Breakthroughs Blog: Tuberculosis

George Fistonich is a recent graduate of the University of Southern California with a Master of Public Health degree, and currently serves as a research and policy fellow at amfAR, The Foundation for AIDS Research. He wrote this guest post about a new amfAR analysis that details the human impact of possible federal budget cuts on global health programs. amfAR recently released a new analysis that outlines the potential effects of budget sequestration on global health programs, using updated figures to reflect recent and accurate estimates. As our analysis illustrates, cutting funding for global health programs—including those that support access to lifesaving HIV and AIDS, tuberculosis (TB), and malaria tools and programs that fund research for the next generation of global health products—would barely make a dent in reducing the US federal deficit. However, cuts to global health and health research programs would have a crippling impact on people around the world. “Sequestration” is a fiscal process by which automatic, indiscriminate, across-the-board cuts would be made to most budget line-items at a certain set percentage. This process was included as a provision in the Budget Control Act of 2011, which would trigger sequestration at the start of the 113th Congress in January, unless Congress is able to pass $1.2 trillion in deficit reductions by the end of this year. The Center on Budget and Policy Priorities estimates that sequestration would lead to an 8.4 percent reduction in funding for non-entitlement federal programs, including all global health and health research and development programs. Under the rules of sequestration, a total of $109.4 billion would be cut for fiscal year 2013, of which nearly $690 million would be taken from global health programs. This cut to global health represents a negligible 0.6 percent of the total deficit reductions for that year, but would lead to devastating human impact worldwide. Secretary of State Hillary Clinton and President Obama both set an ambitious goal last year by announcing the United States’ intent to create an AIDS-free generation. Sequestration would not only undermine this achievable goal, but would undermine the progress we have made so far in providing treatment and care for millions of people worldwide, restrict funding for groundbreaking AIDS research, and ultimately result in thousands of unnecessary deaths in the next year alone. amfAR’s analysis estimates that an 8.4 percent cut to bilateral funding through the President’s Emergency Plan for AIDS Relief (PEPFAR), the President’s Malaria Initiative (PMI), and TB programs would lead to the following in 2013: 273,000 fewer people receiving AIDS treatment. 62,000 more AIDS-related deaths. 122,500 more children becoming orphans. 111,000 fewer HIV-positive pregnant women receiving services to prevent mother-to-child transmission. 21,000 more infants being infected with HIV. 354,000 fewer children receiving food, education, and livelihood assistance. 2.2 million fewer insecticide-treated nets procured. 3.7 million fewer people receiving malaria treatment. 6,000 more malaria-related deaths. 65,000 fewer people receiving TB treatment. 8,000 more TB-related deaths. Sequestration would also lead to the following in 2013 alone due to cuts in multilateral investments: 1.2 million fewer pentavalent vaccines procured through the GAVI Alliance, leading to 13,000 child deaths due to diphtheria, tetanus, pertussis, Haemophilus influenza type B, and hepatitis B. 2.8 million fewer insecticide-treated nets procured; 7,500 more malaria deaths; 102,000 fewer people receiving TB treatment; 12,000 more TB deaths; and 114,000 fewer people receiving AIDS treatment through the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Sequestration would not only limit access to currently available treatment and prevention tools, leading to an increase in HIV and AIDS, TB, malaria, and childhood deaths—it would also hinder research into new tools that are critically needed to fight these diseases. Cutting these programs would do nothing to reduce the federal deficit, and Congress must therefore work to prevent sequestration and protect funding for global health and research and development. Full text of the analysis, including methods for determining these estimates, can be found here.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Secretary of State Hillary Clinton and US Agency for International Development Administrator Rajiv Shah were joined by more than 700 leaders from the private sector, government, and civil society for a major conference devoted to preventing childhood deaths worldwide. "Amid these financial threats and budgetary realities, it is inevitable that some will question the role of the United States in global development," Sen. Richard Lugar (R-IN) said at the conference. "But I would assert this morning that development assistance, when properly administered, remains a bargain for US national security and for our own economic and moral standing in the world." Five new pharmaceutical companies have joined a National Institutes of Health (NIH) program that will pair researchers with certain pharmaceutical industry compounds to help scientists explore new treatment options for patients. The program, called Discovering New Therapeutic Uses for Existing Molecules, is run by the NIH's National Center for Advancing Translational Sciences (NCATS). The US Food and Drug Administration (FDA) has decided to delay its final decision on whether the drug Truvada, made by Gilead Sciences, can be used by certain high-risk, HIV-negative people as a preventive measure against HIV. The FDA says its decision will be announced by September 14, 2012. A Baltimore Sun letter-to-the-editor argues that there are more people living with tuberculosis (TB) “now than at any time in history.” The letter adds that prevention with “new vaccines is the only way to truly make TB a thing of history.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Associated Press reports that “[o]ne in 10 cases of tuberculosis in China cannot be treated by the most commonly-used drugs,” due to drug-resistant strands of the epidemic. Because of this, there is an even greater need for newer or improved health technologies. Researchers at the fifth annual World Science Festival discuss the need for universal vaccines as “new diseases…continue to emerge.” Pharmaceutical company Sanofi could potentially find out in the fall of this year whether or not they can move forward in developing the most advanced vaccine to prevent dengue. Secretary of State Hillary Clinton announced a new public-private partnership initiative between the US and Norway to improve maternal health, including a partnership with drug maker Merck & Co.

Recently, a US Food and Drug Administration (FDA) panel recommended that the HIV and AIDS drug Truvada be approved for HIV prevention among certain groups at risk of infection. Known as pre-exposure prophylaxis (PrEP), this prevention method involves HIV-negative individuals taking antiretroviral drugs to prevent HIV infection. This recommendation from the FDA panel does not oblige the agency to follow suit; however, it often does. The Truvada hearing is illustrative of the important role that the FDA plays in the research, review, regulation, and licensure of global health technologies—both those that are brand new, as well as reviewing new uses for current tools. Indeed, the FDA has a vast amount of expertise that it can leverage to help address regulatory issues in the developing world, where countries often lack the expertise or resources to appropriately review new health tools. In addition to the regulation and review of health products, the FDA also plays a small but important role in research and development (R&D) for global health. Starting in 2010, the FDA engaged in R&D funding for new drugs to combat tuberculosis (TB) though its work with the Critical Path Institute. The Critical Path to TB Drug Regimens brings together leading pharmaceutical companies and other drug developers, global regulatory agencies, and nongovernmental organizations—like GHTC member the Global Alliance for TB Drug Development—to facilitate the development and availability of new TB treatments. In addition to the regulation and review of health products, the FDA also plays a small but important role in research and development (R&D) for global health. Photo credit: PATH/Evelyn Hockstein FDA clearly recognizes the importance of its position in the global regulatory world, as evidenced by its recent Pathway to Global Product Safety and Quality report. It’s equally important that Congress recognize the FDA’s increasing role in global health, and that it works with the agency to provide the funding needed to sustain and expand these activities. This week, the House Agriculture, FDA, and Related Agencies Appropriations Subcommittee will debate its version of fiscal year (FY) 2013 appropriations legislation. And recently both the House and the Senate approved very similar versions of the Food and Drug Administration Safety and Innovation Act (FDASI), including reauthorizations of the Prescription Drug User Fee and Medical Device User Fee programs – which provide a large chunk of FDA’s operating expenses, and must be reauthorized by September 30th. Included in FDASI is the Generating Antibiotic Incentives Now (GAIN) Act, a provision which would extend data exclusivity for new antibiotics to combat drug resistant bacteria—including multi-drug resistant TB—by five years. While incentives that engage the private sector in product development are urgently needed, data exclusivity alone may not solve the gap in antibiotics R&D, and should be combined with several other incentive mechanisms in order to truly leverage the knowledge and resources of the industry. The legislation does request a study be conducted outlining the use and effectiveness of such incentives, a positive step in the right direction. The next few months are a critical time for all of FDA’s programs—and also an excellent opportunity for Congress to make smart reforms that enhance the best of what FDA does, including its work to support global health research and development. Ashley Bennett is the GHTC’s senior policy associate.