to develop and implement policies that will help the agenda be financed and realized. Individual countries will have to find ways to take national priorities already set out for their country and ensure they can feed into the process and drive progress towards the goals. Central to the success of implementing the agenda will be having clear targets and strong indicators to measure progress towards them.4. How the world will pay for the agenda is an open questionPhoto: PATH/Gabe BienczyckiOne of the most daunting questions for the post-2015 agenda is how this expansive and ambitious agenda will be financed. Along with the process of defining the SDGs, there is a secondary track and set of intergovernmental negotiations looking at how to finance development through the Third International Conference on Financing for Development (FfD) in July. A schism has arisen between LMICs and HICs on how the FfD process integrates with the post-2015 process. Many HICs would like to see the FfD process focused on the means of implementation for the SDGs and see the outcomes integrated into the post-2015 agenda, while many LMICs would like it to remain a separate process.Given the universality of this agenda, one should expect financing discussions to look beyond traditional development assistance. Discussions will center on not just how much funding is needed to achieve the agenda, but also on how those funding flows should look different in the future than they do today including how traditional donor recipient nations, especially middle-income countries, can increase their own domestic contributions to development and how the public sector can work together with the private sector to catalyze private-sector investment and financing for development.5. Measuring and monitoring progress towards the SDGs will be an enormous challengeIn the MDGs, there were 50 indicators created to measure the 8 goals and 21 targets. Applying the same ratio, it would take an estimated 480 indicators to measure the 17 goals and 169 targets of the SDGs. Even if negotiators rely on crosscutting indicators that can measure multiple targets and manage to pare down the list to around 100, it will still be enormously difficult and costly for the national statistics agencies to monitor and measure. It’s not currently clear how this will be financed or carried out. Yet getting the monitoring and measuring right will be essential. To get where we want to be by 2030, the world will need to make sure we’re on the right track and meeting our commitments by 2020, but determining if we’re on the right track will require an effective monitoring and reporting framework.6. Health innovation is critical to achieving the SDGs but is not strongly reflected in the agendaPhoto: PATH/Patrick McKernImproving global health will be essential to achieve the overarching goal of sustainable economic development and poverty reduction. However, achieving many of the current SDG health targets—including ending the epidemic of HIV and AIDS, tuberculosis, and malaria; ending preventable deaths in children and newborns; and significantly reducing the number of women dying in childbirth—will be impossible without new tools and technologies. Yet the development of these new technologies will not happen automatically. Thus, it’s essential that the post-2015 agenda prioritize and acknowledge the importance of global health research and development (R&D).Unfortunately, as it stands, the OWG proposal only includes one specific target related to R&D of new health technologies to meet the health needs of developing countries—target 3.b—and some soft targets related to R&D and innovation under goals 9 and 17. Further, various proposals for indicators either ignore the 3.b health R&D target entirely, focus only on the access element of it, or propose a voluntary indicator to measure it. To achieve health for all at all ages by 2030, we’ll need to make sure the SDGs include feasible and appropriate indicators to measure progress on global health R&D at both the global and national levels.7. It’s on all of us to make sure the vision of the SDGs can become a realityWe all own this agenda, and we all have a role to play in implementing it. We must work to hold our national governments accountable for their commitments and also ask ourselves what we can do as individuals to make this vision a reality. What’s clear is business as usual won’t cut it. We must ask each sector and ourselves what we can do differently this time around to achieve the vision of the SDGs.To watch the full panel discussion and webinar on health innovation in the post-2015 agenda, click here.

President Obama discussed global health and innovation in the 2015 State of the Union address. Photo: Official White House Photo by Pete Souza While others were playing State of the Union bingo or creating pretty word clouds, GHTC was closely watching the State of the Union address to see what President Barack Obama would say about US engagement in global health and America’s leadership in science and innovation. GHTC was glad to see the President highlight American involvement in combatting Ebola and underscore the need for a more effective global effort to address future health crises. Obama said: “In West Africa, our troops, our scientists, our doctors, our nurses and healthcare workers are rolling back Ebola — saving countless lives and stopping the spread of disease. I couldn’t be prouder of them, and I thank this Congress for your bipartisan support of their efforts. But the job is not yet done — and the world needs to use this lesson to build a more effective global effort to prevent the spread of future pandemics, invest in smart development, and eradicate extreme poverty.” The President also emphasized how American investments in research and innovation have saved lives and contributed to the economy. He said: “21st century businesses will rely on American science, technology, research, and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time.” GHTC was pleased to see America’s Commander-in-Chief draw attention to the US role in advancing innovation to save lives. For more information on why US policymakers should invest in global health research and development, check out our recent blog post, “10 reasons why US policymakers should support global health research and development.”

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. Last week, Policy Cures released its annual G-FINDER report, which analyzes global investment in neglected disease research and development (R&D). The report revealed a US$193 million (6.2 percent) decrease in global funding from 2012 to 2013 primarily due to the US budget sequester, which led to a $188 million (13 percent) decline in funding for the US National Institutes of Health (NIH), the largest funder of neglected disease R&D worldwide. The United Kingdom’s Review on Antimicrobial Resistance released its first report, which warned that, by 2050, up to 10 million people could die each year from drug-resistant infections, costing the global economy US$100 trillion annually. Economist Jim O’Neill, chief author of the report, believes that this crisis can be mitigated through increased R&D into new antimicrobial drugs and changes in drug-use practices. Two announcements were recently made that could benefit pharmaceutical companies working to develop Ebola vaccines. Last Tuesday, Secretary of the Department of Health and Human Services Sylvia Burwell announced that drug makers developing Ebola vaccines would be offered legal and financial immunity through the Public Readiness and Emergency Preparedness Act, and she urged other nations to follow suit to ensure that “legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine.” Last Thursday, Gavi, the Vaccine Alliance announced that it would commit $300 million to purchase Ebola vaccines once the World Health Organization approved a product. Gavi hopes this move will incentivize pharmaceutical investment and development. The Atlantic takes an in-depth look at the slow and often frustrating work of developing new drugs and treatments. The article explores the careers of leading scientists—including NIH Director Dr. Francis Collins and Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at NIH—illustrating how their work requires patience, resilience, and the ability to constantly live with and learn from failure.