Following the 2012 H5N1 virus outbreak, the Obama administration announced a pause of federally funded Gain-of-Function (GOF) research, or how to increase naturally occurring animal viruses in a lab to make them more infectious among humans.
Now, the White House Office of Science and Technology Policy (OSTP) has released “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).”
Sounds so benign.
But reading the first paragraph should give a person pause: “Section 1., Introduction 1.1., Federal departments and agencies (“agencies”) conducting, supporting, or planning to conduct or support the creation, transfer, or use of enhanced pathogens of pandemic potential should develop review mechanisms that are generally aligned with the approach recommended by the National Science Advisory Board for Biosecurity (NSABB) in its May 2016 report Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research (NSABB Recommendations).”
The new recommendations provide guidelines for reviewing life science research that could enhance the virulence and transmissibility of a pathogen, leading to a potential pandemic pathogen (enhanced PPP) such as avian flu, SARS, Zika, and MERS. A weakness of the new framework is that surveillance activities involving PPPs, including sampling and sequencing, are not considered enhanced and would be exempt from reviews.
No data exists as to what viruses are not enhanced. In other words, if GOF was applied to the influenza virus, it could make the outbreak of the Spanish Flu in 1918 look like a common cold.
The issuance of this policy guidance follows a deliberative process initiated in October 2014 by OSTP and the Department of Health and Human Services (HHS). During this process, the National Science Advisory Board for Biosecurity (NSABB) provided recommendations, suggesting additional scrutiny for studies expected to enhance PPP, along with a Department-level, multi-disciplinary review and ongoing Federal and institutional oversight.
Michael Osterholm, Ph.D., MPH, and director of the University of Minnesota’s Center for Infectious Disease Research and Policy, who was a member of the NSABB during the controversy over the H5N1 papers, said some research is needed to answer questions, such as what it would take for Ebola to become a respiratory virus, findings that would have implications for preparedness.
It was in October 2014 that a Texas nurse became the first person to contract Ebola within the United States despite wearing protective gear. The confirmation came four days after the death of the first patient, Thomas Eric Duncan, 42, a Liberian who arrived in this country in September 2014.
The recommended policy guidance includes pre-funding review mechanisms for research proposals that involve enhanced PPP. Federal departments and agencies planning to fund such studies are encouraged to ensure that the projects adhere to eight specified principles, conduct risk-benefit analyses, and develop risk mitigation plans proportionate to the identified risks.
Paused projects under the existing moratorium will now undergo review using the process outlined in the recommended policy guidance. Projects deemed suitable to proceed will be subject to appropriate risk mitigation measures.
What could go wrong, huh?
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