Last month, legislation was introduced in Wisconsin (SB 401) that would ban gain-of-function research on potential pandemic pathogens.

If passed into law, Wisconsin would become the second state – Florida was the first – to ban the dangerous practice.

In response to the introduction of the legislation, Tom Still of the Wisconsin Technology Council penned an op-ed for the Wisconsin State Journal titled Wisconsin is not Wuhan, So Don’t Ban Gain of Function Research.

“No one denies there can be dangers with gain-of-function experiments, especially if toxins and transmissible pathogens break out,” Still wrote. “Wisconsin isn’t Wuhan, however, and it doesn’t make sense to adopt a ban that would halt important research or put Wisconsin scientists at a competitive disadvantage.”

In response, Justin Kinney and Richard Ebright, co-founders of a new public interest group – Biosafety Now – penned an op-ed titled Protect the Public from High Risk Pathogen Research.

“Laboratory accidents happen,” Kinney and Ebright wrote. “They happen because scientists are human, and humans make mistakes.” 

“The overwhelming majority of scientific research is safe, and only a small fraction of laboratory accidents pose risks to the public. Accidents involving potential pandemic pathogens, however, can have catastrophic consequences. Potential pandemic pathogens are viruses and bacteria that, if released, could cause a devastating pandemic.”

“A bill before the Wisconsin Legislature, SB 401, will protect the public from the hazards of research on potential pandemic pathogens. The bill will do this without having significant costs or adverse impacts. SB 401 is common sense legislation that deserves broad-based support.”

Kinney is an Associate Professor in the Simons Center for Quantitative Biology at Cold Spring Harbor Laboratory. He received a Ph.D. in Physics from Princeton University in 2008 and serves as project leader on two National Institutes of Health research grants. His lab has developed widely-used research methods, including methods that are now used to understand the effects of mutations present in variants of SARS-CoV-2.

“One major concern among many scientists regarding the potential for a lab generated pandemic is a pandemic generated by genetically engineered versions of bird flu,” Kinney told Corporate Crime Reporter in an interview last month. 

“In 2011, two separate research groups announced that they had successfully genetically engineered bird flu – avian influenza – to be transmissible by air between mammals. That was the goal of their research and they reported success in that research.”

“Researchers are concerned that those avian influenza viruses, if they escape the lab, most likely through an infected research worker, could cause an absolutely devastating global pandemic.” 

“Avian influenza kills up to two-thirds of the people it infects. Fortunately, it is not easily transmitted between humans. What these research groups did was they intentionally made avian influenza to be likely to be transmissible between humans. That was the goal of their research. And research on these viruses continues to this day.”

What does the Wisconsin legislation do?

“The first thing it does is quite novel,” Kinney said. “The bill establishes public transparency for research on potential pandemic pathogens. Currently, labs that study potential pandemic pathogens are not required to inform state or local government about where the research is performed, which pathogens they possess, or the potential public health impacts if the pathogen escapes.”

“This bill would address that lack of disclosure by requiring that these laboratories provide this information to the Wisconsin Department of Health Services. We believe that disclosure of this information is essential.” 

“First responders need this information to help them avoid accidental infection when they are responding to laboratory emergencies. Health care providers need this information to diagnose and prevent the spread of laboratory acquired infection.” 

“The need for disclosure for health care workers is particularly important. That knowledge could make the difference between the rapid recognition and containment of laboratory acquired infection and laboratory acquired infection leading to an uncontrolled disease outbreak.” 

“In order for doctors to diagnose your illness, they need important information like where you come from, what risk factors they might be subjected to. People who work in laboratories that study potential pandemic pathogens are subject to significant risk factors that the rest of the population is not subject to and that doctors will not otherwise be aware of, unless they know what research is being conducted in that area where the person was exposed.”

“Also, while researchers in such a laboratory know what pathogens they are working on, the custodial staff that clean those laboratories, they may not know what pathogens the researchers are working on. The other researchers in the building may share equipment, but they will not know what pathogens the other researchers are working on.”

“So there are many people who could be exposed to potential pandemic pathogens. And if they are not aware, that can significantly hinder and delay diagnosis. And that delay in diagnosis could easily provide the pathogen the opportunity to gain a foothold in the population and start spreading out of control.”

And then there is the provision in the legislation that would prohibit the most dangerous research.

“Yes. It prohibits gain-of-function research on potential pandemic pathogens. That is research that makes these pathogens even more dangerous to the public than they already are.”

“This is a very small fraction of biomedical research. The lack of public transparency into research on potential pandemic pathogens makes it impossible to say for certain which institutions in Wisconsin would be affected by this provision. But based on publicly available information, it appears that the bill’s second provision would apply only to the laboratory of Dr. Yoshihiro Kawaoka at the University of Wisconsin.”

“Even though this provision would affect only one laboratory in the entire state, it is an important provision, because that one laboratory performs gain-of-function research that poses extreme risks to public health. Many believe that that one laboratory performs some of the most dangerous experiments in the world.”

Wasn’t there a ban under Obama?

“Well, there was an international reaction to the gain-of-function research being done on avian influenza, both at the Wisconsin lab and by Ron Fouchier at a lab at the Erasmus Medical Center in the Netherlands.”

“Yoshihiro Kawaoka and Ron Fouchier – their labs genetically engineered the avian flu to be genetically transmissible between mammals. And that caused many scientists to become very concerned about the risks of gain-of-function research in virology in general.” 

“In response, virologists announced a self-imposed moratorium starting in 2012.”

“Then in 2014, there were a number of biosafety accidents involving, for example, smallpox at the CDC. The culmination of those events led to the Obama administration initiating a moratorium on gain-of-function research of concern. Not all of gain-of-function research, but just a very narrow swath of it.” 

“That moratorium was lifted and was replaced by what is currently known as the P3CO Framework. It’s a framework by which the National Institutes of Health is supposed to review research proposals and perform an additional risk benefit assessment on these high risk gain-of-function experiments.” 

“The problem is that the framework is not being implemented. An extremely small number of research proposals have ever been reviewed under the framework. In particular, the research that the NIH funded at the Wuhan Institute of Virology was never reviewed under this framework.”

“So there is literally no regulation with the force of law. The framework itself is still very limited. Even if it were to be working, it would apply only to research funded by the National Institutes of Health. It would not apply to research from other government funded agencies. And it would not apply to privately funded research.”

Is there any state in the United States that has laws governing this?

“The Florida legislature passed a law that bans research that creates enhanced potential pandemic pathogens. That research cannot be done in Florida now.”

“The ban provision in the Wisconsin legislation is also only limited to institutions of higher education in Wisconsin. The reporting requirements apply universally throughout the state, whether that research is done publicly or privately.

Does your lab do gain-of-function research?

“Some of the research we do could be classified as gain-of-function. We don’t work on viruses. My research studies gene regulation in harmless bacteria and in human cells. In the course of that research, we introduce genetic mutations into these cells that will enhance gene regulation. Our research is geared toward developing treatments for human disease. But the systems we are working on have no potential to cause disease. That is actually the case for most of this research throughout biomedicine.”

“If you ask researchers doing genetic research whether they are doing gain-of-function research, I think most of them would say yes.  But the technique is not dangerous unless it is applied to potential pandemic pathogens.”

The 1977 flu lab leak and the Wuhan lab leak – how many people did they kill?

“I’m not sure about the 1977 flu. But the current estimates are that Covid-19 has killed somewhere between seven million and twenty million people, maybe as many as twenty-five million.” 

And a million in the United States. Have you thought about liability for those millions of deaths?

“I am unaware of any protection scientists have from liability for the release of potential pandemic pathogens.” 

Should Congress pass a law similar to the Wisconsin legislation?

“We do believe there should be a ban on gain-of-function research on potential pandemic pathogens. There should be transparency on research on potential pandemic pathogens. And that laws regulating potential pandemic pathogens need to be overseen by a federal agency that is independent from the National Institutes of Health or any other government agency that funds research.” 

“Any federal agency that funds risky research cannot be trusted to regulate that risky research. Anthony Fauci and others at the NIH were extremely concerned that the funding from NIH might have been used to create this pandemic. They were extremely concerned about that.” 

“We have been advocating for a new federal agency to oversee and enforce regulations and research on potential pandemic pathogens. The Nuclear Regulation Commission provides a template for such an agency. It would make sense to have a separate agency named something like the Pathogen Regulatory Commission.” 

“It’s critical that the enforcement function be removed from the National Institutes of Health. The NIH has major conflicts of interest.”

[For the complete q/a format Interview with Justin Kinney, see 37 Corporate Crime Reporter 36(12), September 18, 2023, print edition only.]