Government officials consider stepping up oversight of studies of risky viruses: Shots fired

More than 150 virologists have signed a comment that says all the evidence to date points to the coronavirus pandemic starting naturally, and not being the result of some sort of lab accident or attack. malicious.

They worry that continued speculation about a lab in China will fuel calls for greater regulation of experiments with pathogens, and that it will stifle basic research needed to prepare for future pandemics.

The virologists released their statement a day before federal government advisers completed a review of the existing surveillance system for experiments that could worsen existing pathogens.

At a meeting on Friday, those advisers voted to approve, with minor changes, a set of recommendations that call for expanding a special decision-making process. This process is currently evaluating the risks and benefits of experiments that may alter «potential pandemic pathogens» in ways that make them more dangerous.

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

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

He says it’s not yet clear how many NIH-funded research projects might be affected. «We haven’t officially started doing that analysis yet,» Tabak says. «We just received these recommendations today.»

It’s this 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 great 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 it would be done, and whether the benefits are worth it,” says Tom Inglesby, director of the Center for Health Security at the Johns Hopkins Bloomberg School of Public Health.

The origins of the pandemic

This all comes as the lab in China, known as the Wuhan Institute of Virology, is once again making headlines. An internal government watchdog released a report this week criticizing the National Institutes of Health, saying it failed to adequately monitor grants to a nonprofit that collaborated with scientists from the lab. from Wuhan.

Felicia Goodrum, a virologist at the University of Arizona, says open-minded experts have investigated the origins of the pandemic. The available evidence, she says, supports the idea that the virus emerged from nature just as other viruses such as HIV and Ebola have – jumping from animals to people who have come into contact with them. .

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

Basic virus research, she says, is what led to the rapid development of vaccines and drugs to fight the pandemic.

And yet, virologists have watched with dismay as misinformation and conspiracy theories blame science.

«There’s this total disconnect between reality and what happened,» says Michael Imperiale, a virologist at the University of Michigan.

He says that while debates have been going on for years over the wisdom of doing experiments that could make bad viruses even worse, this moment seems different.

«The pandemic,» he says, «has really heightened the urgency with which we have to address these issues, just because of all the controversy that’s existed around, you know, was it a lab leak or not?»

Bird flu study sounds alarm

Unlike, say, nuclear physics research, biology has traditionally had a culture of openness. After the anthrax attacks in 2001, however, biologists began to wrestle with the possibility that their published work could serve as revenue for criminals who wanted to make biological weapons.

And in 2011, there was an outcry after government-funded researchers modified a bird flu virus that can be deadly in humans. Their lab work has made this virus more contagious in lab animals replacing humans.

Critics said they had created a super flu. Proponents said viruses sometimes need to be manipulated in the lab to see what they might be capable of; in nature, after all, mutations happen all the time and that is how pandemic strains emerge.

This episode marked the beginning of a long and heated debate, as well as research moratoriums and, ultimately, the development of new regulations. In 2017, a review system was put in place to weigh the risks and benefits of studies that could make a potential pandemic pathogen worse. So far, only three proposed lines of research, with influenza viruses, have been deemed risky enough to merit this kind of additional scrutiny.

«We’re really talking about a small number of research proposals,» says Lyric Jorgenson, acting associate director for science policy and acting director of the NIH’s Office of Science Policy.

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

If the proposed changes developed by this advisory group are ultimately adopted by the government, an additional layer of oversight would apply to any «reasonably anticipated» study to improve the transmission or virulence of any pathogen in a way that could make it a threat to public health. . This means that more experiments on more viruses would be scrutinized more closely.

«What this new recommendation says is that even if you start with a virus that had no potential to cause an epidemic or a pandemic, if you do research that will modify that virus in a way where it could now cause an uncontrollable disease, or a widespread disease, that needs to be looked at by this new framework,” Inglesby says.

Additionally, 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 anticipated»

The American Society for Microbiology responded positively, stating «we urge the rapid implementation of changes recommended by federal agencies engaged in this work.»

But some virologists think the devil will be in the details if those recommendations turn into policy.

«They keep using that phrase ‘reasonably anticipated,'» Imperiale explains. «How is this going to be interpreted? Will there be clear indications of what is meant by this?»

Researchers often don’t know what will happen when they start an experiment, Goodrum says, especially when the science is cutting edge.

«That’s where great scientific breakthroughs come from. And so, tying our hands behind our backs, saying we can only do science that we can anticipate, then we’re really restricting 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 hoped the experiment of going through a pandemic would simulate more research, not «unnecessarily delay or restrict it.»

He said it looks like many infectious disease researchers in the United States «will face significant delays in their crucial research efforts, if they can continue this research.»

The United States is unusual in that it has a lot of public discussion of these issues and a system to try to manage the risks, Inglesby says.

He thinks surveillance can be strengthened without hampering science.

“I am avidly, absolutely pro-science and pro-research, and in particular pro-research on infectious diseases,” says Inglesby.

But he says there is a very small part of this research «where there is very high risk potential if things go wrong, whether by accident or on purpose. And so we have to find the right balance, between the risks that could unfold and the potential benefits.»