Some of the world’s most high-profile and controversial gain-of-function research on potential pandemic pathogens has taken place at the Influenza Research Institute (IRI) at UW-Madison, under the guidance of Yoshihiro Kawaoka, professor of virology in the Department of Pathobiological Sciences in the School of Veterinary Medicine. The high-security research facility was photographed during a media tour on Feb. 28, 2017, in Madison, Wis. (Jeff Miller / Courtesy of UW-Madison)
‘Gain-of-function research’ has drawn scrutiny from those who spurned pandemic precautions, but biosafety experts say more transparency and caution are warranted.
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Legislation banning a certain type of research on dangerous pathogens is bringing together an unlikely alliance of public health scientists, community activists and Republicans who spurned COVID-19 safety protocols.
For decades, the world’s leading scientists have debated the merits of experiments that make risky pathogens more dangerous — some of the most controversial are done at the University of Wisconsin-Madison.
This year, Wisconsin’s Republican lawmakers have weighed in, introducing state and federal bans on so-called “gain-of-function research on pandemic pathogens,” citing devastation from the COVID-19 virus in their press releases. Several link the COVID-19 outbreak to gain-of-function research conducted at China’s Wuhan Institute of Virology. A recently declassified report said U.S. intelligence agencies found no direct evidence the virus came from a lab, but could not rule out either laboratory or wild origins.
What exactly falls under this category is contested, but in general, the concern lies with experiments that make dangerous pathogens even more virulent or transmissible. It is an extremely small subset of the field — with extraordinarily large consequences.
The research has long raised debates involving philosophy, ethics and the acceptable limits of scientific inquiry. If an accident at a Wisconsin lab could decimate animal and human populations globally, what benefit should the public demand before accepting that risk?
“It’s not that we’re anti-science. It’s not that we’re anti-research,” said Nina Goodale, an environmental activist with Biosafety Now, a nonprofit seeking to regulate dangerous pathogen research and increase the public’s role in oversight. “We’re about pro-transparency and pro-information and pro-public safety.”
The group’s co-founders, professors in genetics, chemistry and quantitative biology, have shared their support for Wisconsin’s bill with legislative staff. Their endorsement was circulated with the co-sponsorship memo, which said it “would establish a role for the public in regulating risky research, would provide critical protections for the citizens of Wisconsin, and would advance environmental justice both in the state of Wisconsin and worldwide.”
Some of the lawmakers sponsoring the state legislation have opposed mask and vaccine mandates, called concern over the deadly delta variant “hysteria,” fought to keep churches open during health emergencies and sought to prohibit health care providers from withholding unproven COVID treatments.
Yet several of the nation’s leading scientists say the bill should not be dismissed as anti-science misinformation. It taps into reasonable debates that precede the coronavirus pandemic, transcend partisan politics and deserve public consideration.
“Biosafety and biosecurity, safety of the workforce, safety of the public, is nothing but bipartisan,” said Dr. Gerald Parker, director of the Pandemic and Biosecurity Policy Program at Texas A&M University. Parker, who also chairs an expert panel convened by the federal government that has proposed stronger oversight, doesn’t support research bans included in the bill, but emphasized this is a moment for the public to engage on the issue.
“I think local and state communities should take an interest, as you’re doing in Wisconsin, and it just needs to have a rational discussion,” Parker said.
In a statement, Interim Vice Chancellor for Research and Graduate Education Cynthia Czajkowski said UW-Madison opposes the bill, but “strongly supports transparent and rigorous oversight of research on pathogens, including those with pandemic potential” and supports “efforts to make sure safeguards in place for this type of research are adequate and effective.”
“At the very least, the Wisconsin legislative proposal is premature, given the ongoing federal review,” she said.
So far Democrats, including Gov. Tony Evers, have not shown any interest in turning the bills into law.
What is gain-of-function research?
Inadequate definitions and slippery terminology have hindered the debate around this type of research. Expert panels convened by the federal government and the American Society of Microbiology have proposed or called for clarifications on two elements: “gain-of-function research” and “potential pandemic pathogens.”
“In the broad category of gain of function, meaning adding functions to organisms, almost all of it is safe and we don’t need to be talking about it,” said Marc Lipsitch, a Harvard epidemiology professor who directs the Center for Communicable Disease Dynamics, in a closing talk at an international pathogen conference earlier this year.
What concerns Lipsitch and others is a small fraction of all gain-of-function experiments, better described as “gain-of-function research of concern,” which the American Society of Microbiology recently defined as the “generation of pathogens with properties that do not exist in nature that may be more pathogenic and/or transmissible.”
Lipsitch is a longtime critic of this type of research. In 2014, he organized the Cambridge Working Group, a panel of international experts in science, law and ethics, which called for strengthened biosafety measures, saying: “Whenever possible, safer approaches should be pursued in preference to any approach that risks an accidental pandemic.”
Just months after the statement, the federal government announced a funding pause on such research until the risks could be assessed. It lasted just over three years. U.S. Rep. Mike Gallagher, R-Green Bay, recently introduced legislation for yet another funding freeze, this time for five years, to allow renewed consideration of the risks and proper regulations.
Although Wisconsin’s bill does not use the more specific term “gain-of-function research of concern,” its definition — research that “may reasonably be anticipated to enhance the transmissibility or virulence of a potentially pandemic pathogen” — suggests the much more specific, dangerous subset.
Yet in its objection, UW-Madison relied on the broader category, claiming the proposal seeks to ban gain-of-function research in general. It failed to mention the bill takes aim specifically at experiments that may enhance the transmissibility or virulence of potential pandemic pathogens.
In a statement to Wisconsin Watch, Czajkowski said: “While the bill appears focused on limiting research on potential pandemic pathogens, it would have more expansive implications due to the broad array of research that would be covered under the definitions in the bill.”
The bill’s lead authors are Sen. André Jacque, R-De Pere, and Rep. Elijah Behnke, R-Oconto. One senator and four representatives have signed on as co-sponsors.
Sen. Andre Jacque, R-De Pere, has proposed legislation in Wisconsin that would ban gain-of-function research on potential pandemic pathogens at institutions of higher education and would require disclosure to the Department of Health Services prior to beginning research of any kind on potential pandemic pathogens. He is seen during Gov. Tony Evers’ State of the State address at the Wisconsin State Capitol in Madison, Wis., on Feb. 15, 2022. (Coburn Dukehart / Wisconsin Watch)
In an email, Jacque denied he is opposed to pandemic precautions, saying the suggestion “could easily be taken as an inflammatory and biased interpretation,” as he authored 10 bills in the 2019-20 session “directly related to mitigating the multi-faceted impacts of the pandemic.”
Those related to video proceedings for health care and courts and unemployment benefits, among other things, but Jacque, who contracted a severe case of COVID-19 in 2021, was a “vocal opponent of mask and vaccine mandates,” according to the Associated Press.
The bill specifically bans gain-of-function research on “potentially pandemic pathogens” — yet another term with varying definitions.
Gain-of-function research of concern on potential pandemic pathogens is a tiny subset of experimentation, estimated at less than 1% of all gain-of-function research.
Under the federal government’s current definition, potential pandemic pathogens are “bacteria, viruses and other microorganisms” that are both “likely highly transmissible and capable of wide, uncontrollable spread in human populations” and “highly virulent, making them likely to cause significant morbidity and/or mortality in humans.” Prime examples include bird flu and the coronavirus that caused COVID-19.
But Wisconsin’s bill defines potential pandemic pathogens much more broadly, far greater than an expanded definition proposed by an expert panel earlier this year.
Wisconsin’s bill considers microorganisms to be potential pandemic pathogens if they are “likely, moderately, or highly” transmissible or virulent, or if it is “likely to pose a severe threat to public health and safety, the capacity of public health systems, or the security of this state if allowed to spread within the general population.”
UW’s Czajkowski noted the definition includes an array of far less risky pathogens that are “merely likely transmissible and capable of wide spread in human populations.”
“There are many diseases, like the common cold, that are transmissible from person to person, and yet don’t pose significant risk to the vast majority of people,” she said. Yet under the bill’s definition, gain-of-function research on common cold viruses would be banned.
Lipsitch said that while he favors increased regulation, Wisconsin’s proposed definition is confusing. He echoed that it could unnecessarily sweep in non-dangerous experiments, adding: “I think it is also a sign that the drafters were kind of loosely adopting language they have seen somewhere else without knowing all the ins and outs.”
Jacque said by email the definition came from a bill introduced in Texas earlier this year.
Biosafety Now has recommended lawmakers amend the definition to match the expert panel’s proposed federal definition.
“I will certainly remain open to potential amendments, including possible avenues to provide additional clarification,” Jacque said.
Wisconsin’s bill specifics: a ban on some research
The Wisconsin bill has two primary provisions. The first is a wholesale ban on gain-of-function research on potential pandemic pathogens at institutions of higher education, which include the University of Wisconsin System, the Wisconsin Technical College System, a tribal college, or a private, nonprofit institution.
In a letter to lawmakers, UW-Madison said the bill would “hamstring the growth of the biotech and biomedical sectors of Wisconsin’s economy,” though the bill does not regulate research at private laboratories.
The penalty for violations would be the institution losing all state funds for the next fiscal year.
UW-Madison claimed the bill would cost the state “millions of dollars of federal grant funding.” According to Biosafety Now co-founders in a recent editorial, there is only one known laboratory in Wisconsin that pursues research that clearly falls under the ban.
Yoshihiro Kawaoka, professor of virology in the Department of Pathobiological Sciences in the School of Veterinary Medicine, has studied avian flu. His controversial 2011 research resulted in the pathogen being transmissible in mammals, sparking an international debate, a self-imposed 60-day moratorium on similar research and, ultimately, a three-year federal funding pause. The research resumed in 2019, but Kawaoka has not resumed similar studies. He was photographed on March 2, 2023, at the Influenza Research Institute in Madison, Wis. (Althea Dotzour / Courtesy of UW-Madison)
It belongs to Yoshihiro Kawaoka, a virology professor at UW-Madison whose controversial research on avian flu sparked an international debate, a self-imposed 60-day moratorium on similar research and, ultimately, a three-year federal funding pause. The research was allowed to resume in 2019, though UW said he has not done similar studies.
Even before that, in 2007, a watchdog group claimed the university’s institutional biosafety committee wrongly allowed Kawaoka to work on genetic material for ebola, even though the pathogen requires a higher-security lab.
Two other incidents at his lab, one recently revealed in reporting, responded to earlier this year by Wisconsin’s congressional delegation and challenged by UW-Madison, featured in the bill’s co-sponsorship memo. Last month, the Republican chair of the House’s select subcommittee on the coronavirus pandemic wrote to UW-Madison’s chancellor requesting a trove of documents pertaining to the university’s gain-of-function research to investigate “federal funding” and “assist in evaluating the need for legislation.”
The university said Kawaoka wasn’t available for an interview. But he has previously said that his studies into avian flu transmission — which resulted in making it more readily transmissible in mammals — were “important to pandemic preparedness.”
UW-Madison spokesperson Kelly Tyrrell said there are “currently no studies on potential pandemic pathogens as defined by federal regulations occurring at UW-Madison. However, should the proposed legislation become law, the university would need to evaluate existing pathogen research to determine what studies would need to be halted to ensure compliance with the more expansive state definition.”
Proponents of gain-of-function research of concern on potential pandemic pathogens say it could lead to more effective treatment, prevention and disease detection.
But critics point out that to date, this tiny subset of research has not produced vaccines or countermeasures. Any advances in scientific understanding must be weighed against the extraordinary public health risks in the unlikely event of an accident or attack.
“Just because we can do an experiment doesn’t mean we should do the experiment,” Parker said. “But if we believe that experiment is really, truly worthwhile, and it will advance our understanding of how a virus could evolve, in a laboratory setting, to become a human transmissible pathogen, even though it’s in mammals, well, that may be worthwhile. But scientists and institutions and funding agencies need to justify it better, and then justify how they mitigated the risk.”
Wisconsin bill seeks to enhance transparency
The bill would require researchers to inform the Department of Health Services of their intent to study any potential pandemic pathogens 90 days before experimentation.
That would be regardless of whether the experiments use state funds or make the pathogen more transmissible or virulent.
The bill would empower DHS to request additional information and, if it determined the research “poses a substantial and unjustifiable risk to public health and safety,” to ask the governor or attorney general to halt the research.
It doesn’t, however, provide DHS additional staff or funding, which Tyrrell said would “unnecessarily delay vital research and create a chilling effect for research in our state,” as researchers would be “unable to quickly assist in developing solutions to emergencies that threaten public safety in the state, and Wisconsin residents would need to rely on science conducted in states not subject to the same restrictions.”
DHS declined comment, saying it does not comment on pending legislation.
Biosafety Now considers reporting an essential component, as it would provide first responders and health providers with knowledge that could inform their emergency response or diagnoses during an outbreak.
Klare Allen, a longtime community activist and member of Biosafety Now, has fought for transparency and against labs of the highest biosafety level in Boston for decades. The founder of two environmental and racial justice organizations, Allen resisted Boston University opening labs doing dangerous pathogen research in her community, known as the “heart of Black culture in Boston,” which has since implemented strict local biosafety regulations.
She supports Wisconsin’s bill because, she said, “what happens in Wisconsin is going to come here, too.”
“No more separation. We have to be together,” Allen added. “We need transparency. We need oversight. We need enforcement.”
In general, leading scientists have recommended “increased engagement and transparency with the public” on this type of research.
In a statement, Czajkowski said the bill would create delays and “make it difficult for UW-Madison researchers to” pursue a number of experiments, including developing vaccines and antivirals, study the cause of respiratory illnesses, explore links between viruses like HPV and cancer, prevent foodborne illness, and track and mitigate hospital-acquired infections such as staph.
With the exception of Biosafety Now, the researchers consulted by Wisconsin Watch did not support the bill’s ban or definitions — but they endorsed its broader goals.
“I think it’s very healthy that state and local communities and legislators and public health are taking a look at what they may need to do in addition to what the federal government does,” Parker said.
“How this bill evolves and whatever happens to the bill, whether it’s rejected or passed, I would just urge the citizens of Wisconsin at the state and local level, and their elected officials, to stay engaged on the subject and be part of the objective conversation on this topic.”
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