Breakthroughs Blog: US budget

The dapivirine ring (Photo: International Partnership for Microbicides) GHTC member the International Partnership for Microbicides (IPM) announced last week the results of two phase 3 clinical trials demonstrating that a monthly vaginal ring filled with the antiretroviral drug dapivirine can reduce the risk of HIV infection in women. The dapivirine ring is the first long-acting HIV prevention method designed for women, and IPM plans to seek regulatory approval for the product. The trials, conducted by IPM and the Microbicide Trials Network (MTN), enrolled 1,959 and 2,629 HIV-negative women and reduced infection rates by 31 and 27 percent, respectively. Efficacy rates were affected by participant age and adherence: for women over 21—who reportedly used the ring more consistently—the dapivirine ring reduced HIV infections by 37 and 56 percent in the trials led by IPM and MTN, respectively. As IPM Founding Chief Executive Officer Dr. Zeda Rosenberg stated, “These findings give new hope to many women at high risk who need more and different options to effectively protect themselves from HIV.” Researchers at the Scripps Research Institute (TSRI) and the US Army Medical Research Institute of Infectious Diseases have discovered potent antibodies against Ebola that could play a critical role in the research and development (R&D) of Ebola vaccines and treatment. The team identified 300 different antibodies against Ebola in the blood of a survivor, using molecules developed by TSRI to hunt for antibodies. Seventy-seven percent of the antibodies were able to combat the virus in mice, providing protection rates ranging from 60 to 100 percent. The three strongest antibodies all targeted distinct vulnerable spots on a certain protein found on the virus’ surface. Anti-Ebola antibodies have been used before, including in ZMapp™, an experimental treatment deployed during the 2014 Ebola outbreak. However, the number of known, effective antibodies was previously limited. This research also revealed a weak spot on the base of the aforementioned Ebola surface protein. As the virus mutates, so do the surface proteins. However, the base of these proteins remains largely the same, and thus, a weak spot on the base of the protein could be a potential target for manifold strains of the virus. US President Barack Obama is calling on Congress to allocate an additional US$200 million for the President’s Malaria Initiative (PMI), a 30 percent increase that would bring the Initiative’s budget to US$874 million. The funding would enable PMI to expand into three new countries—Sierra Leone, Cote D’Ivoire, and Cameroon; eliminate malaria in Zambia and Cambodia; scale up the use of bed nets; and advance R&D for vaccines, drugs, diagnostics, and vector control methods. As resistance grows to both malaria treatments and insecticides, the need for R&D remains critical. Further, resistance to the leading antimalarial was first reported in Cambodia and the most virulent strains are found on the border between Cambodia and Thailand. Thus, eliminating malaria in Cambodia would impede the global spread of drug resistance. With this new funding, PMI would be able to reach an additional 70 million people, ultimately reaching 92 percent of those in malaria endemic regions.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Now that members of Congress are back in their Capitol Hill offices after five weeks of recess, lawmakers must decide what to prioritize and what to push off in the few short weeks left in session before members hit the campaign trail for the upcoming November mid-term elections. In the latest post on Breakthroughs, GHTC Senior Policy and Advocacy Associate, Jenny Howell, provides a breakdown of what lawmakers should do to ensure global health research and development gets the support it needs. Federal funding in the United States for biomedical research has declined by more than 20 percent in the last decade. At the same time, more scientists are competing for a smaller pot of money. NPR highlights two stories of researchers forced out of science because they either can’t get research funding or “because the rat race has simply become too unpleasant.” Scientists at the National Institutes of Health (NIH) have discovered an HIV antibody that could be effective in fighting the deadly disease. According to the scientists, the antibody—called 35O22—can prevent 62 percent of known HIV strains from infecting cells. The NIH-led scientists also found that the antibody closely resembles antibodies that naturally occur in HIV, which could help in the development of an eventual vaccine. Results from a recent clinical trial could change the approach researchers take on the delivery and development of tuberculosis (TB) drugs in the future. While the REMoxTB trial did not successfully prove TB treatment times could be shortened from six to four months by substituting antibiotic moxiflacin for a currently used drug, it did prove that moxiflacin was safe to use to treat TB on its own. Also, because the trial was one of the largest ever for a new TB regimen, the trial left a stronger research infrastructure to conduct other trials in the future. The Bill & Melinda Gates Foundation has committed $50 million to fight Ebola in West Africa. According to Gates Foundation CEO Susan Desmond-Hellmann, the new money will be available for emergency operations and to help develop drugs, diagnostics, and vaccines to fight the disease. The Gates Foundation’s commitment is the largest sum to ever for one outbreak.

With only a few weeks left in session, lawmakers must decide what to prioritize and what to push off. Photo: Photo Phiend After a five week recess, members of Congress returned to their Capitol Hill offices on Tuesday night. Staffers who had enjoyed the brief freedom of wearing jeans to work returned to their suits, and lobbyists and constituents alike returned to waiting in long security lines to enter Congressional offices. With only a few weeks left in session before they hit the campaign trail, lawmakers must decide what to prioritize and what to push off. Here is what we expect Congress may address before session end. Keeping the government open Passing legislation to keep the government funded past September 30th is a top priority for Congress. Given the wrath lawmakers faced following last year’s government shutdown and the looming mid-term elections, it seems almost certain that policy makers will come to a short-term solution to keep the government open. Earlier this week, Chairman Hal Rogers of the House Appropriations Committee offered a stop-gap spending bill that would fund the government through December 11th. Finding funds to fight Ebola Lawmakers appear to be coming together to support additional funding to meet the needs of the Ebola crisis. Last month, the President requested an additional $88 million to bring much needed drugs and supplies to the West African countries ravaged by this deadly disease, and Chairman Rodgers has indicated that the full $88 million will be included in the House version of the continuing resolution (CR). A summary of this CR put out by the House Appropriations Committee notes that this funding will be used to “accelerate [Department of Health and Human Services’] research on Ebola therapies, and additional funding for the [Center for Disease Control and Prevention’s (CDC)] response to the growing outbreak in Africa.” Chairman Rodger’s budget is in line with the current budget cap of $1.012 trillion and would maintain current spending levels. Also included in the GOP-backed bill is $85.1 billion for overseas contingency funding, an extension of the Export-Import Bank through June 2015, and an extension of the Internet Tax Freedom Act through the CR. Strong language supporting global health R&D was included in many of this year's appropriations report, but will it make it into a more long-term budget deal? Caption Photo: PATH/Gabe Bienczycki Dealing with uncertainty GHTC is hopeful that we will not face another government shutdown—we know that funding for research and development (R&D) is best leveraged when there is consistent and certain financial support. Another short-term CR will continue to undermine potential game-changing discoveries and, as detailed in GHTC’s 2014 Policy Report, make planning for the future nearly impossible. Congress bucking at the traditional appropriations process also means uncertainty around what, if any, committee report language will be included in a more long-term budget deal. In previous blogs, GHTC reported on the strong language in support of global health R&D that was included in many of this year’s appropriations bills, including those put out by the subcommittees on Labor, Health and Human Services, Department of Defense, and State and Foreign Operations. We hope this language will be included in whatever final agreement takes place. While House and Senate fiscal year (FY) 2015 appropriators showed only lukewarm support in their funding for global health R&D, some accounts—like those for the National Institutes of Health and CDC’s Center for Global Health—saw funding requests from the Senate that were above both FY 2014 funding and White House requests. A CR means these recommendations for funding increases will continue to be put off. Preventing “the lamest lame-duck” With pending mid-term elections, it’s difficult to predict what this lame-duck session will bring. While Politico is already predicting that this will be the “lamest lame-duck session,” there are a number of common-sense, no-cost bills that Congress could and should pass before the end of the 113th session. The 21st Century Global Health Technology Act, a bill which establishes the US Agency for International Development’s mandate for global health R&D, as well as improves agency coordination, transparency, and reporting would be an easy way for Congress to leverage existing funds and programs without creating any additional spending. Additionally, the Patents for Humanity Program Improvement Act of 2013 would make it easier for American researchers to develop solutions to the world’s most pressing health issues and incentivize first-time researchers to apply their work towards addressing humanitarian needs. While preventing another government shutdown is a step in the right direction, we hope lawmakers will take seriously the need for longer-term solutions. With three months left in the 113th Congress, it’s time to get down to business.

Last week, we reported on exciting policy language included in the Senate Department of Defense appropriations legislation, and earlier this summer, the House and Senate State and Foreign Operations bills also included recognition of the role that new technologies could play in advancing global health. Today we have even more good news to report: The Senate Appropriations Labor and Health and Human Services (LHHS) Subcommittee released its own fiscal year (FY) 2015 appropriations legislation, after a lengthy internal debate on domestic health concerns. Senate supports global health R&D in LHHS appropriations bill. Photo: NIAID Senate calls for increase in NIH funding; still lags behind need The legislation covers funding and policy issues for several key global health research programs at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Office of Global Affairs at the Department of Health and Human Services (HHS). At GHTC we’ve voiced concern that funding for NIH has lagged behind both inflation and the research program needs of the agency. Last week, we learned that the Senate LHHS appropriations subcommittee has appropriated $30.6 billion for NIH—which represents an increase of $606 million over FY 2014. This is a welcome increase; however, as the subcommittee noted in its report introduction, NIH’s funding is still unacceptably low, even with this improvement. Report language supports global health programming at NIH Within NIH, several key research centers were funded at reasonable levels, including the National Center for Advancing Translational Sciences (NCATS) and the National Institute for Allergy and Infectious Disease. The committee expressed its support for continued funding for neglected tropical diseases (NTDs), microbicides, and antibiotic research, as well as government-wide research collaboration, among other priorities. In an exciting move, the committee also included NCATS report language requesting that NCATS include a report in its FY 2016 budget justification “on initiatives targeted at neglected diseases and global health conditions, with specific focus on global health technologies and devices.” Global health is an essential part of NCATS’s mandate, and this language will ensure that it is prioritized within the program. CDC global health programming receives increased funding in bill The legislation also provides strong support for research at the CDC’s global health programs. Under the bill, the National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) would receive an increase over FY 2014 funding levels. In addition, the subcommittee’s report mentions the Chikungunya outbreak in the Caribbean and the United States and encourages coordination between NCEZID and the CDC’s Center for Global Health on global health security efforts. Speaking of the Center for Global Health, this program received a rare increase in the Senate bill over even the President’s FY 2015 budget request. This is likely a result of support for the new Global Health Security Agenda. Most notable was the inclusion of a new line item in the Center’s budget for “Global Health Protection.” The bill also included positive language on CDC’s work on malaria and NTDs and provided continued funding for the National Public Health Institutes—an epidemiology and research capacity-building program in select countries. House LHHS bill has not been released; continuing resolution likely The House Appropriations LHHS Subcommittee has not released a bill for FY 2015 and may not do so at all. As it looks more likely that a continuing resolution will be necessary to continue uninterrupted government funding for NIH, HHS, and CDC global health R&D programs, Congress should work to come to an agreement that robustly supports funding and smart policy improvements for these programs. Ashley Bennett is GHTC’s policy officer.