A panel of experts on Friday endorsed a series of sweeping proposed changes to the federal government’s program to regulate experiments involving the modification of dangerous viruses and other viruses. other pathogens. The move sets the stage for a decision closely watched by the Biden administration about its approach to protecting against laboratory disasters that could trigger a pandemic.
Experts unanimously approved draft recommendation that, among other things, requires health officials to expand their surveillance to less dangerous pathogens, including those similar to the coronavirus. They also recommend ending waivers for research related to vaccine development and surveillance of emerging viruses.
Dr Kenneth Bernard, a retired rear admiral and member of the panel of experts, said: “We have a lot of oversight on paper, but not really a lot of oversight. slight modification.
The proposals have given further impetus in Washington to tighten government oversight of research into dangerous pathogens.
two internals federal watchdog recently issued report that criticize oversee such studies. Republicans in Congress 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 signal ready to actdescribes biological threats as one of the most serious dangers facing the United States.
The Expert Council, the National Scientific Advisory Board on Biosafety, is responsible for advising the government on biosafety issues. Its proposals emerge from a decade of debate over the so-called achieve functional studies, in which pathogens are endowed with new abilities. Council members began discussing their latest reforms in January 2020, only to pause the process so they could focus on pandemic-related research.
However, the pandemic has reinforced what some critics of risky pathogen research see as the need to monitor a broader range of viruses: Although it kills only a tiny fraction of those infected, it corona virus has created a global disaster.
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Now, the question is whether the advisory board’s proposals wipe out a wide range of pathogens or don’t reach far enough.
Advocates of stronger surveillance have been largely cheered by the recommendations and applauded their focus on any experiments that could produce pathogens with pandemic potential.
“If the government lives up to the spirit of what they wrote, this would be a major overhaul of dual-use research oversight in the United States,” said Gregory Koblentz, an expert on biodefenses. at George Mason University, said. used for harm.
However, he said, the White House should go beyond the board’s recommendations in creating an independent agency to do that oversight, streamlining a system he considers too fragmented. .
Other experts have warned that even current proposals go too far. Some have said the recommendations would create a surveillance system so extensive and confusing that it could preclude minimally-risky experiments with potentially huge public health benefits.
“There’s a lot of possibilities that could fall into this category because it’s so vaguely written,” said Gigi Gronvall, a biosecurity expert at the Johns Hopkins Bloomberg School of Public Health. She suggests that the type of research used to create an Ebola vaccine could fall under the new policy. “You could be creating a huge surveillance burden that the government doesn’t have the technical capacity to do,” she said.
Those concerns have been echoed by 150 virologists, who in a comment published on Thursday warned against burdening researchers with unnecessary burdens. They warn that cumbersome regulations “will lead to undue restrictions on pandemic preparedness and response and could leave humanity more vulnerable to future disease outbreaks.” future.”
Seema Lakdawala, a virologist at Emory University, told the advisory board on Friday that additional regulations could, for example, hinder efforts to track bird flu outbreaks. kill millions of chickens and push up egg prices. Influenza strains infecting humans evolved from avian influenza viruses with new mutations.
The advisory panel’s final report will be sent to the White House’s Office of Science and Technology Policy, which will further discuss it with various government agencies before enacting the new policy.
Dr Lawrence Tabak, who is acting director at the National Institutes of Health, said: “I would hesitate to guess what the timeframe is, but I am sure it will be longer than a month. a press conference after the meeting.
Advocates of stronger surveillance have been lobbying in recent days for stronger controls. For example, the panel recommended that the government be more transparent about assessments of potential pathogens. A group of scientists including Dr. Tom Inglesby, 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 view the results of the risk-benefit assessment. before starting any research.
One panel member, Mark Denison, a virologist at Vanderbilt University who voted for the recommendations, said he remains apprehensive about the possibility of limiting testing of monoclonal antibody treatments. new to viral infections.
Even if the White House accepts the advisory board’s core recommendations, it remains unclear whether it will accept some of the more ambitious proposals from experts. For example, the panel proposes to evaluate research on its effects on not only humans but also animals or even plants.
The panel proposed that experiments be subject to scrutiny whether or not they received government funding. Currently, only government-funded research is subject to scrutiny.
That vulnerability gained attention recently when Boston University come under the fire for an experiment in which researchers modified the Omicron variant to learn about its severity. The university said the experiment was not reviewed by the government’s dangerous pathogens committee in part because it was conducted without federal funds, although federal money was used to develop the tools used. used in research.
Council members said closing that loophole would most likely require federal law. “This is going to be a tough problem to deal with,” said Gerald Parker, vice chancellor at Texas A&M University and chairman of the board.
Much of the debate over the panel’s recommendations has revolved around whether biosecurity surveillance should be limited to specific pathogens and types of experiments, or should instead apply broadly to any any research could lead to a dangerous outbreak.
For example, the proposals suggest a high-level review of any research that is “reasonably predicted” to produce a more dangerous pathogen. Dr. Inglesby welcomes that language.
“The results are what matters,” he said. “If that’s a reasonably possible outcome of your job, it should be managed in the same way as something we know has pandemic potential.”
Some virologists say that the threat posed by an experiment can only be determined by evaluating the details of its methodology, such as whether the virus has been modified to grow better in the environment. petri dishes or in mosquitoes or not.
“Who decides what is reasonable, and who decides what is foreseeable?” Angela Rasmussen, a virologist at the Vaccines and Infectious Diseases Foundation at the University of Saskatchewan, Canada. “Will it only affect a few more studies or basically every virology study?”
