It has been widely reported that during the Obama administration Gain-of-Function research was paused on October 17, 2014, but just weeks before President Obama left office, his White House lifted the Gain-of-Function pause with new guidelines.
On January 7, 2017, Obama’s White House Office of Science and Technology Policy (OSTP) released their “Summary: OSTP Issues “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO). “
Their decision included recommended policy guidelines, “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).”
Recognizing the danger of gain of function historically, their recommendations also included the historical references to prior U.S. policies.
“Integration with Policies on Life Sciences Dual Use Research of Concern. At such time as the United States Government next considers revision of the March 2012 United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern and the September 2014 United States Government Policy for the Institutional Oversight of Life Sciences Dual Use Research of Concern, it should consider this recommended P3CO policy guidance in its revisions of the DURC policies. Such a course of action would implement Recommendation 4 of the NSABB Recommendations, which states that “In general, oversight mechanisms for [work with enhanced potential pandemic pathogens] should be incorporated into existing policy frameworks when possible.” It is also consistent with, although not sufficient to fully implement, Recommendation 5, which states that “the U.S. government should consider ways to ensure that all [work with enhanced potential pandemic pathogens] conducted within the U.S. or by U.S. companies be subject to oversight, regardless of funding source,” states their recommendations.
The Obama OSTP 2017 statement cited that “these recommendations will satisfy the requirements for lifting the current moratorium on certain life sciences research that could enhance a pathogen’s virulence and/or transmissibility to produce a potential pandemic pathogen (an enhanced PPP).”
They concluded that the deliberative process was launched in October 2014 at the time of the 2014 pause by OSTP and the Department of Health and Human Services (HHS), which asked the National Science Advisory Board for Biosecurity (NSABB) for feedback from the National Research Council of the National Academy of Sciences, and that in the meantime, the projects had been placed on pause.
When this 2014 pause was executed, the experts were very specific about how they were going to evaluate Gain-of-Function risks and benefits.
As cited in their “U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses, the 2014 report states:
“New USG funding will not be released for gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. The research funding pause would not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses, unless the tests are reasonably anticipated to increase transmissibility and/or pathogenicity,” states the 2014 document.
Their deliberative process included two steps and addressed the broad spectrum of agencies and life science experts who would be involved.
In 2014, the plan for re-evaluation was very specific.
“The NSABB, informed by NRC feedback, will deliver recommendations to the Secretary of Health and Human Services, the Director of the National Institutes of Health, and the heads of all federal entities that conduct, support, or have an interest in life sciences research (including the Assistants to the President for Homeland Security and Counterterrorism and for Science and Technology). The final NSABB recommendations and the outcomes of the NRC conference will inform the development and adoption of a new U.S. Government policy governing the funding and conduct of gain-of-function research. Upon adoption of a federal gain-of-function policy, the U.S. Government will declare the end of the research funding pause.”
By 2017, Obama’s White House acknowledged after thorough deliberations with both domestic and international experts, there were potential benefits but also “significant risks” and their January 2017 recommendations had taken into consideration both the benefits and risks.
They recommended robust oversight, transparency and public dialogue, especially citing “dual use research of concern (DURC),’ and promised that the policy for enhanced PPP would be ongoing and “continue to engage the public.”
So, why is Capitol Hill having such a difficult time getting answers to questions about Gain-of-Function research from the Biden Administration when some experts want to continue the Gain-of-Function research after the world has gone through a global pandemic of such catastrophic economic failure?
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