Kim Lufkin

Last week, the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) announced a key benchmark for the program—the formation of its new Advisory Council, which will meet for the first time later this month. Since NCATS was created, the GHTC has been particularly interested in tracking its progress in taking up initiatives that could accelerate the development of new drugs for global health. As the largest funder of global health research and development in the world, the NIH must ensure that its initiatives and programs like NCATS continue to support the creation of much-needed new tools like vaccines, drugs, and diagnostics. We’ve been waiting for NCATS to announce its Advisory Council members, in the hopes that scientific experts with a background in global health would provide much-needed guidance to the center’s director—as well as NIH Director Francis Collins and Health and Human Services Secretary Kathleen Sebelius—on NCATS policies, initiatives, and programs. It comes as a disappointment, therefore, to learn that no global health experts are serving on the NCATS Advisory Council during this initial four-year term. Much like new initiatives coming out of NCATS, the center’s new council seems to focus primarily on diseases that affect US populations. NCATS should do more to speed the development of drugs for global health. There’s no question that rare and other diseases in the US deserve support from NCATS. But so do neglected diseases that affect people around the world. And as Peter Hotez from the Sabin Vaccine Institute recently pointed out, neglected tropical diseases, traditionally “confined” to developing countries, are becoming the new diseases of poverty in the US. With support from NCATS and other US government programs, researchers should receive much-needed funding to create new tools to fight neglected diseases that have long impacted people overseas and are now appearing domestically. It was encouraging to see that the new Review Board at the Cures Acceleration Network, an NCATS program, includes two global health experts. We hope that NCATS and its Advisory Council follow suit and start prioritizing research for global health.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Christopher Austin has been named the new director of the National Center for Advancing Translational Sciences at the National Institutes of Health. A new analysis compares the innovation and science policies of presidential candidates Barack Obama (D) and Mitt Romney (R). A bill signed into law earlier this year that provided the US Food and Drug Administration (FDA) with funding is at risk due to federal budget negotiations. An opinion piece calls on US policymakers to “get serious” about funding scientific and research efforts. A breakthrough tool to combat tuberculosis has been launchedby the Critical Path Institute and the Clinical Data Interchange Standards Consortium (CDISC). The project was the result of collaboration between the Critical Path Institute, CDISC, the FDA, and others through the Critical Path to TB Drug Regimens. Researchers met this week in Boston for the AIDS Vaccine 2012 conference to discuss the latest in efforts to develop a vaccine against the disease.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The US Food and Drug Administration has announced it will give priority review to a new treatment for multi-drug resistant tuberculosis. The announcement came after the drugmaker applied to the European Medicines Agency for approval. Nils Daulaire, director of the Office of Global Affairs at the US Department of Health and Human Services, writes about the agency’s first-ever global health strategy. Reuters recently examined several scientific breakthroughs in HIV and AIDS in recent years, and how the global financial crisis could impact progress against the disease. An article looks at how the US presidential candidates would handle foreign aid and international development if elected in November. A related piece examines the social, political, and financial issues at play ahead of the presidential election and their implications for domestic and global health programs.

Next week marks a significant step in this year’s presidential elections, as Mitt Romney will become the official nominee for the Republican Party at its convention in Florida. Science and research will likely not appear on the agenda, as Romney, expected Vice Presidential candidate Paul Ryan, and others will instead focus on topics like reducing federal spending. It’s unfortunate that research will not be a part of the conversation, as new predictions coming out this week indicate that if Romney and Ryan win the election in November, changes could be coming for health research and efforts to develop much-needed new tools for global health. As a Nature article this week points out, Ryan—in his current position as chair of the House Committee on Appropriations—has created a federal budget plan that would, according to the American Association for the Advancement of Science, cut spending on non-defense research and development (R&D) by five percent, or $3.2 billion, below President Obama’s fiscal year 2013 request. Over the long term, Ryan’s approach would reduce funding for R&D to “historically small sizes,” according to Nature. Equally concerning, Ryan’s approach to federally funded R&D could alter US government support for the later-stages of research to develop new health products, including clinical trials. While Ryan’s federal budget plan calls out support for basic research, it would reduce spending for projects deemed “best left to the private sector.” As Nature points out, some advocates “worry that this might include research such as clinical trials sponsored by the National Institutes of Health for therapies from which the drug industry would be unlikely to profit.” Global health R&D is an issue that Republicans and Democrats need to start talking about on the campaign trail. This is an issue that Republicans and Democrats alike need to address. Research to develop new vaccines, drugs, diagnostics, microbicides, and other tools for neglected diseases unquestionably falls under the category of products from which private industry is unlikely to profit. For this reason, the US government has long worked with other partners to bridge this gap. Indeed, global health R&D has historically been a bipartisan issue in Congress that also spans Republican and Democratic presidential administrations, making the US government the largest funder of global health research in the world. And no matter the party in power, the US government can do more to maximize its investments in global health R&D by increasing its support for the later stages of research, as more global health products are moving into the final stages. This makes any proposal to reduce US spending for clinical trials even more worrisome. It’s not just health advocates who want the candidates to talk about R&D issues. A new poll released this week by Research!America finds that voters want to hear about health research funding on the campaign trail. Ninety percent of voters said candidates should speak about medical research, in addition to issues such as tax reform and public education. It’s important that the candidates—from Obama and Vice President Biden to Romney and Ryan—start talking about these issues head-on. And no matter which party takes the White House in November, support for global health R&D must continue.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The New York Times and Foreign Policy offer analyses of Republican Presidential nominee Mitt Romney’s foreign policy and international development stance. Scientists have found alarming levels of drug-resistant tuberculosis in Africa, Asia, Europe, and Latin America, reinforcing the urgent need to develop new treatment options. Gilead Sciences has received US Food and Drug Administration approval for a new HIV and AIDS treatment that combines four of the company’s drugs into one. The PATH Malaria Vaccine Initiative has teamed up with the International AIDS Vaccine Initiative and Imperial College London to establish a reference laboratory for measuring immune responses, as more vaccine candidates move into clinical trials. A World Intellectual Property Organization project that aims to promote research for neglected diseases through an intellectual property database has announced the conclusion of its first research agreements. Researchers at the University of Cape Town recently reported promising developments in their effort to develop a single-dose cure for malaria.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and the president and director of the Sabin Vaccine Institute, calls for research to create new drugs, vaccines, and diagnostics to fight neglected tropical diseases, which are appearing in the United States. The National Institute of Allergy and Infectious Diseases has announced that researchers at 14 US institutions will explore new approaches to designing HIV vaccines with new awards that are part of a four-year, $34.8 million initiative. In related news, the National Institutes of Health announced a new funding policy that will result in extra scrutiny for proposals from researchers receiving more than $1 million a year in direct support from grants. Scientists at Yale University are working on a new birth-control drug for male mosquitoes that could slow the spread of malaria. Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), spoke recently with Sens. Al Franken (D-Minn.) and Amy Klobuchar (D-Minn.). The group discussed possible measures to improve FDA and federal regulations for approvals of new medical devices. This week, the White House launched the Presidential Innovation Fellows program. The new program pairs innovators from outside government with innovators inside government on programs like an open data initiative, which also involves the US Agency for International Development. A new poll from GHTC member Research!America finds that 90 percent of voters say it is important for the Democratic and Republican presidential candidates to address medical and health research this year.