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With less than two weeks to go until one of the most anticipated midterm elections in recent memory, there are big questions occupying the minds of Washingtonians and politics junkies from coast to coast: Will the Democrats regain control of the House of Representatives for the first time in eight years? Do they have any chance of retaking the Senate, or might recent swings in the polls signal that Republicans could tighten their hold on the chamber? And, what will it all mean for US support for global health research and development (R&D)? While nothing can be taken for granted in the current political climate, here are our best modest bets on what to expect once the dust settles on November 6. Democrats will take back the House and focus on domestic priorities and oversight Predictions of a “blue wave” have tempered slightly with shifts in the polls in the past couple of weeks, but most expect that Democratic enthusiasm will carry the party far enough to retake the House for the first time since 2010. FiveThirtyEight’s House Forecast gives Democrats a five in six chance of winning control with their model currently predicting a 38-seat pick-up. (Democrats need a net gain of 23 seats to flip the House). Assuming these predictions hold—though we highly recommend refreshing their forecast a few times, as predictions seem to change by the hour—leadership of committees would shift to Democrats with new freshmen joining several committees of interest for global health R&D. Of note:   House Appropriations Committee: Current chairman Rodney Frelinghuysen (R-NJ) is retiring, along with fellow full committee member Tom Rooney (R-FL). And, with another nine Republican committee members in tight races, the make-up of the House Appropriations Committee has the potential to change dramatically in the next Congress. In contrast, only one Democrat currently on the committee, Matt Cartwright (D-PA), is considered vulnerable. If Republicans maintain control of the House, potential candidates to replace the retiring Frelinghuysen as full committee chairman include Representatives Robert Aderholt (R-AL), Kay Granger (R-TX), Mike Simpson (R-ID), Tom Cole R-OK), or Tom Graves (R-GA). Should the Democrats take the House, one of these names will likely fill the ranking member position on the full committee.   All but one member on both sides of the Subcommittee on Labor, Health and Human Services, and Education (LHHS)—which appropriates funds for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA)—are very likely to win re-election. However, with a Democratic take-over, we would still expect significant changes to the subcommittee make-up. On the State, Foreign Operations, and Related Programs (SFOPs) Subcommittee—which appropriates funds for the US Agency for International Development and major global health programs like the President’s Emergency Plan for AIDS Relief—one Republican retirement (Tom Rooney (R-FL)) and one tight race (Mario Diaz-Balart (R-FL)) could bring changes. Though again, a Democratic win would do so regardless.  Nita Lowey is the lead Democrat on both the full Appropriations Committee and the State, Foreign Operations, and Related Programs Subcommittee, and Rosa DeLauro (D-CT) serves as the ranking member of the Labor-HHS, and Education Subcommittee—both of whom are expected to win re-election easily. (Of note: Democrats do not determine chairs or ranking members of committees automatically by seniority, so it could take several months for the dust to fully settle from the election and new leadership for committees to be determined—particularly in the wake of a blue wave.) House Energy and Commerce Committee (E&C): E&C—with jurisdiction over leading agencies in global health R&D, including NIH, CDC, and FDA—will see bigger changes. Three Republican members are retiring—Joe Barton (R-TX), current Vice-Chairman Gregg Harper (R-MS), and Ryan Costello (R-PA)—another two members are in toss-up races, and another five are in competitive races. In contrast, just one Democrat, Gene Green (D-TX), the ranking Democrat on the Health Subcommittee, is retiring, and no Democrats currently on the committee are considered at risk of losing re-election. Congressman Frank Pallone (D-NJ) currently serves as the lead Democrat on the full Committee.  House Foreign Affairs Committee (HFAC): HFAC is where we will see the biggest changes of all in terms of Republican leadership on issues related to global health R&D. A staggering 13 of the 25 Republican committee seats are up for grabs due to retirements or competitive races, and there are no retirements or tight races on the Democrat’s side. HFAC Chairman Ed Royce (R-CA) and Chairman Emeritus Ileana Ros-Lehtinen (R-FL) are both retiring, along with several other long-serving members stepping down or in toss-up races. This will create space for new Republicans to lead on international development, global health, and diplomacy—alongside a potentially large group of freshman Democrats joining the committee. Representatives Michael McCaul (R-TX), Joe Wilson (R-SC), and Ted Yoho (R-FL) are considered leading contenders for chairman or ranking member with Royce’s departure—each with very different backgrounds and views of US engagement internationally. Congressman Elliott Engel (D-NY) new serves as the senior Democrat on the Foreign Affairs Committee   If Democrats take back the House, indications are strong that international issues will rank low on their overall priority list, with oversight of the Trump Administration and key domestic issues like healthcare likely to dominate the agenda. In a recent interview, likely Speaker Nancy Pelosi (D-CA) listed campaign finance reform, domestic drug prices, background checks for gun purchases, and protecting undocumented immigrants who were brought to the United States as children as the Democrats’ top priorities should they retake the chamber. Another interesting consideration in that scenario is how freshman Democrats—many of whom hewed to a populist message on the campaign trail that was light on America’s international leadership obligations—will engage on issues like global health and development once in Washington. Education of new members will be key for advocates as soon as races are called to ensure that the bipartisan consensus that has protected and grown US support for global health over the past fifteen years is maintained as political shifts continue to shake up Congress. Republicans will retain a narrow margin in the Senate—with no end to gridlock in sight As in any election year, roughly one-third of Senate seats are up for grabs, but analysts have called the 2018 electoral map one of the most Republican-friendly in a generation, with Democrats defending 26 of the 35 seats up for re-election—including 10 seats in states that voted for Trump in 2016. The enthusiasm of the Democratic base may not be enough to reverse the narrow 51 to 49 margin that Republicans currently hold in the Senate. Democratic pundits are confident incumbents can defend most of the seats in play but are increasingly pessimistic about picking up new seats in toss-up races in Arizona, Texas, Nevada, and Tennessee—once seen as serious possibilities. In a complete reversal of their House prediction, the FiveThirtyEight Forecast currently gives Republicans a five in six chance of holding on to the Senate. Assuming Republicans maintain a slight majority, the leadership and make-up of key committees are unlikely to change dramatically, though several key retirements will mean new faces are likely to join their ranks. In more detail: Senate Appropriations Committee: Chairman Richard Shelby (R-AL) and Vice Chairman Patrick Leahy (D-VT) are not up for re-election this year, so the leadership of the Senate Appropriations Committee is set; but five Democrats on the committee are up for re-election, with several in tight races. Leadership of the LHHS and SFOPs Subcommittees is also stable, with Chairman Roy Blunt (R-MO) and Ranking Member Patty Murray (D-WA) not up this cycle on the LHHS side and both SFOPs Chairman Lindsey Graham (R-SC) and Ranking Member Leahy hanging on. This is good news for global health R&D, as all four have championed such investments in the past in their leadership of these key subcommittees. Between the two subcommittees, just four members are up for re-election, likely ensuring a good bit of continuity for the next two years.   Senate Health, Education, Labor and Pensions Committee (HELP): The HELP Committee has a larger potential for shifts, with one Republican retiring and seven Democrats up for re-election, though most are expected to return. Chairman Lamar Alexander (R-TN) and Ranking Member Murray are not up for re-election in this cycle.    Senate Foreign Relations Committee: As in the House, the biggest potential changes among Senate committees of interest will be on Foreign Relations, where Chairman Bob Corker (R-TN) is retiring, and Ranking Member Bob Menendez (D-NJ) is in a tighter-than-expected re-election race. Committee member Jeff Flake (R-AZ) is retiring, and another Republican and three Democrats are up this cycle, though all are considered safe seats. Looking ahead Should the Republicans retain control of the Senate and Democrats take the House, as tentatively expected, gridlock in Washington is only expected to intensify, especially as moderates in both parties who have been more open to compromise have retired or been picked off in primaries. Even if Democrats wrestle control of both chambers, another two years of a Republican administration and the ramp-up of a presidential election that promises to be one of the most contentious in generations likely engenders new political challenges in every direction. Add to that the fact that the budget deal currently shaping annual appropriations will expire during the next session of Congress, and you’ve got a recipe for drama! Global health R&D advocates will have to think creatively about messages that could resonate in a divided government in a time of tightening budgets to ensure that critical investments and policies that support the creation of new health tools remain a priority no matter which wildly different midterm prediction comes to pass.

Health ministers of the G20 nations, representing the world’s leading economies, met earlier this month in Mar del Plata, Argentina to chart a course of action on global health for the upcoming year. Under the leadership of Argentina, the meeting and its resulting outcome declaration focused on four themes: antimicrobial resistance (AMR), malnutrition and child obesity, health systems strengthening, and public health preparedness. While the language that found its way into the final declaration is worthy of note and analysis, so too are the items left on the cutting room floor. GHTC was pleased to see health ministers recognize the critical role of research and development (R&D) in combating AMR but was also disappointed to see further commitments on health R&D absent from the declaration. Here we take a closer look at the good, the bad, and the unknown for global health R&D under the G20. The Good Following the precedent set last year under the German presidency, G20 health ministers reaffirmed their commitment to tackling AMR, emphasizing the role of new technologies in confronting this challenge. Importantly, the health ministers encouraged investment in R&D across a range of interventions—including antimicrobials, diagnostics, and vaccines—while “promoting affordable and equitable access to all individuals in need.” Although this inclusion of language on access is not surprising, the framing of R&D in a broad sense is quite positive given the dire need for treatment-supporting technologies that are relevant to low- and middle-income country (LMIC) settings. Ministers also welcomed the work of product development partnerships (PDPs), including the Global Antibiotic Research and Development Partnership and TB Alliance. This call out of PDPs is important because it serves both as a validation of the PDP model and demonstrates that there are ways to support innovation while also working to ensure equitable access, concepts frequently seen as being in tension. GHTC was also pleased to see the declaration define AMR broadly and note its “growing threat among…fungal infections and drug-resistant HIV, malaria and tuberculosis.” While in wealthy countries concerns around AMR primarily center on “superbugs” and facility-acquired infections, the inclusion of health issues predominantly impacting LMICs is a long-overdue acknowledgment of the dangers of AMR in low-resource settings. It was also positive to see health ministers voice support for the 2017 commitment by G20 leaders to “further examine practical market incentives” to encourage stakeholders, including industry, to develop new antimicrobials. One of the key dynamics at play in the global health R&D ecosystem is the reality that there are a number of regions, diseases, and technologies for which there are not functioning commercial markets and as a result people do not have access to the health tools they need. New policies or incentives to help address these market barriers, while ensuring health equity, have the potential to dramatically accelerate progress towards universal access. It is positive that the G20 has committed to moving this agenda forward. While GHTC was pleased to see the G20 continue to shine a spotlight on the role of R&D in addressing AMR, we were disappointed to see the G20 fail to acknowledge the importance of R&D in improving epidemic preparedness—particularly given that under the German presidency, the G20 pledged strong support for collaborative research initiatives, including the World Health Organization R&D Blueprint and the Coalition for Epidemic Preparedness Innovation. The Bad Unfortunately, the declaration takes a narrow approach to improving our ability to prevent, detect, and respond to outbreaks, focusing solely on health system strengthening. It is clear that being better prepared requires having both strong health systems in place and the right technologies on hand to prevent an outbreak from becoming a deadly crisis. We saw with the 2014-2015 Ebola epidemic, the 2015-2016 Zika epidemic, and the recent outbreaks of Nipah virus how the lack of available interventions like vaccines and diagnostics hampered response efforts. These crises have taught us that when it comes to fighting outbreaks, health system strengthening and R&D must go hand in hand. Given the important signaling power of the G20 forum to its members and to the world, it is disappointing to see the G20, under the Argentinian presidency, take such a limited view of health security that fails to include research and product development. We hope future presidencies will take a more comprehensive view. The known and unknown While the G20 Leaders’ Summit will not take place until November, with this declaration, we now know what they will say on health. As such, our attention as advocates now turns to the next holder of the G20 Presidency, Japan, and prognosticating how the G20 will choose to prioritize global health under its presidency.  Given that Japan has a long-documented history of prioritizing universal health coverage, as well as supporting global health R&D, we can be cautiously optimistic that the positive statements under Argentina will be expanded upon, and that we will see a more holistic view of the importance of innovation and R&D in global health at this time next year.   Photo credits: PATH/Georgina Goodwin, G20.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Major funders are betting that a new online platform for genetic sequencing will help health workers worldwide more easily identify mysterious infections and track disease outbreaks. The platform, IDseq, seeks to make metagenomics sequencing—the analysis of genetic material and the matching of those readouts to databases of known microbes—, which can be expensive and technically demanding, more accessible and affordable, particularly in low-resource settings. Free and based in the cloud, IDseq allows researchers to upload patient data, which is then “crunched” against existing databases, to determine what infection a patient has. The Chan Zuckerberg Initiative is supporting the platform’s development, and the Bill & Melinda Gates Foundation announced last week a new training program to support clinicians around the world in using the platform. In an early stage trial, a combination of two broadly neutralizing antibodies (bNAbs)—proteins that can bind to different strains of HIV and prevent the virus from entering human cells—suppressed blood levels of HIV for months after treatment in some people. Participants received up to three infusions of bNAbs over a six-week period with their viral load monitored every one to two weeks. Though further testing and refinement is required, long-acting bNAbs combinations may eventually become an alternative to daily anti-HIV drugs. Researchers hope to test whether engineering the antibodies to last longer in the blood can improve viral suppression and explore new combinations with additional antibodies or other drugs. The Global Antibiotic Research & Development Partnership (GARDP) and Novartis are joining forces to reduce child deaths from antimicrobial resistance (AMR) by accelerating the development of generic antibiotic treatments for children. The strategic partnership will focus on: 1) enhancing the availability of generic antibiotics and increasing access for children in low- and middle-income countries, 2) developing heat-stable pediatric formulations, and 3) leveraging the knowledge and shared expertise of both partners. The partnership between GARDP and Novartis is a response to the World Health Organization’s call for affordable, improved, and adapted antibiotics for this vulnerable population, for which treatment options are limited.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. In a new report, researchers at the Johns Hopkins Center for Health Security highlight 15 promising technologies that could help make the world better equipped to fight emerging infectious disease (EID) outbreaks and prevent such outbreaks from becoming catastrophic events. The list includes innovative solutions from vaccines that spread through populations like viruses to 3D printed drugs. The 15 technologies identified in the report fall under five broad categories—disease detection and surveillance, diagnostics, manufacture of pharmaceuticals, administration of vaccines and drugs, and medical care—and range in use from the early detection of an EID, to preventing its spread, and through to the care of patients. Notably, researchers looked for innovations that could be used in developing countries where EID outbreaks “hit first and hit hardest,” according to Dr. Crystal Watson, lead author of the report.  A novel synthetic DNA vaccine candidate against Ebola, which targets the virus’ surface, offered complete protection from the Zaire strain of the Ebola virus in preclinical research. Importantly, the vaccine candidate also demonstrated durability, showing strong immune responses one year after the last dose—a particularly challenging area for Ebola vaccines. Compared to traditional vaccine approaches that involve injection into muscle, synthetic non-viral–based DNA vaccines can be administered directly into the skin, resulting in consistent, potent, and rapid immunity. The antibody levels resulting from this vaccine candidate were equal to or higher than those for other vaccines currently being evaluated in the clinic at the Wistar Institute Vaccine & Immunotherapy Center, where the research was conducted. One researcher noted the success of an intradermal, low-dose regimen as encouraging in the pursuit to create safe and effective vaccines that are optimized for high-risk areas. A new type of malaria vaccine, known as a transmission-blocking vaccine (TBV), which aims to prevent mosquitoes from becoming infected by malaria parasites when feeding on infected humans, could one day become part of a suite of tools used to combat malaria. While traditionally scientists have focused on developing vaccines that prevent malaria infection from developing after a person is bitten with a parasite-carrying mosquito, a TBV works differently. A TBV signals the human body to begin making anti-malaria antibodies that will be passed to the mosquito when it bites the immunized person, disrupting the transmission cycle between mosquitoes and humans. While a TBV would not directly prevent an immunized person from getting infected, it would reduce the likelihood of people in that community becoming infected. A research team supported by the PATH Malaria Vaccine Initiative, the University of Buffalo and others have shown that the TBV approach could be effective. The researchers found that antibodies from a protein called Pfs25 effectively blocked the development of malaria-causing parasites in the gut of mosquitoes in animal studies.