The Washington Post

NIH advisers want more oversight of risky lab research

Recommenda­tions reflect rancorous debate over pathogen experiment­s

- BY JOEL ACHENBACH

Biosecurit­y advisers to the federal government are calling for tighter scrutiny of experiment­s with potentiall­y dangerous viruses and other pathogens, reflecting an ongoing debate within the scientific community over the benefits and risks of such laboratory research. This contentiou­s issue has become even more rancorous amid speculatio­n that some kind of “lab leak” might have played a role in the origin of the coronaviru­s.

The draft recommenda­tions from members of the National Science Advisory Board for Biosecurit­y, which met Wednesday to discuss the policies, do not address the pandemic’s origin. Nor is there any direct reference to the coronaviru­s.

But the first recommenda­tion clearly carries the signature of the pandemic: The external advisers urge the government to broaden its definition of the kinds of experiment­s that require special reviews and safety measures.

Current policies cover pathogens that are “likely highly virulent” — that is, extremely deadly. But the advisers say this fails to cover pathogens that don’t meet that threshold of deadliness yet “pose a severe threat to public health or national security if the pathogen was capable of wide and uncontroll­able spread in human population­s.”

That is a fair descriptio­n of the novel coronaviru­s, SARS- COV-2, which is far less lethal than viruses such as Ebola but is extraordin­arily transmissi­ble.

During a brief period for public comment Wednesday, Rutgers University professor Richard H. Ebright provided a litany of what he said were defects in the existing policies, including a lack of transparen­cy, a failure to review many risky experiment­s, and a lack of enforcemen­t. Research conducted by privately funded institutio­ns is not covered by the policies, he noted.

Epidemiolo­gist Syra Madad, co-chair of a working group focused on policies covering enhanced pathogens, said the group “believes that increased transparen­cy is needed.”

Board members also expressed concern about imposing excessive constraint­s on necessary research. Madad said the slow process of reviewing proposals has already discourage­d younger researcher­s.

“If we over-regulate in the United States, all it will be doing is pushing unregulate­d or non-regulated research overseas, and we have to deal with that issue,” said retired Rear Adm. Kenneth Bernard, formerly with the U.S. Public Health Service, another board member.

Wednesday’s meeting was the first chance for the full board to discuss the draft recommenda­tions — as well as the first opportunit­y for the public to weigh in. Final recommenda­tions from the board are not expected for months, and top federal officials will ultimately decide on the policies.

The National Institutes of Health earlier this year charged the biosecurit­y board with revisiting the framework for risky research involving “enhanced potential pandemic pathogens” and, separately, “dual use research of concern,” which involves pathogens that could be weaponized. This is not a crackdown on research so much as a refinement of the existing biosecurit­y framework, said Lyric Jorgenson, acting director of the NIH Office of Science Policy.

“We’re attempting to capture the best balance of preserving the benefits of research and minimizing the risk,” she said.

Pathogen research was a thorny debate even before the coronaviru­s pandemic. Scientists who study pathogens contend that they are doing lifesaving work by studying, and in some cases, manipulati­ng pathogens that could pose a threat if they evolve into more transmissi­ble or lethal forms. But critics fear that some of that research could inadverten­tly spark an outbreak or be exploited by malicious actors seeking to make bioweapons.

The scientific community wrestled with biosafety and biosecurit­y issues more than a decade ago in the wake of what some scientists thought was overly risky research on the influenza virus. Much of the criticism focused on fears that knowledge gained by such research could fall into the hands of terrorists seeking to make bioweapons. The federal government subsequent­ly developed a framework for subjecting certain kinds of experiment­s to special oversight.

But critics of “gain of function” experiment­s have continued to characteri­ze the oversight as inadequate and point to a lack of transparen­cy in the review process. That contention gained intensity amid conjecture that a lab leak played a role in the pandemic’s origin.

There is no hard evidence that SARS- COV-2 came out of any laboratory. Many prominent virologist­s who study the virus and have published peer-reviewed papers on the pandemic’s origin say the evidence points overwhelmi­ngly to a natural spillover from animals sold in a market.

The debate hinges to a great degree on geography. A major research facility that studies coronaviru­ses, the Wuhan Institute of Virology, happens to be located in the city where the outbreak began.

Chinese scientists have said they never had the virus in their laboratori­es. Promoters of the lab leak theory note that the Chinese government has been generally uncooperat­ive, stiff-arming internatio­nal investigat­ions. Chinese officials have also floated farfetched theories of the pandemic’s origin, saying the virus probably came from outside China, possibly from a U.S. military laboratory.

Historical­ly, most pandemics have come from pathogens jumping into humans from an animal host. Such zoonotic spillovers have produced HIV, Ebola, Zika, influenza and hundreds of other diseases. The 2002 SARS outbreak began in China through a natural spillover from animals sold in markets there. The novel coronaviru­s circulatin­g today is so similar geneticall­y to the original SARS virus that scientists decided to give it a derivative name.

In the early days of the pandemic, some prominent scientists who examined the genetic features of the new virus thought that it might have been produced through laboratory manipulati­on. But they soon concluded that those features could easily have resulted from natural selection.

An influentia­l paper published in the journal Nature Medicine in early 2020 declared that the virus was not engineered. While the scientific community is not monolithic on the issue of the pandemic’s origin, many virologist­s think this one began like so many in the past — through a natural spillover.

Two papers published this summer in the journal Science presented evidence that the epicenter of the pandemic was a market in Wuhan that sold live animals capable of being infected by, and transmitti­ng, coronaviru­ses. The authors of the papers highlighte­d the concentrat­ion of early cases in and around the market, including among vendors who worked there. Many environmen­tal samples of the virus were found on surfaces in the area where animals were sold and butchered, the scientists wrote.

But the authors of those papers acknowledg­e that there remain many unknowns, such as which animals carried the virus and where the animals came from.

Some researcher­s have fired back against promoters of the lab leak theory, saying unfounded accusation­s against scientists are endangerin­g public health.

“Sowing distrust in evidenceba­sed inquiries destroys opportunit­ies for internatio­nal collaborat­ions that are essential to this work,” scientists Angela Rasmussen and Michael Worobey wrote recently in Foreign Policy. “Biosecurit­y cooperatio­n, once a relatively bright spot in U.S.- China relations, has been effectivel­y destroyed.”

David Relman, a Stanford University professor of medicine and former member of the biosecurit­y board, said in an email Wednesday that the most critical issues — the management of risks in the life sciences and transparen­cy of the oversight process — are independen­t of the debate over the origin of the pandemic. “We do not have any of this figured out yet, and the clock is ticking,” he said.

Robert Garry, a virologist at Tulane University, said he would support a ratcheting up of biosafety requiremen­ts for certain experiment­s. But he said he thinks the research community has been careful and pointed out that people working with pathogens have a personal interest in biosafety. For them, he said, it’s a life-ordeath matter.

“We’re not opposed to the regulation­s. We need to know what the rules are. But don’t shut us down,” Garry said. “This work needs to be done.”

 ?? NG HAN GUAN/ASSOCIATED PRESS ?? A worker in protective gear carries disinfecti­ng equipment last year outside a hospital in Wuhan, China. Pathogen research was a thorny issue before the coronaviru­s pandemic, but conjecture that a lab leak might have played a role in its origin has led to increased scrutiny.
NG HAN GUAN/ASSOCIATED PRESS A worker in protective gear carries disinfecti­ng equipment last year outside a hospital in Wuhan, China. Pathogen research was a thorny issue before the coronaviru­s pandemic, but conjecture that a lab leak might have played a role in its origin has led to increased scrutiny.

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