Kim Lufkin

President Obama officially began his second term in office this week, and will have a host of new faces to work with in Congress and his own administration. Below, we provide a roundup of some of the most critical leadership changes that could affect funding and policies for global health and international development programs. Secretary of State: The Senate Foreign Relations Committee will hold a hearing on the nomination of Sen. John Kerry (D-MA) to be the next secretary of state today. Sen. Bob Menendez (D-NJ) will oversee the hearing, as Kerry is the current chair of the Foreign Relations Committee. The Rethinking Foreign Assistance blog offers four questions to look for during Kerry’s confirmation hearing, including how he would work to ensure that the US Agency for International Development (USAID) is the premier development agency in the world, and what the new Office of Global Health Diplomacy would focus on during his tenure. President Obama officially began his second term in office this week, and will have a host of new faces to work with in Congress and his own administration. House Foreign Affairs Committee: Rep. Ed Royce (R-CA) is the new chair of the House Foreign Affairs Committee, and Rep. Eliot Engel (D-NY) is the new ranking member. The committee oversees legislation that impacts international development and global health efforts, including bills that affect funding and policy priorities at USAID. According to Science Speaks, Engel is a “global health champion” who succeeds former ranking member Howard Berman (D-CA), who lost his re-election bid in November. Royce “brings a mixed record on global health support to the post, having voted yes to the original Leadership Act that authorized the $15 billion President’s Emergency Plan for AIDS Relief (PEPFAR) in 2003, but then voting against reauthorization of PEPFAR in 2008, as the global AIDS response prepared for a transition from emergency to sustainable humanitarian response.” Following a closed-door meeting last week, Engel said, "The Democratic members of the Foreign Affairs Committee represent a wide range of views and experiences, and we will work together to help ensure that US foreign policy best serves our national interests." Other Democrats new to the committee include Rep. Karen Bass (D-CA) for the subcommittee on Africa, global health, global human rights, and international organizations; Rep. William Keating (D-MA) for the subcommittee on Europe, Eurasia, and emerging threats; Rep. Eni F.H. Faleomavaega (D-Samoa) for the subcommittee on Asia and the Pacific; and Rep. Albio Sires (D-NJ) for the subcommittee on the Western Hemisphere. Senate Appropriations and Budget Committees: Several new leaders have joined the Senate Appropriations Committee and the Senate Budget Committee, which are tasked with overseeing a “likely dwindling pool of federal dollars” across the US government. According to Science Speaks, both committees are now chaired by senators who hail “from two states that serve as headquarters to global health agenda setters.” Sen. Barbara Mikulski (D-MD) is the first woman to head the Senate Appropriations Committee. She represents Maryland, the home to the National Institutes of Health, and has been “lauded for her strong support for medical research and public health.” Sen. Richard Shelby (R- AL) is the new lead Republican on the committee. Shelby was one of eight senators to vote against the “fiscal cliff” deal, but has steadily supported PEPFAR. Sen. Patty Murray (D-WA)—whose state is home to global health groups such as the Bill & Melinda Gates Foundation, the Global Alliance to Prevent Prematurity and Stillbirth, the Infectious Disease Research Institute, PATH, Seattle BioMed, and the Washington Global Health Alliance—now heads the Senate Budget Committee. She has been recognized for her support of issues that include health and women’s equity. As co-chair of the Joint Select Committee on Deficit Reduction, Murray called on organizations to submit letters in support of the International Affairs budget.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Results of a first-of-its-kind clinical trial of a new tuberculosis (TB) vaccine candidate show the candidate vaccine was safe and well tolerated. However, the candidate vaccine did not prevent TB disease when administered as a boost to the currently used BCG vaccine. The Bill & Melinda Gates Foundation has awarded the Task Force for Global Health a five-year, $28.8 million grant to establish a research support center for neglected tropical diseases. A new article examines the challenges and opportunities ahead for scientists developing vaccines against infectious diseases such as HIV, malaria, and TB. Scientists have demonstrated the ability to deliver a dried vaccine to the skin without a traditional needle. Researchers say that this technique would offer several benefits, including removing the need for refrigeration, providing a cheaper alternative to hypodermic needles, and reducing safety risks from needle contamination. A new study co-edited by the World Trade Organization, World Health Organization, and World Intellectual Property Organization outlines policies needed to advance new medical and health technologies, and to ensure that they reach the people who need them.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Agency for International Development has released a report to Congress on its activities in global health research and development (R&D). The report also outlines the agency’s strategy for global health R&D from 2011 to 2015. While the Obama Administration is expected to continue including science and technology (S&T) in its diplomacy agenda, US diplomatic efforts in S&T may be more reliant on collaboration with the private sector due to expected government spending cuts. The Global Alliance to Prevent Prematurity and Stillbirth has released a new video, called “Born in Silence,” that sheds light on stillbirth worldwide. Approximately three million babies are stillborn each year worldwide. amfAR—the Foundation for AIDS Research—released updated estimates for the potential human impact of federal budget cuts to US global health programs. A candidate dengue vaccine developed by scientists at the National Institutes of Health has been found to be safe and effective in most vaccine recipients, according to results from an early-stage clinical trial. The World Health Organization Executive Board this week approved a draft resolution on neglected disease R&D financing and coordination. The resolution will be considered at the next World Health Assembly in May.

The New Year has brought some much-needed good news in the fight against tuberculosis (TB). The US Food and Drug Administration (FDA) recently announced that it has approved a new treatment for multidrug-resistant TB that can be used as an alternative when other drugs fail. The approval is the first time in 40 years that the FDA had approved a drug that attacks TB in a different way from currently available treatments. The new drug, bedaquiline, is made by Janssen Therapeutics. It will be sold under the brand name Sirturo, and is the first drug developed specifically to treat multi-drug resistant TB involving the lungs. Sirturo was approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug will likely benefit patients in need. According to the FDA, this program provides patients earlier access to promising new treatments while the drug developer conducts additional studies to confirm the drug’s benefits and safety. The FDA has approved a new treatment for multidrug-resistant TB that can be used as an alternative when other drugs fail. The approval is the first time in 40 years that the FDA had approved a drug that attacks TB in a different way from currently available treatments. Photo credit: PATH. A study in September in The Lancet found that almost 44 percent of patients with TB in countries like Russia, Peru, and Thailand showed resistance to at least one second-line drug. “Multidrug-resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who have don’t have other therapeutic options available,” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said. Given that the standard drugs used to treat the disease were developed in the 1950s and 1960s, it is no surprise that the TB bacterium has become more and more resistant to these older drugs over the past 50 years. There is a pressing and urgent need for even more new TB drugs, which makes this new FDA approval so significant. It is also noteworthy that the FDA approved Sirturo under its accelerated approval program, in addition to granting the drug fast track, priority review, and orphan-product status. Beyond the lifesaving benefits of the drug itself, these FDA programs resulted in quicker access to this much-needed new TB drug and should serve as models for other drugs desperately needed around the world. It’s critical that the FDA continues to support its priority review, fast track, and similar programs, which can help speed access to safe and effective global health drugs. It’s equally critical that Congress provides the FDA with sufficient funding to carry out this global health work. With the threat of sequestration—which would result in a cut of $318 million for the FDA—still looming, policymakers in Congress must prevent sequestration and protect FDA’s global health activities. Otherwise, approvals for new global health drugs like Sirturo could suffer. “There is no question that we need more and better treatments for drug-resistant TB. And we’ll continue to need new drugs as the disease mutates or changes,” FDA Commissioner Margaret Hamburg wrote in a blog post about the approval. “Meanwhile, Sirturo is a welcome addition to the drugs that we have available to treat patients who have multi-drug resistant TB who need this drug as part of their treatment regimen.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The European Medicines Agency has approved the first vaccine against meningitis B, manufactured by Novartis, for use in individuals from two months of age and older. The Institute of Medicine has released a new discussion paper that examines issues related to global health research and development (R&D) coordination, financing, and prioritization. The paper was written in response to recommendations offered by a World Health Organization group on R&D financing and coordination. Investments by the US government and pharmaceutical companies are leading to new-and-improved vaccines. Scientific advances in the next decade, for instance, could lead to a "universal" flu vaccine given every five to 10 years that would fight many strains of a virus, making annual shots obsolete. Disease burden has an enormous impact on a country’s economic situation, halving household incomes in some highly endemic countries, according to a new study. The study authors write that their findings have direct policy implications. A new opinion piece argues that US investments in foreign aid should not become a casualty of the “fiscal cliff.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Outgoing Rep. Howard Berman (D-CA) this week released a bill that aims to reform US foreign assistance efforts, including those focused on global health. Among other goals, the new bill would promote research and innovation in US foreign assistance efforts. A new clinical trial will examine an investigational drug’s early efficacy in patients newly diagnosed with drug-sensitive tuberculosis. The clinical trial—sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health—is led by researchers at the Tuberculosis Research Unit at Case Western Reserve University in Cleveland. A new report from Médecins Sans Frontières and the Drugs for Neglected Diseases initiative finds that despite important progress in research and development for global health over the past decade, only a small fraction of new medicines developed between 2000 and 2011were for the treatment of neglected diseases. Susan Rice, the US ambassador to the United Nations, withdrew her name from consideration for secretary of state this week. In a letter to President Barack Obama, she said "the confirmation process would be lengthy, disruptive, and costly—to you and to our most pressing national and international priorities. That trade-off is simply not worth it to our country." A new report finds a decline in deaths from malnutrition and infectious diseases has caused a shift in global mortality patterns over the past 20 years, with more of the world’s population now living longer and dying from diseases mostly associated with wealthy countries, like cancer and heart disease.