Government officials think of increased scrutiny of high-risk virus studies: Shots

This image shows purified particles of the mpox virus, formerly called monkeypox. Such viruses can be genetically modified in the lab in ways that can make them more dangerous.


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This image shows purified particles of the mpox virus, formerly called monkeypox. Such viruses can be genetically modified in the lab in ways that can make them more dangerous.


More than 150 virologists have joined a commentary that says all evidence to date indicates the coronavirus pandemic started naturally and was not the result of some lab accident or malicious attack.

They worry that ongoing speculation about a lab in China will fuel calls for greater regulation of pathogen experimentation, and that this will stifle the basic research needed to prepare for future pandemics.

The virologists issued their statement a day before federal government advisers completed a review of the existing oversight system for experiments that could make existing pathogens even worse.

At a meeting on Friday, those advisers voted, with minor changes, to approve a set of recommendations calling for the expansion of a special decision-making process. This process is currently weighing the risks and benefits of experiments that could alter “potential pandemic pathogens” in a way that could make them more dangerous.

Their advice will now be considered by officials from multiple agencies and groups across the government who want to weigh in, including the White House Office of Science and Technology Policy and the National Security Council.

“This will be a deliberative process,” said Lawrence Tabak, who serves as director of the National Institutes of Health (NIH).

He says it’s not yet clear how much NIH-funded research projects could be affected. “We haven’t formally started that analysis yet,” says Tabak. “We just received these recommendations today.”

It’s that kind of uncertainty that makes infectious disease experts nervous. But some see the proposed changes as a real step forward.

“The government really has a vested interest, on behalf of all of us, in the public, in knowing when researchers want to make a virus more deadly or more transmissible, and understanding how that would be done and why that would be done, and whether the benefits are worth it,” said Tom Inglesby, director of the Center for Health Security at the Johns Hopkins Bloomberg School of Public Health.

The origin of the pandemic

All this is because the lab in China known as the Wuhan Institute of Virology is making headlines again. An internal government watchdog released a report this week criticizing the National Institutes of Health, saying it was not adequately overseeing the award of grants to a non-profit organization that had collaborated with scientists at its lab in Wuhan.

Felicia Goodrum, a virologist at the University of Arizona, says open-minded experts have been investigating the origins of the pandemic. The available evidence, she says, supports the idea that the virus, like other viruses such as HIV and Ebola, originated in nature: by jumping from animals into humans who came into contact with it.

“The evidence we have so far suggests that SARS-CoV-2 entered the human population through that route,” says Goodrum. “There is no evidence to the contrary or in support of a lab leak, nothing credible.”

Basic research on viruses, she says, has led to the rapid development of vaccines and drugs to fight the pandemic.

And yet virologists have watched in dismay as misinformation and conspiracy theories have blamed science.

“There’s a complete disconnect between reality and what happened,” said Michael Imperiale, a virologist at the University of Michigan.

He says that while the wisdom of doing experiments that can make bad viruses even worse has been debated for years, this moment feels different.

“The pandemic,” he says, “has really increased the urgency with which we have to address these issues, just because of all the controversies that have been out there about, you know, was this a lab leak or not?”

An avian flu study raises the alarm

In contrast to, for example, nuclear physics research, biology has traditionally had a culture of openness. However, after the 2001 anthrax attacks, biologists began to grapple with the possibility that their published work could serve as recipes for evildoers seeking to create biological weapons.

And in 2011, there was protest after government-funded researchers engineered an avian flu virus that can be deadly to humans. Their lab work made this virus more contagious in the lab animals that are substitutes for humans.

Critics said they had created a superflu. Proponents said viruses sometimes need to be manipulated in the lab to see what they’re capable of; after all, mutations occur constantly in nature and this is how pandemic strains arise.

That episode marked the beginning of a long, heated debate, plus research moratoriums and eventually the development of new regulations. A rating system was introduced in 2017 to weigh the risks and benefits of studies that could make a potential pandemic pathogen worse. So far, only three proposed lines of research, involving flu viruses, have been deemed risky enough to merit that kind of additional research.

“We’re really talking about a small number of research proposals,” said Lyric Jorgenson, acting deputy director for science policy and acting director of the NIH’s Office of Science Policy.

She says just before the pandemic began, officials asked advisers from the National Science Advisory Board for Biosecurity to consider whether the government should be more transparent to the public about how it makes decisions about this type of research. Before that work was done, the pandemic hit and everything was put on hold. Last year, officials asked the group to evaluate the regulations more comprehensively.

If the proposed changes developed by this advisory group are eventually adopted by the government, an additional layer of oversight would apply to any research that “may reasonably be expected” to enhance the transmission or virulence of a pathogen in a way that could make it a threat to public health. . That means more experiments with more viruses would get a closer look.

“What this new recommendation says is that even if you start with a virus that has no potential to cause an epidemic or pandemic, if you do research that will change that virus in a way that it could now become an uncontrollable disease. cause, or widespread disease, to be reviewed by this new framework,” says Inglesby.

In addition, the Advisory Group noted that “greater transparency in the review process is needed to build public confidence in the review and oversight processes.”

What is ‘reasonably expected’

The American Society for Microbiology responded positively, saying, “We are urging rapid implementation of the recommended changes by the federal agencies involved in this work.”

But some virologists think the devil is in the details if these recommendations turn into policy.

“They keep using this phrase ‘reasonably expected’,” says Imperiale. “How will that be interpreted? Will there be clear guidance on what is meant by that?”

Researchers often don’t know what will happen when they embark on an experiment, Goodrum says, especially when the science leads the charge.

“That’s where the great scientific progress comes from. And so to tie our hands behind our backs, to say we can only do the science that we can anticipate, then we’re really limiting innovative science,” she says.

Ron Fouchier, the virologist at Erasmus University Medical Center in the Netherlands whose lab did the avian flu experiments more than a decade ago, said in an email that he had hoped the experience of living through a pandemic would simulate more research, not “redundant”. delay or limit.”

He said it appears that many infectious disease researchers in the United States will experience “significant delays in their critical research efforts, if they can continue that research at all.”

The US is unusual in that there is a lot of public discussion about these issues and there is a system in place to manage the risks, Inglesby says.

He thinks supervision can be made stronger without getting in the way of science.

“I am eagerly, absolutely pro-science and pro-research, and especially pro-infectious disease research,” says Inglesby.

But he says there’s a very small part of that research “where there’s a potential for very high risks if something goes wrong, by accident or on purpose. And so we have to strike the right balance between the risks that could arise and the potential benefits.”

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