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UPDATE: since this post, the Senate also approved the spending package and President Obama has signed the final 2014 omnibus bill into law. In an increasingly rare show of bipartisanship, Congress has moved forward an appropriations agreement that should finally settle the issue of fiscal year (FY) 2014 funding levels. Yesterday, the House of Representatives approved the $1.1 trillion Omnibus spending bill, and the Senate is likely to pass the legislation later this week. In line with budget numbers previously agreed to, the bill includes an increase in discretionary spending of $45 billion, split equally between defense and non-defense spending. For global health research, the news is mixed. Funding for many accounts that fund research for new global health tools—such as those at the US Agency for International Development (USAID)—was higher than FY 2013 sequestered levels, and a few accounts even saw further increases. However, the National Institutes of Health (NIH) remains woefully underfunded, even as Congress increased its budget by $1 billion over last year’s post-sequestration levels. Below are a few key highlights from the omnibus agreement: State and Foreign Operations (SFOPS)—Although overall International Affairs funding saw a cut of $6.5 billion (39.7 percent) from last year’s levels, funding for global health actually increased by 4.7 percent over FY 2013 levels to $8.44 billion. Certain subaccounts that contain global health research programs within the SFOPs budget fared particularly well, including funding for the Maternal and Child Health account ($705 million) which saw a 12.4 percent increase from 2013 levels. Additionally, appropriators went above and beyond the President’s request for tuberculosis (TB) funding, allocating $236 million for bilateral TB programs, $45 million over the President’s request and an increase of 5.1 percent from 2013 enacted levels. In another positive move, the USAID Neglected Tropical Diseases program is funded at $100 million—potentially opening the door for the inclusion of research and development (R&D) programming. The bill also provides for $4.067 in funding for the President’s Emergency Plan for AIDS Relief program—which includes key product development programs for malaria, HIV and AIDS, and TB—an overall increase of 3.9 percent. Funding for both family planning and malaria remained similar to last year’s levels. Policy language that accompanied the omnibus also contained support for the continuation of important global health research programming. NIH—The omnibus sets overall 2014 funding for the NIH at $29.934 billion—a $1 billion increase from 2013 post-sequester levels. While this is certainly an improvement from the current situation, this number falls short of White House and Senate requests and represents a $950 million cut from 2012 levels. In more reassuring news, the NIH National Center for Advancing Translational Science (NCATS) was funded at a fairly robust $633 million, however report language included in the omnibus text requested that all funding for the Clinical and Translational Science Awards come out of NCATS funding in FY 2014, whereas in the past funding has been drawn from several centers. Other important centers such as the National Institute of Allergy and Infectious Diseases and the National Institute of Child Health were funded at $4.359 billion and $1.283 billion, respectively—both decreases from FY 2012 levels and the FY 2014 budget request. Centers for Disease Control and Prevention (CDC)—Overall funding for the CDCis set at $6.9 billion, a $567 million increase from 2013 post-sequestration levels. Within the CDC, the National Center for Emerging and Zoonotic Infectious Diseases was funded at $287.3 million, $93 million below the President’s request. CDC’s Global Health account, which includes funding for HIV and AIDS was funding at $383 million, slightly below the President’s request, but a $24 million increase from 2013 post-sequestration levels. In an intriguing move, language included in the CDC section calls for increase coordination of research programming between CDC, the US Food and Drug Administration (FDA), and NIH. You can read the full report here. FDA—Out of the major US agencies involved in global health research, FDA fared the best in the omnibus. FDA is funded at a total of $2.552 billion in discretionary spending, an increase of $91 million from 2013 post-sequestration levels. Notably the omnibus allows FDA to get back $85 million in user fee money that was withheld as a result of the sequester. Department of Defense (DoD)—While we’re still poring through the DoD’s appropriation package, early analysis reports that medical R&D funding saw increases, even as DoD’s overall budget was decreased. This may be a positive sign; as AAAS reports, research programs here may help lessen the impact of dire cuts at NIH. While Congress should be applauded for protecting many of the programs that fund global health research in the omnibus package, the recent downward trend in NIH funding is troubling. NIH is the world’s leading research institution, and has funded the groundbreaking work behind the majority of global health tools available today. The role of NIH in the global health product development cannot be replaced or replicated elsewhere; if support continues to decline, urgently needed innovations will not reach those who need them. Congress and the Administration must continue to push global health progress forward by supporting robust funding for all US agencies that fund global health R&D during the FY 2015 budget and appropriations process. Additional analyses: Kaiser Family Foundation AAAS InterAction budget table

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. The GHTC has launched a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our fourth and final post in the series is by Dr. Cynthia Gama, a principal investigator with MatCH and works with the International Partnership for Microbicides (IPM) in South Africa. Based on her experiences, Cynthia writes about the need for USAID to support R&D for microbicides to protect women from HIV. Q: As a microbicide researcher working in South Africa, you witness every day the impact of HIV on women. Can you tell us about the effect of HIV on women in your community? A: It is very difficult to not see the face of HIV and AIDS every single day when working in communities such as ours. The KwaZulu Natal province in South Africa has a high incidence of HIV and while we all know that women bear the brunt of the epidemic, the resulting impact can been seen not only in the women but also in the young children who have lost their parents; the old grandmothers who care for orphans; the daughters who often drop out of school to help them; and the impact that HIV has had on all aspects of people’s lives. What gives me hope is knowing that we are working toward a product—a microbicide for women— that may help to reverse this trend in our community and give women and their families a better future. Dr. Cynthia Gama of MatCH. Photo: IPM Q: Why are microbicides and other women-controlled prevention methods so important in the fight against HIV? Are currently available prevention methods, like male condoms, realistic options for women in your community and other parts of the world? A: We know that condoms work—both male and female condoms—and we know that South Africa has one of the largest and best-established public-sector male and female condom programs worldwide. Women in our community receive HIV prevention and contraception advice from various sources. While women may have access to these prevention products, the challenge is that women may not always have the ability to negotiate their use with their partners. This could explain the disproportionately high numbers of our women being infected with HIV. As a researcher, I know that women desire more options to protect themselves, hence my commitment to making sure that collectively we can deliver more options to our communities. Our research center and community is involved in The Ring Study, which is evaluating a unique product, a long-acting microbicide ring. Women who participate are shown how to insert the ring themselves, which is designed to stay in place for a month at a time and release an antiretroviral drug to prevent HIV. Q: How has USAID support helped advance your research and the microbicide field as a whole? A: The support that our study sponsor, IPM, receives from donors such as USAID ensures that new products for women are developed, and that we can do the much needed work and research that would one day turn the hope of a microbicide product into reality. Without funding, none of what has been achieved thus far could have been possible. Q: What other benefits of clinical research for microbicide development—such as capacity building and infrastructure development—has USAID support had in your community? A: HIV prevention research has most certainly strengthened the scientific and medical research sector overall. Expertise in conducting large clinical trials is now available and well-developed, and has offered more employment opportunities. USAID support has helped to bring communities closer to science, and helped communities appreciate the need for clinical research and understand its benefits. Q: When a safe and effective microbicide becomes available, what impact are you hoping to see for women in your community and around the world? What role will USAID have played in this effort? A: On that day of jubilation we would know that our sisters, daughters, and granddaughters have much to look forward to. I hope that once a product shows efficacy, that our policy makers will ensure that it is made available as soon as possible. Organizations such as USAID and others together are making it possible for this dream to become reality.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Researchers at Rice University have developed a rapid malaria test that uses laser pulse—eliminating the need to draw blood. The test has been found safe in healthy humans and will soon be tested on humans with malaria symptoms. The White House has nominated Dr. Deborah Birx as the next Global AIDS Coordinator and to lead the President’s Emergency Plan for AIDS Relief (PEPFAR). Dr. Birx is currently the director of the Centers for Disease Control and Prevention’s Global AIDS Program and works on PEPFAR implementation at her agency. The US Agency for International Development and GHTC member Population Council have entered into an agreement to develop a non-antiretroviral-based microbicide to block HIV and other sexually transmitted infections. If successful, the partnership could offer a low-risk, easily accessible product for women in low- and middle-income countries. According to the results of an early-stage clinical trial, patients with multi-drug resistant (MDR) or extensively drug-resistant (XDR) tuberculosis (TB) could be treated by using stem cells taken from their own bone marrow. If successful, the treatment could be an alternative for patients with MDR- or XDR-TB who do not respond to conventional drug treatment options.

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. The GHTC has launched a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our third post is by Brian D’Cruz, a volunteer physician who has worked with Médecins Sans Frontières (MSF) in Congo Brazzaville and Central African Republic. Based on his experience with MSF, Brian writes about the urgent need for USAID to support R&D for neglected tropical diseases (NTDs) like sleeping sickness. Q: As an MSF physician working in Congo Brazzaville and Central African Republic, you saw many patients affected by sleeping sickness—an NTD that primarily occurs in the poorest, most rural areas in Africa. Can you tell us about some of your experiences treating this disease during your time with MSF? A: In Central African Republic, I saw firsthand the suffering caused by sleeping sickness. I vividly remember an 11 year old girl named Natacha. She lived in an area where medical care and screening for sleeping sickness had not been available for years due to increasing violence in the area. Our team was the first to treat sleeping sickness there in several years. Several months before we arrived, Natacha started to experience the symptoms of sleeping sickness—including sleep disturbances, memory problems, spasms of her hands, pain all over her body, and seizures. A few weeks before we arrived, she stopped walking. By the time her family was able to get to us, she could no longer speak or feed herself. During this entire time, her family was powerless to help her. By the time they reached our team, we were able to diagnose Natacha and start treatment, but it was too late. She died a few days after reaching us. Brian D’Cruz (second from the left) and other panelists discuss NTDs at a congressional briefing in June 2013. Photo: Research!America Q: What impact does sleeping sickness have on communities and individuals in Congo and Central African Republic? A: Sleeping sickness is fatal if untreated, and what’s more, patients with this disease suffer enormously before their deaths. MSF has been treating patients with sleeping sickness for more than 25 years and we have seen the consequences of this forgotten deadly disease. Natacha’s death is a vivid and terrible example of the suffering that these patients and their families endure. The effort required to find, screen, diagnose, and treat these patients can be enormous, especially as the disease tends to spread in regions with limited access to appropriate care. Sometimes, as in Natacha’s case, the disease spreads because of surrounding violence; other populations are affected because of mass displacement or because they live in very remote locations. Q: As you mentioned, sleeping sickness is fatal if left untreated. As a physician, do you have adequate tools to detect and treat this disease? A: Tools exist to diagnose and treat the disease, but these techniques are cumbersome and require huge resources. To diagnose patients, you need centrifuges, microscopes, and very complex diagnostic tests along with specially trained technicians capable of interpreting the tests. To make a final diagnosis, every patient must have a lumbar puncture, an often very painful procedure which involves collecting spinal fluid from the patient’s back. These tests must often be performed in areas with very little infrastructure (such as lack of electricity) and poor sanitation. Patients in the first stage of the disease may be treated with seven days of daily injections, but treating the advanced stages of the disease is very difficult. Recently, new treatment protocols have been adopted which are safer and easier, but these treatments still have limitations. The current best treatment is a combination therapy, called NECT, developed by the Drugs for Neglected Diseases initiative. This treatment, although a dramatic step forward, still has significant side effects. It also cannot be emphasized enough that active screening and treatment is a constant need; while efforts into research and development for better diagnostic and treatment are essential, we must also ensure that there are people actively finding patients. Q: What kinds of new health tools and products do you think are necessary to help sleeping sickness patients in the Congo and around the world? A: We desperately need a rapid point of care diagnostic test, much like those used for malaria. We need an affordable test which does not require electricity or refrigeration, which could be read by staff with minimal training. This would dramatically increase our ability to screen for this disease. Also, while the disease is curable, current treatment requires intravenous medications administered under close supervision. As the disease tends to spread in areas with very limited medical care, it can be very difficult to give proper care to patients after they’re diagnosed. An oral pill treatment for both stages of the disease would revolutionize our ability to care for patients. New game-changing tools may be available in the near future. Two new oral drugs are now being tested in clinical trials. If they were found to be safe and effective, they could be given to patients who test positive with a rapid test. Just one test and one short-course oral treatment: this simplified protocol would make a huge difference in remote settings. On-going clinical trials with these new tools need to be fully-financed. Q: USAID currently does not invest in research to create new tools for sleeping sickness and other NTDs. How would support from USAID for NTD research help you as a physician? What difference would this support make in the lives of patients? We would save a lot of lives. We would prevent a significant amount of suffering. This disease causes excruciating pain, disability, psychosis, and ultimately death. Increased funding for programs to find patients and treat them, and for better and more patient-adapted diagnostic and treatment tools, would be game-changers. In addition to sleeping sickness, MSF/Doctors Without Borders works on several other of the most neglected of the neglected diseases, including Chagas, Buruli ulcer, and visceral leishmaniasis. These diseases affect very poor, marginalized people, often in some of the remote places. There is no lucrative potential market in developing medicines for people suffering from NTDs. As a result we have limited diagnostics and archaic, sometimes toxic treatments. If we really want to make a difference in the lives of people suffering from NTDs, we will not only need to increase funding for these specific diseases, we’ll have to seriously start looking at ways to create new types of incentives for research and development of new medicines .