Kim Lufkin

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The House Appropriations Committee has released its fiscal year (FY) 2014 State and Foreign Operations Appropriations bill, which is under consideration today in subcommittee. The bill contains $1.4 billion for the US Agency for International Development—a reduction of $172 million from the FY2013 level. The World Health Organization has added three new drugs developed by GHTC member Drugs for Neglected Diseases initiative to its Essential Medicines List for Children. A new House bill would exempt US Food and Drug Administration (FDA) user fees from sequestration. The FDA's budget is heavily supported by user fees from the industries it regulates, and sequestration would cut about $85 million from the agency's budget in 2013 by hitting these fees. A new guide from the Council on Health Research for Development aims to provide low- and middle-income countries with greater control over research collaborations. The guidance covers issues such as intellectual property rights, ownership of data and samples, capacity building, technology transfer, compensation for indirect costs, and the legislative context of research contracts. The National Center for Advancing Translational Sciences recently awarded a total of $12.7 million to nine research projects aimed at discovering new uses for drugs that failed in previous clinical trials. The Sabin Vaccine Institute Product Development Partnership (Sabin PDP) announced the launch of a soil-transmitted helminth vaccine research program. The program will advance candidates for ascariasis (roundworm) and trichuriasis (whipworm) infections and incorporate them into existing hookworm and schistosomiasis under development by the Sabin PDP to create a vaccine against all four major human helminth infections.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. A new analysis by amfAR, The Foundation for AIDS Research, finds that global health funding accounts for about one quarter of one percent of the total US federal budget. These programs help fight diseases like HIV and AIDS, tuberculosis (TB), malaria, and neglected tropical diseases. As a result sequestration, TB research at federal agencies such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the US Agency for International Development has been reduced significantly. The number of approvals for drug treatments targeting neglected diseases such as HIV and AIDS and malaria has increased in recent years, but research and development spending has leveled off, according to a report from the Tufts Center for the Study of Drug Development. Trevor Mundel, president of the Global Health Division at the Bill & Melinda Gates Foundation, examines how innovative financing can help spur global health research and product development. Reps. Ted Poe (R-TX) and Gerry Connolly (D-VA)—along with Sens. Marco Rubio (R-FL) and Ben Cardin (D-MD)—have introduced companion bills that aim to improve the accountability and transparency of US foreign assistance programs.

Today, the Senate appropriations committee approved a fiscal year (FY) 2014 appropriations bill that outlines funding levels for the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). The Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill would take the positive step of restoring sequestration cuts to CDC and NIH, although there is mixed news for global health programs at the agencies. NIH The bill would fund the NIH at a total of $30.9 billion in FY 2014, restoring this year’s five percent sequestration cut and providing a small increase over last year’s budget. Science Insider reports that the NIH had “strong support” from Senate Appropriations Committee Chair Barbara Mikulski (D-MD), who recently said that she is determined to reverse "reckless cuts to American biomedical research." In her opening remarks earlier today, Sen. Mikulski said, “Because of the investments we have made in NIH over the past decades, … HIV and AIDS is no longer a death sentence, and polio and small pox are essentially eradicated in this country. These medical breakthroughs didn’t just happen, they occurred because this Committee supported NIH, and the NIH supported dedicated scientists who sought knowledge and medical breakthroughs. We must keep up this support.” The bill includes $50 million, five times the FY 2013 level, for NIH’s Cures Acceleration Network, which aims to speed the translation of medical research discoveries in the laboratory that have not advanced far enough to attract significant investments from the private sector. According to Nature, in order to approve a new NIH budget—as opposed to passing yet another continuing resolution for FY 2014—the House and Senate must agree on a common figure for the agency. As a comparison, the House FY 2014 Labor-HHS bill would provide $8 million less for NIH compared with the Senate version. The Senate Labor-HHS appropriations bill for FY2014 would fund the NIH at $30.9 billion and the CDC at $7.022 billion. Credit: PATH/Evelyn Hockstein CDC The Senate bill would provide CDC with $7.022 billion in funding for FY 2014. The bill would restore the $800 million cut from CDC’s budget by sequestration and add a $22 million funding increase. The bill would provide $391.9 million for CDC’s Center for Global Health. This would include $116.9 million for CDC’s Global AIDS Program, which is equivalent to the FY 2013 level, but $15 million below President Obama’s FY 2014 request. The bill would provide $19.3 million for CDC’s Parasitic Diseases and Malaria program, which is comparable to FY 2013 levels, but less than the $22.2 million requested by Obama. CDC’s Division of Tuberculosis Elimination would receive flat funding at the FY 2013 funding level of $140 million. No additional funding for the division’s research programs was allocated. Finally, the bill also contains a total of $19.2 million for Global Public Health Capacity Development. These funds are for a new initiative to support public health capacity building in at least five developing countries over a two-year period to be overseen by CDC. The fate of the Labor-HHS appropriations bill is unclear from this point on. There is a $91 billion funding gap between the House and Senate overall budgets for FY 2014. And while the House Labor-HHS subcommittee has its overall budget, the subcommittee has not announced a date for consideration of a bill. Whatever happens, both the House and Senate must work to protect funding levels at the NIH, CDC, and all federal agencies that support global health and research programs.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. FasterCures recently hosted a congressional briefing, during which more than 100 congressional staffers, patient advocates, academics, and drug developers came together to hear about the importance of federally supported translational research. PATH and Standard Diagnostics, Inc., have formed an agreement to bring to market a rapid test for the neglected tropical disease onchocerciasis, also known as river blindness. For the first time, an international team of researchers has estimated that after an initial dengue infection, a person is protected from infection with other strains for between one and three years. The results have implications for designing more effective dengue vaccine studies. Recent breakthroughs in HIV prevention research and development have confirmed the promise of new options to help end the AIDS epidemic and highlight the urgent need for ongoing research to develop additional prevention options, according to a new report from the HIV Vaccines and Microbicides Resource Tracking Working Group. Health advocates are saying that a free trade pact under negotiation between the United States and 11 Asia-Pacific nations will impose intellectual property rules that could restrict access to affordable medicines in developing countries.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The TB Alliance recently launched an online resource that allows users to follow the progress of the organization’s efforts to develop new drugs for tuberculosis (TB). The US Food and Drug Administration has announced a five-year, $7.5 million contract with the World Health Organization (WHO) to support regulatory science and enhance global regulatory capacity. The funding will support WHO’s efforts to provide substantial regulatory support to many of its 193 Member States. A new report from the Institute of Medicine finds that a National Institutes of Health program to spur the translation of science to clinical therapies is largely successful but could be more collaborative. WHO, the World Trade Organization, and the World Intellectual Property Organization are planning a discussion on the current model for researching and developing new medical and pharmaceutical products—as well as new incentives and collaborative innovation models. The University of Washington has received funding from the Department of Defense to continue a project aimed at developing a small, paper-based device that could test for infectious in areas where diagnostic capabilities are limited.

  “A small, modest investment from the US government could truly transform the lives of people around the world and make a serious public health impact,” Rachel Cohen from the Drugs for Neglected Diseases initiative said yesterday at a congressional briefing focused on neglected tropical diseases (NTDs). NTDs are a group of 17 diseases that infect more than one billion people around the world, most of whom live on less than $1.25 per day. The briefing focused on how the US government has played a significant role in combatting NTDs globally through programs like those at the US Agency for International Development (USAID), which has helped deliver more than half a billion treatments in six years to more than 250 million people. At the same time, Cohen and other panelists stressed that significant changes are needed to make US NTD programs even more successful. For instance, several speakers argued that while USAID’s NTD program has been remarkable in its efforts to provide NTD patients with access to existing therapies, the agency must expand the program to include funding for research into new NTD drugs, vaccines, and diagnostics. The fact that USAID does not currently support NTD product development “is a serious gap in USAID’s efforts against NTDs, as most NTDs do not have adequate prevention, diagnostic, or treatment options,” moderator Kaitlin Christenson, GHTC’s coalition director, pointed out. She added that “many existing NTD drugs are toxic, expensive, and difficult to administer in resource-poor settings.” Christenson and other panelists added that congressional support is critical for USAID to expand its mandate into NTD research and product development. Panelists at a Congressional briefing on Monday discuss the US response to neglected tropical diseases. From left: Kaitlin Christenson, Brian D'Cruz, Rachel Cohen, and Larry Buxbaum. Credit: Research!America Panelists also highlighted that USAID’s program—which currently addresses only seven NTDs—should expand to include research and control efforts for all 17 diseases. Dr. Brian D’Cruz, an emergency physician who has served with Médecins Sans Frontières (MSF), discussed his experience providing treatment for sleeping sickness in the Central African Republic and Democratic Republic of the Congo to illustrate the need for expanded US support. D’Cruz told the story of Natasha, a 12-year-old girl in the Congo who died of sleeping sickness before his MSF team could provide adequate diagnosis and treatment. He added that MSF physicians are hindered in their efforts to treat patients like Natasha by cumbersome diagnostics and outdated, lengthy treatment regimens. Dr. Larry Buxbaum with the Philadelphia Research and Educational Foundation also highlighted that many NTDs, such as Chagas, are increasingly affecting populations in the United States. “Climate change is moving many tropical diseases north,” he said, adding “So while research is needed to help people with NTDs in Africa and South America, this research will be useful right here in the US as well.” D’Cruz also said that he has treated patients with Chagas disease in his capacity as a physician in Northern Virginia: “These NTDs exist just a few metro stops away.” Finally, all the panelists urged US policymakers to become increasingly involved in an ongoing global discussion about how to redefine NTD research and product development efforts. All three of these changes—investing in NTD product development, expanded support for all 17 NTDs, and engaging in global discussions about NTD research—will help ensure that the US makes the greatest impact possible against NTDs worldwide. “We need breakthrough, completely modern therapies and diagnostics for these diseases,” Cohen said, adding, “They are literally in the pipeline. US support could help us get closer and closer to elimination.”