Kim Lufkin

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a new opinion piece, Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) write about the need to sustain US investments in research and development for global health tools to prevent the spread of disease both in the United States and abroad. The International Federation of Pharmaceutical Manufacturers & Associations is calling for increased public-private sector engagement to accelerate progress toward the Millennium Development Goals. The group is also stressing that partnerships be central components of the post-2015 development agenda. Rep. Barbara Lee (D-CA) recently introduced a bill that aims to stop the spread of HIV around the world. The bill, called the Ending the HIV and AIDS Epidemic Act of 2013 (HR 3117), includes a focus on research to create new HIV and AIDS treatment and prevention tools. A new investment fund launched this week that will allow individuals and institutional investors the opportunity to finance the development of late-stage global health technologies. The HOOKVAC consortium has been awarded a grant from the European Commission to expand the Sabin Vaccine Institute Product Development Partnership’s work to develop and test a vaccine for human hookworm. Under the grant, the HOOKVAC consortium will begin the first clinical testing of the human hookworm vaccine in the West African nation of Gabon.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Centers for Disease Control and Prevention (CDC) recently released a report stating that the United States faces "potentially catastrophic consequences" if health officials do not act immediately to combat rising drug resistance to antibiotics. CDC Director Tom Frieden has also stressed that public health efforts, including research, are more important than ever to address emerging health threats like drug resistance. A new Forbes opinion piece argues that public-private partnerships are key to combatting diseases such as HIV and AIDS, tuberculosis, and malaria. In related news, Rajiv Shah—administrator for the US Agency for International Development (USAID)—recently spoke with Scientific American about how USAID is diversifying its partnership base to address global development challenges. “There’s a growing global need for innovative financial solutions,” Graham Macmillan and Hui Wen Chan from the Citi Foundation write as part of a new blog series. “Innovation and collaboration are necessary to tackle” international development challenges, they write, adding that advance market commitments and the International Finance Facility for Immunization are examples of “exciting innovations that have the capacity to make a major impact.” A new opinion piece in Roll Call states that in addition to the “prospect of a government shutdown or a default on the national debt, the most destructive aspect of the federal budget impasse is the sequester’s damage to basic scientific research, especially biomedical research.” The MenAfriVac™ meningitis vaccine has reduced cases of the potentially fatal disease by 94 percent in Africa’s meningitis belt, researchers reported this week in The Lancet.

The GHTC has long stressed that the US Food and Drug Administration (FDA) plays a critical part in efforts to improve global public health. While the FDA is best known for its work to protect the health of US consumers, the agency has a strong history of sharing its expertise to benefit people worldwide and is playing an increasingly vital role in global health issues. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Our new fact sheet and policy brief focus on five key areas at the FDA. First, the FDA leads numerous international programs from its headquarters in the United States and operates offices and posts in ten countries across the globe. As the agency expands and deepens its contributions to global health, it is essential to ensure FDA’s activities contribute to an agency-wide strategy. Therefore, the FDA should create an office of neglected diseases so that it can better drive coordination among its centers and offices to maximize its global—and domestic—health impacts. This new program should be housed within the FDA’s Office of the Commissioner. By formalizing the agency’s global health activities, better oversight can help ensure that related programs and initiatives contribute to a unified goal. The GHTC has released two new resources that provide fresh evidence on the FDA’s growing global health presence, while also offering recommendations for how the agency can continue to strengthen its efforts to improve health and save lives worldwide. Credit: PATH Second, the FDA should continue to build partnerships with global regulatory stakeholders, such as the World Health Organization and national regulatory authorities. Regulatory review of products designed for use in the developing world can be particularly challenging, especially when the national regulatory authorities do not have the capacity or resources to manage the reviews. To address this issue, the FDA offers trainings and contributes to global efforts to improve regulatory harmonization. The agency also supports a variety of global regulatory initiatives. But this is just the beginning. To realize the positive impacts of these investments, FDA should continue to contribute to and expand these efforts. Third, while FDA has taken impressive steps to increase its engagement globally, without formalized reporting and oversight mechanisms the outcomes of this work can wane in the face of other priorities and funding constraints. To increase transparency and accountability for its global health commitments, the FDA should take steps to establish formalized processes to report to Congress on its neglected disease activities. Fourth, while its first priority is the health of Americans, it is essential that the FDA arms itself with global health experts who can help carry out a comprehensive plan. To strengthen the work already being conducted in the agency’s international offices and posts, FDA should dedicate additional staff members and resources to global health engagement. Finally, FDA—like so many agencies across the US government—is facing severe financial constrains due to sequestration and broader budget cuts. We’re facing the possibility of a government shutdown at the end of this month, as congressional policymakers still have not reached an agreement on the federal budget. Without question, this financial uncertainty hinders FDA’s ability to strengthen its role in global health and safeguard the health of American citizens. It’s critical that congressional policymakers pass a smart budget agreement that avoids another round of sequestration cuts while protecting key programs at FDA and other federal agencies that work in global health. As House and Senate leaders continue their budget negotiations, they have the opportunity to demonstrate their commitment to lifesaving and efficient programs at leading agencies like the FDA.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Rep. Leonard Lance (R-NJ) this week reintroduced a bill—called the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act—that aims to stimulate the development of diagnostics and potential therapies that have no patent protection. The World Health Organization has announced it will start charging a fee to manufacturers seeking prequalification of their medicines and pharmaceutical components. Some public health advocates are expressing concern that fees might have a negative effect for procurement and access to medicines. Nature News examines the effects of sequestration and budget cuts on US researchers who receive funding from the National Institutes of Health (NIH). In related news, a new opinion piece in Nature argues that the effects of federal budget cuts provide an opportunity to revisit the NIH’s funding structure. The Centers for Disease Control and Prevention is supporting efforts to develop an all-natural insecticide to prevent malaria and other insect-borne diseases. The Pharmaceutical Research and Manufacturers of America released a report this week showing that 271 vaccines are under development, all in clinical trials or under review by the US Food and Drug Administration. This includes 137 vaccines for infectious diseases.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Building on a 2009 trial that demonstrated a preventive HIV vaccine is possible, researchers in Thailand are moving forward with another phase of an HIV vaccine study. The American Society for Biochemistry and Molecular Biology has released a survey that found 96 percent of scientists say that research budgets are not growing fast enough to keep up with scientific opportunities. Pharmaceutical company Sanofi Pasteur announced that the World Health Organization has prequalified Menomune®, its vaccine to prevent invasive meningococcal disease. A new opinion piece argues that there has been “measurable progress” made in “developing a safe, effective microbicide,” which is a “tribute to the tenacity of advocates and scientists alike.” In the lead up to the United Nations General Assembly later this month, a new online debate asks some of the world's leading experts about changes needed to achieve the health-related Millennium Development Goals by the deadline.

Close on the heels of the announcement that Australia is newly investing in global health product development, the United Kingdom last week also revealed that it’s bumping up its longstanding support in this area. The UK’s Department for International Development (DFID) announced it is investing £138 million—or approximately $215 million—over the next five years into nine product development partnerships (PDPs) to support the development of new drugs, vaccines, insecticides, diagnostic tools, and microbicides. DFID has a long and established history of supporting health research and development (R&D), so this new round of funding is a welcome and much-needed continuation of the department’s recognition that new products are critical components of improving health worldwide. “As a donor, DFID has been a pioneer in supporting both PDPs and global health R&D, and has invested heavily in both for nearly two decades,” said James Snodgrass, senior consultant at Baird's CMC, a global health consulting firm. “DFID really does believe that new technologies can make a critical difference to people's health in poor countries.” DFID is investing approximately $215 million over the next five years into nine PDPs to support the development of new drugs, vaccines, insecticides, diagnostic tools, and microbicides. Credit: PATH This new support from DFID is significant for another key reason. In the wake of the global economic crisis, many donor governments are examining and inspecting their investments across-the-board even more closely. UK “government ministers are minutely scrutinizing every detail of grants this size,” Snodgrass said, adding, “People know this in the global health community, which is why the announcement of DFID's funding is such a vote of confidence in the current [PDP] model.” It’s promising to get this vote of confidence from DFID now, as many UK political parties are gearing up to release their platforms ahead of the next elections. The outcome could have significant ramifications for the country’s role in global health and medical research. Snodgrass points out that while global health R&D is not one of the top concerns of ordinary UK voters, it is a “big concern” for some senior academics, nongovernmental organizations, and Members of Parliament. He adds that “polls currently suggest that the left-wing Labour party might get sufficient votes to gain power at the next elections, and they are likely to continue to be supportive of the R&D agenda.” It’s incredibly encouraging to see that the United Kingdom is boosting its long-standing support for PDPs and that new donors like Australia are starting to enter the field. These funding announcements are even more significant in light of the fact that donors are increasingly putting their investments under a microscope, meaning that PDPs are continuing to demonstrate their ability to advance new, more effective public health tools. As Snodgrass put it, “these grants are welcome support for the need for continuing investment in global health R&D. Globally, such funding may be flat-lining, but it is not yet declining. That is a triumph in the current economic climate.”