An expert panel on Friday endorsed a sweeping set of proposed changes to the federal government’s program for regulating experiments that involve tinkering with risky viruses and other pathogens. The move sets the stage for a closely watched decision by the Biden administration about its approach to protecting against lab disasters that could kick off a pandemic.
The experts unanimously approved draft recommendations that, among other things, ask health officials to extend their oversight to less dangerous pathogens, including ones similar to the coronavirus. They also recommended an end to exemptions for research related to vaccine development and surveillance of emerging viruses.
“We have a lot of oversight on paper, but not really a lot of oversight,” said Dr. Kenneth Bernard, a retired rear admiral and a member of the expert panel, making the case for the proposed changes, which will still receive some slight modifications.
The proposals have added to the momentum in Washington for tightening government oversight of studies of dangerous pathogens.
Two internal federal watchdogs recently issued reports that criticized the monitoring of such studies. Congressional Republicans are preparing to seek testimony from Dr. Anthony S. Fauci, who until recently directed the institute responsible for funding much of the country’s pathogen research. And the Biden administration has signaled a willingness to act, describing biological threats as among the most serious dangers facing the United States.
The expert panel, the National Science Advisory Board for Biosecurity, is charged with advising the government on biosecurity issues. Its proposals emerged out of a decade of debate over so-called gain of function studies, in which pathogens are endowed with new abilities. Members of the board began discussing their latest reforms in January 2020, only to put the process on hold so they could focus on pandemic-related research.
The pandemic, though, reinforced what some critics of risky pathogen research saw as a need for oversight of a broader set of viruses: Despite killing only a tiny fraction of those it infected, the coronavirus created a global catastrophe.
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Now, the question is whether the advisory board’s proposals sweep up too broad a range of pathogens or fail to reach far enough.
Proponents of stronger oversight have largely been heartened by the recommendations and applauded their focus on any experiments that could be expected to produce a pathogen with pandemic potential.
“If the government implements the spirit of what they’ve written, this would be a major overhaul of dual-use research oversight in the United States,” said Gregory Koblentz, a biodefense specialist at George Mason University, referring to research that could also be used to do harm.
Still, he said, the White House should go beyond the board’s recommendations in creating an independent agency to perform that oversight, streamlining a system he considered too fragmentary.
Other experts have warned that even the existing proposals go too far. Some have said that the recommendations would create an oversight system so expansive and confusing that it could discourage minimally risky experiments with huge potential public health benefits.
“There’s a lot that could potentially fall into this because it’s so vaguely written,” said Gigi Gronvall, a biosafety specialist at the Johns Hopkins Bloomberg School of Public Health. She suggested that the type of research used to make the Ebola vaccine could fall under the new policy. “You could potentially be creating a huge oversight burden,” she said, “which the government does not have the technical capacity to implement.”
Those concerns were echoed by 150 virologists, who in a commentary published on Thursday cautioned against hampering researchers with needless burdens. They warned that cumbersome regulations “will lead to unwarranted constraints on pandemic preparation and response and could leave humanity more vulnerable to future disease outbreaks.”
Seema Lakdawala, a virologist at Emory University, told the advisory board on Friday that additional regulations could, for example, interfere with efforts to track the bird flu epidemic that has killed millions of chickens and driven up egg prices. Influenza strains that infect people evolve from bird flu viruses that gain new mutations.
The advisory board’s final report will be sent to the White House’s Office of Science and Technology Policy, which will have further discussions with different government agencies before issuing a new policy.
“I’d be hesitant to even guess what the time frame is, but I am sure that it will be longer than one month,” Dr. Lawrence Tabak, who is performing the duties of director at the National Institutes of Health, said in a news conference after the meeting.
Proponents of stronger oversight have been lobbying in recent days for more aggressive controls. For example, the board recommended that the government be more transparent about its reviews of potential pathogens. A group of scientists including Dr. Tom Inglesby, the director of the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, have argued that the public should be allowed to see the resulting risk-benefit assessments before any research begins.
One board member, Mark Denison, a virologist at Vanderbilt University, who voted for the recommendations, said he nevertheless had reservations about their potential to constrain testing of new monoclonal antibody treatments for viral infections.
Even if the White House embraces the core of the advisory board’s recommendations, it is unclear whether it will adopt some of the experts’ more ambitious proposals. For example, the board suggested evaluating research for its impact on not only humans, but also animals or even plants.
The board proposed that experiments be subject to oversight whether or not they receive government funding. Currently, only government-funded research is subject to monitoring.
That loophole drew attention recently when Boston University came under fire for an experiment in which researchers tinkered with the Omicron variant to learn about its severity. The experiment was not vetted by a government dangerous pathogen committee in part because it was conducted without federal funds, the university said, even though federal money went to develop the tools used in the research.
Board members said closing that loophole would most likely require federal legislation. “This will be a hard one to solve,” Gerald Parker, an associate dean at Texas A&M University and chairman of the board, said at the news conference.
Much of the debate over the board’s proposals has turned on whether biosecurity oversight should be limited to specific pathogens and types of experiments or should instead apply broadly to any research that could plausibly result in a dangerous outbreak.
The proposals, for example, suggest a high-level review of any research that is “reasonably anticipated” to create a more dangerous pathogen. Dr. Inglesby applauded that language.
“The outcome is what matters,” he said. “If that is a reasonable possible outcome of your work, then it should be governed in the same way as something that we know already has pandemic potential.”
Some virologists said that the threat posed by an experiment could only be determined by evaluating the details of its methodology, like whether a virus was being modified to grow better in a petri dish or in a mosquito.
“Who decides what’s reasonable, and who decides what’s anticipated?” said Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. “Is it going to affect just a few more studies or basically every virology study?”
