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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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Researchers say that a new discovery could pave the way for the development of flu treatments or even a universal vaccine. GHTC member the International AIDS Vaccine Initiative, in partnership with India’s Translational Health Sciences and Technology Institute, recently launched a new HIV Vaccine Design Program. An increasing number of new medical devices are aiming to help people deal with health conditions in ways that previously required the aid of a medical professional. GHTC member the PATH Malaria Vaccine Initiative recently named some of the world's most eminent malaria scientists to its Vaccine Science Portfolio Advisory Council. In related news, the biotechnology company Antigen Discovery has received a three-year grant worth $2.5 million from the National Institute of Allergy and Infectious Diseases for its efforts to develop a malaria vaccine.

  In this guest post, Joanna Breitstein, director of communications at the TB Alliance, highlights the response to a new study that indicates a novel tuberculosis (TB) combination drug may be on the horizon. Global press coverage this week cites a Lancet study suggesting that scientists have made significant progress toward developing an effective and affordable treatment for TB, a disease that every year kills more than 1.4 million people and is the primary cause of death among people with AIDS. Released on Monday during a presentation at the International AIDS Conference (IAC), the results of the Phase II trial in South Africa offer hope for a treatment breakthrough amid the growing and dangerous epidemic of drug-resistant forms of TB that, in some cases, are becoming untreatable. Image courtesy of the TB Alliance. In a story by the Associated Press, science writer Lauran Neergaard reports, “Scientists are hot on the trail of a new tuberculosis treatment that a small study suggests might one day offer an alternative to battle this deadly lung disease, even if it’s resistant to today’s two main drugs.” Asked to comment on the new study, IAC Co-Chair Dr. Diane Havlir of the University of California,San Francisco told the Associated Press, “We are cautiously optimistic that we are at the dawn of a new era for TB drugs." In The Guardian, Sarah Boseley quotes TB Alliance CEO Dr. Mel Spigelman, who calls the implications of the findings “huge.” "People with drug-susceptible and [some forms of] drug-resistant TB could be cured in as little as four months or even shorter,” Spigelman tells Boseley. “In the case of multi-drug-resistant TB, we could be reducing their treatment by one to two years or more. The regimen also promises to be in the order of 90 percent cheaper than the current [multi-drug resistant] treatment regimen. There is potential for a dramatically shorter, simpler, cheaper, and more effective regimen all at the same time.’” Also quoted in The Guardian, principal investigator Dr. Andreas Diacon of Stellenbosch University in South Africa says he speaks as a clinician and researcher. "Treating drug-sensitive and drug-resistant TB with the same regimen can simplify the delivery of TB treatment worldwide. The results of this study give healthcare providers on the front lines of the TB epidemic hopes for better, faster tools needed to stop this disease." Spigelman notes in Amy Maxmen’s article in Nature that the Lancet study also validates a new model for speeding development of such treatments. “After a new drug reaches the market, the traditional route is to work from the standard of care and substitute one drug for another. But if you do it in an incremental way, that will give you incrementally better results,” Spigelman says. “Our goal is to shorten the path to getting a new, cohesive regimen out there in one fell swoop.” Mario Raviglione, director of the Stop TB Department at the World Health Organization, says testing multiple new TB drug candidates simultaneously has already proven to be a major advance. "Because of testing drugs in combination, we have already saved several years in the research process to find new, effective regimens to treat TB," according to Raviglione. "The results look strongly promising from this early trial. If further testing holds up these results and the regimen is affordable in poor countries, it is huge progress. We could shorten drug regimens substantially for everyone, regardless of whether the form of TB is sensitive or multi-drug resistant. That would be a dramatic step forward." “If full clinical trials confirm its promise, the therapy could prove a boon for HIV-infected people,” writes Maxmen in Nature. “TB, which is common in its latent form in many parts of the developing world, often becomes active in those who are HIV-positive because of their weakened immune systems.” Unlike some existing therapies, Maxmen continues, the “new combination does not seem to interact adversely with drugs for HIV.” To illustrate the situation on the ground, where both diseases wreak havoc, Maxmen quotes John Farley, deputy director of the antimicrobial product division at the US Food and Drug Administration who once worked with HIV patients in West Africa: “…there were times when our HIV patients would die of drug-resistant TB before we could even get them their antiretroviral therapy,” says Farley in Maxmen’s story.