Scientists advising the National Institutes of Health on Friday released a draft report urging intensified government oversight of experiments on dangerous pathogens, including broadening the definition of the kinds of pathogens that could trigger a pandemic.
The new report from two biosecurity working groups echoes their preliminary recommendations released last fall, which said the definition of “enhanced potential pandemic pathogens” should cover not just the most lethal viruses and bacteria, but also less deadly pathogens that are extremely transmissible — a description that fits the coronavirus SARS-CoV-2.
NIH said the review was not in response to fears that SARS-CoV-2 might have emerged from laboratory research. The debate over lab safety and security intensified during the pandemic but goes back more than a decade, when experiments in the United States and the Netherlands created versions of the influenza virus that were more easily transmitted among ferrets.
The new report does not address the origins of SARS-CoV-2, and instead is part of decade-long effort to figure out what types of processes and oversights will help ensure laboratory research is safe. It notes that biotechnology is advancing rapidly, converging with breakthroughs in engineering and computational sciences to create potential solutions to “some of the most complex challenges we face” as a society.
But that also requires vigilance, the report states, because risks are changing as cheap and easily accessible tools and techniques make it possible to “modify or generate beneficial and harmful agents.”
The draft report from members of the National Science Advisory Board for Biosecurity comes after a nearly year-long review of existing guidelines. The review had been postponed in January 2020 so experts could focus on the pandemic, but NIH officials early last year ordered the biosecurity advisers to resume.
The definitions of potential pandemic pathogens “are too narrow,” the draft report declared. “Overemphasis on pathogens that are both likely ‘highly’ transmissible and likely ‘highly’ virulent could result in overlooking some research involving the creation, transfer, or use of pathogens.”
The report also acknowledges the erosion of trust in laboratory research, driven in part by the debate over the origin of SARS-CoV-2 and associated fears that virologists have been reckless in how they manipulate pathogens in laboratories. The controversy over the origin of the virus has drawn attention to the murky process of government oversight of potentially risky experiments.
“Increased transparency in the review process is needed to engender public trust in the review and oversight processes,” the report states.
Tom Inglesby, director of the Center for Health Security at Johns Hopkins Bloomberg School of Public Health, was among the scientists urging the board to make sweeping revisions to pathogen research oversight. He said the draft report addresses some key issues while leaving others unresolved. One of the fundamental problems, he said, is the lack of clarity on acceptable experimental risks.
Two leaders of one of the board’s working groups said in recent interviews that they were trying to find a “sweet spot” where the benefits of research clearly outweigh any risks.
However, the draft report “didn’t call for a more explicit articulation of risks and benefits in a way that I think could be very useful,” Inglesby said. But, he added, “if we adopted everything the NSABB recommended, it would be a substantial step forward.”
Many scientists have said in recent months that they welcome greater clarity in the research guidelines.
“I don’t think the pandemic started with a lab leak, but I think we can talk about wanting more or different biosafety regulations,” Stephen Goldstein, a research scientist at the University of Utah who was not part of the review process, said in a recent interview.
Benjamin Neuman, a virologist at Texas A&M University, greeted the report skeptically, saying it contained “magical thinking” about the ability of researchers to gauge the pandemic potential of a pathogen.
“The new guidelines place an unusually heavy burden on imagination — guessing what microbes and which modifications are likely to result in a pandemic,” Neuman said in an email. “It’s important to remember that pandemics are rare events, however prominent they may be in our minds right now. Predicting a pandemic is like presenting a row of haystacks and asking someone to guess which, if any, may contain a needle.”
David Relman, a professor of microbiology and immunology at Stanford Medicine, said adoption of the report’s recommendations would strengthen oversight of risky research. But he said the report does not address “information hazards,” dissemination of details about risky research to people who have laboratory skills but may be reckless or have malign intent. “The Board seems to have punted that problem down the road,” Relman said in an email.
Therein lies a fundamental challenge for the scientific community: Knowledge is not easily controlled, especially as the tools for experimenting with pathogens become cheaper and more available.
“The barriers to access for making pathogens from scratch are falling,” said Jaime Yassif, vice president for global biological policy and programs at the nonprofit organization Nuclear Threat Initiative. She praised the report but said oversight should also encompass research that is not funded by the government. “If we leave them out of the picture it’s a big vulnerability,” she said.
The report is part of a long process that is expected to continue for many weeks or months as the recommendations rise through the layers of federal bureaucracy, including NIH’s parent, the Department of Health and Human Services, and other agencies with a stake in this kind of research.
The advisory board will hold a public meeting next Friday to discuss the draft report.