Breakthroughs Blog: Congress

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. On Friday, February 15, President Trump signed into law a spending bill covering funding for State & Foreign Operations (SFOPs) for fiscal year (FY) 2019. The bill provides US$8.8 billion to the overall Global Health Programs account at the State Department and US Agency for International Development (USAID), which is a $150 million increase from the FY18 enacted level and $2.1 billion above the President’s FY19 request. Funding for all global health programs at the State Department and USAID either increased or remained flat compared to the FY18 enacted level and were also well above the President’s budget request. The World Health Organization (WHO) is working to contain an unprecedented outbreak of Lassa fever in West Africa, which has killed 59 people in recent weeks. This Ebola-like virus is transmitted to humans via exposure to contaminated rate urine and droppings, as well as from person-to-person. Although Lassa fever is endemic in parts of West Africa with outbreaks occurring yearly, health officials have confirmed at least 275 cases in Nigeria—the epicenter of the outbreak—since the beginning of the year. WHO has expressed concern regarding the high number of cases so early in the Lassa fever season, which is due to last another four months. Controlling Lassa fever is a challenge because its symptoms can be vague, such as headaches and chest pain, making the disease difficult to diagnose, and there is no licensed vaccine yet available. To contain the current outbreak, WHO is forming a regional coordination mechanism to share, process, and evaluate information regarding suspected cases and is also intensifying public awareness efforts about how to deter rats. In experimental studies conducted in mice, an antibiotic drug called AN12855 was shown to be more effective against tuberculosis (TB) than isoniazid, one of the standard treatments available. The new drug demonstrated both a much lower tendency to develop resistance, and it remained in the tissues where the bacteria that causes TB resides for longer, thus killing the bacteria more effectively. Further studies are required to determine if these outcomes will translate to improvements in treatments for humans. Current treatment for TB can range from six months to more than a year; thus, researchers are working to develop new drug regimens that shorten and simplify treatment.

Two thousand eighteen was a turbulent year in global health. Between reemerging crises, breakthrough scientific discoveries, and the continued looming threat of health research funding cuts, 2018 took us on a roller coaster ride of peril and promise. Now as the year comes to an end, GHTC is taking a moment to reflect on the global health innovation stories and news that shaped 2018.Here are the highlights from our year in review:1. A long-neglected disease sees a breakthroughA patient suffering from sleeping sickness visits a hospital in DRC. PATH/Georgina GoodwinIn 2018, a revolutionary treatment emerged for a neglected tropical disease, sleeping sickness. The first all-oral drug for sleeping sickness, developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, received a positive scientific opinion from the European Medicines Agency—paving the way for the treatment to be rolled out in endemic countries in 2019. This groundbreaking treatment, known as fexinidazole, is a tablet taken once daily for ten days that treats the most common form of sleeping sickness, a disease spread by tsetse flies, which causes neuropsychiatric symptoms and can be deadly if left untreated. Current treatments for sleeping sickness require a complicated series of infusions and pills, are costly, and involve long hospital stays. Fexinidazole is a simple once-a-day pill that could reduce the logistical burdens to treating a disease for which approximately 65 million people in sub-Saharan Africa are at risk. 2. TB captures the spotlight as new research demonstrates promiseThe world’s largest infectious disease killer finally received some well-deserved attention this year as world leaders convened the first-ever United Nations High-Level Meeting on Tuberculosis, at which member states committed to closing the US$1.3 billion annual gap in funding for tuberculosis (TB) research. While time will tell whether this moment will prove a powerful catalyst or an empty promise, the science continues to advance as we wait for the politics to play catch up. This year we saw several exciting new developments in TB research. Aeras and GlaxoSmithKline released the results of a phase 2b clinical trial that showed their candidate vaccine prevented TB from developing in half of those who received it. If it succeeds in additional testing, this vaccine would represent an improvement over the existing vaccine in use and would be the first new TB vaccine developed in over a century. On the treatment side, TB Alliance and partners launched the SimpliciTB trial, to test a new all-oral drug regimen for treating both drug-sensitive and drug-resistant TB, known as BPaMZ, which could slash treatment times for TB by one-third or more and is projected to be markedly less expensive than current therapy. Additionally, TB Alliance was honored this year by GHTC with an Innovating for Impact Partnership Award for the development of child-friendly TB medicines, which are now available in 86 countries and counting.3. A single dose cure for malaria is approvedA patient in Zambia receives a malaria diagnostic test. PATH/Gena Morgan This year, the global health community witnessed regulatory approval of the first new treatment for Plasmodium vivax malaria in 60 years by the US Food and Drug Administration (FDA). The new drug, tafenoquine, is a single-dose treatment developed by GlaxoSmithKline and Medicines for Malaria Venture. P. vivax malaria causes around 8.5 million infections every year in Asia, Latin America, and parts of Africa. It’s tricky to combat because the P. vivax parasite can lie dormant in the liver, where it reactivates, and can cause new episodes of malaria weeks, months, or even years after the initial infection. In a study of the treatment, 60 percent saw no relapse six months after taking the drug. Tafenoquine has been submitted for approval to the Australian regulatory authority and is slated to be submitted for approval in malaria-endemic countries. Experts hope this new treatment will accelerate the path to elimination of this mosquito-borne disease.4. Innovations show promise while the battle against Ebola rages onOne of the most disheartening stories of 2018 was the reemergence of Ebola in the Democratic Republic of Congo (DRC). Ongoing conflict in the region has hampered response efforts, with the outbreak now reaching 500 confirmed cases. Yet, amidst this crisis, there is one reason for optimism: An experimental vaccine appears to be helping those it reaches. Close to 45,000 people have received the experimental rVSV-ZEBOV Ebola vaccine—the largest use of the product since a clinical trial in 2015 showed it worked. While the vaccine’s effectiveness during this outbreak has not been formally assessed, World Health Organization (WHO) officials believe it is having a major impact. The vaccine’s developer, Merck, announced last month that it has begun the process of submitting evidence to seek FDA approval, a crucial step to bring the vaccine to market. Meanwhile, new preliminary research also suggests experimental treatments deployed during the outbreak are improving survival rates, and researchers have begun clinical trials in eastern DRC to test the effectiveness of four of these experimental drugs. This research raises new hope that science may soon offer us both a vaccine and treatments to combat Ebola.5. Congress pushes back against cuts to global health and medical researchWhile the Trump Administration proposed in its fiscal year (FY) 2018 and 2019 budgets to slash funding for global health and medical research programs, in the end Congress pushed back. In March, Congress passed the FY18 omnibus, which protected, and in many cases increased, funding to key US agencies and programs that advance global health research and development (R&D). In September, Congress passed an FY19 spending bill covering the Defense, Labor, Health and Human Services (LHHS), and Education departments. The bill boosted funding for medical research across the Department of Health and Human Services, with the National Institutes of Health receiving a $2 billion increase and the US Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority also receiving modest increases.These funding bills represent a forceful rebuke by Congress of the Administration’s proposals to draw back support for global health and medical research programs and demonstrate that Congressional policymakers on both sides of the aisle want to see the US continue its leadership in advancing innovation to improve the health of those in need around the world. Given that funding for the US Agency for International Development (USAID) was maintained through a continuing resolution that expires on December 21, we now await further action by Congress to determine how FY19 funding for global health accounts at USAID will shake out.6. New vaccines give us a better shot at saving livesA healthworker in Laos prepares a vaccine. PATH/Aaron Joel Santos Two thousand eighteen was a year of innovations in vaccines. In what could be the first new polio vaccine in more than 50 years, researchers have developed a way to freeze-dry an inactivated poliovirus vaccine (IPV) so that it can be stored at higher temperatures and reconstituted for use without losing its potency—potentially offering a new tool to help eradicate the disease. In other vaccine news, Johnson & Johnson (J&J) unveiled promising early-stage results for a tetravalent mosaic-based HIV preventative vaccine regimen. Currently in large-scale clinical trials in sub-Saharan Africa, the vaccine marks only the fifth time in history an HIV vaccine candidate has advanced to human clinical trials, offering new hope for a breakthrough in HIV prevention. Additionally, WHO prequalified new vaccines to combat typhoid and rotavirus, which is the most common cause of severe diarrheal disease in children worldwide. In January, WHO approved a new, highly effective and low-cost typhoid vaccine for global use. In the same month, it prequalified Rotavac, an oral rotavirus vaccine, and later in the year, approved Rotasiil, a first-of-its-kind thermostable vaccine to prevent rotavirus.7. Innovators strive to put greater choice in the hands of patientsOne of the exciting themes we saw across so many global health stories this year was the power of innovation to put greater choice in the hands of patients. People have unique needs, and our toolbox of global health technologies must reflect that. Several scientific developments this year promise to expand family planning choices for women and their families. The first-of-its-kind, self-insertable and removable one-year contraceptive vaginal ring received regulatory approval from the FDA; new research from Uganda showed a self-injectable form of contraception can help women overcome barriers to consistent use; and the first clinical trial was launched for a male contraceptive gel, a technology that could bring more equality to the burden of family planning. In addition, researchers are also advancing long-acting injectable forms of medicines to provide an alternative for individuals who struggle to take frequent pills. For example, HIV-positive patients may soon be able to choose whether they want to use long-acting injectable antiretroviral treatments or daily pills as a form of Pre-Exposure Prophylaxis, and scientists are also working on injectable formulations of medicines for malaria prevention. 8. Scientists pursue wild and weird ways to fight deadly diseases A dog in India. PATH/Gabe BienczyckiWinston Churchill once said, “No idea is so outlandish that it should not be considered.” That’s clearly a motto researchers have taken to heart, as evidenced by the number of stories we read this year about unusual and creative ways scientists are trying to fight infectious diseases. Here’s a sample of some of our favorites. One could say it’s a bacteria-eat-bacteria world out there, with researchers studying whether germ-eating microbes could be used to combat drug-resistant infections. Man’s best friend may also be man’s diagnostic tool, according to new research showing that dogs can be trained to detect malaria in people. In the future, administering a vaccine could be as easy and pain-free as putting on a Band-Aid if microneedle patches in development come to fruition. The contents of your takeout dinner might be the next frontier in HIV prevention, as scientists have developed a technique to modify a strain of rice to produce HIV-neutralizing proteins. While these ideas may seem fantastical, history has taught us that groundbreaking discoveries can come from unusual places. For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2019 and beyond, sign-up now to receive GHTC’s R&D News Roundup newsletter.

While the dust is still settling from the US midterm elections on November 6—with a handful of key races yet to be decided and others headed for run-offs—the major takeaways are set. Democrats have decisively retaken control of the House of Representatives with at least 228 of 435 seats declared in their favor (a 34-seat pickup likely to grow as the remaining races are called). Meanwhile, Republicans have solidified and likely expanded their hold on the Senate, with at least 51 of 100 seats called for Republicans and the still-too-close-to-call remaining races leaning in their favor. With Washington poised for at least two years of divided government, one commentator has predicted that “We may be looking at two years in which a Congress we already regard as pretty dysfunctional doesn’t really function much in the legislative sense.” He foresees a Congress that “functions as an investigative body in the House”—intent on investigating the Trump Administration and flexing oversight muscle— “and a judge-making machine in the Senate”—fulfilling Republicans’ promise to their voters to confirm conservative federal judges. What does all of this mean for US support of global health research and development (R&D)? Of top interest are potential changes to the leadership and makeup of key congressional committees. While these rosters will not be set until early 2019, one broad takeaway is that only a few members currently serving on such committees lost their races. No Senators on committees of interest lost, though Cindy Hyde-Smith (R-MS), currently serving on the Senate Appropriations Committee and its Labor, Health and Human Services and State and Foreign Operations Subcommittees, faces a run-off election on November 27. However, some already-announced retirements will still mean shake-ups for global health leadership in the Senate. Senator Bob Corker (R-TN), who currently chairs the Senate Foreign Relations Committee (SFRC), and fellow committee member Senator Jeff Flake (R-AZ), who chairs the Africa and Global Health Policy Subcommittee, announced their retirements earlier this year. This means we will see at least two new Republican faces on SFRC come 2019, with the potential for more to be added after the top Senate Republicans and Democrats negotiate committee ratios to account for Republicans adding seats to their majority in the chamber. While the House of Representatives overall will look quite different in the 116th Congress due to the change in party control, retirements, and flipped seats, only a few current members on key committees of interest to global health R&D will not be returning. In the House, John Culberson (R-TX), Kevin Yoder (R-KS), David Young (R-IA), and Scott Taylor (R-VA) of the House Appropriations Committee; Leonard Lance (R-NJ) on the Energy and Commerce Committee and its Subcommittee on Health; and Dana Rohrabacher (R-CA) and Dan Donovan (R-NY) on the House Foreign Affairs Committee lost their races. House Foreign Affairs Committee Chairman Ed Royce (R-CA) had already announced his retirement, and it is not yet clear who will succeed him. Donovan’s departure, in particular, will leave a leadership gap on global health among House Republicans. He served on the House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights and International Organizations; several global health-related caucuses; and frequently led or signed Dear Colleague letters on global health appropriations. He is one of several moderate Republicans who have been frequently called upon by the global health community to serve on caucuses or sign Dear Colleague letters who will not be returning to Washington for the 116th Congress. Notably, two-thirds of House Republicans who signed a Dear Colleague letter on fiscal year 2019 maternal and child health funding lost their races or are retiring come January. Of course, a “glass half full” perspective also accounts for some exciting new members set to join the ranks of the 116th Congress who could be cultivated as champions for global health R&D. Of particular interest to global health R&D advocates, at least nine new “science-credentialed candidates” were elected on November 6—eight to the House and one to the Senate. These science-engaged members include a pediatrician (Kim Schrier, a Democrat elected to Washington’s 8th District), a dermatologist who began his career as a naval physician (John Joyce, a Republican elected to Pennsylvania’s 13th District), and a registered nurse with a Master of Public Health degree (Lauren Underwood, a Democrat elected to Illinois' 14th District who served in the Obama Administration as a senior adviser at the Department of Health and Human Services focused on bioterrorism threats and public health emergencies). On both sides of the aisle, many candidates with military or national security backgrounds won their races, which should expand the audience for advocacy on issues of international concern. A quick snapshot of some other freshmen with interesting backgrounds coming to town include: A son of Eritrean refugees (Joseph Neguse, D-CO-2) and a Somali refugee who has previously worked as a community nutrition educator (Ilhan Omar, D-MN-5). A former associate vice president of Florida International University’s Herbert Wertheim College of Medicine (Debbie Mucarsel-Powell, D-FL-26). A former Washington director of Human Rights Watch and Assistant Secretary of State for Democracy, Human Rights, and Labor with experience on the National Security Council (Tom Malinowski, D-NJ-7). A former Secretary of Health and Human Services, who was the longest-serving in history (Donna Shalala, D-FL-27).  There are real challenges to come in the new year. With Democrats taking the House having campaigned on big promises squarely focused on domestic priorities, getting the attention necessary to advance global health R&D will continue to require creative approaches. This is compounded by growing fiscal constraints, including looming budget caps and additional demands on non-defense discretionary funding across the board, which will make maintaining and growing the resources we need even more difficult. One thing is certain: between wins, losses, and retirements, Congress will look very different come January. Educating new members and continuing to cultivate the support of their returning colleagues on the value of US investments in global health R&D will be an exciting challenge.

This afternoon, President Trump signed into law a spending bill that pairs full-year fiscal year (FY) 2019 funding for Labor, Health and Human Services (LHHS) and Defense with a stopgap measure to keep other agencies funded through December—staving off a partial government shutdown on the eve of the end of the fiscal year. The “minibus”-plus-continuing resolution (CR) legislation boosts funding for medical research across the Department of Health and Human Services (HHS) for FY19, while maintaining funding for global health at the US Agency for International Development and the Department of State through December 7 via the CR measure. Given Trump already signed into law a spending package covering Energy, Veterans Affairs, and the Legislative Branch, now 75 percent of the government is funded for the full fiscal year; while the remaining agencies will remain funded through the CR as lawmakers work to finish full-year funding bills for them. While this year’s appropriations approach may be unusual, by recent historical standards, it was also remarkably efficient: Today marks the first time in 22 years that the government has succeeded in getting at least five of the twelve annual spending bills signed into law before the new fiscal year begins. Here’s a breakdown of how global health and medical research funding fared in the spending package: National Institutes of Health The National Institutes of Health received an impressive US $2 billion boost overall (a 5 percent increase over FY18), including increases of 3-9 percent to each center involved in global health research and development (R&D). In increasing order, the package provided a boost of 3.4 percent for the Fogarty International Center, 3.75 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 5 percent for the National Institute of Allergy and Infectious Diseases, and 8.62 percent for the National Center for Advancing Translational Sciences. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) also saw an overall increase from FY18 – depending on how you do the math. In the FY18 omnibus appropriations bill passed in March, CDC received a one-time $480 million funding infusion to support the construction of a replacement Prevention Biosafety Level 4 high containment laboratory to enable continued research on dangerous pathogens like Ebola. Less the cost of that lab, CDC’s overall year-on-year budget rose 1.63 percent. The Center for Global Health was level-funded, while the National Center for Emerging and Zoonotic Infectious Diseases received a 1 percent bump. The bill also established a new CDC-wide Infectious Disease Rapid Response Reserve Fund with an initial infusion of $50 million, a key win for global health security advocates. Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) saw a $25 million budget increase in the bill (a 4.66 percent boost). This—coupled with the House passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018—earlier this week, which reauthorized BARDA and authorized $250 million annually for five years for a new emerging infectious diseases program—is welcome news for those looking to BARDA to play an increasingly robust role in global health R&D. However, given the Senate still needs to pass their own version of a bill and continues to pursue a general all-hazards approach in their bill, a call out for emerging infectious diseases may not come to fruition in the final reauthorization. US Agency for International Development & State Department Global health accounts at the US Agency for International Development and the Department of State will be level funded through December 7 since the funding package signed into law today includes a CR for the State and Foreign Operations appropriations bill.   The bottom line: Yet again, strong congressional support has protected global health R&D from deep cuts to key agencies proposed in the President’s budget request and even won significant increases to some accounts. As we get closer to the midterm elections, we will keep a close eye on political developments that could affect our funding prospects for FY20.