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The House Select Subcommittee on the Coronavirus Pandemic on Wednesday heard testimony from two biosafety experts on the oversight of federally funded “dual-use” and “gain-of-function” research.
While acknowledging the need for biological research advancements, the experts called for increased oversight, safer alternatives and ethical considerations instead of controversial gain-of-function experiments designed to increase the transmissibility of pathogens.
Gerald W. Parker, Jr., DVM, Ph.D., a former commander of the U.S. Army’s bioresearch facility at Fort Detrick, told committee members that while dual-use research — aimed at both constructive and potentially harmful applications — is largely beneficial, a small subset raises serious biosecurity concerns.
Jaime Yassif, Ph.D., vice president of Global Biological Policy and Programs at the Nuclear Threat Initiative, which in 2021 held a tabletop exercise simulating a monkeypox outbreak, joined Parker in recommending incentivizing “safer alternatives” to risky gain-of-function experiments.
However, neither witness disavowed gain-of-function research outright and neither was willing to state that SARS-CoV-2 leaked from the Wuhan Institute of Virology lab.
Subcommittee Chairman Brad Wenstrup (R-Ohio), stating his belief that COVID-19 “likely” leaked from the Wuhan lab, discussed the need to modernize oversight to close “gaps” in biosafety regulation.
However, he also cautioned against stifling beneficial research, stating that “scientists that are conducting their work safely and with proper precautions should not have any concerns about more oversight on bad labs.”
In a press release, Wenstrup noted that infectious diseases — such as COVID-19 and other dangerous coronaviruses — “do not recognize borders.” He highlighted “the importance of interagency coordination and cooperation among credible state actors.”
The hearing came as the federal government is proposing changes to research oversight policies, and just days after the federal government’s public comment period ended.
Proactively ensuring that oversight mechanisms for high-risk labs are improved and modernized ahead of a future health crisis is essential.
— Select Subcommittee on the Coronavirus Pandemic (@COVIDSelect) October 18, 2023
Responding to Wednesday’s proceedings, Francis Boyle, J.D., Ph.D., a bioweapons expert who drafted the Biological Weapons Anti-Terrorism Act of 1989 and is a critic of gain-of-function research, told The Defender that such calls for “safer alternatives” are not enough.
“Dual-use research of concern and gain-of-function research are both euphemisms for developing offensive biological warfare weapons prohibited by international law and U.S. domestic law and that are existentially dangerous to human life,” he said.
“We know that COVID-19 was an offensive biological warfare weapon with gain-of-function properties that leaked out of the Wuhan, China, BSL-4 [biosafety level 4] laboratory and was manufactured in cooperation with the University of North Carolina BSL-3 laboratory,” Boyle added.
Lab leaks ‘happen more often than you think’
Wenstrup said, “While there’s mounting evidence supporting the lab-leak theory, we may never know with 100% certainty the origins of COVID-19.”
He noted, though, that “we do know some things for certain,” including “serious” biosafety concerns by the U.S. Department of State regarding research at the Wuhan Institute of Virology that “the American taxpayer was likely paying for” and that Dr. Anthony Fauci “knew” was being conducted.
This view was mirrored by Rep. James Comer (R-Ky.), chairman of the House Committee on Oversight and Accountability, under which the subcommittee operates, and by subcommittee member Rep. Michael Cloud (R-Texas).
“We have U.S. taxpayer dollars funding research in other countries who are competing against us for preeminence in this, and why we would put that on the American taxpayer is kind of beyond me,” Cloud said. “It’s not a stretch to say that U.S. taxpayer dollars help fund the pandemic.”
Wenstrup added that there has been a long history of prior lab leaks, including the escape of smallpox from a U.K. laboratory in 1978, the accidental release of anthrax from a Soviet Union military research facility, two lab-related releases of SARS in China in 2004, and U.S. leaks and lab-related accidents “as recently as 2016.”
“These lab leaks can occur for a multitude of reasons,” Wenstrup said. “They can occur because of mishandled biological materials, escaped aerosols, laboratory design flaws or human error” and they can lead to “disastrous consequences.”
Highlighting this point, subcommittee member Rep. Mariannette Miller-Meeks (R-Iowa), former president of the Iowa Medical Society, said three such leaks occurred at biological research laboratories in her state between 2019 and 2020.
“None of these incidents were reported to the Iowa Department of Natural Resources, even though the incidents were considered as posing a risk to agriculture and public health,” she said.
Parker, who is now associate dean for Global One Health at the Texas A&M University College of Veterinary Medicine & Biomedical Sciences, told the committee such accidents “happen more often than you think.”
“A high-containment lab consisting of biosafety levels 3 and 4 requires the highest level of containment to protect workers and public safety,” he said. “These labs require a highly skilled workforce and detailed attention to operations and sustainment.”
Parker referred to his experience as commander of the Fort Detrick laboratory, which houses the U.S. Army Medical Research Institute of Infectious Disease.
“I’m a former commander of a high-containment lab, and I know how complex they are and the detailed attention that you have to do there,” he said. “Not all countries share our view of what that means to have strong institutional norms and ethics and the resources needed.”
“Lab accidents and misuse are more likely to occur where there’s a lack of institutional norms,” he added. “This is why it’s imperative for a modernized, harmonized, domestic and international framework to ensure a skilled workforce and institutional norms needed to operate these facilities.”
Potential of COVID ‘lab leak’ a ‘blinking red light’
Wenstrup also referred to controversies over the “The proximal origin of SARS-CoV-2” paper, published in Nature Medicine in March 2020, which was used to refute the “lab-leak” hypothesis of COVID-19’s origin.
In July, the subcommittee released a report presenting evidence of a coordinated effort by federal officials, including Fauci, to suppress the COVID-19 lab-leak hypothesis and promote the “natural origin” theory, including via the “Proximal Origin” paper.
“The authors [of Proximal Origin] were aware that the Wuhan Institute of Virology was conducting risky gain-of-function research with coronaviruses under questionable biosafety conditions, including in BSL2 laboratories,” Comer said, adding, “They were also aware that this research could be done without leaving a trace.”
“Troublingly, the U.S. government also knew about these concerns,” he added.
Wenstrup questioned the witnesses about whether it is common for scientists to rely “more on political implications than actual science” when conducting research and drafting scientific papers.
I don’t think it’s common,” Parker said. “I think virologists … scientists, everybody working in the infectious disease research community, including hazardous pathogens, they want to do this work safely and securely.”
Yassif avoided taking a position on whether a lab leak was responsible for the spread of COVID-19 but said that “hypothetically … such an action would be inappropriate.”
“The evidence as to whether it emerged naturally or resulted from an accident is still inconclusive,” she said. “But the fact that it’s even plausible that so much disruption could have been caused by a possible lab accident is a big blinking red light.”
“The fact that it is even plausible that so much disruption could have been caused by a possible lab accident is a BIG BLINKING RED LIGHT.”
— Select Subcommittee on the Coronavirus Pandemic (@COVIDSelect) October 18, 2023
The possibility that such a leak occurred “signals the urgent need to strengthen biosafety and biosecurity,” Yassif added. “It’s in our interest to take an international approach to bolstering biosafety and biosecurity. That’s because infectious diseases, no matter their origin, do not respect borders.”
“We know enough already that we must take action at the animal-human-environmental interface nexus,” Wenstrup said. “Whether that’s in nature, whether that’s in a laboratory — inaction really is not an option.”
Gain-of-function research has not ‘contributed significantly’ to pandemic studies
Noting that gain-of-function research research “can lead to a bioweapon,” Wenstrup questioned the witnesses as to the positive contributions, if any, of that or dual-use research.
Parker said that while gain-of-function research is “fairly common” and the “vast majority” of such research “can be done safely with appropriate institutional oversight,” there is an “exceedingly small area of gain-of-function research” that is “of concern.”
He described such research as “especially dangerous enhanced pathogen research” in need of “more oversight,” adding his belief that such research has not “contributed significantly to pandemic preparedness” and that such research he oversaw at Fort Detrick “did not affect any of our vaccine development decisions.”
Similarly, Parker said most dual-use research of concern is “improving our way of life, our health, our well-being, our economy, our agriculture” and that “these are important technologies that we need to continue to innovate.”
However, he noted that “there’s another side to that dual-use research” that is subject to “misuse.”
Yassif largely mirrored Parker’s views, saying that gain-of-function research is “important for advancing public health and development of medical countermeasures,” but that it needs to be considered alongside “downside risks of accidental or deliberate misuse,” adding that some such research “perhaps should not” continue.
‘We are not prepared’ for a future pandemic
Parker said the U.S. could play a leading global role in setting biosafety standards.
“Because the United States is viewed as a model for biosafety and biosecurity, it will be necessary to make reforms at home to make the biggest difference worldwide,” he said, adding that the goal is “to harmonize standards and norms.”
Yassif said current international biosafety frameworks are insufficient.
“Biosafety and biosecurity are very weak globally,” she said. “According to the Global Health Security Index, only 6% of countries have national-level oversight measures for dual-use bioscience research.”
“The International Biosafety Framework is primarily … in the form of guidelines and not regulations. And so, it is not enforceable,” she added, noting that it is also not as detailed as U.S. guidelines.
Yassif said there is more work needed to improve domestic biosafety guidelines and international guidelines, practices and regulations.
Wenstrup appeared to agree with the witnesses, stating his concern that research done outside the U.S. limits needed oversight and increases the likelihood of lab leaks and accidents, while it “significantly impairs our ability to respond to emerging threats.”
“We must be able to effectively respond to and assess risks so that we can be prepared for our future pandemic, including the potential deliberate release of a biological weapon,” he added.
Parker made five recommendations for improved biosafety and biosecurity standards, including “a top-to-bottom holistic review of the entire biorisk management framework,” funding of an independent oversight authority by the federal government and incentivizing “safer alternatives” to gain-of-function and dual-use research.
He also called for a “recommitment to international diplomacy,” spearheaded by the U.S. State Department, “to elevate international biosafety and biosecurity harmonization as a diplomatic priority,” and for a “national strategy for high-containment labs” to enable “sharing lessons learned, best practices and increased collaboration.”
Yassif admitted that modern bioscience could be “deliberately exploited by malicious actors or accidentally misused” and that such exploitation could lead to the “next global biological catastrophe.”
Yassif called for “dedicated financial investments for bolstering biosafety and biosecurity” for pandemic preparedness research and development funds, the creation of a dedicated U.S. government office, the implementation of existing guidance and “political and diplomatic support” for similar international initiatives.
“If the U.S. government can achieve the biosafety and biosecurity goals it has set for itself and work with partners in industry and civil society to further advance these goals, it will be a big win for reducing biological risks,” she said.
Parker called for “conversations” and “diplomacy” on “how to better strengthen the World Health Organization” (WHO).
Wenstrup was skeptical of the WHO’s ability to make independent decisions due to its relationship to the U.N. and “members that have a political agenda.”
Responding to these concerns, Parker said that “first and foremost [WHO] member states … have a responsibility” to ensure they have “appropriate guidelines, laws, regulations” and “the appropriate skilled workforce, funding and so forth.”
Yassif said that, even with such goals, “the enforcement part is going to be really challenging” and requires “a shared understanding globally of what the rules of the road are and what are the best practices for biosafety and biosecurity.”
“The WHO is one place that can carry out this work,” Yassif said, adding that “state and local public health capabilities are [also] critical, and we do have to resource them at the level that’s necessary so they can perform their role.”
Parker agreed, stating a “need to provide the right tools” to “local and state colleagues, whether that’s public health, emergency management, the private sector, NGOs.”
When asked by Wenstrup whether the U.S. is prepared for a future pandemic, Yassif simply said “No” while Parker said, “We are not prepared.”
“We know that the American taxpayer was likely paying for some of this dangerous research,” Wenstrup said. “We cannot afford to have another COVID-19 pandemic. We cannot allow dangerous research to continue without proper safeguards in place because the next time might be worse.”
Calls for more oversight not intended to ‘chill’ scientific research
Wenstrup said that calls for more regulation of scientific research, including gain-of-function research, are not an attack on science.
“Desiring more laboratory safety and more oversight isn’t to chill the scientific community from engaging in research,” he said, “but to ensure we’re taking every precaution necessary to protect the public from escaped pathogens — of which, we cannot control, nor fully understand the consequences until it’s too late.”
In a departure from the sometimes contentious nature of previous meetings of the Subcommittee on the Coronavirus Pandemic, ranking member Rep. Raul Ruiz (D-Calif.) largely agreed with Wenstrup’s statements.
“Bolstering international biosafety is at the heart of our efforts to prevent future pandemics,” he said. “The existing framework for ensuring that research across the globe occurs safely relies on a patchwork of non-enforceable standards and guidance.”
“Beyond these international guidance documents, it is incumbent upon each nation to enact its own policies and standards to promote biosafety,” Ruiz added.
Parker suggested that “safer alternatives” to gain-of-function and dual-use research should be “really incentivized,” and “can be used for answering the basic science questions for most of these proposed research proposals.”
Wenstrup said, “As we move forward, we must make sure that our standards and capabilities can effectively respond and assess risks related to new research and biotechnologies — including those capable of unleashing new pandemics.”
For Boyle though, “The best way to protect the American people is to shut down all BSL-3s and BSL-4s immediately.”
“They all leak offensive biological warfare weapons,” he said. “The next pandemic is definitely coming out of those BSL-3s and BSL-4s if we do not act now to shut them down immediately. There is no legitimate scientific or medical reason for these BSL-3s and BSL-4s.”
Watch the hearing: