NEW YORK (GenomeWeb News) – Budget cuts to the National Institutes of Health, whether through the long-term trend of flat funding, hard spending caps, or sequestration, will have a "devastating" impact on the development of new technologies for addressing global health priorities, according to a new report.
The report from the Global Health Technologies Coalition, a group of non-profits focused on improving health in the developing world, spotlights the role US government, and NIH in particular, play in supporting research and development for therapeutic, diagnostic, and preventive tools to combat HIV/AIDS, malaria, tuberculosis, and other rare and tropical diseases.
"The life sciences field is responsible for more than seven million US jobs and contributes $69 billion annually to the US gross domestic product," the coalition said in its report. "Denying federal agencies, such as the NIH, the funding they need to continue vital health research will result in a host of damaging consequences to global public health, patients' lives, scientific careers, and the domestic economy."
Ongoing political battles over government spending and persistent "underfunding" to NIH, pose a risk to the global health R&D pipeline, GHTC officials said in a briefing on Capitol Hill today.
As GenomeWeb Daily News reported in January, a budget agreement restored for 2014 the funding lost to sequestration in 2013, but in providing roughly $30 billion to NIH it still represents a sizable cut compared to the $30.9 billion appropriation of 2012.
"The end of political gridlock in Washington put many global health programs on firmer footing with one notable exception: it continued to weaken [NIH], which is the engine that drives innovation in the fight against infectious diseases," GHTC Director Kaitlin Christenson said in a statement.
"Since FY 2004 the overall [NIH] budget has decreased about 15 percent – that's a conservative estimate. That decrease would continue under the budget cap that has been agreed to under the budget agreement," GHTC Policy Officer Ashley Bennett told GWDN this week.
In its new report, "Innovation for a changing world: The role of US leadership in global health R&D," and on the Hill today, GHTC officials called for NIH to receive $32 billion in funding in fiscal year 2015. The White House has proposed that NIH receive a one percent increase next year to $30.36 billion.
"We think $32 billion is not just reasonable, it is essential for NIH to make up some of the ground that it lost in sequestration and some of the research that it lost during the shutdown, but also to support some of the priorities that the administration has already promoted as key research areas, and to meet the needs of these very ever-changing global health dynamics. These diseases are changing rapidly. We need to be there meeting them," Bennett said.
The sequestration, the short-lived government shutdown in 2013, and reduced spending power at NIH and other agencies could have a major impact on efforts to fight infectious diseases, the group said. Clinical trial sites in the US and abroad that were testing a new TB drug already have been forced to shut down, the report states.
The coalition report looks beyond 2015 and calls on Congress to "develop a long-term budget solution that protects funding for global health product development" not only at NIH, but also at the US Centers for Disease Control and Prevention, the Food and Drug Administration, and the Department of Defense. At CDC in particular, GHTC wants the 2015 budget to spend $464 million to fund the Center for Global Health and $445 million for the National Center for Emerging and Zoonotic Infectious Diseases.
The GHTC also asks that NIH, FDA, CDC, DoD, and the US Agency for International Development sustain their investments in global health discovery and development, and that the government support incentives and financing mechanisms to stimulate R&D for "all stages of the product development process."
The group also said that it wants to see the Obama administration try harder to protect global health funding programs in the next round of budget negotiations, and for Congress to pass the 21st Century Global Health Technology Act, a bill that would codify USAID's role in R&D but would not require new funding.
According to the GHTC report, US federal funding played a crucial role in the development of 53 percent of the 45 global health vaccines, drugs, and diagnostics that were introduced between 2000 and 2010.
NIH, in particular, plays a part that no other groups or agencies do in combating global health problems, Bennett told GWDN.
"NIH is the largest funder of global health research in the world," she said. "The US government, as a whole, is involved in 200 of the 365 products that are in the pipeline right now, and NIH has a piece of that product development," she said. "If you think about the current drugs, diagnostic tools, vaccines, microbicides – all sorts of technologies that we have available today to combat global health diseases and conditions – NIH was involved in nearly all of them, to some extent."
Some of the products now in that R&D pipeline include new tools for diagnosing malaria, HIV, and TB more swiftly and cheaply and in the field; new drugs for treating TB and malaria; a microbicide for preventing HIV infections; insecticides to help control insects that spread diseases such as dengue fever and Chagas disease; and a vaccine for preventing HIV infection.
Bennett said that NIH plays a large role not only in developing new product or treatment leads and in laying the basic research foundation for creating new global health tools, but also in moving new tools toward later stages of R&D.
These are activities that private foundations and companies may not engage in, she said, because foundations and non-government organizations tend to play niche roles in global health, and because there may be no commercially viable market to lure drug or device companies.
The National Center for Advancing Translational Sciences, in particular, "has the potential to do a lot of great work" in moving basic research and early stage innovations closer to the point where they can be taken up by public-private partnerships that engage in later stage development.
Because of the unique role that NIH plays, budget cuts "have a serious effect on the rest of the global health R&D ecosystem," said Bennett, noting that global health problems also can impact the US.
"Global public health does not mean outside of the US; it is the entire planet," she said. "A lot of these diseases cross borders and cross boundaries very easily … especially in the age when there is so much interconnection between populations. So this is an incredibly important area. It is really troubling to see some of these [funding] declines."