Lawmakers and scientists debated the best ways to regulate high-risk government-funded virus research during a hearing of the Senate Committee on Homeland Security and Governmental Affairs on Thursday.
One prominent witness called for a moratorium on gain-of-function research, while another stressed the risks of not pursuing certain kinds of experiments. Meanwhile, some committee members leveraged their time at the dais to grill former public health leaders about the lab-leak theory of COVID-19’s origins and to accuse them of complicity in a cover-up.
“Today, thousands of skilled individuals can create infectious viruses using commercially available synthetic DNA that corresponds to publicly accessible viral genome sequences,” Kevin Esvelt, PhD, of the MIT Media Lab at the Massachusetts Institute of Technology in Boston, told the committee.
To assess the nation’s ability to control access to pandemic viruses, Esvelt said his team — with approval from the Federal Bureau of Investigation — set about gathering DNA encoding fragments from the 1918 influenza pandemic. Of 38 DNA synthesis firms, 36 shipped enough DNA to synthesize the virus three times over, even though the person who placed the order used a pseudonym without any ties to influenza research.
The companies’ actions were “entirely legal,” Esvelt said. “There are no laws regulating DNA synthesis.”
The 1918 influenza virus is a “select agent” (an agent with the potential to pose a severe threat to public health and safety) but can still be legally purchased as long as that DNA is in pieces, “even though we have gifted high school students who can stitch those pieces together,” Esvelt said.
He argued that the U.S. needs a “systemic reappraisal” to define which types of DNA, pathogens, and experiments are safe and which are dangerous. He urged Congress to establish and fund an independent board to determine which laboratories should be granted access to which agents and sequences, to determine when the benefits of “dual use research” — that is, research that can lead to either benefits or harms — exceed the risks, and to assess and determine when disclosing a genome sequence or an experimental outcome “would cause irreparable harm to national security.”
A Moratorium on Gain-of-Function Research
Former CDC Director Robert Redfield, MD, testified — not for the first time — that the most likely theory of COVID-19’s origins was biomedical research followed by an accidental lab leak.
“Unfortunately, the potential national security consequences of conducting the research did not receive full consideration prior to the funding decisions to conduct such high-risk research,” Redfield said.
He argued that while some scientists believe gain-of-function research is vital to “get ahead of viruses” and to develop vaccines and countermeasures, he believes it had the “exact opposite effect” and blames such research for unleashing a new virus in the world without any means of stopping it.
“In my opinion, we should call for a moratorium on gain-of-function research until we have a broader debate and come to consensus as a community [about] the value of such research,” Redfield said.
Ranking Member Rand Paul, MD (R-Ky.), who has publicly stated for months that he believes that the SARS-CoV-2 virus was the result of a lab leak, levied the same allegations of a “vast COVID cover-up” and of federal funding being used to support gain-of-function research at the Wuhan Institute of Virology.
“You don’t need to be convinced that COVID-19 virus originated from a lab leak to recognize the imminent need for oversight mechanisms,” he said. “The mere possibility that the virus could have emerged from such risky research should be more than enough to prompt decisive action.”
On Wednesday, Paul introduced the “Risky Research Review Act,” which calls for creating an independent oversight board to review high-risk life sciences research and issue “binding determinations” related to federal funding.
Redfield heartily supported the bill, as did Sen. Roger Marshall, MD (R-Kan.), who declared that it would “save tens of millions of lives.” And Sen. Ron Johnson (R-Wis.) said he still needed to review the document but was likely to back it.
Real-World Threats
Another witness, Carrie Wolinetz, PhD, a former senior advisor in the NIH Office of the Director who is now at D.C.-based government relations firm Lewis-Burke Associates, took a different tack than some others, highlighting the importance of some high-risk research projects.
“The riskiest experiments with dangerous pathogens are not taking place in a laboratory — they’re happening in real time, in the real world, with viral evolution serving as the lead investigator. That means that when we ask scientific questions or perform experiments, we’ll lack clarity about whether and when we will realize benefit from the research, or if it will pose risks that outweigh those benefits,” she said.
While it’s easy to imagine the risks of certain kinds of research, it’s important not to lose sight of the risk of not conducting such research, she added. Tying scientists’ hands could make the country more vulnerable to the next emerging biological threat, she said.
“Science is an inherently human endeavor, and the question of what is too risky ultimately comes down to human judgment. There is no simple answer,” she said.
The White House’s Office of Science and Technology Policy (OSTP) released a new oversight policy in May that is slated to take effect in Spring 2025.
In addition to OSTP’s policy, which she supports, Wolinetz also called on Congress to support a global approach to biosafety by encouraging the adoption of certain international standards, including ISO 35001, establishing a “non-punitive safety reporting system” similar to what is used in the aviation industry, and strengthening pathogen surveillance and early warning systems.
In addition to more policy-oriented questions, the hearing included the usual accusations against former government health officials that have been lobbed at previous hearings in the House.
Accusations Fly
Sen. Josh Hawley (R-Mo.) accused Wolinetz of being complicit in a cover-up with her former boss, NIH director Francis Collins, MD, PhD, who, according to Hawley, characterized the lab-leak theory as a “very destructive conspiracy.”
“[Y]ou have, and your office, lied to the American people for years … Why was your office so intent on shutting down any talk about this being involved with a lab … Why the hysteria?” Hawley said.
Wolinetz responded that no one in her office, including Collins and former National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, ever suggested “there wasn’t a possibility that the virus had escaped from a lab.”
“Sorry. Ehhhr,” Hawley said, making a buzzer sound. “Wrong. That’s false … You people repeatedly, repeatedly said it could not have come from a lab … Do you regret your role in any of this?” he asked.
Wolinetz said she never played the role that he ascribed to her.
“Do you regret not advising your boss to temper his comments? Do you regret not opposing the censorship? Do you regret it? You’re in a position of tremendous influence,” he said.
“I do not believe censorship took place,” Wolinetz said.