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In this guest post, Heather Ignatius, senior policy and advocacy officer at PATH, writes about the important role US agencies play in advancing global health technologies. In the field of global health, partnerships are often a primary key to success. The complexities of health, policy, and product development are technically nuanced, but together with the US government, PATH and others are making great advances to adapt, develop, and introduce breakthrough technologies across the health spectrum. To demonstrate how essential US government’s contributions have been—and will continue to be—in improving global health through the development and introduction of lifesaving technologies, we recently released three publications highlighting PATH’s work with the US Agency for International Development (USAID), the US Department of Defense (DoD), and the US Department of Health and Human Services (HHS). These collaborations complement the many other global health product development and introduction efforts spearheaded by other private- and public-sector partners. Together, these contributions to improving global health will not only benefit people in developing countries, but also US military personnel and US citizens traveling abroad. We hope that these examples inspire continued investment by the US government in global health research and development. PATH partners with the US government to develop and adapt innovative global health technologies—including thermostable vaccines, injection devices, and medicines—that safeguard the health of mothers and children, like these in Kenya. Credit: PATH/Evelyn Hockstein. Developing innovative technologies in partnership with USAID For more than 25 years, PATH has worked through the HealthTech program at USAID to identify health needs and then adapt, design, develop, and advance appropriate and affordable health technology solutions. Through the HealthTech program, PATH has invented, designed, developed, or co-developed 85 technologies that are tailored to low-resource settings and can be manufactured locally. Examples include diagnostic tests for infectious diseases, portable scales that help health workers screen newborns for low-birthweight status, the Uniject® injection system, and the SILCS diaphragm. HealthTech technologies are in use throughout the world through partnerships with the World Health Organization, the United Nations Children’s Fund, and commercial collaborators. Adapting and introducing diagnostic technologies for low-resource settings with HHS With funding from the National Institutes of Health, PATH is advancing effective, low-cost, and easy-to-use diagnostic tools that can be used in low-resource settings to identify HIV and AIDS, tuberculosis, malaria, and other diseases. These diagnostics improve people’s chances for a healthy recovery while enabling health care workers to better track outbreaks of diseases. Together, PATH and HHS have also worked to increase the availability, accessibility, and affordability of essential point-of-care diagnostic tests by assessing critical clinical needs, identifying innovative technologies, supporting clinical testing, and creating training programs. Developing new vaccine technologies with DoD In collaboration with the US Naval Medical Research Center (NMRC) and the Walter Reed Army Institute of Research (WRAIR), PATH is developing and testing new approaches for vaccines against enterotoxigenic Escherichia coli and Shigella—two of the leading bacterial causes of diarrheal disease worldwide. PATH, WRAIR, and NMRC are collaborating on preclinical and clinical studies as well as manufacturing activities related to vaccine development. Additionally, PATH is working with NMRC, among other partners, to assess potential markets for low-cost and effective vaccines and to demonstrate the opportunity for industry investment in developing these vaccines. With funding from the Defense Threat Reduction Agency, PATH is developing temperature-stable vaccine formulations to support DoD product development efforts. These thermostable formulations will extend the shelf life of vaccines, making them ideal for storing and allowing them to be safely transported and stored for extended periods of time outside of the “cold chain” of proper refrigeration. Thermostable vaccines are especially important for remote areas of the world where limited or no electricity for temperature control makes it challenging to maintain vaccines’ potency.

Wednesday, the White House released President Obama’s fiscal year (FY) 2014 budget request, which overall has mixed results for global health and research programs. Below, we provide specific details on funding levels at key agencies that support global health and research efforts, including the Centers for Disease Control and Prevention (CDC),the US Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Details are still forthcoming about how global health research fared at the Department of Defense. It’s important to note that figures are compared to final FY2012 levels, since Congress is still working on finalizing FY2013 levels. The president's budget for FY2014 requests funding for key US agencies engaged in global health product development. Credit: PATH. CDC CDC’s overall budget took a hit in the president’s request—the president’s FY2014 budget requested $5.2 billion for the agency overall, compared with $5.65 billion in FY2012. However, CDC’s global health programs were slightly increased and were spared major cuts. CDC’s Center for Global Health would receive $393 million in FY2014 under the president’s budget, compared with $376.7 million in FY2012. FDA The FDA got a much-needed increase in the president’s budget request, although much of it is due to an expected uptick in user-fee income. The agency would receive $4.65 billion in FY2014 under the president’s budget, compared with $3.83 billion in FY2012. As noted above, user-fee income plays a large part in this increase in FDA’s budget. User fees would comprise $2.09 billion of the agency’s budget under the president’s request, compared with $1.32 billion in user fees in FY2012. In recent years, Congress has not adequately appropriated stable funding to FDA, instead relying on user fees to make up the difference. Critics have said that relying on user fees is unsustainable and creates a conflict of interest between FDA and the industries it regulates. NIH NIH funding was mostly flat-lined at FY2012 levels—the president’s budget requested $31.3 billion for the NIH in FY2014, compared with $30.8 billion that the agency received in FY2012. The National Institute of Allergy and Infectious Diseases (NIAID), as well as the National Center for Advancing Translational Science (NCATS), received increases that could hint at new programming in those areas. The president requested $4.6 billion for NIAID in FY2014, compared with $4.5 billion the center received in FY2012. NCATS would receive $666 million under the president’s FY2014 budget, compared with $574 million in FY2012. State Department and USAID At USAID, several key programs that fund global health research were cut dramatically—most notably the agency’s tuberculosis (TB) program. Most other programs at USAID were flat-funded or saw small increases. Under the president’s budget, USAID’s global health programs would receive $2.645 billion in FY2014, which is pretty much the same figure ($2.649 billion) for FY2012. Under USAID’s global health programs, several key initiatives saw disappointing funding cuts. The TB program would be reduced to $191 million in FY2014, compared with $236 million in FY2012. The HIV and AIDS program would be cut to $330 million, compared with $350 million in FY2012. The neglected tropical diseases program would be cut to $85 million in FY2014, compared with $89 million in FY2012. Fortunately, the malaria program would see an increase to $670 million in FY2014, compared with $650 million in FY2012. The State Department budget element getting the most buzz is the 5.3 percent cut to the President’s Emergency Plan for AIDS Relief, while the Global Fund to Fight AIDS, TB, and Malaria saw a robust request of $1.65 billion for FY2014. Federal agencies have also released their budget justifications, which detail policy and programmatic priorities for FY2014. We’ll provide a comprehensive update on these budget justifications and key policies that could impact global health research and product development. Usually, the President’s budget request sets a precedent that the advocacy community and Congress respond to—whether they agree or disagree with its content. However, with the request being released so late in the year, Congress has already acted, passing drastically different FY2014 budget resolutions in the House and Senate. House and Senate budget committee activity is moving quickly, with key leaders from US agencies that fund global health research and product development scheduled to testify at appropriations hearings as early as next week. Congress must act to avoid further cuts and fund global health research programs at the robust levels that ensure availability of new technologies to the millions who need them worldwide.

In this guest post, Karen A. Goraleski, executive director of the American Society of Tropical Medicine and Hygiene, writes about the importance of US funding for global health research. This is the third post in a series about this week’s Rally for Medical Research. On April 8 in Washington, DC, thousands of researchers, patients, and advocates participated in The Rally for Medical Research, organized by the American Association for Cancer Research and joined by more than 200 partnering organizations—including the American Society of Tropical Medicine and Hygiene. The rally communicated the research community’s message to policymakers that sequestration and other cuts are simply wrong. ASTMH members join the thousands of researchers, patients, and advocates who participated in The Rally for Medical Research. Credit: ASTMH. While many of the speakers, including journalist Cokie Roberts, spoke of cancer, diabetes, Alzheimer’s, and HIV, we also know that millions of people in the world—far too many—are in desperate need of lifesaving treatments and vaccines for treatable and preventable infections and diseases, especially those that afflict the global poor. Additional cuts (on top of what has been cut over recent years) to threatened tropical medicine and global health research and development programs at the National Institutes of Health, Centers for Disease Control and Prevention, US Agency for International Development, and Department of Defense will send us into an expensive back-slide of money and lives—delaying new vaccines, drugs, and diagnostics from reaching those who need them most. Let’s put things in perspective: tropical medicine and global health represent just a small portion of the US budget, but are making a BIG difference at home and abroad. Isn’t this the return-on-investment that we all clamor for? The US efforts on global health have saved millions of lives, affording families a fighting chance to build more productive lives. Investments in tropical medicine and global health contribute to our nation’s security by protecting US borders from emerging infectious diseases and reducing poverty in the developing world, which in turn creates stable countries that provide economic and security benefits for the US. Research IS the game-changer that Washington so often talks about. As a community, let’s tell this message to our elected officials loud and often until they finally hear us.

In this guest post, Megan Kane, PhD, communications intern, and Morgan McCloskey, global health intern, from Research!America write about a rally earlier this week in support for health science and research. This is the second post in a series about the Rally for Medical Research. Thousands of scientists, patients, and research advocates gathered together on the grounds of the Carnegie Library in Washington, DC, on April 8 to unite behind a call for increased funding for medical research. The Rally for Medical Research was organized by the American Association for Cancer Researchers in conjunction with its annual meeting and was supported by over 200 partnering organizations. Survivors of heart disease, stroke, HIV, Type 1 diabetes, and other debilitating diseases shared their stories. Former POZ magazine editor Regan Hoffman discussed her HIV diagnosis and shared her gratitude for the antiretroviral treatments that allow her to live with this disease. However, she also spoke of the millions of other HIV-positive individuals around the globe who don’t have access to treatment and of her continued hope for a day when science will bring a cure for all those who suffer from HIV. Thousands of scientists, patients, and research advocates gathered together on the grounds of the Carnegie Library in Washington, DC, on April 8 to unite behind a call for increased funding for medical research. Credit: Research!America Reps. Rosa DeLauro (D-CT) and Chris Van Hollen (D-MD), as well as research leaders, spoke about the impact of medical research on their lives. Marc Tessier-Lavigne, president of the Rockefeller University and former chief scientific officer of Genentech, said that sequestration cuts on top of flat-funded research budgets are damaging basic science research. He added that industry will not fill this gap in health research. The event also featured messages in support of research from Sen. Jerry Moran (R-KS) and Rep. David McKinley (R-WV). Closing the ceremony, the Honorable John Edwards Porter, former Congressman and chair of Research!America, encouraged rally attendees to continue the grassroots movement from Monday’s rally in their hometowns and to take the fight to their congressional representatives. Porter said that previous efforts to convince policymakers to increase funding for the National Institutes of Health have not yet been successful and called on scientists to be “intellectual activists” and get “fighting mad.” He encouraged advocates to appeal to Congress on personal levels as well as using the hard facts about the costs of disease. “It’s time for them to step up and have the courage to do their jobs,” Porter said of elected officials. “The job of Congress—appropriators, leadership, every Member—is to choose national priorities going forward and put national resources behind them. … These are people that are accountable to you. … If you can’t get involved and get passionate about what medical research means to our country and our future, who can?” Medical research has the power not only to improve lives here at home, but around the globe. Research!America encourages you to join in with rally attendees and participate in the text petition to Congress, contact your representatives in Congress directly or write a letter to the editor of your local paper.