New NIH program could speed innovations for patients in need worldwide

On Thursday, the House Appropriations Committee will vote on a State and Foreign Operations (SFOPS) appropriations bill for fiscal year (FY) 2013, which will include funding levels for global health and other programs at the State Department and US Agency for International Development (USAID). This vote follows last week’s markup of the bill by the House SFOPS appropriations subcommittee. Overall, the subcommittee’s bill had mixed results for global health and other programs at USAID: while some programs were sustained at FY 2012 levels, others saw significant budget cuts that will affect the agency’s efforts worldwide. Under the subcommittee’s bill, the entire State and Foreign Operations account was cut by nine percent. Many bipartisan programs like the President’s Emergency Program for AIDS Relief (PEPFAR) were flat-funded at FY 2012 levels. USAID’s global health funding, which contributes to global health research and development (R&D) projects, was cut by six percent, a decrease of roughly $150 million. USAID’s operating budget was also slashed by 5%, which will affect all of its programs. No funding levels were outlined for the many disease-specific programs at USAID. These disease-specific funding levels could be added to later versions of the bill, or could be left up to the Obama Administration once the entire appropriations process is completed. The only exception was family planning, which was slashed by one-quarter and given a new overall funding cap of $461 million—$149 million below the FY 2012 levels. It’s important to remember that the final SFOPS budget for FY 2013 will probably look different from the House bill being considered this week. The Senate is working on its own version of the appropriations bill, and both versions will eventually have to be negotiated if Congress follows a typical appropriations process (which it hasn’t done in the past few years). Whatever the final SFOPS budget looks like, it’s critical that Congress fully funds USAID so it can continue its work in all areas of global health, including the agency’s support of R&D to develop new health tools. And if it’s left to the Administration to make decisions about disease-specific program funding at USAID, funding for R&D and innovation for all disease areas needs to remain a top priority at the agency. USAID plays a huge role not just in funding product development to combat global health challenges, but also ensuring that new technologies are appropriate for the communities where they will be used. Some of the tools that have benefited from USAID funding and expertise include the RTS,S malaria vaccine candidate, the groundbreaking CAPRISA microbicide trials, and the Xpert TB diagnostic. USAID also works in partnership with many critical players in the global health R&D space, such as other US agencies, the private sector, nongovernmental organizations, and universities. It’s clear that USAID has seen major successes in its support for global health R&D. As the House Appropriations Committee votes on the SFOPS bill on Thursday and the budget process continues, Congress will have to decide whether it should boldly support USAID’s goal of developing new health tools—tools that are projected to save millions of lives—or withdraw this support and risk halting scientific advancement in its tracks.

With the ever-present specter of federal budget reductions that could impact global health and development programs, the GHTC’s event on Friday to launch our new report couldn’t have come at a better time. The report, released by the GHTC and Policy Cures, provides new and exciting data on US investments over the past 10 years in global health research and development (R&D). It confirms that support from the US Government and its federal agencies has not only contributed to the largest pipeline of new global health products in history, but also that these investments make smart economic sense domestically. Dr. Javier Guzman, director of research at Policy Cures, shared the report’s main findings at Friday’s event, which was co-hosted by Research!America. Guzman outlined that the US Government has contributed significantly to global health R&D—indeed, the United States is the largest funder of R&D efforts worldwide, contributing $12.7 billion from 2000 to 2010. This support has translated into the largest pipeline of new global health drugs, vaccines, diagnostics, and other products, over half of which are supported by the United States. The US Government “needs to keep this momentum going” because “investments in global health R&D really work,” Guzman said. Guzman also stressed a key theme that emerged during the event—that of partnerships. According to Guzman, critical partnerships have formed between the US Government and the active global health R&D community that has emerged over the past ten years. This community includes philanthropic organizations, the pharmaceutical and biotechnology industries, academic institutions, and non-profit groups. The success of these partnerships can be seen in the development and delivery of new health tools like the Xpert ® MTB/RIF test for tuberculosis (TB), which Guzman said is projected to save 100,000 lives every year in India alone. Javier Guzman, Lee Hall, Eric Easom, and Heather Ignatius. Photo credit: PATH Dr. Lee Hall—chief of the Parasitology and International Programs Branch at the National Institute of Allergy and Infectious Diseases (NIAID)—also spoke about the importance of partnerships to his branch at the National Institutes of Health. According to Hall, partnerships between NIAID and academic institutions, industry, endemic country governments, and global organizations are “essential” to translating research into effective products. And Heather Ignatius, senior manager for policy at the Global Alliance for TB Drug Development, stressed that product development partnerships (PDPs) like her organization rely on collaboration with philanthropic organizations such as the Bill & Melinda Gates Foundation, which is currently the top funder of PDPs worldwide, as well as governments and industry groups. Additionally, the panelists emphasized how supporting R&D for new global health tools ultimately benefits the United States. Hall discussed how when President Roosevelt dedicated the NIH in 1940, he identified global health as a priority for the agency. “What perhaps started for humanitarian reasons also has benefits for the US,” Hall said, adding that better health products are needed in this era where infectious diseases know no borders. Guzman also shared how global health R&D creates jobs for Americans and boosts the economy. In 2007, for example, federal support for global health R&D paid $540 million in wages for employees in California. And Eric Easom, program leader for neglected diseases at the California biotechnology company Anacor Pharmaceuticals, reinforced this point when he said that conducting global health R&D allows his company to provide jobs for talented researchers and employees who “truly care about this work. It’s the reason we got into this business in the first place.” Finally, speakers addressed how continued support for research to develop new global health products has the potential to make an enormous impact across the globe. When discussing Anacor’s partnership with the Drugs for Neglected Diseases initiative to develop a new treatment for sleeping sickness, Easom said that the drug candidate is an “innovation that could totally change the game for patients” with the disease. Ignatius emphasized how the US Government must continue its support for global health R&D, and provide increased support for mechanisms like PDPs—much in line with the report recommendations. “We’re on the verge of developing and delivering drastically improved tools. They won’t get there if we can’t finish these final stages of testing,” she said, adding, “Donors must scale up their commitments, and we need increased involvement from the US Government. Now is the time.”