The scientists at Boston University came under fire this week for tinkering with the Covid virus. Breathless headlines claimed that they had created a deadly new strain, and the National Institutes of Health rebuked the university for not asking for permission.
The experiments that were done on mice were not what the media reported. The original strain was more lethal than the manipulated one.
The uproar highlighted flaws in the way the U.S. government regulates research on pathogens that pose a risk. A lack of transparency about how the risk of experiments is judged and a seemingly haphazard pattern in the federal government's oversight policy were revealed.
Boston University was reprimanded by the government, but it didn't raise any red flags about the other experiments it funded. The government's own scientists did one of them.
The Boston episode tells us that the P3CO framework needs to be changed a lot, according to an expert. It's difficult for researchers to understand the whole process.
Every study considered for funding by the N.I.H. is checked for safety concerns by agency experts who decide whether to escalate it to a dangerous pathogen committee.
Some experiments, either because they are conceived later on or because they don't rely on federal funds, end up falling outside the scope of the process. The rules could be changed in the near future. Updating recommendations for research will be delivered by a committee of government advisers by the end of the year.
The P3CO framework is the government's policy for such experiments. Five years ago, it was established in response to a set of controversial experiments in which researchers set out to transform a bird flu virus into a mammal one.
The N.I.H. and other agencies are supposed to flag grant applications for experiments that could potentially produce a new Pandemic. Extra safety measures may be required for risky research.
Critics of P3CO complain that the evaluation is mostly hidden and ignores projects that aren't funded by the U.S. government. The National Science Advisory Board for Biosecurity held a public meeting in January of 2020. The meetings were canceled because of Covid arriving.
In the months that followed, Republican politicians attacked the N.I.H. for supporting past research on coronaviruses, suggesting that a lab leak may have been responsible for the Pandemic. In July, scientists published studies pointing to a market in Wuhan as the origin.
The N.I.H.'s advisory board met in February to work on new recommendations and released a draft last month. The proposal was to expand the scope of pathogens that can prompt a review. Covid has a low mortality rate but is so infectious that it wreaked havoc around the world.
The risk posed by computer software has been considered by the board in its discussions.
The researchers had differing opinions on the new guidelines.
The Harvard T.H. Chan School of Public Health has been pushing for tighter rules since the bird flu experiments.
The comments were submitted to the board last month.
Other scientists were worried about the regulations that would make their work difficult.
"We need to know what paperwork we need to fill out so we can do our jobs, which is to help the public respond to these types of things when they come at us."
The news this week about the Boston University experiments showed the government's policy is ambiguous.
A report about the differences between Omicron and other variant was posted online by a group of people. An Omicron spike was carried by the new virus that was created by the researchers. The modified virus was put into a strain of mice that were sensitive to Covid.
The original strain of Covid killed all the mice. The modified virus was found to kill 80 percent of the time.
A story in The Daily Mail claimed that scientists had created a new strain of Covid that had an 80 percent kill rate. Emily Erbelding, an official with the N.I.H., told the news site Stat that Boston University should have discussed the experiments with the agency before they happened.
Federal guidance is vague on what disclosures are required after a research proposal is approved. Officials don't generally apply the guidance to experiments that are conceived after funding has been granted.
Gregory Koblentz is a biodefense specialist at George Mason University.
Boston University said in a statement to The New York Times that the experiments were approved by its own safety committee.
The scientists did not have to tell the N.I.H. because they used university funds to pay for the experiments. The matter is being reviewed.
The dispute over technical laboratory protocols sent mixed messages to the scientific community and the public.
The National Science Advisory Board for Biosecurity is chaired by Dr. Madad. The policy is being reexamined to make sure that it is clear, transparent, and feasible.
The proposal for the Boston University experiments should have gone through a more thorough evaluation according to experts.
The study would have likely been given the go-ahead even if it had gone through that process.
The coronaviruses has evolved far beyond the variant used in the experiment and is already rampant in humans. The hybrid lab virus is not likely to cause a serious threat if it escapes.
Dr. Bloom said that he understands why people are worried about it. This seems to me to be a low risk.
Questions were raised about the way the N.I.H. and other health agencies had assessed such experiments in the past. Scientists with the FDA published a study in which they injected mice with coronaviruses engineered to carry an Omicron spike.
P3CO rules require the F.D.A. to follow. The agency said in a statement that the hybrid virus was not a new version of the virus. The study did not fall under the dangerous pathogen guidelines because they were not interested in finding new ways to make it more potent.
The agency did not explain why the study passed muster, according to some experts.
It needs to be reviewed if it is anticipated that the research will lead to the enhancement of a potential Pandemic pathogen. The director of the center for health security at the school said in an email that the center was closed.
The F.D.A. researchers are not the only ones doing this. Scientists at the University of Texas Medical Branch in Galveston rely on federal funding for their studies on whether vaccines can protect against coronaviruses.
Scientists can use those techniques to save a lot of time waiting for samples of Omicron viruses from human patients. The Texas experiments were less risky than the Boston one because they generallyinfecting cells, not live animals.
The Texas team's proposals were not forwarded to the dangerous pathogen committee. The agency didn't give a reason. Three studies that the N.I.H. proposed to fund were reviewed.
Random events that bring these particular experiments to public attention can be the result of no one in charge of scanning the medical literature. It shouldn't be like that.
Some people think that research that isn't funded by the government doesn't have to follow the government's rules.
Karmella Haynes is a member of the National Science Advisory Board for Biosecurity and believes that publishing a policy that would be broadly applicable would be ideal. How to actually enforce that is beyond our responsibility.
The Federal Select Agent Program requires anyone wanting to work with dangerous substances to register with the government.
Richard Ebright said that codifying the requirements in regulations with the force of law will not add up.
If Republicans win control of congress in the upcoming elections, federal officials may be under pressure to strengthen oversight.
Better regulations could be further out of reach if there is a political debate.
Gronvall is a biosafety specialist at the school of public health.
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