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In this regular feature on Breakthroughs, Ashley Bennett, senior policy associate at the GHTC, provides an update on what’s currently happening with global health in Congress and an outlook for future legislative activity. The government continues to operate under the continuing resolution (CR) that cut 1.5% across the board to all government programs. At the same time, the Senate is starting the Fiscal Year (FY) 2012 appropriations process, debating several “minibus” bills that combine two or more appropriations accounts. With these minibus bills, the Senate aims to complete work on appropriations as close as possible to the Nov. 18 CR expiration date. Here are some details on two minibus bills that would fund the US Food and Drug Administration (FDA) and the US Agency for International Development (USAID): The Senate recently considered a minibus bill that would fund the FDA, in addition to several other programs. The Senate debated this minibus bill last week, but could not agree to the funding levels before the Senate went into recess. This week, when the Senate is back in session, it will likely approve this measure. Also this week, the Senate will likely consider another minibus that combines State and Foreign Operations (SFOPS) with several other programs, including Energy. The SFOPS account provides funding to USAID. This package could be debated as early as Tuesday, Nov. 1, and amendments will be allowed during debate. The GHTC has heard that if it looks like there won’t be enough votes to approve the package by the end of this week, the bill will be pulled from the floor and the Senate will try again at a later date. As mentioned in the last What’s Ahead on the Hill, the Senate SFOPs funding levels for FY 2012 are roughly $5 billion higher than the House funding levels, but still about $3 billion below FY 2011 levels overall. As the SFOPs account is combined with the often controversial Energy account, the amount of amendments could lead to a lengthy debate. After the State and Foreign Operations minibus is debated, additional funding packages will still be needed to complete work on the Senate side for all of the appropriations accounts. Meanwhile on the House side, Rep. Mike Rogers (R-MI), chair of the House Appropriations Committee, has suggested that he may consider adding accounts to the FDA minibus when it is approved by the Senate and moves to the House for negotiations. It is unclear at this point if this will actually be the case. You can find information on the FDA bill here.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member Bio Ventures for Global Health has released a new report that analyzes the engagement of different players in global health drug and vaccine development. The world invested $630.4 million in tuberculosis research and development in 2010—less than one-third of the projected $2 billion annual investment needed to eliminate the disease as a public health threat by 2050—according to a new report. While spending rose slightly by two percent since 2009, it is the smallest year-on-year increase documented. Funding from the National Institutes of Health supported more than 432,000 jobs and generated more than $62.1 billion in economic activity last year. FSG and GBCHealth look at how pharmaceutical and medical device companies can create shared value in global health by addressing unmet health needs in low- and middle-income countries.

Eleonora Jiménez–Levi is a senior researcher for the Treatment Action Group (TAG), a GHTC member, and wrote this blog post in conjunction with the release of a new report from TAG about funding for tuberculosis (TB) research and development (R&D). TAG has released a new report in collaboration with the Stop TB Partnership, which finds that in 2010 the world invested just $617 million in TB R&D—less than one-third of the estimated $2 billion annual investment needed to eliminate TB as a public health threat by the year 2050. The report, Tuberculosis Research and Development: 2011 Report on Tuberculosis Research Funding Trends, 2005-2010, tracks annual research spending across six TB R&D areas against funding targets set by the Global Plan to Stop TB 2011-2015. The report offers year-to-year data on the leading TB research funders and underscores the urgency of adequate and sustained funding. Dr. Lucica Ditiu, Executive Secretary of the Stop TB Partnership, emphasized this critical need for sufficient funding by saying “with current levels of funding it will be impossible to meet the research targets of the Global Plan to Stop TB 2011-2015. This is a completely unacceptable situation, because those targets are, I would dare to say, even modest. Where is the funding to push ahead research for a point-of-care diagnostic test accessible to all, new drugs for a shorter treatment time and a fully effective vaccine?” For the sixth consecutive year, R&D for TB treatment was the most well-funded research area—growing by 19% from $192 million to $227 million. However, this was just 31% of the $740 million annual Global Plan target for TB treatment research. The report also documents significant funding declines in basic science and vaccines research, which dropped 27% and 29%, to $126.6 million and $78 million, respectively. TB diagnostics accounted for 7% of global total spending with $44.6 million—a 15% increase from 2009. The infrastructure/unspecified category grew 46% to $83 million and operational research rose 17% to $58.1 million in 2010. Measuring these totals against the Global Plan targets, the only category to come close to its annual target was operational research and the farthest one was TB diagnostics. According to the World Health Organization, there were 8.8 million people newly diagnosed with TB and 1.45 million deaths in 2010, including 1.1 million new cases and .35 million deaths among people with HIV. Resources to develop new tools to prevent, detect, and treat TB have never been more urgent. “Recent progress in TB research is clearly threatened by stagnating funding,” said TAG’s executive director, Mark Harrington. “After several years of increasing investment, TB research is finally making headway with two new promising drugs for the treatment of multi-drug resistant TB and a new drug combination active against both drug sensitive and drug resistant TB. Cutting investments now will cost lives in the future.”

Some of the most incredible health research is taking place in Kenya right now. Because of this work, we are on the cusp of the most exciting new tools in global public health in recent years—the first ever malaria vaccine, gels women can use to protect themselves from HIV, new drugs for neglected diseases that affect the poorest of the poor. Kenya is also rolling out an array of lifesaving new health products that research has already made available, like HIV and AIDS drugs, vaccines to protect children from pneumonia, and insecticide-treated wallpaper that prevents malaria inside people’s homes. During the GHTC’s recent trip to Kenya, I was fortunate to visit several of these global health research projects, most of them run by our dedicated coalition members like the Drugs for Neglected Diseases initiative (DNDi), PATH, the International Partnership for Microbicides (IPM), Aeras, and the International AIDS Vaccine Initiative (IAVI). We also saw firsthand how the US is making a huge impact in health research in the country, through the work of agencies like the US Agency for International Development (USAID), Centers for Disease Control and Prevention (CDC), and the Department of Defense (DoD). 3935 - Siaya, Kenya - Kayla Laserson is the Director of the KEMRI/CDC Field Research Station . Photo: Evelyn Hockstain/PATH. Although we visited a range of projects, I was left with the lasting impression that much of this research is so close to producing new health tools that can lead to amazing innovations in public health. “We are on the verge of breakthroughs in malaria and in TB and in other diseases,” Kayla Laserson, director of the CDC/KEMRI Field Research Station in Kisian, said. “What we really need is continued support so we can get the job done, we can finish it, we can show the impact, we can save hundreds of thousands of lives here and globally.” We also saw how past commitments to research are already saving lives. For example, research that led to the development of antiretroviral drugs is one of global public health’s biggest success stories. Rister Kageha, a woman living with HIV close to the town of Kakamega, told us how these drugs had not only saved her life, but also prevented her daughter Sylvia from contracting HIV. Because of these drugs, “I expect to live long,” Rister said, adding that she also hopes for a long life for Sylvia due to the drugs that kept her daughter HIV-negative. Rister Kageha says antiretroviral drugs saved her life. Photo: Evelyn Hockstein/PATH. And while past research has led to some health tools already in use, and current research is producing breakthroughs we could see in next five years, other innovations aren’t as far along down the research pipeline. This is why continued US support is critical to sustain the momentum around these new tools, from discovery to delivery. US support for microbicides, for example, has been vital to recent research successes, and must continue while the research continues over the next several years. A microbicide “is one of the tools that gives us the opportunity that we could actually end the epidemic,” Elizabeth Bukusi, deputy director at the Kenya Medical Research Institute (KEMRI) who works with IPM, said. “I think we can move towards a complete AIDS-free generation that will completely stop the epidemic in its track using microbicides as part of the armament.” She added that the “US has been a critical partner in providing catalystic funds and also in funding a large number of the trials that have looked at microbicides. So US funding is absolutely critical to moving this agenda forward.” The same can be said of US support for all global health tools, not just microbicides. Fortunately, if Kenya is any indication, the US has a long history of supporting research for health products like vaccines and drugs.This long history should not end anytime soon. It’s imperative that this historical leadership continues, so the groundbreaking research the GHTC saw in Kenya can produce the next generation of lifesaving health tools.