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The White House will decide whether to adopt the panel’s recommendations on so-called job-gain experiments.
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By Benjamin Mueller and Carl Zimmer
An expert panel on Friday approved a broad set of proposed changes to the government’s program for experiments involving tinkering with dicy viruses and other pathogens. to lab-created errors that can cause a pandemic.
Experts unanimously approved draft recommendations that, among other things, call on health officials to increase their vigilance for less harmful pathogens, adding those similar to the coronavirus. Exemptions for studies similar to vaccine progression and surveillance of emerging viruses also end.
“We have a lot of oversight on paper, but not a lot of oversight,” said Dr. Kenneth Bernard, a retired rear admiral and panel member, arguing in favor of the proposed changes, which will still get some minor changes.
The proposals added to the push in Washington for government oversight of studies of harmful pathogens.
Two internal federal oversight agencies recently published reports criticizing oversight of those studies. Congressional Republicans to Request Dr. Anthony S. TestifyFauci, who until recently headed the institute guilty of investing much of the nation’s pathogen research. And Biden’s administration has signaled its willingness to act, describing biological threats as one of the gravest risks facing the United States.
The expert panel, the National Scientific Advisory Council on Biosafety, is guilty of advising the government on biosafety issues. Their proposals arose from a decade of debates about so-called gain-of-function studies, in which pathogens are endowed with new capabilities. Council members began discussing their most recent reforms in January 2020, only to suspend the procedure so they can only investigate the pandemic.
However, the pandemic has reinforced what some critics of pathogen studies said as a desire to monitor a broader set of viruses: Although it killed only a small fraction of those infected, the coronavirus created a global catastrophe.
Now the question is whether the advisory committee’s proposals cover too wide a diversity of pathogens or are not sufficiently approved.
Proponents of stricter oversight were largely encouraged by the recommendations and applauded their attention to any experiments that could produce a pathogen with pandemic potential.
“If the government implements the spirit of what it has written, it would be a major overhaul of oversight of dual-use studies in the United States,” said Gregory Koblentz, a biodefense specialist at George Mason University, referring to studies that could also be used to do harm.
Still, he said, the White House goes beyond the board’s recommendations by creating an independent firm to conduct that oversight, simplifying a formula it deemed too fragmented.
Other experts cautioned that even existing proposals go too far. Some said the recommendations would create a surveillance formula so extensive and confusing that it could discourage minimal-risk experiments with massive potential public health benefits.
“There’s a lot of things that can potentially fall into this because it’s written so vaguely,” said Gigi Gronvall, a biosafety specialist at the Johns Hopkins Bloomberg School of Public Health. He advised that the kind of studies used to make the Ebola vaccine may simply fall under the new policy. “It can possibly create a massive oversight burden,” he said, “that the government doesn’t have the technical capacity to implement. “
These considerations echoed 150 virologists, who, in an observation published Thursday, warned that they were opposed to hindering researchers with unnecessary burdens. They warned that burdensome regulations “would lead to unwarranted restrictions on pandemic preparedness and reaction and could make humanity more vulnerable in the long run. “make sprouts. “
Seema Lakdawala, a virologist at Emory University, told the advisory board on Friday that more regulations could, for example, interfere with efforts to track the bird flu outbreak that killed millions of chickens and drove up egg prices. Flu strains that infect others evolve from bird flu viruses that acquire new mutations.
The advisory committee’s final report will be sent to the White House Office of Science and Technology Policy, which will have additional discussions with government agencies before issuing a new policy.
“I’d even be hesitant to guess what the time frame is, but I think it will be more than a month,” said Dr. Lawrence Tabak, who serves as director of the National Institutes of Health. at a press conference after the meeting. .
Proponents of improved surveillance have lobbied in recent days for more competitive controls. For example, the council advised that the government be more transparent in its reviews of potential pathogens. An organization of scientists, added Dr. Tom Inglesby, director of the Johns Hopkins Center. for health security at the Bloomberg School of Public Health, he argued that the public be allowed to see the resulting threat and get evidence of benefits before any study begins.
One board member, virologist Mark Denison of Vanderbilt University, who voted in favor of the recommendations, said he nevertheless had reservations about his potential restriction of new monoclonal antibody treatments for viral infections.
Even if the White House adopts most of the advisory council’s recommendations, it’s unclear whether it will adopt some of the experts’ more ambitious proposals. For example, the council advised comparing studies for their effect not only in humans, but also in animals or even plants.
The council proposed that experiments come under scrutiny, whether they obtain or obtain government funding. Currently, only government-funded studies are monitored.
This loophole recently drew attention when Boston University came under fire for an experiment in which researchers combined the Omicron variant to learn more about its severity. The experiment was not approved by a government committee on harmful pathogens, in part because it was conducted without federal funding, the university said, even though federal money was used to expand the equipment used in the research.
Council members said that in the end this loophole would likely require federal legislation. “It’s going to be hard to solve,” said Gerald Parker, associate dean of Texas A.
Much of the debate over the council’s proposals has focused on whether biosafety surveillance deserves to be limited to express pathogens and types of experiments or deserves instead to be widely applied to any study expected to result in a harmful epidemic.
The proposals, for example, a high-level review of any “reasonably anticipated” study to create a more harmful pathogen. Inglesby applauded this language.
“The result is what matters,” he said. If it is a moderate imaginable end result of its work, then it deserves to be governed in the same way as anything we already know has pandemic potential. “
Some virologists have claimed that the risk posed by an experiment can only be determined by comparing the main points of its methodology, such as whether a virus were changed to grow more in a petri dish or mosquito.
“Who makes a decision about the moderate and who makes a decision about the anticipated?” said Angela Rasmussen, a virologist with the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. essentially all virology studies?”
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