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“Gain-of-function” research designed to make pathogens deadlier in order to develop treatments and countermeasures has been given a green light by the National Institutes of Health (NIH).
The NIH pulled the plug on such research three years ago after several incidents that could have led to public health threats, not the least of which were breaches in working with anthrax in the prestigious labs at the CDC.
“The purpose of this guide notice is to notify applicants that in accordance with the December 2017 issuance of the Department of Health and Human Services’ ‘HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework),’ the NIH is removing the funding pause on the provision of new or continuation funding for gain-of-function research projects,” the NIH stated in a Dec. 19, 2017, announcement.1
The research could include studying simmering potential pandemic threats such as MERS coronavirus or H5N1 avian influenza, both of which could cause considerable human suffering and mortality if they mutate to improve transmissibility. Enhancing these deadly pathogens in high-containment labs could anticipate such a mutation, allowing for the development of treatments and vaccines if the viruses eventually mutate in nature. Of course, the risks include an enhanced pathogen escaping the lab and the possibility that the methods will be malevolently replicated by bioterrorists.
To prevent such incidents and ensure the work is conducted under controlled conditions, the aforementioned HHS Framework2 calls for the following criteria for research on a potential pandemic pathogen (PPP):
Though this will probably be determined on a case-by-case basis, it remains to be seen if possible bioterror agents would be approved for enhancement. The Department of Homeland Security lists 14 agents that meet the “material threat determination” as threats to national security if weaponized. These pathogens include anthrax, glanders, melioidosis, botulism toxin, hemorrhagic fever, tularemia, MDR anthrax, typhus, smallpox, and plague.
Financial Disclosure: Senior Writer Gary Evans, Editor Jesse Saffron, Editor Jill Drachenberg, Nurse Planner Patti Grant, RN, BSN, MS, CIC, Peer Reviewer Patrick Joseph, MD, and Editorial Group Manager Terrey L. Hatcher report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.