Research Roundup: legislation to expedite antibiotic R&D, a graduated approach to drug patents, and more

Aedes aegypti mosquitoes which carry Zika. Photo: Dean Calma/IAEAApril showers bring standing pools of water, the onset of mosquito season, and a new wariness of getting bitten. In 1999, we were caught off guard when the West Nile virus first appeared in North America. In 2010, an outbreak of dengue fever spread locally in Florida after an absence of 60 years. In 2014, chikungunya first arrived in the United States after travelling breathtakingly fast through the Western hemisphere. Now, in 2016, Zika virus is the latest mosquito-borne disease to threaten Americans. Yet our collective national response continues to be one of short-term planning rather than long-term preparedness.Since Zika virus arrived in the Americas in May 2015, there has been an alarming spike in reports of birth defects such as microcephaly, particularly in Brazil. Zika infection has also been linked to adverse pregnancy outcomes and Guillain-Barré syndrome—a temporary paralysis that can prove deadly. The World Health Organization has declared Zika a Public Health Emergency.The virus has now spread to 26 countries, including 312 travel-associated cases in the United States. So far, mosquitoes in the United States haven’t infected anyone, but the Centers for Disease Control and Prevention (CDC) just issued a revised map that shows the mosquitoes that carry this virus and others can be found across the Southern tier of the United States all the way up to southern New England on the East Coast.Faced with this chilling situation, we don’t have ready the tools we need to fight Zika. Just like with Ebola, crucial tools did not exist or were still under development when the outbreak began. R&D is urgently needed to understand the Zika virus and its associated health conditions, and develop new diagnostics, vaccines, or other treatments to combat it. A pregnant woman in El Salvador receives an ultrasound as part of the country's response to the Zika outbreak. Photo: Office of the President of El Salvador Today, the Band-aid approach of emergency funding is the only option available to mitigate the crisis. We applaud President Obama’s call for accelerated research efforts, and the need to inform Americans about how to protect themselves, which the CDC has been quick to do. The National Institute of Allergy and Infectious Diseases, led by Dr. Anthony Fauci, has also called for a “full court press” on research.This requires increased funding for those searching for ways to stop this virus. Diverting resources from the Ebola response, however, is short-sighted. Those efforts are just beginning to show the promise of new diagnostics, advanced therapeutics, and more resilient health systems in Ebola-affected countries. Redirecting funding before the job is finished is dangerous, and will most certainly leave the United States and the world unprepared for the next Ebola outbreak.The fact remains that this long-standing patchwork approach to global health R&D funding only degrades our ability to respond to the guaranteed next global health crisis. With more than 500 mosquito-borne diseases across this globally interconnected world, the question is not if but when we see another virus or disease.Just as we need primed and ready firehouses and firefighters, we need a primed and ready research infrastructure. That requires a prioritized agenda and sufficient funding. America’s “firehouses and firefighters” are the National Institutes of Health, CDC, President’s Malaria Initiative and the Army and Navy’s tropical infectious disease programs.Global health means everyone’s health. It’s time US policymakers stop funding by crisis and commit to sustainable, long-term investment in global health R&D so the most effective health solutions are available when they are needed.Stephen Higgs, PhD, FRES, FASTMH is the president of the American Society of Tropical Medicine and Hygiene and a professor at Kansas State University. Erin Will Morton, MA is director of the Global Health Technologies Coalition, a group more than 25 nonprofits that work to save and improve lives by encouraging the research and development of essential health technologies.

Aedes Aegypti mosquito which carries the Zika virus. Photo: CDC/James GathanyOn Tuesday, the Obama administration announced that it will transfer nearly US$600 million in remaining Ebola funds to fight the growing threat of Zika virus. But many questions remain. Where is the money going? From what accounts will it come? And what does this mean for the Global Health Security Agenda (GHSA) programming which is supposed to help protect against these threats in the future?In February, the President requested $1.9 billion in emergency appropriations to combat the Zika virus outbreak, but authorization was stalled by members of Congress who suggested the Administration reallocate existing funds instead. The Administration continues to stress that the full request is still needed to fight both Zika and complete the Ebola response. With the announcement of the transfer of funds, the Administration is signaling that the risk of waiting for Congress to act on a supplemental funding is too great, and deploying additional funding to address Zika is essential in the short-term—before the summer weather leads to a broader spread of the mosquito-carried virus.Reallocating Ebola funding to address Zika carries consequences. While the Administration acknowledges that some Ebola funds remained unspent, much of this money has been allocated to implement the GHSA—a commitment to help at least 30 countries prevent, detect, and respond to emerging disease threats. GHSA has not received any direct appropriations, largely due to sentiment that remaining Ebola balances should cover the cost. Additionally, as the Ebola response remains unfinished—health systems in West Africa remain fragile and we have not yet developed approved Ebola vaccines or treatments—diverting funding before we have finished the job remains risky.Where is the money going? From where will it come? Vaccine researcher. Photo: NIAID, NIH Because the US Centers for Disease Control and Prevention (CDC) is focused on research and development (R&D) for Zika vaccines, treating those infected, and combating the mosquitoes that spread the virus, many expect the bulk of the $600 million transfer to be directed to CDC Zika efforts. The Washington Post reports that 75 percent of the transfer will go to CDC and the rest to foreign aid accounts. It remains uncertain from what accounts the Ebola transfers will come—and subsequently the impact on programs currently funded through the Ebola supplemental. It seems likely that much of the transfer may come from accounts at the US Agency for International Development and State Department, which as of December 31, 2015, had $400 million in programmed Ebola funds that will expire at the end of fiscal year 2016. Other accounts with remaining funds include: $1.031 billion at CDC for domestic, international, and global health security $363 million at Public Health and Social Services Emergency Fund, which houses the Biomedical Advanced Research and Development Authority $45 million at the US National Institutes of Health $14 million at the US Food and Drug Administration Funds in these accounts do not appear to have expiration dates. As we do not yet know for certain which accounts will fund the $600 million transfer, the impact of this decision on implementation of the GHSA is also uncertain.If funds are transferred from CDC accounts, GHSA efforts could be delayed or stalled. It also remains to be seen whether the Administration will receive additional funding to supplement the Zika response. While Congress has not acted on a request for a stand-alone supplemental funding, members have suggested they are open to providing additional funding in the future should the reallocation of existing funds prove insufficient to both addressing Zika and completing the Ebola response. The possibility remains that we could see additional funding for Zika as part of the regular appropriations process, which is likely to progress in the coming months.