US Panel Approves Plans to Safeguard Lab-Done Virus Research

A The federal advisory panel voted unanimously Friday to advance a set of proposals to strengthen government oversight of pathogen research that could make viruses more transmissible.

The Assessors, a group of experts in biosafety, ethics and infectious diseases, united to vote the set of proposals through minor changes. But some of the scientists attending the public meeting objected to language that they said could inadvertently hamper relatively low-risk gain-of-function research, which manipulates pathogens to study the origins of a virus with the goal of developing treatments. rapid.

the panel draft reportrecommending safeguards including a “federal department-level review” of gain-of-function studies and implementation of a broader definition of pathogens that could cause pandemics, will be finalized and then sent to top officials at the National Institutes of Health, which currently do not. include a permanent director of the NIH or a replacement for the director of the National Institutes of Allergy and Infectious Diseases, Anthony Fauci.


Acting NIH Director Lawrence Tabak, a longtime deputy to former NIH Director Francis Collins, spoke at the beginning of the meeting and stayed for the entire meeting, but did not intervene when questioned by public commentators and the panelists themselves. how the policies would be implemented and how some virus-related research could be unintentionally hampered.

The proposals, if implemented, would only apply to US-funded research. But as the attendees spoke, they noted that the policies would likely ripple across academic arenas and global research efforts.


For some, the prospect of expanding the definition of a virus with pandemic potential was problematic, especially if it meant obstacles to research into its possible spread.

“Experimental transmission studies do not always mimic human conditions and do not always predict transmissibility in humans,” said Seema Lakdawala, an epidemiologist at Emory University. “They are the best we have at the moment,” but estimating the risk to humans from studies in laboratory animals remains “very imprecise,” she added.

Lakdawala pushed for federal regulators to partner with researchers who “understand the nuances behind the systems we use to study things like transmission.”

Some board members also raised concerns, especially about how the new measures could affect researchers’ ability to quickly develop vaccines and treatments based on the evolution of a virus.

Vanderbilt University professor and NIH advisor Mark Denison noted that Therapies with monoclonal antibodies against covid-19 they require almost constant pivots as treatments become useless against evolving strains.

“Would we say that we are going to make these companies do [therapies]people are going to work on them, they’re going to save human lives, but we can’t allow any prospective studies to try to understand how the virus might escape from them because we could create the risk of that virus later being released into the community?” he said Denison.

Other experts heralded the proposal as an important step to strengthen biosecurity and calm public concerns about research into infectious diseases fueled by frustration around the coronavirus pandemic and political rhetoric.

The NIH panel met nearly two weeks after a separate government watchdog group made similar recommendations to strengthen oversight and transparency around studies of infectious diseases.

NIH advisers largely defended the recommendations, arguing that they merely enshrine what have long been best practices in study design, especially when it comes to safety measures aimed at preventing viruses from spilling outside of the laboratory. .

“The idea was not to prohibit any type of research, but if concerns are identified, to find ways to mitigate them,” said Dennis Metzger, professor emeritus of immunology and microbial diseases at Albany Medical College.

Still, almost everyone recognized the charged atmosphere around viruses with pandemic potential.

Rachel Levinson, executive director of research initiatives at Arizona State University, said that while the panel is not involved in implementing the potential policies, regulators will need to follow through on concerns that the policy changes could delay implementation. research.

“This is going to represent a pretty big change and one that is getting a lot of public attention,” he said. “Maybe it’s institution by institution, but we need to make sure you’re not inadvertently inhibiting important research.”

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