News

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 guest post, Margaret McGlynn, president & CEO of the International AIDS Vaccine Initiative (IAVI), writes about a new partnership between IAVI and the Indian government. The post originally appeared on the US Agency for International Development’s (USAID) Impact blog. When you’re dealing with a global public health crisis, having an international presence isn’t just advisable—it is imperative. This applies as much to the development of new tools to prevent disease as it does to treatment. An AIDS vaccine candidate, for example, must be tested in the people who will eventually use it and against the strains of HIV it is devised to protect them from. That’s why (IAVI), in partnership with USAID, has worked diligently over the past several years to establish itself as a truly global nonprofit partner. Using donor funds, IAVI has created an enviable network of research centers in sub-Saharan Africa dedicated to assessing novel AIDS vaccine candidates in clinical trials and conducting supporting epidemiological studies on HIV. These partnerships have made meaningful contributions to the research capacity of many developing countries—a capability that is now helping local researchers tackle other diseases. IAVI and its partners are now applying that same model to support the design of a new generation of AIDS vaccine candidates. Today, IAVI and the Translational Health Sciences and Technology Institute (THSTI), an autonomous institute of the Indian government’s Department of Biotechnology (DBT), launched an HIV Vaccine Design Program near New Delhi. The program is dedicated to the large-scale generation and preclinical evaluation of immunogens, the active ingredients of vaccines. It will focus on devising immunogens capable of eliciting antibodies that can prevent infection by a broad range of the circulating genetic variants of HIV. That challenge, known to researchers as the neutralizing antibody problem, has long stymied progress toward an AIDS vaccine. But recent discoveries of antibodies capable of blocking a number of HIV variants have provided researchers with clues to the design of potentially powerful new vaccine candidates. The HIV Vaccine Design Program will use these insights to develop new methods to generate large numbers of potential HIV immunogens and rapidly assess their potential for use in candidate vaccines. Much of the work will take place in a laboratory housed within THSTI that is being built and staffed with support from IAVI, DBT, and THSTI. The program’s location is no accident. Over the past decade, IAVI has enjoyed a productive partnership for the clinical evaluation of candidate AIDS vaccines with key medical research institutions of the Indian government. Indian scientists have also actively participated in an international consortium of HIV laboratories supported by IAVI to advance HIV vaccine research. The government of India, meanwhile, is in the early phase of its “Decade of Innovation,” a policy that seeks to harness a growing roster of home-grown biotechnology companies, the nation’s deep pool of scientific talent, and global research partnerships to boost innovation in a variety of high-tech fields. The HIV Vaccine Design Program provides an opportunity to engage an emerging economy in the global quest to develop a vaccine against HIV. For India, it creates an opportunity to address a crisis of significant relevance to Indians. As importantly, it seeds the kinds of collaborations that often foster scientific and technical innovation and generate ideas that might be applied to address other diseases that have long hampered development.

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.

In this feature on Breakthroughs, we provide an update on what’s currently happening with global health in Congress and an outlook for future legislative activity. As Congress starts the August recess, there have been a few developments in the fiscal year (FY) 2013 appropriations process, and both House and Senate committees have completed debate on nearly every account. Additionally, both the Administration and Congress have intensified their discussions about the upcoming sequestration cuts, and Congress has proposed continuing resolution to keep the government running at least until March. Below, we provide an overview of recent activity. FY 2013 Appropriations In the past two weeks, the Senate appropriations committee approved its Department of Defense appropriations bill, funding the department at a level $5 billion below President Obama’s request. Language and funding was included in the bill to establish a Peer-Reviewed Medical Research Program, which will set research priorities across the defense department for certain conditions and diseases, including malaria, and the neglected tropical diseases dengue fever, and leishmaniasis. The program is funded at $50 million in the legislation. Additionally, another $50 million was allocated to the Joint Warfighter Medical Research Program, which would accelerate health research for solutions and treatments in projects that the defense department is already funding, including some priority diseases for global health. With the passage of this bill, the Senate appropriations committee completed its work on individual appropriations bills for the year. The only account it did not approve funding for was the Labor-HHS account, which includes funding for the National Institutes of Health and Centers for Disease Control and Prevention, both of which fund global health research programs. On the House side, the full House of Representatives passed its own legislation funding the Department of Defense, which its appropriations committee approved back in May. That legislation approves a funding level above the amount agreed to in last year’s Budget Control Act agreement. Eventually, the differences between the House and Senate versions of the defense legislation will have to be rectified to fund the department for FY 2013. FY 2013 Continuing Resolution It’s been clear for a few months that Congress would not complete FY 2013 appropriations before the next fiscal year begins. In an interesting turn of events, Congress has agreed that it will need a Continuing Resolution (CR) in order to keep the government running into October and beyond, and members have already agreed on the terms of the CR, which will provide $1.047 trillion in discretionary spending. This will prevent further budget debates leading up to the presidential election, and takes one item off of Congress’ to-do list for the post-election session in November and December. Congress will write the agreement during August, and will vote on the deal in September. Sequestration There are roughly 20 days left in the congressional calendar, given the election and upcoming recesses. When the Budget Control Act was passed, Congress was expected to develop a plan to reduce spending or face severe, automatic cuts starting January 2, 2013. As Congress has not been able to agree on an alternative and has very little time left to do so, in January these, roughly, 8.5 percent cuts will likely take place.However, since the CR will delay FY 2013 budget levels from actually being finalized until March, the rate of the cuts for the last part of the FY 2013 fiscal year (March 1-September 30) could be higher—possibly as high as 14 percent. This scenario is still months away, and is dependent on several factors, including an election that could change the Presidential administration and the leadership in Congress. A deal could still be reached that would delay or eliminate sequestration, although there is very little time left to do so. New OMB Guidance Office of Management and Budget (OMB) Acting Director Jeffrey Zients recently sent a memo to department and agency heads with guidance on federal agency submissions for FY 2014. In the memo, Zients asked agencies to cut their bottom-line FY 2014 requests by 5 percent below spending levels appropriated for FY 2013. Zients sent another memo on July 31, informing agency leads of upcoming discussions on the implications of sequestration. Under current law, agencies are restricted in how much they can plan ahead of time for sequestrations. However, without an agreement from Congress on an alternative to the cuts, and with Congress’ insistence, the Administration has started to take steps to plan for the cuts.