US budget cuts could jeopardize development of life-saving tools against major killers

Across-the-board cuts to US R&D programs could have a devastating impact on efforts to develop new drugs for tuberculosis (TB) and HIV/AIDS, the world's first malaria vaccine, and other vital global health products in development, according to a new report from a coalition of nonprofit groups focused on advancing innovation to save lives.

"We know that policymakers are currently facing difficult budget decisions. But any reductions in funds could eliminate essential support for the development of global health tools and slow or halt the progress made against addressing a number of deadly diseases," said Kaitlin Christenson, MPH, director of the Global Health Technologies Coalition (GHTC).

The report from the GHTC, Renewing US leadership: Policies to advance global health research, comes as Washington is bracing for a "budget sequestration" process that, according to some estimates, could cut 5.2 percent from programs across government, including initiatives that have put hundreds of new drugs, vaccines, diagnostics and other disease-fighting tools into the product pipeline and established the US as the world's leader in developing life-saving global health technology.

The analysis finds the cuts to global health R&D "would barely make a dent in reducing the US federal deficit but would have a crippling impact on people's health and lives around the world."

"There is much to lose by pulling back now," the report states.

Some estimates predict that under sequestration, global health initiatives at the State Department and US Agency for International Development (USAID) could lose $482 million, money that supports, among other things, the development of new drugs to quell an alarming resurgence in deadly TB and new tools to escalate the fight against HIV/AIDS. Meanwhile, the National Institutes of Health (NIH), which is supporting a new dengue vaccine candidate, new HIV prevention methods, and potential new treatments for TB, could lose nearly $2 billion.

In addition, the sequestration process would result in steep losses for R&D programs funded by the US Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Department of Defense (DoD). Taken together, the cuts throughout the government could jeopardize any number of the 200 global health products that have advanced in the research pipeline thanks to US support. Conversely, the GHTC finds that "continued and consistent US investment in R&D...will provide the momentum needed to push promising new tools over the finish line." These tools include:

• a new microbicide that could give women the power to protect themselves from contracting HIV with or without their partners' cooperation;
  
• new insecticides that could help control insects that spread deadly diseases like dengue fever, Chagas, filariasis, and leishmaniasis;
  
• new drugs and vaccines to help fight back against the alarming spread worldwide of drug resistant TB;
  
• modern reproductive technology that could greatly lower maternal mortality rates by giving women worldwide the ability to plan for the birth of their next child;
  
• and a new oral drug for African sleeping sickness, which is fatal without treatment.
  

"Today, all across the US government we see solutions emerging to global health problems we've been fighting for decades, or, in some cases, centuries," said Steve Davis, President and CEO of PATH. "The DoD is helping advance a promising AIDS vaccine candidate. The FDA is spurring the development of new drugs and vaccines for TB. NIH is helping to put us ever closer to a malaria vaccine. The CDC is coming up with a new test for detecting dengue virus, which is critical to monitoring its rapid spread. And USAID is providing essential support for new reproductive health technologies."

"US taxpayers are rightly demanding results from federal expenditures," Davis added, "and the wise investments our government has made in global health R&D are clearly providing excellent returns."

The GHTC report notes that US investments in global health R&D have helped deliver "some of the greatest advances" the field has ever experienced. Recent achievements include a new, highly effective Africa-specific vaccine for meningitis A; a new rapid test for detecting TB; and the world's first malaria drug for children. The GHTC also finds that global health expenditures, which include support for product development partnerships (PDPs) with the private sector, are helping boost the nation's economic performance. The report cites evidence that "64 cents of every dollar spent by the US government on global health R&D goes directly to US-based researchers and product developers."

Moreover, the drugs, vaccines and diagnostics so crucial to saving lives in countries with high burdens of infectious diseases are increasingly needed to protect public health on the home front.

For example, just this past summer, Florida experienced its largest TB outbreak in 20 years. Dengue fever has now persisted on the US mainland long enough that it may have developed its own unique US strain. And Chagas, a disease carried by so-called "kissing bugs" that can cause serious heart and digestive problems, is now migrating northward from Latin America. Up to one million cases have been found in the US, with the disease burden believed to be particularly high along the Gulf Coast.

The GHTC report observes that "there are an estimated five million impoverished Americans who live with neglected tropical diseases--including a previously hidden burden of neglected diseases among the poor in the southern United States."

The GHTC asserts that, ultimately, if "the damaging effects of sequestration do take place, agencies must do their best to protect product development priorities within their budgets."

"Even in these difficult fiscal times, US policymakers must persist in their support for global health research," the report states.

US Legacy and Leadership at Risk

The GHTC report finds that the threat of cuts via sequestration is part of a broader and troubling trend that has seen US support for global health decline over the past few years.

For example, the latest Global Funding of Innovation for Neglected Diseases (G-FINDER) survey documented a $30 million drop in 2011 in US support for global health-related research and product development. GHTC worries that the US is drifting in a way that could "put the nation's legacy as a scientific and humanitarian leader at risk."

The report points out that the sequestration debate is occurring at the same time lawmakers are debating funding levels for the rest of this year and for 2014--a separate discussion, but one that also has significant implications for global health research. GHTC views the 2013 and 2014 appropriations process as an opportunity for the US decision makers to step back and re-examine budget priorities and "reverse the trend of decreased global health and R&D funding seen in recent years."

According to the GHTC, "There could not be a better time for the United States to renew its global health R&D legacy."

Also, given that budget pressures will demand better performance from government-funded endeavors, the GHTC is calling for a new "five-year strategy" that coordinates global health research and product development across the federal government. The GHTC envisions a strategy that, among other things, clarifies priorities and provides "metrics to measure success." The GHTC believes work should begin now with the goal of completing the strategy by December 2014.