Health

‘Strictly Window Dressing’: New NIH Gain-Of-Function Regulations Fall Far Short Of Protecting The Public, Experts Say

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Dylan Housman Deputy News Editor
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New oversight regulations aimed at limiting the risk of gain-of-function (GoF) research don’t go far enough to ensure the public will stay safe, scientists told the Daily Caller.

The National Science Advisory Board for Biosecurity (NSABB), a panel within the National Institutes of Health (NIH), voted Friday to recommend new regulations on dangerous experiments that modify pathogens to make them more infectious or deadly toward humans. It will be up to the Biden administration to determine whether or not it will accept those changes and make them into official policy.

The recommendations include extending oversight to less dangerous pathogens, getting rid of exemptions for certain research goals (like vaccine development or surveilling potential pandemic outbreaks) and holding research conducted outside the U.S. to the same standards as research done at home.

Not everyone is convinced these steps will make a huge difference, though.

“The NSABB recommendations fall short — far short — of providing effective oversight of research on enhanced potential pandemic pathogens,” Dr. Richard Ebright, a Rutgers University microbiologist, told the Caller. “The NSABB recommendations do not address the most crucial limitation of current oversight: the fact that funding agencies fail to identify, flag, and forward ePPP-research projects for review by the HHS P3CO Committee,” he added, referring to enhanced potential pandemic pathogen projects and the Potential Pandemic Pathogen Care and Oversight Committee with in the Department of Health and Human Services.

Ebright is among a group of experts who have criticized the NIH for not conducting effective oversight on GoF research, particularly as it pertains to the COVID-19 pandemic. Some proponents of the lab-leak theory of COVID-19’s origin argue that NIH-funded gain-of-function research at the Wuhan Institute of Virology, which was altering bat viruses to make them more dangerous, may have led to the outbreak of the global pandemic.

“Even with these many important recommendations made in the ‘Proposed Biosecurity Oversight Framework for the Future of Science’ document, we are seriously concerned the document does not yet address several of the most important recommendations from our July document,” five prominent scientists told the NSABB in a Jan. 26 letter.

“Fundamentally, we also remain concerned that the new NSABB draft recommendations do not spell out who decides, and at what stage, which proposals need to be subject to department-level review,” wrote David Relman of Stanford, Marc Lipsitch of Harvard, and Tom Inglesby, Anita Cicero and Jaspreet Pannu of Johns Hopkins.

Critics of NIH’s existing oversight rules for GoF research have said the current protocol lacks clarity on which research requires additional review from regulators. Despite a moratorium on GoF research funding between 2014 and 2017, many projects that some experts considered to be GoF still received funding.

Some scientists view the new proposed regulations as more of a political stunt than a practical solution. “In my opinion, the Biden administration has made a hard pivot towards creating the perception that they take the risk of lab accidents seriously, while the substance of their reforms remains to be seen,” Dr. Louis Nemzer of Nova Southeastern University told the Caller.

“I think that public sentiment has strongly turned against risky research, such as gain-of-function, which can create unnatural risks that may not have ever evolved on it own,” Nemzer continued. “Thus, in an example of what I would call political maneuvering, the administration wants to maintain that the current​ pandemic was most likely caused by natural spillover, while in practice taking steps to reassure the public, as if they suspect was actually a lab accident.”

Nemzer called the newly proposed regulations a “step in the right direction,” but characterized the changes as minor and overdue. (RELATED: Fauci-Funded Scientist Engineers New COVID-19, Deadlier Than Omicron, In Boston Lab)

Dr. Hideki Kakeya of the University of Tsukuba agreed. “I think the proposed framework is far from satisfactory. Definitions are still vague and many loopholes will be made afterwards,” he told the Caller. “What I recommend is to restrict research dealing with deadly pathogens to be done only in an isolated area, like an uninhabited island … Otherwise, the potential risk is not acceptable considering the devastating outcome of an accidental lab leak.”

Still, there remain some supporters of GoF research who believe the new regulations would be too cumbersome. Many of those supporters have financial incentives for making such research as easy and unregulated as possible. 150 of those scientists authored a commentary last Thursday accusing critics of GoF research of derailing “rational discourse.”

It will be up to the White House’s Office of Science and Technology Policy to ultimately determine what the new regulations will be.